Device and process for simulating a patient's blood...

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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C378S018000, C378S207000

Reexamination Certificate

active

06314313

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention belongs to the field of devices that make it possible to simulate the body or a part of the body of a patient for the testing of an X-ray apparatus.
An X-ray apparatus generally comprises a tube that allows the emission of an X-ray beam in a given direction, means for positioning at least one part of a patient's body in the X-ray beam, and receiving means that sense the X-rays disposed in the beam after it has passed through the patient's body part. An X-ray apparatus requires the control of many parameters that can deviate over the course of time, which requires maintenance interventions at regular intervals. The reduction in the quality of the images obtained by the receiving means can be linked, for example, to slight changes in the geometry of the apparatus due to wear on the parts, or to variations in the magnetic field surrounding the apparatus.
In order to characterize such deviations, it is necessary to obtain a device that makes it possible to simulate the body of a patient. The display of the simulation device on a screen takes place in a way that is identical to that of the patient's body, and makes it possible to reveal possible deviations and thus to determine whether the X-ray apparatus is working with a precision greater than the minimal precision required or whether, on the contrary, the X-ray apparatus should undergo a maintenance operation in order to restore the precision of the images obtained.
Simulation devices of this type are particularly useful in the field of vascular imaging by image subtraction. The blood vessels of the human body being naturally transparent to X-rays, an image is first taken without the addition of an opacifying product, after which an opacfying product, for example iodine-based, is injected into the patient's blood, which makes the blood opaque to X-rays, then a second image is taken after the opacifying product has been properly distributed through the patient's vascular network. The two images or series of images obtained being numbered by electronic means, an image subtraction is then performed, making it possible to remove from the second image the organs visible in the first one, i.e., the organs naturally visible to X-rays such as the bones, etc.
To simulate the body or a part of the body of a patient, it is possible to use a network of flexible conduits through which water, which is quasi-transparent to X-rays, is first circulated in order to perform the first image acquisition, then through which water to which an opacifying product, generally iodine, is added before performing the second image acquisition. Next, the image substraction is performed in order to display the liquid circuit and to determine whether the X-ray apparatus is properly adjusted or, conversely, whether the image obtained has inconsistencies relative to the liquid circuit, whose geometry is known. However, a device of this type requires the utilization of a liquid, which complicates its handling. The iodine used as an opacifying product can cause bright spots, and it makes it necessary to wash the liquid circuit completely after its use. The handling of these simulation devices is therefore complicated, awkward, time-consuming and hence, costly.
BRIEF SUMMARY OF THE INVENTION
The present invention is a simulation device that is easy to handle and does not require any modification of the X-ray apparatus, while being adaptable to various types of X-ray apparatuses.
The device for simulating a patient's body provides for the testing of a vascular X-ray apparatus of the type comprising a means for emitting an X-ray beam, a means for receiving the X-ray beam, a means for displaying the images obtained, and a means for controlling the injection of opacifying liquid into the patient's vessels.
The simulation device comprises a stationary part for simulating the patient's bones and soft tissues and a moving part for simulating the patient's opacified blood vessels, so as to be able to perform at least one acquisition of an image of the stationary part alone and at least one acquisition of the image of the stationary part and the moving part together, and to obtain an image of the moving part by means of image subtraction. An important advantage of the simulation device is that it does not require the use of difficult-to-handle opacifying products, and that it can be used dry, without the use of water.
Advantageously, the simulation device comprises a means for moving the moving part between a position outside the X-ray beam and a position inside the X-ray beam. The moving means is preferably capable of being controlled by the means for controlling the injection of opacifying liquid. The moving means can comprise a pneumatic actuator, one end of which is integral with the stationary part and another end of which is integral with the moving part, a conduit for supplying air to the actuator, and a syringe connected to the supply conduit of the actuator. The syringe can be disposed inside the means for controlling the injection of the opacifying liquid into the patient's vessels.
Preferably, the syringe is filled with air at the atmospheric pressure.
In one embodiment of the invention, the stationary part has a hollow shape and is made of plexiglas. It can also be made of polycarbonate or any other material of comparable density.
In one embodiment of the invention, the moving part is disposed inside the stationary part and is made of a metal alloy on a plastic support.
The invention is a process for simulating a patient's body for the testing of a vascular X-ray apparatus of the type comprising a means for emitting an X-ray beam, a means for receiving the X-ray beam, a means for displaying the images obtained, and a means for controlling the injection of opacifying liquid into the patient's vessels, in which at least one acquisition of images of a stationary part for simulating the patient's bones and soft tissues and at least one acquisition of images of the stationary part and of a moving part for simulating the opacified blood vessels of the patient are performed, and an image of the moving part is obtained by means of image subtraction.
The simulation device can be controlled by the X-ray apparatus by installing an air-filled syringe into the means for controlling the injection of opacifying liquid. When the syringe is actuated, the air contained in it is forced into the conduit, then into a chamber of the pneumatic actuator, causing the moving part to move from one position to another position. A movement of the syringe in the opposite direction causes the stationary part to move in the opposite direction.
The simulation device can therefore be controlled by the X-ray apparatus without any modification of the latter, or any addition of electronic means that could be complex and costly.


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