Sterile Barrier Assembly and Robotic Surgery Systems

Abstract

Sterile barrier assembly and robotic surgical system. The robotic surgical system (200) includes at least one sterile barrier assembly (210) and at least one non-sterile robotic manipulator (220, 220'). The non-sterile robotic manipulator (220, 220') includes a case (251, 251'), at least one rotary motor (246), and at least one rotor (230, 230') adapted to pivot relative to the case (251, 251'). At least one connector (212, 212') of the surgical drape (201) of the sterile barrier assembly (210) is coupled to the case (251, 251') of the non-sterile robotic manipulator (220, 220'). At least one sterile adapter (221, 221′) of the sterile barrier assembly (210) is coupled to at least one rotor (230, 230′) of the non-sterile robotic manipulator (220, 220′). At least one rotation motor (246) moves the at least one rotor (230, 230′) along with the at least one sterile adapter (221, 221′) relative to a case (251, 251′) of the non-sterile robotic manipulator (220, 220′). A gap (235, 235′) between the at least one connector (212, 212′) of the surgical drape (201) and the at least one sterile adapter (221, 221′) forms a rotatable seal to prevent the sterile robotic manipulator from contaminating the sterile surgical field (255).

Description

[Technical field]

[0001] The present invention generally relates to surgical drapes for robotic surgery. An object of the present invention is a sterile barrier assembly for robotic surgery. The present invention also relates to a robotic surgery system including at least one sterile barrier assembly. The present invention also relates to a method of attaching the sterile barrier assembly as well as a method of removing the sterile barrier assembly. [Background technology]

[0002] Robotic surgery systems are commonly known in the art and typically consist of a robotic central tower (or robotic cart) and multiple robotic arms extending from the central tower. Each robotic arm includes a teleoperated robotic motorized positioning system (or manipulator) for moving a surgical end effector attached distally thereto to perform a surgical procedure on a patient. The patient typically lies on a surgical bed located in an operating room, where sterility is ensured to avoid bacterial contamination from non-sterile parts of the robotic instruments.

[0003] Typically, surgical drapes encase parts of the robot to protect the sterile environment from contamination. The need to encase the robot arises from the fact that such a robot must be used and reused for several surgeries.

[0004] For example, document US-2014-0158141 shows a flexible surgical drape designed to cover the robot central tower and having a number of openings for each one of the robot arms extending from the robot cart, so that the robot arms are not covered by said surgical drape, but by a separate bag of surgical drapes. The surgical drape flexible body may therefore be provided with an insert, such as a hard plastic plate, to form a connection interface with the active part of the robot. For this purpose, a sterile adapter, typically made of hard plastic, is integral with the drape to provide an attachment site for a surgical instrument, and generally constitutes a movable part to transmit an actuation movement, such as a capstan drive movement, to a surgical instrument removably attached thereto to actuate the end effector of the surgical instrument. Examples of known sterile adapters can be found in WO-2009-061915 and WO-2019-006206.

[0005] Drapes for covering a microscope section arranged in an operating room are also known in the art. For example, US-2019-0069969 discloses a tubular drape for fitting a cylindrical end section of an electron microscope, in which a hard covering glass is provided on the drape forming a cup-shaped end of the drape designed to cover the lens of the microscope. This drape solution is therefore unsuitable for transmitting actuation motions downstream of the drape itself, in this case downstream of the lens of the microscope.

[0006] WO-2017-064301 of the same applicant discloses a robotic surgery system solution in which a single robotic arm extends from a robotic carriage and comprises at its distal end a pair of teleoperated robotic motorized manipulator systems arranged in parallel and connected to the same horizontal link of the single robotic arm.

[0007] Known surgical drapes also include tie-down ties that allow the surgical drape to be tied closely to an elongated portion of a robot, such as a robotic arm, thereby reducing the inconvenience of the surgical drape over the robotic instrument during use. Additionally, it is also known to provide a magnetic releasable connection between a portion of a robotic instrument and an edge of the surgical drape.

[0008] WO-2018-189729 in the name of the same applicant shows a sterile barrier solution including a reinforcing element attached to it for the purpose of transmitting linear actuation across the barrier itself. The surface of the reinforcing element may be rounded to ensure single-point contact with a non-sterile actuator. Although advantageous for several reasons, such a solution ends up being difficult to assemble due to the required alignment of the actuator of the teleoperated robotic motorized positioning system with the reinforcing element of the sterile barrier and thus with the distal element of the surgical instrument actuated thereby.

[0009] The surgical drape is typically in the form of a pouch that surrounds the robot, said pouch having a closed end, and one or more pouches may extend further from the closed end of the pouch to accommodate an expandable actuator of the robot, as shown, for example, in WO-2011-143024.

[0010] It is also known to provide a rotatable seal adjacent to a surgical drape for draping both the robot tower and the robot arm that can pivot about an axis relative to the robot tower. An example of this type of solution is shown in WO-2019-150111, where a rotatable seal is arranged at the proximal end of a pouch of a sterile bag draping robot arm for pivotally connecting said proximal end of the pouch to a drape part that drapes the robot tower. Other examples of surgical systems with rotatable seals are shown by US-2016-235490, WO-2017-044884, US-2019-380803 and US-2018-0000472. In these known solutions, the rotatable seal is typically obtained by means of fitting / attaching a first surgical drape having a first ring defining the trough opening to a second surgical drape having an outer ring that contours the second surgical drape after connecting the second surgical drape to the rotatable element.

[0011] There is a felt need to provide a sterility barrier solution having an improved, yet simplified assembly rotatable seal.

[0012] Thus, a need is felt to provide a surgical drape solution that has simplified assembly onto a robotic surgical system, while at the same time providing improved durability with respect to known solutions, without impeding the transmission of actuation motion through and / or across the surgical drape for these reasons.

[0013] At the same time, for these reasons, a need is felt to provide a sterile barrier solution of improved durability with respect to known solutions, without restricting the freedom of movement during surgery of sterile surgical instruments that are distally connectable to the sterile barrier. Summary of the Invention

[0014] It is within the scope of the present invention to overcome the shortcomings noted with reference to the known art.

[0015] These and other scopes are achieved by a sterile barrier assembly according to claim 1, as well as a robotic surgical system according to claim 11, and a method according to claim 24.

[0016] Some preferred embodiments are the subject of dependent claims.

[0017] According to one aspect of the invention, a sterile barrier assembly includes a surgical drape having at least one drape opening, and at least one connector contouring the at least one drape opening and adapted to mate with a case encasing a non-sterile robotic manipulator.

[0018] According to one aspect of the invention, the sterile barrier assembly further comprises at least one sterile adapter having a frame including a coupling device for coupling with at least one surgical instrument, and the at least one connector of the surgical drape and the at least one sterile adapter are made in separate pieces.

[0019] According to one aspect of the invention, the at least one sterile adapter is adapted to pivot relative to the at least one connector of the surgical drape, and a gap is provided between the at least one connector of the surgical drape and the at least one sterile adapter, the gap may be an annular gap, the gap preventing direct contact between a frame of the sterile adapter and the connector of the sterile drape.

[0020] At least one connector of the surgical drape can have a distally facing distal surface and the sterile adapter can have a proximal surface facing proximally, with the distal surface of the connector facing the proximal surface of the sterile adapter that bounds the gap, such that the proximal surface of the sterile adapter bounds a gap distally, while the distal surface of the connector bounds the same gap proximally.

[0021] The drape connector may be integral with the body of the surgical drape.

[0022] The sterile adaptor may include a skirt facing proximally of the gap, and the proximal surface may belong to the skirt.

[0023] According to one aspect of the invention, a robotic surgical system comprising at least one of the sterile barrier assemblies further comprises at least one non-sterile robotic manipulator comprising a case, at least one rotational motor, and at least one rotating body adapted to pivot relative to the case, the rotational motor may be operatively connected to the rotating body.

[0024] According to one aspect of the invention, the at least one connector of a surgical drape of a sterile barrier assembly is coupled to the case of a non-sterile robotic manipulator and the at least one sterile adapter of the sterile barrier assembly is coupled, directly or indirectly, to the at least one rotating body of the non-sterile robotic manipulator, such that the at least one rotary motor is suitable to move the at least one rotating body together with the at least one sterile adapter for rotational movement relative to the case of the non-sterile robotic manipulator, for example by means of a manipulator coupling element.

[0025] At least one connector of a surgical drape of a sterile barrier assembly may be removably and rigidly coupled to said housing of a non-sterile robotic manipulator.

[0026] At least one sterile adaptor of the sterile barrier assembly may be removably and rigidly coupled to said at least one rotator of the non-sterile robotic manipulator.

