Introducer for uterine tamponade assembly with echogenic element and methods of using the same

Abstract

A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end and an atraumatic tip at its distal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. The tamponade balloon catheter includes an echogenic element to aid in visualization by ultrasound during insertion and use. Methods of use of the device are also disclosed.

1 - 22 . (canceled) 
     
     
         23 . A positioning device comprising:
 a stylet configured to be disposed within a catheter lumen and comprising a longitudinal body having a proximal end and a distal end;   a hub at the proximal end of the stylet, the hub comprising an open proximal end, an open distal end and a sidewall extending therebetween defining a drainage hub lumen extending between the open proximal end and the open distal end;   wherein the open proximal end is configured to receive liquid flow from the hub lumen, through the open proximal end, and out of the open proximal end;   wherein the stylet extends from the sidewall of the hub at the distal end of the hub and is radially offset from the longitudinal axis of the hub.   
     
     
         24 . The positioning device of  claim 23 , wherein the drainage hub lumen is unobstructed by the stylet. 
     
     
         25 . The positioning device of  claim 23 , wherein the sidewall of the hub is of a generally uniform thickness. 
     
     
         26 . The positioning device of  claim 23 , wherein a portion of the sidewall of the hub is thicker than another portion of the sidewall of the hub at the distal end of the hub. 
     
     
         27 . The positioning device of  claim 26 , wherein the stylet extends from the thicker portion of the sidewall of the hub at the distal end of the hub. 
     
     
         28 . The positioning device of  claim 26 , wherein the lumen of the hub at the distal end of the hub has a generally D-shape. 
     
     
         29 . The positioning device of  claim 25 , wherein the stylet extends from the sidewall at the distal end of the hub. 
     
     
         30 . The positioning device of  claim 29 , wherein the proximal end of the stylet is embedded within the wall of the hub. 
     
     
         31 . The positioning device of  claim 23 , wherein, when the stylet is disposed within at least a portion of the catheter lumen, the open proximal end remains open. 
     
     
         32 . A positioning device configured for use with a uterine tamponade catheter, the positioning device comprising:
 a stylet having a longitudinal body having a proximal end and a distal end;   a hub at the proximal end of the stylet, the hub comprising an open proximal end, an open distal end and a sidewall extending therebetween defining a drainage hub lumen extending between the open proximal end and the open distal end;   wherein the open proximal end is configured to receive liquid flow from the hub lumen, through the open proximal end, and out of the open proximal end;   wherein the sidewall has a first thickness and a second thickness;   wherein the stylet extends from the sidewall of the hub at the distal end of the hub and is radially offset from the longitudinal axis of the hub such that the drainage hub lumen is unobstructed by the stylet.   
     
     
         33 . The positioning device of  claim 32 , wherein, when the stylet is disposed within at least a portion of a lumen of the uterine tamponade catheter lumen, the open proximal end remains open to provide unobstructed fluid flow from the uterine tamponade catheter lumen, through the drainage hub lumen and out of the open proximal end. 
     
     
         34 . The positioning device of  claim 32 , wherein the first thickness is greater than the second thickness and extends partially circumferentially about the distal end of the hub and the stylet extends from the distal end of the hub at the first thickness. 
     
     
         35 . The positioning device of  claim 32 , wherein the first thickness and the second thickness are substantially the same. 
     
     
         36 . The positioning device of  claim 34 , wherein the first thickness extends only partially between the proximal and distal ends of the hub. 
     
     
         37 . The positioning device of  claim 33 , wherein the first thickness is greater than the second thickness and extends around the entire circumference of at least a portion of the hub. 
     
     
         38 . The positioning device of  claim 32 , wherein the stylet is configured to be disposed within a portion of a lumen of the tamponade catheter, and when the stylet is disposed within the portion of the lumen of the tamponade catheter, the open proximal end remains open. 
     
     
         39 . A system for treating post-partum hemorrhaging comprising:
 a positioning device comprising:   a stylet having a longitudinal body having a proximal end and a distal end, the stylet configured to be disposed within a catheter lumen;   a hub at the proximal end of the stylet, the hub comprising and open proximal end, an open distal end, and a sidewall extending therebetween to define a drainage hub lumen extending between the open proximal end and the open distal end;   wherein the drainage hub lumen is configured to receive liquid flow from the catheter lumen through the open distal end, through the drainage hub lumen and out of the open proximal end;   wherein, the stylet extends from the distal end of the hub and is radially offset from the longitudinal axis of the hub such that the drainage hub lumen is unobstructed by the stylet; and   wherein, when the stylet is disposed within at least a portion of the catheter lumen, the open proximal end remains open.   
     
     
         40 . The system of  claim 39 , wherein the stylet extends from the distal end of the hub at the sidewall. 
     
     
         41 . The system of  claim 39 , the stylet extends from a thickened portion of the sidewall. 
     
     
         42 . The system of  claim 41 , wherein the thickened portion of the sidewall extends only partially circumferentially about the circumference of the distal end of the hub.