阅读说明：本技术 用于对软组织进行微创医疗干预的机器人装置 (Robotic device for minimally invasive medical intervention on soft tissue ) 是由 L·布隆代尔 F·巴达诺 B·纳胡姆 于 2018-11-08 设计创作，主要内容包括：本发明涉及一种使用医疗仪器(13)对患者(30)进行医疗干预的机器人装置(10),所述机器人装置包括：机器人臂(11),所述机器人臂具有若干个自由度并且具有适于接纳所述医疗仪器的端部；图像捕获系统(14),所述图像捕获系统适于捕获关于所述患者的解剖结构的位置信息；存储介质(15),所述存储介质具有所述人体的生物力学模型；处理电路(17),所述处理电路被配置为基于所述生物力学模型、基于所述位置信息并且基于所述医疗仪器为了执行所述医疗干预而要遵循的轨迹(13)来确定所述医疗仪器的位置设定点和取向设定点；控制电路(16),所述控制电路被配置为控制机器人臂(11),以将医疗仪器(13)放置在所述位置设定点和所述取向设定点。(The invention relates to a robotic device (10) for performing a medical intervention on a patient (30) using a medical instrument (13), the robotic device comprising: a robotic arm (11) having several degrees of freedom and having an end adapted to receive the medical instrument; an image capturing system (14) adapted to capture positional information about the patient's anatomy; a storage medium (15) having a biomechanical model of the human body; processing circuitry (17) configured to determine a position setpoint and an orientation setpoint of the medical instrument based on the biomechanical model, based on the position information, and based on a trajectory (13) to be followed by the medical instrument for performing the medical intervention; a control circuit (16) configured to control the robotic arm (11) to place a medical instrument (13) at the position setpoint and the orientation setpoint.)

1. A robotic device (10) for medical intervention on a patient (30) using a medical instrument (13), the robotic device comprising:

-a robotic arm (11) having several degrees of freedom and having an end adapted to receive the medical instrument;

-an image capturing system (14) adapted to capture positional information about the patient's anatomy;

The robot device is characterized in that the robot device comprises:

-a storage medium (15) having a biomechanical model of the anatomy of the human body;

-a processing circuit (17) configured to determine a position setpoint and an orientation setpoint of the medical instrument based on the biomechanical model, based on the position information about the patient's anatomy and based on a trajectory (13) to be followed by the medical instrument for performing the medical intervention;

-a control circuit (16) configured to control the robotic arm (11) to place or assist in placing the medical instrument at the position setpoint and the orientation setpoint.

2. The robotic device (10) of claim 1, wherein the biomechanical model is a model of an anatomical structure in a thoracic region and/or an abdominal region and/or a pelvic region of the human body.

3. the robotic device (10) of any one of claims 1 and 2, wherein the image capture system (14) is a non-radiative type.

4. The robotic device (10) of any one of claims 1 to 3, wherein the image capturing system (14) has at least one so-called non-contact device adapted to capture position information without contact with the patient (30).

5. The robotic device (10) of claim 4, wherein the image capture system (14) has at least one of the following non-contact devices:

-a stereo camera for taking a stereo image of the object,

-a structured-light camera for taking in the structured-light image,

-a time-of-flight camera for taking a time of flight,

-a depth measurement camera.

6. The robotic device (10) of any one of claims 1-5, wherein the image capture system (14) is adapted to supply location information corresponding to a location of an outer surface of the body of the patient (30).

7. the robotic device (10) of any one of claims 1 to 6, wherein the image capturing system (14) has at least one so-called contact device adapted to capture positional information by contact with the patient (30).

8. The robotic device (10) of claim 7, wherein the image capture system (14) has at least one of the following contact devices:

-an ultrasound probe for detecting the position of the object,

-an endoscope.

9. The robotic device (10) of any one of claims 1-8, wherein the control circuit (16) is configured to control the robotic arm according to one of the following modes:

-an automatic mode of operation,

-a collaboration mode in which the user is able to collaborate,

-an automatic tracking mode in which the tracking of the track is performed,

-a collaborative tracking mode.

10. The robotic device (10) of any one of claims 1-9, wherein the processing circuitry (17) is configured to determine or assist in determining a trajectory of the medical instrument based on an image of the patient.

11. The robotic device (10) of any one of claims 1 to 10, wherein the processing circuitry (17) is configured to adjust or assist in adjusting a parameter of a therapy to be performed during the medical intervention by simulating an effect of the parameter based on an image of the patient.

12. The robotic device (10) of any one of claims 1 to 11, having guiding means (12) adapted to guide the medical instrument (13) fixed or intended to be fixed to an end of the robotic arm (11).

13. The robotic device (10) of any one of claims 1 to 12, having at least one human machine interface device (19) of the following devices:

-a display screen for displaying the image,

-a touch-sensitive display screen,

-a keyboard for displaying a plurality of images,

-2D and/or 3D goggles,

-a joystick,

-a motion detection module for detecting a motion of the object,

-a voice control module.

14. The robotic device (10) of any one of claims 1-13, having at least one of the following means for registering an entry point:

-a medical instrument having an atraumatic tip,

-a laser targeting module.

15. the robotic device (10) of any one of claims 1 to 14, wherein the medical instrument (13) is one of the following medical instruments:

-a biopsy needle for the purpose of biopsy,

-a conduit for the gas to be delivered,

-an endoscope,

A therapeutic apparatus using focused ultrasound,

-a laser treatment apparatus for the treatment of a patient,

-a cryotherapeutic apparatus for the purpose of,

-a radio-frequency treatment apparatus for performing a treatment,

-an electroporation therapy apparatus,

-curie therapy treatment apparatus.

