Playa de los Vivos S.A.
Aptd. 6, Paquera Phone & Fax: 011-506-683-0095
Puntarenas, Costa Rica
Central America
heartnet@racsa.co.cr
www.scoti2.com
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Playa de los Vivos S.A. |
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We have developed some new products that we feel could develop a very large world market. Prototypes have been made and tested on animals and humans. A U.S. patent has been issued and patents are pending in Europe. We have already done two test production runs manufacturing the entire product here in Costa Rica. We already have the injection molds for the case. This project is progressing well and the results so far have been very encouraging.
We are seeking contractual marketing relationships with firms in the United States and Europe and possibly other areas.
Background
Heart Akerson was born in the United States
50 years ago. He did his undergraduate studies at Virginia Polytechnic
Institute and his graduate work at University of Oregon both in Physics.
He founded Heart Interface Corp. www.heartinterface.com
initially in Costa Rica but early in its development moved the company
to Kent, Washington where it still resides. This company builds Power
Inverters and Uninterruptable Power Supplies which are protected by his
patents. He acted as CEO and President and sold it five years ago.
It is still operating with annual sales of over $20,000,000.
He now operates a research & development
facility (Playa de los Vivos S.A.) in Costa Rica and has a relationship
with a top quality electronics assembly plant (Espion S.A.) also in Costa
Rica. Espion is a subsidiary of C & K Components, Inc. of Newton,
MA who also has factories in England, Taiwan, Hong Kong and Mainland China
as well as several factories in the USA. Espion is registered with
the F.D.A. Their registration number is #9680310 and their owner/operator
I.D. is #9008112. The present goal is to continue to focus on development
of innovative products which combine physical principles with modern electronics.
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Sonomatic Confirmation Of Tracheal Intubation (SCOTI)
The Problem
Undetected Esophageal Intubation remains
one of the biggest risks to anesthesiology today. Capnography has
improved things in the operating rooms in the United States somewhat but
will probably never become commonplace in the operating rooms in most countries
because of its high cost, about $8,000 to $10,000. It also will probably
never be used in ambulances and “crash carts” in hospitals also because
of its high cost. These emergency intubations generally are done
by less experienced people and the patients are already under more stress
and can tolerate intubation problems for less time.
Even in operating rooms equipped with Capnography equipment the anesthesiologist must connect the respiration equipment after the intubation and wait for 4 or 5 breaths to interpret the result. If it appears the tube is not in the trachea, then the respiration equipment must be disconnected and the intubation tried again. If the geometry of the patient is such that the anesthesiologist can’t get a good view of the glottis then this “hit and miss” method of intubation could use up a lot of precious time when the patient is receiving no oxygen. Since Capnography gives no information while the intubation is actually happening it doesn’t really help with a difficult intubation, it just confirms the results. In addition, in a cardiac arrest, there will be no carbon dioxide exhaled and thus Capnography will not indicate that the tube is in the trachea even if the intubation was done correctly. This is the case in a high percentage of the emergency intubations!
When Capnography isn’t available there are other less reliable methods such as listening for breath sounds but they all also require that the patient is being actively respirated and use up similar amounts of precious time. Because so many intubations go smoothly there is a tendency for them to become routine and make the anesthesiologist overconfident and ignore symptoms and information until it is too late.
More recently disposable carbon dioxide detectors have been on the market to address some of these problems but have had some problems with recently ingested carbonated beverages and also require the patient to be actively respirated for 4 or 5 breaths after the intubation before producing a reliable result. This, like Capnography, will not work with a cardiac arrest.
These commonly used methods of detecting
esophageal intubation entail quantities of gas being pumped into the stomach
which could provoke regurgitation and aspiration of gastric contents.
Another method which uses a syringe to
detect the esophagus’s tendency to restrict airflow has been developed.
To date this (Esophageal Detection Device) has been marketed some but requires
a somewhat tricky process to be performed by the operator.
This method still only indicates tube position after the intubation is
done not while it is happening.
To date no one has developed a system that actually tells you what you need when you need it, i.e. instant indication of whether the tube is in the trachea or in the esophagus while the intubation is happening!
The Solution
SCOTI is a small battery operated device
that connects to the end of the tracheal tube during intubation.
It produces sounds in the normal audio range and determines whether the
tube is in the trachea or the esophagus with special algorithms.
