"MASTER CONTROLLER DEVICE FOR ROBOTIC SURGERY WITH STERILE MANIPULATION INTERFACE FOR ACTUATING A SLAVE DEVICE FUNCTION"
DESCRIPTION
[01 ]. Field of the invention
[02]. The present inventions relates to sterile manipulation interface for a master controller device.
[03]. The present invention further relates to a master controller device comprising said sterile manipulation interface.
[04]. In particular, the master controller device according to the present invention is particularly suitable for being manipulated in a sterile environment.
[05]. The master controller device according to the invention, with the sterile manipulation interface, is for a robotic master-slave teleoperation system for the medical or surgical field.
[06]. The master controller device according to the invention is particularly suitable, although not uniquely intended, for use as a controller device of the type mechanically unconstrained to the operating console of the robotic system.
[07]. Background art
[08]. Robotic surgery apparatuses are generally known in the art and typically comprise a central robotic tower or a cart and one or more robotic arms extending from the tower/cart. Each arm comprises a motorized positioning system (or manipulator) for moving a surgical instrument distally attachable thereto, in order to perform surgical procedures on a patient.
[09]. In order to control the robotic manipulator and thus the slave surgical instrument, the surgeon acts on one or more master controller devices, according to a master-slave teleoperation architecture.
[010]. In the known master devices, control interfaces are typically provided to transmit command signals to the slave surgical instrument, and in particular where the surgical instrument is provided with a degree of freedom of open i ng/closi ng , i.e. , gripping/cutting , the master device typically comprises a control interface (e.g. , formed by two cantilevered flaps) to actuate such a degree of freedom of opening/closing/gripping/cutting .
[01 1 ]. In some prior art examples, the right and left master devices are each provided mounted to a leg of the operating console and supported by a gimbal system which is typically provided with brakes and motors adapted to provide a tactile feedback to the surgeon .
[012]. Otherwise, master devices of the type mechanically/kinematically not constrained to the operating console ("groundless" or "unconstrained" according to the jargon adopted in the field) are known , i.e. , of the "flying" type, which is manipulated by the surgeon in a predeterminable three- dimensional tracking volume without mechanical constraints to the operating console. Such unconstrained "flying" master devices can be used for a mono lateral teleoperation without force feedback, for example. The prior art document WO-2019-220407 to the same Applicant shows some examples of unconstrained master devices.
[013]. U nconstrained master devices are usually equipped with sensors, such as inertial platforms and/or position and/or orientation sensors, such as magnetometers and/or optical markers, for example, to identify the command to be transmitted to the slave surgical instrument. In some known exam ples, a magnetic field emitter is provided, which generates a tracking volume in which the position and orientation of two magnetometer-type sensors with six degrees of freedom are tracked (in particular: three position sensors, such as x, y, z, and three orientation sensors, such as roll, pitch , yaw) provided on the body of the master device, and in particular placed on two moving parts of the master device control gripper. Based on the data from the two sensors, information is determined on the position, orientation and opening/closing of the master control gripper to be transmitted to the enslaved slave device. For example, a closing command signal is transmitted to the jaws of the surgical instrument of the slave device when the detected distance between the two sensors is less than a certain threshold.
[014]. For example, WO-2022-175800 to the same Applicant shows an unconstrained master device solution in which the system control unit verifies the existence of predefined geometric relationships between two tracking sensors adapted to control the position, orientation and opening of a slave surgical device, where the tracking sensors are mounted on respective rigid parts of the master device mutually movable in opening/closing ("grip") .
[015]. The prior art documents US-8812160, US-2020-0237467 and US-2019- 0380791 show some examples of a controller device not mechanically constrained to the operating console, also called "User Interface Device" (U I D). In such known examples, the master controller device is provided i n combination with a control pedalboard. The pedalboard can be arranged, for example, in a specific recess positioned below the screen or display.
[016]. The control pedalboard with the foot switches thereof can be configured to cooperate in combination with the master controller devices and is typically used to enable entry into an enslaved teleoperation , or following , state. Moreover, the control pedals can be configured to control state transitions to and from a limited teleoperation state which, for example, s imultaneously excludes a subset of degrees of freedom of translation, as shown for example in the prior art document WO-2022-175798 to the same Applicant. In accordance with an example described in such a prior art disclosure, it is known to achieve a repositioning of the master controller device in the working area thereof by means of a foot switch which blocks, when pressed by the surgeon, the translations of the control point of the slave device while continuing to allow the following of the rotations.
[017]. In some known examples, a control pedalboard is provided to control the supply of electrosurgical energy from an electrosurgical instrument, such as an electrosurgical scalpel, arranging the control pedalboard in operational connection with an electrosurgical energy generator. In these cases, a safety system is usually provided to avoid undesired discharges, and for example the pedalboard is provided with at least two pedals, and the supply only occurs when both pedals are simultaneously pressed.
[018]. Surgical instruments for robotic surgery comprising an articulated end capable of applying stitches from the end jaws thereof are also known.
[019]. Moreover, surgical instruments for robotic surgery have been suggested, in which one of the two end jaws comprises a longitud inal seat that houses a blade when in the rest configuration , so that the blade can be extracted and exposed to exert a cutting action, if required. The extraction of the blade can occur, for example, by rotating the blade itself with respect to the jaw which receives it at rest.
[020]. The operating distal end of the slave surgical instrument could be provided with a camera, an endoscope or other vision system , as well as with a light energy emitter having LEDs or laser, if required.
[021 ]. The slave surgical instrument is intended to operate in a sterile environment and typically comprises a proximal transmission interface, or "backend" according to the jargon adopted in the field, to receive through a sterile barrier the actuation commands from the motorized manipulato r of the slave device which is operable under the control of the master controller device.
[022]. In the case of unconstrained master controller devices, these are often configured to operate in a sterile environment, i.e. , in the surgical room and near the patient, the surgical bed or the surgical site, where the station for the surgeon is arranged together with at least one control pedalboard.
[023]. In order to operate in a sterile environment, the prior art document EP- 4103095 to the same Applicant shows a solution which utilizes a pair of sterile cheeks or shells to be applied to the sensorized control gripper of the master that is previously and suitably protected by a sterile bag or drape. By virtue of the provision of the shells or cheeks, it is possible to p rovide the surgeon with a sterile manipulation interface arranged outside the sterile bag or drape containing the sensorized control gripper, thus increasing the surgeon’s positive sensation of control over the grip. In order to mount the sterile shell or cheek, there are provided snap-coupling tabs with a rounded tip so as not to damage the sterile drape thereunder.
