Patent Application
20220295174
This application relates generally to systems and methods for medical treatment devices having focused directional alarms, including audible alarms and visual alarm displays.
Medical devices, such as dialysis machines, are known for use in the treatment of renal disease. The two principal dialysis methods are hemodialysis (HD) and peritoneal dialysis (PD). During hemodialysis, the patient's blood is passed through a dialyzer of a hemodialysis machine while also passing dialysate through the dialyzer. A semi-permeable membrane in the dialyzer separates the blood from the dialysate within the dialyzer and allows diffusion and osmosis exchanges to take place between the dialysate and the blood stream. During peritoneal dialysis, the patient's peritoneal cavity is periodically infused with dialysate, or dialysis solution. The membranous lining of the patient's peritoneum acts as a natural semi-permeable membrane that allows diffusion and osmosis exchanges to take place between the solution and the blood stream. Automated peritoneal dialysis machines, also called PD cyclers, are designed to control the entire peritoneal dialysis process so that it can be performed at home, usually overnight, without clinical staff in attendance. Both HD and PD machines may include displays with touch screens or other user interfaces that display information of a dialysis treatment and/or enable an operator or patient to interact with the machine.
Dialysis machines are equipped to generate alerts and/or alarms (hereinafter used interchangeably), include both audible and visual alarms, in response to conditions and situations requiring user attention. Many times, particularly during PD treatment using a PD cycler, alarms occur in the middle of the night when the patient is asleep and cause disturbance of the patient's sleep. Depending on the proximity to other people, the PD cycler can also disturb other people, like a spouse or caregiver in the same room, people in an adjacent bedroom, or even neighbors who share a common apartment wall. This creates frustration in other people who are not dialysis patients, and the stress of upsetting other people increases anxiety for the patient. Furthermore, the line of sight for dealing with a PD cycler alarm is usually such that the patient must sit up or get out of bed to look at the device's display screen, which may cause further disturbance to the patient.
Accordingly, it would be desirable to provide a system that addresses the above-noted concerns and other issues.
According to the system described herein, a dialysis system includes a dialysis machine having an alarm generation component. A directional alarm system is communicatively coupled to the dialysis machine. The directional alarm system includes a directional speaker that generates directional sound waves. In response to generation of an alarm by the alarm generation component of the dialysis machine, the directional speaker emits the directional sound waves indicating the alarm in a controlled direction.
According further to the system described herein, a method for handling notification of a dialysis alarm includes generating an alarm at a dialysis machine using an alarm generation component. The method further includes activating a directional alarm system to the dialysis machine, in which the directional alarm system includes a directional speaker that generates directional sound waves. In response to the generation of an alarm by the alarm generation component of the dialysis machine, the directional sound waves indicating the alarm are emitted from the directional speaker in a controlled direction.
According further to the system described herein, a non-transitory computer readable medium has executable code that when executed by a processor causes execution of a method for handling notification of a dialysis alarm. The method includes generating an alarm at a dialysis machine using an alarm generation component. The method further includes activating a directional alarm system to the dialysis machine, in which the directional alarm system includes a directional speaker that generates directional sound waves. In response to the generation of an alarm by the alarm generation component of the dialysis machine, the directional sound waves indicating the alarm are emitted from the directional speaker in a controlled direction.
According to aspects of the system described herein, multiple feature implementations may be provided in connection with the dialysis system, method of handling alarm notifications, and non-transitory computer readable medium described herein. The directional alarm system may comprise an orientation mechanism to orient the emitting of the directional sound waves in the controlled direction that may be a manual mechanism and/or an automated mechanism that includes a sensor used to locate automatically a desired direction for emitting the directional sound waves. In response to the generation of the alarm, a speaker of the dialysis machine may be deactivated for a period of time while the directional alarm system is functioning. The directional alarm system may include a display component that provides visual display of an alarm. The directional alarm system may include a receiving device disposed remotely from the dialysis machine that receives the directional sound waves and directs the directional sound waves towards a fixed location. The directional alarm system may be in wireless communication with the dialysis machine. If the alarm generated by the alarm generation component is not addressed for a specified time, a safety protocol may be initiated that includes stopping emission of the directional sound waves and causing audible general broadcast of the alarm. A volume of the alarm conveyed by the directional sound waves may be configured to increase automatically from a quieter volume to a louder volume.
Implementations and features of the system described herein are explained with reference to the several figures of the drawings, which are briefly described as follows.
