“Radiation Exposure Self Test (Rest) – Optimized Personal Dosimetry and Kiosk for Reliably Indicating Exposure to Radiation” in Patent Application…
"Radiation Exposure Self Test (Rest) - Optimized Personal Dosimetry and Kiosk for Reliably Indicating Exposure to Radiation" in Patent Application Approval Process
By a
This patent application has not been assigned to a company or institution.
The following quote was obtained by the news editors from the background information supplied by the inventors: "(1) Field of the Invention
"The present invention relates to a radiation exposure test and, more particularly, to a system and a method for a radiation exposure self-test (REST) that provides a near real-time, rapid and accurate indication of radiation exposure.
"(2) Description of Related Prior Art
"Billions of dollars are spent in the development of medical and nonmedical countermeasures that are directed at counteracting the consequences of an intentional attack by an improvised nuclear device. As is well known in the art, when a victim/patient is exposed to ionizing radiation, such as that emitted as a result of the intentional detonation of a nuclear device, it is highly advantageous to administer medical countermeasures and/or medical treatment as close to the time of exposure as possible. That is, it is generally acceptable and advisable to administer such medical countermeasures and/or medical treatment to counteract exposure to radiation within 24 hours so as to increase the probability that such medical countermeasures and/or medical treatment will decrease morbidity and mortality of potential patients. Personal dosimetry is of particular importance as direct in-vivo or direct physiological indicators, at present time, with current technology measure delayed manifestations such as chromosomal aberrations and white blood cell counts. In fact, even people who will eventually die from ARI in the hours and days after exposure will be asymptomatic and without significant physical complaints in the first few days after exposure, thereby missing the time frame when medical counter measures (MCM) would be most effective.
"It is contemplated that detonation of an improvised nuclear device, within an urban area, could easily impact over 1 million potential patients as cited in the DHS planning scenarios. It is to be appreciated that up to ten or more times that number of victims may actually show up for testing. Such detonation would result in immediate deaths due to traumatic injuries, burns and acute radiation illness. Widespread destruction could lead to panic and civil unrest. Radioactive contamination and continued exposure, through ingestion and inhalation of radioactive particles, would present ongoing medical and environmental issues. There also could be a significant loss of critical infrastructure such as command and control, hospital and resource buildings, communications, power, and water due to immediate destruction, contamination and electromagnetic pulse damage, thereby limiting, or severely hindering at the very least, the ability of the local, state and federal authorities to provide necessary care for the potential patients in need of life-saving medical intervention and/or treatment.
"It is further recognized that popular and urgent national research objectives to obtain in-vivo measurements in fingernails and teeth are fundamentally and significantly flawed. For example, in terms of obtaining accurate and timely measurements in the in-vivo environment and the sub-optimal nature of the matrices, it is highly unlikely that these systems will be utilized effectively in a true mass casualty incident, and the measurements obtained are not a direct measurement of physiological response, rather a measurement of sub-atomic changes occurring within inert materials within the body. This enormous effort to 'over build,' fueled by misguided perceptions, is truly a national crisis that is adding millions of dollars to the national budget and is causing delays in the development of a system that would potentially save countless lives in the event that a nuclear mass casualty incident were to occur.
"A significant amount of the current effort underway is focused on developing technologies that take in-vivo measurements from, either a tooth or fingernails. In-vivo versus in-vitro testing is usually done to determine the clinical impact on a living organism bases on the actual response of the body or tissue, for example. In the case of in-vivo measurement of teeth or fingernail(s), there is no direct indication of clinical response of the body that could not be obtained from an external measurement of a driver's license, a credit card or some other measurable material carried in close proximity to the body of an individual. This distinction, by itself could save many billions of dollars in the final costs of implementing, development, building, deploying and eventual
"In public health, the term 'herd immunity' is used to describe a large enough group that has become immune--usually through vaccination--so that the few members that are not vaccinated have an extremely unlikely chance that they will ever come in contact with an infected member, therefore, halting the spread of an infectious disease. With radiation exposure, the term 'herd exposure' could be utilized. In this case, by measuring enough potential patients within a certain area, via a rapid self-test procedure, then at some point, a determination could be made that within this group, testing can be discontinued with confidence that no immediate medical care needs to be given or, at the other extreme, that more medical resources are required to be moved to a specific area based on the number of positive tests.
