Body fluid discharge control device, system, and method

Abstract

Described herein is an automated fluid drainage control device and system and a safety system that works in conjunction with clinical professionals to define protocols and methods for a given patient population to ensure that fluid drainage from the patient is safe and effective. The system also allows for the transport of drainage instructions from a system external to the drainage system and periodically returns drainage data to the external system for inclusion in the patient's chart.

Description

[Technical Field]

[0001] The subject matter of the present disclosure relates to providing devices, systems, and methods for managing cerebrospinal fluid, and more particularly to devices, systems, and methods for draining, analyzing, and controlling cerebrospinal fluid. [Background technology]

[0002] Cerebrospinal fluid (CSF) management involves the application of devices such as shunts, valves, and external drainage systems to optimize the volume and / or pressure of the intracranial cavity and, if necessary, drain excess CSF. CSF management is widely used in the treatment (including surgery) of traumatic brain injury, hydrocephalus, and neurological disorders such as Parkinson's disease and Alzheimer's disease.

[0003] Drainage of cerebrospinal fluid from a patient is traditionally accomplished using one of two methods: lumbar drainage and ventricular drainage. Accessing cerebrospinal fluid involves inserting a catheter into the patient's subdural space. Lumbar drains are placed between the L5-S1 vertebrae (e.g., the subarachnoid sac) in a manner similar to how epidural anesthesia is inserted into the spine. With ventricular drains, a catheter is surgically inserted between the skull bones. In either case, the catheter is then connected to a drainage system that allows for some control over the amount of fluid drained from the patient. The physician then commands the drainage of CSF either at a fixed rate per hour (lumbar drainage) or when intracranial pressure exceeds a predetermined amount (traditionally expressed in mmHg or cmH2O). A schematic diagram of a typical human anatomy and the associated catheter placement and use is shown in Figure 1.

[0004] Body fluid drains and containers are well known in the art. Examples include urinary and other collection devices for draining and collecting cerebrospinal fluid. None of these devices allowed for easy control of the rate of fluid drainage as a function of time until the introduction of U.S. Patent No. 8,475,419 to Eckermann for an "Automated body fluid drain control apparatus and method," which expanded the art. In connection with the drainage of cerebrospinal fluid ("CSF"), in most individuals, the body produces 450 cc of CSF, which fills the body's subarachnoid space over a 24-hour period. There are many instances in which it may be desirable and / or necessary to drain a portion of the CSF. For example, during certain medical procedures, such as brain surgery, surgeons may wish to drain a portion of the CSF to relieve pressure in the intracranial compartment. Additionally, some brain and spinal surgeries in which the dura is penetrated require partial drainage of the CSF to relieve pressure on the wound so that it can heal. Also, in certain head trauma cases where CSF accumulates in the cranial cavity, it may be desirable to drain some of the CSF from the subarachnoid space in the lumbar spinal region to relieve pressure on the brain. Other patents exist in the art, including U.S. Patent No. 9,717,890 to Holper, Traxler, Schroter, Martens, and Holper for a "Drainage system for cerebrospinal fluid."

[0005] Traditional methods of CSF drainage involve creating a tap into the cranial cavity or the subarachnoid space within the spinal column and draining excess CSF through a catheter tube into a reservoir bag. The amount of drainage must be controlled, as draining too much can cause irreparable or fatal damage to the patient.

[0006] Unfortunately, although CSF is produced at a constant rate, the rate at which CSF is removed is not linear. For example, CSF may be removed at 1 cc per hour, then suddenly, 5 cc in 10 minutes. The volume removed must be constantly monitored by the nurse, as removing too much CSF can have irreversible, potentially fatal, consequences. Due to the nonlinear nature of removal and the demands on the nurse's time, a potentially fatal margin of error exists. Therefore, a device for continuously monitoring and controlling CSF removal, as described in U.S. Pat. No. 8,475,419, has been a great boon to the art.

[0007] Volumetric Emission

[0008] As taught in U.S. Patent No. 8,475,471, when a computer-controlled drainage system is utilized to automate cerebrospinal fluid drainage, clinical outcomes for patients can be significantly improved. Passive drainage systems rely on the relative position of the (gravity-driven) drainage system to the patient and the natural pressures generated by physiological processes in the ventricular and subarachnoid spaces (including the central canal of the spinal cord). This process allows for over-drainage of the CSF system within a desired drainage time period. For example, if the desired drainage were to occur over an hour to match the physiological output rate, a drainage of 20 cc per hour would result in all 20 cc being drained within seconds. This significantly reduces CSF pressure and volume, which could potentially lead to hemorrhage. Conversely, in severe trauma, intracranial pressure increases in response to the trauma (due to excessive production of CSF, edema, or blood or other introduced fluids, or other physiological responses), and rapid reduction in pressure and volume may be desirable. Thus, it may be desirable for a programmable volumetric output bolus to initially decrease in volume followed by a return to the previously desired output rate. Additionally, it may be desirable to set minimum and maximum volumetric output limits based on patient population (e.g., pediatric patients versus adult patients may have different minimum and maximum volumetric output limits), initial output default values ​​(e.g., always start at 15 mL / hr for adult patients), minimum and maximum output adjustment (change) limits (e.g., do not adjust output by more than 10% at a time), and an adjustment lockout period (e.g., require the user to wait at least 10 minutes before making another change). Other disclosures known in the art include U.S. Patent Application Serial No. 17 / 466,301 to Morse, Morse, for "Body Fluid Management Systems For Patient Care."

[0009] Furthermore, cerebrospinal fluid is routinely collected during the procedure, requiring access to the fluid before exposure to external contaminants such as air (oxygenation) or body fluids that have been stored for a period of time (biological growth). To further complicate matters, the total volumetric output for a given period cannot be determined without control over the collection means and the volume collected. In the prior art, it is common for CSF samples to represent more than 25% of the programmed total volumetric output for any one period.

[0010] Continuous manometric drainage

[0011] In existing drainage systems, manual pressure measurement systems involve manually opening and closing a stopcock and draining the patient using a combination of fluid pressure at head height to maintain a given intracranial pressure (ICP). These systems have an external fluid-filled transducer that measures the patient's ICP using the pressure at the time of the conversion. Alternatively, these systems can measure ICP using an implantable pressure sensor in a ventricular shunt. In either case, the pressure sensor is not in communication with the manual drain and does not provide feedback to the user or control of the discharge rate. Furthermore, because the manual drain is not in communication with the pressure sensor, the accuracy of the pressure sensor fluctuates depending on the state of the unidentified stopcock. When open, the pressure sensor's accuracy decreases, indicating a noticeable decrease in pressure. When closed, the accuracy returns to a nominal value, and the measured pressure value suddenly returns to normal. Thus, a drain in communication with various means of measuring ICP can adjust the drain's open and closed states to provide normalized pressure values ​​for standardized pressure measurements regardless of the drain's state. Furthermore, unlike manually operated drains, an automated system can open and close the drain many times per minute to achieve a target ICP and provide highly accurate measurements of the patient's ICP.

[0012] During CSF drainage, especially ventricular drainage, it is important to ensure that the device is level with or below the interventricular foramen (also known as the foramen of Monro), which lies behind the fornix and body and anterior to the thalamus, between the roof of the third ventricle and the anterior wall of the third ventricle. This provides the zero reference point for "extraventricular" pressure measurements. Ideally, the zero reference should be at the external auditory canal (EAM) or between the eyebrows for the central brain pressure (BC) when the head is in a strictly supine or lateral position. A 45° head elevation angle was found to overestimate central brain pressure (ICP) by 4.8 + / - 0.8 mmHg, an upright position overestimated ICP by 5.6 + / - 0.5 mmHg, and a 45° lateral position resulted in an underestimation of ICP-BC by 6.3 + / - 1.0 mmHg. The Monro line is located 45 ± 5 mm rostral to the midpoint of the orbital-ear (OM) line, 24 (18–31) mm inferior to the BC, and 13 (8–17) mm anterior to it. A zero reference point aligned with the highest point on the head underestimates the BC-ICP and Monro ICP. Adding 5.9 mmHg or 6.3 mmHg, respectively, to these ICP measurements resulted in deviations of ≤ 1.8 mmHg from the BC-ICP and ≤ 0.9 mmHg from the Monro ICP in all head positions. The EAM and glabella are defined as anatomical structures representative of the BC in the strictly supine or lateral position, but there is a 12 mmHg variation in the different head positions used in clinical practice. The OM line is contiguous with the Monro line when the head is elevated, but not when the head is rotated. When the highest external point on the head is used, ICP values ​​at the brain surface, Monro line, and BC are underestimated. This underestimation is fairly constant and, when corrected, provides the most accurate ICP measurements, as found, for example, in "Best zero level for external ICP transducer" (Peter Reinstrup et al., Acta Neurochir (Wien) 2019, 161(4): 635-642, available at https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC6431298 / ). Therefore, to ensure accuracy of ICP pressure, it is necessary to monitor both the interventricular reference line and head position.

[0013] ICP waveforms can be characterized into normal and abnormal patterns. Referring to Figure 9, a normal ICP waveform is shown showing P1 (impingement wave), P2 (high wave), and P3 (dicrotic peak).

[0014] Attempts have been made by Hammar et al. to use ICP pulse morphology as a surrogate marker of intracranial elastance. They determined that the systolic portion of the vascular ICP waveform reflects arterial activity, while the trailing, descending portion represents SVC pressure. Therefore, if ICP increases, the trailing portion of the ICP waveform (P2 component) will take on the shape of an arterial pulse, and if there is an increase in CVP, the waveform will approach a venous pulse.

[0015] When ICP increases, the vascular (cardiac) waveform amplitude increases, and the respiratory waveform amplitude changes in response to the vascular increase. Other visible phenomena of dysfunctional intracranial compliance include the occurrence of P waves, elevated P2, and waveform rounding. The occurrence of these phenomena is useful in clinical practice in that they alert the neurologist to urgently initiate ICP control measures. It is pertinent to point out that increased ICP can produce characteristic waveforms variously classified by Lundberg as A, B, and C waves. The ICP waveform shown in Figure 10 indicates increased intracranial pressure.

