Patent Description:
<CIT> describes a fluid bag for bedding with an inclined face for inclining the body of a person lying on their back on the bedding to lie on their side. The fluid bag is inflated substantially like a triangle pole when a fluid is supplied into the fluid bag. Two or more fluid bags are superposed one on the other, with at least the vicinities of apexes in close contact with each other, and the apex parts superposed in close contact are disposed in the longitudinal direction of the floor surface. The fluid bags are inflated like a fan whose fulcrum is the apex portion of the superposed fluid bags by supplying a fluid into the fluid bags, whereby the inclined face is provided on the top of the fluid bag overlaid on the uppermost part.

<CIT> describes an adjustable bed that assists a user to turn comfortably in his or her sleep without mental stress. Once an automatic mode starts, measurement on the depth of sleep of the user lying on the bed is launched. The depth of sleep is measured by detecting biological information such as brain waves, heart rate, and respiratory rate of the user using electrode sensors or the like, and analyzing the biological information according to a polysomnography method or the like. If the depth of sleep is <NUM>, i.e., the user is in REM sleep, and if one hour or more has passed since the measurement is launched or since an immediately preceding turn operation, a turn operation is performed to turn the user.

While various systems have been developed, there is still room for improvement. Thus, a need persists for further contributions in this area of technology.

According to the present invention, there is provided a dynamic support system comprising a person support apparatus, a control system, and a plurality of sleep sensors. The person support apparatus comprises a closed air system having at least one support piece configured to form a laterally angled sleep surface having a length defined between a first edge and an opposing second edge spaced from the first edge along a longitudinal axis of the support system. The at least one support piece comprises a pair of laterally-spaced fluid bladders communicatively coupled to each other to allow fluid to move between interior cavities of the fluid bladders. The control system comprises a computer having one or more processors in operational control communication with the person support apparatus. The plurality of sleep sensors are configured to sense user sleep patterns and activity during sleep, each sleep sensor of the plurality of sleep sensors in signal communication with the one or more processors. The plurality of sleep sensors are configured to gather data and generate and transmit to the one or more processors signals indicative of the data gathered. Each sleep sensor is also configured to receive operation control signals from the one or more processors. The control system is configured to: detect when the user begins to fall asleep; monitor the user's sleep patterns and activities as the user begins to sleep; and activate the support apparatus to rotate the user at a time during sleep, after sleep is detected, by activating the support apparatus at a time delay.

A method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; displaying a proposed configuration of a person support structure corresponding to the care protocol for a caregiver to approve; and upon approval by the caregiver, implementing the configuration.

A method comprises receiving a signal indicative of a physiological characteristic; comparing the signal to a threshold to determine if an adverse event is in progress; and upon detecting that an adverse event is in progress, initiating an intervention to stop the adverse event.

A person support surface comprises a mattress ticking and a mattress core. The mattress core is enclosed by the mattress ticking and includes at least one fluid bladder configured to selectively protrude from the person contacting surface and support a portion of at least one of the neck and the upper back of an occupant supported on the person support surface.

A method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; sensing a first physiological characteristic of a person supported on a person support structure; sensing a second physiological characteristic of the person; comparing the first physiological characteristic to the second physiological characteristic; if the difference between the first physiological characteristic and second physiological characteristic is outside a predefined range, configuring the person support structure as a function of the care protocol.

A method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; sensing a first physiological characteristic of a person supported on a person support structure; sensing a second physiological characteristic of the person; comparing the first physiological characteristic to the second physiological characteristic; if the difference between the first physiological characteristic and second physiological characteristic is outside a predefined range, alerting a caregiver that an adverse condition is going to occur.

A support system defines a sleep surface configured to support a user thereon. The support system includes a plurality of support pieces. Each support piece defines a respective support plane having a lateral angle of rotation (or lateral rotational angle) with respect to a base surface of the support piece or an underlying surface. In a particular aspect, one or more of the respective support planes may also have a longitudinal rotational angle with respect to a base surface of the support piece or an underlying surface. A first support piece of the plurality of support pieces defines a first support plane having a lateral rotational angle different from the lateral rotational angles of the other support planes.

Referring now to the illustrative examples in the drawings, wherein like numerals represent the same or similar elements throughout:.

While the present disclosure can take many different forms, for the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. No limitation of the scope of the disclosure is thereby intended. Various alterations, further modifications of the described embodiments, and any further applications of the principles of the disclosure, as described herein, are contemplated.

An adverse event mitigation system <NUM> according to one contemplated embodiment is shown in <FIG>. The adverse event mitigation system <NUM> is configured to help reduce the likelihood of an adverse event occurring and/or stop an adverse event in progress. In some contemplated embodiments, the adverse event mitigation system <NUM> may help reduce the likelihood of obstructive sleep apnea occurring and/or may help stop an obstructive apnea event in progress. In other contemplated embodiments, the adverse event mitigation system <NUM> may help reduce the likelihood of other adverse events occurring and/or stop other adverse events in progress.

The adverse event mitigation system <NUM> includes a person support apparatus <NUM>, a person support surface <NUM> supported on the person support apparatus <NUM>, and a control system <NUM> as shown in <FIG>. In some contemplated embodiments, the person support apparatus <NUM> is a hospital bed frame and the person support surface <NUM> is supported thereon as shown in <FIG>. In other contemplated embodiments, the person support apparatus <NUM> can be a stretcher, an operating room table, or other person supporting structure. The person support apparatus <NUM> includes a lower frame <NUM>, supports <NUM> or lift mechanisms <NUM> coupled to the lower frame <NUM>, and an upper frame <NUM> movably supported above the lower frame <NUM> by the supports <NUM> as shown in <FIG>. The lift mechanisms <NUM> are configured to raise and lower the upper frame <NUM> with respect to the lower frame <NUM> and move the upper frame <NUM> between various orientations, such as, Trendellenburg and reverse Trendellenburg.

The upper frame <NUM> includes an upper frame base <NUM>, a deck <NUM> coupled to the upper frame base <NUM>, and a plurality of actuators <NUM> coupled to the upper frame base <NUM> and the deck <NUM> as shown in <FIG>. The plurality of actuators <NUM> are configured to move at least a portion of the deck <NUM> along at least one of a longitudinal axis, which extends along the length of the upper frame <NUM>, and a lateral axis, which extends across the width of the upper frame <NUM>, between various articulated configurations with respect to the upper frame base <NUM>. The deck <NUM> includes a calf section <NUM>, a thigh section <NUM>, a seat section <NUM>, and a head and torso section <NUM> as shown in <FIG>. The calf section <NUM> and the thigh section <NUM> define a lower limb support section LL1. The head and torso section <NUM> define an upper body support section U1. The seat section <NUM> defines the seat section S1. The calf section <NUM>, the thigh section <NUM>, and the seat section <NUM> define a lower body support section LB1. At least the calf section <NUM>, the thigh section <NUM>, and the head and torso section <NUM> are movable with respect to one another and/or the upper frame base <NUM>. In some contemplated embodiments, the calf section <NUM>, the thigh section <NUM>, the seat section <NUM>, and the head and torso section <NUM> cooperate to move the person support apparatus <NUM> between an substantially planar or lying down configuration and a chair configuration. In some contemplated embodiments, the calf section <NUM>, the thigh section <NUM>, the seat section <NUM>, and the head and torso section <NUM> cooperate to move the person support apparatus <NUM> between a substantially planar or lying down configuration and an angled or reclined configuration. In some contemplated embodiments, the head and torso section <NUM> is moved such that it is at an angle of at least about <NUM>° with respect to a reference plane RP1 passing through the upper frame <NUM>.

The person support surface <NUM> is configured to support a person thereon and move with the deck <NUM> between the various configurations. In some contemplated embodiments, the person support surface <NUM> is a hospital bed mattress as shown in <FIG>. In some contemplated embodiments, the person support surface <NUM> is a consumer mattress. In some contemplated embodiments, the person support surface <NUM> includes a heat and moisture regulating topper positioned on the person support surface <NUM>. In some contemplated embodiments, the person support surface <NUM> can include a pressure mapping topper positioned on the person support surface <NUM>. The person support surface <NUM> includes a calf portion <NUM>, a thigh portion <NUM>, a seat portion <NUM>, and a head and torso portion <NUM> as shown in <FIG>, which is supported on corresponding sections of the deck <NUM>. In one illustrative embodiment, the deck sections help move and/or maintain the various portions of the person support surface <NUM> at angles α, β and γ with respect to the reference plane RP1. In some contemplated embodiments, the person support surface <NUM> is a non-powered (static) surface. In some contemplated embodiments, the person support surface <NUM> is a powered (dynamic) surface configured to receive fluid from a fluid supply FS1 as shown in <FIG>.

The person support surface <NUM> includes a mattress cover <NUM> and a mattress core <NUM> as shown in <FIG>. In some contemplated embodiments, the person support surface <NUM> includes a temperature and moisture regulating topper (not shown) coupled to the mattress cover <NUM>. The mattress cover <NUM> encloses the mattress core <NUM> and includes a fire barrier <NUM>, a bottom ticking <NUM> or durable layer <NUM>, and a top ticking <NUM>. In some contemplated embodiments, the fire barrier <NUM> is the innermost layer of the cover <NUM>, the top ticking <NUM> is the outermost layer, and the bottom ticking <NUM> is positioned between the fire barrier <NUM> and the top ticking <NUM> and is not coupled to the top ticking <NUM>. The bottom ticking <NUM> and the top ticking <NUM> are vapor and air impermeable. In some contemplated embodiments, the top ticking <NUM> and the bottom ticking <NUM> are composed of polyurethane coated nylon and the bottom ticking <NUM> is configured to facilitate movement of the top ticking <NUM> with respect to the fire barrier <NUM>. In other contemplated embodiments, the top ticking <NUM> and/or the bottom ticking <NUM> can be air and/or moisture permeable.

The mattress core <NUM> can be composed of a single type of material or a combination of materials and/or devices. In the case of a powered surface, the mattress core <NUM> includes at least one fluid bladder <NUM> therein that receives fluid from a fluid supply (not shown) to maintain the fluid pressure within the fluid bladder <NUM> at a predetermined level. In some contemplated embodiments, the powered surface can include non-powered components, such as, a foam frame that at least one fluid bladder <NUM> is positioned between. In some contemplated embodiments, a fluid bladder <NUM> can be positioned proximate to the thigh section and inflated or the calf portion <NUM>, thigh portion <NUM>, and/or seat portion <NUM> (including their corresponding deck sections) can be articulated to help prevent the occupant from sliding down the person support surface <NUM> as, for example, the inclination of the head and torso section <NUM> increases with respect to the reference plane RP1. In some contemplated embodiments, wedge shaped bladders are mirrored laterally about the centerline of the person support surface <NUM> and are configured to be inflated consecutively to laterally tilt the occupant, thereby relieving pressure on various portions of the occupant's body to help reduce the occurrences of pressure ulcers.