Dialysate bags 122 may be suspended from the sides of the cart 104, and a heater bag 124 may be positioned in the heater tray 116. Hanging the dialysate bags 122 may improve air management as any air is disposed by gravity to a top portion of the dialysate bag 122. Valves may be attached to a bottom portion of the dialysate bags 122 so fluid is drawn out and air delivery is minimized. Dialysate from the dialysate bags 122 may be transferred to the heater bag 124 in batches. For example, a batch of dialysate may be transferred from the dialysate bags 122 to the heater bag 124, where the dialysate is heated by the heating element. When the batch of dialysate has reached a predetermined temperature (e.g., approximately 98°-100° F., 37° C.), the batch of dialysate may be flowed into the patient. The dialysate bags 122 and the heater bag 124 may be connected to the cartridge via dialysate bag lines 126 and a heater bag line 128, respectively. The dialysate bag lines 126 may be used to pass dialysate from dialysate bags 122 to the cartridge during use, and the heater bag line 128 may be used to pass dialysate back and forth between the cartridge and the heater bag 124 during use. In addition, a patient line 130 and a drain line 132 may be connected to the cartridge. The patient line 130 may be connected to a patient's abdomen via a catheter and may be used to pass dialysate back and forth between the cartridge and the patient's peritoneal cavity during use. The drain line 132 may be connected to a drain or drain receptacle and may be used to pass dialysate from the cartridge to the drain or drain receptacle during use.
The touch screen 118 and the control panel 120 may allow a user to input various treatment parameters to the dialysis machine 102 and to otherwise control the dialysis machine 102. In addition, the touch screen 118 may serve as a display. The touch screen 118 may function to provide information to the patient and the operator of the PD system 100. For example, the touch screen 118 may display information related to a dialysis treatment to be applied to the patient, including information related to a prescription. In various embodiments, the control panel 120 may also include audio and video component capabilities, including speakers, microphones and/or cameras.
The dialysis machine 102 may include a processing module 101 that resides inside the dialysis machine 102, the processing module 101 being configured to communicate with the touch screen 118 and the control panel 120. The processing module 101 may be configured to receive data from the touch screen 118 the control panel 120 and sensors, e.g., temperature and pressure sensors, and control the dialysis machine 102 based on the received data. For example, the processing module 101 may adjust the operating parameters of the dialysis machine 102.
The dialysis machine 102 may be configured to connect to a network 110. The connection to network 110 may be via a wireless connection, such as via WiFi or Bluetooth, or in some cases a non-wireless connection, as further discussed elsewhere herein. The dialysis to machine 102 may include a connection component 112 configured to facilitate the connection to the network 110. The connection component 112 may be a transceiver for wireless connections and/or other signal processor for processing signals transmitted and received over a wired connection. In the case of a wired connection, the connection component 112 may be a port enabling a physical connection to a network component. Other medical devices (e.g., other dialysis machines) or components may be configured to connect to the network 110 and communicate with the dialysis machine 102. Although discussed herein principally in connection with a peritoneal dialysis machine, the system described herein may be used and implemented in connection with other types of medical devices having one or more displays, including home hemodialysis machines and/or other home medical devices.
In some embodiments, the machine 102 may also include a processor 170, and memory 175, the controller 155, the processor 170, and/or the memory 175, or combinations thereof, that may separately or collectively part of the processing module 101, that may receive signals from the sensor(s) 160 indicating various parameters. Each fluid bag (e.g., the dialysate bags 122) may contain an approximate amount of dialysate, such that “approximate amount” may be defined as a 3 L fluid bag containing 3000 to 3150 mL, a 5 L fluid bag containing 5000 to 5250 mL, and a 6 L fluid bag containing 6000 to 6300 mL. The controller 155 may also detect connection of all fluid bags 122 connected.
Communication between the controller 155 and the treatment system may be bi-directional, whereby the treatment system acknowledges control signals, and/or may provide state information associated with the treatment system and/or requested operations. For example, system state information may include a state associated with specific operations to be executed by the treatment system (e.g., trigger pumps and/or compressors to deliver dialysate and the like) and a status associated with specific operations (e.g., ready to execute, executing, completed, successfully completed, queued for execution, waiting for control signal, and the like).
