IT201800005507A1 - ROBOT FOR MINIMALLY INVASIVE SURGERY - Google Patents

Description

ROBOT FOR MINIMALLY INVASIVE SURGERY

DESCRIPTION

The present invention relates to the field of surgical robots and in particular relates to a minimally invasive robotic manipulator for the release of a heart valve, for example of the polymeric type. The present invention relates, even more in detail, to a minimally invasive robotic manipulator for the replacement and positioning of a biological aortic valve equipped with an endoscopic vision and navigation system.

Aortic stenosis is one of the most frequent and serious problems related to valve operation. It can be caused by age but also as a consequence of various diseases including diabetes, infections, metabolic or hormonal conditions, genetic factors, etc. Valvular diseases lead to stenosis (reduced valve opening), valve insufficiency, or mixed disorders (steno-insufficiency). These disorders progressively lead to the death of the patient and become more and more frequent, with an estimated number of 300,000 surgeries per year, a number that is estimated to grow in the coming years. This number is expected to rise as the average age of the population increases.

Traditionally, a sternotomy is performed to position a heart valve, which is an incision at the level of the sternum that allows the patient's rib cage to be opened to reach the aortic vein. This type of traditional intervention involves numerous problems, both during the operation and in the post-operative recovery period. For example, there are often risks of rejection and / or infections related to the need to transfuse blood to the patient, there are known risks of wound infection and moreover the post-operative period is characterized by pain and a prolonged hospital stay. The convalescence is then significantly long, considering that the wound takes about two months to reach complete healing and that during this period the patient is, in theory, at maximum rest, practically immobilized, in order to avoid all those movements that could compromise and / or slow down the healing process.

For these reasons, minimally invasive cardiac surgery (MICS) is gradually becoming an alternative to traditional sternotomy.

MICS is traditionally performed with a thoracotomy (i.e. a cut of about 5-6 centimeters on the chest, above the right breast) or a mini-sternotomy (i.e. an incision of a few centimeters in the upper half of the sternum). MICS has numerous advantages such as in particular the reduction of the risk of mortality and post-operative pain and is particularly indicated in patients who have previously undergone coronary interventions. A different surgical approach, on the other hand, provides for transapical access; this approach, which has developed more recently, involves the use of a small left thoracotomy and therefore allows the introduction directly into the apex of the left ventricle. Obviously, this type of access implies the benefits of direct access to the valve and avoids the potential complications of peripheral access. It is also possible to intervene without general anesthesia.

A further method of treatment for patients with aortic valve diseases is the transcatheter aortic valve implantation or TAVI, of polymeric type valves such as balloon or self-expanding. The TAVI is therefore a further alternative for patients not suitable for treatment with the traditional methods described above. With this technique, the implantation of the aortic valve is performed with a percutaneous approach.

In the transfemoral entry approach, the catheter is led to the aortic valve through the femoral artery. While the transfemoral approach brings advantages, it nevertheless implies the risk of damage to the artofemoral vessels.

The use of robotic surgery in the surgical approaches described above and in particular for the implantation of prosthetic valves with a minimally invasive approach still faces numerous problems, especially related to the ability of the robot to be correctly guided / conducted within the vessel.

The first example of use of robots in the field of cardiovascular and cardiothoracic surgery dates back to 1997 with the use of the AESOPTM 3000 system. coronary. The DA VINCI system (Intuitive Surgical Inc., Sunnyvale, CA, USA) was instead used for the first time in 2002, in a repair procedure of a mitral valve. These systems share numerous advantages, first of all that of allowing less invasive incisions than traditional ones, with the ensuing benefits already described above.

However, the use of robotic vascular surgery is not yet extended to all types of surgery, either because of the cost, or because of the need for specific surgical technical skills, or because of technical limitations. In this latter regard and as mentioned above, known robots have limits with regard to the precision of command and navigation, that is, the ability to position the prosthetic valve in situ.

