Sterile barrier components and robotic surgical systems

Abstract

A robotic surgical system (200) includes at least one sterile barrier assembly (210), at least one non-sterile robotic manipulator (220, 220'), the at least one non-sterile robotic manipulator including a housing (251, 251') and at least one rolling motor (246), and at least one rolling element (230, 230') adapted to pivot relative to the housing (251, 251'); the at least one connector (212, 212') of the surgical drape (201) of the sterile barrier assembly (210) is coupled to the housing (251, 251') of the non-sterile robotic manipulator (220, 220'); the at least one sterile adapter of the sterile barrier assembly (210) is also included. (221, 221') is coupled to at least one rolling element (230, 230') of a non-sterile robotic manipulator (220, 220'); the at least one rolling motor (246) is adapted to move at least one rolling element (230, 230') together with the pivoting at least one sterile adapter (221, 221') relative to the housing (251, 251') of the non-sterile robotic manipulator (220, 220'); the gap (235, 235') between at least one connector (212, 212') of the surgical drape (201) and at least one sterile adapter (221, 221') forms a rotatable seal, which prevents the non-sterile robotic manipulator from contaminating the sterile surgical area (255).

Description

Technical Field

[0001] This invention generally relates to surgical drapes for robotic surgery.

[0002] The purpose of this invention is to provide a sterile barrier assembly for robotic surgery.

[0003] The present invention also relates to a robotic surgical system comprising at least one sterile barrier component.

[0004] The present invention also relates to an installation method and a method for disassembling a sterile barrier assembly. Background Technology

[0005] Robotic surgical devices are generally known in the art and typically include a central robotic tower (or robotic trolley) and multiple robotic arms extending from the central tower. Each robotic arm includes a remotely operated robotic motion positioning system (or manipulator) for moving a surgical end effector attached distally to it to perform surgical procedures on the patient. The patient typically lies on an operating table located in an operating room where sterilization is ensured to avoid bacterial contamination due to non-sterile parts of the robotic device.

[0006] Typically, surgical drapes are used to cover the robot's components to protect the sterile environment from contamination. The need to cover the robot arises from the fact that such a robot must be used and reused in several surgeries.

[0007] For example, document US-2014-0158141 shows a soft surgical drape designed to cover the central tower of a robot and having multiple openings for each robotic arm extending from the robot trolley, such that the robotic arms are not covered by the surgical drape but are instead covered by a separate bag of the surgical drape.

[0008] Therefore, the flexible body of the surgical drape can be provided with inserts (e.g., rigid plastic plates) to form a connection interface with the moving parts of the robot. For this purpose, a sterile adapter, typically made of rigid plastic, is integrally formed with the drape to provide attachment points for surgical instruments, and the sterile adapter typically includes movable parts to transmit actuation actions (e.g., winch-driven actions) to the surgical instruments detachably attached thereto, for actuating the end effectors of the surgical instruments. Examples of known sterile adapters can be found in documents WO-2009-061915 and WO-2019-006206.

[0009] Covering cloths for covering microscope components located in an operating room are also known in the art. For example, document US-2019-0069969 discloses a tubular cover for assembling the cylindrical end portion of an electron microscope, wherein a hard glass cover is disposed on the cover to form a cup-shaped end of the cover designed to cover a microscope lens. Therefore, this cover solution is not suitable for transmitting actuation actions downstream of the cover itself, and in this case, it is not suitable for transmitting actuation actions downstream of the microscope lens.

[0010] Document WO-2017-064301, under the same applicant's name, discloses a solution for a robotic surgical apparatus in which a single robotic arm extends from a robotic trolley and includes at the distal end of the robotic arm a pair of remotely operated robotic manipulator systems arranged in parallel and connected to the same horizontal link of the single robotic arm.

[0011] Known surgical drapes may also include securing cords that allow the drape to be fastened to fit snugly against elongated portions of the robot (such as the robot arm), thereby reducing the burden of the surgical drape covering the robotic device during use. Furthermore, it is known to provide magnetically releasable connections between parts of the robotic device and the edges of the surgical drape.

[0012] Document WO-2018-189729, under the same applicant's name, discloses a sterile barrier solution comprising a reinforcing element attached to a sterile barrier for the purpose of transmitting linear actuation through the barrier itself. The surface of the reinforcing element may be rounded to ensure single-point contact with a non-sterile actuator. While advantageous for several reasons, this solution results in difficult assembly due to the requirement to align the actuator of a remotely operated robotic maneuvering system with the reinforcing element of the sterile barrier, and consequently with the distal element of the surgical instrument actuated therefrom.

[0013] Surgical drapes are typically in the form of a package encapsulating a robot, the package having a closed end, and one or more pouches that can further extend from the closed end of the package to receive an extendable actuator for the robot, as shown, for example, in WO-2011-143024.

[0014] It is also known to provide a rotatable seal proximally to a surgical drape to cover a robotic tower and robotic arm, the robotic arm being pivotable about an axis relative to the robotic tower. An embodiment of such a solution is shown in document WO-2019-150111, wherein the rotatable seal is located at the proximal end of a bag of a sterile package covering the robotic arm, so as to pivotally connect the proximal end of the bag to the drape portion covering the robotic tower. Other embodiments of surgical systems with rotatable seals are shown in documents US-2016-235490, WO-2017-044884, US-2019-380803, and US-2018-0000472. In these known solutions, the rotatable seal is typically obtained by assembling / installing a first surgical drape to a second surgical drape after a second surgical drape has been attached to a rotatable element of the robotic system; the first surgical drape has a first ring defining a slot opening, and the second surgical drape has an outer ring forming the outline of the second surgical drape.

[0015] There is a need to provide a sterile barrier solution with an improved yet simplified rotatable seal.

[0016] Therefore, it is believed that there is a need for a solution for a surgical drape that simplifies assembly of robotic surgical devices, while having improved durability compared to known solutions, without inhibiting the transmission of actuation actions through and / or across the surgical drape for these reasons.

[0017] At the same time, it is believed that there is a need to provide a solution for a sterile barrier with improved durability compared to known solutions, without limiting the degree of freedom of movement of sterile surgical instruments that can be attached to the sterile barrier distally during surgery. Summary of the Invention

[0018] The scope of this invention overcomes the shortcomings mentioned in reference to known technologies.

[0019] These and other scopes are achieved by the sterile barrier assembly of claim 1, the robotic surgical system of claim 11, and the method of claim 24.

[0020] Some preferred embodiments are the subject of the dependent claims.

[0021] 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 that forms the outline of the at least one drape opening and is adapted to engage with a case encapsulating a non-sterile robotic manipulator.

[0022] According to one aspect of the invention, the sterile barrier assembly further includes at least one sterile adapter having a frame that includes a coupling device for coupling with at least one surgical instrument, wherein at least one connector of the surgical drape and at least one sterile adapter are made as separate pieces.

[0023] According to one aspect of the invention, at least one sterile adapter is adapted to pivot relative to 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. This gap may be an annular gap, and the gap prevents any direct contact between the frame of the sterile adapter and the connector of the sterile drape.

[0024] At least one connector of the surgical drape may include a distally facing surface, and the sterile adapter includes a proximally facing surface, wherein the distally facing surface of the connector faces the proximal surface of the sterile adapter that defines the gap. Thus, the proximal surface of the sterile adapter defines the gap distally, while the distally facing surface of the connector defines the same gap proximally.

[0025] The connector of the surgical drape can be integrated with the body of the surgical drape.

[0026] A sterile adapter may include a skirt facing the gap from the proximal side, the proximal surface of which may belong to the skirt.

[0027] According to one aspect of the invention, a robotic surgical system includes at least one of the aforementioned sterile barrier components. The robotic surgical system also includes at least one non-sterile robotic manipulator comprising: a housing, at least one roll motor, and at least one rolling element adapted to pivot relative to the housing. The roll motor may be operatively connected to the rolling element.

[0028] According to one aspect of the invention, at least one connector of the surgical drape of the sterile barrier assembly is coupled to the housing of the non-sterile robotic manipulator, and at least one sterile adapter of the sterile barrier assembly is coupled directly or indirectly (e.g., via an insert manipulator connecting element) to at least one rolling element of the non-sterile robotic manipulator, such that the at least one rolling motor is adapted to move relative to the housing of the non-sterile robotic manipulator, causing the at least one rolling element to move together with the at least one pivotally moving sterile adapter.

[0029] At least one connector of the surgical drape of the sterile barrier assembly can be detachably and rigidly attached to the housing of the non-sterile robotic manipulator.

[0030] At least one sterile adapter of the sterile barrier assembly can be detachably and rigidly coupled to at least one rolling element of the non-sterile robotic manipulator.