In some embodiments, the dialysis machine 102 may include at least one pump 180 operatively connected to the controller 155. During a treatment operation, the controller 155 may control the pump 180 for pumping fluid, e.g., fresh and spent dialysate, to and from a patient. For example, the pump 180 may transfer dialysate from the dialysate bag 122 through, for example, a cassette insertable into a port formed in the dialysis machine, to the heating chamber 152 prior to transferring the dialysis to the patient. In an embodiment, the pump 180 may be a peristaltic pump. The controller 155 may also be operatively connected to a speaker 185 and a microphone 187 disposed in the machine 102. A user input interface 190 may include a combination of hardware and software components that allow the controller 155 to communicate with an external entity, such as a patient or other user. These components may be configured to receive information from actions such as physical movement or gestures and verbal intonation. In some embodiments, the components of the user input interface 190 may provide information to external entities. Examples of the components that may be employed within the user input interface 190 include keypads, buttons, microphones, touch screens, gesture recognition devices, display screens, and speakers. The machine 102 may also be wirelessly connectable via an antenna 192 for remote communication that may be a part of the connection component 112. The machine 102 may also include a display 195 and a power source 197.
The sensors 160 may be included for monitoring parameters and may be operatively connected to at least the controller 155, the processor 170, and/or the memory 175, or combinations thereof. The processor 170 may be configured to execute an operating system, which may provide platform services to application software, e.g., for operating the dialysis machine 102. These platform services may include inter-process and network communication, file system management and standard database manipulation. One or more of many operating systems may be used, and examples are not limited to any particular operating system or operating system characteristic.
The memory 175 may include a computer readable and writeable nonvolatile data storage medium configured to store non-transitory instructions and data. In addition, the memory 175 may include a processor memory that stores data during operation of the processor 170. In some examples, the processor memory includes a relatively high performance, volatile, random access memory such as dynamic random-access memory (DRAM), static memory (SRAM), or synchronous DRAM. However, the processor memory may include any device for storing data, such as a non-volatile memory, with sufficient throughput and storage capacity to support the functions described herein. Further, examples are not limited to a particular memory, memory system, or data storage system.
The instructions stored on the memory 175 may include executable programs or other code that may be executed by the processor 170. The instructions may be persistently stored as encoded signals, and the instructions may cause the processor 170 to perform the functions described herein. The memory 175 may include information that is recorded, on or in, the medium, and this information may be processed by the processor 170 during execution of instructions. The memory 175 may also include, for example, specification of data records for user timing requirements, timing for treatment and/or operations, historic sensor information, and the like. The medium may, for example, be optical disk, magnetic disk or flash memory, among others, and may be permanently affixed to, or removable from, the controller 155.
The sensor(s) 160 may include a pressure sensor for monitoring fluid pressure of the machine 102, although the sensors 160 may also include any of a heart rate sensor, a respiration sensor, a temperature sensor, a weight sensor, an air sensor, a video sensor, a thermal imaging sensor, an electroencephalogram sensor, a motion sensor, an audio sensor, an accelerometer, a capacitance sensor, or any other suitable sensor. It is appreciated that the sensors 160 may include sensors with varying sampling rates, including wireless sensors.
The controller 155 may be disposed in the machine 102 or may be coupled to the machine 102 via a communication port or wireless communication links, shown schematically as communication element 158 that may be a part of the connection component 112. According to various examples, the communication element 158 may support a variety of one or more standards and protocols, examples of which include wireless and/or non-wireless communication, such as USB, Wi-Fi, TCP/IP, Ethernet, Bluetooth, among others. As a component disposed within the machine 102, the controller 155 may be operatively connected to to any of the sensors 160, the pump 180, and the like. The controller 155 may communicate control signals or triggering voltages to the components of the machine 102. As discussed, exemplary embodiments of the controller 155 may include wireless communication interfaces. The controller 155 may detect remote devices to determine if any remote sensors are available to augment any sensor data being used to evaluate the patient.
The connection component 112, 212 may provide for connection of the dialysis machine 102, 202 through a secure gateway to connect to the network, including a network within the home and/or outside the home to send and receive information between devices and/or to a clinic. The connection, network and data transmissions among components, both local and external, may be controlled and/other otherwise incorporated into a system that facilitates such functions with appropriate network infrastructure, and which may, in some implementations, be referred to as a connected health system.