The object of the present invention is therefore to provide a robotic device for minimally invasive surgery, which has high possibilities of command and maneuverability, and which ensures a navigation capacity for the surgeon not comparable to that of robots known in the field.

These and other purposes are achieved by the robotic device according to the invention capable of reaching the intervention site and positioning a heart valve of a known type, under the control of an endoscopic vision and navigation system.

In greater detail, the robotic device for positioning and releasing an aortic valve comprising: - a macro-positioning arm; - a motor unit and actuation means; - a hollow manipulator arm adapted to be operated by said motor unit through said actuation means; a distal end of said manipulator arm, suitable for insertion into a blood vessel of a patient - an introduction terminal adapted to be alternately movable between a retracted position in which it is contained within said distal end and an extracted position in which it projects from said distal end; - means for releasing said valve connected to said introduction terminal; - an integrated navigation system comprising in turn at least viewing means installed on said distal end and an electronic control unit, said electronic control unit being at least instructed to calculate, as a function of the position and orientation of said introduction terminal and of said viewing means with respect to anatomical reference points, a trajectory of said manipulator arm for releasing said valve in the desired position. The robotic device further comprising stabilization means associated with said distal end movable between a closed position and an open position, where in said open position said stabilization means are projecting perimetrically with respect to said distal end, or from said manipulator arm, while in said position tightened, said stabilization means are such as not to substantially exceed the perimetral dimensions of the distal end, or rather of the manipulator arm.

The purposes listed above are also achieved by a method for controlling and guiding the robotic device in a patient's vessel, suitable for releasing a prosthetic valve, comprising the steps of:

- identification of anatomical landmarks;

- acquisition by the electronic control unit of said identified anatomical reference points;

- guide of the manipulator arm in approach to the identified reference points;

- interruption of the movement of the manipulator arm at an established interruption point;

- positioning in the open position of the stabilization means;

- extraction from the distal end of the introducer terminal;

- actuation of the release means for releasing the valve in the desired implant position;

- where the trajectory and orientation of said manipulator arm and said introduction terminal are calculated by said control unit in real time as a function of the position and orientation of the introduction terminal and of the viewing means both reciprocally and with respect to the points anatomical reference.

Further characteristics of the robotic device according to the invention are contained in the secondary claims as annexed.

Characteristics and advantages of the robotic device according to the present invention will become clearer from the following description of an embodiment thereof, given by way of non-limiting example, with reference to the attached drawings, in which:

- Figure 1 schematically shows the device according to the invention, in the condition of operative intervention;

Figure 1a is an enlarged view of a distal end of the robotic device of Figure 1;

Figure 2 shows a terminal for introducing the robotic device, with installed release means for a prosthetic valve, in turn shown in the figure;

- figure 3 shows in isolation means for releasing the prosthetic valve, with this valve still installed;

Figure 4 is an exploded view of the release means of Figure 3;

Figures 5 to 8 show successive steps of the operative connection in the aforementioned distal end of said release means with prosthetic valve mounted on them; And

Figures 9 to 13 show successive stages of releasing the prosthetic valve through the aforementioned release means.

With reference to the aforementioned figures, the surgical robotic device according to the invention comprises a macro-positioning arm 1, of a known type, which allows the macroscopic movements of approaching / moving away from the surgery station. For this purpose, the macro-positioning arm 1 preferably has six degrees of freedom and an actuation that allows the approach and / or removal of a manipulator arm 2 to a patient to be operated on, as desired.

As just mentioned, the manipulator arm 2, of the flexible type, is connected to the macro-positioning arm 1, suitable for being introduced into the body of a patient to be operated on, and in particular into a blood vessel of the same, such as for example and in particular the aorta vein.

The manipulator arm 2 is preferably in the form of a hollow extensible tubular, and defines its own main development axis X.

