US 12,220,541 B2
Sensing and mapping catheter for guiding and supporting balloon catheter
Debby Esther Highsmith, Laguna Niguel, CA (US); Erica Evelyenne Lovejoy, La Puente, CA (US); Ariel Garcia, Glendora, CA (US); and Hamid Massoud, Los Angeles, CA (US)
Assigned to Biosense Webster (Israel) Ltd., Yokneam (IL)
Filed by BIOSENSE WEBSTER (ISRAEL) LTD., Yokneam (IL)
Filed on Jul. 3, 2019, as Appl. No. 16/503,338.
Prior Publication US 2021/0001083 A1, Jan. 7, 2021
Int. Cl. A61M 25/00 (2006.01); A61B 5/00 (2006.01); A61B 5/287 (2021.01); A61B 18/14 (2006.01); A61M 25/01 (2006.01); A61B 18/00 (2006.01)
CPC A61M 25/0105 (2013.01) [A61B 5/287 (2021.01); A61B 5/6853 (2013.01); A61B 5/6857 (2013.01); A61B 18/1492 (2013.01); A61M 25/0041 (2013.01); A61B 2018/00285 (2013.01); A61B 2018/00375 (2013.01); A61B 2018/00577 (2013.01); A61B 2018/00839 (2013.01); A61B 2018/1437 (2013.01); A61B 2562/0209 (2013.01); A61M 2025/0042 (2013.01); A61M 2025/0166 (2013.01); A61M 2205/0266 (2013.01)] 19 Claims
OG exemplary drawing
 
4. An electrophysiology (EP) system, comprising:
a balloon catheter configured with a balloon with a longitudinal length and a lumen extending longitudinally through the balloon, the balloon configured to sit in an ostium of a pulmonary vein when used inside a patient's heart; and
a second catheter comprising:
an elongated shaft defining a longitudinal axis of the second catheter, the shaft including a proximal portion with a first flexibility for axial pushability and a distal portion including a second flexibility for an indirect approach angle to the ostium through the lumen of the balloon catheter, the second flexibility being greater than the first flexibility, the elongated shaft with a configuration for insertion through the lumen of the balloon;
a distal assembly including an elbow portion and a generally circular portion generally transverse to the longitudinal axis, the generally circular portion including a third flexibility greater than the second flexibility for insertion through the lumen of the balloon;
a single axis sensor situated in the generally circular portion, and a cable for the single axis sensor that extends proximally toward the elongated shaft, the cable including a sheath and a pair of wires with distal ends connected to the single axis sensor and extending through the sheath, a portion of the pair of wires at the elbow portion lies on an inside surface of the elbow portion, the sheath having a distal end proximal of the elbow portion;
a plurality of ring electrodes situated on the generally circular portion; and
a preformed elongated support member comprising a shape memory material extending through the distal assembly, the preformed elongated support member being longitudinally coextensive with the distal portion of the elongated shaft and with the distal assembly, the preformed elongated support member includes a linear support member portion, a proximal support member portion proximal of the linear support member portion, and a generally circular support member portion distal of the linear support member portion, the linear support member portion configured with a length equal to or greater than the longitudinal length of the balloon so as to support the balloon when the second catheter is inserted through the lumen of the balloon catheter, the proximal support member portion of the preformed elongated support member having a first cross-sectional diameter D1, the linear support member portion having a second cross-sectional diameter D2, the distal support member portion having a third diameter D3, and D1>D2>D3.
 
1. An electrophysiology (EP) catheter configured for use with a balloon catheter, the balloon catheter configured with a balloon with a longitudinal length and a lumen extending longitudinally through the balloon, the balloon configured to sit in an ostium of a pulmonary vein when used inside a patient's heart, the EP catheter comprising:
an elongated shaft defining a longitudinal axis of the EP catheter, the shaft including a proximal portion with a first flexibility for axial pushability and a distal portion including a second flexibility for an indirect approach angle to the ostium, the second flexibility being greater than the first flexibility, the elongated shaft with a configuration for insertion through the lumen of the balloon;
a distal assembly including an elbow portion and a generally circular portion generally transverse to the longitudinal axis, the generally circular portion including a third flexibility greater than the second flexibility for insertion through the lumen of the balloon;
a first single axis sensor situated in the generally circular portion, and a cable for the single axis sensor that extends proximally toward the elongated shaft, the cable including a sheath and a pair of wires with distal ends connected to the single axis sensor and extending through the sheath, a portion of the pair of wires at the elbow portion lies on an inside surface of the elbow portion, the sheath having a distal end proximal of the elbow portion;
a plurality of ring electrodes situated on the generally circular portion;
a preformed elongated support member comprising a shape memory material extending through the distal assembly, the preformed elongated support member being coextensive with the distal portion of the elongated shaft and with the distal assembly, the preformed elongated support member includes a linear support member portion and a generally circular support member portion, and an elbow support member portion therebetween, the linear support member portion configured with a diameter D1 that ranges between about 0.014″-0.018″ and a length equal to or greater than the longitudinal length of the balloon so as to support the balloon when the EP catheter is inserted through the lumen of the balloon catheter, the generally circular support member portion configured with a diameter D3 that is about 0.011″, and the elbow support member portion configured with a gradually transitioning diameter D2 that transitions from D1 to D3 such that D1>D2>D3; and
a plurality of shielding fibers extending through a lumen of the sheath of the cable of the single axis sensor, distal ends of the shielding fibers terminate distal of the distal end of the sheath of the cable and proximal of the elbow portion of the distal assembly.