Sterile adapters, components, systems, and methods for robotic surgical systems

Abstract

A sterile adapter (101) for a robotic surgical system (102) includes: a frame (103); a proximal coupling device (104) adapted to connect with a non-sterile robotic manipulator system (105); a distal cavity (106) adapted to connect with a surgical instrument (107) for robotic surgery on a patient's anatomy; a membrane (109) having a proximal non-sterile surface (110) and a distal sterile surface (111) opposite to the proximal non-sterile surface (110), the membrane (109) being located between the proximal coupling device (104) and the distal cavity (106), the membrane (109) being stretchable to transmit multiple pushing actions (112) from the proximal non-sterile surface (104) to the distal sterile surface (106), and the frame being rigid to transmit rolling actions.

Description

Technical Field

[0001] One object of the present invention is a sterile adapter for a robotic surgical system.

[0002] In particular, the present invention relates to a sterile adapter suitable for connection to surgical instruments used in robotic surgery.

[0003] The present invention also relates to a robotic surgical system.

[0004] The present invention also relates to a secondary component for a robotic surgical system.

[0005] The present invention also relates to a method. Background Technology

[0006] Robotic surgical devices are generally known in the art and typically include at least one remotely operated robotic arm with a robotic electro-positioning system for moving a surgical end effector attached distally thereto to perform surgical procedures on a patient. In the field of robotic surgery, particularly in microsurgery and laparoscopic surgery, there is a strong need for miniaturization to reduce invasiveness to the patient. Documents WO-2017-064303, WO-2017-064306, WO-2018-189721, and WO-2018-189722, published under the same applicant, disclose various solutions for miniaturizing surgical end effectors by reducing the wrist size of the surgical instrument attached distal to the instrument axis.

[0007] Patients typically lie on an operating table in the operating room, where sterilization is ensured to prevent bacterial contamination from non-sterile parts of the robotic remote control system. A surgical drape is usually placed over the robot to protect the sterile environment from contamination. The need to wrap the robot stems from the fact that such a robot must be used for multiple treatments. The surgical drape may be equipped with inserts, such as rigid plastic plates, to form interfaces for connection to the moving parts of the robot.

[0008] For example, document WO-2011-143024 illustrates a solution for a sterile drape having an annular outer edge rotatably connected to another portion of the drape with reciprocal annular openings, thus forming a two-piece sterile drape. The sterile adapter has an inner frame forming a cross-shaped pattern defining four cloves or slices; each clove receives a bag made of drape material, and each bag has a rigid plate attached distally to it, each plate having a winch for transmitting rotatable actuation from a robot to surgical instruments. Each of these bags includes an additional amount of drape material to allow for expansion of the bags. The document also shows four additional sterile adapters attached distally to the four bags and engaging with the rigid plates of these bags.

[0009] Typically, sterile surgical end effectors (e.g., grippers and / or blades designed to manipulate patients) are attached to the moving part of a robot via a connection interface of a sterile drape, as illustrated in document WO-2016-137611. Therefore, the sterile drape needs to have a connection interface capable of transmitting motion from the robot to the end effector. In the example above, the connection interface is provided with multiple windows to allow direct contact of gears and racks through each of these windows. Furthermore, the sterile drape may also include a securing cord that allows the drape to be tightened to fit snugly against a slender part of the robot (e.g., a slender robot arm), thereby reducing the volume of the drape during use. Examples of establishing a magnetic connection between the robot and the drape are also known.

[0010] The barrier, designed as a connection interface or adapter for transmitting actuation, can also take the form of a foldable truncated conical cuff designed to individually receive a motor piston, and these cuffs can be glued or otherwise secured to the moving parts of the robot, for example, as shown in document WO-2019-006206. However, this known solution does not solve the aforementioned problems and forces the sterile barrier to be glued to the distal face of a non-sterile actuator. For example, when the transmission across the barrier involves lifting machinery or a winch (e.g., designed to wind multiple times to transmit motion), the barrier material may tear or break due to the relative movement of the components required for such transmission. Individually receiving pistons in the bags require each bag to have very high deformability; if the cover material of these bags is not sufficiently deformable or is prone to tearing when it is, it means that the cover material of each bag will break during the retraction of the piston individually housed within it. Furthermore, this known solution describes a sterile adapter with a rectangular box-shaped outer body having a "C" shape to define an internal through-hole defined by the "C"-shaped adapter body itself, so as to receive surgical instruments that must be inserted through the internal through-hole from the proximal side in a direction consistent with the longitudinal extension of the axis of the surgical instrument, thus requiring a further reduction in the available surface area of ​​each bag.

[0011] Document US-2019-0231448 discloses a solution in which three parallel male linear sliders engage with corresponding three parallel female sliders across a removable rubber element to transmit linear displacement action parallel to the free surface of the removable rubber element. The removable rubber element is detachably mounted on the surface of a rigid frame having a circular outer edge, and the surface on which the rubber element is detachably mounted is orthogonal to and spaced apart from the circular outer edge in a distal direction.

[0012] For example, sterile adapters or interfaces can also be found in the following 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, US-9456876, US-10321964, US-2007-064309, US-2009-248039, US-2009-248040, US-20 10-082041, US-2012-289973, US-2015-173840, US-2016-151115, US-2018-325616 and US-2019-053866.

[0013] Document WO-2018-189729, in the name of the same applicant, discloses a sterile barrier solution involving a reinforcing element attached to the sterile barrier to transmit linear actuation across the barrier itself. The surface of the reinforcing element may be hemispherical to ensure single-point contact with a non-sterile actuator. Despite its advantages for several reasons, this solution makes manufacturing and assembly difficult because the actuator, reinforcing element, and actuating element require alignment.

[0014] Therefore, it is believed that there is a need to provide a solution for delivering driving actions across sterile barriers without tearing the barriers.

[0015] There is a need to provide a sterile adapter that allows surgical instruments for robotic surgery to be detachably attached to the manipulator, thereby allowing the removal and replacement of surgical instruments in the sterile surgical area. Summary of the Invention

[0016] The scope of this invention is to overcome the deficiencies mentioned with reference to known techniques.

[0017] These and other scopes are achieved by the sterile adapter of claim 1, the slave robotic assembly of claim 15, the robotic surgical system of claim 27, and the method of claim 29.

[0018] Some preferred embodiments are the subject of the dependent claims.

[0019] According to one aspect of the invention, a sterile adapter for a robotic surgical system is adapted to transfer a plurality of linear actuation actions and a rolling action from a non-sterile robotic manipulator system to a sterile surgical instrument having a rear end and an axis extending from said rear end.

[0020] The sterile adapter can transmit the multiple linear actuation actions and the rolling action without relatively movable parts.

[0021] According to one aspect of the invention, a sterile adapter includes a frame for transferring rolling motion from a non-sterile robotic manipulator system to a sterile surgical instrument. The frame includes a proximal coupling device for coupling with the non-sterile robotic manipulator system and a distal coupling device for coupling with the sterile surgical instrument. The frame defines a through opening between the proximal and distal coupling devices. The frame may be an outer frame of the sterile adapter. The opening may be circular.

[0022] According to one aspect of the invention, the sterile adapter includes a membrane fixed to the frame to seal the through opening, thereby forming a distal cavity between the distal coupling device of the stretchable membrane and the frame.

[0023] According to one aspect of the invention, the membrane is designed to transfer multiple localized linear actuation actions from a non-sterile robotic manipulator across the thickness of the membrane to a sterile surgical instrument.

[0024] According to one aspect of the invention, the membrane is elastically stretchable, such that it is elastically biased toward its generally flat structure.

[0025] According to one aspect of the invention, the distal cavity is adapted to receive at least a portion of the rear end of a sterile surgical instrument, the distal coupling device including at least one abutment surface facing the stretchable membrane and thereby at least partially defining the distal cavity, the at least one abutment surface being adapted to abut a portion of the surgical instrument thereto. For example, in use, the rear end of the surgical instrument abuts against the at least one abutment surface. The at least one abutment surface may be located below the stretchable membrane, for example, below a blocking portion of the membrane. A plurality of local linear actuation actions can apply a pushing action to press the surgical instrument against the at least one abutment surface.

[0026] The distal cavity may include a lateral guiding surface that readily mates with at least one laterally opposing surface of the sterile surgical instrument, and preferably, the lateral guiding surface of the distal cavity of the sterile adapter is substantially flat. The lateral guiding surface is preferably not parallel to the membrane, and more preferably orthogonal to the membrane. The distal cavity may include a lateral opening designed for inserting the sterile surgical instrument into the sterile adapter. Therefore, the insertion direction of the surgical instrument is not parallel to the axis of the surgical instrument, and preferably orthogonal to the axis of the surgical instrument. The distal coupling device may be designed to snap-fit ​​engage with a portion of the surgical instrument, for example, a portion of the rear end and / or a portion of the shaft.

[0027] The distal cavity may include a second lateral opening adapted for access to and from the distal cavity to eject the sterile surgical instrument from the distal cavity of the sterile adapter. Therefore, the disengagement direction of the surgical instrument is not parallel to the axis of the surgical instrument, and preferably orthogonal to the axis of the surgical instrument.

