Surgical device for transperineal biopsy (especially prostate) with a robotic movable arm

Abstract

A device for transperineal (especially prostate) biopsy with a movable arm of a robot, comprising: an ultrasound probe mounted around a first axis; a surgical instrument provided with a needle movable along a first trajectory; and a moving device for the surgical instrument, comprising at least a pair of arms facing each other and arranged along a first longitudinal axis around the ultrasound probe so as to move around the axis along a second trajectory, preferably oscillating, the second trajectory being different from the first trajectory, for guiding and supporting the needle at the free end of each guiding arm; and a connection interface connecting the device to the movable arm of the robot and having an operating module, the operating module comprising a plurality of actuators, each actuator moving the corresponding ultrasound probe or the guiding arm, and a separation module arranged on the operating module, the separation module being configured to transmit the movement to the ultrasound probe or the arm.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the priority benefit of Italian Patent Application No. 102019000002475, filed on February 20, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a surgical device for transperineal biopsy, especially of the prostate, with a robotic movable arm. Background Art

[0004] It is common practice to use robots for minimally invasive surgery. In particular, surgical robots such as those described in US2008004481, US2014039314, US2010056900 or US2015173727 carry one or more specific surgical instruments and allow surgeons to control surgical instruments by integrating high-definition 3D viewing systems and intuitive control systems to perform complex surgical operations in a minimally invasive manner. The surgical robot generally includes a surgical console, a patient-side cart and an observation cart. In particular, the patient-side cart is provided with a plurality of anthropomorphic arms, each of which is provided with a surgical instrument.

[0005] Surgical robots of the currently known type are only compatible and usable with surgical devices, such as devices for robotic biopsy, that have been specifically developed for and associated with a given surgical robot. It is therefore not possible to use surgical devices different from those developed for a given surgical robot, thereby limiting the range of surgical instruments available on the market and increasing their costs.

[0006] As a result, surgical equipment is very expensive and cannot be used with robots other than those for which it was developed. Summary of the invention

[0007] The object of the present invention is therefore to provide a surgical device for transperineal biopsy, in particular of the prostate, of a movable arm of a robot, which does not have the disadvantages of the prior art and which is easy and inexpensive to manufacture.

[0008] According to the present invention, there is provided a surgical device for transperineal (especially prostate) biopsy with a robotic movable arm as claimed in the accompanying claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The invention will now be described with reference to the accompanying drawings, which show non-limiting examples of embodiments of the invention, in which:

[0010] Figure 1 is a perspective view of a transperineal surgical device produced according to the present invention and connected to a connection interface;

[0011] Figure 2 is connected to Figure 1 A partially exploded view of a transperineal surgical device having a connection interface;

[0012] Figure 3 yes Figure 1 and Figure 2 A plan view of an operation module of a connection interface;

[0013] Figure 4 yes Figure 3 A cross-sectional view of the operating module along line IV-IV;

[0014] Figure 5 yes Figure 1 and Figure 2 A plan view of a separation module of a connection interface;

[0015] Figure 6 yes Figure 5 A cross-sectional view of the separation module along line VI-VI; and

[0016] Figure 7 yes Figure 1 and Figure 2 A perspective enlarged view of a portion of a transperineal surgical device from which components have been removed for greater clarity. DETAILED DESCRIPTION

[0017] exist Figure 1 and Figure 2 In the figure, the number 1 generally refers to a connection interface for connecting a surgical device to a movable arm of a commercial robot (not shown), in particular a commercial robot having a wrist of a robotic anthropomorphic arm. The connection interface 1 includes an operating module 2 and a separation module 3, and the separation module 3 is configured to be arranged on the operating module 2 when in use. The operating module 2 is Figure 3 and Figure 4 The separation module 3 is shown in more detail in Figure 5 and Figure 6 is shown in more detail in .

[0018] Advantageously, the separation module 3 provides a sterile separation between the operating module 2 and the surgical instrument. The separation module can thus be disposed of after use.

[0019] The surgical device is generally indicated by the number 4 and comprises a surgical instrument 5, at least one moving device 6 to move the surgical instrument 5 relative to a movable arm, and an intraoperative observation device 7, which is specifically an ultrasound probe 7. Figure 1 In the example shown, the surgical instrument 5 comprises an automatic extraction unit for soft tissue biopsy.

