Sterile adapters, assemblies, systems and methods for robotic surgical systems - Patents.com

Abstract

A sterile adapter (101) for a robotic surgical system (102) includes a frame (103), a proximal connector (104) adapted to connect with a non-sterile robotic manipulator system (105), a distal cavity (106) adapted to connect with a surgical instrument (107) suitable for performing robotic surgery on a patient anatomy, and a membrane (109) having a proximal non-sterile side (110) and a distal sterile side (111) opposite the proximal non-sterile side (110). The membrane (109) is between the proximal connector (104) and the distal cavity (106). The membrane (109) is stretchable to transmit a plurality of pushing motions (112) from the proximal non-sterile side (104) to the distal sterile side (106), and the frame is rigid to transmit a rotational motion.

Description

[Technical field]

[0001] The object of the present invention is a sterile adapter for a robotic surgery system. In particular, the present invention relates to a sterile adapter suitable for connecting to a surgical instrument for a robotic surgery. The present invention also relates to a robotic surgery system. The present invention also relates to a slave assembly for a robotic surgery system. The present invention also relates to a method. [Background technology]

[0002] Robotic surgical devices are generally known in the art and typically comprise at least one teleoperated robotic arm having a robotic motorized positioning system for moving a surgical end effector attached distally thereto to perform a surgical procedure on a patient. In the technical field of robotic surgery, particularly in microsurgery and laparoscopic surgery, the need for miniaturization is strongly felt in order to reduce invasiveness to the patient. WO-2017-064303, WO-2017-064306, WO-2018-189721 and WO-2018-189722 in the name of the same applicant disclose various solutions that allow miniaturization of the surgical end effector by reducing the size of the wrist of the surgical instrument attached to the distal end of the instrument shaft.

[0003] The patient typically lies on a surgical bed in a sterile operating room to avoid bacterial contamination by non-sterile parts of the robotic teleoperation system. Usually, a surgical drape encases 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 for several interventions. The surgical drape may be equipped with an insert, such as a hard plastic plate, to form a connection interface with the active parts of the robot.

[0004] For example, document WO-2011-143024 shows a solution of a sterile drape with an annular outer rim rotatably connected to another part of the sterile drape with a mutual annular opening, thereby forming a two-piece sterile drape, and a sterile adapter with an internal frame describing a cross shape separating four cloves or slices. Each groove receives a pocket made of drape material, each pocket having a rigid plate attached to its distal side, each plate having a capstan for transmitting a rotatable actuation movement from the robot to the surgical instrument through said plate. The pockets each contain an extra amount of drape material that allows the pocket to expand. This document also shows four additional sterile adapters attached distally to the four pockets and engaging said rigid plates of the pockets.

[0005] Typically, a sterile surgical end effector, e.g. a clamp and / or a blade designed to operate on a patient, is attached to the active part of the robot through a connection interface of a sterile drape, as shown for example in WO-2016-137611. The sterile drape is therefore required to have a connection interface capable of transmitting the movements from the robot to the end effector. In the above-mentioned embodiment, the connection interface is provided with windows to allow a rack-and-pinion direct contact through each of said windows. Furthermore, the sterile drape can also constitute a fixing string that allows the sterile drape to be tied to a slim part of the robot, such as the slim arm of the robot, so as to closely fit, thereby reducing the volume of the sterile drape in use. Examples are also known that provide a magnetic attachment between the robot and the drape.

[0006] The connection interface or adapter of the barrier designed to transmit the actuation may also be in the form of foldable cone cuffs designed to receive the motor pistons individually, which may be glued or otherwise fixed to the active part of the robot, as shown for example in WO-2019-006206. However, this known solution does not solve the problem and forces the sterile barrier to be glued to the distal face of the non-sterile actuator. Tearing or breakage of the barrier material may occur if the relative movement of the components required for the transmission across the barrier, for example if such a transmission includes a hoist or capstan designed to wrap multiple times to transmit the motion. The pockets that receive the pistons individually require very high deformations of each of the pockets, resulting in the drape material of the pockets being prone to tearing if the drape material is not sufficiently deformable, or if it is sufficiently deformable, meaning the collapse of the drape material of each pocket during the contraction of the pistons received therein individually. Furthermore, this known solution shows a sterile adapter having a "C" shaped rectangular box-like outer body defining an inner through hole defined by the "C" shaped adapter body itself for receiving a surgical instrument, which must be inserted proximally through said inner valley hole along a direction coinciding with the longitudinal extension of the shaft of the surgical instrument, thereby further reducing the usable surface area of ​​each pocket.

[0007] US-2019-0231448 discloses a solution in which three parallel male wire sliders engage across a removable rubber element, respectively, in order to transmit across the removable rubber element a linear displacement action parallel to the free surface of the removable rubber element, the removable rubber element being removably mounted on a surface of a rigid frame, the rigid frame having a circular outer rim, the surface on which the rubber elements are removably mounted being orthogonal to the circular outer rim and spaced from the circular rim in a distal direction.

[0008] Sterile adapters or interfaces are also described in, for example, documents WO-2009-061915, WO-2016-081286, WO-2016-178028, WO-2017-015599, WO-2017-205308, WO-2017-205333, WO-2019-150086, EP-0591936, EP-3025667, US-5682264, US-6024454, US-9204933, It is known from US-9456876, US-10321964, US-2007-064309, US-2009-248039, US-2009-248040, US-2010-082041, US-2012-289973, US-2015-173840, US-2016-151115, US-2018-325616, US-2019-053866.

[0009] WO-2018-189729 of the same applicant shows a sterile barrier solution with 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 is difficult to manufacture and assemble due to the required alignment of the actuator, the reinforcing element and the actuation element.

[0010] Therefore, a need is felt to provide a solution for transmitting an actuation action across a sterile barrier without the barrier tearing for this reason.

[0011] A need is felt to provide a sterile adapter that can removably couple surgical instruments to manipulators for robotic surgery to enable removal and replacement of the surgical instruments in a sterile operating field. Summary of the Invention

[0012] It is within the scope of the present invention to overcome the shortcomings noted with reference to the known art.

[0013] These and other scopes are achieved by a sterile adapter according to claim 1, a slave robot assembly according to claim 15, a robotic surgery system according to claim 27, and a method according to claim 29.

[0014] Some preferred embodiments are the subject of dependent claims.

[0015] According to one aspect of the present invention, a sterile adapter for a robotic surgical system is adapted to transfer a plurality of linear actuation motions and rotational motions from a non-sterile robotic manipulator system to a sterile surgical instrument having a back end portion and a shaft extending from the back end portion.

[0016] The sterile adapter may be devoid of relatively moving parts for transmitting the plurality of linear actuation motions and the rotational motion.

[0017] According to one aspect of the invention, a sterile adaptor includes a frame for transmitting rotational motion from a non-sterile robotic manipulator system to a sterile surgical instrument, the frame including a proximal connector for coupling with the non-sterile robotic manipulator system and a distal connector for coupling with a sterile surgical instrument, the frame defining an opening therethrough between the proximal connector and the distal connector. The frame may be an outer casing of the sterile adaptor. The opening may be circular.

[0018] According to one aspect of the invention, a sterile adaptor includes a membrane secured to the frame that seals the through opening forming a distal cavity between the stretchable membrane of the frame and the distal connector.

[0019] According to one aspect of the invention, the membrane is designed to transmit multiple localized linear actuation motions through its thickness from a non-sterile robotic manipulator to a sterile surgical instrument.

[0020] According to one aspect of the invention, the membrane is resiliently stretchable so as to resiliently bias the membrane towards its substantially flat configuration.

[0021] According to one aspect of the invention, the distal cavity is adapted to receive at least a portion of a back end of a sterile surgical instrument, and the distal coupling device comprises at least one abutment surface facing the stretchable membrane and thereby at least partially delimiting the distal cavity, the at least one abutment surface being adapted to receive at least a portion of a back end of a sterile surgical instrument thereon. Contact For example, in use, a rear end of a surgical instrument abuts against the at least one abutment surface. May be located under the elastic membrane A plurality of localized linear actuation actions may be capable of exerting a pressing action for loading a surgical instrument against said at least one abutment surface.

[0022] The distal cavity may include a lateral guide surface suitable for mating with at least one laterally facing surface of the sterile surgical instrument, preferably the lateral guide surface of the distal cavity of the sterile adaptor is substantially flat. The lateral guide surface is preferably non-parallel to the membrane, more preferably perpendicular to the membrane. The distal cavity may include a lateral opening designed for inserting the sterile surgical instrument into the sterile adaptor. Thus, the insertion direction of the surgical instrument is non-parallel to the shaft of the surgical instrument, preferably perpendicular to the shaft of the surgical instrument. The distal coupling device may be designed for snap-fit ​​engagement with a part of a surgical instrument, such as a part of the back end and / or a part of the shaft.