[0027] A rotor of a non-sterile robotic manipulator may include a manipulator coupling element, and the sterile adapter may be releasably engaged with the manipulator coupling element in an undercut manner, such as by a bayonet coupling and / or a threaded coupling. The engagement between the sterile adapter and the manipulator coupling element may be distal to the case of the surgical drape and / or distal to the connector. The manipulator coupling element may be at least partially located within the case, while the sterile adapter may be located outside the case, preferably distal to the case enclosing the non-sterile robotic manipulator.

[0028] In accordance with one aspect of the invention, a sterile drape includes a pair of drape openings, a pair of connectors, and a pair of sterile adapters, each connector defining a respective drape opening, each connector made in a separate piece for each sterile adapter, and each sterile adapter adapted to pivot relative to a respective connector of the surgical drape.

[0029] According to one aspect of the invention, a robotic surgical system including a sterile barrier assembly of the type described above having a pair of drape openings, a pair of connectors, and a pair of sterile adaptors further includes a pair of non-sterile robotic manipulators, the robotic surgical system being configured such that each connector of the surgical drape is coupled to a case of a respective robotic manipulator, and each sterile adaptor of the sterile barrier assembly is coupled to a rotor of a respective non-sterile robotic manipulator, such that each rotary motor suitably moves the respective rotor together with each said sterile adaptor in pivotal motion relative to the case of the respective non-sterile robotic manipulator.

[0030] The main body of the surgical drape may be made in one piece and comprises a pair of pouches, each pouch defining a respective drape opening, each pouch suitable for individually draping one non-sterile robotic manipulator of the pair, for example, by attaching the connector of each pouch of the surgical drape to the case of a respective non-sterile robotic manipulator.

[0031] According to one aspect of the invention, a method for installing and / or removing a sterile barrier assembly of a robotic surgical system includes connecting and / or disconnecting at least one connector of a surgical drape to and / or from at least one case of a non-sterile robotic manipulator, and connecting and / or disconnecting a sterile adapter to a rotator of the non-sterile robotic manipulator. The connection to the rotator can be made directly or indirectly, for example, through the intermediation of a manipulator connecting element.

[0032] Connecting the sterile adapter to the rotator directly or indirectly, for example through the intermediation of a manipulator connection element, may include moving the sterile adapter proximally toward the rotator without touching the surgical drape and / or a connector of the surgical drape.

[0033] Connecting the sterile adapter to the rotator directly or indirectly, e.g., by means of a manipulator connection element, may comprise moving the sterile adapter proximally towards the rotator when a surgical drape is already attached to a case of a non-sterile robotic manipulator by its connector. Disconnecting the sterile adapter from the rotator directly or indirectly, e.g., by means of a manipulator connection element, may comprise moving the sterile adapter distally from the rotator when a surgical drape is attached to a case of a non-sterile robotic manipulator by its connector. Thus, the attachment method may consist of first connecting at least one connector of the surgical drape to at least one case of a non-sterile robotic manipulator and thereafter connecting at least one sterile adapter to the rotator of the non-sterile robotic manipulator whose case is already connected to a connector of the surgical drape. Thus, the removal method may include first disconnecting at least one sterile adapter from the rotor of the non-sterile robotic manipulator, and then disconnecting the connector of the surgical drape from at least one case of the at least one non-sterile robotic manipulator from which the sterile adapter has already been disconnected.

[0034] Thanks to the proposed solution, a surgical drape or a surgical bag is provided, the ring of which can surround a rotating body which is rotatable about an axis relative to the surgical drape.

[0035] By virtue of the proposed solution, a sterile barrier assembly is provided which includes a surgical drape and at least a sterile adapter rotatably associated with at least a distal opening of the surgical drape.

[0036] By virtue of the proposed solution, a robotic surgery system is provided which comprises a rotator housed within a case, both the case and the rotator being associated with the same sterile barrier assembly.

[0037] Thanks to the proposed solution, a simple yet advantageous sequence of methods for mounting and / or dismounting the sterility barrier assembly is provided.

[0038] Further features and advantages of the surgical drape, sterile barrier assembly, system and method will appear from the following description of preferred embodiments, given by way of example and not by way of limitation, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0039] [Figure 1] FIG. 1 is an axial view of a robotic surgical system including a sterile barrier assembly, according to an embodiment. [Diagram 2] FIG. 2 is a diagram of a robotic surgical system including a pair of manipulators and a sterile barrier assembly, according to an embodiment. [Diagram 3] FIG. 3 illustrates a robotic surgical system including a surgical drape, according to an embodiment. [Figure 4] FIG. 4 is an enlarged view of details of the system and assembly shown in FIG. [Diagram 5] FIG. 5 is an axial view of a surgical drape, according to an embodiment. [Figure 6] FIG. 6 illustrates an axial view of a sterile adapter of a sterile barrier assembly according to an embodiment. [Figure 7] FIG. 7 is a cross-sectional view of a sterile barrier assembly, according to an embodiment, and diagrammatically illustrates a motor of a robotic surgical system. [Figure 8] FIG. 8 is an axial cross-sectional view of the sterile barrier assembly of FIG. 7 coupled to a robotic surgical system. [Figure 9] FIG. 9 illustrates a sterility barrier assembly, according to an embodiment. [Figure 10] FIG. 10 is a schematic cross-sectional view of the system and assembly shown in FIG. [Figure 11]FIG. 11 is an axial view of a manipulator of a robotic surgical system coupled to a surgical drape, according to an embodiment, where some parts of the system are depicted as transparent for clarity. [Figure 12] FIG. 12 is a perspective view of a robotic surgical system including a pair of manipulators and a pair of respective sterile barrier assemblies, according to an embodiment. [Figure 13] FIG. 13 is an axial view with separate parts of a portion of a robotic surgical system, according to an embodiment. [Figure 14] FIG. 14 shows a cross-section of a portion of a robotic surgical system, according to an embodiment. [Figure 15] FIG. 15 illustrates some steps of the method according to the operating mode. [Figure 15] FIG. 16 illustrates some steps of the method according to the operating mode. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] According to a general embodiment, a sterile barrier assembly 210 for a robotic surgical system 200 is provided.

[0041] The sterile barrier assembly 210 comprises a surgical or sterile drape 201 having at least one drape opening 209, 209'.

[0042] The surgical drape 201 may be configured as a bag designed to fit over the major portions of the robotic surgical system 200 .

[0043] The robotic surgery system 200 may include a robot cart 225 and at least one robot arm 211 extending from the cart 225 and defining a proximal-distal direction zz. The at least one robot arm 211 has a number of arm links 219, 219', 219'', 219'' connected to one another forming a kinematic chain. One of the arm links 219, 219', 219'', 219'' may be connected to at least two non-sterile motorized robotic manipulators 220, 220' suitable for manipulating a robotic end effector, e.g. a wrist, inside a patient's body along multiple degrees of freedom. According to an embodiment, at least one rotary motor 246 is provided suitable for moving the rolling body 230, 230' in a rolling motion about a rolling axis ZZ relative to a case 251, 251' of the non-sterile robotic manipulator 220, 220'.

[0044] The surgical drape 201 may include a body 202, which defines a drape cavity 203. According to a preferred embodiment, the body 202 is made of a flexible sheet of plastic material, such as polyethylene. Preferably, the term "flexible" as used herein means that the drape body is loose, e.g., it is a flexible sheet. According to an embodiment, the body of the sterile drape 201 is made of paper, woven fabric, nonwoven fabric, and / or any material suitable for a surgical drape 201.

[0045] According to a preferred embodiment, the body 202 of the surgical drape 201 is a single piece. Preferably, the body 202 is a single piece of flexible sheet.

[0046] According to a preferred embodiment, the surgical drape 201 may include a first inner surface 204 facing the drape cavity 203 and a second outer surface 205 facing away from the cavity 203 such that the first inner surface 204 and the second outer surface 205 are opposed to each other with respect to the flexible body 202 of the surgical drape 201.

[0047] Preferably, the surgical drape 201 includes a proximal opening edge 206 that defines a proximal opening 207 in the surgical drape 201 for accessing the drape cavity 203. The proximal opening 207 is preferably a through opening.

[0048] According to a preferred embodiment, the proximal open edge 206 is associated with a proximal coupling interface 218 suitable for forming a coupling with a part of the robotic surgical system 200. According to an embodiment, the proximal coupling interface 218 of the proximal open edge 206 of the surgical drape 201 forms a magnetic coupling with a part of the cart 225 of the robotic surgical system 200. For example, the proximal coupling interface 218 comprises a permanent magnet. For example, the proximal coupling interface 218 comprises a ferromagnetic portion suitable for forming a magnetic coupling with a magnetic portion of the cart 225. According to an embodiment, the proximal coupling interface 218 of the proximal open edge 206 of the surgical drape 201 comprises an elastic strip for forming an elastic pressure action on the cart 225 of the robotic surgical system 200. According to an embodiment, the proximal coupling interface 218 of the proximal open edge 206 of the surgical drape 201 comprises a strap for tying to the cart 225.

