Test
Results for EverLift RemovEze Removal Force
Study
In 2004 an outside consultant, Medical Device Designs Incorporated of Madeira Beach, Florida was engaged to quantitatively evaluate Xennovate Medical’s design concept
for reducing the
removal force of a hydrocolloid, while concurrently
minimizing the loss of adhesive force.
This consultant employed a study model developed by him two decades earlier. His model employs the forearm of test subjects, and he has often demonstrated the value of using live skin over stainless steel, the so-called “standard” stainless steel test. In this expert's opinion the stainless steel test does not effectively evaluate the adhesion effects on live skin.
His first test employed Xennovate's standard integrated xm18C formulation with a polyurethane film one mil thick on one side. A series of “sandwiches” were then made
and samples were
tested to determine the optimal location of the
apertured-opening net material (“Tulle”) in
the sandwich. The test results
unequivocally demonstrated that the netting needed to be
as close to the skin as possible to maximize the
reduction in removal force.
A second study was then conducted to quantify several manifestations of the design when the Tulle was merged with the xm18 at the skin surface. The standard of comparison, plain (non-netted) xm18, was identical to the Xennovate laminate in all aspects except for the Tulle on the skin-side surface of the xm18. While a variety of Tulle design’s were employed, with the optimum being a Tulle design with no elongation in the direction of removal. Multiple samples of that Xennovate laminate demonstrated reduced removal forces over 30% (sample measured 70 gm/in compared to the standard of 105 gm/in). The measured amount of “lost” adhesive surface contact due to the Tulle is less than two percent (2%).
Since these tests were completed, xm18(t1) and xm18(t2) formulations with increasingly greater skin adhesion have been developed should our customers have an application requiring fine tuning the removal forces. Additionally, we could employ Tulle with more openings/inch to further reduce the removal force required for an established adhesion force. In short, we stand ready to work with our OEM
or converter
customers to create customized solutions for their
customers’ problems.
Finally, our shear forces have been demonstrated to be extra-ordinary. The strength of our product in this category enables it to remain in place on the patient without accidentally being removed while sleeping, for example.
In 2004 an outside consultant, Medical Device Designs Incorporated of Madeira Beach, Florida was engaged to quantitatively evaluate Xennovate Medical’s design concept
This consultant employed a study model developed by him two decades earlier. His model employs the forearm of test subjects, and he has often demonstrated the value of using live skin over stainless steel, the so-called “standard” stainless steel test. In this expert's opinion the stainless steel test does not effectively evaluate the adhesion effects on live skin.
His first test employed Xennovate's standard integrated xm18C formulation with a polyurethane film one mil thick on one side. A series of “sandwiches” were then made
A second study was then conducted to quantify several manifestations of the design when the Tulle was merged with the xm18 at the skin surface. The standard of comparison, plain (non-netted) xm18, was identical to the Xennovate laminate in all aspects except for the Tulle on the skin-side surface of the xm18. While a variety of Tulle design’s were employed, with the optimum being a Tulle design with no elongation in the direction of removal. Multiple samples of that Xennovate laminate demonstrated reduced removal forces over 30% (sample measured 70 gm/in compared to the standard of 105 gm/in). The measured amount of “lost” adhesive surface contact due to the Tulle is less than two percent (2%).
Since these tests were completed, xm18(t1) and xm18(t2) formulations with increasingly greater skin adhesion have been developed should our customers have an application requiring fine tuning the removal forces. Additionally, we could employ Tulle with more openings/inch to further reduce the removal force required for an established adhesion force. In short, we stand ready to work with our OEM
Finally, our shear forces have been demonstrated to be extra-ordinary. The strength of our product in this category enables it to remain in place on the patient without accidentally being removed while sleeping, for example.