[0016] Referring to FIG. 11, the Lundberg A wave represents the largest increase in ICP (50 mmHg to 100 mmHg). The A wave generally indicates a high rate of cerebral ischemia and impending cerebral herniation and lasts for 5 to 10 minutes. The Lundberg B wave occurs for a shorter period (1 to 2 minutes), and the ICP rise is less significant, at 20 mmHg to 30 mmHg, and is rhythmic in nature. The B wave indicates progressive brain damage, which causes a gradual increase in ICP. The Lundberg C wave correlates with blood pressure fluctuations driven by baroreceptor and chemoreceptor reflex mechanisms and has no clinical significance (see Nag et al., World J. Clin. Cases, Jul 6, 2019, 7(13): 1535-1553, "Intracranial pressure monitoring: Gold standard and recent innovations," https: / / www.wjgnet.com / 2307-8960 / full / v7 / i13 / 1535.htm, last accessed June 14, 2021).

[0017] An additional use case for CSF drainage is the treatment of normal pressure hydrocephalus (NPH), a clinical condition characterized by enlarged ventricles (Hakim & Adams, 1965) and symptoms of gait disturbance, enuresis, and cognitive decline (Fisher, 1982; Williams & Malm, 2016). A shuffling gait with small steps is an early and prominent symptom, which may be due to direct pressure on the midbrain gait center by the enlarged third ventricle (Lee, Yong, Ahn, & Huh, 2005). Gait disturbance provides an opportunity to assess disease progression (Chivukula et al., 2015; Williams et al., 2008) and may even help predict favorable postoperative outcomes (Gaff-Radford & Godersky, 1986).

[0018] If the underlying pathology is inadequate CSF reabsorption, surgical shunting of CSF into the venous or peritoneal cavity may alleviate symptoms, but postoperative success depends on the correct diagnosis. NPH can coexist with, be caused by, and mimic different forms of atherosclerosis.

[0019] A direct method for diagnosing NPH is the constant-infusion lumbar infusion test (LIT, Katzman & Hussey, 1970), in which imitation CSF is injected into the spinal cavity through the intracranial Sylvian aqueduct to stress the brain's ability to reabsorb CSF (Ryding, Kahlon, & Reinstrup, "Improved lumbar infusion test analysis for normal pressure hydrocephalus diagnosis," Brain Behav. 2018 Nov;8(11):e01125, https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC6236248 / , last accessed June 14, 2021).

[0020] The goal of LIT is to increase intracranial CSF volume by lumbar injection of sham CSF. As intracranial CSF volume increases, the only volume that can be reduced to an equal extent is venous volume, since CSF is not compressible. Similarly, the volume of arterial blood delivered to the intracranial cavity during each systole is compensated for by the same amount by compressing the venous pool. Increased resistance to venous blood flow due to venous vascular compression increases intracranial pressure (ICP; Marmarou, Schulman, & Rosende, 1978).

[0021] The LIT test is a combination of volumetric lumbar injection and ICP pressure measurement. In one study, the lumbar injection test was performed using a constant infusion rate (0.80 ml / min) and was considered positive if the steady-state CSF plateau pressure reached a level greater than 22 mmHg (resistance to outflow >14 mmHg / ml / min).

[0022] Another diagnostic test for NPH is the CSF tap test (also known as the cerebrospinal fluid tap test, tap test, or Miller-Fisher test), which typically involves removing 30 mL of CSF via lumbar puncture, after which cognitive function is assessed.

[0023] The predictive value for a positive NPH result is 80% for the lumbar injection test and 94% for the tap test. The disclosed system accommodates both drainage modes with the ability to connect to an external infusion pump, which is connected to a Y-site located distal to the patient but proximal to the disclosed system. The infusion pump reports its infusion rate directly to the disclosed system, which measures ICP using its internal pressure transducer.

[0024] Traditionally, in the prior art, cerebrospinal fluid (CSF) was tested using a process in which a CSF sample was removed from a patient based on an identified risk or event. The fluid was then tested in a laboratory to detect blood and blood products from hemorrhage. In this situation, the fluid from the patient contains red blood cells unless they have undergone complete metabolism, an event that typically takes at least seven days to occur. The red blood cells lyse, releasing oxyhemoglobin, which is subsequently converted to bilirubin. After centrifugation, the culture supernatant appears pink or pinkish-orange in color due to oxyhemoglobin, yellow due to bilirubin, or somewhere in between if both are present.

[0025] With the advent of spectrophotometry, laboratories can now distinguish between oxyhemoglobin (413nm-415nm), oxyhemoglobin and bilirubin (broad peak / shoulder at 450nm-460nm), and bilirubin alone. Methemoglobin can also be distinguished (shifted from 405nm to 413nm when oxyhemoglobin is present). It is also possible to distinguish between glucose (~1500nm), insulin (260nm-350nm), and proteins (up to 1575nm) in body fluids.

[0026] All of these methods rely on traditional laboratory techniques and instrumentation that are applied to the entire liquid column and require re-sampling each time a test needs to be performed.

[0027] With the advent of electromechanical fluid drains, it is now possible to develop and implement clinically driven safety protocols that control and direct the device to more safely drain fluids from a given patient population. In today's environment, all patients are treated by the device as the same. This expansion into the art allows the device to recognize patient-specific physiological parameters and clinical diagnoses, including comorbidities, that instruct the device on how to properly monitor and drain the patient. Furthermore, the same device can be customized for any given patient using a set of clinical parameters entered into the device by the clinician to select the unique drainage conditions applicable to that patient.

[0028] We also discuss the need for new ways to input and select user preferences and data from electromechanical drains for reporting and transmission to a broad ecosystem of interoperable components. Current technology does not provide a means to electronically define or control drainage behavior from a remote system and publish those behaviors to the electromechanical drain. Furthermore, there is no way to define standard values, including boluses, and weaning and adjustment limits for the drain. Finally, today's drain data is manually charted in the patient's chart, which allows for significant inaccuracies due to human error.

[0029] This process begins with the creation and approval of a Drain Protocol Safety Library (DPSL). This DPSL addresses clinical behavior for drainage protocol modalities, including lumbar and ventricular drains. Such protocols include the initial identification of the drain modality, which allows various clinical functions to be defined and controlled for the device. The primary driver of protocol modality is clinical judgment for volumetric or pressure-based drainage. Limits and behaviors are then categorized into protocols according to this overall function. Summary of the Invention

[0030] The present disclosure provides devices, systems, and methods for controlled fluid drainage, particularly of cerebrospinal fluid, which, as discussed above, offer numerous improvements over the prior art.

[0031] In combination with a drain system, the state of the art can be extended to include rapid, repeatable measurements with liquid still in fluid contact with the patient.

[0032] These and other aspects of the invention disclosed in the Detailed Description represent improvements over the state of the art. This Summary is provided to introduce in a simplified form a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0033] BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The foregoing summary, as well as the following detailed description of various aspects, will be better understood when read in conjunction with the accompanying drawings. For purposes of illustration, the drawings show exemplary embodiments, but the subject matter of the disclosure is not limited to the specific methods and instrumentalities disclosed. In the drawings, like reference characters generally refer to the same components or steps of an apparatus throughout the various views. In the following detailed description, various aspects of the invention will be described with reference to the following drawings: [Brief explanation of the drawings]

[0035] [Figure 1] 1 shows a schematic diagram of typical human anatomy and catheter placement and use.

[0036] [Figure 2] 1 shows a schematic diagram of a system implementing aspects of the present disclosure.

[0037] [Figure 3] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0038] [Figure 4] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0039] [Figure 5] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0040] [Figure 6] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0041] [Figure 7] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0042] [Figure 8] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0043] [Figure 9] A graph of a normal ICP waveform is shown.

[0044] [Figure 10] 1 shows a graph of an ICP waveform indicating increased intracranial pressure.

[0045] [Figure 11] This shows a graph of ICP waveforms classified into Lundberg's A wave and Lundberg's B wave.

[0046] [Figure 12] 1 shows a schematic diagram of an embodiment of the present disclosure.

[0047] [Figure 13] 1 shows a schematic diagram of the method of the present disclosure.

[0048] [Figure 14] 1 shows a schematic diagram of the method of the present disclosure.

[0049] [Figure 15] 1 shows a schematic diagram of the method of the present disclosure.

[0050] [Figure 16] 1 shows a schematic diagram of the method of the present disclosure.

[0051] [Figure 17] 1 shows a schematic diagram of the method of the present disclosure.

[0052] [Figure 18] 1 shows a schematic diagram of the method of the present disclosure.

[0053] [Figure 19] 1 shows a schematic diagram of the method of the present disclosure.

[0054] [Figure 20] 1 shows a schematic diagram of the method of the present disclosure.

[0055] [Figure 21] 1 shows a schematic diagram of the method of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0056] The invention of this disclosure is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the claimed invention may be configured in other ways to include various steps or elements similar to those described in this document, in combination with other current or future technologies. Furthermore, although the term "step" or similar terminology may be used herein to encompass different aspects of the method employed, this term should not be construed to imply any particular order among the various steps disclosed herein, unless and until the order of individual steps is explicitly recited. As used herein, the word "approximately" means within 5% of the stated value, and for a given range, applies to both the beginning and end of the given value range.

[0057] In the following description, numerous specific details are set forth to provide a thorough understanding of the present invention. However, the present invention may be practiced without these specific details. Structures and techniques that will be known to those skilled in the art have not been shown in detail so as not to obscure the present invention. By reference to the figures, various key elements that make up devices, systems, and methods that utilize the present invention can be identified.

[0058] At a high level of abstraction, the bodily fluid discharge control devices, systems, and methods described herein operate or are operated in the environment depicted in Figure 1, which includes a patient 800 having a body 810 and bodily fluid 812. The bodily fluid discharge control devices, systems, and methods include the components shown in Figures 2 through 8.