[0049] Preferably, the surgical drape 201 includes at least one distal opening edge 208 , 208 ′ defining a respective distal opening 209 , 209 ′ for accessing the drape cavity 203 .

[0050] The at least one distal opening 209, 209' is preferably a distal through opening 209, 209'.

[0051] According to an embodiment, the drape cavity 203 is a through cavity extending between and communicating through the proximal opening 207 and the at least one distal opening 209, 209', whereby the robotic surgical system 200 can at least partially cover the surgical drape 201 by first fitting the proximal opening edge 206 of the surgical drape 201 around a distal end of a robotic arm 211 of the robotic surgical system 200, then moving the proximal opening edge 206 of the surgical drape 201 proximally, thereby unfolding the surgical drape 201 and fitting the robotic arm 211 with the body 202 of the surgical drape 201, and then coupling the at least one distal opening edge 209, 209' to a respective portion of the robotic arm 211 of the robotic surgical system 200.

[0052] The sterile barrier assembly 210 defines the at least one drape opening 209, 209' and further comprises at least one connector 212, 212' suitable for coupling with the case 251, 251' of the non-sterile robotic manipulator 220, 220'.

[0053] Preferably, the surgical drape 201 comprises at least one annular connector 212, 212' associated with each distal opening edge 208, 208' of the flexible body 202. According to an embodiment, the at least one annular connector 212, 212' is a ring connector 212, 212'.

[0054] Thereby, when the first distal opening edge 208 and the second distal opening edge 208' are provided, each first annular connector 212 is associated with the first distal opening edge 208 to outline the first distal opening 209, and each second annular connector 212' is associated with the second distal opening edge 208' to outline the second distal opening 209'.

[0055] The at least one annular connector 212, 212' has an annular rim 213, 213' facing a respective distal annular opening 209 or 209' and having an annular shape such that the at least one distal opening 209, 209' is outlined by the annular rim 213, 213'. Thereby, the at least one distal opening 209, 209' of the surgical drape 201 has an annular outline. Thus, the at least one distal opening 209, 209' may have the shape of a circle.

[0056] According to a preferred embodiment, the at least one annular connector 212, 212' is more rigid than the body 202 of the surgical drape 201. According to a preferred embodiment, the at least one annular connector 212, 212' is rigid such that manual action applied thereto is not suitable to elastically deform the annular connector 212, 212' without creeping and / or to break it. According to a preferred embodiment, the annular rim 213, 213' of the at least one annular connector 212, 212' is rigid to define an annular contour of the at least one distal opening 209, 209'.

[0057] The sterile barrier assembly 210 includes at least one sterile adaptor 221, 221'. The at least one sterile adaptor includes a frame 223. The frame includes a coupling device 237 for coupling with at least one sterile surgical instrument 240, 240'.

[0058] The at least one connector 212, 212' and the at least one sterile adapter 221, 221' of the surgical drape 201 are made separately.

[0059] The at least one sterile adapter 221 , 221 ′ preferably pivots or rolls relative to the at least one connector 212 , 212 ′ of the surgical drape 201 .

[0060] Advantageously, a gap 235, 235' is provided between the at least one connector 212, 212' of the surgical drape 201 and the at least one sterile adaptor 221, 221'.

[0061] The gap 235, 235' thereby forms a rotatable seal with the at least one connector 212, 212' and with the at least one sterile adapter 221, 221', thereby avoiding rotational friction in the sterile adapter 221, 221' pivotally associated with the at least one connector 212, 212', respectively, while maintaining the sterility of the sterile surgical field 255 (i.e., preventing the sterile surgical field 255 from being contaminated with non-sterile parts of the draped robotic surgical system 200). By virtue of the provision of the gap 235, 235', the sterile adapter 221, 221' is not directly connected to the connector 212, 212' of the surgical drape 201.

[0062] According to a preferred embodiment, the body 202 of the surgical drape 201 further comprises a first distal opening edge 208 and a second distal opening edge 208', each of the first distal opening edge 208 and the second distal opening edge 208' defining a respective distal through opening 209, 209'. Thus, a first distal through opening 209 is defined by the first distal opening edge 208 and a second distal through opening 209' is defined by the second distal opening edge 208'. Thus, when the first annular connector 212 and the second annular connector 212' are provided, each of the first and second annular connectors 212, 212' has an annular rim 213, 213'. A first annular rim 213 is associated with said first annular connector 212 and a second annular rim 213' is associated with said second annular connector 212'. Preferably, each of said annular rims 213, 213' of at least one annular connector 212, 212' defines a connection ring suitable for connection to a robotic surgical system 200.

[0063] The provision of a pair of distal openings 209, 209' associated with respective annular connectors 212, 212' allows a single surgical drape 201 to be used to cover a pair of robotic arms and a portion of the cart 225 of the robotic surgical system 200.

[0064] By providing such at least one annular connector 212, 212', a rotating body 230, 230' can be received within its annular rim 213, 213'. The rotating body 230, 230' can roll about an axis ZZ with respect to the body 202 of the surgical drape 201 and / or with respect to said at least one annular connector 212, 212'.

[0065] According to an embodiment, the term "rotating body 230, 230' capable of rolling around an axis" also encompasses the case where the rolling motion is a relative motion between the rotating body 230, 230' of the robotic surgical system 200 and the annular connector 212, 212' of the surgical drape 201.

[0066] The relative rolling motion may thereby require the annular connectors 212, 212' to roll and / or pivot about an axis and the rotating bodies 230, 230' to be substantially stationary, defining the relative rolling motion.

[0067] According to an embodiment, the term "rotating body 230, 230' capable of rolling around an axis" also encompasses the case where the rotating body 230, 230' can oscillate around an axis relative to the body 202 of the surgical drape 201 and / or relative to the at least one annular connector 212, 212'.

[0068] According to an embodiment, the term "rotating body 230, 230' that can rotate around an axis" also encompasses, for example, a spherical joint, etc., where the rotating body 230, 230' can rotate around a movable axis relative to the body 202 of the surgical drape 201 and / or relative to the at least one annular connector 212, 212'.

[0069] By providing a pair of annular connectors 212, 212', a pair of rotors 230, 230' can be received. Each one of said pair of rotors 230, 230' is received in a respective annular rim 213, 213' so as to be rotatable about an axis ZZ relative to the body 202 of the surgical drape 201 and / or relative to the respective annular rim 213, 213' of the annular connectors 212, 212'. According to an embodiment, each one of said pair of rotors 230, 230' can rotate about an axis ZZ independently of the other rotor of said pair of rotors 230, 230'. The respective rotation axes ZZ of each one of said pair of rotors 230, 230' are not parallel according to a preferred embodiment, but may be parallel to each other, more preferably converging one towards the other.

[0070] The at least one rotating body 230, 230' may have a substantially cylindrical shape adapted to be received within the at least one annular connector 212, 212' in the at least one distal opening 209, 209' of the surgical drape 201 and extend about an axis of rotation that is substantially stationary or even rotatable relative to the at least one annular connector 212, 212'. Alternatively, the at least one rotating body 230, 230' may have a substantially spherical shape adapted to be received within the at least one annular connector 212, 212' in the at least one distal opening 209, 209' of the surgical drape 201 and rotate about an axis of rotation that is substantially stationary or movable relative to the at least one annular connector 212, 212'.

[0071] According to a preferred embodiment, the at least one annular connector 212, 212' is integral with the flexible body 202 of the surgical drape 201. Thereby, the at least one annular connector 212, 212' cannot roll relative to the body 202 of the surgical drape 201. Although not required, the body 202 of the surgical drape 201 is made integral with the at least one annular connector 212, 212', according to an embodiment, they are made of a single piece of material. According to an embodiment, the at least one annular connector 212, 212' is glued and / or fixed and / or clamped and / or pinched and / or thermoformed and / or otherwise fixed to the at least one distal opening edge 208, 208' of the body 202 of the surgical drape 201. Preferably, the connectors 212, 212' are detachably connected to a case 251, 251' that encases the robot manipulator 220, 220'.

[0072] According to an embodiment, the sterile barrier assembly comprises at least one pouch 231, 231' formed by the body 202 of the surgical drape 201 and extending proximally to, and preferably having, the at least one distal open edge 208, 208' such that the at least one pouch 231, 231' is suitable for at least partially draping the robot arm 211 and preferably the at least one manipulator 220, 220' of the robotic surgical system 200.

[0073] According to an embodiment, said proximal opening edge 206 of the surgical drape 201 is suitable for forming a bond with a part of a non-sterile robotic manipulator 220 or 220′ of a robotic surgical system 200. Thereby, the robotic surgical system 200 may be composed of two or more surgical drapes 201 and / or two or more sterile barrier assemblies 210, as shown, for example, in FIG. 12. Thereby, a robotic arm 211 having two non-sterile robotic manipulators 220, 220′ is covered by two surgical drapes 201 each forming a sterile barrier assembly 210.

