Patent ID: 12245837

DETAILED DESCRIPTION OF SOME EMBODIMENTS

According to a general embodiment, a sterile master input handle assembly302for a robotic surgery system300comprises a non-sterile manipulandum310and a sterile surgical drape303draping said non-sterile manipulandum310.

According to a preferred embodiment, said non-sterile manipulandum310is a non-sterile master controller310for a master-slave robotic surgery system300.

According to a preferred embodiment, said non-sterile manipulandum310is per se unsuitable to be re-used within a sterile environment, such as a sterile operatory field311.

According to a preferred embodiment, said non-sterile manipulandum310has body suitable for being hand-held by a surgeon.

Not necessarily said non-sterile manipulandum310is mechanically ungrounded from a master console350of the robotic surgery system300, although according to a preferred embodiment said non-sterile manipulandum310is mechanically ungrounded.

According to a preferred embodiment the non-sterile manipulandum310is mechanically ungrounded, mechanically unconstrained from the robotic surgery system300and the non-sterile manipulandum310is designed to cooperate with a tracking system339of the robotic surgery system300, such as an optical and/or magnetic tracking system, so that the position and/or orientation of the non-sterile manipulandum within a predefined work volume320can be tracked by the tracking system339for controlling a paired slave surgical instrument.

The sterile drape303may be a loose or close-fit sheet of surgical drape material, or it may be partly loose and partly close-fit, and is for example made of polymer material. For example, the body of the surgical drape303is made of flexible sheet, such as polyethylene, and/or polyurethane, and/or polyester.

According to an embodiment, said sterile drape303comprising body having an inner surface304, or non-sterile surface304, and an outer surface305, or sterile surface305, opposite to said inner non-sterile surface304. Thereby, the outer surface305of the surgical drape303is designed to face the surgeon, and the inner surface304of the sterile drape303is designed to face said non-sterile manipulandum310. According to a preferred embodiment, the body of the surgical drape303forms a drape cavity322for enclosing at least a portion of said non-sterile manipulandum310with the purpose of preserve sterility of the manipulandum310. Thereby, the inner surface304of the drape303faces the cavity322. The drape cavity322may be tight sealed or opened forming an opening331to access the cavity322that leads to said outer surface305of the surgical drape303from the cavity322.

Said sterile master input handle assembly302comprises at least one sterile accessory306, suitable to form a sterile interface of the sterile master input handle assembly302for the surgeon fingers. According to an embodiment, said at least one sterile accessory306forms a sterile handgrip of said sterile master input handle assembly302.

Said at least one sterile accessory306mechanically engages with said non-sterile manipulandum310across said sterile surgical drape303. Preferably, said mechanic engagement does not tear the sterile drape303, in other words said the at least one sterile accessory306mechanically engages with said non-sterile manipulandum310across said sterile drape303while preserving the integrity of the sterile drape303.

According to a preferred embodiment, said at least one sterile accessory306is made as a single piece, for example of molded polymer material that is harder and/or stiffer than the sterile drape303. For example, the accessory306is made of a rigid shell, for example a molded polymeric rigid shell, for example made of polyethylene, and/or polyurethane, and/or polyester.

According to a preferred embodiment, a connector308is provided on said accessory306in order to mechanically engage with said non-sterile manipulandum310across said sterile drape303. Said connector308may be integral with said accessory306and may snap-fit said non-sterile manipulandum310.

Advantageously, said at least one sterile accessory306covers at least one portion of the outer surface305of the surgical drape303. Thereby, at least one portion of the sterile drape303results interposed between said at least one accessory306and at least one portion of said non-sterile manipulandum310.

With additional advantage, said at least one sterile accessory306includes at least one interface surface307forming said sterile interface for the surgeon fingers to manipulate the non-sterile manipulandum310across said sterile surgical drape306.

Thanks to such a sterile accessory306it is possible to make the non-sterile manipulandum310, which is draped, easier to handle for a surgeon, for example by a single hand of the surgeon.