[024]. However, the known solutions of master controller devices are by no means without drawbacks and the need remains to provide a solution of master controller device adapted to operate in a sterile environment with improved functions with respect to the prior art and greater interoperability with the related robotic system.
[025]. Solution
[026]. It is an object of the present invention to obviate the drawbacks complained of with reference to the prior art.
[027]. This and other objects are achieved by a device according to claim 1 , as well as by a system according to claim 19, as well as by a sterile interface according to claim 21 , as well as by an assembly according to claim 23.
[028]. S ome advantageous embodiments are the subject of the dependent claims.
[029]. According to an aspect of the invention , a sterile manipulation interface mountable to a sensorized operating portion of a master controller device for a robotic surgical teleoperation system comprises an actuation device to control at least one function of the slave surgical instrument. It is thus possible to control at least one function of the slave surgical instrument by acting exclusively on the sterile manipulation interface.
[030]. The sterile interface preferably comprises a snap-coupling device for being snap-coupled to the sensorized operating portion of the master controller device. The sterile interface can be provided with two separate shell- or dome-shaped bodies which are for example made by rigid plastic molding .
[031 ]. According to an aspect of the invention, a master controller device for a robotic surgical teleoperation system comprises a sensorized operating portion and a sterile manipulation interface comprising at least one sterile manipulation surface and an actuation device for controlling at least one function of the slave surgical instrument.
[032]. The sensorized operating portion is for controlling at least one degree of freedom of position and/or orientation of a slave electrosurgical instrument, for example of the type comprising an articulated end, associable with the master controller device. Therefore, the sensorized operating portion of the master controller device allows controlling the movement of the slave device . [033]. In accordance with a preferred embodiment, the at least one additional function of the slave surgical instrument which is controlled by the actuation device does not comprise controlling said at least one degree of freedom of position and/or orientation controlled by the sensorized operating portion.
[034]. Preferably, the sensorized operating portion is configured to control at least six degrees of freedom, of position and orientation, of the articulated end of the slave surgical instrument and the actuation device of the sterile manipulation interface is configured to activate at least one additional function of the slave surgical instrument which does not include controlling said six degrees of freedom of position and orientation . In accordance with an embodiment, the sensorized operating portion is configured to control seven degrees of freedom , of position and orientation , and opening/closing . The sensorized operating portion can comprise a sensorized control gripper to control, in addition to the six degrees of freedom of position and orientation , also the opening/closing movement of the tips or jaws of the slave surgical instrument.
[035]. The master controller device is preferably a master controller device of the type unconstrained to the operating console, and i n particular the sensorized operating portion can comprise two tracking sensors which are for example respectively mounted on the rigid parts of the control gripper of the sensorized operating portion.
[036]. Said at least one additional function controlled by the actuation device of the sterile manipulation interface can comprise a teleoperation state transition , and in particular enabling a teleoperation , and/or suspending a teleoperation, and/or enabling a limited teleoperation state over a subset of the controllable degrees of freedom , and/or varying the teleoperation scaling factor.
[037]. Said at least one additional function controlled by the actuation device of the sterile manipulation interface can comprise releasing surgical elements such as surgical clips, and/or releasing clinical substances such as surgical glue or drugs, and/or activating a physical or ultrasonic drill.
[038]. Said at least one additional function controlled by the actuation device of the sterile manipulation interface can comprise supplying energ y, e.g ., from the operating distal end of the slave surgical instrument, and/or activating a laser mounted on the slave surgical instrument, and/or activating a light source transmitted by optic fiber along the surgical instrument, and/or supplying ultrasonic energy, and/or supplying radio frequency energy.
[039]. Said at least one additional function controlled by the actuation device of the sterile manipulation interface can comprise modulating and/or adjusting the energy supplied.
[040]. In accordance with a preferred embodiment, said at least one additional function controlled by the actuation device of the sterile manipulation interface comprises supplying electrosurgical energy.
[041 ]. Preferably, but not necessarily, where the sensorized operating portion does not provide information on the degree of freedom of opening/closing, said at least one additional function controlled by the actuation device of the sterile manipulation interface can comprise moving in opening/closing ("grip", "cut", "dilate") the tips or jaws of the articulated end of the slave surgical instrument, such as sudden opening and/or sudden re-closing .
[042]. The actuation device can comprise at least one button, and/or a switch, and/or a ring, and/ or a slide, and/or a slider. A potentiometer for adjusting the supply intensity can be included. The actuation device can comprise at least two switches to control at least two respective functions or the at least two switches are provided one to control the activation of a function and the other to adjust/modulate the supply of the same function .
[043]. The sterile manipulation interface can comprise a single piece or single shell or cheek mountable, for example snap-couplable, on the sensorized operating portion .
[044]. In accordance with the sterile manipulation interface, it comprises two sterile pieces or shells or cheeks mountable, for example snap-couplable, on the sensorized operating portion (e.g . , a sensorized control gripper), each sterile shell or cheek comprising a sterile manipulation surface thereof and a snap-coupling device thereof for being snap-coupled to the sensorized operating portion, for example to opposite rigid parts of the sensorized control gripper. The body of a shell or cheek can be made by rigid plastic molding , and the actuation device can be assembl ed thereto. [045]. Both of the two sterile shells or cheeks can be provided with a portion of the actuation device, and in particular the actuation device can comprise a plurality of push buttons to be pressed simultaneously, the push buttons of said plurality being mounted on both said sterile shells or cheeks.
[046]. A robotic electrosurgical teleoperation system can comprise at least one master controller device of this type comprising a sterile manipulation interface with an actuation device and at least one slave el ectrosurgical instrument operable under the control of the master controller device, and an electrosurgical energy generator, in operational connection with both the slave surgical instrument and the actuation device of the sterile manipulation interface of the master controller device.
[047]. In accordance with an embodiment, the robotic system further comprises a connector connected to the electrosurgical energy generator, said connector comprising a socket, for example of the three-way type, intended to receive a control cable of the sterile manipulation interface to control the electrosurgical energy supply for cutting and coagulation, and an electrosurgical energy supply plug towards the slave surgical instrument.