[0074] Preferably, the at least one pouch 231, 231' is formed by the rotatable seal formed by a sleeve of the surgical drape 201 and one of the sterile adapters 221, 221' and the gap 235, 235'. Preferably, each pouch 231, 231' includes at least one respective drape opening 209, 209' and an opposing proximal pouch opening 254, 254', the rotatable seal being distal to the proximal pouch opening 254, 254'. Preferably distal to the rotatable seal is a sterile adapter 221, 221'.

[0075] According to an embodiment, the surgical drape 201 comprises a pair of the pouches 231, 231', preferably each including a respective distal opening edge 208, 208'. According to an embodiment, the body 202 of the surgical drape 201 has a single pouch 231 for covering the robot arm 211. The single pouch 231 comprises a pair of distal opening edges 208, 209'. According to an embodiment, the body 202 of the surgical drape 201 comprises a bridge portion 232 connecting the distal opening edges 208 and 208' to each other. Preferably, the bridge portion 232 of the body 202 of the surgical drape 201 connects the pair of tubular portions 231, 231' to each other forming a common root portion.

[0076] According to an embodiment, the at least one annular connector 212, 212' forms a free end of the body 202 of the surgical drape 201. Preferably, the at least one annular connector 212, 212' forms a free end of its respective pouch 231, 231'.

[0077] According to an embodiment, the body 202 of the surgical drape 201 comprises a base portion 233 that defines the at least one proximal opening edge 206. The base portion 233 is thereby designed to drape a robotic cart 225. According to an embodiment, the at least one pouch 231, 231' extends from the base portion 233 of the body 202 of the surgical drape 201. By providing the base portion 233 and the at least one pouch 231, 231', the body 202 of a single surgical drape 201 can drape both the robotic cart 225 and at least one robotic arm 211 of the robotic surgical system 200.

[0078] A surgical drape 201 is provided having a body 202 including at least a pouch 231, 231' for draping at least a robotic arm 211 and a base portion 233 for draping a robotic cart 225. The at least one pouch 231, 231' is associated with a pair of annular connectors 212, allowing a single surgical drape 201 to cover a robotic surgical system 200 including at least two robotic manipulators 220, 220' distally attached to at least one robotic arm 211. Preferably, both manipulators 220, 220' are attached to the same link of the robotic arm 211, and preferably the robotic arms are attached to the robotic cart 225.

[0079] According to an embodiment, said annular rim 213, 213' of at least one annular connector 212, 212' has an inner annular surface 214, 214' facing the respective distal opening 209, 209'. Thereby, when a pair of annular connectors 212, 212' is provided, a pair of respective inner annular surfaces 214, 214' is provided. According to an embodiment, each of said inner annular surfaces 214, 214' faces a respective axis of rotation. According to an embodiment, each of said inner annular surfaces 214, 214' defines a ring that outlines a respective distal opening 209, 209'. According to an embodiment, each of said inner annular surfaces 214, 214' is substantially parallel to the proximal-distal direction ZZ. According to an embodiment, each of said inner annular surfaces 214, 214' faces a respective rotating body 230, 230'.

[0080] According to an embodiment, the at least one annular connector 212, 212', preferably each of the annular connectors 212, 212' of the surgical drape 201, comprises a distally facing distal annular surface 215, 215', whereby the distal annular surface 215, 215' of the annular connector 212, 212' faces away from the cavity 203 of the surgical drape 201 along the proximal-distal direction ZZ. According to an embodiment, the at least one annular connector 212, 212', preferably each of the annular connectors 212, 212' of the surgical drape 201, comprises a proximal annular surface 234, whereby the proximal annular surface 234 and the distal annular surface 215, 215' face opposite each other with respect to the annular connector 212, 212'. Thereby, the proximal annular surface 234 faces towards the body 202 of the surgical drape 201. According to an embodiment, the proximal annular surface 234 faces towards the cavity 203 of the surgical drape 201 and faces towards the first inner surface 204 of the body 202 of the surgical drape 201. When the proximal annular surface 234 faces towards the second outer surface 205 of the body 202 of the surgical drape 201, the proximal annular surface 234 may face in a direction away from the cavity 203 of the surgical drape 201.

[0081] According to a preferred embodiment, the distal annular surface 215, 215' of the annular connector 212, 212' of the surgical drape 201 faces distally towards the proximal surface 226 of the frame 223 and / or the skirt 224 of the sterile adapter 221, 221', such that the distal annular surface 215, 215' of the annular connector 212, 212' of the surgical drape 201 and the proximal surface 226 of the frame 223 and / or the skirt 224 of the sterile adapter 221, 221' define said annular gap 235, 235. Thereby, the annular connector 212, 212' of the surgical drape 201 and the sterile adapter 221, 221' are not directly connected to each other. The bearings 246 may preferably be provided interposed between the manipulator connection elements 229, 229' and the case 251, 251' of the robot manipulator 220, 220', thus avoiding providing a bearing 246 that contacts both the sterile adapter 221, 221' and the connector 212, 212' of the drape 201.

[0082] According to an embodiment, the at least one annular connector 212 , 212 ′ comprises a coupling device 216 suitable for coupling the surgical drape 201 to a mating coupling 217 of the robotic surgical system 200 .

[0083] According to an embodiment, the mating portion 217 is part of the robotic arm 211 of the surgical system 200, preferably located near the distal end of the robotic arm 211. According to an embodiment, the mating portion 217 is part of a manipulator 220, 220' of the robotic surgical system 200.

[0084] According to an embodiment, the annular coupling device 216 of the surgical drape 201 comprises a resilient element, e.g., a clip, adapted for snap-fit ​​engagement with the mating coupling portion 217 of the robotic arm 211 of the robotic surgical system 200. According to an embodiment, the coupling device 216 of the surgical drape 201 comprises a magnetic coupling element adapted for forming a magnetic coupling with the mating coupling portion 217 of the robotic arm 211 of the robotic surgical system 200. According to an embodiment, the coupling device 216 of the surgical drape 201 comprises a threaded interface adapted for threadedly engaging with the mating coupling portion 217 of the robotic arm 211 of the robotic surgical system 200. According to an embodiment, the coupling device 216 of the surgical drape 201 comprises a bayonet coupling interface adapted for forming a bayonet-type engagement with the mating coupling portion 217 of the robotic arm 211 of the robotic surgical system 200.

[0085] According to a general embodiment, a sterile barrier assembly 210 is provided that includes at least one surgical drape 201 according to any one of the previously described embodiments.

[0086] According to an embodiment, the at least one sterile adaptor 221, 221' comprises at least a second sheet 222, or membrane 222. The second sheet 222 is preferably a single continuous flexible sheet of plastic material. The second sheet 222 is preferably made of a drape material suitable for draping the robotic surgical system 200. For example, the second sheet 222 is made of the same material as the body 202 of the surgical drape 201. According to a preferred embodiment, the at least one sterile adaptor 221, 221' is arranged coaxially with the at least one annular rim 213, 213' of the at least one annular connector 212, 212' of the surgical drape 201. According to a preferred embodiment, the at least one sterile adaptor 221, 221' has at least one substantially rounded rim 223.

[0087] According to a preferred embodiment, for example as shown in Fig. 6, said second seat 222 has a substantially disc shape. According to a preferred embodiment, said rounded rim 223 or frame 223 of at least one sterile adapter 221, 221' serves as a restraining frame for said second seat 222. According to a preferred embodiment, said at least one sterile adapter 221, 221' has a substantially cylindrical shape. According to a preferred embodiment, said at least one sterile adapter 221, 221' has a substantially spherical shape.

[0088] According to a preferred embodiment, the at least one connector 212, 212' of the surgical drape 201 has an annular rim 213, 213' and the at least one sterile adapter 221, 221' has an annular frame such that the gap 235, 235' is an annular gap.

[0089] According to a preferred embodiment, the annular rim 213, 213' and the annular frame 223 of the sterile adapter 221, 221' are arranged coaxially. Preferably, the substantially rounded rim 223 or frame 223 of the sterile adapter 221, 221' is arranged coaxially with the annular rim 213, 213' of the at least one annular connector 212, 212', so that the sterile adapter 221, 221' can roll on an axis with respect to the respective annular connector 212, 212' having an annular rim 213, 213' that is coaxial with the rounded rim 223 of the sterile adapter 221, 221'.

[0090] According to a preferred embodiment, the at least one sterile adapter 221, 221' is suitable to pivot with respect to the at least one connector 212, 212' of the surgical drape 201 about an axis ZZ passing through the geometric center 257, 257' of the connector 212, 212'.

