Balloon tamponade

• US 9,055,949 B2
• Filed: 02/08/2008
• Issued: 06/16/2015
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: B & D Medical Development LLC
• Original Assignee: B & D Medical Development LLC
• Inventors: Belfort, Michael A., Dildy, Gary A. III
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US12/069,314
• Publication Number:
  US 20080215031A1
• Time in Patent Office: 2,685 Days
• Field of Search: 606/193, 606/119, 606/194, 606/198, 606/199, 604/500, 604/37, 604/97.01, 604/99.01, 604/100.01, 604/101.01, 604/330
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding

Abstract

An implantable device is provided for controlling hemorrhage in a body cavity, comprising an expandable balloon and a conduit for supplying a physiologically compatible fluid to inflate the balloon. When the balloon tamponade device is implanted or inserted into the body cavity, it is inflated with a physiologically suitable fluid, so that the balloon generally conforms to the body cavity and exerts compressive force against the walls, tissues or structures of the body cavity to control hemorrhage. The balloon may have a deforming means to limit expansion of the balloon in a direction to facilitate expansion of the balloon in another direction. The device may have additional tubes within the conduit, or a plurality of separate lumens within the conduit or tubes to allow drainage and irrigation to the body cavity. There is also provided a cuff for attachment of an external traction to the balloon tamponade, to facilitate the compressive effect of the device. In a preferred embodiment, there is provided a dual balloon tamponade in which two balloons are axially spaced along the conduit, providing a means to control hemorrhage from two distinct body cavities, such as a uterus and a vagina. There is also provided a method to control hemorrhage in a body cavity by implantation or insertion of the balloon tamponade, inflating the balloon with a fluid to a sufficient pressure and retaining the fluid pressure within the balloon for a sufficient period of time to determine whether hemorrhage has been controlled. A kit comprising the balloon tamponade apparatus is also provided.

Claims

1. An apparatus for controlling gynecologic and obstetric hemorrhage in a body cavity of a subject, comprising:

at least one expandable balloon having a distal end and a proximal end, the at least one expandable balloon has a flexible structure adapted to be inserted into the uterine cavity and can be filled with fluid volumes between 200 milliliters and 1.0 liter, wherein the exterior shape of the balloon conforms to the area within the uterine cavity;

a conduit extending from a proximal end portion of the apparatus to a distal end portion of the apparatus, the conduit sealably surrounded, in part, by the at least one expandable balloon and including at least one inflation lumen in communication with the interior of the at least one expandable balloon; and

a fluid supply fitting disposed at the proximal end portion of the conduit, the fluid supply fitting configured to directly connect a liquid supply bag to the at least one inflation lumen and facilitating inflation of the at least one expandable balloon to an expanded liquid fill volume in three minutes or less.

2. The apparatus of claim 1, comprising an internal cuff surrounding a portion of the conduit and co-axially spaced on the conduit apart from the at least one expandable balloon, wherein the at least one expandable balloon is configured to deform in shape by inhibiting expansion in at least a first direction and facilitating expansion in at least a second direction, different from the first direction, using the internal cuff.

3. The apparatus of claim 1, wherein the conduit includes at least a second lumen in addition to the at least one inflation lumen, the second lumen and the at least one inflation lumen separated by a plurality of tubes within, or internal webbing of, the conduit.

4. The apparatus of claim 3, wherein at least the second lumen is configured to allow for one or both of drainage from, or irrigation to, the body cavity when the at least one expandable balloon is implanted, the second lumen including an opening at or near the distal end of the conduit for communication with the body cavity and an opening at or near the proximal end of the conduit for communication with an exterior of the subject'"'"'s body.

5. The apparatus of claim 1, comprising a traction means configured to prevent upward displacement of the apparatus further into the body cavity, when implanted in the body cavity.

6. The apparatus of claim 1, wherein the at least one expandable balloon comprises a first expandable balloon and a second expandable balloon co-axially spaced on the conduit from one another, wherein the conduit comprises a first conduit and a second conduit, the first conduit is sealably surrounded, in part, by the first expandable balloon and includes a first inflation lumen in communication with the interior of the first expandable balloon, and the second conduit is sealably surrounded, in part, by the second expandable balloon and includes a second inflation lumen in communication with the interior of the second expandable balloon.

7. The apparatus of claim 6, wherein the first expandable balloon includes at least one fold or pleat configured to facilitate inflation of the balloon.

8. The apparatus of claim 6, wherein the first expandable balloon is positioned distal of the second expandable balloon and includes a liquid fill volume greater than the second expandable balloon.

9. The apparatus of claim 6, wherein the second expandable balloon includes a shape having a maximum diameter between approximately 10 centimeters and approximately 12 centimeters upon inflation.

10. The apparatus of claim 6, wherein a connection disposed between the first and second expandable balloons includes a fitting, the fitting configured to allow the second expandable balloon to be disjoined from the first expandable balloon.

11. The apparatus of claim 6, wherein one or both of the first or second expandable balloons are inflatable to the expanded liquid fill volume in about one minute or less and include a urethane material.

