The field of the invention is that of ultrasound measuring devices. More particularly, the invention relates to an ultrasound measuring device that is particularly suited to measuring an individual's pelvic tilt but it can of course also find other medical applications. For the sake of simplification, however, we shall strive first of all, here below, to describe the invention in the special context of total hip arthoplasty or replacement.
Surgical operations for total hip replacement concern more than 120 000 individuals per year in France. Owing to the ageing of the population, the incidence of these operations is likely to increase constantly in years to come.
A total hip prosthesis generally comprises two parts: a first part attached to the femur, called a femoral part and comprising a stem introduced into the femur fitted with an essentially spherical head and an acetabulum designed to receive the femoral head. The acetabulum, also called a cup or shell when it is semispherical, takes position in the corresponding housing (the anatomical acetabulum) of the iliac or pelvic bone.
The implanting of a prosthetic device by a surgeon is a relatively complex operation since the femoral part, and to an even greater extent the acetabulum, must be placed in an optimized manner, especially to prevent the prosthesis from getting dislocated during high-amplitude motions.
According to classic methods, the pelvis is palpated to locate the three points of the anterior pelvic plane (APP). This anterior pelvic plane (also called the Lewinneck plane) is a reference plane classically used in hip surgery. It is defined by the two iliac spines and the pubic symphysis. This plane enables the prosthetic acetabulum to be oriented suitably, in terms of inclination and anteversion.
The surgeon then inserts the acetabulum, or cup, at the tip of a tool called an impactor. He handles this cup in such a way as to place it so that it has an inclination of 45° and an anteversion of 15° relative to the anterior pelvic plane.
These two values of angles are, however, mean values used by default and do not correspond to all the particular situations that are likely to be encountered.
One improvement to this approach has been proposed in the U.S. Pat. No. 6,205,411. This patent document proposes a pre-operative computerized simulation of the prosthesis using a tomography scan of the bone casing of the pelvis and the femur, done pre-operatively.
The surgeon is guided, during the operation, and by means of an internal body placed on the pelvis and the femur to carry out an operation of locating in space in order to position the acetabulum according to the result of the simulation.
This approach is efficient but has the drawback of high complexity (in terms of tomography, computer simulations etc.) which make its use limited, especially for reasons of cost.
Another approach is proposed in the patent document FR-2 865 928. This technique uses a “mega-head” placed in the acetabular cavity hollowed out in the pelvis. A processing device enables a simultaneous display of a cone of mobility and of extreme positions, as a function of the center of the cup and the geometry of the femoral prosthesis.
The surgeon can then handle the cup by means of an impactor to bring the extreme positions within the cone of mobility.
This technique is simpler than the one described in the document U.S. Pat. No. 6,205,411, and does not require preliminary measurements. However, it proves to be inadequate in practice because the measurements are made per-operatively, the individual being kept unconscious in a particular position (the supine position).
It has indeed been observed that about 13% of arthoplasty operations need revision surgery because of joint dislocation or premature wear and tear of the prosthetic elements, themselves due to a non-optimal positioning of the implants.
In “Toward a Dynamic Approach of THA Planning Based on Ultrasound”, Clinical Orthopaedics and Related Research, 467(4), 901-908, 2009, Dardenne et al. propose to take account of the pelvic dynamics proper to each individual during preoperative treatment of patients to reduce the risks of inappropriate positioning of the prosthesis. To this end, Dardenne et al. recommend the use of ultrasound measurements to determine the pelvic tilt of patients in three positions: standing, seated and supine.
The measuring apparatus used comprises especially a 3D infrared localizer and a 2D ultrasound probe equipped with retroreflective trackers, so as to be capable of being localized in a 3D volume by the infrared localizer. The 2D ultrasound probe must furthermore be calibrated according to a method of calibration based on a special phantom and the introduction of virtual motions applied to the probe, as described in the patent document FR 2 924 810.
