Removable applicator nozzle for ultrasound wound therapy device

• US 7,785,277 B2
• Filed: 06/23/2006
• Issued: 08/31/2010
• Est. Priority Date: 06/23/2005
• Status: Active Grant

• Current Assignee: SANUWAVE Health, Inc.
• Original Assignee: Celleration, Inc. (Adynxx, Inc)
• Inventors: Doten, Greg, Babaev, Eilaz, Van Houten, Alan, Peterson, Michael T.
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): Selkin; Saurel J
• Application Number:
  US11/473,934
• Publication Number:
  US 20070088245A1
• Time in Patent Office: 1,530 Days
• Field of Search: 222/4, 222/5, 222/80, 222/81, 222/165, 222/167, 222/181.2, 222/594, 222/598, 222/617, 251/208, 600/407, 600/408, 600/439, 600/489, 601 2- 4, 604 20- 22
• US Class Current: 601/2
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61H 2201/105 with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A removable applicator nozzle for use in treating a wound is provided. The removable applicator nozzle includes a nozzle, a valve and a cup. The nozzle includes a proximal portion, a distal opening and a valve interface. The proximal portion of the nozzle is engagable with a portion of a transducer of an ultrasound wound therapy device. The distal opening of the nozzle allows at least a portion of a tip of the transducer to pass therethrough. The valve is engagable with the valve interface of the nozzle and the valve selectively allows fluid to flow therethrough. The cup includes an aperture and a puncturing device. The aperture is engagable with the valve and the puncturing device is able to puncture a bottle that is inserted on the cup. Fluid flows from the bottle, through the aperture and the valve and onto a tip of the transducer. The fluid is then moved to the distal opening of the nozzle by a vacuum effect.

Claims

1. An applicator for use in treating a wound, the applicator comprising:

a nozzle including a proximal portion, a distal opening and a valve interface, the proximal portion being engageable with a portion of an ultrasound wound therapy device, the distal opening allowing at least a portion of a transducer tip of the ultrasound wound therapy device to pass therethrough, the valve interface defining an axis therethrough;

a valve comprising a valve opening, an upper portion and a lower portion, the upper and lower portion being rotatable with respect to each other, the lower portion being engageable with the valve interface of the nozzle, and the valve opening allowing fluid to flow therethrough and allowing fluid flow to be reversibly turned on and off; and

a cup including an aperture, the aperture in fluid communication with at least the upper portion of the valve,

whereby, fluid can flow through the aperture of the cup, through the valve and onto at least a portion of the transducer tip of the ultrasound wound therapy device in a manner that avoids aerosolization when contacting the transducer tip.

2. The applicator according to claim 1, wherein when the nozzle is engaged with said ultrasound wound therapy device, the fluid drips on a portion of the transducer tip that is proximal to the distal-most portion of the tip of the ultrasound wound therapy device.

3. The applicator according to claim 1, wherein the cup further comprises a puncturing device which is capable of puncturing a bottle inserted onto the cup.

4. The applicator according to claim 1, wherein the cup further comprises an alignment structure which facilitates positioning a bottle in the cup.

5. The applicator according to claim 1, wherein the cup further comprises at least one indent which enhances the fit of a bottle in the cup.

6. The applicator according to claim 1, wherein the cup further comprises at least one indent which damages a bottle when the bottle is removed from the cup.

7. The applicator according to claim 1, wherein the valve is removable from at least one of the nozzle and the cup.

8. The applicator according to claim 1, wherein the cup is rotatable with respect to the axis defined by the valve interface.

9. The applicator according to claim 1, wherein the nozzle further comprises a distal tip, the distal tip being the portion of the nozzle which extends farthest distally, at least a portion of a transducer tip of the ultrasound wound therapy device extends between the distal opening of the nozzle and the distal tip of the nozzle.

10. The applicator according to claim 1, wherein the diameter of the valve opening is in the range of about 0.027 inches to about 0.037 inches.

11. The applicator according to claim 1, wherein the diameter of the valve opening is in the range of about 0.031 inches to about 0.033 inches.