The surgical device also comprises a motor unit 3 and actuation means for guiding the manipulator arm 2, which has six degrees of freedom for introduction and guidance within the patient's vessel.

The manipulator arm 2 extends between a first end or proximal end 20 directly connected to the macro-positioning arm 1 and a second end or distal end 21 able to be inserted into the body of the patient to be operated on. Inside the manipulator arm 2 there is a housing or introducer terminal 211 (shown separately in Figure 2) intended for connection with release means 4 of a prosthetic valve of a known type, indicated in the figures with the reference V.

The introduction terminal 211 is composed of a hollow extensible tubular 211a and preferably enjoys at least one degree of freedom, i.e. a translation movement along its own axis X ', between a position extracted from the distal end 21 and a retracted position, within the manipulator arm. This translation movement is implemented by an elastic type mechanism; in an embodiment shown in the figures, the elastic-type mechanism comprises a spiral-type spring 211b coaxial with the extendable tubular and wound on it, which is constrained at one end to a gear mechanism 211c or in any case actuated mechanically; the other end of the spiral spring is constrained to the tubular 211a and responds with a thrust in an axial direction to the stress exerted by the gear mechanism on the opposite end, determining the translation along its own axis X 'of the introducer 211. Obviously other systems implementation of the introduction terminal may be provided. The introducer 211 then comprises means for activating the expansion of the valve V such as a DC motor 211d and a second DC motor that powers a rotation movement of the valve, indicated in the figure with the reference number 211e.

The introduction terminal 211 installs release means 4 of the prosthetic valve V. Although different types of release means can be provided, an embodiment of release means for a known type, self-locking aortic prosthetic valve V is illustrated below. , without the need for stitches. Evidently different types of prosthetic valves could be provided, equipping the robotic device according to the invention with suitable release means 4.

According to a technique known in the field, the valve V is installed on the release means 4 in a collapsed position, as shown in Figure 3. This assembly is performed externally to the robotic device, in preparation for the intervention.

With reference now in particular to Figures 3 and 4, the release means 4 comprise a head terminal 41 and a jacket terminal 42 operatively connected by translation means 43 comprising a screw drive, or an expansion screw 43 so as to being able to be mutually approached and / or moved away, according to a direction Y 'de facto defined by the longitudinal development direction of the screw itself. This direction Y 'will correspond, in use, to the direction of insertion Y of the valve V in the implantation site.

Internal abutment elements 43a and 43b are also positioned on the screw 43, in a coaxial arrangement, respectively for opposite annular portions of the valve, namely V1 and V2, respectively of inlet and outlet, with reference to the direction of the blood flow. These internal abutment elements define an internal support core for the collapsed screw.

The head terminal 41 has a substantially conical or mushroom-like shape with a hollow central tubular stem 410. The inlet portion V1 of the valve V is inserted into the stem. connection through a primer indicated in the figures with the number 43c.

The sleeve terminal 42, on the other hand, has a cup shape with an external wall 42a and a hollow central tubular core 42b which engages with the screw 43. Within the jacket tube, in the meatus defined between the aforementioned external wall 42a and the tubular core 42b the outlet portion V2 of the valve.

The second abutment element 43b has a shaped terminal portion 43b 'with protruding radial indentations 430b which engage on respective seats formed on a perimeter ring 211a of the terminal 211, to perfect the connection between the release means 3 and the terminal 211. For allowing the liner 42 to slide with respect to the second abutment element 43b, respective channels 42a 'are formed on the outer wall 42a of the liner in which the aforementioned indentations slide.

As mentioned above, the rotation movement of the screw 43, commanded in the example illustrated by the DC 211d motor, obtains the mutual separation between the head and jacket portions, freeing the annular portions of the valve V which then decompresses, expanding into the position desired, freeing itself from engagement with the release means 4 and implanting itself in the desired implantation site.

In the following, even more in detail, a method of preparation and subsequently of releasing valve V will be described.

