Patent Description:
In particular, the present invention relates to a sterile adapter suitable to connect to a surgical instrument for robotic surgery.

The present invention also relates to a robotic surgery system.

The present invention also relates to a slave assembly for a robotic surgery system.

The present invention also relates to a method.

Robotic surgery apparatuses are generally known in the art and typically comprise at least one tele-operated robotic arm having a robotic motorized positioning system for moving a surgical end effector distally attached thereto, in order to perform surgical procedures to a patient. The need of miniaturization is strongly felt in the technical field of robotic surgery, particularly in microsurgery and laparoscopic surgery to reduce the invasiveness on the patient. Documents <CIT>, <CIT>, <CIT> and <CIT> in the name of the same Applicant disclose various solutions able to miniaturize the surgical end-effector by means of reduction of the size of the wrist of the surgical instrument attached at the distal end of the instrument shaft.

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 tele-operated system. Usually, a surgical drape wraps 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 for several interventions. The surgical drape may be provided with inserts, like rigid plastic plates, in order to form a connection interface with an active part of the robot.

For example, document <CIT> shows a solution of a sterile drape having annular external rim rotatably connected to another portion of the sterile drape having reciprocal annular opening, thereby forming a two-pieced sterile drape, wherein the sterile adapter has an inner frame describing a cross figure delimiting four cloves or slices, each clove receiving a pocket made of drape material, and wherein each pocket has rigid plates attached distally thereto, each plate having a capstan for transmitting through said plates a rotatable actuation actions from the robot to the surgical instrument. Those pockets comprise each an extra amount of drape material allowing to extend the pockets. This document also shows four additional sterile adapters attached distally to the four pockets and engaged with said rigid plates of the pockets.

Usually, a sterilized surgical end-effector, for example a clamp and/or a blade designed to operate on the patient, is attached at the active part of the robot through the connection interface of the sterile drape, as shown for example in document <CIT>. Therefore, the sterile drape is required to have a connection interface able to transmit action from the robot to the end-effector. In the above-mentioned example, the connection interface is provided with windows to permit a rack-and-pinion direct contact through each of said windows. Furthermore, sterile drapes can comprise also fixation strings that allow tying the sterile drape to close-fit an elongated portion of the robot, such as a robotic elongated arm, thereby reducing the volume of the sterile drape when in use. Examples are also known providing magnetic attachment between the robot and the drape.

The connection interface or adapter of the barrier, designed to transmit the actuation, may also be in form of foldable, frusto-conical cuffs designed to individually receive a motor piston, and those cuffs may be glued or otherwise secured to the active parts of the robot, as shown for example in document <CIT>. However, this known solution does not solve the problem and forces to glue the sterile barrier to the distal face of the non-sterile actuators. Tearing or breaking of the barrier material may result from the relative motion of the components required for transmission across the barrier, for example when such a transmission involves hoists or capstans, for example designed to wind multiple times in order to transmit motion. Pockets individually receiving a piston require very high deformation of each of the pockets, the drape material of the pockets results prone to tear if the drape material is not deformable enough or if it is deformable enough implies crumble of the drape material of each pocket during retraction of the piston individually received therein. Moreover, this known solution shows a sterile adapter having a rectangular box-shaped external body having a "C" shape delimiting an inner through hole defined by the "C"-shaped adapter body itself to receive the surgical instrument, which has to be inserted from the proximal side passing through such inner trough hole along a direction coincident with the longitudinal extension of the shaft of the surgical instrument, and that in turn requires to further reduce the usable surface area of each pocket.

Document <CIT> discloses a solution where three parallel male linear sliders engaged across a detachable rubber element with respective three parallel female sliders in order to transmit a linear displacement action parallel to the free surface of the detachable rubber element across the detachable rubber element. The detachable rubber element is detachably mounted on a surface of a rigid frame, the rigid frame having a circular external rim, and surface which the rubber element is detachably mounted to is orthogonal to the circular external rim and spaced from the circular rim in the distal direction.

Sterile adapters or interfaces are also known for example from documents: <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT><CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT><CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

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 manufacture and to assemble because of the requested alignment of actuators, stiffening elements and actuated elements.

Therefore, the need is felt to provide a solution for the transmission of an actuating action across a sterile barrier, without for this reason tearing the barrier.

It is felt the need of providing a sterile adapter able to detachably couple a surgical instrument for robotic surgery to a manipulator, so that to allow removal and exchange of the surgical instrument in a sterile operatory field.

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 slave robot assembly according to claim <NUM>.

Some preferred embodiments are the subject of dependent claims.

According to an aspect of the invention, a sterile adapter for a robotic surgery system is suitable to transmit a plurality of linear actuation actions and a roll action from a non-sterile robotic manipulator system to a sterile surgical instrument having a backend portion and a shaft extending from said backend portion.

The sterile adapter may be devoid of relatively movable parts to transmit said plurality of linear actuation actions and said roll action.

According to an aspect of the invention, the sterile adapter comprises a frame for transmitting the roll action from the non-sterile robotic manipulator system to the sterile surgical instrument, the frame comprising a proximal coupling device, for coupling with the non-sterile robotic manipulator system, and a distal coupling device, for coupling with the sterile surgical instrument, wherein said frame delimits a through opening between said proximal coupling device and said distal coupling device. The frame may be the outer frame of the sterile adapter. The opening may be circular.

According to an aspect of the invention, the sterile adapter comprises a membrane fixed to said frame sealing said through opening forming a distal cavity between said stretchable membrane and said distal coupling device of the frame.

According to an aspect of the invention, the membrane is designed for transmitting through the thickness thereof the plurality of localized linear actuation actions from the non-sterile robotic manipulator to the sterile surgical instrument.

According to an aspect of the invention, said membrane is elastically stretchable with the purpose to result elastically biased towards a substantially flat configuration thereof.

According to an aspect of the invention, said distal cavity is suitable for receiving at least a portion of the backend of the sterile surgical instrument, said distal coupling device comprises at least one abutment surface facing said stretchable membrane and thereby at least partially delimiting said distal cavity, said at least one abutment surface is suitable for a portion of the surgical instrument to abut thereon. For example, when in use, the backend of the surgical instrument abuts against said at least one abutment surface. Said at least one abutment surface may be located beneath the stretchable membrane, such as under the encumber of the membrane. The plurality of localized linear actuation actions may be able to exert a pushing action to load the surgical instrument against said at least one abutment surface.

Said distal cavity may include lateral guiding surfaces apt to mate with at least one lateral countersurface of said sterile surgical instrument, and preferably said lateral guiding surfaces of the distal cavity of the sterile adapter is substantially flat. Said lateral guiding surfaces are preferably non-parallel to the membrane, and more preferably orthogonal to the membrane. Said distal cavity may include a lateral opening designed for inserting said sterile surgical instrument into the sterile adapter. The insertion direction of the surgical instrument is therefore non-parallel to the shaft of the surgical instrument, and preferably is orthogonal to the shaft of the surgical instrument. Said distal coupling device may be designed to snap-fit engage with a portion of a surgical instrument, for example a portion of the backend and/or a portion of the shaft.

Said distal cavity may include a second lateral opening suitable to access the distal cavity with the purpose of pushing said sterile surgical instrument out from said distal cavity of the sterile adapter. Thereby also the detachment direction of the surgical instrument is non-parallel to the shaft of the surgical instrument, and preferably is orthogonal to the shaft of the surgical instrument.

Said membrane may be a single flat piece of material. Said membrane may be shaped as a disc. Said membrane may be integrally mounted to said frame so that not to rotate with respect of the frame. Said proximal coupling device and said distal coupling device of said frame may be made as a single piece. Said proximal coupling device and said distal coupling device of said frame may be devoid of any relative degree of freedom. Said frame may rigidly determine the reciprocal positioning and orientation of said proximal coupling device and said distal coupling device and preferably also of the lateral opening of the distal coupling device.

