Patent Description:
More specifically, the system is implemented with the purpose of generating a multitude of volumetric indicators and perimetric indicators, morphological indicators and a model of the venous tree of a human body, or a portion thereof, which, by using a dedicated method of use not according to the invention, are suitable for obtaining information on the (muscle and fat) mass and on the (lymphatic and vessel) liquid system of a human body, or portions thereof, and also suitable for diagnosing and monitoring pathologies.

Systems and procedures are known in the present status of the art which are used for determining the dimensions of a human body, or of a portion thereof. Systems and methods for assessing and monitoring volumes of a human body, or a portion thereof, are also known, with the purpose of monitoring pathologic statuses, among which the following systems and methods are mentioned:.

Patent documents are known in the present status of the art, including documents <CIT>; <CIT>; <CIT> and <CIT>. Document <CIT> discloses an apparatus and its respective procedure for generating tridimensional (3D) models which represent the dimensions of a human body, by using one or several depth sensors and depth assessing cameras. Determining the dimensions of a body includes measuring any parts of a body, such as for instance the height of a person, the width of his/her chest, the circumference of his/her waist, the length of an arm thereof, etc. Said measurement can be repeated over time to obtain more sets of data which can subsequently be compared to or coupled together for monitoring any changes in the dimensions of a people's body over time. This document describes the assessment of a first image, which allows to generate a first tridimensional model, then to assess a second image, which allows to generate a second tridimensional model. The two images, hence the two models, are subsequently compared to each other to highlight any dimensional changes over time. However, said known systems and methods feature a number of kinds of drawbacks as follows.

First of all, some of said systems and methods require a long time for collecting data or processing data.

Secondly, some of said systems and methods feature high purchasing, maintenance, and operating costs.

Thirdly, some of said systems and methods feature a poor measurement repeatability and are in any case particularly invasive both because of the position taken by the human body during their use, and because of the administration of radiations.

In addition, many of said known systems feature a high risk of human errors, in that they are "operator-dependent" systems and methods, i.e. systems and methods that are much influenced by operator's ability.

The present invention starts from the recognition of the above-mentioned drawbacks to try and correct them.

An object of the present invention is to provide a system for generating a multitude of volumetric indicators and perimetric indicators suitable for monitoring pathologies, while greatly limiting the recourse to approximation operations, hence featuring a high level of reliability and accuracy in the obtained results.

Another object of the present invention is to provide a system as said above, which can be easily embodied, without entailing particularly significant adaptation operations, with reference to means suitable for assessing volumetric and perimetric data, having characteristics even considerably different from each other.

A further object of the present invention is to provide a system as mentioned above, wherein the different volumetric indicators and perimetric indicators suitable for monitoring pathologies in processing operations are easy to update, so as to optimize reliability and effectiveness of the final assessment and diagnostic result.

On the other hand, an object of the present invention is to provide a system as specified above, which allows to make the measurement of volumetric indicators and perimetric indicators, which will not be operator-dependent, more repeatable.

A concept not part of the invention relating to a method for assessing and monitoring volumes of a human body, or portions thereof, through the system according to the present invention for generating volumetric indicators and perimetric indicators is described.

An object of the present invention is also to provide a system for relating said volumetric indicators and perimetric indicators to morphological indicators and to a model of the venous tree of a human body in order to improve diagnostics, progress, and monitoring of pathologies.

Finally, a further object of the present invention is to make it possible to perform orthostatic volumetric measurements, in time repeatable conditions, the patient being in a standing straight position.

In view of such objects, the present invention provides a diagnostic system for assessing and monitoring volumetric and perimetric indicators of a human body, or portions thereof, whose basic characteristic is the subject of claim <NUM>.

Further advantageous characteristics of said procedure are described in the subsequent dependent claims.

Said claims are to be considered here integrally specified.

In one first aspect, the present invention relates to a diagnostic system for generating a multitude of volumetric indicators and perimetric indicators of a human body, or portions thereof, which are suitable for monitoring pathologies and modifications of muscle and fat masses, and of the liquid system, including the lymphatic and vessel ones, of a human body, as indicated in claim <NUM>.

The diagnostic system according to the present invention comprises:.