[0023] The distal cavity may include a second side opening suitable for accessing the distal cavity for the purpose of pushing the sterile surgical instrument out of the distal cavity of the sterile adapter such that the removal direction of the surgical instrument is non-parallel to the shaft of the surgical instrument, and preferably perpendicular to the shaft of the surgical instrument.

[0024] The membrane may be a single flat piece of material. The membrane may be disc-shaped. The membrane may be integrally attached to the frame such that it does not rotate relative to the frame. The proximal and distal connectors of the frame may be made as a single piece. The proximal and distal connectors of the frame may not have any relative degrees of freedom. The frame may rigidly determine the position and orientation of the proximal and distal connectors relative to each other, and preferably the orientation of the lateral opening of the distal connector.

[0025] The distal connector of the frame may define a distal seat having a distal through-opening that opens distally outside the distal cavity, the distal through-opening may be substantially aligned with and coaxial with the through-opening sealed by the elastic membrane.

[0026] A flagging device may be provided for flagging when the sterile adaptor is coupled to the robotic manipulator system. The flagging device may include a flagging pin including a distal flagging end that cantilevers out from a frame body of the sterile adaptor when the sterile adaptor is coupled to the robotic manipulator system.

[0027] According to one aspect of the present invention, a slave robot assembly for a robotic surgical system is provided comprising: a non-sterile robotic manipulator system, a sterile surgical instrument having a back end portion and a shaft extending from the back end portion, and a sterile adaptor adapted to transfer a plurality of linear and rotational actuation motions from the non-sterile robotic manipulator system to the sterile surgical instrument, the sterile adaptor being adapted when coupled to the sterile surgical instrument such that the back end portion and the shaft extend from the sterile surgical instrument. The sterile adaptor comprises a frame for transferring rotational motions from the non-sterile robotic manipulator system to the sterile surgical instrument, the frame comprising a proximal connector coupled to the non-sterile robotic manipulator system and a distal connector, the frame defining a through opening between the proximal connector and the distal connector, the sterile adaptor including a membrane secured to the frame for transferring a plurality of localized linear actuation motions from the sterile robotic manipulator to the sterile surgical instrument through a thickness of the membrane. The membrane is elastically stretchable to result in the membrane being elastically biased toward its substantially flat configuration, the stretchable membrane sealing the through opening forming a distal cavity between the stretchable membrane and the distal connector, the distal cavity receiving at least a portion of a rear end of a sterile surgical instrument, the distal connector comprising at least one abutment surface facing the stretchable membrane thereby at least partially delimiting the distal cavity and against which the surgical instrument protrudes.

[0028] The surgical instrument may be biased against an additional abutment surface formed by a frame of a sterile adaptor, delimiting the cavity and facing the membrane.

[0029] The geometric center of the membrane may be aligned with the shaft of a sterile surgical instrument.

[0030] A plurality of localized linear actuation actions may be oriented perpendicular to the proximal and distal surfaces of the membrane. A plurality of pistons may be provided on the robotic motorized manipulator for exerting the plurality of localized linear actuation actions, the pistons preferably extending perpendicular to the membrane.

[0031] In use the sterile adaptor may rotate with the sterile surgical instrument, in other words the sterile adaptor and the surgical instrument are rotationally united when rotational motion is transmitted to said frame of the sterile adaptor.

[0032] The non-sterile robotic manipulator system may include a plurality of linear actuators, such as the plurality of pistons, and the membrane may be elastically preloaded against a distal end of at least one of the plurality of linear actuators when at least one of the plurality of linear actuators advances distally. For example, the membrane may be decoupled from a distal end of the at least one of the plurality of linear actuators when the at least one of the plurality of linear actuators retracts. The back end of the surgical instrument may include a plurality of linear transmission elements individually aligned with the plurality of pistons.

[0033] A plurality of local linear actuation movements may be aligned with a shaft of a surgical instrument, whereby a plurality of linear actuators, such as the plurality of pistons, are aligned with the shaft and a plurality of transmission elements, such as a back-end rod, are aligned with the shaft.

[0034] The sterile adapter may be removably coupled to the non-sterile robotic manipulator system. The surgical instrument may be removably coupled to the sterile adapter.

[0035] The slave robotic assembly may include at least a rotary joint that transmits the rotational motion to the surgical instrument through the frame of the sterile adaptor. The slave assembly may include at least one rotary motor, the rotary motor operably connected to the rotary joint.

[0036] The robotic surgical system may include a slave robotic assembly and a master console that controls the slave robotic assembly.

[0037] According to one aspect of the invention, a method of transmitting a rotational motion and a plurality of localized linear displacement motions across a sterile barrier includes providing a sterile adapter comprising a frame and a stretchable membrane secured to the frame, and transmitting the rotational motion by the frame of the sterile adapter and the plurality of localized linear displacement motions by the membrane through its thickness, each of the steps of transmitting the rotational motion and transmitting the plurality of localized linear displacement actions may include transmitting to a surgical instrument.

[0038] The stretchable membrane may be a single membrane that is subjected to the multiple linear displacement actions localized at different locations on a proximal surface of the single membrane.

[0039] The localized linear displacement actions may be oriented perpendicular to a proximal surface of the stretchable membrane.

[0040] Further features and advantages of the sterile adapter, assembly, system and method emerge from the hereinafter reported description of preferred embodiments, given by way of example and not intended to be limiting, with reference to the attached figures, in which: [Brief description of the drawings]

[0041] [Figure 1] FIG. 1 is an axial view of a robotic surgical system, according to an embodiment. [Figure 1bis]FIG. 1bis is a detail of FIG. 1 showing two sterile adapters. [Diagram 2] FIG. 2 is an axial view of a sterile adapter, according to an embodiment. [Diagram 3] FIG. 3 is an axial view of a sterile adapter, according to an embodiment. [Figure 4] FIG. 4 illustrates a cross-section of a sterile adapter coupled to a robotic manipulator system and a surgical instrument, according to an embodiment, where some portions of the manipulator system are transparent for clarity. [Diagram 5] FIG. 5 is a schematic diagram illustrating a cross section of a slave assembly having a sterile adaptor, a connector, a robotic manipulator system and a surgical instrument, according to an embodiment. [Figure 6] FIG. 6 illustrates a side view of a portion of a connector of a slave assembly, according to an embodiment. [Figure 7] FIG. 7 is an axial view of a slave assembly as a separated part, according to an embodiment. [Figure 8] FIG. 8 is a bottom view of the sterile adapter of FIGS. [Figure 9] The figures show axial views of a sterile adapter according to an embodiment and a portion of a robotic manipulator system in an unlocked and locked configuration, respectively. [Figure 10] FIG. 10 illustrates axial views of a sterile adapter and a portion of a robotic manipulator system in unlocked and locked configurations, respectively, according to an embodiment. [Figure 11] FIG. 11 shows a cross-sectional view of the sterile adapter and connector when in a locked configuration. [Figure 12] FIG. 12 is an axial cross-sectional view of a slave assembly according to an embodiment. [Figure 13] FIG. 13 is a bottom view of the slave assembly of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] According to a general embodiment, a sterile adaptor 101 for a robotic surgical system 102 is provided.

[0043] The sterile adapter 101 is suitable for transmitting multiple linear displacement motions 112 and rotational motions 160 from a non-sterile robotic manipulator system 105 to a sterile surgical instrument 107 having a back end portion 123 and a shaft 121 extending from the back end portion 123.

[0044] Preferably, the term "surgical instruments" also refers to "medical instruments" and the like.

[0045] The sterile adapter 101 consists of a frame 103 for transmitting rotational motion 160 from a non-sterile robotic manipulator system 105 to a sterile surgical instrument 107. The frame is preferably not suitable for transmitting linear displacement motions 112.

[0046] Preferably, the term "rotational action" as used herein refers to an action that actuates a robot roll joint 174 or a robot twist joint. Preferably, the sterile adapter 101 is integrally attached to a link or body that is distal or acts as an output link of the robot roll joint or twist joint. Such rotational action is preferably motor driven, although this does not imply that the sterile adapter 101 houses a motor for exerting the rotational action 160. According to an embodiment, the term "rotational action" can also encompass an action that actuates a robotic rotary joint. According to an embodiment, the robot manipulator system 105 includes a rotational motor 127 that exerts the rotational action 106.

[0047] The frame 103 of the sterile adapter 101 includes a proximal connector 104 for coupling with a non-sterile robotic manipulator system 105 .

[0048] The frame 103 of the sterile adaptor 101 includes a distal connector 106 for coupling with a surgical instrument 107 .

[0049] The frame 103 defines an opening therethrough between the proximal connector 104 and the distal connector 106 .

[0050] Advantageously, said sterile adapter 101 comprises a membrane 109 fixed to said frame 103 .

[0051] As a further advantage, the membrane 109 seals the through opening in the frame 103, thereby forming a distal cavity 132 between the sterile membrane 109 and the distal connector 106 of the frame 103 of the sterile adapter 101. The membrane 109 is thereby located between the proximal connector 104 and the distal connector 106. The distal cavity 132 thereby forms a pouch for receiving a surgical instrument 107.