Said distal coupling device of the frame may define a distal seat having a distal through opening that opens distally outside of the distal cavity. Said distal through opening may be substantially aligned with the through opening that is sealed by the stretchable membrane, and may be coaxial with the through opening that is sealed by the stretchable membrane.

A flagging device may be provided flagging when the sterile adapter is coupled to the robotic manipulator system. The flagging device may comprise a flagging pin comprising a distal flagging end, protruding cantilevered from the frame body of the sterile adapter when the sterile adapter is coupled to the robotic manipulator system.

According to an aspect of the invention, a slave robot assembly for a robotic surgery system comprises a non-sterile robotic manipulator system, a sterile surgical instrument having a backend portion and a shaft extending from said backend portion, and a sterile adapter, suitable to transmit a plurality of linear actuation actions and a roll action from said non-sterile robotic manipulator system to said sterile surgical instrument, wherein said sterile adapter comprises a frame transmitting the roll action from the non-sterile robotic manipulator system to the sterile surgical instrument, and wherein said frame comprises a proximal coupling device, coupled with the non-sterile robotic manipulator system, and a distal coupling device, coupled with the sterile surgical instrument, and wherein said frame delimits a through opening between said proximal coupling device and said distal coupling device, and wherein said sterile adapter comprises a membrane fixed to said frame, transmitting through the thickness of the membrane the plurality of localized linear actuation actions from the non-sterile robotic manipulator to the sterile surgical instrument, and wherein said membrane is elastically stretchable with the purpose to result elastically biased towards a substantially flat configuration thereof, and wherein said stretchable membrane seals said through opening forming a distal cavity between said stretchable membrane and said distal coupling device; and wherein said distal cavity receives at least a portion of the backend of the sterile surgical instrument; and wherein said distal coupling device comprises at least one abutment surface facing said stretchable membrane and thereby at least partially delimiting said distal cavity; and wherein the surgical instrument abuts against said at least one abutment surface.

The surgical instrument may abut against additional abutment surfaces formed by the frame of the sterile adapter and delimiting said cavity and facing said membrane.

The geometric centre of the membrane may be aligned with the shaft of the sterile surgical instrument.

The plurality of localized linear actuation actions are directed orthogonally to a proximal surface and to a distal surface of the membrane. A plurality of pistons may be provided in said robotic motorized manipulator exerting said plurality of localized linear actuation actions. The pistons preferably extend orthogonally to the membrane.

The sterile adapter when in use may rotate together with the sterile surgical instrument, in other words the sterile adapter and the surgical instrument are integral in rotation when the roll action is transmitted to said frame of the sterile adapter.

The non-sterile robotic manipulator system may comprise a plurality of linear actuators, such as said plurality of pistons, and the membrane may be elastically preloaded against the distal end of at least one of said plurality of linear actuators when said at least one linear actuator of said plurality of linear actuators advances distally. For example, when said at least one linear actuator of said plurality of linear actuators retracts, the membrane may be detached from the distal end of said at least one linear actuator of said plurality of linear actuators. The backend of the surgical instrument may comprise a plurality of linear transmission elements individually aligned with the pistons of said plurality of pistons.

The plurality of localized linear actuation actions may be aligned with the shaft of the surgical instrument. Thereby the plurality of linear actuators, such as said plurality of pistons, are aligned to the shaft, as well as the plurality of transmission elements, such as rods, of the backend are aligned to the shaft.

The sterile adapter may be detachably coupled with said non-sterile robotic manipulator system. The surgical instrument may be detachably coupled with said sterile adapter.

The slave robot assembly may comprise at least a rotary joint transmitting said roll action to the surgical instrument by means of said frame of the sterile adapter. The slave assembly may comprise at least one roll motor, the roll motor may be operatively connected to said rotary joint.

A robotic surgery system may comprise said slave robot assembly and a master console controlling said slave robot assembly.

According to an aspect of the invention, a method for transmission of a roll action and of a plurality localized linear displacement actions across a sterile barrier comprises the step of providing a sterile adapter comprising a frame and a stretchable membrane fixed to said frame, the stretchable membrane being part of the sterile barrier, and the step of transmitting said roll action by means of the frame of the sterile adapter, and the step of transmitting said plurality of localized linear displacement actions by means of the membrane, through the thickness thereof. Each of the steps of transmitting said roll action and of transmitting said plurality of localized linear displacement actions may comprise transmitting to a surgical instrument.

The stretchable membrane may be a single membrane receiving said plurality of linear displacement action localized at various locations on the proximal surface of the single membrane.

Said plurality of localized linear displacement actions may be directed orthogonally to a proximal surface of the stretchable membrane.

Further characteristics and advantages of the sterile adapter, the assembly, the system and the method will appear from the description reported below 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 adapter <NUM> for a robotic surgery system <NUM>.

The sterile adapter <NUM> is suitable to transmit a plurality of linear displacement actions <NUM> and a roll action <NUM> from a non-sterile robotic manipulator system <NUM> to a sterile surgical instrument <NUM>, the sterile surgical instrument <NUM> having a backend portion <NUM> and a shaft <NUM> extending from the backend portion <NUM>.

Preferably, the terminology "surgical instrument" indicates also a "medical instrument" and the like.

Said sterile adapter <NUM> comprises a frame <NUM>, for transmitting the roll action <NUM> from the non-sterile robotic manipulator system <NUM> to the sterile surgical instrument <NUM>. The frame is preferably unsuitable to transmit the plurality of linear displacement actions <NUM>.

Preferably, the term "roll action" used herein means an action that activates a robotic roll joint <NUM> or a robotic twist joint. Preferably, the sterile adapter <NUM> is integrally attached to the link or body that is distal or acts as output link of the robotic roll or twist joint. Such a roll action is preferably motorized, but this does not mean that the sterile adapter <NUM> does house motors for exerting the roll action <NUM>. According to an embodiment, the term "roll action" may also encompass an action that activates a robotic revolving joint. According to an embodiment, said robotic manipulator system <NUM> comprises a roll motor <NUM> exerting said roll action <NUM>.

Said frame <NUM> of the sterile adapter <NUM> comprises a proximal coupling device <NUM>, for coupling with a non-sterile robotic manipulator system <NUM>.

Said frame <NUM> of the sterile adapter <NUM> comprises a distal coupling device <NUM> for coupling with a surgical instrument <NUM>.

Said frame <NUM> delimits a through opening between said proximal coupling device <NUM> and said distal coupling device <NUM>.

Advantageously, said sterile adapter <NUM> comprises a membrane <NUM> fixed to said frame <NUM>.

With additional advantage, said membrane <NUM> seals said through opening of the frame <NUM>, thereby forming a distal cavity <NUM> between said sterile membrane <NUM> and said distal coupling device <NUM> of the frame <NUM> of the sterile adapter <NUM>. Thereby, said membrane <NUM> is located between said proximal coupling device <NUM> and said distal coupling device <NUM>. The distal cavity <NUM> thereby forms a pouch for receiving the surgical instrument <NUM>.

Said membrane <NUM> is designed to transmit through the thickness <NUM> thereof the plurality of localized linear displacement actions <NUM> from the non-sterile robotic manipulator <NUM> to the sterile surgical instrument <NUM>.

According to an embodiment, said membrane <NUM> has a proximal non-sterile surface <NUM> and a distal sterile surface <NUM>, opposite to the proximal non-sterile surface <NUM>, and a membrane thickness <NUM> between said proximal non-sterile surface <NUM> and said distal sterile surface <NUM> of the membrane <NUM>. Thereby, the distal cavity <NUM> is between the distal sterile surface <NUM> of the membrane <NUM> and said distal coupling device <NUM>. Preferably, said membrane <NUM> is a piece of sheet material having a substantially two-dimensional area of extent and a thickness <NUM> that is much smaller than the extent of the sheet material in said two dimensions.

