Patent Description:
<FIG> illustrates a typical surgical instrument <NUM> for performing robotic laparoscopic surgery. The surgical instrument comprises a base <NUM> by means of which the surgical instrument connects to the robot arm. A shaft <NUM> extends between the base <NUM> and an articulation <NUM>. The articulation <NUM> terminates in an end effector <NUM>. In <FIG>, a pair of serrated jaws are illustrated as the end effector <NUM>. The articulation <NUM> permits the end effector <NUM> to move relative to the shaft <NUM>. It is desirable for at least two degrees of freedom to be provided to the motion of the end effector <NUM> by means of the articulation.

A surgeon utilises many instruments during the course of a typical laparoscopy operation. For this reason, it is desirable for the instruments to be detachable from and attachable to the end of the robot arm with an ease and speed which enables instruments to be exchanged mid-operation. It is therefore desirable to minimise the time taken and maximise the ease with which one instrument is detached from a robot arm and a different instrument is attached.

The operating theatre is a sterile environment. Surgical instruments are sterilised prior to use in an operation. It is desirable that the robot arm is shrouded with a sterile drape so as to avoid the need to sterilise it prior to use. Existing sterile drapes can be cumbersome to use and can take a long time to apply over the robot arm. There is a need for an improved mechanism for applying a sterile drape over a robot arm.

<CIT> describes a surgical drape and a suction head for wound treatment. The drape has an aperture for permitting access to the wound area. The drape comprises a strengthening layer <NUM> and a flexible layer <NUM>. The flexible layer has an adhesive-coated layer, covered by a release layer. The release layer is in at least two sections.

<CIT> describes a drape sheet, with a window to expose the operative area. The drape has a fibrous base sheet and a fluid-impervious plastics film secured to the base sheet. <CIT>, <CIT> and <CIT> refer to further prior art documents relevant for the present invention.

According to the present invention, there is provided a surgical drape assembly as claimed in claim <NUM>.

Suitably the packaging insert comprises an engagement portion releasably engageable with the drape. Suitably the retention portion comprises at least one of a recess, an aperture and a protruding portion.

Suitably the retention portion comprises an aperture in the body, the aperture comprising a first edge, and the first edge being configured to retain the drive transfer element in the desired position. Suitably the aperture comprises a second edge opposing the first edge, the first edge and the second edge being spaced apart so as to be frictionally engageable with opposing sides of the drive transfer element.

Suitably the drape comprises three drive transfer elements, and the packaging insert comprises three apertures in the body, each aperture being configured to receive a respective one of the drive transfer elements therethrough and comprising a respective edge configured to retain the respective drive transfer element in the desired position.

Suitably the packaging insert comprises a handle.

Suitably the engagement portion is provided on an underside of the body. Suitably the engagement portion comprises a lip engageable with a drape lip provided on the drape. Suitably the engagement portion comprises a plurality of lips for engagement with a respective one of a plurality of drape lips provided on the drape.

Suitably the packaging insert comprises a deformable portion configured to deform so as to move at least one lip from a position in which the lip is engaged with a respective drape lip to a position in which the lip is disengaged from the respective drape lip. Suitably the packaging insert comprises a deformable portion corresponding to each lip, the deformable portion being configured to deform so as to move the respective lip from a position in which the lip is engaged with a respective drape lip to a position in which the lip is disengaged from the respective drape lip.

Suitably the engagement portion comprises an adhesive portion which is releasably adherable to the drape.

Suitably the packaging insert comprises a side portion, the engagement portion being provided on the side portion. Suitably the packaging insert comprises two side portions, one to either side of the body, the packaging insert comprising two engagement portions, one engagement portion being provided on each of the side portions.

Suitably the engagement portion comprises a protrusion configured to protrude into a corresponding recess on the drape, the protrusion being sized to engage with the recess in an interference fit so as to frictionally engage therewith.

Suitably the engagement portion is configured to engage with the drape with a weaker engagement than an engagement between the drape and the robot arm such that the drape is preferentially retained on the robot arm.

Suitably the packaging insert is formed from a single piece of material by at least one of stamping and bending. Suitably the packaging insert comprises a rigid and/or a semi-rigid material.

Suitably the packaging insert is configured to be packaged together with the drape.

Suitably the drape comprises reinforcement portions.

The mention of features in this Summary does not indicate that they are key features or essential features of the invention or of the claimed subject matter, nor is it to be taken as limiting the scope of the claimed subject matter.

<FIG> illustrates a surgical robot having an arm <NUM> which extends from a base <NUM>. The arm comprises a number of rigid limbs <NUM>. The limbs are coupled by revolute joints <NUM>. The most proximal limb 302a is coupled to the base by a proximal joint 303a. It and the other limbs are coupled in series by further ones of the joints <NUM>. Suitably, a wrist <NUM> is made up of four individual revolute joints. The wrist <NUM> couples one limb (302b) to the most distal limb (302c) of the arm. The most distal limb 302c carries an attachment <NUM> for a surgical instrument <NUM>. Each joint <NUM> of the arm has one or more motors <NUM> which can be operated to cause rotational motion at the respective joint, and one or more position and/or torque sensors <NUM> which provide information regarding the current configuration and/or load at that joint. Suitably, the motors are arranged proximally of the joints whose motion they drive, so as to improve weight distribution. For clarity, only some of the motors and sensors are shown in <FIG>. The arm may be generally as described in our co-pending patent application <CIT>.