[0052] The membrane 109 is designed to transmit multiple localized linear displacement motions 112 through its thickness 169 from a non-sterile robotic manipulator 105 to a sterile surgical instrument 107 .

[0053] According to an embodiment, the membrane 109 has a proximal non-sterile surface 110, a distal sterile surface 111 opposite the proximal non-sterile surface 110, and a thickness 169 between the proximal non-sterile surface 110 and the distal sterile surface 111 of the membrane 109. A distal cavity 132 is thereby located between the distal sterile surface 111 of the membrane 109 and the distal connecting device 106. Preferably, the membrane 109 is a piece of sheet material having a substantial extent in two dimensions and a thickness 169 that is much less than the extent of the sheet material in the two dimensions.

[0054] Preferably, the term "linear displacement action" refers to an action of linearly displacing an element, e.g. a transmission element, and preferably said action displaces an element along a substantially linear path. For example, said linear displacement action is a pushing action. For example, one or more pistons push on a non-sterile surface 110 of the membrane. Thereby, the action exerted by said one or more pistons is transferred by their sterile surfaces 111 to one or more transmission elements individually aligned along a linear direction with said one or more pistons.

[0055] Preferably, the term "multiple localized linear displacement actions" refers to the non-sterile surface of the membrane being biased by multiple pistons, the linear displacement actions being directed laterally relative to the sterile and non-sterile surfaces 111, 110 of the membrane, such that each piston of the multiple pistons presses against a localized region of the non-sterile surface 110 of the membrane.

[0056] The membrane 109 is elastically stretchable so as to elastically bias it towards its substantially flat configuration. According to an embodiment, the membrane 109 functions as a sterile drape. According to an embodiment, the membrane is made of a flexible, stretchable sheet of a transparent plastic material, such as polyethylene.

[0057] The provision of an elastically stretchable membrane allows the transmission of said plurality of local linear displacement actions 112 through the thickness 169 of the membrane 109 by means of locally elastically bending the membrane, whereby the volume of said distal cavity 132 is affected by said plurality of linear displacement actions 112 acting on the proximal surface 110 of said membrane 109. In particular, the stretchable membrane 109 elastically deforms when stretched by said plurality of local linear displacement actions 112, thereby locally modifying the volume of said distal cavity 132. In use, the membrane 109 is thereby elastically preloaded against the distal end of at least one piston of said plurality of pistons such that the piston advances and presses laterally, preferably orthogonally, against the non-sterile surface 110 of the membrane 109 to exert said linear displacement action 112. The material of membrane 109 and / or the geometric parameters of membrane 109 may be selected to ensure that, in use, said elastic preload on the distal end of at least one piston of said plurality of pistons is substantially negligible.

[0058] Preferably, the frame 103 is substantially rigid, and more rigid than the membrane 109 , so as to not stretch when the multiple linear displacement movements 112 are exerted on the proximal non-sterile surface 110 of the membrane 109 .

[0059] According to a preferred embodiment, the membrane 109 is held rigid by the frame 103. According to an embodiment, an outer edge 173 of the membrane 109 is glued to the frame 103. According to an embodiment, an outer edge 173 of the membrane 109 is clamped to the frame 103. According to an embodiment, an outer edge 173 of the membrane 109 is screwed to the frame 103.

[0060] With reference to the figure, the proximal-distal direction is generally indicated as zz. According to an embodiment, a radial direction RR is further defined as a direction perpendicular to and incident on said proximal-distal direction zz. A plurality of linear displacement movements 112 are transmitted along the proximal-distal direction zz.

[0061] According to the embodiment, the frame 103 of the sterile adapter 101 Interior space is included in a cylindrical, preferably disc-like, shape having a predetermined radius along the radial direction RR and a predetermined length along the proximal-distal direction ZZ. According to an embodiment, the radial extent of the frame 103 is greatest near or at its proximal connector 104.

[0062] According to an embodiment, the pressing movement 112 is directed along a proximal-distal direction Zz, i.e. transversely to the membrane, preferably perpendicular to the membrane 109. Thereby, the transmission of a rotational movement through the membrane 109 is avoided, thus reducing the risk of the membrane 109 crumpling.

[0063] Providing a stretchable membrane 109 allows the transmission of multiple localized linear displacement actions 112, preferably multiple localized compression actions 112, across the membrane 109 and through the thickness 169 of the membrane 109 without plastically deforming the membrane 109 for this reason.

[0064] Thereby, the membrane 109 can transmit a plurality of localized linear displacement actions 112 from the proximal non-sterile side 110 to the distal sterile side 111 of the membrane 109. According to an embodiment, the membrane 109 is also capable of transmitting a plurality of localized linear displacement actions 112 backwards from the distal sterile side 111 to the proximal sterile side 110 of the membrane 109.

[0065] Thanks to such a membrane 109 , the stretchable body of the membrane 109 itself acts as a transmission element that transmits said multiple localized linear displacement actions 112 from the non-sterile proximal surface 110 to the sterile distal surface 111 of the membrane 109 .

[0066] Conversely, the membrane 109 is unsuitable for transmitting said rotational movement 160 .

[0067] Thereby, the need to provide the membrane 109 with a rigid insert acting as a transmission element is avoided. Thus, the need to provide the membrane 109 with rigid plates, paddles and / or devices capable of transmitting a rotational action is also avoided. The rotational action may be transmitted by the frame 103 of the sterile adapter 101.

[0068] By providing such a stretchable membrane 109 it is possible to locally deform said membrane 109 elastically in order to transmit at least one linear displacement action 112 in time through the thickness 169 of the membrane 109 .

[0069] The distal connector 106 comprises at least one abutment surface 161 facing the elastic membrane 109 thereby at least partially defining the distal cavity 132 .

[0070] The at least one abutment surface 161 is suitable for abutting a portion of a surgical instrument 107 thereon. Such portion of a surgical instrument 107 abutting against the at least one abutment surface 161 of the distal connector 106 of the sterile adapter 101 may be either a back end portion 123 or a shaft 121 of the surgical instrument 107.

[0071] According to a preferred embodiment, said at least one abutment surface 161 is located below the elastic membrane 109. In other words, said at least one abutment surface 161 is: Under Membrane 109 In other words, the at least one abutment surface 161 of the distal connector 106 faces the membrane 109 and Proximal-distal direction of membrane 109 zz. In other words, the at least one abutment surface 161 is under the shadow of the membrane 109.

[0072] According to a preferred embodiment, the frame 103 rigidly determines the mutual positioning and orientation of the proximal connector 104 and the distal connector 106. Preferably, the frame 103 rigidly determines the mutual positioning and orientation of the proximal connector 104 and the lateral opening 116 of the distal connector 106. Preferably, the frame does not comprise any hinges or moving parts or joints.

[0073] According to a preferred embodiment, the sterile adapter 101 comprises spacer walls 166, 166', preferably two in number, positioned transversely to said distal cavity 132, said spacer walls 166, 166' spacing the membrane 109 from the distal connector 106 at a predetermined distance, preferably along a proximal-distal direction zz. The spacer walls 166, 166' act as guide walls for guiding the insertion of said back-end portion 123 of the surgical instrument 107 into the distal sterile cavity 132.

[0074] According to a preferred embodiment, each spacer wall 166, 166' partially delimits the distal cavity 132 and has a side guide surface 133, 133' adapted to mate with at least one side facing surface 163 of the sterile surgical instrument 107. Preferably, each of the side guide surfaces 133, 133' of the distal cavity 132 of the sterile adapter 101 is substantially flat. Preferably, the at least one side facing surface 163 of the surgical instrument 107 is substantially flat.

[0075] According to a preferred embodiment, the distal cavity 132 comprises a lateral access opening 116 designed for inserting the sterile surgical instrument 107 into the sterile adapter 101. Preferably, the lateral access opening 116 opens in a direction that is transverse to the proximal-distal direction zz, for example in a radial direction RR.

[0076] According to a preferred embodiment, the distal cavity 132 comprises an opposite side window 120 for accessing the distal cavity 132 for the purpose of pushing the sterile surgical instrument 107 out of the distal cavity 132 of the sterile adapter 101. In other words, the sterile distal cavity 132 opens into a side access opening 116, or a first side opening 116, designed for the surgical instrument 107 or at least a part of it to access the distal cavity 132, and into an opposite side window 120, or a second side opening 120, designed for pushing the surgical instrument 107 or at least a part of it out of the distal cavity 132, so that the surgical instrument 107 leaves the cavity 132 through the first opening 116, or the side access opening 116. According to an embodiment, the side access opening 116 is larger than the opposite side window 120. Preferably, both the lateral access opening 116 and the opposite lateral window 120 are bounded by the frame 103, preferably by the spacer walls 164, 164 of the frame 103. Preferably, the lateral access opening 116 and the opposite lateral window 120 are opposed to each other with respect to the frame 103, preferably with respect to the spacer walls 166, 166'.