The regions of interest are then scanned by means of the ultrasound probe and, with a dedicated interface, the user of the measuring apparatus localizes the anatomical landmarks (the anterior-superior iliac spines and the pubic symphysis) in the corresponding ultrasound images.
Although this approach is interesting in its principle, it has several drawbacks that make it complicated to use.
First of all, the ultrasound measuring apparatus presented by Dardenne et al. is bulky because it comprises, on the one hand, an ultrasound acquisition station and, on the other hand, a station for localizing the probe: indeed, before each measurement, this device requires the calibration of the ultrasound probe by means of a phantom plane to then enable the 3D localizing of the 2D points of interest situated in the ultrasound images. Such an apparatus is therefore not portable. This makes the apparatus difficult to use in day-to-day medical consultation.
In addition, the anatomical landmarks constituted by the anterior-superior spines and the pubic symphysis must be localized manually by the surgeon in the ultrasound images. This proves to be a lengthy process and is also more complicated in the seated and standing positions.
There is therefore a need for an ultrasound measuring technique adapted especially but not exclusively to the measurement of an individual's pelvic tilt, that does not have these different drawbacks of the prior art.
The invention meets this need by proposing an ultrasound measuring device that comprises:
Thus the invention relies on a wholly novel and inventive approach to ultrasound measurement, especially but not exclusively in the context of total hip replacement.
Indeed, the invention proposes an ultrasound measurement device enabling the simultaneous acquisition of two images corresponding to two anatomical zones of interest in the patient. This device is particularly simple to use, because the probes have six degrees of freedom relative to each other, thus enabling the device to adapt well to each patient's morphology, and providing efficient image-capturing conditions. This architecture especially enables the practitioner to easily adjust the probes on the anatomical points of interest for the measurement of the pelvic tilt.
In addition, the designing of such a measuring device removes the need to localize the probes, thus enabling the device to be portable and be used in medical consultation. Indeed, the presence of orientation and travel sensors in the measuring device makes it possible to know the position of the two probes, relative to each other and in space. When the anatomical points of interest have been localized in the images acquired by the ultrasound probes, the measuring device of the invention can then directly deduce the relative spatial positions of these anatomical points since the relative positions of the probes are known.
Finally, the measuring device of the invention proposes non-irradiating measurement relying on ultrasound measurement. This is particularly advantageously for the patient, who is thus not exposed to harmful doses of radiation.
According to one embodiment of the invention, said two ultrasound images are a first image of an upper right-hand or left-hand zone of an individual's iliac bone and a second image of a lower zone of said iliac bone, said points of interest comprise an anterior-superior iliac spine and a pubic symphysis of said individual, and said device comprises means to determine a pelvic tilt of said individual on the basis of said relative spatial position of said points of interest.
Indeed, the measuring device of the invention can be applied particularly advantageously in the context of the measurement of a patient's pelvic tilt, i.e. the tilt of the pelvis relative to the vertical, this measurement being done in different positions of the patient (standing, seated, supine). To measure this tilt, it is enough to locate three known points of the pelvis (namely the two anterior-superior iliac spines and the pubic symphysis) defining the APP (anterior pelvic plane) which constitutes the reference plane relative to the patient to measure the pelvic tilt.
According to one aspect of the invention, said means for localizing said points of interest comprise means for processing said ultrasound images by segmentation capable of detecting said points of interest in said images. Such processing means therefore enable an automatic localizing of the anatomical landmarks without the practitioner's being required to take manual action. This advantageously reduces the time of use of the measuring device of the invention.
Such image-processing means comprise a set of processing operations common to both images, comprising especially operations of filtering, thresholding, conversion of intensity, etc.
They also comprise processing operations specific to each of the anatomical sites, given their particular geometrical features.
Thus, according to a first particular aspect of the invention, said means for processing said first image comprise means for identifying a longer segment in said first image, means for adjusting a parabola on said segment and means for detecting said point of interest as a vertex of said parabola. Such a processing enables an automatic detection of the anterior-superior iliac spine in the first image.
