Method and device for measuring ultrasonic activity in an ultrasound delivery system

• US 5,390,678 A
• Filed: 10/12/1993
• Issued: 02/21/1995
• Est. Priority Date: 10/12/1993
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Baxter International Inc.
• Inventors: Gesswein, Douglas H., Mills, Timothy C., Klumb, Pete B.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/134,559
• Time in Patent Office: 497 Days
• Field of Search: 128/660.07, 128/661.01, 128/660.04, 128/662.03, 128/662.06, 128/660.03, 73/625, 601/2, 604/22, 606/2.5
• US Class Current: 606/1
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes

Abstract

A device for measuring ultrasonic activity in an ultrasound delivery system has a sensor for providing an output representative of a sensed ultrasound vibration level, an indicator for receiving the output of the sensor and providing an indication of the vibration level sensed thereby, and a rigid body to which the sensor is attached. The rigid body comprises a sensor attaching portion and a catheter abutting portion configured to abut the distal end of an ultrasound delivery system catheter. Ultrasonic activity of the ultrasound delivery system is measured by abutting the distal end of the catheter to the catheter abutting portion of the rigid body and noting the indication provided by the indicator. Use of a disposable sterile catheter abutting portion removeably attachable to the sensor attaching portion facilitates isolation of the sensor attaching portion within a bag along with an ultrasound transducer.

Claims

1. An improved therapeutic ultrasound delivery system comprising:

a) an ultrasound signal generator for providing an ultrasound drive signal;

b) an ultrasound transducer receiving the ultrasound drive signal for converting the ultrasound drive signal into ultrasound vibration;

c) an ultrasound catheter, having proximal and distal ends, attached at the proximal end to the ultrasound transducer, for transmitting ultrasound vibration from the ultrasound transducer to effect treatment at a desired anatomical site; and

d) a device for measuring ultrasonic activity at the distal end of the catheter to verify proper operation of the ultrasound generator, the ultrasound transducer, and the catheter.

2. The system of claim 1 wherein the device for measuring ultrasonic activity of the distal end of the catheter comprises:

a) a sensor for providing an output representative of a sensed ultrasound vibration level;

b) an indicator receiving the output of the sensor and providing an indication of the vibration level sensed thereby;

c) a rigid body to which the sensor is attached, the rigid body comprising;

i) a sensor attaching portion;

ii) a catheter abutting portion configured to abut the distal end of the catheter; and

d) wherein ultrasonic activity of the ultrasound delivery system is measured by abutting the distal end of the catheter to the catheter abutting portion of the rigid body and noting the indication provided by the indicator.

3. The system of claim 2 wherein the sensor comprises an accelerometer apparatus.

4. The system of claim 2 wherein the indicator comprises a meter apparatus.

5. The system of claim 2 wherein:

a) the sensor attaching portion comprises a female threaded coupling;

b) the sensor comprises a male thread coupling engaging the female threaded coupling; and

c) the catheter abutting portion comprises a recess configured to receive the distal end of the catheter.

6. The system of claim 2 wherein the catheter abutting portion is removably and rigidly attachable to the sensor attaching portion so as to facilitate placement of the sensor attaching portion upon one side of a sterile barrier and placement of the catheter abutting portion upon the opposite side of the sterile barrier.

7. The system of claim 6 wherein the catheter abutting portion is maintained in a sterile condition by the sterile barrier prior to use.

8. The system of claim 6 wherein the catheter abutting portion is disposable.

9. The system of claim 2 wherein the indicator is configured to provide an indication of the condition of ultrasound delivery system providing various different desired ultrasonic activity levels to accommodate various different therapeutic procedures.

10. The system of claim 9 wherein the indication of the condition of ultrasound delivery systems comprises a fail/pass type of indication.

11. The system as in claim 10 wherein the indicator comprises a selector for selecting the type of procedure that the ultrasound delivery system is to be utilized in, the indication of the condition of the ultrasound delivery system being responsive to the the selector.