The valve V is arranged on the release means 4, being reduced to the collapsed state thereon, with simultaneous tightening of the head and jacket portion on the annular portions, causing it to lock in the collapsed position. With the valve thus installed, the release means 4 are then dragged inside the body of the manipulator by the retraction movement of the terminal 211 and the wings 210 are simultaneously closed, around the collapsed valve V. The mushroom portion 411 of the head 41 remains protruding engaging on an annular edge 210a defined by the upper edges of the stabilizing fins 210; therefore this portion defines, in use, the head terminal of the distal end 21 of the manipulator 2.

The release movement of the valve V will then follow the steps described below, with the support of figures 6 to 10. In detail, the release means 4 will be pushed in the X direction towards the outside of the manipulator 2, with the simultaneous disengagement of the head 41 from the circumferential edge 210a which frees the wings and allows them to open.

Finding the wings on the walls of the aorta determine the consequent stabilization of the manipulator at the point of interruption of the movement. Once the manipulator is thus secured in position and the release means are external to it, the screw is activated to move the head terminal 41 and the liner 42 away from each other along the Y 'direction. valve with respect to the abutment elements and therefore the consequent passage from the collapsed position to the extended position V '. The decompression determines the consequent unwinding of anchoring structures of the valve, indicated with the reference V3 and the disengagement of the valve from the release means, with simultaneous engagement on the desired implantation site.

Once the valve has been implanted, the release means are retracted internally to the manipulator, with simultaneous closure of the wings 210. At this point, the manipulator arm is guided out of the vessel, towards the outside of the patient's body.

It is therefore evident that, since the release is carried out remotely with respect to the position of the surgeon, a navigation system is necessary such as to allow the exact positioning of the manipulator arm and of the introduction terminal 211 in order to consequently have a correct positioning of the valve.

The navigation system, macroscopically indicated with the reference number 5, comprises at least internal viewing means 50 and an electronic control unit (not shown). The system also comprises a user interface 51 on which said electronic control unit displays information and images collected by said viewing means. If necessary, the user interface can be connected at the input to the electronic control unit for the insertion of information by the user / surgeon / medical staff.

In greater detail, the internal viewing means 50 are associated with the distal end 21.

The viewing means comprise at least two cameras 50.

In a preferred embodiment, the at least two cameras 50 are arranged radially with respect to the development axis X, on the external periphery of the distal end 21. The positioning of the cameras on the external periphery of the distal end 21 is particularly advantageous because the position is optimal for viewing the vessel cavity, both during the insertion of the manipulator 2 and during the release of the valve.

Furthermore, the internal viewing means 50 can comprise three cameras.

The cameras are, in a preferred setting, circumferentially equally spaced. The navigation system is capable of identifying anatomical landmarks, or target points, which serve as a reference for positioning the prosthetic valve.

The identification of the target points can be carried out on the basis of an external command, or manually selected by the surgeon through the user interface 51, which for this purpose provides a keyboard or a touch screen. Alternatively, the electronic control unit can be instructed to carry out an automatic or semi-automatic detection of the target points on the basis of the images collected by the vision means.

Once identified, the electronic control unit is instructed to acquire the target points; moreover the electronic control unit is instructed to at least calculate in real time the trajectory and orientation of the manipulator arm 2 and of the introduction terminal 211 as a function of the position and orientation of the introduction terminal 211 and of the viewing means 50 both reciprocally and with respect to the anatomical points of reference.

More specifically, given the release means 4, the electronic control unit is instructed to calculate:

(i) the position and orientation of the anatomical reference points with respect to the internal reference system defined by the means of vision;

(ii) the position and orientation of the terminal 211 with respect to the viewing means 50;

(iii) the trajectory necessary to position the manipulator arm 2 in such a way as to ensure the release of the prosthesis in the desired position, based on information (i) and (ii).