According to the system described herein, a medical device, such as a dialysis machine, may be equipped with focused directional speakers and/or displays to direct audible and visual alarms towards the patient, as an intended recipient, in order to minimize disruption to others caused by an alarm. Directional speakers are known that use ultrasonic technology to enable sound emission in a controlled and directional way. Examples of directional speakers include HyperSound speakers manufactured by Turtle Beach Corporation, and reference is made to HyperSound Hearing Solutions, White Paper: HyperSound Clear Technology, Turtle Beach Corporation, 2015, which is incorporated herein by reference. HyperSound speakers emit sound in a controlled, narrow beam by using ultrasound to create audio in the air. The ultrasonic carrier frequency is generated from the emitter at approximately 100 kHz. For further descriptions of directional sound systems, reference is made to U.S. Pat. Nos. 7,298,853 and 9,591,426, which are incorporated herein by reference.
The PD cycler 302 includes software and hardware components to detect many types of errors, anomalies, inconsistencies, exceeding of set thresholds, etc. in connection with a dialysis treatment. As a result of detecting any such error, anomaly etc., a processing module of the PD cycler 302, like the processing module 110, that may include an alarm generation component, such as a processor executing alarm generation software, may perform alarm processing that includes generation of an audible alarm and/or display of an alarm message on the display screen of the PD cycler 302. For example, positioning of the tubing 320 during a treatment may be subject to how and where the patient may be sleeping and/or sitting. The tubing 320 may become kinked, or may collapse, or become otherwise blocked anywhere along the length of the tubing between the patient 315 and the PD cycler 302. Specifically, tubing 320 may kink, collapse, and/or block near the patient 315, e.g., at the catheter 325, and/or where the tubing extends beyond a patient's sleeping area, e.g., off an edge of a bed, or chair, indicated at reference numeral 330. The patient 315 may inadvertently kink, collapse, and/or otherwise block the tubing during normal shifting and/or movement while asleep. In response to detecting a potential kink, collapse, and/or blockage of the tubing 320, the PD cycler 302 may automatically generate an alert, alarm, and/or abort a treatment if fluid cannot freely flow between the patient 315 and the PD cycler 302. The PD cycler 302 may detect the kinked or collapsed tubing to provide warnings to the patient prior to stopping treatment, which are intended to wake the patient so that the tubing can be checked and readjusted as needed to continue the treatment. A kink alarm has been used as an example, but it should be clear that the system described herein may be used in connection with any appropriate alarm that may be generated before, during, or after a dialysis treatment.
According to an implementation of the system described herein, alarm processing and transmission may include causing deactivation of the normal speaker system of the PD cycler 302 for a period of time in favor of operation of the directional speaker system 350. In various implementations, the deactivation of the normal speaker system of the PD cycler 302 may be caused by a signal transmitted from the directional speaker system 350 to the PD cycler 302 and/or may be caused by the PD cycler 302 detecting that the directional speaker system 350 is coupled and functioning. As further described elsewhere herein, safety protocols may enable later actuation of the normal speaker system of the PD cycler 302 in specified circumstances. The directional speaker system 350 includes directional speakers, like that described above that emit directional sound waves, that may be either manually or automatically positioned to focus sound waves 355 directly on an intended recipient, such as the patient 315. In an implementation, as shown in the figure, the directional speaker system 350 may include an orientation mechanism, such as one or more hinge or joint mechanisms, to enable manual directional positioning of the sound wave emitter component of the speaker system 350. Various other implementations for positioning of the speakers to align with the patient 315 are described in further detail elsewhere herein. The speaker system 350 may be communicatively coupled to one or more processors of the dialysis machine 302, such as via a wired connection and/or via wireless connection, for example via WiFi and/or Bluetooth.
The speaker system 350 may be useful for home dialysis patients whose alarming devices at night wake up not only their partners but also neighbors, especially when the patient is hard of hearing or a heavy sleeper and needs to set the volume at the loudest setting in order to hear it to prevent possible serious injury. Accordingly, for example, in the kink alarm scenario discussed above, the dialysis machine 302 and/or other part of the dialysis system 310, may display an alarm (shown as a “!”) on the dialysis machine display and generate an audible alarm intended for the patient and activate the directional speaker system 350 to direct control and direction the sound waves 355 only to the patient so as to wake the patient, but minimize disturbance to others in the vicinity. The focused alert sound may be configured to progress from quiet to loud so as to not shock the patient awake. In further implemented safety features, a safety protocol may provide that, if the patient 315 still does not awaken after a set amount of time to clear the alarm, then the dialysis device generally broadcasts the alarm to the entire room.
