Surgical robotic system

Abstract

A surgical robot comprising: a central inflow pump; a central outflow pump; a central inflow tube comprising a central inflow pump connector for connecting to the central inflow pump; a central outflow tube comprising a central outflow pump connector for connecting to the central outflow pump; one or more robotic arms, each robotic arm comprising an arm inflow / outflow pump; a robotic arm tube for connecting the arm inflow / outflow pump of each robotic arm to the central inflow pump and the central outflow pump; and one or more waste cannisters fluidly connected to the central outflow pump.

Description

[0001] SURGICAL ROBOTIC SYSTEM

[0002] FIELD OF THE PRESENT INVENTION

[0003] The present invention relates to a surgical robotic system, an arthroscopic surgical robot, a method, a method of surgery, a method of performing arthroscopic surgery.

[0004] BACKGROUND

[0005] Arthroscopy is a minimally invasive surgical procedure that allows surgeons to diagnose and treat joint issues. During this procedure surgeons use specialised instruments to navigate within the joint through small incisions or portals. The procedure typically involves the use of a camera (arthroscope) and various instruments such as shavers, punches and suture passers.

[0006] It is known to perform certain types of surgery such as laparoscopic surgery utilising a surgical robot. However, conventional surgical robots are not suited to perform arthroscopic surgery because of the specialised nature of arthroscopic surgery which provides some unique challenges to surgeons. In particular, arthroscopic surgery is highly complex surgery which requires surgeons to be able to perform highly dexterous operations in closely confined spaces such as within a joint. It will be appreciated that in the case of laparoscopic surgery then it is often possible to expand the surgical site and that the surgeon is not normally operating in a highly confined space. However, arthroscopic surgery is different in that surgeons need to perform highly dexterous movements in a closely confined surgical site such as a joint or knuckle. It will further be appreciated that in the case of a joint it is not possible to expand the surgical site.

[0007] To successfully perform arthroscopy, a surgical procedure used to examine and treat conditions within joints, precise fluid management is desirable. During arthroscopy, irrigation fluid is used to distend the joint, provide a clear view for the surgeon, flush out debris from the operative site, manage temperature, and address bleeding. The control of fluid flows in and out of the joint are critical, as they directly impact the speed, safety, and overall success of the procedure.

[0008] The Applicants have developed a surgical robot which is capable of assisting a surgeon to perform arthroscopic surgery. The nature of using a surgical robot to assist with arthroscopic surgery is that the surgical robotic system needs to be able to control a series of operational parameters to a very precise degree. For example, in order to successfully assist a surgeon perform arthroscopic surgery it is necessary for the robotic system to have a high level of control over the inflow / outflow of fluids and to also be able to control precisely functions such as suction and aspiration at the tip of a surgical tool or instrument. Furthermore, the robotic system also needs to be capable of carefully controlling fluid flow, pressure and temperature.

[0009] Conventional arthroscopic fluid management systems typically rely on open-loop control or basic flow regulation mechanisms. These systems are designed to maintain fluid inflow and outflow, suction, and control of both flow rate and pressure. However, many of these traditional systems are unable to accurately predict or adjust to changes in the operative environment, such as shifts in pressure caused by tissue obstruction, joint manipulation, or alterations in fluid dynamics. As a result, they often under or overcompensate, which can lead to undesirable outcomes, including impaired visibility or damage to surrounding tissues. Conventional surgical robots currently provide minimal control over the flow of fluids. To the extent that conventional surgical robots do attempt to control the flow of fluids then conventional surgical robots do this using the open loop control method i.e. various operational parameters are pre-set and the robotic system does not monitor the output. Instead, various components of the robotic system operate only on the basis of the input that they receive based upon a pre-defined set of instructions. Whilst such an approach may be acceptable for laparoscopic surgery such an approach is not acceptable for arthroscopic surgery.

[0010] It will be appreciated by those skilled in the art that a significant problem with conventional surgical robotic systems is that they are unable to respond to external factors. For example, conventional surgical robotic systems are pre-programmed based upon certain assumptions e.g. that surgery will be performed in a temperature controlled operating theatre wherein the temperature will be maintained in the range 18-20 °C. If, for example, for whatever reason the surgery is performed at a location where the temperature is either higher or lower than the expected range, then conventional surgical robotic systems are unresponsive - the control system continues to instruct components to operate based upon pre-set instructions. Conventional surgical robotic systems do not utilise feedback control to monitor any deviation from a desired operational parameter and to adjust the input to components in order to achieve a desired outcome. As a result it is common for conventional robotic systems to either undershoot or overshoot a number of important operational parameters.

[0011] It is desired to provide an improved surgical robotic system.

[0012] SUMMARY

[0013] According to an aspect there is provided a medical device comprising: a network of motors configured to act either as: (i) peristaltic pumps; and / or (ii) extraction fans; and an environmental management system configured to manage the network of motors, wherein the environmental management system comprises a closed loop control system configured to control the network of motors.

[0014] According to various embodiments the medical device may comprise a surgical robotic system.

[0015] The closed loop control system may comprise a feedback control system which is configured:

[0016] (i) to compare an actual output with a desired output and make an adjustment based on feedback to achieve a desired outcome; and / or

[0017] (ii) to utilise a computational model to formulate a first estimate, evaluate the first estimate against a reference and produce an outcome, wherein the estimate is then evaluated against actual operational data and the computational model is then revised; and / or

[0018] (iii) to utilise a controller using a predictive model; and / or

[0019] (iv) to utilise a self-correcting feedback model.

[0020] It will be understood that conventional medical devices and in particular surgical robotic systems do not comprise an environmental management system which is configured to manage a network of motors wherein at least some of the motors operate as either peristaltic pumps or extraction fans and wherein the environmental management system comprises a closed loop control system which is configured to control the network of motors (e.g. peristaltic pumps and / or extraction fans). In particular, conventional medical devices including surgical robotic systems may best be characterised as comprising an open loop control system wherein the control system sets operational parameters for the medical device or robot based upon pre-set instructions. Conventional medical devices and surgical robotic systems do not utilise feedback control to monitor any deviation between a desired outcome and an actual outcome and then vary the input to the device under control so as to achieve a desired outcome.

