Description:FIELD OF THE INVENTION
The present invention relates to a pressure relief system. More particularly, the present invention discloses a spatiotemporal pressure-distributing system that leverages sensors and a translating cam-follower mechanism. Said system discloses real-time pressure mapping, a caregiver alert for pressure concentration zones, and integrates pressure-sensing quilts for continuous monitoring for bedridden users suffering from various ailments.

BACKGROUND OF THE INVENTION
A considerable portion of the healthcare population experiences periods of immobility, particularly among older adults. This lack of movement can lead to a cascade of detrimental effects, including a decline in muscle mass and bone mineral density, ultimately culminating in significant physical impairment. However, one of the most concerning complications associated with immobility is the development of pressure injuries (PIs), also known as bedsores, pressure ulcers, or decubitus ulcers.

PIs are localized areas of tissue damage that arise on the skin and underlying soft tissue due to prolonged exposure to pressure, friction, or shear forces. These forces are often concentrated at specific contact points between the body and external surfaces, such as when lying in bed, sitting in a wheelchair for extended periods, or even wearing a cast. Individuals with compromised health, particularly those with diabetes, circulatory problems, or poor nutrition, are at a heightened risk of developing PIs.

The most common locations for PI development include the buttocks, heels, shoulder blades, back of the head, and the backs and sides of the knees, corresponding to areas of high-pressure during periods of immobility. The underlying cause of PI formation is a disruption in blood flow to the affected skin area, typically exceeding a critical duration of 2-3 hours. This impaired blood flow leads to tissue hypoxia (oxygen deprivation) and ischemia (lack of oxygen and nutrients), ultimately resulting in cell death and tissue breakdown. Furthermore, friction and shear forces can exacerbate PI development by directly damaging skin cells and disrupting blood supply. Being bedridden, unconscious, or immobile puts one at risk of getting a bed sore. The danger rises if the person stays immobile for a long time, is not positioned correctly, or is not supplied with the proper nutrients.

Bedsores can be avoided to a large extent by regularly inspecting the skin for redness, particularly near the bones. The patient can be made to sit straight and upright in a wheelchair and change positions every 15 minutes, with soft cushions in wheelchairs and beds to relieve pressure, keep the skin clean and dry, and provide adequate nutrition. Anti-bed sore and massage beds have existed for a while. The most traditional method was the use of waterbeds, and it has evolved a lot from waterbeds to a lot more sophisticated structure.

Reference is made to patent document US20190104860A1, titled as “Computer-Shaped Motion Bed Systems and Methods” published on 11th March 2019. Which discloses a sensor-based system to identify the body position and works based on a feedback loop. The said system requires electricity, at least a computer, however said machine cannot be operated manually if electricity is not available.

Another Reference is made to patent document US20210307534A1, titled as “Automated Bed and Method of Operation and Thereof” by inventors Krenik Matthew W, Krenik Matthew W. The said document discloses a mechanical bed system which uses grid like top layers, connected to each actuator. Said system is a sensor-based system to identify the load points and requires a microcontroller to process the data. Each grid point is connected to pneumatic or hydraulic actuators, which need to be operated by the microcontroller. The said system is complicated, costly and only works with electricity.

Another reference is made to patent document US4799276A, titled as” Body Rest with Means for Preventing Pressure Sores” by inventor Kadish Ehud, discloses an electrical-mechanical system, which uses a grid like bed and each grid elements are connected to pistons of pneumatic cylinders. Said system also uses micro controllers to selectively operate the pneumatic valves, compressed air storage tank and compressors, which makes said system costly and manually non-operable.

Existing inventions in this field have not fully utilized design assemblies to achieve precise solutions. Furthermore, current state-of-the-art designs often disclose hydraulic and pneumatic beds, which, while offering some pressure relief, lack real-time pressure mapping and a caregiver alert system for pressure concentration zones. Additionally, they do not incorporate pressure-sensing quilts for real-time pressure monitoring. These beds can also be bulky, complex, or require additional air sources, which increases costs and limits portability.

