Sonde de diagnostic bimodale

Abstract

The invention relates to a bimodal diagnostic probe (1) used to examine biological tissues, said probe (1) comprising: A body (12) having an elongated shape along a longitudinal axis (X), the body having a distal portion (11) designed to come as close as possible to the tissues to be examined, at least one ultrasonic device (4) comprising an array of ultrasonic transducers (40), said array of ultrasonic transducers (40) being controlled to emit ultrasonic signals towards the tissues to be examined and to convert the reflected ultrasonic signals into electrical signals, at least one optical device (3) comprising a light source, said at least one light source being controlled to emit a light beam (30) towards the tissues to be examined, the optical device also comprising at least one sensor for capturing the light signals scattered by the tissues. Figure to be published with the abbreviation: Figure 1

Description

Title of the invention: Bimodal diagnostic probe Technical field of the invention

[0001] The present invention relates to a bimodal diagnostic probe, intended to be integrated into a diagnostic system capable of generating images from ultrasonic and optical data. State of the art

[0002] Among endocrine disorders, pituitary adenomas are low-grade, slow-growing tumors representing approximately 10% of primary brain tumors. They can lead to the secretion of abnormally high amounts of one or more hormones (corticotroph adenoma secreting ACTH for Cushing's disease, somatotroph adenoma secreting growth hormone or GH for acromegaly, etc.). Cushing's disease (ACTH-secreting pituitary adenomas) is certainly one of the most detrimental to the patient.

[0003] Complete excision of the corticotroph adenoma allows the patient to be cured. However, its detection is not always possible, despite advances in magnetic resonance imaging (MRI).

[0004] Magnetic resonance imaging is currently the examination of choice for localizing the adenoma. However, visualization of secreting adenomas (including those secreting ACTH (corticotropic hormone)) using imaging is made difficult due to their small size.

[0005] Furthermore, surgical treatment remains the gold standard to date, as it allows for a cure when the excision is complete. Pituitary surgery is performed via a transsphenoidal endonasal approach under endoscopic guidance.

[0006] If an adenoma is visible on MRI, the neurosurgeon knows the location of the adenoma and can access it using an endoscope, allowing visual control of the exploration of the gland and the resection of the adenoma. However, since MRI images and endoscopic visualization cannot be superimposed, exploration of the gland remains difficult.

[0007] In the case of an adenoma not visible on T MRI, it is known to propose a total hypophysectomy, leading to postoperative pituitary insufficiency.

[0008] However, a parameter that differentiates adenomatous tissue from healthy pituitary tissue has recently been identified, namely tissue stiffness (Meyer M et al., 2021). The pituitary gland, and more specifically the anterior pituitary, is indeed a tissue whose extracellular matrix is ​​rich in Reticulin and collagen fibers IV.

[0009] The study of the micromechanical characterization of pituitary adenomas by comparison with the healthy pituitary gland shows that the mean stiffness (expressed in ki-pazcals or kPa), measured by atomic force microscopy (AFM) in adenomatous tissue, differs significantly from that estimated in the healthy pituitary gland. Indeed, the mean stiffness of adenomatous tissue is between 0.1 and 0.2 kPa for the tested adenomas (somatotropic and corticotropic), whereas that measured in the healthy pituitary parenchyma is approximately 10 kPa (Meyer M et al., 2021).

[0010] The intraoperative localization of the lesions could thus be evaluated by an approach based on the measurement of stiffness by means of a non-invasive probe (with respect to the gland) using the ultrasound modality coupled with the optical modality.

[0011] The object of the invention is to have a bimodal probe capable of simultaneously detecting the adenoma by ultrasound mode and enabling its resection by optical mode, said probe: - allowing the superimposition of ultrasonic (elastographic) information onto the optical image usually used by the neurosurgeon; - having a spatial footprint suitable for the introduction of surgical instruments commonly used during this type of surgery;

[0012] By way of non-limitation, the probe of the invention may in particular be used in the following fields of application: excision of pituitary adenomas, brain tumors in the broad sense (meningiomas, gliomas, cavernomas, craniopharyngiomas, etc.), tumors in the broad sense (liver, breast, lung, colon, bladder, prostate, thyroid, ovary). Description of the invention