In some contemplated embodiments, the mattress core <NUM> includes inflatable fluid bladders 54a and 54b, which are configured to protrude from the patient facing surface of the person support surface <NUM> by at least about <NUM> (adjusted for pillow height) and about <NUM> to about <NUM> to support the cervical vertebrae and scapula, respectively. In some contemplated embodiments, the inflatable fluid bladders 54a and 54b are replaced foam bolsters or static air bladders or a combination thereof. In some contemplated embodiments, the distance the fluid bladders 54a and 54b protrude from the patient facing surface of the person support surface <NUM> can vary depending on any number of factors, including, but not limited to, a person's body type and the angle at which the surface is at with respect to the reference plane RP1. In some contemplated embodiments, the fluid bladders 54a and 54b can also be configured to laterally tilt the head and/or torso of the occupant. In some contemplated embodiments, wedge shaped fluid bladders (not shown) are positioned in the head and torso portion <NUM> and are configured to increase the angle of the occupant contacting surface of the head and torso portion <NUM> with respect to the seat portion <NUM> when inflated.

In some contemplated embodiments, the head and torso of the occupant can be tilted at different angles. For example, the person support apparatus <NUM> and/or the person support surface <NUM> can laterally rotate the occupant so that the torso is at an angle of about <NUM>° with respect to the reference plane RP1 and the head is at an angle of about <NUM>° with respect to the reference plane RP1. Rotation of the occupant's torso can help an occupant maintain their head at an angle of about <NUM>° with respect to the reference plane RP1. In some contemplated embodiments, the person support surface <NUM> is configured to allow the occupant's body to be immersed into the surface to improve comfort with lateral positioning. In some contemplated embodiments, support blocks (not shown) can be placed on the surface <NUM> adjacent to the occupant to help maintain the position of the occupant. In some contemplated embodiments, the person support apparatus <NUM> and/or person support surface <NUM> can laterally rotate the occupant so that the torso is at an angle of about <NUM>° with respect to the reference plane RP1 and fluid bladders 54a and 54b can rotate the occupant's head so that it is at an angle of at least about <NUM>°. In some contemplated embodiments, the occupant can be wearing a garment G1 with fluid bladders G2 configured to be inflated to help laterally rotate the occupant so that the torso is at an angle of at least <NUM>% with respect to the reference plane RP1 as shown in <FIG>. In some contemplated embodiments, the garment G1 is configured to provide therapy, including, for example, percussion, vibration, and compression therapies. In some contemplated embodiments, the garment G1 is an airway clearance vest, such as the Vest® Airway Clearance System sold by Hill-Rom. In other contemplated embodiments, the garment G1 can be other therapy garments, including sequential compression devices (SCD). In some contemplated embodiments, fluid can be supplied to the garment G1 via the fluid supply FS1 configured to supply fluid to the fluid bladders 54a and 54b. In some contemplated embodiments, fluid is supplied to the garment G1 and/or fluid bladders G2 by a dedicated fluid supply (not shown). The angle of the occupant's head with respect to the reference plane RP1 may vary depending on the occupant's preferences, their risk of the adverse condition, or other factors.

In the case of a non-powered surface, the mattress core <NUM> is composed of a cellular engineered material, such as, single density foam. In some contemplated embodiments, the mattress core <NUM> includes at least one bladder <NUM>, such as, a static air bladder or a static air bladder with foam contained there within, a metal spring and/or other non-powered support elements or combinations thereof. In some contemplated embodiments, the mattress core <NUM> includes multiple zones with different support characteristics configured to enhance pressure redistribution as a function of the proportional differences of a person's body. Also, in some embodiments, the mattress core <NUM> includes various layers and/or sections of foam having different impression load deflection (ILD) characteristics, such as, in the NP100 Prevention Surface, AccuMax Quantum™ VPC Therapy Surface, and NP200 Wound Surfaces sold by Hill-Rom®.

The control system <NUM> is configured to change at least one characteristic of the person support apparatus <NUM> and/or person support surface <NUM> to help reduce the likelihood of an adverse event occurring and/or stop an adverse event in progress. The control system <NUM> includes a processor <NUM>, an input <NUM>, and memory <NUM>. In some contemplated embodiments, the input <NUM> includes a sensor <NUM>, such as, a position sensor, a pressure sensor, a temperature sensor, an acoustic sensor, and/or a moisture sensor, configured to provide an input signal to the processor <NUM> indicative of a physiological characteristic of the occupant, such as, the occupant's heart rate, respiration rate, respiration amplitude, skin temperature, weight, and position. In some contemplated embodiments, the sensors <NUM> are incorporated into the person support surface <NUM> or topper positioned on the person support surface, for example, as disclosed in <CIT> and <CIT> In some contemplated embodiments, the sensors <NUM> include, for example, RFID tags, accelerometers, proximity sensors, level sensors, or other physical tracking sensors that may be integrated into or coupled to, for example, ear plugs, ear phones, adhesive sensors, earlobe clips, eye covers, hats, nose strips or other devices that are attached to the patient's head or worn by the patient so that the position/orientation of the patient's head can be tracked. Information captured by monitoring the lateral position of the user's upper respiratory tract has several benefits, including one or more of the following: providing more accurate measurements of the upper respiratory angle for diagnosis of positional obstructive sleep apnea (in one example, sleep labs can use the information to more accurately diagnose POSA); providing biofeedback to help the user to train to maintain a posture that prevents POSA; tracking performance of the system to determine if the system is achieving a sufficient upper respiratory angle to prevent apnea; monitoring compliance to determine if the system is being used; monitoring the upper respiratory angle and recording the angle when a sleep apnea event occurs; and controlling a surface capable of providing lateral rotation as a function of the inputs from the sensors <NUM>, tracking whether optimal lateral position has been achieved, and controlling the system to achieve a desired head lateral position and/or upper respiratory angle. In some contemplated embodiments, the sensors <NUM> are tracked by reading devices (i.e., an RFID reader) in a siderail, person support surface, deck, headboard, or location on or in the person support apparatus <NUM> or person support surface <NUM>, or on or in a headwall in the room or other location in the room. In some contemplated embodiments, the sensor <NUM> includes a camera positioned at the foot of the bed or above the bed, as disclosed in <CIT>, for example, to track the orientation of the person's head.

In some contemplated embodiments, the input <NUM> includes a user interface <NUM> configured to receive information from a caregiver or other user. In other contemplated embodiments, the input <NUM> is an Electronic Medical Record (EMR) system <NUM> in communication with the processor <NUM> via a hospital network <NUM>. In some contemplated embodiments, the processor <NUM> can output information, automatically or manually upon caregiver input, to the EMR for charting, which can include therapy initiation and termination, adverse event occurrence information, therapy protocol used, caregiver ID, and any other information associated with the occupant, caregiver, person support apparatus <NUM>, person support surface <NUM>, and adverse event.

The memory <NUM> stores one or more instruction sets configured to be executed by the processor <NUM>. The instruction sets define procedures <NUM> that, when executed by the processor, cause the processor <NUM> to implement one or more protocols that modify the configuration of the person support apparatus <NUM> and/or the person support surface <NUM>. In one illustrative embodiment, the instruction set defines a proactive procedure <NUM> that causes the processor <NUM> to configure the person support apparatus <NUM> and/or the person support surface <NUM> in response to an input specifying that the occupant is at risk for sleep apnea. Procedure <NUM> begins with step <NUM> in which the processor <NUM> receives an input signal from the input <NUM> indicative of the level of risk for an apnea event occurring. In some contemplated embodiments, the level of risk is input from a field in the occupant's EMR. In some contemplated embodiments, the level of risk is input by a caregiver through the user interface <NUM>, which may arise from a doctor's order or be based on a patient scoring system. In some contemplated embodiments, the level of risk is determined based on a risk score that is calculated by the processor <NUM> based on a number of factors, including, but not limited to, those listed in the table below:.

In circumstances where an occupant is known to snore frequently, has a high BMI, has had major surgery, and/or requires postoperative opioids, the occupant may have an elevated risk. In circumstances where an occupant has a low BMI, is not known to snore, had superficial surgery, and/or does not require postoperative opioids, the occupant may have a reduced risk. An example of a scoring system is shown in the table below, where a score of <NUM> can indicate an increased risk, and a score of greater than <NUM> can indicate a significantly increased risk.

In step <NUM>, the processor <NUM> determines which protocol should be implemented based on the level of risk. One type of the protocol is a default protocol set according to the hospital's standard operating procedures/guidelines for patients with specific risk profiles. Another type of protocol is a variable protocol that modifies the default protocol based on the occupant's preferences (i.e., prefers to sleep on their left side), the caregiver's observations, and/or information about the occupant's medical condition (i.e., pressure ulcer susceptibility, BMI, type of surgery, etc.) from the occupant's EMR, sensors <NUM>, and/or other input <NUM>. In some contemplated embodiments, the protocol can be modified to exclude or limit a therapy or movement. For example, the protocol can be prevented from increasing the head of bed angle (the angle between the reference plane RP1 and the head and torso section <NUM> or head and torso portion <NUM>) above a predetermined threshold where the occupant is recovering from abdominal surgery. In some contemplated embodiments, the protocol can caution the caregiver against implementing the configurations based on information obtained from the occupant's EMR or other sources.

In step <NUM>, once the protocol is selected, the configuration settings are communicated to the caregiver, for example, on a graphical user interface or other display device, and the caregiver is prompted to accept/modify the settings. In some contemplated embodiments, the configuration settings can be communicated to a hand held device. In one example, the protocol may require the head of bed angle to be greater than about <NUM>° and the lateral tilt angle to be greater than <NUM>° with respect to the reference plane RP1 for an occupant with an elevated risk score. In another example, the protocol may require the head of bed angle to be about <NUM>° to about <NUM>° and the lateral tilt angle to be about <NUM>° to about <NUM>° with respect to the reference plane RP1 for an occupant with a reduced risk score. In some contemplated embodiments, the upper frame <NUM> can also be moved to a Trendellenburg or reverse Trendellenburg orientation. In some contemplated embodiments, the protocol can require additional therapies to be active, such as, continuous lateral rotation where, for example, the lateral tilt angle changes every <NUM>-<NUM> minutes depending on the occupant's risk of developing pressure ulcers. In some contemplated embodiments, the sleep stage of the occupant can be taken into account so that the occupant is moved only when they are in a sleep state that would allow them to be moved without waking up. In some contemplated embodiments, the person support apparatus <NUM> and/or the person support surface <NUM> are returned to the configuration they were in prior to the implementation of the protocol before the occupant wakes up. In some contemplated embodiments, a manual stop button can be included so that the caregiver, occupant, or other person can terminate the protocol in the event of an emergency. In some contemplated embodiments, the protocol can automatically be terminated when an emergency condition occurs, such as, when the CPR handle (not shown) is pulled by a caregiver or the occupant is coding. In some contemplated embodiments, the procedure <NUM> can be terminated remotely by a caregiver, such as, via the hospital network or over a nurse call system.