[048]. According to an aspect of the invention , an assembly comprises a sterile manipulation interface mountable to a sensorized operating portion of a master controller device for a robotic surgical teleoperation system comprises an actuation device to control at least one function of a slave surgical instrument, said additional function comprising the supply of electrosurgical energy; in which said assembly further comprises an electrosurgical energy generator in operational connection with the actuation device of the sterile manipulation interface. Preferably, the assembly further comprises a connector connected to the electrosurgical energy generator, said connector comprising a socket, for example of the three-way type, intended to receive a control cable of the sterile manipulation interface for controll ing the supply of electrosurgical energy, and an electrosurgical energy supply plug towards the slave surgical instrument.
[049]. B rief description of the drawings
[050]. F urther features and advantages of the invention will become apparent from the following descriptio n of preferred embodiments, given by way of non limiting indication , with reference to the accompanying drawings which are briefly described below. Note that references to “an” embodiment in this disclosure do not necessarily refer to the same embodiment, and are to be understood as at least one. Moreover, for reasons of conciseness and reduction of the total number of figures, a certain figure can be used to illustrate the features of more than one embodiment, and not all the elements of the figure can be necessary for a certain embodiment.
[051 ]. Fig ure 1 shows an axonometric view of a robotic system for surgical teleoperation, according to an embodiment.
[052]. Fig ure 2 shows an axonometric view of a surgical instrument, according to an embodiment.
[053]. Fig ures 3-A and 3-B diagrammatically show a robotic system for surgical teleoperation, according to an embodiment.
[054]. Fig ures 4-A and 4-B diagrammatically show a master controller device, according to an embodiment, respectively in separate parts and in assembled parts.
[055]. Fig ures 5-A and 5-B diagrammatically show a master controller device, according to an embodiment, respectively in separate parts and in assembled parts.
[056]. Fig ures 6-A, 6-B and 7 diagrammatically show some embodiments of a sterile manipulation interface.
[057]. Fig ure 8-A diagrammatically shows in vertical elevation a sterile manipulation interface, according to an embodiment.
[058]. Fig ure 8-B shows a detail of the actuation device of the manipulation interface in Figure 8-A.
[059]. Fig ure 8-C diagrammatically shows in vertical elevation a sterile manipulation interface, according to an embodiment.
[060]. Fig ure 8-D shows a detail of the actuation device of the manipulation interface in Figure 8-C.
[061 ]. Fig ure 8-E diagrammatically shows in vertical elevation a sterile manipulation interface, according to an embodiment. [062]. Figure 8-F shows a detail of the actuation device of the manipulation interface in Figure 8-E.
[063]. Fig ure 9 shows in vertical elevation and in separate parts a master controller device, according to an embodiment.
[064]. Figures 10 and 1 1 are axonometric views of the master controller device in Figure 9.
[065]. Fig ure 1 2 shows in axonometric view a sterile manipulation interface, according to an embodiment.
[066]. Figure 13 shows a pictorial axonometric view of a master controller device, according to an embodiment.
[067]. Figure 14 shows a pictorial axonometric view of a master controller device, according to an embodiment.
[068]. Fig ures 1 5-A, 1 5-B, 15-C, 1 6, and 1 7 are block diagrams showing an actuation device of a sterile manipulation interface, according to some embodiments.
[069]. Fig ure 18-A diagrammatically shows a sterile manipulation interface and a connector for an electrosurgical energy generator, according to an embodiment.
[070]. Fig ure 1 8-B is a diagram showing the sterile manipulation interface and connector in Figure 18-A, according to an embodiment.
[071 ]. Fig ure 1 9 is a diagram showing a sterile manipulation interface and a foot switch , according to an embodiment.
[072]. Fig ures 20 and 21 are block diagrams showing an actuation device of a sterile manipulation interface, according to some embodiments.
[073]. Figures 22-A and 22-B are sectional views of an actuation device of a sterile manipulation interface in an off and on configuration, respectively, according to an embodiment.
[074]. Figures 23-A and 23-B are sectional views of an actuation device of a sterile manipulation interface in an off and on configuration, respectively, according to an embodiment.
[075]. Fig ure 24 pictorially shows in axonometric view a sterile manipulation interface, according to an embodiment. [076]. Detailed description of some embodiments
[077]. Reference throughout this description to "an embodiment" means that a particular feature, structure or function described in relation to the embodiment is included in at least one embodiment of the present invention . Therefore, the formulation “in an embodiment” in various parts of this description do not necessarily all refer to the same embodiment. Moreover, particular features, structures or functions such as those shown in different drawings can be combined in any suitable manner in one or m ore embodiments.
[078]. In accordance with a general embodiment, a master controller device 1 for a robotic surgical teleoperation system 2 is provided.
[079]. The master controller device 1 is preferably a master controller device of the type unconstrained to the operating console ("ungrounded", "groundless", "unconstrained" according to the jargon adopted in the relevant field).
[080]. The master controller device 1 comprises a sensorized operating portion 3, to control at least one degree of freedom of movement and/or orientation of a slave surgical instrument 4 associable with the master controller device.
[081 ]. The robotic system 2 for surgical teleoperation preferably comprises at least one slave surgical instrument 4 which is mounted, for example coupled, to a respective motorized manipulator 1 8 operable under the control of the master controller device 1 . Two master controller devices 1 can be provided, for example right master and left master, intended to be held by the right and left hands H of the surgeon SU, respectively, and in which the robotic system 2 comprises two respective right and left motorized manipulators 18, each operable under the control of the respective master controller device thereof. [082]. The robotic system 2 can further comprise a tracking field generator 1 7 to allow detecting the position and orientation of the sensorized operating portion 3 of the at least one master controller device 1 of the robotic system 2, in a manner known per se. The robotic system 2 can further comprise a screen or display 19 to show the surgical site to the surgeon SU and a vision system 20, such as a microscope and/or a camera and/or an endoscope, in which the display 19 shows images acquired by the vision system 20.
