System and method for managing surgical sponges

Abstract

A system and method for managing surgical sponges. A distributor assembly coupled to a main support includes an internal or first storage location for removably receiving a carton of sponge sorters and an external or second storage location for removably supporting a carton of surgical draping. At least one arm can be supported on the housing, the at least one arm can be movable between an undeployed position and a deployed position. The arm can include a weighing means for measuring a weight of a surgical sponge disposed in the sponge sorter supported by the arm. The arm can be a cantilever beam, and a beam-type load cell can be disposed in a channel of the beam. A processor can determine a fluid weight based on the measured weight and the dry weight correlated to said surgical sponges counted out as detected by a data reader. The processor can estimate blood loss and display on a display.

Description

Technical Field

[0001] Claim of Priority This application claims the priority and all benefits of U.S. Provisional Patent Application No. 63 / 154,147, filed on February 26, 2021, the entire content of which is incorporated herein by reference.

Background Art

[0002] Managing surgical sponges is a prevalent and important area in modern operating rooms, and it is of utmost importance to ensure that surgical sponges (or other objects) are not inadvertently left inside a patient's body or otherwise forgotten. Surgical sponges are an example of such surgical articles, and thus healthcare providers (HCPs) must follow procedures for accounting for every surgical sponge used during a surgery, from the perspective of the obvious problems associated with surgical articles being inadvertently left inside a patient's body.

[0003] In the past, HCP relied on the manual sorting and counting of surgical sponges. Manual sorting and counting of sponges requires handling and exposure to contaminated sponges and is prone to human error. To facilitate the manual sorting and counting of surgical sponges, a known device can provide a stand from which a sponge classifier is detachably suspended. One such stand and sponge classifier is disclosed in U.S. Patent No. 6,607,170 issued on 19 August 2003, which is incorporated herein by reference as a whole, and from which a wire basket is positioned on a stand having conventional hooks for supporting a sponge classifier having a pouch or pocket for receiving one of the surgical sponges each. For several reasons, a sponge classifier may be instructed to be replaced, for example, when all of the pockets of the sponge classifier are used but there are uncounted sponges remaining. Another example involves replacing the sponge classifier during a surgical procedure. In such cases, it is inconvenient for the HCP to leave an adjacent area to store spare sponge classifiers that are not currently in use, or, alternatively, it is inefficient to consume valuable table space within the adjacent area to more conveniently position unused items in a readily usable state.

[0004] More recently, surgical sponge management systems have utilized electronic devices to assist in counting surgical sponges. One such system is disclosed in U.S. Patent Application Publication No. 2013 / 0088354, published on April 11, 2013, which is incorporated herein by reference in whole, and in which a radio frequency identification (RFID) reader detects RFID tags on surgical sponges. Electronically-based devices are typically not sterilizable (e.g., autoclaved) and are therefore instructed to cover the RFID reader with surgical draping. Changing surgical draping between surgical procedures, for example, is inconvenient in this case as well, as it requires the HCP to stock spare unused surgical draping or, alternatively, consume table space.

[0005] Furthermore, an increasingly important area of ​​development is the estimation or quantification of blood loss. Determining blood loss during surgery can be used to monitor patient health by detecting excessive blood loss that indicates surgical complications. Particular attention is paid to delivery, where earlier detection of obstetric hemorrhage can significantly reduce maternal morbidity. While it is known to estimate blood loss during surgery by visual inspection of surgical sponges and other fluid-absorbing materials (e.g., surgical gowns, bedding, or drapes), this is inherently subjective and therefore prone to human error. It is also known to estimate blood loss during surgery by weighing surgical sponges in bulk on a scale. In cases where the user interface can provide a selection of the type of surgical sponge to be weighed, the fluid weight of the surgical sponge can be calculated based on the stored dry weight, which can then be converted into an estimated blood loss. While weighing surgical sponges is more accurate than visual inspection, it poses a significant obstacle to the operating room workflow. In particular, users must transport surgical sponges to a scale for weighing before transporting them to the surgical sponge management system for checkout or countout, and vice versa.

[0006] Therefore, there is a need in the art to provide an improved surgical sponge management system that overcomes one or more of the aforementioned drawbacks. [Overview of the project]

[0007] A system for managing surgical sponges and a method for estimating blood loss by the surgical sponge management system are provided. The system disclosed herein can be modified to manage fluid-absorbing articles other than surgical sponges, and / or items such as surgical devices and other disposable or reusable instruments or objects. The surgical sponge management system includes a stand, an electronic subsystem, and a distributor assembly. The stand may include a main support coupled to a base and extending upward from the base. The main support may be at least partially hollow to accommodate power and / or data cables. The electronic subsystem includes a module base, a display, and a data reader. The module base may include a processor, memory, communication devices, and / or other hardware. The electronic subsystem may be coupled to the main support between a handle and a distributor assembly. The data reader is configured to detect tags associated with surgical sponges.

[0008] The distributor assembly is mounted on a main support, and the distributor assembly can be positioned on a stand. The distributor assembly provides storage and ergonomic distribution of sponge classifiers from cartons and surgical drapings from cartons. The housing of the distributor assembly may include an upper shell coupled to a lower shell. The lower shell may include a lower side wall extending upward from the lower wall. The lower wall may be inclined downward from the rear to the front. The distributor assembly includes at least one mounting bracket for coupling an arm to the housing. The arm can be positioned in an undeployed position within a recess defined by the flange wall and the lower side wall. The arm can extend rearward from the mounting bracket, pivotably coupled to the mounting bracket so as to be movable from the undeployed position to the deployed position, and in the deployed position, the arm extends outward beyond the side wall of the housing. A classifier coupler coupled to the arm is configured to support a sponge classifier.

[0009] The upper shell includes a front wall, a top wall, and an upper side wall that define an internal or first storage area. With the upper side wall of the upper shell fixed to the lower side wall of the lower shell, the first storage area is formed between the front wall, the top wall, and the side wall. The first storage area is sized to receive cartons of sponge classifiers. The housing defines a rear opening communicating with the first storage area and a front opening communicating with the first storage area. The carton distribution opening is accessible through the front opening. An external or second storage area provides storage and ergonomic distribution of surgical drapings. The second storage area can generally be defined by a recess in the top wall of the upper shell. The upper shell may include a first retaining shape and a second retaining shape that at least partially form the second storage area. The first and second retaining shapes may be frames that extend widthwise across the housing and are spaced apart from each other to prevent the carton from moving forward and backward. The second storage area may be further formed by the third and fourth retaining shapes. The third and fourth retaining shapes may be frames that extend depthwise along the upper side walls and are spaced apart from each other to prevent the carton from moving laterally. The third or fourth retaining shape may define a slot aligned with the dispenser opening of the surgical draping carton.

[0010] The arm may include metering means such as load cells, particularly bending beam type load cells. The arm may be cantilevered by a main support. The arm may further include a beam and a loading bar. The beam is coupled to the housing of a distributor assembly, and the classifier coupler is coupled to the loading bar. The load cell couples the loading bar to the beam. A first portion or end of the load cell may be fixed to the beam, and a second portion or end of the load cell may be fixed to the loading bar. The beam may define a channel, and the load cell may be placed within the channel. Alternatively, the load cell may be coupled to the underside of the beam. The arm may include a load limiting plate fixed to a mounting block. A gap adjustment screw may be screw-coupled to the load limiting plate. The gap adjustment screw can be selectively adjusted to a desired position. A set screw may be provided to fix the gap adjustment screw in the desired position. The metering means communicates with a processor. Alternatively, the metering means can communicate wirelessly with a remote processor, and thus processing steps can be performed remotely. The weighing device is configured to sense the measured weight of an object supported by an arm.

[0011] An exemplary method for estimating blood loss may include counting in surgical sponges by having a data reader detect a tag. The tag contains identification data, and the processor is configured to determine the type of surgical sponge from the identification data. The type of surgical sponge is associated with its dry weight stored in memory. Based on the data reader's detection of the tag, the processor can index a counter for the number of surgical sponges to be used during the surgical procedure. The counter can be displayed on a display. The tags on the surgical sponges are, in this case as well, positioned to be detected by the data reader to identify the surgical sponges as those that have been counted out to no longer be used during the surgical procedure. The processor can index the counter and display the counter on a display. The weighing means can automatically detect or sense changes in the measured weight. The processor is configured to determine the fluid weight of the fluid absorbed by the surgical sponges based on the measured weight and dry weight of the surgical sponges identified by the data reader as those that have been counted out. Subtracting the dry weight from the measured weight equals the fluid weight for the counted-out surgical sponges. The state and fluid weight of each surgical sponge can be logged and stored in memory for later investigation and input. The processor estimates the blood loss associated with the surgical sponge based on the fluid weight. The processor transmits the data to be displayed on the display. Another exemplary method involves the use of two or more types of surgical sponges in a surgical procedure.

[0012] This method may include weighing the tare weight to compensate for the tare weight of the sponge classifier. The weighing means may sense that the tare weight is equal to or less than a predetermined size. In addition or alternatively, the user may provide input to a display to weigh the tare of the weighing means with the sponge classifier supported by the arm. The processor determines the fluid weight of the surgical sponge based on the measured weight and the calculated difference between the dry weight and the tare weight.

[0013] This method may include determining whether a change in measured weight correlates with the counting out of the surgical sponge. If the change in measured weight does not correlate with the counting out of the surgical sponge, a warning may be provided on the display. The processor may identify whether pre- or post-tag detection has occurred. Additionally or alternatively, the processor may compare the measured duration with the maximum duration between the detection of the surgical sponge tag and the change in measured weight. Additionally or alternatively, the processor may compare the change in measured weight with a preset maximum sponge weight that indicates a blood-saturated sponge. Finally, the processor may compare the change in measured weight with a preset minimum sponge weight. If the change in measured weight falls below the preset minimum, the processor cannot correlate the change in measured weight for blood loss estimation. If the processor correlates the change in measured weight with the counting out of the surgical sponge, the processor may proceed with the steps of determining the fluid weight of the surgical sponge based on the measured weight and dry weight, estimating the blood loss associated with the surgical sponge based on the fluid weight, and facilitating the display of the estimated blood loss.

[0014] A graphical user interface (GUI) can be displayed on the screen. The screen can be a touchscreen display that provides a user interface for user input. The GUI can include various tiles and information. Tiles can display the net fluid volume of fluid collected during a surgical procedure that has not been absorbed by a surgical sponge or other fluid absorbent material. Tiles can display the number of counting bags (e.g., sponge classifiers) and the date and time of recording. Tiles can display data associated with the fitted surgical sponge, and counters can be displayed in a list field.

[0015] Based on the total weight sensed by the weighing device and the tare weight of the counting bag, the fluid weight of the suitable surgical sponge is determined and displayed within the tile. The estimated blood loss can be calculated or recalculated and displayed within the tile. For fluid absorbent items other than the suitable surgical sponge, a separate tile can be provided. In cases where the processor determines that the change in measured weight does not correlate with the countout of suitable surgical sponges, the tile can be modified so that it can be selected by the user to identify the fluid absorbent item from the item list field. The GUI can provide a summary field along with a breakdown of the type and amount of fluid represented for the net fluid volume, weighed item volume, and estimated blood loss, respectively. The GUI can also provide an option to exclude surgical sponges that are determined to absorb almost entirely non-blood fluid or only non-blood fluid. Surgical sponges can be detected by the data reader, or an exclusion sponge field can be implemented to list surgical sponges that can be selected to be excluded.