According to a second particular aspect of the invention, said means for processing said second image comprise means for identifying a segment in said second image, means for determining an axis of symmetry in said second image, means for adjusting a straight line on said segment and means for detecting said point of interest as an intersection of said axis of symmetry and of said straight line. The axis of symmetry is for example determined by using a method based on the Hough transform. Such a processing operation enables an automatic detection of the pubic symphysis on the second image.
According to one embodiment of the invention, such a measuring device comprises means of validation, by a user of said device, of said points of interest detected by said localizing means. Thus the practitioner can verify that the automatic localizing of the points of interest by the validation device is accurate, and validate it.
If this automatic localizing has failed, the practitioner can make a manual selection of the symphysis and/or of the iliac spine. Indeed, according to one embodiment of the invention, said localizing means comprise means for the selection of said points of interest on the screen by a user of said device. This manual selection can also be used by default, in one alternative embodiment, in place of the automatic detection of the anatomical landmarks.
According to one embodiment of the invention, said device comprises a screen enabling said ultrasound images to be viewed. Such a screen, which can be used to view the images of the anatomical sites acquired by the probes, also serves as an interface between the measuring device and the practitioner.
In one embodiment of the invention, such a screen is fixed to said support by an adjusting ball joint. Indeed, it should be possible to manipulate the measuring device in all positions of the patient: it is therefore important for the screen to be speedily pivotable so that the practitioner can keep it in his field of vision.
As a variant, the screen can consist of a tablet that is detachable from the support.
In one embodiment of the invention, at least one of said probes is connected to said support by a spherical link formed by a sphere that is fixedly attached to said probe, with a surrounding hollow structure that is also spherical, matching the shape of the probe and forming part of the frame. The orientation of the probe is deduced from information coming from an inertial measurement unit fixedly attached to this probe.
Other goals, features and advantages of the invention shall appear more clearly from the following description of a preferred embodiment given by way of a simple illustratory and non-exhaustive example, made with reference to the appended drawings, of which:
The general principle of the invention relies on the designing of a portable ultrasound measuring apparatus comprising two ultrasound probes and an integrated system for measuring the position of the probes. The localizing of the anatomical points of interest in the ultrasound images, combined with knowledge of the position of the probes, makes it possible to determine the relative spatial position of the anatomical points of interest. When such a measuring apparatus is used to measure an individual's pelvic tilt, it therefore makes it possible to obtain a direct, precise and reproducible measurement of the pelvic tilt by using a single, non-irradiating, compact apparatus that can be easily and speedily used by the clinician.
Here below in this document, we shall strive to describe an embodiment of the invention in the context of the operation of total hip replacement surgery. The portable ultrasound measuring device of the invention can however be advantageously used for other medical applications.
To begin with,
As can be seen in
To this end, it is enough to locate three known points of the pelvis (namely the two iliac spines 41 and 42 and the pubic symphysis 43) defining the APP or anterior pelvic plan (XY).
Referring now to
Such a measuring apparatus enables the easy and speedy measurement of the pelvic tilt in different positions of daily life, in order to integrate it into the scheduling of a total hip replacement operation. The use of such an apparatus must make it possible to reduce the number of operations of revision surgery and thus improve the quality of life of patients.
Such a measurement is done by means of the ultrasound probes during pre-operative consultation in at least three positions (for example the standing, seated and supine positions). When it is done by means of the portable ultrasound device in one embodiment of the invention, its main characteristics are that it is:
As illustrated in
In addition, the probes 111 and 112 are movable relative to each other along a slide link, to enable the practitioner to adjust the distance between them. Moreover, they are mounted relative to the support 10 with a ball-joint link for the probe 111, and with a ball-joint link and slide link for the probe 112.
It is indeed necessary that the two probes should be easily adaptable to the patient's morphology in all three positions, standing, seated and supine, whatever the patient's body mass. Preferably, the spacing between the probes 111 and 112 is chosen so that it can vary between about 10 cm and 25 cm.