[0059] The bodily fluid drainage control system 100 includes a drain control device 110, which may be referred to herein as a "drain control device." The system 100 further includes a plurality of drainage reservoir bags 200 and a plurality of drain cassettes 220, as shown in FIGS. 3 and 4 . The drain control device 110 further includes a plurality of drainage reservoir bag attachment portions 120. Each of the plurality of drainage reservoir bags 200 can be securely and reversibly secured to and detached from one of the plurality of drainage reservoir bag attachment portions 120. The drain control device 110 further includes a plurality of drain cassette attachment portions 160. Each of the plurality of drain cassettes 220 can be securely and reversibly secured to and detached from one of the plurality of drain cassette attachment portions 160. Each of the plurality of drain cassettes 220 is single-use and may be referred to as a single-use (disposable) drain cassette 220. Each of the plurality of drain cassettes 220 may include at least two flat surfaces. Each of the plurality of drain cassettes 220 may further include an elastomeric or silicone membrane compressed between at least two of the two flat surfaces. Any of the plurality of drain cassettes 220 may be designed for a specific type of therapy, and in embodiments of the present disclosure, the drain control device 110 automatically changes to that type of therapy. For example, without limiting the foregoing, a drain cassette 220 designed for lumbar drainage may not have a transducer, as opposed to a drain cassette 220 designed for ventricular drainage, which typically has a transducer, and the drain control device 110 prevents switching to an incompatible mode and automatically selects the correct mode for the therapy.

[0060] Referring to FIG. 5, each of the plurality of drain cassette mounting portions 160 further includes a cassette certificate reader 162, a pressure transducer interface 164, a valve actuator 166, a lever 168, a spectrum analysis sensor 170, a liquid level sensor 172, and a valve actuator 174.

[0061] Referring to FIG. 6, each of the plurality of drainage reservoir bag attachments 120 further includes components to enable and ensure safe management of accumulated bodily fluids, namely, a reservoir bag certificate reader 122, a plurality of retention mechanisms, and an attached load cell 124.

[0062] 7 and 12, each of the plurality of drain cassettes 220 further includes components that facilitate drainage of bodily fluids from the body 810, namely, a bag-to-catheter connection 222, a cassette certificate 224, a pressure transducer 226, a multi-state valve 228, a collection port 230, a finger holding pin 232, a spectral analysis port 234, a visual inspection port 236, a fluid sensor port 238, a two-way valve 240, and a bag-to-drain reservoir connection 242.

[0063] 8 , each of the plurality of drainage reservoir bags 200 further includes components that facilitate the retention of bodily fluids drained from the body 810, namely, a bag connection fitting 202, a plurality of bag retention aids 204, and a reservoir bag certificate 206. The reservoir bag certificate 206 may advantageously include a machine-readable identification feature that identifies at least one of the manufacturer of the drainage reservoir bag 200, the date of manufacture, the expiration date of consumables, the maximum volume of the drainage reservoir bag 200, the certificate of the drainage reservoir bag 200, information regarding the proper disposal of the drainage reservoir bag 200, and the amount of bodily fluids 812 currently within the drainage reservoir bag 200.

[0064] Volumetric Emission

[0065] The disclosed fluid drainage control devices, systems, and methods expand upon known technology to further include a limitable, adjustable bolus-volume drainage system with automated control of CSF samples, including collection and simultaneous drainage of cerebrospinal fluid, and recording of the CSF sample size relative to the total CSF volume drained over a period of time. The present disclosure further teaches integration with commercially available infusion pumps for performing lumbar injection tests corresponding to normal pressure hydrocephalus stress tests. While enabling dynamic pressure compensation in ICP sampling has been found to be advantageous because such sampling allows for dynamic measurement of a patient's ICP and / or for ICP drainage while draining CSF from the patient as needed, it is understood that sampling with such dynamic pressure compensation can be applied to any bodily fluid 812.

[0066] The present disclosure teaches an automatic bodily fluid drainage control system 102, which includes a drain control device 110, a plurality of drainage reservoir bags 200, each having a variable size, and a multi-state valve 228, a first flow controllable means having a variable number of states, including, but not limited to, open drain, partially open drain, closed drain, open and collect, partially open and collect, and closed and collect, allowing multiple states to be operated simultaneously. The automatic bodily fluid drainage control system 102 is sometimes referred to as an electromechanical drain. The automatic bodily fluid drainage control system 102 may include a user interface 112. The automatic bodily fluid drainage control system 102 further includes a fluid sensor port 238, which is a measurement device that monitors the amount of bodily fluid being drained. The automatic bodily fluid drainage control system 102 also includes a two-way valve 240, which is a second flow controllable means having an open state and a closed state.

[0067] In some embodiments of the present disclosure, the fluid sensor port 238 of the automatic fluid drainage control system 102 includes or is connected to a fluid flow rate calculator 239 that periodically calculates a volumetric fluid flow rate 229 of CSF or other bodily fluid, where periodicity is a period or timescale appropriate for drainage of CSF or other bodily fluid. The automatic fluid drainage control system 102 adjusts the multi-state valve 228, i.e., the first flow controllable means, to decrease or increase the volumetric fluid flow rate 229 consistently within the calculated drainage volume desired for the period appropriate for fluid drainage. In some embodiments, the multi-state valve 228 is connected to the patient 800 for draining bodily fluid 812 by gravity. In some embodiments, the two-way valve 240 is connected to an output device for storing the draining bodily fluid 812, including, but not limited to, any of a plurality of drainage reservoir bags 200; the bodily fluid 812 may be referred to as "excess fluid." The bodily fluid 812 may include cerebrospinal fluid (CSF). In some embodiments, the automatic bodily fluid drainage control system 102 further includes an outlet 244 connecting the drainage reservoir bag 200, i.e., the reservoir, to the outside air, the outlet 244 including a filter 246, which may be any of a range of sizes and levels of filtration to prevent contaminants from being introduced into the automatic bodily fluid drainage control system 102 and the drainage reservoir bag 200. The bodily fluid 812 may be any liquid that originates in, is produced in, or is introduced into the body 810 (typically intentionally in a medical procedure, but may also include liquids that are unintentionally or accidentally introduced into the body 810), including, but not limited to, cerebrospinal fluid, urine, fluids pumped into and drained from the abdomen of the patient 800 during, for example, peritoneal dialysis, or any other liquid now known or hereafter invented.

[0068] In some embodiments, the automatic body fluid drainage control system 102 further includes a monitoring system 248 that displays a warning if the body fluid 812 is unable or does not provide a liquid volumetric flow rate 229 up to the requested or desired flow rate volume. The monitoring system 248 can display a warning if the automatic body fluid drainage control system 102 is not functioning. In some embodiments, the automatic body fluid drainage control system 102 can include a spectrum analysis port 234. In some embodiments, the automatic body fluid drainage control system 102 can include a machine-readable identifier 235. In some embodiments, the automatic body fluid drainage control system 102 can include multiple drain cassettes 220. Each or any of the multiple drain cassettes 220 can be single-use or otherwise disposable. Each of the multiple drain cassettes 220 can be used to isolate all biohazardous liquids from the automatic body fluid drainage control system 102. In some embodiments, each of the plurality of drain cassettes 220 is independently inserted into and / or removed from the automated bodily fluid drainage control system 102 and operated independently.

[0069] Continuous manometric drainage

[0070] The present disclosure teaches continuous intracranial pressure (ICP) measurement of cerebrospinal fluid (CSF) that directly adjusts the drainage system to accommodate ventricular CSF drainage. As described above, in existing drainage systems, manual pressure measurement systems involve manually opening and closing a stopcock and draining the patient using a combination of fluid pressure relative to head height to maintain a given intracranial pressure (ICP). These systems have an external fluid-filled transducer that measures the patient's ICP using the pressure at the time of the conversion. Alternatively, these systems can measure ICP using an implantable pressure sensor in the ventricular shunt. In either case, the pressure sensor is not in communication with the manual drain and does not provide user feedback or control of the drainage rate. Furthermore, because the manual drain is not in communication with the pressure sensor, the accuracy of the pressure sensor fluctuates depending on the state of the unidentified stopcock. When open, the pressure sensor's accuracy decreases, indicating a noticeable decrease in pressure. When closed, the accuracy returns to nominal, and the measured pressure suddenly returns to normal. Thus, a drain in communication with various means for measuring ICP can adjust the drain's open and closed state to provide normalized pressure values ​​for standardized pressure measurements regardless of the drain's state. Furthermore, unlike manually operated drains, an automated system can open and close the drain many times per minute to achieve a target ICP and provide highly accurate ICP measurements for a patient. In some aspects of the present disclosure, it may prove advantageous to have system 100 capable of passively measuring ICP using the methods of the present disclosure.

[0071] ICP waveforms can be characterized into normal and abnormal patterns. Referring to Figure 9, a normal ICP waveform is shown exhibiting P1 (impingement wave), P2 (high wave), and P3 (dicrotic peak), collectively referred to herein as a normalized ICP waveform pattern 506.

[0072] Attempts have been made by Hammar et al. to use ICP pulse morphology as a surrogate marker of intracranial elastance. They determined that the systolic portion of the vascular ICP waveform reflects arterial activity, while the trailing, descending portion represents SVC pressure. Therefore, if ICP increases, the trailing portion of the ICP waveform (P2 component) will take on the shape of an arterial pulse, and if there is an increase in CVP, the waveform will approach a venous pulse.

[0073] When ICP increases, the vascular (cardiac) waveform amplitude increases and the respiratory waveform amplitude decreases. Other visible manifestations of dysfunctional intracranial compliance include the occurrence of P waves, elevated P2, and waveform rounding. The occurrence of these phenomena is useful in clinical practice in that they alert the neurologist to urgently initiate ICP control measures. It is pertinent to point out that increased ICP can produce characteristic waveforms variously classified by Lundberg as A, B, and C waves. The ICP waveform shown in Figure 10 indicates increased intracranial pressure.

[0074] Referring to Figure 11, Lundberg's A wave represents the largest increase in ICP (50mmHg-100mmHg). The A wave generally indicates a high rate of cerebral ischemia and impending cerebral herniation and lasts for 5 to 10 minutes. The Lundberg B wave occurs for a shorter period (1 to 2 minutes), and the ICP increase is less significant, at 20mmHg-30mmHg, and is rhythmic in nature. The B wave indicates progressive brain damage, which causes a gradual increase in ICP. The Lundberg C wave correlates with blood pressure fluctuations caused by baroreceptor and chemoreceptor reflex mechanisms and has no clinical significance.

