The present disclosure relates to the use of sensors and point of care devices of a patient support apparatus, such as a hospital bed, for example, to determine if a patient has sepsis. The present disclosure is also directed to a system or method for accurately determining sepsis risk in a patient, accurate fluid management for the septic patient, and communicating a therapy operation protocol to a caregiver.
Patients in healthcare facilities may have a risk of developing sepsis during their stay. Sepsis is a negative condition or response that a person's body has to an infection. Sepsis results when a person's immune system stops fighting or has an insufficient response to an infection Sepsis risk assessments of patients oftentimes take place on a sporadic basis with prolonged periods transpiring between the assessments. Furthermore, the results of risk assessments are sometimes only available at a limited number of locations in the healthcare facility such as at an electronic medical records computer or at a computer of a master nurse station. Accordingly, there is a need in the healthcare field to have more timely information regarding the risk assessments of sepsis and there is a need for the risk assessment information to be more readily available to caregivers.
Fluid administration is a fundamental sepsis therapy and usually comprises a sepsis bundle fluid challenge. However, if the fluid leaks into interstitial space instead of entering the circulatory system, it may cause more harm than good to the patient. Thus, there is a need to increase the accuracy of fluid management in sepsis patients.
Many patient supports include a frame, a deck supported by the frame, a mattress, and side rails configured to block egress of a patient from the mattress, and a controller configured to control one or more features of the bed. Monitoring the various components of the patient support apparatus may include monitoring for the position, angle, activity, or other patient attributes. A caregiver may be not be able to determine if the different components are not in compliance with a therapy operation protocol. The ability of the patient support apparatus to determine compliance automatically may be important to prevent any potential harm to patients. Thus, the characterization of the components of the patient support apparatus and patient conditions should be determined and communicated to the caregiver to provide optimal care for the patient.
The present disclosure includes one or more of the features recited in the appended claims and/or the following features which, alone or in any combination, may comprise patentable subject matter.
According to a first aspect of the present disclosure, is a patient support apparatus comprising a sensor providing a first signal indicative of a vital sign of a patient positioned on the patient support apparatus, a point of care device providing a second signal, and a controller coupled to the sensor and the point of care device, including a processor and a memory device, the memory device including instructions that, when executed, cause the controller to receive the first signal from the sensor and the second signal from the point of care device, analyze the first and the second signals to determine data indicative of sepsis, compare the data indicative of sepsis to pre-established acceptable limits, and if the patient is assessed to have a risk for sepsis or has been diagnosed with sepsis, output a command signal.
In one embodiment, the patient support apparatus further comprises a sepsis notification system that responds to the command signal from the controller to display a first visual indication that shows if the patient has risk for sepsis or has been diagnosed with sepsis. In one embodiment, the point of care device is a peripheral device or a connected device. In one embodiment, the point of care device is a cell counter, a cell quality monitor, or a cardiac monitor. In one embodiment, the point of care device is a blood test module and comprises disposable tools for testing blood cell count or blood cell quality. In one embodiment, the point of care device can acquire white blood cell count of the patient in less than about a minute.
In one embodiment, the sepsis notification system responding to the command signal from the controller displays a second visual indication that shows if the patient needs fluid administration. In one embodiment, the second visual indication further indicates an amount of fluid required for fluid administration.
In one embodiment, the controller is configured to communicate with an external nurse call station. In one embodiment, the controller is configured to communicate with an electronic medical record system to receive information from the electronic medical record system indicative of a medical history of a patient supported on the patient support apparatus.
According to second aspect of the present disclosure is a patient support apparatus comprising a sensor providing a first signal indicative of a first vital sign of a patient supported on the patient support apparatus, a point of care device providing a second signal indicative of a cardiac output of the patient, and a controller coupled to the sensor and the point of care device, and including a processor and a memory device, the memory device including instructions that, when executed, cause the controller to receive the first and second signals, calculate a sepsis risk severity and an optimal fluid challenge amount based on the signals.
In one embodiment, the controller further receives and analyzes information from an electronic medical record storing patient information for the patient. In one embodiment, the apparatus further comprises a notification system responding to the command signal from the controller to provide a first visual indication that shows that the patient has risk for sepsis or has been diagnosed with sepsis. In one embodiment, the apparatus further comprises a notification system responding to the command signal from the controller to provide a first indication that shows that the patient has risk for sepsis or has been diagnosed with sepsis, and a second indication that shows an amount of fluid needed for fluid administration.