In some contemplated embodiments, the position and/or the orientation of the occupant with respect to patient facing surface of the person support surface <NUM> is detected and can influence how the person support surface <NUM> and/or the person support apparatus <NUM> are configured to move the occupant to the desired position. For example, if the occupant is positioned along the left edge of the patient facing surface of the person support surface <NUM>, the protocol will not rotate them to the left. In some contemplated embodiments, the protocol is terminated because the occupant is in the correct position. In some contemplated embodiments, the protocol helps to maintain the occupant in the position. The position of the occupant on the person support surface <NUM> can be determined a number of ways, including sensing the force distribution on the upper frame <NUM> utilizing one or more load cells (not shown) coupled to the upper frame <NUM>, calculating the occupant's center of gravity using the one or more load cells, sensing pressures within the fluid bladders <NUM>, using a camera (not shown) or 3D sensor (not shown), or using other methods.

In step <NUM>, if the caregiver accepts the configuration or changes the configuration and accepts the new configuration, the processor <NUM> implements the configuration for a predetermined time. In some contemplated embodiments, the processor <NUM> can implement the configuration the moment the caregiver approves it and stop or change the configuration when the caregiver deactivates it. In some contemplated embodiments, the processor <NUM> will wait to implement the configuration until the occupant is in a predetermined sleep stage and will return to the initial configuration when the occupant begins to wake up. In some contemplated embodiments, procedure <NUM> does not require the caregiver to confirm or accept the settings, and instead automatically initiates the configuration. For example, the configuration can be automatically initiated a predetermined time after the occupant departed from the surgical room, which can be determined based on the occupant's EMR. In some contemplated embodiments, the configuration will not be implemented if the bed is unoccupied.

Procedure <NUM> can be used for a number of other adverse conditions. In some contemplated embodiments, procedure <NUM> can be used to determine if a person is at risk for or has gastroesophageal reflux disease and select a protocol that assists the occupant in maintaining a left lateral decubitus position or semi-reclining position while sleeping. In some contemplated embodiments, procedure <NUM> can be used to determine if a person is at risk for or has chronic respiratory insufficiency and select a protocol for the caregiver to approve that assists the occupant in maintaining a left lateral decubitus position while sleeping. In some contemplated embodiments, the procedure can be used to determine if a person is at risk for of has allergies to, for example, feather or down filled pillows, cushions or covers, and can alert the caregiver so that they can remove the item. In other contemplated embodiments, procedure <NUM> can be used to determine if the person is at risk for or has one or more other conditions, such as, for example, asthma, pregnancy, sleep paralysis or hallucinations, snoring, stroke bruxism, coughing, hypoxaemia in geriatric inpatients, stroke, or tuberculosis, that might be affected negatively by sleeping in the supine position and select a protocol and/or alert the caregiver so that the person support apparatus <NUM> and/or the person support surface <NUM> can be configured to maintain the occupant in a desirable position. In some contemplated embodiments, the procedure <NUM> can be used to change the sleeping position of occupants to help stimulate blood oxygenation, which can undesirably decrease as the occupant remains stationary.

In another illustrative embodiment, the instruction set causes the processor <NUM> to carry out a responsive procedure <NUM> that configures the person support apparatus <NUM> and/or the person support surface <NUM> in response to detection of an adverse event, such as, an apnea event. Procedure <NUM> begins with step <NUM> where the adverse event mitigation system is armed manually by the caregiver or automatically based on information from the occupant's EMR, the caregiver, or calculated by the processor <NUM>.

In step <NUM>, the processor <NUM> receives signals from the sensors <NUM> indicative of the physiological characteristics of the occupant, including, but not limited to, the occupant's heart rate and the respiration characteristics, such as, amplitude and rate, and/or the amount of movement of the occupant.

In step <NUM>, the processor <NUM> compares the signals from the sensors <NUM> to predetermined thresholds to determine if an apnea event is in progress. For example, if there is an interval of at least about <NUM> seconds between breaths then the person is likely having an apnea event. In another example, if the person is taking less than about <NUM>% of a normal breath for at least about <NUM> seconds, then the person is likely having an apnea event. In another example, if there is a drop in oxygen saturation of at least about <NUM>%, then the person is likely having an apnea event. If the person is taking between about <NUM>% and about <NUM>% of a normal breath, the person is likely having a hypopnea event. In some contemplated embodiments, the processor <NUM> determines that an adverse event is in progress and alerts the caregiver that an adverse event is occurring and that it is likely not an apnea event based on the position of the occupant and/or the configuration of the person support apparatus <NUM> and/or the person support surface <NUM>, the occupant's risk score, and/or the occupant's physiological characteristics, medical information from the occupant's EMR, and/or other information. In some contemplated embodiments, the caregiver can be alerted by a visual or audible alarm on the person support apparatus <NUM>, a visual or audible alarm located in the room where the person support apparatus <NUM> is located, and/or a visual or audible alarm located proximate to the room, such as, in the hall way.

In some contemplated embodiments, the caregiver can be notified remotely by a communication system (not shown). In some contemplated embodiments, the communication system is a patient/nurse call system that can include patient stations capable of generating hospital calls and a remote master station which can prioritize and store the calls. One example of such a system is disclosed in <CIT>. Another example of such a system is disclosed in <CIT>.

In another contemplated embodiment, the communication system is a system for transmitting voice and data in packets over a network with any suitable number of intra-room networks that can couple a number of data devices to an audio station, where the audio station couples the respective intra-room network to a packet based network. One example of such a system is disclosed in <CIT>. Another example of such a system is disclosed in <CIT>.

In yet another contemplated embodiment, the communication system is includes a patient/nurse call system, a nurse call/locating badge, an electronic medical record (EMR) database, and one or more computers programmed with work-flow process software. One example of such a system is disclosed in <CIT>. Another example of such a system is disclosed in <CIT>. Yet another example of such a system is disclosed in <CIT>. It should be appreciated that the work-flow process software can be the NaviCare® software available from Hill-Rom Company, Inc. It should also be appreciated that the work-flow process software can be the system disclosed in <CIT>. It should further be appreciated that the badge can be of the type available as part of the ComLinx™ system from Hill-Rom Company, Inc. It should also be appreciated that the badge can also be of the type available from Vocera Communications, Inc.

In still another contemplated embodiment, the communication system is configured to organize, store, maintain and facilitate retrieval of bed status information, along with the various non-bed calls placed in a hospital wing or ward, and remotely identify and monitor the status and location of the person support apparatus, patients, and caregivers. One example of such a system is disclosed in <CIT>. It should be appreciated that the remote status and location monitoring can be the system disclosed in <CIT>. It should also be appreciated that the remote status and location monitoring can be the system disclosed in <CIT>.

In step <NUM>, if the processor determines an apnea event is in progress, the processor <NUM> configures the person support surface <NUM> and/or the person support apparatus <NUM> to intervene and help stop the apnea event. In one illustrative embodiment, the processor <NUM> inflates a bladder <NUM> in the person support surface <NUM> to rotate the occupant onto their side such that they are at an angle of about <NUM>° with respect to the reference plane RP1. In some contemplated embodiments, the upper frame <NUM> can be rotated along the longitudinal axis to laterally tilt the occupant. In another illustrative embodiment, the processor <NUM> increases the head of bed angle to about <NUM>° by moving the head and torso section <NUM> of the person support apparatus <NUM> and/or inflating a bladder <NUM> in the person support surface <NUM>. In some contemplated embodiments, the processor <NUM> increases the head of bed angle and laterally rotates at least a portion of the occupant's body. In some contemplated embodiments, the processor <NUM> implements additional therapies, such as, for example, continuous lateral rotation therapy (CLRT), percussion vibration therapy, heat and moisture management therapy, rotation therapy, or other therapies depending on the occupant's risk for developing additional adverse conditions, such as, pressure ulcers.

In some contemplated embodiments, procedure <NUM> includes step <NUM> and step <NUM> in which the processor <NUM>, after implementing the intervention, receives signals from the sensors <NUM> indicative of the occupant's physiological characteristics and/or the amount of movement of the occupant, and compares them with the predetermined thresholds to determine if the intervention was successful and the apnea event has ceased. In one illustrative embodiment, the processor <NUM> waits a predetermined amount of time, such as, <NUM> seconds, after the intervention has been implemented before it receives signals from the sensors <NUM>. In some contemplated embodiments, the processor <NUM> can receive signals from the sensors <NUM> as the intervention is implemented and stop intervening or maintain the current level of intervention when the apnea event has ceased. For example, the processor <NUM> receives signals from the sensors <NUM> as the head of bed angle and/or the lateral tilt angle are gradually increased and stops increasing the head of bed angle and/or the lateral tilt angle once the apnea event has ceased. In some embodiments, the head of bed angle and/or the lateral tilt angle are gradually increased and an alarm is activated when the angle reaches a predetermined threshold. If the processor <NUM> determines that the intervention was successful, the processor <NUM> can cause the person support apparatus <NUM> and/or the person support surface <NUM> to maintain the current configuration or cause it to return to its initial position.

If the processor <NUM> determines that the apnea event is still in progress, the processor <NUM> can increase the level of intervention. In one illustrative embodiment, the head of bed angle and/or the lateral tilt angle can be increased an additional <NUM>°. In other embodiments, the stimuli can include vibration, sound, temperature, smells, lights (flashing and/or constant), or other stimulus or combinations thereof that may or may not wake the person. In some instances, the goal of the intervention is to stop the apnea event without waking the occupant up, which can include moving the person while the person is in a particular sleep stage and/or causing the person to move from a deeper sleep stage to a lighter sleep stage. In some contemplated embodiments, movement of the occupant can cease if the processor <NUM> detects the person is waking up (based on increased heart rate, respiration rate, and/or movement) or is moving to a lighter sleep stage. If the increased levels of intervention continue to be unsuccessful then the processor <NUM> can initiate an alarm on or near the person support apparatus <NUM> to wake the occupant and/or notify a caregiver via nurse call or other means of communication that they need to intervene. In some contemplated embodiments, if the processor <NUM> receives information that the occupant is sedated, the processor <NUM> can move the occupant to a position, such as, for example, a sitting position or chair position.