[0077] According to a preferred embodiment, the distal connector 106 defines a distal seat 115 having a distal through-opening 164 opening distally outside the distal cavity 132. The frame 103 of the sterile adapter 101 thereby preferably comprises a distal outer surface 165 located distally with respect to the distal connector 106 and facing away with respect to the at least one abutment surface 161, with the distal through-opening opening into the distal outer surface 165.

[0078] According to a preferred embodiment, said distal through-opening 164 is substantially aligned with the through-opening sealed by the stretchable membrane 109, preferably along the proximal-distal direction zz.

[0079] According to an embodiment, said frame 103 defines an annular rim 129 forming the rim of the membrane 109, or a circular rim 129. According to a preferred embodiment, said annular rim 129 holds said membrane 109, whereby the membrane 109 has a periphery, preferably the membrane 109 has a circular body.

[0080] According to a preferred embodiment, the distal trough opening 164 of the sterile adapter 101 has an arcuate edge 175 having a center of curvature that coincides with the geometric center of the rim 129 of the stretchable membrane 109. The distal trough opening 164 is thereby coaxial with the through opening of the frame 103 that is sealed by the stretchable membrane 109.

[0081] According to an embodiment, a lateral abutment wall 119 facing the distal seat 115 of the distal connection device 106 is provided delimiting the bottom of the distal seat 115 and is suitable for forming an abutment surface for a surgical instrument 107 or a part thereof when the surgical instrument 107 is connected to the sterile adapter 101 by inserting it into said distal cavity 132 via said lateral access opening 116. According to an embodiment, a centering and positioning element 118, preferably consisting of a notch, is realised in or near the lateral abutment wall 119 of the sterile adapter 101. According to an embodiment, said root portion 113 of at least one elongated tongue 108 extends from said surgical instrument abutment wall 119. The provision of such centering and positioning elements 118 is provided for operatively connecting the surgical instrument 107 to the sterile adapter 101, said centering and positioning elements 118 preferably determining the correct connection of the surgical instrument 107 to the sterile adapter 101, for example in such a manner as to ensure operative alignment of each of the linear actuators 126 of the robotic manipulator system 105 with the respective transmission elements 124 of the back end 123 of the surgical instrument 107.

[0082] In use, the distal connector 106 of the sterile adapter 101 snap-fits into the counter connector 131 of the surgical instrument 107, whereby the elongated tongues 108, 108' hold the body of the counter connector 131 against the lateral abutment wall 119 of the receiving seat 115 of the sterile adapter 101.

[0083] When the sterile adapter 101 rotates to carry the surgical instrument 107, it rotates about an axis zz that is coaxial with the shaft 121 of the surgical instrument 107, and thus pivots, not rotates.

[0084] According to an embodiment, the membrane 109 is fixed to the annular rim 129, which is made of the frame body 103. According to an embodiment, the annular rim 129 has an inner edge 156 facing the membrane 109 and an annular outer edge. The inner edge 156 may be annular and may have a projection 158 projecting radially inwards, which projection 158 is not intended to partition the membrane 109 in order to avoid discontinuities in the structure and dynamic behavior of the membrane 109. According to an embodiment, the inner edge 156 of the annular rim 129 facing the membrane 109 describes a single rim perimeter 159. According to an embodiment, the annular rim 129 has a constant extension in the radial direction RR.

[0085] According to a preferred embodiment, said membrane 109 is a single piece, preferably a single flat piece or sheet of elastic material, i.e. the membrane is monoblock, thereby reducing the number of components of the sterile adapter 101. Furthermore, the risk of parts of the membrane 109 becoming detached is avoided.

[0086] According to a preferred embodiment, said membrane 109 forms a continuous surface. According to a preferred embodiment, said membrane 109 forms two opposing continuous surfaces 110, 111. According to an embodiment, the term "continuous surface" means that the structural and dynamic behavior of the membrane 109 is continuous along the entire body of the membrane 109, avoiding the provision of rigid parts and / or rigid plates as well as through holes for the passage of actuators and / or transmission devices. According to an embodiment, the term "continuous surface" means that the membrane 109 does not constitute discontinuities. For example, said discontinuities are holes and / or cuffs. Such discontinuities, for example cuffs, require a manufacturing process, for example thermoforming, during manufacturing to plastically deform the membrane 109 to form said discontinuities.

[0087] According to a preferred embodiment, said membrane 109 lies in a plane, preferably perpendicular to the proximal-distal direction ZZ. According to a preferred embodiment, said membrane 109 forms planes 110, 111, which are the planes of the sterile adapter 101. Housed in the frame body 103 According to embodiments, said membrane 109 extends transversely and / or perpendicularly to the proximal-distal direction ZZ. According to embodiments, said membrane 109 has no folds. According to embodiments, said membrane 109 has a constant thickness 169, for example comprised between 2 and 6 millimeters. According to embodiments, said membrane 109 avoids pockets for accommodating actuators and / or transmission devices etc. According to embodiments, said membrane 109 avoids constituting rigid parts, for example consisting of paddles, for transmitting a rotational movement through the membrane 109.

[0088] According to a preferred embodiment, the distal connector 106 of the sterile adapter 101 is designed for snap-fit ​​engagement with a portion of the surgical instrument 107, preferably designed to engage a mating portion 131 of the surgical instrument 107.

[0089] According to a preferred embodiment, said distal connector 106 of the sterile adapter 101 has at least one elongated resilient tongue 108 , 108 ′ projecting in a cantilever manner thereby forming an end 113 , preferably a free end 113 , and a root portion 114 .

[0090] According to an embodiment, the distal connection device 106 of the sterile adapter 101 comprises a distal seat 115 at least partially bounded by the at least one elongated tongue 108, 108', the receiving seat 115 defining a lateral access opening facing towards the same engagement direction 128 of the lateral access opening 116 of the distal cavity 132. According to an embodiment, the at least one elongated tongue 108, 108' is resiliently biased to reduce the width of the access opening 116 of the receiving seat 115 to form a snap-fit ​​engagement with a surgical instrument 107.

[0091] According to a preferred embodiment, said two elongated tongues 108, 108' are provided separating an access opening therebetween for accessing the distal seat 115, preferably separating the distal seat 115.

[0092] According to a preferred embodiment, the at least one elongate tongue 108, 108' is substantially parallel to the membrane 109. In other words, the at least one elongate tongue 108, 108' extends transversely to said proximal-distal direction zz.

[0093] According to an embodiment, said at least one elongated tongue 108, 108', preferably each of said elongated tongues 108, 108', comprises an abutment or retaining portion 117, 117' facing said distal seat 115. Thanks to said retaining portion 117, 117' of the elongated tongue 108, 108', suitable for a snap-fit ​​engagement with the surgical instrument 107, a restraining effect of the surgical instrument 107 in the distal seat 115, preferably against said lateral abutment wall 119, is provided. According to an embodiment, said retaining portion 117, 117' of the elongated tongue 108, 108' faces said lateral abutment surface 119 of the distal seat 115. According to an embodiment, said retaining portion 117, 117' is located on a protuberance projecting inwards towards the receiving seat 115 so as to narrow the access opening 116 to the seat 115.

[0094] According to an embodiment, the access opening of the distal seat 115 for a surgical instrument 107 opens in an engagement direction 128 transverse to the proximal-distal direction zz, so that the surgical instrument 107 can be connected to and disconnected from the sterile adapter 101 with a lateral movement along the engagement direction 128. According to an embodiment, the engagement direction is parallel to or coincides with the radial direction RR.

[0095] Thereby, a surgical instrument 107 can be connected to and disconnected from said sterile adapter 101 with a lateral displacement movement, i.e. engagement direction 128 is transverse to the proximal-distal direction zz. Thereby, a surgical instrument 107 can be moved away from the patient's anatomy and / or away from the surgical bed to be disconnected from said sterile adapter 101. Thereby, said surgical instrument 107 can be connected to said sterile adapter 101 along said lateral engagement direction 128.

[0096] According to an embodiment, the frame body 103 of the sterile adapter 101 defines, between the membrane 109 and the distal coupling portion 106, a distal cavity 132 designed to receive at least a part of the back-end portion 123 of the surgical instrument 107. According to an embodiment, the housing 132 opens on the same side as the access opening of the distal seat 115, such that the back-end portion 123 is received in the distal cavity 132 when the mating portion 131 of the surgical instrument 107 is releasably connected with the coupling device 106 of the sterile adapter 101.

[0097] The linear displacement action 112 exerted locally on the proximal surface 110 of the membrane 109 determines a local stretching of the membrane 109, thereby transmitting such linear displacement action 112 through the thickness 169 of the membrane 109 to the back end 123 of the surgical instrument 107, which consists of a transmission element 124, e.g. a rod, aligned with a linear actuator 126 of the robotic motorized manipulator system 105.

[0098] According to an embodiment, the frame 103 defines at least one ejection window 120 adapted to allow access to a portion of a surgical instrument 107 in order to push it for removal from the distal cavity 106 of the sterile adapter 101, thereby enabling a quick disengagement action, whereby a rear end portion 123 of the surgical instrument 107 also exits from the housing 132. For example, a manual pushing action 122 of the ejection window 120 can disengage the surgical instrument 107 in a direction away from the patient's anatomy.

