WO2019220384A1

WO2019220384A1 - Robot for minimally invasive surgery

Info

Publication number: WO2019220384A1
Application number: PCT/IB2019/054060
Authority: WO
Inventors: Izadyar TAMADDON; Claudio Quaglia; Selene Tognarelli; Arianna Menciassi; Giorgio Soldani; Paola LOSI; Vincenzo Ferrari; Sara CONDINO; Simona CELI; Pier Andrea FARNETI
Original assignee: Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica; Consiglio Nazionale delle Richerche CNR; Universita di Pisa; Scuola Superiore di Studi Universitari e di Perfezionamento SantAnna
Current assignee: Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica; Consiglio Nazionale delle Richerche CNR; Universita di Pisa; Scuola Superiore di Studi Universitari e di Perfezionamento SantAnna
Priority date: 2018-05-18
Filing date: 2019-05-16
Publication date: 2019-11-21
Anticipated expiration: 2020-11-18
Also published as: IT201800005507A1

Abstract

The present invention concerns the field of surgical robots and in particular relates to a minimally invasive robotic manipulator for releasing a polymeric heart valve. In further detail, the present invention relates to a minimally invasive robotic manipulator equipped with an endoscopic imaging and navigation system.

Description

ROBOT FOR MINIMALLY INVASIVE SURGERY

DESCRIPTION

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

Aortic stenosis is one of the most frequent and serious problems related to valve functioning. 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 (narrowing of the valve opening), valve insufficiency, or mixed disorders (steno-insufficiency). These disorders progressively lead to the death of the patient and have become more and more frequent, with an estimated number of 300,000 surgical operations per year, a number that is estimated to grow over the next few 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, that is, an incision is made at the level of the sternum that allows opening the patient's chest to reach the aorta vein. This traditional type of intervention involves numerous problems, both during the operation and during the post-operative recovery period. For example, there are often risks of rejection and/or infection related to the need to transfuse blood to the patient, there are known risks of wound infection and furthermore the post operative period is characterized by pain and a prolonged period of hospital stay. Thus, the period of convalescence is significantly long, considering that the wound takes about two months to completely heal and that during this period the patient is, in theory, resting as much as possible and 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 carried out with a thoracotomy (a cut of about 5-6 centimetres on the chest, above the right breast) or a mini-sternotomy (an incision of a few centimetres 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 operations. A different surgical approach instead involves transapical access; this approach has been developed more recently and involves the use of a small left thoracotomy and therefore allows introduction directly into the apex of the left ventricle. This type of access implies the benefits of direct access to the valve and avoids the potential complications of peripheral access. Furthermore, it is also possible to intervene without a general anaesthetic.

A further treatment method for patients with aortic valve disorders is the transcatheter aortic valve implantation (TAVI) of polymeric-type valves, for example, balloon-type or self-expanding valves. TAVI is therefore a further alternative for patients who are not suited to treatment with the traditional methods described above. With this technique, the aortic valve is implanted through a percutaneous approach.

In the transfemoral entry approach, the catheter is led to the aortic valve through the femoral artery. While on the one hand the transfemoral approach has 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 involves numerous problems, above all related to the ability of the robot to be correctly guided/conducted within the vessel.

The first example of the use of robots in the field of cardiovascular and cardiothoracic surgery dates back to 1997 with the use of the AESOPTM 3000 system. In 1999 the evolution of this system, that is the ZEUS system, was used in the first arterio-coronary bypass operation. The DA VINCI system (Intuitive Surgical Inc., Sunnyvale, CA, USA) was instead used for the first time in 2002, in a mitral valve repair procedure. These systems share many advantages, firstly that of requiring less invasive incisions than traditional ones, with the consequent benefits already described above.

However, the use of robotic vascular surgery is not yet extended to all types of surgery, both for the cost, and for the need for specific surgical technical skills, or for technical limitations. With regard to the latter and as mentioned above, the known robots have limits relating to control and navigation precision, that is, the positioning capacity of 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 command and manoeuvrability possibilities, and which ensures a navigational capacity for the surgeon which is not comparable to that of the robots currently in the field.

These and other objects 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 imaging and navigation system.