In another illustrative embodiment, the instruction set causes the processor <NUM> to carry out a proactive procedure <NUM> that configures the person support apparatus <NUM> and/or the person support surface <NUM> when the processor <NUM> predicts the onset of an adverse event. Procedure <NUM> begins with step <NUM> where the system for mitigating adverse conditions is armed by the caregiver or the bed or EMR based on the occupant's risk profile.

In step <NUM>, the processor <NUM> receives signals from the sensors <NUM> indicative of the physiological characteristics of the occupant and/or the amount of movement of the occupant.

In step <NUM>, the processor <NUM> stores the signal values in the memory <NUM> and determines an amount and/or a magnitude of change in the values for a predetermined time period. The processor <NUM> then compares the amount and/or the magnitude of change to a predetermined threshold to determine if an adverse event is likely to occur. In some contemplated embodiments, the processor <NUM> considers other factors, such as, the occupant's risk score, body position or orientation, person support apparatus <NUM> and/or person support surface <NUM> configurations, medical conditions, and/or other information from the caregiver, occupant's EMR, sensors <NUM>, and/or person support apparatus <NUM> and/or person support surface <NUM> when determining the likelihood of an adverse event occurring. For example, if an occupant is at a high risk for apnea, is in the supine position, and the occupant's respiration rate is decreasing, then an apnea event may occur. In another example, if an occupant's respiration amplitude decreases and the occupant's oxygen saturation decreases then an apnea event may occur. In another example, if an occupant's snoring is very loud and the occupant is at a high risk for apnea, an apnea event may occur. In another example, if an occupant is at high risk and the occupant is receiving <NUM>% normal breath, an apnea event may be unlikely.

In some contemplated embodiments, prediction of an apnea event can be accomplished using a time-domain model of nonlinear time-lagged interactions between heart rate, respiration, and oxygen saturation to help determine when an apnea event is likely. In some contemplated embodiments, prediction of an apnea event can be accomplished using a Bayesian "belief network" model. In some contemplated embodiments, prediction of an apnea event can be accomplished using large memory storage and retrieval (LAMSTAR) artificial neural networks to analyze signals indicative of heart rate variability, nasal pressure, oronasal temperature, submental EMG, and electrooculography. In some contemplated embodiments, prediction of an apnea event can be accomplished by analyzing tracheal breath sounds.

In step <NUM>, the processor configures the person support surface <NUM> and/or the person support apparatus <NUM> as previously described above with respect to procedure <NUM> and procedure <NUM> to intervene and help prevent the apnea event.

In another contemplated embodiment, referring to <FIG>, a support system includes one or more support pieces or units that form a lateral support plane to prevent or restrict the user from sleeping in a supine position, and, more specifically, reduce a time duration that the user sleeps with his/her upper respiratory tract oriented vertically or at an undesirable lateral rotational angle with respect to a vertical plane substantially perpendicular to a horizontal plane. In certain embodiments, the lateral rotational angle of the user's head with respect to the vertical plane is at least <NUM> degrees and, more specifically, at least <NUM> degrees. In an alternative embodiment, the lateral rotational angle of the user's head with respect to the vertical plane may be less than <NUM> degrees. In one embodiment, the support pieces provide multiple support planes for supporting the user's body.

In one embodiment as shown in <FIG>, a support system <NUM> suitable for supporting a user, such as a person, for example, includes plurality of support pieces, namely a first or leg support piece <NUM> forming a first support plane <NUM>, a second or torso support piece <NUM> forming a second support plane <NUM>, and a third or head support piece <NUM> forming a third support plane <NUM> that collectively define a segmented, multi-plane, laterally angled sleep surface <NUM> having progressively greater angles of rotation along a longitudinal axis <NUM> of support system <NUM>, from a first or bottom edge <NUM> of sleep surface <NUM> to an opposing second or top edge <NUM> of sleep surface <NUM>, resulting in relatively greater rotation of the upper respiratory tract of the user (as necessary for efficacy in preventing obstructive apnea) and relatively lesser rotation in the lower body of the user (resulting in greater comfort and perceived stability by avoiding rotation of a majority of the user's body mass). In alternative embodiments, sleep surface <NUM> is formed using any suitable number of support pieces defining corresponding support planes, for example, one support piece forming a smooth contour over a length of sleep surface <NUM> from first edge <NUM> to opposing second edge <NUM> or a plurality of support pieces, such as two support pieces, three support pieces, or more than three support pieces forming a smooth contour over the length of sleep surface <NUM>.

Unlike conventional positional therapies for the prevention of obstructive sleep apnea, which attempt to manipulate the user's sleep position and/or orientation using rotation of one plane, in certain embodiments the system described herein uses multiple support planes formed by one or more support pieces to laterally rotate the user. For example, in one embodiment, two support pieces provide two separate support planes, with a first support plane defined by the first support piece configured to support the torso and the legs of the user, and a second support plane defined by the second support piece configured to support the neck and the head of the user.

In an alternative embodiment, three support pieces provide three separate support planes, with a first support plane defined by the first support piece configured to support the legs of the user, a second support plane defined by the second support piece configured to support the torso of the user, and a third support plane defined by the third support piece configured to support the head of the user.

In a further alternative embodiment, more than three support pieces, for example, numerous independent support pieces having a length in a longitudinal direction of sleep surface <NUM> of <NUM>-<NUM> metres (<NUM>-<NUM> inches) or, more specifically, <NUM>-<NUM> metres (<NUM>-<NUM> inches), or, even more specifically, <NUM> metres (<NUM> inches), provide a corresponding number of separate support planes. Each support piece can be laterally rotated independently of other support pieces to collectively form sleep surface <NUM>. In a particular embodiment, the numerous support pieces can be combined to form separate support pieces, for example, creating a first support piece having a length of <NUM> metres (<NUM> inches) in the longitudinal direction at the foot of the support system <NUM>, an adjacent second support piece having a length of <NUM> metres (<NUM> inches) in the longitudinal direction, and a third support piece adjacent the second support piece having a length in the longitudinal direction of <NUM> metres (<NUM> inches). In these embodiments, the support pieces forming the support planes can be rotated as necessary or desired to achieve an optimal configuration that is clinically effective (i.e., prevents apnea) and demonstrates acceptable tolerance (i.e., allows the user to sleep comfortably). In an alternative embodiment, a continuously sloped sleep surface is formed by a plurality of support pieces without step increases in lateral rotational angle; this is illustrated as a sleep surface with an infinite number of support pieces.

In the embodiments described herein, the length in the longitudinal direction of each support piece and defined support plane (and the resulting location of transitions between support planes) is designed to achieve clinical efficacy and tolerability. Therefore, a specific length can be defined in a number of configurations, including without limitations: (a) generic plane dimensions (e.g., based on average body geometry, a length of a torso section of the user defined so that when an average user's head is supported by a head support piece, a transition between the torso support piece and the leg support piece occurs below the user's S3 vertebrae); (b) customized plane dimensions (e.g., a torso support plane has a suitable length in the longitudinal direction appropriate to the user's leg length, torso length, and/or a distance from the user's shoulder to his/her inseam); or (c) dynamic plane dimensions (e.g., transitions selected on dynamic surface appropriate to user, selection being either user-selected, care-giver defined, or automatically calculated).

In certain embodiments, each support piece defining the corresponding support planes is independently rotatable about an axis extending parallel with a longitudinal axis of the support system. The independent rotation of each support piece allows the caregiver or the user the ability to focus on progressively increasing an angle of rotation in one or more support pieces having support planes positioned to support the torso of the user, and the neck and/or the head of the user. In certain embodiments, an angle of rotation (or lateral rotational angle) at which the one or more support planes defined by the support pieces configured to support the neck and/or the head of the user is positioned is greater than a rotational angle of the one or more support planes defined by the support pieces configured to support the torso of the user, which is greater than a rotational angle at which the one or more support planes defined by the support pieces configured to support the legs of the user is positioned.

In a particular embodiment, the support plane defined by the support piece configured to support the legs and the torso of the user is positioned at a rotational angle of <NUM>° with respect to a base surface of the support piece, while the support plane defined by the support piece configured to support the head of the user is positioned at a rotational angle of <NUM>° with respect to a base surface of the support piece. In an alternative embodiment, a first support plane defined by the support piece configured to support the legs of the user is positioned at a rotational angle of <NUM>° with respect to a base surface of the first support piece, a second support plane defined by a second support piece configured to support the torso of the user is positioned at a rotational angle of <NUM>° with respect to a base surface of the second support piece, and a third support plane defined by the third support piece configured to support the head of the user is positioned at a rotational angle of <NUM>° with respect to a base surface of the third support piece. In alternative embodiments, the support planes can be positioned at any suitable rotational angle including any suitable lateral rotational angle and/or any suitable longitudinal rotational angle.

Referring further to <FIG> and <FIG>, in a particular embodiment, first support piece <NUM> defines support plane <NUM> positioned at a lateral rotational angle α of <NUM>° to <NUM>°, or more specifically, <NUM>° to <NUM>°, or, even more specifically, <NUM>° with respect to a base surface <NUM> of first support piece <NUM>. Second support piece <NUM> defines support plane <NUM> positioned at a lateral rotational angle β of <NUM>° to <NUM>°, or more specifically, <NUM>° to <NUM>°, or, even more specifically, <NUM>°, with respect to a base surface <NUM> of second support piece <NUM>. Third support piece <NUM> defines support plane <NUM> positioned at a lateral rotational angle γ of <NUM>° to <NUM>°, or more specifically, <NUM>°, with respect to a base surface <NUM> of third support piece <NUM>. Other lateral rotational angles and step increases in lateral rotational angles between each support piece may also be used to achieve a progressive lateral rotational angle.

In one embodiment as shown in <FIG>, one or more contoured transitional pieces, such as a first transitional piece <NUM> and a second transitional piece <NUM>, are positionable between adjacent support pieces or at or near a transition line between the adjacent support pieces to provide a gradual continuous transition between support planes. As shown in <FIG>, in one embodiment, a first transitional piece <NUM> is positioned at a transitional line where first support piece <NUM> meets with adjacent second support piece <NUM> to provide lumbar support for the user. Similarly, a second transitional piece <NUM> is positioned at a transitional line where second support piece <NUM> meets with adjacent third support piece <NUM> to provide lumbar support for the user. In particular embodiments, one or more additional transitional pieces can be positioned on the support planes to provide additional support at the neck region and/or the knee region of the user, for example. In other embodiments, increasing the number of contoured transitional pieces allows for more contouring and gradual changes in the angle of support along the length of the support system <NUM>.

