Fluid management system and method

Abstract

A fluid management system is disclosed that includes a software-controlled, electromechanical device for use in combination with a single-use or multi-use tubing set. The fluid management system's functions include fluid pressurization, fluid warming, fluid deficit monitoring (including flow-based and weight-based), aspiration, fluid collection, and fluid drainage (including indirect and direct drainage options). The system can be configured based on the surgical environment (e.g., operating room or clinic) and other user needs and / or preferences.

Description

Technical Field

[0001] This application relates to fluid management systems, and more particularly, to fluid management systems and methods for surgery.

Background Art

[0002] Surgical fluid management systems are used in endoscopic procedures to pressurize a fluid and deliver it to the surgical site to expand the surgical site and continuously flush it to keep the surgical site free of blood and debris for visualization purposes.

[0003] A fluid management system can pressurize a fluid by manipulating the height at which a fluid supply bag is suspended relative to the height of the surgical site, by controlling the air pressure within a pressure cuff or pressure chamber surrounding the fluid supply bag, or typically by pumping (pressurizing) the fluid using a peristaltic pump. Gravity provides a non-pulsatile fluid flow, but fluid pressure control is inadequate. Similarly, a pressure cuff or chamber provides a non-pulsatile fluid flow, but fluid pressure control is inadequate unless the pressure within the cuff or chamber is constantly adjusted to account for the volume of fluid exiting the fluid supply bag. A peristaltic pump can provide good pressure control, but the pulsatility of the fluid flow can impair expansion and visualization at the surgical site.

[0004] Fluid management systems can warm fluids to help mitigate or prevent intraoperative hypothermia, which can lead to adverse events. However, such systems may lack precise fluid temperature control, the ability to adequately warm the fluid at the high fluid flow rates required for many procedures, and / or other capabilities required for specific surgical procedures (e.g., fluid defect monitoring required for surgical hysteroscopy). In facilities lacking a fluid management system with fluid warming capabilities, fluid bags may be preheated in a warming cabinet before use during surgery. However, the use of such warming cabinets may result in dangerously hot fluids, or, if the preheated fluid is not used immediately after the preheating process is complete, it may cool to room temperature, potentially contributing to intraoperative hypothermia.

[0005] A fluid management system may include a deficit monitoring system for calculating the deficit between the amount of fluid supplied to the surgical site and the amount of fluid returned from the surgical site. Currently, fluid deficit monitoring is achieved by subtracting the volume of fluid supplied to the surgical site from the volume of fluid returned from the surgical site to a fluid collection canister, bag, or container. The volume of fluid supplied is determined by monitoring the weight of the fluid source bag, counting the rotations of the peristaltic pump, and / or manually recording the number and volume of fluid bags used during surgery. The volume of fluid returned is determined by monitoring the weight of the canister, bag, or container, and / or manually observing and recording the fluid level in such canister, bag, or container using scale marks. To allow the fluid returned from the surgical site to move into the fluid collection canister, the canister is interconnected with a tandem tube and connected to the surgical site and the suction source. If the fluid collection canister becomes full during surgery, the procedure must be interrupted to allow such canister to be replaced. This process typically involves interrupting suction, disconnecting the canister from the surgical site and suction source, disconnecting the tandem tube, replacing the full canister with a new one, interconnecting the new canister with the tandem tube, reconnecting the new canister to the surgical site and suction source, and resuming suction. Due to the collected blood, tissue, and contaminated bodily fluids, a full fluid collection canister requires regulated "red bag" disposal in most cases unless it is treated with a solidifying agent that allows for unregulated "white bag" disposal.

[0006] The fluid management system may be connected to an internal or external suction source to draw fluid from the surgical site. Since external suction sources are often set to high suction levels in the operating room environment, downregulation may be necessary for the proper operation of specific fluid outflow regulation, defect monitoring, and / or collection functions. Downregulation of the external suction source to provide the desired suction level can be achieved via a manually or electronically controlled regulator. To isolate the regulator from biotoxic fluids, a fluid collection canister, bag, or container is typically placed between the regulator and the surgical site. These canisters, bags, or containers must be removed and replaced after becoming full during surgery.

[0007] During endoscopic surgery, a temporary increase in fluid pressure and / or flow rate may be necessary to maintain or increase inflation and / or to maintain or increase fluid flow for procedural and / or visualization purposes. To provide such a temporary increase, the user may manually operate a syringe, valve, or similar device connected to the fluid inflow line of the surgical scope or instrument. Since the duration of any increase in fluid pressure and / or flow provided by these manual methods is limited to the volume of fluid contained in the syringe, valve, or similar device, the required increase in fluid pressure and / or flow may be interrupted while the syringe, valve, or similar device is refilled with fluid. In other examples, the user may increase fluid pressure by raising the height of a fluid supply bag, manually squeezing a fluid supply bag, or manually pumping the pressure in a pressure bag or cuff surrounding a fluid supply bag. Alternatively, in some examples, the user may increase the setpoint fluid pressure of the fluid management system via the user interface so that the setpoint fluid pressure is set to a higher setpoint fluid pressure, and then the user may decrease the setpoint fluid pressure to the original setpoint fluid pressure or another desired setpoint fluid pressure when an increase in pressure or flow is no longer needed. [Overview of the Initiative]

[0008] An exemplary embodiment of a fluid conditioner for a fluid management system includes a cartridge defining a first fluid chamber and a second fluid chamber. The first fluid chamber receives fluid from a fluid source, and the second fluid chamber receives fluid from the first fluid chamber. At least a portion of the cartridge allows one or more non-contact sensors of the fluid management system to detect at least one characteristic of the fluid moving through the cartridge.

[0009] An exemplary embodiment of a piping set for a fluid management system includes a fluid conditioner, a first pipe, and a second pipe. The fluid conditioner includes a cartridge defining a first fluid chamber and a second fluid chamber, the first fluid chamber receiving fluid from a fluid source, and the second fluid chamber receiving fluid from the first fluid chamber. The second fluid chamber has an outlet for fluid connection of the second fluid chamber to a surgical instrument. The first pipe fluid connection the fluid conditioner to the fluid source, and the second pipe fluid connection the fluid conditioner to the surgical instrument. At least a portion of the cartridge allows one or more non-contact sensors of the fluid management system to detect at least one characteristic of the fluid passing through the cartridge.

[0010] An exemplary embodiment of a fluid management system includes a pump, a control system, and a fluid conditioning unit. The pump delivers fluid from at least one fluid supply container to a surgical site. The control system operates the pump and includes a user interface and one or more non-contact sensors. The user interface enables communication between the control system and the user, including inputting data to the control system. The one or more non-contact sensors detect one or more characteristics of the fluid delivered to the surgical site. The fluid conditioning unit receives the fluid conditioner, which is connected to the pump so that the fluid delivered from the pump travels through the fluid conditioner before moving to the surgical site.

[0011] An exemplary method for monitoring the flow of fluid through a fluid management system includes configuring the control system of the fluid management system to detect the presence of the fluid at one or more locations between the pump and the surgical site using one or more fluid presence sensors. The method further includes configuring the control system to provide notification to the user via a user interface when at least one fluid presence sensor does not detect fluid.

[0012] An exemplary embodiment of a cartridge assembly for a fluid management system includes a fluid conditioner and a fluid heating cartridge. The fluid conditioner has a cartridge defining a first fluid chamber and a second fluid chamber, and at least a portion of the cartridge allows one or more non-contact sensors of the fluid management system to detect at least one characteristic of the fluid moving through the cartridge. The fluid heating cartridge has conduits that are fluidly connected to the first and second fluid chambers of the fluid conditioner so that the first and second fluid chambers are fluidly connected. The fluid heating cartridge allows a heating source of the fluid management system to heat the fluid moving through the conduits when the fluid heating cartridge is used with the fluid management system.

[0013] An exemplary embodiment of a cartridge assembly for a fluid management system includes a fluid conditioner and a pulse damping cartridge. The fluid conditioner has a cartridge defining a first fluid chamber and a second fluid chamber, the first fluid chamber receiving fluid from a fluid source, and the second fluid chamber receiving fluid from the first fluid chamber. At least a portion of the cartridge allows one or more non-contact sensors of the fluid management system to detect at least one characteristic of the fluid moving through the cartridge. The pulse damping component includes at least one flexible sheet defining a conduit, the conduit fluid-connecting the first and second fluid chambers so that the fluid received into the first fluid chamber from the fluid source moves through the conduit into the second fluid chamber. The flexible side sheet expands and contracts as the pressure of the fluid moving through the conduit fluctuates to reduce the pulsation of the fluid.

[0014] An exemplary embodiment of a fluid management system includes at least one fluid supply vessel, a pump, and a control system. The pump delivers fluid from the fluid supply vessel to a surgical site. The control system operates the pump and includes a user interface for communication between the control system and a user, a bolus device operably connected to the pump, and at least one processor operably connected to the user interface, the bolus device, and the pump. The user interface allows the user to input at least one of a setpoint flow rate and a setpoint pressure of the fluid delivered from the pump. The bolus device allows the user to increase at least one of the setpoint flow rates and the setpoint pressure of the fluid to a temporary pressure when the user activates the bolus device. The processor causes the pump to return to the setpoint flow rate and setpoint pressure when the bolus device is stopped.

[0015] An exemplary embodiment of a fluid management system includes at least one fluid supply vessel, a pump, and a control system. The pump delivers fluid from the fluid supply vessel to a surgical site. The control system operates the pump and includes a user interface for communication between the control system and a user, a temporary adjuster (temporary adjuster) operably connected to the pump, and at least one processor operably connected to the user interface, the temporary adjuster, and the pump. The user interface allows the user to input at least one of a setpoint flow rate and a setpoint pressure of the fluid delivered from the pump. If the user has input a setpoint flow rate, the temporary adjuster allows the user to increase the setpoint flow rate of the fluid to an increased temporary flow rate and decrease the setpoint flow rate of the fluid to a decreased temporary flow rate when the user operates the temporary adjuster. When the user inputs a setpoint pressure, the temporary adjustment device also allows the user to increase the setpoint pressure of the fluid to the increased temporary pressure and decrease the setpoint pressure of the fluid to the decreased temporary pressure when the user activates the temporary adjustment device. When the temporary adjustment device is stopped, the processor causes the pump to return to the setpoint flow rate and setpoint pressure.

[0016] An exemplary embodiment of a fluid management system includes a control system having a printer and at least one processor operably connected to the printer. The processor is configured to cause the printer to print one or more documents displaying information about the surgical procedure at any point during the procedure, at set time increments during the procedure, and / or at the end of the procedure. The information about the surgical procedure includes at least one of the following: the date of the surgical procedure, the type of the surgical procedure, the start time of the surgical procedure, the end time of the surgical procedure, the volume of fluid pumped during the surgical procedure, the fluid deficit of the surgical procedure, the fluid deficit at set time intervals during the surgical procedure, the average fluid pressure during the surgical procedure, the presence of a fluid to be heated during the surgical procedure, the average fluid temperature during the surgical procedure, equipment information, physician information, and patient information.

[0017] An exemplary embodiment of a fluid management system for supplying at least two types of fluids to a surgical site includes a pump and a control system. The pump is configured to deliver a first fluid from a first fluid supply container and a second fluid from a second fluid supply container to the surgical site. The control system includes a user interface for communication between the control system and a user, and at least one processor operably connected to the user interface, the pump, and the first and second fluid supply containers. The processor monitors the amount of fluid in each of the first and second fluid supply containers to determine whether the first or second fluid is being delivered to the surgical site by the pump. The processor determines when one of the first and second fluids is being delivered to the surgical site by the pump, and the other of the first and second fluids is desired by the user at the surgical site.

[0018] A method for supplying at least two types of fluids to a surgical site includes configuring a control system for a fluid management system to instruct a user to place a first fluid supply container having a first fluid on a first suspension member of the fluid management system, and to instruct a user to place a second fluid supply container having a second fluid on a second suspension member of the fluid management system. The method further includes configuring the control system to instruct the user to fluidly connect the first fluid supply container to the pump and to start the pump to supply the first fluid to the surgical site after receiving an instruction from the user to supply the first fluid to the surgical site. The method also includes configuring the control system to instruct the user to stop the pump and to fluidly disconnect the first fluid supply container from the pump and to fluidly connect the second fluid to the pump after receiving an instruction from the user to supply the second fluid type to the surgical site. The method further includes configuring the control system to start the pump to supply the second fluid type to the surgical site.

[0019] An exemplary embodiment of a fluid management system includes at least one fluid supply vessel, a pump for delivering fluid from the fluid supply vessel to surgical instruments at the surgical site, and a control system for operating the pump. The control system includes a user interface for communication between the control system and a user, and at least one processor operably connected to the user interface and the pump. The control system can be configured to operate the fluid management system during surgery in one of a first pressure control mode, a second pressure control mode, and a third pressure control mode. The first pressure control mode includes the control system matching a first pressure of the fluid in the fluid management system to a first desired pressure in the fluid management system, set by the user via the user interface. The second pressure control mode includes the control system matching a second pressure of the fluid at the surgical instruments to a second desired pressure of the fluid at the surgical instruments, set by the user via the user interface. The third pressure control mode includes the control system matching the third pressure of the fluid in the patient's body cavity to a third desired pressure of the fluid in the body cavity, which is set by the user via the user interface.

[0020] An exemplary method for enabling or disabling the heating function of a heating assembly for a fluid management system includes configuring the control system to detect the presence of a heating cartridge aligned with the heating assembly using one or more sensors of the fluid management system. The method further includes configuring the control system to enable the heating function of the heating assembly when the sensors detect the presence of the heating cartridge, and to disable the heating function when the sensors do not detect the presence of the heating cartridge.

[0021] An exemplary embodiment of a fluid management system includes at least one fluid supply container, a pump for delivering fluid from the fluid supply container to the surgical site, and a control system for operating the pump. The control system includes a user interface for communication between the control system and a user, and at least one processor operably connected to the user interface and the pump. The control system operates the fluid management system in a first control mode that allows the user to adjust at least one of a visualization condition and an inflation condition at the surgical site. The user adjusts the visualization condition by increasing or decreasing a visualization setting in the user interface, and the user adjusts the inflation condition by increasing or decreasing an inflation setting in the user interface. The processor adjusts the speed of the pump based on the desired visualization condition and the desired inflation condition, as indicated by the user via the user interface.

[0022] An exemplary embodiment of a fluid management system includes a main unit and one or more optional modules. The main unit has a pump configured to deliver fluid from at least one fluid supply container to a surgical site and a control system including at least one processor. The one or more optional modules are operably connected to the processor of the control system. The one or more optional modules include at least one of the following: a defect module for monitoring the amount of fluid returning from the surgical site; a suction module for adjusting the vacuum pressure applied to the surgical site; a fluid collection module for collecting fluid from the surgical site; a fluid suction collection module for returning and collecting fluid from the surgical site; and a fluid discharge module. The fluid management system is configurable between a plurality of configurations. In a first configuration, none of the optional modules are operably connected to the processor of the main unit. In a second configuration, one of the optional modules is operably connected to the processor of the main unit. In a third configuration, at least two of the optional modules are operably connected to the processor of the main unit.

[0023] An exemplary embodiment of a fluid management system includes a main unit, a defect module, and a fluid collection module. The main unit has a pump for delivering fluid from at least one fluid supply container to the surgical site, and a control system including at least one processor. The defect module is detachably and operably coupled to the main unit, and the defect module is configured to monitor the amount of fluid returning from the surgical site. The fluid collection module is detachably and operably coupled to the main unit, and the fluid collection module includes a collection chamber for receiving fluid from the surgical site.

[0024] An exemplary embodiment of a fluid heating cartridge for a fluid management system includes a rigid body, a first flexible side sheet, and a second flexible side sheet. The rigid body has a first side and a second side, and the rigid body absorbs IR energy provided from a heating source of the fluid management system. The first flexible side sheet is attached to the first side of the rigid body such that the first flexible side sheet and the first side of the rigid body define a first fluid path. The second flexible side sheet is attached to the second side of the rigid body such that the second flexible side sheet and the second side of the rigid body define a second fluid path, and the second fluid path is in fluid communication with the first fluid path. The first and second flexible side sheets are capable of transmitting the IR energy provided by the heating source of the fluid management system so that the IR energy heats the fluid moving through the second fluid path.

[0025] An exemplary embodiment of a fluid management system includes a pump, a control system, a heating assembly, and a fluid heating cartridge. The pump delivers fluid from at least one fluid supply vessel to the surgical site. The control system includes a user interface for communication between the control system and the user, including operating the pump and inputting data into the control system. The heating assembly has a heating source and receives the fluid heating cartridge so that the fluid heating cartridge is aligned with the heating source. The fluid heating cartridge includes a rigid body that absorbs IR energy provided from the heating source and at least one flexible side sheet attached to the rigid body, the flexible side sheet and the rigid body defining a conduit. The flexible side sheet is capable of transmitting the IR energy provided by the heating source so that the IR energy heats the fluid as it moves through the conduit. The fluid heating cartridge is fluidly connected to the pump so that the fluid delivered from the pump moves through the conduit before moving to the surgical site. The control system controls the amount of heat provided by the heating source to cause the fluid discharged from the fluid heating cartridge to correspond to (match) a desired fluid temperature set by the user via the user interface.

[0026] An exemplary embodiment of a cartridge assembly for a fluid management system includes a fluid conditioner and a fluid heating cartridge. The fluid conditioner has a cartridge defining a first fluid chamber and a second fluid chamber, and at least a portion of the cartridge allows one or more non-contact sensors of the fluid management system to detect at least one characteristic of the fluid moving through the cartridge. The fluid heating cartridge has conduits that are fluidly connected to the first and second fluid chambers of the fluid conditioner so that the first and second fluid chambers are fluidly connected. The fluid heating cartridge allows a heating source of the fluid management system to heat the fluid moving through the conduits when the fluid heating cartridge is used with the fluid management system.

[0027] An exemplary method for monitoring the flow of fluid through a fluid management system includes configuring the control system of the fluid management system to detect a first temperature of the fluid at one or more first locations between the fluid supply container and the heating cartridge using one or more first non-contact fluid temperature sensors, and to detect a second temperature of the fluid at one or more second locations between the heating cartridge and the surgical site using one or more second non-contact fluid temperature sensors. The method further includes configuring the control system to adjust the fluid temperature of the fluid based on the detected first temperature, the detected second temperature, and one of a desired temperature provided by the user or a default temperature of the fluid management system by adjusting the level of IR energy supplied to the heating cartridge by the heating source.

[0028] An exemplary method of supplying a desired voltage to a first lamp and a second lamp of a lamp assembly using a control system of a fluid management system includes configuring the control system to maintain one or more relay switches in a first position such that the first lamp and the second lamp are in a parallel configuration when the desired voltage is being supplied to the lamp assembly. The method further includes configuring the control system to move the one or more relay switches to a second position such that the first lamp and the second lamp are in a series configuration when the voltage being supplied to the lamp assembly is greater than a predetermined voltage that is greater than the desired voltage.

[0029] An exemplary embodiment of a missing cartridge for a fluid management system includes a cartridge, a first valve, a second valve, at least one inlet opening, and a vacuum opening. The cartridge defines a chamber including a fluid-connected first section, a second section, and a third section. The first valve is disposed between the first section and the second section and is movable between an open position and a closed position. The second valve is disposed between the second section and the third section and is movable between an open position and a closed position. The inlet opening is in fluid communication with the first section for receiving fluid from a surgical site, and the vacuum opening is in fluid communication with the third section for receiving a vacuum pressure that creates a negative pressure within the chamber and draws fluid from the surgical site into the first section through the inlet opening.

[0030] An exemplary embodiment of a deficit cartridge for a fluid management system includes a cartridge defining a chamber, at least one inlet opening, and a vacuum opening. The inlet opening is in fluid communication with the chamber for receiving fluid from the surgical site, and the vacuum opening is in fluid communication with the chamber for receiving the vacuum pressure. At least a portion of the cartridge enables one or more fluid sensors of the fluid management system to detect the amount of fluid moving through the chamber without contacting the fluid.

[0031] An exemplary embodiment of a disposable tubing set for a fluid management system includes at least one fluid return tube for fluid connection to a surgical site, a deficit cartridge fluid-connected to the fluid return tube, and a discharge tube fluid-connected to the deficit cartridge. The deficit cartridge includes a cartridge defining a chamber, a first valve, a second valve, at least one inlet opening, and a vacuum opening. The cartridge defines a chamber including a fluid-connected first section, a second section, and a third section. The first valve is disposed between the first section and the second section and is movable between an open position and a closed position, and the second valve is disposed between the second section and the third section and is movable between an open position and a closed position. The inlet opening is in fluid communication with the first section of the chamber and the fluid return tube, and the vacuum opening is in fluid communication with the third section of the chamber. The discharge tube is fluid-connected to the vacuum opening and is configured to be fluid-connected to a suction source, and a negative pressure is generated in the chamber by the vacuum pressure applied by the suction source, and fluid from the surgical site enters the first section of the chamber through the return tube and the fluid inlet.

[0032] An exemplary embodiment of a fluid management system includes a defect module and a defect cartridge. The defect module includes at least one fluid presence sensor. The defect cartridge is configured to be detachably connected to the defect module and includes a cartridge, a first valve, a second valve, at least one inlet opening, and a vacuum opening. The cartridge defines a chamber including a fluid-connected first section, a second section, and a third section. The first valve is located between the first section and the second section and is movable between an open position and a closed position, and the second valve is located between the second section and the third section and is movable between an open position and a closed position. The inlet opening fluid-communicates with the first section to receive fluid from a surgical site, and the vacuum opening fluid-communicates with the third section to receive (receive) vacuum pressure from a suction source. The first fluid presence sensor is aligned with a first region of the second section when the disposable defect cartridge is connected to the defect module.

[0033] An exemplary embodiment of a fluid management system includes a pump, a control system, and a disposable piping set. The pump delivers fluid from at least one fluid supply container to a surgical site. The control system includes at least one processor and one or more fluid sensors. The disposable piping set is detachably connected to the fluid management system and includes at least one fluid return tube for fluid connection to the surgical site, a discharge tube fluid-connected to a suction source, and a defect cartridge fluid-connected to the fluid return tube and the discharge tube. The defect cartridge includes a cartridge defining a chamber aligned with at least one fluid sensor of the control system. The defect cartridge also includes at least one inlet opening fluid-communicating with the fluid return tube and a vacuum opening fluid-communicating with the discharge tube. The processor of the control system is configured to determine a fluid defect between the fluid supplied to the surgical site and the fluid returned from the surgical site through the defect cartridge, based at least on data obtained from the at least one fluid sensor aligned with the chamber of the defect cartridge.

[0034] An exemplary method for determining the amount of fluid moving through a missing cartridge of a fluid management system during surgery includes configuring the control system of the fluid management system to detect the presence of fluid at a first position within a second section of the missing cartridge and to close a first valve of the missing cartridge to prevent the fluid from moving from the first section of the missing cartridge into the second section of the missing cartridge. The method further includes configuring the control system to determine the volume of fluid in the second section based on the detected presence of the fluid at the first position, and, after detecting the presence of the fluid at the first position, to open a second valve of the missing cartridge to allow the fluid to move from the second section of the missing cartridge into the third section of the missing cartridge.

[0035] An exemplary fluid management system for transferring fluid from a surgical site to a drain of equipment includes a discharge module, a control system, and a deficiency cartridge. The discharge module has at least one fluid presence sensor. The control system has at least one processor operably connected to a first fluid presence sensor of the discharge module. The deficiency cartridge is configured to be detachably connected to the discharge module and includes a cartridge, a first valve, a second valve, at least one inlet opening, and a vacuum opening. The cartridge defines a chamber having a fluid-connected first section, a second section, and a third section. The first valve is located between the first section and the second section and is movable between an open position and a closed position by the discharge module. The second valve is located between the second section and the third section and is movable between an open position and a closed position by the discharge module. The inlet opening is in fluid communication with the first section to receive fluid from the surgical site, and the vacuum opening is in fluid communication with the third section to receive vacuum pressure from a suction source that moves fluid from the surgical site into the defect cartridge and from the defect cartridge into the drain of the equipment. The first fluid presence sensor of the discharge module is aligned with a first region of the second section when the defect cartridge is connected to the discharge module, and the processor determines the volume of fluid that has moved into the drain of the equipment, based at least on data received from the first fluid presence sensor of the discharge module.