[0075] An additional use case for CSF drainage is the treatment of normal pressure hydrocephalus (NPH), a clinical condition characterized by enlarged ventricles (Hakim & Adams, 1965) and symptoms of gait disturbance, enuresis, and cognitive decline (Fisher, 1982; Williams & Malm, 2016). A shuffling gait with small steps is an early and prominent symptom, which may be due to direct pressure on the midbrain gait center by the enlarged third ventricle (Lee, Yong, Ahn, & Huh, 2005). Gait disturbance provides an opportunity to assess disease progression (Chivukula et al., 2015; Williams et al., 2008) and may even help predict favorable postoperative outcomes (Gaff-Radford & Godersky, 1986).

[0076] If the underlying pathology is inadequate CSF reabsorption, surgical shunting of CSF into the venous or peritoneal cavity may alleviate symptoms, but postoperative success depends on the correct diagnosis. NPH can coexist with, be caused by, and mimic different forms of atherosclerosis.

[0077] A direct method for diagnosing NPH is the constant-infusion lumbar infusion test (LIT, Katzman & Hussey, 1970), in which imitation CSF is injected into the spinal cavity through the intracranial Sylvian aqueduct to stress the brain's ability to reabsorb CSF (Ryding, Kahlon, & Reinstrup, "Improved lumbar infusion test analysis for normal pressure hydrocephalus diagnosis," Brain Behav. 2018 Nov;8(11):e01125, https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC6236248 / , last accessed June 14, 2021).

[0078] The goal of LIT is to increase intracranial CSF volume by lumbar injection of sham CSF. As intracranial CSF volume increases, the only volume that can be reduced to an equal extent is venous volume, since intracranial tissue is not compressible. Similarly, the volume of arterial blood delivered to the intracranial cavity during each systole is compensated for by the same amount by compressing the venous pool. Increased resistance to venous blood flow due to venous vascular compression increases intracranial pressure (ICP; Marmarou, Schulman, & Rosende, 1978).

[0079] The LIT test is a combination of volumetric lumbar injection and ICP pressure measurement. In one study, the lumbar injection test was performed using a constant infusion rate (0.80 ml / min) and was considered positive if the steady-state CSF plateau pressure reached a level greater than 22 mmHg (resistance to outflow >14 mmHg / ml / min).

[0080] Another diagnostic test for NPH is the CSF tap test (also known as the cerebrospinal fluid tap test, tap test, or Miller-Fisher test), which typically involves removing 30 mL of CSF via lumbar puncture, after which cognitive function is assessed.

[0081] The predictive value for a positive NPH result is 80% for the lumbar injection test and 94% for the tap test. The disclosed system accommodates both drainage modes with the ability to connect to an external infusion pump, which is connected to a Y-site located distal to the patient but proximal to the disclosed system. The infusion pump reports its infusion rate directly to the disclosed system, which measures ICP using its internal pressure transducer.

[0082] Referring to FIG. 13, the present disclosure teaches a method 500 for draining bodily fluid 812 from a body 810, where the method 500 is based on a desired ICP target pressure 504, and the method 500 is independent of the volume of bodily fluid 812 being drained. The method 500 includes step 510 of measuring an ICP pressure 502 via connection to a pressure transducer 226, which may be a pressure measurement device, sensor, or transducer, and which may be internal or external to the body 810 or the automatic fluid drainage control system 102; step 520 of opening a drain 210 if the ICP pressure 502 exceeds an ICP target pressure 504; step 522 of allowing a quantity of bodily fluid 812 to drain by natural pressure of the patient's 800 body 810 or via a gravity-driven device, where the bodily fluid 812 physically flows to a drain 210 located below the patient 800; step 530 of measuring the amount of bodily fluid 812 drained; step 566 of closing the drain 210; and optionally, step 570 of repeating the above steps until the desired ICP target pressure 504 is achieved. ICP pressure 502 may also be referred to herein as a number of inputs related to ICP pressure 502 and / or a number of values ​​of ICP pressure 502 .

[0083] In some embodiments of the present disclosure, the drain 210 includes a plurality of drain cassettes 220, each of which includes a proximal valve 250, a graduated body 252, and a distal valve 254, with the proximal valve 250 and the distal valve 254 connected to the graduated body 252. Each of the plurality of drain cassettes 220 can include a proximal portion 221 in which the proximal valve 250 is located, closer to the remainder of the automated fluid drainage control system 102 for each of the plurality of drain cassettes 220, and the pressure transducer 226 is located near or on the proximal valve 250 in the proximal portion 221. The proximal portion 221 can further include a membrane 227 that can be connected to the pressure transducer 226 to measure the ICP pressure 502.

[0084] The proximal valve 250 can be a two-position valve, a three-position valve, or a multi-position valve. The distal valve 254 can be a two-position valve, a three-position valve, or a multi-position valve. In a two-position valve, the valve has two possible positions, states, or conditions: open to drain and closed. In a three-position valve, the valve has three possible positions, states, or conditions: open to drain, open to collect, and closed. In a multi-position valve, the valve has multiple possible positions, states, or conditions, including, but not limited to, variably open to drain and collect, fully open to drain, fully open to collect, and closed. For valves with multiple positions, the drain control device 110 and / or the automated fluid drainage control system 102 can calculate the open, closed, or graduated position of the valve as it moves from 100% open to 100% collection to 100% closed and any of the intermediate states.

[0085] In some aspects of the present disclosure, opening 520 the drains 210 in the method 500 further includes opening the proximal valves 250 and keeping the distal valves 254 closed to allow bodily fluid 812 to accumulate in the graduated bodies 252 of the plurality of drain cassettes 220 so that a user 890 having a user profile, also referred to as a user class, can visually inspect the fluid volumetric flow rate 229 in a visual inspection step 532. Opening 520 the drains 210 can occur over a cyclical period, which can be variable. The maximum amount of bodily fluid 812 drained while the drains 210 are in the open 520 state can be variable. In some aspects, the measured volume of drained bodily fluid correlates to the visually accumulated volume, or fluid volumetric flow rate 229, noted in the visual inspection step 532. In some embodiments, the proximal valve 250 can be closed and the distal valve 254 can be open in step 568 of discharging the contents of the graduated body 252 into the processing vessel 256. In some embodiments, the volume 257 of the bodily fluid 812 is recorded. The total volume of the processing vessel 256 is known, and the total volume 257 discharged into the processing vessel 256 can be compared to the total volume of the processing vessel 256, and the user 890 can be notified when the processing vessel 256 is full and that the processing vessel 256 needs to be changed. In the methods and systems described above, the bodily fluid 812 can be CSF.

[0086] The automatic fluid drainage control system 102 can further include an alignment element 130, which can include, but is not limited to, a laser pointer fixed to at least one point on the automatic fluid drainage control system 102 for optically aligning the automatic fluid drainage control system 102 with the interventricular orifice of the patient 800. In some embodiments, the automatic fluid drainage control system 102 further includes a height adjustment control 132 for adjusting the height of the alignment element 130 without adjusting the physical height of the automatic fluid drainage control system 102, wherein the height adjustment of the alignment element 130 is detected by the automatic fluid drainage control system 102 and optionally applies known calculated adjustments to correct for overestimation or underestimation of the ICP pressure 502 resulting from at least one of the ICP pressure 502 inputs. In some embodiments, the automatic fluid drainage control system 102 further includes means for adjusting the physical height of the automatic fluid drainage control system 102 by mechanical, electromechanical, or manual adjustment. In some embodiments, the automatic fluid drainage control system 102 further includes a patient head position detection element 134, which may include a camera, sensor, or other means for detecting the position of the patient's 800 head and observing said position over time, such that the automatic fluid drainage control system 102 can automate adjustments or prompts to the user 890 to adjust the position of the alignment element 130. In some embodiments, the automatic fluid drainage control system 102 allows the user 890 to manually make fixed adjustments to the ICP pressure 502 value to correct for overestimation or underestimation of the ICP pressure 502. In some embodiments, the automatic fluid drainage control system 102 can automatically adjust between an ICP pressure 502 measurement system inside the patient's 800 ventricular system and a pressure transducer 226 located outside the patient's 800 ventricular system.

[0087] In some embodiments, the method 500 further includes monitoring 534 the ICP pressure 502 against a normalized ICP waveform pattern 506. If the pattern of the ICP pressure 502 does not meet the normalized ICP waveform pattern 506, the method 500 further includes issuing an alarm 536. In some embodiments, CSF drainage is applied as a therapeutic correction 538 for the abnormal ICP pressure 502 pattern. The user 890 can, in some embodiments of the method 500, set 540 a prescribed test period 542 for the bodily fluid 812 to correct the abnormal ICP pressure 502 pattern. In some embodiments of the method 500, the automated fluid drainage control system 102 generates an alert if the pattern of ICP pressures 502 remains abnormal when the test period 542 ends, and / or the automated fluid drainage control system 102 generates an alert 544 if the pattern of ICP pressures 502 deteriorates, e.g., if the pattern of ICP pressures 502 deviates from the normalized ICP waveform pattern 506. In some embodiments, the user 890 can select an ICP pattern tolerance 508, which is a pattern range near or very close to the normalized ICP waveform pattern 506 that is desired or normal, and the user 890 can select the ICP pattern tolerance 508 to be applied during or after drainage of the fluid 812 to correct for the pattern of ICP pressures 502 observed by the user 890 or another observer. If the pattern of ICP pressures 502 exceeds the ICP pattern tolerance 508, the alert 544 can be modified or increased by the method 500.

[0088] 14 , the present disclosure teaches a method 600 for draining bodily fluid 812 from a body 810, where the method 600 is based on a desired ICP target pressure 504, and the method 600 is independent of the volume of bodily fluid 812 being drained. The method 600 includes measuring 610 the ICP pressure 502 via connection to a pressure transducer 226, which may be a pressure measuring device, sensor, or transducer, and which may be internal or external to the body 810 or the automated bodily fluid drainage control system 102. The method 600 further includes step 620 of calculating a pressure differential 622 by recording the ICP pressure 502 between the closed position of the proximal valve 250 and the open position of the proximal valve 250, step 630 of adjusting the flow rate of the proximal valve 250 to achieve the desired ICP target pressure 504, and step 640 of measuring the amount of bodily fluid 812 removed by the method 600, and method 600 further includes step 650 of periodically recalculating the pressure differential 622 to ensure that the pressure differential 622 remains within a range that is physiologically acceptable to the patient 800.