[0099] According to an embodiment, the window 120 faces in opposite directions with respect to the access opening 116. According to an embodiment, the window 120 faces in opposite directions with respect to an access side of the housing 123.

[0100] According to an embodiment, the proximal connector 104 comprises a threaded element for threadedly engaging with the robotic manipulator system 105 .

[0101] According to a preferred embodiment, the proximal connector 104 defines a circular shape defining an axially symmetric union.

[0102] The provision of such an annular rim 129 allows the sterile adapter 101 to pivot about an axis preferably parallel to said proximal-distal direction ZZ without tearing or collapsing the membrane 109 for this reason, which would result in the surgical instrument 107 losing its sterility.

[0103] According to an embodiment, the proximal coupling device 104 is designed to form a bayonet type coupling with a part of a robotic manipulator system 105. According to an embodiment, the proximal coupling device 104 comprises an undercut element that is undercut with respect to the proximal-distal direction ZZ for coupling with the robotic manipulator system 105.

[0104] According to an embodiment, the frame body 103 of the sterile adapter 101 comprises a skirt 134 of enlarged radial dimension near its proximal end.

[0105] According to an embodiment, the frame body 103 of the sterile adapter 101 has the proximal connecting device 104, the distal connecting device 106, spacer walls 133, 133' that at least partially define the housing 132, and the window 120 that opens in the radial direction RR on the opposite side of the spacer walls 113, 113'.

[0106] According to an embodiment, the sterile adapter 101 comprises a flagging device 135 for flagging when the sterile adapter 101 is coupled to the robotic manipulator system 105. According to an embodiment, the flagging device 135 has a flag pin 138 with a distal pin end 136, suitable for cantilevering out of the frame body 103 of the sterile adapter 101 when the sterile adapter 101 is coupled to the robotic manipulator system 105, thereby flagging a successful coupling event. According to an embodiment, the flagging device 135 comprises, for example, a resilient device 137 for biasing the distal pin end 136 proximally to be flush with a distal portion of the sterile adapter 101. When the sterile adapter 101 is coupled to the robotic manipulator system 105, the flagging pin 138 abuts against an abutment element 139 of the robotic manipulator system 105 against the biasing action exerted by the resilient device 137, thereby causing the distal pin end 136 of the flagging pin 138 to protrude distally from the sterile adapter 101. A removable panel 150 may be provided to protect the flagging device 135.

[0107] According to an embodiment, the distal pin end 136 is made in a separate piece with respect to the flagging pin 138. According to an embodiment, the elastic device 137 of the connector 140 comprises an axial spring fitted around the flagging pin 138. According to an embodiment, the flag device 135 further comprises a flagged pin housing 148 for receiving at least a part of the flagged pin 138. According to an embodiment, the flagging pin housing 148 for receiving at least a part of the flagging pin 138 forms a through hole extending substantially along the proximal-distal direction ZZ through the side wall 133' of the frame body 103 of the sterile adapter 101. An abutment surface may be provided on the flagging pin housing 148 to stop the displacement of the flagging pin 138 by cooperation with a counter abutment surface that may be provided on the pin 138. For example, the pin 138 may have a flared portion suitable for abutting against a surface of the housing 148. According to an embodiment, the flag pin 138 comprises an angled segment 149 that forms an angle with said proximal-distal direction ZZ and is adapted to abut a surface of the housing 148 .

[0108] According to embodiments, a mechanism is provided that inhibits removal of the sterile adapter from the connector when a surgical instrument is coupled to the sterile adapter.

[0109] According to an embodiment, a sterile adapter 101 transfers a plurality of linear actuation motions 112 and a rotational motion 160 from a non-sterile robotic manipulator system 105 to a sterile surgical instrument 107 having a back end portion 123 and a shaft 121 extending from the back end portion 123. The sterile adapter 101 has a frame 103 that transfers the rotational motion 160 from the non-sterile robotic manipulator system 105 to the sterile surgical instrument 107. The frame 103 has the proximal connector 104 that couples with the non-sterile robotic manipulator system 105 and the distal connector 106 that couples with the sterile surgical instrument 107. The frame 103 defines an opening therethrough between the proximal connector 104 and the distal connector 106. The sterile adapter 10 further comprises a membrane 109 fixed to the frame 103 and transmitting a plurality of local linear actuation motions 112 from the non-sterile robotic manipulator 105 to the sterile surgical instrument 107 through a thickness 169 thereof. The membrane 109 is elastically stretchable and elastically biased towards its substantially flat configuration. The stretchable membrane 109 seals the through opening forming a distal cavity 132 between the stretchable membrane 109 and the distal connector 106. The distal cavity 132 receives at least a portion of a back end 123 of the sterile surgical instrument 107. The distal connector 106 comprises at least one abutment surface 161 facing the stretchable membrane 109, thereby at least partially delimiting the distal cavity 132. The at least one abutment surface 161 is suitable for a surgical instrument 107 to butt thereon, such that the surgical instrument 107 abuts against the at least one abutment surface 161 .

[0110] According to an embodiment, said membrane 109 has the shape of a disk.

[0111] According to an embodiment, the membrane 109 is integrally attached to the frame 103 .

[0112] According to an embodiment, the proximal connector 104 and the distal connector 106 of the frame 103 are made in a single piece.

[0113] According to a typical embodiment, a slave assembly 100 for a robotic surgical system 102 comprises at least one sterile adapter 101 according to any one of the embodiments described above.

[0114] The slave assembly 100 comprises at least one connector 140 coupled to the proximal coupling 104 of the sterile adapter 101. According to an embodiment, the connector 140 comprises a distal mating coupling 141 suitable for forming a connection with the proximal coupling 104 of the sterile adapter 101. According to an embodiment, the distal mating coupling 141 of the connecting body 140 and the proximal coupling 104 of the sterile adapter 101 form a bayonet type engagement.

[0115] According to an embodiment, the slave assembly 100 comprises at least one robotic manipulator system 105 according to any one of the embodiments described above.

[0116] According to an embodiment, the slave assembly 100 comprises at least one surgical instrument 107 according to any one of the above-mentioned embodiments, and includes a back-end portion 123 and a shaft 121 extending from the back-end portion 123. According to a preferred embodiment, the lateral access opening 116 and the contralateral window 120 of the sterile adapter 101 are opposed to each other with respect to the back-end portion 123 of the surgical instrument 107.

[0117] According to an embodiment, the slave robot assembly 100 for a robotic surgical system 102 comprises the non-sterile robotic manipulator system 105, the sterile surgical instrument 107 having the back end portion 123 and the shaft 121 extending from the back end portion 123, and the sterile adapter 101 suitable for transferring a plurality of linear actuation motions 112 and a rotational motion 160 from the non-sterile robotic manipulator system 105 to the sterile surgical instrument 107. The sterile adapter 101 comprises the frame 103 for transferring the rotational motion 160 from the sterile robotic manipulator system 105 to the sterile surgical instrument 107. The frame 103 has the proximal connector 104 coupled to the non-sterile robotic manipulator system 105 and the distal connector 106 coupled to the sterile surgical instrument 107. The frame 103 defines a through opening between the proximal connector 104 and the distal connector 106. The sterile adapter 101 comprises a membrane 109 fixed to the frame 103 and transmitting a plurality of local linear actuation motions 112 from the non-sterile robotic manipulator 105 to the sterile surgical instrument 107 through its thickness 169. The membrane 109 is elastically stretchable and elastically biased towards its substantially flat configuration. The stretchable membrane 109 seals the through opening forming the distal cavity 132 between the stretchable membrane 109 and the distal connector 106. The distal cavity 132 receives at least a portion of the rear end 123 of a sterile surgical instrument 107. The distal connector 106 has at least one abutment surface 161 facing the stretchable membrane 109, thereby at least partially defining the distal cavity 132. The surgical instrument 107 protrudes against the at least one abutment surface 161.

[0118] According to an embodiment, the geometric center of the membrane 109 is aligned with the shaft 121 of the sterile surgical instrument 107 .

[0119] According to an embodiment, a plurality of localized linear actuation movements 112 are oriented perpendicular to the proximal surface 110 of the membrane 109 .

[0120] According to an embodiment, the sterile adapter 101 rotates together with the sterile surgical instrument 107 .

[0121] According to an embodiment, the non-sterile robotic manipulator system 105 includes a plurality of linear actuators 126, and the membrane 109 is elastically preloaded against its distal end when at least one of the plurality of linear actuators 126 advances distally.

[0122] According to an embodiment, the plurality of localized linear actuation movements 112 are aligned with the shaft 121 of the surgical instrument 107 .

[0123] According to an embodiment, the multiple localized linear actuation movements 112 exert a pressing movement for loading the surgical instrument 107 against the at least one abutment surface 161 .