16. The robotic device (10) of any one of claims 1 to 15, having a mobile carriage (18) carrying the robotic arm (11), the mobile carriage having a securing means.

Technical Field

The present invention is in the field of medical interventions and more particularly relates to a robotic device for performing minimally invasive medical interventions on deformable tissues of a patient, for example for treating or diagnosing deformable organs or anatomical structures.

Prior Art

Medical interventions (for diagnosis, therapy and/or surgery) by a minimally invasive or percutaneous route are becoming increasingly important, in particular in oncology for the local treatment of cancer, directly acting on the cells of the affected organs such as liver, kidney, lung, pancreas, breast, prostate.

outside the field of oncology, there are many medical procedures and applications that use a minimally invasive or percutaneous access route, for example by inserting needles: biopsy (collection of tissue for pathological analysis), placement of drainage tubes (aspiration of fluid), injection of therapeutic products (treatment of pain), etc.

in contrast to open or conventional procedures, which may require incisions of tens of centimeters, minimally invasive medical interventions, at best, use small incisions or openings through which an endoscope, probe, needle or other medical instrument is introduced in order to reach, view and/or treat the targeted anatomical region.

Minimally invasive medical interventions can provide many benefits, such as limiting pain and surgical trauma, reducing bleeding during surgical interventions, and reducing hospital stays. They allow medical intervention in outpatient surgery, allowing faster recovery of the patient, reduced scarring, reduced risk of infection, etc.

In addition to the conventional techniques of surgical resection using forceps, scissors, and other medical instruments, several techniques of damaging tissue by minimally invasive or percutaneous approaches have been validated or are being evaluated. For example, laser surgery, cryotherapy, radiofrequency therapy, microwaves, electroporation, or even focused ultrasound and curie therapy may be mentioned. A common feature of most of these techniques is that a very small incision is made and one or more needles, probes or electrodes for delivering precise and localized therapy (hyperthermia, non-hyperthermia or radiotherapy) are inserted up to the targeted anatomical region.

in most cases, medical interventions performed by minimally invasive approaches require the operator to insert medical instruments into the body of the patient up to a certain depth in order to reach the target anatomical region. These procedures are sometimes lengthy and difficult because, in contrast to open procedures, the operator does not always have a direct view of the patient and the anatomy of the organ to be treated. This complicates the identification of anatomical structures, the precise placement of medical instruments, and the avoidance of sensitive anatomical structures (nerves, blood vessels, healthy organs, etc.).

Surgeons may use preoperative medical images (computed tomography (CT), Magnetic Resonance Imaging (MRI), radiography, etc.) that have been used for diagnostic purposes to more easily register anatomical structures and plan medical interventions in advance. The preoperative images provide an illustration of the anatomy that is valid at a given time (not at the time of the medical intervention, but at a time prior thereto).

In order to properly introduce a medical instrument into a patient's body up to a desired location and depth without damaging sensitive anatomical structures during the procedure, the operator must know the location of the instrument within the patient's body. Several systems and methods are available for determining the position and orientation of a medical instrument during minimally invasive interventions when direct visualization of the anatomy by a microscope or endoscope is not feasible.

Image-guided navigation systems (or computer-assisted surgery) allow the position and orientation of a medical instrument to be tracked in real-time by displaying a virtual medical instrument superimposed on an image of a patient's body. These navigation systems use 3D localization techniques to register both the patient and the medical instrument, the most commonly used being of the optical or electromagnetic type.

it is necessary to use an image capture system before, at startup and/or during a medical intervention in order to capture one or more images of the patient (by scanning, MRI, X-ray, ultrasound, etc.). These images are coordinated with the actual position of the patient's anatomy placed on the operating table, by various known registration methods (e.g., rigid or deformable registration of notable points and/or surfaces) or by reference to the position of the image capture system itself, prior to the initiation of the medical intervention.

the optical navigation system registers the position of the medical instrument by means of infrared cameras and emitters or reflectors placed on the medical instrument and the patient according to a known geometry, in order to serve as a reference and track its movements.

An electromagnetic navigation system registers the position of a medical instrument by means of a low-intensity magnetic field generator placed near the patient's body, a sensor that can be incorporated in the medical instrument, and a reference sensor placed on the patient. These electromagnetic navigation systems are compact and do not suffer from the problem of obstruction of the field of view in optical navigation systems. However, they require a specific and restrictive environment in relation to the presence of the magnetic field formed by the magnetic field generator.

although all these known navigation systems can improve the accuracy of the medical procedure by providing in real time the position and orientation of the medical instrument in the image, compared to traditional manual methods, they have significant limitations in terms of minimally invasive medical intervention of deformable tissues.

A first limitation is that the final procedure of introducing the medical instrument up to the target anatomical region is performed manually by the operator, which means that the result depends on the skill of the operator and a high precision cannot be obtained.

A second limitation is that the function of these navigation systems assumes that the target organ or anatomy does not move and deform between the moment of performing the reference examination and the moment of introducing the medical instrument by the operator. In case the examination has been performed several days before the medical intervention and the patient is in a different position on the operating table compared to the position on the examination table, the target organ or anatomical structure may have moved or deformed and the offset between the display position and the actual position of the target organ or anatomical structure may result in a high inaccuracy. In addition, the target organ or anatomy may be simply deformed by the patient's breathing, and known navigation systems are based on patient-controlled breathing, which greatly limits the accuracy achievable by these navigation systems.

robotic devices for assisting in medical procedures for minimally invasive surgery also exist.

in particular, patent US 8795188 discloses a system for medical interventions on a patient and a method for automatically taking into account the periodic movements of the patient (typically the movements of the thorax caused by breathing), wherein the system comprises a robot, means for recording the patient's movements.