[0089] 15 , the present disclosure teaches a method 700 for monitoring infusion of bodily fluid 812 into a catheter 223, the catheter 223 being in fluid communication with an automatic bodily fluid drainage control system 102, the method 700 including connecting 710 an infusion device 770 to the automatic bodily fluid drainage control system 102, which can be accomplished physically, wirelessly, or via a network connection, detecting 720 parameters including the start and infusion rate of the infusion device 770, and monitoring 730 an ICP pressure 502 via connection to a multi-state valve 228 or a spectrum analysis sensor 170. The method 700 can further include remotely controlling 740 the infusion device 770 by the automatic bodily fluid drainage control system 102, which can include starting the infusion, stopping the infusion, and the infusion rate. The method 700 may further include controlling 750 the multiple valve positions of the multiple drain cassettes 220 by the automated fluid drainage control system 102, and the method 700 may further include a user 890 manually controlling the multiple valve positions of the multiple drain cassettes 220.

[0090] Drainage Cassette

[0091] When operating under two different but similar drainage models, namely, volumetric and pressure-based drainage as discussed herein, the automated fluid drainage control system 102 is improved in terms of ease and practicality of use by facilitating correct operation with single-use consumables. The single-use consumables should be easy to attach to and remove from the automated fluid drainage control system 102. This improvement taught by the present disclosure is exacerbated by the need, when using the systems and methods of the present disclosure, to identify and apply the drainage model (volumetric or pressure-based) to the patient 800 and accommodate spectrophotometric analysis of the fluid 812 after it has been drained. Thus, the teachings of both the volumetric and pressure-based drainage models extend to include the present disclosure of single-use consumables that are connected to the automated fluid drainage control system 102 in all models and methods utilized as taught in this disclosure.

[0092] In this disclosure, each of the plurality of drain cassettes 220, which may be referred to as a first drain cassette 220a, a second drain cassette 220b, etc., for any number of the plurality of drain cassettes 220, includes at least one first planar element 260a and at least one second planar element 260b. The first drain cassette 220a can be a single-use cassette, as can the other cassettes of the plurality of drain cassettes 220. In each of the plurality of drain cassettes 220, the first drain cassette 220a can further include a membrane 262, which is compressed between the first planar element 260a and the second planar element 260b, and which can be an elastomer, silicone, or other material now known or hereafter invented. In some embodiments, the first drain cassette 220a, the second drain cassette 220b, and any other cassettes in the plurality of drain cassettes 220 may include a proximal valve 250, which is in fluid contact with bodily fluids 812 of the patient 800 that need to be drained, and the plurality of drain cassettes 220 may include a distal valve 254, which is in fluid contact with one or more of the plurality of drainage reservoir bags 200 that store the bodily fluids 812, and the proximal valve 250 and the distal valve 254 are in fluid contact with each other, and each of the proximal valve 250 and the distal valve 254 is capable of at least two of opening, closing, and partially opening for reduced flow rate.

[0093] In some embodiments, the first drain cassette 220a, the second drain cassette 220b, and any other cassette in the plurality of drain cassettes 220 can include a collection port 230, which is in fluid contact with the proximal valve 250 and which is either an open or closed Luer access point, including, but not limited to, a needleless access valve, a pre-pierced port, or other fluid access means. In some embodiments, the first drain cassette 220a, the second drain cassette 220b, and any other cassette in the plurality of drain cassettes 220 can include a visual inspection port 236 suitable for visual inspection of the bodily fluid 812. In some embodiments, the first drain cassette 220a, the second drain cassette 220b, and any other cassette in the plurality of drain cassettes 220 can include a fluid sensor port 238 that measures the amount of bodily fluid 812 that has been drained or is being drained from the patient 800. In some embodiments, the first drain cassette 220 a, the second drain cassette 220 b, and any other cassettes in the plurality of drain cassettes 220 can include a spectral analysis port 234 suitable for spectrophotometry or other analytical sensor types for analyzing the bodily fluid 812 before the bodily fluid 812 enters the drainage reservoir bag 200 or other suitable drainage reservoir. In some embodiments, the first drain cassette 220 a, the second drain cassette 220 b, and any other cassettes in the plurality of drain cassettes 220 can include a pressure transducer 226, which is in fluid contact with the bodily fluid 812 prior to the proximal valve 250. The proximal valve 250 can be the same component as the multi-state valve 228, or the proximal valve 250 can be a different component from the multi-state valve 228.

[0094] In some embodiments, the first drain cassette 220a, the second drain cassette 220b, and any other cassettes in the plurality of drain cassettes 220 can include a cassette certificate 224, which can include a machine-readable identification element that identifies at least one of the following items, which have been found to be advantageous: the manufacturer of the cassette, the date of manufacture, the expiration date of consumables, the set of drainage modes that the cassette supports, the cassette certificate, information for proper disposal of the cassette, the presence of various single-use cassette features, including but not limited to, a known length of the proximal fluid circuit and a known length of the distal fluid circuit, the type of collection port present, whether an alarm light indicator is present, the size of the reservoir, and the type of analysis supported. In some embodiments, the first drain cassette 220a, the second drain cassette 220b, and any other cassettes in the plurality of drain cassettes 220 can include a machine-writable identification feature 225 that allows the device to write multiple usage and programming information to the first drain cassette 220a or other cassettes so that if the first drain cassette 220a is removed from the automated body fluid drainage control system 102 and installed in a different automated body fluid drainage control system 102, the multiple usage and programming information can be read by the different automated body fluid drainage control system 102. The machine-writable identification feature 225 provides an additional benefit in that it can help prevent counterfeiting and can help prevent medical errors regarding which bag is being used and associated with a patient.

[0095] Drainage Bag

[0096] For safe handling, the bodily fluid 812 must be stored in a sealed environment that prevents contaminants from entering the system, and it is unacceptable for the bodily fluid 812 to leak out of the system and contaminate the larger environment in which the healthcare facility operates from or with biohazardous materials. Therefore, the automated bodily fluid drainage control system 102 of the present disclosure is expanded to include multiple drainage reservoir bags 200. It has been found advantageous to have multiple drainage reservoir bags 200, each of which is single-use, disposable, and sturdy. Each of the plurality of drainage reservoir bags 200 comprises a flexible container for containing a biohazardous or potentially biohazardous bodily fluid 812, each of the plurality of drainage reservoir bags 200 comprising a fluid reservoir volume of at least 250 mL, comprising at least one fluid-infiltrating fitting 202, and comprising a plurality of bag retention aids 204, each of the plurality of bag retention aids 204 adapted to retain the drainage reservoir bag 200 when the drainage reservoir bag 200 is completely filled with bodily fluid 812. In some embodiments of the present disclosure, the fitting 202 is tubularly connected to a male connector suitable for connection to an output port of a drainage system, a luer, or other fitting now known or hereafter invented, and in other embodiments of the present disclosure, the fitting 202 is tubularly connected to a female connector suitable for connection to a drainage system and may be presented with a needleless access valve.

[0097] In some embodiments of the present disclosure, the drainage reservoir bag 200 further includes a filtered outlet 205. In some embodiments of the present disclosure, the fitting 202 further includes a check valve 207. In some embodiments of the present disclosure, the drainage reservoir bag 200 further includes a reservoir bag certificate 206 feature, the reservoir bag certificate 206 being a machine-readable feature that identifies at least one of the following: the manufacturer of the drainage reservoir bag 200, the date of manufacture, the expiration date of the drainage reservoir bag 200, the maximum volume of the reservoir bag 200, the certificate of the drainage reservoir bag 200, information for proper disposal of the drainage reservoir bag 200, and the current amount of bodily fluid in the drainage reservoir bag 200. In some aspects of the present disclosure, the drainage reservoir bag 200 can further include a machine-writable identification feature 208 that allows the automated fluid drainage control system 102 to write multiple usage and programming information to the drainage reservoir bag 200 so that if the drainage reservoir bag 200 is removed from one automated fluid drainage control system 102 and installed in a different automated fluid drainage control system 102, the multiple usage and programming information can be read by the different automated fluid drainage control system 102. The reservoir bag certificate 206 provides an additional benefit in that it can aid in safety checks, such as the amount of fluid in the drainage reservoir bag 200, and can help prevent medical errors regarding which drainage reservoir bag 200 is being used and associated with a patient. The reservoir bag certificate 206 can also help prevent medical errors by preventing the reuse of the drainage reservoir bag 200. The reservoir bag certificate 206 and / or the machine-writable identification mechanism 208 may include an RFID (radio frequency identification) chip and reader, an optical code and reader, or other mechanism now known or hereafter invented.

[0098] Drain control device

[0099] The present disclosure allows the foregoing disclosures to be combined and used in any combination, including, but not limited to, the combination of volumetric drainage and continuous pressure measurement drainage, drainage cassettes, and drainage bags, and the like, to form an embodiment of a system of the present disclosure. The automatic fluid drainage control system 102 can partially or fully automate the process of draining cerebrospinal or other bodily fluids 812 from a patient 800. In some embodiments, the automatic fluid drainage control system 102 further includes an input port 310, which can be used for external connections, including, but not limited to, ICP, ART, and Flushless Transducer. In some embodiments, the automatic fluid drainage control system 102 further includes an output port 320, which can be used for patient monitoring, including, but not limited to, bedside monitoring. The automatic fluid drainage control system 102 can further include a plurality of alarm indicators 330, which can be located in at least one location on the automatic fluid drainage control system 102, and which can flash, change color, or otherwise alert the user 890 that an alarm condition exists and action may be required. In some embodiments, the automatic fluid drainage control system 102 can detect whether the plurality of drain cassettes 220 are inserted correctly, are expired, are not authentic, require priming, or other conditions that may be useful to the user 890. In some embodiments of the present disclosure, when a cassette from the plurality of drain cassettes 220 is inserted, the automatic fluid drainage control system 102 can change to the correct drainage mode if the plurality of drain cassettes 220 so indicates. In some aspects of the present disclosure, if no cassette from the plurality of drain cassettes 220 is inserted, the automated fluid drainage control system 102 may display information on the user interface 112, including, but not limited to, video, text, or schematic diagrams, showing how to insert the first drain cassette 220a or another cassette from the plurality of drain cassettes 220.In some aspects of the present disclosure, the automatic bodily fluid drainage control system 102 can prompt the user 890 to change the drainage reservoir bag 200 or prompt that the drainage reservoir bag 200 is not attached.

