WO2025186766A1

WO2025186766A1 - Prostate biopsy system

Info

Publication number: WO2025186766A1
Application number: PCT/IB2025/052442
Authority: WO
Inventors: Francesco BOVO; Paolo Fiorini
Original assignee: Needleye Robotics Srl
Current assignee: Needleye Robotics Srl
Priority date: 2024-03-08
Filing date: 2025-03-06
Publication date: 2025-09-12
Anticipated expiration: 2026-09-08
Also published as: WO2025186766A8

Abstract

A system (1) for prostate biopsy comprising: a cart (2) comprising a column (5) provided with a first axis (X1); a positioning arm (3) to which a prostate biopsy device (7), which is connected to the column (5), is coupable so that it rotates and/or translates with respect to the first axis (X1); and a graphical interface (4) which is connected to the column (5) so that it rotates and/or translates parallel to the first axis (X1). The system (1) is configured to be arranged between: a non-operational configuration and an operational configuration. The biopsy device (7) is connected to the positioning arm (3) by means of a connecting unit (11) comprising a control handle (12) which is grippable by the health care operator (M) to move the device (7). The control handle (12) comprises: a first actuating device (13A) which is configured to control the rotation of the positioning arm (3) with respect to the first axis (X1) and the radial displacement with respect to the first axis (X1); and a second actuating device (13B) which is configured to control the translation of the positioning arm (3) with respect to the first axis (X1).

Description

PROSTATE BIOPSY SYSTEM

Cross-Reference to Related Applications

This Patent Appl ication claims priority from Italian Patent Application No . 102024000005269 filed on March 8 , 2024 , the entire disclosure of which is incorporated herein by reference .

Technical Field

The present invention relates to a prostate biopsy system .

The present invention is advantageously applied to , but not limited to , the field of transperineal or transrectal biopsy .

Background

It is known to use a prostate biopsy system to collect samples of prostate tissues in a minimally invasive manner .

In particular, the prostate biopsy system of known type carries at least one sample-collection needle and allows a surgeon to perform multiple collections in a minimally invasive way by integrating a vision system, for example an ultrasound machine , with an intuitive biopsy needle handling system .

The prostate biopsy system typically comprises a positioning ( even manual ) system to which the biopsy needle is connected, and a console cart which is typically connected to the vision system . The console cart typically comprises a graphical viewing device ( such as , for example , a screen) to view the tissues of the patient and, in some cases , the path of the biopsy needle in the body of the patient , and an input interface ( such as , for example , a keyboard for entering the patient data and the report ) through which the surgeon can enter inputs to control the vision system, for example the ultrasound machine .

However, in known type systems , the viewing device is arranged in a non-ergonomic way, typically requiring the surgeon to rotate their torso or head to fully view what is shown on the viewing device . However, this posture is in contrast with the surgeon' s free motion during the operation itsel f . Moreover, the needle positioning system is typically physically separated from the console , requiring independent positioning of the console and the needle positioning system . Typically, known systems are composed of three separate elements : the needle positioning system (which can also be manual ) , the vision system, and the computer for storing patient data .

US2015366546A1 relates to a system and a method for real-time ultrasound-guided prostate biopsies .

US2009030339A1 relates to an apparatus and a method for the motori zed positioning of a needle .

The obj ect of the present invention is to provide a prostate biopsy system which is devoid of the above-described drawbacks and is easy and cost-ef fective to manufacture .

Summary

According to the present invention, a prostate biopsy system according to what claimed in the appended claims is provided .

The claims describe preferred embodiments of the present invention forming an integral part of the present description .

Brief Description of the Drawings

To better understand the present invention, an embodiment thereof is now described, by way of mere nonlimiting example , with reference to the accompanying drawings , wherein :

- Figure 1 is a schematic and perspective view of the prostate biopsy system manufactured according to the present invention, in an example of application;

- Figure 2 is a side schematic view of the application example of Figure 1 ;

Figure 3 is a ( top ) schematic plan view of the application example of Figures 1 and 2 ;

- Figure 4 is a schematic perspective view of the system of Figure 1 according to a possible embodiment ;

- Figure 5 is an enlarged schematic view of the system in Figure 4 ; and - Figure 6 is a further enlarged schematic view of the system of Figure 5 .

