Pelvic balloon tamponade

• US 20080215031A1
• Filed: 02/08/2008
• Published: 09/04/2008
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: B & D Medical Development LLC
• Original Assignee: B & D Medical Development LLC
• Inventors: Dildy, Gary A., Belfort, Michael A.
• Granted Patent: US 9,055,949 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 hemorrhage in a body cavity of a subject, comprising a balloon having a distal end and a proximal end, a conduit sealably surrounded by the balloon and comprising an inflation lumen in communication with the interior of the balloon, and wherein the balloon has at least a fold or pleat.

22. The apparatus of any one of claims 1, 2, 6, 13, 15, or 19, further comprising a connecting means connected to the proximal end of an inflation lumen of the conduit, and wherein the connecting means comprises an IV bag spike.

23. The apparatus of any one of claims 1, 2, 6, 13, 15, or 19, further comprising a pressure detection means connected by a connecting means to an inflation lumen of the conduit, wherein the pressure detection means comprises a pressure gauge.

33. A method for controlling hemorrhage in a body cavity of a subject, comprising the steps of:

providing a balloon tamponade apparatus as described in any one of claims 1 through 28;

implanting or inserting the balloon tamponade apparatus in a body cavity;

inflating the balloon with a physiologically compatible medium to inflate the balloon; and

retaining the inflated balloon within the body cavity at a pressure and for a time sufficient to control hemorrhage in the body cavity.

34. A kit comprising:

a. the apparatus of any one of claims 1 through 28;

b. a fluid collection means for collecting fluid discharged from a body cavity;

c. a set of instructions for use of the apparatus; and

d. a containing means for containing (a) through (c).

35. The kit of claim 33, wherein the instructions comprise digital instructions.

36. The kit of claim 33, further comprising a syringe.

37. The kit of claim 33, wherein the containing means is a bag.

2. An apparatus for controlling hemorrhage in a body cavity of a subject, comprising a balloon of a shape and having a distal end and a proximal end, a conduit sealably surrounded by the balloon and comprising an inflation lumen in communication with the interior of the balloon, and a deforming means to deform the shape of the balloon.

3. The apparatus of claim 2, wherein the conduit further comprises a guide lumen in communication with the interior surface of the distal end of the balloon and in communication with the exterior of the balloon, and wherein the deforming means comprises a traction means attached to the interior surface of the distal end of the balloon, the traction means extending the length of the balloon through the guide lumen.

4. The apparatus of claim 3, wherein the traction means comprises a wire having a distal end and a proximal end, wherein the distal end of the wire is attached to the interior surface of the distal end of the balloon and the proximal end of the wire is attached to traction application means.

5. The apparatus of claim 4, wherein the traction application means is selected from among the 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.

6. An apparatus for controlling hemorrhage in a body cavity of a subject, comprising a conduit having a distal end and a proximal end, a first balloon and a second balloon co-axially spaced along the conduit, wherein the conduit is sealably surrounded by each of the first balloon and the second balloon and comprises a first inflation lumen in communication with the interior of the first balloon interior and a second inflation lumen in communication with the interior of the second balloon.

7. The apparatus of claim 6, wherein the first balloon has at least a fold or pleat.

8. The apparatus of claim 6, wherein the first balloon is axially spaced along the conduit adjacent the distal end of the conduit.

9. The apparatus of claim 6, wherein the second balloon is of a shape and is non-conforming to substantially retain the shape upon inflation.

10. The apparatus of claim 6, wherein the conduit comprises the lumen configuration shown in FIG. 6g.

11. The apparatus of claim 6, wherein the 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 at the joint.

12. The apparatus of claim 6, wherein the joint fitting comprises a friction bit, a snap fitting, a threaded fitting, a taper-fit, a collar, a bayonet fitting, or a quick-release fitting.

