Heat Treatment of Surgical Fluids
The system addresses the challenges of temperature and volume management in surgical fluid systems by using a surgical fluid warmer with integrated temperature control and volumetric measurement, enhancing patient safety and procedural efficiency.
Patent Information
- Application Number
- JP2023123037
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-03-25
- Filing Date
- 2023-07-28
- Publication Date
- 2025-04-10
- Estimated Expiration
- 2037-03-24
AI Technical Summary
Existing systems for managing surgical fluids lack effective methods for monitoring and controlling the temperature and volume of surgical fluids during medical procedures, which can lead to unintended hypothermia and inefficient fluid management.
A device and system that includes a surgical fluid warmer with a bowl for holding surgical fluid, a heater for temperature control, and a volumetric measuring device to track the volume of fluid added and removed, along with a user interface for clinician interaction and a controller to manage the system's functions.
The system effectively heats surgical fluids to a safe temperature, minimizing the risk of hypothermia, and accurately monitors the volume of fluid used during procedures, ensuring efficient fluid management and patient safety.
Smart Images

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Abstract
Description
[Technical field]
[0001] cross reference This application claims priority to U.S. Provisional Patent Application No. 62 / 313,249, filed March 25, 2016, the entire contents of which are incorporated herein by reference.
[0002] SUMMARY The present disclosure relates to a system for managing surgical fluids and, more particularly, to a system for regulating the temperature of surgical fluids in a medical procedure room. [Background technology]
[0003] Surgical fluids are used during a variety of different medical procedures. For example, saline is often used during surgery to cleanse the surgical site. Saline can be injected into the surgical site to flush the area of blood and other bodily matter, providing the clinician with a clear view of the area being operated on and a clean surface to perform the surgery. As another example, surgical fluids may be frozen into a slush that is introduced to a particular area of the body. The slush can provide localized hypothermia therapy, cooling the area of the body or organ where the slush is placed. This can be useful to temporarily reduce the amount of oxygenated blood required by the body, such as in emergencies like cardiac arrest or severe head trauma.
[0004] Controlling the temperature of a surgical fluid prior to introduction into the body can be useful to help ensure a safe and effective medical procedure. For example, in the case of a surgical slush, the surgical fluid can be cooled to a temperature sufficient to provide a slush, but not so low that the surgical slush reaches a temperature that would damage organs. As another example, in the case of a liquid irrigation, the surgical fluid can be heated above room temperature before being introduced into the patient's body.
[0005] Anesthetized patients are unable to regulate their body temperature. This is because the parts of the brain that regulate body temperature are shut down by anesthesia. If the surgical irrigation fluid is not heated before it is introduced into the patient, the surgical fluid may cool the patient's core body temperature. For procedures that take longer or involve larger volumes of irrigation fluid, the cumulative cooling effect may increase the risk of unintentional hypothermia. For this reason, surgical fluids may be heated to a temperature approximately the patient's standard body temperature (98.6 degrees Fahrenheit) before introducing the fluid into the patient. This may help minimize the risk of unintentional hypothermia.
[0006] Whether the surgical fluid is heated or cooled before being introduced to the patient, the nurse or other clinician responsible for the surgical fluid during the procedure may monitor the amount of fluid introduced to the patient. Typically, the surgical fluid is pre-packaged in standard size bottles, and the clinician may monitor the number of bottles used during the procedure to determine the amount of fluid introduced to the patient. The clinician may monitor the amount of fluid used to ensure that too much fluid is not introduced to the patient and / or that a proportional amount of fluid is withdrawn from the patient using a suction device. Summary of the Invention
[0007] In general, the present disclosure relates to devices, systems, and techniques for monitoring and / or determining the amount of a substance in a surgical environment and optionally regulating the temperature of such a substance. In some configurations, the device is designed to receive a surgical fluid used during a medical procedure, heat the fluid to a temperature suitable for introduction into a mammalian patient, and actively track the volume of fluid removed from the device during the procedure. The device may track the volume of fluid introduced and / or removed from the device using any suitable volume measuring device. For example, the volume measuring device may be implemented by measuring the weight of the fluid and then determining the volume based on a programmed density of the fluid, by measuring the height of the fluid in a basin, by measuring the volume of fluid dispensed through a fill inlet and / or a dispense outlet, or by yet other volume measuring arrangements. When configured to measure weight, the device may provide a convenient metering apparatus for weighing objects in a surgical environment, such as test strips extracted from a patient. For these metering applications, the device may or may not include temperature regulation capabilities.
[0008] In some examples, the system is configured as a surgical fluid warmer including a bowl that receives and holds the surgical fluid. The bowl is supported on a base, such as a mobile base mounted on caster wheels, allowing the system to be easily moved from one location to another. The system includes a heater that is thermally coupled to the bowl and configured to heat the surgical liquid disposed in the bowl to a target temperature. In addition, the system includes a volume measuring device. The volume measuring device is positioned to obtain volumetric information regarding the volume of surgical fluid added to the bowl. For example, in different applications, the volume measuring device may be implemented using a load cell that directly measures volume by measuring the weight of the bowl and contents therein, a float that rises and falls based on the level of surgical fluid in the bowl, or other sensor that measures the volume of surgical fluid in the bowl. In either configuration, the system may also include a display that displays the volume of surgical fluid used during the procedure. The display may update in substantially real time as fluid is removed from the bowl and introduced to the patient, providing timely and accurate information for the clinician to make clinical decisions.
[0009] In fact, it can be difficult to monitor the total volume of surgical fluid withdrawn from the surgical fluid warmer bowl because the bowl may be refilled during a procedure and / or non-fluid components may be added and withdrawn from the bowl periodically during a procedure. For example, a clinician may place a sterile asepto rubber bulb syringe and / or a sterile graduated measuring container into the bowl and then use these tools to transfer fluid from the bowl to the patient during a procedure. The apparent volume of surgical fluid in the bowl will increase or decrease depending on whether a tool is in or outside the bowl.
[0010] In some systems according to the present disclosure, a user interface is provided with which the clinician can interact to notify the system whether new fluid is being added to the bowl, whether tools are being added or removed from the bowl, etc. For example, the user interface may include a user-operable input, such as a button or other mechanism (e.g., a foot pedal) on a console or touch screen display that the user can press to notify the system that a tool is being added or removed from the bowl. The user interface may include a separate user-operable input that the user can press to notify the system that additional surgical fluid is being added to the bowl. Additionally or alternatively, the system may include a user interface that receives audible inputs or commands from the user, and / or a photodetector that detects user behavior or commands to determine when surgical fluid or tools are being added or removed from the bowl.
[0011] During operation, a controller associated with the system can monitor the volume of fluid in the bowl based on feedback from the volume measuring device. The controller can track reductions in the volume of fluid and attribute those reductions to fluid being removed from and introduced to the patient. When the controller is notified via the user interface that fresh fluid is being added to the bowl, the controller can identify that the corresponding change in the measured volume of fluid in the bowl is associated with new fluid being added to the bowl, rather than fluid previously withdrawn from the bowl being returned from the bowl. Even if the controller is not notified via the user interface that fresh fluid is being added to the bowl, if the controller detects an increase in the volume of fluid in the bowl (e.g., beyond a magnitude typically associated with a tool or fluid being returned to the bowl), the controller can designate the increase in volume as fresh fluid being added. In applications where the system is also configured to check for tools in and out of the bowl, the controller may be notified via the user interface that a tool is being added or removed from the bowl. When so notified, the controller can ignore the corresponding change in the measured volume of fluid in the bowl as associated with the addition or removal of a tool from the bowl, rather than a surgical fluid.
[0012] In applications where the system monitors the volume of fluid removed from the bowl by detecting changes in weight, the system may be designed with a floating bowl configuration that allows the bowl to move relative to one or more load cells. The bowl may move upwards and downwards relative to the ground over a limited range of motion as the weight of the contents placed in the bowl fluctuates. In some configurations, the bowl is mounted to a mounting plate that presses against one or more load cells with an air gap formed between the bowl and the load cell(s). This air gap may be completely free of material or may be filled with a material of less thermal conductivity than the bowl itself, but may serve to thermally isolate the bowl from the load cell(s). During operation, the bowl and contents therein are heated while the weight of the bowl and contents are measured by the load cell(s). Creating an air gap between the bowl and the load cell(s) may help minimize the degree to which the load cell heats up as the bowl and contents heat up. This may help reduce or eliminate weighing inaccuracies caused by the load cell(s) increasing in temperature.
[0013] Regardless of the particular configuration of the bowl relative to the load cell(s), in applications in which the system is configured to measure the amount of material in the bowl and heat the material, the system may use the amount and temperature measurements to control the heating. For example, the system may receive information from the system regarding the amount of material in the bowl and the measured temperature of the material in the bowl. If the system determines that the amount of material in the bowl is relatively small (e.g., below a threshold), the system may control the heater to provide a different heating rate than if the system determines that the amount of material in the bowl is larger. The system may control the heater to heat the material in the bowl until it reaches a measured target temperature. In some examples, the system adjusts and reduces the rate at which the heater delivers heat as the material in the bowl approaches the target temperature (e.g., falls within a threshold range of the target temperature). Controlling the heating rate based on the amount of material in the bowl and / or the measured temperature of the material can be useful to prevent overheating of the material, such as during start-up when the material is heated from an ambient temperature.
[0014] Thermal treatment systems according to the present disclosure can have a variety of other features in addition to or in lieu of volume measurement and tracking capabilities. For example, the system can include a bowl configured to receive a disposable drape. The drape can conform to the shape of the bowl and have a skirt that depends from the sides of the bowl. Placement of the drape within the bowl can establish a sterile field for subsequent introduction of sterile surgical fluids within the bowl and / or tools within the bowl and drape contained therein.
[0015] To ensure that the drape placed in the bowl is suitable and compatible with the system, e.g., capable of withstanding the thermal conditions generated by the system without degradation, the temperature management system may include a contactless reader. The contactless reader may be implemented as part of the system intended to function with a corresponding disposable drape that includes a contactless tag. In operation, when a clinician places a drape in the bowl, the contactless reader may emit a signal that searches for a corresponding tag on the drape. If the system reads the identification information from the contactless tag on the drape and confirms that the drape is approved for use, the system may proceed with the operation. On the other hand, if the system determines that the drape does not have a contactless tag or the identification information on the tag is not approved, the system may prohibit further operation. In one example, the contactless reader and corresponding tag may be implemented using Near Field Communication (NFC) technology. Systems according to the present disclosure may have additional or different features as described herein.
[0016] In one example, a system for thermally treating a surgical fluid is described that includes a bowl, a thermal treatment device, a volumetric measuring device, and a controller. The bowl is configured to receive and hold the surgical fluid. The thermal treatment device is thermally coupled to the bowl and configured to regulate a temperature of the surgical fluid in the bowl. The volumetric measuring device is positioned to obtain volumetric information related to a volume of the surgical fluid in the bowl. According to the example, the controller is configured to receive volumetric information related to a volume of the surgical fluid in the bowl during a procedure from the volumetric measuring device. The controller is further configured to determine a volume of surgical fluid removed from the bowl during a procedure.
[0017] In another example, a method is described that includes engaging a user interface on a device for thermally treating a surgical fluid, thereby notifying the device that surgical fluid is added to the device. The method further includes adding the surgical fluid to a bowl of the device and engaging a user interface of the device, thereby notifying the device that surgical fluid has been added to the device. The method involves removing the surgical fluid from the bowl and displaying, by the device, the volume of surgical fluid removed from the bowl.
[0018] In another example, a system for heating a surgical fluid is described. The system includes a base mounted on wheels and a bowl supported by and rising vertically above the base, the bowl configured to receive and hold a surgical fluid. The system also includes a heater thermally coupled to the bowl and configured to increase a temperature of the surgical fluid in the bowl, and a weighing device positioned to obtain weight information regarding the weight of the bowl and any contents thereof. The system further includes a user interface configured to receive a user indication that surgical fluid is to be added to the bowl. The controller is configured to receive weight measurement information from the weight measurement device regarding the weight of the surgical fluid in the bowl during a procedure, receive via the user interface at least one indication that a medical tool is to be added or removed from the bowl during a procedure, and determine a volume of surgical fluid to be used during a procedure based on the received weight measurement information and the at least one received indication.
[0019] In another example, a thermal treatment system is described that includes a fluid containment vessel, a thermal treatment device, a mounting plate, and a weight measuring device. The fluid containment vessel has a base and at least one sidewall configured to receive and hold a substance. The thermal treatment device is thermally coupled to the fluid containment vessel and configured to regulate a temperature of the substance in the fluid containment vessel. The mounting plate has a first surface and a second surface opposite the first surface. The mounting plate is attached to the fluid containment vessel such that an air gap is formed between the first surface of the mounting plate and the base of the fluid containment vessel. A weight measuring device configured to measure a weight of the fluid containment vessel and any contents therein is positioned on the second surface of the mounting plate.
[0020] In a further example, a thermal treatment system is described. The thermal treatment system includes a bowl configured to receive and hold a substance to be heated, a thermal treatment device thermally coupled to the bowl and configured to regulate a temperature of the substance to be heated in the bowl, a weight measuring device positioned to measure a weight of the bowl and any contents therein, a user interface, and a controller. The controller is in communication with the user interface, the thermal treatment device, and the weight measuring device. The example specifies that the controller is configured to receive, via the user interface, a target temperature to which any contents in the bowl will be heated, receive from the weight measuring device weight measurement information relating to the weight of the bowl and any contents therein, and receive from the temperature sensor temperature measurement information relating to the measured temperature of any contents in the bowl. The controller is further configured to control the thermal treatment device to heat the bowl and any contents therein based on the weight measurement information received from the weight measuring device and the temperature measurement information received from the temperature sensor to heat any contents in the bowl to the target temperature.
[0021] In an additional example, a weight measuring device is described that includes a base and a reservoir supported by the base. The reservoir is configured to receive and hold a substance to be weighed. The reservoir includes a base and a sloped sidewall extending vertically upwardly away from the base, the base and sloped sidewall collectively forming a bounded cavity having an open top surface that receives and holds the substance to be weighed. The device also includes a weighing device positioned to obtain weight information regarding the weight of the reservoir and any contents therein, a user interface, and a controller. The controller is configured to receive weight measurement information regarding the reservoir and the substance to be weighed therein from the weight measuring device, and to display the weight of the substance to be weighed on the user interface.
[0022] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will become apparent from the description and drawings, and from the claims. [Brief description of the drawings]
[0023] [Figure 1] 1A-1D are perspective, side and top views, respectively, of an exemplary system for thermally treating a surgical fluid; [Diagram 2] 1A-1D are perspective, side and top views, respectively, of an exemplary system for thermally treating a surgical fluid; [Diagram 3] 1A-1D are perspective, side and top views, respectively, of an exemplary system for thermally treating a surgical fluid;
[0024] [Figure 4A] FIG. 4 is a cross-sectional view of the exemplary system of FIGS. 1-3 taken along section line A-A shown in FIG.