[0021] By way of contrast, according to embodiments of the present invention a medical device such as a surgical robotic system is provided which comprises a network of motors and which includes an environmental management system which comprises a closed loop control system. In particular, the inputs and outputs of various components including motors in the network of motors are measured and changes are made based using a feedback loop.

[0022] The environmental management system according to various embodiments is particularly advantageous in that by adopting a closed loop control system the medical device or robotic system is better able to control various environmental parameters of the medical device or robotic system. In particular, the environmental management system according to various embodiments offers significantly improved inflow / outflow control of fluid and improved suction control. Furthermore, the environmental management system according to various embodiments also offers significantly improved control of flow, pressure and temperature.

[0023] It will be appreciated, therefore, that the medical device or surgical robotic system according to various embodiments which comprises a closed loop environmental management system represents a significant advance in the art.

[0024] The medical device or surgical robotic system may further comprise one or more fluid circuits, wherein each fluid circuit may comprise a plurality of peristaltic pumps interconnected by one or more fluid tubes.

[0025] The environmental management system may be configured to sense and / or control one or more operative conditions. For example, operative conditions which may be sensed and / or controlled may include temperature, pressure and fluid flow rate.

[0026] The medical device or surgical robotic system may further comprise one or more central pumps configured to regulate fluid inflow and / or fluid outflow.

[0027] The one or more central pumps may be configured to drive fluid through a network to one or more connection nodes.

[0028] The one or more connection nodes may be isolated via one or more anti-reflux valves.

[0029] The medical device or surgical robotic system may further comprise a plurality of distal circuits arranged downstream of the one or more connection nodes.

[0030] Each distal circuit may further comprise an inflow / outflow pump configured to regulate the flow in each distal circuit.

[0031] The medical device may comprise a surgical robotic system, wherein the surgical robotic system comprises: one or more robotic arms having an arm inflow / outflow node; a central connection node comprising a central inflow pump and a central outflow pump, wherein the central connection node is fluidly connected to an arm inflow / outflow node; a fluid flow line connected to the central connection node for directing fluid to the central connection node; one or more waste cannisters fluidly connected to the central outflow pump; and a vacuum system connected to the one or more waste cannisters and the central outflow pump for aspirating fluid.

[0032] According to another aspect there is provided an arthroscopic surgical robot comprising a medical device or surgical robot as described above.

[0033] According to another aspect there is provided a method comprising: providing a medical device or surgical robot as described above; and using the environmental management system to manage the environment of the medical device or surgical robot.

[0034] According to another aspect there is provided a method of surgery comprising a method as described above.

[0035] According to another aspect there is provided a method of performing arthroscopic surgery comprising a method as described above.

[0036] According to another aspect there is provided a surgical robot comprising: a central inflow pump; a central outflow pump; a central inflow tube comprising a central inflow pump connector for connecting to the central inflow pump; a central outflow tube comprising a central outflow pump connector for connecting to the central outflow pump; a robotic arm comprising an arm inflow / outflow pump; a robotic arm tube for connecting the arm inflow / outflow pump to the central inflow pump and the central outflow pump; and one or more waste cannisters fluidly connected to the central outflow pump.

[0037] According to another aspect there is provided a medical device comprising: a central inflow pump; a central outflow pump; a central inflow tube comprising a central inflow pump connector for connecting to the central inflow pump; a central outflow tube comprising a central outflow pump connector for connecting to the central outflow pump; a first inflow / outflow pump; a first tube for connecting the first inflow / outflow pump to the central inflow pump and the central outflow pump; and one or more waste cannisters fluidly connected to the central outflow pump.

[0038] The central inflow pump may comprise one or more peristaltic pumps. The central outflow pump may comprise one or more peristaltic pumps.

[0039] The arm inflow / outflow pump may comprise one or more peristaltic pumps.

[0040] The medical device or surgical robot may further comprise: optionally one or more fluid bags; and an inflow fluid tube arrangement comprising a connector for connecting to the one or more fluid bags and / or a connector for connecting to the central inflow pump.

[0041] The medical device or surgical robot may further comprise: an arm or first fluid tube arrangement comprising a connector for connecting to an arm or first inflow / outflow pump and / or a connector for connecting to the central inflow pump.

[0042] The medical device or surgical robot may further comprise: a central outflow tube arrangement comprising a connector for connecting to the central outflow pump.

[0043] The medical device or surgical robot may further comprise an outflow port comprising a pressure regulator and a fluid trap, wherein the outflow port is configured to generate and regulate negative outflow pressure.

[0044] The medical device or surgical robot may further comprise an environmental management system configured to manage the pumps, wherein the environmental management system comprises a closed loop control system for controlling the pumps.

[0045] The closed loop control system may comprise a feedback control system which is configured to:

[0046] (i) compare an actual output with a desired output and make an adjustment based on feedback to achieve a desired outcome; and / or

[0047] (ii) utilise a computational model to formulate a first estimate, evaluate the first estimate against a reference and produce an outcome, wherein the estimate is then evaluated against actual operational data and the computational model is then revised; and / or

[0048] (iii) utilise a controller using a predictive model; and / or

[0049] (iv) utilise a self-correcting feedback model.

[0050] According to another aspect there is provided a medical device or surgical robot comprising a two-state peristaltic pump assembly comprising: a pump comprising a motor; and a tube mounted within the pump; wherein in a first mode of operation the tube is compressed as the motor rotates so that fluid is drawn through a fluid flow line; and wherein in a second mode of operation the assembly is pressed thereby moving or displacing the motor and / or the tube so that the tube is no longer compressed such that the pump is effectively bypassed.

[0051] According to another aspect there is provided a medical device comprising: a network comprising one or more fluid circuits and one or more pumps, flow regulating devices or pressure regulating devices configured to cause fluid to flow through the one or more fluid circuits; and an environmental management system configured to manage the network, wherein the environmental management system comprises a closed loop control system configured to control the network.

[0052] According to various embodiments the network may comprise: (i) multiple circuits, each circuit comprising a plurality of pumps, pressure regulating devices or flow regulating devices; or (ii) multiple circuits, wherein one or more of the circuits are pumped by a single pump, pressure regulating device or flow regulating device.