As shown in <FIG>, each of first support piece <NUM>, second support piece <NUM>, and third support piece <NUM> has a respective height in a direction perpendicular to longitudinal axis <NUM> of support system <NUM>. In one embodiment, first support piece <NUM> has a maximum height from base surface <NUM> to support plane <NUM> in a direction perpendicular to longitudinal axis <NUM> of <NUM> to <NUM> metres (<NUM> inches), or more specifically, <NUM> to <NUM> metres (<NUM> to <NUM> inches); second support piece <NUM> has a maximum height from base surface <NUM> to support plane <NUM> in a direction perpendicular to longitudinal axis <NUM> of <NUM> to <NUM> metres (<NUM> to <NUM> inches), or more specifically, <NUM> to <NUM> metres (<NUM> to <NUM> inches); and third support piece <NUM> has a maximum height from base surface <NUM> to support plane <NUM> in a direction perpendicular to longitudinal axis <NUM> of <NUM> to <NUM> metres (<NUM> to <NUM> inches), or more specifically, <NUM> to <NUM> metres (<NUM> to <NUM> inches). As a result, the support pieces can be designed with desired heights and defining support planes positioned at desired rotational angles such that support system1100 provides a composite longitudinal plane angle (e.g., reverse Trendelenburg angle) to facilitate the prevention and/or treatment of sleep apnea as well as to improve tolerability.

As described in greater detail below, in certain embodiments, support system <NUM> includes a system control, such as a controller <NUM> shown in <FIG>, having a display configured to display information about support system <NUM> including, without limitation, lateral plane angles of each support piece and/or composite plane angles of each support piece. In one embodiment, controller <NUM> includes one or more processors configured to adjust the rotational angles of the support planes based on data input by the user or a caregiver and/or data signals received from one or more sensors positioned at locations on or near support system <NUM>.

Referring again to <FIG>, in one embodiment, support system <NUM> includes a bolster <NUM> or other suitable boarder positioned along at least one lateral side of support system <NUM> to limit or prevent lateral migration of the user. More specifically, bolster <NUM> extends along at least a portion of the lateral side generally parallel with longitudinal axis <NUM> to prevent or limit lateral movement of the user positioned on sleep surface <NUM> to prevent the user from moving or sliding off sleep surface <NUM>. Bolster <NUM> is bolstered at lower edge <NUM> of sleep surface <NUM> to define an envelopment zone. In one embodiment, bolster <NUM> extends from lower edge <NUM> partially along a length of support system <NUM> to a torso region of the user, but, in this embodiment, terminates below a head portion of the user. In a particular embodiment, at least a portion of bolster <NUM> includes a suitable material to provide a textured surface to facilitate retaining the user in the desired position on the support system <NUM>. Additionally or alternatively, bolster <NUM> may include a formable material, such as a suitable foam material, having one or more different densities along a length of bolster <NUM> to provide an increased envelopment throughout sleep surface <NUM>. A belt and/or an adjustable strap (not shown in <FIG>) or a body may be operatively coupled to bolster <NUM> to facilitate maintaining the user properly positioned on sleep surface <NUM>.

In one embodiment, each of support pieces <NUM>, <NUM>, <NUM> are rotatable about longitudinal axis <NUM> to provide sleep surface <NUM> having a right side slope or, alternatively, a left side slope to allow the user to sleep on his/her right side or left side, respectively. In one embodiment, one or more cylindrical or tubular sections are positioned within at least a portion of first support piece <NUM>, second support piece <NUM>, and third support piece <NUM> and coaxially aligned with longitudinal axis <NUM> to allow each support piece <NUM>, <NUM>, <NUM> to rotate about longitudinal axis <NUM> independently of the other support pieces <NUM>, <NUM>, <NUM>.

As shown in <FIG>, a first cylindrical section <NUM> is positioned within a bore <NUM> defined within a portion of first support piece <NUM> and second support piece <NUM> along longitudinal axis <NUM> to allow first support piece <NUM> and second support piece <NUM> to rotate about longitudinal axis <NUM> and with respect to each other. Similarly, a second cylindrical section <NUM> is positioned within a bore <NUM> defined within a portion of second support piece <NUM> and third support piece <NUM> along longitudinal axis <NUM> to allow second support piece <NUM> and third support piece <NUM> to rotate about longitudinal axis <NUM> and with respect to each other. In an alternative embodiment not shown, a single cylindrical section extends through a bore defined through second support piece <NUM> and into at least a portion of first support piece <NUM> and into at least a portion of third support piece <NUM> to allow each of first support piece <NUM>, second support piece <NUM>, and third support piece <NUM> to rotate about longitudinal axis <NUM> and with respect to each other. In this embodiment, each support piece <NUM>, <NUM>, <NUM> is rotatable between a first orientation having a right side slope, as shown in <FIG>, and a second orientation having a left side slope, as shown in <FIG>. Axial rotation allows each support piece <NUM>, <NUM>, <NUM> to lie flat with a right side slope or a left side slope as shown in <FIG>.

In certain embodiments, support pieces <NUM>, <NUM>, <NUM> are formed of more than one material, for example, two or more materials, such as two foam materials, having different densities, with the less dense material covering the denser material. In this embodiment, the less dense material is laid on the denser material at the respective base surface and the respective support plane of the support piece to allow sleep surface <NUM> to function properly, whether with a right side slope or a left side slope. With the denser material sandwiched between the less dense material, the user will be positioned on the less dense material in either the first or the second orientation.

In this embodiment, support system <NUM> allows the user to sleep on either his/her right side or left side, based on the user's sleeping preference. This sleeping preference may not be static. For example, if the user has an injury, an ache, or a desire to change his/her sleeping preference, the orientation of sleep surface <NUM> can be changed at any time to accommodate the user's sleeping preference. The orientation can be changed from day to day or during the night. Moreover, from a manufacturing standpoint, a versatile support system <NUM> prevents having to manufacture and distribute a sleep surface <NUM> having a right side slope and a separate sleep surface <NUM> having a left side slope, which would increase production and distribution costs. Finally, a potential purchaser would not have to commit to a sleep side before purchasing the product, which might be a deterrent to purchasing the product.

In one embodiment, support system <NUM> includes one or more spacers <NUM> that allow a length of support system <NUM> to be adjusted and customized to a height of the user supported by support system <NUM>. For example, the length of sleep surface <NUM> can be adjusted by adding one or more suitable spacers <NUM> or replacing one or more support pieces <NUM>, <NUM>, <NUM> with a suitable spacer <NUM> of a different length, so that transitional lines between lateral angles of support planes defined by adjacent support pieces <NUM>, <NUM>, <NUM> will desirably occur at a neck region and a hip region of the user. In one embodiment, spacer <NUM> has a same or similar lateral rotational angle and/or a same or similar longitudinal rotational angle as the respective lateral rotational angle and the respective longitudinal rotational angle of an adjacent support piece or the support piece that spacer <NUM> replaces. In an alternative embodiment, spacer <NUM> has a different lateral rotational angle and/or a different longitudinal rotational angle as the respective lateral rotational angle and the respective longitudinal rotational angle of an adjacent support piece or the support piece that spacer <NUM> replaces. As shown in <FIG>, spacer <NUM> is positioned between first support piece <NUM> and second support piece <NUM> to adjust the length of sleep surface <NUM>. As shown in <FIG>, first support piece <NUM> is replaced with spacer <NUM> to adjust the length of sleep surface <NUM>.

Assuming the user positions his/her neck at the appropriate location on sleep surface <NUM>, and an overall length of sleep surface <NUM> is adjustable, in one embodiment only second support piece <NUM> of support system <NUM> has an adjustable length. In alternative embodiments having a support system <NUM> with a fixed length, both first support piece <NUM> and second support piece <NUM> have adjustable lengths. In this embodiment, a length of first support piece <NUM> increases as a length of second support piece <NUM> decreases and, conversely, the length of first support piece <NUM> decreases as the length of second support piece <NUM> increases.

In one embodiment, adjacent support pieces <NUM>, <NUM>, <NUM> and spacers <NUM> can be coupled together using a suitable coupling mechanism including, without limitation, one or more of the following: snaps, straps, buttons, and hook-and-loop fasteners. In certain embodiments, the length of sleep surface <NUM> is adjustable by any combination of inserting one or more spacers <NUM>, replacing one or more support pieces <NUM>, <NUM>, <NUM> with a longer or shorter spacer <NUM>, cutting or trimming one or more support pieces <NUM>, <NUM>, <NUM> to a desired length, and removing one or more support pieces <NUM>, <NUM>, <NUM>. In alternative embodiments, the length of sleep surface <NUM> is not adjustable but one or more of a leg region, a torso region, and a head region of sleep surface <NUM> is adjustable by any combination of inserting one or more spacers <NUM>, replacing one or more support pieces <NUM>, <NUM>, <NUM> with a longer or shorter spacer <NUM>, cutting or trimming one or more support pieces <NUM>, <NUM>, <NUM> to a desired length, and removing one or more support pieces <NUM>, <NUM>, <NUM> without adjusting the length of sleep surface <NUM>.

In a further alternative embodiment, each support piece <NUM>, <NUM>, <NUM> includes one or more inflatable fluid bladders configured to contain a fluid, such as air. In this embodiment, a length of each support piece <NUM>, <NUM>, <NUM> is adjustable by adding fluid or removing fluid from one or more respective fluid bladders. By adding fluid to one or more of the respective fluid bladders, the length of the respective support piece <NUM>, <NUM>, <NUM> is increased and the length of the respective support plane <NUM>, <NUM>, <NUM> is also increased. Conversely, removing fluid from one or more of the respective fluid bladders, the length of the respective support piece <NUM>, <NUM>, <NUM> is decreased and the length of the respective support plane <NUM>, <NUM>, <NUM> is also decreased. The amount of fluid within the respective fluid bladders can be monitored and controlled electronically or by the user or caregiver using a suitable device including, without limitation, a suitable pneumatic pump or nozzle. In certain embodiments, a coupler, such as one or more snaps or straps, are utilized to maintain the desired amount of fluid within the respective fluid bladders and provide additional support to the respective support plane(s), for example, when the fluid bladders are not inflated.

As described herein, sleep surface <NUM> is customizable to anthropometric dimensions of the individual user to facilitate support system <NUM> performance that optimizes or matches the design intent - the body position of the user will prevent or limit undesirable sleep apnea episodes and provide improved comfort.

In certain embodiments, support system <NUM> includes a plurality of support pieces, such as two support pieces, three support pieces, or more than <NUM> support pieces, and more specifically, at least <NUM> support pieces, and even more specifically, <NUM>-<NUM> support pieces. For example, referring to <FIG>, in one embodiment each of a leg region <NUM> corresponding to first support piece <NUM>, a torso region <NUM> corresponding to second support piece <NUM>, and a head region <NUM> corresponding to third support piece <NUM> of support system <NUM> includes a plurality of independent support wedges forming a finer gradation in the longitudinal slope of sleep surface <NUM> to increase user compliance and the effectiveness of support system <NUM> in preventing or limiting sleep apnea episodes and providing more comfort for the user supported on sleep surface <NUM>. The support wedges may be formed of one or more suitable materials including, without limitation, a formable material, a semi-rigid material, a foam material or one or more fluid bladders.