At the same time, it is allowed to re-use the same non-sterile manipulandum310by means of sterilizing the accessory306and/or by means of providing a new sterile accessory306for a new surgery and/or a new step of the same surgery. Preferably, said accessory306can be sterilized with sterilization means for sterile operatory room, such as for example autoclave.

According to an embodiment, said at least one interface surface307is suitable for facing the surgeon and for forming said sterile interface for the surgeon fingers to manipulate the non-sterile manipulandum310across said sterile surgical drape306, when in use.

The sterile master input handle assembly302is designed to receive a manual command for actuating a robotic slave assembly330, suitable for performing surgery, preferably microsurgery, to a patient's anatomy, of a master-slave teleoperated robotic microsurgery system300. According to an embodiment, said at least one sterile accessory306covers at least one portion of the outer surface305of the surgical drape303that in turn covers at least one portion of said non-sterile manipulandum310that has or forms a grip controller designed for controlling a paired slave grip degree of freedom of a robotically actuated slave surgical instrument337operatively connected to said sterile master input handle302. Thereby, the surgeon by means of acting, for example pressing or pushing, on said interface surface307of the accessory306is able to control a paired slave grip degree of freedom of a robotically actuated slave surgical instrument337operatively connected to said sterile master input handle302.

According to an embodiment, said interface surface307of the sterile accessory306is a friction surface, for example a friction surface having a predefined value of surface roughness above a certain threshold greater than the surface roughness of the outer surface of the surgical drape303. According to an embodiment, said interface surface307of the sterile accessory306defines one or more bosses354and/or recesses354′, such as bumps354and/or valleys354′, to facilitate the surgeon hold. According to an embodiment, said interface surface307of the sterile accessory306defines one or more cuts327or notches327to facilitate the surgeon hold and grip thereon. According to an embodiment, said interface surface307of the sterile accessory306is wrinkled or corrugated to facilitate the surgeon hold and grip thereon. According to an embodiment, said sterile accessory306comprises cuts327or notches327or incisions327that locally interrupt the continuity of the interface surface307. Thereby, the friction of the interface surface307is further enhanced. For example, said cuts327or notches327extend transversally to the longitudinal extension of said sterile accessory306. According to an embodiment, the interface surface307is molded so that to present coarse surface finish. According to an embodiment, the interface surface307is treated to increase friction thereof. For example, the surface roughness of the functional surface307may be enhanced by means of surface treatment of the sterile accessory306.

According to an embodiment, said at least one sterile accessory306and said sterile surgical drape303are detachably associated one another. According to an embodiment, said at least one sterile accessory306and said sterile surgical drape303are made of different materials. According to an embodiment, said at least one sterile accessory306and said sterile surgical drape303result locally associated one another, preferably in a detachable manner, due to the fact that at least one portion of the sterile drape303is interposed between a portion of the non-sterile manipulandum310and said at least one accessory306when the accessory306and the non-sterile manipulandum310are mechanically engaged. In other words, preferably the accessory306does not attach to the outer surface305of the sterile drape303and the sterile drape is locally held against at least one portion of said non-sterile manipulandum by means of a retaining action exerted by the mechanical engagement of the sterile accessory306to the manipulandum310across at least one portion of the sterile drape303. Thereby, there is no need to provide attachment means for attaching the at least one sterile accessory to said sterile drape303that may cause localized stress on the sterile drape303, therefore the sterile drape303may be made thinner and of constant thickness, without for these reasons resulting too fragile when in use. The connector308of the sterile accessory306may act as local retaining element for at least one portion of the surgical drape303against the manipulandum310. Thanks to the fact that the sterile accessory306is not attached to the sterile drape303but is engaged to the manipulandum310across the sterile drape's303thickness it is possible to lock in a predefined relative position and spatial orientation the interface surface307and active parts of the manipulandum310.

According to an embodiment, said sterile accessory306is integral with said surgical drape303as shown for example inFIG.11, and preferably said sterile accessory306is integral with the outer surface305of the surgical drape303. For example, said sterile accessory306is welded or glued to said outer surface305of the surgical drape303.

The connector308may be integral with the sterile drape303and at the same time detachably engaged with the manipulandum310, while preserving the integrity of the sterile drape303.