[0025] [Figure 4B] 2 is a perspective top view of the example system of FIG. 1 shown with the bowl removed for purposes of illustrating an example configuration of the height adjustment mechanism.
[0026] [Diagram 5] FIG. 4 is a diagram of an exemplary drape that may be used with the system of FIGS. 1-3.
[0027] [Figure 6] FIG. 4 is a functional block diagram illustrating components that may be used in the example systems of FIGS. 1-3.
[0028] [Figure 7] 1 is a flow chart of an exemplary technique that may be used to monitor the amount of surgical fluid removed from a thermal treatment device during a medical procedure.
[0029] [Figure 8A] 4 is an exemplary user interface that may be used on the exemplary system of FIGS. 1-3.
[0030] [Figure 8B] 4 is an exemplary display that may be used in the exemplary system of FIGS.
[0031] [Figure 9A] 4 illustrates an exemplary bottle pocket configuration that may be used on the exemplary system of FIGS. 1-3. [Figure 9B] 4 illustrates an exemplary bottle pocket configuration that may be used on the exemplary system of FIGS. 1-3.
[0032] [Figure 10] FIG. 2 is a top view of the example system of FIG. 1 showing an example temperature sensor arrangement.
[0033] [Figure 11] 4 is a flow chart illustrating an exemplary process for controlling the amount of thermal energy delivered to a fluid being heated in the exemplary system of FIGS. 1-3.
[0034] [Figure 12] 2 is an exploded cross-sectional view taken along the line A-A shown in FIG. 1, illustrating an exemplary arrangement of components. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] In general, the present disclosure relates to devices, systems, and techniques for monitoring and / or determining the amount of material in a surgical environment and optionally regulating the temperature of such material. In some examples, the system is configured to heat treat the surgical fluid prior to utilizing the fluid during a medical procedure. The surgical fluid may be temperature conditioned within the system to elevate the temperature above ambient temperature or reduce the temperature below ambient temperature. The system may also maintain the surgical fluid at an elevated or reduced temperature relative to ambient temperature until the surgical fluid is ready to be used during a procedure. During use, the surgical fluid may be drawn from the system and dispensed across a surgical site on or within a patient to irrigate the site and flush away bodily matter. A suction device may be used to draw the surgical fluid out of the patient along with the flushed bodily matter and prevent the surgical fluid from accumulating within the patient's open cavity.
[0036] In some examples, a thermal treatment system according to the present disclosure monitors the amount of surgical fluid drawn from the system. By assuming that all drawn surgical fluid that is not returned to the system is introduced to the patient, the system can indicate the amount of surgical fluid introduced to the patient during the procedure. In some configurations, the system includes a display that is updated in substantially real-time and reports the volume of fluid drawn from the system. This information can help guide the clinician performing the procedure. For example, knowing the amount of fluid introduced to the patient during the procedure, the clinician can use the suction device to ensure that a proportional (e.g., equal) amount of fluid is drawn from the patient and collected. As another example, the clinician can determine that the patient is being over-irrigated based on the amount of surgical fluid consumed and slow down or stop further irrigation.
[0037] Thermal treatment systems according to the present disclosure may include additional or different features to provide safe and efficient surgical fluid temperature regulation. For example, the thermal treatment system may include a reader operable to read information coded on a drape inserted into the system. The reader may be implemented using a non-contact reader, such as an optical reader, an RFID reader, an NFC reader, or a similar non-contact reader. The reader may read information coded on or embedded in a drape inserted into the system. If the reader does not detect the coded information on the drape or if the authenticity of the coded information cannot be confirmed, the system may inhibit operation of the thermal treatment device. This means that if the material from which the drape is manufactured is not compatible with the operating conditions (e.g., temperature conditions) of the system, the system will not proceed with operation. As another example, the reader may detect if the drape has already been used based on information read from the drape (e.g., and comparison with stored information identifying drapes that have already been used) and prevent the system from operating if the drape has already been used (and is therefore likely not sterile).
[0038] 1-3 are perspective, side, and top views, respectively, of an exemplary system 10 for thermally treating a surgical fluid. In the illustrated example, system 10 includes a base 12 and a bowl 14. Bowl 14 is supported by and rises vertically above base 12. Bowl 14 may provide an open containment vessel into which surgical fluid may be dispensed or into which other substances being treated may be introduced. Once added to bowl 14, the surgical fluid may be temperature conditioned within the bowl. For example, bowl 14 may be thermally coupled to a thermal treatment device that can increase or decrease the temperature of the thermal fluid. Bowl 14 may also maintain the surgical fluid at a target temperature until the fluid is removed from the bowl and used in the procedure.
[0039] As described in more detail below, the system 10 may monitor the amount of fluid added to and / or removed from the bowl 14. The system 10 may, but is not required to, receive indications when non-fluid components, such as medical tools, are added to and / or removed from the bowl 14. During a procedure, a clinician may add fresh surgical fluid to the bowl 14 and may place one or more medical tools in the bowl. The term fresh surgical fluid or fresh substance refers to a fluid or substance that has been introduced into the bowl 14 (e.g., from a sterile container) for a first time, and not a fluid or other substance that has been withdrawn from the bowl and reintroduced back into the bowl. The medical tool may be a surgical instrument that is held at a controlled temperature before being removed from the bowl 14 and inserted into the patient. Additionally or alternatively, the medical tool may be equipment for delivering the surgical fluid from the bowl 14 to the patient, such as an asepto rubber bulb syringe and / or a graduated measuring container.
[0040] System 10 may determine when surgical fluid is removed from bowl 14 and distinguish when a medical tool is removed from the bowl. System 10 may also identify when fresh fluid is added to bowl 14 and distinguish when a medical tool is added to bowl 14. System 10 may then determine the amount of surgical fluid removed from bowl 14 during the procedure based on the amount of fluid added to the bowl and the current volume of surgical fluid in the bowl. System 10 may further determine when one or more medical tools are added to and / or removed from the bowl to determine the amount of surgical fluid removed from the bowl.
[0041] To allow an operator to interact with the system 10 to control different settings, the system 10 may include a user interface. In the example of FIGS. 1-3, the system 10 includes at least one user interface 16. The user interface 16 may include user inputs through which the clinician inputs information into the system 10, and user outputs through which the clinician receives information from the system. For example, the user interface 16 may include one or more operable inputs with which the clinician may interact to adjust settings of the system 10, to provide an indication that fresh fluid is being added to the bowl 14, to provide an indication that a non-surgical component is being added or removed from the system 10, etc. The operable user inputs may be implemented as physically depressible buttons (e.g., switches), portions of a touch screen with which the clinician can interact, or other features with which the clinician can interact to communicate information to the system 10. The user output of the user interface 16 may be a display that provides graphical and / or textual information regarding the operation of the system 10.
[0042] Although the user interface 16 is illustrated as including a display and one or more buttons that the user physically contacts to interact with the system 10, the system may include any type of interface with which the user may interact to communicate with the system. For example, the system 10 may include a microphone to detect sound (e.g., fluid being poured into the bowl 14) and / or audible commands from the user. As another example, the system 10 may include a light detector to detect user actions (e.g., fluid being poured into the bowl 14, tools being removed from the bowl) and / or non-contact user commands (e.g., a user gesture such as placing a hand or a fluid bottle in front of an optical sensor). When implemented with light detection capabilities, the system may include a camera that monitors the bowl 14 and / or the surrounding space and performs image recognition techniques to detect user interactions and / or commands with the system. As another example, the system may include a light emitter that detects when a path of light, such as a laser beam over the opening of the bowl 14, is broken to detect when a substance is added to and / or removed from the bowl. In this configuration, the system may determine whether surgical fluid or medical tools are being added or removed from the bowl based on the light reflectance characteristics and material properties of the components being added or removed. System 10 can include a number of different types of user interfaces (e.g., physical contact, audible, optical), any of which can be engaged by a user to enable the system to determine information regarding the contents of what is being added or removed from the system.
[0043] Additionally, while system 10 in FIG. 1 illustrates the user interface as having a display physically mounted on bowl 14, it should be understood that a display need not be physically attached to the system and / or that the system may not have a display. For example, system 10 may include a remote electronic device (e.g., a computer, tablet, smartphone, touch screen monitor) that is physically separate from bowl 14 but in wireless communication, either directly or indirectly, with the bowl. A user may interact with the remote electronic device to input parameters for controlling bowl 14 (e.g., a target temperature to which the fluid is to be heated) and / or to receive data from the bowl (e.g., data indicating the volume of fluid added to and / or removed from the bowl, the weight of the substance in the bowl, the set temperature and / or the current temperature for the substance in the bowl).
[0044] In addition to or instead of having a remote user interface 16 through which a user can interact with the bowl 14, the bowl 14 may be configured to transfer data regarding its use to a remote computer. For example, the bowl 14 may transfer data regarding one or more of the target temperature at which the bowl was set during a procedure, the amount of fluid added to the bowl during a procedure, the amount of fluid removed from the bowl during a procedure, the time at which one or more medical tools were added to and / or removed from the bowl, the actual temperature of the fluid in the bowl throughout the procedure and / or when the fluid was removed from the bowl, and combinations thereof. The bowl 14 may transfer data to the remote computer through a removable non-transitory storage medium (e.g., flash drive, CD), through a wired connection, and / or through a wireless connection (e.g., cellular protocol, Bluetooth™ protocol, Wi-Fi protocol, or other radio frequency). In some examples, the bowl 14 transfers data to a cloud computing network. The transferred data may include or be associated with a patient identification corresponding to a patient with whom the system 10 was used during a medical procedure. Using one or more remote computers, data from a single procedure or aggregate data from multiple procedures may be analyzed to identify trends and utilization improvement opportunities, for example, for a particular device or multiple devices within a common ownership structure.
[0045] In applications where the system 10 includes a display, the system may be configured with a single display or multiple displays. In FIGS. 1-3, the system 10 is shown as having a first display forming part of a user interface 16 and a second display 18. The first display is positioned on an exterior surface on one side of the bowl 14, while the second display is positioned on an exterior surface on a substantially opposite side of the bowl. This arrangement may be useful to allow clinicians working on different sides of the bowl 14 to view information regarding the operation of the system 10. In some examples, the second display 18 is part of a user interface that includes the same features and functions (e.g., user input(s) and / or user output(s)) as the first user interface 16. This may allow a clinician to present information to and receive information from the system 10 when working on either side of the system. In other examples, the second display 18 may be a display that provides user output but does not have user input controls. In these applications, a clinician may enter information or commands through user input(s) on user interface 16, but can view output information on both displays. Exemplary user interface and display configurations that may be used as user interface 16 and / or display 18 are described with respect to Figures 8A and 8B.
[0046] In addition, although the first and second displays 18 forming part of the user interface 16 are shown mounted at a downward angle relative to the top edge of the bowl 14, the displays may be mounted at any desired angle. For example, the first and second displays 18 forming part of the user interface 16 may be mounted at the same or different angles relative to the bowl. In one example, the second display 18 is mounted on the system at a steeper angle than the first display (e.g., so that the display is more perpendicular to the ground) to provide greater visibility to a user positioned further from the bowl. Furthermore, although the first and second displays 18 forming part of the user interface 16 are shown on opposing exterior surfaces of the bowl 14, one or both of the displays may be separate from the bowl and communicatively coupled to the bowl as described above (e.g., to display information related to the bowl but not physically connected to the bowl). For example, the first display and / or second display 18 forming part of the user interface 16 may be implemented using a television or computer monitor (e.g., in an operating room), on a portable device carried by the clinician (e.g., mobile phone, tablet computer), or otherwise located physically separate from the bowl 14.
[0047] The thermal treatment system 10 includes a bowl 14. The bowl 14 provides a containment vessel for receiving and holding the surgical fluid. In general, the bowl 14 can define any polygonal (e.g., rectangular, square, hexagonal) or arcuate (e.g., circular, elliptical) shape, or even a combination of polygonal and arcuate shapes. In the illustrated example, the bowl 14 is shown as a generally elliptical shape and includes a base 20 and at least one angled sidewall 22 that extends vertically upwardly away from the base. The base 20 and angled sidewall 22 collectively form a bounded cavity having an open top surface that receives and holds the surgical fluid. Configuring the bowl 14 with angled sidewall(s) instead of straight sidewalls helps prevent the surgical fluid from accumulating at the corners where the sidewall(s) intersect the base. That said, in other examples, the bowl 14 may be formed with straight sidewalls. Additionally, although bowl 14 is illustrated as having an open top surface for adding and withdrawing substances from the bowl, the bowl may be closed on its top surface in other configurations.
[0048] In addition, although bowl 14 is illustrated as having a single reservoir for holding a medical fluid, the bowl may be formed with multiple reservoirs separated from one another. For example, bowl 14 may be a single cavity with an internal partition(s) or divider(s) separating one or more reservoir cavities from fluid communication with one or more other reservoir cavities. Alternatively, bowl 14 may be configured with multiple cavities (e.g., each separately molded or formed), each of the multiple cavities providing a separate reservoir for receiving and holding a fluid. During use, each cavity may be filled with the same fluid, or at least one cavity may be filled with a different fluid than the fluid filled within at least one other cavity. Additionally, in some configurations, each cavity may be provided with a separate heat treatment device, allowing for independent temperature regulation of the different cavities. This can be useful, for example, to heat fluids in different cavities to different temperatures, to heat fluid in one cavity while cooling fluid in another cavity to create slush, or otherwise provide flexibility in temperature control.
[0049] Any type of substance may be introduced into and removed from bowl 14 during a procedure, including any type of surgical fluid during a medical procedure. Exemplary types of medical fluids that may be used during a medical procedure include water, saline, and the like. Surgical fluids may or may not include agents, such as compounds that impart antimicrobial properties, anticoagulant / clotting properties, anesthetic properties, and the like. Alternative substances that may be introduced into bowl 14 may include medical specimens extracted from a patient for weighing (e.g., in embodiments where the bowl is configured to measure weight), blood, platelets, or substances for thermal regulation prior to introduction to a patient, or non-medical related substances (e.g., in applications where system 10 is not used in a medical environment).
[0050] In the configuration of FIGS. 1-3, bowl 14 is supported by and rises vertically above base 12. Specifically, bowl 14 is mounted on an elongated housing 24 that extends vertically upward from base 12. Base 12 and housing 24 can raise bowl 14 to a position that is convenient for a clinician to interact with the bowl. In some examples, housing 24 includes one or more receiving cavities configured to receive a container of surgical fluid. For example, housing 24 may include one or more pockets positioned along the length of the housing into which a surgical fluid container may be inserted. The pockets may or may not be heated to provide preheated surgical fluid. In either case, the pockets may store the container(s) of surgical fluid for immediate access during a medical procedure. If additional surgical fluid is needed during a procedure, the clinician can withdraw a fresh container of surgical fluid from a pocket in housing 24 and add the surgical fluid to bowl 14. For example, Figure 9A shows a thermal treatment system having a bottle pocket 200 formed within a housing that defines a bowl 14. Figure 9B shows another thermal treatment system having a bottle pocket 202 formed along the length of the housing. Such a bottle pocket design may be used in the thermal treatment system 10 of Figures 1-3.
