Method and apparatus for disposing of liquid surgical waste for protection of healthcare workers

ES 2 285 243 T3

DESCRIPTION

Method and apparatus for the disposal of surgical fluid waste intended to protect healthcare workers.

Background of the invention

1. Field of the invention

The present invention relates to surgical procedures, and more particularly to a method and apparatus for the removal of liquid waste during and after the course of said procedures.

2. Description of Related Art

The present invention relates to devices and methods for material handling, monitoring, and documentation for use in the medical field and in one embodiment of a method and apparatus for handling, collecting, measuring and / or disposing of fluids. , including gases and fluids, that are associated with surgery and other medical procedures. The use of the method and apparatus of the present invention will reduce the number of potential health worker exposure events to infectious and possibly toxic wastes associated with surgical, clinical, post-operative, and intensive care settings.

The shared potential for disease effects to health care workers from exposure to biological hazardous materials in a variety of health care settings has long been recognized. State and federal regulatory agencies have issued mandatory guidelines for the control of such materials, particularly bloodborne pathogens.

The presence of biohazard materials is most common in surgical rooms, clinical processing settings, and in post-operative and intensive care units, where bodily fluids, including blood and irrigation fluids, are removed from the patient during the procedure. . Medical personnel can be exposed to these potentially serious biological hazards during the course of their work, through direct contact with blood materials, or more indirectly, through splashing or spraying.

Current methods of extraction, containment, and disposal of high-volume wastes containing these potentially hazardous materials present the greatest risk of exposure to healthcare equipment. For example, during the course of surgery and certain medical procedures, these fluids are continually withdrawn from the procedure site by means of one or more terminal actuators operably coupled to a suction wall via tubing. These fluids are sucked into a terminal collecting device and moved through a pipe to a collecting flask. In order to prevent them from entering a wall suction system where they could contaminate said system, the fluids are collected and stored, for the duration of the procedure, in large bottles (typically 1,500 - 3,000 cc capacity) positioned adjacent to the site of the procedure. process. These vials are necessary to protect the integrity of the wall suction source and to assist the healthcare team in determining the patient's haemostasis. Such vials have graduated markings on them, allowing the healthcare team to make estimates of the volume of fluid lost from the patient during and after the procedure. The vials are usually made of a transparent glass or plastic material and provide the healthcare team with a qualitative visual assessment by observing the fluids within the vial as an indicator of actual blood loss. Fluid contents are retained in the flask adjacent to the procedure site until the procedure is completed, in which temporary post-operative assessment and information on fluid lost by the patient can be assessed.

During a surgical procedure, it is routine for the surgical team to estimate fluid loss using measurements from the calibrations on the vial to roughly quantify the volumes of fluid drawn from the site. These volumes are compared to known amounts of fluids introduced, for example, a sterile saline solution, which provides irrigation of the tissues to improve visualization and prevention of dehydration of the tissues. After the procedure is completed, the fluid withdrawn is measured and an estimate of the total blood loss is determined. This is done to ensure that there are no excess fluids of any kind remaining within the body cavity or that excessive blood loss has not occurred, both circumstances that can place the patient at increased postoperative risk.

Once the total blood loss has been calculated, the health personnel must remove the excess fluids in the vial (s). In a common method, this is done by removing the vial from the procedure site and transporting it to a disposed location within the facility. There, the top of the jar is manually opened and the contents poured into a specially designated drain called a Hopper. The liquid waste is thus drained directly into a sanitary drain, a process that exposes the healthcare worker to most risks from direct contact or exposure to splashes. Once emptied, the jar (s) are placed in a large, red pigment, garbage bag and disposed of as a biohazard waste - a process commonly referred to as "Red Bagging." Alternatively, the flask (s) are opened in the operating room and a gel formed of chemical powders is poured into each flask plastering the gelatinous material. These gelled jars are then Red Bagged and removed to a biohazard storage area for disposal. In larger facilities, the jars, whether or not pre-gelled, are often removed in large wheelbarrows and transported to a biohazard handling area where they are processed and prepared for disposal. Red Bagged materials are disposed of separately from other medical and non-medical waste by companies specializing in that disposal method.