[0020] refer to Figure 3 and Figure 4 , the operating module 2 comprises a bottom wall 8 defined by a plate and having a plurality of through holes 11, each through hole 11 having a respective axis X. The operating module 2 further comprises one or more actuators 12, each actuator comprising an output shaft 13 mounted through a corresponding through hole 11 to rotate about the axis X. The axis X is substantially orthogonal to a plane parallel to the bottom wall 8. Each actuator 12 is configured to cause a certain movement of the surgical device 4 mounted on the connection interface 1.

[0021] The actuator 12 is not an actuator of the robot arm, but an actuator 12 connected to the interface 1 and is dedicated to the operation of the surgical device 4 .

[0022] Figure 1 and Figure 2 A surgical device 4 is shown purely by way of non-limiting example, which comprises in particular two mobile devices 6, each of which comprises two guide arms 14 which guide and support a surgical instrument 5, in particular a needle thereof. As shown, each guide arm 14 of the mobile device 6 and the ultrasound probe 7 are individually operated by a respective actuator 12. Furthermore, the actual positioning of each arm 14 is verified with the help of a respective position sensor 15 which acquires information transmitted by means of a cam tappet system 16, as will be better described below.

[0023] In this way, the angular position can be detected accurately and in particular the angular starting position, ie the zero position, of each guiding arm 14 can be set so that the corresponding actuator 12 can be controlled taking this information into account.

[0024] like Figure 3 and Figure 4 As shown, the output shaft 13 is provided with a motion transmission element 17, which is arranged on the opposite side of the bottom wall 8 with respect to the actuator 12. In other words, the bottom wall 8 separates the actuator 12 from the motion transmission element 17.

[0025] refer to Figure 2 According to a possible embodiment, the operating module 2 includes at least two side walls 18 .

[0026] Advantageously, the side walls 18 have an extension, along a direction parallel to the axis X, at least equal to the longitudinal dimension of the actuators 12 , so as to protect them from accidental lateral impacts.

[0027] According to a further embodiment, the side wall 18 has an extension that is lower than the longitudinal dimension of the actuator 12. In this case, the protection of the actuator 12 will be only partial.

[0028] Preferably, the side walls 18 face each other. The bottom wall 8 and the side walls 18 thus define a seat 19. The actuator 12 is accommodated in the seat 19, while the transmission element 17 is arranged on the opposite side of the bottom wall 8. In other words, the transmission element 17 is not arranged inside the seat 19.

[0029] According to the embodiment shown in the figure, in particular Figure 5 and Figure 6 In the embodiment, the separation module 3 includes a cup-shaped body 21, which includes a bottom wall 22 and a plurality of side walls 23 so as to be arranged on the operation module 2. In other words, the cup-shaped body 21 is configured to be accommodated inside the operation module 2, and in particular to be arranged or assembled on the operation module 2. Specifically, the bottom wall 22 has a plurality of through holes 24, and the cup-shaped body 21 is configured to accommodate the operation module 2, so that each through hole 24 is coaxial with a corresponding hole of the through hole 11 of the operation module 2. In other words, each through hole 24 is coaxial with the axis X of the corresponding through hole 11.

[0030] according to Figure 1 , 5 As shown in FIG. 6 , the side wall 23 is rigid and is preferably made integrally with the bottom wall 22 .

[0031] According to an alternative embodiment (not shown), at least a portion of the side wall 23 is made of a flexible element. The flexible element may comprise, for example, an element made of plastic, such as cellophane. The flexible element is preferably sterile. The flexible element is connected to the bottom wall 22. For example, the connection between the flexible element and the bottom wall 22 is provided by heat sealing.

[0032] The separation module 3 comprises a plurality of transmission members 25, each transmission member 25 being designed in use to transmit the movement from the respective actuator 12 to the surgical device 4. In particular, each transmission member 25 is configured to transmit the movement of the respective actuator 12 to the relatively movable device 6 of the surgical device 4.

[0033] In particular, each transfer member 25 is arranged to pass through a respective through hole 24 to transfer the motion from a respective motion transfer element 17 to a respective ultrasound probe 7 or guide arm 14 .

[0034] According to the preferred embodiment shown, each transmission member 25 comprises a shaft 26, at both ends of which are provided respective motion transmission elements 27 and 28. The shaft 26 is arranged parallel to, in particular coaxially with, the output shaft 13 of the actuator 12, i.e. the axis X. The motion transmission element 27 is connected in a kinematic manner to the respective motion transmission element 17, while the motion transmission element 28 is configured to transmit motion to the surgical device 4. In particular, the motion transmission element 28 can be connected in a kinematic manner to the mobile device 6 of the surgical device 4, as will be described in detail below.

