Method and device for ultrasound drug delivery

• US 6,601,581 B1
• Filed: 11/01/2000
• Issued: 08/05/2003
• Est. Priority Date: 11/01/2000
• Status: Expired due to Term

• Current Assignee: SANUWAVE Health, Inc.
• Original Assignee: Celleration, Inc. (Adynxx, Inc)
• Inventors: Babaev, Eilaz
• Primary Examiner(s): Look, Edward K.
• Assistant Examiner(s): Edgar, Richard A.
• Application Number:
  US09/704,099
• Time in Patent Office: 1,007 Days
• Field of Search: 128/200.14, 128/200.16, 128/203.12, 128/203.15, 604/48, 604/514, 604/57, 604/58, 239/102.2
• US Class Current: 128/200.16
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8262 connectable to external power source, e.g. connecting to automobile battery through the cigarette lighter

Abstract

The present invention concerns a device for creating a directed spray of liquid or powder particles which is produced by contacting the liquid of powder with a radiation surface of an ultrasonic transducer such as a piezofilm or ultrasound tip. The ultrasonic waves cause the spray to project outwardly from the radiation surface and directs it into a patient'"'"'s mouth or onto another target. Directed particle spray delivers sharp dosage and uniformed up to 90% particle size drug delivery.

Claims

1. A device for ultrasonic drug delivery comprising:

(a) means for producing oscillating non-radial ultrasonic waves, said means having a radiation surface; and

(b) means for dispensing a liquid or powder drug onto the radiation surface to produce an aerosol spray upon contact of the dispensed liquid or powder drug with the radiation surface, said aerosol spray having drug particles energized by said oscillating ultrasonic waves;

wherein the means for producing ultrasonic waves operates at a frequency in the range of 20 kHz to 200 kHz, such that said ultrasonic waves carry and direct said energized drug particles into a patient'"'"'s mouth or onto another target for causing penetration of said drug particles below the tissue surface.

2. The device according to claim 1, wherein the means for producing the said oscillating ultrasonic waves comprises a piezofilm or disk, or a transducer tip.

3. The device according to claim 1, wherein the means for producing ultrasonic waves operates at about 100 MHz.

4. The device according to claim 1, wherein the radiation surface is arranged within the device such that the radiation surface is maintained at a distance from the patient'"'"'s mouth or the target to be treated.

5. The device according to claim 1, wherein the radiation surface is positioned within the device at an angle with relation to the horizontal.

6. The device according to claim 5, wherein the radiation surface is positioned within the device at an angle with respect to the horizontal of from 0°

to 90°

.

7. The device according to claim 1, wherein the radiation surface is flat.

8. The device according to claim 1, wherein liquid droplets contact the radiation surface at one point and are atomized.

9. The device according to claim 1, wherein liquid droplets spread on the radiation surface and are atomized.

10. The device according to claim 1, wherein the means for producing ultrasonic waves operates at a fixed frequency.

11. The device according to claim 1, wherein the means for producing ultrasonic waves operates at a modulated frequency.

12. The device according to claim 1, wherein the means for producing ultrasonic waves operates at a pulsed frequency.

13. The device according to claim 1, wherein the means for producing ultrasonic waves produces waves which are sinusoidal.

14. The device according to claim 1, wherein the means for producing ultrasonic waves produces waves which are rectangular.

15. The device according to claim 1, wherein the means for producing ultrasonic waves produces waves which are trapezoidal.

16. The device according to claim 1, wherein the means for producing ultrasonic waves produces waves which are triangular.

17. The device according to claim 1, wherein the liquid or powder drug directed to the patient is precisely dosed with precision suitable for insulin dosing.

18. A method for ultrasonic drug delivery comprising:

(a) providing a means for producing oscillating non-radial ultrasonic waves, said means having a radiation surface;

(b) providing a means for dispensing a liquid or powder drug onto the radiation surface in order to produce an aerosol spray upon contact of the dispensed liquid or powder drug with the radiation surface, said aerosol spray having drug particles energized by said oscillating ultrasonic waves; and

(c) propagating said drug particles into a patient'"'"'s mouth or onto another target, said oscillating ultrasonic waves carrying and directing said energized drug particles for causing penetration of said drug particles below the tissue surface;

wherein the means for producing ultrasonic waves operates at a frequency in the range of 20 kHz to 200 kHz.

19. A device for ultrasonic drug delivery comprising:

(a) a transducer for producing ultrasonic waves, said transducer having a radiation surface positioned at a predetermined intersecting angle with respect to the horizontal; and

(b) a dispenser for dispensing a fluid drug onto the radiation surface to produce an aerosol spray of drug particles having substantially uniform size, wherein the distance between the radiation surface and a dispensing end of the dispenser is greater than the diameter of a drop of fluid dispensed by the dispenser;

wherein the transducer operates at a frequency in the range of 20 kHz to 200 kHz, such that said ultrasonic waves carry and direct said energized drug particles into a patient'"'"'s mouth or onto another target for causing penetration of said drug particles below the tissue surface.

20. The device according to claim 19, wherein the fluid drug is selected from the group consisting of antibiotics, antiseptics, saline, water, and oils.

21. The device according to claim 19, wherein the distance between the radiation surface and the dispensing end of the dispenser is greater than or equal to 0.5 mm.

22. A device for ultrasonic drug delivery comprising:

(a) a transducer for producing non-radial ultrasonic waves, said transducer having a radiation surface positioned at a predetermined intersecting angle with respect to the horizontal; and

(b) a dispenser for dispensing a powder drug onto the radiation surface to produce an aerosol spray of drug particles having substantially uniform size;

wherein the transducer operates at a frequency in the range of 20 kHz to 200 kHz, such that said ultrasonic waves carry and direct said energized drug particles into a patient'"'"'s mouth or onto another target for causing penetration of said drug particles below the tissue surface.

23. A method for ultrasonic drug delivery comprising:

(a) providing a transducer for producing oscillating ultrasonic waves, said transducer having a radiation surface positioned at a predetermined intersecting angle with respect to the horizontal;

(b) providing a dispenser for dispensing a fluid drug onto the radiation surface in order to produce an aerosol spray of drug particles having substantially uniform size, wherein the distance between the radiation surface and a dispensing end of the dispenser is greater than the diameter of a drop of fluid dispensed by the dispenser;

(c) directing said substantially uniform size drug particles into contact with a patient; and

(d) operating said transducer at a frequency in the range of 20 kHz to 200 kHz, such that said ultrasonic waves carry and direct said energized drug particles into a patient'"'"'s mouth or onto another target for causing penetration of said drug particles below the tissue surface.

24. The method according to claim 23, wherein the fluid drug is selected from the group consisting of antibiotics, antiseptics, saline, water, and oils.

25. The method according to claim 23, wherein the distance between the radiation surface and the dispensing end of the dispenser is greater than or equal to 0.5 mm.

26. A method for ultrasonic drug delivery comprising:

(a) providing a transducer for producing non-radial ultrasonic waves, said transducer having a radiation surface positioned at a predetermined intersecting angle with respect to the horizontal;

(b) providing a dispenser for dispensing a powder drug onto the radiation surface to produce an aerosol spray of drug particles having substantially uniform size;

(c) directing said substantially uniform size drug particles into contact with a patient; and

(d) operating said transducer at a frequency in the range of 20 kHz to 200 kHz, such that said ultrasonic waves carry and direct said energized drug particles into a patient'"'"'s mouth or onto another target for causing penetration of said drug particles below the tissue surface.