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    • 专利摘要:
    Device, system and procedure for obtaining computational rhinomanometric curves. The invention relates to a device comprising 6 high frequency ultrasound transducers that allow obtaining 2d digital images of the nasal cavity, which are coupled to a closed structure of elliptical-annular shape. The invention also relates to a system comprising, in addition to the above device, computer processing means configured to manage the electronic means for controlling the device; as well as a procedure that comprises the following steps in a joint and automated way: segmentation of the nasal geometry from the 2d images in dicom format; computational meshing of surface and volume; simulation of the air flow through the nostrils through the numerical discretization of the navier-stokes equations; determination of integral magnitudes both of the flow and of the average pressure drop in the choana; and determination of rhinomanometric curves. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2608861A1
    申请号:ES201630891
    申请日:2016-06-30
    公开日:2017-04-17
    发明作者:Manuel Antonio BURGOS OLMOS；Enrique SANMIGUEL ROJAS；Carlos DEL PINO PEÑAS
    申请人:Universidad de Malaga；Universidad Politecnica de Cartagena；
    IPC主号:
    专利说明:

    DESCRIPTIONDevice, system and procedure for obtaining computational rhinomanometric curves
     5
    Technical Field of the Invention

    The present invention corresponds to the technical field of Engineering applied to Medicine, and more specifically, to the field of rhinomanometry. More specifically, the invention relates to both devices and systems for obtaining high frequency ultrasound digital images in DICOM format of the human nasal cavity from which a three-dimensional reconstruction of said cavity can be generated that allows Obtaining computational rhinomanometric curves. The invention also relates to procedures for the automated obtaining of said computational rhinomanometric curves from digital images in DICOM format of the nasal cavity obtained, either by high-frequency ultrasound or by other imaging techniques for medical use such as nuclear magnetic resonance ( NMR) or computed tomography (CT).  twenty Background of the invention

    Currently, Medicine applies a lot of engineering knowledge to make a better diagnosis of diseases. In particular, Computational Fluid Dynamics (CFD) is a branch of Fluid Mechanics Engineering that solves Navier-Stokes equations 25 that describe the movement of a fluid using computational techniques.

    One of the most widespread instruments to know the flow of air through the human nostril is the conventional rhinomanometer, in which the data of air flow 30 are collected against the loss of pressure that occurs in each nasal passage of independently. Thus, rhinomanometry is the exploratory method that measures air flows and resistance to the passage of these flows in the nostril. To determine rhinomanometric curves with current rhinometers, it is necessary to alter the natural passage of air through the nostril, since it is mandatory to place a flow or pressure sensor that partially or totally blocks one of the nasal passages, or good
    Put on a mask. This modification or intrusion into the natural morphology of the nostril by blocking a passage or placing an obstacle like a mask, completely breaks the real pattern of the flow that would be in normal breathing conditions, that is, with both free passages.
     5
    With the present invention it is intended to accurately determine the rhinomanometric curves in a non-intrusive manner, for which it is necessary to previously have a three-dimensional reconstruction of the nostril in order to identify the geometry through which the air flow circulates. This geometry is very complex given the characteristics of the nostril since there are areas of very different morphology such as the nostrils, the nasal septum, the 10 turbinates, the nasal valve, the choana, etc. Taking into account that within a nostril the surface in contact with the air is considerably increased thanks to the turrets, in order to improve the heat exchange, this partly explains this complexity in its morphology.
     fifteen
    Today, this three-dimensional reconstruction begins with the generation of images of consecutive cross sections of the nostril every 2 or 3 millimeters, and these images are exported in a format called DICOM (English, digital image and communication in Medicine). This format can be generated both by CT (Computerized Axial Tomography) tests that use X-rays, and by nuclear magnetic resonance imaging (NMR).

    However, in this invention the use of ultrasound is proposed to perform the three-dimensional reconstruction of the nostril, based on the emission of ultrasound. Ultrasound is defined as that sound that has a frequency greater than that which can be heard by humans, that is, greater than 20,000 Hz. Thus, this technique is based on echoes, that is, how the emitted ultrasound is reflect. Ultrasound is a diagnostic technique that collects the ultrasound emitted by a probe, which cross to a certain depth (depending on the frequency of the probe) the part of the body that you want to explore, taking advantage of the different speeds of ultrasound propagation through 30 body tissues.

    Although ultrasound can provide less anatomical information than techniques such as CT or MRI, it has interesting advantages: it is very safe, since the patient is not exposed to nuclear radiation and, in addition, ultrasound does not seem to cause any adverse effects; 35 is also a relatively cheap technology and much faster to manufacture and implement.
    On the other hand, this proposal aims to determine only the rhinomanometric curves that are obtained from integral quantities such as flow and pressure drop. Therefore, the high degree of precision obtained in nasal reconstruction by radiological or nuclear tests is not necessary. However, ultrasound technology is evolving very fast, and it is usual to diagnose 5 diseases in fetuses using this technique.