[0013] This objective is achieved by a bimodal diagnostic probe, used to examine biological tissues and intended to be integrated into a diagnostic system capable of generating images from ultrasound and optical data, said probe comprising: - A body with an elongated shape along a longitudinal axis, - The body includes a distal part designed to come as close as possible to the tissues to examine, - At least one ultrasonic device comprising an array of ultrasonic transducers, said array of ultrasonic transducers being controlled to emit ultrasonic signals towards the tissues to be examined and to convert the reflected ultrasonic signals into electrical signals, - At least one optical device comprising a light source, said to at least one controlled light source to emit a beam of light towards the tissues to be examined, the optical device also comprising at least one sensor to capture the light signals scattered by the tissues, - The optical device being arranged to emit said light beam at the distal part of the probe, - The probe comprising a movable part that slides within said body in a direction parallel to the longitudinal axis, said movable part comprising a distal end carrying the ultrasonic device, - The probe comprising means for adjusting the longitudinal position of said moving part.

[0014] According to one particular feature, the probe includes a displacement sensor arranged to detect the longitudinal position of the moving part.

[0015] According to another feature, the probe includes a sliding locking device for the moving part.

[0016] According to another feature, the probe includes at least one mechanical pressure sensor located at the distal end of the moving part.

[0017] According to another feature, the ultrasonic device comprises an array of ultrasonic transducers.

[0018] According to another feature, the probe includes a channel called the operator channel integrated into the body of the probe and extending in a direction parallel to the longitudinal axis.

[0019] The invention also relates to a diagnostic system capable of generating images from ultrasonic and optical data, said system comprising a bimodal probe and a control and processing unit to which said bimodal probe is connected, the bimodal probe being as defined above.

[0020] According to one particular feature, the system includes means for acquiring the longitudinal position of the moving part of the probe and the control and processing unit is configured to determine the longitudinal position of said ultrasonic transducer array relative to the optical device.

[0021] According to another feature, the control and processing unit is configured to correct the image obtained using the ultrasonic device and / or the image obtained using the optical device by taking into account the longitudinal position of said ultrasonic transducer array relative to the optical device and in particular the distal front face from which the light beam is emitted.

[0022] According to another feature, the control and processing unit includes a module for superimposing images obtained through the optical device and images obtained through the ultrasonic device.

[0023] According to another feature, the control and processing unit comprises a module

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[0034] superposition of images obtained using the ultrasound device and images obtained by MRI. Another distinctive feature of the system is that it includes an image processing module for images obtained using the ultrasound device, configured to distinguish the different stiffnesses of the tissues examined. Brief description of the figures Other features and advantages will appear in the detailed description that follows, in conjunction with the attached drawings, in which: - Fig. 1 shows an example of an embodiment of the bimodal probe of the invention; - Figures 2A to 2D show several variants of the embodiment of the distal part of the bimodal probe of the invention; - Fig. 3 schematically shows the hardware and software architecture of the diagnostic system of the invention incorporating said bimodal probe; Detailed description of at least one embodiment With reference to [Fig. 1], according to the invention, the bimodal probe 1 comprises a body 12 elongated along a longitudinal axis (X). The probe 1 comprises a first part called proximal 10 and a second part called distal 11 opposite. The proximal part 10 of the probe includes means 100 for grasping and manipulating the probe 1 by an operator (for example the surgeon). The probe 1 of the invention can in particular be mounted on an articulated arm 2, which optionally can be controlled by the control and processing unit (see below). The distal part 11 of probe 1 includes detection means, intended to be brought close to the tissues to be examined. The detection means of the bimodal probe include an optical device 3 and an ultrasonic device 4. The distal part 11 of the probe advantageously includes a front face 110 oriented perpendicularly to its longitudinal axis (X). This front face 110 is intended to be positioned opposite the tissues to be examined. The optical device 3 includes at least one light source. The light source may include one or more light-emitting diodes in a distal position of the probe or at a distance coupled with at least one optical fiber to carry the light through the body 12 of the probe (as in [Fig. 1]). The light beam 30 is delivered at the distal part 11 of the probe, through the front face 110 of the probe 1 and oriented so as to be emitted in the direction tissues to be examined.

