FIELD OF THE INVENTION

The present invention relates to the field of remotely actuated mechanical systems and more particularly to a mechanical teleoperated device for remote manipulation for use primarily in minimally invasive surgical procedures, using small size access incisions into the patient body. Specifically, the present invention relates to a mechanical teleoperated device with improved kinematics and arrangement of constraints allowing for better positioning of the device over a patient, increased workspace inside the patient and better integration into operating room workflow. This device is also adapted for any suitable remote actuated application requiring a dexterous manipulation with high stiffness, precision and quality force feedback such as assembly manipulation, manipulation in narrow places, manipulation in dangerous or difficult environments, and manipulation in contaminated or clean environments.

BACKGROUND OF THE INVENTION

Open surgery is still the standard technique for most surgical procedures. It has been used by the medical community for several decades and consists of performing the surgical tasks by a long incision in the abdomen, through which traditional surgical tools are inserted. However, due to the long incision, this approach is extremely invasive for the patients, resulting in substantial blood loss during the surgery and long and painful recovery periods at the hospital.

In order to reduce the invasiveness of open surgery, laparoscopy, a minimally invasive technique, was developed. Instead of a single long incision, four to five small incisions are made in the patient through which long and thin surgical instruments and endoscopic cameras are inserted. Because of the low invasiveness, this technique reduces blood loss and shortens hospital stays and pain. When performed by experienced surgeons, this technique can attain clinical outcomes similar to open surgery. However, despite the above-mentioned advantages, laparoscopy requires extremely advanced surgeon skills to manipulate the rigid and long instrumentation. The entry incision acts as a point of rotation, decreasing the freedom for positioning and orientating the instruments inside the patient. The movements of the surgeon's hand about this incision are inverted and scaled-up relative to the instrument tip ("fulcrum effect"), which removes dexterity, sensibility and magnifies the tremors of the surgeon's hands. In addition, these long and straight instruments force the surgeons to work in a uncomfortable posture for hands, arms and body, which can be tremendously tiring during several hours of operation. Therefore, due to these drawbacks of the laparoscopic instrumentation, these minimally invasive techniques are mainly limited to use in simple surgeries, while only a small minority of surgeons is able to use them in complex procedures.

To overcome these limitations, surgical robotic systems were developed to provide an easier-to-use approach to complex minimally invasive surgeries. By means of a computerized robotic interface, these systems enable the performance of a remote laparoscopy where the surgeon sits at a console manipulating two master manipulators to perform the operation through several small incisions. Like laparoscopy, the robotic approach is also minimally invasive, bringing several advantages over open surgery in terms of pain, blood loss, and recovery time. In addition, it also offers better ergonomy for the surgeon compared to open and laparoscopic techniques. However, although being technically easier, Robotic Surgery brings several negative aspects. A major disadvantage of these systems is related with the extremely high complexity of the existing robotic devices, which are composed by complex mechatronic systems, leading to huge costs of acquisition and maintenance, which are not affordable for the majority of surgical departments worldwide. Another drawback of these systems comes from the fact that current surgical robots are voluminous, competing for precious space within the operating room environment and significantly increasing preparation time. Access to the patient is thus impaired, which, together with the lack of force-feedback, raises safety concerns.

W09743942, W09825666 and US2010011900 disclose a robotic tele-operated surgical instrument, designed to replicate surgeons' hand movements inside the patient's body. By means of a computerized, robotic interface, it enables the performance of a remote Laparoscopy where the surgeon sits at a console manipulating two j oy sticks to perform the operation through several small incisions. However, this system does not have autonomy or artificial intelligence, being essentially a sophisticated tool fully controlled by the surgeon. The control commands are transmitted between the robotic master and robotic slave by a complex computer-controlled mechatronic system, which is extremely costly to produce and maintain and difficult to use by the hospital staff. WO 2008130235 discloses a less complex mechanical manipulator for an instrument for minimally invasive surgery, having at a proximal end a handle for operating the instrument connected at a distal end of the manipulator. A parallelogram construction is provided between the proximal end and the distal end for guaranteeing an unambiguous position relationship between the handle and the instrument. This parallelogram construction is coupled with a system of bars for controlling the position of the parallelogram construction. The bars of the system are connected to the parallelogram construction as well as to each other by means of cardan joints. The parallelogram constraint imposed by this mechanical manipulator renders it difficult to obtain a scaled ratio other than 1 : 1 between the amplitude of the movements applied on the handle of this manipulator and the amplitude of the movements reproduced by the instrument connected at the distal end of the manipulator. This reduces the precision of the manipulator which is at the utmost importance for surgical intervention. In addition, due to the high inertia of the rigid elements of the parallelogram construction, this mechanical manipulator should provide poor haptic transparency to the user. Another issue of this system is related with the fact that the first degree of freedom of the parallelogram needs to be aligned with the incision, which limits the positioning of the manipulator over the surgical table and therefore reduces the number of surgical procedures that can potentially be performed. Several other mechanical systems have been developed for remote manipulation in radioactive environments and are disclosed in several documents, such as US2846084. However, although the system disclosed in this document comprises a master-slave architecture, its dimensions, weight and kinematics are not suitable for minimally invasive surgical applications. As disclosed in WO2013014621, the present inventors have already developed a surgical platform that overcomes many of the above-mentioned shortcomings in the known art. However, through continued development, the present inventors have become aware of possible improvements to their prior system that allow for better positioning of the surgical platform over the patient, increased workspace inside the patient and improved workflow in the operating room. Accordingly, an aim of the present invention is to provide a mechanical teleoperated device preferably for minimally invasive surgical procedures capable of manipulating surgical instruments with higher precision, increased haptic transparency and which overcomes the aforementioned drawbacks of the prior art. The system of the present invention provides for greater maneuverability of the device and better workflow in the operating room even as compared to prior surgical platforms provided by the present inventors.