[0028] The membrane can be a single flat sheet. The membrane can be disc-shaped. The membrane can be integrally mounted to the frame so that it does not rotate about the frame. The proximal and distal coupling devices of the frame can be integrated. The proximal and distal coupling devices of the frame can have no relative degrees of freedom. The frame can precisely determine the mutual positioning and orientation of the proximal and distal coupling devices, and preferably also the mutual positioning and orientation of the lateral openings of the distal coupling devices.

[0029] The distal connection device of the frame may define a distal base having a distal through opening that opens distally to the outside of the distal cavity. The distal through opening may be substantially aligned with and coaxial with a through opening sealed by a stretchable membrane.

[0030] A marking device can be configured to mark a sterile adapter when it is connected to a robot manipulator system. The marking device may include a marking pin with a distal marking end that extends cantilevered from the frame body of the sterile adapter when the sterile adapter is connected to the robot manipulator system.

[0031] According to one aspect of the invention, a robotic component for a robotic surgical system includes: a non-sterile robotic manipulator system; a sterile surgical instrument having a rear end and an axis extending from said rear end; and a sterile adapter adapted to transmit a plurality of linear actuation actions and a rolling action from said non-sterile robotic manipulator system to said sterile surgical instrument, wherein the sterile adapter includes a frame that transmits the rolling action from the non-sterile robotic manipulator system to the sterile surgical instrument, and wherein said frame includes a proximal coupling device and a distal coupling device, the proximal coupling device being coupled to the non-sterile robotic manipulator system and the distal coupling device being coupled to the sterile surgical instrument, and wherein said frame is located between the proximal coupling device and the distal coupling device. A through opening is defined between the end coupling devices, and the sterile adapter includes a membrane fixed to the frame that transmits multiple localized linear actuation actions from a non-sterile robotic manipulator across the membrane's thickness to a sterile surgical instrument, and the membrane is elastically stretchable to elastically bias its generally flat configuration, and the stretchable membrane seals the through opening to form a distal cavity between the stretchable membrane and the distal coupling device; and the distal cavity accommodates at least a portion of the rear end of the sterile surgical instrument; and the distal coupling device includes at least one abutting surface facing the stretchable membrane and thereby at least partially defining the distal cavity; and the surgical instrument abuts the at least one abutting surface.

[0032] The surgical instrument can abut against an additional adjacent surface formed by the frame of a sterile adapter, which defines the cavity and faces the membrane.

[0033] The geometric center of the membrane can be aligned with the axis of a sterile surgical instrument.

[0034] Multiple local linear actuation actions can be orthogonally directed to the proximal and distal surfaces of the membrane. Multiple pistons can be arranged in the robotic electric manipulator to apply these local linear actuation actions. The pistons are preferably orthogonal to the membrane extension.

[0035] The sterile adapter can rotate together with the sterile surgical instruments during use; that is, when the rolling motion is transmitted to the frame of the sterile adapter, the sterile adapter and the surgical instruments rotate together.

[0036] A non-sterile robotic manipulator system may include multiple linear actuators, such as the multiple pistons, and a diaphragm may be elastically pre-compressed against the distal end of at least one of the multiple linear actuators as at least one of the linear actuators advances distally. For example, the diaphragm may disengage from the distal end of at least one of the multiple linear actuators when the at least one of the multiple linear actuators retracts. The rear end of the surgical instrument may include multiple linear actuation elements, each aligned with a piston among the multiple pistons.

[0037] Multiple local linear actuation actions can be aligned with the axis of the surgical instrument. Therefore, multiple linear actuators (e.g., the multiple pistons) are aligned with the axis, and multiple transmission elements (e.g., rods) at the rear end are also aligned with the axis.

[0038] The sterile adapter can be detachably connected to the non-sterile robotic manipulator system. Surgical instruments can be detachably connected to the sterile adapter.

[0039] The slave component may include at least one rotary joint that transmits the rolling motion to the surgical instrument via the frame of a sterile adapter. The slave component may also include at least one rolling motor operably connected to the rotary joint.

[0040] A robotic surgical system may include the slave robot component and a main console for controlling the slave robot component.

[0041] According to one aspect of the invention, a method for transmitting a rolling motion and a plurality of local linear displacement motions across a sterile barrier includes: providing a sterile adapter comprising a frame and a stretchable membrane fixed to the frame, the stretchable membrane being part of the sterile barrier; transmitting the rolling motion through the frame of the sterile adapter; and transmitting the plurality of local linear displacement motions through the membrane across its thickness. Each of the steps of transmitting the rolling motion and transmitting the plurality of local linear displacement motions may include transmission to a surgical instrument.

[0042] The stretchable membrane may be a single membrane that receives the plurality of linear displacement actions located at different positions on the proximal surface of the single membrane.

[0043] The multiple local linear displacement actions can be orthogonally directed to the proximal surface of the stretchable membrane. Attached Figure Description

[0044] Further features and advantages of sterile adapters, components, systems, and methods will become apparent from the following description of preferred embodiments, which are given by way of example and not intended to be limiting, with reference to the accompanying drawings, in which:

[0045] - Figure 1 An isometric view of a robotic surgical system according to one embodiment is shown;

[0046] - Figure 1 (II) yes Figure 1 A detailed view showing the two sterile adapters;

[0047] - Figure 2 and Figure 3 An isometric view of a sterile adapter according to one embodiment is shown;

[0048] - Figure 4 A cross-section of a sterile adapter coupled to a robotic manipulator system and surgical instruments according to one embodiment is shown, wherein some portions of the manipulator system are transparent for clarity.

[0049] - Figure 5 A cross-section of a component having a sterile adapter, connector, robotic manipulator system, and surgical instruments is schematically shown according to one embodiment;

[0050] - Figure 6 A side view of a portion of a connector from a component is shown according to one embodiment;

[0051] - Figure 7 An isometric view of a subsidiary component as a plurality of separate parts according to one embodiment is shown;

[0052] - Figure 8 It shows Figure 4 and Figure 5 Bottom view of the sterile adapter;

[0053] - Figure 9 and Figure 10 Axonometric views of a sterile adapter and a portion of a robot manipulator system according to an embodiment are shown in unlocked and locked configurations, respectively.

[0054] - Figure 11 A cross-section of the sterile adapter and connector is shown in a locked configuration;

[0055] - Figure 12 An isometric cross-section of the component according to one embodiment is shown;

[0056] - Figure 13 It shows Figure 12 The bottom view from the component. Detailed Implementation

[0057] According to a general embodiment, a sterile adapter 101 for a robotic surgical system 102 is provided.

[0058] The sterile adapter 101 is adapted to transfer multiple linear displacement actions 112 and a rolling action 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.

[0059] Preferably, the term "surgical instruments" also refers to "medical devices," etc.

[0060] The sterile adapter 101 includes a frame 103 for transferring the rolling motion 160 from the non-sterile robotic manipulator system 105 to the sterile surgical instrument 107. The frame is preferably not suitable for transferring the plurality of linear displacement motions 112.

[0061] Preferably, as used herein, the term "rolling action" refers to the action of actuating the robot rolling joint 174 or the robot torsion joint. Preferably, the sterile adapter 101 is generally attached to a link or body located at a distal end, or serving as an output link for the robot rolling joint or the robot torsion joint. This rolling action is preferably electric, but this does not mean that the sterile adapter 101 actually houses a motor for applying the rolling action 160. According to one embodiment, the term "rolling action" may also include the action of actuating the robot rotary joint. According to one embodiment, the robot manipulator system 105 includes a roll motor 127 for applying the rolling action 106.

[0062] The frame 103 of the sterile adapter 101 includes a proximal coupling device 104 for coupling with a non-sterile robotic manipulator system 105.

[0063] The frame 103 of the sterile adapter 101 includes a remote connection device 106 for connection with a surgical instrument 107.

[0064] The frame 103 defines a through opening between the proximal coupling device 104 and the distal coupling device 106.

[0065] Advantageously, the sterile adapter 101 includes a membrane 109 fixed to the frame 103.

[0066] Another advantage is that the membrane 109 seals the through opening of the frame 103, thereby forming a distal cavity 132 between the sterile membrane 109 and the distal coupling device 106 of the frame 103 of the sterile adapter 101. Therefore, the membrane 109 is located between the proximal coupling device 104 and the distal coupling device 106. The distal cavity 132 thus forms a pouch for receiving surgical instruments 107.

[0067] The membrane 109 is designed to transmit multiple local linear displacement movements 112 from the non-sterile robotic manipulator 105 through the membrane's thickness 169 to the sterile surgical instrument 107.

[0068] According to one embodiment, the membrane 109 has a proximal non-sterile surface 110, a distal sterile surface 111 opposite to the proximal non-sterile surface 110, and a membrane thickness 169 between the proximal non-sterile surface 110 and the distal sterile surface 111 of the membrane 109. Therefore, the distal cavity 132 is located between the distal sterile surface 111 of the membrane 109 and the distal coupling device 106. Preferably, the membrane 109 is a sheet material having a generally two-dimensional extension region and a thickness 169 much smaller than the two-dimensional extension of the sheet material.

[0069] Preferably, the term "linear displacement action" refers to an action that moves an element (e.g., a transmission element) in a linear manner, and preferably, the action causes the element to move along a generally straight path. For example, the linear displacement action is a pushing action. For instance, one or more pistons push a non-sterile surface 110 of a membrane, which in turn transmits the action applied by the one or more pistons through the sterile surface 111 of the membrane to one or more transmission elements, which are aligned in a straight direction with each of the one or more pistons.