[0100] In some aspects of the present disclosure, when one of the plurality of drainage reservoir bags 200 is attached, the automatic fluid drainage control system 102 advantageously displays the amount of bodily fluid in the drainage reservoir bag 200 on the user interface 112, alerts the user 890 when it detects that the drainage reservoir bag 200 contains a user-configurable percentage of the total amount of bodily fluid 812 that can be stored, alerts the user 890 if the drainage reservoir bag 200 has expired, and / or alerts the user 890 if the bag is not authentic. In some aspects of the present disclosure, when a drainage reservoir bag from the plurality of drainage reservoir bags 200 is not inserted, the automatic fluid drainage control system 102 can display information on the user interface 112, including, but not limited to, video, text, or schematic diagrams, showing how to attach one or more of the drainage reservoir bags 200. The user interface 112 can be a wireless or wired interface and can include a touchscreen interface, gesture control, or other input mechanisms now known or hereafter invented. The user interface 112 can include a machine-readable user identification system, including, but not limited to, a user tag, an RFID card, biometric data, a password, a username, and / or user proximity. Based on authentication of the user 890 at the user interface 112, the automated bodily fluid drainage control system 102 can enable a set of privileges, including, but not limited to, the ability to modify the program of the automated bodily fluid drainage control system 102.

[0101] Serial spectrophotometric analysis of cerebrospinal fluid

[0102] Traditionally, in the prior art, cerebrospinal fluid (CSF) was tested using a process in which a CSF sample was removed from a patient based on an identified risk or event. The fluid was then tested in a laboratory to detect blood and blood products from hemorrhage. In this situation, the fluid from the patient contains red blood cells unless they have undergone complete metabolism, an event that typically takes at least seven days to occur. The red blood cells lyse, releasing oxyhemoglobin, which is subsequently converted to bilirubin. After centrifugation, the culture supernatant appears pink or pinkish-orange in color due to oxyhemoglobin, yellow due to bilirubin, or somewhere in between if both are present.

[0103] With the advent of spectrophotometry, laboratories can now distinguish data without the need for centrifuges or other laborious processes. It is common to distinguish between oxyhemoglobin (413nm-415nm), oxyhemoglobin and bilirubin (broad peak / shoulder at 450nm-460nm), and bilirubin alone. Methemoglobin can also be distinguished (shifted from 405nm to 413nm when oxyhemoglobin is present). It is also possible to distinguish between glucose (~1500nm), insulin (260nm-350nm), and proteins (up to 1575nm) in body fluids.

[0104] All of these methods rely on traditional laboratory techniques and instrumentation that are applied to the entire fluid column and require re-sampling each time a test needs to be performed. When combined with a drain system, the state of the art can be extended to include rapid, repetitive measurements with the fluid still in fluid contact with the patient.

[0105] In some embodiments of the present disclosure, the automatic bodily fluid discharge control system 102 includes a plurality of spectrophotometric sensors and a plurality of light sources, where the plurality of light sources are capable of emitting light and the plurality of spectrophotometric sensors are capable of detecting light in a wavelength range extending from approximately 250 nm to approximately 1900 nm. The plurality of spectrophotometric sensors and the plurality of light sources can be configured separately or can include a spectral analysis port 234 of the automatic bodily fluid discharge control system 102. It has been found advantageous that analysis of bodily fluid 812 by the automatic bodily fluid discharge control system 102 can be applied not to a column of pooled bodily fluid 812, but to bodily fluids dynamically discharged in minute volumes (beneficially less than 0.5 mL) and very short time increments (beneficially less than 1 minute). In some embodiments of the present disclosure, the aforementioned data processing, analysis, and storage are performed within the automatic bodily fluid discharge control system 102, such that each spectrophotometric signature can be analyzed and stored without restriction on the automatic bodily fluid discharge control system 102, even if not in communication with a data platform. The aforementioned data processing, analysis, and storage may further include data indexing for multiple drain cassette 220 credentials, drainage sessions, and / or patient 800 information. The automated fluid drainage control system 102 may further include an online data platform for the aforementioned data processing, analysis, and storage, referred to as a data platform 140, which may be referred to herein as a “data platform.” In some embodiments, the automated fluid drainage control system 102 may be capable of receiving multiple signatures 142, which may be stored for uploading to the data platform 140. The automated fluid drainage control system 102 may be capable of storing standard signature patterns 144, which may be stored on the automated fluid drainage control system 102. The automated fluid drainage control system 102 may be capable of downloading standard signature patterns 144, which are stored on the automated fluid drainage control system 102.The automated fluid drainage control system 102 may be able to alert the user 890 if one of the multiple signatures 142 deviates from the standard signature pattern 144. In some aspects of the present disclosure, the automated fluid drainage control system 102 may perform an infusion test, where a known fluid is infused into the CSF space (traditionally lumbar), and changes in the drainage fluid spectral signature for the known fluid are monitored and analyzed to determine the amount of dilution, if any, when the volume of cerebrospinal fluid drained returns to normal levels, sometimes referred to as pre-infusion levels, pre-infusion test, or pre-infusion test levels, and how much volume has returned after being drained.

[0106] Drain Safety Systems, Protocols, and Analysis

[0107] With the advent of electromechanical fluid drains, it is now possible to develop and implement clinically driven safety protocols that control and direct the device to more safely drain fluids from a given patient population. In today's environment, all patients are treated by the device as the same. This expansion into the art allows the device to recognize patient-specific physiological parameters and clinical diagnoses, including comorbidities, that instruct the device on how to properly monitor and drain the patient. Furthermore, the same device can be customized for any given patient using a set of clinical parameters entered into the device by the clinician to select the unique drainage conditions applicable to that patient.

[0108] We also discuss the need for new ways to input and select user preferences and data from electromechanical drains for reporting and transmission to a broad ecosystem of interoperable components. Current technology does not provide a means to electronically define or control drainage behavior from a remote system and publish those behaviors to the electromechanical drain. Furthermore, there is no way to define standard values, including boluses, and weaning and adjustment limits for the drain. Finally, today's drain data is manually charted in the patient's chart, which allows for significant inaccuracies due to human error.

[0109] This process begins with the creation and approval of the Drain Protocol Safety Library (DPSL) 900. This Drain Protocol Safety Library 900 addresses clinical behavior for drainage protocol modalities, including lumbar and ventricular drains. Such protocols include the initial identification of the drain modality, which allows various clinical functions to be defined and controlled for the device. The primary driver of the protocol modality is clinical judgment for volumetric or pressure-based drainage. Limits and behaviors are then categorized into multiple protocols according to this overall function.

[0110] In the following desirable or advantageous features, various modes and functions are described. If a desirable or advantageous feature is not achieved in an operating mode of the disclosed systems and methods, the systems and methods can be, and advantageously are, configured to issue an alarm or warning. In one aspect of the automated fluid drainage control system 102, operating in a volume-based drainage modality, exemplary, but not exclusive, features include, but are not limited to: a Volumetric discharge in a given time b. Valve-controlled volumetric discharge cycle time for a period shorter than 1.a. c Bolus drainage volume over a given time period d Maximum volumetric discharge in a given time e total discharge time, may include:

[0111] In one embodiment of the automated fluid drainage control system 102, exemplary, but not exclusive, features of operation with multiple pressure-based drain modalities include, but are not limited to: a Maximum pressure to discharge b Cycle time of the valve for controlling and monitoring 2.a c Maximum volumetric discharge in a given time d total discharge time; may include:

[0112] The aforementioned basic functions can be refined by first creating a set of protocols differentiated by modality, then by patient population characteristics including mnemonic expressions for easy identification, a checklist of items that the clinician needs to set to start the protocol, and finally by limitations for each concept included in the function to protect any one function. By way of example, and without excluding other possible limitations, these limitations can include: a The default value used b Whether the default value is editable by the bedside clinician c The maximum limit that the clinician cannot exceed and the message that will be displayed if an attempt is made d A recommended upper limit that the clinician can exceed but will be warned is abnormal, along with a message that will be displayed if attempted. e A suggested lower limit that the clinician can exceed but will be warned is abnormal, along with a message that will be displayed if attempted. f The minimum limit that the clinician cannot exceed and the message that appears if an attempt is made g Maximum percentile change per adjustment event and the message displayed if an attempt is made to exceed this limit (e.g., a 10% adjustment with 10 mL / hr output allows only a maximum change of 1 mL per adjustment event) h The minimum percentile change per adjustment event and the message displayed if you attempt to exceed this limit i Definition of the adjustment lockout period for which percentile change limits apply (e.g., a 10% adjustment limit and 5-minute lockout at a 10 mL / hour output would prevent the user from making changes in 1 mL increments more frequently than every 5 minutes).

[0113] 16 , the present disclosure teaches an automated fluid drainage control system 102 capable of receiving, storing, selecting, executing, and operating in a method 902 for a stored drainage protocol 910, where the stored drainage protocol 910 can be designed for volumetric drainage or the stored drainage protocol 910 can be designed for pressure-based drainage. The method 902 can further include the ability to design and implement multiple stored drainage protocols 912 that allow a clinician, who may be a user 890, to develop drainage safety measures based on the needs of a population 892 of patients 800, where the method 902 further includes causing the automated fluid drainage control system 102 to implement the stored drainage protocols 912 to safely drain fluid 812 from a body 810. In such an embodiment, the method 902 includes step 914 of enabling the user 890 to select one of a plurality of protocol modalities 915, including, but not limited to, lumbar drainage and ventricular drainage, and step 916 of enabling the user 890 to use a configuration feature to customize the behavior and / or functionality of the automated fluid drainage control system 102. The method 902 may include setting 917 a plurality of drain stored protocols 910 and / or a plurality of drain stored protocols 912 into the drain protocol security library 900. In some embodiments of the method 902, the user 890 is required to approve the drain stored protocol 910, which may be done using a plurality of credentials of the user 890 to authenticate the drain stored protocol 910 as valid prior to using the drain stored protocol 910. In some embodiments of the method 902, the user 890 is required to approve the drain protocol security library 900 as valid prior to using the drain stored protocol 910. The user 890 may utilize step 918 to define a checklist 919 of steps that must be performed before the user 890 engages with the drain storage protocol 910 and / or drain protocol safety library 900. The user 890 may utilize step 920 to define characteristics 921 of multiple patient populations that apply to the drain storage protocol 910 and / or drain protocol safety library 900.The user 890 can perform a step 922 of assigning a name 923 of the drain storage protocol 910 to the user 890, who can be a different person, including but not limited to an end user 894 of the automated body fluid drainage control system 102, as a reminder of what the function or purpose of the protocol is, and the end user 894 can be required to have any of a set of characteristics or permissions to utilize the drain storage protocol 910. The drain storage protocol 910 can be transmitted to the automated body fluid drainage control system 102 in an electronic transmitting step 924, and in some aspects the drain storage protocol 910 can be given a digital signature 925 prior to the transmitting step 924, and the digital signature 925 is subject to verification 926 by the automated body fluid drainage control system 102 before the drain storage protocol 910 is accepted. In some aspects of the method 902, the automated body fluid drainage control system 102 includes a step 927 requiring the user 890 to play a role in an authentication step 928 to the automated body fluid drainage control system 102, which authentication step 928 is used by the method 902 to determine which of the multiple drain storage protocols 912 the user 890 is authorized to use.

