Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-09-15
2001-05-15
Lateef, Marvin M. (Department: 1911)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S534000, C600S595000, C343S823000, C343S718000, C343S755000, C343S757000, C343S761000, C343S772000
Reexamination Certificate
active
06233479
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the detection of blood pooling near the surface of the body, and more specifically, it relates to technology for the diagnosis of sub-dural or epi-dural hematoma.
2. Description of Related Art
At present, there is no non-invasive way to check patients for hematoma other than a paramedic's verbal/tactile evaluation and x-ray computed tomography (CT). A hematoma can exist in a patient with few or no symptoms, and can grow rapidly, killing or rendering the patient comatose within as little as 10 minutes.
In one of the current procedures for screening head injury patients, paramedics or first responders to the scene of an accident evaluate the patient state (through questions and observations of the patient's behavior) and the accident situation (degree of damage to cars, height of fall, etc.). In cases of severe head injury or concussion, there exists a ranking system called the Glasgow coma scale. The patient is ranked based on observation of reflex response, eye movement, breathing, ability to speak, etc. The ranking can be quite inaccurate if the patient is drunk or has other injuries that impact the ranking procedure (i.e. severe loss of blood, patient is in shock, blocked airway, etc.).
In another currently used head injury screening procedure, patients with known head trauma or suspected head trauma are then sent for a CT scan. The decision to order a CT scan is done conservatively, i.e., even if it is not clearly warranted. This is a precautionary measure since a patient with a sub-dural or epi-dural hematoma may not present with clear symptoms at the outset. Sub-dural or epi-dural hematoma can cause the patient to lapse into a coma or go into respiratory arrest. Time is the critical parameter in determining mortality or morbidity that will result from the injury.
The cost of a CT scan is high. A typical head scan is about $500-$800, and can cost much more if the patient must be sedated or closely monitored during the scan. In many cases, many scans of a single patient are necessary to monitor the development of his/her condition.
The total time required for a scan is about 15 minutes using a helical scan device (faster than the standard CT scanners). If the scanner is physically located right in the emergency room, this time can go down to 5 -10 minutes. However, the actual time to diagnose a hematoma (or other problem) is usually limited by patient transportation, preparation and the need to have a radiologist read the scan. If the scan must be sent out of the emergency room for reading, the overall time can be between 30 minutes and 3 hours. A hospital may need to do many CT scans a day. At a typical ER, between 70% and 90% of CT head scans are unnecessary—i.e., are done for precautionary reasons and yield a negative result.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a Microwave Hematoma Detector for diagnosing blood pooling near the surface of the body and more specifically near the surface of the head.
It is another object of the invention to provide a low cost, non-invasive, portable device for screening head injury patients for the presence and degree of severity of a hematoma.
The Microwave Hematoma Detector can be used immediately at the scene of an injury by a paramedic or first responder, in the emergency room (ER), in local clinics and in hospital intensive care units (ICU) and operating rooms (OR). It allows rapid testing of patients prior to CT scanning, eliminating unnecessary CT scans, or could replace the use of CT for examining head injury victims. It has the potential for saving many lives and reducing long term morbidity for head injury victims by reducing the time of diagnosis. It allows convenient repeated scans to monitor the growth of a hematoma. It has the potential to greatly reduce the medical costs associated with testing and treating head injury victims, as well as reducing the costs of patient rehabilitation and convalescence by reducing the morbidity resulting from current treatment time delays.
The low-cost, Portable Hematoma Detector could completely replace CT for patient screening in the ER. It also has great value for scanning patients that cannot be given a CT scan due to other injuries. This generally means those who must go directly to surgery, i.e., those with life threatening chest or abdominal injuries. The device can be used in trauma centers because it allows immediate care of severely injured or difficult to handle patients such as children.
The invention can be used as a pre-screening device prior to deciding to get a CT scan. A pre-screening device can reduce the number of unnecessary CT's, thereby lowering costs and freeing up the CT scanner for use on the truly critical patient Pre-screening is also very important particularly with children since it is often the case that a child must be anesthetized in order to complete the CT scan Sedation of a patient is undesirable, very expensive, adds risk to the medical care and adds to the time for diagnosis. Reducing the number of unnecessary (negative result) CT scans is therefore of tremendous value and enables much more cost-effective medical care.
Some uses of the invention include (i) detection of sub-dural or epi- dural hematoma, (ii) detection of pneumothorax (air bubble in the thorax) (iii) detection of plaque (occlusion) in the carotid artery, (iv) determination of the perfusion and/or level of necrosis in skin and “skin flap” grafts, (v) detection of anomalies in composite materials for manufacturing quality control and (vi) finding coatings and/or holes on or near the surface of materials for non-destructive evaluation (NDE). The invention may also be used for detection of blood pooling near body surface, detection fluid in sinuses and detection of fluid in lungs. Assessments may be made of burned tissue, infection, tissue damage, “skin flap ” i.e. tissue grafts such as discontinuity between grafted part and rest of body and perfusion in tissue in general. The invention is useful in NDE, e.g., thin films, delaminations in fiberglass or composite materials, stealth aircraft materials inspection and inspection of explosives.
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Haddad Waleed S.
Matthews Dennis L.
Trebes James E.
Lateef Marvin M.
Lin Jeoyuh
Scott Eddie E.
The Regents of the University of California
Thompson Alan H.
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