In order to obviate the drawbacks of the existing state of the art, there is a pressing need for a simple mechanical design, to cater pressure relief for users suffering from pressure ulcers. Said system should be capable of prioritizing portability and offering both electrical and manual operation to work remote areas, with efficient pressure distribution to aid bedridden patients.

OBJECT OF THE INVENTION
In order to overcome the shortcomings in the existing state of the art the main object of the present invention is to provide a pressure relief system for patients suffering from pressure ulcers.

Yet another objective of the invention is to provide a biomechanical bed capable of manually and electrically operable functionality.

Yet another objective of this invention is to provide a pressure relief system that can vary pressure in both longitudinal and transverse directions using a single actuator

Yet another objective of the invention is to provide real time pressure mapping and care giver alert system for pressure concentration zones.

Yet another objective of the invention is to provide pressure-sensing quilts equipped with sensors for real-time pressure monitoring.

Yet another objective of this invention is to provide a system that can predict pressure ulcers/ bedsores by using AI/ ML algorithms and input data from pressure sensors, patient details such as age, weight, medical conditions etc.

Yet another objective of the invention is to provide portable and cost-effective solutions to cater to the needs of bedridden patients.

Yet another objective of the invention is to provide a system capable of easy assembly, disassembly and reassembly.

SUMMARY OF THE INVENTION:
The present invention pertains to a pressure relief system. More particularly, the present invention discloses a spatiotemporal pressure-distributing system that leverages sensors and a translating cam-follower mechanism. Said system offers real-time pressure mapping, a caregiver alert for pressure concentration zones, and integrates pressure-sensing quilts for continuous monitoring, for bedridden users suffering from various ailments such as pressure ulceration or bed sores.

A pressure redistribution system is engineered to effectively mitigate and prevent pressure injuries in individuals subjected to prolonged immobility. The primary objective is to develop a system capable of precisely redistributing pressure in both longitudinal and transverse directions relative to a patient's body, thereby enhancing patient comfort and providing superior pressure relief compared to existing technologies.
The present invention comprises of real-time pressure mapping capability, facilitating the identification of pressure concentration zones, including a caregiver alert system configured to notify caregivers of detected pressure concentration zones. The invention incorporates pressure-sensing quilts for continuous, real-time pressure monitoring across the patient's support surface.
The said invention can also predict pressure ulcers by using AI/ML algorithms for a given patient. The system can use inputs from pressure sensors and patient details such as age, weight, height, and medical conditions. Accordingly, the present invention provides a system comprising an AI/ML model configured to be trained using patient data, the patient data comprising previously collected patient information.
The present invention is the integration of a translating cam-follower (TCF) mechanism and sensors (S) within the support surface. This mechanism is configured to periodically and dynamically shift pressure across the patient's body according to real time pressure mapping, thereby minimizing prolonged stress on specific anatomical regions susceptible to pressure injury formation.
The use of a mechanical actuation, specifically the translating cam-follower mechanism, obviates the necessity for pneumatic or hydraulic components, and sensors in a system that is cost-effective, portable, and energy-independent.
The present invention contemplates a plurality of distinct embodiments configured for integration with both wheelchairs and beds, providing comprehensive solutions for diverse patient care environments. These embodiments are designed to enhance patient care and reduce the incidence of pressure injuries.

BRIEF DESCRIPTION OF DRAWINGS
Figure 1 depicts a) Schematic representation of sensor fabrics for pressure mapping b) test system with 16 sensor element nodes for pressure sensing. Figure 2 depicts design for modular pressure redistributing systems for wheelchairs.
Figure 3 depicts whole field pressure map for a 16-sensor array system a-b) different time intervals b) constant pressure.
Figure 4 depicts variations in pressure index parameters for static and proposed dynamic pressure redistribution system.

DETAILED DESCRIPTION OF THE INVENTION WITH ILLUSTRATIONS AND EXAMPLES
While the invention has been disclosed with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made, and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt to a particular situation or material to the teachings of the invention without departing from its scope.