In further detail, the robotic device for positioning and releasing an aortic valve comprises: - a macro-positioning arm; - a motor unit and actuation means; - a hollow manipulating arm adapted to be actuated by said motor unit through said actuation means; a distal end of said manipulating arm, suitable for insertion into a patient's blood vessel - an introduction end 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 juts out from said distal end; - means for releasing said valve connected to said introduction end; - an integrated navigation system in turn comprising at least imaging means installed on said distal end and an electronic control unit, said electronic control unit being at least instructed to calculate, depending on the position and orientation of said introduction end and of said imaging means with respect to anatomic target points, a trajectory of said manipulating arm for releasing said valve in a desired position. The robotic device further comprises stabilization means associated with said distal end, movable between a locked position and an open position, where in said open position said stabilization means project laterally with respect to said distal end, that is from said manipulating arm, while in the locked position said stabilization means is such as to substantially not exceed the perimetral size of the distal end, that is of the manipulating arm.

The objects listed above are also achieved by a process for controlling and guiding the robotic device in a patient's vessel, suitable for releasing a prosthetic valve, comprising the steps of: identifying anatomic target points;

the electronic control unit acquiring said identified anatomic target points; guiding said manipulating arm in approach to the identified target points; interrupting the movement of the manipulating arm at an established stopping point;

positioning the stabilization means in the open position;

extracting the introduction end from the distal end;

implementing the releasing means for releasing the valve in the desired implant position;

- where the trajectory and the orientation of said manipulating arm and said introduction end are calculated by said control unit in real time according to the position and orientation of the introduction end and the imaging means both mutually and with respect to the anatomic target points.

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

The characteristics and advantages of the robotic device according to the present invention will appear more clearly from the following description of an embodiment thereof, provided by way of non-limiting example with reference to the appended drawings wherein:

- figure 1 schematically shows the device according to the invention, in operating conditions;

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

figure 2 shows an introduction end of the robotic device, with releasing means of a prosthetic valve assembled, in turn shown in the figure;

figure 3 shows only the releasing means of the prosthetic valve, with this valve still assembled;

figure 4 is an exploded view of the releasing means of figure 3;

figures 5 to 8 show the successive steps of the operating connection in the aforementioned distal end of this releasing means with the prosthetic valve assembled thereon; and figures 9 to 13 show the steps following the release of the prosthetic valve through the aforementioned releasing 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 macroscopic movements closer to/further from the location of the surgical intervention. For this purpose, the macro-positioning arm 1 preferably has six degrees of freedom and an actuation which allows moving a manipulating arm 2 closer to/further from a patient to be operated on, in a desired manner.

As just mentioned, the manipulating arm 2 is connected to the macro-positioning arm 1 , of a flexible type, adapted to be 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 manipulating arm 2 is preferably in the form of a hollow stretchable tube, and defines its own main axis X of extension.

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

The manipulating 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 adapted to be inserted into the body of the patient to be operated on. The manipulating arm 2 provides housing for an introduction end or introducer 211 (shown alone in figure 2) designed for the connection with releasing means 4 of a prosthetic valve of known type, indicated in the figures with the reference V.

The introduction end 211 is composed of a hollow extensible tube 211a and preferably has at least one degree of freedom, that is a translation movement along its own axis X', between an extracted position from the distal end 21 and a retracted position, within the manipulating 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 to the extensible tube element and wound around it, which is constrained at one end thereof to a gear mechanism 211c or otherwise mechanically actuated; the other end of the spiral spring is constrained to the tube 211a and responds to the stress exerted by the gear mechanism on the opposite end with a thrust in the axial direction, determining the translation along the axis X’ of the introducer 211. Obviously other actuation systems of the introduction end can be provided. The introducer 211 also comprises means for activating the expansion of the valve V such as a DC motor 211 d and a second DC motor which supply a rotation movement of the valve, indicated in the figure with the reference number 211e.

The introduction end 211 provides releasing means 4 of the prosthetic valve V assembled thereto. Although different types of releasing means can be provided, one embodiment of releasing means for a known type of aortic prosthetic valve V is disclosed below, which does not require stitches. Obviously different types of prosthetic valves could be provided, equipping the robotic device according to the invention with suitable releasing means 4.

According to a known technique in the field, the valve V is assembled on the releasing means 4 in the collapsed condition, as shown in figure 3. This assembly is performed outside the robotic device, in preparation for the intervention.

With reference now particularly to figures 3 and 4, the releasing means 4 comprise a head end 41 and a sleeve end 42 operatively connected by translation means 43 comprising a screw element, i.e. an expansion screw 43 so as to be able to be moved closer to and/or further away from each other, according to a direction Y’ defined by the direction of longitudinal extension of the screw itself. This direction Y’ will correspond, in use, to the insertion direction Y of the valve V at 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, that is V1 and V2, respectively inlet and outlet, with reference to the direction of blood flow.

These internal abutment elements define an inner support core of the collapsed screw.