However, variants describing the use of navigation techniques or continuous laser scanners require images to be captured prior to the procedure and assume that the target organ or anatomy does not move and does not deform relative to the patient's outer envelope (skin). Variants that describe the use of X-ray type images during interventions require complex and radioactive placement of successive image capture systems.

In addition, the above limitations in the case of medical interventions requiring the insertion of a medical instrument into the body of a patient can be generalized to cover medical interventions that do not require the introduction of a medical instrument into the body of a patient. For example, in the case of an apparatus that provides therapy by focused ultrasound, it must also be possible to control the path of the ultrasound waves within the patient's body up to a target anatomical region within the patient's body to which the ultrasound waves must be focused.

Disclosure of Invention

The object of the present invention is to overcome all or some of the limitations of the prior art solutions, in particular those presented above, by providing a solution that helps the operator to position the medical instrument with respect to the organ or anatomical structure within the body of the patient, aiming at a diagnostic or local therapeutic treatment taking into account the fact that the organ or anatomical structure may move or deform within the body of the patient.

To this end, according to a first aspect, the invention relates to a robotic device for medical intervention on a patient using a medical instrument, the robotic device comprising:

-a robotic arm having several degrees of freedom and having an end adapted to receive the medical instrument;

-an image capturing system adapted to capture positional information about the patient's anatomy;

-a storage medium having a biomechanical model of the anatomy of the human body;

-processing circuitry configured to determine a position setpoint and an orientation setpoint of the medical instrument based on the biomechanical model, based on the position information and based on a trajectory to be followed by the medical instrument for performing the medical intervention;

-control circuitry configured to control the robotic arm to place or assist in placing the medical instrument at the position setpoint and the orientation setpoint.

By means of the robotic arm, the positioning accuracy and reproducibility of the medical instrument is much better than the positioning accuracy and reproducibility of the operator. This increase in accuracy means that the treatment selected by the operator can be performed very close to the target organ or target anatomy, and thus the clinical efficacy of the treatment can be improved. Treatment of lesions that are inoperable because they are too small or located near or within critical areas can be envisioned. The accuracy and repeatability also make it possible to reduce the risk of complications due to manual errors in the positioning of the medical instrument, such as: bleeding, pain and loss of function caused by damage to sensitive anatomical structures present on the trajectory.

The robotic device also uses a priori knowledge of the biomechanical model of the human body.

A "biomechanical model" of the human body is understood to be a mathematical model of the human body and thus of the individual anatomical structures (muscles, tendons, skeletal structures, organs, vascular networks, etc.) of the patient in the anatomical region in question, which makes it possible to model deformations of said anatomical structures and mechanical interactions between said anatomical structures. Such a biomechanical model therefore makes it possible, among other things, to determine the deformations and mechanical interactions (and therefore the movements) of the internal anatomical structure of the patient, caused for example by modifying the external envelope of said patient, changing the position of the vessels of the organ, changing the external envelope of the organ, etc. Such modifications may be caused, for example, by the patient's breathing (movement of organs caused by movement of the thorax and diaphragm), changing the patient's position (movement of organs caused by gravity), contact with medical instruments (local deformation), and the like. The anatomical region in question corresponds, for example, to the chest region and/or the abdominal region and/or the pelvic region of the patient.

Thus, the robotic device uses the trajectory, biomechanical model and position information acquired during the medical intervention to determine the actual position of the movable and deformable anatomical structure within the body of the patient, regardless of the position of the patient on the operating table and its respiratory level. This function greatly enhances the performance of medical interventions by avoiding errors due to the operator compensating for the movements associated with the breathing and the internal deformations of the organs, which are not taken into account by the navigation systems and robotic systems known in the prior art.

For all these reasons, the robotic device is particularly suitable for minimally invasive medical intervention on deformable tissues of a patient.

In a particular embodiment, the robotic device may also have one or more of the following features, alone or in all technically possible combinations.

In a particular embodiment, the biomechanical model is a model of an anatomical structure in the thoracic region and/or abdominal region and/or pelvic region of the human body.

in a particular embodiment, the image capture system is of the non-radiative type.

indeed, by considering biomechanical models, the image capture system used during the intervention may be non-radiative. "non-radiation" is understood to mean that ionizing radiation (in particular X-rays) is not generated in the direction of the patient during a medical intervention in order to capture an image. Thus, the amount of radiation is greatly reduced for both the patient and the medical team located near the image capture system. In addition, the image capturing system may be much cheaper and less cumbersome than, for example, a CT scanner, so that the robotic device may be used even in small operating rooms without a CT scanner, which makes its use less restricted.

in a particular embodiment, the image capturing system has at least one so-called non-contact device adapted to capture position information without contact with the patient.

In a particular embodiment, the image capture system has at least one of the following non-contact devices: stereo cameras, structured light cameras, time-of-flight cameras, depth measurement cameras, and the like.

In a particular embodiment, the image capturing system is adapted to supply position information corresponding to a position of an outer surface of the patient's body.

In a particular embodiment, the image capturing system has at least one so-called contact device adapted to capture position information by contact with the patient.

in a particular embodiment, the image capture system has at least one of the following contact means: ultrasonic probes, endoscopes, and the like.

in a particular embodiment, the image capturing system is constituted by one or more contactless devices, i.e. the image capturing system, more generally the robotic device, has only one or more contactless devices without any contact device for capturing images.

In a particular embodiment, the control circuit is configured to control the robotic arm according to one of the following modes: automatic mode, collaborative mode, automatic tracking mode, collaborative tracking mode, etc.

In a particular embodiment, the processing circuitry is configured to determine or assist in determining the trajectory of the medical instrument based on the image of the patient.

In a particular embodiment, the processing circuitry is configured to adjust or assist in adjusting a parameter of a therapy to be performed during the medical intervention by simulating an effect of the parameter based on the image of the patient.