[0070] Preferably, the term "multiple local linear displacement actions" means that the non-sterile surface of the membrane is pushed by multiple pistons, and the linear displacement actions are transversely directed towards the sterile surface 111 and the non-sterile surface 110 of the membrane, such that each of the multiple pistons pushes a local area of ​​the non-sterile surface 110 of the membrane.

[0071] The membrane 109 is elastically stretchable to elastically bias its generally flat construction. According to one embodiment, the membrane 109 serves as a sterile drape. According to another embodiment, the membrane is made of a flexible and stretchable sheet of transparent plastic material (e.g., polyethylene).

[0072] The elastic, stretchable membrane allows the transmission of the plurality of local linear displacement actions 112 through the membrane thickness 169 by locally elastically bending the membrane 109. Therefore, the volume of the distal cavity 132 is affected by these plurality of linear displacement actions 112 acting on the proximal surface 110 of the membrane 109. Specifically, the membrane 109 is stretchable, elastically deforming when stretched by the plurality of local linear displacement actions 112, thereby locally altering the volume of the distal cavity 132. Thus, in use, when at least one piston advances and pushes the non-sterile surface 110 of the membrane 109 transversely and preferably orthogonally relative to the non-sterile surface 110 of the membrane 109 to apply the linear displacement action 112, the membrane 109 is elastically pre-compressed against the distal end of at least one of the plurality of pistons. The material and / or geometry of the membrane 109 can be selected to ensure that, in use, the elastic pre-compression of the distal end of at least one of the plurality of pistons is substantially negligible.

[0073] Preferably, the frame 103 is generally rigid and more rigid than the membrane 109 so as not to stretch when the plurality of linear displacement actions 112 are applied to the proximal non-sterile surface 110 of the membrane 109.

[0074] According to a preferred embodiment, the membrane 109 is held taut by the frame 103. According to one embodiment, the outer edge 173 of the membrane 109 is adhered to the frame 103. According to one embodiment, the outer edge 173 of the membrane 109 is clamped to the frame body 103. According to one embodiment, the outer edge 173 of the membrane 109 is threaded to the frame body 103.

[0075] Referring to the accompanying drawings, the proximal-distal direction is typically denoted by zz. According to one embodiment, the radial direction RR is also defined as a direction orthogonal to and intersecting with the proximal-distal direction zz. Multiple linear displacement actions 112 are transmitted along the proximal-distal direction zz.

[0076] According to one embodiment, the volume-blocking portion of the frame 103 of the sterile adapter 101 is contained in a cylindrical geometry, preferably a disc-shaped geometry, the cylindrical geometry having a given radius in the radial direction RR and a predetermined length in the proximal-distal direction ZZ. According to one embodiment, the radial dimension of the frame 103 is maximized near or at the proximal coupling device 104 of the frame.

[0077] According to one embodiment, the pushing action 112 is oriented in a proximal to distal direction, that is, transverse to the membrane and preferably orthogonal to the membrane 109. Therefore, the transmission of rotational action through the membrane 109 is avoided, thereby reducing the risk of wrinkling the membrane 109.

[0078] The stretchable membrane 109 allows multiple local linear displacement actions 112 (preferably multiple local pushing actions 112) to be transmitted across the membrane 109 and through the thickness 169 of the membrane 109 without causing plastic deformation of the membrane 109.

[0079] Therefore, membrane 109 is capable of transmitting multiple local linear displacement actions 112 from the proximal non-sterile surface 110 of membrane 109 to the distal sterile surface 111 of membrane 109. According to one embodiment, membrane 109 is also capable of transmitting multiple local linear displacement actions 112 in the reverse direction from the distal sterile surface 111 of membrane 109 to the proximal non-sterile surface 110 of membrane 109.

[0080] Because of this membrane 109, the stretchable body of the membrane 109 itself serves as a transmission element to transmit the plurality of local linear displacement actions 112 from the non-sterile proximal surface 110 of the membrane 109 to the sterile distal surface 111 of the membrane.

[0081] Conversely, membrane 109 is not suitable for transmitting the rolling motion 160.

[0082] Therefore, the need to provide a rigid insert for the membrane 109 as a transmission element is avoided. The need to provide a rigid plate, blade, and / or device for the membrane 109 capable of transmitting rotational motion is also avoided. The rotational motion can be transmitted by the frame 103 of the sterile adapter 101.

[0083] The provision of such a stretchable membrane 109 allows for local deformation of the membrane 109 in an elastic manner so that at least one linear displacement action 112 is always transmitted through the thickness 169 of the membrane 109.

[0084] The distal connection device 106 includes at least one adjacent surface 161 facing the stretchable membrane 109 and thereby at least partially defining the distal cavity 132.

[0085] The at least one abutting surface 161 is adapted to abut a portion of the surgical instrument 107 thereto. This portion of the surgical instrument 107 that abuts against the at least one abutting surface 161 of the distal connection device 106 of the sterile adapter 101 may be either the rear end 123 of the surgical instrument 107 or the shaft 121 of the surgical instrument 107.

[0086] According to a preferred embodiment, the at least one adjacent surface 161 is located below the stretchable membrane 109. In other words, the at least one adjacent surface 161 is below the blocking portion of the membrane 109. In other words, the at least one adjacent surface 161 of the distal coupling device 106 faces the membrane 109 and is contained within an extension of the blocking portion of the membrane 109 along the proximal-distal direction. Further, in other words, the at least one adjacent surface 161 is under the shadow of the membrane 109.

[0087] According to a preferred embodiment, the frame 103 precisely defines the mutual positioning and orientation of the proximal coupling device 104 and the distal coupling device 106. Preferably, the frame 103 precisely defines the mutual positioning and orientation of the lateral openings 116 of the proximal coupling device 104 and the distal coupling device 106. Preferably, the frame does not include hinges, movable parts, or movable joints.

[0088] According to a preferred embodiment, the sterile adapter 101 includes spacers 166 and 166', preferably two in number and located laterally with respect to the distal cavity 132. The spacers 166 and 166' separate the membrane 109 from the distal coupling device 106 by a predetermined distance, preferably along a proximal-distal direction. The spacers 166 and 166' serve as guide walls to guide the distal end 123 of the surgical instrument 107 into the distal sterile cavity 132.

[0089] According to a preferred embodiment, each spacer wall 166, 166' includes lateral guide surfaces 133, 133' that partially define the distal cavity 132 and are adapted to mate with at least one laterally opposing surface 163 of the sterile surgical instrument 107. Preferably, each of the lateral guide surfaces 133 and 133' of the distal cavity 132 of the sterile adapter 101 is generally flat. Preferably, the at least one laterally opposing surface 163 of the surgical instrument 107 is generally flat.

[0090] According to a preferred embodiment, the distal cavity 132 includes 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 tangential to the proximal-distal direction zz, for example, the lateral access opening opens in the radial direction RR.

[0091] According to a preferred embodiment, the distal cavity 132 includes opposing lateral windows 120 for accessing and exiting the distal cavity 132 to eject the sterile surgical instrument 107 from the distal cavity 132 of the sterile adapter 101. In other words, the sterile distal cavity 132 is open at a lateral access opening 116 or a first lateral opening 116 designed for the surgical instrument 107 or at least a portion of the surgical instrument 107 to access and exit the distal cavity 132, and at an opposing lateral window 120 or a second lateral opening 120 designed to eject the surgical instrument 107 or at least a portion of the surgical instrument 107 from the distal cavity 132, thereby allowing the surgical instrument 107 to exit the cavity 132 through the first opening 116 or the lateral access opening 116. According to one embodiment, the lateral access opening 116 is larger than the opposing lateral window 120. Preferably, both the lateral access opening 116 and the opposing lateral window 120 are defined by the frame 103, and more preferably by the spacer walls 164 and 164' of the frame 103. Preferably, the lateral access opening 116 and the opposing lateral window 120 are opposite to each other with respect to the frame 103, and more preferably with respect to the spacer walls 166 and 166'.

[0092] According to a preferred embodiment, the distal coupling device 106 defines a distal base 115 having a distal through opening 164 that opens distally to the outside of the distal cavity 132. Therefore, the frame 103 of the sterile adapter 101 includes a distal outer surface 165, preferably located distally to the distal end of the distal coupling device 106 and facing opposite to the at least one adjacent surface 161, with the distal through opening opening to the distal outer surface 165.

[0093] According to a preferred embodiment, the distal through opening 164 is substantially aligned with the through opening sealed by the stretchable membrane 109, preferably substantially aligned with the through opening sealed by the stretchable membrane 109 along the proximal-distal direction zz.

[0094] According to one embodiment, the frame 103 defines an annular outer edge 129 or a circular outer edge 129, which forms the outer edge of the membrane 109. According to a preferred embodiment, the annular outer edge 129 holds the membrane 109. Thus, the membrane 109 has a circumference, and preferably, the membrane 109 has a circular body.

[0095] According to a preferred embodiment, the distal through-opening 164 of the sterile adapter 101 has an arched edge 175 having a center of curvature aligned with the geometric center of the outer edge 129 of the stretchable membrane 109. Therefore, the distal through-opening 164 is coaxial with the through-opening of the frame 103 sealed by the stretchable membrane 109.