The volumetric indicators and the perimetric indicators described in the present invention are to be considered as numerical indices representative of metabolic processes of a human body which allow to monitor pathologies and modifications of muscle and fat masses, and of the liquid system, including the lymphatic and vessel ones, of a human body.

Generating said indicators and monitoring them over time provides information on the progress of pathologies that involve the (muscle and fat) mass and the liquid system (including the lymphatic and vessel ones). Modifications in the morphology of a human body, or a portion thereof, are also monitored via said volumetric indicators and perimetric indicators.

In a second aspect, is described a concept relating to a method not according to the invention for generating and monitoring volumetric indicators and perimetric indicators of a human body, or portions thereof, by using said diagnostic system, characterized in that it comprises the following steps:.

Further characteristics and advantages of the present invention will be better highlighted by looking at the following detailed description of preferred but not exclusive embodiments, which are illustrated for indicative, non-limitative purpose only, by making reference to the attached drawings, wherein:.

The following detailed description relates to specific embodiments of the system of the present invention and a method which is not part of the invention.

With a specific reference to <FIG>, a diagnostic system <NUM> is described, comprising:.

Said system is characterized in that said electronic processor means <NUM> and said software means <NUM> process said volumetric and perimetric data and generate a multitude of volumetric indicators and perimetric indicators suitable for monitoring edemas and pathologies included in a group formed of muscle, cardiovascular, venous system, and lymphatic pathologies, over time.

In one first embodiment of the invention said diagnostic system <NUM> is characterized in that said means suitable for assessing volumetric data and perimetric data <NUM> are means for acquiring images comprising, jointly or disjointly, video cameras, cameras, scanner, echo-dopplers.

Said means for positioning a human body <NUM> comprise: a footboard, one or more supports for portions of a human body, handles, standing bases.

Said means for lighting a human body <NUM> comprise lamps featuring a high chromatic yield index and light diffusers suitable for opening the light beam and for reducing the presence of direct light and shadows. Said means for lighting a human body <NUM> might comprise LED lamps.

With reference to <FIG> , said video cameras <NUM> possibly comprise one or several depth sensors. Conveniently said video cameras <NUM>, comprising depth sensors, are integrally connected to means for positioning a human body <NUM>, in particular they are connected, via folding movable arms <NUM>, to a footboard <NUM> in junction points <NUM>, wherein every arm <NUM> accommodates one or more video cameras <NUM>. Advantageously said depth sensors accommodated in said video cameras <NUM> comprise infrared depth sensors.

In its first embodiment, the present invention is characterized in that said means suitable for assessing volumetric and perimetric data <NUM>, comprising video cameras <NUM>, also include movable laser lines <NUM> suitable for identifying and using marker points and lines 401a-c.

Said means suitable for assessing volumetric and perimetric data <NUM> and said means for positioning a human body <NUM>, being part of the diagnostic system <NUM>, are for instance applied for generating a multitude of lower limb volumetric indicators and perimetric indicators. With reference to <FIG> , said means suitable for assessing volumetric and perimetric data <NUM> are characterized in that they include three movable laser lines <NUM> suitable for identifying and using marker points or lines 401a-c. Advantageously said marker points or lines 401a-c are positioned at the groin, femoral condyles, and malleolus-ankle levels respectively. In one embodiment of the present invention, the human body is in a standing straight position. The first lower limb <NUM> is lifted and leans on a support point <NUM>, as shown in <FIG> , said support point <NUM> being adjustable in height. The second lower limb <NUM> is put in contact with the standing base <NUM> (as is shown in <FIG> ) of the footboard <NUM>. The position of the first lower limb <NUM> being raised makes it easily accessible a collection of said volumetric and perimetric data of the inner thigh and improves the quality of the assessment of said data. The positions of the first lower limb <NUM> and of the second lower limb <NUM> are interchangeable on the support point <NUM> and on the standing base <NUM> of the footboard <NUM>.