[0124] According to an embodiment, the sterile adapter 101 is removably coupled to the non-sterile robotic manipulator system 105 and / or the surgical instrument 107 is removably coupled to the sterile adapter 101 .

[0125] According to an embodiment, the slave robot assembly 100 comprises at least a rotary joint 174 that transmits the rotational motion 160 to the surgical instrument 107 by means of the frame 103 of the sterile adapter 101 .

[0126] According to an embodiment, the slave assembly 100 includes at least one sterile drape 144 covering at least a portion of the robotic slave assembly 100 forming a sterile barrier suitable for preventing contamination of surgical instruments 107.

[0127] Advantageously, the sterile drape 144 cooperates with the membrane 109 of the sterile adapter 101 to form a sterile barrier.

[0128] According to a preferred embodiment, the sterile adapter 101 is disposable. According to a preferred embodiment, the sterile adapter 101 is designed to be a single-use sterile adapter 101.

[0129] According to an embodiment, the connector 140 comprises a proximal connection means 142 for connecting the connector 140 to the robotic manipulator system 105 .

[0130] According to an embodiment, the slave assembly 100 includes a protective case 143 that encloses the robotic motorized manipulator system 105 and at least a portion of the connector 140.

[0131] According to an embodiment, the connector 140 includes a proximal flagging device 145 which cooperates with the flagging device 135 of the sterile adapter 101 to flag when the sterile adapter 101 is mated with the non-sterile connector 140. According to an embodiment, the proximal flagging device 145 comprises the abutment portion 139 for the proximal end of the flagging pin 138 of the flagging device 135. According to an embodiment, the proximal flagging device 145 comprises an elastic element 147 which biases the abutment portion 139, e.g. the distal end of the abutment pin 146, distally towards the flagging pin 138 of the flagging device 135 of the sterile adapter 101. Guiding elements, such as walls of a cavity, may be provided to align the flagging pin 138 and the abutment pin 146 along the proximal-distal direction ZZ and to guide their displacement in the proximal-distal direction ZZ.

[0132] According to an embodiment, the elastic element 147 of the connector 140 consists of a leaf spring fixed to a part of the connector 140. According to an embodiment, the elastic element 147 is form-fitted with the abutment pin 146 so as not to slide along the body of the abutment pin 146.

[0133] According to an embodiment, said connector 140 has a substantially annular shape suitable for pivoting about an axis preferably coinciding with said proximal-distal direction ZZ. Thereby, the proximal connecting portion 142 of the connector 140 is suitable for transmitting a rotational movement 160 to the connector 140, and the distal mating device 141 of the connector is suitable for transmitting a rotational movement to the sterile adapter 101 constituting the membrane 109. In this way, the connector 140, the sterile adapter 101 and the surgical instrument 107 can rotate together with respect to the protective case 143. In other words, the connector 140, the sterile adapter 101 and the surgical instrument 107 can swing together with respect to the protective case 143 when actuated by the rotation operating part 127.

[0134] According to an embodiment, the connector 140 has a substantially annular shape that defines an inner cavity 154 suitable for receiving the linear actuator 126 of the robotic manipulator system 105. According to an embodiment, the inner cavity 154 is a through hole extending in a proximal-distal direction ZZ. The shaft 121 of the surgical instrument 107 is thus integral with the back-end portion 123 such that no relative pivoting movement is allowed. Thereby, no motor is required downstream of the membrane 109, allowing a miniaturization of the surgical instrument, in particular the wrist 122.

[0135] According to an embodiment, said internal cavity 154 of the connector 140 is distally delimited by the membrane 109 of the sterile adapter 101. In other words, the housing 132 of the sterile adapter 101 and the internal cavity 154 of the connector 140 are partitioned by the interposition of said elastic membrane 109. Thereby, the linear actuator of the manipulator system 105 and the transmission rod of the back end 123, received in said internal cavity 154 and in said housing, respectively, are able to exchange a pushing action 112 through the body of the elastic membrane 109.

[0136] According to an embodiment, the elastic device 147 of the connector 140 may form part of an anti-rotation system 151 designed to avoid relative rotation between the connector 140 and the sterile adapter 101 during coupling of the sterile adapter 101 to the connector 140.

[0137] According to an embodiment, the anti-rotation system 151 comprises a radial cantilever element 152 that projects radially away from the axis of rotation of the connector 140 and / or the axis of rotation of the adapter 101 so as to abut against a radially inner blocking tooth 153 of the protective case 143. According to an embodiment, a resilient device 147 of the connector 140 biases the radial cantilever element 152 distally.

[0138] When the abutment pin 146 of the connector 140 engages the flagging pin 138 of the sterile adapter 101 and urges the distal pin end 136 of the flagging pin 138 distally, the radial cantilever element 152 of the anti-rotation system 151 moves distally to avoid abutment against the blocking teeth 153, thereby allowing relative pivoting of both the connector 140 and the sterile adapter 101 with respect to the protective case 143 of the slave robot assembly 100.

[0139] By means of pushing the distal pin end 136 of the flag pin 138 in a proximal direction, it is possible to unlock, e.g. unscrew, the sterile adapter 101 from the connector 140. Preferably, an anti-detachment mechanism 176 is provided to prevent unlocking of the sterile adapter 101 from the connector 140 when a surgical instrument 107 is received in said cavity 132 of the sterile adapter 101. Preferably, said anti-detachment mechanism 176 has an abutment surface integral with the distal pin end 136 of the flag pin 138 and facing the cavity 132 of the sterile adapter 101. The abutment surface of the anti-detachment mechanism 176 is suitable to bias against a portion of a surgical instrument thereby preventing the distal end 136 of the flag pin 138 from being pushed proximally. When a surgical instrument is out of cavity 132, flagged pin 138 is free to move distally when pressed against said flagged pin end 136, disengaging the sterile adapter 101 from connector 140. The pin distal end 136 thereby acts as an unlocking button for the sterile adapter 101, and anti-detachment mechanism 176 acts as a safety device preventing removal of the sterile adapter 101 from the robotic slave assembly 100 while a surgical instrument 107 is received within housing 132. Additionally, the abutment surface of anti-detachment mechanism 176 may be provided without being integrally formed with distal pin end 136 of flagged pin 138.

[0140] According to a typical embodiment, a robotic surgical system 102 includes at least one sterile adapter 101 according to any of the embodiments described above.

[0141] The robotic surgical system 102 may also include at least one master console 130 that controls the slave robotic assemblies 100 .

[0142] The robotic surgical system 102 may be configured to include any of the features or combinations thereof described above in connection with the robotic surgical system 102 .

[0143] According to a preferred embodiment, the robotic surgical system 102 comprises at least one slave assembly 100 according to any of the embodiments described above.

[0144] According to a preferred embodiment, the robotic surgical system 102 includes at least a pair of robotic motorized manipulator systems 105 both connected to a single robotic positioning arm link 155 .

[0145] According to a preferred embodiment, the proximal non-sterile surface 110 of membrane 109 of sterile adapter 101 faces the non-sterile robotic manipulator system 105 and the sterile surface 111 of membrane 109 faces the surgical instrument 107 .

[0146] Advantageously, the robotic surgery system 102 comprises at least a rotary joint 174 or a roll joint 174 or a twist joint 174. Preferably, the at least one rotary joint 174 is a twist joint suitable for transmitting the rotational movement 160 by the frame 103 of the sterile adapter 101.

[0147] According to a preferred embodiment, the sterile adapter 101 is integrally connectable to the roll joint 174 for rotating therewith.

[0148] When the sterile adapter 101 rotates to carry the surgical instrument 107, it rotates about an axis zz that is coaxial with the shaft 121 of the surgical instrument 107, i.e., it pivots but does not rotate, forming a roll joint 174 that transmits said rotational motion 160.

[0149] According to a preferred embodiment, the multiple localized pressing actions 112 urge the sterile surgical instrument 107 against the at least one abutment surface 161 of the sterile adapter 101 .

[0150] According to a preferred embodiment, the sterile surgical instrument 107 comprises at least one distal mating abutment surface 162 which abuts against the at least one abutment surface 161 of the sterile adapter 101 .

[0151] According to a preferred embodiment, the robotic surgical system 102 includes an anti-rotation system 151 designed to prevent relative rotation between the connector 140 and the sterile adapter 101 during coupling of the sterile adapter 101 to the connector 140 .

[0152] According to a preferred embodiment, the anti-rotation system 151 has a radial cantilever element 152 that protrudes radially away from the rotation axis of the connector 140 and / or the rotation axis of the adapter 101 to bias against radially inner blocking teeth 153 of the protective case 143 of the robotic surgical system 100.

[0153] According to a preferred embodiment, the robotic surgical system 102 includes at least a surgical instrument 107. The surgical instrument 107 includes an instrument shaft 121 extending substantially along a proximal-distal direction ZZ and having a proximal end 171 and a distal end 172, a surgical end effector 122 at the distal end 172 of the shaft 121, a back end portion 123 connected to the proximal end 171 of the shaft 121, and a counter coupling device 131 located near or adjacent the proximal end 171 of the shaft 121 suitable for forming a snap-fit ​​engagement with the distal coupling device 106 of the sterile adapter 101.