[0016] Accordingly, according to a first aspect of the present disclosure, a system for managing surgical sponges includes a main support extending from a base and a distributor assembly supported on the main support. The distributor assembly includes a housing, the housing includes a first storage area located inside the housing and configured to removably receive cartons of sponge classifiers, and a second storage area located outside the housing and configured to removably support cartons of surgical drapings. The housing of the distributor assembly includes an upper wall forming the second storage area. The first and second retaining shapes are spaced apart from each other to define the second storage area. The third and fourth retaining shapes are spaced apart from each other to further define the second storage area. The third or fourth retaining shape may define a slot. The upper shell may include a front wall defining a front opening communicating with the first storage area. The lower wall may be inclined downward toward the front wall.

[0017] According to a second aspect of this disclosure, a system for managing surgical sponges includes a main support extending from a base and a distributor assembly supported on the main support. The distributor assembly includes a first storage location for removably receiving cartons of sponge classifiers and a second storage location for removably receiving cartons of surgical drapings. An electronic subsystem is supported on the main support and includes a module base, a display removably coupled to the module base, and a data reader removably coupled to the module base. The electronic subsystem may be supported on the main support between the base and the distributor assembly. A system of the second aspect of this disclosure, including an electronic subassembly, may be provided on top of a system of the first aspect.

[0018] According to a third aspect of this disclosure, a system for managing surgical sponges includes a main support supported by a base and an arm supported by the main support. The arm includes an unsupported distal end to provide a cantilever. A load cell is coupled to the cantilever to sense the total weight of a sponge classifier supported by the arm and the surgical sponges placed within the sponge classifier. The arm may extend from the distributor assembly to provide the cantilever. The proximal end of the arm may be swivelably coupled to the distributor assembly. The arm may include a beam defining a channel, and the load cell may be located within the underside of the beam or coupled to the underside of the beam. A system of the third aspect of this disclosure, including the arm and load cell, may be provided on top of a system of the first and / or second aspect.

[0019] According to a fourth aspect of this disclosure, a system for managing surgical sponges includes a main support supported by a base and an arm supported by the main support. The arm includes a beam, a loading bar, and a load cell for sensing the total weight of a sponge classifier and surgical sponges placed within the sponge classifier, supported by the arm. A first end or portion of the load cell is fixed to the beam, and a second end or portion of the load cell is fixed to the loading bar. The arm may include at least one classifier coupler configured to be coupled to the loading bar and directly support the sponge classifier. The arm may include a load limiting plate fixed to the loading bar and near the second end or portion of the load cell, and a gap adjustment screw screwed to the load limiting plate. The adjustment lock screw may be screwed to the load limiting plate and may be configured to selectively lock the gap adjustment screw in place. The system of the fourth aspect of this disclosure, including the arm and load cell, may be provided on top of the systems of the first and / or second aspects.

[0020] According to a fifth aspect of this disclosure, a method for estimating blood loss includes a data reader detecting tags on surgical sponges to identify surgical sponges as those counted in for use during a surgical procedure. The type of surgical sponge has a dry weight stored in memory. In this case as well, the data reader detects tags on surgical sponges to identify surgical sponges as those counted out to no longer be used during a surgical procedure. Changes in measured weight are sensed by weighing means when the surgical sponge is placed in or placed in a sponge classifier. The fluid weight of the fluid on the surgical sponge is determined by a processor based on the measured weight and dry weight of the surgical sponge identified by the data reader as counted out. Blood loss associated with the surgical sponge is estimated by the processor based on the fluid weight. The estimated blood loss is displayed on a display. The tare weight of the sponge classifier can be sensed by weighing means. The fluid weight of the surgical sponge can be determined by a processor based on the measured weight, dry weight, and tare weight.

[0021] According to a sixth aspect of this disclosure, a method for estimating blood loss includes a data reader detecting tags on a first type of surgical sponge and tags on a second type of surgical sponge. The first type has a first dry weight stored in memory, and the second type has a second dry weight stored in memory. A counter is indexed by a processor to identify the first and second type surgical sponges as counted in for use during the surgical procedure. At least one of these tags is again detected by the data reader. The counter is further indexed by the processor to identify at least one of the first type surgical sponges and / or at least one of the second type surgical sponges as counted out for use during the surgical procedure. Changes in measured weight are sensed by a weighing means with the surgical sponges placed in a sponge classifier. The fluid weight of the surgical sponges is determined by the processor based on the measured weight and dry weight of the surgical sponges identified by the counter as counted out. Blood loss is estimated by the processor based on the fluid weight of the surgical sponge. The estimated blood loss is displayed on the display. The display can also show counters indicating the number of first and second type surgical sponges, respectively, that have been counted out and / or counted in.

[0022] According to a seventh aspect of this disclosure, a method for estimating blood loss includes a data reader detecting a tag on a surgical sponge to identify the surgical sponge as one that has been counted in for use during a surgical procedure. The type of surgical sponge has a dry weight stored in memory. Changes in measured weight are sensed by a weighing means. A processor determines whether the change in measured weight correlates with the counting out of the surgical sponge. If the change in measured weight does not correlate with the counting out of the surgical sponge, a warning is provided on the display. The processor can compare the measured duration and the maximum duration between the detection of the surgical sponge tag and the change in measured weight. The processor can compare the change in measured weight with a preset maximum sponge weight indicating a sponge saturated with blood. The processor can compare the change in measured weight with a preset minimum sponge weight. User input can be received in response to a warning indicating the type of fluid absorbent item placed in the sponge classifier. Another user input can be received identifying a surgical sponge as one saturated with a fluid other than blood. The processor can determine the corrected measured weight based on the value obtained by subtracting the weight of the surgical sponge from the measured weight. Blood loss can then be estimated by the processor based on the corrected measured weight.

[0023] Illustrative diagrams are shown in detail with reference to the drawings below. While the drawings represent schematic diagrams, they are not necessarily to scale, and certain features may be emphasized to better illustrate and describe the innovative aspects of the examples shown. Furthermore, the illustrative diagrams described herein are not intended to be exhaustive, nor are they intended to be limited to or restrictive to the exact forms and configurations shown in the drawings or otherwise disclosed in the detailed description below. [Brief explanation of the drawing]

[0024] [Figure 1]A diagram showing a system for managing surgical sponges. The module base, data reader, and display are shown detached from the mobile stand. The carton of the sponge classifier and the carton of the surgical drape are shown spaced from their respective storage locations on the dispenser assembly. The surgical drape covers the data reader. [Figure 2] A diagram showing a system in which at least one arm is deployed outward from the housing of the dispenser assembly and a sponge classifier is suspended from the arm. [Figure 3] Top perspective view of the dispenser assembly. [Figure 4] Rear view of the dispenser assembly. [Figure 5] Exploded view of the dispenser assembly with the upper housing separated from the lower housing. [Figure 6] One of the arms is shown disassembled, and it is a perspective view of a part of the system including a beam, a loading bar, and a load cell for detecting the measured weights of the sponge classifier and the surgical sponge. [Figure 7] Top perspective view of the arm of FIG. 6, where the beam is shown as transparent to show the load cell of the arm and other subordinate components disposed within the beam. [Figure 8] Top perspective view of another implementation example of the arm where the load cell is positioned outside the beam. [Figure 9] A diagram of a method for estimating blood loss by the system. [Figure 10] A diagram of another method for estimating blood loss by the system. [Figure 11] A diagram of yet another method for estimating blood loss by the system. [Figure 12] A perspective view of a part of the system where a warning is provided on the display. The warning can indicate that a change in the measured weight detected by the weighing means does not correlate with the surgical sponge for which the count-out has occurred. [Figure 13A] This is a screenshot of the graphical user interface (GUI) of the workflow for estimating blood loss using the system. [Figure 13B] This is a screenshot of the graphical user interface (GUI) of the workflow for estimating blood loss using the system. [Figure 14A] This is a GUI screenshot of the workflow in which the system estimates blood loss, with additional fluid-absorbing materials used in addition to the suitable surgical sponge. [Figure 14B] This is a GUI screenshot of the workflow in which the system estimates blood loss, with additional fluid-absorbing materials used in addition to the suitable surgical sponge. [Figure 14C] This is a GUI screenshot of the workflow in which the system estimates blood loss, with additional fluid-absorbing materials used in addition to the suitable surgical sponge. [Figure 14D] This is a GUI screenshot of the workflow in which the system estimates blood loss, with additional fluid-absorbing materials used in addition to the suitable surgical sponge. [Figure 15A] This is a GUI screenshot of a workflow in which the system estimates blood loss, allowing one or more surgical sponges to be excluded from the measured volume of the item. [Figure 15B] This is a GUI screenshot of a workflow in which the system estimates blood loss, allowing one or more surgical sponges to be excluded from the measured volume of the item. [Figure 15C] This is a GUI screenshot of a workflow in which the system estimates blood loss, allowing one or more surgical sponges to be excluded from the measured volume of the item. [Figure 15D]This is a GUI screenshot of a workflow in which the system estimates blood loss, allowing one or more surgical sponges to be excluded from the measured volume of the item. [Figure 16A] This is a GUI screenshot of a workflow where a weighing device detects a reduction in measured weight, and the system estimates blood loss. [Figure 16B] This is a GUI screenshot of a workflow where a weighing device detects a reduction in measured weight, and the system estimates blood loss. [Figure 16C] This is a GUI screenshot of a workflow where a weighing device detects a reduction in measured weight, and the system estimates blood loss. [Modes for carrying out the invention]

[0025] This disclosure relates to a system for managing surgical sponges during surgical procedures, thereby preventing the surgical sponges from being left in the patient's body. The system can further facilitate the estimation of blood loss associated with surgical items in a continuous workflow as described later. Referring to Figures 1 and 2, the surgical sponge management system 10 includes a stand 12, an electronic subsystem 14, and a distributor assembly 16. The stand 12 includes a wheeled base 18 for moving the surgical sponge management system 10 within a medical facility. The wheels may be casters 20 coupled to the base 18, and at least one of the casters 20 may include a brake 22 configured to selectively lock the caster 20. The stand 12 may include a main support 24 coupled to the base 18 and extending upward from the base 18. The main support 24 may be a cylindrical pole, or it may be square or rectangular in axial cross-section to facilitate improved mounting of the electronic subsystem 14. In particular, the main support 24 may include a pair of relatively wide side surfaces 26, 28, one of the pair of side surfaces 26 being the front of the surgical sponge management system 10, and the other of the pair of side surfaces 28 being the rear of the surgical sponge management system 10. The main support 24 may be at least partially hollow to accommodate power and / or data cables 30 extending through the main support 24. The shown implementation example shows the front surface 26 defining an opening 32, in which the power connector 34 is positioned, or adjacent to the opening 32. The power cable 30 extends through the main support 24 and exits through another opening (not shown) in the rear surface 28 of the main support 24. As shown in Figure 2, with the electronic subsystem 14 coupled to the main support 24, the power cable 30 can be coupled to an external power source to power the surgical sponge management system 10. It should be understood that one or more components of the electronic subsystem 14 may include a rechargeable battery, and the connection of the power cable 30 to an external power source can further function to charge the rechargeable battery and, in many cases, simultaneously power the surgical sponge management system 10.For example, to neatly store the power cable 30 in the stand 12, a cord wrap 36 can be attached to the main support 24 on the rear surface 28 near the opening from which the power cable 30 exits. For example, to facilitate the movement of the surgical sponge management system 10 within a medical facility, a handle 38 can be attached to the main support 24 on the front surface 26.