Another aim of the present invention is to provide a mechanical teleoperated device which can be easily adapted to be used for other forms of minimally invasive surgery as well as open surgery, microsurgery, brain surgery or procedures on MRi environments.

SUMMARY OF THE INVENTION

Theses aims and other advantages are achieved by a mechanical teleoperated device for remote manipulation, designed to naturally replicate the operator's hand movements in the vicinity where manipulations must occur. This mechanical teleoperated device comprises: i) a slave manipulator (referred hereafter as a "slave unit") having a number of slave links interconnected by a plurality of slave joints; ii) an end-effector (instrument/tool or a gripper/holder) connected to the distal end of the slave unit; iii) a master maniplulator (referred hereafter as a "master unit") having a corresponding number of master links interconnected by a plurality of master joints; and iv) a handle for operating the mechanical teleoperated device. The mechanical teleoperated device can also be described by considering the end-effector to be part of the slave unit and the handle to be part of the master unit. In a broader sense, the links and joints composing the end-effector can be considered distal slave links and joints, while the links and joints composing the handle can be considered distal master links and joints. The end- effector might be adapted to be releasable from the proximal part of the slave unit.

The mechanical teleoperated device further comprises first mechanical transmission means arranged to kinematically connect the slave unit with the master unit such that the movement (angle of joint) applied on each master joint of the master unit is reproduced by the corresponding slave joint of the slave unit at a predetermined scale ratio, which can advantageously be in the order of 2: 1 or 3 : 1, if each master link is respectively two or three times longer than the corresponding slave link. A scaling down ration of this order of magnitude can significantly improve the precision of the device. In addition, second mechanical transmission means are arranged to kinematically connect the tool or the end-effector with the handle such that the movements applied on the handle are reproduced by the end-effector at a predetermined scaled ratio The mechanical teleoperated device also comprises mechanical constraint means which are usually configured to ensure that one master link of said master unit is guided or constrained to move along its longitudinal axis so that the corresponding slave link of the slave unit always translates along a virtual axis parallel to the longitudinal axis of said guided master link in the vicinity of the remote manipulation when the mechanical teleoperated device is operated.

As compared to prior surgical platforms described by the present inventors in WO2013014621, the description of which is incorporated by reference herein as if presented herein in full, the mechanical teleoperated system of the present invention has a new kinematic model and a new arrangement of mechanical constraints,whose position in the 3D space can be tuned with respect to the mechanical teleoperated system, allowing for much more flexibility in positioning the mechanical teleoperated system over the patient, while allowing shorter distances between a master and slave manipulator, which results in a lighter and more compact system that can be more easily integrated in the operating room workflow.