[083]. The sensorized operating portion 3 of the master controller device 1 can comprise at least one tracking sensor (e.g . , a sensor with six degrees of freedom, and in particular x, y, z position, and roll, pitch, yaw orientation) capable of detecting information on the position and orientation of the master controller device 1 in a predetermined working range. For example, the at least one tracking sensor 21 , 22 comprises a magnetometer-type sensor and the predetermined working field is a tracking volume generated by a magnetic emitter 17. Preferably, two tracking sensors 21 , 22 are provided at six degrees of freedom on the operating portion 3.
[084]. By virtue of the provision of the sensorized operating portion 3, it is possible to control the position and/or orientation of the slave device by moving the master controller device. For example, the slave surgical instrument 4 comprises an articulated end 16 at the distal end of a positioning shaft or rod or stick 26, for example comprising pitch and yaw joints, and the information transmitted by the sensorized operating portion 3 allows controlling the kinematic configuration of the articulated end 1 6, for example by defining a virtual control point with at least six degrees of freedom of position and orientation which is controlled by the detected position and orientation of the sensorized operating portion 3.
[085]. The articulated end 16 of the slave surgical instrument 4 is preferably actuated by actuation tendons (not shown) which receive a command action from the respective motorized manipulator 18, through the provision of a suitable passive transmission interface 27 (backend) of the slave surgical instrument 4, i.e. , without motors and intended to be controlled, through a sterile slave barrier or drape 28, by a respective distal actuation interface of the respective motorized manipulator 1 8 operable under the control of the master device 1 . Therefore, the information acquired by the tracking sensors 21 , 22 and processed by a control unit from the robotic system is used to control a respective motorized manipulator 18 which in turn transm its a mechanical control action to the articulated end 16 of the slave surgical instrument 4, which operates in a sterile environment. [086]. The master controller device 1 is also configured to operate in a sterile environment. To this end, the master controller device 1 comprises a sterile manipulation interface 5, 6, mounted to the sensorized operating portion 3 and comprising at least one sterile manipulation surface 7, 8. The sterile manipulation interface can comprise two pieces 5, 6 or separate parts each provided with a respective sterile manipulation surface 7, 8 thereof . Alternatively, the sterile manipulation interface 5 or 6 comprises a single piece mounted to the sensorized operating portion 3.
[087]. Preferably, the sterile manipulation interface 5, 6 is mou nted to the operating portion 3 through a sterile drape 1 1 . The sterile drape 1 1 can be provided fixed to the sterile manipulation interface 5, 6, e.g . , welded or glued thereto.
[088]. Advantageously, the sterile manipulation interface 5, 6 further comprises an actuation device 9, for controlling at least one additional function Q of the slave surgical instrument 4. It is thus possible to control at least one additional function of the slave device by means of a manual command by actuating an actuation device 9 provided on the sterile manipulation interface 5, 6.
[089]. In accordance with a preferred embodiment, said at least one additional function Q controlled by the actuation device 9 does not comprise controlling said at least one degree of freedom of movement and/or orientation . In other words, the actuation device 9 provides a further possibility of controlling a further function Q with respect to what the sensorized operating portion 3 allows.
[090]. The sensorized portion 3 can thus transmit information on the movement (position and orientation) of the slave device while the sterile manipulation interface comprises a further additional device 9 for controlling an additional function Q.
[091 ]. Obviously, the sensorized operating portion 3 is, in accordance with a preferred embodiment, configured to control at least six degrees of freedom of the articulated end 16 of the slave surgical instrument 4, and in particular at least position and orientation ; even more preferably, the sensorized operating portion 3 comprises a sensorized control gripper with at least two sensors 21 , 22 for controlling seven degrees of freedom of the articulated end 1 6 of the slave surgical instrument 4, and in particular position , orientation and opening/closing or grip.
[092]. The at least one additional fu nction is, according to an embodiment, a single additional function Q of the slave device in addition to said at least one degree of freedom of movement and/or orientation , and preferably said at least six degrees of freedom of at least position and orientation , controlled by the operating portion 3.
[093]. The actuation device 9 is preferably configured so that when actuated, e.g . , by pressing a push button or button , a circuit is closed, so that the closing of the circuit causes the actuation of the at least one additional function . In accordance with an embodiment, the actuation device 9 of the sterile manipulation interface 5, 6 generates an electrical input command for actuating said additional function Q. For example, a push button or switch is provided, which when pressed generates an electrical pulse which is a command signal for actuating said additional function Q and/or is an adjustment command signal that thus carries out said additional function Q.
[094]. As shown for example in Fig ure 3-A, in accordance with a preferred embodiment, the slave surgical instrument 4 is mounted to the robotic manipulator 18 through the sterile slave barrier 28 so that the slave surgical instrument 4 with the articulated end 1 6 thereof is arranged in a sterile environment; and in which, the operating portion 3 of the master device 1 is inside a sterile drape 21 thereof and the sterile manipulation interface 5 is mounted to the operating portion 3 through the sterile drape 21 . A data communication cable 29 can extend from the sensori zed operating portion 3 of the master device, connecting the tracking sensors 21 , 22 of the operating portion 3 to the respective motorized manipulator 18.
[095]. In accordance with a preferred embodiment, said at least one additional function Q controlled by the actuation device 9 is the supply of electrosurgical energy, and for example at least two (cutting and coagulation) switches or push buttons are included. In this case, the robotic system 2 further comprises an electrosurgical energy generator 14 operative ly connected to the actuation device 9 of the sterile manipulation interface 5, 6 of the master device. The operational connection between the actuation device 9 and the electrosurgical energy generator 14 can include a control cable 13 or a power cable 30.
[096]. In accordance with an embodiment, a wired control connection 13 of an electrosurgical energy generator 14 extends from the actuation device 9 of the sterile manipulation interface 5, 6 of the master device, and a power cable 30 extends from the electrosu rgical energy generator 14 which energizes, i.e. , which carries the electrosurgical energy to the articulated end 1 6 of the slave surgical instrument 4. It is thus possible to supply electrosurgical energy to the surgical site by gripping the master contro ller device, without requiring the presence of additional commands, such as a foot switch , for example. Particularly in the case of master devices of the type unconstrained to the operating console, i.e. , flying master controller devices, which have no fix ed defined positioning with respect to an associable command pedalboard, it can be advantageous for the surgeon SU not to have to use the command pedalboard since the positioning thereof with respect to the master device is uncertain.