According to a preferred embodiment, the mechanical engagement between said at least one sterile accessory306and said non-sterile manipulandum310across said sterile surgical drape303locks the position and spatial orientation of said manipulandum310relative to said interface surface307of the accessory306in a predefined configuration. Preferably, said locking of position and spatial orientation is achieved while preserving the integrity of the sterile drape303, and in particular the integrity of the at least one portion of the drape303that is covered by said at least one sterile accessory306.

According to a preferred embodiment, said at least one sterile accessory306mechanically engages with said non-sterile manipulandum310across said sterile surgical drape303in a detachable manner. Thereby, is made possible to re-use the non-sterile manipulandum310for several surgeries by sterilization or disposal of the sterile accessory306and of the sterile drape303.

According to an embodiment, said non-sterile manipulandum310comprises at least one convex body309and said at least one connector308of said at least one sterile accessory306mechanically engages with said at least one convex body309.

According to a preferred embodiment, said at least one accessory306snap-fits with said non-sterile manipulandum310, across said sterile surgical drape303.

According to a preferred embodiment, said connector308of said at least one accessory306comprises at least one positioning clip, for snap-fit engaging with at least one undercut wall329provided on the body of the non-sterile manipulandum310. As shown for example inFIG.4, a sterile accessory306comprises a plurality of connectors308in form of positioning clips308each having a retaining element329′ protruding at or near a free end thereof designed to interlock with a plurality of undercut walls329that are provided on respective niches355of said non-sterile manipulandum310. Thanks to the provision of said niches355it is possible to avoid relative slip between said sterile accessory306and said non-sterile manipulandum310across said sterile drape303. According to an embodiment, the cooperation among said retaining elements329′ of the connector308of the sterile accessory306, said undercut walls329and said niches355of the non-sterile manipulandum310generates an interlocking arrangement that may avoid relative movement, for example relative longitudinal sliding, between said non-sterile manipulandum310and said interface surface307of said sterile accessory306.

Cuts327may be provided on the accessory306to tune the elastic properties of such positioning clips of said connector308of the sterile accessory306. The sterile accessory306, and particularly the at least one interface surface307may be made of rubbery material, in order to favor the grip of the surgeon's fingers thereon. Preferably, in order to mechanically engages the sterile accessory306with said non-sterile manipulandum310, the sterile accessory306is placed over a portion of the outer surface305of the sterile drape303draping the non-sterile manipulandum310and then a pressure is applied to the interface surface307of the sterile accessory306to press the connector308with the aim to snap-fit at least one positioning clip of the sterile accessory306to at least one respective undercut wall329of the non-sterile manipulandum310. In order to facilitate such mechanical engagement, at least one invitation wall356may be provided on or near a portion of said connector308of the sterile accessory306that is designed to mechanically engage with said non-sterile manipulandum310across said sterile drape303. Preferably, in order not to tear the sterile drape303, said at least one invitation wall356may have a substantially rounded surface, preferably devoid of cut edges that when in contact with the outer surface305of the sterile drape303may tear the sterile drape303.

According to an embodiment, said plurality of positioning clips of said at least one connector308are suitable to snap-fit engaging with said at least one convex body309of the non-sterile manipulandum310, preferably forming a reversible snap-fit engagement. Preferably, said at least one connector308, for example comprising a plurality of positioning clips, has an arched concave surface321facing said outer surface305of the surgical drape303so to be suitable for fitting said convex body309of the non-sterile manipulandum310across the sterile drape303. For example, the arched concave surface321of said at least one connector308of the sterile accessory306describes substantially the profile of a “C”. The sterile accessory306itself may comprise an arched concave surface321to conform with the shape of said convex body309of the non-sterile manipulandum310, trapping in between a portion of said sterile drape303.

The at least one sterile accessory306may be in the form of a bell or a cap surrounding said sterile drape303.

