Acoustic add-on device for biofilm prevention in urinary catheter

• US 20070244423A1
• Filed: 03/29/2007
• Published: 10/18/2007
• Est. Priority Date: 05/29/2002
• Status: Active Grant

• Current Assignee: NanoVibronix Inc.
• Original Assignee: NanoVibronix Inc.
• Inventors: Zumeris, Jona, Jacob, Harold
• Granted Patent: US 7,829,029 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2205/10 with powered movement mechanisms
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Abstract

A urinary catheter clip-on device applies surface acoustic waves of Rayleigh-Lamb and/or Love type to a urinary catheter for preventing biofilms on the catheter surfaces. The bacteria is forced to move relative to the vibrating catheter surface. The amplitudes of bacteria vibrations are in nanometer range. The relative motion of bacteria results in bacteria quorum sensing, and disrupts the bacteria attachment process. The method is preventive as surface acoustic waves create low acoustic energy and bacteria is not killed.

Claims

1. A device for preventing catheter associated urinary tract infections on a urinary catheter positioned at least partially within a patient'"'"'s body, the device comprising:

an actuator coupled to the catheter at a location outside of the patient'"'"'s body, and

a driver electrically connected between said actuator and said catheter,

whereby the actuator generates acoustic surface waves of Rayleigh—

Lamb or Love type, or both, on the catheter and transmits acoustic surface waves around the catheter surface in the direction towards the patient'"'"'s body,

whereby the surface waves mechanically create relative oscillation velocity of bacteria in relation to the catheter surface to thereby prevent their attachment to the catheter surfaces.

2. The device according to claim 1, wherein the surface wave-generated bacterial relative elliptical oscillation amplitudes are smaller than the ??potential repulsive zone, an overall net repulsion occurs, being effective in:

inhibiting bacteria attachment to urinary catheter surfaces,

inhibiting adhesion, growth and aggregation of cells into micro colonies on urinary catheter surfaces; and

inhibiting maturation and dissemination of progeny cells for new colony formation.

3. The device according to claim 1, wherein said surface acoustic waves have mechanical amplitudes in the range from about 0.1 nanometers to about 5 nanometers.

4. The device according to claim 3, wherein the velocity of said running wave is about 14 m/s to about 30 m/s, and said velocity magnitudes being close to the acoustic wave velocity in the skin, such that the created acoustic wave does not additionally irritate the skin tissue.

5. The device according to claim 1, wherein the actuator creates an acoustic energy transmission lines towards the liquid and body tissues in acoustic contact with urinary catheter, which may have two components:

a) at a depth equal to two surface wave lengths towards the body tissues, the tissue particles are mechanically-elliptically oscillating, with a velocity of tenths of a meter/second;

b) at a the depth exceeding two surface wave lengths towards the body tissues, the tissue particles are lineally-mechanically oscillating, with nanometer amplitudes;

which thereby result in positive effects on tissues, followed by one or more of the following;

increased repair and healing processes, increased growth of capillary, increased ph of tissue liquids, lowered pain syndrome, and micro massaging.

6. The device according to claim 1, further comprising an additional vibration energy source from balloon resonance.

7. The device according to claim 6, wherein balloon vibrations are excited due to longitudinal type waves transmitted through liquids filling the inflation channel of the balloon and exciting balloon resonance resulting from actuator oscillations in the same frequency as the natural balloon self resonance frequency;

8. The device according to claim 7, wherein the acoustic energy generated by said balloon exceeds by about 5 to about 10 times the surface acoustic energy excited on the catheter surface by said actuator, and the ranges of balloon mechanical vibration amplitudes are from about 0.5 to about 5.0 nm.

9. The device according to claim 8, wherein part of said acoustic surface wave has a transversal vector of up to about 5 cm and whereby biofilm formation is prevented not only on the catheter surface but also on human tissue in adjacent contact with the catheter.

10. The device according to claim 9, wherein the controlling of balloon pressure and shape comprises obtaining directional and focused acoustic energy from balloon to body tissues in contact with it, by this action controlled therapeutic effect may be applied.

11. The device according to claim 1, wherein said driver comprises a controller with power supply, a central processing unit with memory, alarm indicators and oscillator of pulsed or harmonic signals for generating electrical signals which are transformed to actuator.