Description of Embodiments

In Figures 1-4 , reference number 1 generally indicates a prostate biopsy system . In particular, the system 1 is configured to allow a health care operator M ( in particular a surgeon) to col lect a prostate biopsy sample from a patient P, both schematically illustrated with a dotted line in Figures 1-3 .

The system 1 comprises a cart 2 , a positioning arm 3 and a graphical interface 4 .

The cart 2 comprises a column 5 provided with a distal end ED and a proximal end EP, which is opposite to the distal end ED . An axis XI is in particular vertical and extends longitudinally between the distal end ED and the proximal end EP of the column 5. The axis XI is a symmetrical axis of the column 5 .

A prostate biopsy device 7 (which can be of a known type and therefore is not described in detail ) is coupable ( or is coupled) at a free end 6 ( Figures 4 - 6 ) of the positioning arm 3 . The prostate biopsy device 7 is provided with an ultrasound probe 8 and a needle 9 . The positioning arm 3 is connected ( in particular through a peripheral body 14 described later ) to the column 5 , so that it rotates and/or translates with respect to the axis XI . Preferably, the positioning arm 3 comprises at least two arm portions and three joints 10 (in particular, a joint at the connecting area of the two arm portions 3 and one at each free end of the arm portions 3) .

According to one possible embodiment, the positioning arm 3 is a so-called passive arm, that is an arm without drives or braking devices at each joint 10 (i.e., articulation or junction) .

According to an alternative embodiment, the arm 3 comprises a braking device (in particular electric brakes) at the at least one joint 10 (in particular each joint 10) in order to block each portion of the positioning arm 3. The locking of each portion of the arm 3 can occur individually, and preferably independently. According to an alternative embodiment, the locking of each portion of arm 3 is synchronous (i.e. it occurs at the same time) , in particular via an actuating device 13A (described in detail below) .

According to a further alternative embodiment, the positioning arm 3 is a robotic arm, preferably a scara arm, which comprises at each joint 10 (i.e., articulation or junction) a servo drive configured to individually, and preferably independently, actuate or lock (and thus control) each portion of the positioning arm 3 so as to move the prostate biopsy device 7, particularly along the desired trajectory. In particular, in the embodiment in which the positioning arm 3 comprises two arm portions and three j oints 10 and thus three servo drives ( in particular, a servo drive in the j oint 10 within the area of the end 6 , a servo drive in the j oint 10 at the connection between the two portions and a servo drive in the j oint 10 at the area where it connects to column 5 ) .

The graphical interface 4 is in particular a display and is configured to graphically and instantly ( i . e . in real time ) reproduce intervention data ( in particular the input data and the output data ) .

In particular, input data means the input data entered into the system 1 for its proper operation and for carrying out the biopsy; while output data means the output data from the system 1 .

Preferably, the input data comprise at least one datum chosen from : name and surname of the patient P, age of the patient P, testing data, images obtained by magnetic resonance imaging (MRI ) , data relating to any previous biopsies .

While the output data preferably comprise at least one datum chosen from : images detected by the ultrasound probe 8 , results relating to the identi fication of the prostate in the MRI images , results relating to the identi fication of prostate lesions in the MRI images , data relating to the combination of the MRI images with the ultrasound probe images, position of the suspicious tissue samples, position of the needle entry points, needle entry trajectories, actual trajectories followed by the needle.

The graphical interface 4 is connected (in particular through the peripheral body 14 described later) to the column 5, so that it rotates and/or translates with respect to the axis XI .

The system 1 is configured to be arranged between: a non-operational configuration (not illustrated) , in which the ultrasound probe 8 is arranged distant from the patient P to be operated on, so that it cannot be inserted into a natural orifice of the patient P, and preferably the graphical interface 4 has any arrangement (i.e., not predetermined) with respect to the ultrasound probe 8; and an operational configuration (Figures 4 and 5) , in which the ultrasound probe 8 is arranged close to (i.e., at the opening of) , or in, the natural orifice of the patient P, and the graphical interface 4 is arranged transversely, in particular orthogonally, to the ultrasound probe 8, so that it is positioned in use above (in particular distant from) the patient P and between his legs. Therefore, in the operational configuration, the graphical interface 4 is arranged opposite to the health care operator M and between the legs of the patient P.

