Patent Application
20230346609
The field of the disclosure is wetness detection and more specifically disposable wetness detection systems and methods for use in beds, chairs, wheelchairs or on other user supporting surfaces as well as manufacturing processes useful in configuring assemblies for detecting wetness states.
Many people in hospital beds and some people at home in bed get wet often. In many cases when a person gets wet (i.e. feces, urine, blood, sweat), that person senses the wetness and can either address the problem personally or, in the case of a hospital or even at home, may be able to call for assistance so that the problem can be addressed. While a person that has an incontinence problem may be an admitted patient at a hospital or not, unless indicated otherwise and to simplify this explanation, a person with an incontinence problem will be referred to hereafter as a “patient” and a person that is charged with helping the patient will be referred to as a “healthcare assistant” or just as “an assistant” or a “care giver”. In some cases, a healthcare assistant, may be able to detect wetness independent of a patient in a bed (e.g., visually see the problem or sensing the problem in some other fashion). Unfortunately, in some cases, a patient that gets wet in bed is not able to detect the wetness at all or at least for some time. For instance, sometimes a patient may urinate or excrete another liquid while sleeping or a liquid may accidentally be spilled on the patient's bed while sleeping (e.g., a cup may accidentally tip over on an over bed cart) and that patient may not detect the wetness until hours later. As another instance, some patients may not have sensory capability to detect wetness. In other cases, a patient may be drugged to the point where even if she detects wetness, she may not care or may be incapable of signaling for help. In most cases, because of covers or the like, an assistant cannot visually detect wetness.
In addition to making a patient uncomfortable, wetness can lead to rashes, bed sores and, in many cases, infections and sickness or exacerbated sickness. Furthermore, a void on an unprotected bed can destroy a mattress or, at a minimum, can be a mess to clean up.
One solution to deal with wetting issues is for patients to wear diaper type devices while in bed. While diapers work fairly well, they are inconvenient to put on, especially for patients having certain types of problems. In addition, diapers can be uncomfortable to wear and can be embarrassing for some patients.
Another solution is to place a liquid absorbing pad under a patient's midsection while in bed where the pad is designed to wick wetness away from a patient's skin and to soak up a sufficient volume of liquid to minimize the possibility of additional soiling of a mattress of bedding materials. In these cases, eventually pad capacity is reached and pads have to be replaced. While pads work fairly well, they too have shortcomings. First, with standard pads, there is no good way to know when a pad is wet. Second, even if it is known that a pad is wet, it is difficult to determine how wet a pad is other than weighing the pad on a scale. In most cases, minimal wetness that is wicked away from a patient's skin is acceptable for a time and ideally pads are only replaced once wetness nears full absorbing capacity. Third, voiding schedules are not typically known so that pad wetness can happen at any time and volumes of wetness vary over time and with voiding events.
Another solution has been to provide wetness sensor assemblies. For instance, known assemblies provide first and second electrical conductors on a sheet of material that is placed under a patient in bed. A sensor device applies a voltage across the traces and when wetness occurs between the traces, the sensor detects a drop in resistance between the traces and generates a wetness signal. In known systems, these sensor assemblies are fairly expensive and therefore are designed to be cleanable and reusable. While cleanable sensor assemblies are an option, cleaning sensor assemblies to the level required for hospital use is challenging. In addition, the idea of reusing a soiled but “cleaned” sensor assembly makes these options less appealing to many patients as well as-user assistants.
Yet one other solution contemplated has been disposable, single use sensor pad assemblies that can be thrown out once soiled instead of being cleaned and reused. While disposable sensor systems should work in theory, unfortunately they have a several shortcomings that have made these solutions difficult to produce. First, many incontinent patients void fifteen or more times a day so that any disposable solution results in substantial waste generation including pads, sensor components and electronics, etc. Second, because disposable pads need to be used by many patients daily, is it important that any disposable components be relatively inexpensive. In known attempts to produce disposable sensor systems, the sensor systems have not worked well. To this end, sensor pads typically need to be placed under a user in a bed, or under a user on the upper surface of a chair seat, or the like. Many system users are heavy and move while in bed or while seated or otherwise supported on an affordance. Movement subjects sensor pads to substantial friction and tearing forces which can result in damage to sensor traces and ultimately to sensing malfunction. Thus, there is no known disposable wetness sensor solution that works well and instead more robust cleanable solutions have been preferred.
It has been recognized that a disposable pad can be provided where the pad includes anode and cathode traces that have specific characteristics printed on a pad layer which can be combined with other pad layers so that a resulting low cost pad can withstand forces applied by users that shift their weight around on a top surface or that have their weight shifted around (e.g., via an assistant) on a top surface of the pad. An exemplary pad includes multiple layers of material arranged to perform three functions. First, the layers are selected for wicking wetness away from a user's skin and absorbing that wetness in material that is generally separated from the user's skin. Second, the layers are selected and arranged to stop liquid from breaching the boundaries of the pad and spilling over onto a bed, seat or other surface below the pad. Third, the layers include anode and cathode traces printed on one surface of one pad layer where the trace material and mechanical characteristics (e.g., cross sectional width, print thickness, absorption characteristics, etc.) as well as pad layering together result in a durable sensing structure spaced from the patient's skin and direct frictional forces during use yet within the structural components of the pad that becomes wet when liquid is absorbed.
In addition, in at least some cases, sensing electronics are provided in a sensor clip system where one clip system is utilized per user for a typical maximum duration (e.g., 3 to 6 months) and is then thrown out. Thus, in a typical system, a user may run through 100s or even thousands of pads over the course of a 3 month period but would only use a single disposable clip reader system. In most cases, the clip reader system operates to periodically (e.g., every second, every minute, every 180 seconds, etc.) collect wetness data which is wirelessly transmitted to a proximate portable computing device (e.g., a smart phone, smart watch, tablet computing device, laptop, etc.) and most processing occurs in the portable computing device.
In some cases the disclosed sensor system will estimate void volume. In some cases the sensor system is capable of detecting location of wetness on a pad area. In some cases the sensor system is capable of detecting when wetness has reached specific portions of a pad like, for instance, a circumferential boundary of the pad. In some cases, the system can track wetness over time to assess when an initial wetness event occurs after new pad use commences, when subsequent wetness events occur, when a critical level of wetness occurs, how long a user remains wet after initial wetness is detected, etc.
In at least some cases the pad assembly includes a sensor assembly as well as liquid capture or absorbing components. In other cases the sensor system may simply include a sensing assembly and be intended for use with a separate pad assembly. Here, the sensor system would operate as a pad liner to be used with a conventional absorbent pad.
In addition to describing optimized disposable sensor pad assemblies, the disclosure describes a new process for constructing a sensor pad assembly.
In at least some systems the sensor system detects changes in resistance or other electrical parameters that change as a wetness state occurs. For instance, in some cases an exemplary pad includes a pair of traces that wind about on a pad surface where there is a known resistance between the traces when the pad is dry. The resistance level between the traces can be detected by applying a small DC voltage thereacross and measuring the resistance level. Once a wet spot occurs on the pad, the liquid within the wet spot causes a short at the location of that spot which changes the resistance detected by a sensing device. In at least some cases the system tracks one or more pad locations associated with a wet spot over time to assess liquid volume accumulating within a pad assembly. In other cases the system can detect several boundary locations of a current wet spot in order to assess size, liquid volume, a defined location on a pad and closeness of the spot edges with respect to boundaries of the pad.
In at least some cases the sensor system is capable of detecting an electrolytic effect when a positive voltage is detected across the anode and cathode traces where the voltage level can be correlated with known chemicals in the liquid so that a system processor can distinguish between liquids of different types such as urine, blood, sweat, and other liquids associated with, among other things, bed sores, skin breakdown, etc. In addition, in at least some cases the sensor is useable to analyze the makeup of a patient's urine including relative relationships of electrolytes such as sodium, chloride and potassium as well as pH of urine. In some cases sensors will detect both resistance and voltage and use those values in different processes to determine different things. These differences in the liquids detected can be used in some cases to identify other patient conditions and, in some cases, those conditions may justify payments from insurance companies to cover costs associated with the sensing system.
Because many users use the disclosed sensor system over time (e.g., for several months), the sensed wetness data can be used in many cases to identify specific user voiding schedules. This information can then be used to provide pre-wetting event alerts or warning signals to a user or user assistant so that the user or assistant can take steps to avoid pad wetting events thereby reducing the number of pad replacements required and, more importantly, minimizing the number of times each day that a user is subjected to cleaning activities. Thus, for instance, if wetting data shows that a specific user voids within 60 minutes of consuming a drink, an alert may be generated after 45 minutes so the user or assistant has ample time to avoid a wetting event assuming the user's future wetting events follow a schedule similar to prior activities.
In at least some cases it is contemplated that the sensor system can be used in the establishment of a rolling/persistent “Incontinence Training Program”. To this end, in some cases a patient's condition changes over time and therefore their voiding schedule may change as well based on rest, medications taken, medical procedures, dietary changes, liquid consumption changes, etc. In these cases, instead of simply learning a voiding schedule once and applying that schedule thereafter, the system may be programmed to automatically refigure a patient's voiding schedule on a rolling multiple day (e.g., 3 days, 7 days, etc.). Thus, when a patient first starts using pads, a processor may be programmed to track the patient's voiding schedule over a 3 day period to learn the patient's voiding schedule and may then set a pre-voiding alarm/signaling schedule to avoid pad soiling when possible. Here, when a pre-voiding alarm signal is generated, the patient or an assistant may take steps to avoid soiling of the pad. Then, after a fourth day of voiding data is detected, the voiding data from the most recent 3 days (e.g., second through fourth days of pad use) may be used to adjust the pre-voiding alarm signal schedule to account for any condition changes that affect the patient's voiding schedule. This rolling process of refiguring the patient's voiding schedule and adjusting the alarm schedule may continue over time so that pad soiling events can be avoided.
In still other cases, it is contemplated that some system processor may be programmed to obtain other patient condition data and use that other data in conjunction with the patient's voiding schedule to gain further insights into events that affect the patient's voiding schedule. For instance, is the patient's voiding schedule affected by when the patient consumes a medication, is the schedule affected by when the patient eats, sleeps, exercises, participates in physical therapy, etc. Here, the alert schedule can be adjusted automatically based on these other insights.
In addition to being important for avoiding pad soiling events which can be uncomfortable and embarrassing as well as disruptive of patient rest, the warning system that indicates when a patient should try to void in a rest room is also important in many cases for healing the patient's ailments. For instance, in cases where a patient already has bed sores or other skin ailments which are adversely affected by urine and other fluids, avoiding pad soiling events have a positive effect on the overall healing process. In cases where it can be shown that the training and warning system are useful in avoiding pad soiling events, may justify payments from insurance companies will pay for the sensor system as part of an overall healthcare payment program.
In some embodiments, at least a portion of sensor system electronics may be printed on each pad along with the anode and cathode traces. For instance, in at least some cases the sensing electronics will include a battery power source and a processor as well as a resistor where the resistor is located between the traces at one end of trace lengths and the processor applies a voltage at the other end of the trace lengths, detects the resistance between the traces and then compares the detected resistance to a known dry resistance and wet resistances to detect wetness. In some cases the resistor at the one end of the traces may be printed on the pad. In other cases, the resistor may be part of the sensor clip system.
At least some embodiments include a sensor pad assembly for detecting wetness, the pad assembly comprising a breathable polyethylene base layer, a first carbon black trace printed on a top surface of the base layer in a serpentine pattern, a second carbon black trace printed on the top surface of the base layer in a serpentine pattern that does not overlap the first trace, wherein at least a portion of the second trace is adjacent each portion of the first trace and an absorbing subassembly including non-woven layers that envelope a super absorbent polymer (SAP) material, the absorbing subassembly adhered to the top surface of the base layer over the first and second traces.
In some cases at least portions of each of the first and second traces are exposed at ends of the traces for connection to a sensing clip assembly. In some cases at least first ends of the first and second traces are adjacent an edge of the base layer for connection to a sensing clip. In some embodiments second portions of the first and second traces are adjacent an edge of the base layer for connection to a resistive clip. In some cases the base layer is substantially rectangular having at least a first edge wherein the first ends and the second ends of the first and second traces are adjacent the first edge.