[0096] According to one embodiment, a lateral abutment wall 119 of the distal coupling device 106, facing the distal base 115, is provided to define the bottom of the distal base 115, and this lateral abutment wall is adapted to form an abutment surface for the surgical instrument 107 or a portion thereof when the surgical instrument 107 is connected to the sterile adapter 101 by being inserted through the lateral access opening 116 into the distal cavity 132. According to one embodiment, a centering and positioning element 118, preferably including a notch, is implemented in or near the lateral abutment wall 119 of the sterile adapter 101. According to one embodiment, the root 113 of at least one elongated tongue 108 extends from the abutment wall 119 of the surgical instrument. The centering and positioning element 118 is configured to operatively connect the surgical instrument 107 to the sterile adapter 101, and the centering and positioning element 118 preferably defines the correct connection of the surgical instrument 107 to the sterile adapter 101, for example, in such a way as to ensure the operational alignment of each linear actuator 126 of the robotic manipulator system 105 with the corresponding drive element 124 of the rear end 123 of the surgical instrument 107.

[0097] In use, the distal connection device 106 of the sterile adapter 101 engages with the opposing connection device 131 of the surgical instrument 107 in a snap-fit ​​manner, such that the elongated tongues 108 and 108' hold the body of the opposing connection device 131 toward the lateral abutment wall 119 of the receiver 115 of the sterile adapter 101.

[0098] When the sterile adapter 101 rotates and carries the surgical instrument 107, the sterile adapter rotates about an axis zz that is coaxial with the axis 121 of the surgical instrument 107, so the surgical instrument pivots but does not rotate.

[0099] According to one embodiment, the membrane 109 is fixed to the annular outer edge 129, which is formed by the frame body 103. According to one embodiment, the circular outer edge 129 includes an inner edge 156 facing the membrane 109 and an outer annular edge. The inner edge 156 may be annular or may have radially inwardly projecting protrusions 158, and the protrusions 158 do not divide the membrane 109 to avoid structural and dynamic discontinuities in the membrane 109. According to one embodiment, the inner edge 156 of the annular outer edge 129 facing the membrane 109 defines a single outer edge boundary line 159. According to one embodiment, the annular outer edge 129 has a constant extension in the radial direction RR.

[0100] According to a preferred embodiment, the membrane 109 is integral, preferably a single flat component or a sheet-like elastic material. In other words, the membrane is manufactured as a single unit. Therefore, the number of components in the sterile adapter 101 is reduced. Furthermore, the risk of partial detachment of the membrane 109 is avoided.

[0101] According to a preferred embodiment, the membrane 109 forms a continuous surface. According to a preferred embodiment, the membrane 109 forms two opposing continuous surfaces 110 and 111. According to one embodiment, the term "continuous surface" means that the structure and dynamic behavior of the membrane 109 are continuous along the entire body of the membrane 109, thereby avoiding the provision of reinforcing portions and / or reinforcing plates, and avoiding the provision of through holes for actuators and / or transmission devices. According to one embodiment, the term "continuous surface" means that the membrane 109 does not include discontinuous portions. For example, the discontinuous portions are holes and / or cuffs. Such discontinuous portions (e.g., cuffs) require a forming process (e.g., thermoforming, etc.) to manufacture, which plastically deforms the membrane 109 during manufacturing to produce the discontinuous portions.

[0102] According to a preferred embodiment, the membrane 109 is located in a plane, preferably in a plane orthogonal to the proximal-distal direction ZZ. According to a preferred embodiment, the membrane 109 forms planar surfaces 110 and 111 and is contained within a volume-blocking portion of the frame body 103 of the sterile adapter 101. According to an embodiment, the membrane 109 extends transversely and / or orthogonally to the proximal-distal direction ZZ. According to an embodiment, the membrane 109 is wrinkle-free. According to an embodiment, the membrane 109 has a constant thickness 169, for example, a thickness between 2 and 6 millimeters. According to an embodiment, the membrane 109 avoids including bags for accommodating actuators and / or transmission devices, etc. According to an embodiment, the membrane 109 avoids including reinforcements for transmitting rotational motion through the membrane 109, such reinforcements including, for example, blades.

[0103] According to a preferred embodiment, the distal connection device 106 of the sterile adapter 101 is designed to snap-fit ​​with a portion of the surgical instrument 107, and preferably snap-fit ​​with the opposite connection portion 131 of the surgical instrument 107.

[0104] According to a preferred embodiment, the distal connection device 106 of the sterile adapter 101 includes at least one elongated, flexible tongue 108, 108' extending as a cantilever, thereby forming an end 113 (preferably a free end 113) and a root 114.

[0105] According to one embodiment, the distal connection device 106 of the sterile adapter 101 includes a distal base 115, which is at least partially defined by the at least one elongated tongue 108, 108', wherein the receiving seat 115 includes a lateral access opening oriented in the same engagement direction 128 as the lateral access opening 116 of the distal cavity 132. According to one 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, thereby forming a snap-fit ​​engagement with the surgical instrument 107.

[0106] According to a preferred embodiment, the two elongated tongues 108 and 108' are configured to define an access opening for entering and exiting the distal base 115 between them, and preferably define the distal base 115.

[0107] According to a preferred embodiment, at least one elongated tongue 108, 108' is generally parallel to the membrane 109. In other words, the at least one elongated tongue 108, 108' extends transversely in the proximal-distal direction.

[0108] According to one embodiment, the at least one elongated tongue 108, 108' (preferably each of the elongated tongues 108 and 108') includes an abutment or retaining portion 117, 117' facing the distal base 115. Since the retaining portions 117, 117' of the elongated tongues 108, 108' are adapted for snap-fit ​​engagement with the surgical instrument 107, a restraining action is provided to restrain the surgical instrument 107 within the distal base 115 and preferably abut against the lateral abutment wall 119. According to one embodiment, the retaining portions 117, 117' of the elongated tongues 108, 108' face the lateral abutment surface 119 of the distal base 115. According to one embodiment, the retaining portions 117, 117' are located on a protrusion projecting inward toward the receiving seat 115, thereby narrowing the access opening 116 approaching the base 115.

[0109] According to one embodiment, the access opening for the surgical instrument 107 in the distal base 115 is open in an engagement direction 128 transverse to the proximal-distal direction zz, such that the surgical instrument 107 can be connected to or disconnected from the sterile adapter 101 by transverse movement along the engagement direction 128. According to one embodiment, the engagement direction is parallel to or coincides with the radial direction RR.

[0110] Therefore, the surgical instrument 107 can be connected to and disconnected from the sterile adapter 101 with transverse displacement movement. In other words, the engagement direction 128 is transverse to the proximal-distal direction. Therefore, the surgical instrument 107 can be separated from the sterile adapter 101 and moved away from the patient's anatomy and / or the operating table. Therefore, the surgical instrument 107 can be connected to the sterile adapter 101 along the transverse engagement direction 128.

[0111] According to one embodiment, the frame body 103 of the sterile adapter 101 defines a distal cavity 132 between the membrane 109 and the distal connection portion 106, the distal cavity being designed to receive at least a portion of the rear end portion 123 of the surgical instrument 107. According to another embodiment, the housing 132 opens from the same side as the access opening of the distal base 115, such that when the opposing connection portion 131 of the surgical instrument 107 is detachably connected to the coupling device 106 of the sterile adapter 101, the rear end portion 123 is received within the distal cavity 132.

[0112] A linear displacement 112 locally applied to the proximal surface 110 of the membrane 109 determines a local stretch of the membrane 109, thereby transmitting this linear displacement 112 through the thickness 169 of the membrane 109 to the rear end 123 of the surgical instrument 107, the rear end of which includes a transmission element 124 (e.g., a lever) aligned with a linear actuator 126 of the robotic electric manipulator system 105.

[0113] According to one embodiment, the frame 103 defines at least one push-top window 120, which is adapted to allow access to a portion of the surgical instrument 107 to push the instrument out of the distal cavity 106 of the sterile adapter 101. This allows for a rapid disengagement action. Consequently, the rear end 123 of the surgical instrument 107 also exits the housing 132. For example, a push-top action 122 of the hand through the push-top window 120 can disengage the surgical instrument 107 in a direction away from the patient's anatomy.

[0114] According to one embodiment, the window 120 is opposite to the access opening 116. According to another embodiment, the window 120 is opposite to the access side of the housing 123.

[0115] According to one embodiment, the proximal coupling device 104 includes a threaded element for screwing the proximal coupling device onto the robot manipulator system 105.

[0116] According to a preferred embodiment, the proximal coupling device 104 defines a circular shape to define an axially symmetrical coupling body.

[0117] The annular outer edge 129 allows the sterile adapter 101 to pivot about an axis (preferably about an axis parallel to the proximal-distal direction ZZ) without tearing or breaking the membrane 109. Tearing or breaking the membrane 109 would cause the surgical instrument 107 to lose its sterility.

[0118] According to one embodiment, the proximal coupling device 104 is designed to form a bayonet-type connection with a portion of the robot manipulator system 105. According to another embodiment, the proximal coupling device 104 includes an undercut element that is ZZ-cut about the proximal-distal direction for coupling with the robot manipulator system 105.