    Next, the state of the art is reviewed where several examples of documents that try to measure rhinomanometric curves by means of different devices are provided.
     10
    WO2000006019 A1 refers to an acoustic method for reconstructing part of the nostril. In this document, it refers to a device for the measurement of cross sections in the right and left passage of the patient's nostril, at the junction of both passages (coana), as well as to detect the opening of the eustachian tube. The apparatus comprises an electro-acoustic sound emitter, primary and secondary transmission tubes, a computer for generating electrical signals for the transmitter and for sampling, as well as the analysis of electrical signals from the microphone or microphones. The invention further relates to a method for measuring the cross-sections mentioned above.
     twenty
    There are other patents that relate to rhinomanometers that take into account the two open holes simultaneously. However, these patents attempt to reconstruct the three-dimensional flow in the nostrils through questionable and inaccurate calculations based on one or two dimensions. Thus, WO2007087333 A2 refers to an invention constituted by a system and method for the three-dimensional reconstruction of the airways, the evaluation and its analysis from the reconstruction in two dimensions. Specifically, the invention relates to a system and method for acquiring two-dimensional data with respect to a cavity, such as an esophagus or an airway, and manipulating said data to reconstruct the three-dimensional geometric object that represents said cavity. Suitable data collection methods 30 include non-invasive protocols such as acoustics. The resulting three-dimensional geometric object of the cavity is used to diagnose the cavity and its morphology, the management and treatment of the obstruction, provide information for use in the forensic analysis of results, medical-legal evaluation of the diagnosis and treatment of the cavity of obstruction / stenosis. 35

    Other patents are related to the measurement of pressure, sound and flow differences by means of sensors in both nasal passages at the same time. Thus, WO2000006020 A1 refers to the invention of an apparatus for determining the pressure drop through the nasal cavity of a patient during breathing, and the determination of the opening pressure for patients. The apparatus comprises a measuring tube having a proximal end for connection to a patient's nostril and a distal end leading to the surrounding atmosphere, a measuring door and an air flow meter in the measuring tube. According to the invention, the device comprises means for generating a sound signal at the proximal end of the tube, or means for generating a sound signal at the measuring door and means for receiving sound signals at the proximal end of the tube. The invention further relates to a method for measuring the pressure drop.

    Finally, WO2012089853 A1 refers to a three-dimensional reconstruction system of the nasal cavity comprising an input module for digital images 15 for medical use obtained from a computerized axial tomography performed on a person offering a dot map referenced in the planes of cut, a module of calculation of the geometry from the map of previous points, a module of calculation of the mesh of volume corresponding to that geometry and a three-dimensional viewer that allows to visualize the geometry and the volumetric mesh. Through this system, a customized three-dimensional reconstruction of a person's nasal cavity can be calculated and visualized for clinical purposes. Additionally, the system can also provide a simulation of the air-nasal flow in the nasal cavity whose three-dimensional reconstruction has been obtained. The proposed invention differs from this invention in two fundamental aspects. In the first place, the task of reconstruction and 3D meshing of the nasal cavity is performed autonomously by means of DICOM images. Secondly, the simulation is based on the complete equations of fluid mechanics without simplifying. In this sense, it is possible to result in not only the loss of average pressure in the coana against the flow rate, but also the effort made by the air on the walls of the nasal cavities.
     30
    As can be seen, in the examples existing in the state of the art there are methods that somehow obstruct the natural nasal flow, or that try to measure the nasal flow in both passages at the same time. In the latter case, it is a question of carrying out a three-dimensional reconstruction that is not very approximate to the real geometry of the nostril based on measurements in one or two dimensions that are also very questionable. It should be noted that current devices 35 that attempt to calculate the rhinomanometric curve taking into account the two nasal passages, do not
    distinguish the contribution of each passage to the total flow. In other words, it is not known which of the two nasal passages can work abnormally, in the case of a congenital disease or malformation.

