Systems and methods for performing acoustic hemostasis of deep bleeding trauma in limbs

• US 20070066897A1
• Filed: 07/13/2006
• Published: 03/22/2007
• Est. Priority Date: 07/13/2005
• Status: Abandoned Application

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Inventors: Kook, John, Caldwell, Ed, Sekins, K.
• Application Number:
  US11/486,526
• Publication Number:
  US 20070066897A1
• Time in Patent Office: Days
• US Class Current: 600/437
• 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
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

An inflatable cuff having integrated ultrasound transducers is used to effect hemostasis of deep bleeding wounds in limbs. The cuff includes a chamber defined by a bladder or a series of dams into which a fluid may be introduced and pressurized. The pressure of the fluid stops or slows bleeding while high intensity focused ultrasound is applied to effect hemostasis. The fluid may also serve as an acoustic couplant between the limb and the ultrasound transducers. The transducers may be electrostrictive transducers. Diodes may be used to reduce parallel capacitive loading in the transducer array. Bypass capacitors using the electrostrictive material may also be used.

Claims

1. An ultrasound cuff, comprising:

an array of ultrasound transducers adapted to be deployed circumferentially around a body limb; and

a pressurizeable bladder positioned on a first side of the array, wherein the cuff is configured such that when the array is deployed circumferentially around the body limb, the bladder is positioned between the array and the body limb.

2. The cuff of claim 1, where the ultrasound transducers are adapted for both therapy and detection.

3. The cuff of claim 1, comprising a substantially non-expandable layer positioned on a second side of the array opposite the first side, wherein the non-expandable layer is configured to prevent the flexible array from expanding outward when the cuff is deployed around the body limb and the bladder is pressurized.

4. The cuff of claim 1, comprising a plurality of the pressurizeable bladders.

5. The cuff of claim 1, comprising a liquid pressurization module configured to pressurize liquid disposed within the bladder.

6. The cuff of claim 5, wherein the pressurization module is configured to circulate liquid through the bladder.

7. The cuff of claim 5, wherein the pressurization module is configured to cool the liquid.

8. The cuff of claim 5, wherein the pressurization module is configured to degas the liquid.

9. The cuff of claim 1, wherein the ultrasound transducers are configured to provide ultrasonic energy with enough intensity to induce hemostasis.

10. The cuff of claim 1, wherein the bladder covers the entire array.

11. The cuff of claim 1, wherein the ultrasound transducers comprise electrostrictive material.

12. The cuff of claim 11, wherein the electrostrictive material is lead-magnesium-niobate modified with lead titanate.

13. The cuff of claim 1, wherein the ultrasound transducers comprise PZT material.

14. An ultrasound cuff, comprising:

an array of ultrasound transducers having an approximately cylindrical shape; and

a bladder filed with a liquid, the bladder covering the surface of the transducers that are interior to the cylindrical shape.

15. The cuff of claim 14, wherein the liquid is water.

16. The cuff of claim 14, wherein the liquid is physiological saline.

17. The cuff of claim 14, comprising an acoustic couplant material between the bladder and the transducers.

18. The cuff of claim 17, wherein the acoustic couplant material comprises a gel.

19. The cuff of claim 14, comprising an acoustic couplant material disposed on the surface of the bladder that is interior to the cylindrical shape.

20. The cuff of claim 14, wherein the ultrasound transducers comprise electrostrictive material.

21. The cuff of claim 20, wherein the electrostrictive material is lead-magnesium-niobate modified with lead titanate.

22. The cuff of claim 14, wherein the ultrasound transducers comprise PZT material.

23. An ultrasound cuff, comprising:

a flexible array of ultrasound transducers adapted to be deployed circumferentially around a body limb;

at least one seal positioned along at least one edge of at least some of the ultrasound transducers, the seal configured to contact the body limb when the array is deployed circumferentially around the body limb such that a space is maintained between the body limb and the at least some transducers.

24. The cuff of claim 23, wherein the seal comprises a pressurizeable bladder configured to maintain said space when the bladder is pressurized.

25. The cuff of claim 24, comprising a pressurization module configured to pressurize the first pressurizeable bladder.

26. The cuff of claim 25, wherein the pressurization module is a gas pressurization module.

27. The cuff of claim 23, wherein the seal comprises silicone or foam pliant material.

28. The cuff of claim 23, wherein the array comprises a plurality of ultrasound transducer panels, wherein one of said seals extends around the perimeter of each transducer panel.