[0036] An exemplary embodiment of a fluid management system includes a pump, a control system, and a defect cartridge. The pump delivers a first fluid from a first fluid supply container and a second fluid from a second fluid supply container to the surgical site. The control system includes at least one processor and one or more fluid sensors. The defect cartridge is aligned with the fluid sensors of the control system and positioned so that a suction source pulls the first and second fluids from the surgical site into and out of the defect cartridge. The processor of the control system determines a first fluid defect in the first fluid and a second fluid defect in the second fluid, based at least on data obtained from the one or more fluid sensors that monitor the first and second fluids moving through the defect cartridge.

[0037] An exemplary method for monitoring a first fluid deficit for a first fluid and a second fluid deficit for a second fluid during surgery using a fluid management system includes configuring a control system for the fluid management system to determine whether the pump is pumping the first fluid or the second fluid to the surgical site. The method further includes configuring the control system to detect a first supply volume of the first fluid moving to the surgical site, a first fluid return volume of the first fluid moving through the deficit cartridge of the fluid management system after leaving the surgical site, and to calculate the first fluid deficit based on the detected first supply volume and the detected first return volume. The method further includes configuring the control system to detect a second supply volume of the second fluid moving to the surgical site, a second fluid return volume of the second fluid moving through the deficit cartridge after leaving the surgical site, and to calculate the second fluid deficit based on the detected second supply volume and the detected second return volume.

[0038] An exemplary embodiment of a fluid management system includes a pump and a control system. The pump delivers at least one fluid from a fluid container to a surgical site. The control system includes a printer and at least one processor operably connected to the printer, configured to calculate fluid deficits for at least one fluid type. The processor is configured to cause the printer to print one or more documents displaying the calculated fluid deficits for the at least one fluid from the fluid container.

[0039] An exemplary embodiment of a fluid management system includes a raised structure and a control system. The raised structure has two or more suspension members capable of receiving a fluid supply container or a fluid return container. The control system includes a user interface for communication between the control system and the user, at least one processor operationally connected to the user interface, and the two or more suspension members. The user interface instructs the user to suspend the fluid supply container, and the processor monitors a first weight change of the two or more suspension members and designates the first suspension member as the fluid supply suspension member. The control system, via the user interface, instructs the user to suspend the fluid return container, and the processor monitors a second weight change of the two or more suspension members and designates the second suspension member as the fluid return suspension member.

[0040] An exemplary method for determining a fluid deficit between the amount of supply fluid provided to a surgical site by a fluid management system and the amount of return fluid returning from the surgical site to the fluid management system includes configuring the control system of the fluid management system to designate one of a first suspension member and a second suspension member of the fluid management system as a fluid supply suspension member based on a user suspending a fluid supply container from one of the first and second suspension members. The method further includes configuring the control system to designate the other of the first and second suspension members as a fluid return suspension member based on a user suspending a fluid return container from the other of the first and second suspension members. The method further includes configuring the control system to monitor a first force provided to the supply suspension member and determine the amount of supply fluid provided to the surgical site based on the monitored first force. The method further includes configuring the control system to monitor a second force provided to the return suspension member and determine the amount of return fluid returning from the surgical site based on the monitored second force. The method also includes configuring the control system to calculate the fluid deficit based on the determined amount of supply fluid and the determined amount of return fluid.

[0041] An exemplary embodiment of a pressure regulator includes a first chamber, a second chamber, a third chamber, and a flexible membrane. The first chamber has an inlet opening for fluid connection to an external pressure source, the second chamber has an outlet opening for supplying regulated pressure to a regulated source, and the third chamber has a pressure opening for connection to a pressure source. The flexible membrane fluidly isolates the third chamber from both the first and second chambers, and the flexible membrane is movable by the pressure source between a first position in which the flexible membrane fluidly isolates the first chamber from the second chamber and a second position in which the first and second chambers are fluidly connected.

[0042] An exemplary embodiment of a pressure regulator includes a first chamber, a second chamber, a third chamber, a fourth chamber, and a flexible membrane. The first chamber has an inlet opening for fluid connection to an external pressure source, and the second chamber has an outlet opening for supplying regulated pressure to a regulated source. The third chamber has a pressure opening for connection to the pressure source, and the fourth chamber has a sensing opening for connection to a pressure sensor that senses the pressure in the fourth chamber. The flexible membrane fluidly isolates the third and fourth chambers from both the first and second chambers. The flexible membrane is movable by vacuum pressure applied to the first chamber so that the third and fourth chambers are fluidly connected, and is movable by pressure applied by the pressure source so that the first and second chambers are fluidly connected.

[0043] An exemplary embodiment of the fluid management system includes a pump and a disposable pressure regulator. The pump delivers fluid from a fluid supply container to the surgical site. The disposable pressure regulator is positioned between the surgical site and an external vacuum source. The disposable pressure regulator regulates the vacuum pressure supplied to the surgical site by the external vacuum source, and the fluid from the surgical site passes through the pressure regulator before being discharged by the fluid management system.

[0044] An exemplary embodiment of a fluid management system includes a pump and a suction module assembly. The pump delivers fluid from a fluid supply container to a surgical site. The suction module assembly is connected to an external vacuum source and is positioned between the surgical site and the vacuum source. The suction module assembly includes a suction module and a pressure regulator. The suction module has a pressure source and a pressure sensor. The pressure regulator is detachably connected to the suction module and includes a first chamber, a second chamber, a third chamber, and a flexible membrane. The first chamber has an inlet opening for fluid connection to an external vacuum source, the second chamber has an outlet opening for supplying regulated pressure to a regulated source, and the third chamber has one or more openings for connection to the pressure source and pressure sensor of the suction module. The flexible membrane fluidly isolates the third chamber from both the first and second chambers, and the flexible membrane is movable by the pressure source between a first position in which the flexible membrane fluidly isolates the first chamber from the second chamber and a second position in which the first and second chambers are fluidly connected.

[0045] An exemplary embodiment of a fluid management system includes a pump and a suction module assembly. The pump delivers fluid from a fluid supply container to a surgical site. The suction module assembly is connected to an external vacuum source and is positioned between the surgical site and the vacuum source. The suction module assembly includes a suction module and a pressure regulator. The suction module has a pressure source and a pressure sensor. The pressure regulator is detachably connected to the suction module and includes a first chamber, a second chamber, a third chamber, a fourth chamber, and a flexible membrane. The first chamber has an inlet opening for fluid connection to the external vacuum source, and the second chamber has an outlet opening for supplying regulated pressure to a regulated source. The third chamber has a pressure opening for connection to the pressure source of the suction module, and the fourth chamber has a sensing opening for connection to the pressure sensor of the suction module. The flexible membrane fluidically isolates the third and fourth chambers from both the first and second chambers. The flexible membrane is movable by the external vacuum source so that the third and fourth chambers are fluidly connected, and the flexible membrane is movable by the pressure applied by the pressure source so that the first and second chambers are fluidly connected.

[0046] An exemplary method for regulating the vacuum pressure supplied to a surgical site using a fluid management system includes configuring the control system of the fluid management system to provide a first vacuum pressure from the pressure source to the pressure regulator of the fluid management system, thereby moving a flexible membrane located within the pressure regulator from a first position where the flexible membrane fluidly isolates the external vacuum source from the surgical site to a second position where the vacuum source and the surgical site are fluidly connected. The movement of the flexible membrane to the second position causes the vacuum pressure supplied to the surgical site to pull fluid from the surgical site through the disposable pressure regulator before it is discharged by the fluid management system.

[0047] An exemplary method for regulating the vacuum pressure supplied to a surgical site using a fluid management system includes configuring the control system of the fluid management system to provide a first vacuum pressure from the pressure source to the pressure regulator of the fluid management system, thereby moving a flexible membrane located within the pressure regulator from a first position in which the flexible membrane fluidly isolates the external vacuum source from the surgical site to a second position in which the vacuum source and the surgical site are fluidly connected. The movement of the flexible membrane to the second position causes the vacuum pressure supplied to the surgical site to draw fluid from the surgical site into a fluid collection canister located between the surgical site and the pressure regulator. [Brief explanation of the drawing]

[0048] [Figure 1] Figure 1 shows an exemplary embodiment of a fluid control system for an operating room environment.

[0049] [Figure 2] Figure 2 shows an exemplary embodiment of the main unit of the fluid management system shown in Figure 1.

[0050] [Figure 3] Figure 3 shows an exemplary embodiment of the heater and fluid conditioner assembly of the main unit shown in Figure 2.

[0051] [Figure 4] Figure 4 shows an exemplary cartridge assembly for insertion into the heater and fluid conditioner assembly shown in Figure 3.

[0052] [Figure 5] Figure 5 shows an exemplary fluid conditioner and fluid heating cartridge of the cartridge assembly from Figure 4, separated from each other.

[0053] [Figure 6] Figure 6 shows an exemplary fluid path through the cartridge assembly shown in Figure 4.

[0054] [Figure 7] Figure 7 shows an exploded view of the IR lamp subassembly of the heater assembly in Figure 3, which has the cartridge assembly in Figure 4.

[0055] [Figure 7A] Figure 7A shows an exemplary embodiment of a threshold detector in a crossover circuit.

[0056] [Figure 7B] Figure 7B shows an exemplary embodiment of a relay bank for interacting with the crossover circuit of Figure 7A, with the relay bank switch in the first position.

[0057] [Figure 7C] Figure 7C shows the relay bank in Figure 7B with the relay bank switch in the second position.

[0058] [Figure 8] Figure 8 shows another exemplary embodiment of a fluid conditioner for insertion into a fluid conditioning assembly of a fluid management system.

[0059] [Figure 9] Figure 9 shows an exemplary alignment between the fluid conditioner in Figure 5 and the fluid conditioning assembly in Figure 3.

[0060] [Figure 10] Figure 10 shows a cross-sectional view of an exemplary embodiment of the fluid conditioner for the cartridge assembly shown in Figure 4.

[0061] [Figure 11] Figure 11 shows the position of the fluid conditioner aligned with the sensor of the fluid conditioning assembly in Figure 3, illustrating the fluid conditioner in Figure 10.

[0062] [Figure 12] Figure 12 shows a perspective view of the fluid conditioner shown in Figure 10.

[0063] [Figure 13] Figure 10 is an exploded perspective view of the fluid conditioner.

[0064] [Figure 14] Figure 14 shows a perspective view of an exemplary fluid heating cartridge from the cartridge assembly in Figure 4.

[0065] [Figure 15] Figure 15 shows an exploded perspective view of the fluid heating cartridge shown in Figure 14.

[0066] [Figure 16] Figure 16 shows a front view of the fluid heating cartridge shown in Figure 14 when the fluid moving through it is at low pressure.

[0067] [Figure 17] Figure 17 shows a front view of the fluid heating cartridge shown in Figure 14, when the fluid moving through it is under high pressure.

[0068] [Figure 18] Figure 18 shows a cross-sectional front view of the fluid heating cartridge shown in Figure 14, when the fluid moving through it is under high pressure.

[0069] [Figure 19] Figure 19 shows an exemplary embodiment of the main unit for the fluid management system of Figure 1, the main unit including an opening for drawing air through the heater assembly of the main unit for cooling purposes, and another opening for discharging the resulting warm air onto or near one or more fluid supply bags or containers suspended from the fluid management system to preheat the fluid.

[0070] [Figure 20]Figure 20 shows a perspective view of an exemplary embodiment of a missing module and missing cartridge for the fluid management system of Figure 1, with the missing cartridge inserted into the missing module.

[0071] [Figure 21] Figure 21 shows a front view of the missing module and missing cartridge from Figure 20.

[0072] [Figure 22] Figure 22 is a right-hand perspective view of the missing module and missing cartridge shown in Figure 20, with the missing cartridge removed from the missing module.

[0073] [Figure 23] Figure 23 is a left-side perspective view of the missing module and missing cartridge shown in Figure 20, with the missing cartridge removed from the missing module.

[0074] [Figure 24] Figure 24 shows the rear view of the missing cartridge shown in Figure 20.

[0075] [Figure 25] Figure 25 shows a side view of the missing cartridge shown in Figure 20.

[0076] [Figure 26] Figure 26 shows a side view of the missing cartridge from Figure 20 with the valve and port cover removed.

[0077] [Figure 27] Figure 27 shows the missing cartridge of Figure 20 aligned with the movable manifold of the missing module of Figure 20, with the movable manifold in the open position relative to the missing cartridge.

[0078] [Figure 28]Figure 28 shows the movable manifold of the missing module in Figure 20 and the missing cartridge in Figure 20 aligned with it, with the movable manifold in the closed position relative to the missing cartridge so that a connection is made between the missing cartridge and the missing module.

[0079] [Figure 28A] , [Figure 28B] , [Figure 28C] Figures 28A–28C show exemplary connections between the port of the missing cartridge in Figure 20 and the connector of the movable manifold of the missing module in Figure 20.

[0080] [Figure 29] Figure 29 shows an exploded perspective view of the missing cartridge shown in Figure 20.

[0081] [Figure 30] Figure 30 shows a front view of the missing cartridge in Figure 20, aligned with the non-contact fluid presence sensor of the missing module in Figure 20.

[0082] [Figure 31] Figure 31 shows a perspective view of the missing cartridge from Figure 20, aligned with the non-contact fluid presence sensor of the missing module from Figure 20.

[0083] [Figure 32] Figure 32 shows a side view of the missing cartridge shown in Figure 20.

[0084] [Figure 33] Figure 33 shows a side view of the defective cartridge in Figure 20 when the fluid management system's defect monitoring function is in the fill / measure cycle.

[0085] [Figure 34] Figure 34 shows a side view of the defective cartridge in Figure 20 when the fluid management system's defect monitoring function is in the fill / discharge cycle.

[0086] [Figure 35] Figure 35 shows a cross-sectional top view of the missing module shown in Figure 20.

[0087] [Figure 36] Figure 36 shows an exploded perspective view of the missing module in Figure 20.

[0088] [Figure 37] Figure 37 shows a perspective view of an exemplary missing pump manifold assembly for the missing module in Figure 20.

[0089] [Figure 38] Figure 38 shows an exploded perspective view of an exemplary missing cartridge receiving assembly of the missing module in Figure 20 for receiving the missing cartridge in Figure 20.

[0090] [Figure 39] Figure 39 shows a perspective view of an exemplary manifold connection assembly for the missing module in Figure 20 and the missing cartridge receiving assembly in Figure 38.

[0091] [Figure 40] Figure 40 shows a left-side perspective view of the missing module in Figure 20.

[0092] [Figure 41] Figure 41 shows a right-hand perspective view of the missing module in Figure 20.

[0093] [Figure 42] Figure 42 shows a top view of the missing module in Figure 20.

[0094] [Figure 43] Figure 43 shows a cross-sectional view of the missing module in Figure 20 along line AA shown in Figure 42.

[0095] [Figure 44]Figure 44 shows a partial view of the missing module shown in Figure 43, illustrating an exemplary manifold connection assembly for connecting the missing cartridge shown in Figure 20, with the manifold connection assembly in the disengaged position relative to the missing cartridge.

[0096] [Figure 45] Figure 45 shows an exemplary engagement mechanism as shown in Figure 44, where the manifold connection assembly is in the disengaged position relative to the missing cartridge.

[0097] [Figure 46] Figure 46 shows a top view of the missing module in Figure 20.

[0098] [Figure 47] Figure 47 shows a cross-sectional view of the missing module in Figure 20 along line BB shown in Figure 46.

[0099] [Figure 48] Figure 48 shows a partial view of the missing module shown in Figure 43, illustrating the exemplary manifold connection assembly of Figure 44, where the manifold connection assembly is in a position engaged and connected to the missing cartridge.

[0100] [Figure 49] Figure 49 shows an exemplary engagement mechanism as shown in Figure 44, where the manifold connection assembly is in a position engaged and connected to the missing cartridge.

[0101] [Figure 50] Figure 50 shows another exemplary embodiment of the fluid management system shown in Figure 1.

[0102] [Figure 51] Figure 51 shows an exemplary embodiment of a fluid flow monitoring and discharge module for the fluid management system of Figure 50.

[0103] [Figure 52]Figure 52 shows a perspective view of an exemplary embodiment of a suction module and pressure regulator for the fluid management system of Figure 1, with the pressure regulator inserted into the suction module.

[0104] [Figure 53] Figure 53 shows a schematic diagram of an exemplary embodiment of the pressure regulator shown in Figure 52.

[0105] [Figure 54] Figure 54 shows a schematic diagram of another exemplary embodiment of the pressure regulator shown in Figure 52.

[0106] [Figure 55] Figure 55 shows a schematic diagram of the pressure regulator shown in Figure 54, illustrating the valves of the pressure regulator arranged in series.

[0107] [Figure 56] Figure 56 shows a rear perspective view of an exemplary embodiment of the pressure regulator shown in Figure 54.

[0108] [Figure 57] Figure 57 shows a front perspective view of the pressure regulator shown in Figure 56.

[0109] [Figure 58] Figure 58 shows an exploded perspective view of the pressure regulator shown in Figure 56.

[0110] [Figure 59] Figure 59 shows a top view of the pressure regulator shown in Figure 56.

[0111] [Figure 60] Figure 60 shows a rear view of the pressure regulator shown in Figure 56.

[0112] [Figure 61] Figure 61 shows a bottom view of the pressure regulator shown in Figure 56.

[0113] [Figure 62] Figure 62 shows a side view of the pressure regulator shown in Figure 56.

[0114] [Figure 63] Figure 63 shows a cross-sectional view of the pressure regulator shown in Figure 56, cut along line CC shown in Figure 61.

[0115] [Figure 64] Figure 64 shows an exemplary perspective view of the connection between the pressure regulator shown in Figure 56 and an exemplary receiving mechanism for the suction module shown in Figure 52.

[0116] [Figure 65] Figure 65 shows a perspective view of another exemplary embodiment of the pressure regulator shown in Figure 54.

[0117] [Figure 66] Figure 66 shows an exploded perspective view of the pressure regulator shown in Figure 65.

[0118] [Figure 67] Figure 67 is a partial perspective view of the pressure regulator shown in Figure 65.

[0119] [Figure 68] Figure 68 shows a top view of the pressure regulator shown in Figure 65.

[0120] [Figure 69] Figure 69 shows a cross-sectional view of the pressure regulator shown in Figure 65, cut along line DD shown in Figure 68.

[0121] [Figure 70] Figure 70 shows a cross-sectional view of the pressure regulator shown in Figure 65, cut along line EE shown in Figure 68.

[0122] [Figure 71]Figure 71 shows a cross-sectional view of the pressure regulator shown in Figure 65, cut along the line FF shown in Figure 68.

[0123] [Figure 72] Figure 72 illustrates an exemplary top cross-sectional view of the connection between the pressure regulator shown in Figure 65 and an exemplary receiving mechanism for the suction module shown in Figure 52.

[0124] [Figure 73] Figure 73 shows a partial diagram of an exemplary connection between the pressure regulator and the receiving mechanism shown in Figure 72, illustrating the connection between the port of the pressure regulator and the port of the suction module.

[0125] [Figure 74] Figure 74 shows a side cross-sectional view of an exemplary embodiment of the suction module shown in Figure 52.

[0126] [Figure 75] Figure 75 shows a rearward perspective view of the suction module shown in Figure 74.

[0127] [Figure 76] Figure 76 shows an exemplary prompt to the user via the user interface by the fluid management system of Figure 1 regarding the type of action to be performed.

[0128] [Figure 77] Figure 77 shows another exemplary prompt to the user via the user interface by the fluid management system of Figure 1 regarding the type of action to be performed.

[0129] [Figure 78] Figure 78 shows an exemplary prompt to the user via the user interface by the fluid management system of Figure 1 regarding the number of fluid types used during the procedure.

[0130] [Figure 79] Figure 79 shows another exemplary prompt to the user via the user interface of the fluid management system in Figure 1 regarding the number of fluid types used during the procedure.

[0131] [Figure 80] Figure 80 shows another exemplary prompt to the user via the user interface of the fluid management system in Figure 1 regarding the number of fluid types used during the procedure.

[0132] [Figure 81] Figure 81 shows an exemplary embodiment of the action execution screen on the user interface of the fluid management system when the fluid management system is set to pressure control mode.

[0133] [Figure 81A] Figure 81A illustrates a means for calculating compensation height to calculate pressure in a surgical scope or instrument.

[0134] [Figure 82] Figure 82 shows an exemplary embodiment of the action setting screen on the user interface of the fluid management system.

[0135] [Figure 83] Figure 83 shows an exemplary embodiment of the procedure execution screen on the user interface of the fluid management system when the fluid management system is set to the "surgical site" control mode.

[0136] [Figure 84] Figure 84 shows a flowchart of the fluid management system operating in the surgical site control mode shown in Figure 83.

[0137] [Figure 85] Figure 85 shows an exemplary embodiment of a procedure setting screen on the user interface of a fluid management system, which includes the operation of a bolus device.

[0138] [Figure 86] Figure 86 shows the treatment settings screen from Figure 85.

[0139] [Figure 87] Figure 87 shows the treatment settings screen from Figure 85.

[0140] [Figure 88] Figure 88 shows an exemplary embodiment of a procedure settings screen on the user interface of a fluid management system, including the operation of the printer of the fluid management system.

[0141] [Figure 89] Figure 89 shows an exemplary embodiment of an action settings screen on the user interface of a fluid management system, which includes a warning setting to notify the user when the fluid supply container is depleted, and the system is set to a time limit.

[0142] [Figure 90] Figure 90 shows the treatment set screen from Figure 89, where the system is set to percentage settings.

[0143] [Figure 91] Figure 91 shows the action settings screen from Figure 89, where the system is in volume settings.

[0144] [Figure 92] Figure 92 shows an exemplary embodiment of a fluid management system for a physician's office environment, in which a fluid bag is attached to a suspension member of the fluid management system.

[0145] [Figure 93] Figure 93 shows the fluid management system of Figure 92, in which the fluid supply bag and fluid return canister are attached to the suspension member of the fluid management system. [Modes for carrying out the invention]

[0146] The descriptions of embodiments for carrying out the invention are illustrative and not intended to limit the scope of the claims in any way. In fact, the invention is broader than and not limited by the exemplary embodiments, and the terms used in the claims have their ordinary meanings unless specifically referred to in this application. Features and components of one exemplary embodiment may be incorporated into other exemplary embodiments. The inventions within the scope of this application may include additional features or have fewer features than those shown in the exemplary embodiments.

[0147] Where, as described herein, one or more components are described as being connected, joined, fixed, coupled, attached, or otherwise interconnected, such interconnections may be direct, such as between components, or indirect, such as through the use of one or more intermediate components. Also, as described herein, references to “member,” “component,” or “part” are not limited to a single structural member, component, or element, but may include assemblies of components, members, or elements. Also, as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0148] In endoscopic surgery, steady inflation and clear visibility are crucial for the effectiveness and efficiency of the procedure. Fluid management systems are used to supply fluid to the surgical site so that the surgeon has the desired inflation and visibility during the surgical procedure. Fluid management systems can also be used to remove fluid from the surgical site. Various embodiments of fluid management systems described herein relate to modular systems, including software-controlled, electromechanical devices or modules, which can be used alone or in combination with multi-purpose piping sets. The modular surgical fluid management systems described herein are fully configurable to meet user needs, for example, based on the type of surgical procedure (procedure) performed and the surgical environment. Exemplary functions of the fluid management systems described herein include fluid pressurization, fluid heating, fluid deficit monitoring, suction, suction adjustment, fluid collection, and / or fluid discharge to the waste disposal system of the facility. Fluid management systems can be configured based on the surgical field (e.g., gynecological, urological, and / or orthopedic) and environment (e.g., operating room or physician's clinic), as well as other needs and / or preferences of the user and / or facility. The fluid management system may be capable of integrated suction and fluid collection, and / or may be compatible with third-party suction and fluid collection devices, as well as the central suction system of the facility in which the fluid management system is used.

[0149] Referring to Figure 1, an exemplary embodiment of a fluid management system 100 for operating room environments in which gynecological, urological, and orthopedic surgeries are performed is shown. The system 100 includes a raised structure 101, a main unit 102, a defect module 104, a fluid collection module 106, and a fluid discharge module 108. The system 100 may also include a suction module 5201 (Figure 52) and / or a fluid flow discharge module 5101 (Figure 51). In some embodiments, the raised structure 101 includes wheels 103 so that the system 100 can be moved to a desired location or storage area within the operating room. The system 100 can be modular so that the system 100 described above can be configured as desired by the user.