While these disposal and protection techniques are useful in providing some improvement over previous methods, they fall short of providing adequate protection to healthcare personnel assigned to the disposal of biohazard waste. A major spill of fluid from said bottle (s), either by direct contact as a result of a leak or break, splash associated with opening the bottle cap to add gel, while pouring

ES 2 285 243 T3 the liquid contained in the Hopper, or during the removal process itself, is cause for concern. Intense exposure to blood components is one of the most serious risks that any health worker faces in the development of his function. Once the spill occurs, the entire area around the spill must be cleaned and disinfected and the exposed worker faces an uncertain future with consideration of potential infection with bloodborne pathogens. These pathogens include, but are not limited to, HIV, HPV, and other infectious agents.

Document US-A-5 776 118 discloses an apparatus for handling waste fluids in operating rooms comprising two sets of collecting tanks, valves and vacuum pumps, to allow the connection of the second set when the first collecting tank is full. This duplication, however, results in increased cost and size of the apparatus.

The present invention is well suited for use in the medical field, particularly in surgery units, clinical settings, intensive care and post-operative units, provided that such procedures and care have been performed in an operating room or other medical settings. This facilitates the extraction and disposal of certain fluids and liquids which are associated with medical procedures and protocols, and facilitates the assessment or measurement of the amount and other essential characteristics of such liquids, for example, saline, blood, plasma, ascites and the like, produced or used during such procedures or protocols.

In addition, the present invention is well suited for use in many other markets including, but not limited to, veterinary medicine, research facilities, manufacturing and industrial applications, death and mortuary research procedures, and industrial applications, research procedures. death and morgue, and food processing.

3. Summary

The present invention will reduce healthcare personnel contact and the potential for exposure to potentially infectious liquid wastes generated by medical procedures by providing a “no touch” fluid and liquid handling method for use by healthcare workers. health.

The present invention relates to an apparatus as named by appended claim 1 and a method as defined in appended claim 6.

In one embodiment of the present invention, a vacuum system, suitable for collecting medical procedure debris, is operably coupled to one or more executing terminations. The connector used facilitates the coupling of the executors to the pipe and is adapted to receive liquids and / or gaseous material. The system collects and measures the amount of liquid material and in some embodiments displays and stores information regarding the amount of such liquid material for later review by the medical staff leadership.

In accordance with another aspect, the present invention involves a suitable wall-fitted vacuum port connected to a central vacuum cleaner. Connected to the vacuum line is a collection vessel in which fluids are collected and fluid amounts and weights are measured and data stored. The collection vessel can be recyclable or disposable. In the case of recyclable containers and connectors and / or filter units, the bottle, connector and / or filter units are decontaminated before subsequent use.

In a further embodiment, the device is permanently installed within the wall structure of the facility, operably coupled to the existing facility wall suction system, and directly connected to both the facility electrical and sanitary sewer systems.

The device can be installed on the roof structure of the facility, using an installed suction facility and the electrical components of said facility or devices while incorporating a pumping system to remove waste fluids from the medical procedure site.

In the event that a suction line is not readily accessible in the installation, the device of the present invention can employ its own internal suction source such as a vacuum pump.

According to still a further embodiment, the device may be portable, for example, mounted on wheels or other suitable means of propulsion and with a secure or permanent connection to the suction source system, electrical components and sewer drain. This will facilitate maximum flexibility in the location of the device within the procedural setting. For example, the device of the present invention can be modified for installation and / or deployment in portable procedure locations, eg, ambulances, medical transports, portable surgical centers, and / or other standalone fixed procedure settings.

A further aspect of the invention is remote control activation and control by means of a touch or a voice activation mechanism to control and regulate the suction and measurement capabilities.

It is a further aspect of the invention that the connector structure includes more than one inlet connection, by means of which more than one terminal executor can be coupled to the central vacuum system. The flow rate or vacuum pressures with respect to each of the inlet connections can be displayed and controlled separately to provide different degrees of suction in a plurality of lines.

