Devices, systems, and methods facilitating fluid-assisted surgical procedures

The fluid management system addresses fluid level and temperature control issues in surgical systems, ensuring continuous and efficient fluid supply and temperature management during surgical procedures.

WO2025215599A1PCT designated stage Publication Date: 2025-10-16MEDTRONIC XOMED LLC
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Patent Information

Application Number
PCT/IB2025/053822
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-07-02
Filing Date
2025-04-11
Publication Date
2025-10-16

AI Technical Summary

Technical Problem

Existing surgical systems lack effective fluid management capabilities, particularly in monitoring and controlling fluid levels and temperatures during surgical procedures, which can lead to interruptions or inefficiencies.

Method used

A fluid management system with a console, cassette bay, and scale module that monitors fluid levels and temperature, providing notifications and adjusting system settings when fluid levels drop below thresholds, and includes a heater and agitator to manage fluid temperature and circulation.

Benefits of technology

Ensures reliable fluid supply and temperature control, preventing interruptions and enhancing surgical efficiency by maintaining optimal fluid conditions during procedures.

✦ Generated by Eureka AI based on patent content.

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Abstract

A fluid heater system for fluid-assisted surgery includes a fluid heater assembly having a housing, a heater disposed within the housing, at least one fluid line, and an input / output. The at least one fluid line includes an inflow line portion extending into the housing, an outflow line portion extending from the housing, and an internal line portion coupling the inflow line portion and the outflow line portion within the housing. The internal line portion is thermally coupled to the heater within the housing. The I / O is coupled to the housing and configured to connect the heater to a controller to control the heater to thereby control heating of fluid flowing through the internal line portion.
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Description

DEVICES, SYSTEMS, AND METHODS FACILITATING FLUID-ASSISTED SURGICAL PROCEDURESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent ApplicationNo. 63 / 632,834 filed on April 11, 2024, U.S. Provisional Patent Application No. 63 / 632,882 filed on April 11, 2024, and U.S. Provisional Patent Application No. 63 / 666,746 filed on July 2, 2024. The entire contents of each of these applications is hereby incorporated herein by reference.FIELD

[0002] The present disclosure relates to surgical devices, systems, and methods and, more specifically, to fluid-assisted surgical devices, systems, and methods.BACKGROUND

[0003] Fluid is utilized in conjunction with many powered surgical devices, systems, and methods to facilitate performing a surgical task such as, for example, enabling irrigation at a treatment site, aspiration at a treatment site, cleaning of a surgical device, washing of a treatment site, clearing a field of view, cooling a surgical device, etc. Some non-limiting examples of surgical devices that may benefit from the use of fluid include microdebriders, surgical drills, surgical saws, suction irrigators, tissue shavers, endoscopes, balloon or other catheters, energy devices, and the like.

[0004] Powered surgical systems typically include a console connected to a surgical device to power and control the surgical device. Such consoles may further connect to a fluid source and / or fluid collection canister and incorporate a pump to enable control of the flow of fluid to and / or from the surgical site.SUMMARY

[0005] The terms “about,” substantially,” and the like, as utilized herein, are meant to account for manufacturing, material, environmental, use, measurement, and / or other tolerances and variations, and in any event may encompass differences of up to plus or minus 10%. Further, to the extent consistent, any of the aspects detailed herein may be used in conjunction with any or all of the other aspects provided herein.

[0006] Provided in accordance with aspects of the present disclosure is a fluid management system including a console defining a cassette bay, a fluid management cassette, and a scale module. The fluid management cassette is configured for releasable engagement within the cassette bay and includes an input and an output. With the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the cassette, through the cassette, and out of the output of the cassette. The scale module includes a hook configured tosupport a fluid bag including a fluid line connected between the fluid bag and the input of the cassette to supply fluid to the input of the cassette. The scale module includes a scale configured to measure a weight of the fluid bag supported by the scale module and is configured to communicatively couple to the console. The console and / or the scale module are configured to monitor a remaining amount of fluid in the fluid bag based upon the weight of the fluid bag measured by the scale.

[0007] In an aspect of the present disclosure, at least one of the console or the scale module is configured to output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold. Alternatively or additionally, at least one of the console or the scale module is configured to change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below a threshold.

[0008] In an aspect of the present disclosure, the fluid management system further includes a pole assembly. The scale module, in such aspects, is configured to hang from the pole assembly to thereby hang the fluid bag from the pole assembly. The pole assembly may be attached to the console.

[0009] Another fluid management system provided in accordance with the present disclosure includes a console defining a cassette bay, a fluid management cassette, and a support base. The fluid management cassette is configured for releasable engagement within the cassette bay and includes an input and an output. With the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the cassette, through the cassette, and out of the output of the cassette. The support base defines a support surface configured to support a fluid bag including a fluid line connected between the fluid bag and the input of the cassette to supply fluid to the input of the cassette. The support base includes a scale configured to measure a weight of the fluid bag supported by the support surface. The support base is configured to communicatively couple to the console. At least one of the console or the support base is configured to monitor a remaining amount of fluid in the fluid bag based upon the weight of the fluid bag measured by the scale.

[0010] In an aspect of the present disclosure, the support base further includes a heater configured to heat fluid within the fluid bag. In such aspects, at least one of the console or the support base may be configured to control a temperature of fluid in the fluid bag by controlling the heater.

[0011] In an aspect of the present disclosure, the support base further includes at least one temperature sensor configured to provide feedback to facilitate control of the temperature of fluid in the fluid bag.

[0012] In an aspect of the present disclosure, the support base further includes at least one agitator configured to facilitate circulation of fluid within the fluid bag.

[0013] In an aspect of the present disclosure, at least one of the console or the support base is configured to output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold. Alternatively or additionally, at least one of the console or the support base is configured to change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below a threshold. The threshold(s), in aspects, may be determined based upon fluid bag information, system information, and / or procedure information. The threshold(s) may alternatively or additionally be user adjustable at the console.

[0014] Still another fluid management system provided in accordance with aspects of the present disclosure includes a console defining a cassette bay, a fluid management cassette, and a support base. The fluid management cassette is configured for releasable engagement within the cassette bay and includes an input and an output. With the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the cassette, through the cassette, and out of the output of the cassette. The support base defines a support surface configured to support a fluid bag including a fluid line connected between the fluid bag and the input of the cassette to supply fluid to the input of the cassette. The support base includes a heater configured to heat fluid within the fluid bag and at least one agitator configured to facilitate circulation of fluid within the fluid bag. The support base is configured to communicatively couple to the console. At least one of the console or the support base is configured to control a temperature of fluid in the fluid bag by controlling the heater.

[0015] In an aspect of the present disclosure, the console and / or the support base is further configured to control the at least one agitator to facilitate circulation of fluid within the fluid bag.

[0016] In an aspect of the present disclosure, the support base further includes at least one temperature sensor configured to provide feedback to facilitate control of the temperature of fluid in the fluid bag.

[0017] In an aspect of the present disclosure, the console and / or the support base is further configured to control the temperature of fluid in the fluid bag to a temperature set point. The temperature set point may be user adjustable at the console and / or determined based upon at least one of system information or procedure information.

[0018] In an aspect of the present disclosure, the support base further includes a scale configured to measure a weight of the fluid bag supported by the support surface. In such aspects, the console and / or the support base may be configured to monitor a remaining amount of fluid in the fluid bag based upon the weight of the fluid bag measured by the scale.

[0019] In an aspect of the present disclosure, the console and / or the support base is configured to at least one of: output a notification in response to determining that the remaining amount of fluidin the fluid bag is below a threshold; or change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below the threshold.

[0020] Yet another fluid management system provided in accordance with the present disclosure includes a console defining a cassette bay, a fluid management cassette, an input fluid line, an output fluid line, and a clamp body. The fluid management cassette is configured for releasable engagement within the cassette bay and includes an input and an output. With the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the cassette, through the cassette, and out of the output of the cassette. The input fluid line is connected between a fluid bag and the input of the cassette and the output fluid line is connected between an output of the cassette and a surgical device configured to supply fluid to a surgical site. The clamp body is configured for engagement about either of the input fluid line or the output fluid line and includes a heater configured to heat fluid within the input fluid line or the output fluid line. The clamp body is communicatively coupled to the console and the console is configured to control a temperature of fluid within the input fluid line or the output fluid line by controlling the heater.

[0021] In an aspect of the present disclosure, the clamp body further includes at least one temperature sensor configured to provide feedback to facilitate control of the temperature of fluid within the input fluid line or the output fluid line.

[0022] In an aspect of the present disclosure, the clamp body further includes at least one flow sensor configured to provide feedback to facilitate control of the temperature of fluid within the input fluid line or the output fluid line.