Preferably, the term "linear displacement action" means an action that displaces an element, for example a transmission element, in a linear manner and preferably said action displaces the element along a substantially straight path. For example, said linear displacement action is a pushing action. For example, one or more pistons push on the non-sterile surface <NUM> of the membrane, which in turn transmits the action exerted by such one or more pistons by means of the sterile surface <NUM> thereof on one or more transmission elements individually aligned along a straight direction with said one or more pistons.

Preferably, the terminology "plurality of localized linear displacement actions" means that said non-sterile surface of the membrane is urged by a plurality of pistons, and the linear displacement action is directed transverse to the sterile and non-sterile surfaces <NUM>, <NUM> of the membrane, so that each piston of the plurality of pistons pushes on a localized area of the non-sterile surface <NUM> of the membrane.

Said membrane <NUM> is elastically stretchable with the purpose to result elastically biased towards a substantially flat configuration thereof. According to an embodiment, said membrane <NUM> acts as a sterile drape. According to an embodiment, said membrane is made of flexible and stretchable sheet of transparent plastic material, for example polyethylene.

The provision of an elastically stretchable membrane allows the transmission of said plurality of localized linear displacement actions <NUM> through the thickness <NUM> of the membrane <NUM> by means of elastically flexing the membrane locally. Thereby volume of said distal cavity <NUM> is affected by the plurality of linear displacement actions <NUM> acting on the proximal surface <NUM> of said membrane <NUM>. In particular, the membrane <NUM> as being stretchable, elastically deforms when stretched by said plurality of localized linear displacement actions <NUM>, thereby modifying locally the volume of said distal cavity <NUM>. Thereby, when in use, the membrane <NUM> results elastically preloaded against the distal end of at least one piston of said plurality of pistons when said at least one piston advances and pushes the non-sterile surface <NUM> of the membrane transversally, and preferably orthogonally, with respect to the non-sterile surface <NUM> of the membrane <NUM>, so that to exert said linear displacement action <NUM>. The material of the membrane <NUM> and/or the geometric parameters of the membrane <NUM> may be chosen to guarantee that said elastically preload against the distal end of at least one piston of said plurality of pistons is substantially negligible when in use.

Preferably, said frame <NUM> is substantially rigid and is more rigid than the membrane <NUM>, in order not to stretch when said plurality of linear displacement actions <NUM> is exerted on said proximal non-sterile surface <NUM> of the membrane <NUM>.

According to a preferred embodiment, said membrane <NUM> is maintained tight by the frame <NUM>. According to an embodiment, the outer margin <NUM> of said membrane <NUM> is glued to said frame <NUM>. According to an embodiment, the outer margin <NUM> of said membrane <NUM> is pinched to said frame body <NUM>. According to an embodiment, the outer margin <NUM> of said membrane <NUM> is screwed to said frame body <NUM>.

With reference to the Figures, a proximal-distal direction is generally indicated with z-z. According to an embodiment, a radial direction R-R is further defined as the direction orthogonal to and incident with said proximal-distal direction z-z. The plurality of linear displacement actions <NUM> are transmitted along the proximal-distal direction z-z.

According to an embodiment, the volumetric encumber of the frame <NUM> of the sterile adapter <NUM> is contained in a cylindrical geometry, preferably a discoidal geometry, having a given radius along the radial direction R-R and a predefined length along the proximal-distal direction Z-Z. According to an embodiment, the radial size of the frame <NUM> is maximum near or at the proximal coupling device <NUM> thereof.

According to an embodiment, the pushing action <NUM> is directed along the proximal to distal direction z-z, that is to say transversal to the membrane and preferably orthogonal to the membrane <NUM>. Thereby, transmission of rotative action through the membrane <NUM> is avoided, thus reducing the risk of crumple the membrane <NUM>.

The provision of a stretchable membrane <NUM> allows the transmission of a plurality of localized linear displacement actions <NUM>, and preferably a plurality of localized pushing actions <NUM>, across the membrane <NUM> and through the thickness <NUM> of the membrane <NUM>, without for this reason plastically deforming the membrane <NUM>.

Thereby, the membrane <NUM> is able to transmit a plurality of localized linear displacement actions <NUM> from said proximal non-sterile side <NUM> to said distal sterile side <NUM> of the membrane <NUM>. According to an embodiment, the membrane <NUM> is also able to transmit a plurality of localized linear displacement actions <NUM> backwards, from said distal sterile side <NUM> to said proximal non-sterile side <NUM> of the membrane <NUM>.

Thanks to such a membrane <NUM>, the stretchable body of the membrane <NUM> itself acts as transmission element to transmit said a plurality of localized linear displacement actions <NUM> from the non-sterile proximal surface <NUM> to the sterile distal surface <NUM> of the membrane <NUM>.

Conversely, the membrane <NUM> is unsuitable for the transmission of said roll action <NUM>.

Thereby, it is avoided the need of providing the membrane <NUM> with rigid inserts acting as transmission elements. Therefore, it is also avoided the need of providing the membrane <NUM> with rigid plates, paddles and/or devices able to transmit a rotative action. Rotative action may be transmitted by the frame <NUM> of the sterile adapter <NUM>.

The provision of such a stretchable membrane <NUM> allows to locally deform in an elastic manner said membrane <NUM> for transmitting at least one linear displacement action <NUM> at time through the thickness <NUM> of the membrane <NUM>.

Said distal coupling device <NUM> comprises at least one abutment surface <NUM> facing said stretchable membrane <NUM> and thereby at least partially delimiting said distal cavity <NUM>.

Said at least one abutment surface <NUM> is suitable for a portion of the surgical instrument <NUM> to abut thereon. Such a portion of the surgical instrument <NUM> that abuts against said at least one abutment surface <NUM> of the distal coupling device <NUM> of the sterile adapter <NUM> may be either the backend portion <NUM> or the shaft <NUM> of the surgical instrument <NUM>.

According to a preferred embodiment, said at least one abutment surface <NUM> is beneath the stretchable membrane <NUM>. In other words, said at least one abutment surface <NUM> in under the encumber of the membrane <NUM>. In other words, said at least one abutment surface <NUM> of the distal coupling device <NUM> faces said membrane <NUM> and is contained in a prolongation along the proximal distal direction z-z of the encumber of said membrane <NUM>. In further other words, said at least one abutment surface <NUM> is under the shadow of the membrane <NUM>.

According to a preferred embodiment, said frame <NUM> rigidly determines the reciprocal positioning and orientation of said proximal coupling device <NUM> and said distal coupling device <NUM>. Preferably, said frame <NUM> rigidly determines the reciprocal positioning and orientation of the proximal coupling device <NUM> and the lateral opening <NUM> of the distal coupling device <NUM>. Preferably, the frame does not comprise hinges or movable parts or movable joints.

According to a preferred embodiment, the sterile adapter <NUM> comprises spacer walls <NUM>, <NUM>', preferably in number of two and located laterally with respect to said distal cavity <NUM>, said spacer walls <NUM>, <NUM>' space the membrane <NUM> from the distal coupling device <NUM> of a predefined distance, preferably along the proximal-distal direction z-z. The spacer walls <NUM>, <NUM>' act as guiding walls to guide the insertion into the distal sterile cavity <NUM> of said backend portion <NUM> of the surgical instrument <NUM>.

According to a preferred embodiment, each spacer wall <NUM>, <NUM>' comprises a lateral guiding surface <NUM>, <NUM>' delimiting partially said distal cavity <NUM> and adapted to mate with at least one lateral countersurface <NUM> of said sterile surgical instrument <NUM>. Preferably, each of said lateral guiding surfaces <NUM>, <NUM>' of the distal cavity <NUM> of the sterile adapter <NUM> is substantially flat. Preferably, said at least one lateral countersurface <NUM> of the surgical instrument <NUM> is substantially flat.

According to a preferred embodiment, said distal cavity <NUM> includes a lateral access opening <NUM> designed for inserting said sterile surgical instrument <NUM> into the sterile adapter <NUM>. Preferably, said lateral access opening <NUM> opens in a direction that is transverse to the proximal-distal direction z-z, for example it opens in the radial direction R-R.