12. The applicator according to claim 1, wherein the diameter of the valve opening causes fluid that travels therethrough to have a diameter equal to about 60 μ

m.

13. The applicator according to claim 1, wherein when the nozzle is engaged with said ultrasound wound therapy device, fluid drips on a front face of the transducer tip of the ultrasound wound therapy device.

14. The applicator according to claim 1, further comprising an integrated circuit (IC) chip disposed on the applicator, wherein the IC chip communicates with the transducer assembly or ultrasound wound therapy device to limit the number of times the applicator can be used with a transducer assembly.

15. The applicator according to claim 1, wherein the applicator is designed for use with a single patient and wherein the applicator comprises means to prevent re-use of the applicator.

16. The applicator according to claim 1, wherein the nozzle further comprises at least one vent hole.

17. The applicator according to claim 1, wherein the nozzle further comprises a plurality of aligning slots which facilitate the alignment between the nozzle and a transducer assembly.

18. The applicator according to claim 1, wherein at least one of the nozzle, the valve and the cup are disposable.

19. The applicator according to claim 1, further comprising a bottle.

20. The applicator of claim 1, further comprising a radio frequency identification (RFID) tag disposed on the applicator, wherein the RFID tag communicates with an RFID tag reader to indicate the number of times the applicator has been used and thereby limit the number of times the applicator can be used with the transducer assembly.

21. The applicator according to claim 1, wherein the cup contains a single puncturing device.

22. The applicator according to claim 1, wherein the fluid flows via gravity feed.

23. The applicator according to claim 8, wherein rotating the cup adjusts the valve from a closed position, to at least a partially open position.

24. The applicator according to claim 8, wherein the cup is configured to be rotated by a switch on a transducer assembly.

25. The application of claim 15, wherein the valve further includes an expandable foam.

26. The applicator according to claim 16, wherein the cup contains a single puncturing device.

27. The applicator according to claim 16, wherein each of the one or more vent holes has a diameter of about 0.05 inches to about 0.20 inches.

28. The applicator according to claim 19, wherein the bottle is inserted onto the cup.

29. The applicator of claim 19, wherein the bottle includes a sterilized fluid.

30. A method for promoting wound healing comprising the steps of:

providing a transducer which emits ultrasonic energy;

providing an applicator comprising;

a nozzle including a proximal portion, a distal opening and a valve interface, the proximal portion being engageable with a portion of an ultrasound wound therapy device, the distal opening allowing at last a portion of a transducer tip of the ultrasound wound therapy device to pass therethrough,

a valve comprising a valve opening, an upper portion and a lower portion, the upper and lower portion being rotatable with respect to each other, the lower portion being engageable with the valve interface of the nozzle, the upper portion being in fluid communication with a fluid source, and the valve opening allowing fluid to flow therethrough and allowing fluid flow to be reversibly turned on and off, and

a cup including an aperture, the aperture in fluid communication with at least the upper portion of the valve; and

activating the transducer to emit ultrasonic energy; and

turning the cup to selectively allow fluid to flow from the fluid source through the valve opening towards a portion of the transducer;

wherein, following contact of said portion of the transducer with said fluid and activation of the transducer, a spray having consistent particle size and velocity is generated, and wherein the emitted ultrasonic energy is delivered to the wound through the fluid spray at a non-contact distance of at least 0.1 inches from the wound.

31. The method according to claim 30, wherein when the transducer is activated, the transducer tip vibrates at a rate of about 1 kHz to about 10,000 MHz.

32. The method according to claim 30, wherein the fluid source is a bottle containing fluid.

33. The method according to claim 30, wherein the emitted ultrasonic energy and the fluid spray are delivered to the wound for a treatment time which is proportional to the size of the wound.

34. The method according to claim 30, wherein the emitted ultrasonic energy and the fluid spray are delivered to the wound by moving the applicator in a serpentine or checkerboard pattern relative to the wound.