[0035] according to Figure 1-6In the embodiment shown, each of the motion transmission elements 17, 27 and 28 comprises a gear, in particular a gear with face gear meshing. That is, the gear 17, 27 and 28 relative to a certain actuator 12 has respective teeth arranged along respective planes orthogonal to the axis X.

[0036] According to another different embodiment (not shown), each of the motion transmitting elements 17 , 27 and 28 comprises any element capable of being connected in a kinematic manner, preferably positively, such as a joint or a clutch.

[0037] According to another different embodiment (not shown), the elements 17 and 27 are of different types from the transmission element 28 and the corresponding transmission element of the surgical device 4. In other words, the motion transmission element 17 or 27 and the element 28 or the corresponding transmission element of the surgical device 4 (which are therefore not connected to each other in a kinematic manner) will be of different types from each other.

[0038] Obviously, in order to kinematically connect the motion transmission element 17 with the motion transmission element 27 and similarly connect the transmission element 28 with the corresponding motion transmission element of the surgical device 4 , they must be of the same type in order to allow the connection.

[0039] The second bottom wall 22 separates the motion transmitting element 27 from the motion transmitting element 28. In other words, the motion transmitting element 27 and the motion transmitting element 28 are arranged on opposite sides of the bottom wall 22.

[0040] according to Figure 6 As shown, in order to further ensure that no type of substance and / or fluid can be transferred from the separation module 3 to the surgical device 4 and vice versa, the separation module 3 comprises one or more sealing elements 31 , each of which is arranged at a respective through hole 24 .

[0041] Alternatively or additionally, such as Figure 4 As shown, the operating module 2 comprises one or more sealing elements 32 , each of which is arranged at a corresponding through-hole 11 .

[0042] According to one possible embodiment, the separation module 3 includes a support element 33 protruding from the bottom wall 22 of the cup-shaped body 21 to support the surgical device 4. Specifically, the support element 33 is arranged at the side edge of the bottom wall 22 of the cup-shaped body 21. The support element 33 consists of a protrusion arranged at the bottom wall 22. Each support element 33 has a pin 34A or 34B at its own free end, and the pin 34A or 34B is configured to engage the hole 35A or 35B. The hole 35A or 35B is basically a centering hole for the corresponding pin 34A or 34B.

[0043] It is advantageous to arrange the support element 33 on at least one side of the bottom wall 22 of the separation module 3. It is more advantageous to arrange the support element 33 on both sides of the bottom wall 22. Figure 6 The support element 33 arranged on the inner side of the bottom wall 22, i.e. inside the cup-shaped body 21, has a pin 34A, which is configured to engage a corresponding through hole or blind hole 35A arranged in the operating module 2. The hole 35A is preferably a blind hole to prevent substances and / or fluids from being able to pass from the operating module 2 to the surgical device 4 and vice versa.

[0044] Each support element 33 arranged on the outer side of the base wall 22 has a pin 34B configured to engage a corresponding through hole or blind hole 35B (not shown) provided in the base element 36 of the surgical device 4 .

[0045] The hole 35B is preferably a blind hole to prevent substances and / or fluids from being able to pass from the separation module 3 to the surgical device 4 and vice versa.

[0046] According to another embodiment not shown, the support element 33 is arranged on a base element 36 of the surgical device 4. According to this embodiment, the hole 35B is arranged at the base wall 22. The hole 35B is preferably a blind hole. This embodiment allows improved cleaning of the surgical device 4.

[0047] According to one possible embodiment, the separation module 3 comprises an abutment edge 37 at the side wall 23. The abutment edge 37 engages with one or more side portions 38 of the base element 19 of the surgical device 4 in use.

[0048] In order to ensure the correct fixation of the surgical device 4 and the connection interface 1, at least one fixing device 41 is provided. Figure 1 and 2 shown.

[0049] according to Figure 1 and Figure 2 In the embodiment shown, the fixing means 41 are arranged on the base element 36 of the surgical instrument 4 , in particular on at least one of the sides 38 , in order to connect it to the separation module 3 or to the operating module 2 .

[0050] The fixing device 41 comprises a spring rod. In particular, the spring rod comprises a rod 42 hinged on the side 38 of the surgical device 4. The rod 42 is configured to move between a closed position and an open position. In the closed position, the free end of the rod 42 is connected to an adjacent element 43 obtained on the relevant side wall 23 of the cup-shaped body 21 (for example, if the side wall 23 is rigid) or to an adjacent element 43 obtained on the relevant side wall 18 of the operating module 2 (for example, if the side wall 23 comprises a flexible element). In this way, the surgical device 4 can be blocked on the connection interface 1. In the open position, the free end of the rod 42 is separated from the adjacent element 43, thereby allowing the surgical device 4 to be released from the connection interface 1.