The arm terminates in the attachment <NUM> for interfacing with the instrument <NUM>. Suitably, the instrument <NUM> takes the form described with respect to <FIG>. The instrument has a diameter less than <NUM>. Suitably, the instrument has a <NUM> diameter. The instrument may have a diameter which is less than <NUM>. The instrument diameter may be the diameter of the shaft. The instrument diameter may be the diameter of the profile of the articulation. Suitably, the diameter of the profile of the articulation matches or is narrower than the diameter of the shaft. The attachment <NUM> comprises a drive assembly for driving articulation of the instrument. Movable interface elements of the drive assembly interface mechanically engage corresponding movable interface elements of the instrument interface in order to transfer drive from the robot arm to the instrument. One instrument is exchanged for another several times during a typical operation. Thus, the instrument is attachable to and detachable from the robot arm during the operation. Features of the drive assembly interface and the instrument interface aid their alignment when brought into engagement with each other, so as to reduce the accuracy with which they need to be aligned by the user.

The instrument <NUM> comprises an end effector for performing an operation. The end effector may take any suitable form. For example, the end effector may be smooth jaws, serrated jaws, a gripper, a pair of shears, a needle for suturing, a camera, a laser, a knife, a stapler, a cauteriser, a suctioner. As described with respect to <FIG>, the instrument comprises an articulation between the instrument shaft and the end effector. The articulation comprises several joints which permit the end effector to move relative to the shaft of the instrument. The joints in the articulation are actuated by driving elements, such as cables. These driving elements are secured at the other end of the instrument shaft to the interface elements of the instrument interface. Thus, the robot arm transfers drive to the end effector as follows: movement of a drive assembly interface element moves an instrument interface element which moves a driving element which moves a joint of the articulation which moves the end effector.

Controllers for the motors, torque sensors and encoders are distributed within the robot arm. The controllers are connected via a communication bus to a control unit <NUM>. The control unit <NUM> comprises a processor <NUM> and a memory <NUM>. The memory <NUM> stores in a non-transient way software that is executable by the processor to control the operation of the motors <NUM> to cause the arm <NUM> to operate in the manner described herein. In particular, the software can control the processor <NUM> to cause the motors (for example via distributed controllers) to drive in dependence on inputs from the sensors <NUM> and from a surgeon command interface <NUM>. The control unit <NUM> is coupled to the motors <NUM> for driving them in accordance with outputs generated by execution of the software. The control unit <NUM> is coupled to the sensors <NUM> for receiving sensed input from the sensors, and to the command interface <NUM> for receiving input from it. The respective couplings may, for example, each be electrical or optical cables, or may be provided by a wireless connection. The command interface <NUM> comprises one or more input devices whereby a user can request motion of the end effector in a desired way. The input devices could, for example, be manually operable mechanical input devices such as control handles or joysticks, or contactless input devices such as optical gesture sensors. The software stored in the memory <NUM> is configured to respond to those inputs and cause the joints of the arm and instrument to move accordingly, in compliance with a pre-determined control strategy. The control strategy may include safety features which moderate the motion of the arm and instrument in response to command inputs. Thus, in summary, a surgeon at the command interface <NUM> can control the instrument <NUM> to move in such a way as to perform a desired surgical procedure. The control unit <NUM> and/or the command interface <NUM> may be remote from the arm <NUM>.

<FIG> and <FIG> illustrate an exemplary mechanical interconnection of the drive assembly interface and the instrument interface in order to transfer drive from the robot arm to the instrument. <FIG> illustrates the instrument mounted to the drive assembly. <FIG> illustrates an exemplary drive assembly interface <NUM> at the end of a robot arm <NUM>. The drive assembly interface <NUM> comprises a plurality of drive assembly interface elements <NUM>, <NUM>, <NUM>. <FIG> illustrates three drive assembly interface elements. In other examples, there may be greater than or fewer than three drive assembly interface elements. The drive assembly interface elements <NUM>, <NUM>, <NUM> are movable within the drive assembly interface <NUM> along linear paths <NUM>, <NUM>, <NUM>. In the illustrated example, the linear paths <NUM>, <NUM>, <NUM> are disposed on two parallel planes. The central linear path <NUM> is disposed on a plane <NUM> set into the drive assembly interface <NUM> compared to that in which the outer two linear paths <NUM>, <NUM> are disposed. In other implementations, the three linear paths <NUM>, <NUM>, <NUM> can be disposed on the same plane, or all on different planes.

During an operation or surgical procedure, the surgical robot is shrouded in a sterile drape to provide a sterile barrier between the non-sterile surgical robot and the sterile operating environment. The surgical instrument is sterilised before being attached to the surgical robot. The sterile drape is typically constructed of a plastic sheet, for example made of polyester, polypropylene, polyethylene or polytetrafluoroethylene (PTFE). Suitably, the drape is flexible and/or deformable. It is desirable for the sterile drape to be easily and quickly placed in position over the robot arm. It is also desirable for the drape to be easily engageable with the robot arm to effectively interface with the robot arm. This can help reduce time taken in preparing the robot arm for surgery. Using such a drape on the robot arm can mean that the patient is not exposed to the non-sterile surgical robot arm. When exchanging instruments mid-operation, it is desirable for the sterile barrier to be maintained.

The sterile drape does not pass directly between the drive assembly interface <NUM> and the instrument interface <NUM>. The drape comprises an interface structure <NUM> for interfacing between the drive assembly interface <NUM> and the instrument interface <NUM>. <FIG> show an exemplary interface structure <NUM> in isolation. The interface structure <NUM> is also shown in <FIG> attached to the drive assembly interface <NUM> and to the instrument interface <NUM>. The interface structure <NUM> may be integrally formed with the drape. Alternatively, the interface structure <NUM> may be formed separately from the drape and subsequently attached to the drape. Either way, the interface structure <NUM> is sterile. One side <NUM> of the interface structure <NUM> directly contacts the drive assembly interface. The other side <NUM> of the interface structure <NUM> directly contacts the instrument interface. Thus, the interface structure <NUM> prevents the non-sterile drive assembly interface from directly touching the sterile instrument interface and hence maintains the sterile barrier between the two components.