"During the time of such a nuclear detonation or any other similar mass disaster, it is believed that there will be a significant need to accurately identify, screen, triage, and gather data from thousands, if not hundreds of thousands, or millions of potential patients over a very short period of time, optimally 24 hours.
"Further, there may also be a need to identify, screen, then triage the entire population of citizens residing within a certain radius (e.g., a 2 mile radius, a 5 mile radius, a 10 mile radius, a 20 mile radius, etc., depending upon the size of the nuclear detonation and environmental conditions) of ground zero of the nuclear detonation in order to determine which potential patients require immediate medical attention and which potential patients, due to either limited, minimal or possibly no exposure to the radiation, may defer medical attention or receive the necessary support or preventative treatment within a few days or possibly a few weeks, for example, or may not require any medical countermeasures, medical treatment or any attention at all. Moreover, given that the population that may be affected by such a mass disaster could conceivably amount to 1 million or more potential patients, the current medical screening and triage processes are generally unacceptable and insufficient to handle such a large volume of potential patients within such a short duration of time, e.g., within 24 or 48 hours, for example, of the nuclear detonation or some other similar disaster.
"A mean lethal dose of radiation, which typically kills 50% of human beings within sixty (60) days, is a whole-body radiation dose of typically between 3.25 to 4 Gy when, following exposure to such radiation, the victim/patient does not receive any medical care or treatment. However, if the victim/patient receives medical care and attention, such as myeloid cytokines, G_CSF, supportive care, antibiotics, anti-nausea medicines, bone marrow transplants, for example, following whole body exposure to radiation of a dose greater than about 2-3 Gy, then the patient has a higher probability of surviving such radiation exposure. The ability to rapidly self test individual patients within a very short period of time, i.e., 15 seconds per test per person would allow near real time allocation and distribution of resources to the patients most requiring urgent care. Further, depending on available resources, it is generally accepted that a whole-body dose of radiation of greater than 8-10 Gy is likely to be lethal to any victim/patient in a mass casualty setting.
"Researchers are currently developing and testing equipment to measure dose levels in the tooth enamel and fingernails of potential patients of a radiological or a nuclear catastrophe, including a terrorist attack. At present, such test equipment is relatively large, bulky, sensitive to vibrations and temperature, difficult to operate, subject to in-vivo variations, and victim/patient movement. Each measuring device must be operated by specifically trained personnel, and typically requires a scan or data acquisition time of over 5-10 minutes. In addition, the additional time associated with removing the previous victim/patient, fitting new victim/patient, removing and putting on a new pair of gloves, gathering and adding disposables, readjusting tooth or fingernail placement, taking additional universal precautions against infectious disease and allowing additional time for patient movement and re-test if the patient moves significantly during the test procedure, could bring the total cycle time for each patient to typically between at least 10-15 minutes. Many times the patient must be rescanned in order to obtain more accurate data and assess confounding factors such as discolorations, moisture content, recent fingernail clipping and co-existing illness, for example. Infant or younger pediatric patients who may also be preferentially exposed, would typically be unable to remain still for such long scan times or may not have sufficiently developed teeth (for example, deciduous teeth may be too small for an accurate measurement). Likewise, elderly patients or those with significant prior dental work may not be eligible for this test and are less likely to accurately describe symptoms. Lastly, the associated test equipment is fairly expensive, with an estimated cost of several hundred thousand dollars, and, as noted above, is delicate, large and requires specially trained personnel to operate.