    As far as applicants know, there are neither devices nor systems equivalent to the 5 referred to in the present invention, that is, devices and systems that allow the determination of flow-pressure curves for both nasal passages at the same time, and of non-intrusive way, considerably helping the doctor to diagnose alterations or pathologies in the nostril more precisely. In particular, although both the segmentation and the simulation of fluids are widely known, and there are specific computer programs for each of these phases separately, said computer programs are not prepared to exchange information with each other in a simple manner. The advance of the present invention consists in: first, the reconstruction of the nostril from images generated by ultrasound; second, computer processing means configured for the joint and automated realization, segmentation, meshing and numerical simulation from said images generated by ultrasound; Third, the result of the numerical simulation is the loss of average pressure in the coana versus the flow rate.
    Description of the invention

    A first object of the invention relates to a device for obtaining high frequency ultrasound digital images of the human nasal cavity in DICOM format from which it is possible to obtain computational rhinomanometric curves of said cavity by numerical simulation, said device comprising at least a high frequency ultrasonic transducer that allows the obtaining of 2D digital images of the nasal cavity, which is coupled to an elliptical-annular closed structure of a diameter sufficient to surround a human head in a horizontal plane minimizing the risk of contact throughout its perimeter in case of small involuntary movements of the patient. 30

    To allow a scan in horizontal planes of the entire nasal cavity, it is necessary that the at least one high frequency ultrasound transducer travel along the vertical axis of the head, so that the elliptic-annular closed structure to which it is fixed vertically movable, which is achieved by physically connecting said closed structure 35 to at least one vertical structure whose axis is parallel to the vertical axis of the head and
    which serves both as a support for the closed structure and as a guide for its vertical movement.

    To obtain 2D digital images in horizontal planes from which a 3D reconstruction of the nasal cavity is possible, it is necessary that said images be generated in 5 horizontal planes separated from each other approximately 2 - 3 mm, then the closed structure to which coupling at least one high frequency ultrasonic transducer must move vertically approximately 2 - 3 mm, be locked in the corresponding horizontal plane for the generation of the image in said plane, be unlocked after the image generation, and move approximately 2 - 3 mm 10 to the next horizontal plane. For this, the device comprises means for displacement of electrical and / or hydraulic actuation of the closed structure on the support-guide structure, as well as means for locking and unlocking said means of movement.
     fifteen
    For imaging using the at least one high frequency ultrasonic transducer, said at least one transducer must be in contact with the external surface of the patient's head. For this, the at least one transducer must be able to move radially, in each horizontal scan plane, from a resting position, without contact with the external surface of the patient's head, to an operative position, in contact 20 with said surface. For this, the device comprises, for each transducer, both a structure that supports the transducer and in turn serves as a guide in the radial displacement thereof from the rest position to the operating position (and from said operating position back to the resting position), said support-guide structure physically connected to the closed elliptical-annular structure; as displacement means 25 for high-speed actuation for the advance and reverse of the transducer; as means for locking and unlocking said displacement means, as electronic means for controlling both said radial displacement and the generation of images by means of the at least one transducer once it is in operative position. In an embodiment of this first object of the invention, the advance and backward movement of the transducer is carried out on its corresponding support-guide structure, said fixed-static support-guide structure remaining relative to the closed elliptical-circular structure. In another embodiment, it is the support-guide structure of the transducer that moves forward and backward with respect to the closed elliptical-circular structure, the static and fixed transducer remaining relative to its support-guide structure. 35

    In relation to the need for the at least one transducer to be in contact with the external surface of the patient's head for imaging, the device in turn comprises a pressure sensor for each transducer that it detects when the corresponding transducer establishes Sufficient contact with the outer surface of the patient's head for ultrasound imaging. Said pressure sensor 5 provides to the electronic control means information of the pressure exerted on the external surface of the patient's head by the corresponding transducer.

    On the other hand, ultrasound transducers applied in ultrasound techniques that are part of the state of the art require, in addition to contact, the absence of air between said transducer and said external surface, for which it is necessary to include between both a gel conductive or ultrasound gel by means of introducing said conductive gel or ultrasound gel. In an embodiment of this first object of the invention, the at least one transducer comprises, in the contact and imaging region, a coating with conductive gel or ultrasound gel, said coating replaceable either by reason of good hygiene or by wear or coating consumption. In another embodiment, the device comprises means of application of the individualized conductive gel for each transducer, the application of said gel being regulated by electronic control means. In a more particular embodiment of a device comprising conductive gel application means regulated by electronic control means, said electronic control means act on the radial displacement means of the at least one transducer so that, once the pressure sensor linked to said at least one transducer informs the electronic control means that a sufficient contact has been established for the generation of images, said displacement means make the transducer back approximately 2-3 mm, position in which the electronic means they activate the application of an adequate volume of conductive gel, application after which the radial displacement means of the transducer make it advance again until again the pressure sensor informs the electronic control means that a sufficient contact has been established , at which time said electronic means of Trolls deactivate the radial displacement until the corresponding image has been generated, after which the 30 electronic control means activate the radial backward displacement to the rest position.