[0051] According to an alternative embodiment (not shown), the fixing means 41 are arranged on at least two side walls 23 of the cup-shaped body 21 (for example, if the side walls 23 are rigid), preferably facing each other, or on two side walls 18 of the operating module 2, preferably facing each other (for example, if the side walls 23 include flexible elements). In other words, the corresponding lever 42 is hinged on the side wall 23 of the cup-shaped body 21 (if the side wall 23 is rigid) or on the side wall 18 of the operating module 2 (if the side wall 23 includes an elastic element). The corresponding abutment element 43 is obtained in one of the sides 38 of the base element 38 of the surgical device 4.

[0052] In a preferred embodiment, the side wall 23 comprises a flexible element and the surgical device 4 is connected to the operating module 2, keeping the separation module 3 inserted between them. Thus, according to this embodiment, corresponding abutment elements 43 are obtained at the side wall 18 of the operating module 2.

[0053] Advantageously, the fixing device 41 comprises a sensor (not shown) designed to detect the correct closing of the fixing device 41, in particular the correct closing of the rod 42. If the fixing device 41 is not closed correctly or is opened unintentionally during use, the sensor sends a signal to warn the operator of the incorrect closing of the fixing device 41.

[0054] refer to Figure 3 and Figure 4 The bottom wall 8 further comprises at least one or more through holes 44, which are configured to at least partially accommodate the Figure 4 The position sensor 15 is shown.

[0055] More preferably, the through hole 44 is arranged at the center line 45 of the bottom wall 8. The center line 45 refers to the central area of ​​the bottom wall 8 along its longitudinal extension. Specifically, the center line 45 is basically arranged at Figure 3 Preferably, there are more than two through holes 44.

[0056] refer to Figure 5 and Figure 6 , the bottom wall 22 includes one or more through holes 46. The through holes 46 are preferably formed at the center line 47 of the bottom wall 22. The center line 47 refers to the central area of ​​the bottom wall 22 along its longitudinal extension.

[0057] Specifically, the center line 47 is substantially arranged at Figure 5 Preferably, there are more than two through holes 46. The cup-shaped body 21 is configured to receive the operating module 2 so that each through hole 44 is aligned with the corresponding through hole 46, ie, coaxial.

[0058] Advantageously, a sealing element 48, for example consisting of a membrane, is arranged at each through hole 46. The sealing element 48 prevents any substance and / or fluid from being transferred from the operating module 2 to the surgical instrument 4 and vice versa. Furthermore, the flexible sealing element 48 allows the movement of the cam tappet system 16 to be transferred to the position sensor 15 in a precise manner, while maintaining the separation between the elements, in particular the interacting tappets and the position sensor 15.

[0059] like Figure 5 and Figure 6 As shown, the bottom wall 22 has a lower area at the center line 47. At the lower area, the thickness of the bottom wall 22 is preferably equal to the other areas of the bottom wall 22. In other words, the bottom wall 22 has a constant thickness along the entire extension.

[0060] The connection interface 1 thus obtained is suitable for being connected to and carried by a movable arm of a robot. In particular, the bottom wall 8 and the side walls 18 of the operating module 2 form a frame that can be carried by a movable arm of a robot.

[0061] According to a possible alternative, a connection body (not shown) is inserted between the connection interface 1 and the movable arm of the robot. In said case, the connection body acts as an adapter for the connection of the connection interface 1 and the movable arm of the robot.

[0062] The actuators 12 may be connected to a control unit (not shown) of the robot via wires (not shown) carried by the movable arm and may be controlled independently of each other by the control unit depending on the specific use of the surgical device 4. The control unit may belong to the robot or may be an external control unit.

[0063] In use, the separation module 3 and the operating module 2 overlap each other, so that the operating module 2 is arranged in the cup-shaped body 21 of the separation module 3. During the connection of the two modules 2 and 3, the elements 17 and 27 cooperate with each other to ensure the transmission of movement. The transmission is preferably synchronous. The surgical device 4 is arranged on the connection interface 1 and fixed to the connection interface 1 by the fixing device 41.

[0064] The surgical device 4 is a transperineal biopsy device, which includes an ultrasound probe 7 , a surgical instrument 5 and a moving device 6 for the surgical instrument 5 .