According to a preferred embodiment, said distal cavity <NUM> includes a opposite lateral window <NUM> accessing the distal cavity <NUM> with the purpose of pushing said sterile surgical instrument <NUM> out from said distal cavity <NUM> of the sterile adapter <NUM>. In other words, said sterile distal cavity <NUM> opens in a lateral access opening <NUM>, or first lateral opening <NUM>, designed for the surgical instrument <NUM> or at least a portion thereof to access the distal cavity <NUM>, and opens in an opposite lateral window <NUM>, or second lateral opening <NUM>, designed to push the surgical instrument <NUM> or at least a portion thereof out from the distal cavity <NUM>, thereby causing the surgical instrument <NUM> to exit said cavity <NUM> passing through said first opening <NUM>, or lateral access opening <NUM>. According to an embodiment, said lateral access opening <NUM> is larger than said opposite lateral window <NUM>. Preferably, both said lateral access opening <NUM> and said opposite lateral window <NUM> are delimited by said frame <NUM>, and preferably by said spacer walls <NUM>, <NUM> of the frame <NUM>. Preferably, said lateral access opening <NUM> and said opposite lateral window <NUM> are opposite one another in respect of said frame <NUM>, and preferably in respect of said spacer walls <NUM>, <NUM>'.

According to a preferred embodiment, said distal coupling device <NUM> defines a distal seat <NUM> having a distal through opening <NUM> that opens distally outside of the distal cavity <NUM>. Thereby, the frame <NUM> of the sterile adapter <NUM> comprises a distal outer surface <NUM> preferably located distally to said distal coupling device <NUM> and facing opposite in respect of said at least one abutment surface <NUM>, and said distal through opening opens to said distal outer surface <NUM>.

According to a preferred embodiment, said distal through opening <NUM> is substantially aligned with the through opening that is sealed by the stretchable membrane <NUM>, preferably along the proximal-distal direction z-z.

According to an embodiment, said frame <NUM> defines an annular rim <NUM>, or circular rim <NUM>, forming the rim of the membrane <NUM>. According to a preferred embodiment, said annular rim <NUM> holds said membrane <NUM>. Thereby, the membrane <NUM> has a circumferential perimeter and preferably the membrane <NUM> has a circular body.

According to a preferred embodiment, said distal trough opening <NUM> of the sterile adapter <NUM> has an arched edge <NUM> having center of curvature aligned to the geometric center the rim <NUM> of the stretchable membrane <NUM>. Thereby, said distal trough opening <NUM> is coaxial with the through opening of the frame <NUM> that is sealed by the stretchable membrane <NUM>.

According to an embodiment, a lateral abutment wall <NUM> facing the distal seat <NUM> of the distal coupling device <NUM> is provided to delimit the bottom of the distal seat <NUM> and suitable to form an abutment surface for the surgical instrument <NUM> or a portion thereof, when the surgical instrument <NUM> is connected to the sterile adapter <NUM> by insertion in said distal cavity <NUM> through said lateral access opening <NUM>. According to an embodiment, a centering and positioning element <NUM> comprising preferably a notch is realized in or near the lateral abutment wall <NUM> of the sterile adapter <NUM>. According to an embodiment, said root portion <NUM> of the at least one elongated tongue <NUM> extends from said surgical instrument abutment wall <NUM>. The provision of such a centring and positioning element <NUM> is provided in order to operatively connect the surgical instrument <NUM> to the sterile adapter <NUM>, and said centring and positioning element <NUM> preferably determines the correct connection of the surgical instrument <NUM> to the sterile adapter <NUM>, for example in such way to guarantee a working alignment of each of the linear actuators <NUM> of the robotic manipulator system <NUM> with respective transmission elements <NUM> of the backend <NUM> of the surgical instrument <NUM>.

When in use, the distal coupling device <NUM> of the sterile adapter <NUM> snap-fit engages the counter-coupling device <NUM> of the surgical instrument <NUM>, thereby said elongated tongues <NUM>, <NUM>' retain the body of the counter-coupling device <NUM> towards the lateral abutment wall <NUM> of the receiving seat <NUM> of the sterile adapter <NUM>.

When the sterile adapter <NUM> rotates and carries a surgical instrument <NUM>, it rotates about an axis z-z that is coaxial with the shaft <NUM> of the surgical instrument <NUM>, which therefore pivots and does not revolute.

According to an embodiment, said membrane <NUM> is fixed to said annular rim <NUM>, and said annular rim <NUM> is made of said frame body <NUM>. According to an embodiment, the circular rim <NUM> comprises an inner edge <NUM> facing said membrane <NUM> and an outer annular edge. Said inner edge <NUM> may be annular in shape or may have projections <NUM> protruding radially inwards, and said projections <NUM> do not partition the membrane <NUM> so that to avoid discontinuities in the structure and in the dynamic behaviour of the membrane <NUM>. According to an embodiment, said inner edge <NUM> of the annular rim <NUM> facing the membrane <NUM> describes a single rim perimeter line <NUM>. According to an embodiment, said annular rim <NUM> has a constant extension in the radial direction R-R. According to a preferred embodiment, said membrane <NUM> is in single piece, preferably in a single flat piece or sheet of elastic material. In other words, the membrane is made monoblock. Thereby, the number of components of the sterile adapter <NUM> is reduced. Moreover, the risk of disengagement of parts of the membrane <NUM> is avoided.

According to a preferred embodiment, said membrane <NUM> forms a continuous surface. According to a preferred embodiment, said membrane <NUM> forms two opposite continuous surfaces <NUM>, <NUM>. According to an embodiment, the terminology "continuous surface" means that the structural and dynamic behaviour of the membrane <NUM> is continuous along the entire body of the membrane <NUM>, avoiding providing stiffening portions and/or stiffening plates, as well as through holes for the passage of an actuator and/or a transmission device. According to an embodiment, the terminology "continuous surface" means that the membrane <NUM> does not comprises discontinuities. For example, said discontinuities are holes and/or cuffs. Such discontinuities, for example cuffs, requires a forming process of manufacturing, for example thermoforming or the like, that plastically deforms the membrane <NUM> during manufacturing, creating said discontinuities. According to a preferred embodiment, said membrane <NUM> lies in plane, preferably orthogonal to the proximal-distal direction Z-Z. According to a preferred embodiment, said membrane <NUM> forms planar surfaces <NUM>, <NUM> and it is contained within the volumetric encumber of the frame body <NUM> of the sterile adapter <NUM>. According to an embodiment, the membrane <NUM> extends transversally and/or orthogonal to the proximal-distal direction Z-Z. According to an embodiment, said membrane <NUM> does not have folds. According to an embodiment, said membrane <NUM> has constant thickness <NUM>, for example comprised between <NUM> to <NUM> millimetres. According to an embodiment, said membrane <NUM> avoids comprising pockets for hosting an actuator and/or a transmission device or the like. According to an embodiment, said membrane <NUM> avoids comprising stiffened portions, for example comprising paddles, for transmitting a rotational movement through the membrane <NUM>.

According to a preferred embodiment, said distal coupling device <NUM> of the sterile adapter <NUM> is designed to snap-fit engage with a portion of a surgical instrument <NUM>. , and preferably with a counter-coupling portion <NUM> of the surgical instrument <NUM>.

According to a preferred embodiment, said distal coupling device <NUM> of the sterile adapter <NUM> comprises at least one elongated elastic tongue <NUM>, <NUM>' protruding cantilevered and thereby forming an end <NUM>, preferably a free end <NUM>, and a root portion <NUM>.

According to an embodiment, said distal coupling device <NUM> of the sterile adapter <NUM> comprises a distal seat <NUM> delimited at least partially by said at least one elongated tongue <NUM>, <NUM>', wherein said receiving seat <NUM> comprises a lateral access mouth facing towards the same engaging direction <NUM> of the lateral access opening <NUM> of the distal cavity <NUM>. According to an embodiment, said at least one elongated tongue <NUM>, <NUM>' is elastically biased to reduce the width of said access mouth <NUM> of the receiving seat <NUM> to form a snap-fit engagement with the surgical instrument <NUM>.