Throughout the specification and claims, the following terms take the meanings explicitly associated herein unless the context clearly dictates otherwise. The meaning of “a”, “an”, and “the” include plural references. Additionally, a reference to the singular includes a reference to the plural unless otherwise stated or inconsistent with the disclosure herein.
The present invention pertains to a pressure relief system. More particularly, the present invention discloses a spatiotemporal pressure-distributing system that leverages sensors and a translating cam-follower mechanism. Said system offers real-time pressure mapping, a caregiver alert for pressure concentration zones, and integrates pressure-sensing quilts for continuous monitoring, for bedridden users, suffering from pressure ulceration or bed sores.

A pressure redistribution system is engineered to effectively mitigate and prevent pressure injuries in individuals subjected to prolonged immobility. The primary objective is to develop a system capable of precisely redistributing pressure in both longitudinal and transverse directions relative to a patient's body, thereby enhancing patient comfort and providing superior pressure relief compared to existing technologies.
The present invention comprises a real-time pressure mapping capability, facilitating the identification of pressure concentration zones, including a caregiver alert system configured to notify caregivers of detected pressure concentration zones. The said system incorporates pressure-sensing quilts for continuous, real-time pressure monitoring across the patient's support surface.

The said invention is further capable of predicting the onset and progression of pressure ulcers in patients by leveraging advanced Artificial Intelligence (AI) and Machine Learning (ML) algorithms. This predictive functionality enables proactive medical intervention, thereby reducing the risk of severe skin breakdown and associated complications. To achieve this, the system integrates real-time input data collected from strategically placed pressure sensors in the pressure sensing quilts and with relevant patient-specific parameters such as age, weight, height, body mass index (BMI), mobility level, nutritional status, skin integrity, and underlying medical conditions (e.g., diabetes, vascular disorders, or neurological impairments).
The AI/ML model functions by analysing and identifying patterns within this multi-dimensional dataset that are indicative of early-stage pressure ulcer formation. Such a model requires extensive training on large datasets comprising historical patient records, clinical outcomes, and corresponding pressure distribution patterns over time. Moreover, the model can be dynamically updated as new patient data becomes available, allowing it to adapt to diverse patient populations and evolving clinical practices. This intelligent prediction capability empowers healthcare providers/practitioners with early warnings and tailored recommendations to prevent bedsores.”
The present invention is the integration of a translating cam-follower mechanism and sensors within the support surface. This mechanism is configured to periodically and dynamically shift pressure across the patient's body, thereby minimizing prolonged stress on specific anatomical regions susceptible to pressure injury formation. The use of a mechanical actuation, specifically the translating cam-follower mechanism, obviates the necessity for pneumatic or hydraulic components and sensors, resulting in a system that is cost-effective, portable, and energy-independent.
Also, the present invention requires only requires single actuator which can vary the pressure distribution both in longitudinal and transverse directions.
The invention contemplates a plurality of distinct embodiments configured for integration with both wheelchairs and beds, providing comprehensive solutions for diverse patient care environments. These embodiments are designed to enhance patient care and reduce the incidence of pressure injuries.

1. Wheelchair-Compatible Embodiments: The present invention further comprises wheelchair-compatible embodiments of the pressure redistribution system, specifically designed for individuals experiencing prolonged immobility while wheelchair-bound
• Embodiment 1 (Basic): A cost-effective, attachable and detachable pressure redistribution system for a wheelchair, comprising a pressure redistribution actuation mechanism without integrated sensor inputs or real-time monitoring capabilities.
• Embodiment 2 (Advanced): An advanced pressure redistribution system for a wheelchair, comprising the features of Embodiment 1 further integrated with real-time pressure mapping, a mobile/tablet application for monitoring, and a sensor network configured to provide pressure concentration alerts to caregivers.
2. Bed-Compatible Embodiments:
• Embodiment 3 (Basic): A standard bed-sized pressure redistribution system, comprising an automated pressure redistribution mechanism without sensor-based feedback.
• Embodiment 4 (Advanced): A smart pressure redistribution bed system, comprising the features of Embodiment 3 further integrated with real-time pressure monitoring, mobile/tablet application integration, and sensor-driven alerts to caregivers for enhanced pressure management. The system works by using AI/ ML algorithms, the said system can predict pressure ulcers for a given patient and give tailored recommendations.