[0065] The ultrasound probe 7 is configured to be inserted in use into a natural orifice of a patient, such as the rectum. The ultrasound probe 7 is mounted for rotation about an axis Y (transverse, in particular orthogonal to the axis X) and is rotated by a motion transfer member 51 operated by a respective actuator 12 .

[0066] The surgical instrument 5 comprises a sampling unit 52 arranged above the ultrasound probe 7. The sampling unit 52 is designed to perform a biopsy. That is, the sampling unit 52 is provided with a needle 53, which removes matter, soft tissue or other from the patient. Preferably, the sampling unit 52 is a so-called biopsy gun, a guillotine biopsy device or any device suitable for removing matter.

[0067] like Figure 1 and Figure 2 As shown, the needle 53 can be moved along a trajectory TA to place the needle 53 at a given and precise position in the patient's body, which is spaced apart from the patient's natural orifice. As explained in further detail below, the needle 53 is guided and supported by the guide arm 14 of the mobile device 6.

[0068] Preferably, the moving device 6 comprises at least one pair of guiding arms 14 , wherein each arm 14 is arranged at opposite sides around the axis Y. In particular, the two arms 14 are arranged consecutively around the axis Y, but at two different opposite sides.

[0069] Advantageously, the moving device 6 comprises two pairs of guide arms 14 arranged in series around the axis Y, which are respectively movable along a trajectory TE.

[0070] Each arm 14 is operated by its own actuator 12 and is mounted movably, preferably oscillating along a trajectory TE about an axis Y. The arm 14 moving on the trajectory TE guides and supports the needle 53 .

[0071] from Figure 1 and Figure 2 It can be seen that the guide arm 14 guides and supports the needle 39 along the trajectory TA at its free end 54. The free end 54 comprises a guide portion which supports and guides the needle 39 so that it covers the trajectory TA. The trajectory TA covered by the needle 53 is different from the trajectory TE covered by each arm 14.

[0072] exist Figure 7 , a possible embodiment of a surgical device 4 is shown, which includes a member 51 for transmitting motion from a connection interface 1 to a surgical device 4 for transperineal biopsy. The motion transmitting member 51 includes a motion transmitting element 56. The motion is transmitted from the separation module 3 to the surgical device 4 for transperineal biopsy through the dynamic connection between the motion transmitting element 28 of the separation module 3 and the corresponding motion transmitting element 56 of the surgical device 4 for transperineal biopsy. Specifically, the motion is transmitted by a plurality of motion transmitting elements 28 connected to the corresponding motion transmitting elements 56 in a dynamic manner. Each motion transmitting element 56 is mounted on a corresponding shaft 57. The motion transmitting element 56 is arranged between the motion transmitting member 25 and the motion transmitting elements 61, 62.

[0073] according to Figure 7 In the embodiment shown, the motion transmitting element 56 comprises a gear with face gear meshing, which preferably rotates about an axis parallel to the axis X, ie the gear 56 has respective teeth arranged along respective planes orthogonal to the axis about which the gear 56 rotates.

[0074] According to another different embodiment (not shown), the motion transmission element 56 comprises any element that can be connected in a kinematic manner, preferably at the front, such as a joint or a clutch. Obviously, in order for the motion transmission element 56 to be connected in a kinematic manner with the motion transmission element 28 of the connection interface 1, they must be of the same type in order to be able to achieve the connection.

[0075] from Figure 7 , the shaft 57 is configured to pass through a through hole 58 provided at the base member 36. At the opposite end of the shaft 57, a motion transmission element 61 or 62 is configured, depending on whether the ultrasound probe 7 or the guide arm 14 of the mobile device 6 must be operated. In other words, the shaft 57 for operating the ultrasound probe 7 includes the motion transmission element 61 at its own end, while the shaft 57 for operating the guide arm 14 of the mobile device 6 includes the motion transmission element 62 at its own end.

[0076] The motion transmission element 61 is configured to be connected to the motion transmission element 63 integrally connected to the ultrasonic probe 7 in a dynamic manner to transmit the motion from the corresponding transmission member 25 to the ultrasonic probe 7 to rotate it. Specifically, the ultrasonic probe 7 and the motion transmission element 63 are arranged with the hollow shaft 64, that is, installed as one body. The motion transmission element 63 is arranged around the hollow shaft 64, and the ultrasonic probe 7 is arranged inside the hollow shaft 64. The hollow shaft 64 is preferably supported at one end thereof by at least one support bracket 65 fixed to the base element 36.