In one embodiment, the apparatus further comprises the controller communicating with a patient infusion system to automatically adjust fluid input to the patient. In one embodiment, the notification system provides a third indication that shows a sepsis graph indicating a rate of improvement in the patient. In one embodiment, the controller is configured to communicate with an external nurse call station. In one embodiment, the controller can communicate with the sensor and the point of care device though a wireless communication.
According to a third aspect of the present disclosure is a method of predicting sepsis in a patient on a patient support apparatus comprising an inflatable mattress, the method comprising the steps of monitoring a first signal from a sensor, wherein the first signal is indicative of a vital sign of the patient, monitoring a second signal from a point of care device, processing the first signal and the second signal to determine data indicative of sepsis, comparing the data indicative of sepsis to pre-established acceptable limits to assess if the patient has sepsis or has a risk for sepsis, and outputting a command signal to indicate if the patient has sepsis or has a risk for sepsis.
In one embodiment, the method comprises processing the first signal and the second signal to determine data indicative of sepsis comprises a controller analyzing the first and the second signals to determine data indicative of sepsis and comparing the data indicative of sepsis to pre-established acceptable limits. In one embodiment, processing the first signal and the second signal further comprises the controller receiving and analyzing information from an electronic medical record storing patient information for the patient.
In one embodiment, the method further comprises a notification system responding to the command signal from the controller to provide a first visual indication that shows that the patient has sepsis or has a risk for sepsis. In one embodiment, the method further comprises the notification system responding to the command signal from the controller to provide a second visual indication that shows if the patient needs fluid administration. In one embodiment, the method further comprises the notification system responding to the command signal from the controller to provide a third visual indication that shows an amount of fluid needed for fluid administration. In one embodiment, the method further comprises the controller communicating with a patient infusion system to automatically adjust fluid input to the patient. In one embodiment, the method further comprises the notification system responding to the command signal from the controller to provide a fourth visual indication that shows a sepsis graph indicating a rate of improvement in the patient.
In one embodiment, the method further comprises the controller communicating with an external nurse call station. In one embodiment of the method, the point of care device is a peripheral device or a connected device.
The detailed description particularly refers to the accompanying figures in which:
Referring to
The view shown in
The hospital bed 10 includes a base frame 20, which supports a lift system 22. The lift system 22 engages the base and an upper frame 24 such that the lift system 22 moves the upper frame 24 vertically relative to the base frame 20. The lift system 22 includes a head end linkage 27 and a foot end linkage 29. Each of the linkages 27 and 29 are independently is configured and can be operated to cause the hospital bed 10 to move into a tilt position which is when the head end 14 of the upper frame 24 is positioned lower than the foot end 12 of the upper frame 24. The hospital bed 10 can also be moved to a reverse tilt position with the foot end 12 of the upper frame 24 is positioned lower than the head end 14 of the upper frame 24.
The upper frame 24 supports a load frame 26. The load frame 26 supports a head deck 28, which is movable relative to the load frame 26. The load frame 26 also supports an articulated seat deck 30 (seen in
The foot deck 34 includes a first portion 36 and a second portion 38, which moves relative to the first portion 36 to vary the size of the foot deck 34. The second portion 38 moves generally longitudinally relative to the first portion 36 to vary the longitudinal length of the foot deck 34 and, thereby, the longitudinal length of the hospital bed 10.
A foot panel 40 is supported from the second portion 38 and extends vertically from an upper surface 42 of the second portion 38 to form a barrier at the foot end 12 of the hospital bed 10. A head panel 44 is positioned on an upright structure 46 of the base frame 20 and extends vertically to form a barrier at the head end 14 of the hospital bed 10. A left head side rail 48 is supported from the head deck 28 and is moveable between a raised position shown in
The hospital bed 10 also includes a left foot side rail 58 and a right foot side rail 60, each of which is supported directly from the load frame 26. Each of the side rails 48, 50, 58, and 60 are is configured to be lowered to a position below the upper surface 52. It should be noted that when the head deck 28 is moved, the head side rails 48 and 50 move with the head deck 28 so that they maintain their relative position to the patient. This is because both of the head side rails 48 and 50 are supported by the head deck 28.
In the illustrative embodiment, the hospital bed 10 further includes at least one sensor 102 mounted to a deck section of the hospital bed 10 and a control system 104 coupled to the sensor 102 as shown in
In one embodiment, the control system 104 is configured to receive the sensor signals and compare the sensor signals to pre-established acceptable conditions to determine if the patient is at-risk or should be diagnosed with sepsis. In another embodiment, the sensor signals and information stored on the patient's EMR 106 are both compared to the pre-established acceptable conditions to determine if the patient is at-risk or should be diagnosed with sepsis.