As a further aspect of the invention, certain features within the device will alert healthcare workers if the pressure within the system falls below levels set by the hospital or other medical facility. Parameters for displayed pressure, alerts, and alarm functions can be programmed into the system using electrical-based components or microprocessors installed in the device.

The connector used may contain a body having an inlet connection side and an outlet connection side. The outlet connection side is suitably adapted to be coupled to a typical vacuum port in the cabinet and the inlet connection side is adapted to an operable receiver or is coupled to one or more terminal actuators or conductive structures leading to the terminal executors. Any acceptable mating or connection methods can be used including "quick release" type connectors, Luer type,

ES 2 285 243 T3 stop connectors, screw type connectors, or bayonet connection structures. Additionally, proper coupling of the conduits and the connector of the present invention can be achieved by a simple friction fit.

The receptacle of the present invention can comprise a container molded as a bottle to hold a liquid and / or a gaseous medium and can facilitate the separation of a liquid from a gaseous material, however it involves a single suction source suitable for moving and collecting both liquid and gaseous materials inside the container module.

The receptacle may also include an anti-siphon mechanism, such as a swing check valve, to prevent back-flow or counter-flow of liquid content from the system to the procedure site if the suction system malfunctions or the device is otherwise malfunctioning. functioning.

In some embodiments, a chemical separator or other non-mechanical method of separation can be used. For example, a suitable medium can be arranged within or adjacent to the connector ports.

According to yet another aspect of the invention, within the body of the connector, there is a separation structure comprising a mechanical device for separation of the liquid as the gas / liquid combination flows through the separation chamber. The separation chamber may include a suitable fluid counter, flow meter, or monitor for measuring the amount of liquids passing into and / or through the baffle, the separation mechanism, or the trap. Both the original liquid / gas combination collected from the operating site as well as the liquid separated from the gas / liquid material are displaced by a vacuum generated by a suction system and are pushed into the inlet port of said suction system. Alternatively, a pump or other means can be used to convey the gas / liquid material. Each gas / liquid flow passage or conduit portion in the connector may have a separate liquid / gas spacer structure, or they may share a common spacer structure.

The receptacle may also include separation devices that employ a dual chamber to isolate and divert the gas and liquid mixture in a holding chamber, and may incorporate filter grids and screens to further promote gas and liquid separation.

It is contemplated that the separation of gas from liquid may incorporate a baffle, trap, or other suitable device, eg, a baffle, filter, etc. to optimize the separation of liquid and gaseous material.

A liquid metering capacity can be incorporated into the main line of the vacuum portion, that is, in the wall of the operating room, between the connector of the present invention and the inlet port, adjacent to the outlet port. , or in the central mechanical area.

A gas-permeable, but liquid-impermeable filter media is used to prevent accidental flow of liquid into the vacuum system. The filter medium is accessible for replacement or cleaning. The filter mechanism can incorporate sensors to inform healthcare personnel when and if their function is damaged or compromised.

The apparatus has a holding tank with an inlet side and an outlet side. The outlet side incorporates a valve-like mechanism, for example, a solenoid valve that holds fluid in said reservoir until it is opened to allow fluid flow into the metering chamber. The retention tank is preferably placed inside the cabinet of the device in a way that allows its contents to be examined by the healthcare team at any time.

The system further comprises a measurement chamber having an inlet and an outlet passage. Both passages are controlled by a valve mechanism, for example solenoid valves, which work in conjunction with and under the direction of a programmed microprocessor. During the measurement cycle, the flow outlet (bottom) solenoid valve is in the closed position and the top solenoid valve is open, allowing fluids to flow into the measurement chamber. When a sensor, for example a ball float, detects that a predetermined amount of fluid is inside the chamber, the upper solenoid valve closes and measurement is started.

The recorded measurement is a function of the measurement chamber capacity after the sensor closes the upper solenoid. When the amount of fluid inside said measurement chamber is calculated, the measured volume is transmitted to the microprocessor and the data is added with the previously measured volumes and shown to the medical personnel as previously indicated, on the front face of the device, or in a place away from the device. Alternatively, the measurement can be a flow of fluid of known density through a sensor using one of several forms of measurement, eg, an infrared sensor, as a means of determining volume. Separated fluids are measured by volume passing into a metering container of known volume through a valve switching system which may include, but is not limited to, a solenoid valve.

