WO2025057025A1

WO2025057025A1 - Vision system for robotic surgery

Info

Publication number: WO2025057025A1
Application number: PCT/IB2024/058638
Authority: WO
Inventors: Antonello FORGIONE; Renzo ZALTIERI; Davide ORTENZI
Original assignee: VALUEBIOTECH Srl
Current assignee: VALUEBIOTECH Srl
Priority date: 2023-09-11
Filing date: 2024-09-05
Publication date: 2025-03-20
Anticipated expiration: 2026-03-11

Abstract

A vision system for robotic surgery is described, comprising a robotic arm (10), a vision device (12), such as a camera, mounted at a distal end (10a) of the robotic arm (10), a central electronic control unit (16) configured to allow an operator during surgery to appropriately move the vision device (12), via the robotic arm (10), within the body of the patient on whom surgery is being performed, and a cover element (14) releasably connected to the distal end (10a) of the robotic arm (10) via a mechanical coupling system (42, 44) and arranged around the vision device (12) so as to protect the patient during surgery from contamination by the vision device (12). After surgery, the cover element (14) can be disassembled from the robotic arm (10) and then be disposed of and replaced with a new cover element or be sterilized before being reused. The need for sterilization of the vision device (12) after surgery is thus avoided.

Description

VISION SYSTEM FOR ROBOTIC SURGERY

Technical field of the invention

The present invention relates generally to a vision system for robotic surgery, particularly (though not exclusively) minimally invasive robotic surgery. More specifically, the present invention relates to a vision system comprising a robotic arm and a vision device, such as a camera or video camera, mounted at a free end of the robotic arm so that it can be positioned at a given location and with a given spatial orientation within the body of the patient on whom surgery is being performed, by appropriate movements of the robotic arm controlled by an electronic control unit based on commands given by an operator.

State of the art

As is well known, minimally invasive surgery is a surgical technique that involves the use of miniaturized surgical instruments and vision devices (particularly cameras) introduced into the patient through small incisions. Since, unlike traditional surgery, the surgeon does not have a direct view of the region to be operated on, but rather an indirect view, through the camera(s) introduced into the patient's body, it is very important that the cameras provide the surgeon with a perfect view of the tissues and/or organs on which the surgeon is to operate. High- definition cameras are therefore used, as well as high-definition screens on which the images captured by the camera(s) during surgery are displayed.

In the case where minimally invasive surgery is performed by use of robotic surgical systems, the cameras are mounted on robotic arms that are controlled during surgery from the outside by the operator (who may be, for example, the same surgeon who is performing the surgery or an assistant surgeon), for example by means of joysticks or other control members/devices, in order to position the cameras at the desired location and with the desired orientation in order to ensure optimal vision within the region of the patient's body where the surgery is being performed. The commands given by the operator, for example through a joystick, are transmitted to an electronic control unit that manages the movement of the robotic arm, in particular the rotation of the various joints of the arm, according to the operator's commands. Like the surgical instruments used during surgery, the cameras that have been introduced into the patient's body must also be properly sterilized after surgery before they can be used for a new operation. Sterilization is

RECTIFIED SHEET (RULE 91) ISA/EP a time-consuming procedure (typically 3 to 20 hours for ethylene oxide sterilization), during which the cameras are obviously not available for a new operation. In addition, if the camera is not perfectly sterilized, there is a risk that during the next operation it may contaminate the surgical field or, more generally, the body of the patient on whom the next operation is to be performed.

A vision system for robotic surgery, in particular for minimally invasive robotic surgery, comprising a robotic arm and a vision device mounted at a distal end of the robotic arm is known, for example, from US 2021/0378497. Also in this case the entire vision device has to be sterilized after its use. Specifically, the vision device known from this document is properly configured to be sterilized in an autoclave in accordance with standard procedures involving a treatment at a temperature of 134°C and a pressure of 2 atmospheres. More specifically, in order to prevent damage to the vision device during sterilization in an autoclave, the vision device comprises a pair of casings, that is to say, an outer casing and an inner casing, respectively, that are arranged around each other and are securely attached one to the distal end of the end joint of the robotic arm and the other to a base element of the vision device so as to seal the vision device tightly.

Summary of the invention

It is therefore an object of the present invention to provide a vision system for robotic surgery, in particular for minimally invasive robotic surgery, that is not affected by the aforementioned drawbacks of the prior art.