The head end 41 has a substantially conical or mushroom-like shape with a hollow central tubular shaft 410. The inlet portion V1 of the valve V inserts inside the stem. The end of the screw therefore also inserts inside the stem 410, forming a connection through an initiation indicated in the figures with the number 43c. The sleeve end 42 instead has a cup-like shape with an outer wall 42a and a hollow central tubular core 42b which engages with the screw 43. The outlet portion V2 of the valve is within the tubular sleeve, in the gap defined between the aforementioned outer wall 42a and the tubular core 42b.

The second abutment element 43b has a shaped end portion 43b’ with protruding radial indentations 430b which engage on respective seats formed on a perimetral ring 211a of the introduction end 211 , to improve the connection between the releasing means 3 and the end 211. To allow the sliding of the sleeve 42 with respect to the second abutment element 43b, respective channels 42a’ are formed on the outer wall 42a of the sleeve within which the aforementioned indentations run.

The rotation movement of the screw 43, controlled in the example illustrated by the DC motor 211 d, obtains the mutual distancing between the head and sleeve portions, freeing the annular portions of the valve V which then decompresses, expanding into the desired position, freeing itself from the engagement with the releasing means 4 and implanting itself in the desired implantation site.

A method for preparing and subsequently releasing the valve V will be described in the following with additional details.

The valve V is arranged on the releasing means 4, being reduced to the collapsed state thereon, with simultaneous locking of the head and sleeve portions on the annular portions, determining its locking in the collapsed position. With the valve thus assembled, the releasing means 4 is then dragged inside the body of the manipulating arm by the retraction movement of the introduction end 211 and the wings 210 are closed together around the collapsed valve V. The mushroom-shaped portion 411 of the head 41 remains protruding, engaging on an annular edge 210a defined by the upper edges of the stabilization wings 210; therefore this portion defines, in use, the head end of the distal end 21 of the manipulating arm 2.

The releasing movement of the valve V will thus follow the steps described below, with the support of figures 6 to 10. In detail, the releasing means 4 will be pushed in the direction X towards the outside of the manipulating arm 2, with the simultaneous disengagement of the head 41 from the circumferential edge 210a which releases the wings and allows their opening. The wings abut against the walls of the aorta and determine the consequent stabilization of the manipulating arm in the point in which the wings’ movement is interrupted. Once the manipulating arm is thus secured in position and the releasing means is external to it, the screw is activated to distance the head end 41 and the sleeve end 42 mutually along the direction Y. This mutual distancing determines the decompression of the 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 unfolding of valve anchoring structures, indicated with the reference V3, and the disengagement of the valve from the releasing means, with its simultaneous engagement on the desired implantation site.

Once the valve has been implanted, the releasing means are retracted inside the manipulating arm, with the simultaneous closure of the wings 210. At this point, the manipulating arm is driven out of the vessel, towards the outside of the patient's body.

It is clear that, since the release is carried out remotely with respect to the surgeon's position, a navigation system is required such as to allow the exact positioning of the manipulating arm and the introduction end 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 imaging means 50 and an electronic control unit (not shown). The system further comprises a control interface 51 on which said electronic control unit displays information and images collected by said imaging means. The control interface can also be connected in input to the electronic control unit to allow the user/surgeon/medical staff to enter information.

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

The imaging means comprise at least two cameras 50.

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

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

In a preferred arrangement, the cameras are circumferentially regularly spaced.

The navigation system is able to identify anatomic reference points, or target points, which serve as a reference for the positioning of the prosthetic valve.

The identification of the target points can be performed on the basis of an external command, that is, selected manually by the surgeon through the control interface 51 , which for this purpose provides a keyboard or a touch screen. Alternatively, the electronic control unit can be instructed to perform an automatic or semi-automatic detection of the target points on the basis of the images collected by the imaging 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 manipulating arm 2 and of the introduction end 211 according to the position and orientation of the introduction end 211 and of the imaging means 50 both reciprocally and with respect to the anatomic target points.

More in detail, given the releasing means 4, the electronic control unit is designed to calculate:

(i) the position and orientation of the anatomic target points with respect to the internal reference system defined by the imaging means;

(ii) the position and orientation of the introduction end 211 with respect to the imaging means 50;

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

With reference to point (iii), the electronic control unit is able to supply at the output information relating to the point of interruption of the movement of the manipulating arm 2 during the insertion of the prosthetic valve. In fact, as will be described in detail hereinafter, the release of the valve is improved with a simultaneous translation movement in a releasing direction Y improved by the aforementioned releasing means and due to the natural expansion movement of the valve; this translation movement must be considered in the calculation of the trajectory of approach of the arm 2 which therefore must be positioned at a suitable distance from the implantation site of the valve itself.