12. The device according to claim 11, wherein said alarm indicators comprise one or more of a power indicator, low battery circuit, low voltage circuit alarm visual indicator, and an acoustic indicator.

13. The device according to claim 11, wherein said actuator comprises a housing formed of two opening housing parts, a first of said parts containing springing material attached to an internal surface thereof and the second of said parts containing a piezo resonator element.

14. The device according to claim 13, wherein said piezo resonator element is, by means of gluing tape, attached to said springing material, and the acoustically transmitting gluing material is attached to the external surface of said piezo resonator element and is coupled to the external surface of the urinary catheter.

15. The device according to claim 14, wherein said piezo resonator transforms electrical signals to mechanical vibrations which excite surface acoustic waves having mechanical vibration amplitudes of from about 0.1 to about 0.3 nm, said surface waves propagating along the catheter surface.

16. The device according to claim 15, wherein said piezo resonator is a disk-shaped thin piezo ceramic element with electrodes.

17. The device according to claim 14, wherein said piezo resonator element is coupled to the catheter via stabilizing needles for better acoustic energy transfer and elimination of actuator slipping.

18. The device according to claim 16, wherein the vibrations of said actuator piezo element may be applied in multimodes chosen from thickness, longitudinal, and a combination thereof.

19. The device according to claim 16, wherein the acoustic energy is achieved with at least one disk shaped piezo element having dimensions:

26×

26×

0.10 (mm).

20. The device according to claim 19, wherein said piezo resonator element is coated with a silver electrode on one side and with a thin metallic layer on the other side, and the diameter of said metallic layer should be equal to or exceed the piezo element diameter.

21. The device according to claim 11, further comprising a second driver for supplying electric signals to the piezo element, the signals being selected from at least one of the following group:

megahertz frequency signals, kilohertz frequency signals and of electric signals forms and duty cycles, and combinations thereof.

22. The device according to claim 21, wherein said second driver is integrated into the actuator as a chip.

23. The device according to claim 21, whereby the actuator applies short-term stress so as to dislodge the bacteria from the catheter surface.

24. The device according to claim 16, wherein the range of the piezo ceramic oscillations frequencies is from about 1 Hz to about 10 MHz.

25. The device according to claim 16, wherein the distances between max or min vibration amplitudes points of the piezo element must be equal to half surface acoustic wave length excited on the catheter material.

26. The device according to claim 16, wherein the waves are generated in a longitudinal and bending vibration modes by a piezo resonator having a polarization axis perpendicular to the surface of the catheter.

27. The device according to claim 16, wherein the waves are generated by a piezo ceramic material joined to a metal material into a bimorph element, each material being present in a layer at a respective thickness ratio of about 0.95 to about 1.35.

28. The device according to claim 16, wherein said electrodes have non-conductive portions, which may be parallel or non-parallel to the direction of polarization, and the single phase, two-phase, or multi phase electrical signal may be sent from said driver to said electrodes, and

wherein, by means of different connections between electrodes longitudinal, bending and thickness vibrations may be excited simultaneously or separately.

29. The device according to claim 1, wherein the particles and bacteria on the catheter surface are forced in a direction opposite to the direction of vibration transmission, thereby preventing bacteria propagation extraluminally and forcing said bacteria out of the patient'"'"'s body.

30. The device according to claim 1, wherein the energy of said acoustic surface waves has a transverse character, such that the energy may be transferred to the tissues of the human body from an external surface thereof and transferred to urine from the internal surface of the catheter, thus preventing bacteria propagation intraluminally.

31. The device according to claim 30, wherein said transverse vibration energy affects the fluids upon contact and the friction of the fluids is reduced, whereby the vibration may expel the fluid and drying process at the point of contact with the body, which slows or prevents the entry of bacteria extraluminally.

32. The device according to claim 1, wherein mechanical vibration energy is generated by a piezo element, achieving the pushing or pulling of fluids and particulates suspended therein along the surfaces of the catheter.

33. The device according to claim 1, wherein vibrational energy of said acoustic surface waves is of a kind sufficient to stimulate or release nitric oxide from at least small areas of targeted organs or tissues.

34. The device according to claim 1 wherein acoustic surface waves induced on urinary catheter material prevent bacteria virulence occurrence and result in antibiotic use reduction for treatment.