In the embodiment shown in <FIG>, first support piece <NUM> includes two independent support wedges defining respective support planes positioned at different lateral rotational angles, second support piece <NUM> includes three independent support wedges defining respective support planes positioned at different lateral rotational angles, and third support piece <NUM> includes four independent support wedges defining respective support planes positioned at different lateral rotational angles. In alternative embodiments, each support piece <NUM>, <NUM>, <NUM> includes any suitable number of independent support wedges. Generally, an increasing number of independent support wedges within a selected support piece allows for more detailed and specific contouring of sleep surface <NUM> and more gradual changes in rotational angles of adjacent support wedges and support pieces along the length of sleep surface <NUM>.

For example, a support system including a series of support wedges may twist or urge the user's body to rotate and tilt the user's head in a more gradual trend than a support system including only three larger support pieces with respective support planes of different lateral rotational angles. The additional support wedges allow for more comfortable transitions between and within the lower body, the torso, and the upper body of the patient. The increased number of support wedges allow for more specific positioning of the patient's body, and a more effective therapy.

Referring to <FIG>, in one embodiment, each support piece <NUM>, <NUM>, <NUM> defines a support plane positioned at the same or similar lateral rotational angle; however, each support piece <NUM>, <NUM>, <NUM> is made of a material having a different density than the material used to make the other support pieces. The base material of each support piece <NUM>, <NUM>, <NUM> may be the same or different than the base material of the other support pieces, but with a different density. In a particular embodiment, support system <NUM> utilizes varied foam density to achieve a variation in the lateral rotation of the user's body across different body segments. In one particular embodiment, support piece <NUM> is composed of the least dense material, support piece <NUM> is composed of the medium density material, and support piece <NUM> is composed of the most dense material.

In this embodiment, sleep surface <NUM> is formed of support pieces cut to form support planes at the same lateral rotational angle but with different densities. To achieve a greater relative rotation at the head portion of the user, third support piece <NUM> is denser than second support piece <NUM>, while first support piece is less dense than second support piece <NUM> and third support piece <NUM> to achieve a lesser or limited relative rotation at the leg region of the user. In a particular embodiment, rather than having a plurality of discrete support pieces, sleep surface <NUM> is one continuous support piece exhibiting a gradual density transition along a longitudinal length of sleep surface <NUM> such that the leg portion of sleep surface <NUM> is less dense than the opposite head portion of the sleep surface <NUM>. This feature may result in a support system that appears less intimidating to the user and more aesthetically pleasing. Moreover, sleep surface <NUM> is rotatable about longitudinal axis <NUM>, shown in <FIG>, so that sleep surface <NUM> is oriented in one of a lateral right side slope or a lateral left side slope shown in <FIG>.

Referring to <FIG>, in an alternative embodiment, sleep surface <NUM> is formed of a closed air system <NUM> that induces the user's body to rotate laterally when sleeping to facilitate preventing or limiting the incidence of sleep apnea. In certain embodiments, closed air system <NUM> does not require electrical power or control, and allows the user to quietly move sleep orientations between the lateral left side slope and the lateral right side slope during sleep.

In one embodiment, closed air system <NUM> includes one or more pairs of fluid bladders communicatively coupled to each other. For example, as shown in <FIG> and <FIG>, a first pair of fluid bladders <NUM> is positioned within the leg region <NUM> of closed air system <NUM>, a second pair of fluid bladders <NUM> is positioned within a torso region <NUM> of closed air system <NUM>, and a third pair of fluid bladders <NUM> is positioned within a head region <NUM> of closed air system <NUM>. In a particular embodiment, a sleep sensor is positioned in a pillow or on the bladder <NUM>. In a particular embodiment, the fluid bladders are plumbed together using a suitably sized tube or hose, shown schematically by reference number <NUM> in <FIG> and <FIG>, or any suitable coupling mechanism providing communication between the interior cavities of the fluid bladders to allow fluid to move at a desired rate between the coupled bladders. Fluid, such as air, can be added manually or using a suitable pump to each pair of fluid bladders, for example, through one or more nozzles to adjust the firmness and lateral rotational angle of the respective pair of fluid bladders. In this embodiment, the user can adjust the side upon which he/she sleeps (even during sleep) and an amount of fluid contained within the fluid bladders to adjust the firmness of sleep surface <NUM> and/or the lateral rotational angle of each support plane forming sleep surface <NUM>. In this embodiment, each pair of fluid bladders is separated along longitudinal axis <NUM> of support system <NUM>. In a particular embodiment, fluid can be added to the bladders <NUM> based on the sleep state of the person.

In a particular embodiment, closed air system <NUM> includes one or more bolsters <NUM>, as shown in <FIG>, positioned along at least a portion of the opposing lateral sides of support system <NUM> to prevent or limit lateral migration of the user during sleep. In one embodiment, bolsters <NUM> are the same or similar to bolster <NUM> described above with reference to <FIG>. Referring further to <FIG>, each air bladder rests on and is supported by a suitable bottom layer, such as a foam material layer <NUM> and/or a mattress, and can also be covered by another suitable top layer, such as a foam material layer <NUM>. Materials other than foam materials known to those having ordinary skill in the art can be utilize to form the bottom layer and/or the top layer. In a certain embodiment, material layer <NUM> at least partially encloses or envelops one or more of the fluid bladders to retain the fluid bladders properly positioned within support system <NUM>. One or more of the fluid bladders in one or more of the pairs of fluid bladders are inflatable to rotate the user onto his/her right side or left side based at least in part on his/her sleep state.

In one embodiment, one or more pairs of fluid bladders <NUM>, <NUM>, <NUM> include two wedge-shaped fluid bladders that are removably coupled to material layer <NUM> and/or material layer <NUM> using a suitable coupler, such as a hook and loop fastener system. For example, third pair of fluid bladders <NUM> are positioned with respect to the user's upper body or head region and are removably coupled to material layer <NUM> using a hook and loop fastener system such that sleep surface <NUM> is adjustable based at least in part on the size and weight of the user. These fluid bladders are inflatable based on the user's sleep state to urge the upper body of the user to rotate. Additionally, first pair of fluid bladders <NUM> and/or second pair of fluid bladders <NUM> are also inflatable to urge the user's legs and/or the user's torso, respectively, to rotate.

Referring further to <FIG>, each fluid bladder of each pair of fluid bladders <NUM>, <NUM>, <NUM> is inflatable to form a support piece having a desired or selected shape. Select fluid bladders may remain substantially deflated, as shown in <FIG>, or both fluid bladders or only one fluid bladder of one or more pairs of fluid bladders may be inflated to form a desired sleep surface <NUM>, as shown in <FIG> respectively. In an alternative embodiment, as shown in <FIG> a single fluid bladder <NUM> may be utilized in one or more of leg region <NUM>, torso region <NUM>, and head region <NUM> of closed air system <NUM> positioned along longitudinal axis <NUM> of support system <NUM> that, when inflated, urges the user to roll towards either the lateral right side or the lateral left side after the user is in a predetermined sleep state. In this embodiment, fluid bladder <NUM> can be deflated occasionally to allow the user to reposition himself/herself. A pillow can be positioned on third pair of fluid bladders, for example, such that the pillow is inclined when one or more of the fluid bladders are inflated.

The fluid bladders are inflatable with air or another suitable fluid (which can be drained as desired from within the cavities of the fluid bladders into a reservoir). A fluid supply <NUM>, shown in <FIG>, is positioned at or near support system <NUM>, such as on the floor, beneath the bed, or coupled to the bed. The fluid supply is in independent fluid communication with each pair of fluid bladders <NUM>, <NUM>, <NUM> to supply a desired amount of fluid to each fluid bladder based on a signal from a control, for example.

In one embodiment as shown in <FIG>, support system <NUM> includes a suitable computer-implemented control system <NUM> operatively coupled to closed air system <NUM>, such as in operational control communication with closed air system <NUM>. The computer-implemented control system includes a computer <NUM> having one or more processors <NUM> and one or more sleep sensors <NUM>, such as one or more pressure sensors, coupled in signal communication with processors <NUM>. Sleep sensors <NUM> are configured to monitor the user's sleep patterns and transmit signals indicative of the sensed sleep patterns to processors <NUM> for manipulation and evaluation of the data. Based at least in part on the one or more signals received from one or more sleep sensors <NUM>, control system <NUM> is configured to inflate or deflate select fluid bladders to reposition the user during sleep to prevent or limit the occurrence of a sleep apnea episode, for example.

Additionally, in certain embodiments, closed air system <NUM> is configured to rest on a conventional mattress or may be configured or reinforced to rest directly on a support structure, such as a bed frame or a floor. With the fluid substantially removed from each of the fluid bladders, closed air system <NUM> can be folded or rolled into a compact configuration to facilitate storing and transporting closed air system <NUM>. In certain embodiments, closed air system is less expensive than a conventional mattress and more compact to facilitate portability of support system <NUM>. Additionally, closed air system <NUM> as configured prevents or limits disturbance to the user's partner sleeping next to the user.

In certain embodiments as described herein, support system <NUM> is a dynamic support system, rather than a static support system, that is configured to control the configuration of sleep surface <NUM> based at least in part on data entered into control system <NUM> using computer <NUM>, or another control operatively coupled to computer <NUM>, and/or sensed by one or more sleep sensors <NUM>, for example, to improve the performance of sleep surface <NUM> in terms of clinical efficacy and user tolerability.

As described herein and shown schematically, for example, in <FIG> and <FIG>, dynamic support system <NUM> includes, in addition to other components, a plurality of sleep sensors <NUM> configured to sense and monitor various activities including without limitation, the user's body position, a location of the user with respect to sleep surface <NUM>, an orientation, for example, a left side orientation or a rights side sleep orientation, of the user, the user's vital signs including his/her sleep state, and additional relevant user activity during sleep. Each sleep sensor <NUM> is in signal communication with one or more processors <NUM> contained within computer <NUM> and configured to gather relevant data and generate and transmit to processors <NUM> signals indicative of the data gathered. Sleep sensors <NUM> are also configured to receive operation control signals from processors <NUM>.

Within computer <NUM>, data received from sleep sensors <NUM> is analyzed and operational control signals are transmitted to sleep sensors <NUM> as well as to other components of support system <NUM>, such as to fluid supply <NUM> to activate fluid supply <NUM> to provide air to one or more fluid bladders and/or remove air from one or more fluid bladders to adjust sleep surface <NUM> based on signals generated by sleep sensors <NUM> and analyzed within computer <NUM>. In one embodiment, computer <NUM> includes suitable memory <NUM> to store data sensed and/or generated by control system <NUM>.