[0023] In an aspect of the present disclosure, the console is configured to control the temperature of fluid within the input fluid line or the output fluid line to a temperature set point. The temperature set point may be user adjustable at the console and / or determined based upon at least one of system information or procedure information.

[0024] In an aspect of the present disclosure, the clamp body further includes at least one flow sensor configured to enable the console to monitor a remaining amount of fluid in the fluid bag based upon feedback from the flow sensor. In such aspects, the console may be configured to output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold and / or change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below a threshold.

[0025] A fluid heater system for fluid-assisted surgery provided in accordance with the present disclosure includes a fluid heater assembly including a housing, a heater disposed within the housing, at least one fluid line, and an input / output (I / O). The at least one fluid line includes an inflow line portion extending into the housing, an outflow line portion extending from the housing, and an internal line portion coupling the inflow line portion and the outflow line portion within the housing.The internal line portion is thermally coupled to the heater within the housing. The I / O is coupled to the housing and configured to connect the heater to a controller to control the heater to thereby control heating of fluid flowing through the internal line portion.

[0026] In an aspect of the present disclosure, at least one of the inflow line portion or the outflow line portion includes a connector configured to releasably connect the fluid heater assembly along a fluid line.

[0027] In another aspect of the present disclosure, each of the inflow line portion and the outflow line portion includes a connector configured to releasably connect to a fluid line.

[0028] In still another aspect of the present disclosure, the fluid heater assembly is configured to connect along a fluid line disposed between a fluid source and a fluid management cassette. Alternatively or additionally, the fluid heater assembly is configured to connect along a fluid line disposed between a fluid management cassette and a surgical instrument configured to deliver fluid to a surgical site.

[0029] In yet another aspect of the present disclosure, the I / O includes a cable configured to connect to a console having the controller disposed therein. Alternatively or additionally, the I / O is a wireless interface configured to wirelessly connect to a console having the controller disposed therein.

[0030] In still yet another aspect of the present disclosure, the fluid heater assembly further includes at least one temperature sensor disposed within the housing and configured to measure a temperature of fluid within the internal line portion.

[0031] In another aspect of the present disclosure, the fluid heater system further includes a console including the controller. The console may include a user interface. The console may be configured to connect to a fluid management console or may be a fluid management console configured to receive a cassette for pumping fluid through the cassette.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Various aspects and features of the present disclosure are described hereinbelow with reference to the drawings wherein:

[0033] FIG. 1 is a perspective view of a surgical system provided in accordance with aspects of the present disclosure including a surgical device, a console, and a fluid management cassette operably coupling the surgical device and console with one another, wherein the surgical system is shown further including a fluid source and a fluid collection canister;

[0034] FIG. 2 is an enlarged, side view of the area of detail indicated as “2” in FIG. 1;

[0035] FIG. 3 A is a perspective view of a fluid support and scale assembly provided in accordance with the present disclosure shown connected to the console of the surgical system of FIG. 1 in a first configuration;

[0036] FIG. 3B is a perspective view of the fluid support and scale assembly of FIG. 3A shown connected to the console of the surgical system of FIG. 1 in a second configuration;

[0037] FIG. 3C is a perspective view of the fluid support and scale assembly of FIG. 3A shown connected to the console of the surgical system of FIG. 1 in a third configuration;

[0038] FIG. 4 is an enlarged, schematic illustration of a scale module of the fluid support and scale assembly of FIG. 3 A;

[0039] FIG. 5 is a flow diagram of a method provided in accordance with the present disclosure;

[0040] FIG. 6 is a side view of a fluid scale and heater assembly in accordance with the present disclosure shown connected to the console of the surgical system of FIG. 1;

[0041] FIG. 7 is a side view of the fluid scale and heater assembly of FIG. 6;

[0042] FIG. 8 A is a top view of a heater of the fluid scale and heater assembly of FIG. 6;

[0043] FIG. 8B is a top view of an agitator assembly of the fluid scale and heater assembly ofFIG. 6;

[0044] FIG. 9 is a perspective view of a fluid heater assembly in accordance with the present disclosure shown connected to the console of the surgical system of FIG. 1;

[0045] FIGS. 10A and 10B are transverse, cross-sectional views of a clamp body of the fluid heater assembly of FIG. 9 disposed in open and closed conditions, respectively;

[0046] FIG. 11 A is a transverse, cross-sectional view of a portion of the clamp body of the fluid heater assembly of FIG. 9 illustrating a heater thereof;

[0047] FIG. 1 IB is a transverse, cross-sectional view of a portion of the clamp body of the fluid heater assembly of FIG. 9 illustrating first and second sensors thereof;

[0048] FIG. 12 is a front view of a fluid heater system in accordance with the present disclosure shown connected to the console of the surgical system of FIG. 1; and

[0049] FIG. 13 is a front view of a fluid heater assembly of the fluid heater system of FIG. 12 coupled along a connected group of fluid lines;

[0050] FIG. 14 is a front view of the fluid heater system of FIG. 12 connected to the console of the surgical system of FIG. 1 in another manner; and

[0051] FIG. 15 is front view of another fluid heater assembly in accordance with the present disclosure shown connected to the console of the surgical system of FIG. 1.DETAILED DESCRIPTION

[0052] Referring to FIG. 1, a surgical system 10 provided in accordance with the present disclosure generally includes: a console 100; one or more surgical devices 200 configured to be powered, controlled, energized, supplied fluid, and / or supplied vacuum by console 100; one or more fluid management cassettes 300 each operably coupling console 100 with one of the surgical devices 200; one or more fluid sources 400; and / or one or more fluid collection canisters 500. Although plural surgical devices 200, fluid management cassettes 300, fluid sources 400, and / or fluid collection canisters 500 are contemplated, surgical system 10 is described below with reference to only one of each of these features for the purposes of brevity and understanding. Likewise, although console 100 may include plural identical or similar features to accommodate, for example, the plurality of surgical devices 200, fluid management cassettes 300, fluid sources 400, and / or fluid collection canisters 500, each of these features is described in the singular hereinbelow for the purposes of brevity and understanding.

[0053] Console 100 includes: a housing 110; a power button 120; a graphical user interface (GUI) 130 (such as, for example, a touch screen GUI); one or more ports 140; and a plurality of cassette bays 170 each configured to releasably receive a fluid management cassette 300. Console 100 further includes, contained within housing 110, one or more central processing units (CPU’s) and / or microcontroller units (MCU’s), power generating and control hardware, pump hardware, surgical energy generating and control hardware, and / or any other suitable hardware and corresponding firmware / software stored thereon for operating and controlling operation of surgical devices 200, fluid management cassettes 300, and / or other components connected thereto.

[0054] The one or more ports 140 of control console 100 may include, for example, one or more: power ports for powering and controlling connected powered surgical device(s) e.g., surgical device 200; energy ports for providing surgical energy, e.g., monopolar, bipolar, microwave, ultrasonic, thermal, light, and / or other surgical energy, to connected energy device(s); accessory ports for powering and / or communicating with one or more auxiliary devices such as a foot switch, remote controller, surgical display, navigation system, sensor, etc.; and / or any other suitable ports.

[0055] Continuing with reference to FIG. 1, surgical device 200, as noted above, may be powered, controlled, energized, supplied fluid, and / or supplied vacuum by console 100. Surgical device 200 may be configured as, for example and without limitation, one or more of a microdebrider, surgical bur, surgical drill, surgical saw, suction irrigator, tissue shaver, endoscope, sheath for an endoscope (e.g., a lens cleaning sheath), balloon or other catheter, energy device, fluid cooled device, etc.

[0056] In aspects, surgical device 200 includes a handpiece 210 and an end effector 220 releasably engagable with handpiece 210. More specifically, with respect to surgical tissue removal devices, e.g., mi crodeb riders, surgical burs, surgical drills, tissue shavers, etc., handpiece 210 mayinclude a motor 214 disposed therein and a drive rotor 216 coupled to motor 214 and configured to drive a movable (e.g., rotational, reciprocating, oscillating, or combinations thereof) component of end effector 220 to remove tissue from a surgical site. As shown in FIG. 2, for example, end effector 220 may include an outer shaft 222 and an inner shaft 224 configured to be driven by motor 214 via drive rotor 216 to move relative to outer shaft 222 to cut tissue. Further, vacuum may be applied through outer shaft 222 and / or inner shaft 224 to remove the cut tissue (along with fluid and debris) from the surgical site through outer shaft 222 and / or inner shaft 224 and to deposit the cut tissue, fluid, and debris within fluid collection canister 500. Surgical device 200 may also include a power cord 250 configured to connect surgical device 200 to console 100 to power and control motor 214, thereby controlling operation of end effector 220.