[0031] The rolling element of the non-sterile robotic manipulator may include a manipulator connecting element, and the sterile adapter may be detachably engaged with the manipulator connecting element, for example, in an undercut manner (such as via a bayonet (plug) connection and / or a threaded connection). The engagement between the sterile adapter and the manipulator connecting element may be located distal to the housing and / or distal to the connector of the surgical drape. The manipulator connecting element may be at least partially located within the housing, while the sterile adapter may be located outside the housing, and preferably distal to the housing encapsulating the non-sterile robotic manipulator.

[0032] According to one aspect of the invention, a sterile drape includes a pair of drape openings, a pair of connectors, and a pair of sterile adapters, wherein each connector forms the outline of a corresponding drape opening, each connector is made as a separate component relative to a corresponding sterile adapter, and each sterile adapter is adapted to pivot relative to a corresponding connector of the surgical drape.

[0033] According to one aspect of the invention, a robotic surgical system includes: a sterile barrier assembly of the type described above, the sterile barrier assembly having a pair of drape openings, a pair of connectors, and a pair of sterile adapters; the robotic surgical system further includes a pair of non-sterile robotic manipulators; wherein each connector of the surgical drape is coupled to the housing of the corresponding robotic manipulator, and each sterile adapter of the sterile barrier assembly is coupled to a rolling element of the corresponding non-sterile robotic manipulator, such that each rolling motor is adapted to move relative to the housing of the corresponding non-sterile robotic manipulator, causing the corresponding rolling element to move together with the pivotally moving corresponding sterile adapter.

[0034] The body of the surgical drape can be made into a separate piece and can include a pair of bags, each bag defining a corresponding drape opening, each bag being adapted to individually cover one of the pair of non-sterile robotic manipulators, for example by attaching a connector of the corresponding bag of the surgical drape to the housing of the corresponding non-sterile robotic manipulator to cover one of the pair of non-sterile robotic manipulators.

[0035] According to one aspect of the invention, a method for installing and / or removing a sterile barrier assembly of a robotic surgical system includes the steps of: connecting and / or disconnecting at least one connector of a surgical drape from at least one housing of a non-sterile robotic manipulator; and connecting and / or disconnecting a sterile adapter from a rolling element of the non-sterile robotic manipulator. The connection to the rolling element can be direct or indirect, for example, by inserting a manipulator connecting element.

[0036] Connecting a sterile adapter directly or indirectly (e.g., via an insert manipulator connection element) to a rolling element may include moving the sterile adapter proximally toward the rolling element without contacting the surgical drape and / or the connector of the surgical drape.

[0037] Connecting a sterile adapter directly or indirectly (e.g., via inserting a manipulator connection element) to the rolling element may include: moving the sterile adapter proximally toward the rolling element while the surgical drape is already attached to the housing of the non-sterile robotic manipulator via the drape's connector. Disconnecting the sterile adapter directly or indirectly (e.g., via inserting a manipulator connection element) from the rolling element may include: moving the sterile adapter distally from the rolling element while the surgical drape is attached to the housing of the non-sterile robotic manipulator via the drape's connector. Therefore, the installation method may include: first connecting at least one connector of the surgical drape to at least one housing of the non-sterile robotic manipulator, and then connecting at least one sterile adapter to the rolling element of the non-sterile robotic manipulator, whose housing is already connected to the surgical drape's connector. Therefore, the disassembly method may include: first separating at least one sterile adapter from the rolling element of the non-sterile robotic manipulator, and then separating the surgical drape's connector from at least one housing of the at least one non-sterile robotic manipulator, whose sterile adapter has already been separated from at least one non-sterile robotic manipulator.

[0038] The proposed solution provides a surgical drape or surgical pack that can be surrounded by a ring of the surgical drape or surgical pack, the rolling element being rotatable relative to the surgical drape and about an axis.

[0039] The proposed solution provides a sterile barrier assembly comprising a surgical drape and at least one sterile adapter pivotally associated with at least one distal opening of the surgical drape.

[0040] The proposed solution provides a robotic surgical system comprising a rolling element received within a housing, wherein both the housing and the rolling element are associated with the same sterile barrier assembly.

[0041] The proposed solution provides a method for installing and / or removing a sterile barrier assembly, the methods being performed in a simple yet advantageous sequence. Attached Figure Description

[0042] Other features and advantages of surgical drapes, sterile barrier components, systems, and methods will become apparent from the following preferred embodiments, which are given by way of example with reference to the accompanying drawings and are not intended to be limiting, in which:

[0043] - Figure 1 An axonometric view of a robotic surgical system including a sterile barrier assembly according to an embodiment is shown;

[0044] - Figure 2 A view of a robotic surgical system comprising a pair of manipulators and a sterile barrier assembly according to an embodiment is shown;

[0045] - Figure 3 A robotic surgical system including a surgical drape is shown according to an embodiment;

[0046] - Figure 4 for Figure 2 Enlarged views showing details of the system and components;

[0047] - Figure 5 The surgical drape according to the implementation scheme is schematically shown in an axonometric view;

[0048] - Figure 6 The sterile adapter of the sterile barrier assembly according to the embodiment is schematically shown in an isometric view;

[0049] - Figure 7 The sterile barrier assembly according to the embodiment is shown, and a cross-section of the motor of the robotic surgical system is schematically shown;

[0050] - Figure 8 The diagram shows the connection to the robotic surgical system in an axonometric view. Figure 7 The cross-section of the sterile barrier component;

[0051] - Figure 9 A sterile barrier assembly according to an embodiment is shown;

[0052] - Figure 10 Schematic illustration Figure 4 The cross-sections of the system and components shown in the image;

[0053] - Figure 11 This is an axonometric view of the manipulator of a robotic surgical system connected to a surgical drape according to the implementation scheme, wherein some parts of the system are drawn transparently for clarity.

[0054] - Figure 12 A view of a robotic surgical system comprising a pair of manipulators and a pair of corresponding sterile barrier components according to an embodiment is shown;

[0055] - Figure 13 An axonometric view of a single part of a robotic surgical system according to an embodiment is shown;

[0056] - Figure 14 A cross-section of a portion of a robotic surgical system according to an embodiment is shown;

[0057] - Figure 15 and Figure 16 Some steps of the method based on the operating mode are shown. Detailed Implementation

[0058] According to a general implementation, a sterile barrier component 210 is provided for a robotic surgical system 200.

[0059] The sterile barrier assembly 210 includes a surgical drape 201 or a sterile drape 201 having at least one drape opening 209, 209'.

[0060] The surgical drape 201 can be configured as a package designed to fit the main components of the robotic surgical system 200.

[0061] The robotic surgical system 200 may include a robotic cart 225 and at least one robotic arm 211 extending from the cart 225 and defining a proximal-distal direction (zz). The at least one robotic arm 211 may include a plurality of arm links 219, 219', 219”, 219”', which are interconnected to form a kinematic chain. One of the arm links 219, 219', 219”, 219”' may be connected to at least two non-sterile robotic manipulators 220, 220' adapted to manipulate robotic end effectors (e.g., wrists) within the patient's body along multiple degrees of freedom. According to an embodiment, at least one rolling motor 246 is provided, adapted to move the rolling elements 230, 230' about a rolling axis ZZ relative to the housings 251, 251' of the non-sterile robotic manipulators 220, 220'.

[0062] The surgical drape 201 may include a body 202, and the body 202 defines a drape cavity 203. According to a preferred embodiment, the body 202 is made of a flexible sheet of a plastic material (e.g., polyethylene). Preferably, the term "flexible" as used herein means that the body of the drape is loose, for example, it is a flexible sheet. According to embodiments, the body of the sterile drape 201 is made of paper, fabric, non-woven fabric, and / or any material suitable for the surgical drape 201.

[0063] 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 material.

[0064] 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. Therefore, the first inner surface 204 and the second outer surface 205 are opposite to each other with respect to the flexible body 202 of the surgical drape 201.

[0065] Preferably, the surgical drape 201 includes a proximal opening edge 206 that defines a proximal opening 207 of the surgical drape 201 for access to the drape cavity 203, wherein the proximal opening 207 is preferably a through opening.

[0066] According to a preferred embodiment, the proximal opening edge 206 is associated with a proximal coupling interface 218 adapted to form a connection with a portion of the robotic surgical system 200. According to an embodiment, the proximal coupling interface 218 of the proximal opening edge 206 of the surgical drape 201 forms a magnetic coupling with a portion of the trolley 225 of the robotic surgical system 200. For example, the proximal coupling interface 218 includes a permanent magnet. For example, the proximal coupling interface 218 includes a ferromagnetic portion adapted to form a magnetic coupling with a magnetic portion of the trolley 225. According to an embodiment, the proximal coupling interface 218 of the proximal opening edge 206 of the surgical drape 201 includes an elastic band that creates elastic pressure on the trolley 225 of the robotic surgical system 200. According to an embodiment, the proximal coupling interface 218 of the proximal opening edge 206 of the surgical drape 201 includes a strap for attaching to the trolley 225.