Again, the user interface allows visualizing this calculated trajectory and guide information, also exploiting for example augmented reality images, such as reconstructed views of the valve on real images taken by the cameras in real time.

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

Furthermore, external imaging means (not shown) can also be placed side by side with the internal imaging means 50, 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 possible that the navigation system, through the electronic control unit, automatically controls the macro-positioning arm 1 or the manipulating arm 2, based on the combined position information of the imaging means and the target points.

Driving means 6 are also provided with the purpose of allowing the manipulating arm to be controlled by the surgeon/user. In one embodiment, these driving means are materialized by a driving console 6 with a joystick 60. The driving console 6 also has a display 61 which allows the display of information related to the control of the robotic arm.

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

According to a further aspect of the invention, at the distal end 21 , the manipulating arm 2 has stabilization means or wings 210 movable between a locked position and an open position, where in said open position said stabilization means project laterally with respect to this distal end, that is, from said manipulating arm, while in the locked position the wing means 210 are such as to substantially not exceed the perimetral size of the distal end, that is of the manipulating arm. In the locked position, the stabilization means 210 occludes the distal end 21 and therefore prevents the extraction of the introduction end 211 (figure 8). On the contrary, in the open position the stabilization means allows freeing the distal end and allows the extraction of the introduction end 211 (figure 9).

The stabilization means 210 is in a locked position when the manipulating arm 2 is approaching the valve release point, while it is positioned in the open position when the manipulating arm 2 reaches the aforementioned desired point of movement interruption approaching the implant site, to allow the exit and then the release of the valve.

The stabilization means 210 is formed by wings or flaps which, in the open position, is arranged radially with respect to the axis of extension X, like the petals of a flower. When the wings 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. On the one hand, this interference allows the stabilization of the manipulating arm 2 and specifically the distal end 21 in position inside 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 arranged in an intermediate position between the wings 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 occur at the target points, or at 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 end 211.

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

loading the valve on the releasing means;

- operatively connecting the releasing means to the introduction end 211 ; retracting the introduction end 211 inside the distal end 21 ; arranging the stabilization means 210 in a locked position.

Again, as described above, the invention implements the following procedure for the control and guidance of the robotic device described above in a patient's vessel, comprising the steps of:

- identifying anatomic target points;

the acquisition of the anatomic target points identified by the electronic control unit;

driving the manipulating arm 2 in approach to the identified target points; interrupting the movement of the manipulating arm at an established stopping point;

positioning the stabilization means 210 in the open position; extracting the introduction end 211 from the distal end 21 ;

implementing the releasing means 4 for releasing the valve in the desired implant position;

- where the trajectory and the orientation of said manipulating arm 2 and said introduction end 211 are calculated by said control unit in real time according to the position and orientation of the introduction end 211 and the imaging means 50 both mutually and with respect to the anatomic target points.

The robotic device and the method according to the invention, succeed in obtaining the advantageous result of intervening with minimal and micro-invasive methods on the patient. In particular, the simulated imaging allows establishing, a priori, the target points for the valve release and the most effective path to take within the blood vessel with less risk for the patient. It is also possible to establish the best insertion point of the manipulating arm. The operation involves an incision of minimum dimensions on the patient’s chest (about 3-4 centimetres) and the cardiac functions can be stabilized with the aid of machines for extracorporeal circulation (or heart-lung machines). Moreover, thanks to the use of polymeric valves of current design, it is also possible, if necessary, to replace the existing human valve.

These results are clearly obtained thanks to the exceptional ability to control and guide the manipulating arm and the robotic device as a whole, thanks to the endoscopic imaging system described above. The wings 210 also greatly contribute to reducing the risks associated with the intervention, as on the one hand they allow stabilizing the position of the manipulating arm within the vessel, and on the other they prevent the collapse of the latter.

Furthermore, the navigation system in itself provides a number of surprising advantages, first and foremost the possibility of controlling the positioning of the valve starting from real-time arm positioning information and comparing it with recorded information such as, but not limited to, the location of the target points and the type of valve release. With particular reference to the location of the target points, this can also be refined in real time, using a feature tracking functionality.

Furthermore, the navigation system can use this information to calculate a trajectory that is suggested to the surgeon, to help guide the robot. If an automatic driving system is implemented, the trajectory calculated by the navigation system is used as the target path by the automatic driving system.