Alternatively, the fluids can be extracted from the container by a pump, such as a peristaltic pump, where the volumes of liquid extracted by said pump can be calculated, using such parameters as the number of revolutions of the rotor of the pump coupled with the capacity of the internal piping of said pump. As the fluid passes through the peristaltic pump, each revolution has been calibrated in a way that allows a volume value in millimeters to be associated with each revolution. As each revolution is counted, that volume value is transmitted to a display on the front of the panel, updating the volume reading. At the conclusion of the surgery, the value can be transferred to a paper record on the patient's chart and balanced with the fluid input amounts to ensure that no excess fluid has been left in the body cavity and that no excessive loss of fluid that cannot be identified has occurred.

It is contemplated that fluids may alternatively be measured by monitoring and recording pump duty time, liquid weight, or direct volume measurement through the use of flow counting.

Fluid volume measurements are preferred.

ES 2 285 243 T3 ribly stored within a central storage mechanism, such as a microprocessor, and the total volumes of fluid stored during a given procedure are tabulated and displayed on the front face of the unit. These volume measurements can be stored and displayed at other sites within the facility or they can be transmitted to outside storage sites. Data transmission methods may include rugged wiring through electrical facilities or telecommunication lines, or by means of wireless transmission or other acceptable means of data transmission. These values ​​can be displayed as a time course line against extracted volumes.

According to yet another feature, the separated fluids can be retained in a holding chamber using a valve system, for example a solenoid switch, to contain the fluids until they are processed through the metering chamber or until such time. time as an alternate measurement method is completed and the data is transmitted to the microprocessor. The measurement criteria can include other parameters, for example, the weight of the fluid. Here, the measuring container can be suspended from a load cell or strain gauge and produces an output proportional to weight.

The system of the present invention may include an input feature, such as a keyboard counter, touch screen or the like where the amount of liquid brought into the device from the procedure site is measured, stored and / or displayed, and where a known quantity of liquid, eg, saline, anesthesia materials, etc., can be injected into the device. In this embodiment, a calculation feature, for example a microprocessor, a calculator or the like, is provided where the amount of the input liquid can be subtracted from the total volume displayed to calculate, for example, blood loss or saline solution. in use during a surgical procedure. Other calculations can be carried out in addition, such as the calculation of flow rates or weight of the materials thus extracted or measured.

Alternatively, the device can accept the use of a docking port for the use of a computer CPU and input devices, including touch screen and personal data equipment, which can operate in a stand-alone station or in a network capacity. It is anticipated that a printing capability will be available, and the data can be logged and stored for further processing and use.

The above-mentioned remote device can store and display data pertaining to volumes of collected fluids, volume of fluid entered, estimated total blood loss, weight of fluid entered, and other pertinent information including, but not limited to, the system pressure values, course line analysis, calculation and alarms. It is also contemplated that the remote device may have a camera that allows remote monitoring of the color of the fluid within the holding tank.

The fluid from the metering chamber is discharged into a sanitary drain by opening a valve, for example a solenoid valve, on the flow outlet side of said chamber following measurement of the volume of fluid within the said camera and the transmission of the data to the microprocessor. A pressure release valve facilitates the discharge of ambient air to allow a faster emptying of said tank.

In a further embodiment, a device having a holding tank with an inlet side and an outlet side, and a separate sensing tank in which the sensors are positioned such that activation of an electronic sensing element results in activation or deactivation of a pump to control the level of the fluid within the reservoirs. The reservoirs are connected by a pipeline or other vehicle such that the levels within said reservoirs remain the same. When the high level sensor is activated, fluid is pumped from the reservoirs into the drain line and is measured as it passes through the pump. When the fluid level drops below the lower sensor, the pump shuts down. The process repeats itself throughout the process with the resulting volume of fluid pumped from the reservoirs being continuously tabulated and displayed on the front face of said device.