An exemplary method <NUM> utilizing control system <NUM> for monitoring the sleep activities of a user positioned on support system <NUM> is illustrated in <FIG>. As described above, control system <NUM> includes one or more processors <NUM> configured to perform the steps as described herein.

Control system <NUM> is activated <NUM> either manually or automatically to monitor the user's sleep activities and patterns as user begins to sleep. In one embodiment, control system <NUM> detects when the user begins to fall asleep <NUM> and activates support system <NUM> (or a dynamic sleep surface) on a delay <NUM> to rotate the user at a suitable time after sleep is detected, such as after the user has been asleep for <NUM> minutes. In an alternative embodiment, control system <NUM> is programmed to activate support system <NUM> at a preset time, for example, at a <NUM> minute delay, without relying on monitoring the user's sleep activity. In a particular embodiment, control system <NUM> delays inter-sleep rotation of the user until the user is in a deep sleep. Further, when control system <NUM> detects that the user is waking, control system <NUM> will activate support system <NUM> to move sleep surface <NUM> to an initial configuration such that the user can exit from support system <NUM>. In a further embodiment, control system <NUM> prevents activation of support system <NUM> if control system <NUM> detects the user is sleeping in a lateral decubitus position.

Prior to sleep, the user is able to input <NUM> to control system <NUM> sleep data <NUM> including without limitation, preferred sleeping sides and positions, the user's measurements including, for example, the user's height, weight, and inseam and torso measurements, preferred lateral rotational angles and/or longitudinal rotational angles of one or more support planes defining sleep surface <NUM>. Based at least in part on the user's input data, control system <NUM> is configured to activate support system <NUM> to adjust a direction and/or a level of rotation of one or more support planes defining sleep surface <NUM>. For example, if the user prefers a left side slope to sleep surface <NUM>, control system <NUM> activates fluid bladders within support system <NUM> to form the desired lateral left side slope, or if the user's partner is sleeping on the left side of the user, a left angle may be created. In one embodiment, minimal adjustments are made to sleep surface <NUM> to maintain the user's AHI under <NUM> and/or prevent snoring because apneas events and snoring may or may not be equivalent, depending on the user. Additionally, control system <NUM> is configured to collected and record data obtained as the user sleeps to diagnose any undesirable or abnormal sleep activities or conditions, including the user's apnea-hypopnea index (AHI), for example.

During sleep, control system <NUM> assesses the user's comfort level <NUM> and, in a particular embodiment, compares the current evaluation with previous evaluations. The user's body is then mapped <NUM> to map body region locations <NUM>, and user activities and movements <NUM> during sleep. The collected data is then analyzed <NUM> to determine: the location of joints including, for example, the user's neck, hips, and knees; preferred surface orientation (right side vs. left side orientation); and body orientation (e.g., mapping pressures at various locations on sleep surface <NUM> as a result of the user's body orientation, for example, a lateral sleep position indicated by a narrow pressure mapping profile). In one embodiment, location of one or more support planes are calculated and located based on transition points. Under the pressure mapping, specific pressure points are identified to increase or decrease pressure. For example, select fluid bladders are inflated or deflated based on body location and desired lateral rotational angles.

Control system <NUM> then assesses <NUM> the user's body orientation including, for example a determination of head angle <NUM> and chest angle <NUM>. During sleep, control systems also actively monitors <NUM> the user's vital signs, which includes measuring and monitoring the user's respiratory rate and amplitude, AHI, sleep state, snoring, and oxygen saturation (SpOs), for example. If an adverse event is detected, control system <NUM> activates <NUM> one or more components of support system <NUM> to respond appropriately. For example, fluid supply <NUM> may be activated to inflate or deflate one or more fluid bladders. Control system <NUM> may activate fluid supply <NUM> based on one or more of the following events: detection of snoring, detection of an AHI episode (apnea and/or hypopnea), and detection that the user is in a supine position (e.g., supine torso, upper respiratory tract (URT) within <NUM>° of vertical). Control system <NUM> may also activate support system <NUM> to vibrate to wake the user should control system <NUM> detect an adverse event, such as an apnea episode.

Referring to <FIG>, in one embodiment a sleep apnea therapy system is a design based on how an average user responds to the therapy tested on a sufficiently large population. The sleep apnea therapy system will effectively and tolerably treat any user's sleep apnea. As a result, the therapy can be modified to decrease a level of therapy (specifically, an amount of rotation) and still achieve clinical efficacy while optimizing user comfort and increasing usage compliance. By learning how the user reacts to variations in therapy, the sleep apnea therapy system is adjustable to optimize the results of therapy. As shown in <FIG>, the sleep apnea therapy system is design to include, in the embodiment illustrated, an active control of surface (e.g., rotation planes, rotation angles, rotation time/duration, fluid bladder pressure); capabilities to sense and assess tolerability (e.g., sleep state/stage, vitals, movement, user assessment); and sense and assess clinical efficacy (e.g., AHI, respiratory rate, head orientation). With these assessments, tolerability and user compliance is maximized for a clinically effective treatment of obstructive sleep apnea.

As shown in <FIG>, the sleep apnea therapy system incorporates sensing of key elements and evaluates connections between those elements until the balance between the elements is optimized, as shown in <FIG> and <FIG>. As a result, the system is capable of maintaining balance between efficacy and tolerability in spite of changes over time (e.g., the user has a cold or develops a higher body mass index (BMI) illustrated in <FIG>.

In one embodiment, apnea therapy can be integrated as an option in a continuous lateral rotation therapy (CLRT) system. An exemplary CLRT system is configured to deliver lateral rotation as a therapy for the prevention of pressure ulcers, as well as for use in the prevention of ventilator-associated pneumonia and muscular wasting associated with prolonged immobility. The exemplary CLRT system is suitable for use as a therapy for the prevention of sleep apnea with the addition of the following components or elements. In one embodiment, the CLRT system includes a restrained lateral rotation to create or develop progressively greater rotation by limiting rotation in a torso region and/or a head region of the user. Additionally, an augmented lateral rotation increases rotation in the torso region and/or the head region of the user.

Referring to <FIG>, an exemplary CLRT system <NUM> includes a control system <NUM> configured with a rotation function (augmented or restrained rotation). Referring to <FIG>, control system <NUM> is operatively coupled to a support system <NUM>. Control system <NUM> includes an apnea setting configured to select a number of support planes, dimensions of each support plane, and a desired lateral rotational angle and/or a desired longitudinal rotational angle at which one or more support planes are positioned to define the sleep surface. Further, control system <NUM> includes a rotation function that allows constrained rotation at a torso region and/or a head region of the sleep surface (e.g., by pressure modification or by physical constraint), as well as supplemented rotation via a cushion.

As show in <FIG>, control system <NUM> includes an apnea mode, wherein blowers are controlled to initiate and maintain rotation of the support planes. Within the apnea mode, control system <NUM> allows the user or a caregiver to select and/or define one or more therapy modes (e.g., an amount and/or a location of rotation). In one embodiment, control system <NUM> is configured or programmed to suggest rotation protocol based on sensed or input data including, without limitation, one or more of the following: AHI score, BMI, sensed respiratory rate, and sensed SpO<NUM> history. Control system <NUM> is also configured or programmed to select a left side slope or a right side slope based on user preference or an alternating lateral rotation, select a reverse trend or composite longitudinal angle, and manually cancel a protocol and/or return the sleep surface immediately to a flat, initial position. Alternating lateral rotation can be specified to alternate after an elapsed time period, to rotate at a certain speed to avoid waking the user, and to gradually increase lateral rotational angles from a low initial lateral rotational angle at a first rotation toward the maximum desired lateral rotational angle after a specified number of rotations.

In one embodiment, support system <NUM> includes a base support <NUM> including a plurality of inflatable fluid bladders aligned generally parallel to a longitudinal axis of support system <NUM> forming a single support plane <NUM> having a lateral rotation angle θ of <NUM>° to <NUM>°, or more specifically, <NUM>°, with respect to a base plane <NUM> of base support <NUM>. One or more supplemental support wedges <NUM> are positioned on support plane <NUM> within one or more of the leg region, the torso region, and the head region of support system <NUM>. In this embodiment, supplemental support wedge <NUM> is a wedge-shaped inflatable fluid bladder. As shown in <FIG>, supplemental support wedge <NUM> is positioned at the head region of support system <NUM> and forms a supplemental support plane <NUM> having a lateral rotation angle λ of <NUM>° to <NUM>°, or more specifically, <NUM>°, with respect to a base plane <NUM> of supplemental support wedge <NUM>. As a result, in the embodiment shown in <FIG> a supplemental support plane <NUM> is positioned at a total lateral rotational angle t of <NUM>° with respect to base plane <NUM> of base support <NUM> (the sum of angle θ and angle λ). In alternative embodiments, the total lateral rotational angle may be any suitable angle, less than <NUM>° or greater than <NUM>°. Further, one or more supplemental support wedges <NUM> can be positioned within one or more of the leg region, the torso region, and the head region of support system <NUM>.

Referring to <FIG>, in one embodiment support system <NUM> includes laterally positioned side constraints <NUM> to limit inflation of individual fluid bladders forming base support <NUM>. Support system <NUM> may include, with or without laterally positioned side constraints <NUM>, a plurality of fixed length bands <NUM> positioned with respect to individual fluid bladders, such as between adjacent fluid bladders, to limit inflation of the individual fluid bladders.

In one embodiment, a posture garment or shirt <NUM> is worn by a user suffering from sleep apnea to apply an appropriate force, such as a tugging force, on the shoulders, arms, and/or head of the user to urge or cause the desired or necessary head turn to open up the user's upper respiratory tract to prevent or limit the occurrence of sleep apnea or in the event of a sleep apnea episode. Applying forces to cause the user to turn his/her entire body to the lateral decubitus position is an alternative approach to achieving this desired head angle; this may involve the use of whole-body garments or a pant garment in combination with a shirt garment.

As shown in <FIG>, posture shirt <NUM> includes one or more areas <NUM> located on a front portion of posture shirt <NUM>, as shown in <FIG>, and/or a back portion of posture shirt <NUM>, as shown in <FIG>, including a material panel and/or material weaves having a different elasticity than other areas of posture shirt <NUM>. Because of the different material elasticity within areas <NUM>, areas <NUM> tend to pull or urge select parts of the user's torso, extremities, head, and/or neck in a desired direction to open the upper respiratory airway. In a particular embodiment, sections or panels of posture shirt <NUM> within areas <NUM> are made of a different elastic material that work cooperatively to properly position the user's body. Posture shirt <NUM> may have long sleeves, short sleeves, or may not include sleeves, and/or have a hood. Any suitable material known to those having ordinary skill in the art may be used within areas <NUM> and include, without limitation, elastic materials based on composition (one or more of nylon, polyester, polyester fleece, and/or cotton) or weave (one or more of plain, basket, and twill weaves) that impart preferential deformability and recovery inducing a change in the user's posture.

