Patent Description:
It is an object of the present invention a sterile barrier assembly for robotic surgery.

The present invention also relates to a robotic surgery system comprising at least one sterile barrier assembly.

Robotic surgery apparatuses are generally known in the art and typically comprise a robotic central tower (or robotic cart) and a plurality robotic arms extending from the central tower. Each robotic arm comprises a tele-operated robotic motorized positioning system (or manipulator) for moving a surgical end effector distally attached thereto, in order to perform surgical procedures to a patient. The patient typically lies on an operatory bed located in an operatory room, wherein sterilization is ensured in order to avoid bacterial contamination due to the non-sterile parts of the robotic apparatus.

Usually, a surgical drape wraps parts of the robot in order to protect the sterile environment from contamination. The need of wrapping the robot arise from the fact that such robot must be used and re-used for several surgeries.

For example, document <CIT>shows a pliable surgical drape designed to cover the robotic central tower and having a plurality of openings for each one of the robotic arms extending from the robotic cart so that the robotic arms are not covered by said surgical drape but are draped by means of a separate bag of surgical drape.

Therefore, the surgical drape flexible body may be provided with inserts, like rigid plastic plates, in order to form a connection interface with an active part of the robot. To this end, sterile adapters typically made of rigid plastic are integral with the drape to provide an attachment site for a surgical instrument and generally comprise movable parts in order to transmit actuation actions, such as a capstan driving action, to a surgical instrument detachably attached thereto for actuate an end effector of the surgical instrument. Examples of known sterile adapters can be found in documents <CIT> and <CIT>.

Drapes for covering microscope parts located within a operatory room are also known in the art. For example, document <CIT>discloses a tubular drape for fitting a pillar shaped terminal part of an electronic microscope, wherein a covering rigid glass is provided to the drape forming a cup-shaped end of the drape designed to cover the lens of the microscope. This solution of drape is therefore unsuitable to transmit an actuation action downstream the drape itself, and in this case downstream the lens of the microscope.

Document <CIT> in the name of the same Applicant discloses a solution of robotic surgery apparatus wherein a single robotic arm extends from the robotic cart and comprises at the distal end thereof a pair of tele-operated robotic motorized manipulator systems, arranged in parallel and connected to the same horizontal link of the single robotic arm.

Known surgical drapes can comprise also fixation strings that allow tying the surgical drape to close-fit an elongated portion of the robot, such as a robotic arm, thereby reducing the encumber of the surgical drape covering the robotic apparatus when in use. Moreover, it is also known to provide magnetic releasable coupling between parts of the robot apparatus and the margin of the surgical drape.

Document <CIT> in the name of the same Applicant shows a sterile barrier solution involving stiffening elements attached thereto, with the purpose of transmitting linear actuation across the barrier itself. The surface of the stiffening elements may be rounded to guarantee a single point contact with the non-sterile actuators. Despite advantageous for several reasons, such a solution results difficult to assemble because of the requested alignment of the actuators of the tele-operated robotic motorized positioning system with the stiffening elements of the sterile barrier and, in turn, with the distal elements of the surgical instruments thereby actuated.

Surgical drapes typically are in form of bags enclosing the robot, said bag having a closed end, and one or more pouches may further extend from the closed end of the bag to receive an extendable actuator of the robot, as shown for example in <CIT>.

It is also known to provide a rotative seal proximally to the surgical drape in order to drape both a robotic tower and a robotic arm that can pivot about an axis in respect of the robotic tower. An example of this type of solution is shown in document <CIT>, wherein the rotatable seal is located at the proximal end of the pouch of the sterile bag draping robotic arm in order to pivotally connect the proximal end of said pouch to the drape portion draping the robotic tower. Other example of surgery systems having a rotatable seal are shown by documents <CIT>, <CIT>, <CIT> and <CIT>. In these known solutions the rotatable seal is typically obtained by means of fitting/mounting a first surgical drape having a first ring defining a trough opening to a second surgical drape having an outer ring contouring the second surgical drape, after having connected the second surgical drape to a rotatable element of the robotic system.

It is felt the need to provide a solution of sterile barrier with a rotatable seal of improved yet simplified assemblage.

Therefore, the need is felt to provide a solution of surgical drape of simplified assemblage to a robotic surgery apparatus and at the same time of improved durability in respect of known solutions, without for these reasons inhibiting the transmission of an actuation action through and/or across the surgical drape.

At the same time, it is felt the need to provide a solution of sterile barrier of improved durability in respect of known solutions without for this reason to limit the freedom of movement, during surgery, of a sterile surgical instrument distally connectable to the sterile barrier.

It is a scope of the present invention to overcome the drawbacks mentioned with reference to the known art.

These and other scopes are achieved by a sterile barrier assembly according to claim <NUM>, as well as a a robotic surgery system according to claim <NUM>.

Some preferred embodiments are the subject of dependent claims.

According to an aspect of the invention, a sterile barrier assembly comprises a surgical drape having at least one drape opening and at least one connector contouring said at least one drape opening and suitable for coupling with a case encasing a non-sterile robotic manipulator.

According to an aspect of the invention, the sterile barrier assembly further comprises at least one sterile adapter having a frame comprising a coupling device for coupling with at least one surgical instrument, wherein the at least one connector of the surgical drape and the at least one sterile adapter are made in separate pieces.

According to an aspect of the invention, the at least one sterile adapter is suitable to pivot in respect of the at least one connector of the surgical drape and between the at least one connector of the surgical drape and the at least one sterile adapter it is provided a gap. The gap may be an annular gap and the gap prevents any direct contact of the frame of the sterile adapter with the connector of the sterile drape.

The at least one connector of the surgical drape comprises a distal surface facing distally and said sterile adapter comprises a proximal surface facing proximally, and wherein said distal surface of the connector faces said proximal surface of the sterile adapter delimiting said gap. Thereby the proximal surface of the sterile adapter distally delimits the gap while the distal surface of the connector proximally delimits the same gap.

The connector of the drape may be integral with the body of the surgical drape.

The sterile adapter may comprise a skirt facing proximally said gap, said proximal surface may belong to said skirt.

According to an aspect of the invention, a robotic surgery system comprising at least one of said sterile barrier assembly further comprises at least one non-sterile robotic manipulator comprising: a case and at least one roll motor, and at least one rolling body suitable to pivot in respect to said case. The roll motor may be operatively connected to the rolling body.

According to an aspect of the invention, said at least one connector of the surgical drape of the sterile barrier assembly is coupled with said case of the non-sterile robotic manipulator, and said at least one sterile adapter of the sterile barrier assembly is coupled with said at least one rolling body of the non-sterile robotic manipulator either directly or indirectly, for example by interposition of a manipulator connecting element, so that said at least one roll motor is suitable to move at least said one rolling body together with said at least one sterile adapter of a pivoting movement with respect to said case of the non-sterile robotic manipulator.

The at least one connector of the surgical drape of the sterile barrier assembly may be coupled detachably and rigidly to said case of the non-sterile robotic manipulator.

The at least one sterile adapter of the sterile barrier assembly may be coupled detachably and rigidly to said at least one rolling body of the non-sterile robotic manipulator.

The rolling body of the non-sterile robotic manipulator may comprise a manipulator connecting element and said sterile adapter may detachably engage with said manipulator connecting element, for example in an undercut manner such as by means of a bayonet coupling and/or a threaded coupling. The engagement between said sterile adapter and said manipulator connecting element may be located distally to said case and/or distally to said connector of the surgical drape. The manipulator connecting element may be located at least partially within said case while said sterile adapter may be located out of said case, and preferably distally to said case encasing said non-sterile robotic manipulator.

According to an aspect of the invention, the sterile drape comprises a pair of drape openings and a pair of connectors and a pair of sterile adapters, wherein each connector contouring a respective drape opening, each connector being made in separate pieces with respect to a respective sterile adapter, each sterile adapter is suitable to pivot in respect of the respective connector of the surgical drape.

According to an aspect of the invention, a robotic surgery system comprising a sterile barrier assembly of the above-described type having a pair of drape openings and a pair of connectors and a pair of sterile adapters further comprises a pair of non-sterile robotic manipulators, wherein each connector of the surgical drape is coupled to the case of a respective robotic manipulator and each sterile adapter of the sterile barrier assembly is coupled with the rolling body of a respective non-sterile robotic manipulator, so that each roll motor is suitable to move a respective rolling body together with said the respective sterile adapter of a pivoting movement with respect to the case of the respective non-sterile robotic manipulator.