[0150] The main unit 102 may have a control system including one or more processors (not shown) for controlling and / or communicating with various modules and components of system 100 or other equipment. Various modules and components may also have one or more processors (not shown) for performing designated functions and / or communicating with the control system of the main unit 102 or other equipment. The processors can execute instructions (e.g., software code) stored in the system 100's memory (not shown) and / or execute instructions entered into the system by a user. In one embodiment, the control system may have a "Bluetooth" function for connecting to remotely located components or modules of system 100, or other equipment, and a "Wi-Fi" function for connecting to the internet. The control system may include a touchscreen graphical user interface 110 for receiving one or more inputs from a user and displaying information about system 100 (e.g., information regarding fluid pressure, fluid volume, fluid temperature, fluid deficit, etc.).

[0151] Referring to Figures 1-3, the main unit 102 may also include a pump 212 for fluid pressurization (e.g., a peristaltic pump), a heater assembly 314 for fluid heating, a fluid conditioning assembly 315 for sensing one or more fluid properties (e.g., fluid presence, temperature, etc.), a suspension member 116 (e.g., a hook) for suspending fluid supply and / or return containers (e.g., bags, canisters, containers, etc.), and a printer 218 for printing relevant procedure information (e.g., information on procedure type, procedure start time, procedure end time, total fluid volume, average fluid pressure, total fluid deficit, deficit by fluid type, average fluid temperature, etc.) during or after surgery. The control system's processor can communicate with the pump 212, heater assembly 314, fluid conditioning assembly 315, pressure sensor 949 (Figure 9), solenoid valve 951 (Figure 9), suspension member 116, printer 218, defect module 104, fluid collection module 106, fluid discharge module 108, suction module 5201 (Figure 52), fluid flow discharge module 5101 (Figure 51), and / or any other components of system 100.

[0152] The pump 212 may be fluidly connected to one or more fluid containers suspended from the suspension member 116, so that the pump can pump fluid through piping to a surgical range or instrument (e.g., a hysteroscope, cystoscope, ureteroscope, nephroscope, etc.) at the surgical site. The piping set may also include a fluid conditioner (e.g., a fluid conditioner 420 shown in Figure 4 and described herein) that operates in conjunction with one or more non-contact sensors (e.g., non-contact sensors on the fluid conditioning assembly 315, or any other non-contact sensors in the system 100) so that the system 100 can monitor one or more characteristics of the fluid moving to the surgical site. The piping set may also include a fluid heating cartridge (e.g., a fluid heating cartridge 422 shown in Figure 4 and described herein) that operates in conjunction with a heater assembly 314 so that the system 100 can heat the fluid moving to the surgical site.

[0153] The suction source draws fluid from the surgical site through a piping set into the collection container of the collection module 106, into a third-party fluid collection system, or into the waste disposal system of the facility in which system 100 is used. In certain embodiments, the suction source is a vacuum pump integrated into the main unit 102 or the fluid collection module 106. In some embodiments, the fluid collection module also includes a pump and one or more filters, so that the fluid collection module can discharge and filter surgical fumes to remove potentially hazardous byproducts of electrosurgery.

[0154] Referring to Figure 1, the fluid collection module 106 may be independently movable and detachably connected to the raised structure 101 so that the module 106 can be removed from the raised structure 101 and transported to a waste disposal area or room for disposal of the collected fluid. In some embodiments, the collection container of the collection module 106 may include a disposable liner that can be easily replaced after the fluid has been discharged from the suction collection module 106 into the facility's waste treatment system. In some embodiments, the suction source is located outside the system 100 and draws the fluid into either the collection container of the collection module 106, a third-party fluid collection system, or the facility's waste treatment system. In embodiments where the fluid is drawn directly into the facility's waste treatment system, the collection module 106 may be bypassed or removed from the system 100 during use (for example, as shown in Figure 50). The fluid collection module 106 may include a processor that communicates with the main unit 102, the deficiency module 104, the suction module 5201 (Figure 52), other components of the system 100, and / or other facility equipment. In some embodiments, the fluid collection module 106 may include a weighing mechanism (e.g., a scale) that enables the fluid management system 100 to determine the volume of fluid returning from the surgical site for the purpose of monitoring fluid leakage and / or loss.

[0155] Before the fluid moves to the collection module 106, a third-party fluid collection system, or the facility's waste disposal system, the fluid can move through a single or multi-purpose defect cartridge (e.g., the defect cartridge 2010 shown in Figure 25 and described herein) so that the system 100 can calculate and monitor the fluid defect between the fluid supplied to the surgical site and the fluid returned from the surgical site. The defect cartridge can operate in conjunction with the defect module 104 (or the fluid flow discharge module 5101 shown in Figure 51 and described herein) and the main unit 102 to enable the system 100 to calculate and monitor the fluid defect.

[0156] In certain embodiments, the system 100 includes a suction module (e.g., a suction module 5201 shown in Figure 52 and described herein) and a single or multi-purpose pressure regulator (e.g., a pressure regulator 5205 shown in Figures 52-73 and described herein) which is fluid-connected to a piping set and a suction source. The pressure regulator and the suction module operate together and in combination with the main unit 102 to adjust the vacuum pressure provided to the surgical site by the suction source so that fluid can be drawn from the surgical site.

[0157] Figures 4 to 6 illustrate exemplary embodiments of a cartridge assembly 419 for a single or multi-purpose disposable piping set of system 100. The cartridge assembly 419 includes a fluid conditioner 420 and a fluid heating cartridge 422. The fluid conditioner 420 is configured to connect to the heating cartridge 422 to form the cartridge assembly 419 (as shown in Figure 4). Referring, for example, to Figure 5, the fluid conditioner 420 may have one or more connecting members 421 configured to connect to one or more connecting members 423 of the fluid heating cartridge 422. The connecting members 421, 423 of the fluid conditioner 420 and the fluid heating cartridge 422 may be connected by, for example, snap-fit ​​connections, friction-fit connections, etc. In other embodiments, the fluid conditioner 420 and the fluid heating cartridge 422 may be connected by adhesive, ultrasonic welding, or any other suitable means for joining the fluid conditioner and the fluid heating cartridge. In certain embodiments, the cartridge assembly 419 is a single, fully integrated component combining fluid conditioning and fluid heating functions. In these embodiments, the single, fully integrated component of the cartridge assembly 419 may be, for example, a single injection-molded component. In certain embodiments, the cartridge assembly 419 is provided as a fully assembled component of a single or multi-purpose piping set. In some embodiments, the fluid conditioner 420 is provided as a fully assembled component of a single or multi-purpose piping set (for example, including an assembly of the fluid conditioner 420 and piping 841 shown in Figure 8), and the heating cartridge 422 is provided as an accessory component that can be attached to the fluid conditioner 420 as needed. In such embodiments, the user may configure the piping set for fluid heating by removing piping 841 (Figure 8) from the fluid conditioner 420 and connecting the heating cartridge 422 to the fluid conditioner 420.

[0158] In certain embodiments, the main unit 102 can sense whether the fluid conditioner 420 is inserted into the system 100 alone (e.g., without the heating cartridge 422) or whether the cartridge assembly 419 (including the fluid conditioner 420 and the heating cartridge 422) is inserted into the system. For example, the main unit 102 may include one or more sensors (e.g., proximity sensors, mechanical sensors, optical sensors, laser sensors, etc.) that can detect whether the fluid conditioner 420 alone or the cartridge assembly 419 is inserted into the system 100. The control system of the system 100 may enable the fluid heating function of the system 100 (e.g., the heater assembly 314 shown in Figure 3) when the heating cartridge 422 is inserted into the system 100, and disable the heating function when the heating cartridge 422 is not inserted into the system 100.

[0159] Referring to Figure 6, during use of System 100, the fluid may be pumped through the first pipe 624 of the piping set to the inlet port 625 of the fluid conditioner 420. The fluid then flows through the inlet chamber 1053 (Figure 10) of the fluid conditioner along the first flow path 626, through the outlet port 527 (Figure 5) of the fluid conditioner 420, and through the inlet opening 528 (Figure 5) of the fluid heating cartridge 422. The fluid then moves along the fluid path 629 along the first side 1671 (Figures 16-18) of the heating cartridge 422, through the connector or piping 530, and enters the second side 1670 (Figures 16-18) of the fluid heating cartridge 422 along the path 631. Subsequently, the fluid exits the outlet opening 532 (Figure 5) and travels through the inlet port 533 (Figure 5) of the outlet chamber 1054 (Figure 10) of the fluid conditioner 420, and the fluid travels along the path 636 to exit the outlet 634 of the fluid conditioner 422 and travel through the piping 635 of the disposable piping set to the surgical instruments at the surgical site. Although the connector or piping 530 is shown as having a U-shape, the connector or piping can take any suitable form to fluidize the first and second sides of the heating cartridge 422. Although the first and second sides of the fluid heating cartridge are shown as fluidized by the connector or piping 530, it should be understood that the first and second sides can be fluidized without requiring the connector or piping 530. For example, the heating cartridge 422 may have channels that fluidize the first side and the second side.

[0160] In the illustrated embodiment, the fluid enters fluid path 629 through the inlet opening 528 (Figure 5) of the heating cartridge 422, at a lower position relative to the outlet of fluid path 629 at the inlet of the connector or piping 530, and enters fluid path 631 at the outlet of the connector or piping 530, at a lower position relative to the outlet opening 532 (Figure 5) of the heating cartridge 422. The configuration of the inlets and outlets of each of the fluid paths 629 and 631, with lower inlets and higher outlets, promotes more uniform and controlled heating by reducing eddy currents and areas of stagnant flow. Although the fluid is shown to take fluid paths 629 and 631 through the heating cartridge 422, it should be understood that the fluid can take any suitable path through the heating cartridge 422.

[0161] When the cartridge assembly 419 is inserted into the main unit 102 of the system 100, the fluid conditioner 420 aligns with the fluid conditioning assembly 315 (Figure 3), and the fluid heating cartridge 422 aligns with the heater assembly 314 (Figure 3). The fluid conditioner 420 may have a handle 442 that allows the user to easily insert the cartridge assembly 419 into the main unit 102.

[0162] Referring to Figure 7, the heater assembly 314 (Figure 3) may also include an IR lamp assembly 737 used to heat the fluid moving along the fluid paths 629, 631 (Figure 6) of the heating cartridge 422. The IR lamp assembly 737 may include a support structure 738, one or more elongated IR lamps having IR reflective coatings 739 positioned on each side of the heating cartridge 422, and parabolic reflectors 740 positioned on each side of the heating cartridge 422 so that the parabolic reflectors 740 focus the IR energy onto the fluid path. However, the heater assembly 314 may utilize other types of IR lamps such as valves, rings, panels, circular modules, or any other suitable form that can heat the fluid moving through the heating cartridge 422, or any other cartridge, piping, or container that can expose the fluid to the IR lamps.

[0163] Referring to Figure 8, in some embodiments, heating of the fluid during treatment may not be desired or necessary. In these embodiments where the fluid heating cartridge 422 is not required, a connector or piping 841 is used to connect the inlet chamber 1053 (Figure 10) and outlet chamber 1054 (Figure 10) of the fluid conditioner 420. Although the inlet and outlet chambers are shown as fluid-connected by the connector or piping 841, it should be understood that the inlet and outlet chambers can be fluid-connected without requiring the connector or piping 841. For example, the fluid conditioner 420 may have channels for fluid-connecting the inlet and outlet chambers.

[0164] In an alternative embodiment, instead of utilizing the connector or piping 841, the fluid conditioner 420 may be contained within a cartridge assembly having a pulse damping component (not shown) that is structurally similar to the heating cartridge 422 described later with reference to Figures 14-18, but the fluid damping component is not used for fluid heating. For example, the pulse damping component may include a rigid body (e.g., similar to the rigid body 1472 shown in Figures 14-18) and a flexible side sheet (e.g., similar to the flexible side sheets 1473, 1474 shown in Figures 14-18), where the rigid body and flexible side sheet at least partially define a fluid path connecting the inlet chamber 1053 (Figure 10) of the fluid conditioner 420 to the outlet chamber 1054 (Figure 10) of the fluid conditioner 420. In alternative embodiments, the pulse damping component may comprise a flexible container or channel without a rigid body, which defines a fluid path that connects to the inlet chamber 1053 (Figure 10) and outlet chamber 1054 (Figure 10) of the fluid conditioner 420. In any of the embodiments described above, the flexible container or channel can expand and contract to dampen fluid pulsations. That is, the flexible container or flexible side sheet expands and contracts as the pressure of the fluid moving through the conduit fluctuates to reduce fluid pulsations. This damping of fluid pulsations facilitates stable expansion and good visibility during surgical procedures. The fluid conditioner 420 and the pulse damping component can be connected by any suitable means, such as any means discussed in this application with respect to the connection of the fluid conditioner 420 and the fluid heating cartridge 422. In certain embodiments, the fluid conditioner and pulse attenuation components may be included in an integrated cartridge assembly in which the fluid conditioner 420 and the fluid attenuation components are contained in a single cartridge. In certain embodiments, the pulse attenuation components having rigid and flexible side sheets, or a flexible container or channel used for pulse attenuation, may not be connected to the fluid conditioner 420, but instead may be connected by a set of piping between the outlet port 634 (Figure 10) and the surgical site.

[0165] Referring to Figure 9, the fluid conditioner 420 is configured to connect to or align with one or more non-contact sensors (e.g., sensors 943-950) of the fluid conditioning assembly 315 so that the sensors can sense one or more characteristics of the fluid without contacting the fluid. For example, the fluid conditioning assembly 315 may include one or more fluid presence sensors (943, 947, 948, 950), one or more fluid temperature sensors (944, 945, 946), and a port 1062 (Figure 10) to which one or more pressure sensors 949 located in the main unit 102 can be connected. The port 1062 (Figure 10) to which one or more pressure sensors 949 can also be connected to a solenoid valve 951 for releasing excess air accumulated in the fluid conditioner 420. The pressure sensors 949 and the solenoid valve 951 may be connected to the port 1062 by one or more pipes or conduits and connecting components 952. The control system of the fluid management system 100 may be configured to at least partially control the pressurization of the fluid by the pump 212, the heating of the fluid by the heater assembly 314, and the discharge of air from the fluid conditioner 420, based on the interface between the fluid conditioning assembly 315 (Figure 3) and the fluid conditioner 420.

[0166] Referring to Figures 10-13, exemplary embodiments of the fluid conditioner 420 may include a rigid body 1052 defining a first or inlet chamber 1053 and a second or outlet chamber 1054. In some embodiments, the fluid conditioner 420 may include a fully or partially enclosed intermediate chamber 1075 located between the inlet chamber 1053 and the outlet chamber 1054, providing a separation gap between the walls of the inlet and outlet chambers. This separation gap created by the intermediate chamber 1075 prevents heat transfer between the inlet and outlet of the fluid that would occur if the inlet chamber 1053 shared a common wall with the outlet chamber 1054. The rigid body 1052 may be, for example, an injection-molded body. Referring to Figures 12 and 13, the fluid conditioner 420 may further include a film 1255 connected to the rigid body 1052 to define and enclose (contain) the chambers 1053, 1054 to create a flow path. The film 1255 can be attached to the rigid body 1052 by adhesive, laser welding, ultrasonic welding, or any other suitable means. The film 1255 is configured to allow one or more sensors of the sensing assembly 315 (Figure 3) to sense one or more properties of the fluid moving through the inlet chamber 1053 and outlet chamber 1054 without contacting the fluid. The film 1255 can be, for example, a plastic film. In an alternative embodiment, the fluid conditioner 420 does not include the film 1255, but rather the fluid conditioner 420 is a rigid container configured to allow one or more sensors of the sensing assembly 315 (Figure 3) to sense one or more properties of the fluid without contacting the fluid. In some of these embodiments, the portion of the rigid container that aligns with the sensors of the sensing assembly, enabling the sensors to sense the properties of the fluid, may have a reduced thickness relative to the rest of the fluid container. In the above-described embodiment, the inlet chamber 1053 may have an inlet port 625 and an outlet port 527, and the outlet chamber 1054 may have an inlet port 533 and an outlet port 634.The outlet port 527 and the inlet port 533 may have O-rings (e.g., O-ring 1363 shown in Figure 13) for watertight connections. In certain embodiments, the inlet port 625 and the outlet port 634 may have barbed and / or adhesive portions for connection to fluid piping.

[0167] Referring to Figures 9 to 11, the fluid inlet chamber 1053 is aligned with a fluid presence sensor 943 targeting region 1156 and a fluid inlet temperature sensor 944 targeting region 1157. The operation of the pump 212 (Figure 2) causes fluid to flow from the fluid supply bag or container through the inlet port 625 into the inlet chamber 1053. The inlet chamber 1053 may have a protruding wall 1058 that thins or makes shallow sections of the chamber, which mitigates bubble retention by causing laminar flow through these sections. The fluid presence sensor 943 may be used by the system 100 to verify that fluid is present in the inlet chamber 1053 and thus to monitor performance and identify any problems. For example, if the pump is operating but the fluid presence sensor 943 does not detect fluid, the control system may notify the user to check the fluid path between the fluid container and the fluid conditioner 420 for broken piping lines or possible blockages, such as twisted piping or a closed clamp.

[0168] The fluid temperature sensor 944 may have several functions. For example, in an embodiment in which the heater assembly 314 is used to heat a fluid to a desired temperature (e.g., a temperature entered by the user or a default system temperature), the fluid temperature sensor 944 allows the control system to monitor the temperature of the fluid entering the heating cartridge 422, and as a result, the control system can adjust the amount of IR energy provided by the heater assembly 314 to bring the fluid entering the outlet chamber 1054 of the fluid conditioner 420 to the desired temperature. Furthermore, if the user has suspended a preheated fluid bag at a potentially unsafe level with a high fluid temperature, the control system may disable the pump 212 and / or the heater assembly 314 and then notify the user that such operation will remain disabled until the fluid temperature has cooled sufficiently or the fluid supply bag or container has been changed. Alternatively, the control system may continue operation while increasing the airflow through the heater assembly 314 to sufficiently cool the fluid before it reaches the outlet chamber 1054 of the fluid conditioner 420. If such an attempt fails, the fluid outlet temperature sensor 945 targeting region 1159 and / or the fluid upper limit or thermal cutoff temperature sensor ("TCO sensor") 946 targeting region 1160 will cause the control system to disable the fluid pumping and heating operations until the fluid temperature has cooled sufficiently. In addition, assuming a surgical room environment where the user has enabled the fluid heating function, the temperature sensor 944 can be used to inform the user whether the temperature of the fluid entering the fluid conditioner 420 may be too low to achieve the desired fluid temperature. Finally, the control system can also determine if there is a problem with the heater assembly 314. For example, if the temperature sensor 944 detects that the temperature entering the inlet chamber 1053 is acceptable, but the sensor 945 detects that the fluid temperature has not reached the desired fluid temperature, the control system will inform the user that there may be a problem with the heater assembly 314.

[0169] Referring further to Figures 9–11, the outlet chamber 1054 of the fluid conditioner 420 can be designed to separate bubbles from the fluid being delivered to the surgical site, which may be caused by fluid bag replacement or the fluid heating process. For example, the fluid outlet chamber 1054 may have a substantially vertical wall or baffle 1061 (Figures 10–11) that separates bubbles from the fluid when the fluid engages with the wall. As shown in the illustrated embodiment, the baffle 1061 does not have to be connected to the periphery of the outlet chamber 1054.

[0170] In certain embodiments, the outlet chamber 1054 is designed to facilitate monitoring and control of fluid pressure via a pressure sensor 949 located within the main unit 102. For example, the insertion of a fluid conditioner 420 may result in a connection between the outlet chamber 1054 of the fluid conditioner 420, which has a pressure sensor 949 located within the main unit 102 via a pressure port 1062, and one or more pipes or conduits (not shown). Since the pressure of the pocket of air trapped between the fluid in the outlet chamber 1054 and the pressure sensor 949 indicates the fluid pressure, the control system monitors the fluid pressure read by the pressure sensor 949 in relation to the setpoint fluid pressure, and the control system adjusts the speed of the pump 212 to achieve and maintain the setpoint fluid pressure. To ensure pressure monitoring accuracy and guard against excessive pressure conditions, the control system constantly compares the readings of the pressure sensor 949 to ensure they are the same, apart from the normal tolerance of such sensors. Independent of the software, the control system may use redundant hardware circuitry to disable or reverse pump 212 if the fluid pressure exceeds the maximum allowable pressure for treatment.

[0171] To ensure that the pressure sensor 949 remains isolated from the fluid, the outlet chamber 1054 is designed not only to maintain an air pocket between the pressure sensor 949 and the fluid, but also to include a hydrophobic filter 1065 that acts as a fluid barrier. Such a hydrophobic filter 1065 may also act as a bacterial barrier to preserve the sterility of the fluid. To protect the hydrophobic filter 1065 from contact with the fluid entering the outlet chamber 1054 under turbulent or high-flow conditions, the outlet chamber 1054 may include an arc wall or barrier 1066 in combination with a baffle 1061 to ensure that any fluid traveling over the top of the baffle 1061 is directed away from the hydrophobic filter. The pressure port 1062 may also include an O-ring 1364 (Figure 13) for a fluid-tight connection.

[0172] In addition to the presence sensor 943 in the inlet chamber 1053, there may be at least three additional fluid presence sensors (947, 948, 950) aligned with the outlet chamber 1054. The fluid presence sensor 947 ("fluid outlet sensor") located at the outlet port 634 of the outlet chamber 1054 targets region 1167 and is used to ensure proper fluid flow through the fluid conditioner 420. For example, if the control system detects that the pump 212 is pumping fluid but the fluid outlet sensor 947 does not detect fluid, the control system can disable the pump 212 and / or notify the user of a problem with the system 100. Furthermore, if a fluid heating function is present and enabled, the fluid outlet sensor 947 ensures that the fluid heating cartridge 422 is full of fluid before the fluid heating function is started or continued.

[0173] A fluid presence sensor 948, located at the center (midpoint) of the outlet chamber 1054, targets region 1168 and is used to control the amount of air accumulated in the outlet chamber 1054. Under normal operation, the fluid level in the outlet chamber 1054 should be maintained near the center of the outlet chamber. If the fluid center sensor 948 does not detect fluid and the pressure sensor 949 is reading positive pressure, the control system opens a solenoid valve 951 to bleed the excess air accumulated in the outlet chamber 1054 until the fluid center sensor 948 detects fluid (i.e., until the fluid level rises to the center of the outlet chamber 1054). To avoid a significant impact on the pressure monitoring and control functions of system 100, the solenoid valve 951 may have a small orifice or limit, so that the excess air in the outlet chamber 1054 bleeds off at a low, controlled rate. Alternatively, system 100 can average the fluid pressure readings, thereby mitigating the effects of any minute pressure drops associated with the air discharge function, or system 100 can ignore the fluid pressure readings while the solenoid valve 951 remains open.

[0174] A fluid presence sensor 950, located adjacent to the pressure port 1062 of the outlet chamber 1054, targets area 1169 to ensure proper operation of the pressure sensing function of system 100, which requires that a pocket of air be maintained between the fluid in the outlet chamber 1054 and the pressure sensor 949 of the sensing assembly 315. The pressure in this pocket of air, monitored by the pressure sensor 949, increases or decreases as the fluid pressure increases or decreases. When the fluid level reaches the hydrophobic filter 1065 protecting the pressure port 1062, the control system may lose the ability to accurately monitor the fluid pressure. Therefore, if the fluid pressure port sensor 950 senses fluid, the control system may disable the pump 212.

[0175] Referring to Figures 6 and 14 to 18, if the system 100 includes a main unit 102 with a fluid heating function, for example, when configured for an operating room environment, the fluid conditioner 420 will generally be connected to a fluid heating cartridge component 422. By joining the fluid conditioner 420 and the fluid heating cartridge 422, a cartridge assembly 419 is formed, and a fluid connection is made between the inlet chamber 1053 (Figure 10) of the fluid conditioner 420 and the first fluid path 629 (Figure 6) on the first side surface 1671 (Figures 16-18) of the heating cartridge 422. This connection also results in a fluid connection between the second fluid path 631 (Figure 6) on the second side surface 1670 (Figures 16-18) of the heating cartridge 422 and the outlet chamber 1054 (Figure 10) of the fluid conditioner 420.