[0077] The motion transfer element 62 is configured to be connected in a dynamic manner with a motion transfer element 66, which is integrally connected to the cam tappet system 16 to transfer motion from the corresponding transfer member 25 to the corresponding arm 14, thereby causing the corresponding arm 14 to move along the trajectory TE. Specifically, the motion transfer element 66 rotates the cam 16A to which the corresponding arm 14 is connected. The connection between the cam 16A and the guide arm 14 can be provided by a threaded connection.

[0078] In particular, each guide arm 14 is carried on one side by its own cam 16A and on the opposite side by a support element 67. By moving, the cam 16A translates the tappet 16B upwards or downwards, thus transmitting the angular position of the cam 16A to the position sensor 15. In this way, it is possible to accurately detect the angular position and in particular to set the starting angular position, i.e. the zero position, of each guide arm 14, thus commanding the actuator 12 taking into account said information.

[0079] The elements 66 , 67 and 16A associated with each arm 14 are arranged on a hollow shaft 68 coaxial with the Y axis.

[0080] The motion transmission element 66, the cam 16A and the support 67 of each arm 14 are arranged on the hollow shaft 68 so that they can rotate freely on the hollow shaft 68. The shaft 68 is hollow so that the ultrasound probe 7 can be arranged inside it. The ultrasound probe 7 is not connected to the hollow shaft 68 and therefore does not affect the rotation of the hollow shaft 68. Therefore, there is no dynamic interaction between the ultrasound probe 7 and each arm 14. The hollow shaft 68 is supported at its own end by a support bracket (not shown). The support bracket of the hollow shaft 68 is basically similar to the support bracket 65 of the hollow shaft 64.

[0081] according to Figure 7 In the illustrated embodiment, the motion transfer elements 61 and 63 respectively include gears, preferably bevel gears. Gear 61 rotates around a vertical axis parallel to axis X. Specifically, when the transperineal biopsy surgical device 4 is connected to the connection interface 1, the vertical axis is coaxial with axis X. On the other hand, gear 63 rotates around axis Y. According to the present embodiment, the motion transfer elements 62 and 66 respectively include a worm screw and a cylindrical wheel. Worm screw 62 rotates around a vertical axis parallel to axis X. Specifically, when the transperineal biopsy surgical device 4 is connected to the connection interface 1, the vertical axis is coaxial with axis X. On the other hand, gear 66 rotates around axis Y.

[0082] Therefore, the kinetic chain that transmits the motion from the actuator 12 to the ultrasound probe 7 comprises the motion transmitting elements 17 , 27 , 28 , 56 , 61 and 63 .

[0083] The kinematic chain that transmits the motion from the actuator 12 to the respective arm 14 comprises the motion transmitting elements 17 , 27 , 28 , 56 , 62 and 66 .

[0084] from Figure 1 , 2As can be seen from Figure 7, the arm 14 mainly has a longitudinal extension and is arranged so that its own extension is substantially transverse to the axis Y. Preferably, the shape of the arm 14 is similar to a curve. Specifically, as shown in the figure, the arm 14 has a substantially rectangular cross-section that decreases toward the free end, that is, the arm 14 has a cross-section of a larger size than the free end 54 at the end connected to the cam 16A and the support 67. A guide portion 71 is arranged at the free end. The guide portion 71 includes a cylindrical portion arranged substantially tangentially to the cross-section. The guide portion 71 includes a ball joint, which defines a through hole 72 in its interior, and the needle 53 is arranged through the through hole 72. The through holes 72 of the two adjacent arms of the cooperation are arranged facing each other, preferably making them substantially coaxial. It can be clearly seen from the figure that the through hole 72 is substantially transverse relative to the longitudinal extension of the arm 14. The needle 53 is then directed and / or oriented along the trajectory TA by moving along the trajectory TE of each arm 14.

[0085] According to an alternative embodiment not shown, the guide portion 71 of each arm 14 has a "V", "U" or "C" shaped seat, with a substantially transverse longitudinal extension and open transversely. The seats of each arm 14 of the same pair of arms 14 are substantially coaxial with each other.