In one embodiment, the device has a sensor within the holding tank that activates the pump when a flow spill situation occurs. Said holding tank contains a mesh filter located just below the overflow sensor that captures and neutralizes any foam created by the turbulence of the liquid entering the holding tank.

In accordance with another aspect of the invention, information pertinent to fluids entered during a procedure can be entered and stored using automated features, eg, barcode reading of saline packaging.

A cleaning fluid can also be injected into the chamber for chamber cleaning after the lower solenoid valve is activated to release its contents, thereby preparing said chamber for the next measurement cycle. Once the rinsing operation is completed, the lower solenoid valve closes and the next measurement can be performed. Cleaning equipment can facilitate post-procedure decontamination of the internal surfaces of the system. The cleaning solution can be stored within the cover of the device or it can be applied externally, via a suction port. The storage container can be disposable or refillable and contains a pre-mixed concentration of cleaning and sanitizing solution. For example, the decontamination unit can take the form of a plastic container which contains a pre-measured quantity of a decontaminating, disinfecting, sterilizing or cleaning solution. In one embodiment the decontamination unit is adapted to be attached to the filter box or connector and the contents are then removed from the container upon activation of the vacuum source. Once emptied, the container can be disposed of and the system is ready for its next use. The decontamination unit can also include a mechanism or structure to regulate the flow, and / or the decontaminants can be loaded or contained in separate compartments through which they can be delivered together, selectively or sequentially.

ES 2 285 243 T3

The cleaning solution container may contain a concentrated solution that is mixed with water drawn from the water supply facilities or an alternate source of water or a source of saline solution. In addition, the amount of solution in the container can be shown to healthcare personnel for monitoring.

The cleaning solution can be introduced into the separation chamber to allow cleaning of all interior surfaces following the completion of the procedure, or alternatively, it can be introduced into the measurement chamber as a means to rinse and clean the chamber continuously. during the procedure.

In the preferred embodiment, the screen can also include warnings, alarms and other means of notifying health personnel of anomalies, low levels of fluid within the bottle or other parameters to be identified.

The system and method of the present invention can be used in situations and applications in a field other than medical. For example, in certain industries and manufacturing processes, scrubbing or fluid flows are used for cooling and lubrication while a particular procedure is taking place. In these situations, it may be desirable to contain, control or manage the flow of cooling or lubrication material and to measure the amount of liquid that is being used or consumed by the process. Similarly, potentially hazardous and infectious materials in other markets, including but not limited to veterinary medicine applications, research, manufacturing, and industrial facilities, and morgue and death investigation procedures, and food processing applications, present opportunities for additional applications of the invention in all its embodiments.

Other features and advantages of the invention will become apparent from the following detailed description of a preferred embodiment, especially when considered in conjunction with the accompanying drawings in which the numbers in the various views refer to corresponding parts.

Four. Brief description of the figures

Figure 1 is a front view of the panel face of the device comprising a preferred embodiment of the invention;

Figure 2 shows a sectional sectional view of a device not in accordance with the present invention showing the internal structures located within the wall of the device;

Figure 2A shows an embodiment of the apparatus of the invention;

Figure 3 is a close-up view of the inlet ports and pressure gauge displays shown in Figure 1;

Figure 4 is a close-up view of the inlet ports and pressure gauge display shown in Figure 1;

Figure 5 is a close-up view of the fluid volume screen and the calculation function;

Figure 6 is an embodiment of the remote instrument that stores and displays information pertaining to the volume of fluid drawn from the site, volumes of fluid entered, estimated fluid loss, weight of fluid removed, and the weight reference point for evaluation. the density of the sucked material;

Figure 7 is an interpretation demonstrating the fluid loss calculation.

Figure 8 illustrates an access panel with features such as On / Off control, Cleaning Cycle control, Remote Activation control, and Data Store Command.

Figure 9 is a view of a possible barcode reading function;

Figure 10 illustrates the Cleaning Cycle procedure using a separate bottle;

Figure 11 shows an internal cleaning solution storage bottle that can drain through the separation chamber or directly into the measurement chamber, and

Figure 12 is a schematic diagram of the electronic controller used in the system.