The body of the surgical drape may be made in single piece and may comprise a pair of pouches, each pouch delimiting a respective drape opening, each pouch being suitable for individually draping one non-sterile robotic manipulator of said pair, for example by means of attaching the connector of the respective pouch of the surgical drape to the case of the respective non-sterile robotic manipulator.

According to the present disclosure, a method of mounting and/or dismounting a sterile barrier assembly of a robotic surgery system comprises the following steps of connecting and/or disconnecting at least one connector of a surgical drape to and/or from at least one case of a non-sterile robotic manipulator, and connecting and/or disconnecting a sterile adapter to a rolling body of the non-sterile robotic manipulator. The connection to the rolling body may be either direct or indirect, for example by means of interposition of a manipulator connecting element.

Connecting the sterile adapter to the rolling body, either directly or indirectly for example by means of interposition of a manipulator connecting element, may comprise moving the sterile adapter proximally towards the rolling body, without touching the surgical drape and/or the connector of the surgical drape.

Connecting the sterile adapter to the rolling body, either directly or indirectly for example by means of interposition of a manipulator connecting element, may comprise moving the sterile adapter proximally towards the rolling body, when the surgical drape is already attached by means of its connector to the case of a non-sterile robotic manipulator. Disconnecting the sterile adapter from the rolling body, either directly or indirectly for example by means of interposition of a manipulator connecting element, may comprise moving the sterile adapter distally from the rolling body, when the surgical drape is attached by means of its connector to the case of a non-sterile robotic manipulator. The method of mounting may therefore comprise firstly connecting at least one connector of a surgical drape to the at least one case of a non-sterile robotic manipulator, and subsequently connecting at least one sterile adapter to a rolling body of the non-sterile robotic manipulator having its case already connected to the connector of the surgical drape. The method of dismounting may therefore comprise firstly disconnecting at least one sterile adapter from the rolling body of the non-sterile robotic manipulator, and subsequently disconnecting the connector of the surgical drape from the at least one case of the at least one non-sterile robotic manipulator, which the sterile adapter is already disconnected from.

Thanks to the proposed solutions, it is provided a surgical drape or surgical bag able to surround with a ring thereof a rolling body, which is rollable about an axis in respect of the surgical drape.

Thanks to the proposed solutions, it is provided a sterile barrier assembly comprising a surgical drape and at least a sterile adapter pivotally associated to at least a distal opening of the surgical drape.

Thanks to the proposed solutions, it is provided a robotic surgery system comprising a rolling body received within a case, wherein both the case and the rolling body are associated to the same sterile barrier assembly.

Thanks to the proposed solutions, it is provided a method for mounting and/or a method for dismounting a sterile barrier assembly in a simple yet advantageous order.

Further characteristics and advantages of the surgical drape, of the sterile barrier assembly, of the system and of the method will appear from the following description of preferred embodiments, which are given as examples and are not meant to be limiting, which makes reference to the attached figures, in which:.

According to a general embodiment, it is provided a sterile barrier assembly <NUM> for a robotic surgery system <NUM>.

The sterile barrier assembly <NUM> comprises a surgical drape <NUM> or sterile drape <NUM> having at least one drape opening <NUM>, <NUM>'.

The surgical drape <NUM> may be configured as a bag designed to fit a main portion of a robotic surgery system <NUM>.

A robotic surgery system <NUM> may comprise a robotic cart <NUM> and at least one robotic arm <NUM> extending from the cart <NUM> and defining a proximal-distal direction z-z. Said at least one robotic arm <NUM> may comprise a plurality of arm links <NUM>, <NUM>', <NUM>", <NUM>‴ connected one another forming a kinematic chain. One of said arm links <NUM>, <NUM>', <NUM>", <NUM>‴ may be connected to at least two non-sterile motorized robotic manipulators <NUM>, <NUM>', suitable to manipulate a robotic end effector, for example a wrist, within a patient's body along a plurality of degrees of freedom. According to an embodiment, at least one roll motor <NUM>, is provided suitable to move said rolling body <NUM>, <NUM>' of a rolling movement about a rolling axis Z-Z in respect of a case <NUM>, <NUM>' of the non-sterile robotic manipulator <NUM>, <NUM>'.

Said surgical drape <NUM> may comprise a body <NUM>, and said body <NUM> delimits a drape cavity <NUM>. According to a preferred embodiment, said body <NUM> is made of a flexible sheet of plastic material, for example polyethylene. Preferably, the term "flexible" used herein means that the body of the drape is loose, for example it is a flexible sheet. According to an embodiment, the body of the sterile drape <NUM> is made of paper, woven fabric, non-woven fabric, and/or any suitable material for surgical drape <NUM>.

According to a preferred embodiment, said body <NUM> of the surgical drape <NUM> is in single piece. Preferably, said body <NUM> is a single piece of flexible sheet.

According to a preferred embodiment, said surgical drape <NUM> may comprise a first inner surface <NUM> facing the drape cavity <NUM>, and a second outer surface <NUM> facing away from the cavity <NUM>. Thereby, said first inner surface <NUM> and said second outer surface <NUM> are opposite one another in respect of the flexible body <NUM> of the surgical drape <NUM>.

Preferably, said surgical drape <NUM> comprises a proximal opening edge <NUM> delimiting a proximal opening <NUM> of the surgical drape <NUM> for accessing said drape cavity <NUM>, wherein said proximal opening <NUM> is preferably a through opening.

According to a preferred embodiment, said proximal opening edge <NUM> is associated to a proximal coupling interface <NUM> suitable for forming a coupling with a portion of a robotic surgery system <NUM>. According to an embodiment, said proximal coupling interface <NUM> of the proximal opening edge <NUM> of said surgical drape <NUM> forms a magnetic coupling with a part of the cart <NUM> of a robotic surgery system <NUM>. For example, said proximal coupling interface <NUM> comprises a permanent magnet. For example, said proximal coupling interface <NUM> comprises a ferromagnetic portion suitable to form a magnetic coupling with a magnetic part of the cart <NUM>. According to an embodiment, said proximal coupling interface <NUM> of the proximal opening edge <NUM> of said surgical drape <NUM> comprises an elastic strip forming an elastic pressure action on the cart <NUM> of the robotic surgery system <NUM>. According to an embodiment, said proximal coupling interface <NUM> of the proximal opening edge <NUM> of said surgical drape <NUM> comprises straps for tying to said cart <NUM>.

Preferably, said surgical drape <NUM> comprises at least one distal opening edge <NUM>, <NUM>' delimiting a respective distal opening <NUM>, <NUM>' for accessing said drape cavity <NUM>.

Said at least one distal opening <NUM>, <NUM>' is preferably a distal through opening <NUM>, <NUM>'.

According to an embodiment, said drape cavity <NUM> is a through cavity extending between and leading through said proximal opening <NUM> and said at least one distal opening <NUM>, <NUM>'. Thereby, the robotic surgery system <NUM> may be dressed at least partially with said surgical drape <NUM> by firstly fitting said proximal opening edge <NUM> of the surgical drape <NUM> around a distal end of a robotic arm <NUM> of the robotic surgical system <NUM>, then moving proximally said proximal opening edge <NUM> of the surgical drape <NUM> thereby unfolding the surgical drape <NUM> and fitting said robotic arm <NUM> by the body <NUM> of the surgical drape <NUM>, then coupling said at least one distal opening edge <NUM>, <NUM>' to a respective part of the robotic arm <NUM> of the robotic surgery system <NUM>.

Said sterile barrier assembly <NUM> further comprises at least one connector <NUM>, <NUM>' contouring said at least one drape opening <NUM>, <NUM>' and suitable for coupling with said case <NUM>, <NUM>' of said non-sterile robotic manipulator <NUM>, <NUM>'.

Preferably, the surgical drape <NUM> comprises at least one annular connector <NUM>, <NUM>' associated to a respective distal opening edge <NUM>, <NUM>' of the flexible body <NUM>. According to an embodiment, said at least one annular connector <NUM>, <NUM>' is a ring connector <NUM>, <NUM>'.

Thereby, when said first distal opening edge <NUM> and said second distal opening edge <NUM>' are provided, a respective first annular connector <NUM> is associated to said first distal opening edge <NUM> to contour said first distal opening <NUM>, and a respective second annular connector <NUM>' is associated to said second distal opening edge <NUM>' to contour said second distal opening <NUM>'.

Said at least one annular connector <NUM>, <NUM>' comprises an annular rim <NUM>, <NUM>' facing a respective distal annular opening <NUM> or <NUM>' and having an annular shape, so that said at least one distal opening <NUM>, <NUM>' is contoured by said annular rim <NUM>, <NUM>'. Thereby, the at least one distal opening <NUM>, <NUM>' of the surgical drape <NUM> has an annular contour. Thus, the at least one distal opening <NUM>, <NUM>' may have the shape of a circle.