[0086] Each mobile device 6 comprises a pair of arms 14. As previously mentioned, the two arms 14 are arranged on opposite sides of each other around the axis Y. Therefore, each arm 14 moves along its own trajectory TE. The trajectories TE of a pair of arms 14 are substantially parallel to each other and travel in opposite directions. In other words, since the through hole 72 or the seat must remain facing each other, if an arm 14 approaches or moves away from the other arm 14, the latter must follow it to ensure the guidance and support of the needle 53. The same pair of guiding arms 14 preferably moves simultaneously, that is, in a synchronized manner, but in opposite directions. The trajectory TE is at least partially curved, thereby changing the inclination and / or trajectory TA of the needle 53. In this way, the radial movement and / or the inclination of the needle 53 along the trajectory TA can be fine-tuned.

[0087] Advantageously, the surgical device 4 for transperineal biopsy comprises a plurality of pairs of guiding arms 14 .

[0088] In this way, the needle 53 can be acted upon at multiple points, improving the accuracy with which the needle 53 covers the trajectory TA.

[0089] According to a possible embodiment, the device 34 comprises a perforated grid (not shown) used as a viewfinder for the needle 53. The perforated grid is optional. The perforated grid has a plurality of orderly and equidistantly distributed through holes. The perforated grid is optional.

[0090] like Figure 1 and Figure 2 As shown, the surgical device 4 includes a handle 74 .

[0091] In use, the ultrasound probe 7 is inserted into the patient's natural orifice and the actuator 12 connected to a control unit (not shown) is controlled thereby so as to move the ultrasound probe 7 and each arm 14 in a desired manner. By moving the ultrasound probe 7, the angular position of the ultrasound probe 7 can be detected and the organ and the surrounding tissue can be immediately seen. By moving the arms 14 along their trajectory TE, the needle 53 can be guided along the trajectory TA. Taking into account the image mapping obtained in the preoperative stage, such as radiographic imaging or obtained by magnetic resonance, and comparing them with the current image obtained during the operation by the ultrasound probe 7, the trajectory TA is established. In this way, the biopsy target can also be established taking into account the deformation of the organ caused by contact with the ultrasound probe 7. The trajectory TA can therefore be corrected according to the deformation of the organ in contact with the ultrasound probe 7.

[0092] The surgical device 4 for transperineal biopsy described thus far has several advantages.

[0093] The main advantage is that it can be mounted on any commercial robot via the connection interface 1. Therefore, the surgical device 4 is cheaper than any other device specifically made for a precise and given model of medical robot.

[0094] By means of the arms 14, an instant correction of the trajectory TA of the needle 53 can be obtained as a function of the angular position of the ultrasound probe 7. In fact, by acting on the trajectory TE of each arm 14, the trajectory TA of the needle 53 can be influenced.

[0095] Furthermore, the surgical device 4 is advantageous in that the needle 53 is not manually inserted into the patient's body, but is inserted by means of a mobile device 6 that orients and tilts the needle 53 according to an intraoperative image acquired by an ultrasound probe 7. Also taking into account deformation of an organ in contact with the ultrasound probe 7, the surgical device 4 for transperineal biopsy actually allows for instant correlation between preoperative images and intraoperative images.