In some embodiments the base layer is rectilinear having a width dimension and a length dimension and wherein the traces extend at least in part along the length dimension. In some cases the width dimension extends between first and second base layer edges, the first trace includes a series of substantially identical trace portions, each trace portion having a first end and a second end and first, second, third, and fourth sub-portions, the first sub-portion extending from the first end adjacent the first base layer edge to a location adjacent the second base layer edge, the third sub-portion spaced apart from the first sub-portion and extending from a location adjacent the second base layer edge to a location adjacent the first base layer edge, the second sub-portion extending between and connecting ends of the first and third sub-portions proximate the second base layer edge, and the fourth sub-portion extending between and connecting ends of the third sub-portion and a first sub-portion in an adjacent trace portion proximate the first base layer edge. In some cases the second trace includes sub-portions that extend along each of the first, second, third and fourth sub-portions of each of the first trace portions.
In some cases each of the first and third sub-portions are substantially straight and parallel and extend perpendicular to the length dimension of the base layer. In some embodiments each of the second and fourth sub-portions are substantially straight and extend along the length dimension of the base layer. In some cases, the pad is formed as a continuous pad structure extending along a structure length dimension wherein the assembly length is formed by detaching the pad assembly from the continuous pad structure.
Some embodiments further include an integrated resistor between second ends of the first and second traces. In some cases a portion of the first trace is adjacent each portion of the second trace. Some cases further include an upper tissue layer located between the SAP layer and an upper non-woven layer and a lower tissue layer located between the SAP layer and a lower non-woven layer.
Other embodiments includes a sensor pad assembly for detecting wetness, the pad assembly comprising a breathable polyethylene base layer, a lower non-woven layer and an upper non-woven layer, a first carbon black trace printed on the lower non-woven layer in a first trace pattern, a second carbon black trace printed on the lower non-woven layer in a second trace pattern that does not overlap the first trace pattern, wherein at least a portion of the second trace is adjacent each portion of the first trace, the lower non-woven layer adhered to the base layer and an absorbing subassembly including a super absorbent polymer (SAP) material enveloped between the upper non-woven layer and the lower non-woven layer.
Still other embodiments include a sensor pad assembly for detecting wetness, the sensor assembly comprising a breathable polyethylene base layer, a super absorbent polymer (SAP) material layer, a first non-woven layer located between the SAP material layer and the base layer, a first printed carbon black trace located between the SAP material layer and the base layer and forming a continuous first trace pattern and a second printed carbon black trace located between the SAP material layer and the base layer and forming a continuous second trace pattern, wherein at least a portion of the second trace is adjacent each portion of the first trace.
In some cases the first and second trace patterns are printed on the side of the base layer facing the first non-woven layer. In some cases the first and second trace patterns are printed on the first non-woven layer. In some embodiments the first and second patterns are serpentine patterns. In some embodiments at least a portion of the first trace is adjacent each portion of the second trace.
The various aspects of the subject disclosure are now described with reference to the drawings, wherein like reference numerals correspond to similar elements throughout the several views. It should be understood, however, that the drawings and detailed description hereafter relating thereto are not intended to limit the claimed subject matter to the particular form disclosed. Rather, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the claimed subject matter.
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration, specific embodiments in which the disclosure may be practiced. These embodiments are described in sufficient detail to enable those of ordinary skill in the art to practice the disclosure. It should be understood, however, that the detailed description and the specific examples, while indicating examples of embodiments of the disclosure, are given by way of illustration only and not by way of limitation. From this disclosure, various substitutions, modifications, additions rearrangements, or combinations thereof within the scope of the disclosure may be made and will become apparent to those of ordinary skill in the art.
In accordance with common practice, the various features illustrated in the drawings may not be drawn to scale. The illustrations presented herein are not meant to be actual views of any particular method, device, or system, but are merely idealized representations that are employed to describe various embodiments of the disclosure. Accordingly, the dimensions of the various features may be arbitrarily expanded or reduced for clarity. In addition, some of the drawings may be simplified for clarity. Thus, the drawings may not depict all of the components of a given apparatus (e.g., device) or method. In addition, like reference numerals may be used to denote like features throughout the specification and figures.
Information and signals described herein may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof. Some drawings may illustrate signals as a single signal for clarity of presentation and description. It will be understood by a person of ordinary skill in the art that the signal may represent a bus of signals, wherein the bus may have a variety of bit widths and the disclosure may be implemented on any number of data signals including a single data signal.
The various illustrative logical blocks, modules, circuits, and algorithm acts described in connection with embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and acts are described generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the embodiments of the disclosure described herein.
In addition, it is noted that the embodiments may be described in terms of a process that is depicted as a flowchart, a flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe operational acts as a sequential process, many of these acts can be performed in another sequence, in parallel, or substantially concurrently. In addition, the order of the acts may be re-arranged. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. Furthermore, the methods disclosed herein may be implemented in hardware, software, or both. If implemented in software, the functions may be stored or transmitted as one or more instructions or code on a computer-readable medium. Computer-readable media includes both computer storage media and communication media including any medium that facilitates transfer of a computer program from one place to another.
It should be understood that any reference to an element herein using a designation such as “first,” “second,” and so forth does not limit the quantity or order of those elements, unless such limitation is explicitly stated. Rather, these designations may be used herein as a convenient method of distinguishing between two or more elements or instances of an element. Thus, a reference to first and second elements does not mean that only two elements may be employed there or that the first element must precede the second element in some manner. Also, unless stated otherwise a set of elements may comprise one or more elements.
As used herein, the terms “component,” “system” and the like are intended to refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution. For example, a component may be, but is not limited to being, a process running on a processor, a processor, an object, an executable, a thread of execution, a program, and/or a computer. By way of illustration, both an application running on a computer and the computer can be a component. One or more components may reside within a process and/or thread of execution and a component may be localized on one computer and/or distributed between two or more computers or processors.
The word “exemplary” is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs.
Furthermore, the disclosed subject matter may be implemented as a system, method, apparatus, or article of manufacture using standard programming and/or engineering techniques to produce software, firmware, hardware, or any combination thereof to control a computer or processor based device to implement aspects detailed herein. The term “article of manufacture” (or alternatively, “computer program product”) as used herein is intended to encompass a computer program accessible from any computer-readable device, carrier, or media. For example, computer readable media can include but are not limited to magnetic storage devices (e.g., hard disk, floppy disk, magnetic strips . . . ), optical disks (e.g., compact disk (CD), digital versatile disk (DVD) . . . ), smart cards, and flash memory devices (e.g., card, stick). Additionally it should be appreciated that a carrier wave can be employed to carry computer-readable electronic data such as those used in transmitting and receiving electronic mail or in accessing a network such as the Internet or a local area network (LAN). Of course, those skilled in the art will recognize many modifications may be made to this configuration without departing from the scope or spirit of the claimed subject matter.
Hereafter there are different processors that cooperate to perform various functions. For instance, there is a sensor clip (see 22 in
Referring now to the drawings wherein like reference numerals correspond to similar elements throughout the several views and, more specifically, referring to
Sensor pads may take many different forms including rectangular sensor pads, strip shaped pads, pads that are shaped to mirror or at least conform somewhat to anatomical shapes of a human's body, etc. Herein, sensor pads of all types will be referred to as “sensor pad assemblies” or just “sensor pads” in the interest of simplifying this explanation.
Referring still to
Each of the sensor pads 12, 12a, etc., and clip pairs 20, 22 are similarly constructed and operate in a similar fashion and therefore, in the interest of simplifying this explanation, only pad 12 and clip pair 20, 22 will be described here in detail unless indicated otherwise. In addition, unless indicated otherwise, a combination of a sensor pad assembly 12 and clip pair 20, 22 will be referred to hereinafter as a “sensor assembly” 13.
In operation, pad 12 is placed centrally along a length and a width dimension of a patient bed, preferably on top of a sheet or the like prior to the patient getting into the bed so that once the patient is in bed, the pad resides directly under the patient without sheets or other bedding materials between the patient and the pad. In at least some embodiments, the pad is arranged with the clip edge of the pad extending out from under the location of the patient to a lateral side (e.g., left side of the bed) or to the foot of the bed. Upon getting into the bed, the patient arranges their position so that their midsection is generally centrally located on pad or the pad is moved until so located with respect to the patient's preferred position in the bed. A sensor clip pair 20 and 22 is retrieved and the sensor clip 22 is programmed to be associate with a specific patient, facility bed or in some other way that enables data generated by the clip to be associated with a specific location or patient within the facility. Thus, for instance, the clip may be programmed to be associated with patient Mary Monday in bed 34 in room 2507 so that when a pad is wet, the system can report the wetness event on a patient or location basis and the assistant can quickly assess which pad has been soiled and, if needed, attend to the patient's needs or desires.
In other cases the server 28 may be programmed to know or have access to a facility schedule database that can be used to determine which patient is in which hospital room and may simply associate data generated by a clip in a specific room with a patient currently associated with the room.
The clips 20 and 22 are attached to the pad as described in greater detail hereafter. Sensor clip 22 detects wetness on the pad (and lack of wetness) and generates wetness data that either indicates the wet state of the pad or that is useable to discern the wet state of the pad. The clip 22 transmits the wetness data to a proximate portable device 16, to a proximate access point 26, or to some other device that is networked to server 28 or other system computing devices.
Device 16 can take many different forms including a smart phone, a portable tablet type computing device (e.g., and iPad), a laptop computer, etc. Here, in at least some cases the clip will transmit wirelessly via Bluetooth, NFC, WIFI, or other similar wireless protocol to device 16.
Device 16 is Bluetooth or otherwise wirelessly enabled and therefore can receive data transmitted by clip 22. Device 16 may be programmed to receive raw data from clip 22 that can be used by a device 16 processor to discern wetness state of a pad or may receive actual wetness warnings generated by a processor within clip 22. Device 16 stores premeasurement data for the pads which indicates where along the trace pattern length a wet spot occurs based on a measured resistance or electrolytic value. In at least some cases device 16 stores at least some of the received or processed data and can perform calculations and other data processes on that data over time to develop other information related to pad wetness including size of wet spot, rate at which a wet spot size increases, specific patient voiding schedules, and void characteristics, etc.
When the data is stored, the device 16 may store the data with a time stamp indicating when the data was sensed via the clip 22 as well as other wetness event information. Device 16 is also equipped to transmit wirelessly (e.g., via 802.11b or newer versions, or other protocols) to an access point 26 to send either raw or conclusive data to server 28 for storage and processing or further processing. The device 16 may have a printer or may have access to a printer which can print reports that can be included in patient records.
In other embodiments device 16 may be replaced by a wireless relay device mounted to or proximate the patient's bed where the relay device includes a near field communication (NFC) antennae, a processor, and a Bluetooth or other longer transmitting antennae. In this case, sensor clip 22 may transmit to the relay device using an NFC protocol and the relay device may relay the received data on to access point 26 or some other intermediate relay device so that the data is eventually provided to server 28 for processing and storage. Here, wetness and other alerts or warnings may be provided to an assistant or a patient via one of devices 24 or 25 or in some other fashion.
In still other cases, device 26 maybe a Bluetooth gateway/hub capable of receiving wireless signals from a transmitting clip located at substantial distances so that intermediate portable wireless devices (e.g., a tablet) are not needed. For instance, some Bluetooth hubs 26 can receive signals from 300 or more feet away from transmitting clip assemblies, especially in cases where Bluetooth low energy (BLE) technology (e.g., transmitters and receivers) is employed. A gateway solution like this is advantageous as there is no need for periodic intermediate portable computing devices to be located proximate the clips for the system to operate properly. In addition, received signal strength indicator (RSSI) information generated by these types of systems can be used to identify which BLE hub a patient is closest to in cases where the patient is not in her assigned room (e.g., is currently in a wheelchair ambling along in a common area). In this way if there is a voiding event and a patient is not in an assigned room, a caregiver can still identify at least the general location of the patient and service the patient if required.