29. The cuff of claim 23, comprising two of said seals, a first seal positioned on a first side of the array and a second seal positioned on a second side of the array.

30. The cuff of claim 29, wherein the first seal comprises a first pressurizeable bladder configured such that when the array is deployed circumferentially around the body limb, the first bladder also extends circumferentially around the body limb and wherein the second seal comprises a second pressurizeable bladder configured such that when the array is deployed circumferentially around the body limb, the second bladder also extends circumferentially around the body limb.

31. The cuff of claim 30, wherein when the array is deployed circumferentially around the body limb and the first and second pressurizeable bladders are pressurized, the first and second pressurizeable bladders are configured to maintain said space between the body limb and the array.

32. The cuff of claim 23, comprising an inlet port configured to facilitate the introduction of a liquid into the space.

33. The cuff of claim 23, comprising a liquid pressurization module configured pressurize liquid disposed within the space.

34. The cuff of claim 23, wherein the ultrasound transducers comprise electrostrictive material.

35. The cuff of claim 34, wherein the electrostrictive material is lead-magnesium-niobate modified with lead titanate.

36. The cuff of claim 23, wherein the ultrasound transducers comprise PZT material.

37. A method of effecting hemostasis in a wound in a limb, the method comprising:

placing an inflatable cuff with integrated ultrasound transducers around the limb;

inflating the cuff; and

applying high intensity focused ultrasound sufficient to effect hemostasis with the transducers.

38. The method of claim 37, wherein the cuff is inflated to a pressure sufficient to reduce intravascular blood flow.

39. The method of claim 37, wherein the cuff is inflated to a pressure sufficient to stop intravascular blood flow.

40. The method of claim 37, wherein the cuff is inflated to a pressure sufficient to reduce extravascular blood flow.

41. The method of claim 37, wherein the cuff is inflated to a pressure sufficient to stop extravascular blood flow.

42. The method of claim 37, wherein inflating the cuff comprises introducing a liquid into a bladder in the cuff.

43. The method of claim 37, wherein the cuff is inflated to a pressure sufficient to splint the limb.

44. The method of claim 42, wherein the bladder is positioned between the limb and the transducers.

45. The method of claim 42, comprising cooling the liquid while applying the high intensity focused ultrasound.

46. The method of claim 37, wherein inflating the cuff comprises inflating a first and second bladder, wherein the inflated bladders define a space between the limb and the transducers.

47. The method of claim 46, comprising introducing a liquid into the space.

48. The method of claim 47, wherein the liquid comprises a pro-coagulant agent.

49. The method of claim 48, wherein the pro-coagulant is thrombin.

50. The method of claim 47, wherein the liquid comprises an anti-infection agent.

51. The method of claim 50, wherein the anti-infection additive is an anti-biotic.

52. A method of effecting hemostasis in a wound in a limb, the method comprising:

placing a tourniquet on the limb;

placing a cuff with integrated ultrasound transducers around the limb;

applying high intensity focused ultrasound sufficient to effect hemostasis with the transducers.

53. An ultrasound applicator patch, comprising:

an array of ultrasound transducers;

sidewalls disposed around the perimeter of the array, wherein the sidewalls define a space over the ultrasound transducers; and

an inlet port in the sidewalls or the array configured to allow introduction of a fluid into the space.

54. The patch of claim 53, comprising an adhesive disposed on the sidewalls.

55. The patch of claim 53, comprising a strap coupled to the transducers and configure to encircle the limb.

56. A method of effecting hemostasis in a wound, comprising:

positioning the patch of claim 53 over the wound;

introducing a fluid through the inlet port into the space; and

applying high intensity focussed ultrasound sufficient to effect hemostasis with the transducers.

57. An ultrasound applicator patch, comprising:

an array of ultrasound transducers; and

a pressurizeable bladder positioned on a first side of the array, wherein the cuff is configured such that when the array is deployed on the wound, the bladder is positioned between the array and the wound.

58. The patch of claim 57, comprising a strap coupled to the transducers and configure to encircle the limb.

59. A method of effecting hemostasis in a wound, comprising:

positioning the patch of claim 57 over the wound;

introducing a fluid into the pressurizeable bladder; and

applying high intensity focused ultrasound sufficient to effect hemostasis with the transducers.