[0026] Continuing to refer to Figures 1 and 2, the electronic subsystem 14 includes a module base 40, a display 42, and a data reader 44. The module base 40 can be fixed to a stand 12 and, more specifically, can engage with the front 26 of the main support 24. A power connector 34 is electrically coupled to a complementary power port (not shown) on the rear surface of the module base 40. The module base 40 may include a housing 46 and a mount 48 coupled to the housing 46. It is understood that the module base 40 may further include a processor, memory, communication devices, and / or other hardware. The mount 48 is configured to be detachably coupled to a display 42, such as a tablet displaying a graphical user interface. Similarly, the housing 46 may define a cradle 50 configured to be detachably coupled to the data reader 44. The example implementation shown illustrates that the cradle 50 is a recess for receiving and supporting the data reader 44. In many cases, when the HCP mounts the display 42 and data reader 44, the electronic subsystem 14 is preferably coupled to the main support 24 at an optimal height. For example, the electronic subsystem 14 can be coupled to the main support 24 between the handle 38 and the distributor assembly 16, so that the display 42 is relatively close to eye level for most adults of average height. In another example, the display 42 can be positioned at a height of 4 to 6 feet from floor level. Furthermore, the joint between the mount 48 and the module base 40 can provide selective adjustment of the display 42 with one, two, or three or more degrees of freedom. The joint can be a swivel axis that provides vertical adjustment of the display 42 relative to the module base 40 to accommodate users of various heights.

[0027] The data reader 44 is used as a handheld device or supported by the cradle 50 and is configured to transition seamlessly between these configurations. More specifically, when supported by the cradle 50, the surgical sponge can be brought closer to the data reader 44 so that the data reader 44 can detect the unique identification information associated with the tag associated with the surgical sponge. If it is not feasible to bring the surgical sponge closer to the data reader 44 or otherwise move it as desired, the data reader 44 can be efficiently detached from the cradle 50 and operated near the tag associated with the surgical sponge. In an exemplary implementation, the data reader 44 is an RFID reader configured to detect the RFID tag associated with the surgical sponge, as described in International Publication WO2021 / 041795, published on 4 March 2021 and owned by the applicant, and International Publication WO2021 / 097197, published on 20 May 2021, both owned by the applicant, respectively, which are incorporated herein by reference as a whole. Exemplary tags other than RFID tags are disclosed in International Publication WO2017 / 112051, owned by the applicant and published on 29 June 2017, which is incorporated herein by reference in its entirety.

[0028] The distributor assembly 16 can be mounted on the main support 24 in a position opposite to the base 18 of the stand 12. In other words, the distributor assembly 16 can be positioned on top of the stand 12. The distributor assembly 16 and its components described herein, but are not limited to these, provide several advantageous functions, including selectively limiting the area occupied by the surgical sponge management system 10, providing storage and ergonomic distribution of sponge classifiers 52 from cartons 56 of sponge classifiers 52, providing storage and ergonomic distribution of surgical drapings 53 from cartons 58 of surgical drapings 53, and supporting at least one arm 54 having a dependent component for weighing surgical sponges placed in the sponge classifiers 52. In this specification, the cartons 56, 58 can be semi-rigid or rigid containers, such as boxes defining an opening, or alternatively, flexible containers such as bags defining an opening. The sponge sorters 52 can be stacked in a carton 56, rolled together, or otherwise bundled, and are also referred to herein as counting bags by alternative means. Furthermore, herein, surgical draping 53 can refer to a single surgical drape or multiple surgical drapes. A carton 58 of surgical draping 53 may initially contain one, two, three, four, or five or more surgical drapes, and these surgical drapes can be stacked in a carton 58, rolled together, or otherwise bundled.

[0029] Referring next to Figures 3 to 5, the distributor assembly 16 includes a housing 60, which may consist of an upper shell 62 coupled to a lower shell 64. The lower shell 64 may be mounted to a complementary mounting flange (not shown) located at the upper end of the main support 24. Figure 5 shows the lower wall 66 of the lower shell 64 defining four holes for receiving fasteners for mounting the distributor assembly 16 to the main support 24. The lower shell 64 may include a lower side wall 68 extending upward from the lower wall 66. As can be understood from the trapezoidal shape of the lower side wall 68, the lower wall 66 may be inclined downward from the rear to the front when mounted on the main support 24. As will be further described, the downward inclination of the lower wall 66 facilitates the carton 56 of the sponge classifier 52 to descend into a fixed position inside the front wall 70 of the distributor assembly 16, thereby positioning the opening of the carton 56 to communicate adjacent to the front opening 72 of the distributor assembly 16 for ergonomic distribution.

[0030] The distributor assembly 16 includes at least one mounting bracket 74 coupled to the housing 60. The mounting bracket 74 couples an arm 54 to the housing 60. As best shown in Figure 5, the mounting bracket 74 couples to the outer surfaces of each of the lower side walls 68 of the lower shell 64. The lower shell 64 may further include flange walls 76 extending outward from each of the lower side walls 68, and the mounting bracket 74 may further couple to the flange walls 76. The resulting configuration includes an arm 54 positioned within a recess 78 defined by the flange walls 76 and the lower side walls 68. More specifically, the arm 54 may be pivotably coupled to the mounting bracket 74 and extend rearward from the mounting bracket 74. The arm 54 is independently and selectively movable between an undeployed position where the arm 54 is positioned within the recess 78 (see Figures 1 and 3-5) and a deployed position where the arm 54 extends outward beyond the side wall of the housing 60 (see Figure 2). A classifier coupler 79 coupled to an arm 54 is configured to support a sponge classifier 52. The classifier coupler 79 can be at least one hook, two hooks as best shown in Figure 4, or other preferred holding mechanisms such as a clasp, hook-and-eye connection. Each arm 54 may include at least two classifier couplers 79 configured to cooperate in supporting two sponge classifiers. In alternative implementations, the arm 54 may be configured to deploy rotational motion, linear translation, or extensional displacement.

[0031] The upper shell 62 includes a front wall 70, an upper wall 80, and an upper side wall 82. The walls 70, 80, and 82 generally form an L-shape along the contour of the lower shell 64, and thus, when joined together, define the interior or first storage space 84. In particular, the upper side wall 82 of the upper shell 62 is fixed to the lower side wall 68 of the lower shell 64, for example by fasteners, to form the housing 60. Alternatively, the upper shell 62 and the lower shell 64 can be integrally formed by a preferred manufacturing process such as blow molding, injection molding, or 3D printing, so that the housing 60 is structurally monolithic. In other implementation examples, the upper shell 62 and the lower shell 64 can be pivotably joined together, for example by hinges, to allow the upper shell 62 to be swung to access the first storage space 84 for cleaning or other purposes. The housing 60 defines a first storage area 84 between the front wall 70, the top wall 80, and the side walls 68 and 82.

[0032] The first storage area 84 is sized to receive cartons 56 of sponge sorter 52. More specifically, the housing 60 defines a rear opening 86 communicating with the first storage area 84 and a front opening 72 communicating with the first storage area 84. The rear opening 86 is larger than the front opening 72. As best shown in Figure 4, the rear opening 86 can be rectangular, which is often the typical shape of cartons 56 of sponge sorter 52. The rear opening 86 should be sized slightly larger than the carton 56 so that the user can guide the carton 56 into the first storage area 84 through the rear opening 86. The user should load the carton 56 into the first storage area 84 such that the dispenser opening of the carton 56 faces the front opening 72 of the dispenser assembly 16. As described above, the lower wall 66 is inclined downward, thus facilitating the user to fully load the cartons 56 of the sponge sorter 52 into the first storage area 84. The distribution opening of the cartons 56 is accessible through the front opening 72.

[0033] Referring again to Figure 2, the method of suspending the sponge classifiers 52 from the arm 54 of the distributor assembly 16 includes retrieving the sponge classifiers 52 from a carton 56 supported within a first storage location 84 of the distributor assembly 16. The HCP can approach the surgical sponge management system 10 from the front and access the carton 56 of the sponge classifiers 52 through the front opening 72. The HCP can pull one of the sponge classifiers 52 out of the carton 56 through the front opening 72. The ergonomics of the arrangement are advantageous as it does not require the HCP to retrieve objects from, for example, a wire basket supported on a stand. Safety is further enhanced as the distributor assembly 16 is likely to be located above head level. The sponge classifiers 52 can be folded or unfolded when removed from the carton 56. When the sponge classifiers 52 are unfolded, they can take on the configuration shown in Figure 2. The distributor assembly 16 can be positioned above the height of the arm 54, i.e., above the suspension height of the sponge classifier 52, in order to prevent or minimize contamination of the carton 56 of the sponge classifier 52. Furthermore, the central positioning of the distributor assembly 16 on the main support 24 avoids obstructing the upper and lower pockets of the sponge classifier 52. The positioning and configuration of the distributor assembly 16 of this disclosure improves upon known devices, where a lower positioning of the storage unit necessitates the sponge classifier being suspended at a lower suspension height, often requiring the HCP to bend down to near the floor to access the lower pockets. The distributor assembly 16 avoids the aforementioned drawbacks while accommodating a wide range of HCP heights.

[0034] The HCP can hang or suspend a sponge classifier 52 from one of the arms 54. The sponge classifier 52 may include a hole configured to guide onto a hook on a classifier coupler 79. This step can be performed before or after moving the arm 54 from an undeployed position to a deployed position. In other words, the HCP can suspend a sponge classifier 52 from the arm 54 while the arm 54 is positioned within a recess 78 adjacent to the side of the housing 60. The housing 60 prevents the arm 54 from moving away from the HCP during installation, which can be ergonomic if the HCP has to use both hands to support and align the hole and hook. Alternatively, the HCP may, for example, swivel the arm 54 outward, and then the HCP suspends the sponge classifier 52 from the arm 54.

[0035] It is desirable that the surgical sponge management system 10 can be moved around the medical facility whenever the sponge classifier 52 is suspended from the arm 54. However, with the arm 54 deployed, the wingspan of the surgical sponge management system 10 is quite large, making it increasingly difficult to navigate obstacles within the medical facility. The surgical sponge management system 10 advantageously enables the arm 54, to which one or more sponge classifiers are already attached, to be moved from a deployed position to an undeployed position, thereby reducing the wingspan of the surgical sponge management system 10. The reduction in wingspan can be equal to or less than the original occupied area of ​​the surgical sponge management system 10. In other words, the sponge classifier 52 suspended from the arm 54 in the undeployed position is within the protruding outer circumference of the base 18 (i.e., the original occupied area). As a result, the surgical sponge management system 10 can be moved as if one or more sponge classifiers 52 were already suspended and ready for immediate use. The HCP can move the surgical sponge management system 10 by grasping the handle 38 as needed.

[0036] As already discussed, the surgical sponge management system 10 includes an electronic subsystem 14, and in many cases, the components of the electronic subsystem 14 need to be covered with surgical draping 53 to maintain a sterile barrier. As with the internal or first storage location 84, the distributor assembly 16 advantageously provides an external or second storage location 88 for mounted storage and ergonomic distribution of the surgical draping 53. Referring again to Figures 1, 3, and 5, the second storage location 88 can generally be defined by a recess in the upper wall 80 of the upper shell 62. In other words, the upper shell 62 may include a first retaining shape 90 and a second retaining shape 92 that at least partially form the second storage location 88. In the implementation example shown, the first retaining shape 90 and the second retaining shape 92 are frames that extend in the width direction across the housing 60. The first retaining shape 90 and the second retaining shape 92 are preferably spaced apart from each other by a distance slightly greater than the width of the carton 58 of the surgical draping 53. As a result, generally, it is possible to prevent the carton 58 supported within the second storage area 88 from moving forward and backward. The second retaining shape 92 can contour the rear surface of the housing 60, and the first retaining shape 90 can be positioned at any preferred location along the depth of the housing 60.

[0037] The upper shell 62 may further include a third retaining shape 94 and a fourth retaining shape 96 that further form a second storage area 88. In the illustrated implementation, the third retaining shape 94 is a frame extending in depth along one of the upper side walls 82 of the housing 60, and the fourth retaining shape 96 is a frame extending in depth along the other of the upper side walls 82 of the housing 60. The third retaining shape 94 and the fourth retaining shape 96 are preferably spaced apart from each other by a distance slightly greater than the length of the carton 58 of the surgical draping 58. Generally, this can prevent the carton 58 supported within the second storage area 88 from moving laterally.