With reference to point (iii), the electronic control unit is able to output the information of the point of interruption of the movement of the manipulator arm 2 during the insertion phase of the prosthetic valve. In fact, as will be described in detail just below, the release of the valve is perfected with a simultaneous translation movement in a release direction Y perfected by the aforementioned release means and due to the natural expansion movement of the valve; this translation movement must be considered in the calculation of the approach trajectory of the arm 2 which therefore must be positioned at an adequate distance from the implant site of the valve itself.

Furthermore, the user interface allows you to view this calculated trajectory and guide information, also using, for example, augmented reality images, such as reconstructed views of the valve on real images taken by cameras in real time.

Advantageously, the navigation system achieves a stereoscopic view of the vessel; this stereoscopic display is made by the electronic control unit which is instructed to combine pairs of images collected by at least two cameras. However, it is possible for the surgeon to select between stereoscopic and 2D vision, i.e. the single image rendered by each camera in real time.

Furthermore, the internal vision means 50 can also be accompanied by external vision means (not shown), materialized by cameras that frame the intervention area and give the surgeon a global image of the patient shown on the interface 51 described above.

It is also possibly provided that the navigation system, through the electronic control unit, automatically controls the macro-positioning arm 1 or the manipulator arm 2, based on the combined information of the position of the vision means and target points.

Guide means 6 are also provided for the purpose of allowing the surgeon / user to control the manipulator arm. In one embodiment, these driving means are materialized by a driving console 6, with joystick 60. The driving console 6 also installs a display 61 which allows information related to the command of the robotic arm to be displayed.

The guide means 6 can be interfaced with the electronic control unit of the navigation system, to achieve the aforementioned automatic guide.

According to a further aspect of the invention, at the distal end 21, the manipulator arm 2 has stabilization or fin means 210 movable between a closed position and an open position, where in said open position said stabilization means protrude perimeter with respect to said distal end, or from the manipulator arm, while in the clamped position the fin means 210 are such as to substantially not exceed the perimetral size of the distal end, or rather of the manipulator arm.

In other words, in the tightened position the stabilization means 210 occlude the distal end 21 and therefore prevent the extraction of the terminal 211 (Figure 8). On the contrary, in the open position the stabilization means allow free the distal end and allow the extraction of the introduction terminal 211 (Figure 9).

It goes without saying that the stabilizing means 210 are in a locked position when the manipulator arm 2 is approaching the valve release point, while they are arranged in the open position when the manipulator arm 2 reaches the aforementioned desired point of interruption of the movement. approach to the plant site, to allow the exit and therefore the release of the valve.

Advantageously, the stabilization means 210 are materialized by flaps or flaps which, in the open position, are arranged radially with respect to the development axis X, like the petals of a flower. When the fins are in the open position they interfere or in any case come into contact with the walls of the blood vessel within which the arm is inserted. This interference allows on the one hand the stabilization of the manipulator arm 2 and specifically of the distal end 21 in position within the vessel. Again, thanks to the interference action of the wings 210, the vessel is prevented from collapsing on itself.

Advantageously, the cameras 50 are located in an interposed position between the fins 210.

As mentioned above, the valve will be released along an insertion axis Y aligned with the axis of the human valve to be replaced; this release will involve a translation movement of the valve along this axis, due to its natural expansion. It follows that, in order for the valve release movement to end at the target points, or in the desired implantation site, the distal end 21 of the arm must be positioned at a suitable distance from that implantation site, a distance that will precisely take into account the need to extract the terminal 211.

According to what has been described above, the robotic device according to the invention therefore implements the following procedure for loading a prosthetic valve, comprising the steps of:

- load the valve on the release means;

- operatively connecting the release means to the introduction terminal 211;

- retract the introduction terminal 211 within the distal end 21;

- arrange the stabilization means 210 in a tight setting.