5. Detailed description of the realizations

With respect to the fastening, mounting, joining or connecting components of the system of the present invention to form the connector or the system, as a whole, unless otherwise specifically described, as they are directed to include conventional fasteners such as screws, bolt and nut connectors, snap rings, clamps, such as hose clamps, screw clamps and the like, rivets, turnbuckles, pins, and the like. The components can also be connected or coupled by welding, friction fit or deformation. Electrical components and connections can be made using appropriate electrical components and connection methods including conventional components and connectors and suitable display devices such as digital or analog devices, LEDs or other light sources and the like, and suitable integrated electrical components or microprocessor. . Measurement devices, such as flow meters, sensor transducers, and the like for measuring volume, flow rate, weight, or amounts of liquid, can be selected from such measurement devices which are suitable for use in the present invention. . Unless otherwise specifically disclosed or taught, the materials for constructing components of the present invention may be selected from appropriate materials such as metal, metal alloys, fibers, plastics, and the like, and appropriate manufacturing and production methods including methods that include casting, compression, molding and machining can be used.

As shown in Figure 1, the present invention relates to an automatic liquid collection, measurement and disposal device for use in various surgical and post-operative situations in which potentially infectious waste must be removed from the patient's environment, collected and measured for amount of fluid, providing the methods of calculating certain aspects of hemostasis, and automatically eliminating said fluid with minimal contact by the healthcare team. In one embodiment, the present invention encompasses a system enclosed in a cover such as a cabinet 14 in which patient fluids are collected by a terminal stripper (not shown) coupled by tubing to a vacuum source connected to a suction port 1 The suction source can be installed inside the unit or it can depend on existing suction sources. Fluid and gaseous matter is separated within the cabinet unit 14

ES 2 285 243 T3 and the retained fluid is maintained, measured and the data relating to the collected volume is stored before disposal. In the embodiment shown, such a system may include a pair of inlet ports, here labeled port 1 and port 2. Pressure screens 2 and 3 are provided for each port. Also, a fluid quantity display 4, a keyboard 5 for calculating, an observation port 6 and an accessory control panel 7 are built inside the cabinet unit cover 14.

As shown in Figure 2 which differs from the present invention in that it does not encompass a P-pump, but is shown to illustrate the principle of the invention, liquid and gaseous debris from the injury site are sucked into the port of entrance

I that is operably coupled to the injury site by a Luer-type closure 7 that is operably attached to tubing 8 leading to the injury site and through which liquid and gaseous matter is collected. The fluid passes through a separation chamber 9 and the liquid component is deposited in a retention chamber 10. The gases are evacuated through a suction line 9A while the liquid accumulates in the retention chamber 10. When the measurement cycle begins, the holding chamber empties its contents into the measurement chamber 12, via the solenoid valve 11, until the capacity of the chamber 12 is reached, causing the upper solenoid valve 11 to close. . The measurement chamber 12 performs its measurement, sending the data to screen 2 (fig. 1) and storing the information in the memory of the calculator 4. Once the measurement is completed the lower solenoid valve 13 opens and the measurement chamber empties its contents through the pipe (not shown) directly to the sanitary drain. Once empty, the solenoid valve 13 closes and the solenoid valve

II is reopened, starting another measurement cycle. This cycle is automatically repeated until the medical team completes the procedure or ends the measurement cycle.

As shown in Figure 2A, fluid and gaseous waste from the injury site is sucked into the inlet port 1 which is operably coupled to the injury site by a Luer lock 7 which is operably attached to tubing 8 , which is prolonged to the site of the injury and through which the fluid and gaseous matter is collected. The fluid passes through the separation chamber 9 and the fluid is deposited in a retention chamber 10. The gases are evacuated through a suction line 9 while the liquid accumulates in the holding chamber 10. When the liquid level reaches the upper level sensor HS, the measurement cycle begins. A pump P starts and empties the reservoir 10 until the low level sensor LS is reached, causing the pump P to stop. An emergency sensor ES is supplied to close the suction line 9A in the event that the pump fails to start when the high level point is reached. This prevents the liquid from being sucked into the vacuum line. The measurement is completed by multiplying the pump operating time by the volume movement capacity per second of the pump. This data is sent to screen 2 (fig. 1), which visually presents the data accumulated and stored in the calculator's memory 4. The cycle is completed automatically until the medical team completes the procedure or stops the measurement cycle.

