Measuring device intended to come into contact with a tissue and procedure for analyzing the measured tissue data

Abstract

The invention relates to a measuring device intended to be placed in contact with tissue and a method for analyzing the measured tissue data. The invention relates to a measuring device (D) intended to be placed in contact with tissue (T), comprising an indenter (1) configured to cause deformation of the tissue (T), an extensometer (3) configured to measure the resistance force of the tissue (T) to the deformation caused by the indenter (1), and a position sensor (5) configured to measure the indentation depth representative of the movement of the indenter (1). The invention also relates to a method for analyzing tissue data related to tissue (T), which is implemented by computer and comprises an association step (A1) of a measurement of the indentation depth and a measurement of the resistance force to deformation corresponding to the indentation depth.

Description

Technical field of the invention

[0001] The present invention relates to a measuring device intended to be placed in contact with a fabric.

[0002] The invention also relates to a method for analyzing tissue data. State of the art

[0003] In the field of biological tissue analysis, numerous analytical methods exist, generally depending on the tissue being analyzed. In the case of skin, a commonly used method for suspected cancerous lesions is visual examination by a practitioner. This method relies on the ABCDE rule, which allows the practitioner to assess the condition of a skin lesion according to morphological criteria such as asymmetry, border regularity, color, diameter, and thickness. Sometimes, this method is supported by dermoscopy.

[0004] However, in the vast majority of cases, the practitioner's experience and training significantly improve the performance of data analysis from biological tissues. The sensitivity and specificity of these methods are quite good when the practitioner has a thorough understanding of the semiology of skin lesions, which is generally not the case for general practitioners or inexperienced specialists.

[0005] Furthermore, despite the practitioner's experience, the analysis of data from biological tissues can be affected by the nature of the skin being analyzed. Human skin is composed of three layers: the epidermis, the dermis, and the hypodermis. The epidermis is the outermost layer and is subdivided into several other layers, each with its own biomechanical characteristics. The stratum corneum is the outermost layer; it is the one that sheds and is visible to the naked eye. This layer is very rigid and, among other things, protects the human body from external aggressions (chemicals, sun, etc.). Its properties vary from person to person, which is why the biomechanical values ​​of young skin differ from those of aged skin. Aged skin is generally rigid (hard) compared to young skin, which is supple (soft).

[0006] It is known from the state of the art that equipment using more advanced technologies requires optical scanners or impedance measurement. Methods using this equipment are also based on morphological and organizational data with lesion criteria at the cellular level.

[0007] However, their sensitivity and specificity are limited by the size and location of the lesion. These technologies are not easy to use and require training and experience in data interpretation.

[0008] A new generation of connected tools also exists, such as "digital dermoscopy" connected via a smartphone app. Patients can scan their skin with zoom, and reference photos are available for comparison. This type of tool allows patients to monitor suspicious lesions, but these lesions are not always dangerous. These tools primarily have an analytical function based on clinical criteria, which allows for the detection of only advanced melanomas. Object of the invention

[0009] The invention is defined in the claims. The purpose of this application is to propose a solution that addresses one or more of the problems mentioned above.

[0010] This goal can be achieved through the implementation of a measuring device designed to be placed in contact with a fabric, the measuring device comprising: a support surface intended to be positioned in contact with the tissue; an indenter configured to cause deformation of the tissue, the indenter being configured to be movable relative to the support surface between an original position and an indentation position in which the tissue is deformed by the indenter; a strain gauge configured to measure a resistance force of the tissue to the deformation caused by the indenter; a position sensor configured to measure an indentation depth representative of a displacement of the indenter between the original position and the indentation position.

[0011] The previously described arrangements allow for the measurement of biological characteristics of the tissue, including tissue stiffness, which can be characteristic of at least one tissue lesion if it is present at the measurement area.

[0012] The measuring device may also have one or more of the following characteristics, taken alone or in combination.

[0013] According to one embodiment, the tissue is a biological tissue and more specifically a skin.

[0014] According to one embodiment, the position sensor includes a linear position sensor.

[0015] According to one embodiment, the strain gauge has a nominal capacity of ±0.5 N. The electrical power supply is provided at a voltage of 5V.

[0016] In general, the strain gauge is configured to convert a force measurement into an output voltage relative to the force measurement taken.

[0017] According to one embodiment, the original position corresponds to the position of the indenter when it comes into contact with the fabric.