[0119] According to one embodiment, the frame body 103 of the sterile adapter 101 includes a radially enlarged skirt 134 near its proximal end.

[0120] According to one embodiment, the frame 103 of the sterile adapter 101 includes the proximal coupling device 104, the distal coupling device 106, spacer walls 133 and 133' that at least partially define the housing 132, and the window 120 that is radially open in the RR direction at opposite sides of the spacer walls 113 and 113'.

[0121] According to one embodiment, the sterile adapter 101 includes a marking device 135 that marks the sterile adapter 101 when it is coupled to the robot manipulator system 105. According to one embodiment, the marking device 135 includes a marking pin 138 with a distal pin end 136 adapted to cantilever from the frame body 103 of the sterile adapter 101 when it is coupled to the robot manipulator system 105, thereby marking a successful coupling event. According to one embodiment, the marking device 135 includes a resilient device 137 that offsets the marking pin 138 proximally, for example, to offset the distal pin end 136 flush with the distal end of the sterile adapter 101. When the sterile adapter 101 is coupled to the robot manipulator system 105, the marking pin 138 abuts against the adjacent element 139 of the robot manipulator system 105 against the offset action applied by the resilient device 137, thereby causing the distal pin end 136 of the marking pin 138 to protrude distally from the sterile adapter 101. A removable plate 150 may be provided for protecting the marking device 135.

[0122] According to one embodiment, the distal pin end 136 is made as a separate component with respect to the marking pin 138. According to one embodiment, the elastic device 137 of the connector 140 includes an axial spring disposed around the marking pin 138. According to one embodiment, the marking device 135 also includes a marking pin housing 148 that receives at least a portion of the marking pin 138. According to one embodiment, the marking pin housing 148 receiving at least a portion of the marking pin 138 forms a through-hole extending generally along a proximal-distal direction ZZ through a sidewall 133' of the frame body 103 of the sterile adapter 101. An abutment surface may be provided in the marking pin housing 148 to stop displacement of the marking pin 138 by engaging with an opposing abutment surface that may be disposed on the pin 138. For example, the pin 138 may have an extended portion adapted to abut the surface of the housing 148. According to one embodiment, the marking pin 138 includes an inclined section 149 that forms an angle with the proximal-distal direction ZZ and is adapted to abut the surface of the housing 148.

[0123] According to one embodiment, a mechanism is provided to prevent the sterile adapter from being removed from the connector when a surgical instrument is attached to the sterile adapter.

[0124] According to one embodiment, a sterile adapter 101 transmits a plurality of linear actuation actions 112 and a rolling action 160 from a non-sterile robotic manipulator system 105 to a sterile surgical instrument 107 having a rear end portion 123 and a shaft 121 extending from the rear end portion 123. The sterile adapter 101 includes a frame 103 that transmits the rolling action 160 from the non-sterile robotic manipulator system 105 to the sterile surgical instrument 107. The frame 103 includes a proximal coupling device 104 and a distal coupling device 106, the proximal coupling device being coupled to the non-sterile robotic manipulator system 105 and the distal coupling device being coupled to the sterile surgical instrument 107. The frame 103 defines a through opening between the proximal coupling device 104 and the distal coupling device 106. The sterile adapter 101 also includes a membrane 10 fixed to the frame 103. 9. The membrane transmits multiple local linear actuation actions 112 from the non-sterile robotic manipulator 105 through a thickness 169 of the membrane to the sterile surgical instrument 107; and wherein the membrane 109 is elastically stretchable, thereby elastically biasing its generally flat construction; and wherein the stretchable membrane 109 seals the through opening to form a distal cavity 132 between the stretchable membrane 109 and the distal coupling device 106; and wherein the distal cavity 132 accommodates at least a portion of the rear end 123 of the sterile surgical instrument 107; and wherein the distal coupling device 106 includes at least one abutment surface 161 facing the stretchable membrane 109 and thereby at least partially defining the distal cavity 132, the at least one abutment surface 161 being adapted to abut a portion of the surgical instrument 107 thereto, such that the surgical instrument 107 abuts against the at least one abutment surface 161.

[0125] According to one embodiment, the membrane 109 has a disk shape.

[0126] According to one embodiment, the membrane 109 is integrally mounted with the frame 103.

[0127] According to one embodiment, the proximal connection device 104 and the distal connection device 106 of the frame 103 are integrated.

[0128] According to a general embodiment, the slave component 100 for the robotic surgical system 102 includes at least one sterile adapter 101 according to any of the embodiments described above.

[0129] The accessory component 100 includes at least one connector 140, which is coupled to a proximal coupling device 104 of the sterile adapter 101. According to one embodiment, the connector 140 includes a distal opposing coupling device 141 adapted to form a connection with the proximal coupling device 104 of the sterile adapter 101. According to one embodiment, the distal opposing coupling device 141 of the connector 140 forms a bayonet engagement with the proximal coupling portion 104 of the sterile adapter 101.

[0130] According to one embodiment, the slave component 100 includes at least one robot manipulator system 105 according to any of the above embodiments.

[0131] According to one embodiment, the accessory assembly 100 includes at least one surgical instrument 107 according to any of the above embodiments, the surgical instrument including a rear end portion 123 and a shaft 121 extending from the rear end portion 123. According to a preferred embodiment, the lateral access opening 116 of the sterile adapter 101 and the opposing lateral window 120 are opposite each other with respect to the rear end portion 123 of the surgical instrument 107.

[0132] According to one embodiment, the slave robot assembly 100 for a robotic surgical system 102 includes: the non-sterile robotic manipulator system 105; the sterile surgical instrument 107 having the rear end portion 123 and the shaft 121 extending from the rear end portion 123; and the sterile adapter 101 adapted to transmit a plurality of linear actuation actions 112 and rolling actions 160 from the non-sterile robotic manipulator system 105 to the sterile surgical instrument 107; wherein the sterile adapter 101 includes the frame 103, the frame transmitting the rolling actions 160 from the non-sterile robotic manipulator system 105 to the sterile surgical instrument 107, and wherein the frame 103 includes the proximal coupling device 104 and the distal coupling device 106, the proximal coupling device being coupled to the non-sterile robotic manipulator system 105 and the distal coupling device being coupled to the sterile surgical instrument 107; and wherein the frame 103 is in A through opening is defined between the proximal coupling device 106 and the distal coupling device 106; and wherein the sterile adapter 101 includes the membrane 109 fixed to the frame 103, the membrane transmitting a plurality of local linear actuation actions 112 from the non-sterile robotic manipulator 105 through a thickness 169 of the membrane to the sterile surgical instrument 107; and wherein the membrane 109 is elastically stretchable such that it elastically biases towards its generally flat construction; and wherein the stretchable membrane 109 seals the through opening to form the distal cavity 132 between the stretchable membrane 109 and the distal coupling device 106; the distal cavity 132 accommodates at least a portion of the rear end 123 of the sterile surgical instrument 107; the distal coupling device 106 includes at least one abutting surface 161 facing the stretchable membrane 109 and thereby at least partially defining the distal cavity 132; and wherein the surgical instrument 107 abuts against the at least one abutting surface 161.

[0133] According to one embodiment, the geometric center of the membrane 109 is aligned with the axis 121 of the sterile surgical instrument 107.

[0134] According to one embodiment, the plurality of local linear actuation actions 112 are orthogonally directed to the proximal surface 110 of the membrane 109.

[0135] According to one embodiment, the sterile adapter 101 rotates together with the sterile surgical instrument 107.

[0136] According to one embodiment, a non-sterile robotic manipulator system 105 includes a plurality of linear actuators 126, and when at least one of the plurality of linear actuators 126 advances to a distal end, a membrane 109 is elastically pre-compressed against the distal end of the at least one of the plurality of linear actuators 126.

[0137] According to one embodiment, the plurality of local linear actuation actions 112 are aligned with the axis 121 of the surgical instrument 107.

[0138] According to one embodiment, the plurality of local linear actuation actions 112 apply a pushing action to press the surgical instrument 107 against the at least one adjacent surface 161.

[0139] According to one embodiment, the sterile adapter 101 is detachably connected to the non-sterile robotic manipulator system 105, and / or the surgical instrument 107 is detachably connected to the sterile adapter 101.

[0140] According to one embodiment, the robot assembly 100 includes at least one rotary joint 174 that transmits the rolling motion 160 through the frame 103 of the sterile adapter 101 to the surgical instrument 107.

[0141] According to one embodiment, the spin-off assembly 100 includes at least one sterile drape 144 that covers at least a portion of the robotic spin-off assembly 100, thereby forming a sterile barrier suitable for preventing contamination of the surgical instruments 107.

[0142] Advantageously, the sterile cover 144 cooperates with the membrane 109 of the sterile adapter 101 to form a sterile barrier.

[0143] 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.

[0144] According to one embodiment, the connector 140 includes a proximal connection device 142 for connecting the connector 140 to the robot manipulator system 105.

[0145] According to one embodiment, the component 100 includes a protective housing 143 that surrounds at least a portion of the robot electric manipulator system 105 and the connector 140.