[0176] The fluid heating cartridge 422 may include a rigid body 1472 (Figures 14-18), a first thin flexible sheet 1473 (Figures 15-18), and a second thin flexible sheet 1474 (Figures 15-18). Referring to Figures 16-18, the first flexible sheet 1474 is connected to a first side surface 1671 of the rigid body 1472 to define a first fluid flow path 629, and the second flexible sheet 1473 is connected to a second side surface 1670 of the rigid body 1472 to define a second fluid flow path 631. In the illustrated embodiment, the first and second fluid flow paths 629, 631 are connected by a connector or tube 530 (Figures 14-15). In other embodiments, the first and second flow paths may be connected by a channel integrated into the heating cartridge 422. The rigid body 1472 can be, for example, an injection-molded body. The flexible side sheets 1473 and 1474 can be, for example, made of plastic capable of highly transmitting IR to facilitate fluid heating functionality. The rigid body 1472 and the flexible side sheets may be connected by adhesive, laser welding, ultrasonic welding, or any other suitable means.

[0177] The flexible side sheets 1473, 1474 may be configured to expand and contract to effectively dampen fluid pulsations generated by the pump 212, thereby allowing the fluid delivered to the surgical site to be non-pulsating. That is, the system 100 may utilize a peristaltic pump that generates a pulsating fluid flow, but the fluid heating cartridge 422 downstream of the peristaltic pump may include thin, flexible side sheets 1473, 1474 to at least partially define the fluid path and to expand and contract as the pressure of the fluid moving through the heating cartridge fluctuates to dampen fluid pulsations. This damping of fluid pulsations facilitates stable expansion and good visibility during surgical procedures.

[0178] Referring to Figure 6, during operation, fluid from the fluid supply bag or container enters the fluid inlet chamber 1053 (Figure 10) of the fluid conditioner 420 via port 625, enters the fluid heating cartridge 422, flows through the first elongated section of the fluid path 629 on the first side 1671 (Figures 16-18) of the fluid heating cartridge 422, exits the first elongated section of the fluid path, enters the second elongated section of the fluid path 631 on the second side 1670 of the fluid heating cartridge via connector 530, exits the fluid heating cartridge 422, enters the fluid outlet chamber 1054 of the fluid conditioner 420, and then exits the fluid outlet chamber 1054 via port 634 to be delivered to the surgical site.

[0179] System 100 can control the fluid temperature by monitoring the difference between the setpoint fluid temperature and the actual outlet fluid temperature sensed by the temperature sensor 945 (Figure 9), and adjusting the power to the IR lamp assembly 737 (Figure 7) according to proportional-integral control and scaling, which is based on the actual fluid flow rate and / or difference between the actual fluid temperature sensed by the temperature sensor 944 aligned with the inlet chamber 1053 of the fluid conditioner 420 and the actual fluid temperature sensed by the temperature sensor 945 aligned with the outlet chamber 1054 of the fluid conditioner 420. Alternatively, other suitable open-loop and closed-loop control systems can be employed, such as proportional control, integral control, proportional-integral-derivative control, mathematical modeling, predictive control, squared error control, and bang-bang control.

[0180] In addition to the control scheme, the fluid heating efficiency can be enhanced by the use of thin, flexible side sheets 1473, 1474 (Figure 15) of the fluid heating cartridge 422, which are highly capable of transferring IR energy, and an injection-molded rigid body 1472 (e.g., a black injection-molded body) that absorbs IR energy from the IR lamp assembly 737 (Figure 7) and radiates the IR energy back into the fluid. Furthermore, the fluid heating efficiency can be enhanced by elongated sections of the fluid heating cartridge 422 that define the fluid paths 629, 631. The elongated sections of the fluid heating cartridge 422 facilitate uniform heat distribution by introducing fluid into each section at or below the centerline and allowing fluid to exit from each section at the top of the opposite end, so that the fluid moves from lower to higher positions as the fluid moves along each of the fluid paths 629, 631.

[0181] Referring to Figure 19, in certain embodiments, the fluid heating efficiency of system 100 can also be improved by preheating the fluid container 1901. Specifically, the air intake 1903 allows air to be drawn into the main unit 102 by the fan 316 (Figure 3) of the heater assembly 314 (Figure 3) during the fluid heating process to cool the heater assembly 314 and the main unit 102, and this air is heated as a result of interacting with the heater assembly 314. The heated air is then discharged by the main unit 102 through the discharge opening 1905 and directed toward the fluid container 1901 on each side of the main unit 102 so that the fluid in the fluid container is preheated before it is pumped through the fluid conditioner 420 (Figure 6) and the fluid heating cartridge 422 (Figure 6).

[0182] To protect against overheating conditions, system 100 has low and high limits, which deactivate the IR lamp 739 (Figure 7) if the fluid temperature exceeds a low safety limit, and deactivate the IR lamp 739 and pump 212 if the fluid temperature exceeds a high safety limit. In some embodiments, independently of software, system 100 uses hardware circuitry including a thermal cutoff sensor ("TCO") 946 (Figure 9) to deactivate the IR lamp and pump in overheating conditions exceeding the upper limit. In some embodiments, system 100 employs a cooling fan to remove heat to help prevent and / or mitigate overheating conditions. The cooling fan can be electronically controlled based on thermistor or other temperature sensor input and / or heating algorithm conditions that could lead to overheating (e.g., a rapid decrease in flow rate when full heating is required at maximum flow rate).

[0183] Due to the fluid heating function of system 100, which aims to rapidly heat the fluid to a setpoint fluid temperature and maintain that setpoint fluid temperature at a high flow rate, system 100 must be connected to a dedicated 20-amp circuit for markets where the nominal power supply voltage is 120V. However, system 100 can be configured to connect to a standard 15-amp circuit by utilizing lower wattage lamps and / or current limiting power to the lamps. In certain embodiments, the fluid management system 100 is configured to operate with nominal power supply voltages of 120V or 240V without requiring changes to the lamps. For example, system 100 may include a crossover circuit including a threshold detector 770 (Figure 7A) and a relay bank 771 (Figures 7B-7C). Referring to Figure 7, in certain embodiments, the lamp assembly 737 includes four lamps 739 (e.g., two lamps on each side of the cartridge 419). Figure 7B shows the circuit of relay bank 771 for two lamps 739 of lamp assembly 737 (for example, two lamps 739 located on the same side of cartridge 419), having relay contacts 775, 777 in a first position where the lamps 739 are arranged in parallel. Figure 7A shows the circuit of threshold value detector 770 which can move relay contacts 775, 777 (Figures 7B-7C) to a second position (as shown in Figure 7C) where the lamps 739 are arranged in series. Figures 7B and 7C show the circuit for relay bank 771 for two lamps 739 located on one side of cartridge 719 shown in Figure 7, but it should be understood that the circuit for the other two lamps 739 on the other side of the cartridge may be identical to the circuit shown in Figures 7B and 7C.

[0184] Referring to Figure 7A, the threshold detector 770 has AC line inputs 772 and 774, respectively, which are connected to the input side of a bidirectional photocoupler 776, and the voltage supplied to the heating assembly 314 is also applied to inputs 772 and 774. A first Zener diode 778 is positioned between line input 772 and the input of the photocoupler 776, and a second Zener diode 780 is positioned between line input 774 and the input of the photocoupler 776. The Zener diodes 778 and 780 prevent current from flowing from inputs 772 and 774 through the photocoupler 776 until the peak voltage applied to inputs 772 and 774 exceeds a predetermined amount. The photocoupler 776 includes a transistor output element 782 connected to a voltage source 784, and the transistor output element 782 is configured to operate between an "on" position and an "off" position using a line 786 that generates a control signal used to activate a relay coil 788 that operates a relay bank 771. The transistor output element 782 remains off when no current is flowing through the input of the photocoupler 776, and turns on when current flows through the Zener diodes 778 and 780 and enters the input of the photocoupler 776. When the transistor output element 782 is turned on, current from the voltage source 784 energizes line 786 to generate a control signal, which activates coils 788a-d and moves the corresponding contacts of relay bank 771 (e.g., contacts 775, 777) from a first position (as shown in Figure 7B) to a second position (as shown in Figure 7C). In some embodiments, the control signal is applied to a Schmitt trigger 790 and a transistor array 792 before energizing coils 788a-d. The Schmitt trigger 790 ensures that the voltage on line 786 is stable and exceeds a predetermined limit before being connected to the transistor array. The transistor array 792 activates coils 788a to d, moving relay contacts 775 and 777 from the first position to the second position.

[0185] Referring to Figure 7B, in the illustrated embodiment, when the lamps 739 are in a parallel configuration, contacts 775 and 777 are in a first position. When in the first position, contacts 775 and 777 are connected at points 4 and 5 so that both lamps 739 communicate with the circuit inlet 773. This allows half of the current moving through the inlet 773 to move to one lamp 739 along the first path 779 and the other half of the current to move to the second lamp 739 through the second path 781 (through contact 775). In this configuration, the same voltage applied to the inlet 773 is applied individually across both lamps 739 so that each lamp receives the voltage entering the circuit. For example, if 120V is applied to the inlet 773, the 120V is connected to both the first path 779 and the second path 781 so that each lamp receives 120V.

[0186] Referring to Figure 7C, when the threshold detector 770 (Figure 7A) moves contacts 775 and 777 to a second position, an electrical connection is made between points 3 and 5 such that the lamps 739 are connected in series. In this configuration, all current applied to the inlet 773 travels along a single path 783 so that the current travels through one lamp 739, then through contacts 775 at points 3 and 5, and then to the second lamp 739 (the break between points 4 and 5 prevents the current from traveling directly through contacts 775 after entering the inlet 773). Since both lamps 739 are located along a single path 783, the voltage applied to the lamps 739 is divided among the number of lamps located on the path 783. Since the illustrated embodiment includes two lamps 739, each lamp 739 receives half of the voltage entering the inlet 773. For example, if 240V is applied to the input 773, all current flows along a single path 783 such that the voltage drop across one lamp 739 is 120V, and this voltage drop is applied along the single path 783 such that the other lamps receive 120V.

[0187] The fluid management system 100 may be configured to provide accurate and reliable flow-based defect monitoring for surgical procedures performed in an operating room environment. For example, Figures 20–49 show exemplary embodiments of a defect module 104 and a single or multi-purpose defect cartridge 2010 for the fluid management system shown in Figure 1. The use of the defect cartridge 2010 eliminates the need for a canister and avoids exposing the sensors and other durable components of the fluid management system 100 to fluid returning from the surgical site. The defect module 104 works in conjunction with the control system of the main unit 102 and a single or multi-purpose piping set including the defect cartridge 2010 to measure and record the volume of fluid returning from the surgical site as it travels through the defect cartridge 2010. The fluid is drawn both from the surgical site and into and out of the defect cartridge 2010 by a suction source (e.g., a vacuum pump integrated with or external to the system 100). In alternative embodiments, the fluid may be drawn out of the surgical site and pushed into the defect cartridge 2010 by a greater positive pressure than that present inside the defect cartridge 2010 (e.g., a peristaltic pump integrated with or external to system 100, inserted inline between the surgical site and the defect cartridge 2010 and configured to generate suction at the surgical site and generate positive pressure at the inlet to the defect cartridge 2010), and drawn out of the defect cartridge 2010 by a greater negative pressure than that present inside the defect cartridge 2010 (e.g., a vacuum pump integrated with or external to system 100, or sufficient positive pressure inside the defect cartridge 2010 due to the positive pressure generated by the peristaltic pump to push the fluid out of the defect cartridge 2010 to ambient air).

[0188] Referring to Figures 20–23, the defect cartridge 2010 is inserted into the defect module 104. The defect cartridge 2010 may include a front end 2218 that aligns with the opening 2220 (Figures 22–23) of the defect module 104, and a raised portion 2222 (Figures 22–23) that allows a user to easily grasp the defect cartridge 2010 to remove it from the defect module 104. The defect cartridge 2010 includes one or more inlet openings 2012, 2014 configured to connect to one or more fluid return tubes of a piping set, allowing fluid to move from the surgical site into the defect cartridge 2010. The defect cartridge also includes at least one vacuum opening 2016 configured to connect to a discharge tube, allowing fluid to move through the discharge tube after moving through the defect cartridge 2010. The vacuum tube is connected to a suction source so as to supply vacuum pressure to the defect cartridge in order to draw fluid in and out of the defect cartridge 2010 from the surgical site. After inserting the missing cartridge into the missing module 104, the fluid return pipe and discharge pipe can be manually connected to the missing cartridge 2010.

[0189] The control system of the main unit 102 is configured to determine the fluid deficit supplied to and returned from the surgical site by comparing the volume of fluid moving through the deficit cartridge 2010 with the volume of fluid supplied to the surgical site. The control system may calculate the volume of fluid supplied to the surgical site, for example, by monitoring the weight of the fluid supply bag or container (e.g., by using a suspension member 116 operably connected to a load cell) and / or by counting the rotations of the peristaltic pump.

[0190] Referring to Figures 24-28, when the missing cartridge 2010 is inserted into the missing module 104, the manifold connection assembly 2424 (Figures 27-28) engages with the missing cartridge 2010 and connects to the pump manifold assembly (e.g., pump manifold assembly 3513 shown in Figure 37), the positive pressure pump and the negative pressure pump (3515 and 3517 in Figures 35-36, respectively), and the pressure sensor (not shown) of the missing module 104, via a pneumatically operated diaphragm regulator / valve (e.g., regulator / valve 2628, 2630, 2632, 2634 shown in Figure 26) and the pressure sensing area 2636 of the missing cartridge 2010 (Figure 26). The manifold connection assembly 2424 has multiple connectors (e.g., connectors 4510, 4511, 4512, 4513 shown in Figures 45 and 49) for receiving corresponding ports 2540 for each of the regulator / valve and the pressure-sensing area of ​​the missing cartridge 2010. Referring to Figures 27-28 (and Figures 42-49), the connectors of the manifold connection assembly 2424 may be configured to move between an engaged or connected state and a disengaged (unengaged, disengaged) or disconnected state to the port 2540 by a mechanical or electromechanical mechanism 2726 (e.g., a manual lever, a pancake cylinder, or other type of pneumatic, mechanical, or electromechanical actuator). The port 2540 of the missing cartridge 2010 may include an O-ring to enable an hermetically sealed connection between the manifold connection assembly 2424 and the missing cartridge 2010. When the missing cartridge 2010 is inserted into the missing module 104, one or more non-contact fluid sensors 2742 (Figures 30-31) of the missing module 104 are aligned with the desired position on the missing cartridge 2010.

[0191] The connectors of the manifold connection assembly 2424 (for example, connectors 4510, 4511, 4512, and 4513 shown in Figures 45 and 49) may be configured to accommodate any manufacturing or assembly tolerances in the port 2540 of the missing cartridge 2010. That is, the connectors may be configured to move to ensure alignment with the corresponding port 2540 of the missing cartridge 2010, taking into account slight differences in the position of the port 2540 resulting from the manufacturing and assembly of the missing cartridge 2010. For example, referring to Figures 28A-28C, in certain embodiments, the connector 4512 of the manifold assembly 2424 (also shown in Figures 45 and 49) may be a separate component connected to the manifold assembly 2424 by a mounting element 2815 (e.g., an E-clip), and the receiving assembly 3511 of the system 100 (also shown in Figures 38-39) may include an opening 3828 (also shown in Figures 38-39) for receiving the connector 4512, which is larger than the diameter of the connector 4512, so that the connector 4512 can move within the opening 3828.

[0192] Referring to Figure 28A, the manifold connection assembly 2424 is shown in the disengaged position with respect to port 2540 of the missing cartridge 2010. Activation of mechanism 2726 (Figure 28) moves the manifold connection assembly 2424 in direction M so that connector 4512 engages with port 2540 of the missing cartridge 2010. Figure 28B shows the initial engagement between connector 4512 and port 2540, and Figure 28C shows the full engagement between connector 4512 and port 2540. Referring to Figure 28B, port 2540 of the missing cartridge 2010 is not centered on connector 4512, so that port 2540 engages with the edge of the inlet 2813 of connector 4512. The large opening 3828 of the receiving assembly 3511 allows connector 4512 to move within the opening 3828 and align with port 2540. That is, referring to Figure 28C, the continuous movement of the manifold connection assembly 2424 in direction M causes port 2540 to move in alignment with connector 4512. In certain embodiments, the inlet 2813 of connector 4512 is tapered to facilitate the movement of port 2540 to connector 4512. The above-described connection between connector 4512 and port 2540 enables easy and automatic connection between the missing cartridge 2010 and system 100 (e.g., via missing module 104). Although Figures 28A-28C only show the connection between connector 4512 and port 2540 of missing cartridge 2010, it should be understood that other connectors (e.g., connectors 4510, 4511, 4512, and 4513 shown in Figures 45 and 49) may be configured to connect to port 2540 of missing cartridge 2010 in the same manner as described in Figures 28A-28C.

[0193] Referring to Figures 29-34, the missing cartridge 2010 may include a single chamber 2944 having three fluid-connected sections 2946, 2948, and 2950. The three sections include a filling section 2946, a measuring section 2948, and a discharge section 2950, ​​which are always fluid-connected when the system 100 alternates between a "fill / measure" cycle and a "fill / discharge" cycle, thereby minimizing or making the pressure gradient across the three sections substantially equal.

[0194] The filling section 2946 is fluid-connected to the inlet openings 2012, 2014 so that fluid returning from the surgical site can move into the filling section 2946 through the inlet openings 2012, 2014. The discharge section 2950 is fluid-connected to the vacuum port 2016 so that a suction source can supply vacuum pressure to the defective cartridge 2010 to move fluid from the surgical site into the defective cartridge 2010 through the inlet openings 2012, 2014 and to expel the defective cartridge 2010 through the vacuum port 2016. In other embodiments, an in-line pump (e.g., a peristaltic pump) between the surgical site and the ports 2012 and / or ports 2014 can draw fluid from the surgical site, push the fluid through the inlet openings 2012 and / or 2014, and push it out of the defective cartridge 2010 through the vacuum port 2016. Alternatively, an inline pump (e.g., a peristaltic pump) between the surgical site and ports 2012 and / or 2014 may draw fluid from the surgical site and push it through the inlet openings 2012 and / or 2014, while a separate suction source provides vacuum pressure to draw fluid from the missing cartridge 2010 through vacuum port 2016.

[0195] One or more inlet valves 2628, 2630 may be located in the inlet openings 2012, 2014 and may be configured to close to prevent fluid from entering the chamber 2944 in order to avoid overfilling. In certain embodiments, the valves 2628, 2630 are air-operated diaphragm valves connected to the pump assembly of the missing module 104 (for example, an assembly including a positive pressure pump 3515 and a negative pressure pump 3517 shown in Figures 35-36) so that the pump assembly can move the valves 2628, 2630 between open and closed positions. In certain embodiments, the negative pressure pump of the pump assembly opens the diaphragm valve, and the positive pressure pump of the pump assembly assists in closing the diaphragm valve with positive back pressure.

[0196] Furthermore, the air-operated diaphragm valves 2628 and 2630 may operate in conjunction with a pump assembly (for example, an assembly including a positive pressure pump 3515 and a negative pressure pump 3517 shown in Figures 35-36) to act as pressure regulators that adjust the vacuum pressure supplied to the surgical site. That is, the control system of the fluid management system 100 may be configured to adjust the amount of pressure applied to the valves 2628 and 2630 by the pump assembly, which displaces the flexible membrane 2956, allowing fluid to flow through 2628 and 2630, thereby enabling the control system to control the amount of vacuum pressure supplied to the surgical site via a suction source connected to the vacuum port 2016. Referring to Figure 29, for example, the valves 2628 and 2630 may each include a housing component 2958 defining a chamber 2959, which is connected to the pump assembly of the missing cartridge. The flexible membrane 2956 is located within the chamber 2959 and is movable within the chamber 2959 by a pressure pump. When valves 2628, 2630 are in the closed position, the membrane 2956 engages with the chamber 2944 of the missing cartridge 2010, fluidically isolating the filled section 2946 from the inlet openings 2012, 2014. A pressure pump is configured to move the flexible membrane 2956 within the chamber to open valves 2628, 2630, and the pump assembly can adjust the size of the opening by generating a desired pressure difference between the pressure supplied by the pump assembly and the vacuum level within the chamber 2944 of the missing cartridge 2010. The membrane 2956 may be made from, for example, neoprene, silicone, natural rubber, nitrile, EPDM, or any other suitable material. Valves 2628, 2630 may also have a hydrophobic filter 2960 to prevent fluid from moving to the pump assembly in the event of a tear or other failure of the flexible membrane. In other words, valves 2628 and 2630 function similarly to the pressure regulators described with respect to Figures 52-73 of this application in order to regulate the vacuum pressure supplied to the surgical site.

[0197] In the illustrated embodiment, the filling section 2946 is located at the top of the chamber 2944, and the measuring section 2948 is located below the filling section 2946. A valve 2632 is located in the opening between the filling sections 2946 and 2948 and is movable between an open position and a closed position. When the valve 2632 is in the open position, the filling section 2946 and the measuring section 2948 are fluid-connected so that the fluid in the filling section 2946 can move into the measuring section 2948 via gravity. One or more sensors of the missing module 104 are used to measure the fluid in the measuring section 2948. In a particular embodiment, the measuring section includes a main region 3276 (Figure 32) and a narrow region 3277 (Figure 32) located above the main region 3276, and the volume of fluid that can be placed in these regions 3276 and 3777 is known by the system 100 so that the system can determine the volume of fluid moving through the measuring section 2948. The measurement of the fluid in the measurement section 2946 is described in more detail below. The discharge section 2950 is located below the measurement section 2948, and valve 2634 is located at the opening between the measurement section and the discharge section and is movable between an open position and a closed position. When valve 2634 is in the open position, the measurement section 2948 and the discharge section 2950 are fluid-connected so that the fluid in the measurement section 2948 moves into the discharge section 2950 via gravity. In the illustrated embodiment, valves 2632, 2634 are air-operated diaphragm valves connected to the pump assembly of the missing module 104 (e.g., the assembly including pumps 3515, 3517 shown in Figures 35-36) so that the pump assembly moves valves 2632, 2634 between an open position and a closed position.

[0198] Referring to Figure 32, valves 2628, 2630, 2632, and 2634 may include a flexible membrane (e.g., flexible membrane 2956 shown in Figure 29) that is movable between an engaged and disengaged position with respect to the opening 3290 of the missing cartridge 2010. That is, part of the opening 3290 fluidly connects the inlets 2012 and 2014 to the filling section 2946, another part of the opening 3290 fluidly connects the filling section 2946 to the measuring section 2948, and another part of the opening 3290 fluidly connects the measuring section 2948 to the discharge section 2950. The flexible membranes of valves 2628, 2630, 2632, and 2634 engage with the opening 3290 to prevent the movement of fluid between inlets / sections and disengage at least part of the opening 3290 to allow the movement of flow between inlets / sections. The size and spacing of the openings 3290 may be configured to prevent the flexible membrane from being extruded through the openings 3290 when positive pressure is applied to valves 2628, 2630, 2632, and 2634. The size and spacing of the openings 3290 may vary based on the elasticity and / or thickness of the flexible membrane data. The number of openings 3290 associated with each valve 2628, 2630, 2632, and 2634 is configured to ensure proper fluid flow through the missing cartridge 2010. In certain embodiments, the total surface area of ​​the openings on each side of valves 2628, 2630, 2632, and 2634 is substantially equal to the inner cross-sectional area of ​​the pipes attached to the inlet ports 2012 and 2014 of the missing cartridge 2010. Since gravity is the primary force acting on the fluid and moving it between sections 2946, 2948, and 2950 of chamber 2944, in some embodiments, the number of openings 3290 corresponding to valves 2632, 2634 is configured such that a sufficient flow rate through valves 2632, 2634 is large enough to achieve a high flow rate. For example, the number of openings 3290 corresponding to each valve 2632, 2634 may be configured to achieve a target flow rate of 1200 ml / min or more through chamber 2944 without stopping the flow from the surgical site.In certain embodiments, the measuring section 2948 of chamber 2944 can be filled and emptied while fluid flows continuously from the surgical site, so that the fluid flow rate through valves 2632, 2634 can be at least twice the target flow rate through chamber 2944.