[0038] A third retaining shape 94 and / or a fourth retaining shape 96 can define a slot 98. The slot 98 facilitates the ergonomic distribution of the surgical draping 53 from the carton 58. The distributor opening of the fitted carton can be defined on the shortest side of the bottom surface, as best shown in Figures 1 and 2. The distributor opening aligns with the slot 98 when the carton 58 of the surgical draping 53 is supported within the second storage area 88. For example, with a small portion of the surgical draping exposed through the distributor opening (due to the removal of the previous surgical draping), the HCP can simply pull or remove the surgical draping 53 outward (and downward) to distribute it. The carton 58 of the surgical draping 53 is prevented from coming out of the second storage area 88 by the third retaining shape 94 or the fourth retaining shape 96. Similar to the first storage location 84, the ergonomics of the second storage location 88 are advantageous in that the HCP does not require, for example, to be pulled upward. The surgical draping 53 can be spread or opened as needed to cover the electronic subsystem 14 and / or other components. For example, Figure 1 shows the surgical draping 53 covering the data reader 44 by a closure device.

[0039] It is further understood that the first storage area 84 and the second storage area 88 facilitate the ease of removal and replacement of their respective cartons 56, 58. After the carton 56 of the sponge classifier 52 is empty, the rear opening 86 facilitates the ease of removal and replacement of another carton 56. Similarly, after the carton 58 of the surgical draping 53 is empty, the carton 58 can be simply lifted a short distance for removal, and another carton 58 can be positioned in the second storage area 88. The reverse configuration is also intended, in which the first storage area 84 is associated with the carton 58 of the surgical draping 53 and the second storage area 88 is associated with the carton 56 of the sponge classifier 52.

[0040] The distributor assembly 16 of this disclosure advantageously facilitates the compact and space-conscious arrangement of most or all of the accessories of the surgical sponge management system 10 near the display 42 or data reader 44. Compactness is achieved by the first storage location 84 being "inside" the housing 60 of the distributor assembly 16 and the second storage location 88 being "outside" the housing 60. "Inside" can be thought of as the majority of the carton not extending beyond the housing 60, and "outside" can be thought of as the majority of the carton extending beyond the housing or being exposed without obstruction. Naturally, minor modifications to the geometry of the carton relative to the housing 60 and slight changes in placement can be considered within the scope of this disclosure. In one alternative implementation example, for example, the housing 60 of the distributor assembly 16 may not define a rear opening 86, and the upper wall 80 of the upper shell 62 may define an opening positioned in front of the second storage location 88 and communicating with the first storage location 84. The cartons 56 of the sponge sorter 52 can be guided into the first storage area 84 through the opening so that they can be accessed through the front opening 72.

[0041] As described above, the surgical sponge management system 10 can facilitate the estimation of blood loss associated with surgical sponges in a seamless workflow, more specifically, in a seamless workflow of checking out or counting out surgical sponges. In other words, the user can use the data reader 44 to count out surgical sponges and place the surgical sponge(S) into one of the pockets of the sponge classifier 52 (see Figure 2). Without requiring any further action from the user, the surgical sponge management system 10 can be configured to weigh the surgical sponges (and sponge classifier 52), correlate the change in weight to the counted-out surgical sponges, subtract the dry weight associated with the type of surgical sponge, estimate the blood absorbed by the surgical sponge, and update the estimated blood loss on the display 42. To facilitate the weighing of surgical sponges, the arm 54 may include weighing means. Additional advantages realized by integrating weighing means on the arm 54 will also be described in further detail.

[0042] Referring now to Figures 6 and 7, the arm 54 includes a weighing means, a beam 102, and a loading bar 104. The weighing means may be a load cell 100, and other preferred means for weighing an object supported by the arm 54 are also contemplated. The beam 102 is coupled to the housing 60 of the distributor assembly 16 by a mounting bracket 74, and a classifier coupler 79 is coupled to the loading bar 104. The load cell 100 couples the loading bar 104 to the beam 102 such that the mass applied to the loading bar 104 is measurable by the load cell 100. In other words, the loading bar 104 and the beam 102 do not need to be coupled to each other, except for the load cell 100, so that the entire mass supported by the arm 54 is measurable by the load cell 100. In most cases, the mass is a sponge classifier 52 hung from the arm 54, and any surgical sponge or object received in the sponge classifier 52.

[0043] The arm 54 is pivotably coupled to the housing 60 so as to enable the functions described above to be movable between an undeployed position and a deployed position. As a result, the arm 54 can be cantilevered, i.e., supported at or near one end by a mounting bracket 74 and left unsupported at the other end. Due to the structural mechanics of a cantilever, the load cell 100 can be a bending beam type load cell. The bending beam type load cell advantageously provides accurate and repeatable measurements with a small form factor that can be concealed within the arm 54. The load cell 100 can be selected from the group consisting of bending beam type load cells, double bending beam type load cells, shear beam type load cells, S-shaped load cells, canister type load cells, torsion load cells, spoke type load cells, ring torsion load cells, load pins, and strain gauges. One exemplary double bending beam type load cell is commercially available from HBK Inc. (Marlborough, Massachusetts) under the trademark DF2SR-3.

[0044] Continuing to refer to Figures 6 and 7, the beam 102 can define a channel 106, and the load cell 100 can be placed within the channel 106. In one example, the beam 102 is formed from extrusion to define a channel 106 with a square or rectangular cross-section, but other suitable shapes are also conceivable. The channel 106 can be sized to accommodate the load cell 100 and other dependent components of the arm 54, such as a mounting block 108. A first portion or end 110 of the load cell 100 can be fixed to the beam 102, and a second portion or end 112 of the load cell 100 can be fixed to a loading bar 104. As best shown in Figure 7, the first end 110 of the load cell 100 is fixed to the upper surface of the beam 102 by fasteners. The second end 112 of the load cell 100 is fixed to a mounting block 108, and the mounting block 108 itself is fixed to a loading bar 104. The mounting block 108 can be positioned within the channel 106, and the loading bar 104 can be positioned outside the channel 106. The opening 114 of the load cell 100 can be drawn between the first portion 110 and the second portion 112. As the object is supported by the loading bar 104, a downward force is applied to the mounting block 108 and the second end 112 of the load cell 100. This downward force causes a deflection of the load cell 100, which can be measured by a strain gauge or other suitable transducer. Depending on the dimensions and material of the load cell 100 and the characteristics of the opening 114, the measured deflection indicates the load. This deflection is converted into an electrical signal and transmitted to the processor of the electronic subsystem 14. The dependent components of the arm 54 can be sealed or concealed within the beam 102 by providing a cover 116 and end caps 118. Thus, by being positioned within the channel 106, the design of the beam 102 itself protects the load cell 100. Alternatively, Figure 8 shows an example of arm 54 implementation, where certain dependent components are located within channel 106, but the load cell 100 is located outside beam 102. The implementation example in Figure 8 shows that the first end 110 of load cell 100 is coupled to the underside of the lower surface of beam 102.Such an arrangement may be particularly suitable for designs requiring larger weighing means, i.e., designs where the load cell 100 is too large to be placed within the channel 106. A suitable cover can be provided to accommodate the load cell 100, beam 102, etc.

[0045] To further ensure accurate measurement and avoid damage to the load cell 100, the arm 54 may include a load limiting plate 120 fixed to the mounting block 108. A gap adjustment screw 122 is screw-coupled to the load limiting plate 120. The gap adjustment screw 122 has a stop end (not shown) and is selectively movable relative to the load limiting plate 120. The gap adjustment screw 122 can be adjusted to a position such that the stop end prevents further load from being applied to the load cell 100 if the weight on the loading bar 104 exceeds a predetermined maximum weight. For example, the gap adjustment screw 122 can be selectively adjusted to be at its lowest position on the lower inner surface of the beam 102 (or other designated structure) if the load applied to the load cell 100 exceeds a predetermined maximum weight. A set screw 124 may be provided to fix the gap adjustment screw 122 in the desired position corresponding to the predetermined maximum weight. In other words, the load limiting plate 120, the gap adjustment screw 122, and the load cell 100 can be calibrated to a predetermined weight. During calibration, an object of known weight (e.g., 20 pounds) can be applied to the loading bar 104, and the gap adjustment screw 122 can be adjusted to contact the lower inner surface of the beam 102. The object is removed, and the set screw 124 can be tightened. During subsequent operation, if 20 pounds is supported by the arm 54, it can be assumed that the gap adjustment screw 122 should again be in its lowest position.

[0046] The weighing means communicates with a processor (not identified) which may be located within the module base 40. Alternatively, the weighing means can communicate wirelessly with a remote processor and thus remotely perform the processing steps described below and wirelessly return them for display on the display 42. The processor may include a non-temporary computer-readable medium that stores instructions configured to be executed to carry out the methods disclosed herein. These instructions may be provided on a computer program product. The weighing means is configured to detect the measured weight of an object supported by the arm 54, most often a sponge classifier 52 and surgical sponges placed in the pockets of the sponge classifier 52. The measured weight, or a corresponding signal or data indicating the measured weight, is transmitted to the processor.

[0047] In a typical surgical procedure in which surgical sponges are used, the surgical sponges are checked in or counted in as being used during the surgical procedure. Surgical sponges may include tags, such as the RFID tags described above. Referring to Figure 9, exemplary method 130 may include counting in surgical sponges by having a data reader 44 detect the tags (step 132). The RFID tags contain identification data, and the processor is configured to determine the type of surgical sponge from the identification data, in which case the surgical sponge can be considered a suitable surgical sponge, as described further below. Exemplary types of surgical sponges are 4x4 gauze and 18x18 wrap sponges. A feature of the surgical sponge management system 10 is also to consider items that may not be automatically identified based on tags, and such items will hereafter be referred to as fluid-absorbing items. Suitable surgical sponges, fluid-absorbing items, sponge classifiers 52, and other objects can collectively be referred to as “items.” The type of surgical sponge is associated with its dry weight, which is stored in memory. The dry weight can be an average weight based on experience, manufacturing, or other data associated with the type of surgical sponge. Based on the data reader 44 detecting a tag, the processor can index a counter for the number of surgical sponges to be used during the surgical procedure. The counter can be displayed on the display 42 (see Figure 13B). The processor can further add the dry weight to the dry weight of the previous surgical sponge that was previously counted in as to be used. This can be repeated as many times as necessary, based on the expected or actual sponge needs of the surgical procedure. The surgical procedure is then started or continued as planned.

[0048] During or after a surgical procedure, used and unused surgical sponges are checked out or counted out. The tags on the surgical sponges are positioned so that they can be detected by the data reader 44 to identify the surgical sponges as those that have been counted out to no longer be used during the surgical procedure (step 134). The processor indexes the counter accordingly (for example, by subtracting 1 from the previous number) and can display on the display 42 the number of surgical sponges that remain counted in (see Figure 13B). Typically, after the user confirms on the display 42 that the surgical sponges have been counted out, they immediately place the surgical sponges in one of the pockets of the sponge classifier 52 (see Figure 2).