According to a preferred embodiment, said at least one annular connector <NUM>, <NUM>' is more rigid than the body <NUM> of the surgical drape <NUM>. According to a preferred embodiment, said at least one annular connector <NUM>, <NUM>' is rigid so that a manual action applied thereto is unsuitable to elastically deform the annular connector <NUM>, <NUM>' without creep it and/or break it. According to a preferred embodiment, said annular rim <NUM>, <NUM>' of the at least one annular connector <NUM>, <NUM>' is rigid so that to define an annular contour of the at least one distal opening <NUM>, <NUM>'.

Said sterile barrier assembly <NUM> comprises at least one sterile adapter <NUM>, <NUM>' having a frame <NUM> comprising a coupling device <NUM> for coupling with at least one sterile surgical instrument <NUM>, <NUM>'.

Said at least one connector <NUM>, <NUM>' of the surgical drape <NUM> and the at least one sterile adapter <NUM>, <NUM>' are made in separate pieces.

Said at least one sterile adapter <NUM>, <NUM>' is suitable to pivot or to roll in respect of the at least one connector <NUM>, <NUM>' of the surgical drape <NUM>.

Advantageously, between the at least one connector <NUM>, <NUM>' of the surgical drape <NUM> and the at least one sterile adapter <NUM>, <NUM>' it is provided a gap <NUM>, <NUM>'.

Thereby, said gap <NUM>, <NUM>' forms together with said at least one connector <NUM>, <NUM>' and with said at least one sterile adapter <NUM>, <NUM>' a rotatable seal, which avoids to generate rotative friction onto the at least one connector <NUM>, <NUM>' and the respectively pivotally associated sterile adapter <NUM>, <NUM>', while preserving sterility of a sterile operatory field <NUM>, in other words preventing the sterile operatory field <NUM> from being contaminated by the non-sterile parts of the robotic surgical system <NUM>, which is draped. Thanks to the provision of said gap <NUM>, <NUM>' the sterile adapter <NUM>, <NUM>' is not connected directly to the connector <NUM>, <NUM>' of the surgical drape <NUM>.

According to a preferred embodiment, said body <NUM> of the surgical drape <NUM> further comprises a first distal opening edge <NUM> and a second distal opening edge <NUM>', each of said first distal opening edge <NUM> and of said second distal opening edge <NUM>' delimits a respective distal through opening <NUM>, <NUM>'. Thereby, a first distal through opening <NUM> is delimited by said first distal opening edge <NUM> and a second distal through opening <NUM>' is delimited by said second distal opening edge <NUM>'. Thereby, when said first annular connector <NUM> and said second annular connector <NUM>' are provided, each of said first and second annular connectors <NUM> and <NUM>' comprises an annular rim <NUM>, <NUM>', so that a first annular rim <NUM> is associated to said first annular connector <NUM> and a second annular rim <NUM>' is associated to a second annular connector <NUM>'. Preferably, each of said annular rim <NUM>, <NUM>' of the at least one annular connector <NUM>, <NUM>' defines a connection ring suitable for connecting to a robotic surgery system <NUM>.

The provision of a pair of distal openings <NUM> and <NUM>' each associated to a respective annular connector <NUM> and <NUM>' allows to use a single surgical drape <NUM> to drape a pair of robotic arms and a portion of the cart <NUM> of the robotic surgery system <NUM>.

The provision of such at least one annular connector <NUM>, <NUM>' allows to receive within said annular rim <NUM>, <NUM>' thereof a rolling body <NUM>, <NUM>' that can roll about an axis Z-Z in respect of the body <NUM> of the surgical drape <NUM> and/or in respect of said at least one annular connector <NUM>, <NUM>'.

According to an embodiment, with the terminology "a rolling body <NUM>, <NUM>' that can roll about an axis" also encompasses the case wherein the rolling movement is a relative movement between said rolling body <NUM>, <NUM>' of the robotic surgery system <NUM> and said annular connector <NUM>, <NUM>' of the surgical drape <NUM>.

Thereby, said relative rolling movement may require the annular connector <NUM>, <NUM>' to roll and/or pivot about an axis and the rolling body <NUM>, <NUM>' to be substantially stationary, defining a relative rolling movement.

According to an embodiment, with the terminology "a rolling body <NUM>, <NUM>' that can roll about an axis" also encompasses the case wherein the rolling body <NUM>, <NUM>' can pivot about an axis in respect of the body <NUM> of the surgical drape <NUM> and/or in respect of said at least one annular connector <NUM>, <NUM>'.

According to an embodiment, with the terminology "a rolling body <NUM>, <NUM>' that can roll about an axis" also encompasses the case wherein the rolling body <NUM>, <NUM>' can roll about a movable axis in respect of the body <NUM> of the surgical drape <NUM> and/or in respect of said at least one annular connector <NUM>, <NUM>', for example a spherical joint and the like.

The provision of a pair of annular connectors <NUM> and <NUM>' allows to receive a pair of rolling bodies <NUM>, <NUM>', each one of said pair of rolling bodies <NUM>, <NUM>' being received within a respective annular rim <NUM>, <NUM>' in such way that each one of said pair of rolling bodies <NUM> and <NUM>' can roll about an axis z-z in respect of the body <NUM> of the surgical drape <NUM> and/or in respect of a respective annular rim <NUM>, <NUM>' of annular connector <NUM>, <NUM>'. According to an embodiment, each one of said pair of rolling bodies <NUM> and <NUM>' can roll about an axis z-z independently from the other rolling body of said pair of rolling bodies <NUM>, <NUM>'. The respective roll axis z-z of each one of said pair of rolling bodies <NUM>, <NUM>' may be parallel one another, although according to a preferred embodiment are not parallel, and more preferably they converge one towards the other,.

Said at least one rolling body <NUM>. <NUM>' received within said at least one annular connector <NUM>, <NUM>' in said at least one distal opening <NUM>, <NUM>' of the surgical drape <NUM> may have a substantially cylindrical geometry extending around a roll axis that is either substantially stationary or in turn rotatable around a further axis in respect of said at least one annular connector <NUM>, <NUM>'. Alternatively said at least one rolling body <NUM>. <NUM>' received within said at least one annular connector <NUM>, <NUM>' in said at least one distal opening <NUM>, <NUM>' of the surgical drape <NUM> may have a substantially spherical geometry suitable for rolling around a roll axis that is either substantially stationary or movable in respect of said at least one annular connector <NUM>, <NUM>'.

According to a preferred embodiment, said at least one annular connector <NUM>, <NUM>' is integral with said flexible body <NUM> of the surgical drape <NUM>. Thereby, said at least one annular connector <NUM>, <NUM>' cannot roll in respect of said body <NUM> of the surgical drape <NUM>. Not necessary said body <NUM> of the surgical drape <NUM> is made as single piece with said at least one annular connector <NUM>, <NUM>', although according to an embodiment they are made in single piece of material. According to an embodiment, said at least one annular connector <NUM>, <NUM>' is glued and/or fixed and/or clamped and/or pinched and/or thermoformed and/or otherwise secured to said at least one distal opening edge <NUM>, <NUM>' of said body <NUM> of the surgical drape <NUM>. Preferably. the connector <NUM>, <NUM>' is in turn detachably connected to the case <NUM>, <NUM>' encasing said robotic manipulator <NUM>, <NUM>'.

According to an embodiment, the sterile barrier assembly comprises at least one pouch <NUM>, <NUM>' having a lateral wall formed by said body <NUM> of the surgical drape <NUM> and extending proximally in respect to said at least one distal opening edge <NUM>, <NUM>' and preferably comprising said at least one distal opening edge <NUM>, <NUM>'. Thereby said at least one pouch <NUM>, <NUM>' is suitable for draping at least partially said robotic arm <NUM> and preferably said at least one manipulator <NUM>, <NUM>' of the robotic surgery system <NUM>.

According to an embodiment, said proximal opening edge <NUM> of the surgical drape <NUM> is suitable for forming a coupling with a portion of the non-sterile robotic manipulator <NUM> or <NUM>' of the robotic surgery system <NUM>. Thereby, the robotic surgery system <NUM> may comprise more than one surgical drapes <NUM> and/or more than one sterile barrier assemblies <NUM>, as shown for example in <FIG>. Thereby, the robotic arm <NUM> comprising two non-sterile robotic manipulators <NUM>, <NUM>' is draped by two surgical drapes <NUM> each forming a sterile barrier assemblies <NUM>.