[097]. As shown for example in Figure 3-B, in accordance with an embodiment, the actuation device 9 is located along the electrosurgical energy power cable 30 and substantially acts as a switch . In other words, in accordance with this embodiment, the actuation device 9 is interposed connected in series between the generator 14 and the slave surgical instrument 4 (neither the sterile drape 21 of the master device nor the slave sterile barrier 28 are depicted in this figure) .
[098]. As shown in Figures 4 A-B and 5 A-B, the sensorized operating portion 3 of the master controller device 1 can comprise an elongated body with at least one free end and the sterile manipulation interface 5 with the actuation device can be fitted onto said at least one free end. The operating portion 3 can, in this case, comprise two push buttons to control the opening /closing of the slave device i.e. , of the jaws 161 , 1 62 of the articulated end of the slave surgical instrument. The master controller device with a single elongated body can be tracked in space (with the tracking sensors 21 , 22 of the operating portion) or, by virtue of the presence of accelerometers, transmit information on the motion and/or inclination thereof . In this case, the operating portion 3 can have gripping surfaces which allow it to be gripped like a pen or with the palm of the hand like with a cloche. The buttons or push buttons to be pressed can be placed at one end or on the side for better and easier pressing during use. Therefore, the sterile manipulation interface 5, 6, which can be made in one piece, can be configured to cover the buttons or push buttons of the sensorized operating portion. The operating communication cable can exit from one end of the sterile interface longitudinally or laterally or at the rear so as not to interfere with the manipulation, ergonomics or movement of the master controller device in space.
[099]. As shown for example in Figure 6-A, the actuation device 9 can comprise a wired connection for transferring the command of actuating the additional function or which can act as a power cable 30 for a generator, e.g . , an electrosurgical energy generator.
[0100]. As shown for example in Figure 6-B, the actuation device 9 can comprise a wireless connection 31 for the command signal, for example through the provision of a transmitter 32 mounted integrally inside or outside the sterile manipulation interface 5, 6 and actuatable by virtue of a wired connection 13 from the actuation device 9 or to a single rigid or flexible electronic PCB (printed circuit board). In this case, the sterile manipulation interface preferably comprises a power supply battery 33 for the transmitter 32, which can be housed in a dedicated housing provided in the body of the sterile manipulation interface 5, 6.
[0101 ]. As shown for example in Figure 7, the actuation device 9 comprises a wired actuation connection 13 and a command modulation box 41 capable of filtering, limiting or modulating the power of the energy of the function supplied by the instrument. For example, the actuation device 9 is configured to control LEDs and/or sensors, and a modulation box 41 can be included for conditioning the (input or output) signal, and in particular the modulation box 41 can be housed in a seat provided in the sterile manipulation interface 5, 6 and can be contro lled with an adjustment ring or a slide/slider of the actuation device 9 itself. According to another example, the modulation box 41 is arranged along the path of the control cable 13 and is not mounted on the sterile manipulation interface.
[0102]. As shown for example in Figures 8 A-B, the actuation device 9 can comprise an actuation push button, which for example can be pressed and/or released for the activation of said function Q. By pressing the actuation push button , a switch can be actuated, so as to generate a command signal. As shown for example in Figures 8 C-D, the actuation device 9 can comprise a control ring, which for example can be rotated to activate said function Q. A potentiometer can be provided, associated with said actuation ring so as to provide a command signal which includes the modulation of the additional function and not necessarily the mere activation or deactivation thereof. For example, the control ring can allow the supply of various levels of electrosurgical energy depending on the angular stroke thereof, for example it can allow the transition between the supply of electrosurgical cutting (“cut”) and the supply of coagulation ("coag"). As shown for example in Figures 8 E- F, the actuation device 9 can comprise a control slider, which for example has an actuation similar to that of the control ring and multiple levels of selection or activation .
[0103]. The actuation device can comprise a pressure, force, contact or impedance sensor.
[0104]. In accordance with a preferred embodiment, the actuation devi ce 9 comprises a push-button panel, i.e. , it comprises a plurality of actuation interfaces, such as a plurality of push buttons, for example, among the push buttons of said plurality an intentionality push button can be included, i.e. , of the "dead man" type, which must be pressed as a pre-condition, and further push buttons for actuating specific additional functions can also be provided, for example a first push button for supplying electrosurgical cutting ("cut") and a second push button for supplying coagulation ("coag"). For example, Figure 17 shows an embodiment in which a push button or switch of the "dead man" type 93 and two push buttons 91 , 92 or switches for actuating specific respective additional functions Q are provided.
[0105]. When provided in a separate piece, the two interfaces 5 and 6 can each have a command switch thereof for an additional function thereof or for the modulation of the same additional function Q of the slave device. I n such a case, the two sterile manipulation interfaces 5 and 6 can be connected by an electrical communication cable between the two parts.
[0106]. As mentioned above, in accordance with a preferred embodiment, the additional function Q comprises supplying electrosurgical energy. There can be further additional functions contro lled by the actuation device 9, for example "cut" and "coag", i.e. , cutting and coagulation obtainable by modulating the electrosurgical energy supply pattern .
[0107]. Said additional function Q controlled by the actuation device 9 of the sterile manipulation interface 5, 6 can comprise: enabling a teleoperation, and/or suspending a teleoperation , and/or enabling a limited teleoperation state over a subset of the controllable degrees of freedom, and/or varying the teleoperation scaling factor. In other words, acting on the actuation device 9, it is possible to act on the master-slave teleoperation mode, and in particular the actuation device 9 can act as a clutch to decouple some degrees of freedom in order to allow a repositioning of the master device in the wo rking volume (tracking volume) thereof, i.e., to prevent the slave device from following the master device, for example not following the master device in translation while continuing to follow it in orientation.
[0108]. In accordance with an embodiment, said function Q controlled by the actuation device 9 of the sterile manipulation interface comprises opening/closing movement ("grip", "cut", "dilate") of the tips or jaws of the slave surgical instrument. For example, the slave surgical instrument 4 can be a surgical dilator and the activation of the actuation device 9 can cause the opening of the jaws 1 61 , 162 i.e. , dilation. In accordance with another example, the slave surgical instrument 4 can be a needle/scissors holder and the activation of the actuation device 9 can cause the jaws 1 61 , 1 62 to close and/or the cutting blades to close.