The mechanical engagement between said at least one sterile accessory306and said non-sterile manipulandum310across the sterile drape303may be other than a snap-fit engagement. According to an embodiment, the connector308of the at least one sterile accessory306has at least one male element that mechanically engages with at least one respective female element of the non-sterile manipulandum310across the sterile drape303. According to an embodiment, the at least one sterile accessory306and the non-sterile manipulandum310are mechanically engaged across the sterile drape303by means of a force-fit or interference fit engagement. According to an embodiment, the at least one sterile accessory306and the non-sterile manipulandum310are mechanically engaged across the sterile drape303by means of a screwed or nailed connection.

According to an embodiment, said at least one sterile accessory306comprises a second surface328, or inner surface328, facing the outer surface305of the surgical drape303. According to an embodiment, said second surface328is opposite to said at least one interface surface307in respect of the body of said accessory306, as shown for example inFIG.4. The second surface328is preferably concave in shape forming a concave seat353or cavity353for receiving the convex body308, or at least a portion thereof, and a portion of the surgical drape303secured, for example pinched or trapped, in between.

According to an embodiment, said at least one interface surface307of said at least one sterile accessory306has a convex shape. The convexity of the at least one convex interface surface307may be realized in a direction transverse to the direction of main longitudinal development of the interface surface307, to facilitate a rolling movement of the sterile input handle assembly302between/among the surgeon's finger of a single surgeon's hand during robotic surgery.

According to an embodiment, said at least one accessory306has an elongated shape in a longitudinal direction that substantially fits the convex body309and has a convex shape in a direction transverse to said longitudinal direction. According to an embodiment, said at least one interface surface307of said at least one accessory306has the shape of a bulge, exposing a substantially spherical cap surface to the surgeon's fingers.

According to an embodiment, said at least one convex body309of the non-sterile manipulandum comprises at least one convex surface313, so that said arched concave surface321of the accessory306substantially conform with said convex surface313, trapping in between a layer of said sterile drape303. According to an embodiment, the body of the sterile drape303is interposed between, preferably in contact with both, said arched surface321of the clip308of the accessory306and said convex surface313of the convex body309of the non-sterile manipulandum310.

According to a preferred embodiment, said sterile master input handle assembly302comprises a further or second sterile accessory306so as to have at least two sterile accessories306(i.e. a first sterile accessory and a second sterile accessory), wherein said at least two sterile accessories306cooperate with said non-sterile manipulandum310to provide two or more opposite interface surfaces307for the surgeon's fingers to grasp and firmly hold said non-sterile manipulandum310across said sterile surgical drape303in one surgeon's hand. Preferably, said opposite interface surfaces307are provided at opposite sides of the non-sterile manipulandum310resulting opposite one another in respect of the body of the non-sterile manipulandum310. Thereby, when the at least two opposite sterile accessories306cover at least two opposite portions of the non-sterile manipulandum310that have or form cooperating together a grip controller, designed for controlling a paired slave grip degree of freedom of a robotically actuated slave surgical instrument337operatively connected to said sterile master input handle302, the actuation of the grip degree of freedom of the robotically actuated slave surgical instrument337is made further intuitive for the surgeon.

According to an embodiment, the sterile drape303includes at least one pouch312,312′ receiving at least a portion of said manipulandum310of said master input handle assembly302. The at least one pouch312,312′ is at least one portion of said cavity322delimited by at least one sleeve323,323′ of the surgical drape303and having a closed end352.

According to an embodiment non necessarily to be combined with any of the above-mentioned embodiments and as shown for example inFIG.7, the sterile drape303comprises a pair of pouches312,312′ each receiving at least a portion of a non-sterile manipulandum310. Thereby, each pouch312or312′ of said pair of pouches312and312′ receive a portion of said non-sterile manipulandum310, and said pouches312,312′ are in mutual fluidic communication. In other words, the body of a single surgical drape303delimits a cavity322having two pouches312,312′, preferably the pouches321,321′ are delimited by means of a pair of sleeves323,323′ each connected to a respective closed end352. A drape junction351may be formed in the surgical drape303at or near a pouch opening357of each pouch312,312′.