In a particular embodiment, the robotic device has guiding means adapted to guide the medical instrument fixed or intended to be fixed to the end of the robotic arm.

In a particular embodiment, the robotic device has at least one of the following: a display screen, a touch-sensitive display screen, a keyboard, 2D and/or 3D goggles, a joystick, a motion detection module, a voice control module, etc.

In a particular embodiment, the robotic device has at least one of the following means for registering an entry point: medical instruments with atraumatic tips, laser targeting modules, and the like.

in a particular embodiment, the medical instrument is one of the following medical instruments: biopsy needles, catheters, endoscopes, or even therapeutic instruments using focused ultrasound, laser therapeutic instruments, cryotherapeutic instruments, radio frequency therapeutic instruments, electroporation therapeutic instruments, curie therapy therapeutic instruments, and the like.

In a particular embodiment, the robotic device has a mobile carriage carrying the robotic arm, the mobile carriage having a securing means.

Drawings

The invention will be better understood from reading the following description, given as a non-limiting example, with reference to the accompanying drawings, in which:

Figure 1 shows a schematic view of an embodiment of a robotic device for minimally invasive medical intervention of soft tissue,

Figure 2 shows a schematic view of an alternative embodiment of the robotic device of figure 1,

Figure 3 shows a schematic view of another embodiment of the robotic device.

In the drawings, like reference characters designate the same or similar elements throughout the several views. For clarity, elements shown are not drawn to scale unless otherwise indicated.

Detailed Description

Fig. 1 schematically illustrates an embodiment of a robotic device 10 for assisting an operator in a medical intervention, such as minimally invasive intervention of soft tissue.

as shown in fig. 1, the robot apparatus 10 includes a robot arm 11 having several degrees of freedom. The robotic arm 11 has an end adapted to receive a medical instrument 13. In the example shown in fig. 1, the medical instrument 13 is mounted on the end of the robot arm 11 by means of a guiding tool 12, which is adapted to guide said medical instrument 13. To this end, the robot arm 11 has at said end an interface adapted to receive said guiding tool 12.

the robot arm 11 preferably has at least 6 degrees of freedom in order to allow a spatially wide monitoring of the position and orientation of the guiding tool 12 relative to the patient 30 lying on the operating table 20, for example.

the guiding tool 12 is adapted to guide the medical instrument 13, i.e. to restrict a displacement of said medical instrument 13 relative to said guiding tool 12. For example, the guiding means 12 is a slide adapted to guide the translation of the medical instrument 13, so as to limit the displacement of said medical instrument 13, for example during its insertion into the body of the patient 30.

for example, the guiding tool 12 is removably fixed to a robotic arm 11, which is preferably adapted to receive different types of guiding tools 12, e.g. associated with different medical instruments 13 and/or different medical procedures.

The interface of the robot arm 11 may have, for example, an error-proof mechanism for ensuring correct mounting of the guiding tool 12 on the robot arm 11. In a preferred embodiment, the interface may also have an electronic system for automatically identifying the guiding tool 12 installed by the operator, in order to thereafter use in the calculation the characteristics of the guiding tool 12, such as its reference, its dimensions, its weight, its center of gravity, and any other data useful for its function or its performance.

The robotic device 10 is preferably adapted to receive any type of medical instrument 13, in particular for minimally invasive intervention of soft tissue, on a guiding tool 12 carried by the robotic arm 11. For example, the robotic device 10 is preferably adapted to receive and move at least one of the following surgical medical instruments:

-a biopsy needle for the purpose of biopsy,

-a conduit for the gas to be delivered,

-an endoscope,

a therapeutic apparatus using focused ultrasound,

-a laser treatment apparatus for the treatment of a patient,

-a cryotherapeutic apparatus for the purpose of,

-a radio-frequency treatment apparatus for performing a treatment,

-an electroporation therapy apparatus,

Curie therapy treatment instruments and the like.

The robotic device 10 also has a control circuit 16 adapted to control the robotic arm 11 in order to modify the position and orientation of the guiding tool 12 in a reference frame associated with the robotic device 10. The control circuit 16 has, for example, one or more processors and memory devices (magnetic hard disk, electronic memory, optical disk, etc.) in which a computer program product in the form of a set of program code instructions to be executed is stored for controlling the robotic arm 11. Alternatively or additionally, the control circuit 16 has one or more programmable logic circuits (FPGA, PLD, etc.) and/or one or more application specific integrated circuits (ASIC, etc.), and/or a set of discrete electronic components, etc., adapted to control said robotic arm 11.

By means of the control circuit 16, the robotic arm 11 and the guiding tool 12 carried by the robotic arm 11, the medical instrument 13 can be positioned, oriented and guided with a higher accuracy than if the medical instrument 13 were to be handled directly by the operator.

In the example illustrated in fig. 1, the robotic device 10 has a mobile carriage 18, for example mounted on wheels, on which the robotic arm 11 is mounted. This arrangement is particularly advantageous in the sense that it is then particularly easy to move the robot arm 11 from one side of the operating table to the other, from one side of the operating room to the other, etc. The support 18 has a fixing device (not shown) by means of which the support 18 can be fixed relative to the operating table 20. The fixation means may be of any suitable type and may in particular have brakes on wheels, retractable pads or feet, systems for mechanical attachment to the operating table 20, systems for mechanical attachment to the ground, etc.

however, according to other examples, it is not excluded that the robotic arm 11 is removably or permanently (in this case, the operating table is an integral part of the robotic device 10) mounted directly on the operating table. Fig. 2 schematically illustrates an alternative embodiment of the robotic device 10, wherein the robotic arm 11 is removably mounted on the surgical table 20. In the example illustrated in fig. 2, the robotic arm 11 is mounted on a support 110 forming a rigid mechanical link with the rail 21 of the operating table 20.