[0053] According to various embodiments the closed loop control system may comprise a feedback control system which is configured to:

[0054] (i) compare an actual output with a desired output and make an adjustment based on feedback to achieve a desired outcome; and / or

[0055] (ii) utilise a computational model to formulate a first estimate, evaluate the first estimate against a reference and produce an outcome, wherein the estimate is then evaluated against actual operational data and the computational model is then revised; and / or

[0056] (iii) utilise a controller using a predictive model; and / or

[0057] (iv) utilise a self-correcting feedback model.

[0058] According to various embodiments, instead of forcing the user to loop the tubing around the pump roller and establish two connections the tubing may instead be provided pre-assembled in a cassette which may be clicked into a pump mechanism.

[0059] According to various embodiments during an insertion process a compliant tubing section may be pressed against one or more pump rollers which allow the rollers to compress the pump and force fluid through the tubing in order to induce a flow rate once one or more motors are activated in order to turn the rollers.

[0060] According to various embodiments a pressure sensing membrane of the cassette may be pressed against a pressure sensor of the pump allowing for non-invasive pressure measurements. The pressure sensing membrane may be positioned directly downstream of a damping assembly which may be arranged to reduce the oscillatory nature of the flow induced by the peristaltic pump mechanism. It will be understood that this induces a more desirable constant flow behaviour and simultaneously facilitates more precise pressure measurements.

[0061] According to various embodiments the cassette may be further aided by a pronged tube to help with alignment and may be confirmed both by an RF chip and / or a validation procedure optionally during priming comparing expected with measured head pressures.

[0062] During insertion, the pressure sensor of the pump may be pushed down against a biasing member such as a spring or other mechanism in order to let the cassette pass. Once fully inserted, the pressure sensor may be pushed back up by the spring into a cavity in the cassette to engage the pressure sensing membrane. Similarly, during removal the pressure sensor may be pushed down to allow the cassette to pass.

[0063] According to various embodiments the system may be arranged not only for pressure sensing but also additional non-invasive sensing of flow rate and / or temperature and / or optical properties (such as debris load in outflow).

[0064] It will be appreciated, therefore, that one of more pumps in the network which is controlled by the environmental management system may be provided in the form of an insertable cassette.

[0065] BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Various embodiments will now be described, by way of example only, and with reference to the accompanying drawings in which:

[0067] Fig. 1 shows a surgical robot system according to various embodiments;

[0068] Fig. 2 illustrates various aspects of an environmental management system 1000 for a surgical robot according to various embodiments;

[0069] Fig. 3 shows a perspective view of a bedside cart 200 that forms part of the environmental management system 1000;

[0070] Fig. 4 shows various motors in the environmental management system 1000 and a schematic according to various embodiments;

[0071] Fig. 5A shows an inflow tube set which may be utilised according to various embodiments, Fig. 5B shows an outflow tube set which may be utilised according to various embodiments; Fig, 5C shows a schematic of the waste management set up which forms part of the environmental management system 1000.

[0072] Fig. 6A illustrates an all-day tube set 600A. Fig. 6B illustrates a schematic in-use view of the patient tube set 600B. Fig. 6C illustrates a Direct-to-Joint tube set 600C.

[0073] Fig. 7 shows the components of a waste system according to various embodiments;

[0074] Fig. 8 shows a central inflow circuit according to various embodiments;

[0075] Fig. 9 shows an arm drape which is designed for single use according to various embodiments; and

[0076] Fig. 10 shows a drape which is designed for single use according to various embodiments.

[0077] Fig. 11 is a flowchart outlining operation of the environmental management system 1000.

[0078] DETAILED DESCRIPTION

[0079] Various aspects of an arthroscopic surgical robot will now be described.

[0080] Fig. 1 shows a surgical robotic system 100 according to various embodiments and shows a halo structure 110 which may be suspended over a patient to be operated upon and wherein a number of robotic arms are arranged to depend from the halo structure 110. Each robotic arm 120 may be independently controlled and manoeuvred.

[0081] Fig. 2 shows an environmental management system 1000 according to various embodiments and shows how fluid e.g. saline or other surgical fluids may be input into the system from a bedside cart 200 with fluid bags 201 and may then be pumped by one or more peristaltic pumps to the robotic arms 120 via a node 150 which may include an arm drape 210. Fluid from the surgical site may also be aspirated or otherwise removed from the surgical site and passed via an outflow fluid line 157 which is also pumped by one or more peristaltic pumps to waste. In particular, according to the present disclosure and as will be described in more detail below an environmental management system (EMS) 1000 is disclosed which incorporates a network of smart motors which are configured either to act as peristaltic pumps or extraction fans. The various motors / pumps may be interconnected using disposable tubing and waste canisters and may be provided to receive fluid waste which is removed from the surgical site. According to various embodiments the motors may be controlled by a central embedded computer which provides a closed loop system which is able to fully sense and manage a full range of operative conditions as will be described in further detail in the foregoing sections.

[0082] It is evident from Figs 1 to 3 that the robotic arms 120 have an arm inflow and outflow node 150. A central connection node 250 is provided on the bedside cart 200 and comprises a central inflow pump 252 and a central outflow pump 254, wherein the central connection node 250 is fluidly connected to the arm inflow / outflow node 150. Inflow and outflow fluid lines 155 and 157 connect with the central connection node 250 for conveying fluids between the bedside cart 200 and the inflow / outflow node 150. Waste cannisters 210 are fluidly connected to the central outflow pump 254 and a vacuum system is connected to waste cannisters 210 and the central outflow pump for aspirating fluid. Reusable additional canisters 260 may be provided for additional fluid storage during extensive operations.

[0083] All fluid pumps preferably employ a peristaltic mechanism, effectively 'milking' the tubing to control flow without contaminating the sterile pathway. The central pumps 252 and 254 drive fluid through a network leading to connection nodes near the halo 110 of the robot 100, which are isolated by anti-reflux valves to prevent backflow. From these nodes, the system branches into the six distal circuits. Each distal circuit is equipped with an additional distal or arm inflow and outflow pump assemblies denoted by 140, allowing for independent flow regulation in each branch. This arrangement provides precise control over fluid dynamics at multiple points within the system 1000.