[0018] In one embodiment, contact between the indenter and the tissue is detected when the strain gauge registers a strain value exceeding a threshold value, for example, 0.01 mN. In this way, the origin position can be automatically detected by sensing a strain value. This origin position can then serve as the origin point for superimposing a theoretical reference curve with a measured actual curve, which combines a set of tissue resistance force measurements with a set of indentation depth measurements. Thus, the stronger the agreement between the measured curve and the reference curve, the more reliable the analysis result will be.

[0019] According to one embodiment, the indenter includes a distal end having a shape adapted to permit deformation of the tissue substantially perpendicular to the surface of said tissue opposite the bearing surface.

[0020] According to one embodiment, the tissue strain resistance force measurement is mechanically stopped when the distal end of the indenter exceeds an indentation depth of 100 µm. For example, the tissue strain resistance force measurement can be stopped when the position sensor measures a displacement of 100 µm from the origin position, said origin position being able to correspond to the moment when the strain gauge records a strain value greater than a threshold value.

[0021] According to one embodiment, the measurement of the force of resistance to deformation of the tissue can be stopped when the first part is in contact with the second part, or after a predetermined measurement time, or when the measurement is stabilized.

[0022] According to one embodiment, the strain gauge is configured to measure the force of resistance to deformation of the fabric along a measurement axis, and wherein the depth of indentation is measured along the measurement axis, said measurement axis being substantially perpendicular to the bearing surface.

[0023] By substantially perpendicular we mean a direction of the measurement axis within an angular range of 0° to 5° with respect to the direction normal to the fabric.

[0024] According to one embodiment, the position sensor includes an inductive sensor.

[0025] According to one embodiment, the position sensor can have a step of 4 µm over a range of 2mm.

[0026] According to one embodiment, the measuring device comprises a housing including: a first part on which the indenter rests; a second part presenting the bearing surface and being connected to the first part by means of at least one return element.

[0027] The previously described provisions allow the device to be stabilized on the fabric before a user takes a measurement.

[0028] According to one embodiment, the return element comprises at least one spring.

[0029] According to one embodiment, the measuring device includes a camera configured to collect a representative image of the fabric, the measuring device being configured to communicate the image of the fabric, the resistance force to deformation of the fabric and the depth of indentation to a user terminal.

[0030] According to one embodiment, the housing includes a third part defining an aperture, said aperture being configured to delimit an area of ​​interest representative of an area on the surface of the fabric from which the image of the fabric is collected.

[0031] In one embodiment, the aperture is contained within a dark chamber formed in the housing, said dark chamber being configured to delimit a volume protected from external light in which the image of the fabric is collected. In this way, the image collection of the fabric by the camera is reproducible and standardized.

[0032] According to one embodiment, the strain gauge is configured to measure a plurality of tissue deformation resistance forces at a point of interest within the area of ​​interest, as a function of the indentation depth.

[0033] According to one embodiment, the housing includes a fourth part attached to the second part on one side and to the third part on the other side and configured to allow the measuring device to be grasped by one hand.

[0034] In this way, the fourth part can be used as a handle to manipulate the measuring device.

[0035] According to one embodiment, the measuring device includes a processor configured to communicate with the position sensor, strain gauge and camera via a converter element.

[0036] According to one embodiment, the processor can communicate with the user terminal via an antenna.

[0037] According to one embodiment, the processor can communicate with the user terminal via a wired connection.

[0038] In one embodiment, the converter element includes an analog-to-digital converter. For example, said analog-to-digital converter can be configured to operate at 24 bits.

[0039] In general, the converter element can be configured to convert an electrical voltage into a digital signal.

[0040] According to one embodiment, the processor includes a microcontroller configured to control the position sensor and strain gauge in real time.

[0041] In one embodiment, the microcontroller, position sensor, and strain gauge are contained within a volume less than 10050 mm³. This results in more stable measurement signals from the strain gauge and position sensor, ensuring more reliable measurements. Furthermore, the described arrangement reduces the overall size and provides a more ergonomic measurement device.

[0042] According to one embodiment, the converter element is configured to convert a plurality of tissue strain resistance forces into a first signal, and to convert a plurality of indentation depths into a second signal, the processor being configured to determine, from the first signal and the second signal, a target value of tissue strain resistance force corresponding to a predetermined indentation depth.

[0043] According to one embodiment, the processor is configured to communicate the target value and the image of the fabric to the user terminal.

[0044] According to one variant, the target value and tissue image can be analyzed to characterize tissue injury, for example according to a predetermined algorithm.

[0045] In one embodiment, the analysis can be performed using artificial intelligence processing with a trained engine using test data corresponding to known cases. A decision tree can also be used.