[0199] In the illustrated embodiment, the chamber 2944 includes a channel 2952 that fluidly connects the filling section 2946 to the discharge section 2950, ​​and a constricted section 3277 that fluidly connects the filling section 2946 to the measuring section 2948. The channel 2952 and the constricted section 3277 allow the filling, measuring, and discharge sections 2946, 2948, and 2950 to be fluidly connected at all times, including when one or both of the valves 2632, 2634 are in the closed position. This fluid connection between the filling, measuring, and discharge sections 2946, 2948, and 2950 via the channel 2952 and the constricted section 3277 allows the pressure gradient across the three sections of the chamber 2944 to be minimized or substantially equal so that the fluid does not move within the chamber 2944 by a pressure source, rather allowing the fluid to move within the chamber 2944 by gravity. In certain embodiments, the missing cartridge includes a wall 3252 positioned to prevent fluid from entering the channel 2952 and bypassing the measuring section 2948. In alternative embodiments, the missing cartridge 2010, rather than the chamber 2944 containing the channel 2952, includes a connector or pipe (e.g., pipe similar to the piping 841 for the fluid conditioner 420 shown in Figure 8) to fluidize the filling section 2946 to the discharge section 2950 so that the filling, measuring, and discharge sections 2946, 2948, and 2950 are always fluid-connected. While the illustrated embodiment shows the three sections 2946, 2948, and 2950 in a stacked configuration, in alternative embodiments, these three sections can be in a side-by-side configuration, as long as the fluid can move by gravity from the filling section 2946 to the measuring section 2948 and then to the discharge section 2950.

[0200] In various embodiments, the deficiency cartridge 2010 includes a waste vacuum level sensing adjustment port 2636 for connecting to a solenoid valve opening to the circumferential side and a pressure sensor of the deficiency module 104. The control system of the fluid management system 100 can sense the vacuum level in the chamber 2944 via the pressure sensor of the deficiency module 104 and adjust the vacuum pressure supplied to the deficiency cartridge 2010 via the suction source by opening the solenoid valve to atmospheric pressure. Referring to Figure 29, the port 2636 may also include a housing component 2973 defining the chamber 2975, which is connected to the solenoid valve and pressure sensor of the deficiency module 104. A flexible membrane 2977 is positioned within the chamber 2975 and has an opening 2979 that allows pressure measurement within the chamber 2944 and exposes the chamber 2944 to the circumferential side when the solenoid valve is open. The membrane 2977 may be made from, for example, neoprene, silicone, natural rubber, nitrile, EPDM, or any other suitable material. Port 2971 may also have a hydrophobic filter 2981.

[0201] Referring to Figures 30-32, the missing cartridge 2010 is aligned with one or more sensors 2742 of the missing module 104 (e.g., sensors 3062, 3064, 3066, 3068, 3070 shown in Figures 30-31) so that the control system of the fluid management system 100 can use sensors 2742 to detect the volume of fluid moving through the chamber 2944 of the missing cartridge 2010 and / or any potential problems with the fluid flow through the missing cartridge (e.g., potential overflow of fluid in section 2946 of the chamber 2944). In the illustrated embodiment, one or more sensors 2742 include a first fluid presence sensor 3062, a second fluid presence sensor 3064, a third fluid presence sensor 3066, a fourth fluid presence sensor 3068, and a fifth fluid presence sensor 3070. Referring to Figures 32 to 34, in the illustrated embodiment, the first and second fluid presence sensors 3062, 3064 are aligned with the first and second regions 3271, 3272, respectively, within the filling section 2946. These fluid presence sensors 3062, 3064 are used by the control system to close one or both of the inlet valves 2628, 2630 when the fluid in the filling section 2946 reaches the first and second regions 3271, 3272. A third fluid presence sensor 3066 is aligned with a third region 3273 within the measurement section 2948 of the chamber 2944 and is used by the control system to switch from a filling / measurement cycle to a filling / discharge cycle, and to determine the volume of fluid in the measurement section 2948 before switching to a filling / discharge cycle. A fourth fluid presence sensor 3068 is aligned with a fourth region 3274 within the measurement section 2948 and is used by the system to switch from a fill / discharge cycle to a fill / measure cycle. A fifth fluid presence sensor 3070 is aligned with a fifth region 3275 within the measurement section 2948 and is used by the system to provide more accurate real-time fluid volume measurement within the measurement section 2948 and to determine the fluid volume within the measurement section 2948 after the procedure is completed or after the type of fluid being monitored to record the fluid deficit has changed, providing more accurate fluid deficit calculations for the fluid.The illustrated embodiment shows a missing module 104 having five fluid presence sensors for detecting the fluid flow state and volume within the chamber 2944 of the missing cartridge, but it should be understood that any other suitable number of fluid presence sensors can be used by the missing module to detect the fluid flow state and volume. The target regions 3271-3275 may include walls that partially surround them to improve the accuracy of sensor readings and mitigate the effects of fluid turbulence on any bending of the film 2980.

[0202] Referring to Figure 29, in the illustrated embodiment, the missing cartridge 2010 includes a rigid body 2978 and a film 2980. The rigid body 2978 partially defines various sections 2946, 2948, 2950 and channels 2952 and narrow section 3277 of the chamber 2944, and the film 2980 is attached to the rigid body 2978 so as to surround the chamber 2944. The rigid body 2978 can be, for example, an injection-molded body or any other suitable rigid body. The film 2980 is configured so that one or more sensors of the missing module 104 can detect the properties of the fluid passing through the film without contacting the fluid. The film 2980 can be, for example, a plastic film. The film 2980 can be attached to the rigid body 2978 using mechanical fasteners or by adhesive, laser welding, vibration welding, ultrasonic welding or any other suitable means. In an alternative embodiment, the missing cartridge 2010 does not include the film 2980 and is instead made from an injection-molded container that allows one or more sensors of the missing module 104 to detect the characteristics of the fluid passing through the container without contact with the fluid. In another alternative embodiment, the container may be cast or machined from a material that is washable and reusable.

[0203] Figures 33 and 34 show the filling / measurement cycle and filling / discharging cycle of the missing cartridge 2010. Referring to Figure 33, during the filling / measurement cycle, fluid returning from the surgical site is drawn from the surgical site into the filling section 2946 of the missing cartridge 2010 through inlet ports 2012, 2014 via vacuum pressure from a suction source attached to vacuum port 2016. The diaphragm operating valve 2632 is in the open position, which allows the fluid to move from the filling section 2946 to the measurement section 2948 via gravity. The diaphragm operating valve 2634 is in the closed position, which prevents the fluid from moving from the measurement section 2948 into the discharging section 2950. The filling / measurement cycle continues until the fluid level in the measurement section 2948 reaches a predetermined level, which is sensed by the fluid presence sensor 3066 (Figures 30-31) of the missing module 104 targeting region 3273. In the illustrated embodiment, the area of ​​interest 3273 is located in a narrow portion 3277 (Figure 32) of the measuring section 2948, extending upward from the main portion 3276 (Figure 32) of the measuring section 2948. The volume of fluid in the narrow portion 3277 is small compared to the volume of fluid in the main portion 3276 of the measuring section 2948, and therefore, variables including fluid flow rate and turbulence (which may affect the accuracy of the sensed fluid level) do not substantially affect the overall accuracy of the measurement function. In certain embodiments, the ratio of the volume of the main portion 3276 to the volume of the narrow portion can be 5:1 or greater, e.g., 20:1 or greater, e.g., 50:1 or greater, e.g., 75:1 or greater, e.g., 90:1 or greater, e.g., 100:1 or greater. In an exemplary embodiment, the ratio of the volume of the main portion 3276 to the volume of the narrow portion can be about 100:1. The volumes of the fluid in the main portion 3276 and narrow portion 3277 of the measurement section 2948 are known by system 100, so that the system can record the volume of the fluid in the measurement section each time a fill / measure cycle occurs. System 100 records the volume and then proceeds to the fill / discharge cycle.

[0204] Referring to Figure 34, during the filling / discharging cycle, the diaphragm operating valve 2632 is moved to the closed position, which prevents fluid from the filling section 2946 from moving into the measuring section 2948. The diaphragm operating valve 2634 is moved to the open position, which allows the fluid measured in the measuring section 2948 to move into the discharging section 2950 by gravity during the filling / discharging cycle. The fluid entering the discharging section 2950 is then discharged through the vacuum port 2016 via the installed suction source, and the fluid is moved to the equipment's waste disposal system via the indirect-drain or direct-drain method. To discharge the fluid from the discharging section, the discharging cycle relies on the vacuum pressure difference between the vacuum pressure provided by the suction source and the down-regulated vacuum pressure inside the chamber 2944 (regulated via the pressure regulation sensing port 2636). When the fluid presence sensor 3068 (Figures 30-31), targeting region 3274, detects that there is no residual fluid in the measurement section 2948, the system 100 transitions to return to the fill / measure cycle. The alternation between the fill / measure cycle and the fill / discharge cycle continues until the procedure is complete, and the control system determines the fluid deficiency based at least partially on the various volume measurement records taken between the various fill / measure cycles.

[0205] The movement of fluid from the filling section 2946 to the measuring section 2948 and the discharge section 2950 is achieved by gravity, as opposed to an external suction or pressure source. In these embodiments, the valves can be sized to minimize resistance and thereby facilitate high flow rates with relatively low force. Pneumatically operated diaphragm valves 2628, 2630 achieve the allowance or cessation of flow to the missing cartridge 2010, while pneumatically operated diaphragm valves 2632, 2634 achieve the allowance and cessation of flow between sections 2946, 2948, and 2950 by setting the pneumatically controlled pressure by the pressure pumps 3515, 3517 of the missing module 104 (Figures 35-36) to a positive gauge pressure greater than a combination of 1) the maximum pressure expected on either wet side of the valve and 2) any additional pressure required to account for the additional force from the spring constant of the valve diaphragm.

[0206] To prevent overflow, the missing module 104 may have a fluid presence sensor 3064 (Figures 30-31) targeting region 3272, and when the fluid presence sensor 3064 detects fluid in the target region 3272, the control system may be configured to close a fluid return valve 2628 (e.g., a valve connected to a subbody drape and / or floor suction at the surgical site). This ensures that the filling section 2946 does not overfill and flow into the measuring section 2948 through the narrow portion 3277 or into the discharge section 2950 through the channel 2952, and that the remaining capacity of the filling section remains available to receive fluid returning from surgical instruments at the surgical site so as not to interfere with the surgical procedure. The missing module may also have a fluid presence sensor 3062 (Figures 30-31) targeting region 3271, and if the presence sensor 3062 detects fluid in the target region 3271, the control system may be configured to close a fluid return valve 2630 (e.g., a valve connected to a surgical instrument at the surgical site). In an alternative embodiment, valve 2628 may be connected to a surgical instrument at the surgical site, and valve 2630 may be connected to a subbody drape and / or floor suction at the surgical site.

[0207] To provide accuracy in fluid deficiency at the end of a procedure (assuming the end of surgery does not coincide with the end of a fill / measure or fill / drain cycle), the deficiency module 104 includes one or more midpoint fluid presence sensors (e.g., sensor 3070) targeting one or more regions (e.g., region 3275) to provide more accurate real-time measurements of the fluid in the measurement section 2948, allowing for measurement of the fluid in the measurement section 2948 at the end of surgery or after a change in the type of fluid used during surgery.

[0208] Figures 35 to 48 show exemplary embodiments of a defect module 104 that can be used with the fluid management system 100 shown in Figure 1 and the defect cartridge 2010 shown in Figures 20 to 34. Referring to Figure 35, the defect module 104 may include a defect cartridge receiving assembly 3511 for receiving the defect cartridge 2010, one or more sensors 2742 for sensing the characteristics of the fluid moving through the defect cartridge without contact with the fluid, a pump assembly 3514, a pump manifold assembly 3513, a manifold connection assembly 2424 for connecting the defect cartridge 2010 to the pump assembly 3514, a solenoid and pressure sensor (via the pump manifold assembly 3513), a pneumatic mechanism 2726 for moving the manifold connection assembly between an engaged position (e.g., as shown in Figures 47 to 49) and an unengaged (disengaged) position (e.g., as shown in Figures 43 to 45) relative to the defect cartridge 2010, and a printed circuit board (PCB) 3519.

[0209] Referring to Figures 38 and 39, the missing cartridge receiving assembly 3511 includes a base 3821 having a slot or opening 3820 for receiving the missing cartridge 2010 (Figures 30–34). The receiving assembly 3511 also includes one or more walls or components 3822–3826 that substantially isolate the missing cartridge 2010 from the remaining components inside the missing module 104 when the missing cartridge 2010 is placed inside the receiving assembly 3511. The walls or components 3822–3826 and the base 3821 may be connected by one or more fasteners 3827 to create the receiving assembly 3511. The first wall 3822 of the receiving assembly 3511 may be configured to hold one or more sensors 2742 for sensing the characteristics of the fluid moving through the missing cartridge 2010. In the illustrated embodiment, the one or more sensors 2742 are capacitive sensors that detect the presence of fluid. However, other fluid level or presence sensing technologies can be utilized, including infrared sensors, laser sensors, optical sensors, electromechanical sensors (e.g., float sensors with mechanical toggle switch operation, piezoelectric pressure sensors, etc.), inductive sensors, ultrasonic sensors, or any other suitable sensors.

[0210] The second wall 3823 of the receiving assembly 3511 may include a number of openings 3828 for receiving connectors of the manifold connection assembly 2424 (e.g., connectors 4510-4513 shown in Figures 45 and 49) so that the pump assembly 3514 can be operably connected to the diaphragm valve and pressure port of the missing cartridge 2010, as will be described later with reference to Figures 42-49. Referring to Figure 39, the manifold connection assembly 2424 is connected to or adjacent to the wall 3823 of the receiving assembly 3511, and the pneumatic mechanism 2726 may be connected to the manifold assembly 2424 by one or more fasteners and to the missing module 104 by a connecting element or plate 3930.

[0211] Referring to Figures 35 and 36, in the illustrated embodiment, the pump assembly 3514 includes a positive pressure pump 3515 and a negative pressure pump 3517, and the pump assembly 3514 is connected to the connectors of the pneumatic mechanism 2726 and the manifold connection assembly 2424 via the pump manifold assembly 3513. The positive pressure pump 3515 provides pressure to the pneumatic cylinder 2726 to move the manifold connection assembly 2424 between an engaged position (e.g., as shown in Figures 47-49) and an disengaged position (e.g., as shown in Figures 43-45) with respect to the missing cartridge 2010. The positive pressure pump 3515 also facilitates or increases the closing force of the diaphragm valve of the missing cartridge 2010. The negative pressure pump 3517 provides vacuum pressure to the diaphragm valve of the missing cartridge 2010 to move the diaphragm valve to the open position.

[0212] Referring to Figure 37, in the illustrated embodiment, the pump manifold assembly 3513 includes a plurality of accumulators 3732 and solenoid valves 3734 for regulating the pressure supplied by pumps 3515, 3517 and the opening and closing of the diaphragm valves of the missing cartridge 2010. In certain embodiments, the accumulators 3732 vary the positive and negative pressure as follows: (1) to enable the use of smaller pressure pumps that can deliver the required flow rate; and (2) to assist in pressure regulation by reducing the shock of introducing air via a "bang-bang" control scheme (i.e., an open-close control scheme). In the illustrated embodiment, the pump manifold assembly 3513 includes five accumulators 3732 (e.g., holes extending through the assembly 3515) that are capped off at the top and bottom by caps 3735. The solenoid valves 3734 of the pump manifold assembly 3513 may be connected via piping to connectors of the manifold connection assembly 2424.

[0213] Referring to Figures 42-49, the pneumatic mechanism 2726 moves the manifold connection assembly 2424 between a disengaged position with respect to the missing cartridge 2010 (Figures 43-45) and an engaged position with respect to the missing cartridge 2010 (Figures 47-49). Referring to Figures 43-45, when in the disengaged position, the port 2540 for the diaphragm valve and pressure port of the missing cartridge 2010 is not engaged by the connectors 4510-4513. Referring to Figures 47-49, the manifold connection assembly 2424 is moved by the pneumatic mechanism 2726 to the engaged position in direction D (Figure 49) so that the connectors 4510-4513 engage with the corresponding port 2540 of the missing cartridge 2010. When connectors 4510-4513 are engaged with port 2540 of the missing cartridge 2010, the pump assembly 3514 is operably connected to the missing cartridge 2010 so that the pump assembly 3514 can move the diaphragm valve of the missing cartridge between an open and a closed position, and so that the vacuum pressure supplied to the missing cartridge 2010 can be sensed by a pressure sensor in the missing module and adjusted down by opening a solenoid to the atmosphere.

[0214] Referring to Figures 35-49, in certain embodiments, the insertion of the missing cartridge 2010 into the receiving assembly 3511 of the missing module 104 causes all internal connections between the missing cartridge 2010 and the various components of the missing module 104. For example, the insertion of the missing cartridge 2010 into the receiving assembly 3511 causes the pneumatic mechanism 2726 to move the manifold connection assembly to an engagement position with the missing cartridge (e.g., as shown in Figures 47-49), thereby operably connecting the pump assembly 3514 to the missing cartridge. When the missing cartridge 2010 is inserted into the receiving assembly 3511, one or more non-contact sensors 2742 are aligned with the chamber 2944 of the missing cartridge 2010 (Figure 29). These automatic connections between the missing cartridge 2010 and the missing module are advantageous because they limit the amount of connections that the user must make to the missing cartridge 2010. In other words, after inserting the missing cartridge 2010 into the missing module 104, the user only needs to connect the fluid return line to the inlet openings 2012 and 2014 of the missing cartridge 2010 (Figure 20) and the discharge line to the vacuum opening 2016 of the missing cartridge (Figure 20).

[0215] Referring to Figure 50, in certain embodiments, the system 100 may be used in gynecological, urological, and orthopedic surgeries performed in an operating room, equipped with a third-party suction and fluid collection device. In these embodiments, the system 100 may be configured to include a main unit 102 (e.g., any main unit 102 described herein) and a defect module 104 (any defect module 104 described herein), but without including a fluid suction and collection module 106. In this embodiment, a piping set including a defect cartridge 2010 (Figures 20-34) can be used in combination with the main unit 102 and the defect module 104 to determine fluid defects in the fluid during surgical procedures.

[0216] Referring to Figure 51, in some situations, gynecological, urological, and orthopedic surgeries are performed in operating rooms where the equipment prefers or requires “direct drain” disposal of fluids returning from the surgical site. In these situations, the equipment often prefers or requires that the volume of fluid returning from the surgical site be recorded. In some embodiments, system 100 can be configured to include a fluid flow monitoring and discharge module 5101, which includes the features of a defect module 104. The fluid flow monitoring and discharge module 5101 works in conjunction with the equipment’s central suction system, main unit 102, and a set of piping including a defect cartridge 2010 (Figures 20–34) or other similar cartridges to determine the volume of fluid returning from the surgical site and entering the equipment’s waste disposal system, as well as the fluid defect for surgical procedures. The fluid flow monitoring and discharge module 5101 can communicate with the main unit 102 via Bluetooth® or other wired or wireless means to measure, record, and display the return fluid volume and / or fluid defect for surgical procedures.

[0217] Although the fluid flow monitoring and discharge module 5101 is described as operating in conjunction with the main unit 102 of the fluid management system 100, it should be understood that the fluid flow monitoring and discharge module 5101 can also function as a standalone fluid flow monitoring and discharge module capable of communicating with other equipment in the facility via Bluetooth® or other wired or wireless means. After recording the fluid volume, the module 5101 can discharge the fluid directly into the facility's waste disposal system. In certain embodiments, the fluid flow monitoring and discharge module 5101 may be a wall-mounted unit or a cart-mounted unit. In some embodiments, the fluid flow monitoring and discharge module 5101 may include an integrated suction source that operates in conjunction with, or instead of, the facility's central suction system. The use of the defect cartridge 2010 or other similar cartridges isolates the fluid returning from the surgical site from the components of the fluid flow monitoring and discharge module 5101 (e.g., sensors, pumps, etc.), so that circulation of the cleaning solution through the fluid flow monitoring and discharge module is not required after each procedure, which improves procedure efficiency.

[0218] The flow-based defect monitoring function of System 100 (e.g., a combination of defect module 104 and defect cartridge 2010, or fluid flow monitoring and discharge module 5101) enables cost-effective, accurate, and reliable fluid defect monitoring due to the disposable nature of the defect cartridge 2010 and the elimination of canisters. This function also improves treatment efficiency by eliminating interruptions associated with canister setup, connection, replacement, and disposal, and by cleaning the defect module and / or monitoring and discharge module after each treatment. In an alternative embodiment, the defect cartridge 2010 may be configured for multiple treatment use.

[0219] In certain circumstances, the fluid management system 100 may be connected to an external pressure source (e.g., a suction source) used to draw fluid from the surgical site. Since the external suction source is typically set to a high vacuum level in the operating room environment, down-regulation of the vacuum pressure provided by the external suction source may be necessary for the proper operation of certain fluid outflow regulation, defect monitoring, and / or collection functions. Down-regulation of the vacuum pressure provided by the external suction source can be achieved via a manually or electronically controlled regulator ("regulator"), however, replacing or cleaning the regulator after each surgical procedure would be prohibitively expensive and / or excessively cumbersome, so it is desirable to isolate it from biotoxic fluids returning from the surgical site. However, isolating the regulator by placing a fluid collection canister between the regulator and the surgical site is undesirable due to the cost of the canister, the complexity of setting it up, the need to replace the canister during the procedure when it becomes full, and the need to dispose of the canister at the end of the procedure.

[0220] Referring to Figure 52, to overcome the problems associated with the use of regulators, system 100 can utilize single-use or multi-use pressure regulators 5205 that are cost-effective to manufacture and disposable. Due to their disposability, the pressure regulators 5205 do not need to be isolated from biotoxic fluids returning from the surgical site. The pressure regulators 5205 can be used in combination with a pressure source (e.g., an air pump) and one or more pressure sensors of the fluid management system 100 to sense and adjust the vacuum pressure provided by an external suction source to control the rate (speed) of fluid outflow from the surgical site, thereby assisting efforts to provide good inflation and visualization. The pressure pump and pressure sensors may be included in a suction module 5201 configured to be operably connected to the control system of the fluid management system 100, or the pressure pump and pressure sensors may be integrated into the main unit 102 of the fluid management system 100. In embodiments including the use of the suction module 5201, inserting the pressure regulator 5205 into the suction module 5201 provides a fluid connection between the pressure regulator 5205, the pressure sensing mechanism and the bleed mechanism, and the integrated pressure pump of the suction module 5201. After inserting the pressure regulator 5205 into the suction module 5201, the user can manually connect an external suction source and fluid return lines from the surgical site to the connection ports 5202 of the pressure regulator 5205 (e.g., openings 5315, 5317 shown in Figure 53, and openings 5415, 5417 shown in Figures 54-55).

[0221] Referring to Figure 53, a first exemplary embodiment of the pressure regulator 5205 includes three chambers 5307, 5309, and 5311 and a flexible membrane 5313. The first chamber 5307 includes an opening or port 5315 for power connection to an external suction source. The second chamber 5309 has an opening or port 5317 for fluid connection to a surgical site (via one or more fluid lines or tubes). The third chamber 5311 includes one or more ports for connection to a pressure source (e.g., a pressure source 7449 in the suction module 5201 shown in Figure 74) and a pressure sensor (e.g., a pressure sensor 7451 in the suction module 5201 shown in Figures 74-75). In the illustrated embodiment, the third chamber 5311 has a first opening 5319 for connection to a pressure sensor and a second opening 5321 for connection to a pressure source.

[0222] The flexible membrane 5313 is positioned to fluidically isolate (i.e., seal) the third chamber 5311 from both the first chamber 5307 and the second chamber 5309, thereby allowing the pressure source and pressure sensors of the fluid management system 100 (connected to openings 5319, 5321 in the third chamber 5311) to be fluidically isolated from biotoxic fluids returning from the surgical site and traveling through the first and second chambers 5307, 5309. In some embodiments, a hydrophobic filter (not shown) is positioned between the flexible membrane 5313 and the openings 5319, 5321 to provide further protection in preventing fluid from coming into contact with the pressure source and pressure sensors of the fluid management system 100. For example, the hydrophobic filter can prevent fluid from coming into contact with the pressure source and regulator if the flexible membrane 5313 tears or ruptures.