Preferably, said at least one pouch <NUM>, <NUM>' is formed by a sleeve of said surgical drape <NUM> and one of said sterile adapter <NUM>, <NUM>' and said rotatable seal formed by said gap <NUM>, <NUM>'. Preferably, each pouch <NUM>, <NUM>' has at least one respective drape opening <NUM>, <NUM>', and an opposite proximal pouch opening <NUM>, <NUM>', wherein the rotatable seal is distal to said proximal pouch opening <NUM>, <NUM>'. Distally to the rotatable seal preferably there is the sterile adapter <NUM>, <NUM>'.

According to an embodiment, said surgical drape <NUM> comprises a pair of said pouches <NUM>, <NUM>', preferably each comprising a respective distal opening edge <NUM>, <NUM>'. According to an embodiment, said body <NUM> of said surgical drape <NUM> comprises a single pouch <NUM> for covering a robotic arm <NUM>, wherein said single pouch <NUM> comprises a pair of distal opening edges <NUM> and <NUM>'. According to an embodiment, said body <NUM> of the surgical drape <NUM> comprises a bridge portion <NUM> connecting said distal opening edges <NUM> and <NUM>' one another. Preferably, said bridge portion <NUM> of the body <NUM> of the surgical drape <NUM> connects said pair of tubular portions <NUM>, <NUM>' one another forming a shared root portion.

According to an embodiment, said at least one annular connector <NUM>, <NUM>' forms the free end of the body <NUM> of the surgical drape <NUM>. Preferably, said at least one annular connector <NUM>, <NUM>' forms the free end of a respective pouch <NUM>, <NUM>' thereof.

According to an embodiment, said body <NUM> of the surgical drape <NUM> comprises a base portion <NUM> comprising said at least one proximal opening edge <NUM>. Thereby, said base portion <NUM> designed to drape a robotic cart <NUM>. According to an embodiment, said at least one pouch <NUM>, <NUM>' extends from said base portion <NUM> of the body <NUM> of the surgical drape <NUM>. The provision of said base portion <NUM> and of said at least one pouch <NUM>, <NUM>', allows said body <NUM> of a single surgical drape <NUM> to drape both a robotic cart <NUM> and at least one a robotic arm <NUM> of a robotic surgery system <NUM>.

The provision of a surgical drape <NUM> having body <NUM> comprising at least a pouch <NUM>, <NUM>' to drape at least robotic arm <NUM> and a base portion <NUM> to drape a robotic cart <NUM>, wherein said at least one pouch <NUM>, <NUM>' is associated to a pair of annular connectors <NUM>, <NUM>' allows to drape with a single surgical drape <NUM> a robotic surgery system <NUM> comprising at least two robotic manipulators <NUM>, <NUM>' attached distally to at least one robotic arm <NUM>, prefefrably wherein both manipulators <NUM>, <NUM>' are attached to the same link of the robotic arm <NUM>, wherein preferably the robotic arm is in turn attached to a robotic cart <NUM>.

According to an embodiment, said annular rim <NUM>, <NUM>' of the at least one annular connector <NUM>, <NUM>' comprises an inner annular surface <NUM>, <NUM>' facing a respective distal opening <NUM>, <NUM>'. Thereby, when a pair of annular connectors <NUM> and <NUM>' is provided, a pair of respective inner annular surfaces <NUM>, <NUM>' is provided. According to an embodiment, each of said inner annular surfaces <NUM>, <NUM>' faces a respective roll axis. According to an embodiment, each of said inner annular surfaces <NUM>, <NUM>' defines a ring that contours a respective distal opening <NUM>, <NUM>'. According to an embodiment, each of said inner annular surfaces <NUM>, <NUM>' is substantially parallel to the proximal distal direction Z-Z. According to an embodiment, each of said inner annular surfaces <NUM>, <NUM>' faces a respective rolling body <NUM>, <NUM>'.

According to an embodiment, said at least one annular connector <NUM>, <NUM>' of the surgical drape <NUM>, and preferably each of said annular connectors <NUM>, <NUM>', comprises a distal annular surface <NUM>, <NUM>' facing distally. Thereby, the distal annular surface <NUM>, <NUM>' of the annular connector <NUM>, <NUM>' faces away from the cavity <NUM> of the surgical drape <NUM> along the proximal-distal direction Z-Z. According to an embodiment, said at least one annular connector <NUM>, <NUM>' of the surgical drape <NUM>, and preferably each of said annular connectors <NUM>, <NUM>', comprises a proximal annular surface <NUM> facing proximally. Thereby, said proximal annular surface <NUM> and said distal annular surface <NUM>, <NUM>' face opposite one another in respect of said annular connector <NUM>, <NUM>'. Thereby, said proximal annular surface <NUM> faces towards the body <NUM> of the surgical drape <NUM>. According to an embodiment, said proximal annular surface <NUM> faces towards said cavity <NUM> of the surgical drape <NUM> and faces towards said first inner surface <NUM> of the body <NUM> of the surgical drape <NUM>. Said proximal annular surface <NUM> may face away from the cavity <NUM> of the surgical drape <NUM> if faces towards the second outer surface <NUM> of the body <NUM> of the surgical drape <NUM>.

According to a preferred embodiment, the distal annular surface <NUM>, <NUM>' of the annular connector <NUM>, <NUM>' of the surgical drape <NUM> faces distally the proximal surface <NUM> of the frame <NUM> and/or the skirt <NUM> of the sterile adapter <NUM>, <NUM>', so that the distal annular surface <NUM>, <NUM>' of the annular connector <NUM>, <NUM>' of the surgical drape <NUM> and the proximal surface <NUM> of the frame <NUM> and/or the skirt <NUM> of the sterile adapter <NUM>, <NUM>' delimit said annular gap <NUM>, <NUM>'. Thereby the annular connector <NUM>, <NUM>' of the surgical drape <NUM> and the sterile adapter <NUM>, <NUM>' are not directly connected to each other. Bearings <NUM> may be provided preferably interposed between the manipulator connecting element <NUM>, <NUM>' and the case <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>', therefore it is avoided the provision of bearings <NUM> in contact with both the sterile adapter <NUM>, <NUM>' and the connector <NUM>, <NUM>' of the drape <NUM>.

According to an embodiment, said at least one annular connector <NUM>, <NUM>' comprises a coupling device <NUM> suitable to couple the surgical drape <NUM> to a counter-coupling portion <NUM> of a robotic surgery system <NUM>.

According to an embodiment, said counter-coupling portion <NUM> is a portion of a robotic arm <NUM> of the surgical system <NUM> that is preferably located near a distal end of said robotic arm <NUM>. According to an embodiment, said counter-coupling portion <NUM> is a portion of a manipulator <NUM>, <NUM>' of the robotic surgery system <NUM>.

According to an embodiment, said annular coupling device <NUM> of the surgical drape <NUM> comprises an elastic element, for example a clip, suitable for snap-fit engaging said counter-coupling portion <NUM> of the robotic arm <NUM> of the robotic surgery system <NUM>. According to an embodiment, said coupling device <NUM> of the surgical drape <NUM> comprises a magnetic coupling element suitable for forming a magnetic coupling with said counter-coupling portion <NUM> of the robotic arm <NUM> of the robotic surgery system <NUM>. According to an embodiment, said coupling device <NUM> of the surgical drape <NUM> comprises a threaded interface suitable for being screwed to said counter-coupling portion <NUM> of the robotic arm <NUM> of the robotic surgery system <NUM>. According to an embodiment, said coupling device <NUM> of the surgical drape <NUM> comprises a bayonet coupling interface suitable for forming a bayonet-type engagement with said counter-coupling portion <NUM> of the robotic arm <NUM> of the robotic surgery system <NUM>.

According to a general embodiment, it is provided a sterile barrier assembly <NUM> comprising at least one surgical drape <NUM> according to any one of the embodiments previously described.

According to an embodiment, said at least one sterile adapter <NUM>, <NUM>' comprises at least a second sheet <NUM>, or membrane <NUM>. Said second sheet <NUM> is preferably a single continuous flexible sheet of plastic material. Said second sheet <NUM> is preferably made of a drape material suitable for draping a robotic surgery system <NUM>. For example, said second sheet <NUM> is made of the same material of the body <NUM> of the surgical drape <NUM>. According to a preferred embodiment, said at least one sterile adapter <NUM>, <NUM>' is coaxial with said at least one annular rim <NUM>, <NUM>' of said at least one annular connector <NUM>, <NUM>' of the surgical drape <NUM>. According to a preferred embodiment, said at least one sterile adapter <NUM>, <NUM>' comprises at least one substantially rounded rim <NUM>.