[0046] According to one embodiment, the predetermined indentation depth is between 90 µm and 110 µm and more particularly substantially equal to 100 µm.

[0047] The previously described provisions allow for discrimination between different types of skin lesions. For this measurement to be reliable, it is essential to guarantee that the measuring device establishes a measurement at 100 µm of indentation, measured from the point of contact with the tissue, as it is possible to discriminate between skin lesions at this indentation depth.

[0048] Advantageously, determining the tissue deformation resistance force based on an indentation depth eliminates the need to consider the actual tissue deformation force, particularly when there is significant variability between two tissue types, such as young or aged skin. Conversely, if the measurement is performed by applying a fixed force, the tissue might be deformed by approximately 10% in depth for aged skin, while it could be deformed by approximately 50% in depth for young skin. Thus, the tissue data analysis would not be the same. Consequently, as described previously, it is possible, for an indentation depth of 100 µm, to differentiate between melanoma and carcinoma, etc., regardless of the tissue's biomechanical characteristics.

[0049] According to one embodiment, the measurement device includes a lighting device configured to illuminate the area of ​​interest when the image of the tissue is collected by the camera.

[0050] According to one embodiment, the measuring device includes a converging lens and a polarizing lens.

[0051] According to one embodiment, the measuring device is supplied with electrical energy via a storage system comprising a battery.

[0052] According to one embodiment, the measuring device is supplied with electrical energy via a wired power supply.

[0053] According to one embodiment, the first part and the third part are arranged on the same side of the case.

[0054] The objective of this application can also be achieved through the implementation of a computer-implemented tissue data analysis process, the tissue data analysis process comprising the following steps: reception from a strain gauge of a measurement of a force resisting deformation; reception from a position sensor of a measurement of an indentation depth representative of a displacement of an indenter relative to an origin position; association of a measurement of the indentation depth and a measurement of the force resisting deformation corresponding to the indentation depth.

[0055] The previously described provisions allow a user to receive mechanical data, such as the target value, and optical data, such as the tissue image on a user terminal, in order to perform tissue lesion characterization. Specifically, the characterization can correspond to a tissue lesion analysis of the tissue area on which the measurement was taken.

[0056] The data analysis process may also have one or more of the following characteristics, taken alone or in combination.

[0057] According to one embodiment, the tissue data analysis process includes a step of determining a target value of tissue deformation resistance force corresponding to a predetermined indentation depth.

[0058] According to one embodiment, the tissue data analysis process includes a step of receiving an image of the tissue from a camera.

[0059] In one embodiment, the tissue data analysis process may include a step of transmitting the target value and the tissue image to a user terminal. In this way, tissue data analysis is facilitated by the tissue image, which can help to represent any potential tissue damage. In other words, the tissue data analysis process allows for the repetitive and reliable imitation of an expert practitioner's actions. Indeed, the step of determining a target value for the tissue's resistance to deformation at a predetermined indentation depth can be likened to a tissue palpation by the expert practitioner, while the step of receiving a tissue image from a camera can be likened to an observation of the tissue surface by the expert practitioner.

[0060] In one embodiment, the tissue data analysis process includes a step of verifying the charge level of a storage system within a measuring device of a type described previously. In this way, the measuring device can be powered on when the charge level of the storage system exceeds a threshold. Conversely, the measuring device can be placed in a standby state when it is not used for a specified period.

[0061] According to one embodiment, the storage system includes a battery.

[0062] According to one embodiment, the target value determination step is carried out for an indentation depth between 90 µm and 110 µm, and in particular substantially equal to 100 µm.

[0063] According to one embodiment, the step of determining a target value of resistance force to tissue deformation corresponding to a predetermined indentation depth is carried out in less than 1 s, and in particular in less than 0.5 s and more particularly in less than 0.1 s.

[0064] According to one embodiment, the tissue data analysis process includes a step of receiving a measurement instruction from a user, the measurement instruction being intended to: trigger a force measurement of resistance to deformation and an indentation depth measurement when the indenter comes into contact with the tissue; trigger a tissue image collection when the camera is positioned on the tissue surface.

[0065] According to one embodiment, the image of the tissue is acquired after a period of illumination by a lighting device, for example LEDs. The illumination time can be between 1 second and 5 seconds, and more particularly approximately 3 seconds.

[0066] According to one embodiment, the tissue data analysis process is implemented by a processor included in a measuring device of a type of those described above.

[0067] According to one embodiment, the computer includes a data memory, the data analysis process comprising the following steps recording in data memory of the resistance force to deformation and the indentation depth received during the resistance force reception step and the indentation depth reception step; determination of a set of tissue resistance force values ​​measured at indentation depths close to the predetermined indentation value; validation of the target tissue resistance force value based on said set of tissue resistance force values.

