Wound closure hemostasis device

• US 5,792,173 A
• Filed: 07/10/1995
• Issued: 08/11/1998
• Est. Priority Date: 07/10/1995
• Status: Expired due to Fees

• Current Assignee: Stuart D. Edwards
• Original Assignee: Stuart D. Edwards
• Inventors: Lazarus, Peter H., Breen, Richard C., Edwards, Stuart D., Gough, Edward J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/500,381
• Time in Patent Office: 1,128 Days
• Field of Search: 606/190-200, 604/95-104, 666/201-204.55, 128/DIG. 20
• US Class Current: 606/201
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34

Abstract

A wound closure, hemostasis device, such as a femoral hemostat, includes an inflatable balloon with an inflation and deflation outlet. A placement patch includes an aperture for receiving the inflation and deflation outlet. The inflatable balloon is coupled to the placement patch and positioned adjacent to a wound site or a bleeding vessel. A belt straps through the placement patch and around the patient'"'"'s body or a patient'"'"'s appendage and holds the placement patch at the wound site or bleeding vessel. An inflation tube is coupled to the inflation and deflation outlet. An inflation apparatus is coupled to the inflation and deflation outlet.

Claims

1. A wound closure, hemostasis device, comprising:

a balloon with a distal end, an inflation and deflation outlet, an inflatable section and a non-inflatable section extending outward from a periphery of the inflatable section;

a placement patch configured to accommodate balloons of different geometries, and including an aperture for receiving the inflation and deflation outlet, wherein the non-inflatable section of the inflatable balloon is removably coupled to the placement patch;

an attachment mechanism coupled to the placement patch and configured to be strapped around one of a patient'"'"'s body or a patient'"'"'s appendage and hold the placement patch adjacent to one of a wound site or a bleeding vessel; and

an inflation apparatus coupled to the inflation and deflation outlet.

2. The wound closure, hemostasis device of claim 1, wherein the balloon has a geometry which applies pressure around a periphery of one of the wound site or bleeding vessel and pinches surrounding tissue together.

3. The wound closure, hemostasis device of claim 1, wherein the balloon has at least a section with a spherical geometry.

4. The wound closure, hemostasis device of claim 1, wherein the balloon has at least a section with a non-spherical geometry.

5. The wound closure, hemostasis device of claim 4, wherein the balloon has at least a section with a toroidal geometry.

6. The wound closure, hemostasis device of claim 1, wherein the balloon applies a circumferential pressure around one of the wound site or the bleeding vessel.

7. The wound closure, hemostasis device of claim 1, wherein the balloon has a lens on a distal end of the balloon formed as an integral part of the balloon.

8. The wound closure, hemostasis device of claim 7, wherein the balloon is made of a transparent material, and the lens permits improved viewing of one of the wound site or bleeding vessel.

9. The wound closure, hemostasis device of claim 1, wherein the balloon includes one or more ribs formed on one of an internal or external surface of the balloon.

10. The wound closure, hemostasis device of claim 1, wherein the balloon includes one or more rings formed on one of an interior or exterior surface of the balloon.

11. The wound closure, hemostasis device of claim 1 further comprising,

a backing plate coupled to the placement patch supplying sufficient support for the balloon and allowing the balloon to be inflated to larger pressures.

12. The wound closure, hemostasis device of claim 1, wherein the non-inflatable section has an integrally formed injection port.

13. The wound closure, hemostasis device of claim 1, wherein the inflatable section has a geometry with a hollow center, and an injection port is positioned adjacent to the hollow center.

14. The wound closure, hemostasis device of claim 1, further comprising:

a heating element, configured to be coupled to a power source, positioned in one of a surface of the balloon or in an interior of the balloon.

15. The wound closure, hemostasis device of claim 14, further comprising:

a power source connected to the heating element.

16. The wound closure, hemostasis device of claim 15, wherein the power source is one or more batteries positioned on one of the attachment mechanism or placement patch.

17. The wound closure, hemostasis device of claim 14, further comprising:

an electrolytic solution positioned in the interior of the balloon.

