SBIR-STTR Award

This SBIR application supports the development of a fall recovery and patient mobility medical device to reduce medical professional and caregiver injuries caused by lifting patients. The SitAssist device is designed to recover a patient from a prone to sitting position (or vice versa) with minimal patient movement, force and effort. The device is designed both to assist the medical communities “no lift” policies to avoid work related injuries to health care professionals while supporting in home and self-care of limited mobility patients. Current fall recovery strategies require the use of a second, or third person fit enough to use a passive assistive device or knowledgeable enough to operate a Hoyer lift assist device. Beyond accidental falls, the need to move patients from a sitting position to the floor and back for rehabilitative services is increasingly necessary as care centers move to support post-accident/post operative rehabilitation to support better independent living. But direct care-giver lifting/moving of patients results in unacceptable levels of injury to care providers while improper use of lift devices can cause injury (and embarrassment) to the patient, the caregiver or both. To reduce health care worker related injuries and to support in-homecare and self care, Unique Mobility Devices has developed the SitAssist, a simple self-contained device that can lift a person from the floor to a seated position with little minimal patient movement, minimal force and minimal effort. This Phase I project will evaluate the product’s design and use in a commercial health care setting using professional care teams and patients to evaluate the products function, safety and utility. In Aim 1, stress testing of the prototype device will ensure that it is capable of managing a wide range of adult sizes and weights safely. This engineering exercise will test the capability, safety, performance and control of the device. Anthropomorphic models of differing weights (up to 300lbs) and sizes will be used to mimic patients. The device will be put under significant loads with body positioning to mimic maximum stress. An optimized design will then be built for testing in Aim 2. In aim 2, the optimized device will be evaluated by trained medical staff and by patients at a premiere rehabilitative center, Kessler. ~14 staff members (doctors, nurses, physical therapists) will physically test the device using both anthropomorphic models and staff members as proxy patients. All participating staff and ~20 patients will also provide feedback via surveys on device performance, ease of use, safety and potential for injury (patient or caregiver), interface design and operation, patient recovery requirements, managing the device (moving into position from storage), value and potential to reduce caregiver injury long term. The results of this Phase I study will be used to support a 510K filing with the FDA for approval to move into a clinical study in Phase II to evaluate the devices ability to reduce caregiver injury at home and at care facilities. The SitAssist device will be the first to lift a person from the floor to a seated position with little to no assistance from others; no other device can make this claim.

Public Health Relevance Statement:
Narrative: Caregiver lifting of patients, whether at home or in care facilities, represents a major source of caregiver injury. Beyond accidental falls, the need to move patients from a sitting position to the floor and back for rehabilitative services is increasingly necessary as care centers move to support post-accident/post operative rehabilitation to support better independent living. This project supports a simple medical device, the SitAssist, to help prevent caregiver injury while moving patients. The device is designed to provide a simple way of moving a patient from a prone to sitting position, and vice versa, simple, reliably and safely. Long term, the device should reduce caregiver injury related to patient fall recovery and rehabilitative services.

Project Terms:
abstracting; Accidental Falls; Accidents; Adult; Area; Back; base; body position; Caregivers; Caring; Clinical Research; Communities; Data; design; Development; Devices; Engineering; engineering design; Ensure; Evaluation; Exercise; Failure; Fall prevention; falls; Familiarity; Feedback; Floor; Goals; Health Personnel; Health Professional; Healthcare; high risk; Home environment; Independent Living; Injury; Institutes; Institution; interest; Lifting; Medical; medical attention; Medical Device; Medical Staff; meetings; member; Modeling; Movement; novel; Nurses; operation; Operative Surgical Procedures; Patient Care Team; Patients; Performance; performance tests; Persons; Phase; phase 1 study; physical therapist; Physicians; Policies; Population; Positioning Attribute; post-operative rehabilitation; prevent; prototype; Provider; Proxy; Recovery; Rehabilitation therapy; Resort; response; Safety; Self Care; Self-Help Devices; Services; Site; Small Business Innovation Research Grant; Somatotype; Source; Stress; Stress Tests; Structure; Surveys; System; Test Result; Testing; Therapeutic; Time; Training; Update; Weight;