[0068] By "indentation depths close to the predetermined indentation value", we mean tissue strain resistance force values ​​measured at an indentation depth within a 10 µm range around the predetermined indentation depth.

[0069] The previously described provisions allow, in particular, verification that a measurement of the tissue's resistance to deformation force at the predetermined indentation depth is consistent. Thus, the provisions as described eliminate potential measurement artifacts and user handling errors.

[0070] According to one embodiment, the tissue data analysis process includes a step of transmitting an end-of-measurement signal to the user when the measured indentation depth is greater than a threshold value, the threshold value being strictly greater than the predetermined indentation depth.

[0071] According to one embodiment, the threshold value is equal to the value of the predetermined indentation depth plus 20 µm.

[0072] According to one embodiment, the tissue data analysis process may include the following steps implemented by the user terminal: receiving the tissue image and target value from the computer; transmitting the tissue image and target value to a database; receiving an evaluation from the database; transmitting the evaluation to the user.

[0073] The previously described provisions allow the tissue image and target value to be compared to data contained in a local database or a shared database, in order to refine the quality of the diagnosis.

[0074] According to one embodiment, the database can be a local database or a database that resides on a cloud computing infrastructure platform.

[0075] Finally, the purpose of this application can be achieved by implementing a computer program product comprising code instructions arranged to implement the steps of a data analysis process of the type described above, when said program is executed by a processor. Brief description of the drawings

[0076] Other aspects, objectives, advantages, and features of this application will become clearer upon reading the following detailed description of preferred embodiments thereof, given by way of non-limiting example, and made with reference to the attached drawings in which: [ Fig. 1 [ ] is a schematic view of the measuring device according to one embodiment. Fig. 2 [ ] is a schematic view of the first and second parts of the measuring device according to one embodiment. ] Fig. 3[ ] is a schematic view of the third part of the measuring device according to one embodiment. ] Fig. 4 [ ] is a schematic view of the measuring device according to another embodiment. ] Fig. 5 ] is a schematic cross-sectional view of the device of the figure 4 . [ Fig. 6 ] is a schematic view of the position sensor of the device figures 4 And 5 . [ Fig. 7 ] is an example of a sequence illustrating one implementation of the tissue data analysis process. Fig. 8 ] is an example of a curve illustrating the association of a set of resistance force measurements with la tissue deformation with a set of indentation depth measurements. Fig. 9 ] is an example of two curves illustrating the association of a set of tissue deformation resistance force measurements with a set of indentation depth measurements. Fig. 10] is a schematic view illustrating another embodiment of the tissue data analysis process. Detailed description

[0077] In the figures and throughout the description, the same reference numerals represent identical or similar elements. Furthermore, the various elements are not drawn to scale to ensure clarity. Moreover, the different embodiments and variants are not mutually exclusive and can be combined.

[0078] A first embodiment is illustrated on the figure 1 It concerns a measuring device, denoted "D", intended to be placed in contact with a tissue, denoted "T". Generally speaking, tissue T is a biological tissue, and more specifically, skin.

[0079] According to this embodiment, the measuring device D comprises a housing 9 including a first part 11, a second part 13, a third part 15 and a fourth part 17.

[0080] The first part 11 includes a strain gauge 3 and a position sensor 5.

[0081] The second part 13 has a bearing surface marked "S", intended to be positioned in contact with the tissue T. The second part 13 can be connected to the first part 11 by means of at least one return element 21.

[0082] According to one embodiment, the return element 21 may include one or more springs.

[0083] The arrangements described above allow the device to be stabilized on the tissue T before the measurement is taken by a user designated "Usr".

[0084] The third part 15 may include a camera 23 and a lighting system 35.

[0085] Finally, the fourth part 17 can be attached to the second part 13 on one side and to the third part 15 on the other, and configured to allow the measuring device D to be grasped with one hand. In this way, the fourth part 17 can be used as a handle to manipulate the measuring device D.

[0086] Part 11 and Part 2 13 are illustrated in more detail on the figure 2 , in two relative positions of the first part 11 with respect to the second part 13.

[0087] In particular, an indenter 1 relies on the first part 11.

[0088] The indenter 1 can be configured to cause deformation of the tissue T, and to be movable relative to the support surface S between an original position and an indentation position illustrated in Figure 2B in which the tissue T is deformed by the indenter 1.