[0109]. In accordance with an embodiment, the opening/closing of the articulated end 1 6 of the slave surgical instrument 4 is controlled by means of information detected by the tracking sensors 21 , 22, while when the control gripper of the operating portion 3 of the master device is in the reclosed configuration it is possible to command the timely reopening of the slave articulated end by means of the command device 9; in this case, the additional function Q can be a safety function which requires the timely reopening of the tips or jaws 161 , 1 62 of the slave device 4.
[01 10]. According to a preferred embodiment, the operating portion 3 of the master controller device 1 comprises a control grippe r, for controlling at least the opening/closing movement of the tips or jaws 161 , 1 62 of the slave surgical instrument 4.
[01 1 1 ]. The control gripper of the operating portion 3 preferably comprises two rigid parts 23, 24 or rigid flaps relatively movable in opening/closing , which are for example constrained to each other in a rotational joint 25 to rotate about a common axis. The rotational joint 25 which articulates the two rigid parts 21 , 22 preferably comprises an elastic device which biases the rig id parts of the operating portion 3 of the master device towards an open rest configuration (in a manner known per se) . The rigid parts 23, 24 of the control gripper are preferably sensorized to determine the degree of opening/closing and correspondingly control the opening/closing of the jaws 1 61 , 162 of the slave articulated end 1 6. For example, each rigid part 23, 24 comprises a position and orientation sensor 21 , 22 and the detected information on the distance between said sensors is used to control the degree of opening/closing , as well as control, with redundant information acquired by the sensors, the position and orientation of the slave device.
[01 12]. Said at least one additional function Q controlled by the actuation device 9 of the sterile manipulation interface 5, 6 can comprise releasing surgical elements such as surgical clips (surgical clip appliers) or releasing clinical substances (surgical glue/ drugs) from the surgical instrument as well as spraying liquid, such as an aqueous solution , for example.
[01 13]. Said additional function Q controlled by the actuation device 9 of the sterile manipulation interface can comprise activating a drill which can be an ultrasonic drill mounted at the distal end of the positioning rod or shaft of the slave surgical instrument, as well as adjusting the drilling parameters.
[01 14]. In accordance with a preferred embodiment, said at least one additional function Q controlled by the actuation device 9 of the sterile manipulation interface 5, 6 comprises supplying energy to the operating distal end of the slave surgical instrument 4. The energy supplied can be thermal energy, as well as ultrasonic energy supply and/or radio frequency energy supply. In this case, the generator 14 can be a respective thermal energy supply generator, for example by Joul e effect, an ultrasound and/or radiofrequency energy generator. In accordance with an embodiment, said function controlled by the actuation device 9 comprises activating a laser mounted on the slave surgical instrument. In such a case, the generator 14 can be a suitable focused-light energy generator. In accordance with another embodiment, the additional function Q comprises switching on a light source arranged at the distal end of the positioning rod or shaft of the slave surgical instrument 4. In accordance with an embodiment, the additional function Q comprises activating a light source transmitted by optic fiber along the surgical instrument;
[01 15]. In accordance with a preferred embodiment, the sterile manipulation interface 5, 6 comprises two sterile shells o r cheeks 5, 6 fixed to the operating portion 3, for example to a control gripper 3, each sterile shell or cheek 5, 6 comprising a sterile manipulation surface 7, 8 thereof . In order to be snap-coupled to the operating portion 3, each sterile shell or cheek 5, 6 can be provided with a snap-coupling device 10, for example comprising a plurality of elastic coupling tabs obtained by providing notches made, for example by molding or by material removal, on a margin of the sterile shell or cheek. Such snap-coupling tabs 1 0 can comprise a tip, i.e. , a rounded free end to avoid damaging the sterile drape while ensuring a firm snap-coupling to the operating portion 3 through the body of the sterile drape 21 . Each shell or cheek forming the sterile manipulation interf ace 5, 6 can comprise a dome- or shell-shaped body enclosing a housing for receiving a portion of the operating portion 3. The body of a sterile shell or cheek, which is preferably made of rigid plastic, can comprise one or more surfaces facing the other sterile shell or cheek when in operating conditions, for example to form a closing abutment surface for the sensorized control gripper.
[01 16]. As shown for example in Figure 12, a cap or cover can be included, which is fitted onto the master controller device when the sterile interface cheeks or shells are already mounted to the operating portion . For example, said cap or cover is made of elastomer and/or silicone and can have openings to expose the actuation device 9 outside the cap or cover.
[01 17]. In accordance with an embodiment, a releasable coupling device 1 5 can be provided between the two sterile shells or cheeks 5, 6 to couple the two sterile shells or cheeks together, in order to keep the control gripper of the sensorized operating portion 3 in a closed configuration. The releasable coupling device 15 can thus cooperate with the actuation device 9 of the additional function Q which, for example, can only be actuated if the releasable coupling device is active, i.e. , only if the control gripper of the sensorized operating portion 3 is in the closed configuration . To this end, the actuation device 9 can be positioned between the two sterile shells or cheeks 5, 6, i.e. , a push button or a proximity or contact sensor 94 can be included, for example , which is part of the actuation device 9, which is exposed from a sterile shell 5 towards the other sterile shell 6, so that when the two shells are brought close to each other beyond a certain closing threshold, the actuation device 9 is activated.
[01 18]. As shown for example in Figure 13, the sterile manipulation interface 5 can be made in one piece as a cap fitted onto the control gripper of the sensorized operating portion 3, said cap comprising a flexible portion so as to accommodate the opening/closing of the sensorized control gripper 3, said cap defining said two sterile manipulation surfaces 7, 8. In this case, the releasable coupling device 1 5 can be provided between two portions of the same cap to lock and retain the sensorized control gripper in a clo sed configuration.
[01 19]. The one or more shells or cheeks forming the sterile manipulation interface 5, 6 can comprise a dome-shaped body made by molding polymer material (rigid plastic, such as polyurethane and/or polyester, for example) . The actuation device can be made by adding push buttons/sliders/rings to said dome-shaped body made of molded rigid plastic. Therefore, the snap-coupling tabs 10 can also be made by molding and preferably comprise a rounded tip so as not to damage the sterile drape.