[0057] End effector 220 may additionally or alternatively include a sheath 228 disposed about (in fixed or removable fashion) outer shaft 222 and configured to deliver fluid to the surgical site. In such aspects, a proximal hub 230 disposed at the proximal end of sheath 228 may include a port 232 to connect to an inflow fluid line 234 (e.g., tube) to enable fluid to be pumped through sheath 228 and into the surgical site. Alternatively or additionally, port 232 may enable connection of a vacuum line such that sheath 228 may be used for withdrawing fluid from the surgical site. Other suitable configurations of surgical device 200 for treating tissue and / or of fluid supply / removal associated with surgical device 200 are also contemplated.

[0058] Referring back to FIG. 1, fluid source 400, e.g., a fluid bag (sometimes referred to as an IV bag), is fluidly coupled to one or more fluid flow paths defined within fluid management cassette 300, e.g., via a fluid line 402 (e.g., tube) connected to one of the one or more inflow ports 310 of fluid management cassette 300. Fluid management cassette 300 further includes one or more outflow ports 320 to enable a fluid line 234 to connect the outflow of fluid management cassette 300 to port 232 of proximal hub 230 of end effector 220 of surgical device 200 to enable the supply of fluid to (or withdrawal of fluid from) sheath 228. Fluid management cassette 300, when releasably received within a cassette bay 170 of console 100, cooperates with console 100 to define a fluid pump to enable the pumping of fluid from fluid source 400 to end effector 220 of surgical device 200 and / or to enable the pumping of fluid from the surgical site, e.g., at end effector 220 of surgical device 200, to fluid collection canister 500.

[0059] Fluid collection canister 500, in aspects where provided, is fluidly coupled to an outflow port 270 of surgical device 200 via a fluid line 272 and, in aspects, is further coupled to a vacuum source to facilitate the withdrawal of fluid (and tissue, debris, etc.) from the surgical site, through surgical device 200, and to fluid collection canister 500.

[0060] Continuing with reference to FIG. 1, fluid management cassette 300, as noted above, cooperates with console 100 to define a fluid pump when fluid management cassette 300 is releasablyreceived within a cassette bay 170 of console 100. For example, fluid management cassette 300 may include internal tubing that is selectively pinched closed via actuators disposed within console 100 and / or through which fluid is urged via pump drivees disposed within console 100, although other suitable pump configurations are also contemplated. Fluid management cassette 300 may include one or more independently controllable fluid lines defined therein to enable the independent control of fluid flow, e.g., pumping of fluid and / or pinching fluid lines, from one or more inputs 310 to a plurality of outputs 320. Thus, multiple independent fluid functions may be performed from fluid management cassette 300 and, in aspects, from a single fluid source 400, e.g., a fluid bag. In aspects, one or more of the inputs 310 and / or one or more of the outputs 320 of fluid management cassette 300 may be releasable connections or fixed connections. For example, in aspects, an end of fluid line 402 may be fixedly connected to one of the inputs 310 of fluid management cassette 300. The other end of fluid line 402 may be configured to releasable engage fluid source 400. However, in other aspects, fluid line 402 may be releasably connectable to one of the inputs 310 of fluid management cassette 300.

[0061] Fluid management cassette 300 may further be configured to establish one or more contact-based and / or wireless electrical connections with console 100 when fluid management cassette 300 is releasably received within a cassette bay 170 of console 100 to thereby enable data communication therebetween. This data communication may enable, for example, console 100 to identify fluid management cassette 300 (e g., by unique ID, device type, lot number, manufacture date, etc.); to determine or retrieve configuration data, features, components, and / or settings associated with fluid management cassette 300 to facilitate configuring console 100 for use therewith; to authenticate fluid management cassette 300 (e.g., to prevent counterfeit or unverified fluid management cassettes 300 from being used); and to read / write use information to / from fluid management cassette 300 (e.g., a use count, that the cassette has been used, etc.).

[0062] The data communication between console 100 and fluid management cassette 300 additionally or alternatively enables feedback signals, e.g., based upon sensor data such as, for example, a flow rate sensor, pressure sensor, temperature sensor, etc. associated with fluid management cassette 300, and / or control signals, e.g., based upon user inputs received at a user interface of fluid management cassette 300 or a connected surgical device 200, to be communicated to console 100 such that console 100, in turn, can power and / or control surgical device 200 and / or the corresponding pump based thereon. In aspects where fluid management cassette 300 includes one or more flow sensors, feedback signals from the flow sensor(s) can be communicated to console 100 to enable determination of whether there is a blockage or other error, e.g., in a situation where no fluid flow or insufficient fluid flow is detected despite the pump being active or where, despite fluid flow not being active, fluid flow is detected, thus indicating a defective valve or valve actuator.

[0063] In aspects, fluid management cassette 300 may serve as an intermediary to establish data communication between another device connected to fluid management cassette 300 and console 100. That is, rather than electrically connecting directly to console 100, a surgical instrument, auxiliary device, etc., may electrically connect to fluid management cassette 300 which, in turn, electrical connects to console 100, thus enabling data communication between the device and console 100 via fluid management cassette 300.

[0064] Turning to FIGS. 3A-3C, a fluid support and scale assembly 1300 provided in accordance with the present disclosure is shown configured for use with surgical system 10. Fluid support and scale assembly 1300 includes a support pole assembly 1310 and a scale module 1320. Support pole assembly 1310 may be configured to mount to console 100 (as shown) or may be separate from console 100. In either configuration, support pole assembly 1310 includes one or more vertical supports 1312, 1314, a horizontal support 1316, and one or more attachment hooks 1318. The one or more vertical supports 1312, 1314 may include, for example, first and second telescoping vertical supports 1312, 1314 configured to enable selective height adjustment of horizontal support 1316 relative to console 100. A locking mechanism (not shown), e g., a set screw or clamp, may be provided to enable selective locking of vertical supports 1312, 1314 to maintain horizontal support 1316 at a desired height. Horizontal support 1316 of support pole assembly 1310 supports one or more attachment hooks 1318 that, in turn, are configured to support one or more fluid sources 400, e.g., fluid bags. Although one configuration of a support pole assembly 1310 is detailed and illustrated herein, other suitable support pole assemblies are also contemplated. Further, the term “hook,” as utilized herein, is not limited to any particular shape or configuration but, rather, broadly refers to any suitable structure capable of suspending or supporting one or more fluid sources 400, e.g., fluid bags.

[0065] With additional reference to FIGS. 4A and 4B, scale module 1320 of fluid support and scale assembly 1300 includes a housing 1322, a hanger 1324 supported by housing 1322, and a hook 1326 depending from housing 1322. Hanger 1324 is configured to engage one or more attachment hooks 1318 of support pole assembly 1310 to suspend scale module 1320 from horizontal support 1316 of support pole assembly 1310. Housing 1322 houses the internal working component of scale module 1320, as detailed below. Hook 1326 is configured to support one or more fluid sources 400. For example, hook 1326 may be fed through an eyelet of one or more fluid bags to thereby hang the one or more fluid bags from hook 1326.

[0066] Hook 1326 of scale module 1320 extends into housing 1322 wherein hook 1326 is coupled to a scale 1328 configured to measure a weight supported by hook 1326. Thus, with one or more fluid bags hanging from hook 1326, scale 1328 is able to measure the weight of the one or more fluid bags.

[0067] Scale module 1320 further includes a microcontroller 1330 including a processor 1332 and memory 1334 storing instructions to be executed by the processor 1332. Additionally, a user interface device 1336 such as, for example, a speaker, LED, display screen, etc. is disposed on or within housing 1322 and coupled to microcontroller 1330 for providing visual, audible, and / or other feedback to a user. An input / output (I / O) 1338 is also disposed within housing 1322 and coupled to microcontroller 1330 to enable power and / or data communication between scale module 1320 and another device such as, for example, fluid management cassette 300 (FIG. 1) and / or console 100 (FIGS. 3A-3C). As detailed below, I / O 1338 may be connected or connectable to a cable 1342 configured to connect scale module 1320 to fluid management cassette 300 to thereby enable power and / or data communication between scale module 1320 and console 100 when fluid management cassette 300 is engaged within a cassette bay 170 of console 100 (FIG. 3A); I / O 1338 may be connected or connectable to a cable 1344 configured to connect scale module 1320 to a port 140 of console 100 (FIG. 3B) to thereby enable power and / or data communication between scale module 1320 and console 100; and / or I / O 1338 may be configured to wirelessly connect scale module 1320 to console 100 (FIG. 3C) to thereby enable data communication between scale module 1320 and console 100. In aspects where scale module 1320 is configured to wirelessly connect to console 100 (see, e.g., FIG. 3C), or in any other aspects, scale module 1320 may further include a power source 1346, e.g., one or more batteries, configured to power scale module 1320. The power source 1346 may be rechargeable or replaceable.