The interface structure <NUM> comprises a main body <NUM> and drive transfer elements <NUM>, <NUM>, <NUM>. The drive transfer elements are movable relative to the main body. The drive transfer elements are movable along linear paths. Conveniently, when the interface structure <NUM> is attached to the surgical robot arm, the main body <NUM> lies parallel to the surface(s) of the drive assembly interface <NUM>. Suitably in this attached configuration, the main body <NUM> is aligned with the drive assembly interface.

As mentioned above, the interface structure <NUM> comprises drive transfer elements. In the example illustrated in <FIG>, the interface structure comprises three drive transfer elements: a first drive transfer element <NUM>, a second drive transfer element <NUM> and a third drive transfer element <NUM>. The first drive transfer element <NUM> is slidably received in a first slot <NUM>. The second drive transfer element <NUM> is slidably received in a second slot <NUM>. The third drive transfer element <NUM> is slidably received in a third slot <NUM>. Each drive transfer element is slidably movable along its respective slot.

A central portion <NUM> of the first drive transfer element <NUM> comprises a protrusion to the second side <NUM> of the interface structure <NUM>. As can be seen from <FIG>, each of the drive transfer elements comprises a central portion which comprises a protrusion to the second side <NUM> of the interface structure <NUM>. In this example, the central portions of the drive transfer elements comprise recesses to the first side <NUM> of the interface structure <NUM> (visible in <FIG>) for engagement with the fins of the respective drive assembly interface elements.

In other examples, the central portions of the drive transfer elements can be arranged the other way round. In other words, recesses can be provided towards the second side and protrusions can be provided towards the first side. Alternatively, any combination of protrusions and recesses can be provided. This can include one drive transfer element comprising either both a protrusion towards the first side and a protrusion towards the second side, or a recess towards the first side and a recess towards the second side. The configuration adopted will suitably match that of the drive assembly interface <NUM> and the instrument interface <NUM>. In other words, where a drive assembly interface element comprises a protruding fin, the central portion of the respective drive transfer element towards the first side will comprise a recess for receiving the fin. Where the drive assembly interface element comprises a recess, the central portion of the respective drive transfer element towards the first side will comprise a protrusion for engaging with the recess. Similarly, where the instrument interface element comprises a protruding fin, the central portion of the respective drive transfer element towards the second side will comprise a recess for receiving the fin. Where the instrument interface element comprises a recess, the central portion of the respective drive transfer element towards the second side will comprise a protrusion for engaging with the recess.

Generally, each drive transfer element comprises a first portion and a second portion. The central portion suitably comprises the first portion and the second portion. The first portion is engageable with the robot arm. For example, the first portion is engageable with the drive assembly interface, such as being engageable with a drive assembly interface element. The second portion is engageable with the instrument. For example, the second portion is engageable with the instrument interface, such as being engageable with an instrument interface element.

To put it another way, at least one of the first portion and the second portion can be a drive transfer element recess, or a recess in the drive transfer element. At least one of the first portion and the second portion can be a drive transfer element protrusion, or a protruding portion of the drive transfer element. Preferably, the drive transfer element comprises both a drive transfer element recess and a drive transfer element protrusion.

The drive transfer element recess is engageable with an interface protrusion, such as a protrusion on a drive assembly interface element or on an instrument interface element. The drive transfer element protrusion is engageable with an interface recess, such as a recess in a drive assembly interface element or in an instrument interface element.

The interface structure comprises a first fastener <NUM> for retaining the interface structure <NUM> on the robot arm when the interface structure is mounted, or attached, to the robot arm. The drive assembly interface <NUM> comprises a retention lip <NUM>. The first fastener <NUM> is engageable with the retention lip <NUM>. The first fastener <NUM> comprises a ridge <NUM>. During attachment of the interface structure <NUM> to the drive assembly <NUM>, the ridge <NUM> passes over the retention lip <NUM>. The first fastener is resilient to permit flexing so that the ridge <NUM> can pass over the retention lip <NUM>. Once the first fastener has passed the retention lip, a flat portion <NUM> at the rear of the first fastener (in the direction of attachment) abuts a front portion of the retention lip (again, in the direction of attachment) and resists movement of the interface structure <NUM> in a direction away from the robot arm along the longitudinal axis <NUM> of the distal end <NUM> of the arm. In this way, the interface structure <NUM> is retained in position attached to the drive assembly interface <NUM>. To remove the interface structure <NUM> from the robot arm, the first fastener can be released. The first fastener <NUM> is releasable by resiliently deforming the first fastener so as to lift the ridge <NUM> over the retention lip <NUM>. In the example illustrated in <FIG>, the first fastener comprises a tab <NUM>. The tab <NUM> permits a user to lift the first fastener so as to disengage the ridge <NUM> from the retention lip <NUM>. The tab <NUM> need not be provided in all examples. The engagement of the first fastener with the retention lip can provide tactile feedback that the interface structure is correctly or properly attached to the robot arm.

Additional retention features are provided on an edge <NUM> of the interface structure <NUM> in the illustrated example. As illustrated in <FIG>, one edge <NUM> of the interface structure comprises on an internal face thereof two lugs <NUM>, <NUM>. The lugs <NUM>, <NUM> protrude inwardly from the internal face of the edge <NUM> of the interface structure <NUM>. Cooperating retention features are provided on an outer edge of the drive assembly interface <NUM>. Two passages <NUM>, <NUM> are provided on the outer edge of the drive assembly interface <NUM> which communicate with a retention channel <NUM>. In the illustrated example a common retention channel communicates with both passages, but this need not be the case. In alternatives, each passage can communicate with a respective retention channel. The passages <NUM>, <NUM> and the retention channel <NUM> are formed as recesses in the outer edge of the drive assembly interface <NUM>.