The prostate biopsy device 7 is of transperineal (in which the ultrasound probe 8 passes through the natural orifice, i.e., the rectum, of the patient P, while the needle 9 passes through an artificial orifice obtained in the perineum of the patient P) or transrectal type (in which both the ultrasound probe 8 and the needle 9 pass through the natural orifice, i.e., the rectum, of the patient P) .

According to the embodiment illustrated in the accompanying figures, the biopsy device 7 is connected to the positioning arm 3 at the free end 6 by a connecting unit

11 which is configured to releasably connect to the biopsy device 7.

As shown in Figure 5, which is an enlarged view of a part of Figure 4, the connecting unit 11 comprises a control handle

12 (shown in detail in the further enlargement of Figure 6) extending from an opposite side with respect to the ultrasound probe 8 of the prostate biopsy device 7. The control handle 12 is grippable (i.e., it is gripped) by the health care operator M in order to move the prostate biopsy device 7 so as to direct it during the biopsy operation.

As illustrated in Figure 5, which is a magnification of a part of Figure 4, the control handle 12 comprises two actuating devices 13A and 13B (which in particular are electronic devices, preferably buttons, as illustrated in Figures 5 and 6) . The two actuating devices 13A and 13B are arranged on the opposite sides of the handle so as to be ergonomic. The two actuating devices 13A and 13B can be (manually) actuated by the health care operator M independently of each other or both simultaneously by the respective finger.

The actuating device 13A is configured to control the rotation of the arm 3 with respect to the axis XI and the radial displacement with respect to the axis XI (i.e., along the column 5) . Therefore, when activated, the actuating device 13A (in particular, when pressed preferably using the ring finger and/or little finger of the health care operator M) is configured to enable the rotation of the arm 3 about the axis XI and the radial displacement with respect to the axis XI, so as to move the prostate biopsy device 7 (in particular, the space of motion is comprised in a horizontal plane) ; and when deactivated (in particular, not pressed by the health care operator M) it is configured to prevent rotation with respect to the axis XI and radial displacement with respect to the axis XI, so as to lock the position of the prostate biopsy device 7. In particular, if present, the actuating device 13A is configured to control each braking device or servo drive of the arm 3.

The actuating device 13B is configured to control the translation (upward or downward) of the arm 3 with respect to the axis XI (i.e., along the column 5) . Therefore, when activated (in particular, preferably pressed by the thumb of the health care operator M) , the actuating device 13B is configured to enable the translation (upward and downward) of the arm 3 with respect to the axis XI ( i . e . , along the column 5 ) so as to move the prostate biopsy device 7 ( in particular, the space of motion is comprised in a vertical plane ) ; and when deactivated ( in particular, not pressed by the health care operator M) it is configured to prevent the translation with respect to the axis XI ( i . e . , along the column 5 ) .

Advantageously, i f the devices 13A and 13B are simultaneously actuated by a respective finger of the health care operator M, the resulting motion is a linear combination of the two previously described motions .

Advantageously, but not limitedly, the positioning arm

3 and the graphical interface 4 translate in unison ( i . e . with the same stroke ) with respect to the axis XI . In particular, the positioning arm 3 and the graphical interface

4 translate together with respect to the axis XI . On the contrary, the rotation of the positioning arm 3 does not also imply a rotation of the graphical interface 4 with respect to the axis XI . In other words , the rotational motion of the positioning arm 3 with respect to the axis XI is independent of the rotational motion with respect to the axis XI of the graphical interface 4 .

Advantageously, but not limitedly, the cart 2 comprises a peripheral body 14 arranged at the proximal end EP of the column 5 . In particular, the peripheral body 14 has a substantially parallelepiped shape . As illustrated in the accompanying figures , the positioning arm 3 j uts out from a lower surface 15 of the peripheral body 14 ( in particular the j oint 10 of the arm 3 j uts out from the lower surface 15 ) ; whereas , the graphical interface 4 j uts out from an upper surface 16 of the peripheral body 14 which i s opposite the lower surface 15 .

Advantageously, but not limitedly, the cart 2 comprises a support table 17 connected to the peripheral body 14 . The support table 17 j uts out from a lateral surface 18 of the peripheral body 14 that is transverse , in particular orthogonal , to the lower surface 15 and the upper surface 16 of the peripheral body 14 . In particular, the support table 17 is connected to a connecting arm 19 which connects the support table 17 to the peripheral body 14 . In particular, the support table 17 is connected to the peripheral body 14 at the opposite side with respect to the side of the peripheral body 14 to which the graphical interface 4 is connected . The support table 17 is connected close to the same side of the peripheral body 14 as the positioning arm 3 .

