Introducer for uterine tamponade assembly and methods of using the same
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. 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. Methods of use of the device are also disclosed.
1. A positioning device comprising:
a stylet comprising a longitudinal body having a proximal end and a distal end;
a hub at the proximal end of the stylet, the hub comprising a proximal end, a distal end and a sidewall extending there between, the sidewall comprising an uninterrupted curvilinear configuration defining an outer surface of the hub, a hub lumen extending between the proximal and distal ends, wherein the curvilinear sidewall of the hub comprises at least one opening formed therein, an inflation port extending from a proximal end of a catheter and wherein a proximal end of the inflation port is removably received within the at least one hub opening when the distal end of the hub is coupled to the proximal end of the catheter.
2. The device of claim 1 wherein the stylet comprises a lumen extending at least partially between the proximal and distal ends and wherein the hub lumen is in communication with the lumen of the stylet.
3. The device of claim 1 wherein the stylet comprises a tubular cannula and wherein at least a portion of the longitudinal body comprises at least one of a cut, a slit, an opening, a ground surface and an etched surface formed therein.
4. The device of claim 3 wherein the stylet comprises a helical shaped cut in the longitudinal body extending at least partially between the proximal and distal ends of the stylet.
5. The device of claim 1 wherein the stylet is a stainless steel coil.
6. The device of claim 1 wherein the stylet is comprised of at least one of a metal, a metal alloy, a polymer and a co-polymer.
7. The device of claim 1 wherein the stylet comprises a cruciform cross-sectional shape.
8. The device of claim 1 wherein the distal end of the hub comprises a tapered outer surface.
9. The device of claim 8 wherein the tapered outer surface of the hub comprises at least one of threads, ribs, coupling mechanisms, barbs, flanges, channels and projections.
10. The device of claim 1 wherein the proximal end of the hub comprises an atraumatic tip.
11. The device of claim 1 wherein the hub comprises a biocompatible polymeric material.
12. The device of claim 1 wherein the stylet is configured to extend longitudinally within a lumen of a catheter tube.
13. The device of claim 1 wherein the hub opening is configured to removably receive at least one of a valve, adapter, fitting and tubing segment.
14. A catheter assembly comprising:
a positioning device comprising:
a stylet having a proximal end and a distal end; and
a hub at the proximal end of the stylet, the hub comprising a proximal end, a distal end and a sidewall extending there between, the sidewall comprising an uninterrupted curvilinear configuration defining an outer surface of the hub, a hub lumen extending between the proximal and distal ends, and wherein the curvilinear sidewall of the hub comprises at least one opening formed therein,
a tamponade balloon catheter comprising:
a catheter comprising a proximal end and a distal end and at least one lumen extending there between;
an expandable tamponade device at the distal end of the catheter;
an inflation port extending from the proximal end of the catheter;
wherein the stylet is configured to extend longitudinally within at least a portion of the at least one catheter lumen; and
wherein a proximal end of the inflation port is removably received within the at least one hub opening when the distal end of the hub is coupled to the proximal end of the tamponade balloon catheter.
15. The assembly of claim 14 wherein the at least one lumen comprises a drainage lumen and wherein the catheter further comprises an inflation lumen.
16. The assembly of claim 15 wherein the drainage lumen and inflation lumen run parallel to each other and are separated by a septum.
17. The assembly of claim 14 wherein the distal end of the hub comprises a tapered outer surface that is configured to be coupled to the proximal end of the catheter.
18. The assembly of claim 14 wherein the hub lumen is in fluid communication with the at least one catheter lumen.