    In an embodiment of this first object of the invention, the device comprises a single high frequency ultrasound transducer which, since to generate a 3D reconstruction of the nasal cavity, must generate multiple 2D images not only in horizontal planes
    but also from different angles in each horizontal plane, in addition to moving radially from its resting position to its operating position and vice versa, it must move, being in a resting position, perimeter around the head, for which the device comprises means of movement and perimeter positioning of the transducer, locking and unlocking means of said displacement means and 5 perimeter positioning, as well as electronic means of control of all said means. In a more particular embodiment, the elliptic-annular closed structure is not a single solid structure but comprises two equally closed elliptical-annular substructures, an exterior physically connected to the support-guide structure for the vertical movement of the closed elliptical-annular structure as a whole; and an interior to which the transducer is coupled through its corresponding support structure - radial displacement guide, said internal substructure movable through the interior of the external substructure by means of said means of perimeter displacement and positioning subjected to said electronic means of control.
     fifteen
    In an embodiment of this first object of the invention, the device comprises two or more transducers and electronic control means that synchronize the advances and setbacks well transducer over its support-guide structure, either of each set formed by a transducer and its support-guide structure on the closed elliptical-annular structure. In a more particular embodiment, the device comprises three transducers equidistant from each other for the generation of images of the nasal cavity from the front of the patient's head, one of them (central) positioned in the closed elliptical-annular structure. coinciding with the median sagittal plane of the patient's head; and a transducer for the generation of images of the nasal cavity from the back of the patient's head, said posterior transducer positioned in the elliptical-annular closed structure coinciding with the median sagittal plane of the patient's head. In another more particular embodiment, the device comprises five transducers equidistant from each other for the generation of images of the nasal cavity from the front and side parts of the patient's head, one of them (central) positioned in the closed elliptical structure 30 -anularly coincide with the sagittal midplane of the patient's head; and a transducer for the generation of images of the nasal cavity from the back of the patient's head, said posterior transducer positioned in the elliptic-annular closed structure coinciding with the median sagittal plane of the patient's head. 35

    The correct generation of images by means of the device that constitutes the first object of the invention requires that the patient's head be kept in a suitable and immobile position during the process, for which the use of a support and support structure of the patient is appropriate. same that avoids relative displacements of the head with respect to the device and, therefore, facilitates the proper positioning of the device for the realization of a complete scan of the nasal cavity, according to horizontal and vertical anatomical references of the patient's head, such as the interpupillary line. In an embodiment of said first object, the device comprises a support and support structure of the patient's head, said support structure physically connected to the support-guiding structure for the vertical displacement of the elliptically closed structure. cancel. 10

    A second object of the invention relates to a system for obtaining computational rhinomanometric curves of the nasal cavity from 2D digital images in DICOM format of said cavity obtained by a device according to the first object of the invention, including all embodiments. thereof, which comprises, in addition to said first device object of the invention, computer processing means configured to manage the electronic control means of the device and thereby both the displacement and positioning means and their corresponding locking and unlocking means, as the generation of 2D images. In an embodiment of said second object, the system further comprises means for storing the generated images, as well as means for data communication (for example with wireless or USB connectivity) that allow managing or accessing the images generated and stored by the device. In a particular embodiment, the computer processing means are further configured to jointly and automatically perform segmentation, that is, the reconstruction of nasal geometry from 2D images in DICOM format; the generation of 25 surface and volume computational meshes; performing the numerical simulation of the air flow through the nostril, and obtaining the rhinomanometric curves, from which it is possible, for example, to indicate the exact percentage of the flow through each nasal passage ; said computer processing means, and because the images are not generated directly in DICOM format, comprising a module for processing and coding in DICOM format of the generated 2D images, an automatic segmentation module (which does not require human supervision ) of them, a nasal geometry calculation module that generates the corresponding computational surface and volume meshes, and a numerical simulation module that generates the corresponding computational rhinomanometric curves. In a more particular embodiment, said computer processing means 35 further comprise an image processing module
    through interpolation algorithms that compensates for or corrects errors or lack of information, as well as the elimination of images that are not consistent due to excess brightness or unwanted blurring of the images themselves. In an even more particular embodiment, the computer processing means, and where appropriate the storage media and the data communication means, are housed in the support structure - guide for vertical displacement of the elliptically closed structure. cancel.

    Once the 2D images are obtained with the device that constitutes the first object of the invention in parallel sections every 2 or 3 millimeters, in a manner similar to the TAC, the three-dimensional reconstruction of the nostril geometry is carried out using a 10 computer image processing technique called segmentation. Once the geometry is obtained, the numerical simulation stage begins: first, the computational mesh of both the surface and the volume is generated; secondly, air simulation is performed through the nostril by numerical discretization of the Navier-Stokes equations. Once the numerical simulation is finished, the 15 integral quantities of both the flow rate and the average pressure drop in the coana are determined, in order to finally determine the corresponding rhinomanometric curve.