[0114] In one aspect, referring to FIG. 17 , the present disclosure teaches a method 1000 for receiving an electronic drain command 1080 from a third party system 1082 and transmitting the command to an automated body fluid drainage control system 102, the method including an interoperable server system 1010 capable of performing a step 1020 of receiving the electronic drain command 1080 from the third party system 1082, the method connecting (1022) to the automated body fluid drainage control system 102, and after receiving (1024) the electronic drain command 1080 from the third party system 1082, the interoperable server system 1010 transmits (1026) the electronic drain command 1080 to the automated body fluid drainage control system 102. The automated body fluid drainage control system 102 then verifies 1028 that the electronic drain command 1080 comes from an interoperable server system 1010 that was verified by method 1000, the automated body fluid drainage control system 102 processes 1030 the electronic drain command 1080, the automated body fluid drainage control system 102 verifies 1032 that the electronic drain command 1080 is within a plurality of physical parameters for execution of the automated body fluid drainage control system 102, the electronic drain command 1080 is used in step 1034 to configure the automated body fluid drainage control system 102, and the automated body fluid drainage control system 102 executes 1036 the electronic drain command 1080. The electronic drain command 1080 can start a new drain command, adjust an existing drain command, stop an existing drain command, or pause an existing drain command.

[0115] In some aspects, the third party system 1082 may be verified as an approved third party system 1082 in the verification step 1038. In some aspects, the electronic drain command 1080 identifies (1040) the particular automated bodily fluid drainage control system 102 to which the electronic drain command 1080 is to be sent. In some aspects of the present disclosure, the interoperable server system 1010 has or is provided with a plurality of information 1042 indicating the particular automated bodily fluid drainage control system 102 to which the electronic drainage command 1080 is to be sent, and the interoperable server system 1010 determines (1044) whether the interoperable server system 1010 currently has a valid connection to the particular automated bodily fluid drainage control system 102. In some aspects, the interoperable server system 1010 attempts (1046) to initiate a connection 1048 to the automated bodily fluid drainage control system 102 if the connection 1048 does not exist. In some aspects, the interoperable server system 1010 verifies a digital signature 1084 of the electronic drain command 1080, the digital signature 1084 including information 1085 for ensuring and verifying the content and origin of the electronic drain command 1080, before the interoperable server system 1010 accepts the electronic drain command 1080 as valid. In some aspects, the interoperable server system 1010 writes 1086 a server signature 1087 into the content of the electronic drain command 1080 before submitting the electronic drain command 1080 to the automated body fluid drainage control system 102. The automated body fluid drainage control system 102 may verify the server signature 1087 and / or the digital signature 1084 before accepting the electronic drain command 1080 as valid. In some embodiments, the automated bodily fluid drainage control system 102 prompts (1088) the user 890 to receive the electronic drain command 1080 before the automated bodily fluid drainage control system 102 executes (1036) the electronic drain command 1080. In some embodiments, the automated bodily fluid drainage control system 102 examines (1090) the electronic drain command 1080 and compares (1091) the electronic drain command 1080 with a valid drain storage protocol 910 in the drain protocol safety library 900.In some embodiments, the automated bodily fluid drainage control system 102 may verify the electronic drain command 1080 in a verifying step 1092, i.e., require that the electronic drain command 1080 be valid and consistent with a stored drain protocol 910 in the drain protocol safety library 900, and the automated bodily fluid drainage control system 102 may reject an electronic drain command 1080 that is not valid and consistent with a stored drain protocol 910 in the drain protocol safety library 900. In some embodiments, the stored drain protocol 910 includes a checklist 1093 that is presented to the user 890 as steps that must be completed before initiating the stored drain protocol 910, and the checklist 1093 may include detailed instructions 1094 consisting of text, images, video, or other materials that the user 890 inspects before performing the steps of the checklist 1093.

[0116] In some aspects, and with reference to FIG. 18 , the present disclosure includes a method 1100 in which an automated bodily fluid drainage control system 102 receives an electronic drain command 1080 from a third party system 1082, the method including the third party system 1082 having a connection 1102 to the automated bodily fluid drainage control system 102, the automated bodily fluid drainage control system 102 first receiving the electronic drain command 1080 from the third party system 1082 in a receiving step 1104, thereafter the automated bodily fluid drainage control system 102 determining whether the electronic drain command 1080 has been verified or After verifying (1106) that the electronic drain command 1080 came from a verified third-party system 1082, the automated body fluid drainage control system 102 processes (1108) the electronic drain command 1080, after which the automated body fluid drainage control system 102 verifies (1110) that the electronic drain command 1080 is within a plurality of parameters for execution of the automated body fluid drainage control system 102, after which the electronic drain command 1080 configures (1112) the automated body fluid drainage control system 102, and the automated body fluid drainage control system 102 executes (1114) the electronic drain command 1080. 19 , the present disclosure includes a method 1120 of transmitting electronic drain commands 1122 from an automated body fluid drainage control system 102 to a third party system 1082, the method including an interoperable server system 1010 capable of receiving drain data from the automated body fluid drainage control system 102, the automated body fluid drainage control system 102 being configured to monitor a physical process and record actual drain data for a desired drain behavior, and a third party system 1082 capable of receiving a plurality of electronic drain data 1122, the plurality of electronic drain data 1122 from the automated body fluid drainage control system 102 being received by the interoperable server system 1010. In some aspects, the method 1100 can include a transmitting step 1124, wherein the automated body fluid drainage control system 102 transmits the plurality of electronic drain data 1122 to the third party system 1082.

[0117] In some aspects, and referring to FIG. 20 , the present disclosure includes a method 1140 of comparing an approved drain protocol safety library in a drain protocol safety library editor 904 (DPSLE) with a drain protocol safety library 900 (dynamic DPSL) on an automated body fluid drainage control system 102, the method 1140 including sending a request for an updated drain protocol safety library 900 from the automated body fluid drainage control system 102 to the drain protocol safety library editor 904 (1142); sending the known updated drain protocol safety library 900 from the drain protocol safety library editor 904 to the automated body fluid drainage control system 102 (1144); The automated body fluid drainage control system 102 analyzes (1146) the updated drain protocol safety library 900 to determine if there are any differences 1148 that require action by the automated body fluid drainage control system 102. If there are any differences 1148, the automated body fluid drainage control system 102 sends (1150) a request 1151 for an updated drain protocol safety library 900 to the drain protocol safety library editor 904. The drain protocol safety library editor 904 processes (1152) the request 1151 and sends (1154) the updated drain protocol safety library 900 to the automated body fluid drainage control system 102. The automated body fluid drainage control system 102 processes (1156) and stores the updated drain protocol safety library 900. The drain protocol safety library 900 can be stored and transferred in a database file format. The drain protocol safety library 900 can be transferred as compact, line-oriented differential changes and / or as a fully binary-encoded file. The drain protocol safety library 900 can be compressed before being transmitted. The automated body fluid drainage control system 102 and / or the drain protocol safety library editor 904 may digitally sign 1158 the request 1151 with a certificate 1159 to ensure the authenticity of the drain protocol safety library 900.The drain protocol safety library editor 904 can digitally sign 1160 the request 1151 with a certificate 1161 to ensure the authenticity of the drain protocol safety library 900. The automated body fluid drainage control system 102 can send the request 1151 on a regular schedule. The automated body fluid drainage control system 102 can send the request 1151 based on a detectable event. In another aspect of the method 1140, the drain protocol safety library editor 904 can request the currently dynamic drain protocol safety library 900 from the automated body fluid drainage control system 102.

