Ultrasonic catheter drug delivery method and device

• US 6,723,064 B2
• Filed: 06/04/2003
• Issued: 04/20/2004
• Est. Priority Date: 03/21/2001
• 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): Fristoe, Jr., John K
• Application Number:
  US10/454,654
• Publication Number:
  US 20030229304A1
• Time in Patent Office: 321 Days
• Field of Search: 604/21, 604/22, 604/27, 604/13, 606/169
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

An ultrasonic catheter drug delivery device comprises an ultrasound transducer to produce ultrasonic waves, which transducer is mechanically attached to a catheter body or chamber. The ultrasonic transducer has a distal tip with a distal radiation surface, and when a therapeutic agent from a fluid source is directed to the catheter body or chamber, the radiation surface creates ultrasonic pressure and delivers liquid and simultaneously ultrasonic energy to a patient'"'"'s vascularity or a selected body lumen. The method applies therapeutic agent and ultrasonic waves to the vascular area, lung or any body lumen without requiring direct contact between ultrasound transducer and body, dissolves blood clots, and stimulates tissue cells.

Claims

1. A catheter system for ultrasound drug delivery, comprising:

a catheter having a proximal portion comprising a chamber and a distal end, wherein at least one lumen extends longitudinally from said chamber to said distal end;

at least one fluid source in fluid communication with said chamber and providing at least one fluid; and

an ultrasound transducer having a distal end configured and dimensioned to propagate ultrasound waves through said catheter, wherein said ultrasound waves are propagated by the at least one fluid within at least a portion of said catheter by inducing wave motion in said at least one fluid to deliver fluid and/or ultrasound energy to the catheter distal end.

2. The catheter system of claim 1, wherein the transducer distal tip is positioned coaxially outside the chamber.

3. The catheter system of claim 1, wherein wave motion is induced in the at least one fluid adjacent to the transducer distal end.

4. The catheter system of claim 1, wherein the at least one fluid and ultrasound energy are delivered simultaneously to the catheter distal end.

5. The catheter system of claim 1, wherein the transducer distal tip has a central orifice in fluid communication with a fluid source of said at least one fluid source and said chamber.

6. The catheter system of claim 5, wherein the surface of the orifice is non-smooth.

7. The catheter system of claim 5, wherein the orifice surface is ringed, slotted, waved, grooved, or threaded.

8. The catheter system of claim 5, wherein the orifice is configured and dimensioned for admixing the at least one fluid from the at least one fluid source therein.

9. The catheter system of claim 1, wherein the transducer is capable of operating at a frequency of from about 10 kHz to 10³ MHz.

10. The catheter system of claim 1, wherein the transducer distal tip comprises a radial surface and a distal radiation surface.

11. The catheter system of claim 10, wherein the radial surface is not smooth.

12. The catheter system of claim 10, wherein the radial surface is ringed, slotted, waved, grooved, or threaded.

13. The catheter system of claim 10, wherein the distal radiation surface is flat, conical, oval, circular, semi-spherical, square, or rectangular.

14. The catheter system of claim 1, wherein the at least one fluid is a therapeutic agent.

15. The catheter system of claim 1, wherein at least a portion of the ultrasound transducer can be moved backward and/or forward to change ultrasound pressure and/or delivered ultrasound energy level.

16. A catheter system for ultrasonically treating an interior area of the body, the system comprising:

a catheter having at least one lumen;

a transducer having a distal radiation surface configured and dimensioned for coupling with a proximal end of the catheter and for emitting ultrasonic energy therein; and

at least one fluid source for introducing at least one fluid within the proximal end of the catheter, wherein the emitted ultrasonic energy is delivered to the interior area of the body by the at least one fluid through the at least one lumen for treating the interior area of the body with ultrasonic energy.

17. The catheter system according to claim 16, wherein the transducer operates at a frequency from 10 kHz to 10,000 MHz.

18. The catheter system according to claim 16, further comprising means for translating the distal radiation surface for regulating at least one characteristic of the emitted ultrasonic energy.

19. The catheter system according to claim 16, further comprising means for sealingly engaging the distal radiation surface within the proximal end of the catheter.

20. An internal treatment method comprising the steps of:

inserting at least a portion of an ultrasound emitting catheter into a body to be treated, wherein said ultrasound catheter includes an ultrasound transducer with a distal radiation end in fluid communication with the catheter distal tip through at least one lumen, said at ultrasound catheter further including a chamber for introducing at least one fluid therein from at least one fluid source;

guiding the catheter to an internal treatment site;

introducing the at least one fluid within said chamber; and

actuating the ultrasound transducer to emit ultrasonic energy for being propagated via the at least one lumen to the treatment site by said at least one fluid.

21. A treatment method as in claim 20, wherein the ultrasonic catheter has a user-adjustable ultrasonic frequency range including at least a plurality of frequencies between 10 kHz and 1000 MHz.

22. A treatment method as in claim 20, wherein said treatment is beneficial for the promotion of healthy tissue growth or treatment of conditions in the group consisting of ailments affecting urethra, ureter, and fallopian tubes, impotency, and urological disorders related with prostate gland.