[0051] In some examples, bowl 14 is at a fixed height relative to base 12 and / or the surface to which system 10 is mounted (e.g., a floor, counter, tabletop). In other examples, system 10 includes a height adjustment mechanism operable to adjust the height of bowl 14 relative to base 12. This can be useful to allow clinicians of different stature to reposition bowl 14 to a comfortable working height. Figure 4A is a cross-sectional view of system 10 of Figure 1 taken along section line A-A shown in Figure 1, showing an exemplary height adjustment mechanism.
[0052] As shown in the example of FIG. 4A, the system 10 includes a height adjustment mechanism implemented with a piston 26 and an adjustment lever 28 (FIG. 1). The piston 26 may include a sliding shaft positioned in a chamber containing a compressible fluid (e.g., gas, liquid) or a spring. The sliding shaft can be moved by the fluid or spring pressure to raise the bowl 14, and an operator can push the bowl 14 downward to lower the bowl, moving the sliding shaft against the fluid pressure or spring. The adjustment lever 28 can control the position of the piston 26 and, accordingly, the position of the bowl 14. For example, the adjustment lever 28 may open and close a valve that controls the movement of fluid to the piston 26 and / or move a detent in and out of a locking opening. The adjustment lever 28 can be positioned as a hand control as shown in FIG. 1 or may be implemented as a foot control. In other configurations in which the system 10 has a height adjustment mechanism, the height adjustment mechanism may be implemented using a rotating locking collar that controls the position of two sliding shafts relative to each other.
[0053] Mounting the bowl 14 so that it is movable via a height adjustment mechanism can be useful to allow the bowl to move to different heights, for example, depending on the height of the operator using the bowl and the space constraints in the environment in which the bowl is being used. Indeed, in applications in which the bowl 14 is mounted above the piston 26, the bowl may rotate in a horizontal plane unless otherwise constrained. Such a constraint may be provided by the configuration of the piston 26 having a limited range of rotation. However, when the bowl 14 is at an elevated height, the fluid present in the bowl may shift the center of gravity, and the bowl may have an undesirable tendency to vibrate or rock in a horizontal plane. Such vibration or rocking, if too violent, may cause the fluid present in the bowl 14 to spill out of the bowl. To help constrain unintended rotational movement of the bowl 14, the system 10 may include one or more anti-rotation features to help constrain the rotation of the bowl.
[0054] FIG. 4B is a perspective top view of the system 10 (with the bowl 14 removed for illustrative purposes) showing an exemplary configuration of a height adjustment mechanism having an anti-rotation configuration. In this example, the piston 26 is mounted within a central lumen of the housing 24 between the base 12 and the bowl 14. In addition, the height adjustment mechanism includes at least one anti-rotation rod, illustrated as being implemented using two anti-rotation rods 25A, 25B. The anti-rotation rods 25A, 25B extend parallel to the piston 26 and are on different sides of the piston. The anti-rotation rods 25A, 25B can extend partially, and in some instances completely, along the length of the housing 24 and can rise and fall with the piston 26. For example, the anti-rotation rods 25A, 25B can be fixedly connected at one end (e.g., at the top end of the anti-rotation rods 25A, 25B relative to the bowl 14), can move through a fixed opposing member, and / or can be telescopic at the opposing ends of the anti-rotation rods 25A, 25B. When so configured, anti-rotation rods 25A, 25B can raise and lower together with bowl 14 and piston 26 to counter a rotational motor applied to bowl 14 and reduce or eliminate any rotational movement of the bowl.
[0055] In other configurations, the height adjustment mechanism may include two components that are movable relative to one another and are interlocked with a tongue and groove arrangement. For example, the housing 24 and / or piston 26 may include a first member connected to the base 12 and a second member connected to the bowl 14, where the two members are slidable relative to one another. Providing a slidable, interlocking tongue and groove connection between the two members may help minimize rotation of the bowl 14.
[0056] To accommodate the various components positioned within the housing 24 and / or extending from the base 12 to the bowl 14, the lumens defined by the housing 24 may include one or more openings through which the components within the housing extend. In the example of FIG. 4B, the housing 24 defines a first lumen 27 through which the piston 26 is inserted, one or more second lumens 29A, 29B through which one or more anti-rotation rods 25A, 25B are inserted, and an optional third lumen 31 through which wiring may be inserted. The third lumen 31 may be in the form of a wiring channel that allows communication cables to extend from the bowl 14 to the bottom of the housing 24 and / or the base 12.
[0057] For example, as discussed in more detail below, system 10 may include a foot-actuable pedal 40. To transmit and / or receive signals between foot-actuable pedal 40 and bowl 14 (e.g., a controller mounted within the bowl housing), system 10 may include a communication cable (e.g., electrical cable, optical cable) extending from foot-actuable pedal 40 to the bowl. When bowl 14 is in its maximum raised position, the cable may have a length sufficient to reach from foot-actuable pedal to bowl. The cable may have a coil (e.g., a coiled phone cord) to allow the cord to extend or retract as bowl 14 is raised and lowered. As another example, the cable may extend outside of a containment housing that allows the cable to extend out of the housing and retract into the housing as bowl is raised and lowered, respectively. In either case, configuring housing 24 with a wiring lumen physically separate from lumen housing piston 26 may be useful to prevent the cable from being pinched, kinked, or broken by piston 26 when bowl 14 is raised and lowered. In some instances, the different lumens into which the housing 24 is divided extend the length of the housing 24. In other instances, the housing 24 includes one or more divider plates to define lumens, while the space above and / or below the one or more divider plates is not divided.
[0058] Regardless of the particular configuration of the height adjustment mechanism, the height adjustment mechanism may be designed to position the bowl at a height ranging from 24 inches to 60 inches. For example, the height adjustment mechanism may allow an operator to adjust the top surface of bowl 14 to any desired height, including heights within the range of 36 inches to 48 inches. The height adjustment mechanism (e.g., a piston, if used) may provide a force effective to lift a weight of at least 5 kilograms, e.g., 7 kilograms to 15 kilograms, over the entire range of travel.
[0059] The base 12 supports the system 10, for example, on a floor, a tabletop, or a countertop in a medical procedure room. In the configuration of FIGS. 1-3, the base 12 is mounted on wheels 33 so that it is movable from one position to another. One or more of the wheels may be lockable to prevent the base 12 from moving once positioned in a desired position. In other examples, the base 12 does not include wheels 33. Additionally, while the base 12 is illustrated as being physically separate from the bowl 14 and connected to the bowl 14 via the housing 24 and the piston 26, in other examples, the bowl 14 and the base 12 may be physically integrated together to form a unitary structure. Thus, it should be understood that the base 12 need not be a structure physically separate from the bowl 14, but may be a portion of the bowl structure that sits on a support surface. Thus, the base 12 need not be configured with outwardly extending spokes, but may be any type of support structure that forms the base of the bowl 14. In some examples, the system 10 may not include the base 12.
[0060] To power the system 10, including the thermal treatment device that controls the temperature of the surgical fluid disposed in the bowl 14, the system may have a power cord that plugs into a mains / wall power source. To manage the power cord when not in use, the system 10 of FIGS. 1-3 includes a cord wrap structure. Specifically, the illustrated system includes a pair of longitudinally spaced hooks 30 configured to receive the power cord wrapped around it. In other configurations, the system 10 may include a spring-loaded storage device that automatically stores the power cord within a power cord retention chamber. In addition to or instead of using a power cord to provide wall-source power to the system 10, the system may include an internal battery to power the system's functions. If so configured, one or more internal batteries may be provided that may or may not be rechargeable and / or replaceable. In use, the battery may be the primary power source for powering the system 10, or may instead function as a backup power source in the event that the primary power source (e.g., wall power) fails.
[0061] Because the system 10 may be deployed in different geographic regions throughout the world, the system may include circuitry for operating on different power sources. For example, the system may operate on 110 volts of electricity in some countries and 220 volts of electricity in other countries. To configure the system 10 as a universal device capable of operating on any voltage that may be provided from a wall outlet in the local country in which the system may be deployed, the system may include appropriate electrical circuitry. In some examples, the system 10 includes a transformer that steps up or steps down the voltage received from the wall outlet to an appropriate voltage for operating the system 10, including, for example, the thermal treatment device therein. In other examples, the system 10 may include a voltage sensing integrated circuit that detects the voltage from the wall outlet to which the device is connected and provides a control signal for controlling the electrical operation of the device. The control signal from the integrated circuit may cause one or more electrical paths to open or close. For example, when the integrated circuit detects a high voltage (e.g., 220V), electricity may be provided in parallel electrical paths to the thermal treatment device. In contrast, when the integrated circuit detects a lower voltage (e.g., 110V), electricity may be provided in series electrical paths to the thermal treatment device. Thus, the system 10 and the heat treatment devices therein can operate at any supplied voltage without requiring or including a transformer, which can significantly reduce the weight of the system compared to when a transformer is included.
[0062] During use, a clinician may dispense fresh, sterile surgical fluid into bowl 14 in preparation for subsequent use of the surgical fluid during a medical procedure. The surgical fluid may be dispensed directly into bowl 14, but the clinician may insert a sterile drape into bowl 14 before dispensing the surgical fluid into the draped bowl. The sterile drape may be a disposable liner that creates a sterile field that the surgical fluid and other sterile medical components may contact. The drape may separate the sterile field from the non-sterile field.
[0063] If used, the disposable drape may be made of a material that is impermeable to surgical fluids and flexible enough to conform to the walls of bowl 14. The drape may be mating or non-mating. A mating drape may be constructed such that the drape forms to the contours of bowl 14 (e.g., matches the size and / or shape of the bowl). A non-mating drape may be flat or pleated and may have a length sufficient to be placed over bowl 14. In either case, the drape may be placed within bowl 14 to conform to the walls of the bowl. In some examples, the drape also extends over both sides of bowl 14, for example, hanging parallel to housing 24. Additionally, in some examples, the drape may have internal partition(s) or divider(s) that make one or more reservoir cavities isolated from fluid communication with one or more other reservoir cavities. When so configured, the drape can convert a single fluid cavity of bowl 14 into multiple fluid cavities.
[0064] The disposable drape used with bowl 14 may have a thickness sufficient to resist tearing and punctures during normal use, but also thin enough to allow efficient heat transfer through the drape. The disposable drape may be made from any suitable material, but in some examples, the drape is made from a polymeric material (e.g., polyethylene, polypropylene, polystyrene, polyurethane). The drape (or a portion thereof) may be transparent or translucent to allow an operator to see features covered by the drape.
[0065] In one particular application, the disposable drape used with the system 10 and bowl 14 is a thermoformed polymeric drape. A thermoformed drape may be formed by heating a plastic sheet to a temperature at which the plastic sheet becomes flexible and then conforming the plastic sheet to a mold having the dimensions (e.g., size and shape) of the bowl 14. After cooling, the thermoformed drape retains the shape of the mold and, accordingly, the shape of the bowl 14. Depending on the thickness of the plastic sheet used, the resulting thermoformed drape may be rigid or semi-rigid. For example, a semi-rigid drape may maintain the size and shape profile of the bowl 14 but have flexibility that allows the drape to bend and flex. Thermoformed drapes may appear stronger and more sturdy to the clinician than simple flexible plastic sheet drapes and may therefore be desirable due to their apparent resistance to puncture.
[0066] As briefly mentioned above, drapes used with system 10 may include machine-readable information that identifies the drape. When the drape is placed over bowl 14, the machine-readable information may be read by a reader of system 10 to determine if the drape is suitable for use with the system. This may prevent inappropriate drapes, such as drapes that do not have adequate strength or heat resistance characteristics, from being used with system 10. For example, the drape may include information that may be read by an optical or electromagnetic reader to determine if the drape is approved for use with system 10.
[0067] In some configurations according to this example, the drape includes a tag that encodes machine-readable information. The tag may be adhered to the surface of the drape or embedded within the drape (e.g., sealed between different layers of polymeric material). The tag may include information that identifies the drape, such as a code or serial number (e.g., lot or unit number), the name of the manufacturer, date of manufacture, etc. In some configurations, the tag is configured as a contactless tag, where the information may be read by bringing the tag in close proximity to a reader of the system 10, without physical contact with the reader. This may be useful to allow a clinician to position the tag in close proximity to a corresponding reader by simply inserting the drape into the bowl 14, without the need for further placement of the tag. While any type of tag suitable for use with a contactless reader may be used, in some examples, the drape used with the system 10 includes a radio frequency identification (RFID) tag or a near field communication (NFC) tag.
[0068] FIG. 5 is a diagram of an exemplary drape 35 that may be used with the system 10 of FIGS. 1-3. In the illustrated example, the drape 35 includes a rigid or semi-rigid bowl portion 32 that is inserted into the bowl 14 and conforms to the size and shape of the bowl. The bowl portion 32 has a perimeter 34 that extends around and over at least a portion of the edge of the bowl 14, for example, allowing the drape to snap or lock onto the perimeter of the bowl. In different examples, the perimeter 34 may friction fit over the edge of the bowl 14 or may include mechanical engagement features that lock onto or into the edge of the bowl, preventing the drape 35 from being inadvertently removed from the bowl 14. To allow the clinician to view and interact with the system 10, the drape 35 may include physical cutouts or transparent windows 37 configured to be positioned over the user interface 16 and display 18.
[0069] Additionally, in the example of FIG. 5, the drape 35 further includes a skirt 36 and a tag 38 that includes information identifying the drape 35. The skirt 36 is connected to the perimeter 34 and hangs over the edge of the bowl 14. The skirt 36 may be formed of a flexible material, such as flexible plastic, that is bonded to the thermoformed bowl portion 32. The tag 38 may include machine-readable information (e.g., encoded on a computer-readable memory that is part of the tag 38). The tag 38 is positioned on the drape 35 such that when the drape is placed over the bowl 14, the tag is in sufficient proximity for its information to be read by a corresponding reader of the system 10. While FIG. 5 illustrates one exemplary configuration of a drape in accordance with the present disclosure, it should be understood that other configurations of the drape may be used as described herein and the disclosure is not limited in this respect.
[0070] With further reference to the system 10 of Figures 1-3, the exemplary thermal treatment device includes a foot-actuable pedal 40. Typically, medical procedures are performed in an operating room or other medical facility with the assistance of a variety of sterile and non-sterile medical personnel. Sterile personnel refer to those personnel who have taken the necessary precautions that allow them to interact with objects in the sterile field without contaminating the sterile field, while non-sterile personnel refer to those personnel who have not taken those precautions and may contaminate the sterile field. Because the thermal treatment system 10 administers sterile surgical fluids in a sterile field during a medical procedure, sterile personnel are typically required to operate the system.