In the illustrative embodiment, the sensor 102 is a non-contact vital signs monitoring sensor available from EarlySense Inc., 135 Beaver Street Suite 307, Waltham, MA 02452. It provides a signal indicative of vital signs, such as, for example, a detected heart rate and a signal indicative of a detected respiration rate that is processed by the control system 104. This sensor 102 is described in greater detail in U.S. Patent Pub. No. 2018/0184984, which is expressly incorporated herein for the purpose of describing a suitable sensor used to detect patient vital signs. The sensor 102 can be mounted in multiple locations on either the fixed seat deck 32 or head deck 28 as suggested in
In some embodiments, multiple sensors 102 can be positioned on the fixed seat deck 32 and/or head deck 28 to provide multiple detection points with the signals from each of the multiple sensors 102 being monitored to determine an accurate vital sign signal. The use of redundant signals reduces the risk of signal loss due to movement or improper positioning of the patient on the hospital bed 10. The sensor 102 has a relatively thin thickness that permits the sensor 102 to be placed under the mattress 54 and does not interfere with the functionality or therapeutic benefit of the mattress 54. In other embodiments, a different piezoelectric sensor can be utilized in place of the sensor 102. In another embodiment, the sensor 102 can be positioned inside of the mattress 54. In other embodiments, additional sensors can be wearable by the patient and communicatively connected to the control system 104 to provide signals indicative of vital signs of the patient.
In one embodiment, the hospital bed 10 further includes a point of care (PoC) device 120 to collect date to determine the occurrence of a disease indication or compliance with a therapy in conjunction with the vital sign(s) determined by the sensor 102. In the illustrative embodiment, the hospital bed 10 the point of care (PoC) device 120 can be utilized to collect date to determine the occurrence of sepsis in conjunction with the vital sign(s) determined by the sensor 102. The point of care (PoC) device 120 can be a peripheral device, can be attached to the bed 10, can be integrated with the hospital bed 10, can be connected directly to the sepsis monitoring unit 100, and/or can be movable by a caregiver. The point of care (PoC) device 120 can be a blood cell type or blood cell quality counter (e.g., a white blood cell counter), or a cardiac monitor that can acquire and analyze the patient's ECG. The point of care (PoC) device 120 can be an independent device including but not limited to a WBC diagnostic tool (e.g., Athelas etc.), a cardiac monitor (e.g., Cheetah medical, Baster Mortara, Baxter ToSense etc.). The point of care (PoC) device 120 can integrate a blood test module to detect blood cell counts. In some embodiments, the point of care (PoC) device 120 can acquire white blood cell count of the patient in less than about a minute. The point of care (PoC) device 120 can include disposable tools (e.g., finger sticks, glass slides) to assess a drop of blood from the patient. The point of care (PoC) device 120 can include module trays for assessing patient blood, and a location for storing the disposable tools.
Sepsis can be predicted or detected using risk assessments that can vary between each healthcare facility. Some non-limiting examples of scores used to determine if a patient is at-risk for sepsis include a quick sequential (sepsis-related) organ failure assessment score (qSOFA) and/or systematic inflammatory response syndrome score (SIRS). Each method includes a set of criteria such as vital signs and/or other conditions that are defined by pre-established acceptable limits and are triggered when the patient deviates from those acceptable limits. These conditions can be monitored by the point of care (PoC) devices 120. Other examples of assessments or tests used to determine if a patient is at risk for sepsis are described in U.S. Provisional Patent Appl. No. 62/655,385, filed Apr. 10, 2018, which is expressly incorporated by reference herein. The sepsis-status notification system 110 can be programmed to operate with any assessment, test, or score criteria relating to sepsis including those that evolve as medical procedures advance. In some embodiments, the wearable device or sensor can be specifically designed to detect the presence of sepsis such that the scoring methods described above are omitted and/or used in conjunction with the wearable device.
The sepsis protocol can include a therapy operation protocol. The sepsis protocol can include a list of actions or procedures that should be administered to the patient within a certain time period (e.g., within a three hour period and/or a six hour period beginning at the time the patient is diagnosed with sepsis or otherwise determined to be septic). For example, the sepsis protocol may include that within the three-hour protocols and timeframe, the following actions should be taken: 1) obtain blood cultures, 2) obtain a lactate measurement, 3) administer broad spectrum antibiotics, and 4) administer fluids crystalloid. Within a six-hour protocol and timeframe, the following additional actions should be taken: 1) administration of vasopressors for non-responsive resuscitation, 2) maintaining adequate central venous pressure (CVP) and mixed venous oxygen content (CvO2) levels, and 3) obtaining a second lactate measurement if the first lactate measurement was high. Other sepsis risk assessment and sepsis treatment protocols can be used. For example, a sepsis protocol may include fluid administration to the patient.