Figure 3 depicts pressure indicator display panels 2 and 3, which provide pertinent information on the ambient pressure drop within the system, measured in millimeters of mercury or other suitable units. Such pressure drop information is important to surgical personnel to ensure that adequate suction is available for fluid transfer and that there is no potential for return flow that would compromise the injury site and healthcare team. In the exemplary embodiment, a pressure state is indicated by a liquid crystal or an LED digital display. Alternatively, the pressure status can be supplied by a colored light or by an audible beep. This alarm function is programmable using keypad 5 (figure 1).

Figure 4 describes the flow of fluid and gaseous material through the separation chamber 9. The fluid and gas waste is received through the inlet port 1 which is secured with an anti-siphon valve 17 to avoid an accidental backflow of fluid and gas to the collection site. The gas and fluid mixture is separated by the baffle mechanism 18 with the fluid falling into the holding chamber 10 and the gas traveling upward through a filter mechanism 19 which is designed to prevent accidental leakage. of liquid in the primary suction line 20 that is connected to the hospital suction system or in a separate suction source embodiment of its own.

Alternatively, in Figure 4, a suds suppressor is supplied. The fluid enters the primary chamber 9 below a filter mesh foam separator 9 '. As mentioned, the fluid and gas waste is received through the inlet port 1 which is secured with an anti-siphon valve 17 to prevent a backflow of fluid and gas to the fluid collection site. The secondary chamber is connected to the primary chamber in such a way as to allow the free and balanced flow of liquids between the chambers while limiting the presence of foam in the secondary chamber. 10.

Figure 5 is a close-up view of the fluid quantity function 4 of figure 1 and the keypad 5. The fluid screen records the quantity of fluid that has been measured in the metering chamber and disposed of into the sanitary drain. The numeric keypad has a number of uses, including calculating final blood loss estimates, and other features that can be accessed via the 21 function keys. Other data can be stored using at least one function key. For example, the fluid added to the surgical field can be entered into the display panel of the computer 4, allowing the automatic calculation of the fluid loss which decreases the potential for human error in the addition / subtraction. It is further contemplated that a printer (not shown) is supplied to produce the documentation for the patient chart. Real-time input capabilities, either manually or via a barcode reader, allow the surgical team to estimate estimated blood loss or fluid retention during the course of the surgical procedure rather than at the end of the procedure.

Figure 6 depicts an embodiment of a remote instrument 23 that supplies relevant information

ES 2 285 243 T3 current state of the total volume of fluid withdrawn from the injury site on screen 24, the amount of fluid that has been introduced into the surgical field on screen 25 and the calculation of the estimated fluid loss on screen 26. The instrument may also include a display that describes the actual weight of the fluid drawn from the injury site by means of display 27 and the estimated weight of said fluid if it was composed of 100% saline irrigation on display 28. These Descriptions may contain important clinical information for the surgical team pertinent to the nature and composition of the fluid being removed from the injury. The remote instrument can also display information pertinent to ambient pressure within the suction system, including, but not limited to, actual pressure, warning screens, and alarms. A wireless communication link can connect the unit in the operating room to a remote device 23. The device can provide real-time data on suction fields, as well as provide a function screen showing fluid volumes and estimated fluid loss, allowing the anesthetist or staff at a remote monitoring site to be alerted to changes in fluid balance and determine if other vital signs are abnormal. Instrument 23 may also incorporate a touch screen 29 as a data entry means.

A calculator for calculating the estimated fluid loss is described in Figure 7. At the conclusion of the procedure, a healthcare professional types the volume of fluid entered on the keyboard 5, using the keyboard function. Once the fluid entered is entered, additional calculations can be entered through the keyboard to account for the blood and fluids retained by the absorbent materials. Once the entered and adjusted calculations have been made, the keypad is activated and an estimated blood loss is calculated and stored in the calculator's memory for an operational report. It is also contemplated that the display of the calculator 5 has a touch screen capability, adding additional input capabilities that are offered by the keyboard.