"Even if the current in-vivo fingernail or tooth test equipment were operationally viable, and logistically considerations such as high replacement and storage costs were appropriately addressed, the difficulty of moving delicate and bulky equipment, expendables, such as magnetic coils, plastic coverings,
"Generally speaking, there is a concern relating to two types of exposure: acute and chronic. An acute exposure is a single accidental exposure to a high dose of ionizing radiation over a short period of time directly resulting in acute radiation illness when exposure is high enough. An acute exposure has the potential for producing both nonstochastic and stochastic effects. Chronic exposure, which is also sometimes called 'continuous exposure,' is long-term, low level overexposure. Chronic exposure may result in stochastic health effects and is likely to be the result of improper or inadequate protective measures. As is well known in the art, there are three basic ways of controlling exposure to harmful radiation, namely, 1) limiting the time spent near a source of radiation, 2) increasing the distance away from the source, 3) and using shielding to stop or reduce the level of radiation. In addition, the radiation dose is directly proportional to the time spent in the radiation. Therefore, a victim/patient should not stay at or near a source of radiation any longer than is absolutely necessary. The following equation can be used to make a simple calculation to determine the dose that will be or has been received in a radiation area.
"Dose=Dose Rate.times.Time.
"It is to be appreciated that increasing distance from the source of radiation will reduce the dose of ionizing radiation received by a victim/patient. That is, as the radiation travels from the source, the radiation spreads out and becomes less intense. This phenomenon can be expressed by an equation known as the inverse square law, which states that as the radiation travels out from the source, the dosage decreases inversely with the square of the distance.
"Inverse Square Law: I.sub.1/I.sub.2=D.sub.2.sup.2/D.sub.1.sup.2
"As noted above, shielding is a way to reduce exposure to radiation. Generally, the denser the shielding material is, the greater the protection that will be provided by the shielding material. For example, depleted uranium and other heavy metals, like tungsten, are very effective in shielding radiation because their tightly packed atoms make it difficult for radiation to travel through the material without interacting with the atoms. Lead and concrete are the most commonly used radiation-shielding materials primarily because they are easy to work with and are readily available materials. Concrete is commonly used in the construction of radiation vaults.
"As evident above, a continuing need exists for a radiation exposure self-test that will provide a near real-time, rapid and accurate indication of radiation exposure."
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent application: "Wherefore, it is an object of the present invention to overcome the above-mentioned shortcomings and drawbacks associated with currently available prior art indicating, and screening and triaging systems, methods and techniques.
"Another object of the present invention is to provide a portable, noninvasive self-testing test device and method that permits a significant number of victims/patients to self-screen themselves, e.g., self-screen a fingernail within a relatively short duration of time, e.g., within less than 1 minute (total cycle time) and more preferably self-screen themselves utilizing an Optimized Personal Dosimeter (OPD) in about 10-20 seconds while still obtaining reliable test results concerning each such patient's exposure to radiation.
"Still another object of the present invention is to incorporate the noninvasive self-testing test device, e.g., such as a fingernail, a driver's license, both non-invasive into a lightweight, portable kiosk that can be regionally staged and readily transported to a desired location for use. Preferably, the kiosk will have multiple power options including battery-operated as well as have wireless telecommunication capabilities so that the noninvasive self-testing test device is able to operate without being supplied with electrical power or hard wire for communication.
"A further object of the present invention is to quickly provide the victim/patient substantially instantaneously with his/her self-testing results in a way that is easily and readily visible to the victim/patient and the treating medical personnel, upon completion of the self-testing test, so that the victim/patient can be informed as to whether immediate medical countermeasures and/or medical treatment is required for the victim/patient or whether medical countermeasures and/or medical treatment can be delayed for a relatively short duration of time, e.g., a few days to a week or so, so as to permit the other, more seriously irradiated potential patients, to be treated first. This will allow the patient to make an informed decision regarding their care utilizing the readings that are readily available.
"A primary object of the present invention is to provide a system and a method that assists with self-testing by the potentially exposed potential patients so as to free up the limited available nonmedical and medical staff, medical equipment, countermeasures, transportation resources, hospital beds, etc., so that the nonmedical and medical staff can devote their attention to administering medical countermeasures and/or medical treatment to the potential patients requiring immediate medical attention.
"Yet another object of the present invention is to provide substantially instantaneous results, to the self-screened victim, so that a majority of the population, who may have only been exposed to clinically minimal doses of ionizing radiation (e.g., less than about 1-2 Gy for example) can be placed at ease and thereby minimize the possibility of public panic and civil unrest that would otherwise accompany a nuclear detonation, or a similar destabilizing disaster.