According to a preferred embodiment, said two elongated tongues <NUM> and <NUM>' are provided delimiting the access mouth there between to access the distal seat <NUM>, and preferably delimiting the distal seat <NUM>.

According to a preferred embodiment, the at least one elongated tongue <NUM>, <NUM>' is substantially parallel to the membrane <NUM>. In other words, the at least one elongated tongue <NUM>, <NUM>' extend transversally to said proximal-distal direction z-z.

According to an embodiment, said at least one elongated tongue <NUM>, <NUM>', and preferably each of said elongated tongues <NUM> and <NUM>', comprises an abutment portion or retaining portion <NUM>, <NUM>' facing said distal seat <NUM>. Thanks to said retaining portions <NUM>, <NUM>' of the elongated tongue <NUM>, <NUM>' suitable for snap-fit engaging the surgical instrument <NUM>, a constraining action is provided constraining the surgical instrument <NUM> within the distal seat <NUM> and preferably against said lateral abutment wall <NUM>. According to an embodiment, said retaining portions <NUM>, <NUM>' of the elongated tongues <NUM>, <NUM>' face said lateral abutment surface <NUM> of the distal seat <NUM>. According to an embodiment, said retaining portions <NUM>, <NUM>' are located on protrusions protruding inwardly towards the receiving seat <NUM> so that to make the access mouth <NUM> to the seat <NUM> narrower.

According to an embodiment, said access mouth of the distal seat <NUM> for the surgical instrument <NUM> is open in an engagement direction <NUM> transversal to the proximal-distal direction z-z so that the surgical instrument <NUM> can be connected to, and disconnected from, said sterile adapter <NUM> with a transversal movement along an engagement direction <NUM>. According to an embodiment, said engagement direction is parallel to or coincident with said radial direction R-R.

Thereby, the surgical instrument <NUM> can be connected to, and disconnected from, said sterile adapter <NUM> with a lateral displacement movement. In other words, the engagement direction <NUM> is transversal to the proximal-distal direction z-z. Thereby, the surgical instrument <NUM> can be disconnected from said sterile adapter <NUM> moving away from a patient anatomy and/or from an operatory bed. Thereby, the surgical instrument <NUM> can be connected to said sterile adapter <NUM> along said transverse engagement direction <NUM>.

According to an embodiment, said frame body <NUM> of the sterile adapter <NUM> delimits, between the membrane <NUM> and the distal coupling portion <NUM>, a distal cavity <NUM> designed to receive at least a portion of said backend portion <NUM> of the surgical instrument <NUM>. According to an embodiment, said housing <NUM> is open form the same side of the access mouth of the distal seat <NUM>, so that when the counter-coupling portion <NUM> of the surgical instrument <NUM> is detachably connected with the coupling device <NUM> of the sterile adapter <NUM>, the backend portion <NUM> is received within said distal cavity <NUM>.

The linear displacement actions <NUM> locally exerted on said proximal surface <NUM> of the membrane <NUM> determines a local stretch of the membrane <NUM> thereby transferring through the thickness <NUM> of the membrane <NUM> such linear displacement actions <NUM> to the backend <NUM> of the surgical instrument <NUM>, which comprises transmission elements <NUM>, for example rods, aligned with the linear actuators <NUM> of the robotic motorized manipulator system <NUM>.

According to an embodiment, said frame <NUM> delimits at least one ejection window <NUM>, suitable to permit the access to a portion of the surgical instrument <NUM> in order to push it for the removal from said distal cavity <NUM> of the sterile adapter <NUM>. Thereby, a quick disengagement action is allowed. Thereby, the backend portion <NUM> of the surgical instrument <NUM> also exits the housing <NUM>. For example, a hand pushing action <NUM> trough said ejection window <NUM> can disengage the surgical instrument <NUM> in a direction pointing away from the patient anatomy.

According to an embodiment, said window <NUM> faces opposite in respect of said access mouth <NUM>. According to an embodiment, said window <NUM> faces opposite in respect of the access side of the housing <NUM>.

According to an embodiment, said proximal coupling device <NUM> comprises threaded elements in order to be screwed to said robotic manipulator system <NUM>.

According to a preferred embodiment, said proximal coupling device <NUM> defines a circular shape defining an axial-symmetrical coupling body.

The provision of such an annular rim <NUM> allows the sterile adapter <NUM> to pivot about an axis, preferably parallel to said proximal-distal direction Z-Z, without for this reason to tear or crumble the membrane <NUM>. Tearing and crumbling of the membrane <NUM> will result in a loss of sterility of the surgical instrument <NUM>.

According to an embodiment, said proximal coupling device <NUM> is designed to form a bayonet type coupling with a portion of the robot manipulator system <NUM>. According to an embodiment, said proximal coupling device <NUM> comprises undercuts elements, undercut in respect of said proximal-distal direction Z-Z to couple with the robot manipulator system <NUM>.

According to an embodiment, said frame body <NUM> of the sterile adapter <NUM> comprises a skirt <NUM> of enlarged radial dimension near the proximal end thereof.

According to an embodiment, said frame <NUM> of the sterile adapter <NUM> comprises said proximal coupling device <NUM>, said distal coupling device <NUM>, spacer walls <NUM>, <NUM>' delimiting at least partially said housing <NUM> and said window <NUM> open in the radial direction R-R at opposite sides of the spacer walls <NUM>, <NUM>'.

According to an embodiment, said sterile adapter <NUM> comprises a flag device <NUM> flagging when the sterile adapter <NUM> is coupled to the robotic manipulator system <NUM>. According to an embodiment, said flagging device <NUM> comprises a flagging pin <NUM> comprising a distal pin end <NUM>, suitable for protruding cantilevered from the frame body <NUM> of the sterile adapter <NUM> when the sterile adapter <NUM> is coupled to the robotic manipulator system <NUM>, thereby flagging the event of successful coupling. According to an embodiment, said flagging device <NUM> comprises an elastic device <NUM> biasing the flagging pin <NUM> proximally, for example so that to bias the distal pin end <NUM> to be flush with the distal portion of the sterile adapter <NUM>. When the sterile adapter <NUM> is coupled to the robotic manipulator system <NUM>, the flagging pin <NUM> abuts against an abutment element <NUM> of the robotic manipulator system <NUM> against the biasing action exerted by the elastic device <NUM> thereby causing the distal pin end <NUM> of the flagging pin <NUM> to protrude distally from the sterile adapter <NUM>. A removable panel <NUM> may be provided for protecting the flagging device <NUM>.

According to an embodiment, the distal pin end <NUM> is made in separate piece in respect of the flagging pin <NUM>. According to an embodiment, said elastic device <NUM> of the connector <NUM> comprises an axial spring fitted around the flagging pin <NUM>. According to an embodiment, said flagging device <NUM> further comprises a flagging pin housing <NUM> receiving at least a portion of the flagging pin <NUM>. According to an embodiment, said flagging pin housing <NUM> receiving at least a portion of the flagging pin <NUM> forms a through hole extending substantially along the proximal-distal direction Z-Z through a sidewall <NUM>' of the frame body <NUM> of the sterile adapter <NUM>. Abutment surfaces may be provided in said flagging pin housing <NUM> to stop the displacement of the flagging pin <NUM> by means of cooperation with counter-abutment surfaces that may be provided to the pin <NUM>. For example, the pin <NUM> may have a flared portion suitable to abut against a surface of the housing <NUM>. According to an embodiment, the flagging pin <NUM> comprises an inclined segment <NUM> forming an angle with said proximal-distal direction Z-Z and suitable to abut against a surface of the housing <NUM>.

According to an embodiment, it is provided a mechanism that impedes to remove the sterile adapter from the connector when the surgical instrument is coupled to the sterile adapter.