[0067] Preferably, the surgical drape 201 includes at least one distal opening edge 208, 208', which defines a corresponding distal opening 209, 209' for access to the drape cavity 203.

[0068] The at least one distal opening 209, 209' is preferably a distal through opening 209, 209'.

[0069] According to the implementation scheme, the drape cavity 203 is a through cavity extending and guided between the proximal opening 207 and the at least one distal opening 209, 209'. Therefore, the robotic surgical system 200 can be at least partially enclosed with the surgical drape 201 by first fitting the proximal opening edge 206 of the surgical drape 201 around the distal end of the robotic arm 211 of the robotic surgical system 200, then moving the proximal opening edge 206 of the surgical drape 201 proximally to unfold the surgical drape 201 and fitting the robotic arm 211 through the body 202 of the surgical drape 201, and then connecting the at least one distal opening edge 209, 209' to the corresponding portion of the robotic arm 211 of the robotic surgical system 200.

[0070] The sterile barrier assembly 210 further includes at least one connector 212, 212' that forms the outline of the at least one cover opening 209, 209' and is adapted to be coupled to the housing 251, 251' of the non-sterile robotic manipulator 220, 220'.

[0071] Preferably, the surgical drape 201 includes at least one annular connector 212, 212' associated with a corresponding 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'.

[0072] Therefore, when the first distal opening edge 208 and the second distal opening edge 208' are provided, the corresponding first annular connector 212 is associated with the first distal opening edge 208 to form the outline of the first distal opening 209, and the corresponding second annular connector 212' is associated with the second distal opening edge 208' to form the outline of the second distal opening 209'.

[0073] The at least one annular connector 212, 212' includes annular rims 213, 213' facing the corresponding 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 rims 213, 213'. Therefore, at least one distal opening 209, 209' of the surgical cover 201 has an annular profile. Thus, at least one distal opening 209, 209' can have a circular shape.

[0074] 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 actions applied to the annular connector are not suitable for elastically deforming the annular connector 212, 212' without causing creep and / or damage to it. According to a preferred embodiment, the annular edges 213, 213' of at least one annular connector 212, 212' are rigid, thereby defining the annular profile of at least one distal opening 209, 209'.

[0075] The sterile barrier assembly 210 includes at least one sterile adapter 221, 221', which has a frame 223 including a coupling device 237 for coupling with at least one sterile surgical instrument 240, 240'.

[0076] The at least one connector 212, 212' and at least one sterile adapter 221, 221' of the surgical drape 201 are made into separate pieces.

[0077] The at least one sterile adapter 221, 221' is adapted to pivot or roll relative to at least one connector 212, 212' of the surgical drape 201.

[0078] Advantageously, a gap 235, 235' is provided between at least one connector 212, 212' of the surgical drape 201 and the at least one sterile adapter 221, 221'.

[0079] Therefore, the gaps 235, 235' together with the at least one connector 212, 212' and the at least one sterile adapter 221, 221' form a rotatable seal that prevents rotational friction on the at least one connector 212, 212' and the respective pivotally associated sterile adapters 221, 221' while maintaining the sterility of the operatory field 255 (in other words, preventing contamination of the sterile operatory field 255 by the non-sterile parts of the covered robotic surgical system 200). Due to the gaps 235, 235', the sterile adapters 221, 221' are not directly connected to the connectors 212, 212' of the surgical drape 201.

[0080] According to a preferred embodiment, the body 202 of the surgical drape 201 further includes 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 corresponding distal through opening 209, 209'. Therefore, the first distal through opening 209 is defined by the first distal opening edge 208, and the second distal through opening 209' is defined by the second distal opening edge 208'. Therefore, when the first annular connector 212 and the second annular connector 212' are provided, each of the first annular connector 212 and the second annular connector 212' includes annular edges 213, 213', such that the first annular edge 213 is associated with the first annular connector 212, and the second annular edge 213' is associated with the second annular connector 212'. Preferably, each of the annular edges 213, 213' of at least one annular connector 212, 212' defines a connecting ring suitable for connection to the robotic surgical system 200.

[0081] A pair of distal openings 209 and 209', each associated with a corresponding ring connector 212 and 212', are provided, which allows a single surgical drape 201 to cover a portion of the pair of robotic arms and the trolley 225 of the robotic surgical system 200.

[0082] The arrangement of at least one annular connector 212, 212' allows for receiving rolling elements 230, 230' within the annular edges 213, 213' of the annular connector, which can roll about axis ZZ relative to the body 202 of the surgical drape 201 and / or relative to the at least one annular connector 212, 212'.

[0083] According to the implementation scheme, the term "rolling elements 230, 230' that can roll about an axis" also covers the case where the rolling motion is the relative motion between the rolling elements 230, 230' of the robotic surgical system 200 and the annular connectors 212, 212' of the surgical drape 201.

[0084] Therefore, the relative rolling motion may require the annular connectors 212, 212' to roll and / or pivot about an axis and the rolling elements 230, 230' to be substantially stationary, thereby defining the relative rolling motion.

[0085] According to the implementation scheme, the term "rolling elements 230, 230' that can roll about an axis" also covers the case where the rolling elements 230, 230' can pivot about an axis relative to the body 202 of the surgical drape 201 and / or relative to the at least one annular connector 212, 212'.

[0086] According to the implementation scheme, the term "rolling elements 230, 230' that can roll about an axis" also covers the case where the rolling elements 230, 230' can roll about 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' (e.g., a ball joint, etc.).

[0087] The arrangement of a pair of annular connectors 212 and 212' allows for the reception of a pair of rolling elements 230, 230', each of which is received within a respective annular edge 213, 213' in such a way that each of the rolling elements 230 and 230' can roll about an axis zz relative to the body 202 of the surgical drape 201 and / or relative to the respective annular edges 213, 213' of the annular connectors 212, 212'. According to an embodiment, each of the rolling elements 230 and 230' can roll about an axis zz independently of the other rolling element in the pair. The respective rolling axes zz of each of the rolling elements 230 and 230' can be parallel to each other, although not parallel according to a preferred embodiment, and more preferably they converge toward each other.

[0088] The at least one rolling element 230, 230' received within the at least one annular connector 212, 212' in the at least one distal opening 209, 209' of the surgical drape 201 may have a substantially cylindrical geometry extending about a rolling axis that is substantially stationary or rotatable about another axis relative to the at least one annular connector 212, 212'. Alternatively, the at least one rolling element 230, 230' received within the at least one annular connector 212, 212' in the at least one distal opening 209, 209' of the surgical drape 201 may have a substantially spherical geometry adapted to roll about a rolling axis that is substantially stationary or movable relative to the at least one annular connector 212, 212'.

[0089] According to a preferred embodiment, the at least one annular connector 212, 212' is integrally formed with the flexible body 202 of the surgical drape 201. Therefore, the at least one annular connector 212, 212' cannot roll relative to the body 202 of the surgical drape 201. The body 202 of the surgical drape 201 is not necessarily made as a separate piece with the at least one annular connector 212, 212', although according to embodiments they are made from a single piece of material. According to embodiments, the at least one annular connector 212, 212' is glued, and / or secured, and / or clamped, and / or compressed, and / or thermoformed, and / or otherwise secured to the at least one distal opening edge 208, 208' of the body 202 of the surgical drape 201. Preferably, the connector 212, 212' is further detachably connected to the housing 251, 251' encapsulating the robotic manipulators 220, 220'.

[0090] According to the embodiment, the sterile barrier assembly includes at least one bag 231, 231' having a sidewall formed by the body 202 of the surgical drape 201 and extending proximally relative to the at least one distal opening edge 208, 208', and preferably including the at least one distal opening edge 208, 208'. Therefore, the at least one bag 231, 231' is adapted to at least partially cover the robotic arm 211 and preferably cover the at least one manipulator 220, 220' of the robotic surgical system 200.

[0091] According to the implementation, the proximal opening edge 206 of the surgical drape 201 is adapted to form a connection with a portion of a non-sterile robotic manipulator 220 or 220' of the robotic surgical system 200. Therefore, the robotic surgical system 200 may include more than one surgical drape 201 and / or more than one sterile barrier assembly 210, for example in… Figure 12 As shown in the diagram. Therefore, the robotic arm 211, which includes two non-sterile robotic manipulators 220, 220', is covered by two surgical drapes 201, each forming a sterile barrier assembly 210.

