Acoustics – Anatomic or prosthetic relation – Ear and mouth
Reexamination Certificate
2000-06-09
2002-12-31
Dang, Khanh (Department: 2837)
Acoustics
Anatomic or prosthetic relation
Ear and mouth
C181S137000, C221S266000
Reexamination Certificate
active
06499560
ABSTRACT:
FIELD OF INVENTION
This invention relates to disposable diaphragm assemblies for stethoscopes used in the prevention of the spread of infectious diseases through the use of stethoscopes. More particularly, the present invention relates to both existing stethoscopes which may be retrofitted for the use of disposable diaphragm assemblies and to novel stethoscopes which have a main housing or body prepared for the use of the disposable diaphragm assemblies. The present invention also relates to dispensers, both stationary and portable, for the disposable diaphragm assemblies.
BACKGROUND OF THE INVENTION
Most common stethoscopes are designed with a retainer ring to hold a diaphragm in place. One such prior art stethoscope design is shown in
FIGS. 1 and 2
. The retainer ring
1
is attached to the stethoscope head
2
by means of threads
5
. The retainer ring
1
is circular in shape having a vertically oriented side portion
4
, the inside surface of which is threaded. Molded onto or attached onto the bottom face of such side portion
4
is a horizontally oriented lip portion
3
which extends toward the center of the circular retainer ring
1
. A diaphragm
7
is held in place between lip portion
3
and the stethoscope head
2
upon threading or clipping the retainer ring
1
onto the stethoscope head
2
.
FIG. 3
shows an alternative prior art stethoscope design in which an O-ring
6
is used to hold the retainer ring
1
onto the stethoscope head. In each of these prior art devices, the diaphragm is changed by removing the retainer ring, removing the old diaphragm placing a new diaphragm in the retainer ring and re-attaching the retainer ring, Standard non-disposable diaphragms are generally not replaced between use on patients due to the time required to undertake such a change. As an alternative, the stethoscope head and diaphragm may be cleaned between uses. Such cleaning, however, may be detrimental to both the structural integrity and acoustical accuracy of the diaphragm, as such cleaning is often done with alcohol swabs. That is, both the difficulty in changing out diaphragms and the potential harm inflicted on diaphragms by cleaning act as barriers to the use of clean, uninfected stethoscope diaphragms.
The possibility of the transmission of infection between patients, where the stethoscope acts as the source of infection, is recognized in the medical community and is the subject of articles such as “Contaminated Stethoscopes: A Potential Source of Nosocomial Infections” by Mangi et al, Yale Journal of Biology and Medicine, 45,600-45,604 (1972) and “Contaminated Stethoscopes Revisited” by Melinda A. Smith, MPH, et al, Archives of Internal Medicine, Vol. 156 (1996).
A removable stethoscope diaphragm is the subject of U.S. Pat. No. 4,867,268 to Izaak Alan Ulert. It comprises a disposable diaphragm which replaces the diaphragm already in place on conventional stethoscopes. U.S. Pat. No. 4,461,368 to Plourde describes a diaphragm cover which is used for the prevention of the spread of infection from contaminated stethoscopes. The disposable diaphragm of the '368 patent interposes a second layer of material between the source of sound and the ear, which has the potential of diminishing or distorting the sound. Furthermore, the disposable diaphragm of the '368 patent is not easily or quickly interchanged. The lack of ease of use acts as a disincentive to use.
Completely disposable stethoscopes are also currently available. Such stethoscopes, however, do not offer the acoustic quality obtainable with standard stethoscopes. Dedicated stethoscopes are fairly expensive, thereby motivating repeated use which defeats the intended safety features.
There is a need, therefore, for a stethoscope device which provides high-quality acoustic performance in conjunction with an economical means of providing uninfected contact with each patient. Furthermore, there is a need that such device offer medical personnel ease of use with little or no preparation time.
SUMMARY OF THE INVENTION
The present invention addresses the shortcomings of the prior art devices by providing disposable diaphragm assemblies with acoustic performance which is equal to or greater than that of conventional stethoscopes. The present invention does not use a cover over the existing diaphragm of a conventional stethoscope as in the '368 patent. Therefore, the acoustic quality remains high and there is no additional sound attenuation which is present when multiple layers are placed between the source of the sound and the ear.
The disposable diaphragm assemblies of the present invention are inexpensive and therefore, may be changed out between uses so that only clean and uninfected portions of the stethoscope come into contact with a patient. The present invention also addresses the cleanliness and infection issue by providing dispensers for the disposable diaphragm assemblies which permit the disposable diaphragm assemblies to be attached to a stethoscope without contacting the diaphragm assemblies. Therefore, germs and contaminants are not transferred from the hands of medical personnel to patients.
The present invention provides means for retrofitting existing stethoscopes, including standard and open bell or pediatric stethoscopes. In addition, the present invention provides a novel stethoscope which may also be used with the disposable diaphragm assemblies of the present invention.
The present invention includes disposable diaphragm assemblies made of any suitable material, such as but not limited to plastic, rubber or other materials and dispensers stationary or portable, for such disposable stethoscope diaphragms.
REFERENCES:
patent: 4461368 (1984-07-01), Plourde
patent: 4475619 (1984-10-01), Packard
patent: 4867268 (1989-09-01), Ulert
patent: 6019186 (2000-02-01), Zambrano
patent: 6019187 (2000-02-01), Appavu
Lang Heinrich
Ulert Izaak A.
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