[0084] Fig. 4 shows in more detail how the environmental management system according to various embodiments may be arranged to monitor and control a network of motors which operate as peristaltic pumps within a robotic network according to various embodiments. The network of motors may be arranged as a plurality of circuits. For example, in the embodiment shown in Fig. 4 three circuits are shown which correspond with three separate robotic arms. The three circuits are designated as RBA1 , RBA2 and RBA3. For illustrative purposes it can be seen that the first circuit RBA1 includes two central motors FMSin (which is designated as motor M32) and FMSout (which is designated as motor M33). Overall, six robotic arm motors may be provided. For example, in the embodiment shown in Fig. 4 two robotic arm motors are shown in the first circuit RBA1 namely motor RBAI in which is designated as motor M35, and RBAI out which is designated as motor M36. In the second circuit RBA2 one of the arm motors is motor RBA2in which is designated as motor M37 and the second motor RBA2out is designated as motor M38. Similarly, in the third circuit RBA3 one of the arm motors RBA3in is designated as motor M39 and the second motor RBA3out is designated as motor M40.

[0085] The actuators of the environmental management system according to various embodiments may be arranged to function like other motors within the robotic network by the read / write functionality of a Controller Area Network (“CAN”) bus which functions to allow various microcontrollers and devices to communicate with each other. As a result any device (i.e. node) on the network can initiate communication. It will be understood that a Controller Area Network bus utilises identifiers for messages wherein nodes on the network can decide whether or not to accept a message based upon the message identifier which defines the priority and type of data.

[0086] To ensure there is sufficient capability of the environmental management system then according to various embodiments the robotic system may comprise four separate circuits such as a first circuit RBA1 in a first robotic arm, a second circuit RBA2 in a second robotic arm, a third circuit RBA3 in a third robotic arm and well as a fourth circuit which may comprise a direct or joint circuit. The four circuits may be independently controlled in order to control the inflow and / or outflow of fluids. For example, saline from a saline bag may be pumped into one of the circuits by one or more peristaltic pumps and the saline may pass along a cannular or fluid flow channel which may be provided in a robotic arm. The cannular or fluid flow channel may continue in a surgical tool which is attached to the end of the robotic arm. Saline may be carefully controlled to be pumped from an end of the surgical tool in order to irrigate a surgical site or surgical target, and a mixture of saline, body fluids and debris may be extracted via an outflow fluid flow line. The outflow fluid flow line may similarly pass along the length of the robotic arm and the outflow fluid may be directed to waste which may comprise one or more cannisters which receive the outflow fluid. In order to prime the internal (common) circuit and to maintain sufficient (balanced) flow two separate central pumps may be provided which play a role in the overall regulation of fluid inflow and outflow.

[0087] According to various embodiments the various fluid pumps may utilise a peristaltic mechanism to effectively milk associated tubing which passes through the pump thereby regulating and controlling fluid flow. It will be understood that a peristaltic pump is a type of positive displacement pump which may be used for pumping a variety of fluids. A peristaltic pump operates by alternately compressing and then relaxing a flexible hose or tubing through which fluid may be flowing. The term peristaltic is derived from the concept of peristaltic waves of contraction that pass through a human digestive system to move content through the gastrointestinal tract of a human. For example, a peristaltic pump may compress associated tubing by a rotor with rollers, shoes or the like attached which presses against a portion of flexible tubing. The compression of the tubing by the rollers creates a vacuum behind the rollers which has the effect of drawing fluid into the tubing. As the roller moves forwards, the roller pushes fluid in front of it through the tubing. As the roller passes, the tubing’s elasticity causes the tubing to regain its shape and fluid intake is restored in preparation for the next cycle. It will be understood that peristaltic pumps advantageously prevent fluid from coming into contact with any pump mechanism other than the tubing itself which is particularly important for surgical applications in order to maintain a high level of sterility and avoid any possibility of infection. Also, such pumps require a low level of maintenance due to their simplicity and typically only the tubing needs to be maintained. In any event, in the context of a surgical robotic system the tubing comprises disposable tubing which is disposed of after each operation and is not reused. It will also be understood that the gentle squeezing action of such pumps is ideal for handling shear-sensitive fluids such as fluid, biopharmaceuticals and other surgical fluids and for ensuring that fluid is carefully pumped to the surgical site in order to irrigate the surgical site in a manner which does not cause any harm to the patient being operated upon.

[0088] The central pumps may be arranged to drive fluid through a fluid network comprising various connection nodes which may be isolated via anti-reflux valves. Fluid may then be arranged to be directed so as effectively to branch off to one of the four distal circuits which may include a first circuit RBA1 , a second circuit RBA2 and a third circuit RBA3. In order to independently control the flow in each of the four distal circuits an additional distal / arm inflow and outflow pump assembly may be provided in order to regulate the flow in each branch.

[0089] Fig. 3 shows the environmental management system and a schematic according to various embodiments. With reference to the schematic it can be seen how fluid (e.g. saline) may pass from a fluid bag 201 to a connection node 250 comprising a central inflow pump 2522. Fluid may then be directed to an arm inflow / outflow node 150. It will be understood that the arm inflow / outflow node 150 may be provided in one of three robotic arm circuits RBA1 , RBA2 or RBA3. Similarly, fluid which is extracted from the surgical site may pass via an outflow fluid flow path via arm inflow / outflow node 150 back to the connection node 250 and then be diverted via a central outflow pump 254 to waste. According to the particular embodiment shown in Fig. 3 the waste system may comprise one or more cannisters 260 and wherein a vacuum system may be provided in order to assist with extracting the fluid to waste. In order to maintain the biosafety of the overall system the robotic system utilises a series of consumable or disposable tubes which are used e.g. to connect the fluid bag 201 to the connection node 250, to connect the connection node 250 to the arm inflow / outflow nodes 150, to direct fluid within a robotic arm to the surgical site, to direct fluid from the surgical site through the robotic arm to an arm inflow / outflow node 150, to connect an arm inflow / outflow node 150 to the connection node 250, to connect the connection node 250 to the central outflow pump 254 and to connect the central outflow pump 254 to waste which includes waste cannisters 260and a vacuum system . According to various embodiments the tubes or tubing may be prefabricated and may be provided with a pump connector, an anti-reflux valve and a node attachment as necessary. According to various embodiments three different types of tube components or tubing may be used to make up different fluid circuits. The different types of tube components or tubing will now be described in more detail below.