[0092] Preferably, the at least one bag 231, 231' is formed by a sleeve of the surgical drape 201, and one of the sterile adapters 221, 221' and the rotatable seal formed by the gaps 235, 235'. Preferably, each bag 231, 231' has at least one corresponding drape opening 209, 209' and opposing proximal bag openings 254, 254', wherein the rotatable seal is distal to the proximal bag openings 254, 254'. Preferably, the sterile adapters 221, 221' are located distal to the rotatable seal.

[0093] According to one embodiment, the surgical drape 201 includes a pair of bags 231, 231', preferably each bag including a corresponding distal opening edge 208, 208'. According to one embodiment, the body 202 of the surgical drape 201 includes a single bag 231 for covering the robotic arm 211, wherein the single bag 231 includes a pair of distal opening edges 208 and 209'. According to one embodiment, the body 202 of the surgical drape 201 includes a bridging portion 232 that connects the distal opening edges 208 and 208' to each other. Preferably, the bridging portion 232 of the body 202 of the surgical drape 201 connects the pair of tubular portions 231, 231' to each other to form a common root portion.

[0094] According to the embodiment, the at least one annular connector 212, 212' forms the free end of the body 202 of the surgical drape 201. Preferably, the at least one annular connector 212, 212' forms the free end of the corresponding pocket 231, 231' of the annular connector.

[0095] According to one embodiment, the body 202 of the surgical drape 201 includes a base 233, which includes the at least one proximal opening edge 206. Therefore, the base 233 is designed to cover the robotic trolley 225. According to another embodiment, the at least one pocket 231, 231' extends from the base 233 of the body 202 of the surgical drape 201. The arrangement of the base 233 and the at least one pocket 231, 231' allows the body 202 of a single surgical drape 201 to cover the robotic trolley 225 and at least one robotic arm 211 of the robotic surgical system 200.

[0096] A surgical drape 201 with a body 202 is provided, the body including at least one pocket 231, 231' for at least covering a robotic arm 211, and a base 233 for covering a robotic trolley 225, wherein the at least one pocket 231, 231' is associated with a pair of annular connectors 212, 212', which allows 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 wherein the two manipulators 220, 220' are attached to the same link of the robotic arm 211, and preferably wherein the robotic arm is further attached to the robotic trolley 225.

[0097] According to an embodiment, the annular edges 213, 213' of at least one annular connector 212, 212' include inner annular surfaces 214, 214' facing the respective distal openings 209, 209'. Therefore, when a pair of annular connectors 212 and 212' are provided, a pair of corresponding inner annular surfaces 214, 214' are provided. According to an embodiment, each of the inner annular surfaces 214, 214' faces the corresponding rolling axis. According to an embodiment, each of the inner annular surfaces 214, 214' defines a ring forming the contour of the respective distal openings 209, 209'. According to an embodiment, each of the inner annular surfaces 214, 214' is substantially parallel to the proximal-distal direction ZZ. According to an embodiment, each of the inner annular surfaces 214, 214' faces the corresponding rolling elements 230, 230'.

[0098] According to an embodiment, the at least one annular connector 212, 212' (preferably each of the annular connectors 212, 212') of the surgical cover 201 includes a distal annular surface 215, 215' facing distally. Therefore, the distal annular surfaces 215, 215' of the annular connectors 212, 212' are ZZ-away from the cavity 203 of the surgical cover 201 in a proximal-distal direction. According to an embodiment, the at least one annular connector 212, 212' (preferably each of the annular connectors 212, 212') of the surgical cover 201 includes a proximal annular surface 234 facing proximally. Therefore, the proximal annular surface 234 and the distal annular surfaces 215, 215' are opposite each other relative to the annular connectors 212, 212'. Therefore, the proximal annular surface 234 faces the body 202 of the surgical cover 201. According to the implementation scheme, the proximal annular surface 234 faces the cavity 203 of the surgical cover 201 and the first inner surface 204 of the body 202 of the surgical cover 201. If the proximal annular surface faces the second outer surface 205 of the body 202 of the surgical cover 201, then the proximal annular surface 234 may be away from the cavity 203 of the surgical cover 201.

[0099] According to a preferred embodiment, the distal annular surfaces 215, 215' of the annular connectors 212, 212' of the surgical drape 201 face distally toward the proximal surface 226 of the frame 223 and / or the skirt 224 of the sterile adapters 221, 221', such that the distal annular surfaces 215, 215' of the annular connectors 212, 212' of the surgical drape 201, and the proximal surface 226 of the frame 223 and / or the skirt 224 of the sterile adapters 221, 221' define the annular gaps 235, 235'. Therefore, the annular connectors 212, 212' of the surgical drape 201 and the sterile adapters 221, 221' are not directly connected to each other. The bearing 246 can preferably be configured to be inserted between the manipulator connecting elements 229, 229' and the housings 251, 251' of the robot manipulators 220, 220', thus avoiding contact between the bearing 246 and the connectors 212, 212' of the sterile adapters 221, 221' and the cover 201.

[0100] According to the implementation scheme, the at least one ring connector 212, 212' includes a coupling device 216 adapted to couple the surgical drape 201 to the reverse coupling portion 217 of the robotic surgical system 200.

[0101] According to one embodiment, the reverse connection 217 is part of the robotic arm 211 of the surgical system 200, and the reverse connection is preferably located near the distal end of the robotic arm 211. According to another embodiment, the reverse connection 217 is part of the manipulators 220, 220' of the robotic surgical system 200.

[0102] According to one embodiment, the annular coupling device 216 of the surgical drape 201 includes an elastic element (e.g., a clip) adapted to engage the reverse coupling portion 217 of the robotic arm 211 of the robotic surgical system 200 in a snap-fit ​​configuration. According to one embodiment, the coupling device 216 of the surgical drape 201 includes a magnetic coupling element adapted to form a magnetic connection with the reverse coupling portion 217 of the robotic arm 211 of the robotic surgical system 200. According to one embodiment, the coupling device 216 of the surgical drape 201 includes a threaded interface adapted to be tightened to the reverse coupling portion 217 of the robotic arm 211 of the robotic surgical system 200. According to one embodiment, the coupling device 216 of the surgical drape 201 includes a bayonet coupling interface adapted to form a bayonet coupling with the reverse coupling portion 217 of the robotic arm 211 of the robotic surgical system 200.

[0103] According to a general embodiment, a sterile barrier assembly 210 is provided, which includes at least one surgical drape 201 according to any of the foregoing embodiments.

[0104] According to an embodiment, the at least one sterile adapter 221, 221' includes at least a second sheet 222 or membrane 222. The second sheet 222 is preferably a single, continuous sheet of flexible plastic material. The second sheet 222 is preferably made of a drape material suitable for covering 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 adapter 221, 221' is coaxial with at least one annular edge 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 adapter 221, 221' includes at least one substantially rounded edge 223.

[0105] According to, for example, in Figure 6 In the preferred embodiment shown, the second sheet 222 has a substantially disc-shaped form. According to a preferred embodiment, the rounded edge 223 or frame 223 of at least one sterile adapter 221, 221' serves as a constraint frame for the second sheet 222. According to a preferred embodiment, the at least one sterile adapter 221, 221' has a substantially cylindrical shape. According to a preferred embodiment, the at least one sterile adapter 221, 221' has a substantially spherical shape.

[0106] According to a preferred embodiment, the at least one connector 212, 212' of the surgical drape 201 has annular edges 213, 213', and the at least one sterile adapter 221, 221' has annular frames, such that the gaps 235, 235' are annular gaps.

[0107] According to a preferred embodiment, the annular edges 213, 213' and the annular frames 223 of the sterile adapters 221, 221' are arranged coaxially. Preferably, the substantially rounded edges 223 or frames 223 of the sterile adapters 221, 221' are coaxial with the annular edges 213, 213' of the at least one annular connector 212, 212'. Therefore, the sterile adapters 221, 221' can roll about an axis relative to the respective annular connectors 212, 212', which have annular edges 213, 213' coaxial with the rounded edges 223 of the sterile adapters 221, 221'.

[0108] According to a preferred embodiment, at least one sterile adapter 221, 221' is adapted to pivot about an axis zzz relative to at least one connector 212, 212' of the surgical drape 201, the axis passing through the geometric center 257, 257' of the connector 212, 212'.

[0109] According to the implementation scheme, the at least one sterile adapter 221, 221' is integrally coupled to the rolling elements 230, 230' of the robotic surgical system 200. Therefore, the at least one sterile adapter 221, 221' of the sterile barrier assembly 210 can roll about an axis z relative to the surgical drape 201 and / or relative to the at least one annular connector 212, 212'.