More specifically, the present invention aims to provide a vision system that allows to dispense with sterilization after surgery, and is hence available very quickly for a new operation, and that avoids the risk of contamination of the surgical field into which the vision device is inserted during surgery.

These and other objects are achieved according to the invention by a vision system as defined in the attached independent claim 1 .

Additional advantageous aspects of the vision system according to the invention are defined in the dependent claims, the subject-matter of which is to be intended as forming an integral part of the following description.

In summary, the present invention is based on the idea of mounting around the vision device a cover element, sterile or sterilizable, so as to seal the space around the vision device, and to provide the cover element and the distal end of the robotic arm with respective coupling means configured to engage with each other to

RECTIFIED SHEET (RULE 91) ISA/EP ensure the mechanical connection between the cover element and the distal end of the robotic arm, said coupling means being disengageable from each other to allow disassembly of the cover element from the distal end of the robotic arm. The use of such a cover element makes it no longer necessary to sterilize the vision device once the surgery is over, since the cover element prevents the vision device from contaminating the surgical field and therefore allows operation even with a non-sterile vision device.

In order to make the vision device usable again, once a surgical operation has been completed, it will be sufficient to disassemble the cover element that has just been used (and that is, therefore, no longer sterile) from the robotic arm, disengaging their respective coupling means from each other, and replace that cover element with a new sterile cover element or, alternatively, disassemble the cover element that has just been used and sterilize only that element. Such operations are evidently much faster than the operation of sterilizing the vision device and thus allow the vision device to be made available again in a much shorter time than the prior art.

An additional advantage of the present invention is that the vision device can be of any type suitable for use in robotic surgery.

Specifically, the vision device can be a device operating in the visible spectrum or also a device operating in the non-visible spectrum. For example, the vision device can be a camera, which in turn can be of any type, even one that (at least for the time being) is not sterilizable, for example, a multispectral camera, a confocal camera, or a fluorescence camera. In fact, since the present invention does not require sterilization of the vision device, it allows the use even of vision devices that are not sterilizable.

However, the vision device can also be a device operating with ultrasound or other technology (e.g., Rx). In particular, the vision device can be an ultrasound probe.

Brief description of the drawings

Further features and advantages of the present invention will result more clearly from the following description, given purely by way of non-limiting example with reference to the accompanying drawings, in which:

- Figure 1 is a schematic representation of a vision system for robotic surgery according to the present invention;

- Figure 2 shows on an enlarged scale the detail A of Figure 1;

RECTIFIED SHEET (RULE 91) ISA/EP - Figures 3 and 4 are schematic representations, on an enlarged scale with respect to Figure 1 , showing two alternative ways of connecting the vision device and the robotic arm of the vision system of Figure 1 ;

- Figure 5 is a perspective view of the assembly formed by the cover element and the distal element of the end joint of the robotic arm of a vision system according to an embodiment of the present invention;

- Figure 5 is a perspective view of the assembly formed by the vision device, the cover element, and the distal element of the end joint of the robotic arm of a vision system according to an embodiment of the present invention;

- Figure 6 is an exploded view of the vision device and the cover element of the assembly of Figure 5;

- Figure 7 is an exploded view of the assembly of Figure 5, in which the cover element is mounted on the vision device;

- Figure 8 is an axial section view of the assembly of Figure 5;

- Figure 9 is a perspective view, in transparency, of the vision device forming part of the assembly of Figure 5;

- Figure 10 is a perspective, cutaway view of the vision device of Figure 9;

- Figure 11 is an exploded view of the vision device of Figure 10; and

- Figure 12 is a view similar to that of Figure 2, but relating to an alternative embodiment in which the vision device is connected in wireless mode to the control unit of the vision system.

Detailed description

With reference first to Figure 1 , a vision system according to the present invention basically comprises a robotic arm 10, a vision device 12 (which in the embodiment proposed herein is a camera) connected to a distal end 10a of the robotic arm 10, a cover element 14 into which the vision device 12 is inserted, and a central electronic control unit 16 configured to allow an operator to manage the operation of the vision system by properly moving the vision device 12, via the robotic arm 10, within the body of the patient on whom surgery is being performed.