[0068] Referring to FIGS. 3A and 4, as noted above, I / O 1338 of scale module 1320 may be connected or connectable to cable 1342 that, in turn, is configured to be connected to fluid management cassette 300 such that, when fluid management cassette 300 is engaged within a cassette bay 170 of console 100, power and / or data communication between scale module 1320 and console 100 via fluid management cassette 300 is enabled. More specifically, cable 1342 may be bundled with, e.g., disposed within the same outer sheath, bonded to, clipped to, or otherwise attached to fluid line 402 along a portion of the length thereof. This configuration facilitates establishing the necessary fluid and electrical connections such as, for example, fluidly connecting fluid line 402 between fluid source 400 and fluid management cassette 300, and electrically connecting cable 1342 between scale module 1320 and an electrical port of fluid management cassette 300.

[0069] With reference to FIGS. 3B and 4, as noted above, I / O 1338 of scale module 1320 may be connected or connectable to cable 1344 that, in turn, is configured to connect to a port 140 of console 100 to enable power and / or data communication between scale module 1320 and console 100.

[0070] As shown in FIG. 3C, and as also noted above, I / O 1338 may be configured to wirelessly connect scale module 1320 to console 100 to thereby enable wireless data communication betweenscale module 1320 and console 100. The wireless connection may be direct, e.g., via Bluetooth®, or may be indirect such as, for example, by connecting both scale module 1320 and console 100 to WiFi®. As also noted above, scale module 1320 may include a power source 1346, e g., one or more batteries, configured to power scale module 1320, e.g., when not powered by console 100. Alternatively, scale module 1320 may include a mains power plug configured to connect to a mains power supply to power scale module 1320.

[0071] Referring to FIG. 5, in conjunction with FIGS. 3A-4, use of fluid support and scale assembly 1300 is detailed. Initially, as indicated at S 1510, fluid source information is obtained. Fluid source information may include, with respect to a fluid bag, for example: a type of the fluid bag (e.g., model number, manufacturer, etc.); a size of the fluid bag (e.g., absolute dimensions or a manufacturer’s size such as small, medium, or large); a tare weight of the fluid bag (e.g., a weight without fluid); a fluid capacity of the fluid bag (e.g., in volume or weight units); a type of fluid contained within the fluid bag (e.g., saline, sterile water, glycine, mannitol, sorbitol, etc.); etc. The fluid source information may also include, for example, an amount of fluid left in the fluid bag, e.g., an absolute value (in volume or weight units) or a percentage of fluid remaining compared to a capacity of the fluid bag. This fluid source information may be input into console 100 via GUI 130 or may be obtained in any other suitable manner such as, for example, from a separate input device (e.g., a computer, tablet, smartphone, etc.) connected to console 100 or fluid support and scale assembly 1300, via scanning a barcode or QR code associated with the fluid source, by scanning an RFID chip associated with the fluid source, based on other settings (e g., where a particular location, user, or procedure defaults to a particular fluid bag), or in any other suitable manner. Further, the fluid source information may be received directly or may be determined from other fluid source information. For example, where the model number of the fluid bag is input, the size of the fluid bag, tare weight of the fluid bag, and / or fluid capacity of the fluid bag may be determined from the model number, e.g., by accessing one or more lookup tables storing such fluid bag information by model number.

[0072] Continuing with reference to FIG. 5, in conjunction with FIGS. 3A-4, at SI 520, system and / or procedure information may be obtained. System information may include, for example, the type(s) of surgical instrument(s) connected to console 100 and / or fluid management cassette 300, the number of fluid inputs and / or outputs, etc. Procedure information may include, for example, the surgical procedure to be performed, surgeon information, patient information, etc. The system and / or procedure information may be input into console 100 via GUI 130, may be detected by console 100, and / or may be obtained in any other suitable manner such as those detailed above. In other aspects, SI 520 may be omitted.

[0073] At S1530, applicable notification and / or action thresholds are set. The thresholds may be set by the user, e.g., input into console 100 via GUI 130, and / or may be set based upon the fluid source information obtained at S 1510 and / or the system and / or procedure information obtained at SI 520, if so provided. In particular, the user may initiate a manual tare via console 100 and / or the fluid source information may indicate or facilitate determination of a tare weight. Further, the fluid source information may indicate or facilitate determination of the amount of fluid in the fluid source 400. The system and / or procedure information, in aspects where provided, may indicate or facilitate determination of the amount of fluid likely to be utilized and / or a likely rate of fluid utilization. Some or all of this information may be utilized to determine appropriate thresholds for providing notifications to the user and / or for initiating an action. For example, the fluid source information enables determination of the amount of fluid in the fluid source such that appropriate thresholds, e.g., at 20% fluid remaining, 10% fluid remaining, and / or 5% fluid remaining, can be set. The system and / or procedure information may be utilized to refine these thresholds. For example, where instruments are used that utilize relatively less fluid, a surgical procedure is performed that requires relatively less fluid, and / or the user (e.g., surgeon) is a user that utilizes relatively less fluid, the thresholds may be set closer to empty as there may be less risk of fluid running out (and / or since such fluid may run out more slowly). On the other hand, the thresholds may be set at higher fluid levels where instruments are used that utilize relatively more fluid, a surgical procedure is performed that requires relatively more fluid, and / or where the user tends to utilize relatively more fluid, since there may be a greater risk of fluid running out (and / or since such fluid may run out more quickly). As another example, where fluid is more important for instrument operation, surgical function, and / or patient safety, the thresholds may be set at higher fluid levels to help ensure that fluid does not run out, whereas, where fluid is utilized but less critical, thresholds may be set closer to empty as running out of fluid would not be catastrophic. In aspects, console 100 and / or scape module 1320 may implement machine learning algorithms trained on historical data to enable determination of the applicable thresholds based upon the above-noted variables. Further, such machine learning algorithms may continuously be updated to learn fluid utilized for different users, procedures, and / or instruments, thus enabling further tuning of the applicable thresholds.

[0074] Once the thresholds are set, and during use, as indicated at SI 540, scale 1328 is utilized to periodically or continuously measure the weight of the one or more fluid bags 400 hanging from scale module 1320. If the weight (or converted volume) does not meet a first threshold (“NO” at SI 540), scale 1328 continues to periodically or continuously measure the weight of the one or more fluid bags 400 hanging from scale module 1320. If the weight (or converted volume) is less than the first threshold (“YES” at SI 540), the method proceeds to SI 550, wherein a first notification is output. The first notification may be an audio tone, illuminated light, verbal and / or text outputprovided on or from console 100, or any other suitable notification. In aspects, the first notification indicates a remaining amount of fluid (in relative or absolute terms) or a remaining amount of operating time (given the current fluid level and rate of fluid usage).

[0075] As indicated at S1560, after the first notification, scale 1328 is further utilized to periodically or continuously measure the weight of the one or more fluid bags 400 hanging from scale module 1320 If the weight (or converted volume) does not meet a second threshold (“NO” at SI 560), scale 1328 continues to periodically or continuously measure the weight of the one or more fluid bags 400 hanging from scale module 1320. If the weight (or converted volume) is less than the second threshold (“YES” at SI 560), the method proceeds to SI 570, wherein a second notification is output. The second notification may be an audio tone, illuminated light, verbal and / or text notification provided on or from console 100, or any other suitable notification. In aspects, the second notification indicates a remaining amount of fluid (in relative or absolute terms) or a remaining amount of operating time (given the current fluid level and rate of fluid usage). In aspects, the second notification is distinguishable from the first notification such as, for example, increasing in volume (for an audio notification), brightness, and / or blinking frequency (for an illuminated light notification), by different text and / or color backgrounds, and / or otherwise emphasizing that the second notification is more urgent than the first notification. Although two iterations of thresholds and notifications are detailed, it is contemplated that greater or fewer than two be provided.

[0076] Continuing to S1580, after the second notification, scale 1328 is utilized to periodically or continuously measure the weight of the one or more fluid bags 400 hanging from scale module 1320. If the weight (or converted volume) does not meet a third threshold (“NO” at SI 580), scale 1328 continues to periodically or continuously measure the weight of the one or more fluid bags 400 hanging from scale module 1320. If the weight (or converted volume) is less than the third threshold (“YES” at S1580), the method proceeds to S1590, wherein action is taken such as changing system settings. Changing system settings may include, for example, disabling or limiting output of a pump utilizing fluid from the fluid source 400, disabling or limiting use of a surgical device utilizing fluid from the fluid source 400, and / or disabling or limiting use of a surgical device that relies on fluid from the fluid source 400 for safe and / or reliable operation. Limiting output may include, for example, defining a maximum fluid flow rate, defining a maximum operational speed, defining a maximum operational temperature, etc. Once the fluid bag 400 is replaced or refilled, the method returns to S1510 or, in aspects may returns to SI 540 using the same thresholds as previously determined.