[0110] According to the implementation scheme, the at least one sterile adapter 221, 221' is coupled to the annular connector 212, 212' of the surgical drape 201 in a manner that allows relative rolling motion. Therefore, the sterile adapters 221, 221' serve as rolling elements 230, 230'.

[0111] According to an embodiment, the second sheet 222 of the at least one sterile adapter 221, 221' has a pouch-like form defining a proximal opening of the second sheet 222 facing the at least one distal opening 209, 209' of the surgical cover 201, and preferably the second sheet is coaxial with the annular edges 213, 213' of the at least one annular connector 212, 212' of the surgical cover 201. According to an embodiment, the rounded edge 223 of the at least one sterile adapter 221, 221' includes an engagement interface 226 for engaging a reverse engagement interface 227 of the at least one annular connector 212, 212' of the surgical cover 201. A bearing may be provided between the engagement interface 226 and the reverse engagement interface 227.

[0112] According to a preferred embodiment, the at least one sterile adapter 221, 221' includes at least one proximal coupling device 236 adapted to form a detachable integral connection with the rolling elements 230, 230' of the robotic surgical system 200. According to an embodiment, the proximal coupling device 236 is coupled to manipulator connection elements 229, 229', which include proximal connection means for connecting the manipulator connection elements 229, 229' and the sterile adapters 221, 221' to non-sterile robotic manipulators 220, 220'. Preferably, the manipulator connection elements 229, 229' serve as either rolling elements 230, 230' or rolling elements 230, 230'.

[0113] According to a preferred embodiment, the manipulator connection elements 229, 229' are components of the robotic surgical system that connect the sterile adapters 221, 221' to a non-sterile robotic manipulator. Therefore, the sterile adapters 221, 221' are detachably connected to the manipulator connection elements 229, 229'. In this way, connecting the sterile adapters 221, 221' to the surgical drape is avoided; in other words, connecting the sterile adapters 221, 221' to the annular edges 213, 213' of the surgical drape, and to the connectors 212, 212' connected to the surgical drape, is also avoided. Therefore, the connectors 212, 212' of the surgical drape do not exert any structural retention effect on the sterile adapters 221, 221'. Instead, with the sterile adapters 221, 221' engaged with the manipulator connection elements 229, 229', the connectors 212, 212' of the surgical drape engage with the housing 251, 251', which in turn engage with the robot manipulator, causing the sterile adapters 221, 221' and the manipulator connection elements 229, 229' to rotate together relative to the connectors 212, 212' of the surgical drape and the housing 251, 251'.

[0114] According to the implementation, sterile adapters 221, 221' include spring-loaded engagement pins 253, and manipulator connection elements 229, 229' include corresponding spring-loaded reverse engagement pins 259, thereby marking when sterile adapters 221, 221' are engaged with manipulator connection elements 229, 229'. When sterile adapters 221, 221' are not engaged with manipulator connection elements 229, 229', the spring-loaded reverse engagement pins 259 of manipulator connection elements 229, 229' abut against the proximal surface of sterile adapters 221, 221' (such as a portion of the proximal connection device 236 of the sterile adapter). When sterile adapters 221, 221' are connected to manipulator connecting elements 229, 229', spring-loaded engagement pins 253 and reverse engagement pins 259 align and face each other. The reverse engagement pins 259 of the manipulator connecting elements 229, 229' insert into their respective seats 261 and serve as anti-rotation elements to prevent relative rotation between the adapters 221, 221' and the manipulator connecting elements 229, 229'. Figure 14As illustrated in the embodiment: In other words, when the reverse engagement pins 259 of the manipulator connecting elements 229, 229' are in the seat 261 of the sterile adapters 221, 221', they circumferentially abut against the wall of the seat 261 and prevent relative rotation between the adapters 221, 221' and the connecting elements 229, 229'. In this way, the reverse engagement pins 259 of the manipulator connecting elements 229, 229' push the spring-loaded engagement pin 253 distally, thereby determining that the flagging protrusion 260 protrudes distally from the distal portion of the sterile adapters 221, 221'. Figure 13 In this embodiment, the spring-loaded engagement pin 253 is associated with the helical spring 253', and the spring-loaded reverse engagement pin 259 is associated with the flat spring 259'. Preferably, the elastic action of the flat spring 259' overcomes the elastic action of the helical spring 253'.

[0115] According to the implementation plan, in order to disengage the sterile adapters 221, 221' from the manipulator connecting elements 229, 229', the marked protrusion 260 should be pressed to disengage the spring-loaded reverse engagement pin 259, allowing the adapters 221, 221' to rotate and disengage from the manipulator connecting elements 229, 229'.

[0116] According to a preferred embodiment, the sterile barrier assembly 210 further includes at least one labyrinth seal device comprising the gaps 235, 235' forming a rotatable seal. Preferably, the labyrinth seal device is provided with a zigzag path that prevents cross-contamination along the length of the zigzag path. A suction device may be functionally associated with the labyrinth seal to create a recess that mates with the labyrinth seal device to prevent contamination toward the distal side of the sterile barrier assembly 210. According to a preferred embodiment, the at least one labyrinth seal device extends about a rolling axis z. According to a preferred embodiment, the at least one labyrinth seal device forms the outline of the at least one cover opening 209, 209' and the outline of the frame 223 of the sterile adapters 221, 221'.

[0117] According to a preferred embodiment, the sterile barrier assembly 210 includes a pair of sterile adapters 221 and 221', a first gap 235 is disposed between the first distal opening edge 208 of the surgical drape 201 and the first sterile adapter 221, and a second gap 235' is disposed between the second distal opening edge 208' of the surgical drape 201 and the second sterile adapter 221'.

[0118] According to an embodiment, at least one sterile adapter 221, 221' includes a protrusion 224 or skirt 224 facing the gaps 235, 235'. Preferably, the annular skirt 224 extends around a rounded edge 223 and defines at least a portion of the gaps 235, 235'. Thus, the at least one gap 235, 235' is at least partially defined by the skirt 224 of the sterile adapter 221, 221'. According to an embodiment, the skirt 224 of at least one sterile adapter 221, 221' mates with at least one annular connector 212, 212', and preferably with the annular edge 213, 213' of the connector to form the labyrinth seal device. As described above, each skirt 224 includes a proximal surface 226, each proximal surface 226 defining a corresponding gap 235, 235' on the distal side.

[0119] According to an embodiment, the at least one sterile adapter 221, 221' includes a distal connection device 237 adapted to connect, preferably detachably connect, to surgical instruments 240, 240' adapted to perform robotic surgery on a patient's anatomy. According to an embodiment, the distal connection device 237 of the at least one sterile adapter 221, 221' includes means for engaging a portion of the surgical instruments 240, 240' in a snap-fit ​​engagement, for example, the means for snap-fit ​​engagement includes a pair of resilient elongated tongues 238, each resilient elongated tongue forming a free end. According to an embodiment, the distal connection device 237 of at least one second component of the sterile barrier 221 includes a housing 239 for receiving the rear ends 241, 241' of the at least one surgical instrument 240, 240'. Because of the provision of the proximal connection device 236 and the distal connection device 237, the at least one sterile adapter 221, 221' can be detachably connected to the sterile surgical instruments 240, 240'.

[0120] According to the implementation plan, the bearing 243 is disposed within the labyrinth seal device 235.

[0121] According to a general implementation, the robotic surgical system 200 includes at least one sterile barrier component 210 as described in any of the above-described embodiments.

[0122] The robotic surgical system 200 also includes at least one non-sterile robotic manipulator 220, 220', which includes a housing 251, 251', at least one rolling motor 246, and at least one rolling element 230, 230' adapted to pivot relative to the housing 251, 251'.

[0123] The at least one connector 212, 212' of the surgical drape 201 of the sterile barrier assembly 210 is coupled to the housing 251, 251' of the non-sterile robotic manipulators 220, 220'. The housing 251, 251' preferably encapsulates at least one motor, and preferably at least the rolling motor 246.

[0124] The at least one sterile adapter 221, 221' of the sterile barrier assembly 210 is connected to the at least one rolling element 230, 230' of the non-sterile robotic manipulators 220, 220'.

[0125] The at least one rolling motor 246 is adapted relative to the housings 251, 251' of the non-sterile robotic manipulators 220, 220', to move at least one rolling element 230 together with the at least one pivotally moving sterile adapter 221, 221'.

[0126] The gaps 235, 235' between at least one connector 212, 212' of the surgical drape 201 and at least one sterile adapter 221, 221' form a rotatable seal that prevents non-sterile robotic manipulators from contaminating the sterile surgical area 255.

[0127] According to a preferred embodiment, at least one connector 212, 212' of the surgical drape 201 of the sterile barrier assembly 210 is detachably and rigidly connected to the housing 251, 251' of the non-sterile robotic manipulators 220, 220'.

