Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2000-03-10
2001-09-11
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S465000
Reexamination Certificate
active
06287260
ABSTRACT:
The present invention relates essentially to a method and to apparatus for improving the accuracy with which the speed of a fluid, such as a liquid, in particular blood flowing in a duct, such as a blood vessel, in particular the aorta, is measured by means of a signal emitted by a Doppler transducer.
BACKGROUND OF THE INVENTION
Document FR-A-2 424 733 INSERM discloses an ultrasound intracorporeal probe that is inserted into the esophagus to measure the flow rate in the aorta. That prior probe is characterized by a catheter structure whose distal portion has a bag that can be inflated from the outside with a liquid and that surrounds the ultrasound emitter which is housed entirely inside the bag which serves to prevent the emitter from moving inside the duct and which serves to couple the emitter acoustically. The emitter is mounted to rotate inside said inflatable bag on a support block which is disposed substantially on the longitudinal axis of the probe, and it is rotated by a flexible cable connected at its proximal end at the outside to rotary drive means, e.g. in the form of a knob (see the claims and the corresponding text describing the figures, in particular page 2, line 24 to page 4, line 29).
That prior INSERM document has been improved in the context of document U.S. Pat. No. 5,479,928 according to which the intracorporeal probe has in combination: at least one broad-beam ultrasound transducer fixed on the support block in such a manner as to be oriented at an angle of inclination that is not perpendicular relative to the longitudinal axis of the probe; and at least one narrow beam ultrasound transducer fixed on the support block so as to be oriented at an angle that is essentially perpendicular relative to the longitudinal axis of the probe so as to be oriented substantially perpendicularly relative to the longitudinal axis of a duct in which the speed of a liquid is to be measured, and in particular the flow rate of the liquid, specifically the flow rate of blood when the duct is a blood vessel.
The improvement according to that document is entirely satisfactory and is available on the market from SOMETEC under the trade name DYNEMO 3000®.
OBJECTS AND SUMMARY OF THE INVENTION
A main object of the present invention is to resolve the novel technical problem consisting in supplying a solution enabling account to be taken of each feature of the Doppler transducer in order to improve the accuracy with which the speed of a fluid, such as a liquid, is measured by means of a signal emitted by such a Doppler transducer.
Another main object of the present invention is to supply a solution making it possible also to take account of the 3D position of a Doppler transducer, and in particular the angle at which it emits the ultrasound beam, thereby improving the accuracy with which the speed of a fluid, such as a liquid, is measured by means of the signal emitted by such a Doppler transducer.
Another main object of the present invention is to resolve the said novel technical problems in a manner that is particularly simple, low cost, reliable, and usable on a medical and industrial scale.
Those problems are resolved for the first time by the present invention at low manufacturing cost by means of a design that is particularly simple, using a small number of parts, while conserving the operating advantages of prior art probes, in particular the improved probe constituting the subject matter of document U.S. Pat. No. 5,479,928, and sold in the form of the DYNEMO 3000® appliance.
In a first aspect, the present invention provides a method of improving the accuracy with which the speed of a fluid, such as a liquid, in particular blood flowing in a duct, such as a blood vessel, in particular the aorta, is measured by means of a signal emitted by a Doppler transducer, the method being characterized in that the Doppler transducer is associated with a programmable memory which contains at least one correction data item for correcting the Doppler signal transmitted by the transducer to a transducer control and computer unit, in that said computer unit incorporates said signal correction data item in its computation during each speed measurement on the basis of each signal emitted by the Doppler transducer, and computes the speed value while taking account of said correction data item, so as to provide a corrected measurement of the speed of said fluid, thereby improving the accuracy of the measurement.
According to an advantageous characteristic of the method, it is characterized in that said Doppler transducer is incorporated or integrated in a probe, in particular an intracorporeal Doppler effect probe, said Doppler transducer being mounted on the probe to emit an ultrasound beam at an angle relative to the longitudinal axis of the probe; and in that said probe also comprises said programmable memory.
According to another advantageous implementation of the method, it is characterized in that said programmable memory also contains at least one sensitivity data item for informing the user of loss of sensitivity to the Doppler signal, and in that said transducer control and computer unit verifies said sensitivity data item present in the programmable memory on each measurement of the signal transmitted by the transducer in order to verify that the sensitivity as actually obtained on a signal transmitted by the transducer is not too far removed from the sensitivity value present in the programmable memory, and on going beyond a specified limit value, said transducer control and computer unit issues a signal to the user indicative of a loss of sensitivity.
According to yet another advantageous characteristic of the invention, the method is characterized in that the said signal correction data item is obtained on the basis of tests, preferably performed at the manufacturing site, while performing preliminary use tests on the Doppler transducer in order to verify the reliability of its signal.
According to another advantageous characteristic of the method of the invention, it is characterized in that the sensitivity data item is obtained during tests, preferably performed at the manufacturing site, while measuring the flow speed of a fluid that is flowing at a known speed.
According to yet another advantageous characteristic of the method of the invention, the method is characterized in that the signal correction data item comprises at least the angle at which the Doppler beam is emitted by the Doppler transducer relative to the axis of the probe, so that the speed value takes account of said real working angle of the beam from the Doppler transducer.
Advantageously, the sensitivity data comprises at least one average of a plurality of sensitivity measurements obtained with a corresponding number of uses of the Doppler transducer, each sensitivity measurement resulting from the amplitude of the signal received from the transducer.
According to another advantageous characteristic of the method of the invention, it is characterized in that the transducer control and computer unit continuously computes the mean of a plurality of recently calculated sensitivity measurements and compares it with the sensitivity mean initially written as sensitivity data in the programmable memory, and, beyond a certain difference relative to the initially programmed sensitivity measurement, issues a signal to the user indicative of a loss of sensitivity.
According to yet another advantageous characteristic of the invention, the method is characterized in that when the Doppler transducer operates in combination with an additional transducer, e.g. for measuring the diameter of a duct in which said fluid flows, at least one sensitivity data item relating to said additional transducer is preferably also provided in said programmable memory in order to verify its sensitivity over time and likewise issue a signal to the user in the event of sensitivity being lost.
In a second aspect, the present invention also provides an apparatus for improving the accuracy with which the speed of a fluid, such as a liquid, in partic
Hascoet Gerard
Pechoux Thierry
Amster Rothstein & Ebenstein
Arrow International Inc.
Lateef Marvin M.
Patel Maulin
LandOfFree
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