BRIEF DESCRIPTION OF FIGURES

The invention will be better understood according to the following detailed description of several embodiments with reference to the attached drawings, in which:

- Figure 1 shows a perspective view of a mechanical telemanipulator according to an embodiment of the invention disclosed in WO2013014621 ;

- Figure 2 shows a schematic view of a mechanical telemanipulator according to an embodiment of the invention disclosed in WO2013014621;

Figure 3 illustrates some of the limitations of the mechanical telemanipulator according to an embodiment of the invention disclosed in WO2013014621; Figure 4 illustrates some advantages of the mechanical telemanipulator according to an embodiment of the current invention over the mechanical telemanipulator according to an embodiment of the invention disclosed in WO2013014621;

Figure 5 shows a schematic view of a mechanical telemanipulator according to an embodiment of the current invention;

Figure 6 shows the kinematic and constraint difference between the mechanical telemanipulator according to an embodiment of the current invention and the mechanical telemanipulator according to an embodiment of the invention disclosed in WO2013014621;

Figure 7 shows a perspective view of a mechanical telemanipulator according to an embodiment of the current invention in a first active position;

Figure 8 shows a perspective view of a mechanical telemanipulator according to an embodiment of the current invention in a second active position;

Figure 9 shows a perspective view of a mechanical telemanipulator according to an embodiment of the current invention in a third active position;

Figure 10 shows a perspective view of a mechanical telemanipulator according to an embodiment of the current invention in a fourth active position;

Figure 11 shows a perspective view of a mechanical telemanipulator according to an embodiment of the current invention in a fifth active position;

Figure 12 shows a perspective view of a mechanical telemanipulator according to the preferred embodiment of the current invention in a sixth active position;

Figure 13 shows a schematic view of a mechanical telemanipulator according to an embodiment of the current invention where the position of the mechanical constraint can be changed in relation to the ground to which the first degree-of-freedom of the mechanical telemanipulator is attached;

Figure 14 shows a schematic view of a mechanical telemanipulator according to another embodiment of the current invention where the position of the mechanical constraint can be changed in relation to the ground to which the first degree-of-freedom of the mechanical telemanipulator is attached;

Figure 15 shows a perspective view of a surgical platform comprising at least one mechanical telemanipulator according to an embodiment of the current invention; Figure 16 shows a perspective view of a surgical platform comprising at least one mechanical telemanipulator according to an embodiment of the current invention, a movable base and at least one articulated positioning manipulator; Figure 17 shows a perspective view of the movable base and at least one articulated positioning manipulator of the surgical platform of Figure 16;

Figure 18 illustrates a first solution of how the mechanical telemanipulators of the surgical platform of Figure 16 can be removed from the surgical area during a surgical procedure;

Figure 19 illustrates a second solution of how the mechanical telemanipulators of the surgical platform of Figure 16 can be removed from the surgical area during a surgical procedure;

Figure 20 shows a first perspective view of the surgical platform of Figure 16 in a "compact storage" configuration;

Figure 21 shows a second perspective view of the surgical platform of Figure 16 in a "compact storage" configuration;

Figure 22 shows the kinematics of a mechanical telemanipulator having a constraint on the slave manipulator and a RCM on the master manipulator according to an embodiment of the present invention;

Figure 23 shows the kinematics of a mechanical telemanipulator with constraints on both the master and slave manipulator according to an embodiment of the present invention;

Figure 24 shows the kinematic model of an embodiment of the current invention where an incision pointer is mounted on the mechanical telemanipulator so that the RCM can be localized and precisely with the body incision of the patient;

Figures 25 and 26 show two different views of the surgical platform, in a detailed stage of design, using two mechanical telemanipulators according to an embodiment of the current invention;

Figure 27 shows a perspective view of a mechanical telemanipulator, in a detailed stage of design, according to an embodiment of the current invention.

DETAILED DESCRIPTION OF THE INVENTION

The mechanical telemanipulator 34, according to an embodiment of the present invention, is intended to be used in a surgical platform, like the mechanical telemanipulator 1 shown in Figure 1, whose description is fully disclosed in WO2013014621 and which description is fully incorporated herein by reference as if presented herein in full. One of the key features of this type of mechanical telemanipulators consists of its master-slave architecture, which enables a natural replication of the user hand movements, on a proximal handle 2, by a distal end-effector 3 on a remote location. According to Figure 2, the mechanical telemanipulator 1 may comprise: i) a master manipulator 4 having a number of master links 7, 8, 9, 10, 11 , rotating over a plurality of master joints 12, 13, 14, 15, 16, a ii) a handle 2 for operating the mechanical telemanipulator 1, connected to the distal end of the master manipulator 4, iii) a slave manipulator 5 having a number of slave links 17, 18, 19, 20, 21 (generally corresponding to the master links 7, 8, 9, 10, 1 1), and rotating over a plurality of slave joints 22, 23, 24, 25, 26 (generally corresponding to the master joints 12, 13, 14, 15, 16); and iv) an end-effector 3 (instrument/tool or a gripper/holder) connected to the distal end of the slave manipulator 5. More particularly, the kinematic chain formed by the plurality of articulated slave links 17, 18, 19, 20, 21 and corresponding slave joints 22, 23, 24, 25, 26 of the slave manipulator 5, may be substantially identical to the kinematic chain formed by the plurality of articulated master links 7, 8, 9, 10, 1 1 and corresponding master joints 12, 13, 14, 15, 16 of the master manipulator 4.