As the interface structure <NUM> is mounted to the drive assembly interface <NUM>, the lugs <NUM>, <NUM> will pass through the passages <NUM>, <NUM> and into the retention channel <NUM>. The interface structure <NUM> can be moved along the longitudinal axis <NUM> of the distal end of the arm <NUM>. The retention channel <NUM> is parallel to the longitudinal axis <NUM> of the distal end of the arm. The movement of the interface structure in this direction (i.e. parallel to the longitudinal axis <NUM>) moves the lugs along the retention channel <NUM> away from the openings to the passages <NUM>, <NUM>. At the same time, the first fastener <NUM> is moved to engage with the retention lip <NUM>. When the lugs <NUM>, <NUM> are moved away from the openings to the passages <NUM>, <NUM>, the interface structure will be restricted to move along the longitudinal axis <NUM> of the arm <NUM>. The lugs <NUM>, <NUM> will abut an upper edge <NUM> of the retention channel <NUM> to restrict movement of the interface structure <NUM> away from the drive assembly interface <NUM> in a direction transverse to the longitudinal axis <NUM>. In other words, the engagement of the lugs in the retention channel will prevent or restrict the interface structure from being lifted off the drive assembly.

As can be seen from <FIG>, in this example the lugs <NUM>, <NUM> comprise an upright portion <NUM>, <NUM>. As the interface structure is moved along the longitudinal axis <NUM> of the distal end of the arm <NUM> so as to engage the lugs in the retention channel <NUM>, the front face of the upright portions <NUM>, <NUM> will move into abutment with faces <NUM>, <NUM> adjacent the passages <NUM>, <NUM>. This abutment between the upright portions <NUM>, <NUM> and the faces <NUM>, <NUM> serves to limit the movement of the interface structure, and provides tactile feedback that the limit of travel has been reached. The upright portions <NUM>, <NUM> need not be provided in every example.

Thus this combination of retention features of the interface structure <NUM>, i.e. the first fastener <NUM> and the lugs <NUM>, <NUM>, restricts the removal of the interface structure <NUM> from the robot arm.

In one example, prior to attaching the interface structure to the drive assembly interface, the drive assembly interface elements are driven to a desired position, such as an interfacing position. Suitably the interfacing position, or the desired position, is for engaging the drive assembly interface elements with respective drive transfer elements and/or respective instrument interface elements. This desired position is suitably with the drive assembly interface elements at one end of their respective travel, for instance towards the end of the drive assembly interface away from the proximal end of the robot arm. The interface structure can be arranged so that the drive transfer elements are correspondingly at cooperating positions within their respective travel, for instance with one of the drive transfer elements (suitably the drive transfer element with the shortest extent of travel) being at one end of its respective travel. In this way, the engagement of the drive transfer elements with the drive assembly interface elements is reliably effected. This method of engagement can be done without needing to drive or otherwise move the drive transfer elements and/or the drive assembly interface elements back and forth to effect engagement.

Engaging the interface structure with the drive assembly in this way can mean that the main body of the interface structure is then able to move relative to the drive assembly interface by up to the full travel of the drive transfer element with the shortest travel.

The surgical drape is packaged in a sterile package prior to being used. The drape can be packaged together with a packaging insert, examples of which are schematically shown in <FIG>. The packaging insert is packaged with the drape in a way so as to be engaged with the drape, for example by being engaged with the interface structure. The packaging insert provides a convenient way of holding and/or manipulating the drape in general, and the interface structure in particular, as the drape is engaged with the robot arm.

Once the drape has been engaged with the robot arm, the packaging insert can be removed from the drape. In the illustrated examples the packaging insert is disposable, and once removed from the drape it can be discarded. One method of using the packaging insert is as follows. The packaging insert is packaged together with the drape. When the drape packaging is opened, a user can hold the packaging insert and use it to position the interface structure of the drape onto the drive assembly interface of the robot arm. If appropriate, the packaging insert can be used to apply pressure to engage the interface structure with the drive assembly interface, for example by engaging one or more drive transfer elements with corresponding ones of drive assembly interface elements. The packaging insert could then be removed from the interface structure and discarded. The drive transfer elements which had been retained by the packaging insert, as will be described below, will then be free to move. The interface structure could then be moved along the drive assembly interface, for example towards a distal end of the arm, to cause engagement of the interface structure with the drive assembly interface. The remainder of the drape could then be applied to the robot arm, as discussed below.

Where the portion of the drape for positioning between the drive assembly interface and the instrument interface is a flexible and/or a compliant portion, the packaging insert can guide the flexible or compliant portion into engagement with the drive assembly interface. For example, where the drive assembly interface element comprises a cup or recess, the packaging insert can guide the flexible or compliant portion of the drape so as to sit within the cup or recess. The packaging insert can provide sufficient material of the drape so that adjacent drive assembly interface elements can move relative to one another without thereby tearing or ripping the material of the drape. The packaging insert suitably comprises a protruding portion around which the flexible or compliant portion sits, and which guides the flexible or compliant portion into the cup or recess.

The packaging insert <NUM> comprises a body <NUM> and an engagement portion <NUM> which is releasably engageable with the drape, for example by being releasably engageable with the interface structure. In the illustrated example the packaging insert comprises a second engagement portion <NUM>. In other examples one or more engagement portion can be provided. The provision of the engagement portion is not necessary in all examples. The engagement portion can cause a portion of the drape, for example the interface structure, to remain fast with the packaging insert when engaged thereto. The engagement between the packaging insert and the drape permits the drape to be manipulated by manipulation of the packaging insert. Suitably the engagement portion is engaged with the drape when the drape is in its sterile package. Thus, on opening the sterile package, a user can hold the packaging insert and can straightforwardly use it to position the drape on the robot arm.