[0091] According to an embodiment, the at least one sterile adapter 221, 221' is integrally coupled to a rotator 230, 230' of the robotic surgical system 200, thereby allowing the at least one sterile adapter 221, 221' of the sterile barrier assembly 210 to roll about an axis ZZ relative to the surgical drape 201 and / or relative to the at least one annular connector 212, 212'.

[0092] According to an embodiment, the at least one sterile adapter 221, 221' is coupled to the annular connector 212, 212' of the surgical drape 201 in a manner allowing a relative rolling motion, whereby the sterile adapter 221, 221' functions as a rolling body 230, 230'.

[0093] According to an embodiment, the second sheet 222 of at least one sterile adapter 221, 221' has the form of a pouch defining a proximal opening of the second sheet 228 facing the at least one distal opening 209, 209' of the surgical drape 201, preferably coaxial with the annular rim 213, 213' of the at least one annular connector 212, 212' of the surgical drape 201. According to an embodiment, the rounded rim 223 of the at least one sterile adapter 221, 221' comprises an engagement interface 226 which engages with a mating interface 227 of the at least one annular connector 212, 212' of the surgical drape 201. A bearing may be provided between the engagement interface 226 and the mating interface 227.

[0094] According to a preferred embodiment, said at least one sterile adaptor 221, 221' comprises at least one proximal coupling device 236 suitable for forming a detachable integral connection with a rotator 230, 230' of the robotic surgical system 200. According to an embodiment, said proximal coupling device 236 is coupled to a manipulator coupling element 229, 229' comprising a manipulator coupling element 229, 229' and a proximal coupling means for coupling the sterile adaptor 221, 221' to a robotic non-sterile manipulator 220, 220'. Preferably, said manipulator coupling element 229, 229' acts as or is the rotator 230, 230'.

[0095] According to a preferred embodiment, the manipulator connection element 229, 229' is a component of a robotic surgery system that connects the sterile adapter 221, 221' to the non-sterile robotic manipulator. The sterile adapter 221, 221' is thereby releasably connected to the manipulator connection element 229, 229'. In this way, the sterile adapter 221, 221' avoids connecting to a surgical drape. In other words, the sterile adapter 221, 221' can avoid connecting to the connector 212, 212' of the surgical drape as well as to the annular rim 213, 213' of the surgical drape. As a result, the surgical drape connector 212, 212' does not provide any structural retention to the sterile adapter 221, 221'; rather, the surgical drape connector 212, 212' engages the case 251, 251' and the sterile adapter 221, 221' engages the manipulator connection element 229, 229' which engages the robotic manipulator. This causes the sterile adapter 221, 221' and the manipulator connection element 229, 229' to rotate together relative to the surgical drape connector 212, 212', which in turn rotates together with the case 251, 251'.

[0096] According to an embodiment, the sterile adapter 221, 221' has a spring-loaded engagement pin 253 to flag when the sterile adapter 221, 221' is coupled to the manipulator coupling element 229, 229'. The manipulator coupling element 229, 229' has a spring-loaded counter-engagement pin 259. When the sterile adapter 221, 221' is not coupled to the manipulator coupling element 229, 229', the spring-loaded counter-engagement pin 259 of the manipulator coupling element 229, 229' abuts against a proximal surface of the sterile adapter 221, 221', such as a part of the proximal coupling device 236 of the sterile adapter. When the sterile adapter 221, 221' is coupled to the manipulator coupling element 229, 229', the spring-loaded engagement pin 253 and the counter-engagement pin 259 align and abut one towards the other. The counter-engagement pins 259 of the manipulator connecting elements 229, 229' penetrate into the respective seats 261 and act as anti-rotation elements preventing relative rotation between the adapter 221, 221' and the manipulator connecting elements 229, 229', as shown, for example, in Fig. 14. In other words, the counter-engagement pins 259 of the manipulator connecting elements 229, 229', when in said seat 261 of the sterile adapter 221, 221', abut circumferentially against the wall of said seat 261, preventing relative rotation between the adapter 221, 221' and the connecting elements 229, 229'. In this way, the counter-engagement pins 259 of the manipulator connecting elements 229, 229' are determined to push said spring-loaded engagement pins 253 distally, thereby causing the flag-like projections 260 to protrude distally from the distal portion of the sterile adapter 221, 221'. 13, the spring loaded engagement pin 253 is associated with a coil spring 253' and the spring loaded counter engagement pin 259 is associated with a flat spring 259'. Preferably, the elastic action of the flat spring 259' overcomes the elastic action of the coil spring 253'.

[0097] According to an embodiment, to disengage the sterile adapter 221, 221' from the manipulator coupling element 229, 229', the flag 260 is pressed, thereby releasing the spring-loaded counter-engagement pin 259. This causes the adapter 221, 221' to rotate and disengage from the manipulator coupling element 229, 229'.

[0098] According to a preferred embodiment, the sterile barrier assembly 210 further comprises at least one labyrinth seal device defining the gap 235, 235' forming a rotatable seal. Preferably, the labyrinth seal device provides a tortuous path that prevents cross contamination over the length of the tortuous path. A suction device may be operatively associated with the labyrinth seal device and cooperate with the labyrinth seal device to form a recess that prevents contamination distal to the sterile barrier assembly 210. According to a preferred embodiment, the at least one labyrinth seal device extends about the axis of rotation ZZ. According to a preferred embodiment, the at least one labyrinth seal device contours the at least one drape opening 209, 209' and contours the frame 223 of the sterile adapter 221, 221'.

[0099] According to a preferred embodiment in which the sterile barrier assembly 210 comprises a pair of sterile adapters 221, 221', a first gap 235 is provided between the first distal opening edge 208 of the surgical drape 201 and the first sterile adapter 221, and a second gap 235' is provided between the second distal opening edge 208' of the surgical drape 201 and the second sterile adapter 221'.

[0100] According to an embodiment, at least one sterile adapter 221, 221' comprises a protrusion 224 or skirt 224 facing said gap 235, 235'. Preferably, said annular skirt 224 extends around the rounded rim 223 and bounds at least a portion of said gap 235, 235'. Thereby, said at least one gap 235, 235' is at least partially bounded by the skirt 224 of the sterile adapter 221, 221'. According to an embodiment, said skirt 224 of at least one sterile adapter 221, 221' cooperates with at least one annular connector 212, 212' and preferably with said annular rim 213, 213' thereof to form said labyrinth seal arrangement. As mentioned above, each skirt 224 has a proximal surface 226, which bounds a respective gap 235, 235' in the distal direction.

[0101] According to an embodiment, the at least one sterile adaptor 221, 221' comprises a distal coupling device 237 suitable for forming a connection, preferably a detachable connection, with a surgical instrument 240, 240' suitable for performing robotic surgery on a patient's anatomy. According to an embodiment, the distal coupling device 237 of the at least one sterile adaptor 221, 221' comprises means for snap-fit ​​engagement with a part of the surgical instrument 240, 240'. For example, the means for snap-fit ​​engagement comprise a pair of resilient elongated tongues 238 each forming a free end. According to an embodiment, the distal coupling device 237 of the at least one second component of the sterile barrier 221 comprises a housing 239 for receiving a rear end 241, 241' of the at least one surgical instrument 240, 240'. Thanks to the provision of the proximal coupling device 236 and the distal coupling device 237, the at least one sterile adapter 221, 221' is capable of being detachably coupled to a sterile surgical instrument 240, 240'.

[0102] According to an embodiment, a bearing 243 is provided within said labyrinth seal arrangement 235 .

[0103] According to a typical embodiment, a robotic surgical system 200 includes at least one sterility barrier assembly 210 according to any one of the embodiments described above.

[0104] The robotic surgery system 200 further comprises at least one non-sterile robotic manipulator 220, 220' comprising a case 251, 251', at least one rotary motor 246, and at least one rotor 230, 230' adapted to pivot relative to the case 251, 251'.

[0105] The at least one connector 212, 212' of the surgical drape 201 of the sterile barrier assembly 210 is coupled to the case 251, 251' of the non-sterile robotic manipulator 220, 220'. The case 251, 251' preferably contains at least one motor, preferably containing at least the rotation motor 246.

[0106] The at least one sterile adapter 221, 221' of the sterile barrier assembly 210 is coupled to the at least one rotor 230, 230' of a non-sterile robotic manipulator 220, 220'.

[0107] The at least one rotary motor 246 is suitable for moving the at least one rotor 230, 230' together with the at least one sterile adapter 221 in a pivoting motion relative to the case 251, 251' of the non-sterile robotic manipulator 220, 220'.

[0108] The gap 235, 235' between the at least one connector 212, 212' of the surgical drape 201 and the at least one sterile adapter 221, 221' forms a rotatable seal, thereby preventing non-sterile robotic manipulators from contaminating the sterile surgical field 255.