Bluetooth. An implementation of the display panel 452 may include a sound-generating glass product that may be overlayed on the display panel 452 and which can be used to notify the patient of the dialysis machine status using focused directional sound that is generated from the sound-generating glass. In an implementation, the sound generating glass component of the display panel 452 may include a HyperSound Glass product that includes a glass pane layered with a set of transparent films allowing it to generate an ultrasound beam and includes appropriate processing components therefor.
Since the face of the sound generating glass of the display panel 452 is pointing directly at the patient, text of the visual alarm generated by the dialysis machine 302 and displayed on the display screen of the dialysis machine 302 may be transmitted or projected on the display panel 452. This provides that the patient can see it without needing to sit up or otherwise move to face the main screen of the dialysis machine 302, which may not be in a line of sight with the patient due to the room or treatment configuration. Additionally the display panel 452 may include controls that enable muting or clearing the alarm. These controls may be provided via touchscreen interfacing and/or remotely using infrared/optical/voice/etc. sensors so the patient does not need to get out of bed to interact with the dialysis machine user interface. The directional alarm system 450 may be connected to an arm 454 that may be positioned so that the display panel 452 is pointing at the patient's sleeping location thereby providing for the directional speaker functionality of the directional alarm system 450 to be focused and directed to the patient along with the visual display component. The arm 454 may be manually adjustable. In other implementations, a more advanced mechanism 456 may be provided that include sensors to automatically track the patient, for example, detecting the patient using laser/audio/infrared/etc. signals, and using those signals to control motors and actuators to align directionally the display panel 452 in a configuration to direct the directional speakers towards the patient 315.
In other implementations, for a patient with some hearing loss who cannot hear certain frequencies as well as others, the system may allow optimization of alarms via selection of the frequency to which the patient is best able to respond. The system could further enable selection of frequencies in which the perception ratio between the patient and the spouse is optimal to alert the patient but not disturb the spouse. This could be reached by a hearing test in which both the patient and spouse select the frequencies best suited to both wake the patient and not disturb the spouse. As a safety protocol, during an actual alarm event, the dialysis device may cycle through the alarm tones in the order of most preferred to least preferred if the patient does not respond within the designated time. This system may include periodic hearing checks to ensure the optimum frequency is produced.
Embodiments or implementations discussed herein may be combined with each other in appropriate combinations in connection with the system described herein. Additionally, in some instances, the order of steps in the flow diagrams, flowcharts and/or described flow processing may be modified, where appropriate. The system may further include a display and/or other computer components for providing a suitable interface with a user and/or with other computers.
Aspects of the system described herein may be implemented or controlled using software, hardware, a combination of software and hardware and/or other computer-implemented or computer-controlled modules or devices having described features and performing described functions. Data exchange and/or signal transmissions to, from and between components of the system may be performed using wired or wireless communication. This communication may include use of one or more transmitter or receiver components that securely exchange information via a network, such as the Internet, and may include use of components of local area networks (LANs) or other smaller scale networks, such as Wi-Fi, Bluetooth or other short range transmission protocols, and/or components of wide area networks (WANs) or other larger scale networks, such as mobile telecommunication networks.
Software implementations of aspects of the system described herein may include executable code that is stored in a computer-readable medium and executed by one or more processors. The computer-readable medium may include volatile memory and/or non-volatile memory, and may include, for example, a computer hard drive, ROM, RAM, flash memory, portable computer storage media, an SD card, a flash drive or other drive with, for example, a universal serial bus (USB) interface, and/or any other appropriate tangible or non-transitory computer-readable medium or computer memory on which executable code may be stored and executed by a processor. The system described herein may be used in connection with any appropriate operating system. The meanings of any method steps of the invention(s) described herein are intended to include any suitable method of causing one or more parties or entities to perform the steps unless a different meaning is expressly provided or otherwise clear from the context.
As used herein, an element or operation recited in the singular and preceded with the word “a” or “an” should be understood as not excluding plural elements or operations, unless such exclusion is explicitly recited. References to “one” embodiment or implementation of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Furthermore, a description or recitation in the general form of “at least one of [a], [b] or [c],” or equivalent thereof, should be generally construed to include [a] alone, [b] alone, [c] alone, or any combination of [a], [b] and [c].
Embodiments and implementations of the invention will be apparent to those skilled in the art from a consideration of the specification or practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.
