Acoustics – Anatomic or prosthetic relation – Ear and mouth
Reexamination Certificate
1997-03-08
2001-03-27
Dang, Khanh (Department: 2837)
Acoustics
Anatomic or prosthetic relation
Ear and mouth
Reexamination Certificate
active
06206134
ABSTRACT:
REFERENCE TO RELATED PATENT
This application is related to the invention in our U.S. Pat. No. 5,448,025 and the teaching and technology thereof are incorporated by reference herein.
BACKGROUND OF THE INVENTION
Field of the Invention
This invention relates to the medical devices art and more particularly to an improved detachable, disposable cover for a stethoscope head. The cover provides protection from patient to patient contamination and does not interfere with the intended purpose and function of the stethoscope.
Description of the Prior Art
A number of arrangements for providing protection to a stethoscope head have heretofore been proposed. Various patents show the range of covers and the different structures described therein for the purpose of covering the head of a stethoscope. In our U.S. Pat. No. 5,448,025 there is described a cover that is detachably secured by a peelable adhesive applied to one side of a thin plastic film to the head of the stethoscope to provide a seal thereover for protecting the stethoscope head from contamination from the ambient environment as well as preventing patient to patient contamination. Such an arrangement is satisfactory for many applications wherein the detection of comparatively strong sounds from the portion of the anatomy to which the stethoscope is applied is to be obtained.
In U.S. Pat. Nos. 5,424,495 and 5,528,004 there is described a disposable, detachable cover that is secured to the diaphragm of the stethoscope by an adhesive which is continuous over the entire surface of the cover in contact with the diaphragm.
Other United States patents have shown other variations of detachable covers for stethoscopes. In U.S. Pat. No. 4,871,046 there is described a disposable shield for a stethoscope head in the form of an envelope in which the sides of a thin plastic sheet are folded over defining two top portions overlying the bottom portion with heat sealed edges. This cover loosely covers the head of the stethoscope in the form of an envelope type covering with excess material above the head. Such excess material can move and thus distort the sound to be detected and interfere with the normal operation of the stethoscope in detecting the various bodily generated sounds. In U.S. Pat. No. 4,461,368 there is disclosed a comparatively complex and relatively expensive cover having a flexible latex membrane with a rigid rim. The use of the two separate parts of this cover can, in some situations, increase the likelihood of generating extraneous sounds which can mask or distort the sound it is desired to detect.
The state of the prior art is further indicated by the following U.S. Pat. Nos.: 5,054,063; 4,867,268; 4,867,265; 3,867,925; 3,614,991; 3,543,875; 3,225,841; 3,213,960; 2,651,380; 2,650,269; and 2,507,375.
In many applications, however, where the stethoscope is used to detect comparatively weak sounds or sounds that tend to be masked by other sounds, the prior art devices are not completely satisfactory. Not only must the cover be inexpensive so that it may be disposed after each use, but it must not distort or mask the sound to be detected. It has been found that in covers wherein a thin plastic film- like membrane is provided with an adhesive on one side thereof for detachably securing the cover to the diaphragm of the stethoscope some small air pockets may be trapped between the diaphragm and the cover. These trapped air pockets or air bubbles have been found to distort or mask the sounds which are to be detected. While manipulation of the cover on the diaphragm by repeated smoothing movements may eliminate some of the air pockets, such activity takes time and cannot guarantee removal of all trapped air pockets. Further, such manipulation of the cover on the diaphragm may damage the diaphragm.
It has been found that while complete sealing of the diaphragm head to eliminate possible environmental contamination is often desirable, the more important consideration is eliminating patient to patient contamination in order to achieve a lack of sound distorting or masking effects which could be caused by the cover. The protection from environmental contamination may be accomplished by any of the conventional techniques now used in the medical profession for such purposes. The stethoscope is, of course, exposed to the environment between applications of the cover. Therefore, the patient to patient type contamination can be prevented by the cover even in those structures where there is not complete protection from environmental contamination if the cover is designed to eliminate sound distortion or masking, or otherwise interfering with the intended purpose of the stethoscope.
Thus, there has long been a need for a cover for a stethoscope head that is inexpensive, quickly and easily attached, prevents or minimizes patient to patient contamination and which does not distort or mask the sounds it is desired to detect.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide an improved stethoscope head cover that does not distort or mask the sounds to be detected.
It is another object of the present invention to provide a stethoscope head cover which minimizes or eliminates the possibility of patient to patient contamination and also eliminates the effect of sound distorting or masking caused by air pockets or bubbles trapped between the diaphragm and the cover.
It is yet another object of the present invention to provide such a stethoscope head cover that is inexpensive, can be quickly and easily installed and removed and may be conveniently dispensed to the user of the stethoscope.
The above, and other objects of the present invention are achieved, in a preferred embodiment of the present invention, by providing a stethoscope head cover which overlies the diaphragm of the stethoscope and the surrounding rim thereof and which is fabricated from a thin sheet of plastic with a discontinuous layer of peelable adhesive on one surface of the plastic. The discontinues layer of adhesive is in a predetermined pattern and the pattern is selected so that air passageways are provided from the regions between the cover and the diaphragm and past the rim to regions external the stethoscope. The cover generally comprises a flat, thin plastic sheet with the discontinuous layer of a peelable adhesive applied to one surface of the sheet. The adhesive adheres to both the diaphragm and the rim of the stethoscope leaving the aforesaid air passages for eliminating trapped air pockets or bubbles between the diaphragm and the cover. The preferred embodiments of the present invention utilize a thin sheet of vinyl as flat plastic sheet to form a membrane like body member with a uniform thickness in the broad range of from about 0.01 mil to about 1.0 mil. The preferred thickness range within this broad range is from about 0.1 mil to 0.4 mil. Since most stethoscope heads are round and the diaphragm therein is round, the preferred geometrical shape of the cover according to the present invention is also round with a diameter on the order of one half inch to three inches to accommodate the range of diaphragm sizes.
The pattern for the discontinuous layer of adhesive may be, for example, a plurality of small “dots” of adhesive of any desired geometric shape such as round, irregular, “T” shaped,
shaped or the like in a pattern of any desired spaced apart array over the surface of the plastic sheet. Other patterns for the discontinuous layer of adhesive may include a series of parallel stripes of adhesive, a series of zig-zag stripes of adhesive, a plurality of radial extending stripes of adhesive, a plurality of arcuate stripes of adhesive, or any other discontinuous layer of adhesive providing the desired air passageways.
REFERENCES:
patent: 5448025 (1995-09-01), Stark et al.
patent: 5587561 (1996-12-01), Budayr et al.
patent: 5686706 (1997-11-01), Wurzburger
Mikelionis Raymond J.
Stark Wayne T.
Dang Khanh
Finkelstein Don
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