[0109] According to a preferred embodiment, the at least one connector 212, 212' of the surgical drape 201 of the sterile barrier assembly 210 is releasably and rigidly coupled to the case 251, 251' of the non-sterile robotic manipulator 220, 220'.

[0110] According to a preferred embodiment, said at least one sterile adapter 221, 221' of the sterile barrier assembly 210 is releasably and rigidly coupled to said at least one rotor 230, 230' of a non-sterile robotic manipulator 220, 220'.

[0111] According to a preferred embodiment, said rotor 230, 230' houses at least one motor of a non-sterile robotic manipulator 220, 220' suitable for actuating a degree of freedom of a surgical instrument 240, 240' attached to a sterile adapter 221, 221'.

[0112] According to an embodiment, the robotic surgical system 200 comprises a master console 244. According to an embodiment, the robotic surgical system 200 comprises a robotic slave assembly adapted to be controlled by the master console 244. The robotic slave assembly includes a robotic cart 225 and at least one robotic arm 211 extending from the cart 225 and defining a proximal-distal direction ZZ. At least one electronic controller may be disposed within the robotic cart 225.

[0113] According to an embodiment, the robotic surgical system 200 comprises at least one surgical instrument 240, 240'. The surgical instrument 240, 240' comprises an instrument shaft 242 extending substantially along a proximal-distal direction ZZ and having a proximal end and a distal end, a surgical end effector 245 at the distal end of the shaft 242, and a back-end portion 241, 241' at or near the proximal end of the shaft 242. According to an embodiment, the back-end portion 241, 241' is adapted to receive a pressing action transmitted through and across the second sheet 222 of the second component of the sterility barrier 210. According to an embodiment, the back-end portion 241, 241' comprises a plurality of transmission rods or the like adapted to be pressed to activate at least one actuation cable [not shown] of the surgical instrument, which in turn activates an end effector 245, for example a surgical wrist 245. According to an embodiment, the transmission rods are linearly displaceable.

[0114] According to an embodiment, the sterile barrier assembly 210 is disposed adjacent, or in other words upstream, of the at least one surgical instrument 240, 240', such that the sterile barrier assembly 210 is located upstream of the rear end 241, 241' of the at least one surgical instrument 240, 240'. According to an embodiment, the sterile barrier assembly 210 is located proximally, or in other words upstream, of the shaft 242 of the at least one surgical instrument 240, 240'.

[0115] According to an embodiment, the robotic cart 225 comprises at least a ground contacting unit 252, e.g., wheels 252, suitable for supporting the robotic cart 225 at rest on a floor of a surgical theater. According to an embodiment, the at least one ground contacting unit 252 is not covered by the surgical drape 201.

[0116] According to an embodiment, the at least one robotic arm 221 comprises a number of arm links 219, 219', 219'', 219''' joined to each other at respective joints forming a kinematic chain. The robotic arm 211 is preferably a passive arm, excluding motors, designed to be moved by human action, e.g. pulled by an operator. The robotic arm 211 may be configured with a braking system at the joints of the arm links 219, 219', 219'', 219'''. According to an embodiment, one of the arm links 219, 219', 219'', 219''' is connected to at least two motorized robotic manipulators 220, 220' suitable for manipulating a robotic end effector (e.g. wrist 245 of a surgical instrument 240, 240') inside a patient's body along multiple degrees of freedom.

[0117] The robotic surgical system 200 includes the at least one rotor 230. 230'.

[0118] According to an embodiment, the rotor 230, 230' constitutes or is connected to the second component of the sterility barrier 221, such that the second component of the sterility barrier 221 moves together with the rotor 230, 230'. According to an embodiment, each electric manipulator 220, 220' comprises a case 251, 251' and at least a motor 246, 247.

[0119] According to an embodiment, said at least one motor 246, 247 of a manipulator 220, 220' comprises at least one rotary motor 246 suitable for rolling a rolling body 230, 230' about a rolling axis ZZ relative to said case 251, 251'.

[0120] According to a preferred embodiment, the at least one annular connector 212, 212' of the sterile barrier assembly 210 is coupled to the case 251, 251' of the manipulator 220, 220'. Also, the at least one second component sterile barrier 221 is coupled to the at least one rotating body 230, 230'. A bearing 243 may be provided between the at least one rotating body 230, 230' and the case 251, 251' of the manipulator 220, 220'. Preferably, the mating coupling 217 is arranged in the case 251, 251', preferably in the distal part of the case 251, 251'.

[0121] According to an embodiment, the at least one motor 246, 247 of the manipulator 220, 220' further comprises at least one linear motor 247 suitable for moving the rotating body 230, 230' along at least one linear direction, for example a vertical direction, preferably along three linear directions substantially perpendicular to each other with respect to the case 251, 251'. Preferably, the at least one linear motor 247 acts proximally, in other words upstream, with respect to the rotating motor 246. According to an embodiment, the at least one manipulator 220, 220' has three linear guide devices 248, 249, 250. The three linear guide devices 248, 249, 250 are coupled to the at least one linear motor 247 (preferably, the three linear guide devices 248, 249, 250 are each coupled to a linear motor). Three linear guiding devices 248, 249, 250 are suitable for guiding the linear movement of said rotating body 230, 230' along three orthogonal directions. The manipulator 220, 220' also comprises at least one rotation transmission element (such as, for example, a transmission belt) suitable for transmitting a rotational motion R from said rotation motor 246 to said at least one rotating body 230, 230'.

[0122] According to a preferred embodiment, motors 246 , 247 are all located proximal, or upstream, of the sterile barrier assembly 210 .

[0123] According to a preferred embodiment, the at least one surgical instrument 240, 240' is coupled to the rotor 230, 230'.

[0124] According to an embodiment, an anti-rotation system is provided that is designed to avoid relative rotation between the rotor 230, 230' and the case 251, 251' of the manipulator 220, 220' during coupling of the second component of the sterility barrier 221 to the rotor 230. According to an embodiment, the anti-rotation system comprises a radial cantilever element that projects away radially with respect to the axis of rotation of the rotor 230, 230' and abuts against a radially inner blocking tooth of the case 251, 251'.

[0125] According to an embodiment, there are two motorized manipulators 220, 220' attached to the same link of the robot arm 221. Each manipulator 220, 220' has three orthogonal degrees of freedom. The three orthogonal degrees of freedom of one manipulator 220 are parallel to the three orthogonal degrees of freedom of the other manipulator 220'. Downstream of each manipulator 220, 220' is provided a rotary motor 246 which moves the rotor 230, 230' attached to it about a rolling axis ZZ relative to the case 251, 251'. Preferably, downstream of the rotor 230, 230', preferably integral therewith, there is provided an instrument shaft which at its distal end has an articulated end effector with degrees of freedom, for example pitch, yaw and grip.

[0126] According to a preferred embodiment, and as shown for example in FIG. 10, as described above, the gap 235, 235' is between the proximal surface 226 of the skirt 224 of the sterile adapter 221, 221' and the distal surface 215, 215' of the connector 212, 212' of the surgical drape 201. The sterile adapter 221, 221' releasably connects to the manipulator connecting element 229, 229', which in turn releasably connects to the case 215. This allows the sterile adapter 221, 221' and the manipulator connecting element 229, 229' to rotate together relative to the surgical drape 201, while the sterile adapter 221, 221' can be disengaged from the manipulator connecting element 229, 229' without requiring any movement on the surgical drape 201 and relative to the connector 212, 212' of the surgical drape 201. The sterile adapters 221, 221' can thereby be disconnected and / or connected to the manipulator connection elements 229, 229' during surgery without compromising the integrity of the surgical drape 201 for this reason, and in some embodiment events, without touching any part of the surgical drape 201.

[0127] In accordance with a preferred embodiment, the sterile adapter 221, 221' is attached to a robotic manipulator and is permitted to rotate relative to the case 251, 251' without being received within the case 251, 251'. Rather, the sterile adapter 221, 221' is distal to the surgical drape 201, although it includes a membrane 222 that forms part of the sterile barrier assembly 210.

[0128] According to an embodiment that is not necessarily combined with the above-mentioned embodiments, a sterile adaptor 221, 221' for a robotic surgical system 200 is adapted to transfer a plurality of linear actuation motions and rotational motions from a non-sterile robotic manipulator 220, 220' to a sterile surgical instrument 240, 240' having a back end 241 and a shaft 242 extending from said back end portion 241. The sterile adaptor 221, 221' comprises a frame 223 and a membrane 222. The frame 223 is for transferring rotational motions from the non-sterile robotic manipulator 220, 220' to the sterile surgical instrument 240, 240'. The frame 223 comprises a proximal coupling device 236 for coupling with the non-sterile robotic manipulator 220, 220' and a distal coupling device 237 for coupling with the sterile surgical instrument 240, 240'. The frame 223 defines an opening between the proximal coupling device 236 and the distal coupling device 237. A membrane 222 is fixed to the frame 223 for transmitting a plurality of local linear actuation motions from the non-sterile robotic manipulator 220, 220' to the sterile surgical instrument 240, 240' through its thickness. The membrane 222 is elastically stretchable for elastically biasing towards its substantially flat configuration. The stretchable membrane 222 seals the through opening forming a distal cavity 239 between the stretchable membrane 222 and the distal coupling device 237, the distal cavity 239 being suitable for receiving at least a portion of a back end 241 of the sterile surgical instrument. The distal coupling device 237 has at least one abutment surface facing the stretchable membrane 222 and thereby at least partially delimiting the distal cavity 236. The at least one abutment surface is suitable for abutting a portion of a surgical instrument 240, 240', such as a back end 241 thereon.