Suitably the packaging insert <NUM> comprises a handle <NUM> for permitting a user to more easily hold and/or manipulate the packaging insert. In the example illustrated in <FIG>, the handle <NUM> is in the form of a tab. The tab is provided adjacent the body <NUM>. Suitably the handle may comprise a raised portion, permitting a user to hold the packaging insert without needing to touch the drape itself. This can assist in retaining the sterility of the drape as it is positioned on the robot arm. The handle can take any suitable form on and/or adjacent the body of the packaging insert. Referring to <FIG>, the handle is provided along one side of the body <NUM> of the packaging insert <NUM>. In other examples, the handle can be provided along less than the whole length of one side, for example to one end or another, or centrally. In other examples more than one handle can be provided. For example, two handles can be provided along one side of the body <NUM>, or at least one handle can be provided along two or more sides of the body <NUM>. The handle or handles can be unitary with the body of the packaging insert. This configuration can facilitate ease of manufacture.

Suitably the packaging insert can be held and manipulated by a user using only one hand. The handle can be configured and/or sized to be holdable by a single hand. A user may therefore be able to use the packaging insert to position the drape with one hand, and may use the other hand to manipulate the remainder of the drape. In this way, a single user can correctly position the drape over the drive assembly interface, and can also position the remainder of the drape over the end of the robot arm.

The engagement of the engagement portion with the drape is releasable. Once the drape is positioned as desired on the robot arm, the packaging insert is removed from the drape. This can be achieved by the engagement of the packaging insert with the drape being weaker than the engagement of the drape with the robot arm, as will be discussed in more detail below.

The engagement portion can comprise an adhesive portion <NUM>. The adhesive portion can, prior to or as part of the packaging of the drape, be adhered to the drape. Suitably the adhesive portion is adhered to the interface structure <NUM>. The adhesive portion is of sufficient strength to hold the drape and permit manipulation of the drape by the packaging insert. Once the drape is mounted to the robot arm, for example by the interface structure being engaged with the drive assembly interface (such as by the drive transfer elements being engaged with the drive assembly interface elements) or being retained on the drive assembly by the fastener <NUM> and/or the lugs <NUM>, <NUM>, pulling on the packaging insert <NUM> away from the drive assembly interface <NUM> will cause the engagement portion to disengage from the drape. In other words, the adhesive portion holds the drape with a force which is weaker than that with which the interface structure engages with the drive assembly interface or with which the fastener <NUM> and/or the lugs <NUM>, <NUM> retain the interface structure <NUM> on the drive assembly.

Suitably the packaging insert <NUM> comprises a plurality of engagement portions. The packaging insert can comprise a plurality of adhesive portions. The adhesive portions <NUM>, <NUM> can be provided on opposite sides of the packaging insert <NUM>. This configuration permits a more stable engagement between the packaging insert and the drape. In the example illustrated in <FIG>, the packaging insert comprises two adhesive portions. A first adhesive portion <NUM> is provided towards a first edge of the packaging insert <NUM>. A second adhesive portion <NUM> is provided towards a second edge of the packaging insert <NUM>. In other examples, different numbers of adhesive portions can be provided.

The packaging insert <NUM> comprises a plurality of apertures <NUM>, <NUM>, <NUM>. The apertures are configured to receive therethrough a portion of a respective drive transfer element, for example part of the central portion of a drive transfer element. In the example illustrated in <FIG> three apertures are provided, corresponding to the three drive transfer elements illustrated in <FIG>. A protruding portion, such as a fin, of a first drive transfer element <NUM> is receivable through a first aperture <NUM>. A protruding portion, such as a fin, of a second drive transfer element <NUM> is receivable through a second aperture <NUM>. A protruding portion, such as a fin, of a third drive transfer element is receivable through a third aperture <NUM>.

The apertures comprise respective retention portions. Referring to <FIG>, the retention portion comprises a forward edge (the uppermost edge of the aperture in the orientation of <FIG>) of each of the apertures. The first aperture <NUM> comprises a first forward edge <NUM>. The second aperture <NUM> comprises a second forward edge <NUM>. The third aperture <NUM> comprises a third forward edge <NUM>.

The retention portions retain the drive transfer elements. For instance, the retention portions retain the drive transfer elements in the desired position for interfacing with the drive assembly interface elements. Where the drive transfer element is retained at one end of its respective travel, the packaging insert need only comprise one retention portion for each aperture and/or for each drive transfer element. In other words, the respective drive transfer element need only be retained behind the respective forward edge of the aperture. The drive transfer element can, in this configuration, be restricted from moving away from the retention portion by virtue of it being at an end of its respective travel. The retention portion restricts the drive transfer element from moving forwards (i.e. in an upwards direction in the orientation of <FIG>), and ensures that as the interface structure is placed into position on the drive assembly interface, the drive transfer elements align with the drive assembly interface elements.

Where the desired (or interfacing) position of a drive transfer element is not at an end of its travel, the aperture of the packaging insert usefully comprises a rear edge opposing the forward edge. The rear edge is spaced from the forward edge by the length (along the direction of motion) of the drive transfer element, for example the protruding portion or fin, that is receivable through the aperture. The drive transfer element is retained between the forward edge and the rear edge. The first aperture <NUM> comprises a first rear edge <NUM>. The second aperture <NUM> comprises a second rear edge <NUM>. The third aperture <NUM> comprises a third rear edge <NUM>. Each aperture <NUM>, <NUM>, <NUM> is sized to retain the drive transfer element via an interference fit. Thus, where the drive transfer elements are retained by apertures of the packaging insert in an interference fit, the apertures can act as the engagement portion.

In the example illustrated in <FIG>, the three apertures <NUM>, <NUM>, <NUM> are arranged in a line across the body of the packaging insert. That is to say, the apertures are aligned with one another. This need not be the case. In other examples the interfacing positions of the drive transfer elements need not be aligned, thus the apertures therefore also need not be aligned. The apertures can be provided in any suitable location across the body of the packaging insert.