[0071] Configuring the thermal treatment system 10 with a foot-actuatable pedal 40 can be useful to provide an alternative mechanism for interacting with the system. In some examples, the foot-actuatable pedal 40 can serve as a user input that can be used by a clinician in addition to or instead of the user interface 16 to input information into the system 10. For example, a clinician can press the foot-actuatable pedal 40 to provide indications to the system 10, such as that fresh fluid is being added to the bowl 14, that non-surgical components are being added or removed from the system 10, etc. Depending on the configuration of the system 10, the foot-actuatable pedal 40 can provide an alternative input for communicating information to the system that can also be implemented using the user interface 16, as described above. In other configurations, the foot-actuatable pedal 40 can be used to communicate information to the system 10 that cannot be provided through the user interface 16.
[0072] Actuation of the pedal 40 (e.g., pushing the pedal downwards with the foot or pulling the pedal upwards) can communicate information to the system 10 without the need for the clinician to use their hands to interact with the user interface 16 (if the user interface 16 is configured to receive input via physical contact from a user input). Configuring the system 10 with a foot-actuable pedal 40 can be useful for a variety of reasons. For example, sterile personnel may not be able to engage the user interface because their hands are occupied. In these situations, the sterile personnel may engage the foot-actuable pedal 40 to interact with the system 10. As another example, non-sterile personnel may be tasked with interacting with the system 10, such as adding fresh surgical fluid to the bowl 14. Because these non-sterile personnel are not necessarily undergoing a sterilization protocol, they may not be permitted to interact with features in the sterile field, including the user interface 16. However, because the foot-actuable pedal 40 may be in a non-sterile field (e.g., outside of the drape 35), the non-sterile personnel may use the pedal to interact with the system 10. For example, when adding fresh surgical fluid to bowl 14, the attendant may press foot-actuatable pedal 40 a first time to indicate that surgical fluid is being added to the bowl. After adding surgical fluid to bowl 14, the attendant may press foot-actuatable pedal 40 a second time to indicate that surgical fluid has been added to the bowl.
[0073] Although pedal 40 is described as actuable, the entire pedal need not move or actuate to be considered a foot-actuable pedal. For example, pedal 40 may have a transducer or other switch, a portion of which moves in response to an operator physically pressing pedal 40. The exterior portion of pedal 40 that is contacted by the operator's foot may or may not move. In either case, pedal 40 may send a control signal to a controller of system 10 in response to an operator pressing pedal 40.
[0074] 6 is a functional block diagram illustrating components of an exemplary configuration of a thermal treatment system 10, including the base 12, bowl 14, user interface 16, and display 18 previously described. The system 10 of the illustrated example also includes a controller 42, a volumetric measuring device 44, a thermal treatment device 46, a temperature sensor 48, and a non-contact reader 50. The controller 42 is communicatively connected to the user interface 16, the display 18, the foot actuatable pedal 40, the volumetric measuring device 44, the thermal treatment device 46, the temperature sensor 48, and the non-contact reader 50. The controller 42 can send communication signals to and / or receive communication signals from the user interface 16, the display 18, the foot actuatable pedal 40, the volumetric measuring device 44, the thermal treatment device 46, the temperature sensor 48, and the non-contact reader 50 via wired or wireless connections, shown in the example of FIG. 6 as wired connections.
[0075] The controller 42 includes a processor 52 and a memory 54. The memory 54 stores software for executing the controller 42 and may also store data generated or received by the processor 52, for example, from the volume measurement device 44, the temperature sensor 48, and the non-contact reader 50. The processor 52 executes the software stored in the memory 54 to manage the operation of the system 10.
[0076] The system 10 of FIG. 6 also includes a power source 56 for delivering operating power to the various components of the system. The power source 56 may be a replaceable or rechargeable battery. Additionally or alternatively, the power source 56 may be a power inlet that receives power from an external power source. For example, the power source 56 may be a power inlet connected to a cord that plugs into a wall outlet to deliver power to the system 10. The power received from the external power source may recharge a battery included in the system 10 and / or may directly power the various components of the system.
[0077] The various components of system 10 are shown as housed within a housing or shell 58 that surrounds and defines bowl 14. Housing or shell 58 may house the various components of system 10 between the surfaces forming bowl 14 and the exterior wall surfaces of the housing. When so configured, the electrical components of system 10 shown in FIG. 6 may rise and fall with housing 58 as the height adjustment mechanism adjusts the vertical height of bowl 14. In other configurations, any or all of the electrical components shown in FIG. 6 may be housed in housing 24 and / or base 12.
[0078] In operation, controller 42 may control system 10 using information stored in memory 54 and instructions associated with instructions received from an operator via user interface 16. Instructions executed by controller 42 may, for example, control thermal treatment device 46 to heat or cool surgical fluid in bowl 14 to a target temperature set by an operator using user interface 16. Instructions executed by controller 42 may, for example, determine the amount of surgical fluid removed from bowl 14 during a medical procedure based on feedback from volumetric measuring device 44 and control user interface 16 and / or display 18 to display a graphical and / or textual indication of the amount of fluid used during the procedure. In some examples, instructions executed by controller 42 may determine whether a drape placed over bowl 14 (e.g., drape 35 from FIG. 5) is approved for use with system 10 based on feedback from non-contact reader 50, for example, and further control user interface 16 and / or display 18 to output an indication of whether the drape is approved.
[0079] The controller 42 communicates with the thermal treatment device 46 to control the temperature of the surgical matter disposed within the bowl 14. The thermal treatment device 46 is thermally coupled to the bowl 14 and is operable to regulate the temperature of the bowl and any contents therein. The thermal treatment device 46 may be implemented using any device that generates a controllable temperature output. In some examples, the thermal treatment device 46 may cool the bowl 14 and any contents therein (e.g., relative to ambient temperature) to produce a semi-frozen slush from the surgical fluid disposed within the bowl. In other examples, the thermal treatment device 46 may heat the bowl 14 and any contents therein (e.g., relative to ambient temperature) to produce a warmed surgical fluid.
[0080] When the thermal treatment device is implemented as a warming device, the thermal treatment device may generate heat via electrical resistance. The heat generated by the electrical resistance may be transferred into bowl 14 and any contents therein by conduction, convection, and / or radiation. For example, wiring that generates heat via electrical resistance may be positioned in thermal and / or physical contact with bowl 14, for example, within enclosure 58. The heat generated by thermal treatment device 46 may be transferred into bowl 14 and any contents therein via conduction.
[0081] In other examples, system 10 according to the present disclosure does not include thermal treatment device 46. In these configurations, system 10 may be configured to track the volume removed from bowl 14 and / or provide a gravimetric measurement without thermally conditioning the contents within bowl 14. For example, system 10 in such a configuration may provide a gravimetric measurement device that may be utilized to measure the weight of various objects, such as tissue samples extracted from a patient. System 10 may be configured with the features and functions described herein but without the thermal conditioning features and functions in such configurations.
[0082] As an example, the thermal treatment device 46 may be a film heater positioned in thermal communication with the bowl 14. The film heater may be a thin film heater or a thick film heater. In a thin film heater, a layer of resistive material may be vacuum deposited on the surface of a substrate (e.g., a flexible polymer sheet), and then a thin layer of conductive metal is deposited on top of the resistive material. Portions of the resulting film stack may be etched into a pattern of metal conductors. In a thick film heater, a paste that is a mixture of binder, carrier, and metal oxide may be deposited (e.g., printed on the substrate) on the substrate and then fired in a furnace. A thin film heater may have a thickness of less than 5 millimeters, e.g., less than 2 millimeters, less than 1 millimeter, less than 0.5 millimeters, or less than 0.25 millimeters.
[0083] Regardless of the particular configuration of thermal treatment device 46, the thermal treatment device may be positioned inside housing 58 to transfer thermal energy to / from bowl 14 and any contents thereof. For example, thermal treatment device 46 is positioned inside housing 58 and in contact with base 20 and / or sidewall(s) 22 of bowl 14 such that thermal energy is transferred via conduction through the base and / or sidewall during operation of the heat transfer device. Bowl 14 may be manufactured from a thermally conductive metal, such as aluminum or stainless steel, to facilitate efficient transfer of thermal energy from thermal treatment device 46 through the walls of the bowl to the surgical fluid inside bowl 14.
[0084] When the thermal treatment device 46 is implemented as a film heater, the film may be wrapped around at least a portion of the base 20 and / or sidewall(s) 22 to position the film for transferring thermal energy into any contents within the bowl 14. For example, the film heater may be substantially centered on the base 20 of the bowl 14, cover a majority of the base (e.g., more than 50 percent of the base area) or substantially the entirety of the base. The film heater may at least partially, and in some instances completely, encase the sidewall(s) 22 of the bowl 14. The amount of surface area of the base 20 and / or sidewall(s) 22 covered by the film heater may vary depending, for example, on the size of the bowl 14 and the heating capacity of the film heater. In some instances, at least 25 percent of the cumulative exterior surface area of the bowl 14 (base 20 and sidewall(s) 22) is covered by the film heater, such as at least 50 percent of the surface area.
[0085] To monitor the temperature of bowl 14 and / or the contents therein, the example system 10 of FIG. 6 includes a temperature sensor 48. Temperature sensor 48 may sense the temperature of bowl 14 and / or the temperature of its contents. In various examples, temperature sensor 48 may be a thermocouple, a bimetallic mechanical temperature sensor, an electrical resistance temperature sensor, an optical temperature sensor, or any other suitable type of temperature sensor. Temperature sensor 48 may generate a signal representative of a magnitude of the sensed temperature and communicate the generated signal to controller 42. Controller 42 may receive a signal from temperature sensor 48 indicative of the temperature measured by the sensor at periodic intervals or continuously. Thus, discussion of controller 42 receiving measurement information from temperature sensor 48 at particular times is not intended to indicate that the controller cannot or does not receive measurement information at other times.
[0086] In some examples, temperature sensor 48 is positioned on an exterior surface of bowl 14 (e.g., on the opposite side of base 20 or sidewall(s) 22 from the surgical fluid) and is configured to measure the temperature of the fluid through the wall surface. However, in other examples, bowl 14 may include a port through which temperature sensor 48 extends to measure the temperature of the fluid directly within the bowl, rather than indirectly through the wall surface of the bowl. This may allow for more accurate temperature measurement of the contents of bowl 14, for example, to more accurately control heat treatment device 46, than if the temperature measurement was made indirectly through the wall surface of the bowl.
[0087] FIG. 10 is a top view of bowl 14 showing an exemplary placement of temperature sensor 48. In the illustrated example, bowl 14 defines an opening 49 that extends through the wall surface of the bowl (e.g., substantially centered in base 20 in the illustrated configuration). Temperature sensor 48 extends through opening 49 and may be sealed within the opening with, for example, a rubber gasket or other polymeric material between the temperature sensor and the surrounding wall surface. Temperature sensor 48 may be thermally isolated from the remainder of bowl 14 by positioning insulation between the temperature sensor and the remainder of the bowl. This configuration may be useful, for example, when a film heater is wrapped around the wall surface of bowl 14 because the temperature of the wall may differ from the temperature of the fluid within the bowl. When heat is delivered to the wall of the bowl and / or the fluid within the bowl is in equilibrium with the bowl, the bowl may be at a different temperature than the fluid within the bowl. Thus, extending temperature sensor 48 through opening 49 in bowl 14 and thermally isolating it from the remainder of the bowl can provide a more accurate measurement of the actual temperature of the fluid in the bowl than if the temperature measurement was made through the wall of the bowl.
[0088] During operation of the system 10, the clinician may engage the user interface 16 to set a target temperature at which the bowl 14 and contents therein are intended to be thermally regulated using the thermal treatment device 46. For example, the user interface 16 may include a temperature control with which the clinician may interact to set the target temperature. The temperature control may be a knob, a switch, an interactable portion of a touch screen, or other user interaction feature with which the clinician may issue a command to set the target temperature. In response to receiving a target or set temperature from an operator via the user interface 16, the controller 42 may perform different actions. The controller 42 may control a display associated with the user interface 16 and / or the display 18 to display the target temperature received from the operator. Additionally or alternatively, the controller 42 may control the thermal treatment device 46 to regulate the temperature of the bowl 14 and contents therein until a temperature signal from the temperature sensor 48 indicates that the measured temperature is equal to the target temperature.
[0089] In some examples, thermal treatment device 46 may heat the surgical fluid in bowl 14 to a temperature close to the patient's normal body temperature, such as a temperature within the range of 90° F. (32.2° C.) to 120° F. (48.9° C.), such as 95° F. (35° C.) to 105° F. (40.6° C.). The fluid initially introduced into the bowl may be at ambient temperature (e.g., 60° F. (15.6° C.) to 75° F. (23.9° C.)), an elevated temperature that bowl 14 is intended to maintain, or even below ambient temperature. Controller 42 may control the display on user interface 16 if the user attempts to set the target temperature above a threshold level, such as above 100° F. (37.8° C.) or above 110° F. (43.3° C.). In some such applications, controller 42 may prohibit the user from setting a higher temperature and may control thermal treatment device 46 to prevent heating above the threshold. In other configurations, the controller 42 may acknowledge or receive a high temperature warning provided by the user through the user interface 16 and allow the user to raise the target temperature above a threshold, for example, to a maximum temperature. The maximum temperature may be the maximum temperature to which the thermal treatment device 46 can heat the fluid in the bowl 14, or may be a lower temperature stored by the controller 42 for safety reasons. For example, the maximum temperature may be set as a temperature below 130° F. (54.4° C.), such as a temperature below 120° F. (48.9° C.).
[0090] In some examples, if the controller determines that no material is present in bowl 14, controller 42 prevents or terminates operation of thermal treatment device 46. If surgical fluid is not added to bowl 14 prior to activating thermal treatment device 46 or within an appropriate period of time after activating the thermal treatment device, controller 42 may prevent or terminate operation of the device. For example, if thermal treatment device 46 is configured to heat bowl 14, controller 42 can prevent the heater from dry heating the bowl when no surgical fluid is present in the bowl or when an insufficient amount of surgical fluid is present in the bowl. This can help prevent damage to bowl 14 and / or thermal treatment device 46.
[0091] In some examples, controller 42 determines whether a sufficient amount of substance (e.g., surgical fluid) is present in bowl 14 based on feedback from volume measuring device 44. Controller 42 can determine a volume of substance present in bowl 14 based on signals received from volume measuring device 44. Controller 42 can compare the determined volume to information stored in memory 54, such as information indicating a threshold amount of substance that needs to be present in bowl 14 to enable operation of thermal treatment device 46. Controller 42 can prevent thermal treatment device 46 from activating until it determines that a threshold amount of substance is present in bowl 14 and / or can terminate operation of thermal treatment device 46 if, for example, a threshold amount of substance has not been added to the bowl within a certain period of time after activating the thermal treatment device.