According to a preferred embodiment as shown for example in <FIG>, said second sheet <NUM> has a substantially disc shape. According to a preferred embodiment, said rounded rim <NUM>, or frame <NUM>, of the at least one sterile adapter <NUM>, <NUM>' acts as constraining frame for the second sheet <NUM>. According to a preferred embodiment, said at least one sterile adapter <NUM>, <NUM>' has a substantially cylindrical shape. According to a preferred embodiment, said at least one sterile adapter <NUM>, <NUM>' has a substantially spherical shape.

According to a preferred embodiment, said at least one connector <NUM>, <NUM>' of the surgical drape <NUM> has an annular rim <NUM>, <NUM>' and said at least sterile adapter <NUM>, <NUM>' has an annular frame so that said gap <NUM>, <NUM>' is an annular gap.

According to a preferred embodiment, the annular rim <NUM>, <NUM>' and the annular frame <NUM> of the sterile adapter <NUM>, <NUM>' are arranged coaxially. Preferably, said substantially rounded rim <NUM> or frame <NUM> of said sterile adapter <NUM>, <NUM>' is coaxial with the annular rim <NUM>, <NUM>' of said at least one annular connector <NUM>, <NUM>'. Thereby, the sterile adapter <NUM>, <NUM>' may roll about an axis in respect of a respective annular connector <NUM>, <NUM>' having the annular rim <NUM>, <NUM>' coaxial with said rounded rim <NUM> of the sterile adapter <NUM>, <NUM>'.

According to a preferred embodiment, the at least one sterile adapter <NUM>, <NUM>' is suitable to pivot in respect of the at least one connector <NUM>, <NUM>' of the surgical drape <NUM> about an axis z-z, which passes through the geometric centre <NUM>, <NUM>' of the connector <NUM>, <NUM>'.

According to an embodiment, said at least one sterile adapter <NUM>, <NUM>' is integrally coupled to a rolling body <NUM>, <NUM>' of the robotic surgery system <NUM>. Thereby, said at least one sterile adapter <NUM>, <NUM>' of the sterile barrier assembly <NUM> can roll about an axis z-z in respect of the surgical drape <NUM> and/or in respect of said at least one annular connector <NUM>, <NUM>'.

According to an embodiment, said at least one sterile adapter <NUM>, <NUM>' is coupled to said annular connector <NUM>, <NUM>' of the surgical drape <NUM> in such way that a relative rolling movement is allowed. Thereby, the sterile adapter <NUM>, <NUM>' acts as rolling body <NUM>, <NUM>'.

According to an embodiment, said second sheet <NUM> of the at least one sterile adapter <NUM>, <NUM>' has form of a bag defining a proximal opening of second sheet <NUM> facing said at least one distal opening <NUM>, <NUM>' of the surgical drape <NUM>, and preferably coaxial with said annular rim <NUM>, <NUM>' of said at least one annular connector <NUM>, <NUM>' of the surgical drape <NUM>. According to an embodiment, said rounded rim <NUM> of the at least one sterile adapter <NUM>, <NUM>' comprises an engaging interface <NUM> that engages a counter-engaging interface <NUM> of the at least one annular connector <NUM>, <NUM>' of the surgical drape <NUM>. Bearings may be provided between said engaging interface <NUM> and said counter-engaging interface <NUM>.

According to a preferred embodiment, said at least one sterile adapter <NUM>, <NUM>' comprises at least one proximal coupling device <NUM> suitable to form a detachable integral connection with a rolling body <NUM>, <NUM>' of the robotic surgery system <NUM>. According to an embodiment, said proximal coupling device <NUM> is coupled with a manipulator connecting element <NUM>, <NUM>' comprising proximal connecting means for connecting the manipulator connecting element <NUM>, <NUM>' and the sterile adapter <NUM>, <NUM>' to a robotic non-sterile manipulator <NUM>, <NUM>'. Preferably, said manipulator connecting element <NUM>, <NUM>' acts as or is a rolling body <NUM>, <NUM>'.

According to a preferred embodiment, said manipulator connecting element <NUM>, <NUM>' is a component of the robotic surgery system connecting said sterile adapter <NUM>, <NUM>' to the non sterile robotic manipulator. Thereby, the sterile adapter <NUM>, <NUM>' is connected in a detachable manner to the manipulator connecting element <NUM>, <NUM>'. In this way, the sterile adapter <NUM>, <NUM>' avoids to connect to the surgical drape, in other words the sterile adapter <NUM>, <NUM>' avoids to connect to the annular rim <NUM>, <NUM>' of the surgical drape as well as to the connector <NUM>, <NUM>' of the surgical drape. Thereby, the connector <NUM>, <NUM>' of the surgical drape does not extert any structural holding action on the sterile adapter <NUM>, <NUM>', and rather the connector <NUM>, <NUM>' of the surgical drape engages with the case <NUM>, <NUM>' while the sterile adapter <NUM>, <NUM>' engages with the manipulator connecting element <NUM>, <NUM>' which is in turn engaged to the robotic manipulator, so that the sterile adapter <NUM>, <NUM>' and the manipulator connecting element <NUM>, <NUM>' together rotate with respect to the connector <NUM>, <NUM>' of the surgical drape and with the case <NUM>, <NUM>' as well.

According to an embodiment, the sterile adapter <NUM>, <NUM>' comprises a spring-loaded engaging pin <NUM> and the manipulator connecting element <NUM> ,<NUM>' comprises a respective spring-loaded counter-engaging pin <NUM>, to flag when the sterile adapter <NUM>, <NUM>' is coupled to the manipulator connecting element <NUM>, <NUM>'. When the sterile adapter <NUM>, <NUM>' is not coupled to the manipulator connecting element <NUM>, <NUM>', the spring-loaded counter-engaging pin <NUM> of the manipulator connecting element <NUM>, <NUM>' abuts against a proximal surface of the sterile adapter <NUM>, <NUM>', such as a part of the proximal coupling device <NUM> of the sterile adapter. When the sterile adapter <NUM>, <NUM>' is coupled to the manipulator connecting element <NUM>, <NUM>', the spring-loaded engaging pin <NUM> counter-engaging pin <NUM> are aligned and abut one toward the other, the counter engaging pin <NUM> of the manipulator connecting element <NUM>, <NUM>' penetrates in a respective seat <NUM> and acts as anti-rotation element that avoids relative rotation of the adapter <NUM> ,<NUM>' and the manipulator connecting element <NUM>, <NUM>', as shown for example in <FIG>: in other words, the counter engaging pin <NUM> of the manipulator connecting element <NUM>, <NUM>' when in said seat <NUM> of the sterile adapter <NUM>, <NUM>' abuts circumferentially against the walls of said seat <NUM> and avoids relative rotation between adapter <NUM>, <NUM>' and connecting element <NUM>, <NUM>'. In this way, the counter engaging pin <NUM> of the manipulator connecting element <NUM>, <NUM>' pushes distally said spring-loaded engaging pin <NUM>, thereby determining a flagging protrusion <NUM> to protrude distally from the distal portion of the sterile adapter <NUM>, <NUM>'. In the example of <FIG> the spring-loaded engaging pin <NUM> is associated to coil spring <NUM>' and the spring-loaded counter-engaging pin <NUM> is associated to flat spring <NUM>'. Preferably the elastic action of the flat spring <NUM>' overcomes the elastic action of the coil spring <NUM>'.

According to an embodiment, in order to disengage the sterile adapter <NUM>, <NUM>' from the manipulator connecting element <NUM>, <NUM>', the flagging protrusion <NUM> shall be pressed, thereby disengaging the spring-loaded counter-engaging pin <NUM>, so that the adapter <NUM>, <NUM>' is able to rotate to disengage from the manipulator connecting element <NUM>, <NUM>'.

According to a preferred embodiment, said sterile barrier assembly <NUM> further comprises at least one labyrinth seal device comprising said gap <NUM>, <NUM>' forming a rotatable seal. Preferably, said labyrinth seal device provides a tortuous path that prevents mutual contamination across the length of the tortuous path. An aspiration device may be functionally associated to the labyrinth seal to create a depression that cooperates with said labyrinth seal device to prevent contamination towards the distal side of the sterile barrier assembly <NUM>. According to a preferred embodiment, said at least one labyrinth seal device extends around the roll axis z-z. According to a preferred embodiment, said at least one labyrinth seal device contours said at least one drape opening <NUM>, <NUM>' and contours the frame <NUM> of said sterile adapter <NUM>, <NUM>'.