    Thus, a third object of the invention relates to a method for the automated obtaining of computational rhinomanometric curves of the nasal cavity from 20 digital 2D images in DICOM format of said cavity, said method comprising the jointly and automated of the following stages of computer processing: segmentation or reconstruction of nasal geometry from 2D images in DICOM format; generation of the computational mesh of both surface and volume; simulation of air flow through the nostrils by numerical discretization of the Navier-Stokes equations; determination of integral quantities of both the flow rate and the average pressure drop in the coana; and determination of rhinomanometric curves. This procedure is performed automatically without the need for human intervention and does not amount to the juxtaposition of programs already available. In an embodiment of said third object, the rhinomanometric curves are obtained from 30 2D digital images in DICOM format generated by ultrasound, particularly by a device according to the first object of the invention or by a system according to the second object of the invention. In a more particular embodiment, the procedure for the automated obtaining of computational rhinomanometric curves of the nasal cavity from 2D digital images in DICOM format generated by ultrasound additionally comprises a stage of computer processing of treatment
    of images using interpolation algorithms (linear or non-linear) that compensates or corrects errors or lack of information, that is, those spaces or volumes that are not well defined by the ultrasound sensor are filled. In an even more particular embodiment, said method comprises a first stage of generating said images, either by a device according to the first object of the invention, or by a system 5 according to the second object of the invention.

    Finally, the invention also extends to computer systems; as well as to computer programs or program instructions, more particularly to computer programs in or on carrier means, configured to execute the computer processing steps 10 according to the third object of the invention. The computer program may be in the form of source code, object code or an intermediate code between source code and object code, such as partially compiled form, or in any other form suitable for use in the implementation of the methods constituting said third object of the invention. The carrier medium can be any entity or device capable of carrying the program. For example, the carrier medium may comprise a storage medium, such as a ROM, for example a CD ROM, a DVD ROM, or a semiconductor ROM, or a magnetic recording medium, for example a hard disk. In addition, the carrier means can be a transmissible carrier medium such as an electrical or optical signal that can be transmitted via electrical or optical cable or by radio or other means. When the computer program 20 is contained in a signal that can be transmitted directly by a cable or other device or medium, the carrier means may be constituted by said cable or another device or medium. Alternatively, the carrier means may be an integrated circuit in which the computer program is encapsulated (embedded), said integrated circuit being adapted to perform, or to be used in carrying out the methods constituting said third object of the invention. In accordance with the above, aspects of the invention are also computer systems that implement said computer processing steps according to the third object of the invention, as well as computer programs, storage media readable by computer systems, and transmissible signals capable of making a system IT company carries out said computer processing steps according to the third object of the invention.

    Other advantages and features of the invention will be apparent in view of the description presented below.
     35
    Brief description of the figures

    To complement the description and in order to help a better understanding of the characteristics of the invention, according to an example of practical implementation thereof, a set of figures in which with 5 Illustrative and non-limiting, the following has been represented:
    :
    Figure 1 shows a front three-dimensional view of a particular embodiment of a device according to the first object of the invention.
     10
    Figure 2.- Top (a) and front view (b) of the particular embodiment represented in Figure 1. The closed elliptical-annular structure performs a vertical movement (v). The transducers perform a horizontal-radial movement (h). Figure 3.- Illustrative representation of the wireless communication between a device 15 according to the first object of the invention and a computer system that executes computer processing steps according to the third object of the invention.Figure 4.- Example of a 3D geometry of a nostril obtained from segmentation (a). Detail of the surface mesh near the nostrils (b). twenty
    Figure 5.- Example of three-dimensional numerical simulation showing only the current lines that result from the simulation of the air flow through the pit in the inspiration (a), (c) and (e) and expiration ( b), (d) and (f), when the nasal passages work individually (a) - (d) or jointly (e) - (f). 25
    Figure 6. Example of the rhinomanometric curves that are obtained from the simulations as shown in Figure 5. The inspiration and expiration phases of the two nasal passages (right + left) working simultaneously or individually are shown.  30 Detailed description of an embodiment of the invention

    The constitution and characteristics of the invention will be better understood with the aid of the following description of an embodiment example, it being understood that the invention is not limited to said embodiment, but that the protection encompasses all those alternative embodiments that may be included within the content. and the scope of the claims.
    Likewise, the present document refers to various documents as prior art, being understood by reference the content of all these documents, as well as the complete content of the documents referred to in said documents, in order to offer a description as possible complete state of the art in which the present invention fits. The terminology used below is intended to describe the examples of embodiments that follow and should not be construed as limiting or restrictive.