According to another embodiment as shown for example inFIG.8, the sterile drape303comprises two pouches312,312′ that are made as separate pieces so that the sterile drape303comprises multiple drape pieces, each one of the pouches312,312′ being delimited by a sleeve323,323′ having a closed end352and an opposite pouch opening357that may coincide with the drape opening331of the respective single drape piece.

According to an embodiment, said at least one sterile accessory306is in form of a cheek surrounding at least partially at least one convex body309of the non-sterile manipulandum310, across the sterile drape303, with the purpose of making the non-sterile manipulandum310safer to manipulate when draped by a surgical drape303. According to an embodiment, said at least one sterile accessory306in form of a cheek defines a concave seat353facing the outer surface305of the sterile drape303and preferably in contact with it, the concave seat353is designed for hosting a portion of the manipulandum310.

According to an embodiment, the sterile master input handle assembly302comprises at least one degree of freedom between said two opposite interface surfaces307,307′. The at least one degree of freedom may be a grip GM, GM′ degree of freedom designed to control a paired slave degree of freedom of grip GSL, GSL′ of a slave surgical instrument337,337′. To activate the grip degree of freedom, the two opposite interface surfaces307,307′ may be moved, for example moved by means of application of a pressing action, towards each other by the surgeon's fingers318. Said degree of freedom between the two opposite interface surfaces307,307′ may be defined by the non-sterile manipulandum310, which for example comprises two parts316,316′ movable one in respect to the other, such as two articulated parts and/or a press-button and/or two parts slidingly associated to each other.

According to an embodiment, said degree of freedom between the two opposite interface surfaces307,307′ is defined by the at least one accessory306itself, for example by means of a deformable bridge345between two opposite interface surfaces307,307′ of the accessory306, as shown for example inFIG.14. Said degree of freedom between the two opposite interface surfaces may be an elastically loaded degree of freedom. For example, the deformable bridge345between two accessories is an elastically deformable bridge, which for example comprises or is made of a flat spring.

According to an embodiment, the elastic action of said elasically-loaded degree of freedom biases said two opposite interface surfaces307,307′ away to each other.

In at least one configuration said two opposite interface surfaces307,307′ define together a convex, cylindrical geometry, as shown for example inFIG.13. For example, when the sterile master input handle assembly302is in a closed configuration, the closed configuration might be obtained by moving towards each other two articulated parts of the non-sterile manipulandum310and/or the two opposite interface surfaces307,307′, then the two opposite interface surfaces define together a convex, cylindrical geometry. The provision of such a convex, cylindrical geometry favors the rolling of the sterile master input handle assembly between/among the surgeon's fingers318of a surgeon's hand319. Said two opposite sterile accessories may be made in single piece, in other words said two sterile accessories may be monobloc.

According to a preferred embodiment, said non-sterile manipulandum310comprises at least a pair of elongated elements316,316′ hinged one another forming a tool joint317, for example a pin joint317. Preferably, said elongated elements316,316′ are rigid bodies. According to a preferred embodiment, the terminology “rigid body” means that such a body is deficient or devoid of flexibility. According to an embodiment, the terminology “rigid body” means that such a body is unable to provide elastically flexural deformation when in operative conditions. According to an embodiment, the sterile drape303is made of material that allows relative movement between the elongated elements316,316′ of the manipulandum310. Thereby, the sterile drape303is flexible or at least partially flexible so that it allows the spatial movement of the manipulandum310and allows to move each and all the degrees of freedom of the manipulandum, such as a gripping degree of freedom thereof.

Thereby, as the sterile drape303comprises a pair of pouches312,312′ in single or multiple pieces, it is possible to individually house the elongated elements316,316′ of said pair of said elongated elements316or316′ within a respective pouch312or312′.

According to an embodiment, the sterile drape303comprises a bifurcation from which said pair of pouches312,312′ extend distally.

According to an embodiment, at least one of the elongated elements316,316′ of said non-sterile manipulandum310, and preferably each of said elongated elements316,316′, comprises at least one convex body309. Thereby, said at least one convex body309is a portion of at least one elongated element316,316′ of said master input tool310.