According to a preferred embodiment wherein said sterile barrier assembly <NUM> comprises a pair of sterile adapters <NUM> and <NUM>', a first gap <NUM> is provided between said first distal opening edge <NUM> of the surgical drape <NUM> and a first sterile adapter <NUM>, and a second gap <NUM>' is provided between said second distal opening edge <NUM>' of the surgical drape <NUM> and a second sterile adapter <NUM>'.

According to an embodiment, the at least one sterile adapter <NUM>, <NUM>' comprises a projection <NUM> or skirt <NUM> facing said gap <NUM>, <NUM>'. Preferably, said annular skirt <NUM> extends around the rounded rim <NUM> and delimits at least a portion of said gap <NUM>, <NUM>'. Thereby, said at least one gap <NUM>, <NUM>' is delimited at least partially by the skirt <NUM> of the sterile adapter <NUM>, <NUM>'. According to an embodiment, said skirt <NUM> of the at least one sterile adapter <NUM>, <NUM>'cooperates with the at least one annular connector <NUM>, <NUM>', and preferably with said annular rim <NUM>, <NUM>' thereof, to form said labyrinth seal device. As mentioned above, each skirt <NUM> comprises a proximal surface <NUM>, each proximal surface <NUM> distally delimiting a respective gap <NUM>, <NUM>'.

According to an embodiment, said at least one sterile adapter <NUM>, <NUM>' comprises a distal coupling device <NUM> suitable to form a connection, and preferably a detachable connection, with a surgical instrument <NUM>, <NUM>' suitable to perform robotic surgery to a patient anatomy. According to an embodiment, said distal coupling device <NUM> of the at least one sterile adapter <NUM>, <NUM>' comprises means for snap-fit engaging a portion of said surgical instrument <NUM>, <NUM>', for example said means for snap-fit engaging comprises a pair of elastic elongated tongues <NUM> each forming a free end. According to an embodiment, said distal coupling device <NUM> of the at least one second component of sterile barrier <NUM> comprises a housing <NUM> for receiving a backend portion <NUM>, <NUM>' of said at least one surgical instrument <NUM>, <NUM>'. Thanks to the provision of said proximal coupling device <NUM> and of said distal coupling device <NUM>, said at least one sterile adapter <NUM>, <NUM>' can detachably couple with a sterile surgical instrument <NUM>, <NUM>'.

According to an embodiment, bearings <NUM> are provided within said labyrinth seal device <NUM>.

According to a general embodiment, a robotic surgery system <NUM> comprises at least one sterile barrier assembly <NUM> according to any one of the embodiments described above.

Said robotic surgery system <NUM> further comprises at least one non-sterile robotic manipulator <NUM>, <NUM>' comprising a case <NUM>, <NUM>', and at least one roll motor <NUM>, and at least one rolling body <NUM>, <NUM>' suitable to pivot in respect to said case <NUM>, <NUM>'.

Said at least one connector <NUM>, <NUM>' of the surgical drape <NUM> of the sterile barrier assembly <NUM> is coupled with said case <NUM>, <NUM>' of the non-sterile robotic manipulator <NUM>, <NUM>'. The case <NUM>, <NUM>' preferably encases at least one motor, and preferably encases at least said roll motor <NUM>.

Said at least one sterile adapter <NUM>, <NUM>' of the sterile barrier assembly <NUM> is coupled with said at least one rolling body <NUM>, <NUM>' of the non-sterile robotic manipulator <NUM>, <NUM>'.

Said at least one roll motor <NUM> is suitable to move at least said one rolling body <NUM>, <NUM>' together with said at least one sterile adapter <NUM>. <NUM>' of a pivoting movement with respect to said case <NUM>, <NUM>' of the non-sterile robotic manipulator <NUM>, <NUM>'.

Said gap <NUM>, <NUM>' between the at least one connector <NUM>, <NUM>' of the surgical drape <NUM> and the at least one sterile adapter <NUM>, <NUM>' forms a rotatable seal, which prevents the non-sterile robotic manipulator to contaminate a sterile operatory field <NUM>.

According to a preferred embodiment, said at least one connector <NUM>, <NUM>' of the surgical drape <NUM> of the sterile barrier assembly <NUM> is coupled detachably and rigidly with said case <NUM>, <NUM>' of the non-sterile robotic manipulator <NUM>, <NUM>'.

According to a preferred embodiment, said at least one sterile adapter <NUM>, <NUM>' of the sterile barrier assembly <NUM> is coupled detachably and rigidly with said at least one rolling body <NUM>, <NUM>' of the non-sterile robotic manipulator <NUM>, <NUM>'.

According to a preferred embodiment, said rolling body <NUM>, <NUM>' houses at least one motor of the non-sterile robotic manipulator <NUM>, <NUM>' suitable for actuating a degree of freedom of a surgical instrument <NUM>, <NUM>' attached to the sterile adapter <NUM>, <NUM>'.

According to an embodiment, said robotic surgery system <NUM> comprises a master console <NUM>. According to an embodiment, said robotic surgery system <NUM> comprises a robotic slave assembly, suitable to be controlled by said master console <NUM>, said robotic slave assembly comprising a robotic cart <NUM> and at least one robotic arm <NUM> extending from the cart <NUM> and defining a proximal-distal direction Z-Z. At least one electronic control device may be located inside the robotic cart <NUM>.

According to an embodiment, said robotic surgery system <NUM> comprises at least one surgical instrument <NUM>, <NUM>' comprising a instrument shaft <NUM> extending substantially along the proximal-distal direction Z-Z and having a proximal end and a distal end, a surgical end effector <NUM> at the distal end of the shaft <NUM> and a backend portion <NUM>, <NUM>' at or near the proximal end of the shaft <NUM>. According to an embodiment, the backend portion <NUM>, <NUM>' is suitable to receive a pushing action transmitted through and across the second sheet <NUM> of the second component of sterile barrier <NUM>. According to an embodiment, the backend portion <NUM>, <NUM>' comprises a plurality of transmission rods or the like, suitable to be pushed in order to actuate at least one actuation cable [not shown] of the surgical instrument to in turn actuate the end effector <NUM>, for example a surgical wrist <NUM>. According to an embodiment, said transmission rods are linearly displaceable.

According to an embodiment, said sterile barrier assembly <NUM> is located proximally to, in other words upstream, said at least one surgical instrument <NUM>, <NUM>'. Thereby said sterile barrier assembly <NUM> is located upstream the backend <NUM>, <NUM>' of the at least one surgical instrument <NUM>, <NUM>'. According to an embodiment, said sterile barrier assembly <NUM> is located proximally to, in other words upstream, a shaft <NUM> of said at least one surgical instrument <NUM>, <NUM>'.

According to an embodiment, said robotic cart <NUM> comprises at least a ground contact unit <NUM>, for example a wheel <NUM>, suitable to support said robotic cart <NUM> resting on a floor of an operating arena. According to an embodiment, said at least one ground contact unit <NUM> is not draped by said surgical drape <NUM>.

According to an embodiment, said at least one robotic arm <NUM> comprises a plurality of arm links <NUM>, <NUM>', <NUM>", <NUM>‴ jointed one another in respective joints forming a kinematic chain. Said robotic arm <NUM> is preferably a passive arm devoid of motors designed to be moved by a human action, for example pulled by an operator. Said robotic arm <NUM> may comprise brake systems at the joint of said arm links <NUM>, <NUM>', <NUM>", <NUM>'". According to an embodiment, one of said arm links <NUM>, <NUM>', <NUM>", <NUM>‴ is connected to at least two motorized robotic manipulators <NUM>, <NUM>', suitable to manipulate a robotic end effector, for example a wrist <NUM> of a surgical instrument <NUM>, <NUM>', within a patient's body along a plurality of degrees of freedom.

Said robotic surgery system <NUM> comprises said at least one rolling body <NUM>.

According to an embodiment, said rolling body <NUM>, <NUM>' comprises, or is coupled to, said second component of sterile barrier <NUM>, so that said second component of sterile barrier <NUM> moves integrally with said rolling body <NUM>, <NUM>'.

According to an embodiment, each motorized manipulator <NUM>, <NUM>' comprises a case <NUM>, <NUM>' and at least a motor <NUM>, <NUM>.

According to an embodiment, said at least one motor <NUM>, <NUM> of the manipulator <NUM>, <NUM>' comprises at least one roll motor <NUM>, suitable to move a rolling body <NUM>, <NUM>' of a rolling movement about a rolling axis Z-Z in respect of said case <NUM>, <NUM>'.