[0154] According to a preferred embodiment, to transmit the pushing motion 112, the proximal surface 110 of the membrane 109 contacts the distal surface of a linear actuator 126 of the robotic manipulator system 105, and as the linear actuator 126 advances distally, the body of the membrane 109 extends so that the distal surface 111 of the membrane 109 contacts the proximal surface of a transmission rod 124 of the back-end portion 123 of the surgical instrument 107.

[0155] According to a preferred embodiment, the counter coupling device 131 is located near or at the proximal end 171 of the shaft 121 of the surgical instrument 107 .

[0156] According to a preferred embodiment, the counterconnector 131 of the surgical instrument 107 has a body with a tapered shape, e.g., a frustoconical shape, to form-fit the size of the distal seat 115. According to a preferred embodiment, the body of the counterconnector 131 tapers towards the distal end 172 of the shaft 121.

[0157] The provision of a tapered body of the mating coupling device 131 of the surgical instrument 107 allows it to shape-fit into the receiving seat 115 of the sterile adapter 101 when the back-end portion 123 of the surgical instrument 107 is pushed distally as a result of the pushing action 112 exerted on the transmission rod 124 of the back-end portion 123.

[0158] According to an embodiment, the surgical instrument 107 comprises an instrument shaft 121 extending substantially along a proximal-distal direction zz and having a proximal end 171 and a distal end 172, a surgical end effector 122 at the distal end of the shaft 121, and a back end portion 123 at or near the proximal end of the shaft 121.

[0159] The shaft 121 preferably extends along a direction that is aligned and preferably coaxial with both the distal opening 115 of the coupling device 106 of the sterile adapter 101 and the opening in the frame 103 of the sterile adapter 101 that is sealed by the membrane 109. In other words, the shaft 121 is designed to pivot or roll about its longitudinal axis of deployment, but not rotate, when the sterile adapter 101 rolls or twists relative to a reference point of the protective case 143 and / or the motorized manipulator system 105 or robotic surgery system 102.

[0160] According to an embodiment, the back-end part 123 is suitable for receiving the pushing movement 112 transmitted through and across the membrane 109. According to an embodiment, the back-end part 123 comprises a plurality of transmission rods 124 or the like suitable for being pushed to activate at least one actuation cable 125 of a surgical instrument, which in turn activates an end effector 122, for example a surgical wrist 122. According to an embodiment, said transmission rods 124 are linearly displaceable.

[0161] According to an embodiment, the back end portion 123 houses the transmission rod 124 and the proximal portion of the actuation cable 125 or tendon 125 .

[0162] According to an embodiment, in order to transmit said multiple local linear displacement movements 112, a proximal non-sterile surface 110 of the membrane 109 contacts a distal portion 168 of a linear actuator 126 of the robotic manipulator system 105, and when the linear actuator 126 advances distally, the body of the membrane 109 stretches such that a distal surface 111 of the membrane 109 contacts a proximal portion 167 of a transmission element 124 of a rear end portion 123 of the surgical instrument 107. According to an embodiment, said linear actuator 126 is suitable for exerting a pushing movement 112.

[0163] According to an embodiment, the robotic manipulator system 105 is part of a slave assembly 100 of the robotic surgical system 102 and is adapted to be controlled by a master console 130 of the robotic surgical system 102 .

[0164] According to an embodiment, the robotic manipulator system 105 comprises a plurality of electric actuators capable of actuating linear actuators 126 for exerting the pushing action 112, and preferably the linear actuators 126 are linearly displaceable along a proximal-distal direction zz.

[0165] According to an embodiment, the robotic manipulator system 105 further comprises a rotary actuator 127 suitable for pivoting the sterile adapter 101 about a rotation axis preferably parallel to and preferably coincident with the proximal-distal direction zz.

[0166] The manner in which the rotational motion 160 and the multiple localized linear displacement actions 112 are transmitted across the sterility barrier is described below.

[0167] The method for transmitting a rotational motion 160 and a plurality of localized linear displacement motions 112 across a sterility barrier includes the following steps.

[0168] Providing a sterile adaptor 101 including a frame 103 and a stretchable membrane 109 secured to the frame 103, wherein the stretchable membrane 109 is part of a sterile barrier.

[0169] Transmitting the rotational movement 160 by a frame 103 of the sterile adapter 101 .

[0170] Transmitting said plurality of localized linear displacement motions 112 by membrane 109 through its thickness 169.

[0171] Preferably, the rotational motion 160 and the plurality of local linear displacement motions 112 are exerted by at least one motorized manipulator system 105. The motor of the at least one motorized manipulator system 105 may be housed in a motor box or motor housing 170, preferably covered by a protective case 143. The motor of the motorized manipulator system 105 is preferably upstream of a sterile adaptor. Distal to the sterile adaptor a surgical instrument may be connected, which may include a shaft having an articulated end effector at or near its distal end including pitch, yaw and grip degrees of freedom, all actuated by a linear displacement motion transmitted through the membrane 109 of the sterile adaptor, which in turn actuates an actuation cable connected to the articulated end effector via the shaft.

[0172] According to a preferred mode of operation, a sterile adapter 101 according to any of the above-mentioned embodiments is designed to carry out the above-mentioned method steps, whereby the method comprises the step of providing a sterile adapter 101 according to any of the above-mentioned embodiments.

[0173] According to a preferred mode of operation, a slave assembly 100 according to any of the above-mentioned embodiments is designed to carry out the above-mentioned method steps, whereby the method comprises the step of providing a slave assembly 100 according to any of the above-mentioned embodiments.

[0174] According to a preferred mode of operation, a robotic surgical system 102 according to any of the above-described embodiments is designed to perform the above-described method steps, whereby the method includes the step of providing a robotic surgical system 102 according to any of the above-described embodiments.

[0175] Thanks to the above features provided together or separately in specific embodiments, it is possible to address the above-mentioned needs providing the above-cited advantages.

[0176] In particular, the transmission of rotational motion and multiple local linear displacement motions can be achieved by a sterile adapter connected to a rotational joint of a robotic surgical system.

[0177] The rotational movement is transmitted by the rigid frame 103 of the sterile adapter.

[0178] A plurality of localized linear displacement motions are transmitted by the stretchable membrane 109 through its thickness 169 .

[0179] The instrument shaft can pivot about its own longitudinal axis of deployment, avoiding the need for a motor on the instrument 107.

[0180] The surgical instrument 107 is removably connectable to the sterile adapter 101 and remains within the sterile surgical field.

[0181] A local linear displacement motion 112 actuates a degree of freedom of an end effector, such as a wrist device, at the distal end of the shaft of the surgical instrument.

[0182] The body of the membrane 109 is uninterrupted and is capable of transmitting multiple localized linear displacement movements 112 .

[0183] The membrane is not suitable for transmitting rotational movements.

[0184] The membrane rotates (ie, rolls) with the adapter frame and, therefore, with the surgical instrument when the rotational motor 127 imparts a rotational motion to the sterile adapter frame.

[0185] The membrane lacks pockets to individually receive each single linear actuator.

[0186] The ratio of "membrane area" to "frame volume" is optimized.

[0187] The sterile adapter offers a compact yet highly functional solution.

[0188] The same membrane transmits at least one pair of agonist and antagonist agonistic actions to the surgical instrument, in other words, the multiple linear actuators can consist of both agonist and antagonist actuators acting on the same membrane.

[0189] The same membrane by being subjected to multiple linear displacement actions generated by multiple linear actuators perpendicular to the proximal and distal surfaces of the membrane will be subjected to slight local deformations with respect to known solutions having separate pockets for receiving each single linear actuator individually, which may lead to a more robust solution.

[0190] The same membrane that accepts multiple linear displacement movements allows for simpler manufacturing and assembly with respect to known solutions.

[0191] The membrane is resiliently preloaded against a distal end of at least one linear actuator, such as a piston, as the linear actuator advances distally for the purpose of transmitting a linear displacement action to a rear end of a surgical instrument housed within the cavity of the sterile adapter.

[0192] The rotation motor 127, which provides the roll degree of freedom for the surgical instrument, is upstream of the linear actuator of the motorized manipulator, causing the linear actuator to rotate or roll together with the sterile adapter.

[0193] The geometric center of the membrane is aligned with the shaft of the surgical instrument.

[0194] The surgical instrument is inserted laterally into the sterile adapter.

[0195] The cavity of the sterile adaptor for receiving the instrument forms a laterally open pouch, said pouch being deformed by a linear displacement action acting perpendicular to the membrane.

[0196] The surgical instrument can be inserted into the sterile adapter after the sterile adapter is connected to the robotic manipulator.

[0197] The sterile adapter defines a portion of the sterile barrier and a seat for the surgical instrument, the seat for the surgical instrument projecting distally from the sterile barrier.

