(WHS-P37) NOVEL THERAPY FOR LONG-TERM PRESSURE INJURY PREVENTION: PRELIMINARY EVALUATION OF A BIOMIMETIC IMPLANTED STIMULATOR FOR AUTOMATED REGULAR WEIGHT SHIFTING
Friday, May 17, 2024
7:30 AM – 5:00 PM East Coast USA Time
Background: Pressure injury (PrI) prevention is a major challenge for many people with limited mobility, often leading to prolonged bedrest, hospitalization and even death. Clinical practice guidelines recommend weight-shifting every 20 minutes, but this is difficult when busy with activities of daily living. Prevention thus remains a major challenge which we have found that intermittent gluteal neuromuscular electrical stimulation (iGSTIM) can address. Unfortunately, while surface gluteal electrical stimulation has been used for short periods it has limited efficacy for long term use. A fully implanted iGSTIM system was requested by many people desperate for a new alternative to PrI prevention. iGSTIM using bilaterally implanted electrodes provides sustained and effective, regular and automatic weight-shifting, which increases muscle bulk, reduces intramuscular adipose tissue and maintains improved tissue health over many years.
Methods: Newly emerged technologies have enabled us to build soft flexible stimulators and electrode arrays that are implantable and biocompatible for implantation. The mechanically biomimetic and functionally flexible 4-channel stimulator, flexSTIM can provide clinically relevant weight-shifting for up to 14 hours/day. Preliminary biocompatibility testing of flexSTIM has been completed in five New Zealand White rabbits.
Results: Biocompatibility testing of system components implanted for a six month period found that flexSTIM and the intramuscular electrodes were well tolerated. We also have successfully created and reproduced a rabbit spinal injury survival model with animals exhibiting sustained loss of unilateral hind limb function while remaining healthy with independent bowel and bladder function.
Conclusions: Further development will include review and refinement of pre-clinical protocols as needed for evaluation of sustained flexSTIM function, reliability and safety.