SBIR-STTR Award

Pressure ulcers or decubitus ulcers, more commonly known as bedsores are a huge problemaffecting 2.5 million patients every year in the US and causes 60,000 deaths every year.Pressures exceeding 32 mm of Hg in the bony prominences in the back of the patient body leadto bedsores. Despite the existing low air loss mattresses, alternating pressure mattresses and thestate-of-the-art air fluidized beds, bedsores prevail, and its prevention remains a huge healthcarechallenge. Current hospital protocol is to turn patient every two hours. This is very disturbing andcause of pain to a resting patient who is dealing with other co-existing health conditions besidesbedsores. Caregivers and nurses must turn heavy patients around, which sometimes lead tohurting their backs in the process. When not performed adequately and frequently (every 2 hours)as required, it is considered as negligence of care and causes litigation against nursing homesand hospitals causing huge financial losses to them. We propose a compliant-mechanism-based mattress that will obsolete the current clinical protocol of nurses and caregivershaving to turn the patient every two hours. It will operate with minimal power, make smallclicking noise when changing from one stable state to another using amount of force required toopen a desk drawer. This switching of states can be further automated and can include a simplecounter for documented evidence of alternating pressure to support against litigation of negligentcare. In specific aim 1, machine learning using trained neural network will determine the functionalrequirements of the mattress (e.g., optimal amplitude and pitch for the undulation of the pressurepoints) by conducting a cohort pressure profile study that involves a bed that intentionally appliespressure on resting bodies. In specific aim 2, ideal topology with pitch and amplitude ofundulations discovered in aim 1 will be developed using FACT and optimized using BLOT tocreate a prototype bi-stable compliant-mechanism-based mattress as a new approach for shiftingpressure points on a patient's body. FACT is advanced technique using freedom andconstraint topologies for topology synthesis of the mattress and BLOT provides boundarylayer optimization of the topology. Proposed mattress is innovative, disruptive, affordable,lightweight, does not use noisy air pumps, has no leakage issues and will eliminate thescourge of bedsores in the existing immobile and aging population. Project Narrative Numerous currently marketed alternating pressure mattresses have not received recommendations from reviewers due to poor correlation and unconvincing outcomes for bedsore prevention. Our approach of using neural network based machine learning will bring a new methodical approach to discerning the pitch and amplitude of undulations required to prevent dead pressure zones that exceed safe pressure of 32 mm of Hg on the patient's back, which is fundamental to preventing bedsores. This will further serve as input to designing the prototype compliant-mechanism-based mattress using the freedom and constraint topologies (FACT) approach and the boundary learning optimization tool (BLOT) with end effect of developing an innovative mattress for preventing bedsores in the immobile and aging population. Affect ; Air ; Air Pressure ; Back ; Dorsum ; Beds ; Body Weight ; Clinical Protocols ; Computers ; Data Analyses ; Data Analysis ; data interpretation ; Cessation of life ; Death ; decubitus ulcer ; Bed Sores ; Bedsore ; Pressure Sore ; Pressure Ulcer ; pressure injury ; Extravasation ; Leakage ; Spillage ; Fatigue ; Lack of Energy ; Freedom ; Liberty ; Health ; Hospitals ; Lasers ; Laser Electromagnetic ; Laser Radiation ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Learning ; Mattresses ; Methods ; Negligence ; Noise ; Nurses ; nurse ; Nursing Homes ; nursing home ; Pain ; Painful ; Patients ; pressure ; Recommendation ; Rest ; Shoulder ; Work ; Litigation ; Caregivers ; Care Givers ; Healthcare ; health care ; Nursing Protocols ; Caring ; base ; Pump ; improved ; Training ; fluid ; liquid ; Liquid substance ; lightweight ; light weight ; tool ; Filamentous Fungi ; Molds ; machine learned ; Machine Learning ; Hour ; Protocol ; Protocols documentation ; Techniques ; System ; Width ; Height ; cohort ; Scourge ; novel ; Participant ; Prevention ; Modeling ; preventing ; prevent ; Data ; Monitor ; Process ; cost ; design ; designing ; novel strategies ; new approaches ; novel approaches ; novel strategy ; Outcome ; innovation ; innovate ; innovative ; Network-based ; prototype ; aging population ; aged population ; population aging ; Geometry ; Injections ; neural network ; machine learning algorithm ; machine learned algorithm ;

Pressure injuries (i.e., bedsores) affect 2.5 million Americans every year and 60,000 die from them. Although several commercial alternating-pressure and low air-loss mattress products already exist toaddress this scourge, these products are not optimally effective and lack the evidence to deserve a strongmedical recommendation. Moreover, they are expensive, heavy, and loud, and can exhibit lack of air-permeation, air leakage issues, and round-the-clock power consumption. We propose a multi-stablecompliant-mechanism-based (MSCMB) mattress to overcome these issues and optimally preventprolonged levels of harmful pressure in the existing immobile and aging population. During Phase I of ourcurrent grant, which began May 1st, 2021, we successfully fabricated a bed that consists of 1,260 linearactuator pistons that can be controlled by a computer to impart any undulating pressure pattern on apatient's back. By the end of Phase I (April 30th, 2022), we will have used this bed to complete a study,which involves machine learning to determine (i) what factors predominantly affect bedsore prevention inalternating pressure approaches, and (ii) what the optimal height of (i.e., amplitude) and distance between(i.e., pitch) each pressure peak should be for different categories of patients. We will use this informationto inform the design of the final products that will be prototyped and perfected in Phase II. During Phase I,we also generated a MATLAB tool that was used to design a large portion of our proposed MSCMBmattress concept and have prototyped it to demonstrate its functionality and to collect preliminary data.The design tool and the lessons learned during the fabrication and testing of the prototype will be heavilyleveraged in Phase II to successfully perform the proposed aims. These aims are to (i) create the finalMSCMB mattress products that best reduce pressure injuries for different categories of patients, (ii)produce a smart phone app and a web-based computer software that can be used to remotely set theswitching frequency of the actuated versions of the MSCMB mattress designs, (iii) conduct a study toidentify the most effective kind and thickness of foam pad to use on top of each MSCMB mattress product,(iv) determine and perfect the final process for manufacturing the MSCMB mattresses, and (v) perform auser evaluation study of the MSCMB mattress products.

Public Health Relevance Statement:
Narrative The objective of this work is to learn what factors affect the prevention of pressure injuries (i.e., bedsores) via an alternating pressure approach and incorporate the knowledge learned within the production of a multi-stable compliant-mechanism-based (MSCMB) mattress, which will disruptively alleviate the suffering of the 2.5 million Americans, who are affected each year by such injuries. At the completion of Phase I (April 30th, 2022), we will have finished a study, which utilizes a custom-fabricated bed of 1,260 actuator pistons to impart any desired pressure pattern on a patient's back, and will have used the bed in conjunction with machine learning to determine the optimal pressure pattern for reducing bedsores in different categories of patients. In Phase II, we will leverage the knowledge learned from this study and from designing and fabricating the preliminary MSCMB mattress prototype (also generated during Phase I), to (i) create final MSCMB mattress products that best reduce pressure injuries for different categories of patients, (ii) produce a smart phone app and a web-based computer software that can be used to remotely set the switching frequency of the actuated versions of the MSCMB mattress designs, (iii) conduct a study to identify the most effective kind and thickness of foam pad to use on top of each MSCMB mattress product, (iv) determine and perfect the final process for manufacturing the MSCMB mattresses, and (v) perform a user evaluation study of the MSCMB mattress products.

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