13. An apparatus for controlling hemorrhage in a body cavity of a subject, comprising a first expansible balloon having a distal end and a proximal end, a first conduit having a distal end and a proximal end, the first conduit being sealably surrounded by the first balloon and having a first inflation lumen in communication with the interior of the first balloon, and a second lumen, wherein the second lumen has an opening at or near the distal end of the first conduit for communication with a body cavity and an opening at or near the proximal end of the first conduit for communication with an exterior of the subject'"'"'s body.

14. The apparatus of claim 13, wherein the first conduit further comprises a third lumen, and wherein the second lumen is an irrigation lumen and the third lumen is a drainage lumen.

24. The apparatus of either of claims 13 or 14, further comprising an irrigation supply tube connected to the irrigation lumen through a connecting means, and wherein the connecting means comprises a luer lock.

25. The apparatus of either of claims 13 or 14, further 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.

15. An apparatus for controlling hemorrhage in a body cavity of a subject, comprising a first expansible balloon having a distal end and a proximal end, a first conduit having a distal end and a proximal end, the first conduit being sealably surrounded by the first balloon and having a first inflation lumen in communication with the interior of the first balloon, and a first cuff surrounding the first conduit.

16. The apparatus of claim 15, further comprising a second cuff surrounding the first conduit.

17. The apparatus of claim 16, wherein the first cuff is disposed at or near either the proximal end of the balloon and is within the body cavity and the second cuff is disposed at or near the proximal end of the conduit and is external to the subject'"'"'s body.

18. The apparatus of claim 16, wherein the first cuff is flexible and movable along the conduit.

19. An apparatus for controlling hemorrhage in a body cavity of a subject, comprising an expansible balloon having a distal end and a proximal end, a conduit having a distal end and a proximal end, the conduit being sealably surrounded by the balloon and having a inflation lumen and a deflation lumen, each of said lumens being in communication with the balloon interior, wherein said inflation lumen and deflation lumen allow substantially simultaneous fluid supply and fluid withdrawal from the interior of the balloon to replace or circulate an inflation fluid through the balloon interior.

20. The apparatus of claim 19, wherein the inflation fluid is warmed or cooled in order to warm or cool a body cavity.

21. The apparatus of claim 19, wherein fluid circulation for warming or cooling is enabled by a closed loop which connects the inflation and deflation lumens.

30. The balloon of claim 20, wherein the balloon has a fluid fill volume of at least 800 milliliters.

26. A balloon tamponade for controlling hemorrhage in a body cavity of a subject, comprising:

a. an expansible balloon having a plurality of folds or pleats, and having a distal end and a proximal end,

b. 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,

c. a traction wire extending the length of the guide lumen, and

d. a cuff surrounding the conduit at or near the proximal end of the conduit, wherein the conduit is sealably surrounded 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 at the distal end of the balloon, and wherein the irrigation lumen and drainage lumen are each in communication with a 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 opening at or near the proximal end of the conduit, and wherein the traction wire is attached to an interior surface of the balloon at the distal end of the balloon and is attached to the cuff at the proximal end of the conduit.

27. A dual balloon tamponade for controlling hemorrhage in a body cavity of a subject, comprising:

a. an expansible first balloon having a distal end and a proximal end, and comprising a plurality of folds or pleats;

b. an expansible second balloon, having a distal end and a proximal end;

c. 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;

d. 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; and

e. a first semi-rigid cuff disposed between the first and second balloons, and surrounding either the proximal end of the first balloon or the distal end of the second conduit.

28. The dual balloon tamponade of claim 27, wherein the first conduit further comprises an irrigation lumen and a drainage lumen, each of the irrigation lumen and drainage lumen having an opening in communication with a body cavity and an opening in communication with the exterior of the subject'"'"'s body, to provide channels for irrigation of and drainage from the body cavity.

29. A rapid-fill balloon for controlling hemorrhage in a body cavity, comprising an expansible balloon having a plurality of folds or pleats.

31. The balloon of claim 29, wherein the balloon is capable of being inflated to fill volume in less than three minutes.

32. The balloon of claim 29, wherein the balloon is capable of being inflated to a fill volume between 300 and 1,000 milliliters without requiring application of pressure to overcome the elasticity of the balloon.