By John D. Perry, PhD, Inventor
The combination
blood-flow sensor ("photoplethysmograph") and muscle activity sensor
("electromyograph") was first developed to investigate the mechanisms of sexual
arousal. Along the lower edge of the sensor barrel a single longitudinal
silver EMG electrode is visible. (Two other long silver electrodes are located at 90
and 180 degrees behind the sensor body.) Above the electrode, the dark circle of a
photocell aimed at the vaginal wall is visible. To the left of the photocell, the
white base of a miniature incandescent lamp is visible. A five-pin DIN plug was
molded into the base. An insertion stop, right, prevents the sensor from going too
far into the vagina, and a retaining bulb, left, helps to prevent it from falling out
during contractions.
The manufacturing
simplicity of circular electrodes was explored with this prototype device, made and tested
in 1975. Unfortunately, the device proved relatively insensitive to pelvic muscle
contractions. In a 1991 article, Binnie et al came to the conclusion that circular
electrodes were not suitable for EMG work, while longitudinal electrodes provided
virtually identical information to the traditional inserted needle electrodes. The
"sub" shape proved unstable, as the device was expelled like a missile
on
contraction.
The circular
electrodes soon gave way to longitudinal ones, shown here in a clear acrylic sensor which
reveals their construction [1976]. Two of the three electrodes are visible here. The
retaining bulb has been made larger, and the insertion stop is also bigger. This
sensor was made in a mold, carefully created by mating two small doorknobs and a central
cylinder. "Hobby" epoxies, used to make trinkets and novelties, were used
for the construction. Later, a dentist suggested using pink denture acrylics
The first 50 vaginal
EMG sensors were hand-made, in plaster molds, on a kitchen counter between 1976 and 1981.
Most users were research psychologists involved in biofeedback. Note the
irregularities on the color and the poor seal of the electrodes. This one was made
for Elizabeth Noble, PT, about 1977, and was used for several years before being replaced
(to take it out of sight and circulation!) with a brand new sensor (next below).
In 1981 the inventor
was approached by William Farrall, a manufacturer of specialized scientific instruments.
Farrall began to make highly polished, refined sensors in his Nebraska factory.
Unfortunately, a high failure rate (over 50%) due to surface imperfections caused
the price to rise to $250, and eventually $450 a decade later. More than a thousand
of these sensors were hand-made by one woman who worked in Farrall's factory. These
sensors were designed to be cold-sterilized in "Cidex" and used forever.
After refining the
vaginal sensor (above), Farrall starting making anal sensors as well (right). This
allowed treatment of female children considered too young for vaginal placements, and of
men of all ages. The growing awareness of the problem of post-prostate surgery
incontinence, and of the treatability of fecal incontinence and functional constipation
("anismus") led to a high demand for these devices starting in the mid 1980s.
The Evolution of the Single-User Sensor
The use of insertable sensors to treat pelvic muscle disorders had barely gotten of the scientific ground when the first epidemics of genital herpes created (totally unfounded) fears of the use of sterilized sensors, and the need for a "single-user" sensor became obvious.
In 1984 the inventor
met William Benton, founder of Verimed, Inc. who said "I can make that for you to sell
for $19.95!". We formed EMG Sensor Corporation as a joint venture, and in late
1985 two large crates containing 2,000 sterilized, individually-wrapped sensors arrived in
Philadelphia. Final quality check found several "defective" sensors, so
100 bags were opened and tested -- with a 20 percent failure rate. Upon
investigation, it was learned that excessive solvent glue had penetrated the pressure-fit
internal connections and had often "insulated" the bare wires inside. The
first batch could not be sold. [Later, they would be used as decorations for a
Christmas Tree.]
Eventually, the manufacturing problems were solved -- at great expense to Verimed --
and the Single-User Sensor
reached
the market -- at $149.95, more than seven times the original target. The three
plastic parts had to be extensively modified by hand before assembly. Wires were
spot-welded to the electrodes for better reliability. The Single-User Sensor was
immediately a success, and many thousands were sold in the US and Europe. In an
attempt to lower the consumer cost, the original molds were purchased from Verimed, but
production problems continued. A plea for help went out.
In December 1992 Self-Regulation Systems of Redmond, Washington, agreed to invest the
$50,000+ needed to create an
entirely
new mold (one which would not require expensive hand-finishing work). After the
AHCPR issued its favorable Guideline on Incontinence in March, 1992, the demand for
sensors increased dramatically. Many clinicians could not obtain any insertable
sensors for several months, and began to substitute surface patch electrodes instead.
Finally in April, 1994 SRS announced production of their new single-user sensors --
priced at $59.95 (Quantity 5).
Over the years many attempts have been made to create
a replacement for the
original sterilizable sensors made by Farrall Instruments from 1981 to 1993. A
retired jeweler and instrument maker helped design and hand-crafted several experimental
sensors. This one (left) includes a central catheter hole for use with a deep vaginal
pressure balloon to measure inter-abdominal pressure (based on a paper by Molly Doroghty.)
German researcher Dr. Paul Enck wanted a
longer, narrower anal EMG sensor to use with obese fecal incontinence research
subjects; several of these "T-Bar" sensors (right) were made in 1988 for his
research. These experimental designs were shown at the 1989 AAPB convention.
Five years later Thought Technology, Ltd., introduced a "T-Bar"
sensor of very similar design.
Last revised on May 04, 2005
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