In a second embodiment of the invention, said diagnostic system <NUM> is characterized in that advantageously said means suitable for assessing volumetric data and perimetric data <NUM> also comprise means suitable for acquiring volumetric data and blood vessel flow data (not shown in the figures). Said means suitable for acquiring volumetric data and blood vessel flow data comprise, as an example, an echo-doppler or an echo-color doppler, operationally connected to said electronic processor means <NUM>, to said software means <NUM>, and to said means for positioning a human body <NUM>. In this second embodiment of the invention, said means suitable for acquiring volumetric data and blood vessel flow data are suitable for generating morphological indicators and a model of the venous tree of a human body, or a portion thereof. With a special reference to the lower limbs <NUM> - <NUM>, said model of the venous tree is advantageously classified on the basis of eleven standard models of the venous tree or phenotypes. Said phenotypes are a classification of various typologies of chronic venous insufficiency of the lower limbs, a pathological situation wherein an increase in the volume of the limbs takes place, related to a deficit of the drainage system constituted by veins.

Surprisingly a correlation was identified between the model of the venous tree of the lower limbs and the volumetric and perimetric indicators of the lower limbs. In particular, the specific model of the venous tree as determined via the diagnostic system <NUM>, i.e. the specific phenotype, characterizes each individual human body. The evolution of said volumetric and perimetric indicators generated for each individual human body over time is related to the specific phenotype of each individual human body, via a statistical relationship, hence they allow an improved monitoring over time of edemas and pathologies falling in the group formed of muscle, cardiovascular, venous system, and lymphatic system pathologies.

Said monitoring over time is made, for example, on edemas and pathologies of the lower limbs. It has been found that the best therapy applicable to the treatment of edemas and pathologies of the lower limbs can be defined on the basis of the phenotypes, and therapeutic effectiveness can be measured by monitoring said volumetric indicators.

With a special reference to <FIG>, a method is here described for assessing and monitoring volumetric indicators and perimetric indicators of a human body, or parts thereof, determined according to the system <NUM>, and characterized in comprising the following steps:.

In one of its embodiments, the present invention comprises the steps of generating and monitoring volumetric indicators and perimetric indicators for the lower limbs. Advantageously the assessment of said volumetric and perimetric data by using means suitable for assessing volumes and perimeters is made with the help of several video cameras, the human body being in a standing straight position. Said assessment of said volumetric and perimetric data is made, for instance, by acquiring, in a rapid succession, several images from four video cameras <NUM> positioned in a circular manner about the lower limb thus obtaining several views of one and the same lower limb. Said video cameras <NUM> include one or several infrared depth sensors and are integrally connected to said means for positioning a human body <NUM>, in particular they are connected, via folding movable arms <NUM>, to a footboard <NUM> at junction points <NUM>, wherein every arm <NUM> accommodates one or several video cameras <NUM>.

Said volumetric and perimetric data processing by using electronic processor means and software means is made on the images acquired from each of the four video cameras <NUM>, i.e. by processing several views of one and the same lower limb acquired in a rapid succession. Said software means apply image processing and transformation algorithms in order to perform a superimposition of said images, and to apply a filter for cleaning up the images themselves, so as to obtain a cloud of points which characterizes and represents the lower limb. Said software means also make a segmentation of the cloud of points of the lower limb at several cutting levels, i.e. several cutting planes. For every cutting plane of the cloud of points of the lower limb, said software means define a projection of said closest points on the plane, thereby drawing up a polyline which plots the perimeter of the lower limb at the assessment height of interest. The area enclosed by said polyline is subsequently calculated by the software means, and the volume is determined in correspondence with the height of the plane defined for segmentation. The thickness of said plane is, for example, <NUM>. In one embodiment of its own, the method described in the present invention is characterized in that the generation of volumetric and perimetric indicators is made, the lower limbs being subdivided into quartiles, by generating one global volumetric indicator of the limb and one volumetric indicator for each of said quartiles of the limb. <FIG> shows an example of such subdivision of a lower limb into quartiles: Ist quartile <NUM>, IInd quartile <NUM>, IIIrd quartile <NUM>, IVth quartile <NUM>. The length of the Ist quartile <NUM> and that of the IInd quartile <NUM> equal a value corresponding to A/<NUM>. The length of the Illrd quartile <NUM> and that of the IVth quartile <NUM> equal a value corresponding to B/<NUM>. The parameters A and B represent segments of said lower limb, A+B defining the length of the limb from the groin to the malleolus.

Just as an example, said volumetric indicators generated by said electronic processor means and said software means can equal values falling in the following ranges, cubic centimeter (cc) being taken as measuring unit:.