[0035] The optical device 3 also includes at least one optical camera for capturing light waves reflected by the tissues after illumination. The optical camera can be located in the distal or proximal part of the body 12. In the case of the proximal configuration (as in [Fig. 1]), the transmission of light from the area to be examined to the optical camera can be achieved by means of an optical fiber network or any other optical device. The optical camera, composed of several photodiodes, is configured to convert the captured light waves into electrical signals usable by a processing module (see below).

[0036] Figures 2A to 2D show several examples of the implementation and positioning of the components of the optical device and the ultrasonic device. Observation of the area to be examined is, for example, carried out through an optical receiver 31, which may incorporate one or more lenses.

[0037] The ultrasonic device 4 comprises several ultrasonic transducers 40, advantageously an array of ultrasonic transducers. These ultrasonic transducers 40 may be piezoelectric elements or capacitive micromachined ultrasonic transducers (CMUTs). The material of the piezoelectric element may be quartz, ceramic (lead zirconate titanate or polyvinylidene fluoride), or polymer. The array of ultrasonic transducers 40 may take various forms, this form being adaptable to the cross-section of the body of the bimodal probe.

[0038] By way of example, the transducer matrix may have a semi-circular shape ([Fig.2A]), rectangular shape ([Fig.2B]), annular shape ([Fig.2C]) or circular shape ([Fig.2D]).

[0039] The ultrasonic device 4 is controlled to insonify a region of interest with ultrasonic waves: in an elastographic mode, a plane shear wave is induced in the region of interest by insonification, and the propagation of the shear plane is measured in real time at high speed by imaging. The ultrasonic part of the probe 1 thus operates in transmit-receive mode.

[0040] According to the invention, the bimodal probe 1 comprises a part 13 mounted movable in sliding relative to the body 12 of the probe along the longitudinal axis (X) of the probe.

[0041] This movable part 13 has a distal end, located on the side of the distal part 11 of the probe. At this distal end, the movable part 13 carries the ultrasonic device 4. It is thus possible to adjust the position of the ultrasonic device 4 relative to the rest of the body 12 of the probe.

[0042] On the proximal side, the movable part 13 may include a gripping handle 132, which can be used by the operator to slide the movable part 13 along its axis.

[0043] This movable part 13 allows the ultrasound device 4 to be moved and the ultrasound transducer array 40 to be brought as close as possible to the tissues to be examined to enable ultrasound imaging, while the light beam 30 of the optical device can be emitted from a more distant position in order to maintain a field of view suitable for surgery. It is thus possible to adjust the position of each of the two devices, using only a single probe 1.

[0044] According to the invention, the probe 1 may include means for adjusting (not shown) the longitudinal position of the movable part relative to the probe body. These adjustment means may consist of several notches or any other equivalent solution. A locking element 131 in position may be integrated into the probe. In [Fig. 1], it can be seen that the movable part is displaced longitudinally by a distance D_x.

[0045] A displacement sensor 130 can also be integrated into the probe 1 to detect the position of the moving part 13 relative to the rest of the probe body 12.

[0046] The sliding of the movable part 13 of the probe 1 can be done manually or by motor. The probe 1 can thus incorporate an electric motor, controlled to allow translational movement of the movable part 13. The transfer of motion from the electric motor to the movable part 13 can be implemented using a rack and pinion and / or worm gear mechanism or any other equivalent solution.

[0047] Advantageously, the probe 1 may include a channel, called the operator channel 5 (Figures 2A to 2D), which extends through its body 12 in the longitudinal direction (X). This channel 5 may be used by the operator either to inject substances for cleaning or any other operation, or to aspirate liquid or solid waste, thus allowing the operator to reach the tissues to be examined from outside the probe 1.

[0048] The moving part 13 may be equipped with at least one pressure sensor (not shown) for measuring the force applied to the tissues during the elastographic measurement. The purpose of the pressure sensor is to avoid causing tissue damage through contact with the probe 1, to achieve minimal tissue deformation, and advantageously, to ensure that a force of the same intensity is always applied during each ultrasonic measurement.

