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

Patent metadata

Field	Value
Publication number	US-2020093498-A1
Application number	US-201916570034-A
Country	US
Kind code	A1
Filing date	Sep 13, 2019
Priority date	Sep 21, 2018
Publication date	Mar 26, 2020
Grant date	—

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.

First claim

We claim:

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 defining a hub lumen, wherein the sidewall comprises a first portion having a first thickness and a second portion comprising a second thickness, wherein the second thickness is greater than the first thickness, and wherein the stylet is coupled to the second portion.

2 . The device of claim 1 wherein the distal end of the stylet comprises an atraumatic tip, the atraumatic tip comprising at least one of a ball, sphere, dome, hook, eyelet, ring and loop.

3 . The device of claim 1 wherein the atraumatic tip of the stylet is formed from the same material as the stylet.

4 . The device of claim 1 wherein the atraumatic tip of the stylet is formed from a material that is different from the material of the stylet.

5 . The device of claim 1 wherein the stylet comprises an outer diameter of about 0.015 inches to about 0.125 inches.

6 . The device of claim 1 wherein the sidewall of the hub comprises an outer surface, and wherein at least a portion of the outer surface comprises at least one of threads, ribs, coupling mechanisms, barbs, flanges, channels and projections.

7 . The device of claim 1 wherein the hub comprises a durometer of about 25D to about 40D.

8 . The device of claim 1 wherein the first portion comprises a first durometer and the second portion comprises a second durometer, and wherein the first durometer is different than the second durometer.

9 . The device of claim 1 wherein the second portion extends between the proximal and distal ends of the hub.

10 . The device of claim 1 wherein the second portion extends around an entire circumference of at least a portion of the hub.

11 . The device of claim 1 wherein the second portion extends at least partially around a circumference of at least a portion of the hub.

12 . 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, and a tamponade balloon catheter comprising: a catheter comprising a proximal end and a distal end and at least one lumen extending there between, wherein the catheter comprises at least one echogenic element disposed thereon; and an expandable tamponade device disposed about at least a portion of the catheter; wherein the stylet is configured to extend longitudinally within at least a portion of the at least one catheter lumen.

13 . The assembly of claim 12 wherein the at least one echogenic element is positioned at the distal end of the catheter.

14 . The assembly of claim 12 wherein the echogenic element comprises a plurality of echogenic beads.

15 . The assembly of claim 14 wherein the echogenic beads are embedded in a polymeric material.

16 . The assembly of claim 15 wherein the polymeric material is over-molded on to the distal end of the catheter.

17 . The assembly of claim 14 wherein the echogenic beads are formed from at least one of glass, polymeric material, metals and combinations thereof.

18 . The assembly of claim 12 wherein the echogenic element comprises a polymeric coating.

19 . The assembly of claim 12 wherein the echogenic element is coupled to the catheter by at least one of bonding, RF welding, adhesives, over-molding and mechanical attachment mechanisms.

20 . The assembly of claim 12 wherein the hub further comprises a proximal end, a distal end and a sidewall extending there between defining a hub lumen, wherein the sidewall comprises a first portion having a first thickness and a second portion comprising a second thickness, wherein the second thickness is greater than the first thickness, and wherein the stylet is coupled to the second portion.

21 . The assembly of claim 12 wherein the hub further comprises a proximal end, a distal end and a sidewall extending there between defining a hub lumen, wherein the sidewall of the hub comprises an outer surface, and wherein at least a portion of the outer surface comprises at least one of threads, ribs, coupling mechanisms, barbs, flanges, channels and projections.

22 . The assembly of claim 12 wherein the proximal end of the catheter further comprises an inflation port and wherein a proximal end of the inflation port is configured to be removably received within the hub lumen.

Assignees

• Cook Medical Technologies Llc

Inventors

• Roberts Erin
• Nichols Shawn
• Pedersen Wesley

Classifications

• A61B2017/12004

  for haemostasis, for prevention of bleeding · CPC title

• A61B17/12099 Primary

  characterised by the location of the occluder · CPC title

• A61B2017/1205

  Introduction devices · CPC title

• A61B2090/3925

  ultrasonic · CPC title

• A61B2017/4216

  Operations on uterus, e.g. endometrium · CPC title