According to an embodiment, said at least one elongated element316,316′ and preferably each of said elongated elements316,316′, comprises a groove324, preferably located along the at least one convex body309thereof, designed to receive at least a portion of the yielding body of the surgical drape303when the sterile accessory306is mechanically engaged with a portion of the non-sterile manipulandum310. For example, wrinkles and the like of the surgical drape303may find room within said groove324of the non-sterile manipulandum310to favor the mechanical engagement of the sterile accessory306to the non-sterile manipulandum310.

According to an embodiment, said at least one elongated element316,316′ and preferably each of said elongated elements316,316′, delimits a sensor slot325for housing at least a portion of a sensor, preferably in a detachable manner. The slot325may comprise abutment reference surfaces for the sensor with the purpose of receiving the sensor in a predefined accurate position and/or orientation with respect to the body of the elongated element316,316′. For example, said sensor is a tracking sensor suitable to cooperate with a tracking fieldfield generator339provided within the sterile operatory field311for example near or at a master console350.

The master console350may comprise at least one tracking field generator that may be provided integral with the surgeon, for example the tracking field generator is on a wearable item to be worn by the surgeon such as a belt or bracelet or the like, or the at least one tracking field generator may be provided on a surgical chair or the at least one tracking field generator may be provided on the master console350. The console350may comprise a tower for the surgeon to stand near to the console350and the tracking system339may be integral with the tower of the master console350.

According to an embodiment, said groove324of the manipulandum310is also suitable to receive a cable connection to said sensor when received within said slot325. A cover326or lid326may be provided to cover said slot325. A sensor slot seat may be provided on the second surface328of said sterile accessory306of size and shape suited to receive said sensor slot325with or without said lid326, and said sensor slot seat may be in communication with said concave seat353and/or a part thereof. The portion of the sterile accessory306covering said sensor slot325of an elongated element316,316′ of the non-sterile manipulandum310may be devoid of connectors so as to not interfere with the sensor detection of the sensor received in said sensor slot325. Preferably, said sensor is a magnetic tracking sensor (i.e. a magnetometer) cooperating with said tracking field generator.

According to an embodiment, the tracking system339is an optical tracking system comprising at least one camera, for example a set of stereoscopic cameras, and the master input handle assembly302comprises at least one optical marker with the purpose of being optically tracked by the tracking system. Said one or more slots325and/or said groove324may act as optical marker.

According to an embodiment, said at least one accessory306is disposable, in other words is designed to have a single-use in a sterile environment.

According to an embodiment, said at least one accessory306is designed to be sterilized, so that can be re-utilized for several surgeries.

Thanks to the provision of such an accessory306forming an increased friction surface307with the purpose to form a surface for the surgeon fingers to handle a non-sterile manipulandum310, it is avoided the need to dispose the non-sterile manipulandum310after a single surgery session. Therefore, the non-sterile manipulandum310is maintained sterile by covering it with the sterile drape303. Moreover, the provision of the accessory306makes the surgeon feels to firmly and precisely hold the draped non-sterile manipulandum310.

Thanks to the provision of such at least one interface surface307, a surgeon may alternate hand microsurgery and robotic-aided microsurgery during a single intervention, without for this reason compromise the sterility of the sterile operatory field311. Thereby, it is avoided the need of dispose the non-sterile manipulandum310each time the surgeon switches from hand microsurgery to robotic-aided microsurgery and vice-versa during a single intervention.

According to a general embodiment, it is provided a master controller assembly301for robotic surgery comprising at least one sterile master input handle assembly302according to any one of the embodiments described above and a master console350. The master controller assembly301is designed to control a slave robot assembly330.

The master controller assembly301may be remotely located, and the master console350may be remotely located.

The master controller assembly301may be draped and located within a sterile operatory field311, and at this end the master console350of the master controller assembly301may be draped by a console drape349.

According to an embodiment, the master controller assembly301comprises a tracking system339, which may belong to the master console350, such as an optical and/or magnetic tracking system suitable to track position and/or orientation of at least one portion of the sterile master input handle assembly302, and/or of the non-sterile manipulandum310within a predefined tracking volume.