[0129] The non-sterile robotic manipulator 220, 220' may include a motor for exerting the multiple linear displacement actions, for example a motor that actuates multiple pistons, each piston exerting one of the linear displacement actions on the same membrane 222 of the sterile adapter 221, 221'.

[0130] According to an embodiment, the distal cavity 239 includes a side guide surface suitable for mating with at least one lateral opposing surface of the sterile surgical instrument 240, 240', and preferably, the side guide surface of the distal cavity 239 of the sterile adapter 221, 221' is substantially flat.

[0131] According to an embodiment, the distal cavity 239 includes a lateral opening designed for inserting the sterile surgical instrument 240, 240' into the sterile adapter 221, 221'.

[0132] According to an embodiment, the distal coupling device 237 is designed to engage a portion of a surgical instrument 240, 240' in a snap-fit ​​manner.

[0133] According to an embodiment, the distal cavity 239 includes a second side opening suitable for accessing the distal cavity 239 for the purpose of pushing the sterile surgical instrument 240, 240' out of the distal cavity 239 of the sterile adapter 221, 221'.

[0134] According to an embodiment, the membrane 222 is a single flat piece.

[0135] According to an embodiment, the distal coupling device 239 defines a distal seat having a distal through opening that opens distally outside the distal cavity.

[0136] According to an embodiment, the distal through-opening is substantially aligned with the through-opening sealed by the elastic membrane 222 and is preferably coaxial with the through-opening sealed by the elastic membrane 222.

[0137] According to an embodiment, the at least one abutment surface is beneath the stretchable membrane 222 , preferably beneath the encumber of the membrane 222 .

[0138] According to an embodiment, the frame 223 rigidly determines the positioning and orientation of the proximal coupling device 236 and the distal coupling device 237 relative to one another, and preferably the location of the lateral opening of the distal coupling device 236 .

[0139] According to an embodiment, the sterile adapter 221, 221' has a spring-loaded engagement pin 253. The manipulator coupling elements 229, 229' are provided with respective spring-loaded counter-engagement pins 259, which are adapted to flag when the sterile adapter 221, 221' is coupled to the manipulator coupling elements 229, 229' as previously described.

[0140] Below, a method for installing the sterile barrier assembly is described, and a method for removing the sterile barrier assembly is described.

[0141] A method for installing and / or removing a sterile barrier assembly for a robotic surgical system includes the following steps.

[0142] Connecting and / or disconnecting at least one connector 212, 212' of the surgical drape 201 to at least one case 251, 251' of the non-sterile robotic manipulator 220, 220'.

[0143] Connecting and / or disconnecting the sterile adapter 221, 221' to the rotor 230, 230' of the non-sterile robotic manipulator 220, 220'.

[0144] In accordance with an operational mode, the steps of connecting and / or disconnecting the sterile adapters 221 , 221 ′ do not involve any motion to the sterile drape 201 .

[0145] According to a mode of operation, the step of connecting includes moving the sterile adapter 221, 221' proximally (e.g., a rotational movement such as threading the adapter onto the rotator 230, 230') directly or indirectly through the interposition of the manipulator connecting element 229, 229'. If a manipulator connecting element 229, 229' is provided that is interposed between the rotator 230, 230' and the sterile adapter 221, 221', the step of connecting includes moving the sterile adapter 221, 221' proximally (e.g., a rotational movement such as threading the adapter 221, 221' onto the manipulator connecting element 229, 229').

[0146] According to an aspect of operation, the step of disconnecting comprises moving the sterile adapter 221, 221' proximally (e.g., a rotational movement to unscrew the adapter from the rotator 230, 230'). If a manipulator connection element 229, 229' is provided between the rotator 230, 230' and the sterile adapter 221, 221', the step of disconnecting comprises moving the sterile adapter 221, 221' distally (e.g., a rotational movement to unscrew the adapter 221, 221' from the manipulator connection element 229, 229').

[0147] According to an operational aspect, the method includes first connecting the connector 212, 212' of the surgical drape 201 to the case 251, 251' of the manipulator 220, 220' and then connecting the sterile adapter 221, 221' to the rotator 230, 230' of the robotic manipulator 220, 220'. In the case of a manipulator connecting element 229, 229' interposed between the rotator 230, 230' and the sterile adapter 221, 221', the connecting step includes first connecting the connector 212, 212' of the surgical drape 201 to the case 251, 251' of the manipulator 220, 220' and then connecting the sterile adapter 221, 221' to the manipulator connecting element 229, 229' attached to the rotator 230, 230' of the robotic manipulator 220, 220'. Attachment of the manipulator connecting elements 229, 229' to the rotators 230, 230' may be performed prior to connecting the connectors 212, 212' of the surgical drape 201 to the case 251, 251'. Thus, connection of the connectors 212, 212' of the surgical drape 201 to the case 251, 251 may be performed after attachment of the manipulator connecting elements 229, 229' to the rotators 230, 230'.

[0148] According to an operational mode, the disconnecting step includes first disconnecting the sterile adapter 221, 221' from the rotator 230, 230' of the robotic manipulator 220, 220', and then disconnecting the connector 212, 212' of the surgical drape 201 from the case 251, 251'. If a manipulator connection element 229, 229' is provided between the rotator 230, 230' and the sterile adapter 221, 221', the disconnecting step includes first disconnecting the sterile adapter 221, 221 from the manipulator connection element 229, 229' attached to the rotator 230, 230' of the robotic manipulator 220, 220', and then disconnecting the connector 212, 212 of the surgical drape 201 from the case 251, 251'. The method may include the step of decoupling (i.e., disconnecting) the manipulator connecting elements 229, 229′ from the rotators 230, 230′. This step may be performed after disconnecting the connectors 212, 212′ of the surgical drape 201 from the case 251, 251′.

[0149] Thereby, the sterile adapter 212, 212' may be the last component of the sterile barrier assembly to be connected.

[0150] Thereby, the sterile adapter 212, 212' may be the first component of the sterile barrier assembly to be disconnected.

[0151] In accordance with an operational aspect, the steps of connecting and / or disconnecting the sterile adapters 221, 221' are performed intraoperatively.

[0152] In light of the above, a method for attaching a sterile barrier assembly may include the following steps: first, connect at least one connector 212, 212' of the surgical drape 201 to at least one case 251, 251' of the robotic manipulator 220, 220', and then connect at least one sterile adapter 221, 221' to a rotator 230, 230' of the at least one robotic manipulator 220, 220', where the at least one robotic manipulator 220, 220' has a case 250, 251' that is already connected to at least one connector 212, 212' of the surgical drape 201. If two robotic manipulators 220, 220' are provided, the method for attachment involves first connecting the connector 212, 212' to the case 251, 251' of either manipulator 220, 220' and then connecting the respective sterile adaptor 221, 221'.

[0153] In view of the above, a method for removing a sterile barrier assembly includes first disconnecting at least one sterile adapter 221, 221' from a rotor 230, 230' of at least one robotic manipulator 220, 220'. The at least one robotic manipulator 220, 220' has a case 250, 251'. The case is connected to at least one connector 212, 212 of a surgical drape 201. Next, disconnecting at least one connector 212, 212 of the surgical drape 201 from the at least one case 251, 251' of the robotic manipulator 220, 220'. If two robotic manipulators 220, 220' are provided, one skilled in the art will appreciate that the method for removal is to first disconnect the sterile adapter 221, 221' from either manipulator 220, 220', and then disconnect the connector 212, 212' from the case 251, 251' of the respective manipulator 220, 220'.

[0154] In operation, the method is performed by a sterile barrier assembly and / or a robotic surgical system according to any of the embodiments described above.

[0155] The above-mentioned features provided individually or in combination in specific embodiments may satisfy the above-mentioned needs providing the above-cited advantages.

[0156] In particular, a sterile barrier assembly 210 is provided that can prevent contamination of the sterile surgical field 255 while at the same time disengaging a rotatable seal to avoid localized frictional wear of the surgical drape 201 against the sterile adapters 221, 221' and / or connectors 212, 212'.