In other examples, a greater or fewer number of apertures can be provided. In the example illustrated in <FIG>, a single aperture <NUM> is provided. Each of the drive transfer elements is receivable through this common aperture <NUM>. This configuration can be used where each of the drive transfer elements is aligned in the interfacing position. The retention portion in this example comprises a forward edge <NUM> of the single aperture <NUM>.

In other examples, any suitable number of apertures can be provided. Suitably each drive transfer element is receivable through one of one or more apertures provided in the packaging insert.

In one example of the instrument interface, three drive transfer elements are provided. The outer two drive transfer elements have a range of motion of, for example, <NUM>. The central drive transfer element has a range of motion of, for example, <NUM>. Thus, suitably the central drive transfer element is retained by the packaging insert at one end of its range of motion, so that the interface structure can be moved along the drive assembly interface by up to <NUM> during attachment. The outer two drive transfer elements are suitably retained by the packaging insert so that they are able to move by up to <NUM> as well. If attachment of the interface structure to the drive assembly interface is effected by a shorter travel than <NUM>, then the drive transfer elements can accordingly be retained in configurations that permit this shorter travel once the interface structure has been mounted onto the drive assembly interface.

The packaging insert has been discussed above as comprising one or more apertures to receive therethrough a protruding portion of a corresponding drive transfer element. Where the drive transfer element comprises a recess instead of a protrusion, the packaging insert can comprise a protruding portion to engage with the recess. The packaging insert can comprise apertures and/or protrusions to correspond with the configuration of the interface structure. In other words, where the drive transfer element comprises a protrusion to the second side <NUM> (i.e. the side of the interface structure <NUM> to which the packaging insert is engaged), the packaging insert can comprise a corresponding recess or aperture. Where the drive transfer element comprises a recess to the second side <NUM>, the packaging insert can comprise a corresponding protrusion. Suitably, where the packaging insert comprises a protrusion, the retention portion comprises a forward edge of the protrusion. Similarly to the above discussion, this permits the drive transfer element to be retained in position, i.e. in the desired or interfacing position, by the packaging insert.

The adhesive portions <NUM>, <NUM> illustrated in <FIG> are provided on the body <NUM> of the packaging insert <NUM>. In another example illustrated in <FIG>, the packaging insert <NUM> comprises two side folds <NUM>, <NUM> provided on opposite sides of the body <NUM>. A first side fold <NUM> comprises two adhesive portions <NUM>, <NUM>. A second side fold comprises a further two adhesive portions <NUM>, <NUM>. The provision of the adhesive portions on side folds of the packaging insert permits the adhesive portions to adhere to the sides of the interface structure rather than to the main body of the interface structure. This permits a stable engagement between the packaging insert and the interface structure. This configuration also permits the adhesive portions to be disengaged from the drape whilst the body of the packaging insert retains the interface structure in position. Once disengaged, the packaging insert can be removed quickly and/or easily without disturbing the position of the interface structure. This can therefore help to ensure that the interface structure remains in the correct position as the packaging insert is removed.

In one example, the body <NUM>, <NUM> can itself be adhesive. For example the whole of the body can be adhesive.

The adhesive force, or attractive force, can be provided by a 'smooth-on-smooth' contact. For example at least a portion of the body of the packaging insert facing the interface structure can be smooth, and at least a portion of the interface structure facing the packaging insert can be smooth. The smooth portions are suitably arranged to face one another so that they come into contact when the packaging insert is attached to the interface structure. The close proximity of these smooth surfaces can provide sufficient adhesive force to retain the packaging insert on the interface structure.

In the example illustrated in <FIG>, the side folds <NUM>, <NUM> are provided along the length of the body <NUM>. This need not be the case. In other examples, a side fold can be shorter than the length of the body of the packaging insert. The side folds need not be of equal length. One side fold can be shorter than the other side fold. For example, the first side fold can extend along the length of the body and comprise two adhesive portions. The second side fold can extend adjacent a shorter central part of the body and comprise a single adhesive portion. In this way, three adhesive portions are provided which can engage with the interface structure in a stable manner. Other combinations of length of side fold, numbers of adhesive portions on each side fold, and positioning of the adhesive portions on the side folds are also possible.

Referring now to <FIG>, in one example the engagement portion comprises a protrusion <NUM> which protrudes from an underside of the body <NUM> of the packaging insert <NUM>. The protrusion <NUM> is sized and shaped to engage via an interference fit with an indent <NUM> in the interface structure. The protrusion <NUM> is suitably deformable to as to fit within the indent <NUM> and yet stiff enough to be able to frictionally engage therewith, for example with walls of the indent <NUM>, so as to hold the packaging insert <NUM> together with the interface structure <NUM>.

In another example, illustrated in <FIG>, the engagement portion of the packaging insert <NUM> comprises a lip <NUM>. The lip <NUM> is provided on a side fold adjacent the body <NUM> of the packaging insert <NUM>. The lip could instead be provided on the body <NUM> of the packaging insert <NUM>. As illustrated, the lip <NUM> faces inwardly (i.e. towards a central portion of the packaging insert <NUM>. The inwardly facing lip <NUM> is configured to engage with a corresponding outwardly facing lip or L-shaped projection provided on the interface structure (not shown). A portion of the outwardly facing lip on the interface structure is receivable into a recess <NUM> adjacent the inwardly facing lip <NUM>. Suitably a pair of opposing lips <NUM>, <NUM> are provided on the packaging insert, which are engageable with a corresponding pair of opposing lips provided on the interface structure.

The lip <NUM> is suitably resilient and/or deformable. The lip <NUM> can engage with the interface structure lip by a push attachment, which can cause the lip <NUM> to pass over the interface structure lip and thereby to engage with it to hold the packaging insert together with the interface structure. The lip can comprise a chamfered portion, or lead-in, on its lower edge to assist in engaging the packaging insert with the interface structure in a push fit.