The robotic arm 10 is shown in Figure 1 purely schematically. The robotic arm 10 may be a robotic arm of any type, particularly an articulated arm, that is, an arm provided with articulation joints each interposed between a pair of rigid arm segments to allow relative rotation of such rigid arm segments about a respective axis of rotation. The robotic arm 10 is provided, in a per-se-known manner, with

RECTIFIED SHEET (RULE 91) ISA/EP electromechanical drive means (for example, electric motors and/or linear actuators associated with suitable motion transmission and/or conversion mechanisms) arranged to control, under the management of a motion control unit 18 of the central electronic control unit 16, the movement of the distal end 10a of the arm to position and orient the vision device 12 in a desired manner. In this regard, the motion control unit 18 is connected to the drive means of the robotic arm 10, as indicated by arrow C, to transmit to such drive means suitable control signals to control the positioning and orientation of the distal end 10a of the robotic arm 10, and thus of the vision device 12.

Preferably (but not necessarily), the robotic arm 10 is made as a disposable arm and is therefore intended to be disposed of as waste, once it has been used during a surgical operation, to be replaced with a new arm. In this way, it is not necessary at the end of a surgical operation to subject the robotic arm 10 to sterilization, but it is sufficient to replace the used robotic arm with a new robotic arm. The robotic arm 10 is advantageously made of recyclable materials, so that the various materials from which it is made can be recovered and reused.

With reference also to Figures 2 to 4, the vision device 12 (which is depicted in these figures in a purely schematic manner) basically comprises at least one lens 20, at least one sensor 22, in particular a CMOS sensor, and lighting means 24, in particular (but not necessarily) LED-type lighting means, arranged to illuminate the external environment framed by the vision device 12. These components of the vision device 12 are all of a per-se-known type and will therefore not be described in detail herein. The vision device 12 also comprises a casing 26 in which the aforementioned components of the vision device are mounted.

As mentioned above, any other vision device suitable for the purpose can be used instead of a camera. For convenience, reference will be made in the present description to the case where the vision device is a camera, but what is illustrated herein is equally applicable to the case where the vision device is not a camera.

The cover element 14 (which is also purely schematically shown in these figures) is mounted around the casing 26 of the vision device 12 and has the function of preventing contact of the vision device (which is a non-sterile object) with the surgical field. After surgery, therefore, the used cover element 14 can be disposed of and replaced with a new cover element, which of course must be sterile, and the vision device 12 can thus be used again without the need to undergo sterilization. In other words, the cover element 14, once fitted around the vision device 12 and once coupled to the distal end 10a of the robotic arm 10, seals the space around

RECTIFIED SHEET (RULE 91) ISA/EP the vision device. This prevents the vision device 12 from being contaminated by the external environment and, of course, also prevents the vision device 12 from contaminating the patient's body cavity into which it is inserted or, more generally, the vision device 12 from contaminating the surgical field.

The cover element 14 comprises a tubular part 14a, or sleeve, having in particular a cylindrical shape, and a lid 14b that closes the tubular part 14a at one end (front end). The cover element 14 can be made in one piece. Alternatively, as shown in Figure 6, the tubular part 14a and the lid 14b can be made as separate pieces and be properly connected to each other, either before or after inserting the vision device 12 into the tubular part 14a of the cover element 14.

The cover element 14 is made of a biocompatible material, preferably a material that is also recyclable. For example, biocompatible polymers and metals can be used as materials for the cover element 14.

In addition, in the case where a camera is used as the vision device 12, at least the lid 14b must be made of a material that is transparent to light so that it does not obstruct vision when the camera is inserted into the cover element. For example, the lid 14b may be made of glass, in which case it will be a separate piece from the tubular part 14a. Alternatively, both the tubular part 14a and the lid 14b can be made of plastic material that is transparent to light. The lid 14b can also be configured to function not only as a protective element but also as an additional lens, so as to optimize the distribution of the light emitted by the lighting means 24 into the patient's cavity and/or so as to optimize the characteristics of the optical system of the vision device 12.

More generally, the lid 14b, and possibly also the tubular part 14a, of the cover element 14 will be made of material(s) transparent to the radiation used for the operation of the vision device 12, so that the cover element 14 will not prevent proper operation of the vision device 12.