Advantageously, but not limitedly, according to the illustrated embodiment , the positioning arm 3 is connected, in particular hinged, to the peripheral body 14 so that it rotates about an axis X2 , which is parallel to the axis XI ; and/or the graphical interface 4 is connected, in particular hinged, to the peripheral body 14 by a connecting arm 20 so that it rotates about an axis X3 , which is parallel to the axis XI ; and/or the support table 17 is connected, in particular hinged, to the peripheral body 14 so that it rotates about an axis X4 , which is parallel to the axis XI . In particular, the graphical interface 4 comprises the connecting arm 20 , and the table 17 comprises the connecting arm 19 .

Advantageously, but not limitedly, as illustrated in Figures 1-4 , the positioning arm 3 and the connecting arms 19 and 20 are configured to rotate about respective vertical and parallel axes X1 -X4 . In particular, the positioning arm 3 and the connecting arms 19 and 20 are articulated arms with multiple degrees of clearance . Therefore , there are more axes of rotation than the previously described axes XI- X4 .

Advantageously, but not limitedly, as illustrated in the accompanying figures , the cart 2 comprises at least one housing 21 . The housing 21 may be at least partially visible from the outside of the cart 2 ( as in the accompanying Figures 1-4 ) or it may be completely obtained within the body of the cart 2 and thus not visible from the outside . The housing 21 is configured to house an electronic control unit (not illustrated) , preferably a computer, configured to process data ( in particular input data to obtain output data ) and an input interface (not illustrated) , in particular a keyboard, through which at least a part of the input data is entered, and a vision system, typically an ultrasound machine . Preferably, the electronic control unit is also configured to store patient data and images provided by the vision system .

Advantageously, but not limitedly, the system 1 comprises a sterile isolation element (not illustrated) which partially covers at least the connecting unit 11 . In particular, the isolation element is configured to leave the ultrasound probe 8 and the needl e 9 uncovered and to cover the remaining part of the biopsy device 7 .

Advantageously, but not limitedly, the cart 2 is provided with a plurality of ( in particular four ) wheels 22 so that it can be easily moved and locked in the desired position .

In use , the health care operator M places the graphical interface 4 on the patient P and between his legs , and then places the biopsy device 7 via the actuation of the actuating devices 13A and 13B, which can be actuated by the health care operator M independently of each other or both simultaneously by the respective finger .

The system 1 described up to here has a plurality of advantages .

Firstly, the system 1 provides an ergonomic solution, as the graphical interface 4 is arranged, when in use , above the patient P and between his legs . Therefore , during the biopsy operation, the graphical interface 4 is in front of the health care operator M, thus facilitating the use of the system 1 . In other words , thanks to the arrangement of the graphical interface 4 , the system 1 allows for the accuracy of the biopsy to be improved, since the health care operator M can view the actual traj ectory of the needle 9 on the peripheral interface 4 , also having in the same visual field the biopsy device 7 to be guided .

Secondly, thanks to the handle 12 of the connecting unit 11 provided with the actuating devices 13A and 13B, the health care operator M can easily and readily move and lock the device 7 to carry out the prostate biopsy .

Thirdly, i f the system 1 comprises the connecting arm 3 made as a robotic arm, the precision and accuracy when moving the biopsy device 7 can be further increased, while still having a system with many degrees of clearance .

Furthermore , the system 1 has the advantage of being spatially compact .

Fourthly, the system 1 can also include the ultrasound machine in the housing 21 for collecting and viewing the patient data via the interface 4 , thus saving space in the clinic or operating room . Therefore , the system 1 is spatially less bulky . In addition, thanks to the actuating devices 13A and

13B made at the handle , the positioning arm 3 can be controlled by the health care operator M with a single hand . Finally, the system 1 can be advantageously used to perform the transperineal biopsy, either when the positioning arm 3 is a passive arm or an arm provided with at least a braking device or a robotic arm, pre ferably a scara arm . Whereas , the system 1 can be advantageously used to perform the transrectal biopsy in the case where the positioning arm 3 is a passive arm or an arm provided with at least a braking device .