[0089] The strain gauge 3 can be configured to measure a tissue resistance force T to deformation caused by the indenter 1, and the position sensor 5 can be configured to measure an indentation depth representative of a displacement of the indenter 1 between the original position and the indentation position.

[0090] The indenter 1 may include a distal end 7 having a shape adapted to permit deformation of the tissue T substantially perpendicular to the surface of said tissue T opposite the bearing surface S.

[0091] By substantially perpendicular we mean a direction within an angular range of 0° to 5° with respect to the normal direction of the tissue surface T.

[0092] According to one embodiment, the original position corresponds to the position of the indenter 1 when it comes into contact with the tissue T.

[0093] In one embodiment, contact between the indenter 1 and the tissue T is detected when the strain gauge 3 registers a strain value greater than a threshold value, for example, 0.01 mN. In this way, the origin position can be automatically detected by sensing a strain value. This origin position can then serve as the origin point for superimposing a theoretical reference curve with a measured actual curve, which combines a set of tissue deformation resistance force measurements with a set of indentation depth measurements. Thus, the stronger the agreement between the measured curve and the reference curve, the more reliable the analysis result will be.

[0094] According to one embodiment, the measurement of tissue resistance force T is mechanically stopped when the distal end 7 of the indenter 1 exceeds an indentation depth of 100 µm. For example, the measurement of tissue resistance force T can be stopped when the first part 11 is in contact with the second part 13, or after a predetermined measurement time, or when the measurement is stabilized.

[0095] The strain gauge 3 can be configured to measure the resistance force to deformation of the fabric T along a measurement axis. In this case, the indentation depth is measured along the measurement axis, said measurement axis being substantially perpendicular to the bearing surface S.

[0096] By substantially perpendicular we mean a direction of the measurement axis within an angular range of 0° to 5° with respect to the normal direction of the tissue surface T.

[0097] According to one embodiment, the strain gauge 3 has a nominal capacity of ±0.5 N. The electrical power supply is provided at a voltage of 5V.

[0098] In general, strain gauge 3 can be configured to convert a force measurement into an output voltage relative to the force measurement taken.

[0099] According to one embodiment, the strain gauge 3 is configured to measure a plurality of resistance forces to deformation of the tissue T at a point of interest contained within an area of ​​interest on the surface of the tissue T, as a function of the depth of indentation.

[0100] According to one embodiment, the position sensor 5 includes a linear position sensor.

[0101] According to one embodiment, the position sensor 5 includes an inductive sensor.

[0102] According to one embodiment, the position sensor 5 can have a step of 4 µm over a range of 2mm.

[0103] Part 3, section 15, is illustrated on the figure 3 In particular, it can define an aperture 27 configured to delimit the area of ​​interest representative of an area on the surface of tissue T from which an image of tissue T is collected.

[0104] According to one embodiment, the aperture 27 is contained within a dark chamber formed in the housing 9, said dark chamber being configured to delimit a volume protected from external light in which the image of the fabric T is collected. In this way, the image collection of the fabric T by a camera 23 is reproducible and standardized.

[0105] The third part 15 may include the camera 23 configured to collect an image of tissue T representative of tissue T. The measuring device D may then be configured to communicate the image of tissue T, the force of resistance to deformation of tissue T and the depth of indentation to a user terminal 25.

[0106] According to one embodiment, the measuring device D includes a lighting device 35 configured to illuminate the area of ​​interest when the image of the tissue T is collected by the camera 23.

[0107] The measuring device D may also include a converging lens 37 and a polarizing lens 39.

[0108] The fourth part 17 may include a processor 29 configured to communicate with the position sensor 5, the strain gauge 3 and the camera 23 via a converter element 31.

[0109] According to one embodiment, the processor 29 can communicate with the user terminal 25 via an antenna 33. Alternatively, the processor 29 can communicate with the user terminal 25 via a wired connection.

[0110] In one embodiment, the processor 29 includes a microcontroller configured to control the position sensor 5 and the strain gauge 3 in real time. In another embodiment, the microcontroller, the position sensor 5, and the strain gauge 3 are contained within a volume less than 10050 mm³. In this way, the measurement signals from the strain gauge 3 and the position sensor 5 are more stable, thus ensuring more reliable measurement. Furthermore, the described arrangement reduces the overall size and provides a more ergonomic measurement device.

[0111] In one embodiment, the converter element 31 includes an analog-to-digital converter. For example, said analog-to-digital converter can be configured to operate at 24 bits.

[0112] In general, the converter element 31 can be configured to convert an electrical voltage into a digital signal.