The packaging insert can be disengaged from the interface structure by disengaging the lip <NUM> from the interface structure lip. As mentioned above, the lip <NUM> can be resilient and/or deformable. The force needed to resiliently deform the lip <NUM> so as to disengage the packaging insert from the interface structure is preferably less than the force with which the interface structure is retained on the drive assembly interface, for example by the fastener <NUM> and/or the lugs <NUM>, <NUM>.

Referring to <FIG>, the packaging insert <NUM> comprises a tab <NUM> coupled to the lip <NUM>. The tab <NUM> is provided on an upper side of the packaging insert. The packaging insert comprises a pivot portion <NUM>, about which the lip <NUM> can pivot relative to a remainder of the packaging insert. The pivot portion <NUM> can be a crease or fold, or other weakened portion of the packaging insert. The packaging insert is configured so that as the lip <NUM> pivots about the pivot portion <NUM>, the lip <NUM> disengages with the lip of the interface structure. The tab is provided to one side of the pivot portion <NUM> so that pressing sideways on the tab <NUM> causes the lip <NUM> to pivot about the pivot portion <NUM>. In this way, the lip <NUM> can be disengaged from the interface structure lip via movement of the tab <NUM>.

Suitably a second tab <NUM> is provided adjacent a second lip <NUM>, to one side of a second pivot portion <NUM>. Movement of the second tab <NUM> likewise causes the second lip <NUM> to pivot about the second pivot portion <NUM>. This disengages the second lip <NUM> from a corresponding interface structure lip.

Suitably the tabs <NUM>, <NUM> are provided so that moving the distal ends of the tabs towards one another causes disengagement of the lips <NUM>, <NUM> from the interface structure. In other words, a pinching motion can be used by a user to disengage the packaging insert <NUM> from the interface structure <NUM>. This pinching motion can be done with a single hand. The tabs <NUM>, <NUM> and pivot portions <NUM>, <NUM> are examples of a deformable portion which can deform so as to move the lip <NUM> from a position in which it is engaged with a corresponding lip of the interface structure to a position in which it is disengaged from the corresponding lip of the interface structure.

The lips or flanges <NUM>, <NUM> on the packaging insert <NUM> need not be inwardly facing. In other examples the lips <NUM>, <NUM> on the packaging insert <NUM> can be outwardly facing lips which are engageable with inwardly facing lips on the interface structure.

Examples of such configurations are illustrated in <FIG> and <FIG>. The packaging insert <NUM> illustrated in <FIG> comprises two outwardly facing lips <NUM>, <NUM>. The packaging insert <NUM> illustrated in <FIG> comprises two outwardly facing lips <NUM>, <NUM>.

<FIG> and <FIG> also show examples of alternative deformable portions. A deformable portion can take the form of a single fold (as in <FIG>, at <NUM>) or multiple folds such as two folds (as in <FIG>, at <NUM>, <NUM>). The folds preferably extend from the top side of the packaging insert to permit ease of holding by a user.

The fold or folds are configured so that on pinching the fold, the lowermost portions of the fold are brought together. This causes the outwardly facing lips <NUM>, <NUM>, <NUM>, <NUM> to move from an engaged position in which they are engageable with corresponding lips of the interface structure to a disengaged position in which they are disengaged from the corresponding lips of the interface structure. Thus, pinching the fold or folds can disengage the packaging insert <NUM>, <NUM> from the interface structure.

In the example illustrated in <FIG>, the lips <NUM>, <NUM> extend along the whole length of the side of the body <NUM> of the packaging insert <NUM>. Similarly, the lips <NUM>, <NUM> can extend along the whole length of the side of the body <NUM>, <NUM> of the packaging insert <NUM>, <NUM> shown in <FIG> and <FIG>. Preferably the lips <NUM>, <NUM> do not extend along the whole length of the side of the body. This can mean that the deformable portion, i.e. the fold or folds, need not extend along the whole length of the side of the body. This can permit other engagement portions, such as one or more adhesive portions, to be provided on the body for engagement with the drape. It also permits the retention portion to be provided in a more convenient manner on the body.

The provision of lips and folds as described above advantageously permits formation of the packaging insert from a sheet of material by a stamping and/or bending process. This allows the formation of the packaging insert by a cost-effective method. The packaging insert is suitably made from a resilient and/or deformable material. Preferably the packaging insert is made from a sheet material. Suitably the packaging insert is made from cardboard. Making the packaging insert from cardboard permits it to be easily folded and/or cut into the desired shape, and enables it to be formed in a low-cost manner, which conveniently permits the packaging insert to be a disposable part. The packaging insert can be disposed of together with standard surgical waste, for example by incineration.

The engagement portion can be provided in any combination of the above-mentioned examples of engagement portion. Any one or more of any type of engagement portion can be provided with any one or more of any other type of engagement portion. Similarly, the retention portion can be provided in any combination of the above-mentioned examples of retention portion. Any one or more of any type of retention portion can be provided with any one or more of any other type of retention portion.

Suitably the packaging insert comprises an indication of orientation. This can prevent the drape being incorrectly positioned on the robot arm. For example, the packaging insert can comprise a feature indicating a particular orientation with respect to the robot arm and/or the drive assembly interface. Preferably the packaging insert comprises an orientation feature which permits the drape to be positioned on the robot arm in the correct orientation and restricts the drape from being positioned on the robot arm in an incorrect orientation.

Suitably the orientation feature comprises one or more of the aperture <NUM> or apertures <NUM>, <NUM>, <NUM>, the side folds <NUM>, <NUM>, the protrusion <NUM> and the handle <NUM>.

Examples have been discussed above that comprise only one or some of the features of the packaging insert. Likewise, the illustrated examples comprise a subset of the features of the packaging insert. This is for ease of understanding.