As shown in fig. 1 and 2, the robotic device 10 also has an image capturing system 14 adapted to capture positional information about the anatomy of the patient 30 in a reference frame associated with the robotic device 10 or in a coordinate system different from the reference frame, the matrix of which to the reference frame is a priori or can be determined. In a preferred embodiment, the image capture system 14 is non-radiative in order to limit the amount of radiation to which the patient 30 and the medical team are exposed.

the image capture system 14 enables the capture of positional information about the anatomy of the patient 30. For example, the positional information about the anatomical structure of the patient 30 corresponds to a position of an outer surface of a body of the patient 30 in a reference frame, a position of a bone structure of the body of the patient 30 in the reference frame, a position of an organ or a blood vessel within the body of the patient 30 in the reference frame, and the like.

in general, any type of image capture system 14 suitable for providing positional information about the anatomy of the patient 30 may be used in the robotic device 10. For example, the image capture system 14 may have one or more so-called non-contact devices adapted to capture location information without contact with the patient 30, and/or one or more so-called contact devices adapted to capture location information by contact with the patient 30. The image capturing system of the robotic device preferably has only one or more non-contact devices and no contact devices.

In a particular embodiment, the image capture system 14 has at least one of the following non-contact devices:

-a stereo camera for taking a stereo image of the object,

-a structured-light camera for taking in the structured-light image,

-a time-of-flight camera (ToF camera),

Depth measurement cameras (e.g. RGB-D cameras), etc.

For example, such a contactless device makes it possible to capture positional information representing the position of the outer surface of the body of the patient 30 relative to the contactless device.

In a particular embodiment, the image capture system 14 has at least one of the following contact devices:

An ultrasound probe (capture by non-invasive contact),

endoscope (capture by invasive contact), etc.

such a contact arrangement makes it possible to capture position information representing the position of organs or blood vessels within the body of the patient 30, for example.

For example, the image capturing system 14 is integrated in the robot arm 11 or mounted at the end of said robot arm 11.

in the illustrated example of fig. 1 and 2, the image capture system 14 is mounted on a support other than the robotic arm 11. For example, the support is an articulated arm 140, optionally a motorized articulated arm, in which case it forms a different robotic arm than the robotic arm 11 carrying the guiding tool 12 of the medical instrument 13. In the example shown in FIG. 1, the articulated arm 140 is carried by the mobile carriage 18, as is the robotic arm 11. In the example illustrated in fig. 2, an articulated arm 140 carrying the image capture system 14 is carried by the mobile carriage 18.

Moreover, according to other examples, it is not excluded to have the image capturing system 14 carried by an operator to obtain positional information about the anatomy of the patient 30.

For example, the position and spatial orientation of the image capturing system 14 are known in the reference frame of the robotic device 10, either through knowledge of the geometry of the image capturing system as it is carried by the robotic arm 11, or through the use of a 3D positioning system, such as an optical, electromagnetic, or other type of navigator.

As shown in fig. 1 and 2, the robotic device 10 also has a storage medium 15 that stores a biomechanical model of the human anatomy. In the illustrated example of fig. 1 and 2, the storage medium 15 is shown as being distinct from the control circuit 16. However, according to other embodiments, the storage medium 15 may also be one of the storage devices of the control circuit 16.

It should be noted that the biomechanical model of the human body is not necessarily specific to the patient 30 under consideration, but may be a biomechanical model of a general patient having, for example, the same gender, height, body type, etc. as the patient 30 on which the medical procedure is to be performed. The biomechanical model preferably includes the major anatomical structures of the thoracic, abdominal and pelvic regions (such as the chest and abdominal walls, muscles, tendons, bones and joints, organs, vascular systems, etc.), as well as their deformation models and their mechanical interactions. The biomechanical model also preferably takes into account gravitational effects that depend on the position of the patient 30.

these biomechanical models are known in the scientific literature, see for example the following publications:

"SOFA A Multi-Model Framework for Interactive Physical Simulation [ SOFA: interactive physical simulation multi-model framework ] ", f.failure, etc., for soft tissue biomechanical modeling for computer-assisted surgery-mechanical biology, tissue engineering and biomaterial research, volume 11, spamming;

"a Personalized biomedical Model for Respiratory Motion Prediction" b.fusion et al, international conference on medical image computing and computer-assisted intervention, 2012;

"Patient-Specific biomedical Model as wheel-Body CT Image Registration Tool" by Mao Li et al, medical Image analysis, 5 months 2015, pages 22-34.

For example, a biomechanical model may be created from the transcription of a database of three-dimensional medical images (CT scans, MRI scans, etc.). The geometry of the structure of interest can be extracted from the medical image by segmentation and reconstruction algorithms. The analysis of the image database makes it possible to calculate the average geometry of the components of the biomechanical model and the main parameters representing the deformation of all medical images of the database. Each structure may be assigned mechanical properties and different boundary conditions in order to create its biomechanical model. The biomechanical model preferably includes modeling of the musculoskeletal system consisting of bone, muscle, tendons, ligaments, and cartilage.

As shown in fig. 1 and 2, the robot device 10 further has a processing circuit 17. The processing circuitry 17 is configured to determine a position set point and an orientation set point of the guidance tool 12 based on a biomechanical model of the anatomy of the human body and based on the position information captured by the image capture system 14.

The processing circuit 17 has, for example, one or more processors and memory devices (magnetic hard disk, electronic memory, optical disk, etc.) in which a computer program product in the form of a set of program code instructions to be executed is stored for determining the position and orientation set points. Alternatively or additionally, the processing circuit 17 has one or more programmable logic circuits (FPGA, PLD, etc.) and/or one or more application specific integrated circuits (ASIC, etc.), and/or a set of discrete electronic components, etc., suitable for determining said position and orientation set points.