[0090] Fig. 5A shows an inflow tube set 500A which may be utilised according to various embodiments. The inflow tube set may be configured to connect with one or more fluid bags and may contain a central inflow pump connector and a central connection node attachment. This component is designed for all day use. The inflow tube circuit 500A is may be used for common joint surgeries where the distance between the bedside cart and the surgical site is within a typical range. The bag spike 210 and the central inflow pump 252 are located on the bedside cart 200, with the tubing running towards the ground before connecting to the robotic system 100. To minimise tripping hazards in the operating room, the tubes are primarily positioned along the ground. Consequently, the tubing must be robust enough to withstand external forces, such as accidental stepping by staff. The material and thickness of the tubes should ensure durability and maintain the integrity of the fluid delivery system even under such conditions. Connectors 510 attached to the end of the tube sets are designed to be easily attached to adjacent components, ensuring a secure connection capable of sustaining operating pressures of up to 2,000 mmHg without leaks. The clamps 520 allow for manual control of fluid flow when necessary.

[0091] Fig. 5B illustrates an outflow tube circuit 500B. The outflow tubing facilitates the efficient removal of fluids and debris from the surgical site back to the bedside cart 200’s waste management system. The outflow tubing 500B may have a higher internal diameter (8 mm) than the inflow tubing 500A to reduce the risk of blockages due to debris and may have a wall thickness of 2 mm to withstand clinical forces such as collapse due to negative gauge pressures or accidental stepping. The setup and connectivity of the proximal waste storage system is designed to facilitate a “mix-and-match” setup of waste cannisters and overflow cannisters according to user preference. Arm pumps 540 may be located in close vicinity with the robotic arms 120 and used to pump waste fluid from the surgical site during use.

[0092] Figure 5C illustrates a box diagram to illustrate the components of a waste system 500C with waste cannisters 210 being connected with the outflow pump 254 that can be connected using connectors 515 with an overflow line being connected to overflow cannisters 260.

[0093] Figures 6A to 6E illustrate tube sets which are configured for use with the EMS 1000.

[0094] Fig. 6A illustrates an all-Day Tube Set 600A is designed for continuous use throughout one operating day. After merging downstream of the two saline bags 201 via a Y connector, the tube will extend for a short distance along the patient cart before connecting to a single-use tube set to avoid sterile tubing or connectors lying on the floor. Bag spike connectors 601 are used for connecting the saline bags 201 via tubing to the Y- connector 602. The All day tube set may be provided with a in-flow connector 605.

[0095] Fig. 6B illustrates a Single Use Patient Tube Set 600B which is utilised to transport fluid between the robot 100 and bedside cart 200 powered by the central pumps 252 and 254. Its length is selected to facilitate flexibility in positioning of the bedside cart and robot throughout the operating room. At the halo 120, a check valve avoids backflow of the debris towards the All-day Tube. The node 150 which is attached at the halo alongside the operating arms, facilitates branching of the flow into one direct-to-joint and up to five operating arm inflow and outflow streams respectively.

[0096] Fig. 6C illustrates a Direct to Joint Tube Set 600C which connects the node 150 directly to the joint, providing a dedicated pathway for fluid delivery. Using the pump bracket 253 It is expected to supply the majority of inflow and outflow via its pump bracket 253 and stay connected throughout the entirety of the surgery. It includes an external branch for a pressure sensor 257, which will connect at the pump and is essential for monitoring intra-articular pressure. The set terminates in portal stabbers, which retain the tubing set inside the cannula.

[0097] Fig. 7 shows another detailed view of the components of a waste system 700 according to various embodiments and shows a portion of suction tubing 701 leading to a nozzle or a catheter. An ON / OFF valve 710 is provided between the vacuum line and a vacuum source 702. Also shown is a variable orifice suction control valve 711 and a vacuum gauge 712 for monitoring the vacuum. A bacterial filter 713 is provided together with a cut off valve 714. A collection vessel 715 is shown having an additional cut-off valve and wherein a disposable liner and gelling agent 716 may also be provided. It will be understood that whilst the overall system according to various embodiments functions as a fluid inflow, fluid outflow and then suction system that other configurations may also be provided. For example, it will be understood that in some cases surgeons may be less interested in fluid management and fluid irrigation and instead may be more interested in being able to aspirate a surgical site. In order to accommodate such modes of operation this a two-state peristaltic pump assembly has been developed which will now be described in more detail below.

[0098] According to various embodiments the disposable tubes or tubing may include a prefabricated pump connection which allows the motors of the environmental management system to function as peristaltic pumps. In an initial configuration (i.e. pump setup) a tube or tubing may be situated between a ridged outer wall and an internal mobile roller. In this pump setup the tube or tubing may be compressed and as the motor rotates fluid is drawn through the system. In a second or bypass configuration the casing of the assembly can be pressed which moves, translates or displaces the rotor and tubing inside the unit to a region where the external casing is wider and as a result the tube or tubing is no longer compressed. Accordingly, in this configuration the pump is effectively bypassed.

[0099] Fig. 8 shows a pump connector 800 according to various embodiments. A buckle joint 810 is shown which is easy to remove. The motor or pump does not require a valve or sealing and the tubing is easy to remove and replace.

[0100] The environmental management system according to various embodiments has been designed to both match and exceed the performance specifications of conventional systems and to be capable of operating at various operational parameters which have been determined as being optimal. For example, according to various embodiments the robotic system may be configured to achieve an inflow which may be set at or greater than 1200ml / min and wherein the base outflow may be set equal to the inflow but should also be capable of being operated in a surge mode operation at flow rate of 1500ml / min. The joint pressure may be arranged to be at least 150mmHg.