    An embodiment of a device according to the first object of the invention comprising five transducers (3) equidistant from each other for the generation of images of the nasal cavity from the front and side parts of the figures is shown in Figures 1, 2 and 3. head of the patient, one of them (central) positioned in the closed elliptical-annular structure coinciding with the mid-sagittal plane of the patient's head; and a transducer for the generation of images of the nasal cavity from the back of the patient's head, said posterior transducer positioned in the closed elliptical-annular structure 15 coinciding with the mid-sagittal plane of the patient's head. The transducers (3) are coupled to the closed elliptical-annular structure (1), said structure (1) physically connected (2) to the support-guide structure (5) for vertical displacement (v), the object of said vertical displacement (v) both the positioning of the structure (1), once the patient is placed, as well as the generation of the 20 2D images when moving vertically every approximately 2-3 mm, depending on the necessary resolution. The patient places the head on a support and support structure (4) that prevents or minimizes their movements during scanning (see figure 3). Said vertical displacement (v) is performed by an electric or hydraulic actuator (not included in the figures), both of high precision. Said actuator incorporates an emergency stop mechanism to prevent damage to the patient in the event that the patient accidentally moves. The elliptic-annular closed structure (1) is covered by a padded protector to prevent damage to the patient in case of accidental contact. On the other hand, the transducers (3) are covered by removable protectors made of conductive gel or ultrasound gel. These protectors are replaced by hygiene for every 30 patients. To ensure contact between the transducers and the patient, the transducers perform a horizontal-radial movement (h). Thus, the movement of the vertical displacement (v) of the closed elliptical-annular structure (1) and the horizontal-radial (h) of the transducers (3) is performed synchronously to avoid damage to the patient, and guaranteeing Good quality in 2D images. The actuators responsible for the displacement of the transducers (3) are high speed but with a pressure sensor that stops them
    when the contact between sensor and skin is necessary to guarantee the correct emission of ultrasonic waves, avoiding damage to the patient. Within the structure (2) that physically connects the structures (1) and (5) a microprocessor can be installed to manage and synchronize the actuators of both displacements (v) and (h). In addition, in said structure (2) a wireless connection card can be included to remotely connect a computer that executes the computer processing steps that allow obtaining rhinomanometric curves from the images generated by the device. In said structure (2) a memory unit can also be included to store the generated 2D images, and one or several USB ports for extracting the images as an alternative to wireless communication (see figure 3). The power supply of the device can be 10 by means of connection to the mains, although an alternating / continuous rectifier and a battery can be included, as in the case of laptops, which guarantees the power supply in case of a network failure electric

    Next, an embodiment of the computer processing steps according to the third object of the invention is detailed:
    i. From the 2D images of the nasal cavity, a segmentation is performed to subsequently proceed to the reconstruction of the geometry of the nostril. Said geometry can begin in the nostrils and end at the beginning of the larynx (figure 4), that is, from the coana or area where both nasal passages join. twenty
    ii. Once the geometry is reconstructed, the computational mesh of both surface and volume is generated (Figure 4).
    iii. Using a simulation model of laminar or turbulent flow, and with the appropriate boundary conditions, the simulation is carried out. Some simulation examples with a clogged hole or the two free holes are included in Figure 5. 25
    i. Obtaining rhinomanometry curves is done systematically. For this, in the simulations an average pressure drop is established between the choana and the inlet holes, which are at atmospheric pressure, and the larynx where a pressure greater or less than the atmospheric pressure is imposed for expiration or inspiration, respectively . After the simulation, the flow rate caused by said average pressure drop in the coana is determined. An example of these curves is shown in Figure 6 for both a blocked hole and the two free holes.

    In this text, the word “understand” and its variants (such as “understanding”, etc.) should not be interpreted in an exclusive way, that is, they do not exclude the possibility that what is described includes
    other elements, steps etc. In the context of the present invention, the term "approximately" and the terms of its family (such as "approximate", etc.) should be understood as indicative values very close to those accompanying the aforementioned term. That is to say, a deviation should be accepted within the acceptable limits from an exact value, since the person skilled in the art will understand that said deviation from the indicated values is inevitable due to inaccuracies in the measurement, etc. . The same applies to the terms "around" and "substantially."