[0146] According to one embodiment, the connector 140 includes a proximal marking device 145 that cooperates with a marking device 135 of a sterile adapter 101 for marking when the sterile adapter 101 is connected to a non-sterile connector 140. According to one embodiment, the proximal marking device 145 includes an abutment portion 139 for marking the proximal end of a marking pin 138 of the marking device 135. According to one embodiment, the proximal marking device 145 includes an elastic element 147 that biases the abutment portion 139 (e.g., the distal end of an abutment pin 146) distally toward the marking pin 138 of the marking device 135 of the sterile adapter 101. Guiding elements (e.g., the wall of the cavity) may be provided to align the marking pin 138 and the abutment pin 146 in a proximal-distal ZZ direction and guide their displacement in the proximal-distal ZZ direction.

[0147] According to one embodiment, the elastic element 147 of the connector 140 includes a spring sheet that is fixed to a portion of the connector 140. According to another embodiment, the elastic element 147 is shaped to fit the abutment pin 146 so as not to slide along the body of the abutment pin 146.

[0148] According to one embodiment, the connector 140 has a generally annular shape suitable for pivoting about an axis, which preferably coincides with the proximal-distal direction ZZ. Therefore, the proximal connection 142 of the connector 140 is adapted to transmit rotational action 160 to the connector 140, and the distal relative connection 141 of the connector is adapted to transmit rotational action to the sterile adapter 101 including the membrane 109. Thus, the connector 140, the sterile adapter 101, and the surgical instrument 107 can pivot integrally about the protective housing 143. In other words, the connector 140, the sterile adapter 101, and the surgical instrument 107 can pivot together as a single component about the protective housing 143 when driven by the rotation actuator 127.

[0149] According to one embodiment, the connector 140 has a generally annular shape forming the contour of an inner cavity 154 adapted to accommodate the linear actuator 126 of the robotic manipulator system 105. According to one embodiment, the inner cavity 154 is a through opening extending ZZ in a proximal-distal direction. Therefore, the shaft 121 of the surgical instrument 107 is integral with the rear end portion 123, disallowing relative pivoting movements. Consequently, a motor is not required downstream of the membrane 109, allowing for miniaturization of the surgical instrument, particularly the wrist 122.

[0150] According to one embodiment, the cavity 154 of the connector 140 is defined at its distal end by a membrane 109 of the sterile adapter 101. In other words, the housing 132 of the sterile adapter 101 and the cavity 154 of the connector 140 are separated by the insertion of the stretchable membrane 109. Therefore, the linear actuator of the manipulator system 105, housed in the cavity 154, and the drive rod of the rear end 123, housed in the housing, can exchange actuation 112 via the body of the stretchable membrane 109.

[0151] According to one embodiment, the elastic device 147 of the connector 140 may form part of an anti-rotation system 151 designed to prevent relative rotation between the connector 140 and the sterile adapter 101 during the engagement of the sterile adapter 101 with the connector 140.

[0152] According to one embodiment, the anti-rotation system 151 includes a radial cantilever element 152 that projects radially away from the axis of rotation of the connector 140 and / or adapter 101 to abut against radially inwardly protruding teeth 153 of the protective housing 143. According to one embodiment, an elastic device 147 of the connector 140 biases the radial cantilever element 152 distally.

[0153] When the abutment pin 146 of connector 140 engages the marking pin 138 of sterile adapter 101 to bias the distal pin engagement 136 of the marking pin 136 distally, the radial cantilever element 152 of anti-rotation system 151 moves distally such that the radial cantilever element avoids abutting the block tooth 153, thereby allowing connector 140 and sterile adapter 101 to pivot relative to each other about the protective shell 143 of robot assembly 100.

[0154] The sterile adapter 101 can be unlocked (e.g., unscrewed) from the connector 140 by pressing the distal pin end 136 of the marking pin 138 proximally. Preferably, an anti-removal mechanism 176 is provided to prevent the sterile adapter 101 from being unlocked from the connector 140 when the surgical instrument 107 is received within the cavity 132 of the sterile adapter 101. Preferably, the anti-removal mechanism 176 includes an abutment surface integral with the distal pin end 136 of the marking pin 138 and facing the cavity 132 of the sterile adapter 101, the abutment surface of the anti-removal mechanism 176 being adapted to abut against a portion of the surgical instrument, thereby preventing the distal end 136 of the marking pin 138 from being pressed proximally. When the surgical instrument is removed from the cavity 132, the marking pin 138 moves freely distally when pressed against the marking pin end 136, thereby disengaging the sterile adapter 101 from the connector 140. Therefore, the distal pin 136 acts as an unlocking button for the sterile adapter 101, and the anti-removal mechanism 176 acts as a safety device to prevent the sterile adapter 101 from detaching from the robot and assembly 100 while the surgical instrument 107 is housed within the housing 132. The abutting surface of the anti-removal mechanism 176 may also be configured not to be integrally formed with the distal pin end 136 of the marking pin 138.

[0155] According to a general embodiment, the robotic surgical system 102 includes at least one sterile adapter 101 according to any of the above embodiments.

[0156] The robotic surgical system 102 may also include at least one main control console 130 for controlling the slave robot component 100.

[0157] The robotic surgical system 102 may include any of the features described above or a combination of these features.

[0158] According to a preferred embodiment, the robotic surgical system 102 includes at least one slave component 100 according to any of the above embodiments.

[0159] According to a preferred embodiment, the robotic surgical system 102 includes at least one pair of robotic electric manipulator systems 105, each of which is connected to a single mechanical positioning arm link 155.

[0160] According to a preferred embodiment, the proximal non-sterile surface 110 of the membrane 109 of the sterile adapter 101 faces the non-sterile robotic manipulator system 105, and the sterile surface 111 of the membrane 109 faces the surgical instrument 107.

[0161] Advantageously, the robotic surgical system 102 includes at least a rotary joint 174, a rolling joint 174, or a torsion joint 174. Preferably, the at least one rotary joint 174 is a torsion joint adapted to transmit the rolling motion 160 through the frame 103 of the sterile adapter 101.

[0162] According to a preferred embodiment, the sterile adapter 101 may be integrally connected to the rolling joint 174 so as to rotate with the rolling joint.

[0163] When the sterile adapter 101 rotates and carries the surgical instrument 107, the sterile adapter rotates about an axis zz (which is coaxial with the axis 121 of the surgical instrument 107) to form a rolling joint 174 that transmits the rolling motion 160.

[0164] According to a preferred embodiment, the plurality of local pushing actions 112 push the sterile surgical instrument 107 against the at least one adjacent surface 161 of the sterile adapter 101.

[0165] According to a preferred embodiment, the sterile surgical instrument 107 includes at least one distally adjacent surface 162 that abuts against the at least one adjacent surface 161 of the sterile adapter 101.

[0166] 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 the engagement of the sterile adapter 101 to the connector 140; and / or wherein,

[0167] According to a preferred embodiment, the anti-rotation system 151 includes a radial cantilever element 152 that protrudes radially away from the axis of rotation of the connector 140 and / or adapter 101 to abut against the radially inwardly oriented block teeth 153 of the protective shell 143 of the robotic surgical system 100.

[0168] According to a preferred embodiment, the robotic surgical system 102 further includes at least a surgical instrument 107, which includes an instrument shaft 121, a surgical end effector 122, a rear end portion 123, and a relative coupling device 131; the instrument shaft generally extends ZZ in a proximal-distal direction and has a proximal end 171 and a distal end 172; the surgical end effector is located at the distal end of the shaft 121; the rear end portion is connected to the proximal end 171 of the shaft 121; the relative coupling device is located near or at the proximal end 171 of the shaft 121, and the relative coupling device is adapted to form a snap-fit ​​engagement with the distal coupling device 106 of the sterile adapter 101.

[0169] According to a preferred embodiment, in order to transmit the pushing action 112, the proximal surface 110 of the membrane 109 contacts the distal surface of the linear actuator 126 of the robot manipulator system 105, and as the linear actuator 126 advances distally, the body of the membrane 109 extends such that the distal surface 111 of the membrane 109 contacts the proximal surface of the drive rod 124 of the rear end 123 of the surgical instrument 107.

[0170] According to a preferred embodiment, the relative coupling device 131 is located near or at the proximal end 171 of the shaft 121 of the surgical instrument 107.

[0171] According to a preferred embodiment, the opposing coupling device 131 of the surgical instrument 107 includes a body having a tapered shape, such as a truncated cone, to mate with the size and shape of the distal base 115. According to a preferred embodiment, the body of the opposing coupling device 131 tapers towards the distal end 172 of the shaft 121.

[0172] The tapered body of the relative coupling device 131 of the surgical instrument 107 allows it to mate with the shape of the receiver 115 of the sterile adapter 101 when the rear end 123 is pushed distally by the pushing action 112 applied to the drive rod 124 of the rear end 123 of the surgical instrument 107.

[0173] According to one embodiment, the surgical instrument 107 includes an instrument shaft 121 that generally extends along a proximal-distal direction and has a proximal end 171 and a distal end 172, a surgical end effector 122 at the distal end of the shaft 121, and a rear end portion 123 located at or near the proximal end of the shaft 121.

[0174] Shaft 121 preferably extends in a direction aligned and preferably coaxial with both the distal opening 115 of the coupling device 106 of the sterile adapter 101 and the opening sealed by the membrane 109 of the frame 103 of the sterile adapter 101. In other words, shaft 121 is designed to not rotate, but to pivot or roll about its longitudinally extending axis, when the sterile adapter 101 rolls or twists about a reference point of the protective housing 143 and / or the electric manipulator system 105 or the robotic surgical system 102.