The result is displayed with a light which is green when the tube is in
the trachea and red when it is in the esophagus. The color of the
light is updated 10 times a second so the perceived feedback is instant
and continuous allowing for the anesthesiologist to make many rapid “trial
and error” intubation attempts in a few seconds, a process which would
take several minutes without this device. After the intubation SCOTI
is disconnected and put away. This is the first device which can
actually help with the intubation process while it is happening!
In addition, the device also has an LCD readout which displays a number
between 0 and 100 which allows the operator to interpret the output of
the algorithm himself. This also allows for large amounts of data
to be gathered in the field which could be used to improve the device.
SCOTI also contains an audible indicator that gives the operator the information
of the lights and LCD. SCOTI automatically configures itself when
it is turned on to operate with whatever size tube and attachments that
are hooked to it.
| SCOTI is currently 145.0mm X 63.5mm X
62.5mm and weighs 300 grams. A proprietary disposable bacteria filter with
corrugated tube and fittings is used to avoid the risk of contamination
between patients and to minimize the weight in the operators hand.
With this disposable circuit connected SCOTI can sit on the operating table
by the patient’s head, be strapped to the operators arm or belt or be held
by an assistant. The common 9 volt battery will last several weeks
in an operating room and will indicate when it is getting low with enough
charge left to do a typical days work.
The 510(k) application with the FDA is
in the process and should be fairly straightforward since it is a non-significant
risk device.
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Barriers to Competition
A United States Patent has been issued
#5,331,967. An application has been filed under the Patent Cooperation
Treaty for Europe.
Over 95% of the circuit exists in a Programmable Gate Array making reverse engineering extremely difficult. This also allows for future upgrades without changing any of the parts or the circuit board. It only requires changing an inexpensive PROM and could even be done in the field.
The contents of this PROM are protected by software copyright laws.
This could be manufactured inexpensively and sold for a low enough price to discourage competition.
The Market
This could be sold as an excellent complement
to Capnography for operating rooms in the USA. Its low cost would
warrant its use on “crash carts” and ambulances. The average hospital
would probably require 10 for operating rooms and 20 for “crash carts”.
Notice that the “crash carts” actually make up the biggest part of the
market. This should be an easy sell since “crash carts” don’t use
Capnography and generally have less experienced people doing the intubations.
Ambulances, emergency rooms and paramedics would also be ideal markets.
It could easily be imagined that SCOTI would eventually be required in
most hospitals much as Capnography has been required. With the current
push to make health care more affordable a $600 device that could potentially
have more impact on intubation problems than $5,000 to $10,000 Capnography
equipment would be well received.
Internationally the market would be further enhanced by the tighter budgets which rule out Capnography. In fact, this device would probably supplant Capnography sales where they were marginally affordable.
Testing
SCOTI has been tested in the USA on animals
and clinical trials have been performed in the emergency rooms of six hospitals.
In Costa Rica there have been clinical trials in operating rooms.
Each patient has an intentional Esophageal intubation and then a tracheal
intubation to compare the results. The results have been excellent.
Tests have been done which simulated patients with difficult geometry’s
by not exerting enough pressure on the Laryngoscope to see the glottis.
SCOTI was used to do a “blind “ intubation and then more pressure was exerted
on the Laryngoscope to confirm the results. The American Anesthesiology
Association granted SCOTI a scientific exhibition booth at their annual
convention in San Francisco in October of 1994. The product was very
well received by anesthesiologists from all over the world.
Similar tests have been completed at John Radcliff Hospital in Oxford, England and St. Barts Hospital in London, England. Both these tests have confirmed the same positive results and have also be published.
A multicenter clinical trial was conducted in the Emergency Rooms of several Hospitals in the United States. So far there have been 664 tracheal intubations and 345 esophageal intubations proving its effectiveness.
SCOTI
Playa de los Vivos has developed and is
continuing to develop products which determine whether an endotracheal
tube is in the trachea or in the esophagus by using physical principles
with sound waves. A U.S. Patent has been issued #5,331,967 with the
title “Tracheal Intubation Monitoring Apparatus and Method” by Steve Heart
Akerson. In addition to the U.S patent SCOTI is protected by patent
#EP 0 684 785 B1 in Europe.The patent attorneys are:
Baker & Botts Phone:202-639-7700
Attn: James B. Arpin
FAX: 202-639-7890
The Warner
1299 Pennsylvania Ave., N.W.
Washington, D.C. 20004-1109
More Information
See the SCOTI web page at www.scoti2.com
for more information and an interactive computer simulation of SCOTI.
Email us at heartnet@racsa.co.cr
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We look forward to hearing from you.
Dr. Heart Akerson
President