Referring still to Figure 2, the proximal master joint 12 and the proximal slave joint 22 can be considered to be merged in a single joint connecting the mechanical telemanipulator 1 to a ground 27. In the same way, the proximal master link 7 and the proximal slave link 17 can also be considered to be merged in a single connecting link.

The configuration of the mechanical telemanipulator 1 can also be described by considering the end-effector 3 to be part of the slave manipulator 5 and the handle 2 to be part of the master manipulator 4. In a broader sense, the links and j oints composing the end-effector 3 can be considered distal slave links and joints, while the links and j oints composing the handle 2 can be considered distal master links and joints.

The mechanical telemanipulator 1 further comprises mechanical transmission systems arranged to kinematically connect the slave manipulator 5 with the master manipulator 4 such that the movement (angle of joint) applied on each master joint of the master manipulator 4 is reproduced by the corresponding slave joint of the slave manipulator 5. For each degree of freedom of the mechanical telemanipulator 1, different types of mechanical transmissions can be used. In order to minimize the system's overall friction, the mechanical transmission between the majority of the master and slave joints is essentially in the form of pulley -routed flexible elements, where each driven pulley of the slave joint is connected to the respective driving pulley of the master joint, by a multi-stage closed cable loop transmission. However, other types of mechanical transmission can be used, comprising rigid and/or geared elements.

Another key feature of the mechanical telemanipulator 1 disclosed in WO2013014621 lies in the mechanical constraint 28 of the mechanical telemanipulator which is configured to constraint movements of the slave manipulator 5 in correspondence with the constraints imposed by an incision realized on a patient. Referring to Figure 2, in an embodiment of the invention, the mechanical constraint 28 is configured to ensure that, when the mechanical telemanipulator 1 is in operation, the master link 11 of the master manipulator 4 always translates along and rotates about a single point so that the corresponding slave link 21 always translates along and rotates about a fixed point in the space 29, also known as the Remote- Center-of-Motion, RCM.

Therefore, the movement applied on the handle 2, forces the movement of the master joints 12, 13, 14, 15, 16 of the master manipulator 4, by the direct mechanical transmission system and the mechanical constraint 28, to drive the respective movement of the slave joints 22, 23, 24, 25, 26 of the slave manipulator 5. As a result, the multi-articulated end-effector 3 connected to the distal end of the slave manipulator 5 is moved in an equivalent movement of the handle 2, while the slave link 21 always translates along and rotates about the RCM 29.

During a minimally invasive surgical procedure, the RCM 29 is brought in coincidence with the surgical incision point, reducing trauma to the patient and improving cosmetic outcomes of the surgery.

Some embodiments of the invention disclosed in WO2013014621 may have a few limitations in terms of its positioning over the patient. As can be seen in Figure 3, with this specific kinematic model, an alignment 33 between the 1 ^st degree-of-freedom, DOF, of the mechanical telemanipulator 1 and the incision 29 on the patient 30 is required. This prerequisite, together with the fact that the neutral position of instrument shaft 21 is perpendicular with the alignment line 33, limits the forward angulation that can be reached inside the patient and forces the distance between the master manipulator 4 and the slave manipulator 5 to be large in order to avoid collisions of the handle 2 with the patient 30 and surgical table 31. In addition, the fact that the handle 2 cannot be positioned over the patient 30, limits the ranges of procedures that can be done.

To overcome the above mentioned set of limitations, another embodiment of WO2013014621 can be formulated, as can be seen in Figure 4. Due to its new kinematics and constraint setup (shown in Figure 5), with this mechanical telemanipulator 34 the RCM 29 (and therefore the incision point on the patient) doesn't have to be aligned with the first DOF of the mechanical telemanipulator 34 and the neutral position of the instrument shaft 21 doesn't have to be perpendicular with any alignment line. As can be seen in Figure 4, these features allow for much more flexibility in positioning the mechanical telemanipulator 34 over the patient 30, while allowing shorter distances between the master manipulator 4 and the slave manipulator 5, which results in a lighter and more compact system 1 that can be more easily integrated in the operating room workflow.

Figure 5 shows the new kinematic model of the system, with a total of 6 degrees-of- freedom (excluding the three degrees -of-freedom of the handle 2 and end-effector 3) and the constraint 28, which is now fixed to a second ground 37 and not to the proximal master link 7, as in the embodiment 1. As can be seen in Figure 6, this kinematics of the embodiment 34 has one more DOF that the kinematics of the embodiment 1, which consist in the master joint 35 and the correspondent slave joint 36.