[0049] By integrating the weighing means with the arm 54 of the surgical sponge management system 10, the placement of a surgical sponge in the sponge classifier 52 is automatically detected or sensed by the weighing means as a change in measured weight (step 136). The measured weight and / or change in measured weight are transmitted to the processor. The processor is configured to determine the fluid weight of the fluid absorbed by the surgical sponge based on the measured weight (or change in measured weight) and dry weight of the surgical sponge identified by the data reader as counted out. In other words, the processor recognizes the type of counted-out surgical sponge based on the tag detected by the data reader 44 and correlates the dry weight for that type of surgical sponge from memory. Subtracting the dry weight from the change in measured weight equals the fluid weight for the counted-out surgical sponge (step 138). The fluid weight for each surgical sponge can be logged and stored in memory for later investigation and input. By an approximation conversion (or another preferred approximation) that 0.994 grams of fluid is equal to 1 milliliter of blood, the processor estimates the blood loss associated with the surgical sponge based on the fluid weight (step 140). The processor transmits this data to be displayed on the display 42 (step 142) (see Figure 13A). It will be readily apparent that the above-described functionality advantageously eliminates the need for the user to determine, recall, and / or manually input the number of surgical sponges of each type that have been counted out until the estimated blood loss can be determined. Similarly, it eliminates the need to transport the surgical sponges to a separate scale for weighing. Furthermore, the surgical sponge management system 10 provides estimated blood loss without increasing the area occupied in the operating room. The above-described steps can be performed automatically in real time without requiring the user to change the HCP's familiar workflow of counting in and counting out surgical sponges.In alternative implementation examples described later, the display 42 may provide the user with an option to manually input or edit the types of surgical sponges counted in and counted out, in which case the processor is intended to be able to automatically update the estimated blood loss based on the input or edited input. The display 42 is further intended to provide the user with an option to manually input or edit estimates of non-blood fluids (e.g., amniotic fluid) and / or exclude surgical sponges that contain only non-blood fluids.

[0050] Another exemplary method 150 involves the use of two or more types of surgical sponges in a surgical procedure. Referring to Figure 10, a data reader 44 detects tags on a first type of surgical sponge and tags on a second type of surgical sponge (step 152). The first type has a first dry weight stored in memory, and the second type has a second dry weight stored in memory. For example, the first type could be a 4x4 gauze and the second type could be an 18x18 wrap sponge, with the wrap sponge being heavier than the gauze. The processor indexes the counters to identify the first and second types of surgical sponges as counted in for use during the surgical procedure (step 154). In other words, the processor tracks how many of each of the gauze or wrap sponges have been counted in.

[0051] After the surgical procedure, the data reader 44 again detects at least one of the tags that should be counted out. The processor further indexes the counter to identify at least one of the first type of surgical sponges or at least one of the second type of surgical sponges as being counted out to no longer be used during the surgical procedure (step 156). For example, six of the eight gauzes that were counted in may have been counted out afterward, and three of the eight wrap sponges that were counted in may have been counted out afterward. With the surgical sponges placed in the sponge classifier 52, the weighing means senses the measured weight (step 158). The processor determines the fluid weight of the surgical sponges based on the measured weight and dry weight of the surgical sponges identified by the counter as being counted out. In this example, the processor subtracts six times the dry weight of the gauze and three times the dry weight of the wrap sponges from the measured weight. The processor estimates blood loss based on the fluid weight of the surgical sponge (step 164) and transmits the data to the display 42 to display the estimated blood loss (step 166). In this case as well, the user only needs to count out the surgical sponges in a familiar manner, and the estimated blood loss can be updated in real time. Furthermore, gauze and wrap sponges, for example, do not need to be counted out in a specific order or group, as the processor indexes the counters accordingly.

[0052] The weighing means senses the weight of the objects supported by the arm 54, including the sponge classifier 52 itself in addition to the surgical sponges placed inside the sponge classifier 52. Thus, this method may include weighing the tare weight to compensate for the tare weight of the sponge classifier 52. In one example, the weighing means may detect that the tare weight is equal to or less than a predetermined size. In other words, it can be empirically established that the tare weight of an empty sponge classifier is less than a predetermined size, and that used and unused surgical sponges are greater than a predetermined size. In response to the user suspending the sponge classifier 52 from the arm 54, the weighing means senses a change in the measured weight. If the change in measured weight is equal to or less than a predetermined size, the processor determines that the object that caused the change in measured weight is the sponge classifier 52. In another example, the user may provide input to the display 42 to weigh the tare of the weighing means with the sponge classifier 52 supported by the arm 54. The processor associates the measured weight with the tare weight at the moment of user input. After performing the subsequent steps of the method described above, the processor determines the fluid weight of the surgical sponge based on the calculated difference between the measured weight and the dry weight and tare weight.

[0053] As described above, integrating the weighing means into the surgical sponge management system 10 offers several advantages, including, in addition to real-time estimation of blood loss, ensuring that the counted-out surgical sponge (not another surgical sponge) is actually placed in the sponge classifier 52, and avoiding the placement of non-sponge objects in the sponge classifier 52. Referring to Figure 11, an exemplary method 170 includes a data reader 44 detecting a tag on a surgical sponge to identify it as one that has been counted in for use during a surgical procedure (step 172). The weighing means senses a change in measured weight in the manner described above (step 174). The processor determines whether the change in measured weight correlates with the counted-out of a surgical sponge (step 176). If the change in measured weight does not correlate with the counted-out of a surgical sponge, a warning 126 (see Figure 12) can be provided on the display 42 (step 178).

[0054] To determine whether a change in measured weight correlates with the counting out of a surgical sponge, the processor can identify whether pre- or post-tag detection has occurred. In other words, the weighing means senses a change in measured weight when the surgical sponge has not been counted out. Such a situation may occur if the user forgets to have the data reader 44 detect the tag before placing the surgical sponge in the sponge classifier 52. Additionally or alternatively, the processor can compare the measured duration with the maximum duration between the detection of the surgical sponge's tag and the change in measured weight. As described above, typically, the user places the surgical sponge in the sponge classifier 52 immediately after it has been counted out. If the maximum duration, e.g., 10, 20, or 30 seconds, has elapsed before the weighing means detects a change in measured weight, the processor can be configured not to correlate the change in weight with a tag most recently detected by the data reader 44. Simply put, it is unlikely that a surgical sponge placed in the sponge classifier 52 is the same surgical sponge that was counted out, for example, 60 seconds earlier. Alternatively, the processor may provide a warning 126 on display 42 so that the user again counts out the surgical sponge as verification, or provides confirmation user input to display 42, etc. Additionally or alternatively, the processor may compare the change in measured weight with a preset maximum sponge weight that represents a sponge saturated with blood. In other words, memory may store empirical data indicating the maximum weight achievable by a surgical sponge fully saturated with blood or a non-blood fluid. If the change in measured weight is greater than the preset maximum sponge weight, it may indicate that an item other than a sponge has been received into the sponge classifier. In this case, the processor cannot use the measured weight to estimate blood loss. For example, Figure 2 shows that an object other than a sponge (O) is placed in one of the pockets of the sponge classifier 52. Furthermore, warning 126 may be provided on display 42 by this particular warning shown in Figure 11.Finally, the processor can compare the change in measured weight with a preset minimum sponge weight. If the change in measured weight falls below the preset minimum, the processor cannot correlate the change in measured weight for blood loss estimation. A change in measured weight less than the preset minimum sponge weight may indicate that (i) an item other than a small sponge has been received into the sponge classifier, (ii) a sponge type smaller than the counted-out surgical sponge has been received into the sponge classifier 52, (iii) a surgical sponge or item has been removed from the sponge classifier 52 and another surgical sponge or item has been added, or (iv) the sponge classifier 52 has been carelessly moved or supported, such as being partially supported by the surgical stand. In contrast, if the processor correlates the change in measured weight with the counting out of a surgical sponge, the processor can proceed with the remaining steps of the method described herein, namely the step of determining the fluid weight of the surgical sponge based on the measured weight and dry weight, the step of estimating the blood loss associated with the surgical sponge based on the fluid weight, and the step of facilitating the display of the estimated blood loss.

[0055] In certain implementations, the processor can also be configured to compare the measured weight with a preset maximum load weight, i.e., the maximum weight configured to be safely supported by the arm 54 while ensuring the accurate operation of the surgical sponge management system 10. The preset maximum load weight can be selectively adjusted to avoid damage to the load cell 100 and / or to prevent tilting of the surgical sponge management system 10. If the weight measured by the weighing means exceeds the preset maximum load weight determined by the processor, a warning 126 can be provided on the display 42.

[0056] Integrating the weighing means with the surgical sponge management system 10 and managing it on a software-based graphical user interface (GUI) displayed on the display 42 further provides an efficient sponge management workflow. The display 42 can be a touchscreen display that provides a user interface for user input. Figures 13A and 13B represent GUI screenshots of the workflow, where count-in, count-out, and weighed surgical sponges are known to the surgical sponge management system 10. In other words, the tags associated with the compliant surgical sponges contain identification data, and the processor automatically determines from this identification data the type of surgical sponge whose dry weight is stored in memory. Exemplary compliant surgical sponges are commercially available from Stryker Corporation (Kalamazoo, Michigan) under the trademarks SurgiCount Safety Sponges or SurgiCount Sponges. Conversely, as will be discussed later, these workflows can further compensate for sponges and / or other fluid-absorbing articles that have tags associated with surgical sponges that do not have tags, or whose tags are unreadable or compliant.

[0057] The GUI screenshots include various tiles and information described below, intuitively arranged on the display 42. While the GUI screenshots will be described in the context of the specific numerical values ​​and item types displayed therein, it will be easily understood that these are for illustrative purposes only. Figure 13A includes a tile 180 displaying the net fluid volume of fluids collected during a surgical procedure that have not been absorbed by a surgical sponge or other fluid-absorbing item. The net fluid volume can be entered manually or captured by other means. The net fluid volume may include irrigation fluid, amniotic fluid, etc., which may be mixed with blood. The net fluid volume can be observed visually by viewing the postpartum V-drape on the display of the surgical suction system or by other means. The net fluid volume can be obtained by using a system commercially available from Gauss Surgical Inc. (Menlo Park, California) under the trademark Triton.

[0058] The GUI screenshot includes a tile 182 displaying the number of counting bags (e.g., sponge classifier 52) and the date and time of recording. The tare weight associated with the counting bag can be stored in memory. As described above, the processor can be configured to automatically determine that a counting bag is supported on the arm 54 based on whether the weight is consistent with or does not exceed a predetermined size for the counting bag. The GUI screenshot also includes a tile 184 displaying data associated with the fitted surgical sponge. Referring simultaneously to Figure 13B, the GUI screenshot includes a counting status field 188 containing counters for each type of surgical sponge that is used or in use during a surgical procedure. Figure 13B shows that each of the five 18x18 wrap sponges and each of the ten 4x4 gauzes were previously counted in and subsequently counted out by the data reader 44. The fact that the counting status is automatically updated by the detection of a tag by the data reader 44 indicates that the surgical sponge is a fitted surgical sponge.

[0059] The counting status is also reflected in tile 184 in Figure 13A. In particular, tile 184 includes the type and number of surgical sponges and an indicator that all surgical sponges have been counted out. Based on the total weight sensed by the weighing means and the tare weight of the counting bag, the fluid weight of the fitted surgical sponges is determined. Based on the fluid weight of the fitted surgical sponges, the estimated blood loss associated with the surgical sponges is determined and displayed in tile 184. The information displayed in tile 186 can be made more prominent or visually emphasized. In the examples of Figures 13A and 13B, the fitted surgical sponges are the only objects being weighed, and therefore the estimated blood loss displayed in tile 186 corresponds to the estimated blood loss displayed in tile 184. After the user completes the process, or if otherwise desired, the estimated blood loss can be calculated or recalculated and displayed in tile 190. The cylindrical arrangement of tiles 180, 186, and 190 is intuitively presented to the user as a form of a mathematical problem that is easily recognizable.

