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ZYM Manufacturing Ltd.
.Ph. (604) 940-1764 Cell (604) 781-8407 e-mail: mjzarry@telus.net GST # 89245 1683 Jan.5, 2010 A DYNAMIC OVERLAY FOR SEAT CUSHIONS AND BEDS, TO PROVIDE ALTERNATING PRESSURE IN ORDER TO REDUCE THE PROBABILITY OF DEVELOPING PRESSURE SORES .(Decubitus Ulcers) By: Myron Zarry THE PROBLEM Bed sores, pressure sores, or decubitus ulcers all refer to the same condition, and occur at rates that are unacceptably high, given that they are 100% preventable. The current methods of prevention require repositioning a person in a chair every 10-15 minutes, and once an hour for the bed ridden. This exercise is disruptive for the patient, and time consuming for the care giver, thus the incidence and occurrence rates listed below. -Two thirds of pressure sores occur in patients older than 70 years. -The rate of occurrence in nursing homes is estimated to be 17-28%. -Neurologically impaired individuals have an annual incidence of 5-8%, with a lifetime risk of 25-85%. -Pressure sores are listed as the direct cause of death in 7-8% of all paraplegics. -Patients over 65 years, with a hip fractures acquired pressure sores (stage 2 or higher) at the rate of 36.1% within 32 days of hospital admission. -Patients who achieve a healed wound have a recurrence rate as high as 90%.
Ref: Don R Revis Jr, MD, University of Florida College of Medicine. Aug 27,2009.

Many products have been produced in an attempt to deal with this affliction, yet the problems persist. The most effective products, variable pressure air beds and fluidized beds, still require the care giver to reposition the patient regularly, and they aren’t recommended for home use. These products are prone to leakage, are noisy, and expensive. The proposed equipment is designed to eliminate the occurrence of pressure sores by maintaining adequate capillary flows in all contacted areas of the body through shifting pressure from one area to another. This was originally suggested by R.J. Houle.
Ref: Evaluation of Seat Devices Designed to Prevent Ischemic Ulcers in Paraplegic Patients, Arch. Phys. Med., 50:587-594 Ref: Mooney et al. “Pressure Distribution in seat Cushions” – Bulletin of Prosthetics Research

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ETIOLOGY It is generally agreed that the onset of pressure sores is caused by point force applied to one area over time. This results in the compression of capillary vessels, which in a period of two hours, without relief, can lead to irreversible changes and necrosis. There is also an opinion that low pressure contact, without movement, leads to the same result.
Ref: Don R Revis Jr, MD, University of Florida College of Medicine. Aug 27,2009. Ref: www.bedsores.org (attached document)

THEORY OF THE SOLUTION ASSUMPTION #1: If you’re not moving, gravity always wins. ASSUMPTION #2: Micro and/or macro motion is essential to life. I will deal with the problems presented by a seat cushion as these conditions are more severe than encountered with a bed mattress, as far as pressure loading is concerned. KNOWN: - capillary blood pressure at the arterial limb is about 30mmHg. - equal pressure distribution over available sitting area varies between 50-70 mmHG.
Ref: Bioastronautics Data Book NASA SP-3006

- there are no cushions available that are safe for prolonged sitting by a paralyzed person. Ref: Mooney et al. “Pressure Distribution in seat Cushions” – Bulletin of Prosthetics Research THEREFOR: - a “perfect” passive cushion will not work because the equal pressure distribution exceeds the capillary “in flow” pressure (30mmHg). SOLUTION: An active device must be designed that provides for alternating tissue bridging and pressure reduction below 30mmHg. Healthy skin will tolerate high pressures for short periods of time, if the pressurized area is lowered alternately to allow capillary “in flow”. The amplitude required for the pressure change should be low to reduce possible skin damage from friction and shear forces. The apparatus should be suitable for home and institutional use, quiet in operation, and portable for wheelchair and long flight/transport use. ACTUAL SOLUTIONS Over the last several months I have tried many combinations of materials and mechanics to achieve the objectives of the theoretical solution. Results to date: SEATING CUSHION OVERLAY: This is composed of ¾” diameter latex tubing laid transversely on ¾” centers over the seating area. The tubing is enclosed with closed cell foam on the bottom and 1” open cell