[0092] In another example, controller 42 indirectly determines whether a sufficient amount of substance (e.g., surgical fluid) is present in bowl 14 based on feedback from temperature sensor 48. Upon receiving the target temperature from the operator via user interface 16, controller 42 may activate thermal treatment device 46 and then monitor the temperature of bowl 14 based on feedback from temperature sensor 48. For example, controller 42 may monitor the temperature of bowl 14 from the time thermal treatment device 46 is activated and generate a temperature profile indicative of the change in said temperature of the bowl over time. Controller 42 may compare the temperature profile generated during operation of thermal treatment device 46 to a temperature profile stored in memory 54. The temperature profile stored in memory 54 may represent a predicted change in the temperature of the bowl over time when an appropriate (e.g., threshold) amount of substance is present in the bowl. If the controller 42 determines that the temperature profile generated during operation of the thermal treatment device 46 deviates from the temperature profile stored in memory 54 by more than a threshold amount (e.g., by more than 1 percent, more than 5 percent, more than 10 percent), the controller 42 may terminate operation of the thermal treatment device 46.
[0093] In some examples, such as those in which the volume measuring device 44 is implemented as a weighing device, the controller 42 monitors both the weight of the bowl 14 and any contents therein (e.g., via the weighing device), as well as the temperature profile generated during operation of the thermal treatment device 46 (e.g., as measured by the temperature sensor 48) to determine the contents within the bowl. Upon receiving an instruction, for example, via the user interface 16, to initiate a thermal adjustment, the controller 42 may detect the weight of the bowl 14 and the contents therein, and further receive data indicative of the temperature of the bowl 14 from when the thermal treatment device 46 was activated, thereby providing a temperature profile indicative of the change in the temperature of the bowl over time. If the controller 42 detects a weight within the bowl 14 but determines that the temperature profile generated during operation deviates from the temperature profile stored in memory, the controller may determine that an unidentified tool is present within the bowl 14. In response, the controller 42 may respond by controlling a display or providing other user output (e.g., an audible, visual message) to instruct the user to remove the tool. Controller 42 may or may not inhibit continued heat adjustment unless the user removes the tool, as determined, for example, by controller 42 detecting a change in weight of bowl 14 and the contents therein.
[0094] As another example, if controller 42 detects a weight in bowl 14 but does not receive an indication via user interface 16 that fluid was to be in the bowl, the controller may further compare the temperature profile generated during operation to a temperature profile stored in memory corresponding to a heating profile of the fluid. If controller 42 determines that the generated temperature profile substantially matches the stored temperature profile, the controller may determine that the initial weight measured in bowl 14 is a fluid that was not identified through user interface 16. In such a situation, controller 42 may store the measured weight corresponding to the contents of bowl 14 as a fluid weight / volume in a memory associated with the controller. The controller may then include this weight / volume when tracking subsequent additions or removals of fluid from the bowl, for example, to help ensure that the total amount of fluid withdrawn from the bowl is accurately tracked even if an operator fails to indicate when fluid is being initially added to bowl 14.
[0095] Thus, in some configurations, controller 42 can detect the weight of bowl 14 and its contents, as well as the temperature profile of the bowl produced during thermal conditioning. Controller 42 can compare the weight and / or temperature profile to information stored in memory to determine the contents in bowl 14, such as whether only air is present in the bowl, whether a tool is present, and / or whether a fluid is present in the bowl. Controller 42 can provide a user output based on the determined contents of the bowl.
[0096] In addition to, or instead of, controlling the thermal treatment device 46 based on the measured temperature profile, the controller 42 may control the rate of heating by the thermal treatment device 46 based on information received from the volume measuring device 44 and the temperature sensor 48. For example, if the volume measuring device 44 is implemented as a metering device, the controller 42 may receive information regarding the bowl 14 and any contents therein (e.g., surgical fluid). The controller 42 may further receive information regarding the temperature of any components in the bowl 14 from the temperature sensor 48. The controller 42 may control the rate of heating, and therefore the amount of thermal energy, delivered by the thermal treatment device 46 based on the received weight and temperature information.
[0097] During operation, thermal treatment device 46 may increase the temperature of the fluid in bowl 14 from a starting temperature to a target temperature more rapidly when a relatively small amount of fluid is present in the bowl than when a relatively large amount of fluid is present in the bowl. Because there may be a thermal equilibrium time lag between when the fluid in bowl 14 reaches the target temperature and when temperature sensor 48 measures that target temperature, thermal treatment device 46 may have a tendency to overheat the fluid in the bowl. That is, the fluid in bowl 14 may be heated to a temperature above the target or set temperature before controller 42 receives a signal from temperature sensor 48 that the target temperature has been achieved and can control thermal treatment device 46 to stop delivering heat to the fluid. This temperature overheating phenomenon may be more pronounced when a relatively small amount of fluid is placed in bowl 14 and the fluid heats up relatively quickly.
[0098] To help control the rate at which the fluid in bowl 14 is heated for more precise heating, controller 42 may adjust the rate at which heat-treatment device 46 delivers heat based on the amount of fluid in the bowl. Figure 11 is a flow chart that illustrates an exemplary process that system 10 may follow to control the amount of thermal energy delivered by heat-treatment device 46 to bowl 14 and any contents therein.
[0099] 11 , controller 42 receives (250) target temperature information from a user via user interface 16. As described above, the user may interact with user interface 16 using a variety of different communication mediums, such as physical contact with the user interface, audible commands, or contactless commands detected by the user interface. The target temperature information may specify a target temperature to which the fluid in bowl 14 will be heated.
[0100] Controller 42 also receives (252) information regarding the amount of fluid in bowl 14 from volume measuring device 44. For example, if volume measuring device 44 is implemented as a metering device, controller 42 may receive information regarding bowl 14 and any contents therein. If controller 42 determines that there is no fluid in bowl 14 or that there is an insufficient amount of fluid in the bowl, the controller may not activate heat treatment device 46, but may instead control the display of user interface 16 to provide instructions to the user to add fluid to the bowl. In either case, controller 42 may analyze the information regarding the amount of fluid in bowl 14 and use that information to control heat treatment device 46.
[0101] With reference to the information stored in memory, controller 42 may determine whether the amount of fluid in bowl 14 is relatively small or whether there is a larger amount of fluid in the bowl and may further determine a heating rate based on the amount of fluid (254). For example, controller 42 may compare gravitational measurement information indicative of the amount of fluid in bowl 14 to one or more threshold weights stored in memory associated with the controller. If controller 42 determines that the weight of the fluid in the bowl is greater than the threshold weight, the controller may control thermal treatment device 46 to heat the bowl and any fluid therein at a first heating rate. In contrast, if controller 42 determines that the weight of the fluid in the bowl is less than the threshold, the controller may control thermal treatment device 46 to heat the bowl and any fluid therein at a second heating rate that is less than the first heating rate. More thermal energy is delivered to bowl 14 during the first heating rate than at the second heating rate.
[0102] The threshold(s) used to set the heating rate delivered by the thermal treatment device 46 may vary depending, for example, on the amount of thermal energy the device can supply within the size of the bowl 14. In some examples, the threshold weight is a weight less than 5 kg, e.g., a weight less than 2 kg or a weight less than 1000 g. For example, the threshold may be 500 g or less. Additionally or alternatively, the threshold may be established based on a maximum amount of fluid that may be added to the bowl 14. For example, the threshold may correspond to an amount of fluid in the bowl 14 that is less than 50% of the maximum amount of fluid that may be added to the bowl, e.g., less than 30% of the maximum amount. For example, the threshold may be a value that corresponds to an amount of fluid in the bowl 14 that is in the range of 2% to 30% of the maximum amount of fluid that may be added to the bowl, e.g., 5% to 20% of the maximum amount. The lower end of these ranges may correspond to an amount of fluid below which the thermal treatment device 46 will not activate if the system 10 is so configured. In examples where the maximum volume of the bowl 14 is less than 10 liters, such as 5 liters, the threshold may be a value in the range of 0.25 liters to 1 liter. This may correspond to a weight value of 250 grams to 1 kilogram if the fluid is assumed to have a density of 1 Kg per liter.
[0103] In some examples, the rate of heating delivered by the thermal treatment device 46 is controlled by varying the voltage or current delivered to the thermal treatment device. In other examples, the rate of heating delivered by the thermal treatment device 46 is controlled by varying the duty cycle or operating frequency of the thermal treatment device. For example, a first heating rate may correspond to an operating duty cycle of the thermal treatment device that is greater than the operating duty cycle during a second heating rate. By way of example, the operating duty cycle of the thermal treatment device 46 for the first heating rate may be a 100% duty cycle. In contrast, the operating duty cycle of the thermal treatment device 46 for the second heating rate may be less, such as a duty cycle in the range of 25% to 75%. The operating duty cycle may be considered the percentage of time during a given period that the thermal treatment device 46 is active and delivering thermal energy to the bowl 14, as opposed to being cycled off and not delivering thermal energy to the bowl 14. The thermal treatment device 46 may operate at full power and be cycled on and off periodically to vary the duty cycle.
[0104] 11 , controller 42 is configured to control thermal treatment device 46 to heat bowl 14 and the fluid therein at a heating rate determined to be appropriate for the amount of fluid present in the bowl (256). Controller 42 may receive temperature measurement information from temperature sensor 48 regarding a measured temperature of the fluid in bowl 14 (258). Controller 42 may continue to transfer heat to the fluid in bowl 14 at a rate determined to be appropriate for the amount of fluid present in the bowl until the temperature of the fluid measured via temperature sensor 48 reaches a target temperature. Once the target temperature is reached, controller 42 may control thermal treatment device 46 to stop transferring heat to the bowl and the fluid therein.
[0105] Controlling the amount of heat delivered to bowl 14 based on the amount of fluid determined to be present in the bowl can be useful in preventing overheating of the fluid. In some examples, controller 42 is configured to control heat treatment device 46 to adjust the rate of heating applied to the bowl when temperature measurement information from temperature sensor 48 indicates that the fluid in the bowl is approaching a target temperature. Controller 42 may adjust the heating rate by decreasing (e.g., gradually, in a step change) the rate of heating provided to bowl 14 regardless of what the initial rate of heating delivered to the bowl was. For example, when controller 42 determines that the fluid in bowl 14 is within a certain degree range of the target temperature, such as 5 degrees Fahrenheit or 10 degrees Fahrenheit from the target temperature, the controller may reduce the amount of heat delivered to the bowl compared to the amount of heat delivered before the fluid reached the certain degree range. This can help slow down the heating rate as the fluid approaches the target temperature and prevent overheating.
[0106] System 10 of FIG. 6 also includes a volume measuring device 44. Volume measuring device 44 is configured to measure, either directly or indirectly, a volume of a substance (e.g., surgical fluid) present in bowl 14. Volume measuring device 44 can generate volumetric information regarding the amount of surgical fluid present in the bowl and communicate that information to controller 42. This information can be used by controller 42 to monitor the amount of fluid added and removed from bowl 14 during a procedure and, accordingly, determine the surgical volume consumed during a procedure. Controller 42 may receive a signal from volume measuring device 44 at periodic intervals or continuously, indicative of the volume measured by the sensor. Discussion of controller 42 receiving measurement information from volume measuring device 44 at a particular time is not intended to indicate that the controller cannot receive measurement information at other times.
[0107] Volume measuring device 44 may be implemented using any device that measures the amount of fluid in bowl 14 such that the volume can be determined. In different applications, volume measuring device 44 may be implemented using a load cell that indirectly measures the volume by measuring the mass of bowl 14 and the contents therein, a float that rises and falls based on the level of surgical fluid in the bowl, an optical or electrical resistance sensor that detects the volume level in the bowl, or even other types of sensors. For example, bowl 14 may be configured with a dispensing outlet through which fluid is released from the bowl. The fluid may be released directly to the patient via a tubing line or into a fluid container (e.g., graduated) that is then used to carry the fluid to the patient. A flow meter may be provided that measures the volume of fluid passing through the dispensing outlet. As another example, bowl 14 may be configured with a flow meter that measures the volume of fluid as it is added to the bowl. The amount of fluid added to the bowl may be mathematically reduced by the amount of fluid remaining in the bowl to determine the amount of fluid used. Regardless of the configuration, volume measuring device 44 may generate an electrical signal whose magnitude is proportional to the volume of the substance present in and / or expelled from bowl 14. The signal can include volume information, in that the volume of the substance present in bowl 14 can be determined by controller 42 based on the signal.
[0108] In applications in which the volume measuring device 44 is implemented as a weighing device, the controller 42 may subtract the weight of any drapes placed within the bowl 14 to determine the contents of the bowl. For example, the controller 42 may reduce the measured weight by the tare weight of the bowl 14 and / or any drapes placed therein, which may be measured at start-up or may be stored in a memory associated with the controller 42. As another example, the weight of a drape placed on the bowl 14 may be stored on a contactless tag associated with the drape. The contactless reader 50 may read the drape weight from the tag when the drape is placed on the bowl, and the controller 42 may subsequently use the drape weight to reduce the measured weight.
[0109] Volume measuring device 44 may be positioned around bowl 14 in a location suitable for detecting the volume of surgical fluid present in bowl 14. The particular location at which volume measuring device 44 is positioned may vary depending on the type of device used to measure the volume of fluid present in the bowl. For example, in the case of a float that rises and falls based on the volume of fluid present in bowl 14, the float may be positioned within bowl 14 and connected to a transducer in housing 58 that detects and transmits the relative position of the float. As another example, in the case of a load cell that measures the weight of bowl 14 and its contents, the load cell may be positioned below bowl 14 (e.g., in contact with base 20) to measure the weight of the bowl and its contents.
[0110] When the volume measuring device 44 is implemented as a weighing device, the weighing device may include any type of weighing scale capable of determining the weight or mass of an object. For example, the weighing device may be implemented using one or more load cells, strain gauges, spring scales, analytical balances, pressure scales, pneumatic scales, or any other device or apparatus capable of measuring the weight or mass of an object. In some examples, the weighing device comprises one or more load beams positioned under the bowl 14 to measure the weight of the bowl and its contents. For example, a multi-load beam weighing device having two or more load cells may function as a bridge load cell. Such a weighing device may obtain the weight of the bowl 14 and the contents therein and provide an analog strain signal to a circuit board that conditions and converts these measurements into a single mass value.
[0111] Although volume measuring device 44 may be positioned in various positions relative to bowl 14, FIG. 12 illustrates an exemplary arrangement of components when volume measuring device 44 is implemented as a gravimetric measuring device. Specifically, FIG. 12 illustrates an exploded cross-sectional view of bowl 14 taken along cross-sectional line AA shown in FIG. 1 illustrating an exemplary arrangement of components. In the illustrated example, system 10 includes bowl 14, gravimetric measuring device 44, and thermal treatment device 46. Gravimetric measuring device 44 is illustrated as being implemented with at least one load cell, which is shown in the cross-sectional view with respect to load cells 45A, 45B. Thermal treatment device 46 is illustrated as a thin film heater at least partially wrapped around base 20 and sidewall 22 of bowl 14. Housing 58 is illustrated as including at least one sidewall 58A enclosing at least one sidewall 22 of the bowl upwardly from base 58B.