[0060] Figures 14A to 14D illustrate a workflow in which a suitable surgical sponge exists, as described above, but other fluid-absorbing items also exist. In this case, these items may not have tags detectable by the data reader 44, or the tags may not be predefined in memory as suitable. For example, these items may be "off-the-shelf" items such as blue towels, blue shoes, and peripads. The type of these items may not be automatically recognized by the surgical sponge management system 10 from the data reader 44, but memory may have a stored dry weight for each of these items. The dry weight may have been previously entered into the database.

[0061] In this workflow, the user can place fluid-absorbing items into a counting bag. Because fluid-absorbing items may not contain tags detectable by the data reader 44, the processor determines that the change in measured weight does not correlate with the countout of surgical sponges, particularly suitable surgical sponges. Tiles 186 in Figures 13A and 13B, which display the values ​​of the weighed items, are generally changed to tile 192, which represents a warning. Additionally, tile 194 can be visually highlighted or changed to be selectable by the user. Tiles 192 and 194 indicate to the user that the software assumes an "unknown item" based on the fact that the change in measured weight does not correlate with the countout of suitable surgical sponges. The user can select tile 194, after which the item list field 196 in Figure 14B is displayed. The user can select one or more fluid-absorbing items from the item list field 196. After saving, a GUI screenshot of Figure 14C can be provided, in which tile 182 displays the counting bag, tile 184 displays the fitted surgical sponge, and tile 198 displays the fluid absorbent items. Tile 198 includes the date and time of recording of the fluid absorbent items, as well as their type and number. In this case, the items are three blue towels and one peripad. Here, the user is taking into account the change in measured weight detected by the weighing means, so a warning tile 192 returns to tile 186, which displays the weighed item volume, in this case the sum of the weighed item volume of the fitted surgical sponge and the weighed item volume of the other fluid absorbent items. After the user completes the process, or otherwise as desired, the total estimated blood loss can be calculated and displayed in tile 190 as shown in Figure 14D. Furthermore, the GUI screenshot in Figure 14D can further provide the summary field 200, where the breakdown of the type and number of fluids represented for each net fluid volume is displayed in tile 180, the measured item volume is displayed in tile 186, and the estimated blood loss is displayed in tile 190.

[0062] As mentioned above, the user can be provided with an option to exclude surgical sponges that are determined to have absorbed almost entirely non-blood fluids or only non-blood fluids. Such a workflow is illustrated with reference to the GUI screenshots in Figures 15A to 15D. Figure 15A, like Figure 13A, includes tiles 180, 182, 184, 186, and 190 that display information including the weighed item volume associated with each of the suitable surgical sponges. However, in this example, the user has visually determined that three of the suitable surgical sponges have absorbed an excess of non-blood fluid, such as amniotic fluid. Therefore, the user would like to exclude the weights associated with those surgical sponges from the estimated blood loss determination. However, the user cannot simply remove those surgical sponges from the counting bag, as the unverified reduction of the measured weight sensed by the weighing means may be designed to limit or prevent further functionality (described herein with reference to Figures 16A to 16C). Similarly, the user cannot simply place the surgical sponges into the counting bag, as the aforementioned "unknown item" items should be generated. Therefore, by excluding surgical sponges, the measured weight associated with those surgical sponges is subtracted, but the processor is instructed to allow the surgical sponges to be placed in or returned to the counting bag without issue. For this purpose, Figure 15A includes a virtual button or tile 202, and by selecting tile 202, a GUI screenshot of Figure 15B (initially unimplemented) is presented. Exclusion of surgical sponges can be carried out in at least two ways. Firstly, with the GUI screenshot of Figure 15B displayed, the data reader 44 can detect the tags of the surgical sponges. An excluded sponge field 204 can be implemented to list the excluded surgical sponges. If the tags are not detectable, or for other reasons, the user can select the button or tile 206 to see the active sponge field 208 on the GUI screenshot of Figure 15C. The active sponge field 208 lists all the remaining surgical sponges that have been counted in.The user can visually correlate the sponge identification code presented on the tag with the corresponding sponge identification code presented in the active sponge field 208. Upon completion, a GUI screenshot of Figure 15D can be viewed, showing the excluded sponge subfield 210 as part of tile 184 or as the tile itself. In this example, two 18x18 wrap sponges and one 4x4 gauze are listed as excluded. Accordingly, tile 186, which displays the weighed item volume, and tile 190, which displays the estimated blood loss, are also reduced.

[0063] For unsuitable fluid absorbent items saturated with fluids other than blood, the user may simply choose not to place them in the counting bag, as the item may not have been counted before. If the fluid absorbent item has been counted before, an option to count it out or exclude it can be provided on the GUI.

[0064] The GUI screenshots in Figures 16A to 16C illustrate an example where the weighing device detects a decrease in measured weight. A decrease in measured weight may indicate that a surgical sponge or fluid absorbent item has been removed from the counting bag, or that the counting bag has been removed from the arm 54 or moved to a different position on the arm 54. Figure 16A includes a tile 212 that displays the decrease in measured weight sensed by the weighing device. In one example, the tile 212 itself can simply be removed by returning the counting bag to the arm 54 from which it was just removed. In another example, however, the user may have changed the items being returned to be supported by the arm 54, such as replacing one surgical sponge with another in the counting bag, or adding an additional surgical sponge to the counting bag. The GUI screenshots in Figures 16B and 16C illustrate such an example, where a peripad has been added to the counting bag before it is returned to be supported on the arm 54. Because the weight reintroduced to arm 54 does not match the reduction in measured weight shown on tile 212, tile 192 is implemented (tile 212 remains presented). Similar to the previous example described with reference to Figures 14A-14D, tile 194 can also be visually highlighted or modified to be selectable by the user. The user can select tile 194, after which the item list field 196 is displayed (see also Figure 14B). The user can select one or more fluid-absorbing items from the item list field 196. After saving, a GUI screenshot of Figure 16C can be provided, in which tile 182 displays the counting bag, tile 184 displays the fitted surgical sponge, and tile 198 displays the fluid-absorbing items. Tile 198 in Figure 16A contains three blue towels, while tile 198 in Figure 16C contains an additional peripad. Here, the user takes into account the change in measured weight sensed by the weighing device, so the warning tile 192 returns to tile 186, and the volume of the weighed item is displayed. After the user completes the process, or otherwise as desired, the total estimated blood loss can be calculated or recalculated and displayed.

[0065] Specific embodiments of the surgical sponge management system are further disclosed with reference to the following exemplary clauses.

[0066] Clause 1 - A method for estimating blood loss during a surgical procedure by a surgical sponge management system, wherein the surgical sponge management system includes a processor, a display communicating with the processor, a data reader communicating with the processor, a memory communicating with the processor, and a weighing means communicating with the processor, and a sponge classifier is configured to be detachably coupled to the weighing means, the method comprising the steps of: sensing a change in measured weight by the weighing means; determining by the processor whether the change in measured weight correlates with the counting out of a suitable surgical sponge; and providing a warning by the display if the change in measured weight does not correlate with the counting out of a surgical sponge.

[0067] Clause 2 - The method according to Clause 1, further comprising the steps of: receiving user input in response to a warning; displaying an item list field on a display containing fluid-absorbing articles, wherein the type of surgical sponge has a dry weight stored in memory; receiving another user input of one selection of fluid-absorbing articles corresponding to an item placed in a sponge classifier; the processor determining the fluid weight of the fluid on the fluid-absorbing article based on the measured weight and dry weight; the processor estimating the blood loss associated with the fluid-absorbing article and the surgical sponge based on the fluid weight; and displaying the estimated blood loss on a display.

[0068] Clause 3 - A method for estimating blood loss during a surgical procedure by a surgical sponge management system, wherein the surgical sponge management system comprises a processor, a display including a user interface communicating with the processor, a data reader communicating with the processor, a memory communicating with the processor, and a weighing means communicating with the processor, and a sponge classifier configured to receive surgical sponges, each including a tag, detachably coupled to the weighing means, the method comprising the step of the data reader detecting the tag of a surgical sponge and identifying the surgical sponge as one that has been counted in for use during a surgical procedure, and each type of surgical sponge having a dry weight stored in memory A method comprising the steps of having, identifying; sensing a change in the measured weight of a surgical sponge while the surgical sponge is placed in a sponge classifier using weighing means; receiving user input to a user interface to facilitate the exclusion of surgical sponges saturated with fluids other than blood; identifying one surgical sponge to be excluded; determining the fluid weight of the fluid on the other surgical sponges based on the measured weight and dry weight of the other surgical sponges using a processor; estimating the blood loss associated with the other surgical sponges based on the fluid weight using a processor; and displaying the estimated blood loss using a display.

[0069] Clause 4 - The method according to Clause 3, wherein the step of identifying one surgical sponge to be excluded further includes the step of detecting a tag on the one surgical sponge, in this case also by a data reader.

[0070] Clause 5 - The method according to Clause 3, wherein the step of identifying one surgical sponge to be excluded further includes the step of receiving another user input to a user interface for selecting one surgical sponge from an active sponge field displaying a list of counted surgical sponges.

[0071] Clause 6 - A method for estimating blood loss during a surgical procedure by a surgical sponge management system, wherein the surgical sponge management system comprises a base, a main support supported by the base, a processor, a display communicating with the processor, a data reader communicating with the processor, a memory communicating with the processor, and a weighing means communicating with the processor, wherein a sponge classifier is configured to be detachably coupled to the weighing means, and the method comprises the steps of: sensing a decrease in measured weight by the weighing means, and providing a warning by the display to indicate a decrease in measured weight.

[0072] Clause 7 - The method of Clause 6, further comprising the steps of sensing by a weighing means an increase in the measured weight, wherein the increase is equal to a decrease, and removing a warning from the display.

[0073] Clause 8 - The method according to Clause 6, further comprising the steps of: sensing by a weighing means an increase in measured weight, where the increase is greater than the decrease; providing another warning by display; receiving user input in response to the warning, where the user input is a selection of a fluid absorbent article corresponding to an item placed in a sponge classifier; determining by a processor the fluid weight of the fluid on the fluid absorbent article based on the measured weight and dry weight; estimating blood loss associated with the fluid absorbent article and other surgical sponges based on the fluid weight; and displaying the estimated blood loss by display.

[0074] Clause 9 - A computer program product that includes instructions configured to be executed on a processor in order to carry out the steps set out in any one of Clauses 1 through 8.

[0075] Clause 10 - A surgical sponge management system comprising a processor configured to execute instructions for carrying out the steps described in any one of Clauses 1 through 8.

[0076] Clause 11 - A distributor assembly for a surgical sponge management system, comprising a lower wall adapted to be supported on a main support, an upper wall located opposite the lower wall, a side wall extending between the lower wall and the upper wall, and a front wall extending between the side walls and defining a front opening, the distributor assembly including a first retaining shape and a second retaining shape separated from the first retaining shape, wherein the lower wall, upper wall, side wall, and front wall define a first storage area configured to removably receive cartons of sponge classifiers, and the upper wall defines at least partially a second storage area configured to removably support cartons of surgical drapings.

[0077] Clause 12 - The distributor assembly according to Clause 11, comprising an arm coupled to one of the side walls and configured to move away from one of the side walls from an undeployed position to a deployed position.

[0078] Clause 13 - The distributor assembly according to Clause 12, further comprising a flange wall extending outward from the side wall and defining a recess, wherein the arm is positioned within the recess in an undeployed position.

[0079] Clause 14 - A distributor assembly according to Clause 12 or 13, wherein the arm is supported to move for rotational motion, linear translation, or telescopic displacement so as to move from an undeployed position to a deployed position.

[0080] Clause 15 - A distributor assembly according to any one of Clauses 11 to 14, wherein the upper wall is configured to pivot relative to the lower wall.