Still according to what is described above, the invention implements the following procedure for controlling and guiding the robotic device described above in a vessel of a patient, comprising the steps of:

- identification of anatomical landmarks;

- acquisition of the anatomical reference points identified by the electronic control unit;

- guiding the manipulator arm 2 in approach to the identified reference points;

- interruption of the movement of the manipulator arm at an established interruption point;

- positioning in the open position of the stabilization means 210;

- extraction from the distal end 21 of the introduction terminal 211; - actuation of the release means 4 for releasing the valve in the desired implant position;

- where the trajectory and orientation of said manipulator arm 2 and said introduction terminal 211 are calculated by said control unit in real time as a function of the position and orientation of the introduction terminal 211 and of the viewing means 50 are reciprocally both with respect to the anatomical points of reference.

The robotic device and the procedure according to the invention manage to obtain the advantageous result of intervening with mini and micro invasive methods on the patient. In particular, thanks to the simulated vision, it is possible to establish in advance the target points for valve release and the most effective path within the blood vessel and with less risk for the patient. It is also possible to determine the best insertion point for the manipulator. The operation involves a minimum size incision on the patient's chest (about 3-4 centimeters) and heart functions can be stabilized with the aid of extracorporeal circulation machines (or heart-lung machines). Furthermore, thanks to the use of polymer valves of current conception, it is possible to implant even, if necessary, without replacing the existing human valve.

These results are evidently obtained thanks to the exceptional ability to control and guide the manipulator arm and the robotic device as a whole, thanks to the endoscopic vision system described above. The wings 210 also contribute significantly to reducing the risks associated with the intervention as they allow on the one hand to stabilize the position of the manipulator arm within the vessel, on the other they prevent the latter from collapsing.

Furthermore, the navigation system in itself achieves several surprising advantages, such as first of all the possibility of controlling the positioning of the valve starting from positioning information of the arm provided in real-time and compared with recorded information such as, for example, but not limited to the location. of the target points and the type of valve release. With particular reference to the localization of target points, this can also be refined in real time, through a feature tracking function.

Furthermore, the navigation system can use this information to calculate a trajectory that is suggested to the surgeon, to facilitate the guidance of the robot. In the event that an automatic guidance system is implemented, the trajectory calculated by the navigation system is used as the target trajectory by the automatic guidance system.

Furthermore, the vision means allow the surgeon to have a perfect view of the surgery site, thanks to the possibility of choosing the image, between stereoscopic and 2D as well as the possibility of combining with them a reconstructed image, for example of the valve, in order to create an augmented reality image.

Therefore, the ability of the navigation system to ensure the correct position of the arm and the synergistic interaction with the flaps 210 which ensure stable positioning of the arm, allow the valve to be released even remotely, in the desired position.

The present invention has been described with reference to a preferred embodiment thereof. It is to be understood that there may be other embodiments that refer to the same inventive core, all falling within the scope of the claims set out below.

Bibliography

[1] Lung B. et. Al. "A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease." Euro Heart J. 2003 Jul; 24 (13): 1231-43.

Claims (19)