18. The wound closure, hemostasis device of claim 14, wherein the heating element is an RF antenna.

19. The wound closure, hemostasis device of claim 1, wherein the balloon is made of a plurality of membranes.

20. The wound closure, hemostasis kit of claim 1, wherein the balloon has a lens on a distal end of the balloon formed as a lens that is non-integral with the balloon and applied to the balloon'"'"'s distal end.

21. The wound closure, hemostasis device of claim 20, wherein the balloon is made of a transparent material, and the lens permits improved viewing of one of the wound site or bleeding vessel.

22. A wound closure, hemostasis kit, comprising:

a plurality of balloons, each balloon having a distal end, an inflatable section, a non-inflatable section and an inflation and deflation outlet, the inflatable section of each balloon having a different lateral cross-section geometry;

a placement patch configured to be removably coupled to the non-inflatable section of each balloon;

an attachment mechanism coupled to the placement patch configured to be strapped around a patient to hold the placement patch adjacent to one of a wound site or a bleeding vessel.

23. The wound closure, hemostasis kit of claim 22, further comprising an inflation apparatus coupled to the inflation and deflation outlet and the inflation apparatus is a hand operated bulb with a regulator valve coupled to the inflation bulb.

24. The wound closure, hemostasis kit of claim 22, wherein at least one balloon inflatable section has a geometry which applies pressure around a periphery of one of the wound site or the bleeding vessel and pinches surrounding tissue together.

25. The wound closure, hemostasis kit of claim 22, wherein at least one balloon inflatable section has at least a section with a spherical geometry.

26. The wound closure, hemostasis kit of claim 22, wherein at least one balloon inflatable section has at least a section with a non-spherical geometry.

27. The wound closure, hemostasis kit of claim 26, wherein at least one balloon inflatable section has at least a section with a toroidal geometry.

28. The wound closure, hemostasis kit of claim 22, wherein at least one balloon inflatable section applies a circumferential pressure around one of the wound site or the bleeding vessel.

29. The wound closure, hemostasis kit of claim 22, wherein at least one balloon includes a lens at the distal end of the balloon inflatable section.

30. The wound closure, hemostasis kit of claim 29, wherein the lens is formed integrally with the balloon inflatable section.

31. The wound closure, hemostasis kit of claim 29, wherein the lens is a separate element which is not integrally formed with the balloon inflatable section.

32. The wound closure, hemostasis kit of claim 29, wherein at least one balloon is made of a transparent material, and the lens permits improved viewing of one of the wound site or bleeding vessel.

33. The wound closure, hemostasis kit of claim 22, wherein at least one balloon includes one or more ribs formed on one of an internal or external surface of the balloon.

34. The wound closure, hemostasis kit of claim 22, wherein at least one balloon includes one or more rings formed on one of an interior or exterior surface of the balloon.

35. The wound closure, hemostasis kit of claim 22, further comprising,

a backing plate coupled to the placement patch supplying sufficient support to the placement patch to allow the balloon to be inflated to larger pressures.

36. The wound closure, hemostasis kit of claim 22, wherein at least one balloon non-inflatable section is a non-inflatable bag with an injection port.

37. The wound closure, hemostasis kit of claim 36, wherein at least one balloon inflatable section has a geometry with a hollow center, and the injection port is positioned adjacent to the hollow center.

38. The wound closure, hemostasis kit of claim 22, further comprising:

a heating element positioned on one of a surface of at least one balloon inflatable section or in an interior of at least one balloon inflatable section.

39. The wound closure, hemostasis kit of claim 38, further comprising:

a power source connected to the heating element.

40. The wound closure, hemostasis kit of claim 39, wherein the power source is one or more batteries positioned on one of the belt or placement patch.

41. The wound closure, hemostasis kit of claim 38, further comprising:

an electrolytic solution positioned in the interior of the balloon.

42. The wound closure, hemostasis kit of claim 38, wherein the heating element is an RF antenna.

43. The wound closure, hemostasis kit of claim 22, wherein at least one balloon inflatable section is made of a plurality of membranes.