According to an embodiment, the sterile adapter <NUM> transmits a plurality of linear actuation actions <NUM> and a roll action <NUM> from the non-sterile robotic manipulator system <NUM> to the sterile surgical instrument <NUM> having a backend portion <NUM> and a shaft <NUM> extending from said backend portion <NUM>, the sterile adapter <NUM> comprising said frame <NUM> transmitting the roll action <NUM> from the non-sterile robotic manipulator system <NUM> to the sterile surgical instrument <NUM>, the frame <NUM> comprising said proximal coupling device <NUM>, coupling with the non-sterile robotic manipulator system <NUM>, and said distal coupling device <NUM>, coupling with the sterile surgical instrument <NUM>, wherein said frame <NUM> delimits a through opening between said proximal coupling device <NUM> and said distal coupling device <NUM>; and wherein said sterile adapter <NUM> further comprising said membrane <NUM> fixed to said frame <NUM>, transmitting through the thickness <NUM> thereof the plurality of localized linear actuation actions <NUM> from the non-sterile robotic manipulator <NUM> to the sterile surgical instrument <NUM>; and wherein said membrane <NUM> is elastically stretchable resulting elastically biased towards a substantially flat configuration thereof; and 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> receiving at least a portion of the backend <NUM> of the sterile surgical instrument <NUM>; and wherein said distal coupling device <NUM> comprises at least one abutment surface <NUM> facing said stretchable membrane <NUM> and thereby at least partially delimiting said distal cavity <NUM>, said at least one abutment surface <NUM> being suitable for a portion of the surgical instrument <NUM> to abut thereon so that the surgical instrument <NUM> abuts against said at least one abutment surface <NUM>.

According to an embodiment, said membrane <NUM> has shape of a disc.

According to an embodiment, said membrane <NUM> is integrally mounted with said frame <NUM>.

According to an embodiment, said proximal coupling device <NUM> and said distal coupling device <NUM> of said frame <NUM> are made in single piece.

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

Said slave assembly <NUM> comprises at least one connector <NUM> coupled to the proximal coupling device <NUM> of the sterile adapter <NUM>. According to an embodiment, said connector <NUM> comprises a distal counter-coupling device <NUM> suitable to form a connection with said proximal coupling device <NUM> of the sterile adapter <NUM>. According to an embodiment, said distal counter-coupling device <NUM> of the connection <NUM> and the proximal coupling portion <NUM> of the sterile adapter <NUM> form a bayonet type engagement.

According to an embodiment, said slave assembly <NUM> comprises at least one robotic manipulator system <NUM> according to any one of the embodiments described above.

According to an embodiment, said slave assembly <NUM> comprises at least one surgical instrument <NUM> according to any one of the embodiments described above, and comprising a backend portion <NUM> and a shaft <NUM> extending from said backend portion <NUM>. According to a preferred embodiment, said lateral access opening <NUM> and said opposite lateral window <NUM> of the sterile adapter <NUM> are opposite one another in respect of said backend portion <NUM> of the surgical instrument <NUM>.

According to an embodiment, said slave robot assembly <NUM> for a robotic surgery system <NUM> comprises said non-sterile robotic manipulator system <NUM>, said sterile surgical instrument <NUM> having said backend portion <NUM> and said shaft <NUM> extending from said backend portion <NUM>, and said sterile adapter <NUM>, suitable to transmit a plurality of linear actuation actions <NUM> and a roll action <NUM> from said non-sterile robotic manipulator system <NUM> to said sterile surgical instrument <NUM>; wherein said sterile adapter <NUM> comprises said frame <NUM> transmitting the roll action <NUM> from the non-sterile robotic manipulator system <NUM> to the sterile surgical instrument <NUM>, and wherein said frame <NUM> comprises said proximal coupling device <NUM>, coupled with the non-sterile robotic manipulator system <NUM>, and said distal coupling device <NUM>, coupled with the sterile surgical instrument <NUM>; and wherein said frame <NUM> delimits a through opening between said proximal coupling device <NUM> and said distal coupling device <NUM>; and wherein said sterile adapter <NUM> comprises said membrane <NUM> fixed to said frame <NUM>, transmitting through the thickness <NUM> thereof the plurality of localized linear actuation actions <NUM> from the non-sterile robotic manipulator <NUM> to the sterile surgical instrument <NUM>; and wherein said membrane <NUM> is elastically stretchable resulting elastically biased towards a substantially flat configuration thereof; and wherein said stretchable membrane <NUM> seals said through opening forming said distal cavity <NUM> between said stretchable membrane <NUM> and said distal coupling device <NUM>; said distal cavity <NUM> receives at least a portion of the backend <NUM> of the sterile surgical instrument <NUM>; said distal coupling device <NUM> comprises at least one abutment surface <NUM> facing said stretchable membrane <NUM> and thereby at least partially delimiting said distal cavity <NUM>; and wherein the surgical instrument <NUM> abuts against said at least one abutment surface <NUM>.

According to an embodiment, the geometric center of the membrane <NUM> is aligned with the shaft <NUM> of the sterile surgical instrument <NUM>.

According to an embodiment, the plurality of localized linear actuation actions <NUM> are directed orthogonally to a proximal surface <NUM> of the membrane <NUM>.

According to an embodiment, the sterile adapter <NUM> rotates together with the sterile surgical instrument <NUM>.

According to an embodiment, the non-sterile robotic manipulator system <NUM> comprises a plurality of linear actuators <NUM> and the membrane <NUM> is elastically preloaded against the distal end of at least one of said plurality of linear actuators <NUM> when said at least one linear actuator <NUM> of said plurality of linear actuators <NUM> advances distally.

According to an embodiment, the plurality of localized linear actuation actions <NUM> are aligned with the shaft <NUM> of the surgical instrument <NUM>.

According to an embodiment, the plurality of localized linear actuation actions <NUM> exert a pushing action to load the surgical instrument <NUM> against said at least one abutment surface <NUM>.

According to an embodiment, said sterile adapter <NUM> is detachably coupled with said non-sterile robotic manipulator system <NUM> and/or wherein said surgical instrument <NUM> is detachably coupled with said sterile adapter <NUM>.

According to an embodiment, said slave robot assembly <NUM> comprises at least a rotary joint <NUM> transmitting said roll action <NUM> to the surgical instrument <NUM> by means of said frame <NUM> of the sterile adapter <NUM>.

According to an embodiment, said slave assembly <NUM> comprises at least one sterile drape <NUM> covering at least a portion of said robotic slave assembly <NUM> forming a sterile barrier suitable to impede contamination of the surgical instrument <NUM>.

Advantageously, said sterile drape <NUM> cooperates with said membrane <NUM> of the sterile adapter <NUM> to form a sterile barrier.

According to a preferred embodiment, said sterile adapter <NUM> is disposable. According to a preferred embodiment, said sterile adapter <NUM> is designed to be a single-use sterile adapter <NUM>.

According to an embodiment, said connector <NUM> comprises proximal connecting means <NUM> for connecting the connector <NUM> to the robotic manipulator system <NUM>.

According to an embodiment, said slave assembly <NUM> comprises a protective case <NUM> enclosing at least a portion of the robotic motorized manipulator system <NUM> and said connector <NUM>.

According to an embodiment, said connector <NUM> comprises a proximal flagging device <NUM> cooperating with the flagging device <NUM> of the sterile adapter <NUM> to flag when the sterile adapter <NUM> is coupled with the non-sterile connector <NUM>. According to an embodiment, said proximal flagging device <NUM> comprises said abutment portion <NUM> for a proximal end of the flagging pin <NUM> of the flagging device <NUM>. According to an embodiment, said proximal flagging device <NUM> comprises an elastic element <NUM> biasing said abutment portion <NUM>, for example the distal end of an abutting pin <NUM>, distally towards the flagging pin <NUM> of the flagging device <NUM> of the sterile adapter <NUM>. Guiding elements, such as walls of a cavity, may be provided to align the flagging pin <NUM> and the abutment pin <NUM> along the proximal-distal direction Z-Z and to guide the displacement thereof in the proximal-distal direction Z-Z.