[0128] According to a preferred embodiment, the at least one sterile adapter 221, 221' of the sterile barrier assembly 210 is detachably and rigidly connected to the at least one rolling element 230, 230' of the non-sterile robotic manipulators 220, 220'.

[0129] According to a preferred embodiment, the rolling elements 230, 230' accommodate at least one motor of the non-sterile robotic manipulators 220, 220', which is adapted to actuate the degrees of freedom of surgical instruments 240, 240' attached to sterile adapters 221, 221'.

[0130] According to one embodiment, the robotic surgical system 200 includes a main console 244. According to another embodiment, the robotic surgical system 200 includes a robot slave component adapted to be controlled by the main console 244, the robot slave component including a robot trolley 225 and at least one robot arm 211 extending from the trolley 225 and defining a proximal-distal ZZ direction. At least one electronic control device may be located within the robot trolley 225.

[0131] According to an embodiment, the robotic surgical system 200 includes: at least one surgical instrument 240, 240', the surgical instrument including an instrument shaft 242 extending substantially in a proximal-distal direction ZZ and having a proximal end and a distal end; a surgical end effector 245 located at the distal end of the shaft 242; and a rear end portion 241, 241' located at or near the proximal end of the shaft 242. According to an embodiment, the rear end portions 241, 241' are adapted to receive a pushing motion transmitted by a second sheet 222 penetrating and passing through a second member of a sterile barrier 210. According to an embodiment, the rear end portions 241, 241' include a plurality of actuators, etc., adapted to be pushed to actuate at least one actuation cable [not shown] of the surgical instrument, thereby actuating the end effector 245 (e.g., surgical wrist 245). According to an embodiment, the actuators are linearly displaceable.

[0132] According to one embodiment, the sterile barrier assembly 210 is located proximal to the at least one surgical instrument 240, 240', in other words, upstream of the at least one surgical instrument. Therefore, the sterile barrier assembly 210 is located upstream of the rear ends 241, 241' of the at least one surgical instrument 240, 240'. According to another embodiment, the sterile barrier assembly 210 is located proximal to the axis 242 of the at least one surgical instrument 240, 240', in other words, upstream of the axis of the at least one surgical instrument.

[0133] According to one embodiment, the robotic trolley 225 includes at least a ground contact unit 252 (e.g., a wheel 252) adapted to support the robotic trolley 225 placed on the floor of the surgical area. According to another embodiment, the at least one ground contact unit 252 is not covered by the surgical drape 201.

[0134] According to an embodiment, the at least one robotic arm 221 includes a plurality of arm links 219, 219', 219"', 219"', which are connected to each other in corresponding joints to form a kinematic chain. The robotic arm 211 is preferably a passive arm without a motor, designed to move by human action, such as being pulled by an operator. The robotic arm 211 may include a braking system at the joints of the arm links 219, 219', 219"'. According to an embodiment, one of the arm links 219, 219', 219"', 219"' may be connected to at least two motorized robotic manipulators 220, 220', adapted to manipulate robotic end effectors, such as the wrists 245 of surgical instruments 240, 240', along multiple degrees of freedom within the patient's body.

[0135] The robotic surgical system 200 includes at least one rolling element 230, 230'.

[0136] According to the implementation scheme, the rolling elements 230, 230' include the second component of the sterile barrier 221 or the second component connected to the sterile barrier, such that the second component of the sterile barrier 221 moves integrally with the rolling elements 230, 230'.

[0137] According to the implementation plan, each motor manipulator 220, 220' includes a housing 251, 251' and at least one motor 246, 247.

[0138] According to the implementation scheme, the at least one motor 246, 247 of the manipulators 220, 220' includes at least one rolling motor 246 adapted to move the rolling elements 230, 230' about the rolling axis ZZ relative to the housings 251, 251'.

[0139] According to a preferred embodiment, at least one annular connector 212, 212' of the sterile barrier assembly 210 is connected to the housings 251, 251' of the manipulators 220, 220', and at least one second member of the sterile barrier 221 is connected to at least one rolling element 230, 230'. A bearing 243 may be provided between the at least one rolling element 230, 230' and the housings 251, 251' of the manipulators 220, 220'. Preferably, the reverse connection portion 217 is located on the housings 251, 251', and more preferably on the distal portion of the housings 251, 251'.

[0140] According to the embodiment, the at least one motor 246, 247 of the manipulators 220, 220' further includes at least one linear motor 247 adapted to move the rolling elements 230, 230' along at least one linear direction (e.g., vertical direction), and preferably adapted to move the rolling elements 230, 230' along three linear directions substantially orthogonal to each other relative to the housings 251, 251'. Preferably, the at least one linear motor 247 acts proximal to the rolling motor 246, in other words, upstream of the rolling motor. According to the implementation scheme, the at least one manipulator 220, 220' includes: three linear guide devices 248, 249, 250, which are coupled to the at least one linear motor 247, and preferably each linear guide device is coupled to the linear motor, and the linear guide device is adapted to guide the linear motion of the rolling elements 230, 230' in three orthogonal directions; and at least one rolling conveying element (e.g., a conveyor belt) adapted to convey the rolling motion R from the rolling motor 246 to the at least one rolling element 230, 230'.

[0141] According to the preferred embodiment, motors 246 and 247 are both located near the sterile barrier assembly 210, that is, upstream of the sterile barrier assembly.

[0142] According to a preferred embodiment, the at least one surgical instrument 240, 240' is connected to the rolling element 230, 230'.

[0143] According to an embodiment, an anti-rotation system is provided, designed to prevent relative rotation of the rolling elements 230, 230' and the housings 251, 251' of the manipulators 220, 220' during the engagement of the second component of the sterile barrier 221 with the rolling elements 230, 230'. According to an embodiment, the anti-rotation system includes a radially cantilever element that projects radially away from the axis of rotation of the rolling elements 230, 230' to abut against radially inward block teeth of the housings 251, 251'.

[0144] According to the implementation scheme, two manipulators 220, 220' are attached to the same link of the robot arm 221. Each manipulator 220, 220' has three Cartesian degrees of freedom, with the three Cartesian degrees of freedom of one manipulator 220 parallel to the three Cartesian degrees of freedom of the other manipulator 220'. Downstream of each manipulator 220, 220', a rolling motor 246 is provided for moving the rolling bodies 230, 230' attached thereto, so that the rolling bodies roll relative to the housings 251, 251' about the rolling axis ZZ. Preferably, a mechanism shaft is present downstream of the rolling bodies 230, 230', and preferably the mechanism shaft is integral with the rolling bodies. The mechanism shaft has an articulated end effector at its distal end, such as an articulated end effector with pitch, yaw, and gripping degrees of freedom.

[0145] According to a preferred embodiment, and as described above, for example in Figure 10 As shown, gaps 235, 235' are located between the proximal surface 226 of the skirt 224 of the sterile adapters 221, 221' and the distal surfaces 215, 215' of the connectors 212, 212' of the surgical drape 201, wherein the sterile adapters 221, 221' are detachably connected to the manipulator connection elements 229, 229', and wherein the connectors 212, 212' are detachably connected to the housing 215. Therefore, the sterile adapters 221, 221' and the manipulator connection elements 229, 229' can rotate together with respect to the surgical drape 201, while the sterile adapters 221, 221' can be separated from the manipulator connection elements 229, 229' without any action on the surgical drape 201 or its connectors 212, 212'. Therefore, sterile adapters 221, 221' can also be detached from and / or connected to manipulator connection elements 229, 229' during surgery without compromising the integrity of surgical drape 201, and in some implementation scenarios, it is not necessary to touch any part of surgical drape 201.

[0146] According to a preferred embodiment, sterile adapters 221, 221' are mounted to the robotic manipulator and allow rotation relative to housings 251, 251' without being received within housings 251, 251'. Conversely, sterile adapters 221, 221', while including a membrane 222 forming part of sterile barrier assembly 210, are located away from surgical drape 201.