[0049] The probe may have an electric battery housed in its body 12, to power its various components (optical device, ultrasonic device) and / or be connected to an external power source.

[0050] With reference to [Fig.3], in order to function, the bimodal probe 1 is integrated into a more global diagnostic system.

[0051] By way of non-limitation, in addition to the bimodal probe 1, the diagnostic system may include at least one control and processing unit UC and a human-machine interface HMI.

[0052] The human-machine interface (HMI) allows, in particular, the entry of physiological data relating to the patient being monitored, the configuration of the operation of the probe 1 (for example by adjusting the position of the mobile part 13 carrying the ultrasound device 4) and the type of processing applied to the ultrasound data (B-mode, elastography, Doppler).

[0053] The probe 1 is for example removably connected to said control and processing unit UC.

[0054] The control and processing unit UC comprises: - A data transmission / reception module Ml to which the probe's optical device is connected; this module Ml is responsible for controlling the light source (for example, one or more light-emitting diodes) to emit the light beam 30 towards the tissues to be examined and for receiving data representative of the light fluxes received by the optical camera integrated into the optical device 3 to convert them into electrical data; each light-emitting diode can, for example, be controlled individually; - An M2 module for processing data representative of the luminous flux captured by the optical device; - A data transmission / reception module M3 to which the ultrasonic device of the probe is connected; this module is responsible for controlling several ultrasonic transducers 40 to emit ultrasound towards the tissues to be examined and for receiving data representative of the ultrasonic waves received by the ultrasonic transducers 40; - At least one M4 module for processing representative data of the ultrasonic waves captured by the ultrasonic transducers, this M4 processing module being able to be configured to perform classic mode B processing, elastography processing and / or Doppler type processing (optional); - A module M5 for measuring the position of the moving part 13 carrying the ultrasonic device relative to the body 12; responsible for sending or not sending position data to the module M6. - An M6 module for controlling the position of the moving part 13, responsible for moving the latter. - An M7 module for controlling articulated arm 2. - An M8 module for superimposing images obtained via optical mode and via ultrasonic mode; this module will notably be able to rely on the different possible ultrasonic treatment modes mentioned above (B-mode, elastography, Doppler); - Optionally, an M9 module for acquiring images obtained by MRI and an M10 module for processing these images; - Optionally, an Ml 1 module for superimposing images obtained by MRI and those obtained by an ultrasonic processing mode;

[0055] Mode B corresponds to the classic visualization mode used during an ultrasound.

[0056] The M4 module for processing representative ultrasound wave data makes it possible to generate a tissue stiffness map. These images are, for example, three-dimensional ultrasound scans of the region of interest.

[0057] This mapping can reflect raw measurements or relative measurements, by zone. The human-machine interface (HMI) can, for example, be configured to set one or more tissue stiffness thresholds and configure the images obtained taking into account each set threshold. For example, it is possible to display the observed areas with different colors depending on their stiffness level relative to each of the pre-recorded thresholds. This will make it easier to distinguish pathological areas from healthy areas.

[0058] It should be noted that the M8 image overlay module will be able to adapt the images generated by the ultrasonic device by taking into account its position determined by the displacement sensor.

[0059] Each M8, M1 image overlay module allows for the superimposition of images obtained using the optical device 3 and the ultrasonic device 4 integrated into the same probe 1. In other words, the probe of the invention allows for the real-time and simultaneous acquisition of images via these two imaging channels. It will also be possible to superimpose images acquired via MRI.

[0060] By way of non-limiting information, probe 1 can thus be used to locate the lesion and then to confirm the diagnosis by: - Superposition of the elastographic image and the B-mode image (B-mode = ultrasound visualization mode) - Superposition of the image obtained via optical data and the elastographic image; - Superposition of the image obtained by MRI and the elastographic image; - Spatialization and calculation of the lesion volume: combination of different modalities and correlation study (common areas and areas specific to each mode).