Device 16 is also programmed, in at least some embodiments, to generate wetness state change warnings or notifications that are presented to the assistant so that the assistant can determine how to handle specific wetness situations. Here, for instance, if the system indicates that a small wet spot occurs on a pad, the assistant may use discretion and decide not to swap in a new pad given pad absorption capabilities and, subsequently when the patient voids a second time so that the wet spot or liquid volume increases substantially, the assistant may decide to discard the current pad and swap in a new pad. In other cases, the system may automatically track the patient's voiding schedule and provide reminders to the patient and/or the attending assistant prior to a likely event so that the patient or assistant can take steps to avoid a pad soiling event (e.g., arrange a trip to a restroom if possible). Other warnings and notifications are contemplated.
Referring still to
In still other cases sensor device 22 may itself be programmed to perform at least a subset of system calculations to assess pad state changes and generate alerts as well as to transmit raw data as well as conclusions via an access point or the like to server 28. In some cases sensor device 22 may have smart speaker capabilities built in as described in greater detail below.
Referring to
In some embodiments pad 12 is designed so that a user can link up sensor clips to either top or bottom edges of the pad 12 so that a user cannot place the pad on a bed or other supporting surface in a wrong orientation which can be frustrating. In these cases, the pad configuration along each of the top and bottom edges would be structurally similar with each of anode and cathode traces coming near opposite edges of the pad to be connected to a sensor clip 22 and a resistor clip 20 as described hereafter. In other cases, one edge of the pad may be designed for clip connection and the opposite edge may be covered with absorbent layers as described hereafter and shown in
In
Referring still to
A large printer device prints or otherwise applies a specifically formulated black carbon dispersion as traces to the top side/surface of sheet material 48 to form anode and cathode traces 40 and 42, respectively. In some embodiments the traces 40 and 42 may be applied to the PE or PP side of sheet 48. In some cases the PE side is printed on and the PP side forms the bottom surface to keep the pad in place on the surface bed, chair etc. In some cases the sheet is continuously printed as a roll of material 48 is unwound.
As shown, in at least some cases the anode and cathode traces are continuously printed on sheet 48 and then the sheet is cut from top to bottom edges to a sizes appropriate for intended use. In particularly advantageous systems, flexography is used to print the dispersion on sheet 48. Here, it should suffice to say that flexography is a form of printing which utilizes a flexible relief plate which operates essentially like a modern version of a letterpress that can be used for printing on almost any type of substrate.
The flexographic printing process is controlled in several ways to create an optimized trace pattern that has optimized sensing and robustness characteristics. To this end, during printing a viscosity controller is manipulated to maintain centipoise (e.g., liquid viscosity) at an operating point between 35 and 55 cP and, in particularly advantageous cases, at 40 cP. The temperature for drying during printing is maintained at a temperature within a range between 110 and 225 degrees F. and, in preferred cases, at around 10-15 degrees F. below the material damage temperature of sheet 48. The viscosity, press speed, anilox (80 LPI), plate, and substrate surface tension, anilox configuration (3-4 units), and impression pressure are also all controlled. The following are examples of the setting on the flexographic printer that have been shown to work well:
It is believed that each of the above operating characteristic values can be adjusted up or down by 10-15% with minimal effects on the ultimate characteristics of the pad assembly. In addition, in at least some cases, the printing process is repeated on each length of sheet 48 to increase the thickness of the combined traces applied until the traces can conduct sufficient current for sensing purposes. To this end, the printing system operates an automatic print design registration control to print multiple conductor layers of the same design until a required trace thickness is achieved.
In some embodiments the black carbon dispersion has a potential of hydrogen (pH) level greater than seven and less than ten with 0.5 to 5% surfactant and 0.5 to 5% drying solution. This mixture has been shown to result in high quality traces which conduct over distances required for most applications contemplated by this disclosure. This mixture and the sheet material 48 described above enable anode and cathode trace printing without substantial penetration of the black carbon dispersion into the top surface of sheet 48 which is required for sensing purposes.
One particularly useful carbon black solution for printing the traces is sold using the tradename Unibond 2951 which is manufactured by Unichem, Inc. of Haw River, North Carolina. The specific Unibond 2951 dispersion used for printing the traces has 27-31% solids, a pH of between 8.7 and 9.7, a density of 8.5+ lbs./gal. and a viscosity of 30-50 cPs. The drying and curing temperature of the Unibond 2951 is within a range between 150-190 degrees F. in some cases and the curing temperature is within the range between 240-360 degrees F. with a viscosity of 12,000-14,000 for producing traces that can last in storage for 10-15 years, but is limited by the melt temperature of the substrate that the dispersion is applied to. In particularly advantageous embodiments the curing temperature is within 10% of the melt temperature of the sheet material 48.
Referring again to
Cathode trace 42 also forms a serpentine pattern that winds back and forth along parallel lines between top and bottom ends of sheet 48 where the cathode pattern is interleaves with the anode pattern. Thus, as shown, each “vertical” run of the anode trace 40 runs parallel to one vertical trace of the cathode and each vertical cathode trace runs parallel to one vertical anode trace. Each trace 40 and 42 has a uniform thickness dimension and a uniform width dimension in the illustrated embodiment that is between 5 and 20 millimeters and the space between adjacent anode and cathode trace sections is also between 5 and 20 millimeters and is uniform in the illustrated embodiment. In particularly advantageous embodiments the uniform trace width is between 5 and 15 millimeters and the spaces therebetween have a similar uniform spacing. In other cases the anode and cathode traces may have different thickness and width dimensions or different parts of adjacent traces may be separated by varying open, non-printed spaces on the face of sheet 48. The diameter of the printing roller is a controlling factor of the image length, the traces 40 and 42 need to be adjusted to be a width with the open non-printed spaces that allows repeatability and covers the entire circumference of the printing roller.
In at least some embodiments the specific black carbon dispersion material is applied so that 1 to 8 grams of the coating material is applied per square meter of printed trace. In particularly advantageous embodiments the material is applied so that the range of grams per square meter applied is between 2 and 5 grams. With applications within these ranges, tests have shown that sufficient trace conduction occurs for sensing purposes and, when applied material is less than in these ranges, failure rate increases appreciably.
In at least some cases the amount of dispersion material applied per unit area of each trace is substantially uniform throughout the traces. In other cases, different amounts of dispersion material is applied so that different sections of the traces having the same length dimension have different resistance levels. In other cases the conductivity of the dispersion material applied to different sections of a trace may have different resistive values so that different sections of the traces have different resistance values per unit length.
In some embodiments the resistance value per unit length of each trace is known and therefore can be used in calculations to determine where along the trace lengths a wet spot occurs. The idea here is that when a wet spot occurs between adjacent portions of the cathode and the anode traces, a short occurs at that location which can be detected by the sensor clip 22. The clip measures the resistance detected and can use that measurement along with the known resistance value per unit trace length to assess where the short occurred.
Referring to
In at least some cases alignment indicia may be printed on a top surface of the pad indicating a location at which the sensor clip pair devices are to be mounted to make proper connections to traces on the pad. To this end, see exemplary indicia at 17 and 19 on pad 12 in
Referring again to
Cover 79, in at least some embodiments, is at least somewhat translucent in some embodiments so that an assistant can see through the cover to observe the state of one or more LED light signaling devices located within the housing cavity. In
The housing member 78 includes features on a surface opposite cover 79 that cooperate with features on jaw member 72 to form a hinge 74 with spring 76 located between distal facing surfaces of housing 70 and member 72. Spring 76 causes the jaw member 72 end opposite the spring to clamp closed as shown in
As shown, a voltage can be applied between prongs 75, 77 and 89 via a battery (e.g., 3 volt) located within housing 70. Indicia 67 and 65 are located on the lateral sides of housing 70 that can be used to align probes 75 and 77/89 with portions of traces 40 and 42 respectfully, when connecting the clip 22 to a pad. To this end, an assistant can observe alignment of the indicia with the traces to increase the chances of making a good sensing connection between the probes and the traces. In some cases the indicia will simply include painted lines. In other cases, the indicia will include channels formed in the external surface of the housing 70. In some cases the indicia is only provided on the housing 70 and not the jaw 72 (see
Referring yet again to
Referring now to
Referring still to
In some cases battery 90 is designed to store sufficient energy for powering the clip 22 for up to 6 months of normal use given the power supply interrupt function of component 88. In other cases the battery 90 is designed for 3 months of normal use. In at least some cases, sensor clip 22 is intended to be used multiple times (e.g., hundreds of times in some cases) with a single patient and then discarded to avoid problems with bodily contamination and a general sense of uncleanliness when medical equipment is reused. In other cases, battery 90 may be replaceable so that other clip 22 components can be reused with different patients. In some cases it is contemplated that the electronics from clip 22 may be sterilized, removed and placed within a new housing 70 for use with additional patients where the housing operates to seal off the electronics from biological contamination. In other cases the battery 90 may be wirelessly recharged.
Referring to
Referring still to
Referring to
In at least some cases it is contemplated that signaling may also be provided via a patient's computing device 25 and/or an assistant's portable computing device 16. Here, for instance, upon successful connection of clip pair 20, 22 to a pad 12, sensor clip 22 may transmit a signal to assistant's device 16 indicating success and an application program running on device 16 may provide a visual signal or audible signal indicating successful connection. Similar connection success messages may be provided via patient phone 25 to provide direct reassurance to the patient that the wetness sensing system is operating properly.
Referring still to
Referring now to
Referring again to
Referring now to
Referring again to
Referring now to
Referring to
Regarding the expected “ranges”, referring again to
In at least some cases the clip is programmed to use an initial impedance reading to determine trace lengths between the clip pair and the processor then compares the initial impedance with impedance ranges associated with one, two, three, four, five, etc., switchback lengths between the clip pair. If the initial impedance measurement is in one of the expected ranges, the processor determines that the clips are properly connected and functioning properly. In addition, based on which range the initial reading is in, the processor determines the length of the pad between the clip pair. For instance, the processor determines if there are 2, 3, 4, 5, etc. trace switchbacks between the clip pair.
The length of pad is important in at least some cases where the processor generates alert signals when wetness is near an edge of the pad and may run off the pad. In this regard, if wetness is detected two switchbacks away from the sensor clip at the location 35 indicated in
In other cases pad lengths may be precut and instructions provided for specific locations at which clips should be attached to the pad edge so that the trace/pad length is known and there is no need to adjust system operation based on trace/pad length between the clip pair. For instance, see again indicia 17 and 19 in
After the clips are properly installed, processor 80 starts a wetness sensing process wherein the processor 80 periodically (e.g., every second to 180 seconds, depending on how the clip processor is programmed) applies a DC voltage across the traces 40 and 42 and detects impedance or resistance of the traces, resistor R1 and any wet spots that appear on the pad between trace sections. Where the pad is dry, the pad circuit is through the traces 40 and 42 as well as the resistor R1 and the impedance remains generally at the initially impedance that was detected at the time of initial clip connection. If the pad is wet between adjacent portions of the traces 40 and 42, at least a partial short occurs at the point of wetness and therefore the measured impedance or resistance changes and that change is indicative of a wet pad. In this regard, see in
Referring still to
Referring to
In at least some cases processor 80 or some other system processor (e.g., in device 16, at the server 28, etc.) or computing device may be programmed to track the progression of growth of a detected wet spot over time and use that information to estimate other conditions. For instance, referring again to
As indicated above, the period between wetness state sensing activities may be constant (e.g., every second, every 3 minutes, etc.) in some embodiments. In other embodiments, to reduce battery usage, the period between sensing activities may be varied based on most recent detected conditions. For instance, an initial period between detections may be set to 3 minutes. Once an initial small wet spot is detected, the period may be shortened to 1 minute. Once a pad reaches 50% absorption capacity, the period may be shortened to sensing every second so that current condition changes are monitored on a more granular level. In other cases, when a set spot is initially detected, the time between sensing events may be changed from every 3 minutes to every second as the spot location or wetness continues to change during a voiding event. Once the wet spot characteristics associated with a voiding event stabilize, the time between sensing events may again be lengthened to 3 minutes assuming that the wet spot location is not near a pad edge and the time can then be shortened again once another voiding event is detected.