[0101] According to various embodiments the system may be configured to perform a number of functions including flow control i.e. maintaining a constant inflow and outflow rate. In addition, the system may be configured to maintain pressure control i.e. maintaining a constant pressure and temperature control i.e. preventing excessive heat. The system may also be operated in a mixed control mode of operation wherein the system may be configured to set a maximum pressure and temperature together with an ideal flow range and wherein the system then automatically regulates inflow and outflow accordingly.

[0102] The main contributors of system pressure are the height of the fluid bag (pgh) and losses. Whilst there may be unavoidable losses due to system friction, the most important are the deliberate losses from the flow regulation. According to various embodiments the surgical robotic system may be configured to regulate fluid flow such that the surgical robot controls pressure from maximum values (Pmax) to OmmHg with no flow (0.5pvA2). According to various embodiments pressure may be measured indirectly by determining the pressure from calculations (Po-Ploss). Alternatively, pressure in the system may be estimated by determining the back electromotive force (“EMF”) of one or more of the pump motors. Other embodiments are also contemplated wherein direct pressure sensing may be incorporated within the direct to joint circuit. An interface may be provided to transmit pressure sensing from the direct to joint circuit back to the embedded computer. It will be understood that regulation of fluid flow is via the pumps which includes a central inflow pump, an arm inflow pump, an arm outflow pump and a central outflow pump and wherein both the central and arm pumps must function in order for flow to occur. In order to ensure the pumps can perform in an optimal manner then it is desirable to determine an optimal pump connector radius, an optimal tube diameter and an optimal pump rpm. The present Applicants have determined that in the context of assisting with arthroscopic surgery then the peristaltic pumps perform best at low rpms i.e. < 40 rpm. Accordingly, it has been determined that connectors having a 75 mm radius and tubes or tubing having a 10 mm ID are advantageous.

[0103] Its has been determined that an optimal flow rate for the central inflow pump is 1200 ml / min, an optimal flow rate for an arm inflow pump is 90 ml / min and a maximum joint pressure of 150 units is desirable. It has also been determined that an optimal flow rate for the arm outflow pump is 135 ml / min (i.e. greater than the corresponding inflow flow rate) and the optimal flow rate for the central outflow pump is 1500 ml / min (i.e. greater than the corresponding inflow flow rate). According to various embodiments the system may be operated in a mixed control mode of operation wherein in this mode of operation a target pressure and maximum pressure are selected along with a maximum temperature. The optimal flow rates are then calculated in order to achieve the target pressure. According to various embodiments the temperature may be monitored during operation and as the temperature approaches a desired temperature then limits may be set with regard increases or decreases to the various flow rate i.e. inflow and outflow flow rates. Embodiments are contemplated wherein an inflow flow rate may be increased and a corresponding outflow flow rate may also be increased proportionally. Similarly, embodiments are contemplated wherein an inflow flow rate may be decreased and a corresponding outflow flow rate may also be decreased proportionally.

[0104] It should be understood that an environmental management system according to various embodiments comprises a number of components which cooperate to provide environmental management of the surgical robot.

[0105] The environmental management system comprises components such as central motors FMSin (designated as M32) and FMSout (designated as M33) and which are shown in Fig. 3. Similarly, the environmental management system according to various embodiments may be configured to control the operation of the six arm motors namely RBAI in (designated as M35), RBAI out (designated as M36), RBA2in (designated as M37), RBA2out (designated as M38), RBA3in (designated as M39) and RBA3out (designated as M40) again shown in Fig. 3.

[0106] In addition, the environmental management system may comprise components such as the vacuum system shown in Fig. 6 which may be provided with a regulator / fluid trap 612 and wherein a control interface with the embedded computer may also be provided.

[0107] The environmental management system may further comprise a fluid pole and a central inflow tube arrangement which may comprise two bag spikes with clamps, a central inflow pump connector and a central node with anti-reflux valve. In addition, the environmental management system may further comprise a central outflow tube together with a robot drape, a central outflow pump connector and tubing to connect to a central node.

[0108] The environmental management system may further comprise an arm tube arrangement which may be provided with an arm drape and wherein the arm tube arrangement may comprise an arm inflow / outflow pump connector and a tube to connect to the central node together with an anti-reflux valve. The arm tube arrangement may further comprise a distal robotic arm (RBA) smart end plate (“SEP”) connector which may comprise a Luer lock with a three way stopcock instrument connector, a ten pin Redel to Redel (female to female) pass through connection and articulating disc rotor connections (such as motors designated as M7, M8 and M9 as shown in Fig. 3).

[0109] In addition, the environmental management system may comprise disposable tubing to interconnect the various motors, one or more 5I disposable canister bags and one or more 10I reusable waste tanks. Various supports and fixings for attachment onto the frame of the surgical robot (as shown in Fig. 1) may also be provided.

[0110] Fig. 8 shows a central inflow circuit which is designed for all day use. According to various embodiments two bag spikes 1205 may be provided to allow alternation of fluid supply and continued flow. Ratchet locks may be provided in order to minimise air bubbles. Anti-reflux valves may be provided to reduce pack down spills and optimize directional flow. According to various embodiments 1000 mm or more of feed in tube length may be provided. The tubing which may be utilised may have a 10mm ID. A central inflow pump connector may be provided in order to prime the system and coordinate input supply. The central inflow circuit may further comprise a central node with a chamber for common inflow and a chamber for common outflow. Three arm circuit connectors 1210 (with anti-reflux connection to the relevant inflow and outflow chambers) are also shown. One direct to joint inflow connection and one central outflow connection may also be provided.

[0111] Fig. 9 shows an arm drape which is designed for single use. Tubes may be provided which are fully integrated within the sterile arm drapes for ease of setup. The proximal end may be arranged to connect to the central node with the inflow and outflow tube connecting to the appropriate connector. An inflow / outflow pump connector may be fabricated into the assembly. A smart end plate (“SEP”) distal connector may also be provided. Arm tubing may be provided which distally terminates with a three-way stopcock. For instruments with a common lumen then the outflow stopcock can be attached to the inflow for single lumen use.