[0061] Said probe can also help in the following situations: - Guiding the excision by projecting the lesion onto the 2D image obtained using optical data; - To monitor the resection of the lesion through spatialization and calculation of the lesion volume; - At the final resection check;

[0062] The medical applications targeted by the present invention are pituitary adenomas, brain tumors in the broadest sense (meningiomas, gliomas, cavernomas, craniopharyngiomas, etc.), tumors in the broadest sense (liver, breast, lung, etc.), and in particular recurrences of the aforementioned tumors. In the example of pituitary tumors, and more specifically ACTH-secreting pituitary microadenomas, the diagnostic system first detects the lesion by measuring the stiffness of the scanned tissues, then guides the excision in real time by locating important vascular structures using the device's Doppler function, and finally enables complete excision of the adenoma by precisely delineating the lesion's contours in order to remove it entirely without removing healthy tissue, thus avoiding surgical exploration that could be harmful to the gland.

[0063] The invention has many advantages, including: - We obtain a probe with a compact architecture while having optical and ultrasonic bimodality; - We obtain a probe with a solution that allows it to come into contact with the tissues to be examined to perform ultrasound imaging and then return to its initial position to leave the field of vision of the optical modality clear.

Claims

Claims

1. Bimodal diagnostic probe (1), used to examine biological tissues and intended to be integrated into a diagnostic system capable of generating images from ultrasound data and optical data, said probe (1) comprising: - A body (12) having an elongated shape along a longitudinal axis (X), - The body (12) comprising a distal portion (11) intended to come as close as possible to the tissues to be examined, - At least one ultrasound device (4) comprising a matrix of ultrasound transducers (40), said matrix of ultrasound transducers (40) being controlled to emit ultrasound signals towards the tissues to be examined and to convert the reflected ultrasound signals into electrical signals, - At least one optical device (3) comprising a light source, said at least one light source being controlled to emit a light beam (30) towards the tissues to be examined,the optical device also comprising at least one sensor responsible for capturing the light signals diffused by the tissues, - Characterized in that: - The optical device (3) is arranged to emit said light beam (30) at the distal part (11) of the probe, - The probe (1) comprises a part (13) mounted to slide in said body (12) in a direction parallel to the longitudinal axis (X), said movable part (13) comprising a distal end carrying the ultrasound device (4), - The probe (1) comprises means for adjusting the longitudinal position of said movable part (13).,

2. Probe according to claim 1, characterized in that it comprises a position sensor arranged to detect the longitudinal position of the movable part (13).

3. Probe according to claim 1 or 2, characterized in that it comprises a locking device (131) for the sliding of the movable part (13).

4. Probe according to one of claims 1 to 3, characterized in that it comprises at least one mechanical pressure sensor located at the distal end of the movable part (13).

5. Probe according to one of claims 1 to 4, characterized in that the ultrasonic device (4) comprises a matrix of ultrasonic transducers (40).

6. Probe according to one of claims 1 to 5, characterized in that it comprises a channel called the operating channel (5) integrated into said body (12) of the probe and extending in a direction parallel to the longitudinal axis (X).

7. Diagnostic system capable of generating images from ultrasound data and optical data, said system comprising a bimodal probe (1) and a control and processing unit (UC) to which said bimodal probe is connected, said system being characterized in that the bimodal probe is as defined in one of claims 1 to 6.

8. System according to claim 7, characterized in that it comprises means for acquiring the longitudinal position of the movable part (13) of the probe and in that the control and processing unit (UC) is configured to determine the longitudinal position of said matrix of ultrasonic transducers (40) relative to the optical device (3).

9. System according to claim 8, characterized in that the control and processing unit (UC) is configured to correct the image obtained using the ultrasound device (4) and / or the image obtained using the optical device (3) taking into account the longitudinal position of said matrix of ultrasound transducers (40) relative to the optical device (3).

10. System according to one of claims 7 to 9, characterized in that the control and processing unit (UC) comprises a module (M8) for superimposing the images obtained using the optical device (3) and the images obtained using the ultrasound device (4).

11. System according to one of claims 7 to 10, characterized in that the control and processing unit (UC) comprises a module (Ml 1) for superimposing the images obtained using the ultrasound device (4) and the images obtained by MRI.

12. System according to one of claims 7 to 11, characterized in that it comprises a module (M4) for processing the images obtained using the ultrasound device, configured to distinguish the different stiffnesses of the tissues examined.

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