[0077] In addition to the above, scale module 1320 enables leak detection, e.g., where it is determined that fluid levels in fluid bag 400 are decreasing but the associated instruments and / orpumps are not in use or, in the other hand, blockage detection, e.g., where it is determined that fluid levels in fluid bag 400 are stagnant despite use of the associated instruments and / or pumps.

[0078] The above method and / or other functionality associated with scale module 1320 may be performed by microcontroller 1330 of scale module 1320, a CPU and / or MCU of console 100, or may be shared between scale module 1320 and console 100. Likewise, the notification outputs may be provided by hardware associated with scale module 1320 and / or console 100.

[0079] Turning to FIGS. 6-1 IB, it has been found that warming surgical fluid prior to introduction into a surgical site helps control bleeding during surgical procedures. In accordance with aspects of the present disclosure, systems and methods for warming surgical fluid prior to introduction into a surgical site are provided, wherein the surgical fluid is warmed, for example, to from about 40°C to about 60°C or, in aspects, from about 45°C to about 55°C. Other temperature ranges are also contemplated. Further, the particular temperature or temperature range, whether within or outside the above-noted ranges, may depend upon the surgical instruments utilized, the procedure to be performed, and / or other factors.

[0080] Referring to FIGS. 6-8B, a fluid scale and heater assembly provided in accordance with the present disclosure is shown generally identified by reference numeral 1600. Fluid scale and heater assembly 1600 includes a base 1610 and one or more cables 1620. Base 1610 defines a support surface 1612 configured to receive and support a fluid source 400, e.g., fluid bag. In aspects, support surface 1612 is recessed, concave, bordered, textured, and / or otherwise configured to facilitate retention of a fluid source 400 thereon. Base 1610 also includes a scale 1614, a heater 1616 and, in aspects, one or more agitators 1618.

[0081] Base 1610 further includes a microcontroller 1630 including a processor 1632 and memory 1634 storing instructions to be executed by the processor 1632. Additionally, a user interface device 1636 such as, for example, a speaker, LED, display screen, etc. is disposed on or within base 1610 and coupled to microcontroller 1630 for providing visual, audible, and / or other feedback to a user. An input / output (I / O) 1638 is also disposed within base 1610 and coupled to microcontroller 1630 to enable power and / or data communication between base 1610 and another device such as, for example, fluid management cassette 300 and / or console 100. Although scale 1614, heater 1616, agitators 1618, and microcontroller 1630 are illustrated as separate layers stacked on one another, other suitable configurations are also contemplated.

[0082] Scale 1614 is configured to weigh the fluid source 400 supported on support surface 1612 and, thus, fluid scale and heater assembly 1600 may cooperate with console 100 to provide any of the fluid monitoring functionality detailed above with respect to fluid support and scale assembly 1300 and / or the method of FIG. 5.

[0083] Heater 1616 may be configured as a flexible heater circuit 1617 (FIG. 8B) or any other suitable heater. Heater 1616 is configured to generate thermal energy to heat fluid within the fluid source 400 supported on support surface 1612. Heater 1616 may be controllable to a temperature set point and / or may be controlled to achieve a suitable temperature via selective switching heater 1616 ON and OFF. In aspects, heater 1616 includes two or more heating zones to enable independent localized control of heating of two or more areas of heater 1616.

[0084] In aspects, base 1610 further includes one or more temperature sensors 1613 configured to sense a temperature at or near support surface 1612 and from which the temperature of fluid within the fluid source 400 can be determined. Alternatively, one or more temperature sensors along fluid line 402, within fluid management cassette 300, and / or along fluid line 234 (FIG. 1) may be provided. Regardless of the location and / or configuration of the temperature sensor(s), temperature feedback may be utilized to control heater 1616 to achieve a desired temperature of fluid within the fluid source 400. In aspects, heater 1616 may be controlled to heat fluid within the fluid source 400 to and / or maintain the fluid at a temperature set point, e g., within the above-noted range. In aspects, the temperature set point is user input, user adjustable, and / or determined based upon other information such as, for example, system information and / or procedure information, e.g., that may indicate a fluid temperature suitable based upon the procedure information and / or system information.

[0085] The one or more agitators 1618 may include, for example, vibration elements (e.g., piezoelectric transducers), cam rollers, pistons, etc. configured to produce suitable agitation energy (e.g., vibration energy or other suitable mechanical energy) to facilitate mixing fluid within the fluid source 400. In this manner, while fluid closer to support surface 1612 may initially be heated faster and / or to a greater temperature compared to fluid farther from support surface 1612, the agitation energy imparted to the fluid source 400 by the one or more agitators 1618 circulates the fluid therein to thermally homogenize the fluid within fluid source 400. Temperature feedback from the abovenoted temperature sensor(s) may be utilized to detect temperature fluctuations and, based thereon, activate the one or more agitators 1618 to facilitate thermal homogenization of the fluid within the fluid source 400. Alternatively or additionally, any other suitable activation duration, pattern, etc. of the one or more agitators 1618 may be provided.

[0086] The one or more cables 1620 of fluid scale and heater assembly 1600 enable connection of fluid scale and heater assembly 1600 to console 100 and / or a mains power supply. More specifically, fluid scale and heater assembly 1600 may include a cable 1620 configured to connect to a port 140 of console 100 to enable data communication between fluid scale and heater assembly 1600. More specifically, information may be input or received at console 100 and communicated to fluid scale and heater assembly 1600 via cable 1620 and / or weight measurements obtained by fluidscale and heater assembly 1600 may be communicated to console 100 via cable 1620. Further, temperature set points, temperature feedback data (e.g., from one or more temperature sensors), etc. may be communicated between console 100 and fluid scale and heater assembly 1600 via cable 1620. As an alternative to connection of cable 1620 to a port 140 of console 100, the above-detailed data communication may be accomplished wirelessly, similarly as detailed above (see FIG. 3C).

[0087] In aspects, as noted above, fluid scale and heater assembly 1600 may include a cable 1620 configured to connect to a mains power supply. More specifically, as the power requirements for fluid scale and heater assembly 1600 and, in particular, of heater 161 thereof, may be beyond that capable of being provided through a port 140 of console 100, cable 1620 may connect fluid scale and heater assembly 1600 to a mains power supply to enable powering fluid scale and heater assembly 1600 separately from console 100, while data communication is provided by a data connection to console 100 (e g., via another cable 1620 or wirelessly).

[0088] Continuing with reference to FIG. 6, in use, a temperature of fluid to be delivered to the surgical site may be set on GUI 130 or console 100 and / or may be determined based upon system information and / or procedure information, similarly as detailed above. Based on the temperature set point, and temperature sensor feedback, heater 1616 and / or agitators 1618 of fluid scale and heater assembly 1600 are controlled to achieve and maintain the temperature of the fluid within fluid source 400 at the set point or within a suitable range of the set point.

[0089] The above functionality associated with fluid scale and heater assembly 1600 may be performed by microcontroller 1630 of fluid scale and heater assembly 1600, a CPU and / or MCU of console 100, or may be shared therebetween. Likewise, notification outputs may be provided by hardware associated with fluid scale and heater assembly 1600 and / or console 100.

[0090] Turning to FIGS. 9-1 IB, a fluid heater assembly 1900 provided in accordance with the present disclosure includes a clamp body 1910 and one or more cables 1920. Clamp body 1910 defines a generally elongate tubular configuration and includes first and second substantially C- shaped clamp arms 1912, 1914 connected to one another by a hinge 1916 to enable clamp arms 1912, 1914 to pivot between a closed configuration (FIG. 10A), wherein arms 1912, 1914 cooperate to substantially enclose an internal cavity 1915 defining a substantially cylindrical configuration, and an open configuration (FIG. 10B) wherein arms 1912, 1914 are open to provides access to internal cavity 1915. In aspects, complementary lock features 1917, 1918, e.g., mechanical latch components, magnets, etc., disposed on arms 1912, 1914 enable releasably locking of arms 1912, 1914 in the closed configuration (FIG. 10A).

[0091] Clamp body 1910 is configured for engagement about a fluid line, e.g., fluid line 234. However, although clamp body 1910 is shown engaged about fluid line 234 downstream from fluid management cassette 300, it is also contemplated that clamp body 1910 be disposed upstream fromfluid management cassette 300 such as, for example, engaged about fluid line 402. Clamp body 1910 further includes a heater 1930 disposed on or within either or both arms 1912, 1914 and, in aspects, one or more sensors 1942, 1944 disposed on or within either or both arms 1912, 1914. Heater 1930 may be configured as a flexible heater circuit 1932 (FIG. 11 A) or any other suitable heater. Heater 1930 is configured to generate thermal energy to heat fluid flowing through fluid line 234. Heater 1930 may be controllable to a temperature set point and / or may be controlled to achieve a suitable temperature via selective switching heater 1930 ON and OFF. In aspects, heater 1930 includes two or more heating zones to enable independent localized control of heating of two or more areas of heater 1930.