12. An improved therapeutic ultrasound delivery system comprising:

a) an ultrasound signal generator for providing an ultrasound drive signal;

b) an ultrasound transducer receiving the ultrasound drive signal for converting the ultrasound drive signal into ultrasound vibration;

c) an ultrasound catheter, having proximal and distal ends, attached at the proximal end to the ultrasound transducer, for transmitting ultrasound vibration from the ultrasound transducer to effect treatment at a desired anatomical site; and

d) a device for measuring ultrasonic activity of the distal end of the catheter, the device comprising;

i) an accelerometer apparatus for providing an output representative of a sensed vibration level;

ii) a meter apparatus receiving the output of the accelerometer apparatus and providing an indication of the sensed vibration level;

iii) a rigid body comprising an accelerometer apparatus attaching portion to which the accelerometer apparatus is attached and a disposable catheter abutting portion comprising a recess configured to receive the distal end of the catheter, the catheter abutting portion being removably and rigidly attachable to the accelerometer apparatus attaching portion and disposed upon one side of a sterile barrier and the catheter abutting portion disposed upon the opposite side of the sterile barrier;

e) wherein the device for measuring ultrasonic activity verifies proper operation of the ultrasound generator, the ultrasound transducer, and the catheter by measuring ultrasonic activity at the distal end of the catheter.

13. A method for measuring ultrasonic activity in a therapeutic ultrasound delivery system, the method comprising the steps of:

a) activating the ultrasound delivery system;

b) abutting a distal end of an ultrasound catheter of the ultrasound delivery system to a device for measuring ultrasonic activity;

c) noting the level of ultrasonic activity as indicated by an indicator responsive to the device for measuring ultrasonic activity;

d) inserting the distal end of the catheter into a patient'"'"'s vasculature;

e) advancing the distal end of the catheter to a desired location within the patient'"'"'s vasculature; and

f) applying ultrasound energy to effect treatment at the desired location.

14. The method of claim 13 further comprising the step of selecting a desired procedure to be performed, the indicator being responsive to such selection so as to indicate whether the measured level of ultrasonic activity is sufficient for performance of the selected procedure or is insufficient for the performance of the selected procedure.

15. The method of claim 13 wherein the step of noting the level of ultrasonic activity comprises noting a fail/pass indication provided by the indicator.

16. The method as recited in claim 13 wherein the step of abutting a distal end of an ultrasound catheter to a device for measuring ultrasonic activity comprises abutting the distal end of the catheter to a catheter abutting portion formed from a rigid body, the rigid body having a sensor attached thereto for providing an output to the indicator representative of the level of ultrasound vibration sensed thereby.

17. The method as recited in claim 16 further comprising the step of attaching the catheter abutting portion to the rigid body so as to capture a sterile barrier therebetween.

18. The method as recited in claim 17 wherein the sterile barrier comprises a bag.

19. The method as recited in claim 17 further comprising the step of maintaining the catheter abutting portion sterile to use.

20. A method for performing a therapeutic ultrasound procedure, said method comprising the steps of:

a) disposing an ultrasound transducer within a sterile bag such that a sterile ultrasound catheter extends from the bag;

b) disposing a rigid body having an ultrasound vibration sensor attached thereto within the bag;

c) attaching a catheter abutting portion of the rigid body thereto such that the catheter abutting portion is disposed outside of the bag;

d) activating the ultrasound delivery system;

e) abutting a distal end of an ultrasound catheter of the ultrasound delivery system to a device for measuring ultrasonic activity;

f) noting the level of ultrasonic activity as indicated by an indicator responsive to the device for measuring ultrasonic activity; and

g) applying ultrasound energy to effect treatment at an anatomical site.

21. The method of claim 20 further comprising the step of selecting a desired procedure to be performed, the indicator being responsive to such selection so as to indicate whether the measured level of ultrasonic activity is sufficient for performance of the selected procedure or is insufficient for the performance of the selected procedure.

22. The method of claim 20 wherein the step of noting the level of ultrasonic activity comprises noting a fail/pass indication provided by the indicator.

23. The method of claim 20 further comprising the step of again abutting the distal end of the ultrasound catheter to the catheter abutting portion of the rigid body and again noting the level of ultrasonic activity after the step of applying ultrasound energy to an anatomical site.