[0223] The first chamber 5307 is adjacent to the second chamber 5309 and is separated from the second chamber 5309 by a substantially vertical extension member or wall 5323 and a substantially horizontal extension member or wall 5361. The wall 5361 includes an opening 5363 that fluidly connects the first chamber 5307 to the second chamber 5309. The pressure source of the fluid management system 100 is configured to move the flexible membrane 5313 between an engaged position with the wall 5361 and one or more disengaged positions with the wall 5361, so that when the flexible membrane is in an engaged position the first and second chambers 5307, 5309 are fluidly isolated from each other, and when the flexible membrane 5313 is in one of the disengaged positions the first and second chambers 5307, 5309 are fluidly connected to each other (through the opening 5363). The size and spacing between the openings 5363 prevent the membrane 5313 from rupturing due to excessive extrusion through the openings when positive pressure is applied to stop the flow across the valve. The size and spacing of the openings 5363 may vary based on the elasticity and thickness of the material of the flexible membrane 5313. The number of openings 5363 can ensure adequate flow, and in some embodiments, the combined surface area of ​​the openings on either side of each valve may be approximately equal to or greater than the inner cross-sectional area of ​​the piping expected to be attached to the port 5315.

[0224] The fluid management system 100 is configured to provide pressure to the third chamber 5311 through the opening 5319, and the system 100 is configured to sense and regulate the pressure in the third chamber 5311 by sensing the pressure through the pressure sensor and the opening 5321 and modulating the pressure provided by the pressure source to achieve a desired pressure setpoint (for example, by modulating the air pump speed of the pressure source 7449 of the suction module 5201 shown in Figure 74). The system 100 controls the pressure source to pull the flexible membrane 5313 away from the wall 5361 when a positive pressure exists in the chamber 5309 that is greater than the pressure in the first chamber 5307 or the pressure in the third chamber 5311 (in addition to the force required to displace the flexible membrane 5313). If a positive pressure exists in the second chamber 5309 (in addition to the force required to displace the flexible membrane 5313) than in the first and third chambers 5307 and 5311, the fluid can displace the flexible membrane 5313 and create a fluid connection between the chambers 5307 and 5309 through the wall 5361 and the hole 5363 through the displaced flexible membrane 5313, thereby supplying the desired regulated pressure (for example, the smaller of the pressure in the first chamber 5307 or the pressure in the third chamber 5311, in addition to the force required to displace the flexible membrane 5313) to the surgical site through the opening 5317 of the second chamber 5309. Under nominal conditions, the pressure of the external suction source present in the first chamber 5307 is lower than the pressure in the other chambers 5309 and 5311 of the pressure regulator 5205, the regulated pressure in the third chamber 5311 is higher than the pressure in the second chamber 5309, and the regulated pressure in the third chamber 5311 is adjustable to allow for adjustment of the pressure supplied to the surgical site through the opening 5317 of the second chamber 5309.

[0225] When the first chamber 5307 and the second chamber 5309 are fluid-connected, the biotoxic fluid moves from the surgical site through opening 5317 into the second chamber 5309, through the opening between the flexible membrane 5313 and the wall 5361, through hole 5363 into the first chamber 5307, and through opening 5315 into the waste collection section of the system 100 or the equipment. If it is desired that the valve be closed and the flow from the surgical site be stopped, the system 100 applies a more positive pressure in the third chamber 5311 than the maximum pressure expected in the second chamber 5309 (e.g., the pressure caused by the weight of the water column in the height difference between the valve inlet 5317 and the surgical site) and the pressure in chamber 5307, in addition to the pressure required to displace the flexible membrane 5313. If the pressure in chamber 5311 is greater than the pressures in both chambers 5307 and 5309 (in addition to the pressure required to displace the flexible membrane), the flexible membrane 5311 is held against the other system pressures with sufficient force against the wall 5361 so that the flow is substantially stopped. The flexible membrane 5313 seals the third chamber from the first and second chambers 5307, 5309 to prevent biotoxic fluids from moving into the third chamber 5311 and coming into contact with the pressure source and / or pressure sensor of system 100.

[0226] If the pressure from the surgical site (available in chamber 5309) is a positive pressure higher than the gauge pressure supplied by the external suction source via the first chamber 5307, the gauge pressure supplied to the third chamber 5311 by the pressure source of system 100, and the pressure required to stretch the flexible membrane 5313, then the regulated vacuum pressure supplied to the surgical site can be equal to the more positive gauge pressure among the gauge pressure supplied by the external suction source (via the first chamber 5307) or the gauge pressure supplied by the pressure source of system 100 (to the third chamber 5311), and the pressure required to stretch the flexible membrane 5313. In other words, if the flow rate from the surgical site is negligible compared to the flow capacity of the external pressure source (supplied via the first chamber 5307), then the pressure supplied to the surgical site (via chamber 5309) will be the pressure closest to absolute vacuum among the pressure supplied by the external pressure source (via the first chamber 5307) or the pressure supplied by the pressure source of system 100 (in the third chamber 5311), and the pressure required to stretch the flexible membrane 5313.

[0227] In certain embodiments, the pressure required to stretch the flexible membrane 5313 may be modeled by a transfer function to determine the pressure setpoint of the pressure source of system 100 (supplied into the third chamber 5311) required to achieve a desired controlled vacuum pressure in the second chamber 5309 supplied to the surgical site. System 100 may be configured to change the controlled vacuum pressure supplied to the surgical site via the pressure sensors and pressure pumps of system 100 by changing the pressure supplied to the third chamber 5311. Alternatively, the pressure supplied by the external suction source (through the first chamber 5307) and supplied to the second chamber 5309 may be adjusted to a more positive pressure by adjusting the pressure supplied to the third chamber 5311 by the pressure source of system 100 to a pressure greater than the pressure supplied by the external suction source. Since the regulated pressure setpoint is variable, this also allows the pressure regulator 5205 to function as a simple two-way valve to enable and disable flow as needed by regulating the pressure supplied to the third chamber 5311 at a pressure higher than the pressure in either the first chamber 5307 or the second chamber 5309.

[0228] In certain embodiments, the flexible membrane 5313 is configured such that the pressure supplied by the pressure source in the third chamber 5311 pulls the flexible membrane 5313 away from the wall 5361, and the regulated vacuum pressure supplied to the surgical site is greater than the pressure supplied by the pressure source of system 100 and is between approximately 10 mmHg and approximately 30 mmHg. The flexible membrane 5313 may be made from, for example, neoprene, silicone, natural rubber, nitrile, EPDM, other rubber compounds, or any other material that allows the flexible membrane to move between an engaged position and an unengaged position.

[0229] The pressure regulator 5205 can have a housing 5325 that at least partially defines three chambers 5307, 5309, 5311 and includes openings 5315, 5317, 5319, 5321. The housing 5325 can be made of, for example, polycarbonate, any suitable type of plastic material, or any other suitable material. In certain embodiments, the housing 5325 has a first component 5327 that includes the first and second chambers 5307, 5309 and a second component 5329 that includes the third chamber 5311, and the flexible membrane 5313 is disposed between the first component 5327 and the second component 5329 to fluidly isolate the chambers of the first component 5327 from the chambers of the second component 5329. The first component 5327, the second component 5329, and the flexible membrane 5313 can be connected by snap-fit connections, adhesive connections, one or more fasteners, laser welding, ultrasonic welding, vibration welding, or any other suitable means.

[0230] Referring to the embodiment shown in FIG. 53, when the desired minimum regulated pressure supplied to the surgical site is a positive gauge pressure, the pressure supplied by the external pressure source can be a positive gauge pressure or a negative gauge pressure. When the desired regulated pressure is a negative gauge pressure (i.e., a vacuum pressure), the pressure supplied by the external suction source needs to be a negative gauge pressure that is more negative than the minimum gauge pressure desired to be regulated because the pressure supplied by the external pressure source is not sensed. In other words, the pressure supplied by the external pressure source (via the first chamber 5307) does not need to be consistent if the maximum gauge pressure supplied by the external pressure source is not higher than the desired regulated pressure setpoint for the regulated source (e.g., the surgical site) (e.g., it does not need to be regulated and can have pressure fluctuations).

[0231] The embodiment of the pressure regulator 5205 shown in FIG. 53 is effective in regulating an external suction source that provides a vacuum level known to be negative relative to the desired regulated vacuum pressure provided at the surgical site. However, a second embodiment of the pressure regulator 5205 (shown in FIGS. 54 - 73) enables the fluid management system 100 to regulate an external suction source that provides an unknown or variable vacuum level and sense when the vacuum level is sufficient to reach a desired regulated set point. Referring to FIGS. 54 and 55, the second embodiment of the pressure regulator 5205 utilizes two valves of the first embodiment (FIG. 53) arranged in series.

[0232] Referring to FIG. 54, a second exemplary embodiment of the pressure regulator 5205 includes four chambers 5407, 5409, 5411, 5412 and a flexible membrane 5413. The first chamber 5407 includes an opening or port 5415 for fluid connection to an external suction source. The second chamber 5409 has an opening or port 5417 for fluid connection to the surgical site (via one or more fluid lines or tubes). The third chamber 5411 includes one or more ports 5419 for connection to a pressure source (e.g., the pressure source 7449 of the suction module 5201 shown in FIG. 74), and the fourth chamber 5412 includes one or more openings 5421 for connection to one or more pressure sensors (e.g., the pressure sensors 7451 of the suction module 5201 shown in FIGS. 74 - 75). Alternative embodiments can incorporate sensors from the same port connections of the pressure regulator 5205 for redundancy of the pressure source or improved regulation.

[0233] The flexible membrane 5413 is positioned to fluidically isolate (i.e., seal) each of the third and fourth chambers 5411, 5412 from both the first and second chambers 5407, 5409, thereby enabling the pressure source and pressure sensor of the fluid management system 100 to be fluidically isolated from biotoxic fluids returning from the surgical site and traveling through the first and second chambers 5407, 5409. The first chamber 5407 is adjacent to the second chamber 5409 and is separated from the second chamber 5409 by a vertical extension member or wall 5423 and a horizontal extension member or wall 5465. Wall 5465 includes an opening 5467 that fluidly connects the first chamber 5307 to the second chamber 5309. The flexible membrane 5413 is movable from an engaged position and one or more disengaged positions with respect to the wall 5465. The first and second chambers 5407, 5409 are fluidly isolated from each other when the flexible membrane 5413 is in the engaged position, and are fluidly connected to each other (through the opening 5467) when the flexible membrane 5413 is in the disengaged position. The third chamber 5411 is adjacent to the fourth chamber 5412 and is separated from the first chamber 5412 by a vertical extension member or wall 5431 and a horizontal extension member or wall 5461. The wall 5461 includes an opening 5463 that fluidly connects the third chamber 5411 to the fourth chamber 5413. The flexible membrane 5413 is also movable from an engaged position with the wall 5461 and one or more disengaged positions. When the flexible membrane 5413 is in the engaged position, the third and fourth chambers 5411, 5412 are fluidly isolated from each other, and when the flexible membrane 5413 is in the disengaged position, the third and fourth chambers 5411, 5412 are fluidly connected to each other (through the opening 5463).

[0234] To better illustrate that the embodiment of the pressure regulator 5205 shown in Figure 54 utilizes the two valves of the first embodiment of the pressure regulator shown in Figure 53 in series, the first chamber 5407 is shown to have a first portion 5408 and a second portion 5410, but the pressure across both the first and second portions 5408, 5410 supplied by the external intake source is the same (because there is no barrier that can seal the first and second portions 5408, 5410 together). Referring to Figure 55, the first valve 5501 of the pressure regulator 5205 utilizes the external intake source (through the first portion 5408 of the first chamber 5407) to regulate the transfer of pressure supplied by the pressure source of the fluid management system from the third chamber 5411 to the fourth chamber 5412. The second valve 5503 utilizes the pressure in the fourth chamber 5412 (via the transfer of pressure from the third chamber 5411 to the fourth chamber 5412) to regulate the transfer of pressure supplied by the external suction source from the second portion 5410 of the first chamber 5407 to the second chamber 5409, so that the pressure in the second chamber 5409 becomes substantially equal to the desired controlled vacuum pressure at the surgical site.

[0235] Referring to Figures 54 and 55, the pressure in the first portion 5408 of the first chamber 5407 causes the flexible membrane 5413 to either be in an engaged or disengaged position with respect to the wall 5461. For example, if the vacuum pressure supplied by the external suction source is negative compared to the pressure supplied into the third chamber 5411 by the pressure source of system 100, the flexible membrane 5413 stretches away from the wall 5461 so that the third chamber 5411 and the fourth chamber 5412 are fluidly connected. When the third and fourth chambers 5411 and 5412 are fluidly connected, the pressure in the fourth chamber 5412 is substantially equal to the pressure in the third chamber 5411. In comparison, if the vacuum pressure supplied by the external suction source is positive compared to the pressure supplied into the third chamber 5411 by the pressure source, the flexible membrane is in a position to engage with the wall 5461, fluidly isolating the fourth chamber 5412 from the third chamber 5411.

[0236] The fluid management system 100 senses the pressure in the fourth chamber 5412 via one or more pressure sensors in the system 100, thereby enabling the system 100 to determine whether the pressure supplied by the external suction source is not providing sufficient vacuum pressure to meet the desired controlled vacuum pressure at the surgical site. That is, if the external suction source is not providing sufficient pressure to pull the flexible membrane 5413 away from the wall 5461, air will slowly flow out of the fourth chamber 5412 through a small orifice or valve in the system 100, which may be opened at all times or periodically to a more positive gauge pressure to gradually bring the pressure in the fourth chamber 5412 closer to a more positive gauge pressure, and the pressure sensors in the system 100 sense that the pressure in the fourth chamber 5412 is not equal to the pressure supplied to the third chamber 5411 by the pressure source, thereby enabling the system to determine that the pressure supplied by the external suction source is not sufficient to meet the desired controlled vacuum pressure at the surgical site. The pressure sensed by system 100 in the fourth chamber 5412 can be used to determine the actual pressure present in the first chamber 5407 if it is lower than the positive gauge pressure that is slowly released into the fourth chamber 5412, given sufficient time to release (bleed off) the pressure. If system 100 determines that the external suction source is not supplying sufficient vacuum pressure, system 100 may be configured to notify the user to adjust the external pressure source (for example, by increasing the suction setting of the external pressure source, not logging the line leading to the external pressure source, finding a leak in the line leading to the external pressure source, etc.) to ensure that it is sufficient to adjust the vacuum pressure at the surgical site down to the desired adjusted vacuum pressure.

[0237] Referring to Figures 54 and 55, the second valve 5503 of the pressure regulator 5205 utilizes the pressure supplied by the pressure source of the fluid management system in the fourth chamber 5412 to regulate the movement of pressure supplied by the external suction source to the second chamber 5409, and consequently to the surgical site. That is, the system 100 controls the pressure source to stretch the flexible membrane 5413 away from the wall 5465 so that a desired controlled vacuum pressure is supplied to the surgical site through the opening 5417 of the second chamber 5409, thereby fluidizing the first chamber 5407 and the second chamber 5409. The biotoxic fluid moves from the surgical site through the opening 5417 into the second chamber 5409, through the opening 5467 between the flexible membrane 5413 and the wall 5465 into the first chamber 5407, and through the opening 5415 into the waste collection section of the system 100 or the equipment. The flexible membrane 5413 seals each of the third and fourth chambers 5411, 5412 from both the first and second chambers 5407, 5409, preventing biotoxic fluids from coming into contact with the pressure source and / or pressure sensor of the system 100.

[0238] If the pressure from the surgical site available within chamber 5409 is a positive pressure higher than both the gauge pressure supplied by the external suction source (through the first chamber 5407), the gauge pressure supplied by the pressure source of system 100 (inside the third chamber 5411), and the pressure required to stretch the flexible membrane 5413, then the regulated vacuum pressure supplied to the surgical site can be equal to the higher positive gauge pressure among the gauge pressure supplied by the external suction source (through the first chamber 5407), or the gauge pressure supplied by the pressure source of system 100 (inside the third and fourth chambers 5411 and 5412), and the pressure required to stretch the flexible membrane 5413. In other words, if the flow rate from the surgical site is negligible compared to the flow capacity of the external pressure source (supplied via the first chamber 5407), then the pressure supplied to the surgical site (via chamber 5409) is the pressure closest to absolute vacuum among the pressure supplied by the external pressure source (via the first chamber 5407) and the pressure required to stretch the flexible membrane 5413, or the pressure supplied by the pressure source of system 100 (into the third and fourth chambers 5411, 5412) and the pressure required to stretch the flexible membrane 5413.

[0239] In certain embodiments, the pressure required to stretch the flexible membrane 5413 may be modeled by a transfer function to determine the pressure setpoint of the pressure source of system 100 (supplying to the third chamber 5411 and the fourth chamber 5412) required to achieve a desired controlled vacuum pressure in the second chamber 5409 supplied to the surgical site. System 100 may be configured to change the controlled vacuum pressure supplied to the surgical site via the pressure sensors and pressure pumps of system 100 by changing the pressure supplied to the third and fourth chambers 5411, 5412. Alternatively, the pressure supplied to the second chamber 5409 by an external suction source (via the first chamber 5407) can be adjusted to a more positive pressure by adjusting the pressure supplied to the third and fourth chambers 5411, 5412 by the pressure source of system 100 to a higher pressure than the pressure supplied by the external suction source. Since the regulated vacuum pressure setpoint is variable, this also allows the pressure regulator 5205 to function as a simple two-way valve to enable and disable flow as needed by regulating the pressure supplied to the third and fourth chambers 5411, 5412 at a pressure higher than the pressure in either the first chamber 5407 or the second chamber 5409.

[0240] In certain embodiments, the flexible membrane 5413 is configured such that the pressure supplied by the pressure sources in the third and fourth chambers 5411, 5412 pulls the flexible membrane 5413 away from the wall 5423, and the regulated vacuum pressure supplied to the surgical site is approximately 10 mmHg to approximately 30 mmHg higher than the pressure supplied by the pressure sources of the system 100, for example, by approximately 20 mmHg higher. The flexible membrane 5413 may be made from, for example, neoprene, silicone, natural rubber, nitrile, EPDM, other rubber compounds, or any other material that allows the flexible membrane to move between an engaged position and an unengaged position.

[0241] In certain embodiments, the fourth chamber 5412 is pneumatically attached to a small orifice or valve of the fluid management system 100, which may be opened continuously or periodically, to bleed off pressure to a gauge pressure that is greater than or equal to the maximum gauge pressure expected from either the pressure source of the fluid management system 100 or an external suction source. The opened orifice or valve bleeds off pressure at a negligible flow rate compared to the flow capacity of the pressure source of the fluid management system, ensuring that the pressure inside the fourth chamber 5412 is equal to a higher gauge pressure from the external pressure source or a desired controlled pressure in the second chamber 5409, and any additional force required to stretch or open the flexible membrane 5413.

[0242] The embodiment of the pressure regulator 5205 shown in Figures 54 and 55 enables non-wetted indirect sensing of the pressure source of the fluid management system 100, helping to ensure that the external suction source is pressurized enough to regulate the vacuum pressure of the system's pressure source to the desired vacuum pressure in order to regulate the vacuum pressure down in the second chamber 5409 and at the surgical site. The ability to indirectly sense the pressure supplied by the external suction source via the cost-effective disposable pressure regulator 5205 is beneficial because it allows the system 100 to prompt the user to adjust the external suction source (by increasing the suction setting of the external suction source, by clearing blockages in the lines leading to the external suction source, by finding leaks in the lines leading to the external suction source, etc.) and ensure that if the regulated vacuum pressure level is detrimental to the safety or effectiveness of the intended use of the regulated vacuum pressure from the system, it is sufficient to regulate the vacuum pressure at the surgical site down to the desired regulated vacuum pressure or prevent the system from operating.

[0243] Figures 56 to 64 show one embodiment of the pressure regulator 5205 shown in Figures 54 and 55. In the illustrated embodiment, the pressure regulator 5205 includes a housing 5625 that includes openings 5415, 5417, 5419, and 5421, at least partially defining four chambers 5407, 5409, 5411, and 5412. The housing 5625 may be made from, for example, polycarbonate or any other suitable material. Referring to Figure 58, in a particular embodiment, the housing 5625 has a first component 5827 including the first and second chambers 5407, 5409 and a second component 5829 including the third and fourth chambers 5411, 5412. The first and second components 5827, 5829 may be, for example, injection molded parts. The flexible membrane 5413 is positioned between the two components 5827 and 5829 to fluidly isolate the chambers 5407 and 5409 of the first component 5827 from the chambers 5411 and 5412 of the second component 5829. In some embodiments, the pressure regulator 5205 may also include a cover 5833 for covering the portion of each component 5827 and 5829 that faces outward from the chamber. The first component 5827, the second component 5829, the flexible membrane 5413, and the cover 5833 may be connected by snap-fit ​​connections, adhesive connections, one or more fasteners, ultrasonic welding, a combination thereof, or any other suitable means. In some embodiments, the pressure regulator 5205 may include one or more hydrophobic filters 5835 to help maintain a bacterial barrier between the pressure source and pressure sensor of the fluid management system 100.

[0244] Referring to Figure 64, in certain embodiments, the pressure regulator 5205 shown in Figures 56-63 may be used in combination with a suction module (e.g., suction module 7404 shown in Figures 74-75) which includes a pressure pump (e.g., pressure pump 7449 shown in Figure 74) and a pressure sensor (e.g., pressure sensor 7451 shown in Figures 74-75) for sensing and regulating an external suction source to control the rate of fluid outflow from the surgical site. When the pressure regulator is inserted into the suction module, the pressure regulator 5205 may be configured to connect a port 5419 for a third chamber 5411 to a receiving mechanism 6437 (Figure 64) which automatically connects to a port 6439 operably connected to the pressure pump of the suction module. The connection between the pressure regulator 5205 and the receiving mechanism may also automatically connect a port 5421 for a fourth chamber 5412 to a port 6441 which is operably connected to a sensor and / or air bleed mechanism of the suction module. The connection mechanism 6437 may include a channel 6443 for receiving the end 6445 of the pressure regulator 5205 to enable a secure connection between the pressure regulator 5205 and the suction module. After inserting the pressure regulator into the suction module 5205, the user can manually connect an external suction source to port 5415 for the first chamber 5407 and a fluid return line from the surgical site to port 5417 for the second chamber 5409.

[0245] Figures 65 to 73 show another embodiment of the pressure regulator 5205 shown in Figures 54 and 55. In the illustrated embodiment, the pressure regulator 5205 includes a housing 6525 that at least partially defines four chambers 5407, 5409, 5411, and 5412 and includes openings 5415, 5417, 5419, and 5421. The housing 6525 may be made from, for example, polycarbonate or any other suitable material. In a particular embodiment, the housing 6525 has a first component 6829 that includes the first and second chambers 5407, 5409 and a second component 6827 that includes the third and fourth chambers 5411, 5412. The first and second components 6827, 6829 may be, for example, injection molded parts. The flexible membrane 5413 is positioned between the two components 6827 and 6829 to fluidly isolate the chambers 5407 and 5409 of the first component 6827 from the chambers 5411 and 5412 of the second component 6829. In some embodiments, the pressure regulator 5205 may also include a cover 6633 for covering the portion of each component 6827 and 6829 that faces outward from the chamber. The first component 6827, the second component 6829, the flexible membrane 5413, and the covers 6533 and 6633 may be connected by snap-fit ​​connections, adhesive connections, one or more fasteners, ultrasonic welding, a combination thereof, or any other suitable means. In some embodiments, the pressure regulator 5205 may include one or more hydrophobic filters 6635 to help maintain a bacterial barrier between the pressure source and pressure sensor of the fluid management system 100. The pressure regulator 5205 may also include one or more sealing members 6643 (e.g., O-rings) for making a fluid-tight connection. In certain embodiments, the housing 6525 has a gripping member or handle 6547 to help the user insert the pressure regulator into and remove it from a suction module or other component of the fluid management system 100.