In figure 8 a further embodiment of the accessory panel 7 is described which facilitates the operator with the selection choices of such auxiliary functions as On / Off (push button 32), Cleaning (push button 33), Remote Activation Control ( push button 34), and Data Store Command (push button 35). These are representative characteristics and are neither exclusive nor limiting. Other features can be added or replaced as determined by technological advances, regulations or user needs.

Figure 9 depicts an embodiment of a method for automatically entering and storing pertinent information of fluids being introduced to the injury site from an external source. The saline packet 36 has a barcode that is scanned by a barcode reader 37 that is operably coupled to the data storage module 60 of the system. The volume of saline solution and possibly other information can be automatically taken into account in the final blood loss calculation and can also be sent to other departments in the facility for data collection purposes and inventory analysis and management.

Figure 10 is intended to illustrate additional accessories for implementing a cleaning cycle for the system to be used at the completion of a service cycle. The cleaning solution kit consists of a bottle 39 containing a predetermined volume of a liquid cleaning solution, a tube 40 and a Luer connector 41 to couple the assembly to the inlet port 1 (fig. 1) by the Luer connector crimp 41 . The operator activates the cleaning cycle by depressing the cleaning cycle switch 33. Fluid is drawn from bottle 39 and passes through the valves and chambers shown in Figure 2 before passing to the sanitary drain. Once the cycle is complete the Luer connector 41 will be disconnected from the inlet port and the cleaning solution kit is disposed of as a biohazard waste.

An alternative embodiment is depicted in Figure 11 in which the cleaning solution is stored in a container 42 within the device cabinet 14 adjacent to the separation chamber 9. When the operator activates the cleaning cycle, a predetermined volume of cleaning solution it enters the device through a solenoid valve 43 into the separation chamber 9, preparing the instrument for the next use. An alternative embodiment facilitates continuous cleaning of the device during the procedure with those amounts being stored for later analysis and comparison with the estimated blood loss. In this embodiment, the actual amounts of cleaning solution used can be displayed on the front panel of the device cabinet 14.

Figure 12 is a schematic diagram of the control module for the system of the present invention. It is seen to include a microprocessor 50 having an address wire 52, a data wire 54, and a control wire 56 connected to ROM memory 58, a RAM memory 60, and an input / output (I / O) interface 62. The microprocessor 50 is adapted to the manual reception inputs from a keyboard 64, by means of the input / output module 62 as well as to the signal inputs of a revolution counter 66 of a peristaltic pump. Thus, depending on the type of volume measurement system incorporated, the volume information will be either manually entered, via the keyboard, or automatically entered from the pump's revolution counter 66.

Under the control of a program stored in ROM memory 58, the microprocessor will control solenoid valves 11 and 13 (fig. 29) to first transfer fluid from chamber 9 to weighing and measuring chamber 12 and to subsequently empty the weighing chamber. weigh 12 once the appropriate measurements have been obtained. In the case of the embodiment of fig. 2A, the microprocessor will receive inputs from the level sensors LS and HS and ES to control the on / off state of the pump P and will accumulate data of liquid fluid from the revolutions of the pump or from a flow meter arranged in the line leading to sanitary drainage.

Screens 1 and 2 shown in Fig. 3 as well as screen 4 in Fig. 4 receive information from the microprocessor 50, through the module en8

ES 2 285 243 T3 input / output, as indicated by block 70 in a schematic drawing of Fig. 12.

The remote instrument illustrated in Fig. 6 is coupled via a wireless link 72 to the input / output interface 62 with which the data computed and entered into the RAM memory 60 can be transferred to the remote station 74. On the other hand , data originating from remote station 74 can be transferred via wireless link 72 to microprocessor 50.

Since the calculations necessary to operate the system of the present invention involve only simple mathematical operations of addition, subtraction and multiplication, the application program executed by the microprocessor 50 can quickly be perceived by those skilled in the art, obviating the need to establish hereafter the source code at this point.