In a further embodiment of the present invention, the method for generating and monitoring volumetric indicators and perimetric indicators of a human body, or parts thereof, as determined according to the system <NUM>, is characterized in comprising the following additional steps ( <FIG> ):.

Advantageously the assessment of said data on blood vessels of a human body, or a portion thereof, by using means suitable for acquiring volumetric data and blood vessel flow data, is made by using means suitable for acquiring volumetric data and blood vessel flow data (not shown in the figures).

Just as an example, said means suitable for acquiring volumetric data and blood vessel flow data comprise an echo-doppler or an echo-color doppler, operationally connected to said electronic processor means (<NUM>), to said software means (<NUM>), and to said means suitable for positioning a human body (<NUM>).

In this embodiment of the invention, said means suitable for acquiring volumetric data and blood vessel flow data are suitable for generating morphological indicators and a model of the venous tree of a human body, or a portion thereof.

With a special reference to the lower limbs, said model of the venous tree is advantageously classified on the basis of eleven standard models of the venous tree, or phenotypes. Said phenotypes are a classification of various typologies of chronic venous insufficiency of the lower limbs, a pathological situation wherein an increase in the volume of the limbs takes place, related to a deficiency of the drainage system constituted by veins.

It was experimentally confirmed that relating the volumetric indices to the venous hemodynamic data (analyzing the blood flow in the veins of the lower limbs), as obtained by using the software means <NUM> suitable for characterizing the various morpho-functional typologies of said venous system, leads to a diagnostic classification of the pathologies of the lower limbs, based on objective data, hence processable in the mentioned models of the venous tree.

Analyzing said volumetric and perimetric indicators, generated at every clinical test with the model of the venous tree, over time, allows an accurate monitoring of pathologies falling in the group comprising muscle, cardiovascular, venous system, and lymphatic system pathologies.

For example, said monitoring over time is made on edemas and pathologies of the lower limbs.

According to the present embodiment, the basic model of the venous tree of the lower limbs is semi-automatically performed and classified by said software means (<NUM>) in a specific category of phenotypes and/or sub-categories thereof, referable to volumetric data and blood vessel flow data.

Here follows an exemplary monitoring of volumetric indices in relation to the progress of a pathology of the lower limbs.

In one first example, the diagnostic system and its respective method was applied for assessing and monitoring volumetric and perimetric indicators of the lower limbs <NUM> and <NUM>. Said diagnostic system <NUM> was configured as follow:.

The volume of the lower limb to be assessed and monitored was: diameter: variable; height: <NUM>.

Three markers positioned at the groin, femoral condyles, and malleolus-ankle levels respectively have been used to apply the method.

The diagnostic system according to the present invention, and its respective method, made it possible to generate the following volumetric indicators for the first lower limb, for instance, as an average of several measurements:.

<FIG> shows how the individual volumetric indicators <NUM>, <NUM>, <NUM> and <NUM> for the two lower limbs <NUM> and <NUM>, whose variation is related to the pathological status of the lower limbs being analyzed, vary as a function of time (t1, t2, t3).

The foregoing demonstrates that the present invention allows to achieve the objects presented in the introduction in an easy and advantageous manner.

Claim 1:
A diagnostic system (<NUM>) for assessing and monitoring volumetric indicators and perimetric indicators of a human body, or portions thereof, comprising:
- means suitable for assessing volumetric and perimetric data (<NUM>),
- electronic processor means (<NUM>) and software means (<NUM>) operationally connected to said means suitable for assessing volumetric and perimetric data (<NUM>), to process said volumetric and perimetric data generating volumetric and perimetric indicators,
- means for positioning a human body (<NUM>) operationally connected to said means suitable for assessing volumetric and perimetric data (<NUM>),
- means for lighting a human body (<NUM>) connected to said means for positioning a human body (<NUM>) and operationally connected to said means suitable for assessing volumetric and perimetric data (<NUM>) and to said electronic processor means (<NUM>),
characterized in that said means suitable for assessing volumetric data and perimetric data (<NUM>) are means for acquiring images comprising, video cameras (<NUM>) integrally connected to the means for positioning a human body (<NUM>), being connected to a footboard (<NUM>), via folding movable arms (<NUM>), at junction points (<NUM>), wherein every arm (<NUM>) accommodates one or more video cameras (<NUM>).