The cover element 14 must, of course, be a sterile element when it is mounted on the vision device 12 prior to surgery. In this regard, two different approaches can be taken, both of which fall within the scope of the present invention. According to one approach, the cover element 14 is configured as a disposable element, intended to be disposed of as waste (possibly recyclable) once it has been used. According to another approach, the cover element 14 is reused after being sterilized. In the latter case, it will be useful to have a plurality of cover elements 14 associated with the same vision device 12 to ensure that there is always a sterilized cover element available for use in a surgical operation.

RECTIFIED SHEET (RULE 91) ISA/EP The central electronic control unit 16 (also shown purely schematically in Figure 1) comprises, in addition to the motion control unit 18, a video control unit 28 that is connected to the vision device 12 via a power supply line 30 to supply power to the sensor(s) 22 and the lighting means 24, as well as via a data line 32 for data transmission with the sensor(s) 20 and lighting means 22. Although in the example of Figure 1 the two lines 30 and 32 are shown as separate lines, it is possible to provide a single connection line between the vision device 12 and the video control unit 28 that functions both as power supply line and as data line.

The central electronic control unit 16, or rather the video control unit 28 of the central electronic control unit 16, is also connected to a display device 34, such as a monitor or wearable device, via a data line 36, so that video data coming from the vision device 12 and appropriately reprocessed by the video control unit 28 are transmitted to the display device 34.

The vision device 12 is advantageously connected to the distal end 10a of the robotic arm 10 by means of a quick connection system (schematically shown in Figures 1 to 4) designed to provide electrical and data connection between the vision device 12 and the robotic arm 10 via the power supply line 30 and the data line 32, respectively (or, alternatively, via a single connection line acting both as power supply line and as data line). Such a quick connection system comprises a first connector element 38 (e.g., a male element) mounted on the vision device 12 and a second connector element 40 (e.g., a female element) mounted on the distal end 10a of the robotic arm 10. As an alternative to a quick connection system, the connection between the vision device 12 and the robotic arm 10 can also be obtained in wireless mode, as described below with reference to Figure 12.

As shown in Figure 3, it is possible to connect the vision device 12 to the distal end 10a of the robotic arm 10 via the above-mentioned quick connection system once the vision device 12 has been inserted into the cover element 14. Alternatively, as shown in Figure 4, it is possible to first connect the vision device 12 to the distal end 10a of the robotic arm 10 via the aforementioned quick connection system and then mount the cover element 14 to protect the vision device 12.

Regardless of the mode used for mounting the vision device 12 to the distal end 10a of the robotic arm 10, the cover element 14 is releasably connected to the distal end 10a by means of a mechanical coupling system comprising first mechanical coupling means provided on the cover element 14 and second mechanical coupling means provided on the distal end 10a, said first and second mechanical coupling means being configured to engage with each other to provide

RECTIFIED SHEET (RULE 91) ISA/EP mechanical coupling between the cover element 14 and the distal end 10a and being also disengageable from each other to allow disassembly of the cover element 14 from the distal end 10a.

More specifically, such a mechanical coupling system is a quick coupling system, i.e., a coupling system that does not require the use of mechanical tools for coupling between the two parts. In the example shown herein (as can be seen in particular in Figures 5 and 7), the quick coupling system is a bayonet coupling system, in which the first mechanical coupling means are formed by a pair of L- shaped slits 42, which are provided at the end of the tubular part 14a of the cover element 14 facing the distal end 10a of the robotic arm 10 (i.e., at the end of the tubular part 14a axially opposite to the one at which the lid 14b is mounted) and are arranged on diametrically opposite sides to each other, while the second mechanical coupling means are formed by a pair of pins 44, which are mounted in corresponding radial holes 46 provided at the distal end 10a of the robotic arm 10 and are adapted to fit each into the respective slit 42 of the cover element 14 as a result first of an axial translational movement of the cover element 14 towards the distal end 10a and then of a rotational movement of the cover element 14 relative to the distal end 10a about its longitudinal axis.

Alternatively, such quick coupling means might, for example, be snap-on coupling means. In this case, for example, the tubular portion 14a of the cover element 14 may be provided, at its end facing the distal end 10a of the robotic arm 10, with a radially inwardly projecting edge suitable for snap engagement in a circumferential groove formed at the distal end 10a of the robotic arm 10.