[0113] According to one embodiment, the converter element 31 is configured to convert a plurality of tissue strain resistance forces T into a first signal, and to convert a plurality of indentation depths into a second signal. The processor 29 is then configured to determine, from the first and second signals, a target value of tissue strain resistance force T corresponding to a predetermined indentation depth.

[0114] In this case, the processor 29 can be configured to communicate the target value, and the image of tissue T to the user terminal 25.

[0115] According to one variant, the target value and the tissue image can be analyzed using an algorithm to characterize a tissue lesion.

[0116] In particular, the analysis can be performed using artificial intelligence processing with a trained engine using test data corresponding to known cases. It is also possible to use a decision tree.

[0117] In one embodiment, the predetermined indentation depth is between 90 µm and 110 µm, and more particularly approximately 100 µm. The previously described provisions allow for discrimination between different types of skin lesions. For this measurement to be reliable, it is essential to guarantee that the measuring device D establishes a measurement at 100 µm of indentation, measured from the contact with tissue T, as it is possible to discriminate between skin lesions at this indentation depth.

[0118] Advantageously, determining the tissue deformation resistance force based on an indentation depth eliminates the need to consider the deformation force of the tissue itself, particularly when there is significant variability between two types of tissue, such as young or aged skin. Conversely, if the measurement is performed by applying a fixed force, the tissue might be deformed by approximately 10% in depth for aged skin, while it could be deformed by approximately 50% in depth for young skin. Therefore, the analysis of the tissue data would differ. Consequently, as described previously, it is possible, for an indentation depth of 100 µm, to differentiate between melanoma and carcinoma, etc., regardless of the biomechanical characteristics of the tissue.

[0119] The arrangements described above allow measurement of biological characteristics of the T tissue and in particular the stiffness of the T tissue and an image of the T tissue which may be characteristic of at least one tissue lesion if it is present at the measurement area.

[0120] Another embodiment of the measuring device D is shown in the figures 4 to 6 According to this embodiment, and as shown in the figure 4A The first part 11 and the third part are arranged on the same side of the housing 9. Thus, the bearing surface S includes the opening 27 of the third part 15, as illustrated in the figure 4B (view from below), and 4C (side view).

[0121] Thus, the indenter 1, the position sensor 5 and the strain gauge 3 are arranged on the same side of the housing 9.

[0122] In this way, image acquisition of the fabric T by the camera 23 can be carried out simultaneously with a measurement of the resistance force to deformation of the fabric by the strain gauge 3. In other words, it is not necessary to operate a rotation of the housing 9 to carry out the measurement of a resistance force to deformation of the fabric by the strain gauge 3 and the image acquisition of the fabric T by the camera 23.

[0123] According to the embodiment shown on the Figures 4 to 6 , at least one return element 21 consists of a spring included on the position sensor 5. Said position sensor 5 can therefore bear against the first part 11 ( Figures 5A and 6B ) during measurement. The return element 21 also allows the device to return to a rest position when the measuring device D is not performing a measurement ( Figures 5B and 6A ).

[0124] As illustrated on the figure 7, one embodiment also relates to a method of analyzing tissue data concerning a tissue T, the method being implemented by computer and for example a processor 29 configured to communicate with a camera 23, a strain gauge 3, and a position sensor 5 via a converter element 31, the processor 29 being able to be supplied with electrical energy by a storage system 41. According to an alternative variant, the processor 29 of the measuring device D can be supplied with electrical energy via a wired power supply.

[0125] In particular, the 41 storage system may include a battery.

[0126] According to one embodiment, the data analysis process may include a V1 verification step of the storage system load level 41.

[0127] In this way, the measuring device D can be switched on when the charge level of the storage system 41 exceeds a threshold storage level. Furthermore, the measuring device D can be placed in a standby state when it is not used for a specified period.

[0128] According to one variant, the data analysis process may include a step R7 of receiving a measurement instruction from a user Usr, the measurement instruction being intended for trigger a measurement M1 of resistance force to deformation following the transmission T9 of a first measurement instruction to the strain gauge 3, and to trigger a measurement M3 of indentation depth when an indenter 1 of the type previously comes into contact with the fabric T, following the transmission T11 of a second measurement instruction to the position sensor 5; trigger a collection M5 of the image of the fabric T when the camera 23 is disposed on the surface of the fabric T, following the transmission T13 of a third measurement instruction to the camera 23.

[0129] According to one embodiment, the image of tissue T is collected M5 after illumination by a lighting device 35, for example LEDs. The illumination time can be between 1 second and 5 seconds and more particularly approximately equal to 3 seconds.