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foam on top yielding a flexible overlay mat less than 2” thick. The tubes are alternately plumbed to form two separate and closed pneumatic circuits, which are alternately pressurized and evacuated. The relative amplitude of the adjacent tubes is ½” at maximum pressure and vacuum. The amplitude can be changed by altering power to the system, or dampened with additional layers of memory foam. The cycle of alternation will likely be every 2-10 minutes. POWER: The alternating pressurization and evacuation of the latex tubes takes energy. There are several routes possible to supply the required power for the device. I have used a combination of pneumatic cylinders to create the pressure differentials for experimental purposes. Most hospitals and care facilities have compressed air and/or vacuum lines plumbed into the patient rooms. In this situation, a fairly simple arrangement of solenoids and timers will control the cycles. The portable use of the overlay on wheelchairs, or in transport conditions (aircraft, car, etc.) which requires prolonged sitting will be powered by a12VDC pressure/vacuum pump. “Charles Austen Pumps Limited”, in the U.K., manufactures pumps that are small, quiet, and suitable for this application. The power requirements are low, and 10-12 hour operational time is achievable on a single battery charge. Most cars have a 12VDC plugin source on the dash board and the 0.7 Amp draw is within the available supply range. The “at home” use of the apparatus would be more efficient with a 110VAC pump available from the same manufacturer. DOES IT WORK? A prototype has been constructed that demonstrates the theory. The changes are noticeable to a person of normal health, as long as the pressures are changing every 1-2 seconds. At the therapeutic rate, cycling every 2-10 minutes, pressure changes are imperceptible. The adjacent tubes are evacuated and filled at the same rate, and at the same time, so there won’t be any net motion of the patient. An assortment of pressure sensors has been constructed and placed between the person and the overlay in order to determine the actual pressures occurring while in use. The results indicate that alternating pressures appear to be dropping below 30 mmHg. (I don’t have the lab and test equipment needed for precise calibration of the testing apparatus, therefore the value stated is offered with reservation subject to further equipment development and/or independent testing.) This pressure is below capillary “in flow” pressure and will allow blood flow to replenish oxygen and nutrients to tissue that has been exposed to pressures greater than 30mmHg in the previous cycle. Vigorous massage is not recommended in the areas of compromised skin health. The proposed system may have unforeseen beneficial effects in delaying muscular atrophy, and maintaining tissue health by increasing capillary blood flows through slow and gentle pressure changes.( I’m not sure that pressure changes every ten minutes constitutes a massage.) Ref: Hands For Health LLC (attached) Medical professionals should be involved to evaluate the system and make sure that more good, than harm, results from use of the overlay.

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The latex tubing, even when not being alternately cycled, is similar to cushion material in compressibility and support characteristics. I doubt that any greater harm will result in the “power off” condition, than results in sitting on a cushion (although this is potentially damaging – as discussed).

IN GENERAL: I am disappointed that suitable products haven’t been developed and marketed to successfully solve these problems, but optimistic about the results we have achieved so far. A person who is suffering from decubitis ulcers, with the accompanying pain, suffering, loss of what limited mobility they had, and anxiety over the potential of sepsis and possible death would likely pay any price. I don’t know what the market will bear, but I do know that the U.S. spends $1 billion annually on treatment of pressure sores – not to mention the increasing litigation and suits directed toward institutions for allowing a preventable condition to develop. There is probably a favorable cost/benefit ratio buried in these numbers somewhere that can be used to support sales and marketing of the product. The bed overlay is similar to the cushion system except obviously larger. The low profile and relative firmness should provide a viable option for hip fracture and surgery patients that can’t tolerate the movement induced, and instability, of conventional air beds. SUMMARY: Repeating from “KNOWN”. - there are no cushions available that are safe for prolonged sitting by a paralyzed person. Ref: Mooney et al. “Pressure Distribution in seat Cushions” – Bulletin of Prosthetics Research I believe that this device has ethical and commercial merits, and should be developed and manufactured to reduce the damage and costs associated with the occurrence of pressure sores among the infirmed population. Please feel free to share this information, or consult with others that may be interested in the furtherance of these goals. Thank you for your consideration of this subject; Myron Zarry If you would like to see a demonstration of the prototype, let me know.

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