[0081] Clause 16 - The distributor assembly according to Clause 15, wherein the upper wall is integrally formed with the front wall, and the front wall is pivotably coupled to the lower wall by a hinge.

[0082] Clause 17 - A distributor assembly according to any one of Clauses 11 to 16, wherein the top wall, bottom wall, and side wall define a rear opening, and a first storage area is accessible through the rear opening.

[0083] Clause 18 - A distributor assembly according to any one of Clauses 11 to 17, wherein the lower wall is inclined downward toward the front wall.

[0084] Clause 19 - A distributor assembly for a surgical sponge management system, comprising an upper shell defining a front opening and a lower shell configured to be attached to a main support of a stand, wherein the upper shell is coupled to the lower shell to define a rear opening opposite to the front opening, further defining a first storage area between the upper shell and the lower shell, and allowing insertion and removal of cartons of sponge classifiers or surgical drapings through the rear opening, such that the rear opening is larger than the front opening and accessible through the front opening.

[0085] Clause 21 - The distributor assembly according to Clause 20, wherein the upper shell includes a first retaining shape and a second retaining shape separated from the first retaining shape, such that the upper shell defines a second storage location outside the upper shell.

[0086] Clause 22 - The distributor assembly according to Clause 20 or 21, further comprising arms swivelably coupled to a lower shell adjacent to both side walls.

[0087] Clause 23 - The distributor assembly according to Clause 22, wherein the side walls of the lower shell define recesses, and each of the arms is positioned in one of the recesses in its undeployed position.

[0088] Clause 24 - The distributor assembly according to Clause 23, wherein the upper shell includes a third retaining shape and a fourth retaining shape separated from the third retaining shape, so as to further define a second storage location.

[0089] Clause 25 - The distributor assembly according to Clause 24, wherein the third or fourth retaining shape is a frame defining a slot.

[0090] The foregoing disclosure is not intended to be exhaustive or to limit this disclosure to any particular form. The terminology used is intended to be descriptive rather than restrictive. In light of the foregoing teachings, many modifications and variations are possible, and the invention can be carried out in ways other than those specifically described. It should be understood that structures and functions described with reference to one arm are incorporated by reference so as to be carried out with reference to the other arm. Furthermore, the technical concepts that can be understood from the above embodiments are described below. [Aspect 1] A system for managing surgical sponges, Bass and, A main support extending from the base, A distributor assembly supported on the main support, Equipped with, A system comprising a housing comprising a first storage area located inside the housing and configured to removably receive cartons of sponge classifiers, and a second storage area located outside the housing and configured to removably support cartons of surgical drapings. [Aspect 2] The system according to embodiment 1, further comprising an arm rotatably coupled to the housing, wherein the arm is rotatable relative to the housing between an undeployed position in which the arm is positioned within a recess of the housing and a deployed position in which the arm extends beyond the side wall of the housing. [Aspect 3] The system according to embodiment 2, further comprising a mounting bracket that rotatably connects the arm to the housing, wherein the arm is of a cantilever type. [Aspect 4] The system according to embodiment 3, wherein the arm comprises a load cell configured to sense a change in the measured weight of an object supported by the arm. [Aspect 5] The system according to embodiment 4, wherein the arm further comprises a beam defining a channel, and the load cell is positioned within the channel and coupled to the beam. [Aspect 6] The system according to embodiment 5, wherein the arm further comprises a loading bar, and the loading bar is coupled to the load cell at an end or portion opposite to the beam. [Aspect 7] The system according to any one of embodiments 1 to 6, wherein the housing of the distributor assembly comprises an upper wall defining the second storage location. [Aspect 8] The system according to any one of embodiments 1 to 7, wherein the housing of the distributor assembly comprises a first retaining shape and a second retaining shape separated from the first retaining shape so as to define the second storage location, and the first retaining shape and the second retaining shape are configured to prevent the carton of the surgical draping from moving forward and backward. [Aspect 9] The system according to embodiment 8, wherein the housing of the distributor assembly comprises a third retaining shape and a fourth retaining shape separated from the third retaining shape to further define the second storage location, and the third retaining shape and the fourth retaining shape are configured to prevent lateral movement of the carton of the surgical draping. [Aspect 10] The system according to embodiment 9, wherein at least one of the third and fourth retaining shapes defines a slot sized to be positioned near the dispenser opening of the carton of the surgical draping. [Aspect 11] The system according to any one of embodiments 1 to 10, wherein the housing comprises an upper shell and a lower shell coupled to the upper shell, and the upper shell comprises a front wall defining a front opening that communicates with the first storage location. [Aspect 12] The system according to embodiment 11, wherein the lower shell comprises a lower wall that slopes downward toward the front wall. [Aspect 13] The system according to embodiment 11 or 12, wherein the housing defines a rear opening that communicates with the first storage location, and the rear opening is larger than the front opening. [Aspect 14] A handle coupled to the main support, A module base coupled to the main support and positioned between the handle and the distributor assembly, An electronic subassembly located within the module base, The system according to embodiment 4, further comprising: [Aspect 15] The system according to embodiment 14, wherein the electronic subassembly comprises a processor communicating with the load cell, and the system further comprises a display detachably coupled to the module base and communicating with the processor, wherein the display is configured to display an estimated blood loss determined by the processor based on the measured weight sensed by the load cell. [Aspect 16] A system for managing surgical sponges, Bass and, A main support extending from the base, A distributor assembly supported on the main support and comprising a first storage area for removably receiving cartons of sponge classifiers and a second storage area for removably receiving cartons of surgical drapings, An electronic subsystem supported on the main support, Equipped with, The electronic counting system comprises a module base, a display detachably coupled to the module base, and a data reader detachably coupled to the module base. [Aspect 17] The system according to embodiment 16, wherein the electronic subsystem is supported on the main support between the base and the distributor assembly. [Aspect 18] The system according to embodiment 17, wherein the main support is hollow and configured to accommodate a power cable, and an opening is defined on the front surface of the main support to facilitate electrical connection between the power cable and the electronic subsystem. [Aspect 19] The system according to embodiment 18, wherein the main support defines a second opening on the rear surface of the main support, and the power cable extends from the second opening so as to be coupled to an external power supply. [Aspect 20] The system according to embodiment 19, wherein the main support comprises a cord wrap positioned near the second opening. [Aspect 21] The system according to any one of embodiments 16 to 20, further comprising a handle supported on the main support, wherein the handle is positioned between the electronic subsystem and the base. [Aspect 22] The system according to any one of embodiments 16 to 21, further comprising an arm coupled to the distributor assembly, wherein the arm comprises a load cell configured to detect a change in the measured weight of an object supported by the arm. [Aspect 23] The system according to embodiment 22, wherein the arm further comprises a beam defining a channel, and the load cell is positioned within the channel and coupled to the beam. [Aspect 24] The system according to embodiment 23, wherein the arm further comprises a loading bar, the loading bar being coupled to the load cell at an end or portion opposite to the beam. [Pattern 25] The system according to any one of embodiments 22 to 24, wherein the arm is of the cantilever type. [Aspect 26] A system for managing surgical sponges, Bass and, The main support is supported by the aforementioned base, An arm supported by the main support, Equipped with, A system comprising: an arm having a distal end that is not supported to provide a cantilever; and a load cell coupled to the cantilever to sense the total weight of a sponge classifier supported by the arm and the surgical sponges placed within the sponge classifier. [Aspect 27] The system according to embodiment 26, further comprising a distributor assembly coupled to the main support, wherein the arm extends from the distributor assembly to provide the cantilever beam. [Aspect 28] The system according to embodiment 27, wherein the arm further comprises a proximal end rotatably coupled to the distributor assembly. [Aspect 29] The system according to any one of embodiments 26 to 28, wherein the arm further comprises a beam defining a channel, and the load cell is positioned within the channel of the beam. [Aspect 30] The system according to any one of embodiments 26 to 28, wherein the arm further comprises a beam, and the load cell is coupled to the lower surface of the beam. [Aspect 31] The system according to embodiment 29 or 30, wherein a first end or portion of the load cell is fixed to the beam, and the arm further comprises a loading bar fixed to a second end or portion of the load cell. [Aspect 32] A system for managing surgical sponges, Bass and, The main support is supported by the aforementioned base, An arm supported by the main support, Equipped with, The system comprises an arm, a beam, a loading bar, and a load cell for sensing the total weight of a sponge classifier supported by the arm and the surgical sponges placed within the sponge classifier, wherein a first end or portion of the load cell is fixed to the beam, and a second end or portion of the load cell is fixed to the loading bar. [Aspect 33] The system according to embodiment 32, further comprising at least one classifier coupler configured to be coupled to the loading bar and to directly support the sponge classifier. [Aspect 34] The aforementioned arm, A load limiting plate fixed to the loading bar and fixed near the second end or portion of the load cell, A gap adjustment screw screw screwed to the load limiting plate, Furthermore, The system according to embodiment 32 or 33, wherein the gap adjustment screw includes an adjustable, positionable stopper for limiting the load applied to the load cell when the total weight exceeds a predetermined maximum value. [Aspect 35] The system according to embodiment 34, wherein the arm further comprises an adjustment lock screw screwed to the load limiting plate, and the adjustment lock screw is configured to selectively lock the gap adjustment screw in a fixed position. [Aspect 36] An electronic subassembly comprising a processor supported on the main support and communicating with the load cell, A display supported on the main support and communicating with the processor, Furthermore, The display is configured to display the estimated blood loss determined by the processor based on the measured weight sensed by the load cell. A system as described in any one of the three items in 32 to 35 of the Specification Act. [Aspect 37] It communicates with the aforementioned processor and has a memory that stores the dry weight of the surgical sponge, A data reader supported on the main support and communicating with the processor, Furthermore, The data reader is configured to detect a tag associated with each of the surgical sponges, The processor is configured to determine the estimated blood loss based on the measured weight and the dry weight of the surgical sponge. The system described in embodiment 36. [Aspect 38] The system according to any one of embodiments 33 to 37, wherein the load cell is selected from the group consisting of a bending beam type load cell, a double bending beam type load cell, a shear beam type load cell, an S-shaped load cell, a canister type load cell, a torsion load cell, a spoke type load cell, a ring torsion load cell, a load pin, and a strain gauge. [Aspect 39] A method for estimating blood loss during a surgical procedure using a surgical sponge management system, wherein the surgical sponge management system includes a processor, a display supported to communicate with the processor, a data reader communicating with the processor, a memory communicating with the processor, and a weighing means supported by a main support and communicating with the processor, wherein a sponge classifier is configured to receive surgical sponges, including tags, which are detachably supported by the weighing means, and the method is, The steps include: detecting the tag on the surgical sponge using the data reader and identifying the surgical sponge as one that has been counted in for use during the surgical procedure, and identifying the type of the surgical sponge having a dry weight stored in the memory; The steps include: detecting the tag on the surgical sponge again using the data reader and identifying the surgical sponge as one that has been counted out so as not to be used during the surgical procedure; The weighing means detects a change in the measured weight while the surgical sponge is placed inside the sponge classifier. The processor determines the fluid weight of the fluid on the surgical sponge based on the measured weight and dry weight of the surgical sponge, which are identified by the data reader as having been counted out. The processor performs the steps of estimating the blood loss associated with the surgical sponge based on the fluid weight, The steps include displaying the estimated blood loss on the aforementioned display, Methods that include... [Aspect 40] The sponge classifier has a tare weight, and the method is The step of sensing the tare weight of the sponge classifier using the weighing means, and the step of sensing that the tare weight is equal to or less than a predetermined size, The processor determines the fluid weight of the surgical sponge based on the measured weight, the dry weight, and the tare weight. The method according to embodiment 39, further comprising: [Aspect 41] The sponge classifier has a tare weight, and the method is The steps include receiving user input to measure the tare weight of the weighing means so that the tare weight is equal to the measured weight, The processor determines the fluid weight of the surgical sponge based on the measured weight, the dry weight, and the tare weight. The method according to embodiment 39, further comprising: [Aspect 42] The method according to any one of embodiments 39 to 41, wherein the steps of determining the fluid weight, estimating the blood loss, and displaying the estimated blood loss are performed automatically in real time when the weighing means detects a change in the measured weight, without requiring further user input. [Aspect 43] The weighing means provides a second step of sensing the change in the measured weight, The process involves the processor determining whether the second change in the measured weight correlates with the counting out of the second surgical sponge, The display provides a warning if the second change in the measured weight does not correlate with the counting out of the second surgical sponge. The method according to any one of embodiments 39 to 41, further including the method according to any one of embodiments 39 to 41. [Aspect 44] The method according to embodiment 43, further comprising the step of receiving an input indicating the type of fluid-absorbing article placed in the sponge classifier in order to take into account the second change in the measured weight. [Aspect 45] The steps include receiving another input to identify one of the surgical sponges as being saturated with a fluid other than blood, The processor determines the corrected measured weight based on the value obtained by subtracting the weight of one surgical sponge from the measured weight. The processor performs the steps of estimating the blood loss based on the corrected measured weight, The method according to embodiment 43 or 44, further comprising: [Aspect 46] The step of determining whether the second change in the measured weight correlates with the counting out of the second surgical sponge is, The processor determines whether or not the second tag of the second surgical sponge has been detected. The processor performs the step of comparing the measured duration and the maximum duration between the detection of the second tag of the second surgical sponge and the second change in the measured weight, The processor performs the steps of comparing the change in the measured weight with a preset maximum sponge weight representing a blood-saturated sponge, and The processor performs the step of comparing the second change in the measured weight with a preset minimum sponge weight. The method according to embodiment 43, further comprising at least one of the following. [Aspect 47] The method according to embodiment 46, further comprising the step of not repeating the step of determining the fluid weight, the step of estimating the blood loss, and the step of displaying the estimated blood loss for the second surgical sponge if the second surgical sponge is not counted out. [Aspect 48] The method according to any one of embodiments 43 to 47, further comprising the step of not displaying an updated estimate of the blood loss if the second change in the measured weight does not correlate with the counting out of the second surgical sponge. [Aspect 49] A method for estimating blood loss during a surgical procedure using a surgical sponge management system, wherein the surgical sponge management system includes a processor, a display supported to communicate with the processor, a data reader communicating with the processor, a memory communicating with the processor, and a weighing means supported by a main support and communicating with the processor, wherein a sponge classifier is configured to receive surgical sponges, each including a tag, which are detachably supported by the weighing means, and the method is The steps include detecting the tags on a first type of surgical sponge and the tags on a second type of surgical sponge using the data reader, wherein the first type has a first dry weight stored in the memory and the second type has a second dry weight stored in the memory; The steps include indexing a counter so that the processor identifies the first type and the second type of surgical sponges as being counted in for use during the surgical procedure, The data reader then detects at least one of the tags again. The processor further indexes the counter to identify at least one of the first type of surgical sponges and / or at least one of the second type of surgical sponges as being counted out to no longer be used during the surgical procedure. The weighing means detects a change in the measured weight while the surgical sponge is placed inside the sponge classifier. The processor determines the fluid weight of the surgical sponge based on the measured weight and dry weight of the surgical sponge, which have been identified as counted out by the counter. The processor performs the steps of estimating blood loss based on the fluid weight of the surgical sponge, The steps include displaying the estimated blood loss on the aforementioned display, Methods that include... [Aspect 50] The method according to embodiment 49, further comprising the step of displaying the counter on the display showing the number of each of the first type and the second type of surgical sponges that have been counted out and / or counted in. [Aspect 51] The weighing means provides a second step of sensing the change in the measured weight, The steps include providing a warning via the display indicating that the second change in the measured weight does not correlate with the data reader detecting another surgical sponge, The method according to embodiment 49 or 50, further comprising: [Aspect 52] The method according to embodiment 51, further comprising the step of receiving user input to a user interface indicating the type of fluid-absorbing article placed in the sponge classifier. [Aspect 53] The steps include receiving another user input to the user interface for identifying the surgical sponges that are saturated with a fluid other than blood, The processor determines the corrected measured weight based on the value obtained by subtracting the weight of one surgical sponge from the measured weight. The processor performs the steps of estimating the blood loss based on the corrected measured weight, The method according to embodiment 52, further comprising: [Aspect 54] A method for estimating blood loss during a surgical procedure using a surgical sponge management system, wherein the surgical sponge management system includes a processor, a display supported to communicate with the processor, a data reader communicating with the processor, a memory communicating with the processor, and a weighing means supported by a main support and communicating with the processor, wherein a sponge classifier is configured to receive surgical sponges, including tags, which are detachably supported by the weighing means, and the method is, The steps include: detecting the tag on the surgical sponge using the data reader and identifying the surgical sponge as being counted in for use during the surgical procedure, and identifying the type of the surgical sponge having a dry weight stored in the memory; The weighing means provides a step of sensing a change in the measured weight, The processor performs the step of determining whether the change in the measured weight correlates with the counting out of the surgical sponge, The steps include providing a warning via the display if the change in the measured weight does not correlate with the counting out of the surgical sponge, Methods that include... [Aspect 55] The step of determining whether the change in the measured weight correlates with the counting out of the surgical sponge is, The processor performs the steps of comparing the measured duration and the maximum duration between the detection of the tag on the surgical sponge and the change in the measured weight, The processor performs the steps of comparing the change in the measured weight with a preset maximum sponge weight representing a blood-saturated sponge, and The processor performs the step of comparing the change in the measured weight with a preset minimum sponge weight. The method according to embodiment 54, further comprising at least one of the following. [Aspect 56] If the change in the measured weight correlates with the counting out of the surgical sponge, The processor performs the steps of determining the fluid weight of the surgical sponge based on the measured weight and the dry weight, The processor performs the steps of estimating the blood loss associated with the surgical sponge based on the fluid weight, The steps include displaying the estimated blood loss on the aforementioned display, The method according to embodiment 54 or 55, further comprising: [Aspect 57] The method according to any one of embodiments 54 to 56, further comprising the step of receiving user input in response to the warning indicating the type of fluid-absorbing article placed in the sponge classifier. [Aspect 58] The steps include receiving another user input to identify one of the surgical sponges as being saturated with a fluid other than blood, The processor determines the corrected measured weight based on the value obtained by subtracting the weight of one surgical sponge from the measured weight. The processor performs the steps of estimating blood loss based on the corrected measured weight, The steps include displaying the estimated blood loss on the display, The method according to embodiment 57, further comprising: [Aspect 59] The steps include comparing the measured weight with a preset maximum load weight, The steps include providing a load warning via the display if the measured weight exceeds the preset maximum load weight, The method according to any one of embodiments 39 to 58, further including the method according to any one of embodiments 39 to 58. [Aspect 60] A computer program product comprising instructions configured to be executed on a processor in order to carry out the steps described in any one of embodiments 39 to 59.