If the clips are properly attached to the pad and a circuit with the traces 40 and 42 is completed, at block 192 processor 80 illuminates the indicator LED green indicating to the assistant that the sensor assembly is operational. In some cases the clip processor will also generate a voice signal indicating “The clips are properly attached and the sensing assembly is now functioning.” If the clips are not properly attached so that the circuit with the traces does not occur, at block 194 the processor 80 controls LED 69 to indicate the red color and at block 186 the assistant disconnects the clip(s) and reconnects the clips until the greenlight is illuminated. Improper clip connection may also result in the processor generating a voice signal “Please reattach the clips at different locations to properly configure the sensing system.” If neither the green nor red condition is indicated after the assistant tries to make a proper connection, clip 22 has malfunctioned and the assistant can retrieve another sensor clip 22 at 188 and attach the new clip at 184.
Once the clip pair 20 and 22 is operational at block 196, the clip processor 80 establishes a wireless link to a proximate portable monitoring device 16 (see again
In at least some cases, the system generates wetness state values based on perceived size of a wet spot on a pad including, dry, wet, wetter and soaked values. For instance, the wetness states may include the following based on estimated wet spot area size and associated estimated liquid levels absorbed:
Referring still to
Referring now to
In at least some embodiments it is contemplated that the clip processor 80 in the single clip design 220 shown in
Referring to
Referring now to
Referring now to
During printing, first conductive pattern 400 is printed on a PE film as shown in
Referring still to
While it is advantageous if all pads are manufactured to have the same operating characteristics, it has been recognized that depending on materials used to construct a pad as well as manufacturing constraints that even similar pads may operate differently because of mechanical differences like trace thickness or absorption into a substrate, trace width, etc. For this reason, in at least some cases it is contemplated that when a sensor is attached to a specific pad, the sensor processor may detect an initial resistance of the pad and then make adjustments based thereon regarding spot locating algorithms based on specific pad resistance initially detected. Here, it is contemplated that a table may be stored that represents different resistances within a range of possible expected initial resistance values that correlates shorted locations on a pad with resistance changes. Then, when the processor detects an initial dry pad resistance, the processor can access the table, identify short location data to use to assess where a spot occurs based on resistance changes and operate accordingly.
Referring now to
As best seen in
While some embodiments will not include any type of spring at hinge 506, in other embodiments there may be a spring 569 (shown in
In at least some embodiments there are finger recesses in front ends of the housing and jaw as shown at 508 and 510 so that a user can grip the distal ends of the housing and jaw to pull them apart when the clip assembly is to be opened. As shown, finger recess 510 extends an entire height dimension of jaw 502 and recess 508 only extends about half the height of housing 504 to provide a lip for finger gripping. While the recesses are shown in a surface opposite the hinge 506, in other embodiments the recesses may be formed in one or both side surfaces of housing 504 and jaw 502.
Referring still to
Lower jaw 502 forms openings 526 and 528 to receive distal ends of the connector pins when the jaw 502 is closed to the housing 504 as in
In some cases the pins are soldered to a PCB that includes the sensor device processor and that is located within the housing cavity. In other cases the pins are actually crimped onto wires that are connected to the circuit board. The crimping arrangement is more robust than a soldered connection in at least some cases.
Indicia or recesses (or protruding ribs) 512 and 514 are formed in the side surfaces of housing 504 and jaw 502 that are aligned with the pins 520, 522 and 524 (seen best in
Referring still to
Referring still to
An additional advantage of providing magnets in the clip assembly is that the magnets can operate as a coupling mechanism to other metal structures during storage. For instance, where the thickness of the jaw 502 in
While resistor clip 550 is shown as having a housing and a jaw that have height dimensions similar to height dimensions of components of sensor clip 500 in
While not labelled, resistor clip 550 includes trace connecting pins, magnets and a hinge arrangement that is similar to the same components described above with respect to
In some embodiments the polarity of the magnets may be revered in the sensor clip 500 and the resistive clip 550. To this end, see that in
In at least some cases it is contemplated that a single clip having the design features of clip 500 in
In a single clip configuration, the pad assembly would include traces where both ends of each trace are located adjacent a small portion of an edge of a pad assembly so that both the resistor and the sensor pins can connect to trace ends as needed (see
In at least some cases it is contemplated that the single clip design may have resistor and sensor contacts that are spaced apart along a length dimension (e.g., between the hinge end and opposite end) of the clip assembly so that a clip width dimension can be reduced. To this end see
One advantage of clip assemblies that rely on features (e.g., force generating assembly) other than a spring to maintain clip jaws closed is that an assembly with smaller overall dimensions can be constructed. To this end, an overall closed clip height H3 dimension of assembly 500 shown in
Another advantage is that a more box like assembly can be constructed that has parallel oppositely facing side surfaces. To this end, see again
Another advantage is that there are no assembly components that extend outward out of the box like shape that could be snagged on a sheet, a user, etc., which could result in undue damage to a sensing pad assembly or discomfort for a patient. To this end see
Yet one other advantage is that, other than the jaw gap, the
To increase patient comfort and minimize the possibility of a clip becoming dislodged from a pad, a dimensionally small clip design is preferred in at least some cases. To this end, in at least some cases the overall width of a clip may be anywhere within a range between one quarter inch and two inches and in particularly advantageous cases the width is within a range between three fourths inch and one and one quarter inch, the height dimension H3 of a closed clip may be within a range between one quarter inch and one inch and in particularly advantageous embodiments may be around one half an inch and the length dimension of a clip may be within a range between one inch and five inches with particularly advantageous clips having a length between two inches and four inches. The thickness of the jaw member should be minimal and, in at least some embodiments, is within a range between one tenth inch and one quarter inch with a particularly advantageous thickness of substantially two tenths inch. In at least some cases, the hinge is designed so that an angle formed by facing surfaces of the housing and jaw when in an open state is within a range between 7 degrees and 35 degrees. In some cases the open clip angle between the facing surfaces is within a range between 10 and 20 degrees and in particularly advantageous embodiments the angle is substantially 15 degrees. With the clip open, in at least some cases the gap dimension at the distal ends of the jaw and housing is within a range between half an inch and two inches and, in particularly advantageous embodiments the gap dimension at the distal ends is substantially seven tenths of an inch, which is wide enough to easily slip the clip onto a pad edge prior to closing the jaws to secure the clip to the pad for sensing purposes.
In at least some cases the overall clip assembly structure may be minimized by including at least some of the components that are described above as being located in the clip housing in a supplemental housing that is tethered to the clip housing. For instance, see
In at least some cases it is contemplated that a clip battery may be rechargeable. For instance, a clip battery may be a lithium ion type battery where the clip processor can control a battery recharging process. Here, in some cases recharging may be via electrical connection though the clip pins or the magnets or via induction. In the case of induction, a charging pad with a liquid impermeable top flat charging surface may be provided near a patient's bed or the like and a clip may be placed on the top charging surface when not in use. Thus, for instance, if a patient gets out of bed for a shower and so that a soiled pad can be replaced, the clip sensor device may be placed on the charging pad for 30 minutes and be recharged for use. Here, it is contemplated that a typical clip battery should be able to be recharged to almost full capacity within 15-30 minutes as power requirements are minimal in most cases.
While large, generally rectangular, absorptive sensor pad assemblies are described above for use in bed applications, in at least some cases smaller and/or differently shaped sensor assemblies with different types of substrate substructures will be configured that are suitable or optimized for use in other applications. To this end, the trace printing process described above can be used to print any trace patterns and therefore to accommodate other useful general wetness sensing patterns. In addition, the trace printing process can be used to apply sensor trace patterns to other substrate structures such as, for instance, a liner material without absorptive layers, a cotton or other bed sheet type material, a fabric formed into a garment that can be worn by a patient that is absorptive, breathable, or that blocks fluid from passing through, or many other substrate structures that do not melt during a printing process.
While differently shaped sensor assemblies/pads may be used in many different applications, in at least some cases the differently shaped assemblies may be purposefully configured to be used in specific applications and, in particular, for use in “wearable” applications where the sensor assembly is designed to at least somewhat contour to a patient's body when in use. By providing assemblies that contour to a patient's body, patient comfort can be increased appreciably without sacrificing any sensing capabilities. In addition, where a sensor assembly extends along a length dimension of a patient's body or a portion of the patient's body in use, at least some sensor assemblies can be used to assess a likely source of wetness on a patient's body where different sources have different health or medical implications.
Referring to
With a width in one of these ranges, the sensor assembly 600 is suitable for use in applications where it is advantageous to detect wetness, blood, etc., in relatively smaller or constrained spaces or areas. For instance, a sensor assembly having a two inch width may be suitable for use within a diaper 800 as shown in
In at least some cases the lower surface of assembly 600 will be constructed of a material known to cause at least some friction with the fibers that constitute the inside surface 804 of diaper so that the pad assembly 600 will naturally stay in place once inserted into the diaper while a patient wears diaper 800.
In other cases, it is contemplated that adhesive strips 612 or even an entire adhesive layer may be applied to the rear side of sensor assembly 600 so that the assembly can be adhered to the inside diaper surface 804. In at least some cases to minimize cost as well as to ensure that the adhesive does not affect operation of the sensing mechanisms in the pad assembly, the adhesive may form strips that do not overlap the sensing traces 604 and 606 as shown in phantom at 612 in
Referring again to
In still other cases it is contemplated that the clip assemblies may clip on to the upper edges 812 and 802 of the diaper as well as the upper ends of the pad strip 600 with the contact pins extending through both the diaper and the sensing pad assembly as shown in
When the sensor clip is attached to a sensor assembly, the clip should be arranged so that the external surface of the housing is facing away from the patient's body in cases where there is an LED or other light indicator or an audible indicator located on the external housing surface side or that is viewable from that side.
While not shown, it is contemplated that a single clip arrangement akin to clip 533 shown in
In still other cases it is contemplated that a simplified resistor clip arrangement may be provided that is connected to trace ends prior to inserting a strip 600 in a diaper where the resistor clip then resides within the diaper completely once a patient puts the diaper on. Thus, the end resistance may be provided via a resistor that is integrated into a sensor assembly, by a clip that clips to ends of sensor assembly traces and is then located within a device (e.g., a diaper, a cast, a wound dressing, etc.) that is worn by a patient, or by a clip that clips to an end of the sensor assembly traces outside a device that is worn by a patient.
In some cases the strips 600 may come in predefined lengths and the sensor system may use information about those lengths/trace shapes and dimensions, to program sensing functionality. Thus, for instance, wetness location along a strip may be a function of length of the strip used to perform the sensing activity.
In other cases a roll of strip sensor material including continuous traces may be provided where an assistant rips off or otherwise cuts off a sensor strip in a required or desired length when needed. Thus, for instance, a care giver or assistant may cut off a 6 inch strip for one application and an 18 inch strip for a second application. In any of these cases, system clips can be attached to strip edges irrespective of strip length and initial impedance readings can be used to assess strip length and adjust operations accordingly.
Referring again to
Referring again to
Referring now to
To provide strip sensor 600a within cast 712, strip 600a may be adhered to or otherwise located adjacent a side of a patient's leg and the cast may be formed around the leg and strip or placed over the strip to hold the strip in place adjacent a patient's leg. In an alternative embodiment, strip sensor 600a may be adhered to or otherwise attached to the inside surface of one of the pieces of a two or three piece cast assembly and then the assembly may be fitted onto a patient's leg and strapped or otherwise held in place.
Referring to
In some cases the strip 600a may be wrapped helically around a patient's leg as indicated by arrows 641. In other embodiments a strip sensor assembly 600a may extend down one side of a patient's calf, down below the patient's heel, and then up the other side of the patient's calf in a stirrup formation so that wetness can be attributed to one side or the other or both sides of a patient's leg within a cast. Other strip wrapping or application patterns are contemplated.