The master input handle assembly302may be mechanically ungrounded and mechanically unconstrained with respect to the tracking system339of the master console350and/or with respect to the master console350, and designed to be hand-held by the surgeon.

According to an embodiment, a pair of mechanically ungrounded, mechanically unconstrained sterile master input handle assemblies302are provided, each designed to be hand-held by a single hand of the surgeon, so that the surgeon holds during robotic surgery two master input handles302, one in each surgeon's hand. The two mechanically ungrounded, mechanically unconstrained sterile master input handle assemblies302may control, for example individually, two paired slave surgical instruments337of the robotic surgery system300.

According to a general embodiment, it is provided a robotic surgery system300suitable for microsurgery comprising at least one sterile master input handle assembly302according to any one of the embodiments described above.

Preferably, said robotic surgery system300comprises at least one master console350.

According to a preferred embodiment, said robotic surgery system300further comprises a slave robot assembly330. According to an embodiment, said slave robot assembly330comprises at least one surgical arm334manipulating said surgical instrument337. According to an embodiment, said salve robot assembly330comprises at least one micromanipulator335manipulating said surgical instrument337. Preferably, said at least one micromanipulator335is directly connected in series to said surgical arm334forming a kinematic chain with said surgical arm334and manipulates said surgical instrument337. According to an embodiment, at least two micromanipulators335are directly connected in series to said surgical arm334forming an at least two-branched kinematic chain with said surgical arm334. According to an embodiment, said slave robot assembly330comprises at least one robotic cart336and said at least one arm334extends from the robotic cart336.

According to an embodiment, said robotic surgery system300comprises a control unit, the tracking system339may belong to the control unit, the control unit being suitable for receiving at least a position and orientation associated to said non-sterile manipulandum310and suitable for transmitting a command signal to the slave robot assembly330to actuate said surgical instrument337. According to an embodiment, said control unit is suitable for receiving a first command signal containing information about said manual command and to transmit a second command signal containing information about said manual command to the slave robot assembly330in order to actuate said surgical instrument337.

The control unit preferably belongs to the master console350.

According to an embodiment, said robotic surgery system300, and preferably said master console350of said robotic surgery system300, further comprises at least one tracking system339comprising a field generator, suitable to detect within a predefined tracking volume position and orientation of said non-sterile manipulandum310, preferably through detection of the at least the position of the sensors housed within said slots325and/or the position of said slots325.

According to an embodiment, said at least one tracking system339generates said predefined tracking volume, for example by means of a field generator, for example a magnetic field generator and/or an optical camera set. For example, said magnetic field generator is located integral with the surgeon.

At least one slave drape338may be provided to drape at least a portion of the robotic slave assembly330.

Preferably, said master manipulator310and/or said sterile master input handle302controls the slave robotic surgery system300activating at least a grip degree of freedom of an articulated end-effector located at or near the distal end of the shaft of the surgical instrument337.

The sterile master input handle302preferably also controls the positioning of the slave robot assembly330by means of controlling said at least one micromanipulator335, which for example is a Carthesian manipulator having three orthogonal linear degrees of freedom. The manipulator335is preferably upstream the shaft of the surgical instrument337. The articulated end effector located at or near the distal end of the shaft of the surgical instrument337may comprise also a pitch and a yaw degrees of freedom, which can be controlled by said sterile master input handle assembly302. The articulated end effector of the surgical instrument337preferably comprise pitch, yaw and grip degrees of freedom, and the surgical instrument337may also comprise a roll degree of freedom about the shaft thereof.

According to an embodiment, said robotic surgery system300further comprises at least one surgical microscope342. A microscope drape343may be provided for draping at least a portion of the microscope342.

According to a general embodiment, it is provided a sterile operatory field311comprising at least one sterile master input handle assembly302according to any one of the embodiments described above.

According to an embodiment, said sterile operatory field311further comprises at least a portion of at least one robotic slave manipulator330according to any one of the embodiments described above. Thereby, said sterile operatory field311further comprises at least a portion of at least one robotic surgery system300according to any one of the embodiments described above.