[0112] Fig. 10 shows a drape which is designed for single use. Tubes may be fully integrated within a sterile surgical robotic drape for ease of setup. According to various embodiments the proximal end may be arranged to connect to the central node with the inflow and outflow tube connecting to the appropriate connector. A central outflow pump connector may be fabricated into the assembly which also provides a ridged mounting site for the assembly. The arrangement may comprise two direct to joint tubes for direct to joint inflow / outflow. The distal termination may be provided with an anti-reflux valve in order to minimise spill. The distal termination may be designed to connect to a suction and waste unit or may be arranged to connect direct to a wall mounted suction and waste unit.

[0113] Fig 11 shows a flow chart depicting operation of the EMS system 1000 in accordance with a proposed embodiment. The initial step involves starting the system and loading or updating the user parameters. A virtual EMS Model with associated parameters may be saved and accessed by the EMS system 1000. The virtual EMS is a functional model that uses a virtual twin of the robot 100 along with a fluid dynamics and thermodynamics model to forecast and mitigate future fluctuations. As the robot is aware of it’s future actions prior to executing the steps it is able to accommodate for the affect, it will have on the cavity prior to that occurring. The system forecasts and implements a best guess for the initial running parameters and loads various process variables when the system is initiated. Once the robot 100 is being used for performing any surgery, regular status checks and parameter measurements are carried out and any differences between predicted and actual measurements may be corrected in a closed loop. The virtual model may also be improved..

[0114] Various further embodiments are contemplated wherein one or more of the pumps may be provided in the form of a cassette. Arthroscopy requires the establishment of a controlled pressurised fluid environment with inflow and outflow in the joint to achieve the required distension, visibility, temperature control and pressure control in order to operate safely. The fluid environment may be established by flushing the joint with saline using a tubing sets connected to an IV bag. In order to increase control and precision one or more peristaltic pumps may be provided for inflow only or both inflow and outflow. In order to allow the peristaltic pumps to compress the tubing and push fluid through the system, the tubing sets may include a compliant section which may be looped around the pump rollers by the user and clicked into connectors to secure them to the pump assembly. However, the setup time of this fluid environment and the unreliability of the tubing-pump connection (with dislodgement reported in approx. 10% of cases) is a common user frustration. It is desired to improve the ease, speed and reliability of a fluid environment establishment since several pumps and tubing sets often need to be reliably connected for each patient case. With this in mind, according to various embodiments, instead of forcing the user to loop the tubing around the pump roller and establish two connections the tubing may instead be provided pre-assembled in a cassette which may be clicked into the pump.

[0115] According to various embodiments during an insertion process a compliant tubing section may be pressed against the pump rollers which allows the rollers to compress the pump and "milk" the fluid through the tubing in order to induce a flow rate once the motors are activated to turn the rollers.

[0116] According to various embodiments a pressure sensing membrane of the cassette, which itself is directly adjacent to the fluid flow and which deforms depending on its pressure state, may be pressed against a pressure sensor of the pump allowing for non-invasive pressure measurements.

[0117] The pressure sensing membrane may be positioned directly downstream of a damping assembly which may be arranged to reduce the oscillatory nature of the flow induced by the peristaltic pump mechanism. This induces a more desirable constant flow behaviour and simultaneously facilitates more precise pressure measurements.

[0118] According to various embodiments the correct insertion of a cassette may be further aided by a pronged tube to help with alignment and may be confirmed both by an RF chip and a validation procedure during priming comparing expected with measured head pressures. During insertion, the pressure sensor of the pump may be pushed down against a biasing member (spring) to let the cassette pass. Once fully inserted, the pressure sensor may be pushed back up by the spring into a cavity in the cassette to engage the pressure sensing membrane. Similarly, during removal the pressure sensor may be pushed down to allow the cassette to pass.

[0119] According to various embodiments the system may be arranged not only for pressure sensing but also additional non-invasive sensing of flow rate and / or temperature and / or optical properties (such as debris load in outflow).

[0120] According to various embodiments the measured head pressure (Phead) sensed by the pump inflow pressure sensor of the pump near the inflow pump cassette may be used to calculate the in-joint pressure PjOint using the following equation: wherein Piossis dependent on pump speed and system setup and is determined as explained below. A pump control processor may be utilised to store or read dimensions and other values for the known identified components in order to calculate a pressure loss (Pioss) curve based on the dimensions and characteristics of the inflow tubing, the inflow cannula, and the endoscope that define an inflow path to the surgical site in the joint. The coefficients may be provided in an equation including speed or velocity, typically revolutions per minute (RPMs) of an inflow pump motor to calculate a Phead value at a point on the Piosscurve as defined for a given inflow pump motor speed. Obtaining a Piossvalue on the P|0SScurve for an RPM value of the inflow pump motor requires an algorithm or program which calculates a second order polynomial using the load coefficients COEF1 , COEF2 as set forth in the following equation: value).

[0121] It will be appreciated, therefore, that one of more pumps in the network which is controlled by the environmental management system may be provided in the form of an insertable cassette.

[0122] Whilst particular embodiments have been illustrated and described, it would be obvious to those skilled in the art that various changes and modifications can be made without departing from the scope of the present invention.

Claims

Claims1 . A surgical robot comprising: a central inflow pump; a central outflow pump; a central inflow tube comprising a central inflow pump connector for connecting to the central inflow pump; a central outflow tube comprising a central outflow pump connector for connecting to the central outflow pump; one or more robotic arms, each robotic arm comprising an arm inflow / outflow pump; a robotic arm tube for connecting the arm inflow / outflow pump of each robotic arm to the central inflow pump and the central outflow pump; and one or more waste cannisters fluidly connected to the central outflow pump.

2. A surgical robot in accordance with claim 1 further comprising: a central connection node that includes the central inflow pump and the central outflow pump, and an arm inflow / outflow node for each robotic arms that comprises the inflow / outflow pump.

3. A surgical robotic system in accordance with claim 2 wherein each of said one or more robotic arms with the inflow / outflow nodes comprises a respective inflow / outflow pump to form a corresponding distal circuit for regulating flow in each distal circuit during use.