In still other cases it is contemplated that a cast pad assembly and clip assembly akin to those described above with respect to
While one strip assembly 600a is shown in
While square, rectangular and strip shaped sensor pads are contemplated and may be provided for advantageous use in many applications, it has been recognized that many other trace patterns can be printed or otherwise formed on a pad substrate assembly where the other patterns are even better suited to some applications. For instance, in a diaper application, in at least some cases it may be advantageous to provide a sensor pad assembly better shaped to account for an “average” or “standard” human shape or so that the location of a sensor clip can be located to a patients side as opposed to in near the patient's back or belly area. To this end, see for instance
Referring now to
The L shape enables wetness sensing within the cast and also may facilitate assessment of where along anatomical portions of a patient's body wetness is occurring. For example, in a case where a patient was treated for a calf lesion prior to applying a cast, wetness adjacent the calf would have different medical implications than wetness along the underside of the patient's foot absent wetness at the calf location. In these cases, the resistive value detected by sensor clip 533 could be used to determine if wetness occurs along the patient's calf or along the patient's foot so that an assistant can identify appropriate treatment activities. Thus, for instance, a first detected resistive value may indicate that wetness occurs along the patient's foot and a second value may indicate that wetness occurs along the patient's calf.
In at least some cases the traces may have different resistivity along different portions of their lengths. For instance, in some cases extremely low resistance trace sections may be provided along at least sections of traces for passing current with greater impedance along other trace sections that are provided for wetness detection. For example, in
In other cases, referring again to
In some cases it may be that at least sections of sensor traces are electrically insulated so that no liquid short can occur between those trace sections and other trace sections. For instance, see again
Referring also to
Insulated trace sections may be near the ends of the traces or along trace sections that are spaced from the trace ends. In at least some cases two, three or a different number of insulating trace sections may be separated by exposed sections to form different sensing and non-sensing patterns.
In at least some embodiments it is contemplated that distinct sensor sections may be formed where sensing applications optimally require wetness location determination at a small set of different and spaced apart locations. To this end, see for instance
Referring still to
Bridge subassembly 906 includes a substrate substructure 930 that is strip shaped and extends from an edge of substrate substructure 911 to substructure 916. In at least some cases substructure 930 will include a layered assembly that is akin to the layered substructures 911 and 916 and, in that regard, the three substructures may simply be formed via the same laminated layer set, albeit cut out to form the dual sensor and bridge shape as shown. In other cases substructure 930 may include some of the layers that are included in substructures 911 and 916 but not others. For instance, while substructures 911 and 916 may each including absorptive material layers, substructure 930 may not.
Referring still to
In use, the
In the case of a leg cast, while a sensor assembly may extend from an upper edge of the cast for connecting a sensor clip assembly, in some case it may be advantageous to provide some type of additional support structure for the clip so that the clip does not tear or otherwise damage the upper end of the sensor assembly. For instance, see
Other strip assembly trace patterns are contemplated. For instance, see
While most of the sensor assemblies described above include traces printed on assemblies that include absorptive padding or substructure of some type, in at least some applications, sensor device absorption is not required and, for that reason, in at least some cases a sensor assembly may include resistive traces printed on non-absorptive substrates. For instance, in the cast applications described above, in at least some cases absorption is not required and in those cases the assembly substrates may be essentially non-absorptive. As another instance, in a diaper application, most diapers are equipped with liquid absorption capabilities and in those cases the sensor assembly may include a non-absorptive substrate.
In at least some cases it is contemplated that instead of absorbing liquid, a substrate may be purposefully designed to provide no barrier or minimal liquid barrier so that wetness can pass through the substrate and to other product features designed to deal with liquid. Here, the substrate is said to be “breathable” as it is designed to pass air and liquid. Again, in a diaper application, there is no reason for absorption and instead liquid should be passed through an assembly substrate to the absorbing layers that are provided within the diaper itself. In a cast application there may be mechanical features (e.g., a sock, cotton batting layer, etc.) that are designed to dissipate minimal wetness and in those cases sensor pad absorption may not be desired or, perhaps, the pad will be designed to absorb somewhat for wetness sensing purposes but to pass excessive liquid in a breathable fashion.
In addition to being configured to be used as an insert of a liner strip or the like, in at least some applications it is contemplated that a strip type sensor assembly may be configured as a disposable wrap that includes an embedded sensor where the wrap allows moisture to penetrate through for wound care. Here, for instance, the wrap may be cut to any length and be placed over a wound or wrapped around a part of a patient's body to cover the wound in a manner akin to the way an ace bandage is wrapped around a sprained ankle, wrist, or the like. Again, in this case, the wrap may come as a roll of sensor material including traces printed on a substrate subassembly where an assistant can cut off pieces of the roll to desired lengths.
While the embodiments described above generally include disposable sensor pads and inserts that include printed sensor traces, in other cases it is contemplated that reusable sensor assemblies may be constructed using similar printed trace sensor arrangements. For instance, a washable bed pad including one or more washable and absorbing fabric layers may be constructed where sensor traces are printed or otherwise located within the fabric laminate construction. Here, in some embodiments the pad structure will include a liquid impermeable bottom layer to avoid a case where urine or other liquid penetrate the pad and run into a bed mattress or the like. In at least some cases it is contemplated that patients will not want to reuse washed sensor pads for incontinence but may be more open to use of these types of pads in other contexts like, for instance, wound care, sweating, etc. Thus, these types of reusable and washable pad assemblies, while useful in most applications, may be restricted to use in applications other than those related to patient voiding activity.
In at least some embodiments, as data is collected on a patient's voiding schedule, that information is used to predict future voiding activities and a system processor is programmed to generate alert signals so that a patient or an assistant can arrange for the patient to use a restroom or a bed pan if possible prior to a voiding event causing a mess. To this end, in at least some cases the server 28 shown in
In particularly advantageous embodiments the day tracking period will start immediately when the wetness tracking system is initially used with a patient so that any wetness tracking data that is generated is used to generate most accurate future wetness predictions possible. Then, once patient wetness data has been generated for a maximum tracking period, the tracking period will roll forward. For instance, assume a first patient is admitted to a hospital on day 1 and the wetness tracking system is used with the first patient starting on day 1 to generate a voiding schedule where the patient voids every 3 hours. During the second day, while the wetness tracking system continues to track voiding schedule, the system may also use the day 1 voiding schedule to generate predicted void event alerts 15 minutes prior to the 3 hour predicted void times. Over the next few days, as more wetness/voiding data is obtained, the software continually updates the predictive voiding schedule to be more accurate. In at least some cases a maximum tracking period will be 7 days. In these cases, the process of fine tuning the voiding schedule continues until 7 days of wetness/voiding data has been generated. In the event that the wetness tracking system is used with the first patient for more than 7 days, the data used to develop the voiding schedule rolls forward and includes the most recent 7 days of data.
As predicted void alerts are presented to a patient and/or assistant and the patient uses a toilet or bed pan to void instead of wetting a bed or a diaper, wetting events should occur less frequently. Here, if the server is programmed to adjust the voiding schedule based on detected wetting events alone, the predictive schedule would become inaccurate in a short duration of time. For this reason, in at least some cases it is contemplated that a patient and/or assistant will be responsible for indicating when a patient voids in a toilet or a bed pan so that that information can be used to update a predicted void schedule for a patient. Thus, for instance, an assistant that receives a predicted void alert for a first patient and then helps the patient to use a toilet may use her tablet or other portable computing device 16 (see again
In other cases once a predicted void alert is generated, the system may require an assistant or patient to acknowledge the alert and may, based on that acknowledgement, automatically presume that a void occurred (e.g., that the patient responded to the alert by using a toilet or a bed pad. Here, acknowledgement may be via a portable computing device or the like.
In still other cases, after an alert is acknowledged, the system may require a separate confirmation that a patient associated with the alert actually voided. For instance, once an assistant acknowledges a predicted void alert for a first patient, if the assistant has not confirmed a void within 15 minutes, the system may automatically request confirmation as a second follow-up alert.
In some cases the predictive wetness software program may access other medical records information and use that information to increase void prediction accuracy. For instance, a first patient may routinely void two hour after she falls asleep. Here, if a patient monitoring system detects patient sleep state, the time at which the first patient enters a sleep state can be used along with the predictive void information to generate an alert. Other information that may be used as alert triggers includes detected or recorded liquid consumption, medication consumption, procedure types and times, food consumption, etc.
In some cases the system may triage the alerting process. To this end, where a patient and an assistant each uses and has access to a portable computing device, the server may automatically send a first predicted void message to the patient to encourage the patient to go to a restroom to void. In cases where a TV or other display screen including Bluetooth, WiFi, or other wireless capabilities is present in a patient's room, an alert may be presented to the patient via that device. If the patient does not acknowledge that a void occurred within a threshold period of time (e.g., 10 minutes), the system may automatically generate and present a second alert to an assistant
The system may also be programmed to track if a patient is capable of going to a restroom or using a bed pan herself or if she needs assistance and may adjust alerts accordingly. For instance, in a case where four alerts for four consecutive predicted voids are first sent to a patient and then to an assistant if the patient does not confirm voids, the system may automatically determine that the patient is incapable of responding to the alerts and, for future alerts, may only send those to the assistant.
In some cases in addition to indicating a wet state, an alert will also include other wetness characterizing information that an assistant can use to assess how best to respond to a patient's condition. For instance, an alert may indicate a wetness volume or degree of absorbing pad saturation (e.g., “dry”, “damp”, “wet”, “wetter”, “soaked”).
As another instance, an alert may indicate liquid type(s) associated with a wet condition. For example, is the liquid detected urine, sweat, blood, or some unknown liquid? As another instance, the alert may indicate where on the area of a sensor pad assembly wetness has occurred. For example, is the wetness in the middle of a large bed pad or near a pad edge. As another example, in the case of a strip sensor assembly used in a cast, an alert may indicate where along the length of the sensor assembly wetness occurred (e.g., two inches from a first end, at a second end, etc.).
As yet one other instance, where a sensor assembly has different portions adjacent different parts of a patient's body, an alert may indicate which part of the patient's body is adjacent a wet spot. For example, in the case of a cast that wraps a patient's foot and calf, an alert may indicate that a wet spot is detected on the inside of a patient's calf.
In some cases it is contemplated that an assistant may be able to affirmatively ignore an alert. For instance, in the case of a cast where slight wetness occurs adjacent an underside of a patient's foot as opposed to near a calf lesion, an assistant may select an option to ignore an associated alert. Here, the sensor system in at least some embodiments would continue to monitor for exacerbated wetness or wetness at the patient's calf or adjacent other anatomical areas of the patient's leg and would generate other alerts at later times when conditions change. Here, when an assistant ignores an alert, if an alert was being provided to a patient, that alert may be halted or some indication may be generated for the patient indicating that the assistant has received the alert and will attend to the patient at a required time.
In some cases specific alert types may not be able to be ignored. For instance, a soaked wetness condition at a calf area where a calf lesion was treated may not be ignorable and may require an assistant to be present at a patient's location to disable the alert.
As still one other instance, where a portion of a sensor assembly is adjacent an inflicted part of a patient's body, an alert may indicate that wetness is adjacent the inflicted body part. For example, an alert may indicate “A substantial amount of blood has been detected adjacent patent A's left calf wound.” Many other alert types are contemplated.
In some cases where a sensor pad or additional affordances have absorption capabilities and where the system is programmed to assess saturation levels, the system may be programmed to only generate alerts when pre-defined saturation levels or other void parameters are met. For instance, in some cases when a sensor pad assembly is only damp as the assembly has absorbed a minimal amount of urine, the system may not generate an alert. Once the assembly is at least somewhat saturated, the system may then generate an assistant alert.
In some cases assistants and even patients may subscribe to alerts and, effectively, select alerts that meet certain criteria so that assistants are not inundated with trivial notifications of conditions insufficient to warrant a care activity. For instance, while a system server may track and record all liquid detection events, an assistant may not want to be notified when a patient that is using a wetness absorption affordance (e.g., a diaper, bed pad, etc.) is only damp as that condition typically does not pose a substantial health risk. In this case, the assistant may opt, via an interface provided on a portable computing device 16 (see again
An exemplary but incomplete list of alert types that the system may generate include the following:
In some cases the system will automatically generate a facility map and indicate real-time wetness sensor assembly status for each patient in a facility on the map. To this end, see, for instance
In some cases the map will also be controlled to indicate the states of issued predicted void event alerts. For example, in
Referring still to
Referring now to
Instead of having recesses as guiding indicia as shown in clip 500, clip 1000 includes ribs 1002 that extend proud of the external surface of the clip housing. The ribs can be detected via touch and also eliminate the crevices that are formed by alignment recesses so that clip 1000 should be easier to clean and sterilize. In addition, in at least some cases, the ribs may be painted with or otherwise formed using a glow in the dark material so that the ribs can be better seen during night use.