[0246] Referring to Figures 72 and 73, in certain embodiments, the pressure regulator 5205 shown in Figures 65-71 may be used in combination with a suction module (e.g., suction module 7404 shown in Figures 74-75) which includes a pressure pump (e.g., pressure pump 7449 shown in Figure 74) and a pressure sensor (e.g., pressure sensor 7451 shown in Figures 74-75) for sensing and regulating an external suction source to control the rate of fluid outflow from the surgical site. When the pressure regulator 5205 is inserted into the suction module, the pressure regulator 5205 may be configured to connect a port 5419 for a third chamber 5411 to a receiving mechanism 7237 which automatically connects to a port 6439 operably connected to the pressure pump of the suction module. The connection between the pressure regulator 5205 and the receiving mechanism may also automatically connect a port 5421 for a fourth chamber 5412 to a port 7241 which is operably connected to a sensor and / or air bleed mechanism of the suction module. The connection mechanism 6437 may include a channel (not shown) for receiving the end of the pressure regulator 5205 to enable a secure connection between the pressure regulator 5205 and the suction module (for example, as shown in the embodiment shown in Figure 64). After inserting the pressure regulator into the suction module 5205, the user can manually connect an external suction source to port 5415 for the first chamber 5407 and a fluid return line from the surgical site to port 5417 for the second chamber 5409.

[0247] Figures 74 and 75 show exemplary embodiments of a suction module 5201 that can be used with various embodiments of the fluid management system 100 shown in Figure 1 and the pressure regulator 5205 shown in Figures 53-73. The suction module 5201 may include a receiving mechanism 7437 for receiving the pressure regulator 5205 (e.g., receiving mechanism 6437 shown in Figure 64 or receiving mechanism 7237 shown in Figure 72), an integrated pressure pump 7449, one or more valves 7452, 7453 for connecting the pressure pump to the pressure regulator 5205, and a printed circuit board (PCB) 7448 having one or more pressure sensors 7451.

[0248] The integrated pressure pump 7449 can be configured to supply positive or negative pressure to the pressure regulator 5205 through an opening 5419 (Figure 54) of the pressure regulator. For example, the pump 7449 may be an air pump having two ports (not shown), and the suction module 5201 may include valves 7452, 7453 (e.g., three-way valves) connected to the opening 5419 of the pressure regulator 5205 and the port of the pump 7449. The first port of the pump 7449 may be configured to draw air into the pump 7449, and the second port of the pump 7449 may be configured to push air out of the pump, so that the pump 7449 can supply both positive and negative pressure for pressure regulation and stopping flow through the valves. For example, if the port that draws air into the pump 7449 is left open to the surroundings and the port that pushes air out of the pump 7449 is connected to a substantially sealed container, the pump 7449 will accumulate positive pressure in the substantially sealed container. Conversely, if the port that pushes air out of pump 7449 remains open to the surroundings, and the port that draws air into pump 7449 is connected to a substantially sealed container, pump 7449 will accumulate vacuum pressure in the substantially sealed container. In this embodiment, valves 7452 and 7453 are ported such that the pump ports can each be opened to ambient air pressure and connected to supply pressure to a suction module. The control system software may modulate the state of valves 7452 and 7453 to configure the pump to supply positive or vacuum pressure to the system based on desired valve states and adjustment setpoints. Pump 7449 may be fluidly connected to valves 7452 and 7453 by piping. In other embodiments, pump 7449 may be configured to supply either positive or negative pressure to a pressure regulator, or the suction module 5201 may include separate positive and negative pressure pumps to supply pressure to a pressure regulator 5205. In certain embodiments, the accumulator 7450 is fluidly positioned between the pressure pump 7449 and the pressure regulator 5205 to assist in regulating the pressure supplied to the pressure regulator 5205 by the pressure pump 7449.

[0249] One or more pressure sensors 7451 can be used to monitor both the pressure supplied to the third chamber 5411 (Figure 54) of the pressure regulator 5205 by the pressure pump 7449 and the pressure in the fourth chamber 5412 (Figure 54) of the pressure regulator 5205. In certain embodiments, the pressure sensor 7451 may be operably connected by pneumatic piping to an accumulator 7450 to monitor the pressure supplied to the pressure regulator 5205, and the pressure sensor 7451 may be operably connected by pneumatic piping to an opening 5421 (Figure 54) of the pressure regulator 5205 to monitor the pressure in the fourth chamber 5412. The pressure sensor 7451 enables the fluid management system 100 to sense the pressure in the fourth chamber 5412 (Figure 54) of the pressure regulator 5205 and determine whether the pressure supplied by an external suction source connected to the first chamber 5407 (Figure 54) is not providing sufficient vacuum pressure to meet the desired controlled vacuum pressure at the surgical site.

[0250] Referring to Figure 75, in a particular embodiment, the suction module 5201 includes a valve 7554 that allows the fourth chamber 5412 (Figure 54) of the pressure regulator 5205 to be opened continuously or periodically to bleed off pressure to a gauge pressure greater than or equal to the maximum gauge pressure expected from either the pressure pump 7449 (Figure 74) or an external suction source. The opened orifice or valve bleeds off pressure at a flow rate negligible compared to the flow capacity of the pressure pump 7449, ensuring that the pressure inside the fourth chamber 5412 (Figure 54) is a higher gauge pressure from the external pressure source or a desired regulated pressure supplied to the surgical site.

[0251] Referring to the operation of the fluid management system 100 described in this application, the control system may be configured to guide the user through a setup process using, for example, commands, illustrations, animations, videos, and / or system feedback via a user interface 110. Referring to Figures 76 and 77, in a particular embodiment, the system 100 prompts the user (via the user interface 110) to select the surgical field and procedure to be performed, thereby allowing the system 100 to set default operating parameters for the procedure, as well as a safe and acceptable range of adjustment for these parameters (stored in the system 100's memory). For example, system 100 can prompt the user to select a field such as "gynecology," "urology," or "orthopedics." If the user selects "urology," system 100 can prompt the user to select one of the following procedures: "cystoscopy," "PCNL," "TURBT," "TURP," or "ureteroscopy." Based on the user's selection, system 100 can set default operating parameters for the procedure (e.g., pressure control mode or flow control mode, setpoint fluid pressure or flow rate, enable or disable fluid heating, enable or disable fluid leakage monitoring, etc.).

[0252] In certain embodiments, system 100 can provide the user with instructions for attaching (installing) piping sets to various components of system 100. For example, system 100 can instruct the user to insert a cartridge assembly 419 (Figure 4), which includes a fluid conditioner 420 (Figure 4) and a fluid heating cartridge 422 (Figure 4), into the main unit 102, and then to position or route the piping connecting the fluid supply container and the cartridge assembly 419 through or into the pump 212 (Figure 2). System 100 can prompt the user to indicate whether fluid deficiency monitoring should be performed during the procedure. In certain situations, system 100 may require fluid deficiency monitoring to be performed based on user input regarding the type of procedure being performed. For example, if the user selects a surgical hysteroscopy procedure, fluid deficiency monitoring is required. For other gynecological and urological procedures, fluid deficiency monitoring may be optional. If the user does not select the surgical hysteroscopy procedure and does not choose to enable fluid defect monitoring for the selected procedure, the system 100 may instruct the user to spike and suspend the fluid bag. If the user selects surgical hysteroscopy, or selects another procedure and chooses to enable the fluid defect monitoring function for the selected procedure, the system 100 may prompt the user to indicate whether one or more fluid types will be used during the procedure and what those fluid types are, as shown in Figures 78-80.

[0253] In various embodiments, system 100 can be configured to monitor and display fluid deficits by fluid type. For example, in operative hysteroscopy, a surgeon can utilize multiple fluid types during a procedure based on the type of procedure being performed and the surgical instruments being used. These fluids can have different osmolalities, electrolyte contents, and viscosities. The amount of these fluids absorbed by a surgical patient depends on fluid pressure, the length of the procedure, and the extent of surgical disruption of the endometrial venous sinuses, and, particularly, on the myometrium when the intrauterine fluid pressure is greater than the mean arterial pressure of the surgical patient. Thus, the ability (function) to monitor and display fluid deficits by fluid type enhances patient safety.

[0254] Referring to FIGS. 78 - 80, after the user indicates the number of fluid types used during the procedure, system 100 can prompt the user (via user interface 110) to select the specific fluids used during the procedure. System 100 can set a maximum allowable deficit limit for each specific fluid type (based on information stored in the memory of the control system or based on information input by the user). For example, the maximum allowable deficit limit for a hypotonic, electrolyte - free fluid is 1000 ml, and the maximum allowable deficit limit for an isotonic, electrolyte - containing fluid is 2500 ml. Also, system 100 can set a maximum total deficit limit for the procedure based on the sum of the fluid deficits of the selected fluid types. For example, the maximum total deficit limit for this procedure can be 2500 ml.

[0255] In various embodiments, the system 100 provides the user (via the user interface 110) with instructions for suspending a fluid supply container. For example, with respect to a first fluid type selected by the user, the system 100 may instruct the user on which suspension member 116 (Figures 1 and 2) to use, suspend the fluid supply container, and then instruct the user to monitor the suspension members 116 (Figures 1 and 2) to ensure that the fluid supply container is positioned on the correct suspension member; or it may indicate which suspension member 116 (Figures 1 and 2) is used to hold the fluid supply container, and then prompt the user to monitor the weight of the suspension member 116 (e.g., via a load cell connected to the suspension member) to determine when the fluid container is positioned on the corresponding suspension member 116. The system 100 can repeat the above process for a fluid container holding a second fluid type.

[0256] During the procedure, the system 100 may be configured to monitor and display the fluid deficiency level for a first fluid type (via the user interface 110) by subtracting the amount of fluid returned from the surgical site (determined, for example, using the deficiency cartridge 2010 and the deficiency module 104, or by monitoring the weight of a fluid collection container suspended from member 116 (Figures 1 and 2)) from the volume of fluid pumped to the surgical site (determined, for example, by monitoring the weight of a fluid supply container, monitoring the amount of pump rotation of pump 212, etc.).

[0257] In certain embodiments, the user can switch to a second fluid type via the user interface 110 (for example, by pressing a “Change Fluid Type” button or other similar button). The system 100 can then instruct the user to close the piping line(s) connecting the fluid supply vessel for the first fluid type to the pump 212 (for example, by closing the clamp(s) on the piping line(s)). The system 100 may also instruct the user to collect all residual fluid of the first fluid type from the surgical site, submucosal drapes, and floor. The system 100 can then instruct the user to fluidize the piping line for the fluid supply vessel for the second fluid type (for example, by opening the clamp(s) on the piping line(s)). In alternative embodiments, the system 100 may be configured to detect when the user switches to a second fluid type (via one or more processors in the control system). In certain embodiments, the piping lines may be automatically fluidically connected or disconnected by pinch valves.

[0258] After fluid connection of the piping lines for the second fluid type, the user can begin purging the first fluid type from system 100. In certain embodiments, the user stops the pump, removes the scope and / or surgical instruments from the body cavity constituting the surgical site, and allows the body cavity to discharge the first fluid type into the subbody drape. When complete, the user fluidly disconnects the first fluid type from the pump by closing the associated clamp(s), fluidly connects the second fluid type to the pump by opening the associated clamp(s), directs the scope and / or surgical instruments into the subbody drape, presses a “Purge” or similar button on the user interface 110 of system 100, and causes system 100 to pump (feed) the volume of the second fluid type necessary to push the first fluid type out of the cartridge assembly 419, the fluid inlet pipe, and the scope and / or instruments. In certain embodiments, the system 100 can pump (feed) a second fluid type necessary to induce purging until the user presses a “Stop Purge” or similar button on the user interface 110 of the system 100. After purging is complete and the underbody drape is empty, the system 100 records the fluid deficit for the first fluid type, empties the deficit cartridge 2010 (Figures 33-34), and then, via the user interface 110 of the system 100, indicates to the user that the procedure can proceed to the second fluid type. This process may be repeated, alternating between the first and second fluid types.

[0259] After the first fluid type has been purged from system 100, system 100 can begin monitoring and displaying fluid deficit levels for the second fluid type. System 100 may be configured to display total fluid deficit, deficit of the first fluid type, and / or deficit of the second fluid type. In certain embodiments, a user can select whether system 100 displays total fluid deficit, deficit of the first fluid type, deficit of the second fluid type, and / or any combination thereof via a toggle switch or similar button on the user interface 100.

[0260] In some embodiments, if the user does not notify system 100 of a fluid change (i.e., a change from a first fluid to a second fluid), system 100 may stop pump 212 and temporarily suspend the fluid flow. For example, system 100 may prompt the user to indicate whether a change in fluid type was intended, and if the user indicates that a change in fluid type was not intended, the system may instruct the user to check for any issues that may affect the weight on the suspension member associated with the other fluid type (e.g., leaks from bags, open clamps, or partially open clamps). If the user indicates that a change in fluid type was intended, system 100 may instruct the user to initiate a system purge (as described above). The user may switch fluids multiple times using the procedures described herein.

[0261] In certain embodiments, a user who initially indicated that only one fluid would be used for treatment may, during treatment, indicate to the system 100 via the user interface 110 that a second fluid will be used by pressing the "Settings" button or icon or similar button or icon on the user interface 110, and then the "Add Second Fluid" button or icon or similar button or icon. The system 100 may then instruct the user via the user interface 110 to suspend the second fluid type, purge the first fluid type, record the loss of the first fluid type, and continue treatment using the second fluid type as described above. The system can track losses for the first fluid type, the second fluid type, and total losses.

[0262] In certain embodiments, once the fluid container is positioned on the suspension member 116, the system 100 can guide the user to complete the piping installation process. For example, if the fluid suction collection module 106 is used but the defect module 104 is not, the instructions may include connecting the fluid lines returning from the surgical site, the subbody drape, and the floor (if applicable) to the fluid suction collection module 106. If the defect module 104 is used, the instructions may include inserting the defect cartridge 2010 into the defect module 104, connecting the suction source to the defect cartridge 2010 (e.g., via the vacuum port 2016), and connecting the fluid return piping lines (from the surgical site) to the defect cartridge 2010 (e.g., via the fluid inlet ports 2012, 2014). If the suction module 5201 is used, the instructions may include inserting the pressure regulator 5205 into the suction module 5201, connecting the suction source to the pressure regulator 5205 (e.g., via port 5315 shown in Figure 53 or port 5415 shown in Figures 54-55), and connecting the fluid return piping line (from the surgical site) to the pressure regulator 5205 (e.g., via port 5317 shown in Figure 53 or port 5417 shown in Figures 54-55). If the fluid flow discharge module 5101 (Figure 51) is used, the instructions may include inserting the deficiency cartridge 2010 (or a similar fluid volume monitoring cartridge) into the fluid flow monitoring and discharge module 5101, and connecting the fluid return line (from the surgical site) to the deficiency cartridge (e.g., via fluid inlet ports 2012, 2014).

[0263] Following the piping installation process, system 100 may instruct the user to complete the priming process. For example, system 100 may instruct the user to fluidly disconnect the fluid conditioner 420 (Figure 10) from the surgical instrument being used at the surgical site (for example, by closing a clamp on the piping that connects the fluid conditioner 420 to the surgical instrument). System 100 may also instruct the user to fluidly connect at least one of the fluid supply containers to the pump 212 (for example, by opening a clamp on the piping that connects the fluid supply container to the pump 212). Subsequently, the system 100 may instruct the user to begin priming the piping set (for example, by pressing the “priming” button or other similar button) so that the system 100 pumps fluid into the fluid conditioner 420 from at least one fluid container until the system 100’s pressure sensor indicates that the fluid in the fluid outlet chamber 1054 (Figure 10) of the fluid conditioner 420 has reached a specific fluid pressure, and / or until the system 100’s fluid presence sensor (e.g., fluid presence sensor 948 shown in Figure 9) targeting the fluid outlet chamber 1054 indicates that the fluid has reached a specific level. After the system 100 determines that the pressure or fluid level in the outlet chamber 1054 is sufficient, the system 100 may stop the pump 212. Next, the fluid pressure in the outlet chamber 1054 of the fluid conditioner 420 may be reduced by reversing the pump 212 or by opening a solenoid valve (e.g., solenoid valve 951 shown in Figure 9) until a desired fluid pressure or fluid level in the outlet chamber 1054 is achieved. The volume of fluid required to prime the piping set is known and may be added as a constant offset for the purpose of monitoring and displaying the volume of pumped fluid and fluid deficit (if applicable).

[0264] Referring to Figure 81, the system 100 may include a procedure execution screen 8101 (via the user interface 110). In the illustrated embodiment, the procedure execution screen 8101 for a system in pressure control mode is shown. In alternative embodiments, the system 100 may be in flow control mode or flex control mode. Each of these control modes is described in more detail below. The user can start a procedure by pressing the “Play,” “Execute,” or similar icon or button 8103 on the navigation bar at the bottom of the screen 8101. The user can also change default operating settings via adjustment controls / buttons on the execution screen 8101, such as the fluid pressure setpoint condition 8105 (when the system 100 is in pressure control mode), the fluid flow rate setpoint condition (not shown, when the system 100 is in flow control mode), and the defect alarm level 8107 (when defect monitoring is required or selected). In certain embodiments, the system 100 may only allow the user to change the default operating settings within a safe and acceptable adjustment range 8111 for the procedure. The procedure execution screen 8101 may also allow the user to enable / disable the fluid heating function and display the fluid temperature 8112 by using the switch 8113.

[0265] In addition to displaying the actual conditions 8115 and setpoint conditions 8105 for pressure (or flow rate, if system 100 is in flow control mode), and the actual conditions 8117 and setpoint conditions 8107 for fluid deficit (if applicable), the procedure execution screen 8101 may also display other information. For example, the procedure execution screen 8101 may display fluid inflow or volume pumping 8121 into the surgical site, (if system 100 is in pressure control mode) fluid flow rate 8123, and / or fluid pressure (not shown - if system 100 is in flow control mode). The procedure execution screen 8101 may also have a navigation bar consisting of icons or buttons that can be used before or during the procedure, such as a "Settings" button 8128, a "Help" or "Troubleshooting" button 8127, a "Notifications" button 8129, a "Maintenance" button 8181, and / or a "Case Closed" or "Procedure Closed" button 8133.

[0266] In some embodiments, pressing the "Settings" button 8128 displays a settings screen (not shown) on the user interface 110 that allows the user to adjust, set, or enable other functions of the system 100. For example, referring to Figure 82, the system 100 may include a procedure settings screen 8202 that allows the user to set or adjust the control mode that the system 100 follows for a procedure. In this embodiment, the system 100 may be set to pressure control mode 8204, flow control mode 8206, or flex control mode 8208. In certain embodiments, the system 100 may have one of the control modes (e.g., pressure control mode 8204) as the default, but the user can change the type of control mode on the procedure settings screen 8202. When the system 100 is in flow control mode 8206, the system changes the speed of the pump 212 to achieve and maintain a user-selected fluid flow rate setpoint (e.g., set by the user on the procedure execution screen 8101), provided that the maximum allowable fluid pressure for the procedure is not exceeded. In other words, the fluid pressure is changed to achieve the desired fluid flow rate.

[0267] When system 100 is in pressure control mode 8204, system 100 changes the speed of pump 212 to achieve and maintain a user-selected fluid pressure setpoint (e.g., set by the user on the procedure execution screen 8101 shown in Figure 81), provided that the maximum allowable fluid flow rate for the procedure is not exceeded. In other words, the fluid flow rate is changed to achieve the desired fluid pressure. In some embodiments, system 100 can be controlled to a user-selected fluid pressure setpoint as the desired fluid pressure in the system. In some embodiments, system 100 can be controlled to a user-selected fluid pressure setpoint as the desired fluid pressure in a surgical scope or instrument. Referring to Figure 81A, for ergonomic reasons corresponding to operating the graphical user interface 110 to suspend the fluid supply container from the suspension member 116 and inserting the components (e.g., the cartridge assembly 419 and / or missing cartridge 2010 described herein) into the main unit 102, the height H1 of the main unit 102 may be higher than the operating table 8151. In certain embodiments, the system 100 can compensate for the head pressure resulting from the difference H3 between the height H1 of the main unit 102 and the assumed or input height H2 of the patient 8153 when calculating the required system pressure. That is, the system 100 can make the compensated height H3 equal to the pressure adjustment and then subtract the pressure adjustment from the user-selected fluid pressure setpoint in the surgical scope or instrument. In some embodiments, the system 100 can be controlled to the user-selected fluid pressure setpoint as the desired fluid pressure in the body cavity constituting the surgical site. In these embodiments, in addition to calculating the pressure adjustment based on the compensated height H3 as described with reference to Figure 81A, the system 100 may also take into account known constraints of the piping set and assumed or calibrated constraints of the surgical scope or instrument in order to determine the required system pressure.Therefore, in some embodiments, the user may choose for the system 100 to monitor and display (via the graphical user interface 110) fluid pressure in the system, fluid pressure in a surgical scope or instrument, or fluid pressure in a body cavity constituting the surgical site.

[0268] In endoscopic surgery, good and stable inflation and clear visibility are crucial for the effectiveness and efficiency of the procedure. While fluid pressure and flow rate are key factors in achieving satisfactory inflation and visibility of the surgical site, some users may lack a clear understanding of how fluid pressure and flow rate (influenced by the state of the surgical site and the constraints on fluid inflow and outflow of the surgical instruments and piping sets delivering fluid to and from the surgical site) affect inflation and visibility. Referring to Figure 83, in an exemplary embodiment, system 100 may alternatively be set to a flex control mode, which allows the user to achieve the desired state of the surgical site simply by adjusting the inflation and visibility. That is, in this mode, the user is not concerned with whether system 100 is operating in dynamic fluid pressure control mode or fluid flow rate control mode, and the user is not concerned with setpoint pressure or flow rate either. Alternatively, the user can provide feedback to the system 100 regarding the condition of the surgical site via the user interface 110, and the system 100 will determine whether to operate in pressure control mode or flow control mode, and further determine appropriate setpoints for the fluid pressure and / or flow rate for the procedure.

[0269] Referring to Figure 83, when the user selects flex control mode, the system 100 sets a default fluid pressure setpoint for the procedure and presents "inflation" controls or buttons 8351, 8352 and "visualization" controls or buttons 8353, 8354 on the user interface 110. For example, the user can increase inflation by pressing the "+" (increase) button 8351 or decrease inflation by pressing the "-" (decrease) button 8352, and the user can increase visualization by pressing the "+" (increase) button 8353 or decrease visualization by pressing the "-" (decrease) button 8354. The user interface 110 may also display other information (similar to the procedure execution screen 8101 shown in Figure 81). For example, the user interface 110 may display the fluid inflow or volume 8321 pumped into the surgical site, the fluid flow rate 8323, and / or the fluid pressure 8324. The user interface may also display the fluid temperature 8312 and allow the user to enable / disable the fluid heating function by using a switch 8313. The user interface 110 may also have a navigation bar consisting of icons or buttons that can be used before or during a procedure, such as a "Settings" button 8328, a "Help" or "Troubleshooting" button 8327, a "Notifications" button 8329, a "Maintenance" button 8331, and / or a "Case Closed" or "Procedure Completed" button 8333.

[0270] Referring to Figure 84, when the system is set to flex control mode (as shown in 8402), the system 100 may default to pressure control mode (as shown in 8404). In the illustrated embodiment, expansion adjustment causes the system to enter fluid pressure control mode and adjusts the pressure setpoint for treatment, while visualization adjustment causes the system to enter fluid flow control mode and adjusts the flow setpoint for treatment.

[0271] If the user adjusts the inflation (as shown in 8406), the system 100 maintains or transitions to a pressure control mode setting (as shown in 8408), and the system 100 adjusts the setpoint pressure of the procedure to satisfy the desired inflation by the user. In various embodiments, inflation adjustments relative to the fluid pressure setpoint may never exceed the maximum allowable setpoint pressure for the procedure. If the user indicates that additional inflation is desired, but the pressure setpoint is at the maximum allowable level (as shown in 8410), the system 100 determines whether the flow rate to the system 100 is at the maximum allowable flow rate (as shown in 8412). If the flow rate is at the maximum allowable flow rate, the system 100 may notify the user (via the user interface 110) that the system 100 is operating at the pressure and flow rate limits for that procedure (as shown in 8414). If the flow rate is not at the maximum allowable flow rate, the system 100 may instruct the user to open the scope inlet and outlet valves to increase the fluid flow rate (as shown in 8416), thereby increasing the amount of fluid moving through the surgical site. Returning to the step shown in 8410, if the fluid setpoint pressure is not at the maximum allowable pressure, system 100 determines whether the flow rate to system 100 is at the maximum allowable flow rate (as shown in 8418). If the flow rate is at the maximum allowable flow rate, system 100 may instruct the user to restrict the fluid outflow from the surgical site (as shown in 8420) by partially closing the scope outlet valve, partially closing the clamp on the outlet piping, and / or using fixed or variable limiting device components in the outlet piping of the surgical instrument. If the flow rate is not at the maximum allowable flow rate, system 100 may increase the expansion by increasing the pressure setpoint (as shown in 8422).