According to an embodiment, said sterile operatory field311further comprises at least one operatory bed341providing a support for a patient's anatomy to be treated.

According to a general embodiment, it is provided a surgical drape303for a master input handle assembly302comprising in single piece a pair of pouches312,312′ for individually receiving a pair of elongated elements316,316′ of a non-sterile manipulandum310. The surgical drape303may be associated to one or more sterile accessories306according to any one of the embodiments described above. The non-sterile manipulandum310of the surgical drape303may be a non-sterile manipulandum310according to any of the embodiments described above.

Thanks to the features described above, provided either alone or in combination in particular embodiments, it is possible to respond to the above-mentioned needs providing the above-cited advantages, and in particular:it is made easier to control a robotic surgery system from a sterile environment, such as a sterile operatory field;it is provided a sterile master controller comprising a non-sterile manipulandum suited to receive a manual command from the surgeon across and through a drape sheet having at least one accessory that allows the non-sterile manipulandum310to be confidently grasped by the surgeon across the sterile barrier;it is avoided the contamination of the non-sterile manipulandum310that may comprise the most expensive features such as sensors, reference surfaces, optical markers, rotational joints, and the like, which therefore can be used for several surgeries;thanks to the provision of said assembly having a drape303draping a non-sterile manipulandum310it is allowed to locate the sterile master handle assembly302, and therefore the surgeon, within the sterile operatory field311, for example near the operatory bed341;thereby, it is allowed the surgeon to alternate hand microsurgery and robotic-aided microsurgery during a single intervention, without for this reason needing to sterilize the master controller;the draped unconstrained master manipulandum may in its entirety be moved freely within a master work volume near the operatory bed avoiding contamination of the master manipulandum;thanks to the provision of such a sterile accessory, it is provided a solution able to drape a master controller preserving sterility and at the same time making the master input tool easier to manipulate when draped by a surgical drape;at the same time, thanks to the connector308of the accessory306the sterile drape303results easier to fit around the non-sterile manipulandum310;no need to make a master controller disposable is envisaged even in case of handling the master input tool within a sterile operatory field, as the master input tool can be draped without for this reason loosing grip for the surgeon;the master sterile drape303may have a loose body that drapes air other than the non-sterile manipulandum310, therefore thanks to the provision of said at least one connector308it is allowed to constrain a portion of the drape303to a portion of the non-sterile manipulandum310, preferably at or near the at least one convex body309thereof;thereby, the connector308at the same time locally close-fits the body of the sterile drape303against non-sterile manipulandum310and holds the friction surface307in place.

To the embodiments described above, one skilled in the art may, to satisfy contingent and specific needs, make numerous modifications, adaptations, and replacements of elements with others that are functionally equivalent, without however departing from the scope of the appended claims.

LIST OF REFERENCES

300Robotic surgery system, or robotic microsurgery system301Master workstation of the robotic surgery system302Master sterile handle assembly303Surgical drape, or sterile drape, or drape304Inner non-sterile surface of the sterile drape305Outer sterile surface of the sterile drape306Sterile accessory, or accessory307Interface surface, or surface, of the sterile accessory308Connector of the sterile accessory309Convex body of the manipulandum310Non-sterile manipulandum of the master sterile handle assembly311Sterile operatory field312,312′ Pouch of the sterile drape313Convex surface of the convex body316,316′ Elongated element of the manipulandum317Joint318Surgeon's finger319Surgeon's hand320Work volume321Arched clip surface322Drape cavity323,323′ Drape sleeve325Sensor slot326Cover or lid327Cuts, or notches328Second surface of the accessory329Undercut walls329′ Retaining elements330Slave robotic assembly331Opening of the drape334Robotic arm335Manipulators336Robotic cart337Surgical instrument338Slave drape339Tracking system341Operatory bed342Surgical microscope343Microscope drape345Bridge349Master console drape350Master console351Junction of the sterile drape352Closed end of the sterile drape353Concave seat of the accessory353′ Seat or cavity for the sensor slot354Bump of the accessory354′ Recess of the accessory355Niche356Invitation wall357Pouch opening