CLAIMS 1. A robotic device for positioning and releasing an aortic valve comprising: - a macro-positioning arm (1); - a motor unit (3) and actuation means; - a hollow manipulator arm (2) adapted to be operated by said motor unit (3) through said actuation means, provided with a distal end (21) suitable for insertion into a blood vessel of a patient, and with a terminal of introduction (211) adapted to be alternatively movable between a retracted position in which it is contained within said distal end (21) and an extracted position in which it projects from said distal end (21); - release means (4) of said valve connected to said introduction terminal (211); - said robotic device being characterized in that it further comprises an integrated navigation system (5) comprising in turn at least vision means (50) installed on said distal end (21) and an electronic control unit, said electronic control unit being at least instructed to calculate, as a function of the position and orientation of said introduction terminal (211) and of said viewing means (50) with respect to anatomical reference points, a trajectory of said manipulator arm for release in the desired position of said valve; said robotic device being further characterized in that it comprises stabilization means (210) associated with said distal end (21) movable between a closed position and an open position, where in said open position said stabilization means protrude perimeter with respect to said end distal, or from said manipulator arm, while in the closed position said stabilization means (210) are such as to substantially not exceed the perimetral dimensions of the distal end, or rather of the manipulator arm. The robotic device according to claim 1 wherein said viewing means (50) of said navigation system comprise at least two cameras. The robotic device according to claim 2 wherein said at least two cameras (50) are arranged circumferentially equally spaced on the periphery of said distal end (21). The robotic device according to any one of the preceding claims, wherein said electronic control unit identifies said reference points. The robotic device according to claim 4 wherein said identification is made on the basis of an external command given by a user through a user interface (51). The robotic device according to claim 4 wherein said identification is made automatically by the navigation system. The robotic device according to any one of claims 2 to 6 in which said electronic control unit is instructed to combine pairs of images transmitted by said at least two cameras to obtain a stereoscopic vision. 8. The robotic device according to claim 7, in which said electronic control unit is instructed to superimpose a reconstructed image on said images transmitted by said at least two cameras to obtain augmented reality images. The robotic device according to any one of the preceding claims, in which said electronic control unit is operatively interfaced with guiding means (6) of said device, to realize the automatic guiding of said motor assembly and said actuation means on the basis of said calculated release trajectory. The robotic device according to any one of claims 2 to 9 wherein said stabilization means (210) have dimensions such as to interfere, in said open position, with walls of said blood vessel. The robotic device according to claim 10 wherein said stabilizing means comprise a plurality of fins (210) arranged in a radial pattern on the periphery of said distal end (21). The robotic device according to claim 10 or 11 in which said at least two video cameras are placed in an interposed position between the fins (210) of said plurality. 13. The robotic device according to any one of the preceding claims in which said release means (4) comprise a head terminal (41) and a jacket terminal (42) which can be approached or removed from each other according to an insertion direction (Y ') of said valve by effect of translation means, to said reciprocal movement corresponding to the release of said valve. 14. The robotic device according to claim 13 wherein said translating means comprise a screw drive extending according to said insertion direction. The robotic device according to claim 14 wherein the retraction movement of said terminal (211) within said distal end corresponds to the closing movement of said stabilizing means, while the extraction movement of said terminal (211) externally to said distal end corresponds to the opening movement of said stabilizing means. The robotic device according to any one of claims 13 to 15, wherein said head (41) is such as to axially engage on a circumferential edge (210a) defined by said stabilization means (210) in a closed position. 17. Process for loading a prosthetic valve on a robotic device such as that of claims 1 to 16 comprising the steps of: - loading said valve on said release means; - operatively connecting said release means to said introduction terminal (211); - retracting said introducer terminal (211) into said distal end (21); - arranging said stabilization means (210) in a tight setting. 18. Process for controlling and guiding a robotic device in a vessel of a patient for releasing a prosthetic valve according to any one of claims 1 to 16, comprising the steps of: - identification of anatomical landmarks; - acquisition of said anatomical reference points by said electronic control unit; - guiding said manipulator arm (2) in approach to the identified reference points; - interruption of the movement of said manipulator arm (2) at an established interruption point; - positioning in the open position of said stabilization means (210); - extracting said distal end (21) of said introducer terminal (211); - actuation of the release means (4) for the release of said valve in the desired implant position; - where the trajectory and orientation of said manipulator arm (2) and said introduction terminal (211) are calculated by said control unit in real time as a function of the position and orientation of the introduction terminal (211) and of the viewing means (50) both reciprocally and with respect to the anatomical reference points. 19. The process according to claim 18 wherein said step of calculating said trajectory and orientation in real time is calculated on the basis of the information released by the following steps: - calculate the position and orientation of the anatomical reference points with respect to said means of vision; - calculate the position and orientation of said terminal (211) with respect to said viewing means (50).