[0198] 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]

[0199] 100 Slave robot assembly or slave assembly 101 Sterile adapter or adapter 102 Robotic Surgery System 103 Sterile adapter frame 104 Proximal connector for sterile adapter 105 Robot manipulator system or electric manipulator system 106 Distal connector for sterile adapter 107 Surgical instruments 108, 108' Long tongue 109 Sterile Adapter Elastic Membrane 110 Proximal non-sterile surface of membrane 111 Distal sterile surface of membrane 112 Localized Linear Displacement Actions 113, 113' End of elongated tongue 114 The base of the long, thin tongue 115 Distal seat of sterile adapter 116 Side access opening 117, 117' Retaining or abutting part of elongated tongue 118 Centering Elements 119 Side abutment wall of distal sheet 120 Second opening of sterile adapter 121 Surgical instrument shafts 122 End effector or wrist of surgical instrument 123 Back end (or back end part) of surgical instruments 124 Back-end transmission element (or rod) 125 Operating cables or tendons of surgical instruments 126 Linear Actuator for Robot Manipulator System 127 Rotational Motor of Electric Manipulator System 128 Engagement direction 129 Annular or circular rim of sterile adapter 130 Master Console of Robotic Surgery System 131 Paired joints of surgical instruments 132 Distal cavity of sterile adapter 133, 133' Side guide surface of sterile adapter 134 Sterile Adapter Skirt 135 Sterile adapter flagging device 136 Distal pin end of flag device 137 Elastic elements of flag devices 138 Flag Pin for Flag Device 139 Flag pin contact part 140 Slave assembly connector or annular connector 141 Distal pair coupling device of connector 142 Proximal connection part of connector 143 Protective case for slave assembly 144 Sterile Drape for Robot Slave Assembly 145 Connector Proximal Flag Device 146 Connector abutment pin 147 Elastic device for connector 148 Sterile Adapter Flagging Pin Housing 149 Flagging Pin Slope Segment 150 removable panels 151 Anti-rotation device 152 Radial cantilever elements of anti-rotation systems 153 Blocking teeth of anti-rotation system 154 Connector Internal Cavity 155 Robot Arm Link 156 Inner edge of annular rim 158 Annular rim protrusion 159 Circular rim outer periphery 160 Rotational Movement 161 Sterile adapter contact surface 162 Opposing contact surfaces of surgical instruments 163 Side facing surface of surgical instrument 164 Distal through opening of distal valve seat 165 Distal outer surface of the frame of the sterile adapter 166, 166' Sterile Adapter Spacer Wall 167 Proximal part of back-end transmission element 168 Distal part of the linear actuator of the manipulator 169 Membrane Thickness 170 Motor box or housing 171 Proximal end of shaft 172 Distal end of shaft 173 Outer edge of membrane 174 Roll Joint of Robotic Surgery System 175 Arched Edge 176 Falling prevention mechanism zz Proximal-distal direction RR radial direction

Claims

1. 1. A sterile adapter (101) for a robotic surgical system (102) suitable for transferring a plurality of linear actuation motions (112) and rotational motions (160) from a non-sterile robotic manipulator system (105) to a sterile surgical instrument (107) having a rear end (123) and a shaft (121) extending from the rear end (123), comprising: a frame (103) for transmitting the rotational motion (160) from the non-sterile robotic manipulator system (105) to the sterile surgical instrument (107), comprising: a proximal connector (104) for coupling with said non-sterile robotic manipulator system (105); a distal connector (106) for coupling with said sterile surgical instrument (107); a frame (103), the frame (103) defining a through opening between the proximal connector (104) and the distal connector (106); a membrane (109) fixed to the frame (103) for transmitting the plurality of linear actuation motions (112) from the non-sterile robotic manipulator system (105) to the sterile surgical instrument (107) through a thickness (169) of the membrane (109). the membrane (109) being elastically stretchable such that it is elastically biased towards a substantially flat configuration; the membrane (109) seals the through opening forming a distal cavity (132) between the membrane (109) and the distal connector (106); the distal cavity (132) is adapted to receive at least a portion of the rear end (123) of the sterile surgical instrument (107); the distal connection device (106) comprises at least one abutment surface (161) facing the membrane (109) and at least partially delimiting the distal cavity (132); A sterile adapter (101), wherein the at least one abutment surface (161) is suitable for a portion of the sterile surgical instrument (107) to abut on the at least one abutment surface (161).

2. the distal cavity (132) includes lateral guide surfaces (133, 133′) adapted to mate with at least one lateral facing surface (163) of the sterile surgical instrument (107); 2. The sterile adapter (101) of claim 1, wherein the side guiding surfaces (133, 133') of the distal cavity (132) of the sterile adapter (101) are substantially flat.

3. A sterile adapter (101) as described in either claim 1 or 2, wherein the distal cavity (132) includes a lateral opening (116) designed for inserting the sterile surgical instrument (107) into the sterile adapter (101).

4. A sterile adapter (101) as described in any of claims 1 to 3, wherein the distal cavity (132) includes a second lateral opening (120) suitable for accessing the distal cavity (132) for the purpose of pushing the sterile surgical instrument (107) out of the distal cavity (132) of the sterile adapter (101).

5. A sterile adapter (101) as described in any one of claims 1 to 4, wherein the membrane (109) is a single flat piece.

6. A sterile adapter (101) as described in any one of claims 1 to 5, wherein the membrane (109) has a disk shape.

7. The distal coupling device (106) defines a distal seat (115) having a distal through opening (164) that opens distally outside the distal cavity (132); A sterile adapter (101) according to any one of claims 1 to 6, wherein the distal through opening (164) is substantially aligned with and coaxial with the through opening sealed by the membrane (109).

8. The at least one abutment surface (161) is below the membrane (109), A sterile adapter (101) as described in any one of claims 1 to 7, wherein the at least one abutment surface (161) faces the membrane (109) and is included in an extension of the distal connection device (106) extending along the proximal-distal direction (z-z) of the membrane (109).

9. A sterile adapter (101) as described in any one of claims 1 to 8, wherein the membrane (109) is integrally attached to the frame (103).

10. A slave robot assembly (100) for a robotic surgical system (102), comprising: A non-sterile robotic manipulator system (105); a sterile surgical instrument (107) having a rear end (123) and a shaft (121) extending from said rear end (123); a sterile adapter (101) adapted to transfer a plurality of linear actuation motions (112) and rotational motions (160) from said non-sterile robotic manipulator system (105) to said sterile surgical instrument (107); the sterile adapter (101) includes a frame (103) that transfers the rotational motion (160) from the non-sterile robotic manipulator system (105) to the sterile surgical instrument (107); the frame (103) comprises a proximal connector (104) coupled to the non-sterile robotic manipulator system (105) and a distal connector (106) coupled to the sterile surgical instrument (107); the frame (103) defines a through opening between the proximal connector (104) and the distal connector (106); The sterile adapter (101) comprises a membrane (109) fixed to the frame (103); the membrane (109) transmits the plurality of linear actuation motions (112) from the non-sterile robotic manipulator system (105) to the sterile surgical instrument (107) through a thickness (169) of the membrane (109); the membrane (109) being elastically biased towards a substantially flat configuration such that the membrane (109) is elastically stretchable; the membrane (109) seals the through opening forming a distal cavity (132) between the membrane (109) and the distal connector (106); the distal cavity (132) receives at least a portion of the rear end (123) of the sterile surgical instrument (107); the distal connector (106) comprises at least one abutment surface (161) facing the membrane (109) and at least partially defining the distal cavity (132); The sterile surgical instrument (107) abuts against the at least one abutment surface (161), of a slave robot assembly (100).

11. A slave robot assembly (100) as described in claim 10, wherein the geometric center of the membrane (109) is aligned with the shaft (121) of the sterile surgical instrument (107).

12. A slave robot assembly (100) as described in claim 10 or 11, wherein the plurality of linear actuation movements (112) are oriented perpendicular to a proximal surface (110) of the membrane (109).

13. The membrane (109) is a single membrane, 13. The slave robot assembly (100) of claim 12, wherein the single membrane is subjected to the multiple linear actuation motions (112) acting on multiple locations of the proximal surface (110) of the single membrane.

14. A slave robot assembly (100) as described in any of claims 10 to 13, wherein the non-sterile robotic manipulator system (105) comprises a plurality of linear actuators (126).

15. A slave robot assembly (100) as described in any of claims 10 to 14, wherein the plurality of linear actuation motions (112) are aligned with the shaft (121) of the sterile surgical instrument (107).

16. A slave robot assembly (100) as described in any of claims 10 to 15, wherein the linear actuation movements (112) of the plurality of linear actuation movements (112) exert a pushing movement such that a load is applied to the sterile surgical instrument (107) against at least one abutment surface (161).

17. A slave robot assembly (100) as described in any of claims 10 to 16, wherein the sterile adapter (101) is removably coupled to the non-sterile robotic manipulator system (105).

18. A slave robot assembly (100) as described in any of claims 10 to 17, wherein the sterile surgical instrument (107) is removably coupled to the sterile adapter (101).

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