The apparatus is handled by taking the probes 111 and 112 directly by hand. Thus, the mechanism of the apparatus (support 10, screen 12 and hinges) are situated above the practitioner's hands and therefore do not hamper the handling of the apparatus.
This architecture enables the practitioner to easily adjust the probes to the anatomical sites of interest for the measurement of pelvic tilt, namely the pubic symphysis and the iliac spines. This architecture is moreover compact, robust and stable.
In addition, in order to localize the two probes 111 and 112 relative to each other, the orientation and the distance between the two probes must be measured. It is indeed necessary to know the position of the two probes relative to each other when the practitioner is capturing the ultrasound images.
The embodiment of
One solution for the position of the inertial measurement units 802 and 803 fixedly attached to the ultrasound probes 111 and 112 is illustrated in
The translation between the two probes 111 and 112 is measured by means of a travel sensor 90, illustrated in
Finally, in order to know the position of the ultrasound measurement apparatus of the invention relative to the vertical, this apparatus also comprises an inertial measurement unit 801, illustrated in
The portable ultrasound apparatus of
The assembly is easy to transport for use in medical consultation, as illustrated in
Referring now to
During a medical consultation preparatory to a total hip replacement operation, the practitioner applies the ultrasound probes 111, 112 to the patient in order to simultaneously locate the pubic symphysis 43 and one of the anterior-superior iliac spines 41 or 42. Once these anatomical sites have been located, the practitioner launches the processing sequence which will integrate all the information coming from the different sensors 1221 integrated with the ultrasound measurement device enabling the computation of the pelvic tilt.
Thus, when a new measurement 70 is started, the practitioner first of all adjusts the ultrasound probes 111, 112 mounted on ball-joint links and mutually hinged by means of a slide link, in order to place them so that they face the anatomical sites of interest 41, 42, 43. He then views 71 the images obtained by means of the control screen 12, and adjusts 72 the position of the probes more finely if necessary. He validates these acquisitions when they enable him to distinguish the pubic symphysis 43 (
The following step referenced 73 is that of the automatic treatment of the image, which makes it possible to achieve the automatic location of the anatomical sites of interest constituted by the pubic symphysis 43 and the iliac spines 41, 42.
A common processing base is first of all applied to the two images (of the pubic symphysis 43 and of one of the spines 41, 42); it is followed by processing operation specific to each of the anatomical sites taking account of their special geometrical features.
The basic processing of the ultrasound images can, for example, be broken down as follows:
The specific final processing operations are the following:
In the course of a step referenced 75, the user 74 validates or does not validate the automatic detection of the anatomical reference markers of interest operated by the apparatus during the step referenced 73.
If this automatic detection is validated, the user 74 views the results on the screen, during a step referenced 76.
If not, the user 74 can make a manual selection 77 of the symphysis 43 and/or of the iliac spine 41, 42 on the touch screen 1214.
The system of the invention then records the set of data and computes the pelvic tilt during a step referenced 78.
To this end, when the anatomical sites of interest have been located in the ultrasound images acquired by the probes, the system determines their relative spatial positions from the data delivered by the inertial measurement units, fixedly attached to the probes and the support, and by the translation sensor integrated into the slide link.
The geometrical principle of the computation of the pelvic tilt is illustrated in
With: {right arrow over (vSP-EI)}=[0 L 0]·RM+[LS+DxEI DyEI 0]·RSEI−[LS+DxSP DySP 0]·RSSP,
where the different variables, measured at the time of the validation of the ultrasound images by the user are:
The portable ultrasound measuring apparatus resolves the problems of low precision or those linked to the invasive methods of measurement of the pelvic tilt as well as the autonomy, portability and ease of use of the equipment needed for this measurement. It enables especially:
The method of measurement proposed by the present invention is non-irradiating and the precision of the measurement, estimated by simulation, shows a mean standard deviation of about 1.9°, which is comparable to that obtained by Dardenne et al.
Number | Date | Country | Kind |
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1550416 | Jan 2015 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2015/080361 | 12/17/2015 | WO | 00 |