Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
1999-12-20
2001-04-10
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
C600S590000, C033S514000, C433S072000
Reexamination Certificate
active
06213959
ABSTRACT:
BRIEF DESCRIPTION OF THE INVENTION
The present invention relates in general to the preliminary screening for a sleep-related breathing disorder and, more particularly, to a tool for use in obtaining measurements of the oral cavity.
BACKGROUND OF THE INVENTION
The obstructive sleep apnea syndrome (OSAS) is a sleep disorder in which the patient exhibits breathing pauses during sleep, resulting in excessive daytime sleepiness, sleep fragmentation, and intermittent hypoxia. Patients suffering from the disorder have a greater risk of developing diurnal hypertension, myocardial infarction, ventricular failure, pulmonary hypertension, cardiac dysrhythmias and stroke. In addition to health problems, OSAS significantly reduces the effectiveness and alertness of the individual during the day which adversely effects the individual's lifestyle and increases the risk of injury to the individual and others from motor vehicle and work-related accidents.
OSAS is typically diagnosed by polysomnographic testing. This procedure involves monitoring the patient overnight to record brain activity, eye movements, chin and leg muscle movements, cardiac rhythm, snoring intensity, oronasal airflow, respiratory muscle effort, and blood oxygen saturation. The test is time consuming, labor intensive and expensive. Thus, a method of screening patients to reliably determine whether or not they may be at risk for OSAS reduces the number of patients who are unnecessarily subjected to polysomnographic testing. More importantly, earlier diagnosis and treatment of OSAS would be promoted because the screening results would eliminate the reluctance of a physician to prescribe polysomnographic testing for those patients who do not exhibit dramatic OSAS symptoms.
Mathematical formulas have been developed to clinically predict whether a patient is likely to suffer from OSAS. These mathematical models primarily rely on measurements of body mass index and neck circumference, two factors which are indicative of the obesity of the patient. Obesity is one of the important risk factors for OSAS. However, not all patients who suffer from OSAS are obese. Although prior mathematical models have combined the body mass index and neck circumference measurements with oxygen saturation levels, witnessed apneas and questionnaire data, these mathematical models are of little use in screening patients who are not obese. A system of screening patients without relying on whether or not they are obese would ensure that further testing is prescribed for all patients at risk for OSAS independent of their body weight.
Another significant risk factor in the development of OSAS is craniofacial dysmorphism (disproportionate craniofacial anatomy). Abnormalities associated with craniofacial dysmorphism include a reduction in the upper airway caliber which makes the airway susceptible to collapse during sleep. Abnormalities in craniomandibular morphology, such as a narrow or posteriorly displaced mandible, are often found in OSAS patients. Another abnormality commonly found in OSAS patients is a highly arched palate. A system of quickly and accurately detecting the presence of a narrow or posteriorly displaced mandible and/or a highly arched palate would facilitate the assessment of a patient's OSAS risk.
OBJECTS AND SUMMARY OF THE INVENTION
It is a primary object of the present invention to provide a system of screening patients for OSAS.
It is a further object of the present invention to provide a tool which may be used to measure the oral cavity of a patient.
It is another object of the present invention to provide a measurement tool which may be used to easily, accurately and quickly obtain measurements of the palatal height, the spacing between the second molars, and the overlap between the upper and lower incisors.
It is yet another object of the present invention to provide a system for converting measurements of the oral cavity and other patient data into a morphometric model value which may be used to predict whether further testing of the patient for OSAS is warranted.
A more general object of the present invention is to provide a measurement tool which may be efficiently and inexpensively manufactured, and which is suitable for either disposal after a single use or sterilization to permit the tool to be reused.
In summary, the present invention provides a tool for measuring the oral cavity. The tool includes first and second measuring members pivotally coupled together for relative pivotal movement of the measuring members about a pivot axis. The first measuring member includes a first leg portion positioned forwardly of the pivot axis and a dial portion with graduations provided thereon. The second measuring member includes a second leg portion positioned forwardly of the pivot axis and a pointer. The second leg portion moves relative to the first leg portion and the pointer moves across the dial upon relative pivotal movement of the first and second measuring members to designate the first graduations and indicates a first measured value indicative of the spacing between the leg portions. One of the measuring members also has second graduations provided thereon in the form of a linear scale such that the second graduations provide a measurement indicative of the spacing between two members, for example the size of the overlap between the upper and lower right central incisors. The measurement tool also includes a support member positionable in the oral cavity of a patient, with the patient biting on upper and lower bite surfaces of the support member. The support member is formed with an opening shaped to slidably receive and support the first leg portion and a slot offset from the opening. The slot is shaped to receive the second leg portion, with the second leg portion being movable within the slot as the second measuring member is pivoted relative to the first measuring member.
Additional objects and features of the invention will be more readily apparent from the following detailed description and appended claims when taken in conjunction with the drawings.
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Kushida, Clete A., “A Predictive Morphometric Model for the Obstructive Sleep Apnea Syndrome,” Ann Intern Med. (1997), vol. 127, pp 581-587.
Haas Michael W.
Marmor II Charles
O'Connor Cary
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