[0092] The one or more sensors 1942, 1944 of clamp body 1910 may include one or more temperature sensors 1942 configured to sense a temperature of fluid line 234 such that the temperature of fluid flowing through fluid line 234 can be determined. Temperature feedback from temperature sensors 1942 may be utilized to control heater 1930 to achieve a desired temperature of fluid flowing through fluid line 234. The one or more sensors 1942, 1944 may additionally or alternatively include one or more flow sensors 1944 configured to sense a flow rate of fluid through fluid line 234. Feedback from flow sensor(s) 1944 may be utilized in conjunction with feedback from temperature sensors 1942 to achieve a desired temperature of fluid flowing through fluid line 234. That is, a greater flow rate may require heating heater 1930 to higher temperatures as the fluid to be heated spends less time passing through clamp body 1910. On the other hand, heater 1930 may not need to be heated to as high of a temperature when a lower flow rate is detected as the fluid to be heated spends more time passing through clamp body 1910. Flow sensor(s) 1944 may also be utilized for leak and / or blockage detection, similarly as detailed above.

[0093] Flow sensor(s) 1944 may additionally or alternatively be utilized to provide fluid flow feedback that is utilized in conjunction with fluid source information (as detailed above) to monitor a remaining amount of fluid in fluid source 400. That is, rather than weighing fluid source 400, flow sensor(s) 1944 of clamp body 1910 of fluid heater assembly 1900 enables determination of an amount of fluid exiting fluid source 400, e.g., flowing to the surgical site, thus, enables determination (in conjunction with fluid source information) of the remaining amount of fluid in fluid source 400. The methods and / or functionality detailed above with respect to fluid support and scale assembly 1300 (FIGS. 3A-4) and the method of FIG. 5 may thus apply equally to fluid heater assembly 1900, wherein the methods and / or other functionality associated with fluid heater assembly 1900 may be performed by a CPU and / or MCU of console 100, or in any other suitable manner. Notification outputs may be provided by hardware associated with fluid heater assembly 1900 and / or console 100.

[0094] The one or more cables 1920 of fluid heater assembly 1900 enable connection of fluid heater assembly 1900 to console 100 and / or a mains power supply, and may be employed in any of the manners detailed above with respect to fluid scale and heater assembly 1600 (FIG. 6).

[0095] Turning to FIG. 12, a fluid heater system 2000 provided in accordance with the present disclosure includes a fluid heater assembly 2010 configured for operably coupling along a fluid line, e.g., fluid line 234, and a fluid heater console 2060 configured to control fluid heater assembly 2010 and / or communicate with a fluid management console, e.g., console 100.

[0096] Fluid heater assembly 2010 includes a housing 2012, an inflow line portion 2014a extending into housing 2012, an outflow line portion 2014b extending from housing 2012, an internal line portion 2014c connecting inflow and outflow line portions 2014a, 2014b, respectively, with one another within housing 2014, and a heater 2016 disposed within housing 2012 and thermally coupled to internal line portion 2014c. In aspects, line portions 2014a, 2014b, 2014c are portions of a single tube or other fluid-conveying device, although multiple different tubes, reservoirs, or other suitable fluid-carrying lines, and / or combinations thereof are also contemplated for defining line portions 2014a, 2014b, 2014c.

[0097] Further, in aspects, inflow and outflow line portions 2014a, 2014b may include fluid connectors 2015a, 2015b, e.g., male and / or female luer connectors, to enable fluid coupling of fluid heater assembly 2010 along fluid line 234, e.g., between upstream and downstream portions of fluid line 234, which may also include complementary connectors 2017a, 2017b, respectively, e.g., female and / or male luer connectors. Alternatively, inflow and / or outflow line portions 2014a, 2014b may be integral with the upstream and downstream portions of fluid line 234, respectively, such that fluid heater assembly 2010 is integral with fluid line 234. In these and other aspects, fluid line 234 may be integral with fluid management cassette 300 or may be removably connected thereto.

[0098] With momentary reference to FIG. 13, in aspects where multiple fluid lines 234, e.g., fluid lines 234a, 234b, 234c, are connected to one another (e.g., within a common outer sheath, having connected or shared outer walls, etc.) along portions of the lengths thereof, e.g., along at least a portion of the lengths from the one or more fluid management cassettes 300 (FIG. 12) to the one or more surgical devices, one of the fluid lines 234a may be separated from the other fluid lines 234b, 234c, for a portion of the lengths thereof to enable connection (releasable or integral connection) of the fluid line 234a to fluid heater assembly 2010 to enable fluid within fluid line 234a to be heated. In such aspects, the fluid lines 234a, 234b, 234c are connected with one another upstream and / or downstream of fluid heater assembly 2010 to facilitate fluid line management and establishing connections to and between the one or more fluid management cassettes 300 (FIG. 12) and the one or more surgical devices.

[0099] Referring again to FIG. 12, heater 2016 may be configured as a flexible heater circuit (see FIG. 8B), other resistive electrical heater, or any other suitable heater. Regardless of the particular configuration of heater 2016, heater 2016 is configured to generate thermal energy to heat fluid flowing through internal line portion 2014c.

[0100] Fluid heater console 2060 may be supported by a pole assembly 2080, as shown and as similarly as detailed above with respect to FIGS. 3A-3C, may be supported on console 100, similarly as detailed above with respect to FIG. 6, or may be supported in any other suitable manner. Fluid heater console 2060, as noted above, is configured to control fluid heater assembly 2010. More specifically, fluid heater console 2060 may include a user interface (UI) 2062 having, for example, one or more display screens 2064 for displaying information to a user and one or more input devices such as, for example, where display screen 2064 includes touch-screen functionality, one or more buttons 2066, dials, control knobs, etc., to receive input from a user. Fluid heater console 2060 may be connected to fluid heater assembly 2010 via a cable 2068 or via wireless communication. Regardless of the manner of communication, fluid heater console 2060 is configured to variably control heater 2016 of fluid heater assembly 2010 such that the fluid flowing through fluid heater assembly 2010 is capable of being controlled to a temperature set point and / or to selectively switch heater 2016 ON and OFF such that the fluid flowing through fluid heater assembly 2010 is capable of being controlled to a temperature set point. The temperature set point may be input by the user via UI 2062 of console 2060. Alternatively, fluid heater console 2060 may communicate with fluid management console 100 and / or fluid management cassette 300 to receive temperature set point information and / or information from which a temperature set point can be determined, e.g., by accessing a look-up table or running an algorithm to determine the temperature set point based on a type of procedure to be performed, a type of instrument connected, surgeon preference, etc. In addition or as an alternative to a temperature set point, a temperature profile may be implemented wherein fluid heater assembly 2010 is controlled such that the fluid flowing through fluid heater assembly 2010 is heated in accordance with the temperature profile which may include different times, durations, and / or temperatures of heating. Further, in aspects, fluid heater console 2060 communicates with fluid management console 100 to control heating based upon activation of a connected instrument s) such as, for example, by activating heating when one or more instruments is in use and / or deactivating heating when one or more instruments is not in use, or vice versa.

[0101] In order to facilitate feedback-based temperature control, fluid heater assembly 2010 may include one or more temperature sensors such as, for example, an upstream temperature sensor 2022 disposed upstream of heater 2016 and / or a downstream temperature sensor 2024 disposed downstream of heater 2016. A flow rate sensor(s) is also contemplated in addition to or in replacement of either or both temperature sensors 2022, 2024 such that the flow rate of fluid throughfluid heater assembly 2010 may be utilized as part of the feedback-based temperature control, e.g., as the heating requirements vary depending upon the amount of time the fluid to be heated is in thermal communication with the heater 2016 Reverse feedback may also be provided from fluid heater console 2060 to fluid management console 100 to vary the pump speed and, thus, flow rate of fluid through fluid heater assembly 2010 to thereby enable control of the temperature of fluid by flow control in addition or as an alternative to heater control.

[0102] As detailed above, fluid heater console 2060 is configured, in aspects, to communicate with a fluid management console, e.g., console 100, to facilitate control of heater 2016. For example, fluid heater console 2060 may include a cable 2072 having a plug 2074 configured to connect to a port 140 of console 100 to thereby enable power and / or data communication between fluid heater console 2060 and console 100, although wireless communication is also contemplated. Control of heater 2016 may additionally or alternatively be performed similarly as detailed above with reference to FIGS. 9-1 IB. In aspects, fluid heater console 2060 is configured to control heater 2016 to heat fluid, e.g., saline, at least about 15, 20, 25, or 30 degrees C, e.g., from about 20 degrees C to about 35, 40, 45, or 50 degrees C, at flow rate through fluid heater assembly 2010 of at least about 80, 90, 100, or 110 ml / min. As such, fluid can be sufficiently heated for particular purposes, e.g., bleeding control. Of course, different heating temperature and / or flow rates are also contemplated for other purposes, as are varied temperature and / or flow rate profiles.