[0175] According to one embodiment, the rear end portion 123 is adapted to receive a pushing action 112 transmitted through and across the membrane 109. According to one embodiment, the rear end portion 123 includes a plurality of drive rods 124, etc., which are adapted to be pushed to actuate at least one drive cable 125 of a surgical instrument, thereby actuating an end effector 122 (e.g., a surgical wrist 122). According to one embodiment, the drive rods 124 are linearly displaceable.

[0176] According to one embodiment, the rear end portion 123 accommodates the proximal end of the drive rod 124 and the drive cable 125 or tendon 125.

[0177] According to one embodiment, in order to transmit the plurality of local linear displacement actions 112, the proximal non-sterile surface 110 of the membrane 109 contacts the distal end 168 of the linear actuator 126 of the robotic manipulator system 105, and as the linear actuator 126 advances distally, the body of the membrane 109 extends such that the distal surface 111 of the membrane 109 contacts the proximal end 167 of the transmission element 124 of the rear end 123 of the surgical instrument 107. According to one embodiment, the linear actuator 126 is adapted to apply the pushing action 112.

[0178] According to one embodiment, the robot manipulator system 105 is part of a slave component 100 of the robotic surgical system 102 and is adapted to be controlled via a main console 130 of the robotic surgical system 102.

[0179] According to one embodiment, the robot manipulator system 105 includes a plurality of electric actuators capable of driving a linear actuator 126 to apply the pushing action 112, and preferably, the linear actuator 126 is capable of linear displacement along a proximal-distal direction.

[0180] According to one embodiment, the robot manipulator system 105 further includes a rotation actuator 127 adapted to pivot the sterile adapter 101 about a rotation axis, which is preferably parallel to and coincides with the proximal-distal direction zz.

[0181] The method for transmitting rolling motion 160 and multiple local linear displacement motions 112 across a sterile barrier will be described below.

[0182] A method for transmitting rolling motion 160 and multiple local linear displacement motions 112 across a sterile barrier includes the following steps:

[0183] - Provides a sterile adapter 101, which includes a frame 103 and a stretchable membrane 109 fixed to the frame 103, the stretchable membrane 109 being part of a sterile barrier;

[0184] - The rolling motion 160 is transmitted through the frame 103 of the sterile adapter 101;

[0185] - The plurality of local linear displacement actions 112 are transmitted through the membrane 109 through its thickness 169.

[0186] Preferably, the rolling motion 160 and the plurality of local linear displacement motions 112 are applied by at least one electric actuator system 105. The motor of the at least one electric actuator system 105 may be housed within a motor housing or motor enclosure 170, which is preferably covered by a protective shell 143. The motor of the electric actuator system 105 is preferably located upstream of the sterile adapter. At the distal end of the sterile adapter, a surgical instrument may be connected, and the surgical instrument may include a shaft having an articulated end effector at or near its distal end, the articulated end effector including pitch, yaw, and gripping degrees of freedom, all driven by linear displacement motion transmitted through a membrane 109 of the sterile adapter, which in turn drives a drive cable connected to the articulated end effector via the shaft.

[0187] According to a preferred operating mode, the sterile adapter 101 according to any embodiment of the above embodiments is designed to perform the above method steps. Therefore, the method includes the step of providing the sterile adapter 101 according to any embodiment of the above embodiments.

[0188] According to a preferred operating mode, the slave component 100 according to any embodiment of the above embodiments is designed to perform the above method steps. Therefore, the method includes the step of providing the slave component 100 according to any embodiment of the above embodiments.

[0189] According to a preferred operating mode, the robotic surgical system 102 according to any embodiment of the above embodiments is designed to perform the above method steps. Therefore, the method includes the step of providing the robotic surgical system 102 according to any embodiment of the above embodiments.

[0190] Because of the features provided either together or separately in a particular embodiment, it is possible to respond to the aforementioned requirements that provide the above advantages, in particular:

[0191] -The transmission of rolling motion and multiple local linear displacement motions can be achieved through a sterile adapter connected to the rotary joint of the robotic surgical system;

[0192] - The rolling motion is transmitted by the rigid frame 103 of the sterile adapter;

[0193] - Multiple local linear displacement actions are transmitted by the stretchable membrane 109 through its thickness 169;

[0194] - The axis of the surgical instrument can pivot about its own longitudinally extending axis, thus avoiding the need to house a motor in the surgical instrument 107.

[0195] - Surgical instrument 107 can be detachably connected to sterile adapter 101 and held within the sterile surgical area;

[0196] - Local linear displacement motion 112 drives the degree of freedom of the end effector (e.g., wrist device) located at the distal end of the axis of the surgical instrument;

[0197] -The main body of the membrane 109 is uninterrupted and capable of transmitting multiple local linear displacement movements 112;

[0198] - Membranes are not suitable for transmitting rolling motion;

[0199] - When the rolling motor 127 produces a rolling motion on the frame of the sterile adapter, the membrane rotates (i.e., rolls) together with the frame of the adapter and with the surgical instruments.

[0200] -The membrane does not have a bag for individually receiving a single linear actuator;

[0201] - The ratio of "membrane area" to "frame volume" has been optimized.

[0202] - Sterile adapters offer a compact yet powerful solution;

[0203] - The same membrane transmits at least one pair of agonist and antagonist muscle drive actions to the surgical instrument; in other words, multiple linear actuators may include agonist and antagonist muscle actuators that both act on the same membrane.

[0204] - The same membrane that receives multiple linear displacement actions orthogonal to the proximal and distal surfaces of the membrane generated by multiple linear actuators is subjected to smaller local deformations relative to known solutions with corresponding bags for individually receiving the respective single linear actuators, which results in a more robust solution.

[0205] - The same membrane that receives multiple linear displacement actions allows for simpler manufacturing and assembly compared to known solutions;

[0206] - As at least one linear actuator (e.g., a piston) advances distally, the membrane is elastically pre-compressed against the distal end of the at least one linear actuator to transmit linear displacement action to the rear end of the surgical instrument housed within the cavity of the sterile adapter;

[0207] - A rolling motor 127, which provides the rolling freedom for surgical instruments, is located upstream of the linear actuator of the electric manipulator, so that the linear actuator rotates or rolls together with the sterile adapter;

[0208] - The geometric center of the membrane is aligned with the axis of the surgical instrument;

[0209] - The surgical instruments are inserted laterally into the sterile adapter;

[0210] - The cavity of the sterile adapter that contains the instrument forms a bag with a side opening, which is deformed by a linear displacement action acting orthogonally to the membrane;

[0211] - After connecting the sterile adapter to the robot manipulator, surgical instruments can be inserted into the sterile adapter;

[0212] - The sterile adapter defines a portion of the sterile barrier and a base for the surgical instrument, wherein the base for the surgical instrument protrudes distally from the sterile barrier.

[0213] Those skilled in the art can make many changes and adjustments to the above embodiments, or replace these elements with other functionally equivalent elements to meet possible needs without departing from the scope of the appended claims.

[0214] List of reference numerals

[0215] 100 From robot components, or from components

[0216] 101 Sterile adapter or adapter

[0217] 102 Robotic Surgical System

[0218] 103 Frame of sterile adapter

[0219] 104 Proximal connection device for sterile adapters

[0220] 105 Robotic manipulator system or electric manipulator system

[0221] 106. Remote connection device for sterile adapters

[0222] 107 Surgical Instruments

[0223] 108, 108' slender tongue

[0224] 109 Stretchable membrane for sterile adapters

[0225] 110 Non-sterile surface of the membrane at the proximal end

[0226] 111. Sterile surface of the distal end of the membrane

[0227] 112 Local linear displacement action

[0228] 113, 113' The tip of the slender tongue

[0229] 114 The base of the slender tongue

[0230] 115 Distal base of sterile adapter

[0231] 116 Lateral entrance / exit opening

[0232] 117, 117' The retaining part or adjacent part of the slender tongue

[0233] 118 Centering element

[0234] 119 Lateral Adjacent Wall of the Distal Base

[0235] 120 Second opening of sterile adapter

[0236] 121. Axis of surgical instruments

[0237] 122 End effector or wrist of surgical instruments

[0238] 123 The rear end or rear tip of a surgical instrument

[0239] 124. Rear-end transmission element or rod

[0240] 125 Drive cables or tendons for surgical instruments

[0241] 126 Linear actuators for robot manipulator systems

[0242] 127 Rolling motor of electric control system

[0243] 128 Joint direction

[0244] 129. The annular or circular outer edge of the sterile adapter

[0245] Main control console of the 130 robotic surgical system

[0246] 131 Relative connection parts of surgical instruments

[0247] 132 Distal cavity of sterile adapter

[0248] 133, 133' Lateral guiding surfaces of the sterile adapter

[0249] 134 Skirt of the sterile adapter

[0250] 135 Marking device for sterile adapters

[0251] 136 Marking pin distal pin connector

[0252] 137 Elastic element of marking device

[0253] 138 Marking pin of marking device

[0254] 139 Adjacent portion of the marking pin

[0255] 140 From the component's connector or ring connector

[0256] 141. Relative coupling device at the distal end of the connector.