According to a preferred embodiment, said at least one annular connector <NUM>, <NUM>' of the sterile barrier assembly <NUM> couples with said case <NUM>, <NUM>' of the manipulator <NUM>, <NUM>' and said at least one second component of sterile barrier <NUM> couples to said at least one rolling body <NUM>, <NUM>'. Bearings <NUM> may be provided between said at least one rolling body <NUM>, <NUM>' and said case <NUM>, <NUM>' of the manipulator <NUM>, <NUM>'. Preferably, said counter-coupling portion <NUM> is located on said case <NUM>, <NUM>', ad preferably on a distal portion of said case <NUM>, <NUM>'.

According to an embodiment, said at least one motor <NUM>, <NUM> of the manipulator <NUM>, <NUM>' further comprises at least one linear motor <NUM> suitable to move said rolling body <NUM>, <NUM>' along at least one linear direction, for example along the vertical direction, and preferably is suitable for moving said rolling body <NUM>, <NUM>' along three linear directions substantially orthogonal one another in respect of said case <NUM>, <NUM>'. Preferably, said at least one linear motor <NUM> acts proximally, in other words upstream, to said rolling motor <NUM>. According to an embodiment, said at least one manipulator <NUM>, <NUM>' comprises three linear guiding devices <NUM>, <NUM>, <NUM> coupled to said at least one linear motor <NUM>, and preferably each one coupled to a linear motor, and suitable for guiding the linear movement of the rolling body <NUM>, <NUM>' along three orthogonal directions, and at least one roll transmission element, for example a transmission belt, suitable to transmit a rolling action R from said roll motor <NUM> to said at least one rolling body <NUM>, <NUM>'.

According to a preferred embodiment, motors <NUM>, <NUM> are all provided proximally to, in other words upstream, the sterile barrier assembly <NUM>.

According to a preferred embodiment, said at least one surgical instrument <NUM>, <NUM>' is coupled to said rolling body <NUM>.

According to an embodiment, an anti-rotation system is provided designed to avoid relative rotation of the rolling body <NUM>, <NUM>' and the case <NUM>, <NUM>' of the manipulator <NUM>, <NUM>' during the coupling of the second component of sterile barrier <NUM> to said rolling body <NUM>. According to an embodiment, said anti-rotation system comprises a radially cantilevered element, radially protruding away to the rotation axis of the rolling body <NUM>, <NUM>', to abut against a radially inward block tooth of the case <NUM>, <NUM>'.

According to an embodiment, there are two motorized manipulators <NUM>, <NUM>' attached to a same link of a robotic arm <NUM>, each manipulator <NUM>, <NUM>' has three Cartesian degrees of freedom, the three Cartesian degrees of freedom of one manipulator <NUM> are parallel to the three Cartesian degrees of freedom of the other manipulator <NUM>'; downstream each manipulator <NUM>, <NUM>' is provided a roll motor <NUM> for moving a rolling body <NUM>, <NUM>' attached thereto of a rolling movement about a rolling axis Z-Z in respect of said case <NUM>, <NUM>'. Preferably, downstream the rolling body <NUM>, <NUM>' and preferably integral thereto, there is a instrument shaft having at its distal end an articulated end effector, for example having a pitch, a yaw and a grip degrees of freedom.

According to a preferred embodiment, and as mentioned above, shown for example in <FIG>, the gap <NUM>, <NUM>' is between the proximal surface <NUM> of the skirt <NUM> of the sterile adapter <NUM>, <NUM>' and the distal surface <NUM>, <NUM>' of the connector <NUM>, <NUM>' of the surgical drape <NUM>, wherein the sterile adapter <NUM>, <NUM>' is detachably connected to the manipulator connecting element <NUM>, <NUM>', and wherein the connector <NUM>, <NUM>' is detachably connected to the case <NUM>. Thereby the sterile adapter <NUM>, <NUM>' and the manipulator connecting element <NUM>, <NUM>' together rotate with respect to the surgical drape <NUM>, and at the same time the sterile adapter <NUM>, <NUM>' can be detached from the manipulator connecting element <NUM>, <NUM>' without requiring any action onto the surgical drape <NUM> nor on the connector <NUM>, <NUM>' of the surgical drape <NUM>. Thereby, the sterile adapter <NUM>, <NUM>' can be detached from, and/or connected to, the manipulator connecting element <NUM>, <NUM>' also during surgery without for this reason compromising the integrity of the surgical drape <NUM>, and in some embodiment event without touching any part of the surgical drape <NUM>.

According to a preferred embodiment, the sterile adapter <NUM>, <NUM>' is mounted to the robotic manipulator and is allowed to rotate with respect to the case <NUM>, <NUM>' without being received within the case <NUM>, <NUM>'. Rather the sterile adapter <NUM>, <NUM>', although comprising a membrane <NUM> which forms part of the sterile barrier assembly <NUM>, is distal to the surgical drape <NUM>.

According to an embodiment non necessarily combinable with the embodiments described above, a sterile adapter <NUM>, <NUM>' for a robotic surgery system <NUM> is suitable to transmit a plurality of linear actuation actions and a roll action from a non-sterile robotic manipulator <NUM>, <NUM>' to a sterile surgical instrument <NUM>, <NUM>' having a backend <NUM> and a shaft <NUM> extending from said backend portion <NUM>, wherein the sterile adapter <NUM>, <NUM>' comprises:.

wherein said stretchable membrane <NUM> seals said through opening forming a distal cavity <NUM> between said stretchable membrane <NUM> and said distal coupling device <NUM>, and wherein said distal cavity <NUM> is suitable for receiving at least a portion of the backend <NUM> of the sterile surgical instrument, and wherein said distal coupling device <NUM> comprises at least one abutment surface facing said stretchable membrane <NUM> and thereby at least partially delimiting said distal cavity <NUM>, and wherein said at least one abutment surface is suitable for a portion of the surgical instrument <NUM>, <NUM>', such as the backend <NUM>, to abut thereon.

The non-sterile robotic manipulator <NUM>, <NUM>' may comprise motors for exerting said plurality of linear displacement actions, for example motors actuating a plurality of pistons, each piston exerting one of said linear displacement actions on the same membrane <NUM> of the sterile adapter <NUM>, <NUM>'.

According to an embodiment, said distal cavity <NUM> includes lateral guiding surfaces apt to mate with at least one lateral countersurface of said sterile surgical instrument <NUM>, <NUM>', and wherein preferably said lateral guiding surfaces of the distal cavity <NUM> of the sterile adapter <NUM>, <NUM>' is substantially flat.

According to an embodiment said distal cavity <NUM> includes a lateral opening designed for inserting said sterile surgical instrument <NUM>, <NUM>' into the sterile adapter <NUM>, <NUM>'.

According to an embodiment, said distal coupling device <NUM> is designed to snap-fit engage with a portion of a surgical instrument <NUM>, <NUM>'.

According to an embodiment, said distal cavity <NUM> includes a second lateral opening suitable to access the distal cavity <NUM> with the purpose of pushing said sterile surgical instrument <NUM>, <NUM>' out from said distal cavity <NUM> of the sterile adapter <NUM>, <NUM>'.

According to an embodiment, said membrane <NUM> is in single flat piece.

According to an embodiment, said distal coupling device <NUM> defines a distal seat having a distal through opening that opens distally outside of the distal cavity.

According to an embodiment, said distal through opening is substantially aligned with the through opening that is sealed by the stretchable membrane <NUM>, and preferably is coaxial with the through opening that is sealed by the stretchable membrane <NUM>.

According to an embodiment, said at least one abutment surface is beneath the stretchable membrane <NUM>, and preferably under the encumber of the membrane <NUM>.

According to an embodiment, said frame <NUM> rigidly determines the reciprocal positioning and orientation of said proximal coupling device <NUM> and said distal coupling device <NUM>, and preferably of the lateral opening of the distal coupling device <NUM>.

According to an embodiment, the sterile adapter <NUM>, <NUM>' comprises a spring-loaded engaging pin <NUM> and the manipulator connecting element <NUM> ,<NUM>' comprises a respective spring-loaded counter-engaging pin <NUM>, to flag when the sterile adapter <NUM>, <NUM>' is coupled to the manipulator connecting element <NUM>, <NUM>', as previously described.

In the following will be described a method for mounting a sterile barrier assembly, and will be described a method for dismounting a sterile barrier assembly.

A method of mounting and/or dismounting a sterile barrier assembly of a robotic surgery system comprises the following steps:.

According to a mode of operation, the step of connecting and/or disconnecting a sterile adapter <NUM>, <NUM>' does not involve any action to the sterile drape <NUM>.