The distal end 10a of robotic arm 10 is formed, for example, as in the embodiment shown in the figures, by the distal part of an end joint of the robotic arm 10, which distal part is coupled to a proximal part (not shown) of the joint so as to be orientable with respect to it around an axis of rotation.

In order to ensure a tight seal between the cover element 14 and the distal end 10a of the robotic arm 10, to prevent the entry of liquids or fumes that may interfere with the operation of the vision device 12, and to prevent the exposure of non- sterile parts of the robotic arm 10, as well as of the vision device 12, during surgery, suitable sealing means are provided between the cover element 14 and the distal end 10a. Such sealing means comprise, for example, as shown in Figures 7 and 8, a sealing ring 48, which is mounted in a circumferential groove 50 provided at the distal end 10a of the robotic arm 10 and cooperates with the internal cylindrical surface of the tubular portion 14a of the cover element 14 when the latter is coupled

RECTIFIED SHEET (RULE 91) ISA/EP to the distal end 10a.

An example of the vision device 12 is shown in detail in Figures 9 to 11 , in which parts and elements identical or corresponding to those in Figures 1 to 4 have been given the same reference numbers.

The vision device 12 in Figures 9 to 11 first comprises a pair of lenses 20, in particular barrel lenses, arranged side by side with their respective optical axes parallel to each other. The use of two lenses allows for stereoscopic vision and thus improves the surgeon's perception of the environment in which the surgeon is operating. Each lens 20 is associated with a respective sensor 22, which, as mentioned, is preferably a CMOS sensor. In addition, each lens 20 is preferably associated with a respective protective glass 52, advantageously mounted at the distal end of the casing 26. The vision device 12 further comprises, as lighting means, a pair of LED light sources 54 and a pair of light guides 56(but alternatively different types of lighting means might be used), each of which is associated with a respective LED light source 54 and extends along a longitudinal axis that is oriented parallel to the optical axes of the lenses 20. More specifically, the light guides 54 are arranged on opposite sides with respect to a plane passing through the optical axes of the lenses 20. Each light guide 54 is preferably associated with a respective protective glass 58. The lenses 20 are inserted into respective cylindrical holes 60 provided in the casing 26 of the vision device 12, while the light guides 56 are inserted into respective cylindrical holes 62, also provided in the casing 26. Both the cylindrical holes 60 and the cylindrical holes 62 open on the same face of the casing 26, facing on the axially opposite side from the distal end 10a of the robotic arm 10.

The vision device 12 also comprises, as electronic components, a set of printed circuit boards 64. The electronics on board the vision device 12 might be suitably packaged by epoxy resin.

Finally, with reference to Figure 12, according to a further embodiment the data connection between the vision device 12 and the video control unit 28 of the central electronic control unit 16 is achieved in wireless mode, instead of via the data line 32 illustrated above. In this case, the vision device 12 is provided with a wireless communication module 66, such as a Bluetooth module, suitable for communicating in wireless mode with the video control unit 28, as indicated by arrow W. The vision device 12 is also provided with a battery 68 (or, more generally, with power storage means) suitable for powering the wireless communication module 66. In this case, the battery 68 can also advantageously

RECTIFIED SHEET (RULE 91) ISA/EP be used to supply power to the sensor 22 and the lighting means 24 of the vision device 12, instead of the power supply line 30 of the previously illustrated embodiment. According to a variant embodiment (not shown), the vision device may be powered in wireless mode.

The present invention has been described herein with reference to some embodiments thereof, but it is clear that other embodiments may be envisaged that share with the ones described herein the same inventive core, as defined by the appended claims.

In particular, although in the embodiments proposed herein the lighting means are integrated into the vision device, it is still possible to provide for a lighting system integrated into the robotic arm and associated with a light guide system capable of transmitting the light generated by the lighting system to the field to be illuminated. Furthermore, although the present invention has been illustrated with reference to a given type of camera as a vision device, it is not limited to that specific type, but may provide for the use of any other type of camera suitable for application in robotic surgery.

Finally, as mentioned above, although the present invention has been illustrated with reference to a camera as a vision device, any other vision device suitable for application in robotic surgery, such as an ultrasound probe, may be provided. In the case of use of a vision device other than a camera, such as in the case of use of an ultrasound probe, the cover element may have, instead of a transparent lid, a flap or window on the tubular part of the same element.