[0112] Additionally, system 10 includes a mounting plate 60 defining a first side 62 and a second side 64 opposite the first side. Mounting plate 60 is attached to bowl 14 such that an air gap 66 is formed between the mounting plate and the bowl. For example, air gap 66 may be defined between first side 62 of mounting plate 60 and a bottom surface of bowl 20. Weight measuring device 44 is positioned on second side 64 of mounting plate 60. Thus, in this configuration, the mounting plate is interposed between bowl 14 and weight measuring device 44 such that there is an air gap 66 between the bowl and the weight measuring device.
[0113] Configuring the system 10 with an air gap 66 between the bowl 14 and the weight measuring device 44 can be useful to help thermally isolate the weight measuring device from the heat treatment device 46 and / or the heated contents of the bowl 14. In different examples, the air gap 66 may be completely devoid of material or may be filled with insulating material. In either case, isolating the bowl 14 from the weight measuring device 44 can help reduce or eliminate erroneous weight measurements caused by the weight measuring device being at a different calibrated operating temperature. This can help improve the accuracy of weight measurements made using the device and control settings determined based on weight measurements, such as heating rate, for example.
[0114] In some examples, the air gap 66 is sized to limit the extent to which the temperature of the weight measuring device 44 rises above the ambient temperature, for example, when the heat treatment device 46 is operating and / or when the bowl 14 contains heated contents. For example, the air gap 66 may have a size effective to prevent the weight measuring device 44 from reaching a temperature more than 5 degrees Celsius above the ambient temperature when any contents in the bowl are heated to a temperature in the range of 90 degrees Fahrenheit (32.2 degrees Celsius) to 120 degrees Fahrenheit (48.9 degrees Celsius). In some examples, the air gap 66 may be less than 5 cm, such as less than 2 cm. By way of example, the air gap 66 may be in the range of 0.1 cm to 10 cm.
[0115] The mounting plate 60 may be attached to the bowl 14 in many different locations. In one example, the mounting plate 60 may extend up and be fixedly attached under the lip formed where the sidewall 22 curves at the top of the bowl 14. As another example, the mounting plate 60 may be fixedly attached under the base 20 of the bowl 14, as shown in FIG. 12. When the mounting plate 60 is attached under the base 20, the system 10 may include one or more spacers 68 located between the first surface 62 of the mounting plate and the bottom of the base 20. The length of the spacer 68 may dictate the size of the air gap 66. For example, the spacer may have a top end attached to the bottom of the base 20 and a bottom end attached to the top or first surface 62 of the mounting plate 60.
[0116] To enable weight measuring device 44 to detect changes in the weight of the contents of bowl 14, the bowl may float or move relative to the weight measuring device. For example, bowl 14 and mounting plate 60 (if so configured) attached to it through spacers 68 may be configured to move upward and downward relative to weight measuring device 44 as the amount of weight in the bowl changes. Second surface 64 of mounting plate 60 may press against load cells 45A, 45B with varying degrees of force depending on the amount of weight in the bowl.
[0117] To prevent a user from inadvertently pulling bowl 14 out of housing or shell 58, the range of movement that bowl 14 (and mounting plate 60 when attached) can move may be limited. Housing 58 may have an internal protrusion, detent, or narrowing that bowl 14 and / or mounting plate 60 contact when it reaches the upper limit of travel. As another example, one or more fixed rods 70 may be attached to housing 58 and extend through mounting plate 60. Fixed rods 70 may have a protrusion or extension at the top end of fixed rod 70 above first surface 62 of mounting plate 60. Thus, bowl 14 and mounting plate 60 may translate vertically upward along fixed rod 70 until the top of the mounting plate contacts the extension of the fixed rod. Bowl 14 and mounting plate 60 may further translate vertically downward along fixed rod 70 until the bottom of the mounting plate contacts the top surface of load cell 45A, 45B. In this manner, bowl 14 can be suspended within housing 58 over a limited range of movement.
[0118] To allow bowl 14 to move upwardly and downwardly through a range of motion, the top surface of the bowl may be movably connected to housing 58 such that the top surface may move without exiting the housing. In the illustrated configuration, sidewall 22 of bowl 14 extends generally horizontally and terminates in a lip 72 that transitions from the remainder of the sidewall, which is generally vertically oriented. Housing 58 includes a flange portion 74 that extends over the end of lip 72. Housing flange 74 may be configured to flex upwardly and downwardly to maintain a fit over lip 72 as bowl 14 moves upwardly and downwardly. In other configurations, lip 72 may be fixedly coupled to housing 58, or bowl 14 may even not include a lip.
[0119] When weight measuring device 44 is implemented using one or more load cells 45A, 45B, the load cells may be positioned at positions spaced apart from one another beneath base 20 and / or mounting plate 60. As an example, system 10 may include four load cells arranged in a rectangular pattern beneath bowl 14 to measure weight substantially uniformly across the bowl. The number and positioning of the load cells may vary based on, for example, the size and shape of bowl 14. In different examples, weight measuring device 44 has an accuracy of measuring the weight of the contents of bowl 14 within 250 g of their actual weight, such as within 100 g of the actual weight of the contents of bowl 14, within 50 g of their actual weight, within 10 g of their actual weight, within 5 g of their actual weight, within 1 g of their actual weight, within 0.5 g of their actual weight, or within 0.1 g of their actual weight.
[0120] During operation, the volume within bowl 14 as well as the weight of the bowl's contents may rise and fall as fluids are added and removed from the bowl, and as medical hardware is added and removed from the bowl. To enable controller 42 to distinguish when fluids are added or removed from bowl 14 as compared to when non-fluid components are added or removed, the controller may be informed of the type of substance being added or removed from the bowl. For example, controller 42 may be informed of the type of substance being added and / or removed from bowl 14 via a clinician's interaction with one or more user interfaces of system 10.
[0121] In some examples, the user interface 16 receives user input by a clinician to selectively indicate to the controller 42 when a non-fluid component, such as a medical tool or hardware, is being added or removed from the bowl. The user input may be a physically movable button (e.g., a switch, slide, knob), a selectable computer icon, a portion of a touch screen, or the type of user input discussed herein. In operation, the clinician may interact with the user input (e.g., press a button) to thereby provide a first indication to the controller 42 that a non-fluid component is being added or removed from the bowl 14. After subsequently adding or removing a non-fluid component from the bowl 14, the clinician may again interact with the user input (e.g., press a button) to thereby provide a second indication to the controller 42 that the clinician has completed adding or removing a non-fluid component to or from the bowl 14. Alternatively, controller 42 may automatically determine, without input from the user (e.g., without the user interacting with user interface 16), that the clinician has completed adding or removing the non-fluid component to bowl 14 after a threshold amount of time has elapsed since receiving the first instruction, such as at least 10 seconds, at least 30 seconds, or at least 1 minute. In this alternative configuration, the clinician may, but is not required to, interact with the user input for a second time after adding or removing the non-fluid component to bowl 14 or from the bowl.
[0122] The controller 42 may receive volumetric information from the volume measuring device 44 regarding the volume of surgical fluid present in the bowl. In some examples, the system has a user engagement feature (e.g., a button) that the user can interact with to switch between output reporting in volume units and weight units. If the volume measuring device 44 is a weighing device, the volumetric information may be in the form of weight information. In either case, the controller 42 may determine the volume of surgical fluid present in the bowl 14 based on the volumetric information received from the volume measuring device 44. The controller 42 may store the determined volume in memory 54. In response to receiving a first indication via the user interface that a clinician plans to add or remove a non-fluid component to or from the bowl 14, the controller 42 may receive volumetric information from the volume measuring device 44 indicating a change in the volume of surgical fluid present in the bowl 14. The volume change may be caused by the clinician adding or removing a non-fluid component from the bowl 14, rather than an actual change in the amount of fluid present in the bowl. Thus, controller 42 may ignore any change in the volume of surgical fluid determined to be present in bowl 14 between receipt of the first instruction and receipt of the second instruction indicating that the clinician has completed adding or removing non-fluid components to / from the bowl. Controller 42 may ignore the change in volume by referencing the volume of surgical fluid determined to be present in bowl 14 stored in memory 54 prior to receiving the first instruction and setting the stored volume as the actual volume present in bowl 14 after the non-fluid components have been added to or removed from bowl 14.
[0123] Although the system 10 and controller 42 may be configured to receive user input indicating when non-fluid ingredients are added or removed from the bowl 14, the system may still accurately track the volume of fluid removed from the bowl without implementing this functionality. In these applications, the user may be instructed to start with any non-fluid ingredients (e.g., prior to the addition of fluid) that will be used during the procedure, either in the bowl 14 or outside the bowl. If non-fluid ingredients are initially added to the bowl, the controller 42 may determine the weight of the non-fluid ingredients (when configured with a weight measuring device) and subsequently tare or otherwise reduce the weight of the non-fluid ingredients when determining the volume of fluid removed from the bowl. The user may be instructed that non-fluid ingredients initially present in the bowl need to be returned to the bowl (otherwise the system may attribute the missing weight of the non-fluid ingredients to the result of the fluid removed) in order to obtain an accurate measurement of the volume of fluid removed from the bowl. Alternatively, the user may initially start with no non-fluid ingredients in the bowl. The user may then be instructed that non-fluid components need to be removed from the bowl in order to obtain an accurate measurement of the volume of fluid removed from the bowl (otherwise the system may consider the non-fluid components to be the result of additional fluid actually being removed from the system). Instructing the user that volume readings need to be taken with non-fluid components either "in" or "out" of bowl 14 in order to obtain an accurate reading may simplify operation and user interaction with system 10.
[0124] In addition to or instead of having a user input to indicate when medical hardware is being added or removed from the bowl 14, the system 10 may include being configured to receive a user input from a user to indicate to the controller 42 when fresh surgical fluid is to be added to the bowl 14. The user input may be a physically movable button (e.g., a switch, slide, knob), a selectable computer icon, a portion of a touch screen, or other user interaction discussed herein. Additionally or alternatively, the user input may be a foot-actuable pedal 40. For example, the system 10 may be configured with multiple user interfaces, any of which may be used to indicate to the controller 42 when fresh surgical fluid is to be added to the bowl 14. The system 10 may include one user input that is part of a user interface 16 that a clinician (e.g., a sterile field personnel) can interact with to indicate to the controller 42 when fresh surgical fluid is to be added to the bowl 14. The system 10 may also include another user input in the form of a foot-actuable pedal 40 that a clinician (e.g., a sterile field personnel or a non-sterile field personnel) can interact with to indicate to the controller 42 when surgical fluid is to be added to the bowl 14.
[0125] In operation, the clinician may interact with any user input (e.g., by manipulating a user input on the user interface 16 or actuating the foot pedal 40) that provides an indication when fresh surgical fluid is to be added to the bowl 14. When the clinician initially interacts with one of the user inputs / interfaces, the controller 42 may receive a first indication that fresh surgical fluid is to be added to the bowl 14. After subsequently adding the surgical fluid to the bowl 14, the clinician may again interact with the user input / interface (e.g., by manipulating a user input on the user interface 16 or actuating the foot pedal 40), thereby providing a second indication to the controller 42 that the clinician has completed adding the surgical fluid to the bowl 14. Alternatively, the controller 42 may automatically determine that the clinician has completed adding the fresh surgical fluid to the bowl 14 (e.g., without the user interacting with the user input or interface) after a threshold amount of time has elapsed since receiving the first indication, such as at least 10 seconds, at least 30 seconds, or at least 1 minute.
[0126] In some examples, the system 10 is configured to receive a signal from the volume measuring device 44 when power is turned on to determine, for example, whether a user may have placed surgical fluid in the bowl 14 before powering on the unit. If the controller 42 receives data indicating that a volume of material is present in the bowl 14 after power is turned on, the controller may take various responsive actions. The controller 42 may control the display of the user interface 16 to issue a prompt asking the user if the detected volume is fluid added to the bowl. Additionally or alternatively, the controller may automatically determine that the detected volume is fresh fluid in the bowl (e.g., without the user interacting with the user input / interface). For example, the controller 42 may control the display to ask the user if the detected volume is surgical fluid added to the bowl, and if the user does not respond after a threshold amount of time, the controller may automatically designate the measured volume as fresh fluid and store the measured volume in memory. The threshold amount of time may be any amount of time discussed above, such as at least 10 seconds, at least 30 seconds, or at least one minute. If volume measuring device 44 is implemented as a weight measuring device, controller 42 may detect the volume of fluid that may be present in bowl 14 at start-up by detecting a weight in bowl 14 that exceeds an expected tare weight (e.g., the weight of the bowl and / or drape 35 expected to be draped over the bowl).
[0127] The controller 42 may receive volume information from the volume measuring device 44 regarding the volume of surgical fluid present in the bowl before, during, and after the addition of fresh surgical fluid to the bowl 14. The controller 42 may determine the volume of surgical fluid present in the bowl 14 based on the volume information received from the measuring device 44. The controller 42 may store the determined volume in the memory 54. In response to receiving a first indication that the clinician plans to add fresh surgical fluid to the bowl 14, the controller 42 may receive volume information from the volume measuring device 44 indicating an increase in the volume of surgical fluid present in the bowl 14. The volume change may be caused by the clinician adding fresh surgical fluid to the bowl 14. After receiving a second indication that the clinician has completed adding surgical fluid to the bowl 14, the controller 42 may receive updated volume information from the volume measuring device 44 indicating the volume of surgical fluid present in the bowl 14. The updated volume information includes the increase in volume due to the clinician adding fresh surgical fluid to the bowl. In this manner, controller 42 can distinguish between when an increase in volume in bowl 14 is due to the clinician adding fresh fluid to the bowl and when the increase is associated with the clinician returning unused surgical fluid that was previously removed from the bowl.
[0128] During operation, controller 42 may detect a large increase in volume greater than would normally be expected by returning non-fluid ingredients to bowl 14 and / or returning fluid removed from the bowl to the bowl. For example, fresh surgical fluids are often provided in containers that are 500 g or 1000 g. If a user adds a fresh container of fluid to bowl 14 but neglects to first provide a user input to the system indicating that fresh fluid is being added, controller 42 may be programmed to automatically (e.g., without the user interacting with the user input / interface) designate such a large weight and / or volume increase as fresh fluid added to the bowl. For example, controller 42 may automatically designate a large increase in volume and / or weight greater than a threshold as fresh fluid added, rather than a non-fluid ingredient or the expected fluid being returned to the bowl. The threshold may be a volume greater than 400 mL (or 400 g), such as a volume greater than 450 mL (or 450 g), or a volume equal to or greater than 500 mL (or 500 g). Other thresholds may be used. If so configured, the controller 42 may control the display to ask the user if the detected large volume is surgical fluid added to the bowl, and if the user does not respond after a threshold amount of time, the controller may automatically designate the large volume change as fresh fluid and store the volume increase in memory.