35. The method according to claim 30, wherein the fluid source is a fluid bag.

36. The method of claim 30, wherein the step of turning the cup to selectively allow fluid to flow from the fluid source through the valve opening towards a portion of the transducer is performed before the step of activating the transducer.

37. The method of claim 30, wherein one or more vent holes are disposed on the nozzle.

38. The method of claim 30, wherein the cup contains a single puncturing device.

39. The method of claim 30, wherein the fluid is not pressurized.

40. The method according to claim 31, wherein the transducer tip vibrates at a rate of about 30 kHz to about 50 kHz.

59. The method of claim 37, wherein each of the one or more vent holes has a diameter of about 0.05 inches to about 0.20 inches.

41. A kit comprising, an applicator comprising:

a nozzle including a proximal portion, a distal opening and a valve interface, the proximal portion being engageable with a portion of an ultrasound wound therapy device, the distal opening allowing at least a portion of a transducer tip of the ultrasound wound therapy device to pass therethrough, the valve interface defining an axis therethrough,

a valve comprising a valve opening, an upper portion and a lower portion, the upper and lower portion being rotatable with respect to each other, the lower portion being engageable with the valve interface of the nozzle, and the valve opening allowing fluid to flow therethrough and allowing fluid flow to be reversibly turned on and off, and

a cup including an aperture, the aperture in communication with at least the upper portion of the valve; and

a bottle, wherein the bottle is not pressurized.

42. The kit according to claim 41, further comprising instructions for use and one or more sterile swabs for cleaning one or more of a surface of the bottle, a portion of the applicator, a puncturing device, or a portion of an ultrasound wound therapy device.

43. The kit according to claim 41, wherein the bottle includes a fluid and the fluid is sterilized.

44. The kit according to claim 41, wherein the cup further comprises a puncturing device which is capable of puncturing a bottle inserted onto the cup.

45. The kit according to claim 41, wherein the cup further comprises an alignment structure which facilitates positioning a bottle in the cup.

46. The kit according to claim 41, wherein the cup further comprises at least one indent which enhances the fit of a bottle in the cup.

47. The kit according to claim 41, wherein the cup further comprises at least one indent which damages a bottle when the bottle is removed from the cup.

48. The kit according to claim 41, wherein the applicator is designed for use with a single patient and wherein the applicator comprises means to prevent reuse of the applicator.

49. The kit according to claim 41, wherein the bottle includes a fluid and the fluid includes a therapeutic drug.

50. The kit according to claim 41, wherein the bottle includes a fluid and the fluid comprises saline.

51. The kit according to claim 41, wherein the bottle includes a fluid and the fluid consists of saline.

52. The kit according to claim 41, wherein the bottle includes a fluid and the fluid does not include a therapeutic drug.

53. The kit according to claim 42, wherein the kit is labeled as intended for use with a single patient.

54. The kit according to claim 44, further comprising instructions for use and one or more sterile swabs for cleaning one or more of a surface of the bottle, the cup portion of the applicator, the puncturing device, or a portion of an ultrasound wound therapy device.

55. The kit according to claim 50, wherein the bottle includes a fluid and the fluid does not include a therapeutic drug.

56. A kit comprising, an applicator comprising:

a nozzle including a proximal portion, a distal opening, and a valve interface, and at least one vent hole, the proximal portion being engageable with a portion of an ultrasound wound therapy device, the distal opening allowing at least a portion of a transducer tip of the ultrasound wound therapy device to pass therethrough, the valve interface defining an axis therethrough, and

a valve comprising a valve opening, an upper portion and a lower portion, the upper and lower portion being rotatable with respect to each other, the lower portion being engageable with the valve interface of the nozzle, and the valve opening allowing fluid to flow therethrough and allowing fluid flow to be reversibly turned on and off; and

a fluid bag.

57. The kit according to claim 56, further comprising instructions for use and one or more sterile swabs for cleaning one or more of a surface of the fluid bag, a portion of the applicator, or a portion of an ultrasound wound therapy device.

58. The kit of claim 56, wherein each of the one or more vent holes has a diameter of about 0.05 inches to about 0.20 inches.