[0103] With reference to FIG. 14, in conjunction with FIG. 12, in aspects, rather than fluid heater assembly 2010 coupled downstream of fluid management cassette 300 between fluid management cassette 300 and the surgical device configured to deliver fluid to the surgical site (see FIG. 12), it is also contemplated that fluid heater assembly 2010 be coupled upstream of fluid management cassette 300 such as, for example, between the fluid source 400 and fluid management cassette 300.

[0104] Turning to FIG. 15, rather than fluid heater system 2000 having a separate console 2060 (FIG. 12) connected to fluid management console 100, as detailed above with reference to FIG. 12, the features and functionality of console 2060 (FIG. 12) may be incorporated into fluid management console 100. In such aspects, as shown in FIG. 15, fluid heater assembly 2010 includes a cable 2092 having a plug 2094 configured to connect to a port 140 of console 100 to thereby enable power and / or data communication between fluid heater assembly 2010 and console 100, although wireless communication is also contemplated, e.g., wherein a wireless interface replaces cable 2092 as the input / output (VO). More specifically, in wireless configurations, fluid heater assembly 2010 may include a one or more batteries (not shown) disposed within or mounted on housing 2012 and configured to power the heater of fluid heater assembly 2010. The batteries, in such configurations, may be integral, removable, rechargeable, and / or replaceable. In aspects, the batteries may be disposable along with fluid heater assembly 2010, e g., in single use configurations. It is alsocontemplated that fluid heater assembly 2010 be configured for repeated use, e.g., capable of withstanding autoclave sterilization or other suitable sterilization and / or cleaning in preparation for reuse, and, in such aspects, the batteries may remain aseptic to avoid the need for sterilization, may be removed and separately cleaned and / or sterilized, may be removed and replaced, and / or may be integrally sealed within fluid heater assembly 2010 for sterilization and / or cleaning therewith. Battery powered and / or wireless communication configurations are also contemplated in aspects where a separate console 2060 (FIG. 12) is provided.

[0105] Aspects of this disclosure may be further described by reference to the following numbered paragraphs:

[0106] 1. A fluid management system, comprising: a console defining a cassette bay; a fluid management cassette configured for releasable engagement within the cassette bay, wherein the fluid management cassette includes an input and an output and wherein, with the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the fluid management cassette, through the fluid management cassette, and out of the output of the fluid management cassette; and a scale module including a hook configured to support a fluid bag including a fluid line connected between the fluid bag and the input of the fluid management cassette to supply fluid to the input of the fluid management cassette, the scale module including a scale configured to measure a weight of the fluid bag supported by the scale module, wherein the scale module is configured to communicatively couple to the console, and wherein at least one of the console or the scale module is configured to monitor a remaining amount of fluid in the fluid bag based upon the weight of the fluid bag measured by the scale.

[0107] 2. The fluid management system according to 1, further comprising a cable connected to the scale module and configured to connect to a port of the console to communicatively couple the scale module to the console.

[0108] 3. The fluid management system according to 1, further comprising a cable connected to the scale module and configured to connect to the fluid management cassette to communicatively couple the scale module to the console via the fluid management cassette.

[0109] 4. The fluid management system according to 1, wherein the scale module is configured to wirelessly communicatively couple to the console.

[0110] 5. The fluid management system according to any of 1-4, wherein at least one of the console or the scale module is configured to at least one of: output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold; or change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below the threshold.

[0111] 6. The fluid management system according to 5, wherein the threshold is determined based upon fluid bag information.

[0112] 7. The fluid management system according to 5 or 6, wherein the threshold is determined based upon at least one of system information or procedure information.

[0113] 8. The fluid management system according to any of 5-7, wherein the threshold is user adjustable at the console.

[0114] 9. The fluid management system according to any of 1-8, further comprising a pole assembly, wherein the scale module is configured to hang from the pole assembly to thereby hang the fluid bag from the pole assembly

[0115] 10. The fluid management system according to 9, wherein the pole assembly is attached to the console.

[0116] 11. A fluid management system, comprising: a console defining a cassette bay; a fluid management cassette configured for releasable engagement within the cassette bay, wherein the fluid management cassette includes an input and an output and wherein, with the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the fluid management cassette, through the fluid management cassette, and out of the output of the fluid management cassette; and a support base defining a support surface configured to support a fluid bag including a fluid line connected between the fluid bag and the input of the fluid management cassette to supply fluid to the input of the fluid management cassette, the support base including a scale configured to measure a weight of the fluid bag supported by the support surface, wherein the support base is configured to communicatively couple to the console, and wherein at least one of the console or the support base is configured to monitor a remaining amount of fluid in the fluid bag based upon the weight of the fluid bag measured by the scale.

[0117] 12. The fluid management system according to 11, further comprising one of: a cable connected to the support base and configured to connect to a port of the console to communicatively couple the support base to the console; or a cable connected to the support base and configured to connect to the fluid management cassette to communicatively couple the support base to the console via the fluid management cassette.

[0118] 13. The fluid management system according to 11 or 12, wherein the support base further includes a heater configured to heat fluid within the fluid bag.

[0119] 14. The fluid management system according to 13, wherein at least one of the console or the support base is configured to control a temperature of fluid in the fluid bag by controlling the heater.

[0120] 15. The fluid management system according to 14, wherein the support base further includes at least one temperature sensor configured to provide feedback to facilitate control of the temperature of fluid in the fluid bag.

[0121] 16. The fluid management system according to any of 13-15, wherein the support base further includes at least one agitator configured to facilitate circulation of fluid within the fluid bag.

[0122] 17. The fluid management system according to any of 11-16, wherein at least one of the console or the support base is configured to at least one of: output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold; or change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below the threshold.

[0123] 18. The fluid management system according to 17, wherein the threshold is determined based upon fluid bag information.

[0124] 19. The fluid management system according to 17 or 18, wherein the threshold is determined based upon at least one of system information or procedure information.

[0125] 20. The fluid management system according to any of 17-19, wherein the threshold is user adjustable at the console.

[0126] 21. A fluid management system, comprising: a console defining a cassette bay; a fluid management cassette configured for releasable engagement within the cassette bay, wherein the fluid management cassette includes an input and an output and wherein, with the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the fluid management cassette, through the fluid management cassette, and out of the output of the fluid management cassette; and a support base defining a support surface configured to support a fluid bag including a fluid line connected between the fluid bag and the input of the fluid management cassette to supply fluid to the input of the fluid management cassette, the support base including a heater configured to heat fluid within the fluid bag and at least one agitator configured to facilitate circulation of fluid within the fluid bag, wherein the support base is configured to communicatively couple to the console, and wherein at least one of the console or the support base is configured to control a temperature of fluid in the fluid bag by controlling the heater.

[0127] 22. The fluid management system according to 21, further comprising one of: a cable connected to the support base and configured to connect to a port of the console to communicatively couple the support base to the console; or a cable connected to the support base and configured to connect to the fluid management cassette to communicatively couple the support base to the console via the fluid management cassette.

[0128] 23. The fluid management system according to 22, further comprising a cable connected to the support base and configured to connect to a mains power supply.

[0129] 24. The fluid management system according to any of 21-23, wherein the at least one of the console or the support base is further configured to control the at least one agitator to facilitate circulation of fluid within the fluid bag.

[0130] 25. The fluid management system according to any of 21-24, wherein the support base further includes at least one temperature sensor configured to provide feedback to facilitate control of the temperature of fluid in the fluid bag.

[0131] 26. The fluid management system according to any of 21-25, wherein the at least one of the console or the support base is configured to control the temperature of fluid in the fluid bag to a temperature set point.

[0132] 27. The fluid management system according to 26, wherein the temperature set point is user adjustable at the console.

[0133] 28. The fluid management system according to 26, wherein the temperature set point is determined based upon at least one of system information or procedure information.

[0134] 29. The fluid management system according to any of 21-28, wherein the support base further includes a scale configured to measure a weight of the fluid bag supported by the support surface, and wherein at least one of the console or the support base is configured to monitor a remaining amount of fluid in the fluid bag based upon the weight of the fluid bag measured by the scale.

[0135] 30. The fluid management system according to 29, wherein at least one of the console or the support base is configured to at least one of: output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold; or change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below the threshold.