A surgical drape assembly can comprise a drape and the packaging insert as described above packaged together with the drape. As discussed above, the packaging insert is configured to be held with one hand. Thus with one hand a user can position the drape, such as the interface structure of the drape, on the drive assembly of the robot arm. With another hand, a user can place the remainder of the drape, such as the flexible material of the drape, over a remaining portion of the robot arm.

Suitably the drape comprises one or more reinforcement portions. The reinforcement portion can comprise a strengthened or stiffened portion of the drape. Suitably the reinforcement portion comprises a ring or part-ring, such as a horseshoe shape. The reinforcement portion permits a user, with one hand, to hold the reinforcement portion and use it to place the drape over the robot arm. An example of a packaged drape assembly comprising reinforcement portions is illustrated in <FIG>. The illustrated drape assembly comprises a body <NUM> of a packaging insert engaged with a portion of the drape. The drape comprises two reinforcement portions. An inner reinforcement portion comprises a ring <NUM>. Conveniently the inner reinforcement portion <NUM> is flexible. An outer reinforcement portion comprises a part-ring <NUM>. The outer reinforcement portion <NUM> is suitably flexible. The outer reinforcement portion can deform to permit ease of location of the drape over the robot arm. The resilience in the outer reinforcement portion <NUM> also provides an engagement with the robot arm. For example, the outer reinforcement portion <NUM> can act as a clip for holding the drape on the robot arm.

Additionally or alternatively, the drape can comprise attachment features, for example one or more fastener, such as clips or magnetic attachments, which clip or attach to the robot arm. The attachment features are preferably configured to attach to particular features of the robot arm. Suitably, the fasteners fasten to complimentary fasteners, such as complimentary-shaped fasteners, on the robot arm. For example, the fastener on the reinforcement portion may be a clip which fastens to a complimentary-shaped recess in the surface of the robot arm. The fasteners may take any suitable form, for example clips, clasps, buckles, latches, plugs, sockets, hooks, eyes, poppers, eyelets, buttons, and/or hook and loop fasteners such as Velcro as long as they are capable of securing the reinforcement portion to the arm whilst the arm is being manipulated.

The drape suitably comprises a series of attachment features which are configured to pass at least one of along and around the robot arm. In other words, the drape can comprise a series of attachment features which are configured to attach to a series of successive points on the robot arm between the distal end of the robot arm and the base. Additionally or alternatively, the drape can comprise a series of attachment features which are configured to attach to a series of points around the circumference of the robot arm, for example adjacent a joint of the robot arm.

In this way, the drape can be conveniently located on the robot arm. Each time a drape is applied to the robot arm (suitably this will be a new drape each time, since each drape is suitably disposable) the drape can be repeatably located on the robot arm. This consistency of location of the drape on the robot arm can help to ensure that there is sufficient freedom of movement permitted to ensure that the robot arm is unhindered in its desired movements.

In some examples the drape comprises a first portion and a second portion. The drape can comprise a first reinforcement portion at an end of the first portion and a second reinforcement portion at an end of the second portion. The first reinforcement portion and the second reinforcement portion are suitably configured to be engageable with one another in a sealing manner so as to permit the first portion of the drape and the second portion of the drape to be joined to one another so as to maintain the sterile barrier. For example, the first portion may be generally conical, for covering the distal portion of the robot arm. The second portion may be generally cylindrical for covering a more proximal portion of the robot arm.

In some examples, the reinforcement portions are hollow. Suitably the reinforcement portions comprise at least a portion of a cooling structure for cooling the robot arm. The hollow portion of the reinforcement portion is suitably in communication with a source of cooling fluid. The cooling fluid might be air, or any other suitable fluid. Conveniently, the use of air as a cooling fluid means that the cooling fluid can safely be emitted to the surroundings of the robot arm.

The reinforcement portion suitably has a series of orifices. These orifices are openings in the outer surface of the reinforcement portion which go through to the hollow portion. In other words, they are through-holes. Cooling fluid inside the reinforcement portion passes through these orifices to the exterior of the reinforcement portion. Thus, the orifices are bleed holes for the cooling fluid. The orifices are directional. They enable the cooling fluid to be aimed in particular directions. Suitably, the orifices are directed towards the robot arm in order to feed cooling fluid from the reinforcement portion towards the robot arm.

The orifices may be regularly spaced around the surface of the reinforcement portion facing the robot arm. Alternatively, the orifices may be arranged around the surface of the reinforcement portion facing the robot arm so as to only be located on those parts of the reinforcement portion which are directed to the portion of the robot arm which is to be cooled.

The reinforcement portion suitably comprises biasing projections. Each biasing projection is directed towards the robot arm, and is configured to contact the robot arm so as to space the reinforcement portion from the robot arm. The biasing projections thus support the reinforcement portion. They prevent the reinforcement portion from directly contacting the robot arm. They thus prevent the reinforcement portion from hindering movement of the robot arm. Suitably, there are at least two biasing projections per reinforcement portion. There may be more than two biasing projections per reinforcement portion. Each biasing projection may take any suitable form, for example a leaf spring. The biasing projection can comprise an attachment feature, such as a fastener.

The instrument could be used for non-surgical purposes. For example it could be used in a cosmetic procedure.

Claim 1:
A surgical drape assembly comprising:
a surgical drape comprising:
a drive transfer element (<NUM>, <NUM>, <NUM>) for transferring drive between a surgical robot arm (<NUM>) and a surgical instrument (<NUM>);
a packaging insert (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) configured to engage a portion of the surgical drape for locating the surgical drape on the surgical robot arm (<NUM>),the packaging insert being releasably engageable with the surgical drape and comprising:
a body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>); and
a retention portion (<NUM>, <NUM>, <NUM>, <NUM>) engageable with the drive transfer element for retaining the drive transfer element in a desired position.