[0130] The tissue data analysis process includes the following steps: reception R1 from strain gauge 3 of a force measurement of resistance to deformation; reception R3 from position sensor 5 of an indentation depth measurement representative of a displacement of an indenter 1 relative to an origin position; association A1 of an indentation depth measurement and a force measurement of resistance to deformation corresponding to the indentation depth; reception R5 from camera 23 of an image of the tissue T; determination D1 of a target value of the force resistance to deformation of the tissue T corresponding to a predetermined indentation depth.

[0131] According to one embodiment, the target value is determined for an indentation depth between 90 µm and 110 µm, and in particular substantially equal to 100 µm.

[0132] According to one embodiment, the processor 29 can be capable of communicating with a user terminal 25 via an antenna 33; the method can then include a transmission step T1 of the target value and the image of the tissue to a user terminal 25 via the antenna 33. According to another non-limiting variant, the processor 29 can be capable of communicating with a user terminal 25 via a wired connection.

[0133] The previously described provisions allow the user Usr to receive mechanical data, such as the target value, and optical data, such as the image of tissue T on a user terminal 25, in order to perform a diagnosis. In particular, the diagnosis may involve an analysis of tissue damage to the area of ​​tissue T on which the measurement was taken.

[0134] In other words, the tissue data analysis process allows for the repetitive and reliable imitation of an expert practitioner's actions. Indeed, step D1, which determines a target value for the tissue's resistance to deformation at a predetermined indentation depth, can be compared to a tissue palpation by the expert practitioner, while step R5, which receives a tissue image from a camera, can be compared to an observation of the tissue surface by the expert practitioner.

[0135] According to a particular embodiment in which the processor 29 includes a data memory 43, the data analysis process may further comprise the following steps: recording S1 in data memory 43 of the force resistance to deformation and the depth of indentation received during the reception step R1 of the force resistance to deformation and the reception step R3 of the depth of indentation; determination D3 of a set of values ​​of force resistance to deformation of tissue T measured at depths of indentation close to the predetermined value of indentation; validation V2 of the target value of force resistance to deformation of tissue T as a function of said set of values ​​of force resistance to deformation of tissue T.

[0136] By "indentation depths close to the predetermined indentation value", we mean tissue strain resistance force values ​​T measured at an indentation depth within a 10 µm range around the predetermined indentation depth.

[0137] THE figures 8 And 9illustrate embodiments in which each measurement of a set of tissue deformation resistance strength measurements T is associated with an indentation depth measurement from a set of indentation depth measurements. In particular, the figure 8 illustrates the indentation depths close to the predetermined indentation value and the corresponding forces Fmax and Fmin. figure 9A This illustrates, in particular, how it is possible to discriminate between different types of melanoma by implementing measurement device D as described in this application. figure 9A is a graphical representation of the stiffness measured by the implementation of the measurement device D as a function of different lesions (invasive melanoma or non-invasive melanoma) and healthy skin (melanocyte). figure 9B shows the results of stiffness measured by the implementation of the measurement device D according to a standardized matrix of increasing stiffness (0.2% to 4%).

[0138] The previously described provisions allow, in particular, verification that a measurement of the tissue's resistance to deformation force (T) at the predetermined indentation depth is consistent. Thus, the provisions as described eliminate measurement artifacts and user handling errors.

[0139] Finally, the tissue data analysis process may include a step T3 of transmitting an end-of-measurement signal to the user Usr when the measured indentation depth exceeds a threshold value, the threshold value being strictly greater than la predetermined indentation depth.

[0140] According to one embodiment, la The threshold value is equal to the predetermined indentation depth value plus 20 µm.

[0141] According to an embodiment illustrated on the Figure 10The tissue data analysis process may include the following steps implemented by the user terminal 25: reception R9 of the tissue image T and the target value from processor 29; transmission T5 of the tissue image T and the target value to a database 45, 47; reception R11 of an evaluation from the database 45, 47; transmission T7 of the evaluation to the user Usr.

[0142] The arrangements described above allow the image of tissue T and the target value to be compared with data contained in a local database 45 or in a shared database 47, in order to refine the quality of the diagnosis.

[0143] The present application relates finally to a computer program product comprising code instructions arranged to implement the steps of a data analysis process of the type described above, when said program is executed by a processor 29.