[0136] 31. A fluid management system, comprising: a console defining a cassette bay; a fluid management cassette configured for releasable engagement within the cassette bay, wherein the fluid management cassette includes an input and an output and wherein, with the fluid management cassette engaged within the cassette bay of the console, the console is configured to pump fluid from the input of the fluid management cassette, through the fluid management cassette, and out of the output of the fluid management cassette; an input fluid line connected between a fluid bag and the input of the fluid management cassette; an output fluid line connected between an output of the fluid management cassette and a surgical device configured to supply fluid to a surgical site; and a clamp body configured for engagement about either of the input fluid line or the output fluid line, the clamp body including a heater configured to heat fluid within the input fluid line or the output fluid line, wherein the clamp body is configured to communicatively couple to the console, and wherein the console is configured to control a temperature of fluid within the input fluid line or the output fluid line by controlling the heater.

[0137] 32. The fluid management system according to 31, further comprising one of: a cable connected to the clamp body and configured to connect to a port of the console to communicatively couple the clamp body to the console; or a cable connected to the clamp body and configured to connect to the fluid management cassette to communicatively couple the clamp body to the console via the fluid management cassette.

[0138] 33. The fluid management system according to 32, further comprising a cable connected to the clamp body and configured to connect to a mains power supply.

[0139] 34. The fluid management system according to any of 31-33, wherein the clamp body further includes at least one temperature sensor configured to provide feedback to facilitate control of the temperature of fluid within the input fluid line or the output fluid line.

[0140] 35. The fluid management system according to any of 31-34, wherein the clamp body further includes at least one flow sensor configured to provide feedback to facilitate control of the temperature of fluid within the input fluid line or the output fluid line.

[0141] 36. The fluid management system according to any of 31-35, wherein the console is configured to control the temperature of fluid within the input fluid line or the output fluid line to a temperature set point.

[0142] 37. The fluid management system according to 36, wherein the temperature set point is user adjustable at the console.

[0143] 38. The fluid management system according to 36 or 37, wherein the temperature set point is determined based upon at least one of system information or procedure information.

[0144] 39. The fluid management system according to any of 31-38, wherein the clamp body further includes at least one flow sensor, and wherein the console is configured to monitor a remaining amount of fluid in the fluid bag based upon feedback from the flow sensor.

[0145] 40. The fluid management system according to 39, wherein the console is configured to at least one of: output a notification in response to determining that the remaining amount of fluid in the fluid bag is below a threshold; or change a system setting in response to determining that the remaining amount of fluid in the fluid bag is below the threshold.

[0146] 41. A fluid heater system for fluid-assisted surgery, comprising: a fluid heater assembly, including: a housing; a heater disposed within the housing; at least one fluid line, including: an inflow line portion extending into the housing; an outflow line portion extending from the housing; and an internal line portion coupling the inflow line portion and the outflow line portion within the housing, the internal line portion thermally coupled to the heater within the housing; and an I / O coupled to the housing and configured to connect the heater to a controller to control the heater to thereby control heating of fluid flowing through the internal line portion.

[0147] 42. The fluid heater system according to 41, wherein at least one of the inflow line portion or the outflow line portion includes a connector configured to releasably connect the fluid heater assembly along a fluid line

[0148] 43. The fluid heater system according to 42, wherein each of the inflow line portion and the outflow line portion includes a connector configured to releasably connect to a fluid line.

[0149] 44. The fluid heater system according to 42, wherein the fluid heater assembly is configured to connect along a fluid line disposed between a fluid source and a fluid management cassette.

[0150] 45. The fluid heater system according to 42, wherein the fluid heater assembly is configured to connect along a fluid line disposed between a fluid management cassette and a surgical instrument configured to deliver fluid to a surgical site.

[0151] 46. The fluid heater system according to 41, wherein the I / O includes a cable configured to connect to a console having the controller disposed therein.

[0152] 47. The fluid heater system according to 41, wherein the I / O is a wireless interface configured to wirelessly connect to a console having the controller disposed therein.

[0153] 48. The fluid heater system according to 41, wherein the fluid heater assembly further includes at least one temperature sensor disposed within the housing and configured to measure a temperature of fluid within the internal line portion.

[0154] 49. The fluid heater system according to 41, further comprising: a console including the controller, wherein the console includes a user interface and is configured to connect to a fluid management console.

[0155] 50. The fluid heater system according to 41, further comprising: a console including the controller, wherein the console is a fluid management console configured to receive a cassette for pumping fluid through the cassette.

[0156] 51. A method of fluid-assisted surgery, comprising: activating a fluid management console to pump fluid along a fluid path from a fluid source to a surgical site to control bleeding at the surgical site, wherein a fluid heater assembly is disposed along the fluid path between the fluid source and the surgical site; and controlling heating of a heater of the fluid heater assembly to heat the fluid pumped into the surgical site.

[0157] 52. The method according to 51, wherein controlling the heater includes heating the fluid by at least 15 degrees.

[0158] 53. The method according to 52, wherein activating the fluid management console to pump the fluid includes pumping the fluid at a rate of at least 90 ml / min.

[0159] 54. The method according to 51, wherein controlling the heater includes heating the fluid by at least 25 degrees.

[0160] 55. The method according to 54, wherein activating the fluid management console to pump the fluid includes pumping the fluid at a rate of at least 100 ml / min.

[0161] 56. The method according to 51, wherein controlling heating of the heater is performed by a controller disposed within the fluid management console.

[0162] 57. The method according to 51, wherein controlling heating of the heater is performed by a second console coupled to the fluid heater assembly.

[0163] 58. The method according to 57, wherein the heating of the heater is controlled at least in part based on communication between the second console and the fluid management console.

[0164] 59. The method according to 51, wherein the fluid heater assembly is disposed between the fluid source and the fluid management console.

[0165] 60. The method according to 51, wherein the fluid heater assembly is disposed between the fluid management console and the surgical site.

[0166] It will be understood that various modifications may be made to the aspects and features disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various aspects and features. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended thereto.

Claims

WHAT IS CLAIMED IS:

1. A fluid heater system for fluid-assisted surgery, comprising: a fluid heater assembly, including: a housing; a heater disposed within the housing; at least one fluid line, including: an inflow line portion extending into the housing; an outflow line portion extending from the housing; and an internal line portion coupling the inflow line portion and the outflow line portion within the housing, the internal line portion thermally coupled to the heater within the housing; and an input / output (I / O) coupled to the housing and configured to connect the heater to a controller to control the heater to thereby control heating of fluid flowing through the internal line portion.

2. The fluid heater system according to claim 1, wherein at least one of the inflow line portion or the outflow line portion includes a connector configured to releasably connect the fluid heater assembly along a fluid line.

3. The fluid heater system according to claim 2, wherein each of the inflow line portion and the outflow line portion includes a connector configured to releasably connect to a fluid line.

4. The fluid heater system according to claim 2 or 3, wherein the fluid heater assembly is configured to connect along a fluid line disposed between a fluid source and a fluid management cassette.

5. The fluid heater system according to claim 2 or 3, wherein the fluid heater assembly is configured to connect along a fluid line disposed between a fluid management cassette and a surgical instrument configured to deliver fluid to a surgical site.

6. The fluid heater system according to any one of claims 1-5, wherein the I / O includes a cable configured to connect to a console having the controller disposed therein.

7. The fluid heater system according to any one of claims 1-5, wherein the I / O is a wireless interface configured to wirelessly connect to a console having the controller disposed therein.

8. The fluid heater system according to any one of claims 1-7, wherein the fluid heater assembly further includes at least one temperature sensor disposed within the housing and configured to measure a temperature of fluid within the internal line portion.

9. The fluid heater system according to any one of claims 1-8, further comprising: a console including the controller, wherein the console includes a user interface and is configured to connect to a fluid management console.

10. The fluid heater system according to any one of claims 1-8, further comprising: a console including the controller, wherein the console is a fluid management console configured to receive a cassette for pumping fluid through the cassette.

11. The fluid heater system according to any one of claims 1-10, further comprising at least one bypass fluid line coupled to the at least one fluid line at least one of upstream or downstream of the housing, the bypass fluid line bypassing the housing such that fluid flowing through the bypass fluid line is not heated.

12. The fluid heater system according to any one of claims 1-11, wherein the controller is configured to heat the fluid flowing through the internal line portion based upon information regarding a type of procedure to be performed.

13. The fluid heater system according to any one of claims 1-12, wherein the controller is configured to heat the fluid flowing through the internal line portion in accordance with a temperature profile.

14. The fluid heater system according any one of claims 1-13, wherein the controller is configured to heat the fluid at least about 15 degrees C at flow rate through the internal fluid line of at least about 80 ml / min.

15. The fluid heater system according any one of claims 1-14, wherein the fluid heater assembly further includes at least one flow sensor disposed within the housing and configured to measure a flow of fluid within the internal line portion, and wherein the controller is configured to control the heating of the fluid flowing through the internal line portion in accordance with the measured flow of fluid within the internal line portion.

Citation Information

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