Design of Sensor Integrated Flexible Fabrics for Pressure Mapping

The present invention focuses on the development of a sensor-embedded flexible fabric configured for real-time pressure mapping. This fabric comprises a plurality of conducting polymers and flexible pressure sensors integrated within its layers, thereby ensuring user comfort and seamless usability. The design further includes a sensor array embedded within a soft, flexible fabric. The spatial resolution of pressure data is determined by the number of sensing regions, arranged in an M x N grid configuration. Higher values of M and N yield a high-resolution spatial mapping of pressure variations. The placement of these sensing regions is optimized to cover critical contact points while maintaining the fabric's structural integrity and flexibility. A schematic representation of the proposed pressure-sensing fabric is depicted in Fig. 1a. A prototype, wherein M = N = 4, is illustrated in Fig. 1b, showing a pressure sensing layer and its corresponding data acquisition system.

A dedicated data acquisition system is designed to utilize microcontrollers and IoT peripherals for seamless data streaming to a mobile/tablet application. The acquired signals are subsequently converted into real-time heatmaps, which provide clear visualization of pressure distribution and facilitate the generation of an alert in case of prolonged exposure to excessive pressure in localized areas. This real time pressure data is given as an input to an AI/ML algorithm which is trained based on large datasets comprising historical patient records, clinical outcomes, and corresponding pressure distribution patterns over time. This allows the system to predict the possibility of pressure ulcers on a given patient and provide tailor made recommendations based on his medical conditions.

Design of a Single-Actuator-Based Pressure Redistribution System – An Innovative Approach for Achieving Spatial and Temporal Pressure Variation with a Realistic Bed Structure

The present invention is configured to achieve pressure relief along both longitudinal and transverse directions while maintaining realistic bed surface features. This is accomplished through a novel linear cam-follower mechanism

The entire bed surface is effectively divided into a two-dimensional grid of cushion elements, designed to replicate the feel of an actual bed. Each cushion element is mechanically coupled to a follower tip, which in turn rests upon a translating cam. As the translating cam oscillates, its motion is transferred to the individual cushion elements via their respective followers. The simultaneous undulation of these multiple top layers (cushions) results in a variable distribution of pressure across the bed surface.

The internal configuration of the bed is a primary linear cam, is responsible for pressure redistribution along the longitudinal axis of the bed-bound patient. A secondary cam is incorporated to achieve transverse pressure redistribution. This system uniquely combines the longitudinal and transverse pressure redistribution requirements utilizing a single actuator. The single actuator powers the secondary cam, and its motion induces a periodic relative motion among the primary cams, characterized by a phase difference. This system can be embodied either as a stand-alone, dedicated bed or, with minor design modifications, adapted for integration with existing hospital beds of standard dimensions.
When the followers are in their mean position, the system presents the configuration of a conventional bed surface. With the progression of time, the individual cushion elements periodically reposition, this dynamic repositioning results in significant pressure redistribution for bed-bound patients.

In a bed embodiment, when the secondary cam oscillates within a horizontal plane, the profile of the secondary cam induces a reciprocating motion in the primary cams, also within the horizontal plane. The motion of these primary cams is configured such that a phase difference exists between adjacent cams. The resulting motion of the primary cams has been simulated.

Pressure Mapping of Sensor Arrays for the Proposed Pressure Relief System
For initial investigations, pressure data is acquired from a 16-sensor element array. Pressure values are calculated in real time at various discrete steps. A whole-field map illustrating the pressure distribution at different time points is provided in Fig. 3. As evident from Fig. 3, effective pressure redistribution occurs across the monitored domain