RECTIFIED SHEET (RULE 91) ISA/EP

Claims

1. Vision system for robotic surgery, comprising a robotic arm (10), a vision device (12) mounted at a distal end (10a) of the robotic arm (10), and a cover element (14), sterile or sterilizable, arranged to enclose the space around the vision device (12), so as to prevent the vision device (12) from contaminating the surgical field and/or the patient's body during a surgical operation, characterized in that the cover element (14) is releasably connected to the distal end (10a) of the robotic arm (10) by means of a mechanical coupling system (42, 44), so as to be removable from the robotic arm (10) after surgery to be disposed of and replaced with a new cover element (14) or to be sterilized before being reused, wherein said mechanical coupling system (42, 44) comprises first mechanical coupling means (42) provided on the cover element (14) and second mechanical coupling means (44) provided at the distal end (10a) of the robotic arm (10), said first mechanical coupling means (42) and said second mechanical coupling means (44) being configured to engage with each other to provide a mechanical connection between the cover element (14) and the distal end (10a) of the robotic arm (10) and also being disengageable from each other to allow disassembly of the cover element (14) from the distal end (10a) of the robotic arm (10), and in that it further comprises including sealing means (48) interposed between the cover element (14) and the distal end (10a) of the robotic arm (10) to ensure a tight seal between the cover element (14) and the distal end (10a) of the robotic arm (10) in the condition where the cover element (14) is connected to the distal end (10a) of the robotic arm (10).

2. System according to claim 1 , wherein the cover element (14) is made of biocompatible material.

3. System according to claim 1 or claim 2, wherein the cover element (14) comprises a tubular or hollow part (14a), having in particular a cylindrical shape, and a lid (14b), which closes said tubular or hollow part (14a) at an end opposite to the distal end (10a) of the robotic arm (10).

4. System according to any one of the preceding claims, wherein the vision device (12) comprises a camera, video camera, or other instrument operating in the visible spectrum.

5. System according to claim 3 and claim 4, wherein said tubular part (14a) of the

RECTIFIED SHEET (RULE 91) ISA/EP cover element (14) is made of polymer or metal, and wherein the lid (14b) of the cover element (14) is made of light-transparent material, in particular glass.

6. System according to any one of the preceding claims, wherein said mechanical coupling system (42, 44) is a quick coupling system, such as a snap-on coupling system or a bayonet coupling system.

7. System according to claim 6, wherein said mechanical coupling system comprises, as first mechanical coupling means (42), at least one L-shaped slit provided at the end of the cover element (14) facing the distal end (10a) of the robotic arm (10), and, as second mechanical coupling means (44), at least one pin mounted on the distal end (10a) of the robotic arm (10) and configured to engage in the corresponding L-shaped slit of the cover element (14).

8. System according to any of the preceding claims, further comprising lighting means (24) for illuminating the external environment framed by the vision device (12).

9. System according to claim 8, wherein said lighting means (24) are integrated into the vision device (12).

10. System according to any of the preceding claims, wherein the vision device (12) is releasably connected to the distal end (10a) of the robotic arm (10).

11. System according to any one of the preceding claims, further comprising a central electronic control unit (16) configured to allow an operator to manage the operation of the vision system, said central electronic control unit (16) comprising a motion control unit (18) configured to control the movement of the robotic arm (10) to suitably position the distal end (10a), and thus the vision device (12), within the body of the patient on whom surgery is being performed, depending on the commands given by the operator, and a video control unit (28) configured to manage the operation of the vision device (12).

12. System according to claim 11 , further comprising a display device (34), such as a monitor or wearable device, connected to the video control unit (28) of the central electronic control unit (16) so as to receive video data coming from the vision device (12) and suitably reprocessed by the video control unit (28).

13. System according to claim 11 or claim 12, wherein the distal end (10a) of the robotic arm (10) and the vision device (12) are provided with connection means (38, 40) for data transmission between the vision device (12) and the video control unit (28) and for power supply of the vision device (12).

14. System according to claim 11 or claim 12, wherein the vision device (12) is

RECTIFIED SHEET (RULE 91) ISA/EP provided with wireless communication means (66) for transmitting data in wireless mode between the vision device (12) and the video control unit (28), and with power storage means (68) for supplying power to the vision device (12), including in particular said wireless communication means (66).

RECTIFIED SHEET (RULE 91) ISA/EP