In the illustrated example of fig. 1 and 2, the processing circuit 17 is shown as distinct from the control circuit 16. However, according to other embodiments, the processing circuit 17 may be integrated with said control circuit 16 or use means also used by the control circuit. In addition, the storage medium 15 is shown as being distinct from the processing circuit 17. However, according to other embodiments, the storage medium 15 may also be one of the storage devices of the processing circuit 17.

In addition, the position set point and the orientation set point of the guidance tool 12 are determined based on the trajectory to be followed by the medical instrument 13 during the medical intervention.

In case a medical intervention requires the introduction of a medical instrument 13 into the body of the patient 30, the trajectory corresponds to the trajectory along which the medical instrument 13 has to travel within the body of the patient 30 and along which the medical instrument has to be guided during the medical intervention. For example, the trajectory corresponds to the position of an entry point through which the medical instrument 13 has to pass into the body of the patient 30, e.g. on an outer surface of the anatomy of the patient 30, and the trajectory also corresponds to the position of a target point at the region of the target anatomy within the patient 30 to be reached by the medical instrument 13. For example, the entry point and the target point are stored in the form of coordinates in a coordinate system associated with the anatomy of the patient 30.

In case the medical intervention does not require the introduction of a medical instrument 13 into the patient's body 30, for example in case of a focused ultrasound therapy instrument, the trajectory corresponds to the trajectory the ultrasound waves have to travel within the body of the patient 30. For example, the trajectory corresponds to the position of an entry point through which the ultrasound waves have to pass into the body of the patient 30, e.g. on the outer surface of the anatomy of the patient 30, and the trajectory also corresponds to the position of a target point within the patient 30 on which the ultrasound waves have to be focused. For example, the entry point and the target point are stored in the form of coordinates in a coordinate system associated with the anatomy of the patient 30.

The trajectory may be predetermined by other means than the robotic device 10, in which case, for example, the trajectory is stored in the storage medium 15 prior to the medical intervention. Alternatively or additionally, the trajectory may also be determined by the robotic device 10, as described in the following description.

For example, the processing circuitry 17 contains an algorithm for coordinating the biomechanical model with positional information about the anatomy of the patient 30, which information is supplied by the image capture system 14. Thus, the processing circuitry 17 may determine the position and orientation of the patient 30 in a reference frame associated with the robotic device 10. The processing circuitry 17 may also determine the position of the entry point of the trajectory and the position of the target point in the reference frame, taking into account deformations of the anatomy of the patient 30 with respect to the anatomy of the patient 30 considered for determining the trajectory (caused by gravity, respiration, mechanical contact with medical instruments, etc.). For example, the algorithm makes it possible to propagate the motion of the skin surface to the internal volume and correctly calculate the position of the internal anatomy. According to another example, the position and deformation of an organ may be determined from information about the position of a blood vessel of the organ (e.g. position information supplied by an ultrasound probe). According to another example, the position and deformation of an organ may be determined from information about the position of the outer surface of the organ (e.g., position information supplied by an endoscope). The capturing of the information about the position of the anatomy of the patient 30 and the calculation for coordinating the biomechanical model with said information about the position of the anatomy of the patient 30 is preferably done in real-time or near real-time, so that the position of the entry point and the position of the target point in the reference frame can be updated in real-time or near real-time to monitor the motion and deformation of the anatomy of the patient 30. Such updating may also be performed during insertion of the medical instrument 13 into the body of the patient 30 to take account of deformations caused by movements of said medical instrument 13.

After having determined the parameters of the trajectory (the positions of the entry point and the target point) in the reference frame associated with the robotic device 10, or simultaneously with such a determination, the processing circuitry 17 determines the position set point and the orientation set point of the guiding tool 12 to conform to the trajectory.

the control circuitry 16 may then control the robotic arm 11 to place the guidance tool 12 or to assist the operator in placing the guidance tool at the position set point and the orientation set point determined by the processing circuitry 17. In a preferred embodiment, the control circuit 16 is adapted to control the robotic arm 11 according to one of the following modes:

-an automatic mode of operation,

-a collaboration mode in which the user is able to collaborate,

-an automatic tracking mode in which the tracking of the track is performed,

-a collaborative tracking mode.

In the automatic mode, the control circuit 16 moves the robotic arm 11 from its current position and orientation to a position set point and an orientation set point by automatically calculating a trajectory between the current position and the position set point.

In the cooperation mode, the control circuit 16 moves the robot arm 11 in the direction of the forces exerted by the operator, which may be exerted on the guiding tool 12 or on one axis of the robot arm 11. These forces are measured and calculated by means of one or more sensors (not shown in the figures) fitted at the end of the robot arm 11 and/or each axis thereof. Geometric constraints may be integrated in the collaborative mode to limit the movement of the robotic arm 11 and thus facilitate medical procedures. For example, motion may be constrained to be within a certain region, outside a certain region, along a certain axis or curve, around a certain point, and so on. The constraints may be defined by any type of geometry and associated behavior (inclusion/exclusion). In the cooperative mode, the control circuitry 16 assists the operator in placing the guidance tool 12 at the position set point and the orientation set point.

in tracking mode, the control circuitry 16 moves the robotic arm 11 in the direction of movement of the patient 30 to place the guidance tool 12 at a position set point and an orientation set point that are updated by the processing circuitry 17 in real time or near real time. In this case, the medical instrument 13 moves in a reference frame associated with the robotic device 10, but remains substantially stationary during this time in a coordinate frame associated with the target organ.

in the cooperative tracking mode, the control circuit 16 moves the robotic arm 11 in the direction of movement of the patient 30, with flexibility as to the position to be controlled. For example, the operator may exert a force on the guidance tool 12 and may be able to slightly and temporarily deviate the position of the guidance tool 12 from the position set point and the orientation set point. The robotic arm 11 applies a force that opposes the operator's force and which attempts to return the guidance tool 12 to the position and orientation set points when the operator is not applying the force. The level of flexibility may be adjustable, for example, by a stiffness parameter or a distance parameter.