Referring still to
In some cases additional light pipes may be included in the clip assembly for periodically providing light for other purposes. For instance, see the phantom light pipes shown at 1014 and 1016 that extend from the same internal LEDs as pipes 1012 to the indicia for lighting up the indicia for nighttime use. Here, the side light pipes can be used to align the contacts with traces and/or as additional indicating devices.
As another instance, see that a bottom end of another light pipe is shown at 1020 in
Referring again to
Referring still to
In cases where a clip at the edge of a pad is soiled, most soiling occurs near the inner end of the clip arrangement as opposed to the outer end. For this reason, another advantage associated with clip 1000 shown in
In at least some cases a contact clip may also include a wireless transmitter and assembly 1300 may also include a wireless receiver for communicating sensed data via Bluetooth or some other NFC protocol from the contact clip to assembly 1300 so that the wires can be eliminated.
In at least some embodiments it is contemplated that a clip type sensor device may include other components. For instance, referring again to
Here, when the processor receives a query, the processor determines the nature of the question using AI and can formulate an answer based on an instantaneous detection of pad condition or on a prior detected as stored pad state. For instance, the answer may be “Your pad is completely dry at this time” or “Your pad is slightly damp.” As another instance, a patient may query “How much time until my next restroom reminder?” and the processor may respond “32 minutes.” Here, the idea is any anxiety on the part of the patient can be addressed with a simple question and automated answer so that the patient need not both with physically locating the clip or manually checking the condition of the pad.
In a case where a patient wants an assistant to address the pad condition, the clip processor may be programmed to facilitate communication with an assistant. For instance, if the processor tells a patient that a pad is somewhat wet and the patient is uncomfortable for some reason and wants the pad replaced, the patient may be able to voice a request for an assistant to come to the patient's room to attend to the wet pad.
In cases where an assistant comes into a patient's room to check on the patient, again, instead of having to fumble around looking for a sensing clip, the assistant may simply voice a query regarding the sensing system status to access audibly broadcast state information. The assistant may query “Alertwet, what is the status of the wetness pad?” and the processor may answer “The pad is partially wet, however, you should change it now as the patient is due for a restroom alert 15 minutes from now.” Here, the assistant may continue and query “How long has the pad been wet?” and the processor may respond “45 minutes.”
As briefly described above, in at least some cases it is contemplated that a smart speaker type device (see 27 in
Unless indicated otherwise, herein an Alexa, Google or other type voice activated smart computing device will simply be referred to as a “smart speaker”. Here, the smart speaker may perform many different functions relatively inexpensively. First, the smart speaker may be programmed to facilitate a sensor clip commissioning process whereby a specific clip is associated with the specific smart speaker. For instance, when a clip is brought into a patient's room and is opened (e.g., the clip jaw is opened), the clip may transmit a Bluetooth signal within the room announcing itself to the smart speaker. Here, the smart speaker may audibly query if the assistant wants to associate the clip device with the smart device and upon an affirmative answer, may associate with the clip and cause the clip to chirp or clip light devices to blink to confirm association. Association may also be triggered by attaching a clip to a sensing pad or by some other triggering activity.
Once associated with a smart speaker, the clip may then transmit sensor system state signals from a clip processor. For instance, when the clip is attached to a sensor pad, the clip may send a signal to the smart speaker indicating a successful circuit and the smart speaker may audibly indicate “Alertwet sensor system now operational.” The smart speaker may be programmed to route system state signals to a remote computer or portable computing device used by an assistant or to the system server for further processing. The smart speaker may also be programmed to generate warning signals when specific system states occur such as, for instance, a wet pad state. Here, the smart speaker may generate a light warning signal, a sound warning signal, a voice signal, and/or a signal to transmit to a remote computer of the system server.
In some embodiments the smart speaker will include a microphone and will be able to answer verbal patient and/or assistant queries like the ones described above either onboard the smart speaker or by connecting to an AI server 28 in the cloud that is programmed to process queries, lookup information needed to answer queries and to formulate audio or other signals in response to the queries. Thus, a patient or assistant may query the state of a sensing system, if the system is operating properly, etc.
In at least some cases a smart device may be specially programmed to only perform functions related to the wetness sensing system. In other cases the smart device may be used to perform other healthcare or medical related functions (e.g., monitor other medical equipment states, provide other warnings, etc.). In still other cases the smart device may be a general-purpose smart device like Alexa where the device just runs a wetness sensing system application program in parallel with all the other functions that the smart device can perform.
In at least some embodiments where different sensor pad types having different trace shapes, lengths, and operational characteristics are available for use in different types of wetness sensing applications (e.g., bed wetting, within a cast, in a diaper, etc.), specific and different types of sensor clip systems may be designed to operate with each different sensing pad or strip type so that the sensor clips only need to be programmed to account for the specific operating characteristics of a specific pad/strip type. Thus, for instance, in a case where two pad/strip types are available for use, a first rectangular bed pad type 12 as shown in
In other cases, it is contemplated that a single clip type may be able to operate with many different sensor pad types where the single clip type modifies its operations based on the type of pad that the clip is attached to. For instance, in some cases a sensor clip processor may be able to read a pad type identifier that is provided directly on a pad. For example, in the case of a pad like the one shown in
In some cases, an assistant may have to do something during a pad and clip commissioning process to make pad type known to the sensor clip processor. For instance, in some cases bar/matrix codes may be provided on each pad indicating pad type and on each sensor clip identifying the specific clip and an assistant using a smart phone or other code reader may be required to read both a pad code and a clip code to associate the clip with the pad. Once a smart phone associates a clip and an instance of a pad, the phone may transmit a pad type indicator to the clip causing the clip, again, to load and run a subprogram that is associated with the pad type.
In still other cases the sensor clip may simply operate as a raw data reader, data router, and state indicator where all data calculations, conclusions and storage occur at a system server 28 or some other system computing device. Here, for instance, where a sensor clip reads a pad type code or a smart phone or other smart device associates a clip with a specific pad type in some fashion, the pad type and associated clip identifier may be provided to server 28 which then runs subprograms for the specific pad type and clip combination to facilitate system processes. Here, when an alert is required, the server may transmit alert signals to one or each of the sensor clip, an assistant's computing device, and another warning device (e.g., a smart speaker in a patient's room) as needed.
In still other cases it is contemplated that a patient may have her own smart phone capable of running application programs where one of the programs may be a wetness sensor program capable of performing at least a subset of the processes and providing a subset of the features described above in conjunction with a sensor clip and sensor pads. To this end, with a wetness sensor program loaded onto a smart phone device that has Bluetooth communication capabilities, the patient may associate a sensor clip with the smart phone by entering clip identifying information, reading a bar code from the clip device using a smart phone camera, performing a commissioning procedure where the clip broadcasts an identifying signal and the phone uses that signal to establish a relationship, or in some other fashion.
Once the clip and phone are associated, the patient or an assistant may place a sensing pad or strip on a bed surface or otherwise for sensing wetness and may attach the sensing clip (and resistive clip where used) to the pad/strip, at which point the sensor clip may start monitoring for wetness. Here, as described above, the sensor and/or smart phone device may perform some process to identify pad type in cases where the system supports more than one pad type with different operating characteristics and may run a subprogram that is related to a specific pad type. Here, the clip may simply collect raw data and send it along to the patient's phone device for processing or for further transmission on to a system server (see again 28 in
When a sensing clip and a resistive clip are initially attached to a clean pad, in at least some embodiments the sensor clip may run an additional commissioning procedure to identify a baseline dryness/wetness level for the specific pad and specific application prior to soiling. To this end, it has been recognized that pads can have different dampness or dryness condition based on humidity and storage conditions of those pads and that the initial dryness condition (e.g., dryness level prior to a soiling event) can have appreciable effects on wetness algorithm accuracy. Here, by identifying the effects of pad dampness on trace impedance prior to use, that effect can be used to adjust wetness algorithms to compensate for the initial dampness.
In these cases, a pad including traces that have known and expected impedance characteristics is provided. Here, the pad traces may be of a pre-defined length so that expected dry pad impedance is clearly known. In other cases where different pad lengths can be ripped off a roll of pad material, increments of trace impedance corresponding to possible lengths may be known. Here, the pads are designed so that a damp pad that does not include a wet spot will not completely short out pad traces which would short the clip resistor out of the circuit. Thus, here, a difference between a detected pad resistance and the expected pad resistance given specific pad type or possible impedance increments associated with different lengths of a specific pad type is indicative of an initial dampness level, not a wet spot. Upon attaching the sensor and resistor clips to the pad traces, an initial commissioning voltage is applied across the traces, a pre-soiling resistance value associated with the traces and the attached resistor clip is detected and that detected resistance is compared to the expected dry pad and clip resistance value (or values in the case of a pad that may have different lengths and trace lengths) to identify a difference which is indicative of the current dryness/dampness of the pad. The wetness detection algorithms are adjusted to compensate for the difference (e.g., for the pre-soiled dryness/wetness condition of the pad).
In addition to pad dampness due to storage humidity prior to a soiling event, pad dampness may be affected by environmental factors during use and prior to a soiling event. For this reason, in at least some cases it is contemplated that the pre-soiling dampness detection and compensation process described above may be periodically performed prior to a soiling event to adjust wetness algorithms and increase wetness detection accuracy. To this end, humidity within patient rooms can vary appreciably and could affect wetness detection accuracy. In addition, different patients sweat to different degrees and sweating affects pad dampness pre-soiling event in at least some cases. Here for instance, the pre-soiling event dampness detection and algorithm adjustment process may be performed every 10 minutes to increase detection algorithm accuracy.
While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, the invention is not intended to be limited to the particular forms disclosed. For example, while at least some of the embodiments above include a clear or at least semi-transparent cover member so that visual LED signaling can be observed from outside a sensor clip housing, in other embodiments the entire housing structure may be semi or fully transparent and the clip assembly may be designed so that LED light exists in many directions from the housing and can be seen generally from any vantage point about the housing structure. In these cases, light signaling should be viewable from a clip LED regardless of how the clip is attached to a sensing assembly.
In at least some cases, after pad and sensor clip initiation using a resistive clip wherein the pad/trace length is determined, the resistor clip may be removed and the sensor clip may operate alone to detect wetness without the resistive clip.
While the pads described above include two conductive/resistive traces that extend along each other from end to end where each trace has an intentionally defined resistance per unit length, in other embodiments it is contemplated that only one of the two traces may be intentionally resistive and the other trace may be essentially purely conductive.
While most of the pads described above include separate traces printed on the same level within a pad laminate, in other cases it is contemplated that first and second traces may be printed on opposite sides of an absorptive layer where, when the absorptive layer is dry, there is no electrical short between the two traces and, where wetness in the absorptive layer causes a short between the two traces. Here, the first and second traces could be essentially identical, with an upper trace simply separated from the lower by the absorptive layer. This arrangement would operate in a fashion like the dual trace pads described above for detecting wetness, location of wetness, etc.
Additional Clip Design
Still other clip assembly designs are contemplated. For instance, see the sensor clip assembly 1350 shown in
With this “sloped shape”, when clip assembly 1400 is attached to a sensor pad assembly edge and positioned with the top surface facing upward, the sloped surface has two advantageous effects. First, if a patient moves to a position where a body part is above assembly 1350 (e.g., rolls over onto the assembly), the sloped top surface reduces the potentially annoying feeling of having a rigid clip assembly between a bed surface and the patient. Second, if a patient moves on a sensing pad such that the patient's body contacts assembly 1350 and places a lateral force thereon, the sloped surface reduces the magnitude of the lateral force so that it is less likely the clip assembly 1350 will become detached from the pad or will damage the pad and render it useless or ineffective. The upper surface of assembly 1350 also forms ramped surfaces from lateral edges toward the flat top portion that perform similar functions to the sloped front surface.