According to a mode of operation, the step of connecting comprises moving proximally the sterile adapter <NUM>, <NUM>', for example of a rotative motion such as to screw the adapter to the rolling body <NUM>, <NUM>', either directly or indirectly by means of interposition of a manipulator connecting element <NUM>, <NUM>'. When it is provided a manipulator connecting element <NUM>, <NUM>' interposed between the rolling body <NUM>, <NUM>' and the sterile adapter <NUM>, <NUM>', the step of connecting comprises moving proximally the sterile adapter <NUM>, <NUM>', for example of a rotative motion such as to screw the adapter <NUM>, <NUM>' to the manipulator connecting element <NUM>, <NUM>'.

According to a mode of operation, the step of disconnecting comprises moving proximally the sterile adapter <NUM>, <NUM>', for example of a rotative motion such as to unscrew the adapter to the rolling body <NUM>, <NUM>'. When it is provided a manipulator connecting element <NUM>, <NUM>' interposed between the rolling body <NUM>, <NUM>' and the sterile adapter <NUM>, <NUM>', the step of disconnecting comprises moving distally the sterile adapter <NUM>, <NUM>', for example of a rotative motion such as to unscrew the adapter <NUM>, <NUM>' from the manipulator connecting element <NUM>, <NUM>'.

According to a mode of operation, the method comprises firstly connecting the connector <NUM>, <NUM>' of the surgical drape <NUM> to the case <NUM>, <NUM>' of the manipulator <NUM>, <NUM>', and subsequently connecting the sterile adapter <NUM>, <NUM>' to the rolling body <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>'. When it is provided a manipulator connecting element <NUM>, <NUM>' interposed between the rolling body <NUM>, <NUM>' and the sterile adapter <NUM>, <NUM>', the step of connecting comprises firstly connecting the connector <NUM>, <NUM>' of the surgical drape <NUM> to the case <NUM>, <NUM>' of the manipulator <NUM>, <NUM>', and subsequently connecting the sterile adapter <NUM>, <NUM>' to the manipulator connecting element <NUM>, <NUM>' attached to the rolling body <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>'. Attaching the manipulator connecting element <NUM>, <NUM>' to the rolling body <NUM>, <NUM>' may be carried out before connecting the connector <NUM>, <NUM>' of the surgical drape <NUM> to the case <NUM>, <NUM>', so that connecting the connector <NUM>, <NUM>' of the surgical drape <NUM> to the case <NUM>, <NUM>' may be carried out after having attached the manipulator connecting element <NUM>, <NUM>' to the rolling body <NUM>, <NUM>'.

According to a mode of operation, the step of disconnecting comprises firstly disconnecting the sterile adapter <NUM>, <NUM>' from the rolling body <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>', and subsequently disconnecting the connector <NUM>, <NUM>' of the surgical drape <NUM> from the case <NUM>, <NUM>'. When it is provided a manipulator connecting element <NUM>, <NUM>' interposed between the rolling body <NUM>, <NUM>' and the sterile adapter <NUM>, <NUM>', the step of disconnecting comprises firstly disconnecting the sterile adapter <NUM>, <NUM>' from the manipulator connecting element <NUM>, <NUM>' attached to the rolling body <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>', and subsequently disconnecting the connector <NUM>, <NUM>' of the surgical drape <NUM> from the case <NUM>, <NUM>'. The method may also comprise the step of disattaching (i.e. disconnecting) the manipulator connecting element <NUM>, <NUM>' from the rolling body <NUM>, <NUM>', this step may be carried out after having disconnected the connector <NUM>, <NUM>' of the surgical drape <NUM> from the case <NUM>, <NUM>'.

Thereby, the sterile adapter <NUM>, <NUM>' may be the last component of the sterile barrier assembly to be connected.

Thereby, the sterile adapter <NUM>, <NUM>' may be the first component of the sterile barrier assembly to be disconnected.

According to a mode of operation, the step of connecting and/or disconnecting a sterile adapter <NUM>, <NUM>' is carried out during surgery.

In the light of the above, a method for mounting a sterile barrier assembly may comprise the steps of: firstly connecting at least one connector <NUM>, <NUM>' of a surgical drape <NUM> to at least one case <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>', and subsequently connecting at least one sterile adapter <NUM>, <NUM>' to the rolling body <NUM>, <NUM>' of the at least one robotic manipulator <NUM>, <NUM>', wherein the at least one robotic manipulator <NUM>, <NUM>' having its case <NUM>, <NUM>' already connected to the at least one connector <NUM>, <NUM>' of a surgical drape <NUM>. When two robotic manipulators <NUM>, <NUM>' are provided, a skilled in the art will understand that the method for mounting may comprise firstly connecting the connector <NUM>, <NUM>' to the case <NUM>, <NUM>' of either manipulator <NUM>, <NUM>', and subsequently connecting the respective sterile adapter <NUM>, <NUM>'.

In the light of the above, a method for dismounting a sterile barrier assembly may comprise the steps of: firstly disconnecting at least one sterile adapter <NUM>, <NUM>' from the rolling body <NUM>, <NUM>' of the at least one robotic manipulator <NUM>, <NUM>', wherein the at least one robotic manipulator <NUM>, <NUM>' having its case <NUM>, <NUM>' connected to the at least one connector <NUM>, <NUM>' of a surgical drape <NUM>, and subsequently disconnecting the at least one connector <NUM>, <NUM>' of the surgical drape <NUM> from at least one case <NUM>, <NUM>' of the robotic manipulator <NUM>, <NUM>'. When two robotic manipulators <NUM>, <NUM>' are provided, a skilled in the art will understand that the method for dismounting may comprise firstly disconnecting the sterile adapter <NUM>, <NUM>' from either manipulator <NUM>, <NUM>', and subsequently disconnecting the connector <NUM>, <NUM>' from the case <NUM>, <NUM>' of the respective manipulator <NUM>, <NUM>'.

According to a mode of operation, the method is carried out by means of a sterile barrier assembly and/or a robotic surgery system according to any of the embodiments described above.

By virtue of the features described above, provided either independently or in combination in particular embodiments, it is possible to meet the above mentioned needs providing the above cited advantages, and in particular:.

Those skilled in art may make many changes and adaptations to the embodiments described above or may replace elements with others which are functionally equivalent in order to satisfy contingent needs without however departing from the scope of the appended claims.

Claim 1:
Sterile barrier assembly (<NUM>) for a robotic surgery system (<NUM>) comprising:
- a surgical drape (<NUM>) having at least one drape opening (<NUM>, <NUM>');
- at least one connector (<NUM>, <NUM>') contouring said at least one drape opening (<NUM>, <NUM>') and suitable for coupling with a case (<NUM>, <NUM>') of a non-sterile robotic manipulator (<NUM>, <NUM>'); and
- at least one sterile adapter (<NUM>, <NUM>') having a frame (<NUM>) comprising a coupling device (<NUM>) for coupling with at least one surgical instrument (<NUM>, <NUM>'), said at least one sterile adapter (<NUM>, <NUM>') being suitable to be coupled with at least one rolling body (<NUM>, <NUM>') of the non-sterile robotic manipulator (<NUM>, <NUM>'), wherein said at least one rolling body (<NUM>, <NUM>') is suitable to pivot in respect to said case (<NUM>, <NUM>');
wherein
- the at least one connector (<NUM>, <NUM>') of the surgical drape (<NUM>) and the at least one sterile adapter (<NUM>, <NUM>') are made in separate pieces;
- the at least one sterile adapter (<NUM>, <NUM>') is suitable to pivot in respect of the at least one connector (<NUM>, <NUM>') of the surgical drape (<NUM>);
- between the at least one connector (<NUM>, <NUM>') of the surgical drape (<NUM>) and the at least one sterile adapter (<NUM>, <NUM>') it is provided a gap (<NUM>, <NUM>'); and wherein
said at least one connector (<NUM>, <NUM>') of the surgical drape (<NUM>) comprises a distal surface (<NUM>, <NUM>') facing distally and said sterile adapter (<NUM>, <NUM>') comprises a proximal surface (<NUM>) facing proximally,
said distal surface (<NUM>, <NUM>') of the connector (<NUM>, <NUM>') faces said proximal surface (<NUM>) of the sterile adapter (<NUM>, <NUM>') delimiting said gap (<NUM>, <NUM>');
said gap (<NUM>, <NUM>') prevents the non-sterile robotic manipulator to contaminate a sterile operatory field (<NUM>) while avoids direct connection of the sterile adapter (<NUM>, <NUM>') to the connector (<NUM>, <NUM>') of the surgical drape (<NUM>),
said gap (<NUM>, <NUM>') forms together with said at least one connector (<NUM>, <NUM>') and with said at least one sterile adapter (<NUM>, <NUM>') a rotatable seal, which avoids generating rotative friction onto the at least one connector and the at least one sterile adapter, while preserving sterility of the sterile operatory field.