[0157] The sterile adapters 221 , 221 ′ and connectors 212 , 212 ′ may be spaced in a proximal-distal direction such that the sterile adapter frame 223 is distal to the respective connectors 212 , 212 ′ of the surgical drape 201 .

[0158] The sterile adapters 221, 221' can be removed from the robot without having to remove the surgical drape 201.

[0159] At the same time, the connector of the surgical drape 201 is removed from the robot's case 251, 251' without the need to remove the sterile adapters 221, 221' for this reason.

[0160] The motor may be located upstream of the rotatable seal of the sterile barrier assembly.

[0161] A surgical drape is provided that can receive rotating bodies without structural damage or plastic deformation.

[0162] A sterility barrier assembly is provided having two separate parts with a gap therebetween that allows relative rolling movement between the two separate parts.

[0163] A sterile barrier assembly is provided having coupling means for forming a reversible connection with at least one surgical instrument.

[0164] A single surgical drape can be employed to drape the robotic arm and the robotic cart, thereby reducing the number of components in the robotic surgical system and thereby reducing the time required for draping.

[0165] Those skilled in the art may make numerous modifications and adaptations to the above-described embodiments, or may substitute other elements that are functionally equivalent to meet their foreseeable needs, without departing from the scope of the appended claims. [Explanation of symbols]

[0166] 200 Robotic Surgery System 201 Surgical drapes or sterile drapes 202 Flexible body of surgical drape 203 Through Hollow 204 First Inner Surface 205 Second Outer Surface 206 Proximal opening edge 207 Proximal opening 208 Distal opening edge or first distal opening edge 208' distal opening edge, or second distal opening edge 209 Drape distal opening or first distal opening 209' Drape distal opening or second distal opening 210 Sterile Barrier Assembly 211 Robot Arm 212 connector, or annular connector, or first annular connector 212' connector, or annular connector, or second annular connector 213 Annular rim of first annular connector 213' annular rim of second annular connector 214 Inner surface of annular rim of first annular connector 214' inner surface of the annular rim of the second annular connector 215 Distal surface of annular rim of first annular connector 215' a distal surface of the annular rim of the second annular connector 216 Annular connector coupling device for surgical drape 217 Paired Joints of Robotic Surgical Systems 218 Proximal Attachment Interface of Surgical Drape 219, 219', 219'', 219'''', arm link of robot arm 220, 220' Manipulator for robotic surgery system, or robotic electric manipulator 221, 221' Sterile Adapter 222 Second sheet of sterile barrier assembly 223 Adapter frame or rounded rim 224 Adapter Skirt 225 Cart for Robotic Surgery System 226 Proximal surface of adapter 228 Proximal opening of second sheet 229 Manipulator Connection Element 230, 230' Rotating Body 231, 231' Surgical drape pouch 232 Bridge part of surgical drape body 233 Base part of surgical drape 234 Proximal annular surface of annular connector 235, 235' gap 236 Adapter proximal coupling device Distal coupling device of 237 adapter 238 Long and thin tongue or elastic tongue 239 Adapter Housing 240, 240' surgical instruments 241 Back-end of surgical equipment 242 Shafts of surgical instruments 243 Bearing 244 Master Controller 245 Surgical instrument wrist, or end effector 246 Rotary Motor 247 Linear Motor 248, 248', 248'' Linear guide device 251, 251' Case or protective case for robot manipulator 252 Grounding Unit 254, 254' proximal pouch opening 255 Sterile Operating Room Field 256, 256' connector center 257, 257' Center of adapter frame ZZ axis R Rotation direction

Claims

1. A sterile barrier assembly (210) for a robotic surgical system (200), comprising: a surgical drape (201) having at least one drape opening (209, 209'); at least one connector (212, 212') having a contour of said at least one drape opening (209, 209') and adapted to mate with a case (251, 251') of a non-sterile robotic manipulator (220, 220'); at least one sterile adaptor (221, 221') having a frame (223) including a coupling device (237) for coupling to at least one surgical instrument (240, 240'); said at least one sterile adapter (221, 221') is suitable for coupling with at least one rolling element (230, 230') of said non-sterile robotic manipulator (220, 220'); said at least one rolling element (230, 230') being adapted to pivot relative to said case (251, 251'); the at least one connector (212, 212') and the at least one sterile adapter (221, 221') of the surgical drape (201) are made in separate pieces; the at least one sterile adapter (221, 221') is adapted to pivot relative to the at least one connector (212, 212') of the surgical drape (201); a gap (235, 235') is provided between the at least one connector (212, 212') of the surgical drape (201) and the at least one sterile adapter (221, 221'); the at least one connector (212, 212') of the surgical drape (201) includes a distal surface (215, 215') facing distally; The sterile adapter (221, 221′) includes a proximal surface (226) facing proximally; A sterile barrier assembly (210), wherein the distal surface (215, 215') of the at least one connector (212, 212') faces the proximal surface (226) of the sterile adapter (221, 221') that defines the gap (235, 235').

2. the at least one connector (212, 212') of the surgical drape (201) has an annular rim (213, 213'); said at least one sterile adapter (221, 221') having an annular frame; The sterility barrier assembly (210) of claim 1, wherein the gap (235, 235') is an annular gap.

3. The sterility barrier assembly (210) of claim 2, wherein the annular rim (213, 213') and the annular frame (223) of the sterile adapter (221, 221') are coaxially disposed.

4. The at least one sterile adapter (221, 221') has a protrusion (224) or skirt (224) facing proximal to the gap (235, 235'); The sterility barrier assembly (210) of any of claims 1 to 3, wherein the projection (224) or the skirt (224) has the proximal surface (226).

5. The surgical drape (201) comprises: A pair of drape openings (209, 209'); a pair of connectors (212, 212'), said pair of connectors (212, 212') outlining each of said pair of drape openings (209, 209'); a pair of sterile adaptors (221, 221'), each of the pair of sterile adaptors (221, 221') having a frame (223), the frame (223) including a coupling device (237) for coupling to a surgical instrument (240, 240'); each of the pair of connectors (212, 212') of the surgical drape (201) and each of the pair of sterile adapters (221, 221') are made of separate parts; each of the pair of sterile adaptors (221, 221') is adapted to pivot relative to each of the pair of sterile adaptors (221, 221') of the surgical drape (201); A sterile barrier assembly (210) as described in any one of claims 1 to 4, wherein a gap (235, 235') is provided between each of the pair of connectors (212, 212') of the surgical drape (201) and each of the pair of sterile adapters (221, 221').

6. The sterile barrier assembly (210) of claim 5, wherein the surgical drape (201) is a single piece.

7. The surgical drape (201) comprises a pair of pouches (231, 231'), Each of the pair of pouches (231, 231') separates each of the pair of drape openings (209, 209'); A sterile barrier assembly (210) according to claim 5 or 6, wherein each of the pair of pouches (231, 231') is suitable for draping one of the non-sterile robotic manipulators (220, 220').

8. A robotic surgery system (200), comprising: The robotic surgery system (200) comprises at least one sterile barrier assembly (210) according to any one of claims 1 to 7 and at least one non-sterile robotic manipulator (220, 220'), The at least one non-sterile robotic manipulator (220, 220′) A case (251, 251'), At least one rotary motor (246); at least one rolling element (230, 230') adapted to pivot relative to said case (251, 251'); the at least one connector (212, 212') of the surgical drape (201) of the sterile barrier assembly (210) is coupled to the case (251, 251') of the at least one non-sterile robotic manipulator (220, 220'); the at least one sterile adapter (221, 221') of the at least one sterile barrier assembly (210) is coupled to the at least one rolling element (230, 230') of the at least one non-sterile robotic manipulator (220, 220'); A robotic surgery system (200), wherein the at least one rotational motor (246) is suitable for rotationally moving the at least one rolling body (230, 230') together with the at least one sterile adapter (221, 221') relative to the case (251, 251') of the at least one non-sterile robotic manipulator (220, 220').

9. 9. The robotic surgical system (200) of claim 8, wherein the at least one connector (212, 212') of the surgical drape (201) of the sterile barrier assembly (210) is detachably and rigidly coupled to the case (251, 251') of the at least one non-sterile robotic manipulator (220, 220').

10. The robotic surgical system (200) of claim 8 or 9, wherein the at least one sterile adapter (221, 221') of the sterile barrier assembly (210) is detachably and firmly connected to the at least one rolling body (230, 230') of the at least one non-sterile robotic manipulator (220, 220').

11. the at least one rolling body (230, 230') of the non-sterile robotic manipulator (220, 220') comprises a manipulator coupling element (229, 229'); A robotic surgical system (200) as described in any of claims 8 to 10, wherein the engagement between the at least one sterile adapter (221, 221') and the manipulator coupling element (229, 229') is distal to the case (215) of the surgical drape (201) and / or distal to the connector (212, 212').

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