A second difference is that assembly 1350 includes at least a first pad stop member 1402 that performs several functions including mechanically limiting the position of a sensor pad edge that is inserted within the clip jaw structure. It is important that sensor pad traces be aligned with clip assembly sensing pins so that the pins make reliable contact with the traces upon assembly attachment to a sensor pad for sensing purposes. The at least a first stop member 1402 is positioned with respect to the clip jaw gap such that with an edge of an exemplary sensor pad abutting a front facing stop surface of the stop member, sensor pins are aligned with pad traces within the clip jaw gap.
In a particularly advantageous clip assembly as shown in
In a case where the clip assembly includes stop members, when a pad edge abuts the front facing surfaces (e.g., stop surfaces) of both stop members 1402 and 1404, that condition can be used by a person to know that the clip assembly 1350 is properly aligned with the pad edge (e.g., is substantially perpendicular thereto) and that the pad is inserted into the clip jaw gap to the correct depth such that the clip assembly pins are aligned with the pad traces. Here, during pad edge insertion, a person can tactilely feel when the pad edge abuts the stop surfaces and use that feeling as a guide to halt further movement and as a trigger to close the clip assembly onto the pad edge.
The stop surfaces perform other functions as well that make the clip assembly overall more robust and optimally functional. For instance, the housing sub-assembly 1500/1600 is formed with cutouts 1611, 1613 having surfaces that cooperate with surfaces of the stop members 1402 and 1404 to guide housing sub-assembly 1500/1600 relative to jaw 1400 between aligned open and closed states/positions. In addition to guiding part movements, the cutout and stop member surfaces cooperate to alleviate lateral and end to end forces on the clip assembly hinge mechanism, especially when the assembly is in an open state. In this regard, see
As another instance, the stop members and housing sub-assembly 1500/1600 are designed so that the stop members can be seen by a person inserting a pad edge into an open clip assembly and therefore operates as visual pad insertion guides Thus, in addition to the tactile indication that a pad is properly inserted into an open clip assembly, a user can visually see a pad edge relative to the stop surfaces to assess if the pad is optimally inserted.
As another instance, the stop members extend upward from an internal surface of the jaw 1400 past the internal surface of the housing sub-assembly 1500/1600 when the clip assembly is in its fully open state or position (see again
A third difference is that the assembly 1350 is generally wider than the earlier described embodiments, the width important for several reasons. First, the larger width of assembly 1350 allows for a wider external/lower surface of jaw 1400, which reduces the likelihood that assembly 1350 will be inadvertently flipped over by patient movement during use. In use, it is important that the top surface of member 1600 faces upward so that the indicator lights are not blocked from view by a bed, a sheet, or other things. Second, the larger width means that the facing internal surfaces of the clip members that contact an inserted pad can have larger areas which increases support for the edge portion of a pad inserted into the clip and also, in at least some embodiments, results in more friction between the clip and an inserted pad which reduces lateral forces placed on the pad at the prong piercing locations so that pad damage at those locations is minimized or eliminated. Third, the larger width allows for gradual ramped or sloped upper edge surfaces of the clip assembly as described above while still providing a sufficiently sized housing cavity for accommodating a processor, sensor device, battery, etc.
A fourth difference is that the housing sub-assembly 1500/1600 includes two different components, a base member 1500 and a cover member 1600, that couple together independent of other fastening mechanisms to form a substantially hermetically sealed cavity for the clip processor, sensor circuitry, and a battery. Here, eliminating other fasteners means that there are less crevices and cracks in the overall assembly design which makes it easier to clean and sterilize the assembly. In addition, fewer components means the assembly has a lower overall cost.
A fifth difference is that assembly 1350 has a specific clip hinge structure that has been designed to have particularly small dimensions while still meeting robustness requirements given complimentary functions of other assembly features. For instance, while jaw 1400 and housing sub-assembly 1500/1600 are formed using inexpensive and light weight plastic, hinge inserts 1800 (see
A sixth difference is that clip assembly 1350 has a wide jaw forming portion 1352 and a narrower central lever portion 1354 (see
Referring now to
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Hinge limit member 1434 extends upward from the internal surface 1422 of member 1441 at first end 1434 and, in top plan view, is generally U-shaped with a shoulder member 1443 located adjacent the first end 1414 and first and second arm members 1445 and 1447 extending forward form opposite ends of the shoulder member 1443 toward second end 1416. The shoulder and arm members form a space or cavity 1432 that opens forward and upward between the arm members. A top surface of limit member 1434 is substantially flat and parallel to internal surface 1412. Proximate first end 1434, the top surface of limit member 1434 angles downward and rearward as best seen in
Referring again to
Referring still to
Member 1441 forms hinge insert receiving openings 1440 and 1442 that extend through the thickness of member 1441 from external to internal surfaces. Opening 1440 is formed immediately in front of arm member 1445 while opening 1442 is formed immediately in front of arm member 1447. As best seen in
A clearance recess 1460 is formed in internal surface 1412 between openings 1440 and 1442 having a depth less than 0.070 inches and, in some cases, in a range between 0.025 and 0.050 inches. Recess 1460 provides a clearance space for a lower corner portion of the housing sub-assembly 1500/1600 when in the open position as shown in
Referring to
Referring now to
Cavity forming member 1550 includes an end adjacent finger member 1542 and forms second end 1504 of base member 1500. Cavity forming member 1550 forms a cavity 1514 that opens through top surface 1510 which includes a rectangular portion 1530 adjacent finger member 1524, a cylindrical portion 1528 adjacent the rectangular portion opposite finger member 1524, and first, second and third probe portions 1520, 1522 and 1524 that extend from the rectangular portion toward first end 1504. As best seen in
Referring still to
Finger member 1542 is relatively thin compared to cavity forming member 1550 and, to increase stiffness of member 1542 a triangular bracket 1581 is formed between an undersurface of member 1540 and an adjacent wall portion of member 1550. A shelf surface 1587 is formed adjacent finger member 1542.
Referring specifically to
Referring to
A lip 1626 (
To increase the sealing effect between the cover and base members, the cover may be formed of a plastic material that is relatively softer than the plastic material used to form the base member 1500 and jaw 1400. For instance, in some cases the cover 1600 is formed using 40-60 durometer commercial grade plastic and base 1500 is formed using 90-120 durometer plastic which is relatively harder, where the cover material may slightly flex or resiliently deform when the base 1500 is slid into engagement therewith to increase the sealing effect and friction therebetween.
Referring to
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Similarly, cutout recess 1624 forms three walls or surfaces, a forward-facing surface 1629, a rearward facing surface 1633 and a side facing surface 1631 between surfaces 1629 and 1633. A dimension between forward facing surface 1629 and rearward facing surface 1633 is similar to but greater than the dimension between oppositely facing surfaces 1466 and 1421 of member 1404. A dimension between side facing cutout surfaces 1625 and 1631 is similar to the dimension between guide surfaces 1407 and 1409 formed by stop members 1402 and 1404, respectively.
Cutouts 1622 and 1624 are formed in cover member 1600 at locations such that once the clip assembly is assembled, the cutouts are generally aligned with stop members 1402 and 1404, respectively, with side facing surfaces 1625 and 1631 abutting guide surfaces 1407 and 1409, respectively, when the clip assembly is in a closed state.
While generally aligned with members 1402 and 1404, in a particularly advantageous embodiment, the cutouts are located such that there are small gaps G1 and G2 between the forward and rearward facing surfaces of the stop members and the cutouts (
In
To assemble the clip assembly components, referring to
Referring to
While the pins 1700, 1701 are shown extending downward from the housing subassembly 1500/1600 in the illustrated embodiment and the circuitry is located in upper sub-assembly 1500/1600, it should be appreciated that in other embodiments the circuitry may be located within a cavity formed by jaw 1400 and/or pins may extend upward form the internal surface of jaw 1400 into openings formed in the upper jaw sub-assembly. In cases where the circuitry is in one of the upper and lower jaw sub-assemblies and the pins in the other, there would be connectors/contacts within the circuit housing sub-assembly to form an electrical connection with the pins upon closing the clip assembly.
While the circuitry and pins may be in different ones of the upper and lower clip sub-assemblies, placing both in the upper housing sub-assembly 1500/1600 is advantageous for several reasons. First, liquid flows downward so placing the circuitry in the upper housing sub-assembly reduces the likelihood that any liquid will enter the circuitry cavity. Second, with the distal pin ends extending from the internal surface of the upper housing sub-assembly, the internal and upper surface 1412 of lower jaw 1400 is substantially flat and smooth so that there are no edges or mechanical structures that a pad edge can become snagged on during insertion. In fact, in some cases, the upper/internal surface 1412 of jaw 1400 is completely smooth to reduce friction as a pad edge is inserted into a clip and slides there along. To increase friction on a pad once inserted and the clip assembly is closed, in at least some cases the lower and internal surface 1469 of subassembly 1500/1600 is textured to reduce sliding of the pad edge with respect to the clip. In at least some embodiments the pin and clip dimensions are such that when the clip is in an open state, the distance between the distal ends of the pins and the upper surface of law 1400 is within a range between 0.15 and 0.5 inches and, in particularly advantageous embodiments, the dimension is 0.25 inches+/−5%.
In at least some embodiments each pin has a circular cross section and has a diameter within a range between 16 and 24 gauge and in particularly advantageous embodiments has a range between 18 and 22 gauge. Gauges in this range are sufficiently robust to withstand forces applied in normal intended use where the assembly is expected to be opened and closed several hundred times in at least some cases. In at least some cases each pin is hollow and the distal ends are sharpened to form angled ends (see
Referring to
Next, the housing subassembly 1500/1600 is positioned above jaw 1400 with stop members 1402, 1404 aligned with the cutouts 1622, 1624 and hinge block 1580 aligned with cavity 1432. Housing sub-assembly 1500/1600 is moved toward jaw 1400 until block 1580 resides substantially within cavity 1432 formed by jaw 1400 and the upper holes 1820 of both inserts 1800 are aligned with opening 1580 formed by jaw 1400. Second spring pin 1804 (
The fully assembled clip assembly 1350 is shown in
To open the clip assembly from its closed state shown in
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As best seen in
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In other embodiments it is contemplated that assembly 2000 may include one or more indicator lights 2022 (shown in phantom in
While the signal and sync clip assemblies 1350 and 2000, respectively, may be constructed in different sizes and with different dimensions for use in different applications (e.g., relatively smaller for a wearable application as in
Dimensions of some of the plastic members have been chosen to optimally facilitate certain functions and so that clip assemblies have desirable characteristics given typical applications. For instance, to minimize user discomfort if a user rolls over onto a clip, overall clip height (e.g., dimension between upper and lower surfaces when the clip is in the closed state) is minimized to the extent possible without sacrificing required assembly durability. In advantageous cases the overall height of the clip assembly is less than one inch and in particularly advantageous embodiments the overall height dimension is 0.75 inches+/−5%. As another instance, in many cases clip assembly users will be elderly and the users may have ailments which make it difficult to manipulate small devices or to generate enough force with a small device to close a clip device on a pad edge with the distal prong ends fully penetrating a multi-layer pad. For this reason, in at least some applications a length dimension of the jaw and facing housing assembly that form the clip jaw structure should be relatively long so that leverage that results from a longer housing and jaw structure can generate a greater closing force with less effort. The greater force is concentrated at the hinge mechanism including the plastic features that connect to the metal hinge inserts and therefore, given characteristics of the plastic used to construct the assemblies, there are minimal dimensional requirements for the plastic features that form the hinge structure to ensure that those features do not deform under the leveraged force. Many other operational and desirable assembly characteristics have been considered in designing the clip assemblies described herein and optimal ranges of dimensions contemplated are as follows.
Referring again to
First end 1352 (
Referring still to
Pin holes 1472 include two holes that are spaced apart laterally and aligned at the same lengthwise location between ends 1414 and 1416 and between the lengthwise location of magnet hole 1470 and second jaw end 1416 and a single hole that is centrally located widthwise and located about midway between magnet hole 1470 and second end 1416. The dimension between second end 1416 and the central axis of the single hole is within a range between 0.75 inches and one inch and is optimally 0.9 inches+/−5% and the dimension along the length of jaw between central axis of the single hole and the pair of lengthwise aligned holes is in a range between 0.65 inches and 0.85 inches and is optimally around 0.75 inches+/−5%.