Claims

1. A measurement device (D) intended to be placed in contact with a tissue (T), the measurement device (D) comprising: a. a housing (9) comprising a first part (11), and a second part (13) connected to the first part (11) through at least one biasing element (21), the second part (13) including a bearing surface (S) intended to be positioned in contact with the tissue (T); b. an indenter (1) bearing on the first part (11) of the housing (9) and being configured to cause a deformation of the tissue (T), the indenter (1) being configured to be movable relative to the bearing surface (S) between an initial position and an indentation position in which the tissue (T) is deformed by the indenter (1); c. a strain gauge (3) configured to measure a force of resistance of the tissue (T) to the deformation caused by the indenter (1), said measurement of force of resistance to deformation of the tissue (T) being mechanically stopped when the first part (11) abuts against the second part (13); d. a position sensor (5) configured to measure an indentation depth representative of a displacement of the indenter (1) between the initial position and the indentation position; the measurement device (D) being configured to automatically detect the initial position which corresponds to the position of the indenter (1) when it comes into contact with the tissue (T), which is detected when the strain gauge (3) records a strain value greater than a threshold value.

2. The measurement device (D) according to claim 1, wherein the strain gauge (3) is configured to measure the force of resistance to deformation of the tissue (T) along a measurement axis, and wherein the indentation depth is measured along the measurement axis, said measurement axis being substantially perpendicular to the bearing surface (S).

3. The measurement device (D) according to any one of claims 1 or 2, comprising a camera (23) configured to collect an image of the tissue (T) representative of the tissue (T), the measurement device (D) being configured to communicate the image of the tissue (T), the force of resistance to deformation of the tissue (T), and the indentation depth to a user terminal (25).

4. The measurement device (D) according to claim 3, wherein the housing (9) comprises a third part (15) defining an opening (27), said opening (27) being configured to delimit an area of interest representative of an area on the surface of the tissue (T) from which the image of the tissue (T) is collected.

5. The measurement device (D) according to claim 4, wherein the strain gauge (3) is configured to measure a plurality of forces of resistance to deformation of the tissue (T) at a point of interest included in the area of interest, as a function of the indentation depth.

6. The measurement device (D) according to any one of claims 4 or 5, wherein the housing (9) comprises a fourth part (17) secured, on the one hand, to the second part (13) and, on the other hand, to the third part (15), and configured to allow the measurement device (D) to be held by a hand.

7. The measurement device (D) according to any one of claims 1 to 6, comprising a processor (29) configured to communicate with the position sensor (5) and the strain gauge (3) through a converter element (31) on the one hand, and intended to communicate with a user terminal (25) through an antenna (33) on the other hand, the converter element (31) being configured to convert a plurality of forces of resistance to deformation of the tissue (T) into a first signal, and to convert a plurality of indentation depths into a second signal, the processor (29) being configured to determine, from the first signal and the second signal, a target value of force of resistance to deformation of the tissue (T) corresponding to a predetermined indentation depth.

8. The measurement device (D) according to claim 7, wherein the processor (29) is configured to communicate the target value and the image of the tissue (T) to the user terminal (25).

9. The measurement device (D) according to any one of claims 7 or 8, wherein the predetermined indentation depth is comprised between 90 µm and 110 µm, and more particularly substantially equal to 100 µm.

10. A method for analyzing tissue data relating to a tissue (T), implemented by a computer, the method for analyzing tissue data comprising the following steps: a. receiving (R1), from the strain gauge (3) of a measurement device (D) according to any one of claims 1 to 9, a measurement of a force of resistance to deformation; b. receiving (R3), from the position sensor (5) of the measurement device (D), a measurement of an indentation depth representative of a displacement of the indenter (1) relative to the automatically detected initial position, the initial position corresponding to the position of the indenter (1) when it comes into contact with the tissue, which is detected when the strain gauge (3) records a strain value greater than a threshold value; c. associating (A1) a measurement of the indentation depth and a measurement of the force of resistance to deformation corresponding to the indentation depth; d. determining (D1) a target value of force of resistance to deformation of the tissue (T) corresponding to a predetermined indentation depth.

11. The method for analyzing tissue data according to claim 10, wherein the step (D1) of determining the target value is carried out for a predetermined indentation depth comprised between 90 µm and 110 µm, and in particular substantially equal to 100 µm.

12. The method for analyzing tissue data according to any one of claims 10 or 11, comprising the following steps: - recording (S1) in a data memory (43) the force of resistance to deformation and the indentation depth received during the step (R1) of receiving the force of resistance to deformation and the step (R3) of receiving the indentation depth; - determining (D3) a set of values of force of resistance to deformation of the tissue (T) measured at indentation depths close to the predetermined indentation depth; - validating (V2) the target value of force of resistance to deformation of the tissue (T) as a function of said set of values of force of resistance to deformation of the tissue (T).

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