Figures 7 to 12 show the mechanical telemanipulator 34 in different working configurations.

A key feature of this invention consist in the possibility to move the constraint 28 (and therefore the RCM 29) in the 3D space in relation to the ground 27, to which the mechanical telemanipulator 34 is fixed by the first joint 12 (Figures 13 and 14). This can be achieved by and articulated system 38 that can be fixed to a second ground 37 (Figure 13) or directly to the ground 27 (Figure 14). This feature allows for an increased flexibility in reaching an optimal position of the telemanipulator 34 over the patient, while allowing for a desired workspace inside the patient with an ideal ergonomy for the surgeon. A surgical platform 45, which comprises at least one mechanical telemanipulator 34, can be seen in Figure 15. It is arranged in a way that the mechanical telemanipulators 34 can be placed over the surgical table 31 , while having their RCM 39 merged with the incision points in the patient.

According to Figures 16 and 17, the surgical platform 45, may further comprise a movable base 39, and at least one articulated positioning manipulator 40, whose distal extremity 41 is fixed to the mechanical telemanipulator 34 so that it can be moved over the surgical table 31 and stably fixed in specific positions of the 3D space. In other embodiments of the current invention, instead of a single movable base 39, each one of the two articulated positioning manipulators 40 may be mounted on a separate movable base, independent from the movable base of the other articulated positioning manipulator 40.

Each articulated positioning manipulator 40 should be gravity -compensated (together with the mechanical telemanipulator 34 that is being carried) by means of systems of counterweights and/or springs. In addition, each articulated positioning manipulator 40 should be provided with a system of clutches/brakes on each one of the joints so that they are blocked by default and can be released and moved when a switch 43 is pressed. By pressing the switch 43, the mechanical telemanipulator 34 can be moved in the 3D space to be positioned over the patient or to be removed from the surgical area 42 to a remote location 44, in particular during a surgical procedure (Figures 18 and 19) but also before or after. This feature is critical for an easy integration of the surgical platform with the operating room workflow, were the mechanical telemanipulators can be used interactively with other types of surgical instrumentation (for instance, standard laparoscopic instruments) during the same surgical procedure.

In order to be precisely positioned over the patient and aligned with the body incision of the patient, an incision pointer 47 (Figure 24) can be mounted on each mechanical telemanipulator 34 during their positioning over the patient, when the detachable instrument containing the end-effector 3 is still not mounted on the mechanical telemanipulator 34. As can be seen in Figure 24, the incision pointer 47 can be rigidly attached to the distal moving link 49 of the articulated system 38 so that its distal extremity is pointing to the RCM 29 of the mechanical telemanipulator 34 (whose 3D position with respect to the ground 27 is changing according to the positional configuration of the articulated system 38). Then, as soon as the distal extremity of the incision pointer 47 is brought to be substantially coincident to the incision of the patient body (where a surgical trocar may be in place) the 3D position of the mechanical telemanipulator 34 is blocked in the 3D space but releasing the switch 43 of the articulated positioning manipulator 40.

As shown in Figures 20 and 21, the surgical platform 45 allows for a compact storing position, where the mechanical telemanipulators 34 are brought by the articulated positioning manipulators 40 to a protected location over the platform's movable base 39. In the shown embodiment, the position of both telemanipulators is substantially vertical but in other embodiments of the current invention they may be in other special configurations (for instance, substantially horizontal).

Figures 25 and 26 show two different views of the surgical platform 45 in a more detailed stage of design, while Figure 27 shows an embodiment of the current invention, used on the mechanical telemanipulator 34, where the articulated system 38 provides 2 degrees-of- freedom LI , L2 (corresponding to the linear displacement between the link 48 and the ground

27 and the linear displacement between the distal link 49 and the link 48) to the constraint 28.

While this invention has been shown and described with reference to particular embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. For instance, knowing that each master joint 12, 13, 14, 35, 15, 16 is kinematically connected with the corresponding slave joint 22, 23, 24, 36, 25, 26 another embodiment of the current invention can be achieved by placing the constraint

28 on a slave link 21 to have the RCM 29 on the master manipulator 4, around which the master link 1 1 would always rotate about and translate along (Figure 22). Similarly, a different embodiment of the present invention could be reached by having the constraint 28m in the master link 11 and placing a second constraint 28s on the slave manipulator 5 (Figure 23), so that the slave link 21 would always rotate about and translate along a point that is coincident with the incision.