"A further embodiment of the system should be to measure and record the lower doses of less than 2-4 Gy in increments of approximately 0.1 Gy to support military combat readiness and deployment decisions and non military exposures for long term follow-up, and continued monitoring for continuing exposure or re-exposure.
"A still further object of the present invention is to quickly, reliably and accurately facilitate self-testing of the exposed and potentially exposed population so that the potentially exposed population can be readily and quickly segregated and triaged into at least two of groups, namely (1) a first group of potential patients who were exposed to a clinically significant dose of ionizing radiation (e.g., exposed to a dose of ionizing radiation greater than 2 Gy, for example, and thus most likely require immediate medical countermeasures and/or medical treatment), and (2) a second group of potential patients who were not exposed to a clinically significant dose of ionizing radiation (e.g., only exposed to a dose of ionizing radiation less than 1-2 Gy, for example and thus most likely do not require any immediate medical countermeasures and/or medical treatment. In this way, the available medical resources, in near real time, (e.g., the medical and support personnel, the medical countermeasures, the medicines, etc.) can be more efficiently and expeditiously utilized for treating only patients exposed to a clinically significant dose of ionizing radiation and thereby increasing the probability that a majority of those treated patients may successfully respond to the administered medical countermeasures and/or medical treatment. That they do not require immediate medical care may assist with maintaining evacuation and facilitate directing necessary potential patients to local hospitals, shelters and
"A further object of the invention is to provide a vast majority of citizens with an optimized card (e.g., a driver's license, a voter ID card, an employee ID card, a college/student ID, a bank or other credit card, a dog tag, etc.) that will generally be carried within the general population a majority of the time and contains a substrate embedded in the plastic matrix, added as an additional layer of film, strip, pellet or area of dense concentration, that is designed to absorb and retain varied radiation exposure and change physical characteristics so that such substrate can be an accurate indicator of the dose of ionizing radiation that the potential victim/patient has been exposed to acutely and over the lifetime of the victim. The substrate/matrix could also maximize measurement of different particles or energy levels seen in radiological exposures, and previous exposure readings will be stored for lifetime cumulative doses or environmental or occupational exposure.
"Still another object of the present invention is to incorporate the noninvasive self-testing test device, according to the present invention, into a relatively lightweight, easily deployable and portable kiosk (e.g., preferably weighing less than 30 pounds and more preferably weighing about 10 pounds or less) of which a majority of the population is quite familiar with and can be readily used to administer the self testing of the potential victim/patient in a quick and convenient manner. All of the associated components, including a suitable power supply such as a battery as well as a wireless transmission transmitter and receiver, are contained within the kiosk and thereby this facilitates ease of transport and set up by personnel.
"Yet another object of the present invention is to provide each of the noninvasive self-testing test devices with the number of power imports to facilitate either recharging of the internal power supply or battery and/or the continuous supply of electrical power thereto.
"A still further object of the present invention is to facilitate ease of cleaning of the noninvasive self testing test device, following each use, so as to prevent or minimize generation of any false reading(s). Further, each noninvasive self-testing test device will have the capability of verifying and calibrating the test results to facilitate further triaging of each victim/patient following self-testing by the noninvasive self-testing test device.
"Another object of the present invention is to incorporate a magnetic strip, a chip or some other conventional informational, visual or data/electronic storage mechanism or device on or into the OPD so that such information or data can be easily and accurately read during the self-testing, and thereby provide medical personnel with the desired relevant information relating to the potential victim/patient, e.g., the street where the victim/patient resides, the sex of the victim/patient, the year in which the victim/patient was born, etc., without violating any of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules and Laws. Such information may be very useful in determining an area or areas of a city, town or region in which a majority of the population was exposed to a clinically sufficient dose of ionizing radiation so that such information may be utilized to assist with triaging of any victim(s)/patient(s) who did not have his/her designated card in his/her possession at the time of possible exposure to radiation. Such victim/patient can then merely indicate where he/she was located, at the time of the incident, and the medical personnel can then make an educated determination of whether or not either immediate medical countermeasures and/or medical treatment are required for such victim/patient or whether such medical countermeasures and/or medical treatment may be delayed. It is important to note that due to the EMP of a blast, embedded chips and other infrastructure may be damaged and therefore each kiosk reading may be limited to the exposure reading only from the OPD.