Claims

1. A device (4) for transperineal biopsy with a robotic movable arm, the device (4) comprising: an ultrasound probe (7) mounted for rotation about a first axis (Y) and configured to be inserted into a natural orifice of a patient in use; A surgical instrument (5) provided with a needle (53) movable along a first trajectory (TA) and configured to be inserted at a distance from the natural orifice during use; a moving device (6) of the surgical instrument (5), comprising at least one pair of guiding arms (14) facing each other and arranged around the first axis (Y) so as to move around the first axis (Y) along a second trajectory (TE) different from the first trajectory (TA), in order to guide and support the needle (53) at the free end (54) of each guiding arm (14); and A connection interface (1) designed to be connected to the movable arm of the robot and comprising an operating module (2) and a separation module (3), wherein the operating module (2) comprises a plurality of actuators (12), each actuator (12) moving a corresponding ultrasonic probe (7) or the guide arm (14), and the separation module (3) comprises a cup-shaped body (21) arranged on the operating module (2); The operating module (2) comprises a first bottom wall (8) having a plurality of first through holes (11), the plurality of first through holes (11) having respective second axes (X) substantially intersecting the first axis (Y); each actuator (12) comprises a first output shaft (13), the first output shaft (13) being provided with a first motion transmission element (17) and being mounted through the respective first through hole (11), wherein the first motion transmission element (17) is arranged on the opposite side of the first bottom wall (8) relative to the actuator (12); the cup-shaped body (21) comprises a second bottom wall (22) having a plurality of second through holes (24), each of the second through holes (24) being coaxial with the respective first through hole (11), and the separation module (3) comprises a plurality of transmission members (25), each of the transmission members (25) being arranged through the respective second through hole (24) to transmit motion from the respective first motion transmission element (17) to the respective ultrasound probe (7) or the guide arm (14); Wherein, the device (4) comprises a plurality of pairs of guide arms (14); each pair of guide arms (14) is arranged continuously along the first axis (Y); Wherein, the device (4) further comprises: a second motion transmission element (61) and a third motion transmission element (63), the second motion transmission element (61) being rotatable about the respective second axis (X) and the third motion transmission element (63) being rotatable about the first axis (Y), and the second motion transmission element (61) and the third motion transmission element (63) being kinematically connected to each other to transmit the motion from the respective transmission member (25) to the ultrasound probe (7); and a fourth motion transfer element (62) and a fifth motion transfer element (66, 16A), the fourth motion transfer element (62) being rotatable about the respective second axis (X) and the fifth motion transfer element (66, 16A) being rotatable about the first axis (Y), and the fourth motion transfer element (62) and the fifth motion transfer element (66, 16A) being kinematically connected to each other to transfer the motion from the respective transfer member (25) to the corresponding guide arm (14); wherein the second motion transmitting element (61) comprises a first gear (61); The third motion transmission element (63) comprises a second gear (63) mounted on a third hollow shaft (64) coaxial with the first axis (Y), and the ultrasonic probe (7) is integrally mounted in the third hollow shaft (64); The fourth motion transmitting element (62) includes a third gear (62); The fifth motion transmitting element (66, 16A) comprises a fourth wheel (66) mounted on a fourth hollow shaft (68), to which a cam (16A) is integrally mounted, causing the movement of the corresponding guide arm (14) connected thereto; wherein a cam (16A) acting on a tappet (16B) transmits the angular position of the cam (16A), which is also the angular position of the arm (14), to a position sensor (15); Each guide arm (14) is provided with a first through hole (11) or a seat at the free end (54), and the needle (53) extends through the first through hole (11) or the seat; and the first through holes (11) or the seats of a pair of arms (14) facing each other are coaxial.

2. The device (4) according to claim 1, comprising: The sixth motion transfer element (56) is arranged at the opposite end of the second shaft (57), and the corresponding second motion transfer element (61) or the fourth motion transfer element (62) is arranged on the second shaft (57); the sixth motion transfer element (56) is arranged between the transfer member (25) and the second or fourth motion transfer element (61, 62).

3. The device (4) according to claim 2, wherein the first motion-transmitting element (17) and the sixth motion-transmitting element (56) comprise gear wheels (17, 56); and The transmission member (25) comprises two gears (27, 28).

4. Device (4) according to claim 1, the guide arm (14) having a cross-section that decreases along the free end (54) and being arranged continuously along the first axis (Y) and having a longitudinal extension that intersects the first axis (Y).

5. Device (4) according to claim 1, wherein the second track (TE) covered by each arm (14) is at least partially curved.

6. Device (4) according to claim 2, comprising a base element (36) provided with a plurality of third through holes (58) through which the second shaft (57) is arranged.

7. The device (4) according to claim 1 comprises fixing means (41) to block a base element (36), the base element (36) being configured to engage an adjacent element (43) obtained on a wall (23, 18) of the separation module (3) or the operating module (2) to separate the base element (36) from the corresponding separation module (3) or the operating module (2).

8. The device (4) according to claim 1, the separation module (3) comprising a supporting element (33) protruding from the second bottom wall (22) of the cup-shaped body (21).

9. According to the device (4) according to claim 1, the first bottom wall (8) has at least one fourth through hole (44), which is formed at the first center line (45) of the first bottom wall (8), and the second bottom wall (22) has at least one fifth through hole (46), which is formed at the second center line (47) of the second bottom wall (22); the cup-shaped body (21) is configured to be arranged on the operating module (2) so that the fifth through hole (46) is aligned with the fourth through hole (44).

10. The device according to claim 1, wherein the first bottom wall (8) has at least one fourth through hole (44), the fourth through hole (44) is formed at the first center line (45) of the first bottom wall (8), and the second bottom wall (22) has at least one fifth through hole (46), formed at the second center line (47) of the second bottom wall (22); the cup-shaped body (21) is configured to be arranged on the operating module (2) so that the fifth through hole (46) is aligned with the fourth through hole (44); the position sensor (15) is arranged in the fourth through hole (44); the sealing element (48) is arranged in the fifth through hole (46); and the cam (16A) and the push rod (16B) are respectively arranged on opposite sides of the sealing element (48).

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