[0257] 142 Proximal connection portion of the connector

[0258] 143 From the protective case of the component

[0259] 144 robots remove the sterile cover from the components.

[0260] 145 Proximal marking device for connector

[0261] 146 Adjacent pins of connectors

[0262] 147. Elastic device for connectors

[0263] 148. Marking pin housing for sterile adapter

[0264] 149 Inclined section of the marking pin

[0265] 150 removable board

[0266] 151 Anti-rotation system

[0267] 152 Radial cantilever element of anti-rotation system

[0268] 153 Anti-rotation system block teeth

[0269] 154 The inner cavity of the connector

[0270] 155 robotic arm linkage

[0271] 156 The inner edge of the outer edge of the ring

[0272] 158. Protrusions on the outer edge of the ring

[0273] 159. The perimeter of the outer edge of the ring.

[0274] 160 Scrolling motion

[0275] 161 Adjacent surfaces of sterile adapters

[0276] 162 Adjacent surfaces of surgical instruments

[0277] 163 Lateral opposing surfaces of surgical instruments

[0278] 164. Distal through opening of the distal base

[0279] 165 Distal outer surface of the frame of the sterile adapter

[0280] 166' and 166' are the spacers for the sterile adapters.

[0281] 167. The proximal end of the rear transmission element

[0282] 168 Distal end of robot linear actuator

[0283] 169. Membrane thickness

[0284] 170 Motor housing or motor enclosure

[0285] Proximal end of shaft 171

[0286] 172-axis distal end

[0287] 173 The outer edge of the membrane

[0288] 174 Rolling joints for robotic surgical systems

[0289] 175 Arched edge

[0290] 176 Anti-removal mechanism

[0291] zz Proximal-distal direction

[0292] RR radial

Claims

1. Slave robot assembly (100) for a robotic surgery system (102), comprising: - a non-sterile robot manipulator system (105); - a sterile surgical instrument (107) having a rear end portion (123) and a shaft (121) extending from the rear end portion (123); - a sterile adapter (101) adapted to transfer a plurality of linear actuation motions (112) and a roll motion (160) from the non-sterile robot manipulator system (105) to the sterile surgical instrument (107); wherein the sterile adapter (101) comprises a frame (103) transferring the roll motion (160) from the non-sterile robot manipulator system (105) to the sterile surgical instrument (107), and wherein the frame (103) comprises a proximal coupling device (104) coupled with the non-sterile robot manipulator system (105) and a distal coupling device (106) coupled with the sterile surgical instrument (107); and wherein the frame (103) delimits a through opening between the proximal coupling device (104) and the distal coupling device (106); and wherein the sterile adapter (101) comprises a membrane (109) fixed to the frame (103) transferring the plurality of linear actuation motions (112) from the non-sterile robot manipulator system (105) through a thickness (169) of the membrane to the sterile surgical instrument (107); and wherein the membrane (109) is elastically stretchable so as to be elastically biased towards a substantially flat configuration; and wherein: - the stretchable membrane (109) seals the through opening to form a distal cavity (132) between the stretchable membrane (109) and the distal coupling device (106); - the distal cavity (132) accommodates at least a portion of the rear end portion (123) of the sterile surgical instrument (107); wherein a linear actuation motion of the plurality of linear actuation motions (112) is directed orthogonally to a proximal surface (110) of the membrane (109); - the distal coupling device (106) comprises at least one abutment surface (161) facing the stretchable membrane (109) and at least partially delimiting the distal cavity (132) therefrom; - the sterile surgical instrument (107) abuts the at least one abutment surface (161).

2. The slave robot assembly (100) of claim 1, wherein, A geometric center of the membrane (109) is aligned with the shaft (121) of the sterile surgical instrument (107).

3. The slave robot assembly (100) according to claim 1 or 2, wherein The membrane (109) is a single membrane receiving the plurality of linear actuation motions (112) acting at different locations of the proximal surface (110) of the single membrane.

4. The slave robot assembly (100) according to any one of claims 1 to 3, wherein, The sterile adapter (101) rotates together with the sterile surgical instrument (107).

5. The slave robot assembly (100) according to any one of claims 1 to 4, wherein, The non-sterile robotic manipulator system (105) includes a plurality of linear actuators (126), and the membrane (109) is elastically pre-compressed against a distal end of at least one linear actuator (126) of the plurality of linear actuators (126) when the at least one linear actuator (126) of the plurality of linear actuators (126) is advanced distally.

6. The slave robot assembly (100) according to any one of claims 1 to 5, wherein, The non-sterile robotic manipulator system (105) includes a plurality of linear actuators (126), and the distal end portion (123) of the sterile surgical instrument (107) includes a plurality of stems (124) respectively aligned with the plurality of linear actuators (126).

7. The slave robot assembly (100) according to any one of claims 1 to 6, wherein, The linear actuation action of the plurality of linear actuation actions (112) is aligned with the shaft (121) of the sterile surgical instrument (107).

8. The slave robot assembly (100) according to any one of claims 1 to 7, wherein, The linear actuation action of the plurality of linear actuation actions (112) applies a pushing action to press the sterile surgical instrument (107) against the at least one abutment surface (161).

9. The slave robot assembly (100) according to any one of claims 1 to 8, wherein, The sterile adapter (101) is detachably coupled with the non-sterile robotic manipulator system (105).

10. The slave robot assembly (100) according to any one of claims 1 to 9, comprising at least one rotational joint (174) transmitting the rolling motion (160) through the frame (103) of the sterile adapter (101) to the sterile surgical instrument (107); and wherein, The slave robotic assembly (100) includes at least one rolling motor (127).

11. The slave robot assembly (100) according to any one of claims 1 to 10, wherein, The distal cavity (132) of the sterile adapter (101) includes lateral guide surfaces (133, 133') that are adapted to cooperate with at least one lateral opposite surface (163) of the sterile surgical instrument (107).

12. The slave robot assembly (100) of claim 11, wherein, The lateral guide surfaces (133, 133') of the distal cavity (132) of the sterile adapter (101) are substantially flat.

13. The slave robot assembly (100) according to any one of claims 1 to 12, wherein, The distal cavity (132) of the sterile adapter (101) includes a lateral opening (116) designed for insertion of the sterile surgical instrument (107) into the sterile adapter (101).

14. The slave robot assembly (100) according to any one of claims 1 to 13, wherein, The distal coupling means (106) of the sterile adapter (101) is designed to snap-fit engage with a portion of the sterile surgical instrument (107).

15. The slave robot assembly (100) according to any one of claims 1 to 14, wherein, The distal cavity (132) of the sterile adapter (101) includes a second lateral opening (120) adapted for access to the distal cavity (132) to push the sterile surgical instrument (107) out of the distal cavity (132) of the sterile adapter (101).

16. The slave robot assembly (100) according to any one of claims 1 to 15, wherein, The membrane (109) of the sterile adapter (101) is a single flat piece.

17. The slave robot assembly (100) according to any one of claims 1 to 16, wherein, The distal coupling means (106) of the sterile adapter (101) defines a distal seat (115) having a distal through opening (164) that is distally open to the outside of the distal cavity (132).

18. The slave robot assembly (100) of claim 17, wherein, The distal through opening (164) is substantially aligned with the through opening sealed by the stretchable membrane (109).

19. The slave robot assembly (100) of claim 17, wherein, The distal through opening (164) is coaxial with the through opening sealed by the stretchable membrane (109).

20. The slave robot assembly (100) according to any one of claims 1 to 19, wherein, The at least one abutment surface (161) of the sterile adapter (101) is located underneath the stretchable membrane (109).

21. The slave robot assembly (100) according to any one of claims 1 to 19, wherein, The at least one abutment surface (161) of the sterile adapter (101) is located underneath a blocking portion of the membrane (109).

22. The slave robot assembly (100) according to any one of claims 1 to 21, wherein, The frame (103) of the sterile adapter (101) strictly determines the mutual positioning and orientation of the proximal coupling means (104) and the distal coupling means (106).

23. The slave robot assembly (100) of claim 13, wherein, The frame (103) of the sterile adapter (101) strictly determines the mutual positioning and orientation of the lateral openings (116) of the distal coupling means (106).

24. The slave robot assembly (100) according to any one of claims 1 to 23, the sterile adapter (101) comprising a marker device (135) which is marked when the sterile adapter (101) is coupled to an associable non-sterile robot manipulator system (105); and / or wherein, - the marker device (135) comprises a marker pin (138) comprising a distal marker end which is adapted to cantilever from the frame (103) of the sterile adapter (101) when the sterile adapter (101) is coupled to the non-sterile robot manipulator system (105).

25. The slave robot assembly (100) according to any one of claims 1 to 24, wherein, The membrane (109) of the sterile adapter (101) has a disc shape.

26. The slave robot assembly (100) according to any one of claims 1 to 25, wherein, The membrane (109) of the sterile adapter (101) is integrally mounted with the frame (103).

27. The slave robot assembly (100) according to any one of claims 1 to 26, wherein, The proximal coupling means (104) and the distal coupling means (106) of the frame (103) are integral.

28. A robotic surgical system (102) comprising at least one slave robot assembly (100) according to any one of claims 1 to 27.

29. The robotic surgical system (102) according to claim 28, comprising at least one master console (130) which controls the at least one slave robot assembly (100).

Images