Claims

1. A system for managing surgical sponges, Bass and, A main support extending from the base, A distributor assembly supported on the main support, Equipped with, The distributor assembly comprises a housing having an upper shell and a lower shell coupled to the upper shell, wherein the housing defines a first storage area located inside the housing and configured to removably receive cartons of sponge classifiers, and a second storage area located outside the housing and configured to removably support cartons of surgical draping for covering the electronic equipment of the system. The upper shell comprises a front wall defining a front opening that communicates with the first storage area, and an upper wall defining the second storage area. system.

2. The system according to claim 1, further comprising an arm rotatably coupled to the housing, wherein the arm is rotatable relative to the housing between an undeployed position in which the arm is positioned within a recess of the housing and a deployed position in which the arm extends beyond the side wall of the housing.

3. The system according to claim 2, further comprising a mounting bracket that rotatably connects the arm to the housing, wherein the arm is of a cantilever type.

4. The system according to claim 3, wherein the arm comprises a load cell configured to sense a change in the measured weight of an object supported by the arm.

5. The system according to claim 4, wherein the arm further comprises a beam defining a channel, and the load cell is positioned within the channel and coupled to the beam.

6. The system according to claim 5, wherein the arm further comprises a loading bar, the loading bar being coupled to the load cell at an end or portion opposite to the beam.

7. The system according to any one of claims 1 to 6, wherein the housing of the distributor assembly comprises a first retaining shape and a second retaining shape separated from the first retaining shape so as to define the second storage location, and the first retaining shape and the second retaining shape are configured to prevent the carton of surgical draping from moving forward and backward.

8. The system according to claim 7, wherein the housing of the distributor assembly comprises a third retaining shape and a fourth retaining shape separated from the third retaining shape, so as to further define the second storage location, and the third retaining shape and the fourth retaining shape are configured to prevent lateral movement of the carton of the surgical draping.

9. The system according to claim 8, wherein at least one of the third and fourth retaining shapes defines a slot sized to be positioned near the dispenser opening of the carton of the surgical draping.

10. The system according to claim 1, wherein the housing comprises an upper shell and a lower shell coupled to the upper shell, the upper shell having a front wall and the lower shell having a lower wall inclined downward toward the front wall.

11. The system according to claim 10, wherein the housing defines a rear opening that communicates with the first storage location, and the rear opening is larger than the front opening.

12. A handle coupled to the main support, A module base coupled to the main support and positioned between the handle and the distributor assembly, An electronic subassembly located within the module base, The system according to claim 4, further comprising:

13. The system according to claim 12, wherein the electronic subassembly comprises a processor communicating with the load cell, and the system further comprises a display detachably coupled to the module base and communicating with the processor, wherein the display is configured to display an estimated blood loss determined by the processor based on the measured weight sensed by the load cell.

14. A system for managing surgical sponges, Bass and, A main support extending from the base, A distributor assembly supported on the main support, comprising a housing having an upper shell and a lower shell coupled to the upper shell, a first storage area for removably receiving cartons of sponge classifiers, and a second storage area for removably receiving cartons of surgical draping for covering the electronics of the system, An electronic subsystem supported on the main support, Equipped with, The electronic subsystem comprises a module base, a display detachably coupled to the module base, and a data reader detachably coupled to the module base. The upper shell comprises a front wall defining a front opening communicating with a first storage area, and an upper wall defining a second storage area, wherein the opening of the carton of the sponge classifier is accessible through the front opening when the carton of the sponge classifier is received into the first storage area.

15. The system according to claim 14, wherein the electronic subsystem is supported on the main support between the base and the distributor assembly.

16. The system according to claim 15, wherein the main support is hollow and configured to accommodate a power cable, and an opening is defined on the front surface of the main support to facilitate electrical connection between the power cable and the electronic subsystem.

17. The system according to claim 16, wherein the main support defines a second opening on the rear surface of the main support, and the power cable extends from the second opening so as to be coupled to an external power supply.

18. The system according to claim 17, wherein the main support comprises a cord wrap positioned near the second opening.

19. The system according to claim 15, further comprising a handle supported on the main support, wherein the handle is positioned between the electronic subsystem and the base.

20. The system according to any one of claims 14 to 19, further comprising an arm coupled to the distributor assembly, wherein the arm comprises a load cell configured to detect a change in the measured weight of an object supported by the arm.

21. The system according to claim 20, wherein the arm further comprises a beam defining a channel, and the load cell is positioned within the channel and coupled to the beam.

22. The system according to claim 21, wherein the arm further comprises a loading bar, the loading bar being coupled to the load cell at an end or portion opposite to the beam.

23. The system according to claim 20, wherein the arm is of the cantilever type.

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