Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-08-09
2001-04-03
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S459000
Reexamination Certificate
active
06210329
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to medical storage and carrying cases, and more particularly, to an apparatus for organizing, storing, transporting and utilizing devices and supplies commonly used for obstetrical or vascular surgical and postoperative evaluations.
BACKGROUND OF THE INVENTION
Most obstetricians and nurse-midwives recommend that the first prenatal medical appointment for a pregnant woman be scheduled as early as possible in the pregnancy. Typically, subsequent prenatal visits initially occur at one-month intervals, then twice a month, then weekly in the latter stages of uncomplicated pregnancy. Complicated pregnancies may warrant twenty or more prenatal visits. For many practices of obstetrics-gynecology, prenatal visits constitute the majority of office appointments. Each prenatal visit recurrently utilizes a small collection of obstetrical supplies and instruments.
At each prenatal visit the practitioner attempts to detect, across the surface of the maternal abdominal wall, evidences of fetal cardiac activity. Traditionally this was ascertained by auscultation of fetal heart sounds using a specialized obstetrical stethoscope. Contemporary methods are more rapid and reliable, and typically give the gravid patient the immediate reassurance that her developing baby is alive and well. Of such newer cardiac activity detection methods, sensitive microphones and fetal electrocardiogram recordings have been largely supplanted in today's medical office by the compact, easy-to-use ultrasonic Doppler device. Essentially a medical sonar, it detects Doppler frequency shifts in those returning ultrasonic energy waves which it has reflected off moving components of the fetal cardiovascular system, such as flow of blood in the largest fetal vessels. Such frequency shifts are then converted to an audible signal.
Most commercially available Doppler units are portable, battery-operated devices small enough to be cradled in the palm of the hand. These typically comprise a probe or transducer that is applied to the surface of the maternal abdomen and wired to a separate speaker-containing base unit. When the device is not in use it may be placed in the lab coat pocket of the practitioner, or left on or within storage cabinetry. Some models provide a clip by which the base unit may be attached to the practitioner's pocket edge or belt, and some provide a niche within the base unit, to store the probe.
A hand-held fetal Doppler is an expensive medical device. It is fragile, small enough to be easily concealed, and fascinates the patient and her family with its function: they are able by means of it to hear sounds made, albeit indirectly, by the baby. To a young child accompanying its mother into the examination room, the device may resemble a toy. Perhaps because of its capabilities and natural appeal, dropping, tampering and theft are the chief reasons for Doppler repair or replacement. Therefore the hand-held Doppler, while it must be easily accessible to medical personnel, needs protection from unauthorized handling. This might involve fixing the Doppler to a protective base, integrating the Doppler function into a multifunctional piece of equipment too large to be concealed, and/or fashioning an alarm system triggered by tampering.
Practical advances in hand-held Doppler design generally comprise elimination of the wire or cord between the Doppler probe and base unit, digital display of the fetal heart rate, and multiple probes for a single base unit.
Doppler devices minus the wire or cord avoid the annoyances of entanglement, twisting, or inappropriate wire length that can interfere with Doppler use. One such design integrates a transmitter into the Doppler probe. It sends an RF or infrared signal to a remote base unit where a circuit converts the signal into a sound. Another design simply integrates speaker and probe into a single hand-held housing. Accordingly, the present invention accommodates such variations in Doppler design, and additionally provides mechanisms for theft and tampering protection for Doppler models with either one or two portable housings.
Models which numerically display fetal heart rate obviate the need for the practitioner to count the fetal signal over a short time span and then mentally convert the data to beats per minute. However, the base unit must be positioned by the present invention so that the practitioner can easily read the fetal heart rate display.
Doppler models with more than one probe allow the practitioner to select the frequency range of ultrasonic wave detection that is most appropriate for the particular gestational age of the fetus. This enables, for example, Doppler detection of fetal life earlier in pregnancy or in obese patients. Protected storage of a readily accessible standby probe is therefore preferable, and is not provided by the prior art.
As with Doppler, sonography (ultrasound scanning) involves the painless application of a small hand-held device, the sonogram scanhead, upon a body surface, in this case the maternal abdominal or vaginal wall, enhanced by ultrasound conduction gel applied at the interface. This technology converts the reflected ultrasonic energy waves into cross-sectional fixed or moving images of the targeted internal wave-reflecting structures. Laypersons and professionals alike regard it as the chief diagnostic technique for many obstetric situations. Its understandable, instantaneous images enable the skilled medical professional to demonstrate findings to the patient as her scan progresses. Such participation of the patient demystifies the obstetric complication and often communicates the rationale for the medical recommendations which follow.
Not uncommonly at a routine prenatal visit a practitioner must broach the disturbing possibility of an obstetric problem amenable to ultrasound study. A sonogram offered immediately, not scheduled for some more convenient day, minimizes the patient's understandable tension and suspense and allows prompt redirection of medical management. Unfortunately, however, the scanning equipment often lies idle and inaccessible in an examination room then occupied by another patient. Scan capability in each exam room should instead permit an immediate sonogram with minimal disruption of office function.
While sonography should hardly be offered primarily to entertain, it is immensely popular with patients and it lacks known medical risk. Because it can reveal the undeniably humanoid image and heart motions of the fetus several weeks before the hand-held Doppler can demonstrate fetal life, sonography can foster that earlier parent-to-child and parent-to-parent bonding and commitment which invariably strengthen the family unit and promote a desire to nurture the pre-born child. Sensing this, even couples with apparently uncomplicated pregnancies desire and benefit from a sonogram.
Whether because of client expectations or the weight of proven medical benefit, ready availability of scan equipment in each obstetrical exam room is highly desirable. While someday sonography may supplant Doppler fetal heart detection at the routine prenatal visit, today the low portability and high cost of scanning equipment restricts any-visit sonography to the offices of perinatologists and a very few generalist obstetricians. The practical need for hand-portable, sophisticated yet cost-effective obstetric sonography equipment remains unmet. Miniaturization of already costly sonography devices may render them too expensive for the office. Situating a complete conventional scanning unit in each exam room, likewise unaffordable (such computer-based devices suffer rapid obsolescence), additionally encourages tampering with the unattended equipment.
The conventional sonogram scanhead itself is as compact as is a hand-held Doppler. Its attached two-meter computer style electronic cable with multi-pin connector yields this scanhead assembly somewhat more awkward than a hand-held Doppler to transport. Yet if it were possible to scan a patient in any exam room by
Christmas Robert Caldwell
Watts Robert
Bernstein Jason A.
Bernstein & Associates
Docsystems, Inc.
Greenwald John W.
Imam Ali M.
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