35. The device according to claim 1, wherein vibrational energy of said acoustic surface waves reduces existing biofilm, augments the effectiveness of antibiotics against the biofilm and produces antimicrobial and antithrombogenic surfaces.

36. The device according to claim 1, wherein acoustic surface waves induced micro streaming and affect in wound healing process.

37. The device according to claim 1, wherein vibrational energy of said acoustic surface waves inhibits infections of inner organs in acoustic contact with catheter

38. The device according to claim 1, wherein vibrational energy of said acoustic surface waves increases slipping of the catheter and lowers coefficient of friction, thereby preventing injury, irritation, inflammation, ensuring less pain and less trauma to the patient and facilitating medical and surgical procedures.

39. The device according to claim 1, wherein said urinary catheter is coated on an internal or external surface thereof, or on both surfaces thereof, by copper, silver alloy, silver hydrogel, antibiotic coat, or any other antimicrobial coat, and said device thereby prevents bacteria adhesion and biofilm formation on these antimicrobial surfaces, increasing antimicrobial action time of the coating agents.

40. The device according to claim 39, wherein said surface acoustic waves are applied in the interface between catheter material surface and coating layers, thereby influencing on antimicrobial agent activeness, controlling the velocity and time of this agent'"'"'s diffusion.

41. The device according to claim 39, wherein said surface acoustic waves are applied in the interface between said catheter coating layer and body tissues, thereby resulting in prevention of contaminations from occurring on the surface and thus increasing antimicrobial action time of the coating agents, increasing antimicrobial agent activeness, controlling the velocity and time of this agent'"'"'s diffusion.

42. The device according to claim 39, wherein said surface acoustic waves are applied in two interfaces:

between catheter material surface and coating layers and between said catheter coating layer and body tissues, thereby resulting in prevention of contaminations to occur on the surface and thus increasing antimicrobial action time of the coating agents, increasing antimicrobial agent activeness, controlling the velocity and time of this agent'"'"'s diffusion.

43. The device according to claim 5, wherein said urinary catheter is coated on an internal or external surface thereof, or on both surfaces thereof, by copper or silver alloy, silver hydrogel, antibiotic coat, or any other antimicrobial coat, and the balloon resonance thereby increases antimicrobial action on tissue healing processes in addition to preventing bacteria adhesion and biofilm formation on these antimicrobial surfaces and increasing antimicrobial action time of the coating agents.

44. The device according to claim 6, wherein the electric pulses produce piezoelectric effects which generate high frequency micro-mechanical vibration energy in the actuator at frequencies of from about 100 to about 500 kHz with acoustic intensity of 200 mW/cm² and amplitudes of 300-800 nanometers.

47. The device according to claim 1, wherein the catheter is manufactured from materials including:

silicone rubber, Teflon®

, polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyurethane (PU), polytetrafluoroethylene (PTFE), Nylon®

, polyethylene terephthalate (PET), and glass, the said materials being used alone or with different coats.

48. The device according to claim 1, wherein the catheter is manufactured from materials with enhanced surface area substrates such as nanofiber substrates, other riffled surfaces

49. The device according to claim 1, wherein said actuator lowers the coefficient of friction of said catheter surface, thereby prevent injury, irritation, or inflammation to the patient and to facilitate medical and surgical procedures.

50. The device according to claim 1, wherein said actuator is attached to the patient'"'"'s leg with a specially designed securement system.

51. The device according to claim 1, wherein said actuator is incorporated into a detachable patch that can be secured to said patient'"'"'s leg, and is connected to either a disposable or nondisposable energy source and said driver.

52. The device according to claim 1, wherein said surface acoustic waves have frequencies in the range from about 100 KHz to about 1 MHz.

53. The device according to claim 1, wherein said surface acoustic waves are of running wave type.

45. An actuator for prevention of RBC aggregation, by creating surface acoustic energy wherein acoustic surface waves are activated with from about 0.05 to about 0.2 mW/cm² to effectively prevent E. coli-induced RBC aggregation;

whereby these surface waves mechanically create relative oscillation velocity of bacteria in relation to RBC, and thereby prevent their aggregation.

46. The actuator according to claim 45, wherein increasing the output to beyond a 0.35 mW/cm² threshold converts the inhibition into a significant enhancement of bacterial attachment and can activate FimH force sensor activity.