[0147] According to an embodiment not necessarily combined with the above embodiments, sterile adapters 221, 221' for a robotic surgical system 200 are adapted to transmit a plurality of linear actuation and rolling movements from non-sterile robotic manipulators 220, 220' to sterile surgical instruments 240, 240', the sterile surgical instruments having a rear end 241 and a shaft 242 extending from said rear end 241, wherein the sterile adapters 221, 221' include:

[0148] - Frame 223 for transferring rolling motion from non-sterile robotic manipulators 220, 220' to sterile surgical instruments 240, 240', wherein frame 223 includes a proximal coupling device 236 for coupling with the non-sterile robotic manipulators 220, 220'; and a distal coupling device 237 for coupling with the sterile surgical instruments 240, 240', wherein frame 223 defines a through opening between the proximal coupling device 236 and the distal coupling device 237; and

[0149] - Membrane 222, fixed to the frame 223, for transmitting multiple localized linear actuation actions from non-sterile robotic manipulators 220, 220' to sterile surgical instruments 240, 240' through the thickness of the membrane, the membrane 222 being elastically stretchable, its purpose being to elastically bias the membrane toward its substantially flat construction; and

[0150] The stretchable membrane 222 seals the through opening to form a distal cavity 239 between the stretchable membrane 222 and the distal coupling device 237, wherein the distal cavity 239 is adapted to receive at least a portion of the rear end 241 of a sterile surgical instrument, and wherein the distal coupling device 237 includes at least one abutment surface facing the stretchable membrane 222 and thereby at least partially defining the distal cavity 236, and wherein the at least one abutment surface is adapted to abut a portion (such as the rear end 241) of the surgical instrument 240, 240' abutment on the at least one abutment surface.

[0151] The non-sterile robotic manipulators 220, 220' may include motors (e.g., motors actuating multiple pistons) for applying the plurality of linear displacement actions, each piston applying one of the linear displacement actions on the same membrane 222 of the sterile adapters 221, 221'.

[0152] According to the embodiment, the distal cavity 239 includes a lateral guide surface that readily mates with at least one laterally opposing surface of the sterile surgical instruments 240, 240', and wherein, preferably, the lateral guide surface of the distal cavity 239 of the sterile adapters 221, 221' is substantially flat.

[0153] According to the implementation scheme, the distal cavity 239 includes a lateral opening designed for inserting the sterile surgical instruments 240, 240' into sterile adapters 221, 221'.

[0154] According to the implementation scheme, the distal connection device 237 is designed to snap into a portion of the surgical instruments 240, 240'.

[0155] According to the implementation scheme, the distal cavity 239 includes a second lateral opening adapted to enter the distal cavity 239 for the purpose of pushing the sterile surgical instruments 240, 240' out of the distal cavity 239 of the sterile adapters 221, 221'.

[0156] According to the implementation scheme, the membrane 222 is a single flat piece.

[0157] According to the implementation scheme, the distal connection device 239 defines a distal seat having a distal through opening that opens distally on the outside of the distal cavity.

[0158] According to the implementation scheme, the distal through opening is substantially aligned with the through opening sealed by the stretchable membrane 222, and preferably coaxial with the through opening sealed by the stretchable membrane 222.

[0159] According to the embodiment, the at least one adjacent surface is below the stretchable membrane 222, and preferably under the obstruction of the membrane 222.

[0160] According to the implementation scheme, the frame 223 rigidly determines the mutual positioning and orientation of the proximal connection device 236 and the distal connection device 237, and preferably determines the mutual positioning and orientation of the lateral opening of the distal connection device 236.

[0161] According to the implementation scheme, sterile adapters 221, 221' include spring-loaded engagement pins 253, and manipulator connection elements 229, 229' include corresponding spring-loaded reverse engagement pins 259 for marking when sterile adapters 221, 221' are engaged with manipulator connection elements 229, 229', as previously described.

[0162] The following describes a method for installing a sterile barrier assembly and a method for removing a sterile barrier assembly.

[0163] A method for installing and / or removing a sterile barrier component of a robotic surgical system, the method comprising the following steps:

[0164] - To connect and / or disconnect at least one connector 212, 212' of the surgical drape 201 from at least one housing 251, 251' of the non-sterile robotic manipulators 220, 220';

[0165] - Connect and / or disconnect the sterile adapters 221, 221' from the rolling elements 230, 230' of the non-sterile robotic manipulators 220, 220'.

[0166] Depending on the operating mode, the steps of connecting and / or disconnecting the sterile adapters 221, 221' do not involve any action on the sterile cover 201.

[0167] Depending on the operating mode, the connection step includes moving the sterile adapters 221, 221' proximally, for example, by directly or indirectly tightening the rotary adapters onto the rolling elements 230, 230' through the insertion of the manipulator connecting elements 229, 229'. When manipulator connecting elements 229, 229' are provided between the rolling elements 230, 230' and the sterile adapters 221, 221', the connection step includes moving the sterile adapters 221, 221' proximally, for example, tightening the rotary adapters 221, 221' onto the manipulator connecting elements 229, 229'.

[0168] Depending on the operating mode, the separation step includes moving the sterile adapters 221, 221' proximally, for example, by unscrewing the rotating adapters from the rolling elements 230, 230'. When manipulator connection elements 229, 229' are provided between the rolling elements 230, 230' and the sterile adapters 221, 221', the separation step includes moving the sterile adapters 221, 221' distally, for example, by unscrewing the rotating adapters 221, 221' from the manipulator connection elements 229, 229'.

[0169] According to the operating mode, the method includes: first, connecting the connectors 212, 212' of the surgical drape 201 to the housings 251, 251' of the manipulators 220, 220'; then, connecting the sterile adapters 221, 221' to the rolling elements 230, 230' of the robot manipulators 220, 220'. When manipulator connecting elements 229, 229' are provided and inserted between the rolling elements 230, 230' and the sterile adapters 221, 221', the connection step includes: first, connecting the connectors 212, 212' of the surgical drape 201 to the housings 251, 251' of the manipulators 220, 220'; then, connecting the sterile adapters 221, 221' to the manipulator connecting elements 229, 229', which are attached to the rolling elements 230, 230' of the robot manipulators 220, 220'. The manipulator connecting elements 229, 229' can be attached to the rolling elements 230, 230' before the connectors 212, 212' of the surgical drape 201 are attached to the housings 251, 251', so that the connectors 212, 212' of the surgical drape 201 can be attached to the housings 251, 251' after the manipulator connecting elements 229, 229' have been attached to the rolling elements 230, 230'.

[0170] According to the operating mode, the separation steps include: first, separating the sterile adapters 221, 221' from the rolling elements 230, 230' of the robot manipulators 220, 220'; then, separating the connectors 212, 212' of the surgical drape 201 from the housings 251, 251'. When manipulator connecting elements 229, 229' are provided between the rolling elements 230, 230' and the sterile adapters 221, 221', the separation steps include: first, separating the sterile adapters 221, 221' from the manipulator connecting elements 229, 229', which are attached to the rolling elements 230, 230' of the robot manipulators 220, 220'; then, separating the connectors 212, 212' of the surgical drape 201 from the housings 251, 251'. The method may also include the step of removing (i.e., separating) the manipulator connecting elements 229, 229' from the rolling elements 230, 230', which may be performed after the connectors 212, 212' of the surgical cover 201 have been separated from the housings 251, 251'.

[0171] Therefore, sterile adapters 212, 212' can be the final component of the sterile barrier assembly to be connected.

[0172] Therefore, sterile adapters 212, 212' can be the first component of the sterile barrier assembly to be separated.

[0173] Depending on the operating mode, the steps of connecting and / or disconnecting sterile adapters 221, 221' are performed during the operation.

[0174] In summary, a method for installing a sterile barrier assembly may include the following steps: first, connecting at least one connector 212, 212' of a surgical drape 201 to at least one housing 251, 251' of a robotic manipulator 220, 220'; then, connecting at least one sterile adapter 221, 221' to the rolling elements 230, 230' of at least one robotic manipulator 220, 220', wherein the housing 250, 251' of at least one robotic manipulator 220, 220' has already been connected to at least one connector 212, 212' of the surgical drape 201. When two robotic manipulators 220, 220' are provided, those skilled in the art will understand that the installation method may include: first connecting the connector 212, 212' to the housing 251, 251' of either manipulator 220, 220', and then connecting the corresponding sterile adapter 221, 221'.

[0175] In summary, a method for disassembling a sterile barrier assembly may include the following steps: first, separating at least one sterile adapter 221, 221' from the rolling elements 230, 230' of at least one robotic manipulator 220, 220', wherein the housings 250, 251' of at least one robotic manipulator 220, 220' have been connected to at least one connector 212, 212' of a surgical drape 201; then, separating at least one connector 212, 212' of the surgical drape 201 from at least one housing 251, 251' of the robotic manipulator 220, 220'. When two robotic manipulators 220, 220' are provided, those skilled in the art will understand that the method for disassembly may include first separating the sterile adapter 221, 221' from either manipulator 220, 220', and then separating the connectors 212, 212' from the housings 251, 251' of the respective manipulator 220, 220'.

[0176] Depending on the mode of operation, the method is performed using a sterile barrier assembly and / or a robotic surgical system according to any of the embodiments described above.

