Tubular large bore transseptal crossing sheath
Disclosed is an electrically enabled introducer sheath, such as for crossing a septum into a left atrium and guiding a large bore catheter across the septum and into the left atrium. The sheath includes an elongate, flexible tubular body, having a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. A tubular insulation layer surrounds the sidewall and leaves exposed an annular conductive surface at the distal end. The tubular body has a proximal hub, having at least one access port in communication with the central lumen and a connector in electrical communication with the conductive sidewall. The central lumen is configured to receive a radio frequency conducting wire, to facilitate crossing the septum.
1 . A transseptal crossing catheter system, the system comprising:
an electrically enabled introducer sheath comprising:
an elongate, flexible tubular body comprising an electrically conductive sidewall defining a central lumen, the electrically conductive sidewall comprising:
a proximal end, and
a distal end comprising an annular surface disposed on a distal-most face of the elongate, flexible tubular body, the annular surface being integral with the proximal end of the electrically conductive sidewall and being electrically conductive;
at least four distal extensions disposed on the distal end, wherein the at least four distal extensions are configured to enhance delivered radiofrequency energy density to organic tissue, and wherein each of the at least four distal extensions comprise a leading charge transfer surface forming a scalloped surface;
a wire being movable relative to the elongate, flexible tubular body to extend at least partially through the electrically enabled introducer sheath and to extend distally through and beyond the annular surface of the elongate, flexible tubular body;
a first tubular insulation layer surrounding the electrically conductive sidewall and leaving the annular conductive surface exposed at the distal end;
a second insulation layer disposed on an outer surface of the wire, wherein the second insulation layer is separate from the first tubular insulation layer, and wherein the second insulation layer is in between the wire and the electrically conductive sidewall; and
a proximal hub on the elongate, flexible tubular body comprising:
at least one access port in communication with the proximal end and the central lumen, and
a connector in electrical communication with the electrically conductive sidewall.
2 . The system as in claim 1 , wherein the electrically conductive sidewall comprises a stainless steel tube.
3 . The system as in claim 1 , wherein the electrically enabled introducer sheath has an outside diameter of about 0.050 inches.
4 . The system as in claim 3 , wherein the electrically enabled introducer sheath has an inside diameter sufficient to receive a 0.035 inch guidewire.
5 . The system as in claim 4 , wherein the wire comprises a 0.035 inch guidewire having sufficient structural integrity to guide a large bore catheter transvascularly through a septal wall and into a left atrium of a heart without breaking.
6 . The system as in claim 5 , wherein the large bore catheter has an inside diameter sufficient to receive the electrically enabled introducer sheath therethrough.
7 . The system as in claim 1 , wherein the electrically enabled introducer sheath has an outside diameter of at least about 0.040 inches.
8 . The system as in claim 1 , wherein the electrically enabled introducer sheath has an outside diameter of at least about 0.045 inches.
9 . The system as in claim 1 , wherein the electrically enabled introducer sheath exhibits sufficient structural integrity to guide a large bore catheter transvascularly through a septal wall and into a left atrium of a heart without breaking.
10 . The system as in claim 9 , in which no part of the electrically conductive sidewall is a braided or woven wire.
11 . The system as in claim 1 , wherein an outer diameter of the elongate, flexible tubular body remains substantially constant from the distal end towards the proximal end.
12 . The system as in claim 1 , wherein an outer diameter of the proximal end of the elongate, flexible tubular body tapers towards an outer diameter of the distal end of the elongate, flexible tubular body, and wherein the outer diameter of the proximal end is greater than the outer diameter of the distal end.
13 . A transseptal crossing catheter system, the system comprising:
an electrically enabled introducer sheath comprising:
an elongate, flexible tubular body comprising an electrically conductive sidewall defining a central lumen, the electrically conductive sidewall comprising:
a proximal end,
a distal end comprising an annular surface disposed on a distal-most face of the elongate, flexible tubular body, the annular surface being integral with the proximal end of the electrically conductive sidewall and being electrically conductive, and
at least four distal extensions disposed on the distal end, wherein the at least four distal extensions are configured to enhance delivered radiofrequency energy density to organic tissue, and wherein each of the at least four distal extensions comprise a leading charge transfer surface forming a scalloped surface;
a first tubular insulation layer surrounding the electrically conductive sidewall and leaving the annular conductive surface exposed at the distal end;
a second tubular insulation layer disposed on an inner surface of the electrically conductive sidewall; and
a proximal hub on the elongate, flexible tubular body comprising:
at least one access port in communication with the proximal end and the central lumen, and
a connector in electrical communication with the electrically conductive sidewall; and
a wire being movable relative to the elongate, flexible tubular body to extend at least partially through the electrically enabled introducer sheath and to extend distally through and beyond the annular surface of the elongate, flexible tubular body.
14 . The system of claim 13 , wherein the leading charge transfer surface comprises a substantially flat surface.
15 . The system of claim 13 , wherein the leading charge transfer surface is configured to enhance delivered energy density.