Fig. 3 schematically shows a preferred embodiment in which the robotic device 10 has a human interface device 19. In the example illustrated in fig. 3, the human interface device 19 is a display screen, preferably a touch screen. The human interface device 19 allows the operator to control the robotic device 10 and, if appropriate, to view images relating to the medical procedure to be performed. The human interface device 19 may be used, for example, in planning a medical procedure to establish a trajectory of the medical instrument 13, for example, by displaying the real-time or near real-time position of the medical instrument 13 relative to the position of the target point in the reference frame, or to visualize the progress of the medical instrument 13 within the body of the patient 30. The human interface device 19 may also be used to display images supplied by the image capture system 14.

In the example illustrated in fig. 3, the human interface device 19 is carried by a mobile carriage 18, which likewise carries the robotic arm 11. According to other examples, it is not excluded that the human interface device 19 is carried by a separate console, or is removably mounted, for example, on a rail of the operating table 20. Further, alternatively or additionally, other human interface devices 19 may be considered. For example, the human interface device 19 may include: a mouse, a keyboard, a touch pad, a joystick, a non-contact movement detection module for registering the movement of the operator's hand, finger, head or eyes, or a voice control module, etc. Additionally, the 2D and/or 3D goggles may also replace or supplement the display screen.

To ensure safe use of the robotic device 10, the human interface device 19 may also include a confirmation module (wired or wireless pedals, box knobs, remote controls, switches on the robotic arm 11) to protect the movement of the robotic arm 11, which is then affected by activation of the confirmation module.

In a preferred embodiment, the processing circuitry 17 is configured to determine or assist the operator in determining the trajectory of the medical instrument 13 based on the image of the patient. In the following description, a non-limiting example of an embodiment of the robotic device 10 is described for planning a medical intervention requiring the introduction of a medical instrument into the body of the patient 30.

For example, the medical intervention may be defined by a trajectory, a medical instrument 13 to be used, and a treatment parameter. For example, the trajectory consists of a target point located in the organ to be treated and an entry point located at the skin. The medical instrument 13 is defined by several characteristics such as its length, its diameter, its 3D geometry, etc. The treatment parameters may include settings of the ablation technique, such as power of the delivered current, treatment time, diameter of the region, distance margin, and the like.

For example, the robotic device 10 may download images of the patient 30 (CT scans, PET (positron emission tomography) scans, MRI scans, X-rays, ultrasound, etc.) from a hospital system or an external system (cloud computing) or an external storage medium (USB, CD, DVD, etc.) and, for example, allow viewing of the images in two-dimensional cross-sectional planes and reconstruction of the images in three-dimensional form on the human interface device 19. For example, rigid and non-rigid registration algorithms allow for the merging of several images of the same patient 30 to provide the operator with all the anatomical and functional information needed to plan a medical intervention. The operator may then plan one or more trajectories according to the medical intervention to be performed. For example, in the case of ablation by irreversible electroporation, the robotic device 10 makes it possible to produce perfectly parallel trajectories to optimize the efficacy of the treatment.

For example, the position of the target point of the trajectory and the position of the entry point are manually identified in the image by the operator. The trajectory of the medical instrument 13 in the anatomy can be visualized and modified in the image to ensure that the tip of the medical instrument 13 reaches the optimal target point and that the insertion of the medical instrument 13 does not damage the sensitive anatomy between the entry point and the target point. To facilitate the decision-making process during planning, the robotic device 10 may incorporate segmentation algorithms that automatically identify the contours and volumes of certain organs, nerves, arteries, veins and blood vessels, bones, and lesions to be treated of interest. Alternatively, the robotic device 10 may automatically determine the target point and the entry point. The target point is calculated, for example, by a shape recognition method and based on the parameters of the treatment and the volume of the target lesion. The entry point may be calculated by a method for optimizing indicators such as the distance between the trajectory of the medical instrument 13 and sensitive anatomical structures and the position relative to a preferred insertion region defined at the skin. Alternatively or additionally, the robotic device 10 may also accumulate a large amount of planning data over its use, which is reused and analyzed to suggest a selection of optimal entry points and target points through artificial intelligence algorithms.

In a preferred embodiment, the processing circuitry 17 is configured to adjust or assist the operator in adjusting the parameter of the treatment to be performed during the medical intervention by adjusting or assisting the operator based on the influence of the parameter on the image of the patient. For example, from the treatment parameters, trajectory information and the medical instrument 13, the robotic device 10 may calculate the effect of the treatment on the anatomy and enable visualization of an accurate simulation of the image of the patient 30. For example, for thermal ablation, the calculation may take into account, among other things, the presence of adjacent blood vessels and their cooling effect (heat dissipation effect). The operator can then adjust the planning data to optimize the clinical outcome of the treatment.