    On the other hand, the invention is not limited to the specific embodiments that have been described but also covers, for example, the variants that can be made by the average person skilled in the art (for example, as regards the choice of materials, dimensions, components, configuration, etc.), within what follows from the claims.
    权利要求:
    Claims (26)
    [1]

    1. Device for obtaining high frequency ultrasound digital images of the human nasal cavity in DICOM format from which it is possible to obtain computational rhinomanometric curves of said cavity by means of numerical simulation, said device comprising:
    to. at least one high frequency ultrasound transducer (3) that allows the obtaining of 2D digital images of the nasal cavity, said at least one radially displaceable transducer (h) from a resting position (without contact with the external surface of the head of the patient) to an operative position 10 (in contact with said surface), for which said at least one transducer is coupled to
    b. a structure that supports the transducer and in turn serves as a guide in the radial movement thereof from the rest position to the operative position (and from said operative position again to the rest position), said connected support-guide structure physically to
    C. a closed elliptical-annular structure (1) of a diameter sufficient to surround a human head in a horizontal plane minimizing the risk of contact throughout its perimeter in case of small involuntary movements of the patient, said vertically movable structure, which is 20 get connecting it physically (2) to
    d. at least one vertical structure (5) whose axis is parallel to the vertical axis of the head and which serves both as a support for the closed structure and as a guide for the vertical displacement (v) of said structure (1);
    and. means for introducing a conductive gel (ultrasound gel) between the at least one transducer (3) and the external surface of the patient's head;
    F. high speed actuating displacement means for the advance and reverse of the transducer (3); as well as means for locking and unlocking said means of movement; and electronic means for controlling both said radial displacement (h) and the generation of images by means of at least one transducer (3) once it is in operative position;
    g. means of displacement of electric and / or hydraulic actuation configured to move vertically the structure (1) on the structure (5), as well as means for locking and unlocking said means of displacement;
    h. electronic control means configured both (i) to control the different travel means and their corresponding locking means and
    unlocking, such as (ii) to control the generation of images by means of the at least one transducer (3).
    [2]
    2. Device according to the preceding claim characterized in that the vertical displacement means (v) are managed by the electronic control means so that the elliptical-annular closed structure (1) moves vertically 5 stopping every approximately 2-3 mm .
    [3]
    3. Device according to any of the preceding claims characterized in that the radial advance and retraction (h) of the at least one transducer (3) is achieved by moving said at least one transducer (3) on its corresponding support-guide structure, said said remain fixed and static support-guide structure with respect to the elliptic-circular closed structure 10 (1).
    [4]
    Device according to any one of claims 1 or 2 characterized in that the radial advance and retraction (h) of the at least one transducer (3) is achieved by displacing the support-guide structure of the transducer (3) with respect to the closed structure of elliptic-circular shape (1), the transducer (3) remaining fixed and static with respect to its support-guide structure.
    [5]
    5. Device according to any of the preceding claims characterized in that the conductive gel introduction means consist of a coating of the at least one transducer (3) with conductive gel or ultrasound gel, said coating replaceable either for reasons of hygiene or wear or consumption of the coating.
    [6]
    Device according to any one of claims 1 to 4 characterized in that the conductive gel introduction means consist of individualized conductive gel application means for each at least one transducer (3), the application of said gel being regulated by electronic means of control. 25
    [7]
    Device according to any one of the preceding claims characterized in that it comprises a single high frequency ultrasonic transducer (3) movable both radially (h) from its resting position to its operative position and vice versa, and, being in a resting position, perimeter around the head, for which the device comprises means of displacement and perimetral positioning of the transducer (3), means of blocking and unblocking said means of displacement and perimeter positioning, all said means regulated by electronic control means.
    [8]
    Device according to the preceding claim characterized in that the elliptical-annular closed structure (1) comprises two equally closed substructures of elliptic-annular shape, an exterior physically connected to the support-guide structure
    for the vertical movement (v) of the closed elliptical-annular structure as a whole; and an interior to which the transducer (3) is coupled through its corresponding support structure - radial displacement guide, said internal substructure movable through the interior of the external substructure by means of perimetral displacement and positioning means. 5
    [9]
    Device according to any one of claims 1 to 6, characterized in that it comprises two or more transducers (3) whose radial advances and setbacks (h), either of each transducer (3) on its support-guide structure, or of each set formed by a transducer (3) and its support-guide structure on the closed elliptical-annular structure (1), are synchronized by electronic control means.
    [10]
    10. Device according to the preceding claim characterized in that it comprises:
    to. three transducers (3) equidistant from each other for the generation of images of the nasal cavity from the front of the patient's head, one of them (central) positioned in the closed elliptical-annular structure (1) in a coincident way with the middle sagittal plane of the patient's head;