[0118] In some aspects, and referring to FIG. 21 , the present disclosure includes a method 1200 for collecting a plurality of demographic and clinical information 1250 about a patient 800 or two or more patients and associating the plurality of demographic and clinical information 1250 with an automated body fluid drainage control system 102 used with a third-party system 1082, the method 1200 including a step 1202 of connecting the automated body fluid drainage control system 102 with the third-party system 1082, wherein in a receiving step 1204, the automated body fluid drainage control system 102 receives a patient data feed 1240 from the third-party system 1082, the patient data feed 1240 comprising a plurality of clinical data 1242, and wherein a user 890 associates 1206 the automated body fluid drainage control system 102 with the patient data feed 1240 using a process that may be manual. The automated fluid drainage control system 102 then returns the plurality of clinical data 1242 to the data platform 140, which then stores the plurality of clinical data 1242, including the demographic and clinical information 1250 and the spectral signature associated with the patient 800. The plurality of clinical data 1242 can then be processed at any time. The plurality of clinical data 1242 can be stored and transmitted in an encrypted format and / or the plurality of clinical data 1242 can be compressed using a digital compression algorithm. The plurality of clinical data 1242 can be anonymized for storage and / or transmission. The plurality of clinical data 1242 can be forwarded to an analytics engine 1246 for processing. The plurality of clinical data 1242 may be analyzed by the analysis engine 1246 in analysis 1244 and may include de-identified data elements from N-dimensional data elements, also referred to as de-identified N-dimensional data elements, from a combination or intersection of the clinical data 1242 and demographic and clinical information 1250 obtained from the third-party system 1082 and stored in the data platform 140.In some embodiments, the clinical data 1242 can be grouped into statistically likely treatment parameters so that any particular instructions for the automated fluid drainage control system 102, including but not limited to settings, drain storage protocols 910, and other instructions or programming, exist or can be verified to exist within a given standard deviation for a patient population. In some embodiments, the clinical data 1242 can be used by the automated fluid drainage control system 102 to detect compounds, drugs, molecules, or other spectral signatures in the cerebrospinal fluid such that the analysis engine 1246 can detect unidentified molecules, drugs, compounds, or spectral signatures 1247 and / or the analysis 1244 can indicate changes in the spectral signatures 1247 over time during the course of treatment for the patient 800 over a definable period of time, including but not limited to the entire course of treatment. The drainage data, patient data feed, and clinical data together may be referred to as "data." In some embodiments of the present disclosure, the presence or concentration of any of a set of molecules 1252, including but not limited to oxyhemoglobin, bilirubin, methemoglobin, glucose, proteins, and drugs, is detected 1254 by analysis 1244. If the presence or concentration of any of the set of molecules 1252 is detected 1254 by analysis 1244, the detections can be grouped into normative patterns 1256 for a given population of patients 800, such that the patterns 1256 can be used to distinguish spectral signatures 1247 of patients 800 who are normal over the course of treatment from spectral signatures 1247 of patients 800 who are abnormal over the course of treatment. In some embodiments, treatments can be grouped into outcome groups that provide clinical insight into the most likely outcomes of the current treatment of the patient 800. In some embodiments, detected clinically relevant alerts 1258 can be forwarded to the data platform 140, and such clinically relevant alerts 1258 can be detected by the automated bodily fluid drainage control system 102 and / or other elements of the systems or methods disclosed herein.In some aspects, one or more of the clinically relevant alerts 1258 may be transmitted in a transmitting step 1260 to a third party system 1082 and / or the automated fluid drainage control system 102 for notification and / or presentation to a healthcare provider or any user 890. In some aspects, the treatment patterns, spectral signatures 1247, and groupings are forwarded to the data platform 140 for real-time analysis, retrospective analysis, or other analysis that may be performed over any period of time, any such analysis being an action of the automated fluid drainage control system 102. In some aspects, one or more of the treatment patterns, spectral signatures 1247, and groupings may be transmitted in a transmitting step 1262 to a third party system 1082 and / or the automated fluid drainage control system 102 for notification and / or presentation to a healthcare provider or any user 890. In some aspects, one or more of the treatment pattern, the spectral signature 1247, and the groupings may be transferred to the data platform 140, which stores the one or more of the treatment pattern, the spectral signature 1247, and the groupings in a spectroscopically safe profile 1264. The spectroscopically safe profile 1264 may be transferred to the automated fluid drainage control system 102 in a transferring step 1266 for real-time analysis, retrospective analysis, or other analysis that may be performed over any period of time; any such analysis may be a drainage procedure. In some aspects, the spectroscopically safe profile 1264 may trigger a highly relevant alert 1268 that may be sent to the third-party system 1082 and / or the automated fluid drainage control system 102 in a sending step 1270 as a notification to the user 890. The automated fluid drainage control system 102 may include a user interface 150 that allows for the configuration of alerts to be forwarded to the user 890 or any healthcare provider. In some aspects, the user interface 150 allows for testing of the standard signature pattern 144 by a trained healthcare provider and / or user 890 .The user interface 150 may allow for review of the detected alert, including but not limited to real-time review. In some embodiments, dismissal of the alert associated with the clinically relevant alert 1258 on any device, including but not limited to the third-party system 1082, the analytics engine 1246, the data platform 140, and the automated fluid drainage control system 102, in a sending step 1272, sends a notification of the alert cleared 1274 to all of said other devices for general alert management.

[0119] In some aspects, the automated bodily fluid drainage control system 102, in a reporting step 1280, can report device diagnostic data 1282 to facilitate maintenance of the automated bodily fluid drainage control system 102. In some aspects, the automated bodily fluid drainage control system 102, in an updating step 1290, can be updated remotely without physical interaction with the user 890.

[0120] Specific aspects of the present invention have been described above. From the foregoing, it will be seen that the present invention is well adapted to attain all of the objects and objectives set forth above, together with other advantages that are obvious and inherent in the inventive apparatus disclosed herein. It will be understood that certain features and subcombinations are useful and can be employed without reference to other features and subcombinations. The present invention is expressly described as not being limited to the aspects described above; on the contrary, additions and variations to what is expressly described herein are intended to be within the scope of the present invention. Moreover, it is understood that the features of the various aspects described herein are not mutually exclusive and can exist in various combinations and permutations even if such combinations and permutations are not expressly stated herein without departing from the spirit and scope of the invention. Indeed, variations, modifications, and other implementations of what has been described herein will occur to those skilled in the art without departing from the spirit and scope of the invention. Accordingly, the present invention is not limited solely to the foregoing illustrative description.

Claims

1. A bodily fluid drainage control system including a drain control device and a plurality of drain cassettes, wherein the plurality of drain cassettes are single-use drain cassettes, and the plurality of single-use drain cassettes include at least two flat surfaces.

2. The system of claim 1 , wherein the single-use drain cassette further comprises an elastomer or silicone membrane compressed between at least two of the two flat surfaces.

3. 2. The system of claim 1, further comprising a proximal valve in fluid contact with the bodily fluid that needs to be drained and a distal valve in fluid contact with a drainage reservoir bag that stores the bodily fluid, wherein each of the proximal valve and the distal valve is in fluid contact with each other, and each of the proximal valve and the distal valve is capable of at least two of the following positions: open for drainage, closed, partially open, and variably open.

4. 4. The system of claim 3, further comprising a collection port in fluid contact with the proximal valve, the collection port being either an open or closed Luer access point, including but not limited to a needleless access valve, a pre-pierced port, or other fluid access means.

5. The system of claim 4 further comprising a reservoir suitable for visual inspection of the bodily fluid.

6. 6. The system of claim 5, further comprising a fluid sensor port for measuring the amount of fluid being expelled.

7. 7. The system of claim 6, further comprising a spectral analysis port suitable for spectrophotometric or other analytical sensors for analyzing the bodily fluid before it enters the reservoir.

8. The system of claim 7 , further comprising a pressure transducer in fluid contact with the bodily fluid prior to the proximal valve.

9. 10. The system of claim 8, further comprising a machine-readable identification element that identifies at least one of the following items: manufacturer of the cassette, date of manufacture, expiry date of consumables, set of drainage modes supported by the cassette, certification of the cassette, information for proper disposal of the cassette, presence of various single-use cassette features including known length of proximal fluid circuit and known length of distal fluid circuit, type of collection port present, whether a warning light indicator is present, size of the reservoir, and type of corresponding analysis.

10. 10. The system of claim 9, further comprising a machine-writable identification mechanism that allows usage and programming information to be written to the cassette so that when the cassette is removed from the system and installed in a different automatic body fluid drainage control system, the information can be read by the different automatic body fluid drainage control system.

11. A body fluid drainage control system including a drain control device and a plurality of drainage reservoir bags, the drainage reservoir bags having a fluid storage volume of at least 250 mL, and including at least one bag connection fitting and a plurality of bag retention aids.

12. 12. The system of claim 11, wherein the bag connection fitting is tubularly connected to a male connector suitable for connection to an output port of a drainage system, a luer, or other fitting.

13. 12. The system of claim 11, wherein the bag connection fitting is tubularly connected to a female connector suitable for connection to a drainage system and is presented with a needleless access valve.

14. The system of claim 11 , wherein each of the drainage reservoir bags includes a filtered outlet.

15. The system of claim 11 , wherein the bag connection fitting includes a check valve.

16. 12. The system of claim 11, wherein each of the drainage reservoir bags includes a machine-readable identification feature that identifies at least one of the following: a manufacturer of the drainage reservoir bag, a manufacturing date, a consumable expiration date, a maximum volume of the reservoir bag, a certification for the drainage reservoir bag, information for proper disposal of the drainage reservoir bag, and an amount of bodily fluid currently in the drainage reservoir bag.

17. 12. The system of claim 11, further comprising a machine-writable identification mechanism that enables usage and programming information to be written to the drainage reservoir bag so that when the drainage reservoir bag is removed from the system and installed in a different automated fluid drainage control system, the information can be read by the different automated fluid drainage control system.

18. 1. A bodily fluid drainage control system comprising a drain control device including a plurality of drainage reservoir bag attachments, a plurality of drainage reservoir bags, and a plurality of drain cassettes, each of the plurality of drain cassettes being reversibly securely fastened to and detached from one of a plurality of drain cassette attachments, each of the plurality of drain cassette attachments further comprising a cassette certificate reader, a pressure transducer interface, a valve actuator, a lever, a spectrum analysis sensor, a liquid level sensor, and a valve actuator, and each of the plurality of drainage reservoir bag attachments further comprising a reservoir bag certificate reader, a plurality of retention mechanisms, and an attached load cell.

19. 20. The system of claim 18, wherein each of the plurality of drain cassettes further comprises a bag-to-catheter connection, a cassette certificate, a pressure transducer, a multi-state valve, a collection port, a finger holding pin, a spectral analysis port, a visual inspection port, a liquid sensor port, a two-way valve, and a bag-to-drain reservoir connection.

20. 20. The system of claim 18, wherein each of the plurality of drainage reservoir bags further comprises a bag connection fitting, a plurality of bag holding aids, and a reservoir bag certificate.

21. 20. The system of claim 18, further comprising a plurality of input ports and a plurality of output ports.

22. 22. The system of claim 21, wherein the drain control device further comprises a plurality of alarm indicators disposed in at least one location on the system.

23. The system of claim 22, further comprising a user interface, wherein the system is capable of displaying information on the user interface about how to attach the first drain cassette and / or the drainage reservoir bag, and wherein the system is capable of displaying information on the user interface about the status of the drain cassette and / or the drainage reservoir bag and whether any user action is required.

24. 24. The system of claim 23, wherein the system further comprises a touchscreen interface, the system communicatively connected to a data platform.

25. 25. The system of claim 24, further comprising a machine-readable user identification system and a plurality of information regarding a set of privileges that are enabled based on authentication of the user.

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