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

Therefore, the ability of the navigation system to guarantee the correct position of the arm and the synergistic interaction with the wings 210 which guarantee a stable positioning of the arm, allow the release of the valve in the desired position, also remotely.

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 relate to the same inventive nucleus, all falling within the scope of protection of the claims provided below.

References

[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

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 manipulating arm (2) adapted to be actuated 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 an introduction end (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 juts out from said distal end (21);

- releasing means (4) of said valve connected to said introduction end (211);

- said robotic device being characterized in that it further comprises an integrated navigation system (5) in turn comprising at least imaging means (50) located on said distal end (21) and an electronic control unit, said electronic control unit being at least instructed to calculate, according to the position and the orientation of said introduction end (211) and of said imaging means (50) with respect to anatomic target points, a trajectory of said manipulating arm for releasing said valve in a desired position; said robotic device being further characterized in that it comprises stabilization means (210) associated with said distal end (21) movable between a locked position and an open position, where in said open position said stabilization means project laterally with respect to said distal end, while in the locked position said stabilization means (210) are such as to substantially not exceed the perimetral size of the distal end, that is of the manipulating arm.

2. The robotic device according to claim 1 wherein said imaging means (50) comprise at least two cameras.

3. The robotic device according to claim 2 wherein said at least two cameras (50) are arranged circumferentially regularly spaced on the periphery of said distal end (21).

4. The robotic device according to any of the previous claims, wherein said electronic control unit identifies said anatomic target points.

5. The robotic device according to claim 4 wherein said identification is performed on the basis of an external input given by a user through a control interface (51).

6. The robotic device according to claim 4 wherein said identification is performed automatically by the navigation system.

7. The robotic device according to any of claims from 2 to 6 wherein said electronic control unit is instructed to match pairs of images obtained by said at least two cameras in order to obtain a stereoscopic view.

8. The robotic device according to claim 7, wherein said electronic control unit is instructed to overlap a simulated image to said transmitted images of said at least two cameras in order to obtain augmented reality images.

9. The robotic device according to any of the previous claims wherein said electronic control unit is operatively associated with driving means (6) of said device, in order to obtain an automatic driving of said motor unit and said actuation means on the basis of the calculated releasing trajectory.

10. The robotic device according to any of claims from 2 to 9 wherein said stabilization means (210) are designed to come into contact, in said open position, with walls of said blood vessel.

11. The robotic device according to claim 10, wherein said stabilization means comprise a plurality of wings (210) arranged radially on the perimeter of said distal end (21).

12. The robotic device according to claim 10 or 11 wherein said at least two cameras are arranged in an intermediate position between the wings (210) of said plurality.

13. The robotic device according to any of the previous claims wherein said releasing means (4) comprises a head end (41) and a sleeve end (42) which can be reciprocally approached or distanced according to an insertion direction (Y) of said valve by effect of translation means, to said reciprocal displacement movement corresponding to the releasing of said valve.

14. The robotic device according to claim 13 wherein said translation means comprises a screw element extending along said insertion direction.

15. The robotic device according to claim 14, wherein the retraction movement of said introduction end (211) within said distal end corresponds to the closing movement of said stabilization means, while the extraction movement of said end (211) externally to said distal end corresponds to the opening movement of said stabilization means.

16. The robotic device according to any of claims from 13 to 15 wherein said head end (41) is adapted to axially engage on a circumferential edge (210a) defined by said stabilization means (210) in said closed position.

17. Procedure 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 releasing means;

operatively connecting said releasing means to said introduction end (21 1);

retracting said introduction end (211) into said distal end (21); arranging said stabilization means (210) in a locked position.

18. Procedure for controlling and driving a robotic device suitable for releasing a prosthetic valve according to any of the claims from 1 to 16 in a patient's vessel, comprising the steps of:

identifying anatomic target points;

the acquisition of said anatomic target points by said electronic control unit;

driving said manipulator arm (2) in approach to the identified target points; interrupting the movement of said manipulating arm (2) at an established stopping point;

positioning said stabilization means (210) in the open position; extracting said distal end (21) of said introduction end (211); implementing the releasing means (4) for releasing said valve to the desired implant position;

- where the trajectory and the orientation of said manipulating arm (2) and said introduction end (211) are calculated by said control unit in real time according to the position and orientation of the introduction end (211) and the imaging means (50) both mutually and with respect to the anatomic target points.

19. The procedure according to claim 18 wherein said step of calculating said trajectory and orientation in real time is performed on the basis of the information issued by the following steps:

calculating the position and orientation of the anatomic target points with respect to said imaging means;

calculating the position and orientation of said introduction end (211) with respect to said imaging means (50).