"Still another object of the present invention is to facilitate communication (e.g., preferably wireless communication or by direct connection via electrical wires) between each one of the noninvasive self-testing test devices and a wireless control center to facilitate the exchange of information as well as facilitate control and/or modification of the radiation threshold of each one of the self-testing test devices, in real-time, so as to facilitate more efficient triaging and allocation of resources of the potential patients which may have been exposed to radiation.
BRIEF DESCRIPTION OF THE DRAWINGS
"The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate various embodiments of the invention and together with the general description of the invention given above and the detailed description of the drawings given below, serve to explain the principles of the invention. It is to be appreciated that the accompanying drawings are not necessarily to scale since the emphasis is instead placed on illustrating the principles of the invention. The invention will now be described, by way of example, with reference to the accompanying drawings in which:
"FIG. 1 is a diagrammatic perspective view of a designated card containing a first substrate of retaining and indicating any exposure to high-energy radiation and a second substrate capable of retaining and indicating any exposure to low-energy radiation, with an integral magnetic strip;
"FIG. 1A is a diagrammatic perspective view of a designated card that has a combined substrate containing both a first substrate capable of retaining and indicating any exposure to high-energy radiation and a second substrate capable of retaining and indicating any exposure to low-energy radiation, with an integral magnetic strip;
"FIG. 2 is a diagrammatic front elevational view showing a slight variation of the designated card, according to the present invention, and FIG. 2A is a right side elevational view of FIG. 2;
"FIG. 3 is a diagrammatic view of a noninvasive self-testing test device, according to the present invention, in a first loading position for receiving the designated card that contains both the first and the second substrates, for self screening to provide a reliable indication of whether or not the victim/patient to whom that designated card was issued, was exposed to a clinically sufficient dose of ionizing radiation;
"FIG. 3A is a diagrammatic view of the noninvasive self-testing test device, according to the present invention, in a second scanning position in which the designated card is inserted within the noninvasive self-testing test device for determining exposure of the first and/or second substrates to radiation and simultaneously reading the magnetic strip contained on the card--the measurement device may be, for example, an electron spin resonance spectrometer, an optical spectrometer, or a MOSFET-based electronic dosimeter;
"FIGS. 4, 4A and 4B respectively show an alternative embodiment of the noninvasive self-testing test device, according to the present invention, in a first loading position for receiving the designated card, in a second scanning position for scan the data contained on a conventional magnetic strip, and in a third reading position for scanning, via a radiation detection head, of the radiation exposure of the designated card;
"FIG. 5 is a diagrammatic view of showing a location where a nuclear detonation, e.g. a nuclear event, occurred and a radiussed area, a safe distance away from the nuclear detonation, diagrammatically showing a plurality of peripheral sites that were temporarily set up to assist potential patients with self-testing of their designated cards to determine exposure of his/her first and/or the second substrates, contained on or incorporated into the designated card, for determining whether or not such victim/patient was exposed to a clinically sufficient dose of ionizing radiation;
"FIG. 6 is a diagrammatic view showing a typical arrangement for one of the plurality of peripheral sites in which each site is equipped with a plurality of the kiosk style noninvasive self-testing test devices to assist each potential victim/patient with self-testing of his/her designated card to determine the exposure of the first and/or second substrates (contained on the designated card of the victim) to radiation and assist with evacuating, sheltering and triaging all of the potential patients being self-screened into at least two groups of patients, and possibly three or four groups; and
"FIG. 7 is a diagrammatic depiction of a medical treatment area, either located as part of, adjacent to or not far from one or more of the plurality of peripheral triage sites, to which the potential patients who were determined as being exposed to a clinically significant dose of radiation are directed for administration of medical treatment."
URL and more information on this patent application, see: Gougelet, Robert M.; White,
Keywords for this news article include: Patents, Hospital, Legal Issues.
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