[0177] By utilizing the features described above, provided independently or in combination in specific embodiments, the aforementioned needs that provide the advantages cited above can be met, in particular:

[0178] - A sterile barrier assembly 210 is provided, which can prevent contamination of the sterile surgical area 255 and can disengage the rotatable seal to avoid localized frictional wear on the sterile adapters 221, 221' and / or the connectors 212, 212' to the surgical drape 201.

[0179] - Sterile adapters 221, 221' and connectors 212, 212' may be spaced apart in a proximal-distal direction, such that the sterile adapter frame 223 is distal to the corresponding connectors 212, 212' of the surgical drape 201;

[0180] - Sterile adapters 221, 221' can be removed from the robot without removing the surgical drape 201;

[0181] - Meanwhile, the connector of the surgical drape 201 can be detached from the robot housing 251, 251' without removing the sterile adapters 221, 221'.

[0182] - The motor can be located upstream of the rotatable seal of the sterile barrier assembly;

[0183] - A surgical cover is provided that can receive rolling elements without causing structural damage or plastic deformation;

[0184] - A sterile barrier assembly is provided, which is made of two separate pieces having a gap therebetween, which allows relative rolling movement between the two separate pieces;

[0185] - A sterile barrier assembly with a coupling device is provided to form a reversible connection with at least one surgical instrument;

[0186] - A single surgical drape can be used to cover the robotic arm and the robotic cart, thereby reducing the number of components in the robotic surgical system and thus reducing the time required for covering.

[0187] Those skilled in the art can make many changes and modifications to the above embodiments, or can replace the elements with other functionally equivalent elements to meet possible needs without departing from the scope of the appended claims.

[0188] List of reference numerals

[0189]

[0190]

[0191]

Claims

1. A sterile barrier assembly (210) for a robotic surgical system (200), the sterile barrier assembly comprising: - Surgical drape (201), said surgical drape having at least one drape opening (209, 209'); - At least one connector (212, 212') that forms the outline of the at least one cover opening (209, 209') and is adapted to be coupled to the housing (251, 251') of a non-sterile robotic manipulator (220, 220'); as well as - At least one sterile adapter (221, 221'), the at least one sterile adapter having a frame (223) including a coupling device (237) for coupling with at least one surgical instrument (240, 240'); the at least one sterile adapter (221, 221') is adapted to couple with at least one rolling element (230, 230') of the non-sterile robotic manipulator (220, 220'), wherein the at least one rolling element (230, 230') is adapted to pivot relative to the housing (251, 251'); wherein - The at least one connector (212, 212') and the at least one sterile adapter (221, 221') of the surgical drape (201) are made as 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') and the at least one sterile adapter (221, 221') of the surgical drape (201); and wherein The at least one connector (212, 212') of the surgical drape (201) includes a distal surface (215, 215') facing distally, and the sterile adapter (221, 221') includes a proximal surface (226) facing proximally. The distal surfaces (215, 215') of the connectors (212, 212') face the proximal surfaces (226) of the sterile adapters (221, 221') to define the gap (235, 235'); The gaps (235, 235') prevent the non-sterile robotic manipulator from contaminating the sterile surgical area, while also preventing the sterile adapters (221, 221') from being directly connected to the connectors (212, 212') of the surgical drape (201).

2. The sterile barrier component (210) according to claim 1, wherein, The at least one connector (212, 212') of the surgical drape (201) has an annular edge (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.

3. The sterile barrier component (210) according to claim 2, wherein, The annular edges (213, 213') and the annular frame (223) of the sterile adapter (221, 221') are arranged coaxially.

4. The sterile barrier assembly (210) according to any one of claims 1 to 3, wherein, The sterile adapter (221, 221') includes a protrusion or skirt facing the gap (235, 235') from the proximal side, the skirt including the proximal surface (226).

5. The sterile barrier assembly (210) according to any one of claims 1 to 3, wherein, The surgical drape (201) includes: - A pair of cover openings (209, 209'); - A pair of connectors (212, 212'), each of the pair of connectors forming the outline of a corresponding cover opening (209, 209'); - A pair of sterile adapters (221, 221'), each of the pair of sterile adapters having a frame (223), the frame of each sterile adapter including a coupling device (237) for coupling with a corresponding surgical instrument (240, 240'); in: - Each connector (212, 212') and corresponding sterile adapter (221, 221') of the surgical drape (201) is manufactured as a separate piece; - Each sterile adapter (221, 221') is adapted to pivot relative to the corresponding connector (212, 212') of the surgical drape (201); - A gap (235, 235') is provided between each connector (212, 212') of the surgical drape (201) and the corresponding sterile adapter (221, 221').

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

7. The sterile barrier assembly (210) according to claim 5, wherein, The surgical drape (201) includes a pair of bags (231, 231'), each of the pair of bags (231, 231') defining a corresponding drape opening (209, 209'), and each of the pair of bags (231, 231') being adapted to cover a non-sterile robotic manipulator (220, 220').

8. A robotic surgical system (200), the robotic surgical system comprising: - At least one sterile barrier component (210) according to any one of claims 1 to 7; - At least one non-sterile robotic manipulator (220, 220'), said non-sterile robotic manipulator comprising: -Outer shell (251, 251'), -At least one rolling motor (246), and - At least one rolling element (230, 230'), said at least one rolling element being adapted to pivot relative to the housing (251, 251'); in: - The at least one connector (212, 212') of the surgical drape (201) of the sterile barrier assembly (210) is connected to the housing (251, 251') of the non-sterile robotic manipulator (220, 220'); - The at least one sterile adapter (221, 221') of the sterile barrier assembly (210) is connected to the at least one rolling element (230, 230') of the non-sterile robotic manipulator (220, 220'); - The at least one rolling motor (246) is adapted relative to the housing (251, 251') of the non-sterile robotic manipulator (220, 220') to move the at least one rolling element (230, 230') together with the at least one pivotally moving sterile adapter (221, 221'); - The gap (235, 235') between the at least one connector (212, 212') and the at least one sterile adapter (221, 221') of the surgical drape (201) prevents the non-sterile robotic manipulator from contaminating the sterile surgical area (255) while avoiding direct connection of the sterile adapter (221, 221') to the connector (212, 212') of the surgical drape (201).

9. The robotic surgical system (200) according to 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 connected to the housing (251, 251') of the non-sterile robotic manipulator (220, 220').

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

11. The robotic surgical system (200) according to claim 8 or 9, wherein, The rolling element of the non-sterile robotic manipulator (220, 220') includes manipulator connecting elements (229, 229'), wherein the sterile adapter (221, 221') is detachably engaged with the manipulator connecting elements (229, 229'), and wherein the engagement between the sterile adapter (221, 221') and the manipulator connecting elements (229, 229') is distal to the housing (215) and / or distal to the connector (212, 212') of the surgical drape (201).

12. A robotic surgical system (200), the robotic surgical system comprising: - The sterile barrier assembly (210) according to any one of claims 5 to 7; - A pair of non-sterile robotic manipulators (220, 220'), each of the pair of non-sterile robotic manipulators (220, 220') comprising: -Outer shell (251, 251'), -At least one rolling motor (246), and - At least one rolling element (230, 230'), said at least one rolling element being adapted to pivot relative to the housing (251, 251'); in: - Each connector (212, 212') of the surgical drape (201) of the sterile barrier assembly (210) is connected to the housing (251, 251') of the corresponding non-sterile robotic manipulator (220, 220'); - Each sterile adapter (221, 221') of the sterile barrier assembly (210) is connected to the rolling element (230, 230') of the corresponding non-sterile robotic manipulator (220, 220'); - Each rolling motor (246) is adapted relative to the housing (251, 251') of the corresponding non-sterile robotic manipulator (220, 220') to move the corresponding rolling element (230, 230') together with the pivoting corresponding sterile adapter (221, 221'); - The gaps (235, 235') between each connector (212, 212') of the surgical drape (201) and the corresponding sterile adapter (221, 221') prevent the non-sterile robotic manipulator from contaminating the sterile surgical area (255).

13. The robotic surgical system (200) according to claim 12, wherein, The surgical drape (201) includes a pair of bags (231, 231'), each of the pair of bags (231, 231') defining a corresponding drape opening (209, 209'), each of the pair of bags (231, 231') covering one of the pair of non-sterile robotic manipulators (220, 220').

14. The robotic surgical system (200) according to claim 12 or 13, the robotic surgical system comprising at least one surgical instrument (240, 240'), the at least one surgical instrument being coupled to the at least one sterile adapter (221, 221') such that the at least one surgical instrument (240, 240') is integrally coupled to the at least one rolling element (230, 230') of the non-sterile robotic manipulator (220, 220').

15. The robotic surgical system (200) according to claim 12 or 13, wherein, A bearing (243) is provided between the at least one rolling element (230, 230') and the corresponding housing (251, 251') of the non-sterile robotic manipulator (220, 220').

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