According to an embodiment, said elastic element <NUM> of the connector <NUM> comprises a leaf spring secured to a portion of the connector <NUM>. According to an embodiment, said elastic element <NUM> is form-fitted with said abutment pin <NUM> in order to not to slide along the body of said abutment pin <NUM>.

According to an embodiment, said connector <NUM> has substantially an annular shape suitable to pivot about an axis, preferably coinciding with said proximal-distal direction Z-Z. Thereby, the proximal connection portion <NUM> of the connector <NUM> is suitable to transmit rotative action <NUM> to the connector <NUM> and the distal counter-coupling device <NUM> of the connector is suitable to transmit rotative action to the sterile adapter <NUM> comprising the membrane <NUM>. This way, the connector <NUM>, the sterile adapter <NUM> and the surgical instrument <NUM> can integrally pivot in respect of the protective case <NUM>. In other words, the connector <NUM>, the sterile adapter <NUM> and the surgical instrument <NUM> can pivot all together as a single piece in respect of the protective case <NUM>, when actuated by a rotative actuator <NUM>.

According to an embodiment, said connector <NUM> has substantially an annular shape that contours an inner cavity <NUM> suitable for receiving said linear actuators <NUM> of the robotic manipulator system <NUM>. According to an embodiment, said inner cavity <NUM> is a through hole extending in the proximal-distal direction Z-Z. Thus, said shaft <NUM> of the surgical instrument <NUM> is integral with the backend portion <NUM> so that no relative pivoting action is allowed. Thereby, no motors are needed downstream the membrane <NUM> allowing the miniaturization of the surgical instrument and particularly of the wrist <NUM>.

According to an embodiment, said inner cavity <NUM> of the connector <NUM> is delimited distally by the membrane <NUM> of the sterile adapter <NUM>. In other words, the housing <NUM> of the sterile adapter <NUM> and the inner cavity <NUM> of the connector <NUM> are partitioned by means of interposition of said stretchable membrane <NUM>. Thereby, linear actuators of the manipulator system <NUM> and transmission rods of the backend <NUM> received in said inner cavity <NUM> and in said housing, respectively, can exchange pushing actions <NUM> through the body of the stretchable membrane <NUM>.

According to an embodiment, said elastic device <NUM> of the connector <NUM> may form a part of an anti-rotation system <NUM> designed to avoid relative rotation of the connector <NUM> and the sterile adapter <NUM> during the coupling of the sterile adapter <NUM> to the connector <NUM>.

According to an embodiment, said anti-rotation system <NUM> comprises a radially cantilevered element <NUM>, radially protruding away to the rotation axis of the connector <NUM> and/or of the adapter <NUM>, to abut against a radially inward block tooth <NUM> of the protective case <NUM>. According to an embodiment, the elastic device <NUM> of the connector <NUM> biases distally the radially cantilevered element <NUM>.

When the abutting pin <NUM> of the connector <NUM> engages the flagging pin <NUM> of the sterile adapter <NUM> biasing distally the distal pin end <NUM> of the flagging pin <NUM>, the radially cantilevered element <NUM> of the anti-rotation system <NUM> is moved distally so that it avoids abutting against the block tooth <NUM>, thereby allowing relative pivot of both the connector <NUM> and the sterile adapter <NUM> in respect of the protective case <NUM> of the slave robot assembly <NUM>.

By means of pressing the distal pin end <NUM> of the flagging pin <NUM> towards the proximal direction, it is possible to unlock, for example unscrew, the sterile adapter <NUM> from the connector <NUM>. Preferably, an anti-removal mechanism <NUM> is provided in order to avoid unlocking the sterile adapter <NUM> from the connector <NUM> when a surgical instrument <NUM> is received within said cavity <NUM> of the sterile adapter <NUM>. Preferably, said anti-removal mechanism <NUM> is comprises an abutment surface integral with the distal pin end <NUM> of the flagging pin <NUM> and that faces the cavity <NUM> of the sterile adapter <NUM>, said abutment surface of the anti-removal mechanism <NUM> is suitable to abut against a portion of the surgical instrument thereby preventing the distal end <NUM> of the flagging pin <NUM> to be pressed proximally. When the surgical instrument is out from the cavity <NUM>, then the flagging pin <NUM> is free to move distally when pressed onto said flagging pin end <NUM>, thus disengaging the sterile adapter <NUM> from the connector <NUM>. Thereby the pin distal end <NUM> acts as a unlock button for the sterile adapter <NUM> and the anti-removal mechanism <NUM> acts a safety device preventing to detach the sterile adapter <NUM> from the robotic slave assembly <NUM> while the surgical instrument <NUM> is received within the housing <NUM>. The abutment surface of the anti-removal mechanism <NUM> may also be provided not integrally formed with the distal pin end <NUM> of the flagging pin <NUM>.

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

The robotic surgery system <NUM> may comprise also at least one master console <NUM> controlling said slave robot assembly <NUM>.

The robotic surgery system <NUM> may comprise any of the features or combination thereof described above in relation of the robotic surgery system <NUM>.

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

According to a preferred embodiment, said robotic surgery system <NUM> comprises at least a pair of robotic motorized manipulator systems <NUM> both connected to a single robotic positioning arm link <NUM>.

According to a preferred embodiment, said proximal non-sterile surface <NUM> of the membrane <NUM> of the sterile adapter <NUM> faces said non-sterile robotic manipulator system <NUM>, and said sterile surface <NUM> of the membrane <NUM> faces said surgical instrument <NUM>.

Advantageously, said robotic surgery system <NUM> comprises at least a rotary joint <NUM> or roll joint <NUM> or twist joint <NUM>. Preferably, said at least one rotary joint <NUM> is a twist joint suitable to transmit said roll action <NUM> by means of the frame <NUM> of the sterile adapter <NUM>.

According to a preferred embodiment, said sterile adapter <NUM> is integrally connectable to said roll joint <NUM> in order to rotate with it.

When the sterile adapter <NUM> rotates and carries a surgical instrument <NUM>, it rotates about an axis z-z that is coaxial with the shaft <NUM> of the surgical instrument <NUM>, which therefore pivots and does not revolute, forming such a roll joint <NUM> transmitting said roll action <NUM>.

According to a preferred embodiment, said plurality of localized pushing actions <NUM> urge said sterile surgical instrument <NUM> against said at least one abutment surface <NUM> of the sterile adapter <NUM>.

According to a preferred embodiment, said sterile surgical instrument <NUM> comprises at least one distal counter-abutment surface <NUM> abutting against said at least one abutment surface <NUM> of the sterile adapter <NUM>.

According to a preferred embodiment, said robotic surgery system <NUM> comprises an anti-rotation system <NUM>, designed to avoid relative rotation of the connector <NUM> and the sterile adapter <NUM> during the coupling of the sterile adapter <NUM> to the connector <NUM>; and/or wherein.

According to a preferred embodiment, said anti-rotation system <NUM> comprises a radially cantilevered element <NUM>, radially protruding away to the rotation axis of the connector <NUM> and/or of the adapter <NUM>, to abut against a radially inward block tooth <NUM> of a protective case <NUM> of robotic surgery system <NUM>.

According to a preferred embodiment, said robotic surgery system <NUM> further comprises at least a surgical instrument <NUM> comprising a instrument shaft <NUM> extending substantially along the proximal-distal direction Z-Z and having a proximal end <NUM> and a distal end <NUM>, a surgical end effector <NUM> at the distal end <NUM> of the shaft <NUM>, a backend portion <NUM> connected to the proximal end <NUM> of the shaft <NUM>, a counter-coupling device <NUM> located near or at the proximal end <NUM> of the shaft <NUM> suitable for forming a snap-fit engagement with said distal coupling device <NUM> of the sterile adapter <NUM>.