[0120]. As shown for example in Figure 14, the sterile manipulation interface 5 can comprise a single shell or cheek mounted to one rigid part 21 of the sensorized control gripper 3, and the releasable coupling device 1 5 allows coupling the single cheek to the other rigid part 22 of the sensorized control gripper 3.
[0121 ]. As shown for example in Figure 15-A, the actuation device 9 can comprise a switch 1 2 arranged in parallel to the power cable 30 for the additional function of the slave surgical instrument 4. The generator 14, in the absence of a power signal, generates on the power cable 30 a low power control signal which, when the switch 1 2 is closed, is re-transmitted back to the generator 14 allowing energization, for example with monopolar electrosurgical energy, of the slave surgical instrument 4 from the same power signal 30. Therefore, this solution includes a switch and a total of two signal lines, an outgoing line for both control and power supply and a return line.
[0122]. As shown for example in Figure 15-B, the actuation device 9 can comprise a switch 12 arranged on a control cable 13 of a generator 14, for example an electrosurgical power generator. When the switch 1 2 is closed, it is re-transmitted back to the generator 14 allowing energization , for example with monopolar electrosurgical energy, of the slave surgical instrument 4 by means of the power signal on 30. Therefore, this solution includes a switch and a total of three signal lines, one control output, one control return and one power supply.
[0123]. As shown for example in Figure 15-C, the actuation device 9 can comprise a switch 12 arranged on a control cable 13 of a generator 14, for example a bipolar electrosurgical energy generator with outward outgoing path 30 and return path 34. Therefore, this solution includes a switc h and a total of four signal lines, one of control output, one of control return , one of power supply output 30, and one of power supply return 34.
[0124]. As shown for example in Figure 16, the actuation device 9 can comprise two switches 1 2 for actuating two add itional functions Q, such as electrosurgical cutting mode and electrosurgical coagulation mode, for example, which can be connected to the same generator 14. The two switches 1 2 can share the same control signal with two separate return paths. In order to allow the distinction between the two switches 12, these can have different geometries and properties, e.g . , shape, surface texture, consistency, and different color (e.g . , yellow and blue) .
[0125]. As shown for example in Figures 18 A-B, a connector 35 can be included, comprising a three-way socket 36 intended to receive the plug of the control cable of the sterile manipulation interface 5, 6 and comprising both a plug 38 intended to be connected to the generator 14 and a plug 37 used to transmit the power signal to the slave surgical instrument 4.
[0126]. As shown for example in Figure 19, a command pedalboard 39, i.e. , a foot switch 39, can be arranged in parallel with the actuation device 9 of the sterile manipulation interface 5, 6 to transmit a command signal to th e generator 14. For example, in this case, the command signal for activating said function Q can be sent either by means of the pedalboard or by means of the actuation device 9.
[0127]. As shown for example in Figure 21 , the sterile manipulation interface 5 can comprise a housing for receiving a generator 14 and a power supply battery 33 thereof, so that the actuation of the actuation device 9 activates the generator 14 integrated with the sterile manipulation interface 5, 6.
[0128]. As shown for example in Figures 22 A-B and 23 A-B, the sterile manipulation interface 5 can further comprise an impermeable barrier 40 to protect the actuation device 9, which is preferably provided in addition to the sterile drape 1 1 . In particular, the impermeable barrier 40 can be arranged above the push buttons of the actuation device 9. For example, the impermeable barrier 40 can be formed by a cap enclosing the sterile manipulation interface 5, 6. In accordance with an embodiment, the impermeable barrier is arranged below the push button of the actuation device 9.
[0129]. A sensor or push button 94 of the actuation device can be provided between the sterile shells or cheeks 5 and 6, for example arranged on a surface 42 of a sterile cheek 5 intended to abut against the other sterile cheek 6 or against the sensor or push button 94 itself, when arranged within a predeterminable closing threshold distance. As shown for example in Figure 24, a sterile cheek or shell 5 can comprise said sensor or push button 94 of the actuation device 9 to activate the additional function when the sterile cheek is in contact, i.e. , when the sensorized control gripper is in the closed configuration and the other sterile cheek or shell 6 can comprise a slider for adjusting/modulating the same additional function.
[0130]. Obviously, in accordance with a general embodiment, a sterile manipulation interface 5, 6 according to any one of the previously described embodiments is included. In particular, said sterile manipulation interface 5, 6 can be provided in a separate piece with respect to the sensorized operating portion 3 of the master controller device 1 and for example comprises a shell or cheek body comprising the actuation device 9 and possibly wiring 13 or 30. [0131 ]. In accordance with an embodiment, the sterile manipulation interface can be provided together with an electrosurgical energy generator 14, thus forming a sterile manipulation interface assembly with actuation device and electrosurgical energy generator, so that the actuation device 9 controls the supply of electrosurgical energy, i.e. , in other words the additional function in this case comprises supplying electrosurgical energy.
[0132]. As mentioned above, a connector 35 is preferably provided to be inserted into the electrosurgical energy generator 14 comprising a socket 36, which can be a two-way socket or a three-way socket, intended to receive a control cable 13 of the sterile manipulation interface 5, 6 to control the supply of electrosurgical energy (in the three-way case: for supplying electrosurgical energy for cutting and coagulation) and a plug 37 for supplying electrosurgical energy for the slave surgical instrument. The electrosurgical energy generator 14 preferably and correspondingly comprises a two- or three-way socket.
[0133]. In accordance with a general embodiment, a robotic surgical teleoperation system 2 is provided, comprising at least one master controller device 1 according to any one of the previously described embodiments.
[0134]. In accordance with a general embodiment, a robotic electrosurgical teleoperation system 2 is provided, comprising at least one master controller device 1 according to any one of the previously described embodiments, at least one slave surgical instrument 4 comprising an articulated end 16 operable under the control of the master controller device 1 , and an electrosurgical energy generator 14, in operational connection with both the slave surgical instrument 4 and the actuation device 9 of the sterile manipulation interface 5, 6 of the master controller device 1 .
[0135]. The sensorized operating portion 3 is preferably of the control gripper type and is configured to control at least one degree of freedom of position and/or orientation of the articulated end 1 6, and preferably at least six degrees of freedom of position and orientation of the articulated end 1 6, and even more preferably also the opening /closing of the tips or jaws of the articulated end of the slave device.