12. The apparatus of claim 1, wherein the at least one expandable balloon has a fluid fill volume between 300 milliliters and 1.0 liters and is capable of being inflated to fill volume in less than three minutes without requiring application of pressure to overcome the elasticity of the balloon.

13. The apparatus of claim 5, wherein the traction means is selected from a group consisting of a tab, a ring, a grip, a ratchet, a clamp, a friction wheel, a bead or step catch, or other latching or locking means at an internal cuff or an external cuff.

14. The apparatus of claim 3, wherein at least the second lumen comprises a deflation lumen in communication with the at least one expandable balloon interior, the at least one inflation lumen and the deflation lumen configured to allow substantially simultaneous liquid supply and liquid withdrawal from the interior of the at least one expandable balloon to replace or circulate an inflation liquid therethrough.

15. The apparatus of claim 14, wherein the inflation liquid is warmed or cooled in order to warm or cool the body cavity.

16. The apparatus of claim 14, wherein liquid circulation for warming or cooling is enabled by a closed loop which connects the inflation and deflation lumens.

17. The apparatus of claim 1, comprising a connecting means connected to the proximal end of the inflation lumen of the conduit.

18. The apparatus of claim 1, comprising a pressure gauge or sensor configured to detect the internal pressure of an inflation liquid within the at least one expandable balloon.

19. The apparatus of claim 17, wherein the connecting means comprises a luer lock.

20. The apparatus of claim 1, comprising a control means connected to a drainage lumen of the conduit to control drainage from the body cavity, wherein the control means is a stop-cock.

21. The apparatus of claim 1, wherein the at least one expandable balloon is of a size having 800 milliliters neutral inflation and 1.5 liters full fill volume when inflated.

22. The apparatus of claim 1, wherein an external surface of the at least one expandable balloon is coated, impregnated, infused, permeated or otherwise includes one or both of a hemostatic material or a pharmaceutical composition for contact with a wall, tissue or structure within the body cavity, when implanted.

23. The apparatus of claim 2, wherein the at least one expandable balloon is configured such that placement of a force, in a direction toward an end of the apparatus, on the conduit portion limits expansion of the balloon in the first direction and facilitates expansion, at least partially, in the second direction.

24. A balloon tamponade for controlling gynecologic and obstetric hemorrhage in a body cavity of a subject, comprising:

an expansible balloon having a distal end and a proximal end which has a flexible structure adapted to be inserted into the uterine cavity and can be filled with fluid volumes between 300 milliliters and 1,000 milliliters in three minutes or less to substantially fill a first body cavity;

a conduit having a distal end and a proximal end and having an inflation lumen, a guide lumen, an irrigation lumen and a drainage lumen;

a traction wire extending the length of the guide lumen; and

an internal cuff surrounding the conduit at or near the proximal end of the balloon, wherein the conduit is sealably surrounded, in part, by the balloon, the inflation lumen is in communication with the interior of the balloon and the guide lumen is in communication with an interior surface of the balloon at the distal end of the balloon, and wherein the irrigation lumen and drainage lumen are each in communication with the body cavity through openings at or near the distal end of the conduit and are each in communication with the exterior of the subject'"'"'s body through an opening at or near the proximal end of the conduit, and wherein the traction wire is fixedly attached to the interior surface of the balloon at the distal end of the balloon and is fixedly attached to the internal cuff at the proximal end of the balloon.

25. A dual balloon tamponade for controlling gynecologic and obstetric hemorrhage in a body cavity of a subject, comprising:

an expandable first balloon having a distal end and a proximal end which has a flexible structure adapted to be inserted into the uterine cavity and can be filled with fluid volumes between 300 milliliters and 1,000 milliliters in three minutes or less to substantially fill a first body cavity;

an expandable second balloon configured to substantially fill a second body cavity, the second balloon co-axially spaced from the first balloon, having a distal end and a proximal end;

a first conduit having a distal end and a proximal end, and comprising a first inflation lumen in communication with the interior of the first balloon and being sealably surrounded by the first balloon; and

a second conduit having a distal and a proximal end, and comprising a second inflation lumen in communication with the interior of the second balloon and being sealably surrounded by the second balloon, and wherein the second conduit is slidably engaged over the first conduit.

26. The apparatus of claim 25, comprising a fluid supply fitting disposed at or near the proximal end of the first or second conduit, the fluid supply fitting configured to directly connect a liquid supply bag to the first or the second inflation lumen thereby facilitating rapid inflation of the expandable first balloon or the expandable second balloon when pressure is applied to the liquid supply bag.

27. The dual balloon tamponade of claim 25, wherein the second conduit has a joint disposed between the first and second balloons, wherein the joint is comprised of a joint fitting to allow the second balloon to be disjoined from the first balloon.

28. The dual balloon tamponade of claim 25, wherein the balloons are inflated by filling with a volume of liquid via an IV bag, wherein the IV bag is spiked and squeezed through a direct fill mechanism.

29. The dual balloon tamponade of claim 25, wherein the first balloon is conforming and the second balloon is nonconforming to the area within the uterine cavity.

30. The dual balloon tamponade of claim 25, wherein the first balloon is made of polyurethane.