To objectively evaluate the effectiveness of the pressure redistribution system, the following statistical parameters are considered
Mean Pressure Per Zone: "Mean Pressure Per Zone” represents the average pressure recorded within each designated zone of the system. This parameter assesses the overall load distribution and identifies areas of sustained pressure. A higher mean pressure in a specific zone indicates prolonged stress, thereby increasing the risk of discomfort and pressure injuries in that area.
Peak Pressure Index (PPI): "The Peak Pressure Index (PPI)” identifies the highest localized pressure within a specific zone. This parameter is critical for evaluating the risk of pressure sores, as prolonged exposure to high peak pressure can lead to tissue breakdown. A high PPI value indicates excessive pressure in certain areas, thereby increasing the likelihood of tissue damage. The system's active redistribution mechanism aims to lower PPI, thus preventing localized stress points.
Pressure Distribution Index (PDI): "The Pressure Distribution Index (PDI)” quantifies the uniformity of pressure spread across different zones. A higher PDI value signifies a more uniform pressure distribution, which reduces the potential for pressure concentration in a single area. Conversely, a lower PDI indicates an uneven pressure spread, thereby increasing the likelihood of localized high-pressure zones.
Skewness of Pressure Distribution: "Skewness of pressure distribution” describes the asymmetry in the pressure data, indicating whether pressure values are predominantly concentrated in lower or higher ranges. Positive skewness values (greater than 1) denote a dominance of higher-pressure values, signifying that certain areas experience significantly more pressure than others. This condition suggests an increased risk of pressure injuries due to localized high-pressure zones.

These statistical parameters are evaluated at different time intervals for both static and the proposed dynamic pressure redistribution system, with results presented in Fig. 4.

The results as shown in Fig. 4 show that the static system indicates prolonged pressure concentration and an increased risk of pressure sores. The dynamic bed brings in variations in all quantitative parameters leading to an effective solution for the pressure relief system.
, Claims:We claim:
1. A pressure relief system for immobile patients comprising:
 a flexible fabric having integrated layers;
 a plurality of pressure sensors embedded within said integrated layers, said plurality of pressure sensors comprising a combination of conducting polymers and flexible pressure sensors; wherein said plurality of pressure sensors are arranged in an M x N grid configuration to form a sensor array for real-time pressure mapping, wherein M and N define a spatial resolution of pressure variations;
 a translating cam-follower mechanism operably coupled to the cushion elements;
 an actuator;
 a data acquisition system is operably coupled to said sensor array, said data acquisition system configured to acquire signals from said plurality of pressure sensors;
 convert said acquired signals into real-time heatmaps for visualization of pressure distribution;
 a pressure ulcer prediction system using AI/ML algorithms based on real time pressure sensor data and patient details;
to generate an alert in response to prolonged exposure to excessive pressure in localized areas.

2. The pressure relief system as claimed in claim 1, wherein the placement of said plurality of pressure sensors is optimized to cover critical contact points while maintaining structural integrity and flexibility of the flexible fabric.

3. The pressure relief system as claimed in claim 1, wherein said data acquisition system comprises microcontrollers and IoT peripherals configured for seamless data streaming to a mobile or tablet application.

4. The pressure relief system as claimed in claim 1 wherein said data acquisition system
- acquire pressure data from the sensor array,
- generate real-time pressure distribution heatmaps,
- detect pressure concentration zones,
- generate alerts for caregivers upon detection of prolonged exposure to excessive pressure in localized areas;

5. The pressure relief system as claimed in claim 1 wherein single actuator is configured to independently vary the pressure distribution both in longitudinal and transverse directions.

6. The pressure relief system as claimed in claim 1 wherein said translating cam-follower mechanism comprises of
- at least one primary linear cam for redistributing pressure along a longitudinal axis of the support surface,
- at least one secondary cam for redistributing pressure along a transverse axis of the support surface,
- a plurality of follower tips each mechanically coupled to a respective cushion element and in contact with the primary and secondary cams.

7. The pressure relief system as claimed in claim 1 and claim 5 wherein said actuator is connected to the secondary cam, wherein movement of the secondary cam induces periodic relative motion among the primary cams with a phase difference, such that the cushion elements are dynamically repositioned to redistribute pressure across the support surface.

8. The pressure relief system as claimed in claim 1 wherein said Artificial Intelligence (AI) and Machine Learning (ML) algorithms integrates real-time input data collected from strategically placed pressure sensors in the pressure sensing quilts and with relevant patient-specific parameters such as age, weight, height, body mass index (BMI), mobility level to provide healthcare practitioners with early warnings and tailored recommendations for preventing bedsores.