In one embodiment, a compression posture shirt <NUM> is worn like a typical shirt and naturally twists the torso, neck and/or head of the user. Unlike conventional posture shirts, there is no need to insert bladders or tennis ball-like inserts to urge the user to turn or rotate from a supine sleep position. Moreover, compression posture shirt <NUM> for sleep apnea does not require any user training because posture shirt <NUM> pulls and tugs on the user without the need of intervention from the user.

In certain embodiments, electrical circuitry, such as one or more processors and/or one or more circuit boards, is operatively coupled to, such as in electrical or electronic communication with, control system <NUM> to monitor operation of one or more components of support system <NUM> or control system <NUM> to monitor operation of one or more components of support system <NUM>, collect, process, and/or store information, such as operation data and motor usage data, and transmit information, such as operation data and motor usage data, to one or more of the following computer-implemented machines or devices including, without limitation, a control and/or display device within or operatively coupled to support system <NUM> or support system <NUM>, and/or a control and/or display device on a computer or network of computers at one or more nurse stations or administrative stations, for example.

In one embodiment, electrical circuitry, such as one or more processors and/or one or more circuit boards, is contained within control system <NUM> or control system <NUM> and connected in communication with support system <NUM> or support system <NUM>, respectively. In a particular embodiment, one or more sensors or other suitable detection components are operatively coupled to support system <NUM> or support system <NUM> and/or control system <NUM> or control system <NUM> to detect operation. The one or more sensors are configured to generate and transmit electronic signals representative of the detected operation to the circuit board, which is configured to collect, process, and/or store such information, and generate and transmit information to one or more computer-implemented machines or devices in communication with the circuit board, as described above.

In certain embodiments, the one or more computer-implemented machines or devices in communication with the circuit board include a controller in signal communication, either wired or wireless signal communication, with the circuit board contained within support system <NUM> or support system <NUM>. The controller includes a suitable display to display information received from the circuit board and/or information generated by the controller based on the information received from the circuit board. In a particular embodiment, the controller is configured to generate command signals and transmit the command signals to the circuit board contained within support system <NUM> or support system <NUM> to control operation of support system <NUM> or support system <NUM> and/or adjust parameters and/or limits, for example, programmed into the circuit board.

The above embodiments may be described in terms of functional block components and various processing steps. Such functional blocks may be realized by any number of hardware and/or software components configured to perform the specified functions. For example, embodiments may employ various integrated circuit components, e.g., memory elements, processing elements, logic elements, look-up tables, and the like, which may carry out a variety of functions under the control of one or more processors, microprocessors or other control devices. Similarly, where the elements of the above embodiments are implemented using software programming or software elements the embodiments may be implemented with any programming or scripting language such as C, C++, Java, assembler, or the like, with the various algorithms being implemented with any combination of data structures, objects, processes, routines or other programming elements. Furthermore, the embodiments could employ any number of conventional techniques for electronics configuration, signal processing and/or control, data processing and the like. The word mechanism may be used broadly and is not limited to mechanical or physical embodiments, but can include software routines in conjunction with processors, etc..

The particular implementations shown and described herein are illustrative examples of the invention and are not intended to otherwise limit the scope of the invention in any way. For the sake of brevity, conventional electronics, control systems, software development and other functional aspects of the systems (and components of the individual operating components of the systems) may not be described in detail. Furthermore, the connecting lines, or connectors shown in the various figures presented are intended to represent exemplary functional relationships and/or physical or logical couplings between the various elements. It should be noted that many alternative or additional functional relationships, physical connections or logical connections may be present in a practical device. Moreover, no item or component is essential to the practice of the invention unless the element is specifically described as "essential" or "critical.

The order of execution or performance of the operations in embodiments illustrated and described herein is not essential, unless otherwise specified. That is, the operations may be performed in any order, unless otherwise specified, and embodiments as described may include additional or fewer operations than those disclosed herein. For example, it is contemplated that executing or performing a particular operation before, contemporaneously with, or after another operation is within the scope of aspects of the invention.

Embodiments may be implemented with computer-executable instructions. For example, aspects of the disclosure are not limited to the specific computer-executable instructions or the specific components or modules illustrated in the figures and/or described herein. Other embodiments may include different computer-executable instructions or components having more or less functionality than illustrated and described herein.

Many other embodiments of the present disclosure are also envisioned. For example, a method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; displaying a proposed configuration of a person support structure corresponding to the care protocol for a caregiver to approve; and upon approval by the caregiver, implementing the configuration. In another contemplated embodiment, the configuration causes the person support structure to raise a first section of the person support structure such that the first section forms an angle of greater than <NUM>° with respect to the reference plane. In another contemplated embodiment, the configuration causes the person support structure to laterally tilt an occupant supported on the person support structure to a side such that the occupant is are at an angle of greater than <NUM>° with respect to the reference plane. In another contemplated embodiment, the configuration causes the person support structure to move to at least one of a Trendelenburg and reverse Trendelenburg position. In another contemplated embodiment, the configuration causes a therapy to be initiated. In another contemplated embodiment, the therapy includes heat and moisture regulating therapy. In another contemplated embodiment, the therapy includes continuous lateral rotation therapy. In another contemplated embodiment, the therapy includes at least one of percussion therapy and vibration therapy. In another contemplated embodiment, the proposed configuration is modified as a function of a second input indicative of the orientation of a person supported on the person support structure. In another contemplated embodiment, the proposed configuration is modified as a function of a second input indicative of the position of a person supported on the person support structure. In another contemplated embodiment, the method further comprises the steps of: receiving an input indicative of the sleep state of the person supported on the person support structure; and if the person is waking up, restoring the person support structure to a previous configuration. In another contemplated embodiment, the person support structure is configured upon an occupant reaching a predetermined sleep stage. In another contemplated embodiment, the method further comprises the steps of: receiving a configuration override command; and restoring the person support structure to a previous configuration. In one contemplated embodiment, the configuration override command is communicated from a remote location. In another contemplated embodiment, the configuration override command is communicated when a CPR function is activated. In another contemplated embodiment, the configuration override command is communicated from a GUI coupled to the person support structure. In another contemplated embodiment, the method further comprises the step of notifying a caregiver if the presence of a material would aggravate an adverse condition. In another contemplated embodiment, the method further comprises the steps of: receiving an input indicative of a material proximate to the person supported on the person support structure determining if the material increases the person's risk for developing an adverse condition.

In another example, a method comprises receiving a signal indicative of a physiological characteristic; comparing the signal to a threshold to determine if an adverse event is in progress; and upon detecting that an adverse event is in progress, initiating an intervention to stop the adverse event. In one contemplated embodiment, the second intervention includes increasing the magnitude of the first intervention. In another contemplated embodiment, the second intervention includes alerting a caregiver.

In another example, a person support surface comprises a mattress ticking and a mattress core. The mattress core is enclosed by the mattress ticking and includes at least one fluid bladder configured to selectively protrude from the person contacting surface and support a portion of at least one of the neck and the upper back of an occupant supported on the person support surface. In one contemplated embodiment, the at least one fluid bladder is configured to support the cervical vertebrae of an occupant. In another contemplated embodiment, the at least one fluid bladder is configured to protrude a distance of at least about <NUM> from the occupant facing surface. In another contemplated embodiment, the at least one fluid bladder is configured to support the scapula of an occupant. In another contemplated embodiment, the at least one fluid bladder is configured to protrude a distance of at least about <NUM> from the occupant facing surface. In another contemplated embodiment, the at least one fluid bladder is configured to protrude a distance of about <NUM> to about <NUM> from the occupant facing surface. In another contemplated embodiment, the at least one fluid bladder is configured to protrude a distance of less than about <NUM> from the occupant facing surface. In another contemplated embodiment, the at least one fluid bladder is configured to laterally tilt an occupant's head when inflated. In another contemplated embodiment, the at least one fluid bladder is inflated upon detecting the onset of an adverse condition.

In another example, a method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; sensing a first physiological characteristic of a person supported on a person support structure; sensing a second physiological characteristic of the person; comparing the first physiological characteristic to the second physiological characteristic; if the difference between the first physiological characteristic and second physiological characteristic is outside a predefined range, configuring the person support structure as a function of the care protocol.

In another example, a method comprises determining a person's level of risk for developing an adverse condition; selecting a care protocol based on the level of risk; sensing a first physiological characteristic of a person supported on a person support structure; sensing a second physiological characteristic of the person; comparing the first physiological characteristic to the second physiological characteristic; if the difference between the first physiological characteristic and second physiological characteristic is outside a predefined range, alerting a caregiver that an adverse condition is going to occur.

Any theory, mechanism of operation, proof, or finding stated herein is meant to further enhance understanding of principles of the present disclosure and is not intended to make the present disclosure in any way dependent upon such theory, mechanism of operation, illustrative embodiment, proof, or finding. It should be understood that while the use of the word preferable, preferably or preferred in the description above indicates that the feature so described can be more desirable, it nonetheless cannot be necessary and embodiments lacking the same can be contemplated as within the scope of the disclosure, that scope being defined by the claims that follow.

In reading the claims it is intended that when words such as "a," "an," "at least one," "at least a portion" are used there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. When the language "at least a portion" and/or "a portion" is used the item can include a portion and/or the entire item unless specifically stated to the contrary.

Claim 1:
A dynamic support system (<NUM>) comprising:
a person support apparatus comprising a closed air system (<NUM>) having at least one support piece configured to form a laterally angled sleep surface having a length defined between a first edge and an opposing second edge spaced from the first edge along a longitudinal axis of the support system, the at least one support piece comprising a pair of laterally-spaced fluid bladders (<NUM>, <NUM>, <NUM>) communicatively coupled to each other to allow fluid to move between interior cavities of the fluid bladders;
a control system (<NUM>) comprising a computer (<NUM>) having one or more processors (<NUM>) in operational control communication with the person support apparatus; and
a plurality of sleep sensors (<NUM>) configured to sense user sleep patterns and activity during sleep, each sleep sensor of the plurality of sleep sensors in signal communication with the one or more processors (<NUM>) and configured to gather data and generate and transmit to the one or more processors (<NUM>) signals indicative of the data gathered, each sleep sensor (<NUM>) also configured to receive operation control signals from the one or more processors (<NUM>); and
wherein the control system (<NUM>) is configured to:
detect when the user begins to fall asleep;
monitor the user's sleep patterns and activities as the user begins to sleep; and
activate the support apparatus to rotate the user by one or more of the fluid bladders at a time during sleep, after sleep is detected, by activating the support apparatus at a time delay.