[0129] During a medical procedure, controller 42 may periodically or continuously receive volume information from volume measuring device 44 indicating the current volume of surgical fluid present in bowl 14. For example, controller 42 may receive initial volume measurement information from volume measuring device 44 at the beginning of a medical procedure indicating, for example, the volume of surgical fluid initially placed in bowl 14. At one or more measurement times during a medical procedure (e.g., continuously), controller 42 may receive updated volume information from volume measuring device 44 indicating the current volume of surgical fluid present in bowl 14 at the measurement time. Controller 42 may compare the volume of surgical fluid present in bowl 14 at the measurement time to the total volume of fresh surgical fluid added to the bowl (the initial volume of surgical fluid placed in bowl 14 and any fresh surgical fluid subsequently added to the bowl). The total volume of fresh surgical fluid added to bowl 14 may be monitored by controller 42 and stored in memory 54. By determining the difference between the current volume of surgical fluid at the measurement time and the total volume of fresh surgical fluid added to the bowl at the time of the measurement, the controller 42 can determine the volume of surgical fluid used during the medical procedure at the time of the measurement.
[0130] In some examples, controller 42 controls a display associated with user interface 16 and / or display 18 to display the amount of surgical fluid used during the procedure. In different examples, controller 42 may control the display to display the weight and / or volume of surgical fluid used during the medical procedure as of a measured time. Controller 42 may continuously update the display, for example, as fluid is removed from bowl 14 by the clinician to provide real-time information to the clinician indicative of the amount of surgical fluid used during the procedure.
[0131] As noted above, the controller 42 of the example of FIG. 6 is communicatively coupled to a contactless reader 50. The contactless reader 50 is configured to read information stored on a contactless tag present on a drape disposed over the bowl 14. The contactless tag may be placed in physical contact with the contactless reader 50, but the reader may also be capable of reading information from the tag by placing the tag in close proximity to the reader without physically contacting the reader. In one example, the contactless reader 50 is implemented as a Near Field Communication (NFC) reader. In another example, the contactless reader 50 is a Radio Frequency Identification (RFID) tag or an optical reader.
[0132] Regardless of the particular configuration of the contactless reader 50, the reader can read identification information stored on a machine-readable tag present on a drape placed on the bowl 14. The identification information may be in the form of a numeric code, a manufacturer name or brand, or other information that identifies the source and / or type of drape to which the machine-readable tag is attached. The controller 42 can control the contactless reader 50 to read the identification information from the machine-readable tag present on the device placed on the bowl 14. The controller 42 can compare the identification information to authentication information stored in the memory 54. The authentication information may provide a corresponding numeric code or other information suitable for determining whether the drape placed on the bowl 14 is approved for use with the bowl. If the controller 42 determines that the identification information read from the machine-readable tag on the drape matches the authentication information stored in the memory, the controller can allow the system 10 to proceed. For example, controller 42 may enable thermal treatment device 46 to regulate the temperature of bowl 14 and / or volume measuring device 44 to measure the volume of surgical fluid present in the bowl.
[0133] In contrast, if controller 42 determines that the identification information read from the machine-readable tag on the drape does not match the authentication information stored in memory, controller 42 may inhibit operation of system 10. For example, controller 42 may inhibit thermal treatment device 46 from regulating the temperature of bowl 14 and / or volumetric measuring device 44 from measuring the volume of surgical fluid present in the bowl. In some additional examples, controller 42 may similarly inhibit operation of system 10 if non-contact reader 50 does not identify a machine-readable tag indicating, for example, that a drape has not been placed over bowl 14 or that a drape without a machine-readable tag has been placed over the bowl.
[0134] In some examples, the controller 42 may start a timer and / or a start time may be written to the tag 38 (e.g., using a non-contact reader 50 with writing capabilities) after detecting that the drape placed on the bowl 14 has an approved tag. After a threshold amount of time has elapsed based on the start time written on the timer and / or tag, the controller 42 may determine that the tag and corresponding drape have expired. The threshold amount of time may range from 1 hour to 24 hours, such as 4 hours to 18 hours or 6 hours to 14 hours. The controller 42 may control the user interface 16 to provide a time warning before the tag and drape expire (e.g., 1 hour, 30 minutes, 15 minutes before expiration). If it is determined that the tag and corresponding drape have expired, the controller 42 may control the heat treatment device 46 to stop heating the bowl 14. Such an arrangement may help ensure that the drape covering bowl 14 is periodically replaced with a new drape to promote sterility and may help ensure the integrity of the drape.
[0135] FIG. 7 is a flow chart of an exemplary technique that may be used to monitor the amount of surgical fluid removed from a thermal treatment device during a medical procedure. The exemplary technique of FIG. 7 is described with respect to the thermal treatment system 10 described with respect to FIGS. 1-3 and 6, but the technique may be implemented by systems having other configurations described herein. In the example of FIG. 7, a clinician engages a user input on the system 10 to indicate that the user intends to add fluid to the bowl 14 (100). The clinician may engage the user input by interacting with the user interface 16 or by actuating the foot-actuable pedal 40. In response to engaging the user input, the controller 42 receives a first indication indicating that the user intends to add surgical fluid to the bowl (102). The controller 42 may control a display on the system 10 to provide instructions or prompts telling the user to add surgical fluid to the bowl 14.
[0136] In the technique of FIG. 7 , a clinician adds surgical fluid to bowl 14 (104). Controller 42 receives volume information from volume measuring device 44 indicating an increase in volume as the clinician adds surgical fluid to the bowl (106). If volume measuring device 44 is a weighing device, controller 42 may receive weight information regarding bowl 14 and any contents therein. When the clinician completes adding surgical fluid to bowl 14, the clinician re-engages user input on system 10 to indicate that the user is finished adding surgical fluid to bowl 14 (108). The clinician may re-engage user input by interacting with user interface 16 or by actuating foot-actuable pedal 40. In response to engaging user input, controller 42 receives a second indication indicating that the user is finished adding surgical fluid to bowl 14 (110).
[0137] The technique of FIG. 7 further involves the controller 42 determining the volume of surgical fluid added to the bowl 14 between when the clinician interacts with the user interface to indicate that fluid is to be added to the bowl and when the clinician interacts with the user interface to indicate that fluid is completed being added to the bowl (112). For example, if the volume measuring device 44 is a weighing device, the controller 42 may determine the difference in weight between the bowl 14 and any contents therein (e.g., medical tools with or without surgical fluid) before receiving the first instruction and the weight of the bowl and contents therein, including surgical fluid, after receiving the second instruction. The controller 42 may determine the volume of fluid added to the bowl 14 by multiplying the weight change by the density of the surgical fluid stored in memory 54.
[0138] During operation of the system 10, the clinician removes surgical fluid from the bowl 14 with the technique of FIG. 7 (114). The controller 42 receives volume measurement information from the volume measuring device 44 indicating the change in volume present in the bowl 14 as the clinician removes fluid (116). For example, when the volume measuring device 44 generates volume information at a measurement time, the controller 42 can receive the volume measurement information and determine the volume of surgical fluid in the bowl at the measurement time. If the volume measuring device 44 is a weighing device, the controller 42 can receive weight information regarding the bowl 14 and its contents. The controller 42 can determine the change in the total volume of fluid in the bowl 14, for example, by determining a weight difference and multiplying the weight change by the density of the surgical fluid stored in the memory 54. In some examples, the controller 42 further controls a display on the system 10 to indicate the volume of fluid consumed during the procedure.
[0139] 7 technique, the clinician engages a user input on the system 10 to indicate that the user intends to add medical hardware (e.g., a medical tool) to the bowl 14 or remove medical hardware from the bowl (118). The clinician may engage the user input by interacting with the user interface 16. In response to engaging the user input, the controller 42 receives a first indication indicating that the user intends to add medical hardware to the bowl 14 or remove medical hardware from the bowl (120). The clinician subsequently adds medical hardware to the bowl or removes medical hardware from the bowl (122).
[0140] Once the clinician has completed adding or removing medical hardware from bowl 14, the clinician again engages user input on user interface 16 to indicate that the user has finished adding or removing medical hardware (124). In response to engaging the user input, controller 42 receives a second indication indicating that the user has completed adding or removing medical hardware from bowl 14 (126). Controller 42 may then determine a change in the measured volume of surgical fluid in bowl 14 between when the clinician engaged the user interface to indicate that medical hardware is to be added or removed from the bowl and when the clinician engaged the user interface to indicate that the hardware change is complete (128). For example, if volume measuring device 44 is a weighing device, controller 42 may determine a weight difference between bowl 14 and its contents before receiving the first instruction and the weight of the bowl and its contents after receiving the second instruction. The change in weight may be due to the addition or removal of medical hardware from the bowl 14 instead of any addition or removal of medical fluid from the bowl.
[0141] In the technique of FIG. 7, controller 42 ignores (130) any change in measured volume between when the clinician interacts with the user interface to indicate that medical hardware is to be added or removed from the bowl and when the clinician interacts with the user interface to indicate that the hardware change is complete. Controller 42 may ignore the change in volume by referencing the volume of surgical fluid determined to be present in bowl 14 (and stored, for example, in memory 54) prior to receiving the first instruction and setting the stored volume as the actual volume present in the bowl after medical hardware is added or removed from bowl 14. Thus, controller 42 may control the display of system 10 such that when medical hardware is added to or removed from bowl 14, the volume of surgical fluid consumed during the procedure and reported on the display does not change.
[0142] 8A is an exemplary user interface 150 that may be used as the user interface 16 in the system 10. The user interface 150 includes a power button 152 for turning the system 10 on and off, a first user input 154, a second user input 156, a temperature control 158, and a display 160. Both the first user input 154 and the second user input 156 are illustrated in the form of depressible buttons, although other user input configurations may be used as described herein. The temperature control 158 allows the clinician to set a target temperature to which the surgical fluid in the bowl 14 is heated, including raising and lowering the target temperature. In addition, the user interface 150 includes a temperature indicator light 155 (e.g., by turning on / off or by changing color) that indicates when the surgical fluid in the bowl 14 is at the target temperature. The user interface 150 also includes a service button 153 that allows the user to switch the display 160 to a service / options menu from which various programming options and preferences may be selected.
[0143] The first user input 154 is operable (e.g., depressable) by the clinician to indicate that a non-fluid component, such as a medical tool, is to be added or removed from the bowl 14. Pressing the first user input 154 a first time notifies the system 10 that a medical tool is to be added or removed from the bowl 14. Pressing the first user input 154 a second time notifies the system 10 that the clinician has completed adding a medical tool to the bowl 14 or removing a medical tool from the bowl (regardless of whether the clinician actually adds or removes the tool).
[0144] The second user input 156 is operable (e.g., depressable) by the clinician to indicate that fresh surgical fluid is to be added to the bowl 14. Pressing the second user input 156 a first time notifies the system 10 that surgical fluid is to be added to the bowl 14. Pressing the second user input 156 a second time notifies the system 10 that the clinician is finished adding surgical fluid to the bowl 14 (whether or not the clinician actually adds fluid). The clinician may engage the foot-actuatable pedal 40 in lieu of the second user input 156 to notify the system that surgical fluid is to be added to the bowl 14 and / or has been added to the bowl.
[0145] Display 160 may display information entered or generated by system 10. For example, in FIG. 8A, display 160 displays target temperature 162 entered into system 10 via temperature control 158, as well as actual temperature 164 of the surgical fluid in bowl 14 as measured by temperature sensor 48 (FIG. 6). Display 160 also displays total (cumulative) volume 166 of surgical fluid added to bowl 14 during the procedure, and volume 168 of surgical fluid used (removed) from the surgical bowl during the procedure. Thus, the difference between total volume 166 of surgical fluid added to bowl 14 and volume 168 of surgical fluid used is the volume of surgical fluid remaining in the bowl. In other configurations, display 160 may display the amount of surgical fluid added to and / or removed from bowl 14 in a different format, such as by weight, a graph chart, etc.
[0146] 8B is an exemplary display 170 that may be used as display 18 in system 10. As shown, display 170 may be configured to display the same information as display 160 on user interface 150. However, as mentioned above, display 170 may be positioned on a different side of bowl 14 than user interface 150 to allow a clinician working on a different side of the bowl to view information entered or generated by the system.
[0147] The techniques described in this disclosure may be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques described may be implemented in one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combination of such components. The term "processor" may generally refer to any of the above logic circuits, alone or in combination with other logic circuits, or any other equivalent circuitry. A control unit comprising hardware may also implement one or more of the techniques of this disclosure.
[0148] Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules, or components may be implemented together or separately as distinct but interoperable logical devices. Depicting different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by distinct hardware or software components. Rather, functionality associated with one or more modules or units may be performed by distinct hardware or software components or may be integrated within a common or distinct hardware or software component.
[0149] The techniques described in this disclosure may also be embodied or encoded in a non-transitory computer-readable medium, such as a computer-readable storage medium containing instructions. The instructions embedded or encoded in the computer-readable storage medium may cause a programmable processor or other processor to perform a method, for example, when the instructions are executed. The non-transitory computer-readable storage medium may include forms of volatile and / or non-volatile memory, including, for example, random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), flash memory, hard disks, CD-ROMs, floppy disks, cassettes, magnetic media, optical media, or other computer-readable media.
[0150] Various implementations have been described. These and other implementations are within the scope of the following claims. The following are exemplary embodiments of the invention. [1] 1. A system for thermally treating a surgical fluid, the system comprising: a basin configured to receive and hold a surgical fluid; a thermal treatment device thermally coupled to the bowl and configured to regulate a temperature of the surgical fluid within the bowl; a volume measuring device positioned to obtain volumetric information regarding a volume of surgical fluid in the bowl; a controller configured to receive volumetric information from the volume measuring device regarding a volume of the surgical fluid in the bowl during a procedure and to determine a volume of the surgical fluid removed from the bowl during the procedure. [2] The system of any one of items 1 and 3-31, wherein the controller is configured to receive volume measurement information from the volume measuring device indicating an increase in the volume of the surgical fluid in the bowl and determine, without input from a user, that the increase in the volume of the surgical fluid is fresh surgical fluid added to the bowl. [3] Further comprising a user interface; the controller receiving at least one indication via the user interface that surgical fluid is to be added to the bowl during the procedure; and determining a volume of the surgical fluid removed from the bowl during the procedure based on the received volume measurement information and the received at least one instruction. [4] The system of any one of items 1-3 and 5-31, wherein the at least one indication is an indication that a user is about to add fresh surgical fluid to the bowl, and the controller is configured to determine, without input from a user, when the user has finished adding the fresh surgical fluid to the bowl. [5] The controller includes at least receiving a first indication via the user interface that the user intends to add the surgical fluid to the bowl; receiving volumetric information from the volume measuring device regarding a volume of the surgical fluid placed in the bowl following the first instruction received via the user interface; receiving a second indication, either upon expiration of a timer or via the user interface, indicating that the user has finished adding the surgical fluid to the bowl; and determining a volume of the surgical fluid added to the bowl between receiving the first instruction and receiving the second instruction; receiving volume measurement information from the volume measuring device at a measured time during the procedure and establishing from that information a volume of the surgical fluid in the bowl at the measured time; and determining a difference between the volume of the surgical fluid added to the bowl and the volume of the surgical fluid at the measurement time. [6] The system of any one of items 1 to 5 and 7 to 31, wherein the user interface includes at least one of a button and a foot-actuable pedal, and receiving the first instruction via the user interface includes the user pressing the button or foot-actuable pedal a first time, and receiving the second instruction via the user interface includes the user pressing the button or foot-actuable pedal a second time. [7] The system of any one of items 1-6 and 8-31, wherein the user interface includes a first user input and further includes a second user input operable by the user to selectively add a non-fluid ingredient to the bowl or remove the non-fluid ingredient from the bowl. [8] The system of any one of items 1-7 and 9-31, wherein the controller is further configured to receive at least one instruction entered via the second user input that the non-fluid component is to be added to or removed from the bowl during the procedure, and to determine a volume of the surgical fluid used during the procedure based on the received volume measurement information and the at least one instruction received via the second user input. [9] The controller includes at least receiving volumetric information from the volume measuring device regarding a volume of the surgical fluid in the bowl; receiving a first indication via the second user input that the user intends to add or remove the non-fluid ingredient from the bowl; receiving a second indication via the second user input that the user has finished adding or removing the non-fluid ingredient to the bowl; subsequent to receiving the second instruction, receiving volumetric information from the volume measuring device regarding a volume of the surgical fluid in the bowl after adding or removing the non-fluid component; and ignoring a change in the volume of the surgical fluid measured by the volume measuring device between receipt of the first instruction and receipt of the second instruction.