4. A surgical robotic system in accordance with claim 1 or claim 2 wherein the central connection node and / or the robotic arm inflow outflow mode is / are isolated via one or more anti-reflux valves.

5. A surgical robotic system in accordance with any one of the preceding claims wherein the central outflow pump and / or central inflow pumps comprises one or more peristaltic pumps.

6. A surgical robotic system in accordance with any one of the preceding claims wherein the arm inflow / outflow pump comprises one or more peristaltic pumps.

7. A surgical robotic system in accordance with any one of the preceding claims further comprising: one or more fluid bags; and an inflow fluid tube arrangement comprising a connector for connecting to the one or more fluid bags and / or a connector for connecting to the central inflow pump.

8. A surgical robotic system in accordance with any one of the preceding claimsfurther comprising: an arm fluid tube arrangement comprising a connector for connecting to an arm inflow / outflow pump and / or a connector for connecting to the central inflow pump.

9. A surgical robotic system in accordance with any one of the preceding claims further comprising a central outflow tube arrangement comprising a connector for connecting to the central outflow pump.

10. A surgical robotic system in accordance with any one of the preceding claims further comprising further comprising an outflow port comprising a pressure regulator and a fluid trap, wherein the outflow port is configured to generate and regulate negative outflow pressure.11 . A surgical robotic system in accordance with any one of the preceding claims wherein the central inflow pump, the central outflow pump and the respective inflow / outflow pumps for each of the robotic arms form a network of motors configured to act either as: (i) peristaltic pumps; and / or (ii) extraction fans and wherein the surgical robotic system further comprises an environmental management system configured to manage the network of motors, wherein the environmental management system comprises a closed loop control system configured to control the network of motors.

12. A surgical robotic system in accordance with claim 1 1 wherein the closed loop control system comprises a feedback control system which is configured to:(i) compare an actual output with a desired output and make an adjustment based on feedback to achieve a desired outcome; and / or(ii) utilise a computational model to formulate a first estimate, evaluate the first estimate against a reference and produce an outcome, wherein the estimate is then evaluated against actual operational data and the computational model is then revised; and / or(iii) utilise a controller using a predictive model; and / or(iv) utilise a self-correcting feedback model. make an adjustment based on feedback to achieve a desired outcome.

13. A surgical robotic system in accordance with claim 1 1 or claim 12 wherein the environmental management system is configured to sense and / or control one or more operative conditions.

14. A medical device comprising: a network of motors configured to act either as: (i) peristaltic pumps; and / or (ii) extraction fans; and an environmental management system configured to manage the network of motors, wherein the environmental management system comprises a closed loop controlsystem configured to control the network of motors.

15. A medical device as claimed in claim 14, wherein the closed loop control system comprises a feedback control system which is configured to:(i) compare an actual output with a desired output and make an adjustment based on feedback to achieve a desired outcome; and / or(ii) utilise a computational model to formulate a first estimate, evaluate the first estimate against a reference and produce an outcome, wherein the estimate is then evaluated against actual operational data and the computational model is then revised; and / or(iii) utilise a controller using a predictive model; and / or(iv) utilise a self-correcting feedback model. make an adjustment based on feedback to achieve a desired outcome.

16. A medical device as claimed in claim 14 or 15, further comprising one or more fluid circuits, wherein each fluid circuit comprises a plurality of peristaltic pumps interconnected by one or more fluid tubes.

17. A medical device as claimed in claim 14, 15 or 16, wherein the environmental management system is configured to sense and / or control one or more operative conditions.

18. A medical device as claimed in any one of claims 14 to 17, further comprising one or more central pumps configured to regulate fluid inflow and / or fluid outflow.

19. A medical device as claimed in claim 18, wherein the one or more central pumps are configured to drive fluid through a network to one or more connection nodes.

20. A medical device as claimed in claim 19, wherein the one or more connection nodes are isolated via one or more anti-reflux valves.21 . A medical device as claimed in claim 19 or 20, further comprising a plurality of distal circuits arranged downstream of the one or more connection nodes.

22. A medical device as claimed in claim 21 , wherein each distal circuit further comprises an inflow / outflow pump configured to regulate the flow in each distal circuit.

23. A surgical robotic system comprising a medical device as claimed in any preceding claim.

24. A surgical robotic system as claimed in claim 23, further comprising: one or more robotic arms having an arm inflow / outflow node;a central connection node comprising a central inflow pump and a central outflow pump, wherein the central connection node is fluidly connected to an arm inflow / outflow node; a fluid flow line connected to the central connection node for directing fluid to the central connection node; one or more waste cannisters fluidly connected to the central outflow pump; and a vacuum system connected to the one or more waste cannisters and the central outflow pump for aspirating fluid.

25. An arthroscopic surgical robot comprising a surgical robot as claimed in claim 23 or 24.

26. A method comprising: providing a medical device as claimed in any of claims 14 to 22; and using the environmental management system to manage the environment of the medical device.

27. A medical device comprising a two-state peristaltic pump assembly comprising: a pump comprising a motor; and a tube mounted within the pump; wherein in a first mode of operation the tube is compressed as the motor rotates so that fluid is drawn through a fluid flow line; and wherein in a second mode of operation the assembly is pressed thereby moving or displacing the motor and / or the tube so that the tube is no longer compressed such that the pump is effectively bypassed.

28. A surgical robot comprising a medical device as claimed in claim 27.

29. A medical device comprising: a network comprising one or more fluid circuits and one or more pumps, flow regulating devices or pressure regulating devices configured to cause fluid to flow through the one or more fluid circuits; and an environmental management system configured to manage the network, wherein the environmental management system comprises a closed loop control system configured to control the network.

30. A medical device as claimed in claim 28, wherein the closed loop control system comprises a feedback control system which is configured to:(i) compare an actual output with a desired output and make an adjustment based on feedback to achieve a desired outcome; and / or(ii) utilise a computational model to formulate a first estimate, evaluate the firstestimate against a reference and produce an outcome, wherein the estimate is then evaluated against actual operational data and the computational model is then revised; and / or(iii) utilise a controller using a predictive model; and / or (iv) utilise a self-correcting feedback model.

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