[0272] When the user adjusts the visualization (as shown in 8424), the system 100 maintains or transitions to a flow control mode setting (as shown in 8426) so that the system 100 can adjust the setpoint flow rate of the procedure to satisfy the user's desired visualization. In various embodiments, visualization adjustments to the fluid flow setpoint can never exceed the maximum allowable setpoint flow rate for the procedure. If the flow setpoint is at the maximum allowable level (as shown in 8428), the system 100 determines whether the fluid pressure for the system 100 is at the maximum allowable pressure (as shown in 8430). If the pressure is at the maximum allowable pressure, the system 100 can notify the user (via the user interface 110) that the system 100 is operating at the pressure and flow limits for that procedure (as shown in 8414). If the pressure is not at the maximum allowable flow rate, the system 100 can instruct the user to limit the fluid outflow from the surgical site (as shown in 8432), thereby allowing the system 100 to increase the fluid pressure within the surgical site. The user can restrict outflow from the surgical site, for example, by partially closing the outflow valve of the surgical instrument, partially closing a clamp on the outflow piping, and / or by using fixed or variable limiting components in the outflow piping of the surgical instrument. Returning to the step shown in 8428, if the setpoint flow rate of the fluid is not at the maximum allowable flow rate, the system 100 determines whether the fluid pressure relative to the system 100 is at the maximum allowable flow rate (as shown in 8434). If the pressure is at the maximum allowable pressure, the system 100 may instruct the user to open the scope inflow / outflow valve (as shown in 8436) to increase the fluid flow rate through the surgical site. If the pressure is not at the maximum allowable pressure, the system 100 may increase the flow rate setpoint (as shown in 8438) to increase visibility.

[0273] In other words, by utilizing expansion controls 8351 and 8352, the user can set system 100 to pressure control mode and adjust the setpoint fluid pressure for the procedure to the maximum allowable level for the procedure while maintaining the maximum allowable flow rate that cannot be exceeded. By utilizing visualization controls 8353 and 8354, the user can set system 100 to flow control mode and adjust the setpoint fluid flow rate for the procedure to the maximum allowable level for the procedure while maintaining the maximum allowable fluid pressure that cannot be exceeded. Thus, system 100 provides the user with more intuitive control over the condition of the surgical site, while always displaying the actual fluid pressure and flow rate, keeping them within safe pressure and flow rates for the procedure.

[0274] Referring to Figures 85–87, system 100 may include a bolus feature or bolus device used to temporarily increase fluid pressure and / or flow rate in order to maintain or increase expansion and / or to maintain or increase fluid flow for procedural and / or visualization purposes. The bolus feature or bolus device may include a “bolus” icon or button on one of the screens, including a graphical user interface, a pneumatic, electric, or wireless foot pedal, and / or other actuation devices that enable the surgeon to temporarily increase fluid pressure and / or flow rate for procedural and visualization purposes. The bolus device may be operably connected to the pump 212 of system 100 (Figure 2), so that the surgeon can operate the bolus device to temporarily increase pressure or flow rate by operating the pump 212, and the pump returns to normal settings to provide fluid at setpoint pressure and flow rate after the surgeon has stopped the bolus device. Because the surgeon operates the bolus device, it can be provided when needed without requiring manual operation of the bolus device or interaction between the circulatory nurse and the system. The bolus feature also prevents the setpoint pressure and / or flow rate of the fluid management system from changing due to only a temporary increase in pressure and / or flow rate.

[0275] The bolus device can interface with the system pneumatically, electrically, or wirelessly (for example, via Bluetooth®). The bolus device can be configured by the user via the user interface 110. For example, the user may use a toggle switch 8510 (via the user interface 110) to switch the bolus device between an "on" and an "off" state. In certain embodiments, the user may choose to operate the bolus device in a transient mode 8501 where the increase is sustained as long as the foot pedal is pressed. Alternatively, the user may choose to operate the bolus device in a sustained mode 8503 where the foot pedal is pressed to activate the bolus device and then pressed again to deactivate it. In another embodiment, the user may choose to operate the bolus device in a timed mode (not shown) where the foot pedal is pressed to activate the bolus device, and the system 100 maintains the bolus device in the activated state for a desired period of time. Whether the increase caused by the bolus device is relative to the fluid pressure or flow rate setpoint may depend, for example, whether system 100 is in pressure mode or flow control mode when the bolus is activated. The user may choose to have an increase equal to a setpoint increment (e.g., a pressure increase of 25 mmHg or a flow rate increase of 50 ml / min), a percentage increase beyond the setpoint (e.g., 20%), or the maximum allowable fluid pressure or fluid flow rate for treatment. The increases in fluid pressure and fluid flow rate may be limited to the maximum allowable setpoint for treatment.

[0276] The bolus device of this application is beneficial because it is known and safe to increase fluid pressure or flow rate. Specifically, the user sets the increase, and the actual fluid pressure and flow rate are displayed on the user interface 110 of the system 100, and this increase never exceeds the maximum permissible safety limits for this procedure. Furthermore, the duration of the increase is appropriate as it is determined and controlled by the surgeon. Also, since the surgeon controls the bolus device, for example via a foot pedal, the bolus device does not need to be operated by a circulatory nurse, and the bolus device does not involve interaction with the system.

[0277] In an alternative embodiment, system 100 may include a temporary adjustment feature (function) or device used to temporarily increase or decrease fluid pressure and / or flow rate, thereby allowing the user to temporarily increase or decrease inflation and / or visualization at the surgical site. This adjustment feature (function) or device may include a “temporary” icon or button representing the temporary adjustment in one of a screens, including a graphical user interface combined with a foot pedal or other type of actuator. In certain embodiments, the actuator includes pneumatic, electric, or wireless foot pedals, such as a foot pedal with rocker action, or a dual foot pedal configuration that allows the surgeon to temporarily increase or decrease fluid pressure and / or flow rate for treatment and visualization purposes. The adjustment device may be operably connected to the pump 212 of system 100 (Figure 2) so that the surgeon can activate the device to temporarily increase or decrease pressure or flow rate by operating the pump 212, and so that after the surgeon stops the adjustment device, the pump returns to its normal settings for providing fluid at setpoint pressure and flow rate. Since the surgeon operates the adjustment device, temporary adjustments to pressure and / or flow rate can be made as needed without requiring manual operation of the device or interaction between the circulatory nurse and the system 100. The adjustment device can interface with the system pneumatically, electrically, or wirelessly (e.g., via Bluetooth®) and can be configured by the user via the user interface 110 for mode (temporary or maintained) and adjustment type (fixed, percentage, or maximum).

[0278] In certain embodiments, system 100 may include a printer (e.g., printer 218 shown in Figure 2) for printing appropriate information about the surgical procedure during or after the procedure. Referring to Figure 88, in a situation where system 100 is tracking fluid defects for a procedure, the user may choose (via user interface 110) to automatically record and print fluid defects at set time intervals (e.g., every 10 minutes) during the procedure. As shown in Figure 88, user interface 110 may include a toggle button to turn on or off automatic recording and printing of fluid defects at set time intervals during the procedure. This capability (function) eliminates the need for the user to periodically check for fluid defect information and manually record or print it. In some embodiments, the user may request (via user interface 110) to record fluid defects at set time intervals during the procedure and print them at the end of the procedure. In some embodiments, the user may request (via user interface 110) to display defect information from previous time intervals. In some embodiments, the system 100 may be configured to print fluid defects at volume intervals for defect monitoring (e.g., individually for each fluid defect and / or for every 50 ml volume for every fluid defect). In some embodiments, instead of printing to the system 100's own printer, the system 100 may be configured to communicate automatically with a printer in the facility where the system 100 is being used (e.g., via wired, Bluetooth®, or WiFi®) and print relevant information during or after treatment, or at set time intervals during treatment.

[0279] System 100 can be configured to provide the user with the ability (function) to print relevant procedure information at the end of the procedure, including but not limited to the date, procedure type, start time, end time, volume of fluid pumped, fluid deficit (if applicable), fluid deficit at set time intervals (if applicable), average fluid pressure, fluid heating enabled / disabled, and / or average fluid temperature. In some embodiments, the user may choose to have different or additional information printed, including but not limited to equipment information, physician information, patient information, fluid deficit by fluid type (if applicable), fluid deficit by time increment (if applicable), fluid pressure range, fluid flow range, notification and warning list, and alarm list. Furthermore, the user may choose to transmit the relevant procedure information to the equipment's data acquisition and / or record-keeping system via the Bluetooth® or Wi-Fi® functionality of System 100.

[0280] To avoid treatment interruptions caused by depleted fluid supply bags, system 100 can record the initial weight of the fluid supply bags suspended from each suspension member 116 (Figure 1), the current weight of the fluid supply bags on each suspension member 116, and the current fluid flow rate for treatment. System 100 can also provide an audible and / or visual indicator if it determines that a fluid bag may be depleted. System 100 can also provide an audible and visual indication when the estimated time until a fluid bag is depleted falls below a specified level.

[0281] Alternatively, referring to Figures 89-91, the user may choose to receive an audible and / or visual indicator (via the user interface 110) when the percentage of remaining fluid (based on the initial volume of the fluid bag) falls below a specified level. Referring to Figure 89, the system 100 may be set to a “time” setting 8902 that notifies the user when the amount of time until the bag is consumed falls below a predetermined time (as shown in 8903), based on the current or average flow rate. Alternatively, the system 100 may be set to a “percentage” setting 8904 that notifies the user when the percentage of remaining fluid supply falls below a predetermined percentage (as shown in 8904). Alternatively, the system 100 may be set to a “volume” setting 8906 that notifies the user when the volume of fluid remaining in the fluid supply container falls below a predetermined volume (as shown in 8907). If the above levels are set appropriately, the user (typically a circulatory nurse) will have time to change the fluid bag without interrupting the procedure. To avoid confusion and ensure a high level of attention to alarm conditions, the user can mute or reduce the sound levels of certain indicators, alerts, and alarms provided by the switch or button 8910 and the selection window 8912. However, in some embodiments, adjusting the alerts / indicators is not possible for certain safety-critical alarms.

[0282] Referring to Figures 92 and 93, exemplary embodiments of a fluid management system 9200 for a physician's clinic environment where gynecological and urological procedures are performed are shown. System 9200 includes a main unit 9202 which may include any or all of the features described above for the main unit 102 of the fluid management system 100 used in an operating room environment. For example, the main unit 9202 may include a control system having one or more processors (not shown) for controlling various components of system 9200 (e.g., a user interface, and various fluid pressure sensors, vacuum pressure sensors, fluid temperature sensors, fluid presence sensors, etc.). The processors can execute instructions (e.g., software code) stored in the memory (not shown) of system 100 and / or execute instructions entered into the system by a user. In one embodiment, the control system may have a "Bluetooth" function for connecting to remotely located components or modules of system 9200 and a "Wi-Fi" function for connecting to the internet. The control system may include a touchscreen graphical user interface 9210 for receiving (accepting) one or more inputs from the user and displaying information about the system 9202 (e.g., information about fluid deficiency, fluid temperature, fluid pressure, expansion, visualization, etc.).

[0283] The main unit 9202 may also include a pump for fluid pressurization (e.g., pump 212 shown in Figure 2), a vacuum pump for providing suction, a fluid conditioning assembly (e.g., fluid conditioning assembly 315 shown in Figure 3), and a fluid conditioning assembly (e.g., fluid conditioner 420 shown in Figure 10) for sensing one or more properties of the fluid moving through the fluid conditioner (e.g., fluid presence, fluid temperature, etc.), and a suspension member 9216 (e.g., a hook) for suspending a fluid supply or recovery container 9217 (e.g., a bag, canister, container, etc.). In some embodiments, the main unit 9202 may include a heating assembly (e.g., heating assembly 314 shown in Figure 3) for receiving a heating cartridge (e.g., heating cartridge 422 shown in Figures 14-18), and as a result, the system may be configured for fluid heating during procedures, where applicable. The control system's processor can communicate with the pump, sensors, fluid conditioning assembly, heating assembly (if applicable), and suspension member 9216 via circuit, and the processor can be configured to control these components. In certain embodiments, the suspension member 9216 is operably connected to a load cell so that the control system can monitor the weight of the fluid container 9217.

[0284] System 100 for an operating room environment may include a cartridge assembly 419 (Figure 4) including a fluid conditioner 420 and a fluid heating cartridge 422, while System 9200 for a physician's clinic may or may not include a fluid heating function. In embodiments that do not include a fluid heating function, the fluid conditioner 420 described with reference to System 100 may be used with System 9200, but the fluid conditioner 420 may include a connector or tube 841 (Figure 8), a pulse attenuation component, or a channel integrated into the fluid conditioner 420 that connects an inlet chamber 1053 (Figure 10) to an outlet chamber 1054 (Figure 10), instead of a heating cartridge 422. If System 9200 includes a fluid heating component, the heating cartridge (e.g., heating cartridge 422 shown in Figures 14-18) may be an accessory attached to the fluid conditioner 420 so that System 9200 can perform fluid heating.

[0285] System 9200 can be configured to perform defect monitoring by a weight-based method, in contrast to the flow-based defect monitoring method described with the fluid management system 100. Flow-based defect monitoring (as used in System 100) is suitable for operating room environments due to the generally higher fluid volume usage associated with longer and more complex surgical procedures performed there. However, since surgical procedures performed there are generally shorter and use less fluid, the complexity and cost of flow-based defect monitoring functionality may not be necessary in a physician's clinic environment. Therefore, System 9200 can be configured to include weight-based defect monitoring. In certain embodiments, a suspension member 9216 is configured for a dual purpose: to hold and monitor the weight of a fluid container 9217. That is, the processor of System 9200 can be operably connected to a load cell in the suspension member 9216, thereby enabling System 9200 to monitor the weight of the fluid container 9217. At least one fluid container 9217 is for supplying fluid to the surgical site, and at least one fluid container 9217 is for fluid returning from the surgical site. System 9200 monitors the weight of the suspension member 9216 to determine the volume of fluid flowing into the surgical site (based on the weight of the fluid supply container) and the volume of fluid returning from the surgical site (based on the weight of the fluid return container), and calculates the fluid deficit, which is the difference between the fluid inflow volume and the fluid outflow volume. System 9200 can be configured to monitor and display the fluid volume and fluid deficit. System 9200 can also be configured to provide notifications or alarms if the deficit level exceeds a default limit or adjustment limit set by the user.

[0286] Similar to system 100 described in this application, system 9200 may be configured to guide the user through the setup process using instructions, illustrations, animations, and / or system feedback via the user interface 9210. For example, system 9200 may first prompt the user to select the surgical field and procedure to be performed, thereby allowing system 9200 to set default operating parameters for the procedure, as well as a safe and acceptable range of adjustment for these parameters.

[0287] If deficit monitoring is requested or selected by the user, the system 9200 may prompt the user to indicate the type of fluid to be used and set a maximum deficit limit for that fluid. The system 9200 may then instruct the user to suspend a fluid supply container and indicate when the container is placed on the suspension member 9216 (the system verifies the placement by monitoring the weight of each suspension member). The system 9200 may also instruct the user to suspend a fluid supply container 9217 on a specific suspension member 9216 (the system 9200 verifies the placement by monitoring the weight of the specified suspension member). The system 9200 may then instruct the user to connect a fluid return line to a fluid return container 9217, connect the fluid return container 9217 to a suction source (e.g., an integrated suction source on the main unit 9200 or an external suction source), and then suspend the fluid return container on another suspension member 9216. When the system 9200 senses that the fluid return container 9217 has been suspended, the system 9200 may set and record the weight of the empty fluid container to zero so that the fluid deficit can be properly calculated for the procedure. Alternatively, the system 9200 may instruct the user to place the fluid supply container 9217 on the suspension member 9216, and when the system 9200 senses that the fluid supply container is properly placed, the system 9200 may instruct the user to prepare and suspend the fluid return container as described above. The system 9200 can appropriately assign suspension members to the respective fluid supply and fluid return containers by monitoring the weight change of each suspension member during the procedure, or by comparing the respective weights on the suspension members after the procedure is complete. The system 9200 can accommodate standard canisters capable of holding up to 5L of fluid, but piping sets intended for procedures performed in a physician's clinic environment may also be used for the fluid collection function described.

[0288] If defect monitoring is not required or selected, the system 9200 may prompt the user to place the fluid supply container 9217 on the suspension member 9216, to place or route the piping connecting the fluid container(s) to the fluid conditioner(s) (e.g., fluid conditioner 420), and to insert the fluid conditioner into or through the pump 212 into the main unit 9202.

[0289] Following the piping installation process, system 9200 can instruct the user to complete the priming process, as described above with reference to system 100. Once priming is complete, the user interface transitions to a procedure execution screen (e.g., procedure execution screen 8101), where the user can start and control the procedure.

[0290] While various aspects, concepts, and features of the invention of this disclosure may be described and illustrated herein to be embodied in combination in exemplary embodiments, these various aspects, concepts, and features may be used individually or in any of their various combinations and subcombinations in many alternative embodiments. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, various alternative embodiments relating to various aspects, concepts, and features of the disclosure may be described herein, including alternative materials, structures, configurations, methods, devices, and components, and alternatives relating to form, fit, and function, but such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or to be developed later. A person skilled in the art can readily adopt and use one or more aspects, concepts, or features of the invention in additional embodiments within the scope of this application, even if such embodiments are not expressly disclosed herein.

[0291] Furthermore, certain features, concepts, or aspects of the disclosure may be described herein as preferred configurations or methods, but such descriptions are not intended to imply that such features are required or necessary unless expressly stated so. Additionally, illustrative or representative values ​​and ranges may be included to aid in understanding this application, but such values ​​and ranges should not be constrained, and are intended to be critical values ​​or ranges only when expressly stated so.

[0292] Furthermore, various embodiments, features, and concepts may be expressly identified herein as inventive or forming part of the disclosure, but such identification is not intended to be exclusive. Rather, there may be inventive embodiments, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, and such disclosure is instead described in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as required in all cases, and the order in which the steps are presented is such that they are required or construed as required unless expressly stated otherwise. Terms used in the claims have their full ordinary meanings and are not in any way limited by the descriptions of embodiments herein.

Claims

1. A fluid management system, A pump configured to deliver fluid from at least one fluid supply container to the surgical site, A fluid conditioning portion for receiving a disposable fluid conditioner, wherein the disposable fluid conditioner is connected to the pump such that the fluid delivered from the pump moves through the disposable fluid conditioner before moving to the surgical site, A control system for operating the pump, A user interface for communication between the control system and the user, including inputting data into the control system, One or more non-contact sensors, The control system comprises, The one or more non-contact sensors of the control system include one or more fluid presence sensors configured to detect the presence of the fluid when the fluid is moving through the disposable fluid conditioner, and a pressure sensor configured to detect the pressure of the fluid. A fluid management system comprising a control system configured to discharge air from a disposable fluid conditioner in the vicinity of at least one fluid presence sensor, based on the fact that at least one of the one or more fluid presence sensors does not detect the fluid in at least a portion of the disposable fluid conditioner and that the pressure sensor is reading a positive pressure.

2. The fluid management system according to claim 1, wherein the disposable fluid conditioner is aligned with one or more non-contact sensors of the fluid management system when the disposable fluid conditioner is placed in the fluid conditioning portion.

3. The fluid management system according to claim 1, wherein the disposable fluid conditioner includes a port that enables the pressure sensor of one or more non-contact sensors of the fluid management system to detect the pressure of the fluid.

4. The fluid management system according to claim 1, wherein the disposable fluid conditioner comprises an inlet chamber and an outlet chamber fluidly connected to the inlet chamber, the inlet chamber receiving the fluid delivered from the pump, and the fluid passing through the disposable fluid conditioner and out of the outlet chamber before moving to the surgical site.

5. The fluid management system according to claim 4, wherein the disposable fluid conditioner comprises a rigid body and a film defining the inlet chamber and the outlet chamber, the film enabling at least some of the one or more non-contact sensors of the fluid management system to detect one or more properties of the fluid passing through the film.

6. The fluid management system according to claim 5, wherein the one or more fluid presence sensors are configured to detect the presence of the fluid in the disposable fluid conditioner through the film.

7. The fluid management system according to claim 4, wherein one of the one or more fluid presence sensors is positioned near the outlet chamber of the disposable fluid conditioner to detect the presence of the fluid in the outlet chamber.

8. The fluid management system according to claim 7, wherein the control system is configured to discharge the air from the outlet chamber until the level of the fluid in the outlet chamber is detected by the fluid presence sensor in order to maintain the amount of air in the outlet chamber above the position of the fluid presence sensor.

9. The fluid management system according to claim 4, wherein the disposable fluid conditioner further comprises a connector for connecting the inlet chamber to the outlet chamber.

10. The fluid management system according to claim 5, wherein the disposable fluid conditioner includes an internal fluid path connecting the inlet chamber to the outlet chamber, and the internal fluid path is at least partially defined by the rigid body and the film.

11. The fluid management system according to claim 4, wherein the disposable fluid conditioner further comprises a fluid heating cartridge for fluidly connecting the inlet chamber to the outlet chamber, the fluid heating cartridge is configured to expose the fluid to IR energy from a heating source of the fluid management system in order to heat the fluid when the fluid conditioner is inserted into the fluid management system.

12. The fluid heating cartridge comprises a rigid body and a thin, flexible side sheet defining a conduit, the conduit being fluidly connected to the inlet chamber and the outlet chamber such that fluid received into the inlet chamber from the at least one fluid supply container moves through the conduit into the outlet chamber, and the conduit of the fluid heating cartridge is aligned with the heating source of the fluid management system when the fluid conditioner is positioned within the fluid conditioning portion of the fluid management system, according to claim 11.

13. The fluid management system according to claim 12, wherein the conduit includes an inlet conduit and an outlet conduit, the inlet conduit being defined by a first side of the rigid body and a first flexible side sheet of the flexible side sheet, and the outlet conduit being defined by a second side of the rigid body and a second side sheet of the flexible side sheet.

14. The fluid management system according to claim 12, wherein the flexible side sheet is configured to expand and contract as the pressure of the fluid moving through the conduit fluctuates to reduce the pulsation of the fluid.

15. The fluid management system according to claim 11, wherein the one or more non-contact sensors of the control system include an inlet temperature sensor aligned with the inlet chamber and an outlet temperature sensor aligned with the outlet chamber, and the control system controls the amount of IR energy supplied to the fluid heating cartridge by the heating source based on the temperatures detected by the inlet temperature sensor and the outlet temperature sensor and one of the default setpoint temperature of the fluid management system or a user-input setpoint temperature.

16. The fluid management system according to claim 15, wherein when at least one of the inlet temperature sensor and the outlet temperature sensor detects a temperature greater than a predetermined value, the control system is configured to disable the pump in order to prevent the pump from pumping fluid.

17. The fluid management system according to claim 15, wherein the one or more non-contact sensors of the control system include capacitive sensors.

18. The fluid management system according to claim 15, wherein the one or more non-contact sensors of the control system include an inlet fluid presence sensor aligned with the inlet chamber of the fluid conditioner, and the control system is configured to provide a first notification to the user through the user interface when the control system detects that the pump is operating and the inlet fluid presence sensor has not detected any fluid in the inlet chamber.

19. The fluid management system according to claim 18, wherein the one or more non-contact sensors of the control system include an outlet fluid presence sensor aligned with the outlet chamber of the fluid conditioner, and the control system is configured to provide a second notification to the user through the user interface when the control system detects that the pump is operating and the outlet fluid presence sensor has not detected any fluid in the outlet chamber.

20. The fluid management system according to claim 1, wherein the pressure sensor is connected to a port of the disposable fluid conditioner, the pressure sensor measures the pressure of the fluid in the outlet chamber of the disposable fluid conditioner, and the at least one fluid presence sensor is a midpoint fluid presence sensor aligned with the midpoint of the outlet chamber.

21. The fluid management system according to claim 20, further comprising a solenoid valve connected to the port of the disposable fluid conditioner, which is movable from a closed position to an open position in order to discharge the air from the outlet chamber.

22. The fluid management system according to claim 20, wherein the one or more non-contact sensors further comprises a port fluid presence sensor aligned with the outlet chamber of the fluid conditioner and located above the midpoint fluid presence sensor, and the control system is configured to disable the pump to prevent the pump from pumping fluid when the port fluid presence sensor detects fluid.

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