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Several ways to associate a sensor clip assembly with a specific patient/user or a specific patient/user location (e.g., room) within a facility (e.g., medical care facility) are described above. Additional ways to associate are contemplated. For instance, in some cases each bed within a hospital may have an NFC tag attached thereto which stores a bed identifier. Here, when a sensor clip is initially attached to a pad and activated, the clip may transmit is signal to a proximate Ipad or other wireless portable computing device identifying the specific clip assembly by a clip specific identifier code. The portable device running a wetness application responds by querying proximate NFC tags for bed identifiers and, upon receiving the bed identifier associated with a proximate NFC tag, automatically associates the newly activated clip with the specific bed and transmits that correlated information on a system server for storage. Thereafter whenever the clip transmits any information, the information includes a header identifying the specific clip so that when the server receives the transmitted information, the server can associate the information with the patient specific bed. The bed and patient ID may be used to add a further level of association for reporting and alerting purposes. In particularly advantageous cases, the clip to bed association may be completely automatic without requiring any activity on the part of a caregiver of or a system user other than activating the clip by attaching to a pad.
In still other embodiments it is contemplated that specific rooms or locations or beds within a facility may be unambiguously associated with specific patients and specific locations with the facility in a system database. In this case, when a clip is attached to a pad and activated, the clip may automatically generate an activation signal identifying the clip and transmit that signal in a near field space. A portable computing device (e.g., smart watch or the like) may be programmed to receive the activation signal and to use a location service within the facility to triangulate or otherwise identify the portable device location within the facility and to associate the specific current device location with one of the rooms, locations or beds associated with a specific patient. In cases where a patient can be unambiguously identified in this way, the system may associate the clip assembly with that patient and initiate wetness data tracking for that patient. Where there is ambiguity regarding which of more than one patient or location is to be associated with the clip assembly, the system may automatically query the portable device user to identify which of several patients or locations are to be associated with the clip for information tracking purposes. In some embodiments the portable computing device may be a wireless smart watch which would routinely be proximate a clip when initially attached to a pad and activated so that one to one clip to patient or location or bed, etc., association can be automatically facilitated.
In still other cases it is contemplated that an NFC sensor device may be associated with each bed in a care facility where the NFC sensor device receives signals from any activated clip in the vicinity of the bed so that clip signals can be unambiguously associated with a specific bed. Here, the NFC sensor device may transmit received signals with a bed identifier on to a system server for processing.
When a clip is removed from a pad for any reason, in at least some cases it is advantageous to transmit a disconnect signal from the clip to the system server to memorialize the disconnect and so that the wetness tracking application stops expecting wetness data transmissions from the clip which could cause the server to misidentify a clip malfunction. In at least some cases, to ensure that the disconnect signal is transmitted to and received by the system server, upon detaching the sensor clip from a pad, the clip processor immediately transmits a burst of broadcasts so to the server (e.g., typically via relay devices as described above) to ensure that the disconnect signal is received and processed. Thereafter, the clip is automatically powered down to conserve battery energy.
In some embodiments it is contemplated that both Ipads/portable wireless computing devices and BLE beacons may be used at the same time in a single system to collect clip transmitted data in the most optimal way possible at any given time based on current circumstances. Thus, for instance, where a patient resides in her assigned bed at a known location, clip transmitted information may be obtained an I-pad proximate the clip and, when the same patient is located in a common area outside an assigned space, the BLE hub may obtain clip transmitted information.
Referring again to
Referring now to
See also
Similarly, referring again to
Operation of clips 22a and 22b is synchronized so that clip 22b places resistance across the traces during periods that clip 22a applies voltage across the traces and while clip 22a is sensing the trace and applied resistance, and so that clip 22a places resistance across the traces during periods that clip 22b applies voltage across the traces and while clip 22b is sensing the trace and applied resistance.
In at least some embodiments the clips 22a and 22b alternately apply voltage at consecutive times when resistance values are to be detected. Thus, for instance, where wet status is to be checked every 10 seconds, at a first detection time, clip 22a may apply voltage while clip 22b applies resistance and the processor in clip 22a may detect pad resistance, at a second detection time 10 seconds later, clip 22b may apply voltage while clip 22a applies resistance and the processor in clip 22b may detect pad resistance, at a third detection time, clip 22a may apply voltage while clip 22b applies resistance and the processor in clip 22a may detect pad resistance, and so on.
Referring again to
In the case of the system described above with respect to
In some cases, clips 22a and 22b may simply be programmed to alternate between applying voltage and resistance across the two traces at wet status detection times. In this case, when the clips 22a and 22b are first attached to a pad, the clips have to cooperate to synchronize operation. For instance, whenever a clip 22a or 22b is initially attached to a pad, the processor in that clip may be programmed to detect that the clip has been attached to a pad and to detect whether a second clip has been attached to the pad proximate the other end of the traces. To this end, a newly attached clip may alternate between applying a voltage across the traces and detecting a voltage across the traces and, when a voltage is detected, use that signal to recognize that a second clip has been attached to the other end of the traces. In at least some cases one or both of the clips will generate an alert or notification signal (e.g., light an LED, generate an audible chirp, etc.) to indicate that the two clips have been properly attached to the pad.
In at least some cases, each clip will be assigned a clip specific ID number or code. Once clips attached to a pad are “aware” of each other, one of the clips may transmit its ID number to the other clip via the traces and the receiving clip may be programmed to transmit its ID number along with the received ID number to a proximate system receiving device (e.g., a portable tablet device, a local laptop, a local access point, etc.) and one of the system processors external to the clips may store the associated clip ID numbers together so that the system can associate signals received from the two clips together.
In other systems, once first and second clips attached to a pad are aware of each other, one of the clips may assume the role of communicating with system processors and devices external to the clips. Thus, for instance, in a case where first clip 22a assumes the role of communicating with an external device, pad resistance detected by second clip 22b may be transmitted wirelessly or via the pad traces to first clip 22a and first clip 22a may transmit the received resistance to an access point 26 (see again
In still other cases, a wireless tablet or smart phone or other portable computing device may be used during a commissioning procedure to associate first and second sensor clips 22a and 22b with a specific patient, bed in a medical facility, room in a medical facility, etc., so that data received from each of the clips 22a and 22b attached to a pad can be associated and used to calculate wet spot area, volume, etc. In this regard, each clip 22a and 22b may include a barcode printed on an external surface that can be read via a portable device camera or may be able to transmit a clip identifying number via NFC, Bluetooth, or other wireless communication protocol to a proximate portable device receiver and the portable device may be programmed to capture a patient identifier from a patient identifying device and the two clip ID numbers and to correlate the clips with the patient, with the patient's bed, etc.
In at least some embodiments the first of the two clips that detects the other clip attached to the pad is programmed to transmit a synchronizing signal to the other clip indicating a start time and duration of a wet status detection cycle (e.g., starting at time t0 with a duration of 10 seconds). Here, the receiving clip aligns its detection cycle based on the synchronizing signal.
At the cycle start time, second clip 22b applies resistance to a second end of the pad traces, first clip 22a applies a sensing voltage to the first end of the traces and detects the resistance at the first end (e.g., combined trace resistance, applied resistance, and resistance due to any fluid on the pad). As in other embodiments, the detected first end resistance is used to detect fluid 230 on the pad as well as the closest location 234 from first clip 22a along the trace lengths at which any fluid causes a short between adjacent portions of the traces.
Once first clip 22a detects the first end resistance, clip 22a switches to apply resistance to the first trace ends and, at the next status detection time (e.g., t0+10 seconds), clip 22b applies a sensing voltage to the second end of the traces and detects the resistance at the second end (e.g., combined trace resistance, applied resistance, and resistance due to any fluid on the pad). The detected second end resistance is used to detect fluid 230 on the pad as well as the closest location 232 from second clip 22b along the trace lengths at which any fluid causes a short between adjacent portions of the traces. Using the two shorted trace locations 232 and 234, a system processor estimates the size of any wet spot and volume of fluid absorbed by the pad.
Thus, two sensor clips attached to a pad can communicate through the pad traces to automatically associate with each other prior to detecting wet status of the pad. Once associated, all pad resistances detected by either of the clips 22a or 22b that are transmitted from those clips are related to the single pad until one of the clips is removed from the pad. When one of two clips is removed from a pad, the next time each clip attempts to detect pad resistance, that clip recognizes that the resistance applied by the other clip is missing and the clip disassociates from the pad and the other clip. Each of the clips automatically reassociates with another clip commonly attached to another pad (e.g., upon replacement of a soiled pad) in the manner described above.
In some cases where two sensing clips 22a and 22b are used together at opposite ends of pad traces to detect first and second edges of a wet spot, instead of alternating sensing between clips 22a and 22b initially, clip 22a may initially apply voltage and clip 22b may initially apply resistance during detection periods until clip 22a initially detects wetness on a pad. Here, when clip 22a initially detects a set spot, clip 22a may transmit a signal to clip 22b to initiate alternate resistance detection events between clips 22a and 22b and a detection timing schedule, after which clips 22a and 22b cooperate to detect wet spot edges as described above.
Referring again to
In addition to helping form a seal at area 2400, it has been recognized that it is advantageous to construct cover 1600 from a soft and somewhat flexible plastic material so that the upper surface of the clip assembly in a typical operation position is not rigid. In this regard, in a typical operating position and orientation when clip 1350 is attached to a pad for use on a top surface of a bed, the lower surface of lower jaw 1400 rests on the top surface of the bed and the upper surface of cover 1600 generally faces upward. In this orientation, a person in the bed may roll over and her hip or some other body part can press against clip 1350. In a case where the upper surface of cover 1600 is rigid, pressing a body part against the rigid cover would cause discomfort and, in some cases, could cause a bed sore to develop. The soft/flexible cover member, along with the sloped upper edge surfaces of clip 1350 substantially reduce and in some cases eliminate discomfort during use.
Referring still to
Referring again to
In at least some embodiments, label 2412 extends along substantially the entire surface area of the top surface forming portions of base 1500 and cover 1600 so that the label presents a smooth and uninterrupted upper surface. In some cases, label 2412 is transparent. A transparent label is particularly advantageous in cases where LEDs are provided in openings 1630 (see again
While label 2412 may be flexible in some cases, in other cases it has been determined that there is an advantage to using an at least somewhat rigid label 2412. In this regard, while a soft/flexible cover 1600 is advantageous for creating a seal at area 2400 as illustrated in
In some cases, the label is formed on Lexan polycarbonate sheet material which is stiff, is impact resistant, and highly resistant to chemicals including most cleaning agents used in medical facilities. A cleanable material label is important as clip assemblies will often be cleaned in a medical facility environment after each use (e.g., 100 or more times throughout the like of the clip assembly). In other cases, acrylic sheet may be used instead of Lexan.
Referring again to
Referring now to
In still other embodiments, a sealing gasket may be provided between body 1500 and cover 1600 for sealing off cavity 1514 from fluids. Referring to
While the embodiments described above include a resistance applied to ends of traces opposite a clip sensor assembly, certain aspects of the present disclosure can be used with pads having traces where no resistance is applied to trace ends opposite the sensing clip. For instance, the clip design shown in
To be clear, while several different embodiments of the clip assemblies, pads, and overall systems are described above where certain features are only described with respect to some of the embodiments, it is contemplated that any of the features could be added to or supplemented into or swapped into any of the embodiments with advantageous effect.
Thus, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims. To apprise the public of the scope of this invention, the following claims are made:
This application claims priority to U.S. provisional patent application Ser. No. 63/436,202, filed on Dec. 30, 2022 which is titled “Wetness Pad Assembly, System and Method,” and is a continuation-in-part of U.S. patent application Ser. No. 17/231,564 filed on Apr. 15, 2021, which claims priority to U.S. provisional patent application Ser. No. 63/033,610, filed on Jun. 2, 2020 which is titled “Wetness Pad Assembly, System and Method”, each of which applications is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63436202 | Dec 2022 | US | |
| 63033610 | Jun 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17231564 | Apr 2021 | US |
| Child | 18219462 | US |