[0136]. The actuation device 9 of the sterile manipulation interface 5, 6 of the master controller device 1 is configured to control the supply of electrosurgical energy from the slave surgical instrument 4.
[0137]. Preferably, at least two push buttons are provided on the actuation device 9 to control the supply of electrosurgical energy for both cutting and coagulation , respectively.
[0138]. As mentioned above, a connector 35 connected to the electrosurgical energy generator 14 is preferably provided, comprising a three-way socket 36 intended to receive a control cable 13 of the sterile manipulation interface 5, 6 to control the supply of electrosurgical energy fo r cutting and coagulation, and an electrosurgical energy supply plug 37 for the slave surgical instrument. The electrosurgical energy generator 14 correspondingly comprises a three-way socket (coagulation, cutting, and supply).
[0139]. Operation example 1
[0140]. In accordance with this example, the actuation device 9 comprises a single actuation device 9, for example a single push button or a single button switch , so that the pressure exerted by the surgeon's finger thereon generates the supply of electrosurgical energy f rom the slave surgical instrument. Obviously, the single push button or switch can be configured to actuate said additional function even where this does not comprise supplying electrosurgical energy, for example the application of a surgical clip (surgica l clip applier) . [0141 ]. Operation example 2
[0142]. In accordance with this example, the actuation device 9 comprises at least two push buttons, one push button being arranged on a sterile shell or cheek and the other push button being arranged on the other sterile shell or cheek, and the activation of said function occurs only if both push buttons are pressed at the same time.
[0143]. Operation example 3
[0144]. In accordance with this example, the actuation device 9 comprises at least one push button arranged on the sterile manipulation interface and the actuation of the slave device function occurs only when one or more further controls are met, which can compri se the control over the degree of freedom of opening /closing between the rigid parts or distance between the rigid parts. The activation of the function can thus only occur when the control gripper is closed (control by the tracking system of the control gripper) and the at least one push button of the sterile manipulation interface is pressed.
[0145]. By virtue of the features described above, given either separately or in combination in particular embodiments, it is possible to respond to the needs mentioned above, thus achieving the aforementioned advantages, in particular:
[0146]. - it is possible to maneuver the master device in a sterile environment, for moving the articulated end of the slave surgical instrument, and at the same time it is possible to control a further function of the slave device which is not related to the movement of the slave articulated end ;
[0147]. - the further function can be the supply of electrosurgical energy;
[0148]. - the device for actuating the additional function is arranged on the sterile manipu lation interface of the master device, and for example is located next to the manipulation surfaces to control the position and orientation of the slave articulated end, so as to allow for a simple control over the additional function by the surgeon ;
[0149]. - the provision of a separate command pedalboard can be avoided, resulting in an increase in comfort for the surgeon who does not have to look for the pedalboard while maneuvering the unconstrained or flying master controller device in the tracking volume and can thus keep his/her attention directed to the surgical site;
[0150]. - the sterile manipulation interface, for example with one or two sterile shells made of molded rigid plastic, with its actuation device can be provided separately from the sensorized operating portion and can be mounted by snap-coupling thereto;
[0151 ]. - for example, the sterile manipulation interface can be provided together with an electrosurgical energy generator and if required with the necessary wiring for the operational connection between the actuation device and the generator.
[0152]. Those skilled in the art may make several modifications and adaptations to the above-described embodiments and may replace elements with functionally equivalent elements, without however departing from the scope of the appended claims.
LIST OF REFERENCE SIGNS
1 MASTER CONTROLLER DEVICE, OR MASTER DEVICE
2 ROBOTIC SYSTEM FOR SURGICAL TELEOPERATION
3 SENSORIZED OPERATING PORTION OF THE MASTER DEVICE, E.G., SENSORIZED
CONTROL GRIPPER
4 SLAVE DEVICE, OR SLAVE SURGICAL INSTRUMENT
5 STERILE MANIPULATION INTERFACE
6 STERILE MANIPULATION INTERFACE
7 STERILE MANIPULATION SURFACE
8 STERILE MANIPULATION SURFACE
9 ACTUATION DEVICE OF THE STERILE MANIPULATION INTERFACE
10 SNAP COUPLING DEVICE TO THE OPERATING PORTION
11 STERILE DRAPE OR SHEET OF THE MASTER DEVICE
12 SWITCH
13 CONTROL CABLE
14 GENERATOR
15 COUPLING DEVIC
16 ARTICULATED EN
17 TRACKING FIELD
18 MOTORIZED MANIPULATOR
19 DISPLAY OR SCREEN
20 VISION SYSTEM
21 FIRST TRACKING SENSOR
22 SECOND TRACKING SENSOR
23 FIRST RIGID PART OF THE SENSORIZED CONTROL GRIPPER
24 SECOND RIGID PART OF THE SENSORIZED CONTROL GRIPPER
25 JOINT OF THE SENSORIZED CONTROL GRIPPER
26 POSITIONING SHAFT OR ROD OR STICK
27 TRANSMISSION INTERFACE
28 SLAVE STERILE BARRIER
29 DATA COMMUNICATION CABLE OF THE OPERATING PORTION SENSORS
30 POWER CABLE
31 WIRELESS CONNECTION
32 T RANSMITTER
33 BATTERY
34 RETURN PATH TO GENERATOR
35 CONNECTOR
36 SOCKET OF THE CONNECTOR FOR THE CONTROL CABLE
37 PLUG OF THE CONNECTOR FOR POWERING THE SLAVE INSTRUMENT
38 PLUG OF THE CONNECTOR FOR THE CONNECTION WITH THE GENERATOR
39 FOOT SWITCH
40 IMPERMEABLE BARRIER
41 SIGNAL MODULATION BOX
42 ABUTMENT SURFACE
91 SWITCH
92 SWITCH
93 SAFETY SWITCH, E.G., OF THE “DEAD MAN” TYPE
94 PUSH BUTTON OR PROXIMITY OR CONTACT SENSOR 61 JAW OR TIP OF THE SLAVE ARTICULATED END 62 JAW OR TIP OF THE SLAVE ARTICULATED END
Q ADDITIONAL FUNCTION OF THE SLAVE SURGICAL INSTRUMENT SU SURGEON
H SURGEON'S HAND