According to a preferred embodiment, in order to transmit said pushing action <NUM>, the proximal surface <NUM> of the membrane <NUM> comes into contact with a distal surface of a linear actuator <NUM> of the robotic manipulator system <NUM>, and as the linear actuator <NUM> advances distally, the body of the membrane <NUM> stretches so that the distal surface <NUM> of the membrane <NUM> comes into contact with a proximal surface of a transmission rod <NUM> of the backend portion <NUM> of the surgical instrument <NUM>.

According to a preferred embodiment, said counter-coupling device <NUM> is located near or at the proximal end <NUM> of the shaft <NUM> of the surgical instrument <NUM>.

According to a preferred embodiment, said counter-coupling device <NUM> of the surgical instrument <NUM> comprises body having a tapered shape, for example a frusto-conical shape, in order to form-fit the size of the distal seat <NUM>. According to a preferred embodiment, the body of said counter coupling device <NUM> tapers towards the distal end <NUM> of the shaft <NUM>.

The provision of a tapered body of said counter-coupling device <NUM> of the surgical instrument <NUM> allows to form-fit the receiving seat <NUM> of the sterile adapter <NUM> when the backend portion <NUM> is pushed distally as effect of the pushing action <NUM> exerted on the transmission rods <NUM> of the backend portion <NUM> of the surgical instrument <NUM>.

According to an embodiment, said surgical instrument <NUM> comprises a instrument shaft <NUM> extending substantially along the proximal-distal direction z-z and having a proximal end <NUM> and a distal end <NUM>, a surgical end effector <NUM> at the distal end of the shaft <NUM> and a backend portion <NUM> at or near the proximal end of the shaft <NUM>.

The shaft <NUM> preferably extend along a direction that is aligned and preferably coaxial with both the distal opening <NUM> of the coupling device <NUM> of the sterile adapter <NUM> and the opening of the frame <NUM> of the sterile adapter <NUM> that is sealed by the membrane <NUM>. In other words, the shaft <NUM> is designed for not to revolute, but instead to pivot or roll around its axis of longitudinal development when the sterile adapter <NUM> rolls or twists in respect of the protective case <NUM> and/or a reference point of the motorized manipulator system <NUM> or of the robotic surgery system <NUM>.

According to an embodiment, the backend portion <NUM> is suitable to receive the pushing action <NUM> transmitted through and across the membrane <NUM>. According to an embodiment, the backend portion <NUM> comprises a plurality of transmission rods <NUM> or the like, suitable to be pushed in order to actuate at least one actuation cable <NUM> 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 <NUM> are linearly displaceable.

According to an embodiment, the backend portion <NUM> houses said transmission rods <NUM> and a proximal portion of said actuation cables <NUM> or tendons <NUM>.

According to an embodiment, in order to transmit said plurality of localized linear displacement actions <NUM>, the proximal non-sterile surface <NUM> of the membrane <NUM> comes into contact with a distal portion <NUM> of a linear actuator <NUM> of the robotic manipulator system <NUM>, and as the linear actuator <NUM> advances distally, the body of the membrane <NUM> stretches so that the distal surface <NUM> of the membrane <NUM> comes into contact with a proximal portion <NUM> of a transmission element <NUM> of the backend portion <NUM> of the surgical instrument <NUM>. According to an embodiment, said linear actuator <NUM> is suitable to exert a pushing action <NUM>.

According to an embodiment, said robotic manipulator system <NUM> is a portion of a slave assembly <NUM> of said robotic surgery system <NUM> and is suitable to be controlled by means of a master console <NUM> of said robotic surgery system <NUM>.

According to an embodiment, said robotic manipulator system <NUM> comprises a plurality of motorized actuators, able to actuate linear actuators <NUM> for exerting said pushing action <NUM>, and preferably, said linear actuators <NUM> are linearly displaceable along the proximal-distal direction z-z.

According to an embodiment, said robotic manipulator system <NUM> further comprises a rotative actuator <NUM> suitable to make the sterile adapter <NUM> to pivot around a rotation axis, preferably parallel to the proximal-distal direction z-z, and preferably coinciding with said proximal-distal direction z-z.

A method of transmission of a roll action <NUM> and of a plurality localized linear displacement actions <NUM> across a sterile barrier will be described in the following.

The method of transmission of a roll action <NUM> and of a plurality localized linear displacement actions <NUM> across a sterile barrier comprises the following steps:.

Preferably, said roll action <NUM> and said plurality of localized linear displacement actions <NUM> are exerted by at least one motorized manipulator system <NUM>. Motors of the at least one motorized manipulator system <NUM> may be housed within a motor box or motor housing <NUM> preferably covered by a protective case <NUM>. The motors of the motorized manipulator system <NUM> are preferably upstream the sterile adapter. Distally to the sterile adapter, a surgical instrument may be connected, and the surgical instrument may comprise a shaft having at or near the distal end thereof an articulated end effector comprising a pitch, a yaw and a grip degrees of freedom, which are all actuated by the linear displacement actions transmitted through the membrane <NUM> of the sterile adapter, which in turn actuates actuation cables connected to the articulated end effector through the shaft.

According to a preferred mode of operation, the sterile adapter <NUM> according to any of the embodiments described above is designed to perform the method steps mentioned above. Thereby, the method comprises the step of providing a sterile adapter <NUM> according to any of the embodiment described above.

According to a preferred mode of operation, the slave assembly <NUM> according to any of the embodiments described above is designed to perform the method steps mentioned above. Thereby, the method comprises the step of providing a slave assembly <NUM> according to any of the embodiment described above.

According to a preferred mode of operation, the robotic surgery system <NUM> according to any of the embodiments described above is designed to perform the method steps mentioned above. Thereby, the method comprises the step of providing the robotic surgery system <NUM> according to any of the embodiment described above.

Thanks to the features described above provided either together or disjointly in particular embodiments, it is allowed to respond to the above-mentioned needs providing the above cited advantages, and in particular:.

Claim 1:
Slave robot assembly (<NUM>) for a robotic surgery system (<NUM>) comprising:
- a non-sterile robotic manipulator system (<NUM>);
- a sterile surgical instrument (<NUM>) having a backend portion (<NUM>) and a shaft (<NUM>) extending from said backend portion (<NUM>);
- a sterile adapter (<NUM>), suitable to transmit a plurality of linear actuation actions (<NUM>) and a roll action (<NUM>) from said non-sterile robotic manipulator system (<NUM>) to said sterile surgical instrument (<NUM>);
wherein said sterile adapter (<NUM>) comprises a frame (<NUM>) transmitting the roll action (<NUM>) from the non-sterile robotic manipulator system (<NUM>) to the sterile surgical instrument (<NUM>),
and wherein said frame (<NUM>) comprises a proximal coupling device (<NUM>), coupled with the non-sterile robotic manipulator system (<NUM>), and a distal coupling device (<NUM>), coupled with the sterile surgical instrument (<NUM>);
and wherein said frame (<NUM>) delimits a through opening between said proximal coupling device (<NUM>) and said distal coupling device (<NUM>);
and wherein said sterile adapter (<NUM>) comprises a membrane (<NUM>) fixed to said frame (<NUM>), transmitting through the thickness (<NUM>) thereof the plurality of localized linear actuation actions (<NUM>) from the non-sterile robotic manipulator (<NUM>) to the sterile surgical instrument (<NUM>);
and wherein the localized linear actuation actions of said plurality are directed orthogonally to a proximal surface (<NUM>) of the membrane (<NUM>);
and wherein said membrane (<NUM>) is elastically stretchable resulting elastically biased towards a substantially flat configuration thereof;
and 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>);
- said distal cavity (<NUM>) receives at least a portion of the backend (<NUM>) of the sterile surgical instrument (<NUM>);
- said distal coupling device (<NUM>) comprises at least one abutment surface (<NUM>) facing said stretchable membrane (<NUM>) and thereby at least partially delimiting said distal cavity (<NUM>);
- the surgical instrument (<NUM>) abuts against said at least one abutment surface (<NUM>).