Claims

1. A system (1) for prostate biopsy comprising: a cart (2) comprising a column (5) provided with a distal end (ED) and a proximal end (EP) , which is opposite to the distal end (ED) and a first axis (XI) , in particular vertical axis, extending longitudinally between the distal end (ED) and the proximal end (EP) ; a positioning arm (3) , in which at one of its free ends (6) a prostate biopsy device (7) provided with an ultrasound probe (8) and a needle (9) is coupable; the positioning arm (3) is connected to the column (5) so that it rotates and/or translates with respect to the first axis (XI) ; and a graphical interface (4) , in particular a display, configured to graphically and instantly reproduce intervention data, in particular input data and output data; the graphical interface (4) is connected to the column (5) so that it rotates and/or translates with respect to the first axis (XI) ; wherein, the system (1) is configured to be arranged between: a non-operational configuration, in which the ultrasound probe (8) is arranged distant from a patient to be operated on, so that it cannot be inserted into a natural orifice of the patient; and an operational configuration, in which the ultrasound probe (8) is arranged close to, or in, the natural orifice of the patient (P) , and the graphical interface (4) is arranged transversely, in particular orthogonally, to the ultrasound probe (8) , so that it is positioned in use above the patient and between his legs; wherein the biopsy device (7) is connected to the positioning arm (3) by a connecting unit (11) comprising a control handle (12) extending from an opposite side with respect to the ultrasound probe (8) of the prostate biopsy device (7) ; the control handle (12) is grippable by the health care operator (M) to move the prostate biopsy device (7) so as to direct it during the biopsy operation; the system (1) is characterized in that the control handle (12) comprises: a first actuating device (13A) which is configured to control the rotation of the positioning arm (3) with respect to the first axis (XI) and the radial displacement with respect to the first axis (XI) ; and a second actuating device (13B) which is configured to control the translation of the positioning arm (3) with respect to the first axis (XI) .

2. The system (1) according to claim 1, wherein the positioning arm (3) comprises at least two portions of the positioning arm (3) and three joints (10) ; and wherein: the positioning arm (3) is a passive arm that is devoid of drives or braking devices at each joint (10) ; or the positioning arm (3) comprises a braking device at least at one joint (10) for individually, and preferably independently, locking each portion of the positioning arm ( 3 ) ; or the positioning arm (3) is a robotic arm, preferably a scara arm, which comprises at each joint (10) a servo drive configured to individually, and preferably independently, actuate or lock each portion of the positioning arm (3) so as to move the prostate biopsy device (7) .

3. The system (1) according to claim 1 or 2, wherein the prostate biopsy device (7) is a device for transperineal or transrectal biopsy.

4. The system (1) according to any one of the preceding claims, wherein the prostate biopsy device (7) is releasably connected to the connecting unit (11) .

5. The system (1) according to any one of the preceding claims, wherein the cart (2) comprises a peripheral body (14) arranged at the proximal end (EP) of the column (5) ; and wherein the positioning arm (3) juts out from a lower surface (15) of the peripheral body (14) ; whereas, the graphical interface (4) juts out from an upper surface (16) of the peripheral body (14) that is opposite the lower surface ( 15) .

6. The system (1) according to claim 5, wherein the cart (2) comprises a support table (17) connected to the peripheral body (14) ; the support table (17) juts out from a lateral surface (18) of the peripheral body (14) that is transverse, in particular orthogonal, to the lower surface (15) and the upper surface (16) of the peripheral body (14) .

7. The system (1) according to claim 5 or 6, wherein: the positioning arm (3) is connected, in particular hinged, to the peripheral body (14) so that it rotates about a second axis (X2) , which is parallel to the first axis (XI) ; and/ or the graphical interface (4) is connected, in particular hinged, to the peripheral body (14) so that it rotates about a third axis (X3) , which is parallel to the first axis (XI) ; and/ or the support table (17) is connected, in particular hinged, to the peripheral body (14) so that it rotates about a fourth axis (X4) , which is parallel to the first axis (XI) .

8. The system (1) according to any one of the preceding claims, wherein the cart (2) comprises at least one housing (21) configured to house an electronic control unit, preferably a computer, configured to process data, and an input interface, in particular a keyboard, through which at least part of the input data is input, and a patient vision device, preferably an ultrasound machine.