[10] The system described in any one of items 1 to 9 and 11 to 31, wherein the second user input includes at least one of a button and a foot-operable pedal, and receiving the first instruction via the second user input includes the user pressing the second user input a first time, and receiving the second instruction via the second user input includes the user pressing the user input a second time.
[11] 32. The system of any one of items 1-10 and 12-31, wherein the volume measuring device includes one of a flow meter, a float that changes position based on the volume of the surgical fluid in the bowl, and a weighing device configured to measure the weight of the bowl and any contents therein.
[12] The system of any one of items 1-11 and 13-31, wherein the volume measuring device is the weighing device, and the weighing device includes one or more load cells positioned below the bowl.
[13] The system of any one of items 1 to 12 and 14 to 31, wherein the heat treatment device includes a heater.
[14] 32. The system of any one of items 1-13 and 15-31, wherein the heater includes a film heater wrapped around the bowl.
[15] The system of any one of items 1-14 and 16-31, wherein the user interface further includes a temperature control configured to receive instructions from the user to adjust a target temperature of the surgical fluid in the bowl.
[16] 32. The system of any one of items 1-15 and 17-31, further comprising a temperature sensor configured to measure the temperature of the bowl and any surgical fluid therein.
[17] The controller: receiving temperature measurement information from the temperature sensor; comparing the received temperature measurement information with a temperature profile stored in a memory; The system described in any one of items 1 to 16 and 18 to 31, further configured to terminate operation of the thermal treatment device if the received temperature measurement information deviates from the temperature profile stored in the memory by more than a threshold amount.
[18] 32. The system of any one of items 1-17 and 19-31, further comprising a non-contact reader configured to read information contained on a machine-readable tag of the surgical drape.
[19] The controller: comparing the identification information read from the machine readable tag with authentication information stored in a memory; The system described in any one of items 1 to 18 and 20 to 31, wherein the system is configured to prohibit operation of the heat treatment device if the identification information does not match the authentication information.
[20] The system according to any one of items 1 to 19 and 21 to 31, wherein the contactless reader includes at least one of a radio frequency identification (RFID) reader or a near field communication (NFC) reader. [twenty one] 32. The system of any one of items 1-20 and 22-31, further comprising a surgical drape positioned over and substantially conforming to the bowl, the surgical drape forming a sterile barrier separating a sterile field from a non-sterile field. [twenty two] 32. The system of any one of items 1-21 and 23-31, further comprising a base, the bowl being supported by the base. [twenty three] The system of any one of items 1 to 22 and 24 to 31, wherein the base is mounted on wheels. [twenty four] The system of any one of items 1-23 and 25-31, wherein the bowl is vertically above the base. [twenty five] 32. The system of any one of items 1-24 and 26-31, further comprising a height adjustment mechanism operable to adjust the height of the bowl relative to the base.
[26] 32. The system of any one of items 1-25 and 27-31, wherein the height adjustment mechanism includes a piston and an adjustment lever operable to control a position of the piston.
[27] The system of any one of items 1-26 and 28-31, further comprising a pair of longitudinally spaced hooks configured to receive a power cord wrapped therearound.
[28] 32. The system of any one of items 1-27 and 29-31, wherein the bowl includes a base and a sloped sidewall extending vertically upwardly away from the base, the base and sloped sidewall collectively forming a bounded cavity having an open top surface that receives and retains the surgical fluid.
[29] The system of any one of items 1 to 28, 30, and 31, wherein the user interface is attached to an exterior surface of the bowl.
[30] 32. The system of any one of items 1-29 and 31, wherein the user interface includes a first display mounted on one side of the bowl and further includes a second display mounted on an opposite side of the bowl.
[31] 31. The system of any one of claims 1 to 30, wherein the user interface is configured to be physically, audibly, or optically engaged by a user.
[32] engaging a user interface on a device for thermally processing a substance to thereby notify said device that a substance is to be added to said device; adding said substance to a bowl of said device; engaging the user interface of the device thereby notifying the device that the substance has been added to the device; removing material from said bowl; and displaying a volume of material removed from the bowl by the device.
[33] engaging the user interface of the device to thereby inform the device that a non-fluid ingredient is to be added to or removed from the bowl; adding or removing the non-fluid ingredients to or from the bowl; 46. The method of any one of items 32 and 34-45, further comprising engaging the user interface of the device, thereby notifying the device that the non-fluid ingredient has been added to or removed from the bowl.
[34] 46. The method of any one of items 32, 33, and 35-45, further comprising adjusting the temperature of the material in the bowl.
[35] 46. The method according to any one of items 32 to 34 and 36 to 45, wherein the regulating of the temperature comprises heating the substance in the bowl.
[36] 46. The method according to any one of items 32 to 35 and 37 to 45, further comprising engaging a temperature control on the device to thereby adjust the target temperature to which the substance is regulated.
[37] 46. The method of any one of items 32-36 and 38-45, further comprising removing a portion of the substance from the bowl and introducing the substance into a patient undergoing a medical procedure.
[38] 46. The method of any one of items 32-37 and 39-45, further comprising displaying, by the device, an amount of the substance removed from the bowl during the medical procedure.
[39] 46. The method according to any one of items 32 to 38 and 40 to 45, wherein displaying the amount of the substance comprises displaying a volume of the substance.
[40] 46. The method of any one of items 32-39 and 41-45, further comprising engaging a button to switch from displaying the volume of the substance to displaying the weight of the substance.
[41] 46. The method of any one of items 32-40 and 42-45, wherein engaging with the first operable user input and engaging with the second operable user input include at least one of pressing a touchscreen display, pressing a button on a housing of the device, and activating a foot pedal on the device.
[42] 46. The method of any one of items 32-41 and 43-45, further comprising inserting a drape into the bowl.
[43] 46. The method of any one of items 32-42, 44, and 45, wherein inserting the drape includes positioning a machine-readable tag carried by the drape over a contactless reader of the device.
[44] 46. The method of any one of items 32 to 43 and 45, wherein the machine-readable tag comprises one of a radio frequency identification (RFID) tag and a near field communication (NFC) tag.
[45] 45. The method of any one of items 32 to 44, further comprising activating a height adjustment mechanism of the device, thereby adjusting the height of the bowl.
[46] 1. A system for heating a surgical fluid, the system comprising: a base mounted on the wheel; a bowl supported by and vertically above the base, the bowl configured to receive and hold a surgical fluid; a heater thermally coupled to the bowl and configured to increase a temperature of the surgical fluid within the bowl; a weighing device positioned to obtain weight information regarding the weight of the bowl and any contents therein; a user interface configured to receive a user instruction that a surgical fluid be added to the bowl; a controller configured to receive weight measurement information from the weight measuring device regarding a weight of the surgical fluid in the bowl during the course of a procedure, receive via the user interface at least one indication that surgical fluid is to be added to the bowl during the procedure, and determine a volume of surgical fluid removed from the bowl based on the received weight measurement information and the at least one received indication.
[47] The controller includes at least receiving a first indication via the user interface that the user intends to add the surgical fluid to the bowl; receiving weight measurement information from the weight measuring device following the first instruction received via the user interface regarding a weight of the surgical fluid placed in the bowl; receiving a second indication, either upon expiration of a timer or via the user interface, indicating that the user has finished adding the surgical fluid to the bowl; and determining a weight of the surgical fluid added to the surgical bowl between receiving the first instruction and receiving the second instruction; receiving weight measurement information from the weight measuring device at a measured time during the procedure and establishing from that information a weight of the surgical fluid in the bowl at the measured time; determining a difference between a weight of the surgical fluid added to the bowl and a weight of the surgical fluid at the measured time; 58. The system of any one of items 46 and 48-57, configured to determine a volume of the surgical fluid used during the procedure by: determining a volume of the surgical fluid removed based on the determined weight difference and density of the surgical fluid.
[48] The system of any one of items 46, 47, and 49-57, wherein the user input includes a first user input and further includes a second user input intervenible by a user to selectively add a medical tool to the bowl or remove the medical tool from the bowl.
[49] The system of any one of items 46-48 and 50-57, wherein the first user input and the second user input each include at least one of a contact area of a touch screen display, a button on a housing, and a foot pedal.
[50] The controller includes at least receiving weight measurement information from the weight measurement device regarding a weight of the bowl and any contents therein; receiving a first indication via the user interface that the user intends to add or remove a medical tool to or from the bowl; receiving a second indication via the user interface that the user has added or removed a medical tool from the bowl; and subsequent to receiving the second instruction, receiving weight measurement information from the weight measurement device regarding a weight of the bowl and any contents therein; and adjusting the weight measurement information received after receiving the second instruction to account for weight changes caused by adding or removing the medical tool from the bowl, thereby determining the volume of the surgical fluid used during the procedure.
[51] The system of any one of items 46-50 and 52-57, wherein the controller is further configured to determine a volume of the surgical fluid used during the procedure by at least determining a difference between an initial weight of the bowl with surgical fluid therein and the weight of the bowl with medical fluid therein at a measurement time, and determining a volume of the surgical fluid used based on the determined weight difference and a density of the surgical fluid stored in a memory associated with the controller.
[52] The system of any one of items 46-51 and 53-57, wherein the heater includes a film heater positioned in thermal communication with the bowl.
[53] The system of any one of items 46-52 and 54-57, further comprising a non-contact reader configured to read information contained on a machine-readable tag of the surgical drape.
[54] The system according to any one of items 46 to 53 and 55 to 57, wherein the contactless reader includes at least one of a radio frequency identification (RFID) reader or a near field communication (NFC) reader.
[55] 58. The system of any one of items 46-54, 56, and 57, further comprising a surgical drape positioned over and substantially conforming to the bowl, the surgical drape forming a sterile barrier separating a sterile field from a non-sterile field, the drape comprising one of an RFID tag and an NFC tag.
[56] 58. The system of any one of items 46-55 and 57, further comprising a height adjustment mechanism operable to adjust the height of the bowl relative to the base.
[57] 58. The system of any one of claims 46 to 57, wherein the user interface includes a first display mounted on one side of the bowl and further includes a second display mounted on an opposite side of the bowl.
Claims
1. 1. A system for thermally treating a surgical fluid, the system comprising: a basin configured to receive and hold a surgical fluid; a thermal treatment device thermally coupled to the bowl and configured to regulate a temperature of the surgical fluid within the bowl; a near field communication reader configured to read information contained in a near field communication tag of a surgical drape disposed within the bowl between the bowl and the surgical fluid; and a controller, the controller comprising: Controlling the near field communication reader to emit a signal to search for the near field communication tag of the surgical drape; Next, receiving identification information read from the near field communication tag of the surgical drape placed in the bowl via the near field communication reader; comparing the identification information read from the short-range wireless communication tag with authentication information stored in a memory; and The system is configured to inhibit operation of the thermal treatment device if the identification information does not match the authentication information.
2. The system of claim 1 , wherein the identification information includes identification information regarding thermal compatibility of the drape with respect to a temperature at which the bowl is controlled by the thermal treatment device.
3. The system of claim 1 , wherein the identification information includes information regarding a source of the drape.
4. The system of claim 3 , wherein the authentication information is in the form of a numeric code.
5. 2. The system of claim 1, wherein the controller is further configured to inhibit operation of the thermal treatment device if the near field communication reader does not detect the near field communication tag of the drape in response to emitting a signal to search for the near field communication tag.
6. The controller compares the identification information read from the short-range wireless communication tag with information identifying a drape that has already been used and that is stored in a memory; The system of claim 1 , configured to inhibit operation of the thermal treatment device if the comparison indicates that the drape has already been used.
7. 10. The system of claim 1, further comprising a weight measuring device positioned to obtain weight information regarding a volume of the surgical fluid in the bowl, the controller being configured to receive weight measurement information from the weight measuring device regarding a weight of the surgical fluid in the bowl during a procedure and to determine a volume of the surgical fluid removed from the bowl during the procedure.
8. The controller: receiving the weight measurement information of the drape based on the information read from the short-range wireless communication tag via the short-range wireless communication reader; adjusting the weight measurement information received from the weight measurement device to subtract from the measured weight a received weight of the drape based on information read from the near field communication; The system of claim 7 , configured to:
9. 10. The system of claim 1, further comprising the surgical drape disposed within the bowl, the surgical drape forming a sterile barrier separating a sterile field from a non-sterile field.
10. 2. The system of claim 1, further comprising a plurality of surgical drapes, each of the plurality of surgical drapes including a near field communication tag, and each of the plurality of surgical drapes being replaced with a new drape a threshold amount of time after detecting that the drape placed over the bowl has the near field communication tag.
11. The system of claim 1 , wherein the thermal treatment device comprises a heater.
12. a user interface configured to receive an instruction from a user to adjust a target temperature of the surgical fluid in the bowl; a temperature sensor configured to measure a temperature of the bowl and the surgical fluid therein; and The system of claim 1 further comprising:
13. The controller: receiving temperature measurement information from the temperature sensor; comparing the received temperature measurement information with a temperature profile stored in memory; and terminating operation of the thermal treatment device if the temperature of the bowl and surgical fluid therein exceeds a threshold amount from the temperature profile stored in the memory. The system of claim 12, further configured to:
14. The system of claim 1 , further comprising a housing that encloses a sidewall of the bowl, and the near field communication reader is on a periphery of the housing.
15. The system of claim 14 , wherein the drape includes a skirt, and the near field communication tag is positioned on the skirt.
Citation Information
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