    b. and a transducer (3) for the generation of images of the nasal cavity from the back of the patient's head, said posterior transducer (3) positioned in the elliptical-annular closed structure (1) coinciding with the plane Sagittal half of the patient's head. twenty
    [11]
    11. Device according to claim 9 characterized in that it comprises:
    to. five transducers (3) equidistant from each other for the generation of images of the nasal cavity from the front of the patient's head, one of them (central) positioned in the closed elliptical-annular structure (1) coinciding with the middle sagittal plane of the patient's head; 25
    b. and a transducer (3) for the generation of images of the nasal cavity from the back of the patient's head, said posterior transducer (3) positioned in the elliptical-annular closed structure (1) coinciding with the plane Sagittal half of the patient's head.
    [12]
    12. Device according to any of the preceding claims characterized in that 30 comprises a support and support structure (4) of the patient's head, said structure (4) physically connected to the structure (5) that serves as a guide support for the patient. vertical displacement (v) of the closed elliptical-annular structure (1).
    [13]
    13. System for obtaining computational rhinomanometric curves of the nasal cavity from 2D digital images in DICOM format of said cavity 35 characterized in that it comprises:
    to. A device according to any one of claims 1 to 12; Y
    b. Computer processing means configured to manage the electronic control means of the device and thereby both the displacement and positioning means and their corresponding locking and unlocking means, as well as the generation of 2D images. 5
    [14]
    14. System according to the preceding claim characterized in that the computer processing means are housed in the support structure - vertical displacement guide (5) of the closed elliptical-annular structure (1).
    [15]
    15. System according to any of claims 13 or 14, characterized in that it comprises means for storing the generated images, as well as means for communicating data (for example with wireless or USB connectivity) that allow managing or accessing the generated images and stored by a device according to any one of claims 1 to 12.
    [16]
    16. System according to the preceding claim characterized in that the storage means and the data communication means are housed in the support-guide structure for vertical displacement (5) of the elliptic-annular closed structure (1).
    [17]
    17. System according to any of claims 13 to 16 characterized in that the computer processing means comprise:
    to. A DICOM format processing and coding module of the generated 2D images;
    b. An automatic segmentation module that reconstructs nasal geometry from said 2D images in DICOM format;
    C. A module for calculating nasal geometry that generates the corresponding computational meshes of surface and volume; and 25
    d. A numerical simulation module that generates the corresponding computational rhinomanometric curves.
    1. Modules (b), (c) and (d) operating sequentially and automatically (without human supervision).
    [18]
    18. System according to the preceding claim characterized in that the computer processing means further comprise an image processing module by interpolation algorithms (linear or non-linear) that compensates for or corrects errors or lack of information in relation to 3D volumes derived from 3D images, and that eliminates images that are not consistent due to excess brightness or blur.
    [19]
    19. Procedure for obtaining automated rhinomanometric curves 35 of the nasal cavity from 2D digital images in format
    DICOM of said cavity, said procedure comprising performing jointly and automatically the following stages of computer processing:
    to. segmentation or reconstruction of nasal geometry from 2D images in DICOM format;
    b. generation of the computational mesh of both surface and volume; 5
    C. simulation of air flow through the nostrils by numerical discretization of the Navier-Stokes equations;
    d. determination of integral quantities of both the flow rate and the average pressure drop in the coana; Y
    and. determination of rhinomanometric curves. 10
    [20]
    20. Method according to the preceding claim characterized in that the 2D digital images in DICOM format from which the computational rhinomanometric curves are automatically obtained are images generated by ultrasound by means of a device according to any of claims 1 to 12.
    [21]
    21. Method according to claim 19 characterized in that the digital 2D images in DICOM format from which the computational rhinomanometric curves are automatically obtained are images generated by ultrasound by means of a system according to any of claims 13 to 18.
    [22]
    22. A method according to any one of claims 19 to 21 characterized in that it comprises a computer processing step of image processing 20 by interpolation algorithms that compensates for or corrects errors or lack of information.
    [23]
    23. Method according to any of claims 20 to 22 characterized in that it comprises the previous stage of generating 2D digital images in DICOM format from which the computational rhinomanometric curves are automatically obtained.
    [24]
    24. Computer program comprising program instructions capable of making a computer system carry out the computer processing steps of the method according to any one of claims 19 to 23.
    [25]
    25. Storage medium readable by a computer system comprising 30 program instructions capable of making a computer system carry out the computer processing steps of the method according to any one of claims 19 to 23.
    [26]
    26. Transmissible signal comprising program instructions capable of making a computer system carry out the computer processing steps of the method according to any one of claims 19 to 23.
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    同族专利:
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    ES2608861B2|2017-10-26|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    WO1995001127A1|1993-06-29|1995-01-12|Boston University|Nasopharyngealometric apparatus and method|
    US20140330115A1|2011-07-21|2014-11-06|Carrestream Health, Inc.|System for paranasal sinus and nasal cavity analysis|
    US20160007842A1|2014-07-09|2016-01-14|Acclarent, Inc.|Guidewire Navigation for Sinuplasty|
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