Thus, the above planning process makes it possible to plan a wide variety of medical procedures, such as: laser surgery, ablation by cryo, radio frequency, microwave, or electroporation, curie therapy, endoscopy, and any technique that requires the insertion of one or more medical instruments 13 into the body of a patient 30. The above-described planning process also makes it possible to plan various medical procedures that do not require the insertion of the medical instrument 13 into the body of the patient 30, for example in the case of treatment by focused ultrasound.

all data required for planning may be protected by the robotic device 10 in the memory means of the processing circuitry 17 or in the storage medium 15, or on an external storage medium, and subsequently reloaded to modify elements or to perform treatments on the day of operation with the robotic device 10.

an example of the use of the robotic device 10 to perform a pre-planned medical procedure and the need to insert the medical instrument 13 into the body of the patient 30 is now described.

to begin operation, the robotic device 10 is brought into the operating room and placed next to the patient 30. With the robotic arm 11 mounted on the mobile carriage 18, the robotic device 10 is immobilized prior to the stage of registering the position of the patient 30.

The operator then controls the robotic device 10, for example by means of the human interface device 19, so as to initiate the stage of registering the patient 30. The stage of registering the patient 30 aims at determining the position of the patient 30 in the reference frame related to the robotic device 10, the positions of the entry point and the target point, and the position set point and the orientation set point of the guiding tool 12 by using the biomechanical model, the position information provided by the image capturing system 14 and the planned trajectory.

Once the position of the patient 30 is known and coordinated with the preoperative images, the operator initiates a positioning phase aimed at placing the guiding tool 12 at a position setpoint and an orientation setpoint appropriate for the medical intervention to be performed.

for example, the robotic device 10 considers the size of the guide tool 12, the location of the entry point, and the direction to the target point to automatically position the robotic arm 11 in such a way that the guide tool is aligned on the selected trajectory, at some safe distance from the adjustable entry point. The operator may then control the robotic arm 11, for example in a collaborative mode, to adjust the position of the guiding tool 12 as close as possible to the entry point while maintaining alignment on the trajectory, then to arrest the movement of the robotic arm 11, and then to insert the medical instrument 13 through the guiding tool 12.

In a preferred embodiment, the robotic device 10 has a registration device (not shown in the figures). Thus, with the robotic device 10, the operator can accurately register the entry point on the patient's skin on which the incision is to be made. For example, the means for registering the entry point correspond to a medical instrument with an atraumatic tip inserted into the guiding tool 12, or to a laser targeting module integrated in the medical instrument 13 or in the guiding tool 12.

after the incision is completed, the operator may initiate a guidance phase by inserting the medical instrument 13 through the guidance tool 12 until the tip of the medical instrument reaches the planned target point. The control of the insertion depth may be based simply on the length of the medical instrument 13 and/or on a mechanical stop system integrated in the guiding tool 12. Alternatively or additionally, the guiding tool 12 may have a sensor for indicating the insertion depth of the medical instrument 13. The robotic device 10 may then display the position of the medical instrument 13 in the image in real time or near real time, and may provide a message to the operator as the target point is approached, reached, or has been passed. In another variant, the medical instrument 13 is mechanically attached to the guiding tool 12 and the robotic arm 11 automatically inserts the medical instrument 13 up to the planned target point.

during insertion, the processing circuitry 17 may use a biomechanical model of the patient 30 to estimate local deformations of the organ or anatomical structure through which the medical instrument 13 passes, and take these deformations into account to update the position of the target points.

Depending on the operational requirements during the guidance phase, the robotic device 10 is activated, for example, in a tracking mode or a coordinated tracking mode to maintain the position of the guidance tool 12 relative to the target anatomy regardless of the motion of the patient 30. The robotic device 10 may also be activated in a collaborative mode during the boot phase by applying or not applying geometric constraints. The cooperation mode, constrained on the trajectory axis, may be used for, for example, staged biopsy execution.

When the medical instrument 13 has reached the target point, the following planned medical interventions may be performed for diagnostic purposes or for local treatment: for example, tissue sampling for biopsy, liquid nitrogen delivery for cryotherapy, current generation for radiofrequency ablation, injection of radioactive sources for curie treatment, direct visualization of anatomy for endoscopic procedures and insertion of medical instruments into the working channel of an endoscope, and so forth.

at any time during or after the boot phase, the operator can verify correct execution of the insertion of the medical instrument 13 by controlling the image. Depending on the equipment available to hospitals and operating rooms, the anatomical region of interest may be examined using fixed or mobile imaging equipment (CT scanners, MRI scanners, radiological C-arc plates (arceau), ultrasound probes, etc.). In a preferred embodiment, the images are transmitted directly to the robotic device 10, the processing circuitry 17 of which includes, for example, a registration algorithm for automatically merging these intraoperative images with the preoperative images. The robotic device 10 then displays planning information superimposed on the intra-operative images to assess the progress or efficacy of the treatment and, if necessary, to determine the corrections that must be made.

In a preferred embodiment of the invention, the processing circuit 17 may also comprise a segmentation algorithm for automatically identifying the necrotic region, comparing it with the planned region, calculating and displaying the margin obtained in terms of diameter or volume, and indicating the diameter or volume still to be treated. Optionally, the robotic device 10 may also provide information needed to supplement the treatment, such as the location and parameters of one or more additional ablation trajectories.

More generally, it should be noted that the embodiments and uses considered above have been described as non-limiting examples, and that other variants are therefore conceivable.

in particular, the invention has been described based on mounting the medical instrument 13 on the robotic arm 11 by means of the guiding means 12. However, it should be noted that the robotic device 10 may also be used without the use of the guiding tool 12. For example, in case it is not necessary to introduce the medical instrument 13 into the body of the patient 30, for example in case of an external treatment by focused ultrasound, the use of the guiding means 12 is not required. In addition, in the case where the medical instrument 13 has to be inserted into the body of the patient 30, particularly if the operator inserts the medical instrument 13 into the patient body 30, the guide tool 12 needs to be used, but if the robot arm 11 automatically inserts the medical instrument 13 into the body of the patient 30, the guide tool is not necessarily needed.