Compliance with the sepsis protocols can increase the patient's chance of survival after being diagnosed with sepsis. The sepsis-status notification system 110 is configured to increase compliance with the protocols by notifying the caregiver and others near the patient if the patient is at-risk or diagnosed with sepsis, an amount of time that has passed, and a status of the actions that need to be completed for compliance with the protocols.
As shown in
Once the patient is determined to be at-risk or diagnosed with sepsis, the control system 104 sends a command signal to the sepsis-status notification system 110 to cause the sepsis-status notification system 110 to provide the indication to the caregiver at step 216. The sepsis monitoring unit 100 continues monitoring and updating the indications provided by the sepsis-status notification system 110 in real time until administration of the protocols is completed.
Fluid administration for sepsis patients is critical and can be accomplished non-invasively. For example, a Baxter Starling Fluid Management System can be employed provide recommendation for fluid administration to sepsis patients. Such a system combines cardiac monitoring with patient positioning by measuring bio-impedance and calculating a full hemodynamic profile including stroke volume and cardiac output when determining if fluid administration is needed (as seen in
In one embodiment, the control system 104 calculates and displays sepsis risk severity and an optimal fluid challenge amount for the patient using a combination of vital signs being monitored by the sensor 102 and the point of care (PoC) device 120 (e.g., cardiac monitor) (as seen in
The control system 104 can determine an accurate estimate of fluid that needs to be administered based on data obtained from the sensor 102 and the point of care (PoC) device 120 (e.g., cardiac monitor). The sepsis-status notification system 110 can display a visual or audible indication that the patient is septic by using a plurality of devices. Additionally, or alternatively, the sepsis-status notification system 110 can display a visual or audible indication about fluid administration and/or fluid responsiveness of the patient. For example, the sepsis-status notification system 110 can display a sepsis graph indicating a rate of improvement in the patient and indicate fluid responsiveness of the patient (as seen in
As shown in
The control system 104 sends a command signal to the sepsis-status notification system 110 to cause the sepsis-status notification system 110 to provide the indication to the caregiver at step 226. Additionally, the indication can be displayed on or around the hospital bed 10 or transmitted wirelessly to a remote location through the hospital network 108. The control system 104 can determine the amount of fluid required for administration in step 228, and can communicate that amount to the infusion system 122 in step 230. The control system 104 sends a command signal to the sepsis-status notification system 110 to cause the sepsis-status notification system 110 to provide the indication to the caregiver about the amount of fluid required for administration at step 232. The sepsis monitoring unit 100 continues monitoring and updating the indications provided by the sepsis-status notification system 110 in real time until administration of the protocols is completed.
As shown in
In one embodiment, the MCB 166 communicates with each device through a connection 178 or wirelessly using the SOM 164 and the hospital network 108. The connection 178 can be a simple UART interface, a CAN interface, a discrete wiring connection, or any other suitable connection. Each of the connections 162, 168, 170, 174, 178, and 184 can be a simple UART interface, a CAN interface, a discrete wiring connection, or any other suitable connection as required for the particular application. Relative to the sepsis-status notification system 110, the MCB 166 includes a processor 165 and a non-transitory memory device 167 that stores instructions. When appropriate, the instructions are executed to operate the sepsis monitoring unit 100 and display the indications. Some of the processing and instructions can be resident on the SOM 164 as it relates to specific tasks to be executed under the direction of the MCB 166.
Referring to the left head side rail 48 shown in
As shown in
The sepsis-status notification system 110 can use the other devices 66, 68, and 72 to indicate that the patient is septic and action is needed. The sepsis-status notification system 110 can use the other devices 66, 68, and 72 to indicate that the patient needs fluid administration and/or the amount of fluid that needs to be administered. The MCB 166 is configured to send a command signal to one or more of the devices 66, 68, 72 to cause the devices to display an alert message 74 when the patient is diagnosed with sepsis. The MCB 166 can also send a command signal to one or more of the devices 66, 68, 72 to cause the devices to provide an audible alert to notify the caregiver to check the device or to audibly convey the alert message 74. As shown in
Although this disclosure refers to specific embodiments, it will be understood by those skilled in the art that various changes in form and detail can be made without departing from the subject matter set forth in the accompanying claims.
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63/381,207, filed Oct. 27, 2022, which is expressly incorporated by reference herein.
Number | Date | Country | |
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63381207 | Oct 2022 | US |