US 3749087 A
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United States Patent 1 1 Klohr July 3I,-I973 I SPIROMETER MOUTIIPIECE  Inventor: Robert E. N. Klohr, Fenton, Mo.
 Assignee: Sherwood Medical Industries Inc.,
St. Louis, Mo.
 Filed: Feb. 16, 1972  Appl. No.: 226,954
Related US. Application Data  Continuation of Set, bio/881,836, Dec. 3, 1969,
 US. Cl. 128/2.08, 206/632 A ] Int. Cl A6lb 5/08  Field of Search I28/2.08, 145.5, 128/272, 262, 349; 46/88, 90; 206/632 R, 63.2 A
 References Cited UNITED STATES PATENTS 1,098,222 5/1914 Brasefield 128/262 3,512,521 5/1970 Jones I28/2.U8 3,333,844 8 1967 Jurschak I28/2.08 ux 3,457,920 7/1969 Thompson.... 128/1455 x 3,421,509 1 1969 Fiore 128/349 3,505,996 4 1970 Cowley 128/I45.8
FOREIGN PATENTS OR APPLICATIONS 303,252 10/1968 Sweden 206/632 R Primary Examiner- Kyle L. Howell Attorney Donald S. Olexa et al.
57 ABSTRACT A disposable mouthpiece and flexible bag which are adapted to be connected with a spirometer or spirometer interface. The mouthpiece is completely surrounded by the flexible bag with a major portion of said bag being inserted within the bore of the mouthpiece for shipping. In use the bag is forced from the bore of the mouthpiece into an interface device or spirometer.
3 Claims, 12 Drawing Figures SPIROMETER MOUTHPIECE This is a continuation of Ser. No. 881,836, filed Dec. 3, 1969, now abandoned.
BACKGROUND OF THE PRESENT INVENTION Spirometers are known in the art to be devices which provide a visual representation of the patients expiratory cycle in volume.
Generally, spirometric devices include an expandable chamber carrying a marking stylus. Movable in timed relation to the expandable chamber in a direction transverse to the stylus movement is a record upon which the stylus records a graph representing air volume. In the past tubing was provided from the expandable chamber directly to a mouthpiece into which the patient exhales.
There are several disadvantages in these prior constructions, a primary one being that the patient contaminates the expandable chamber or bellows within the spirometer and since this chamber or bellows is not designed to be removed after each use there arises a probability of transferring a communicable disease, such as tuberculosis, to another patient using the spirometer. Another disadvantage in these prior constructions is that the mouthpiece itself, into which the patient exhales, may become contaminated after use by a patient.
A primary object of the present invention is to provide an interface for a spirometer with a disposable mouthpiece that eliminates contamination of the spirometer and reduces the likelihood of mouthpiece contamination.
SUMMARY OF THE PRESENT INVENTION In accordance with the present invention a spirometer is provided with an interface between the spirometer bellows and the patient to prevent the direct exhalation of the patients air into the spirometers bellows. The interface device includes a rigid plastic interface chamber having one end connected through flexible tubing to the spirometer bellows.
The other end of the rigid interface chamber has an opening which receives a disposable mouthpiece and flexible interface wall combination. The disposable mouthpiece consists ofa tubular member which during manufacture is inserted within a clear flexible plastic bag with the bag thereafter being sealed closed. The tubular member is then shifted to one corner of the bag and the bag is held contiguous with the outside of the tubular member. Thereafter holes are pierced in the corner of the bag covering the central opening of the tubular member and the free end of the bag is evacuated and inserted within the interior of the tubular member. It is in this condition. that the tubular member and the flexible interface wall are shipped to the physician.
When it is desired that a patients spirogram be taken, a new mouthpiece and interface wall combination is inserted as a unit into the rigid interface chamber with the end of the tubular mouthpiece into which the bag was inserted pointing into the chamber. The projecting end of the mouthpiece, which is covered by one corner of the'plastic bag at that time, is then further opened and rolled back exposing a contamination free mouthpiece for the patients use. Thereafter, the portion of the flexible container within the mouthpiece is forced into the rigid interface chamber either by a finger or a plunger or even by a short, quick breath. The spirometer interface is thus ready for the patients use. As the patient exhales into the mouthpiece the flexible container expands inside the rigid interface chamber forcing contamination free air therefrom into the spirometers bellows eliminating contamination thereof.
There are several advantages to this construction in addition to those set forth above. One is that the combined mouthpiece and interface wall not only eliminates contamination of the spirometer but through its compact size resulting from the novel method of manufacture, significantly reduces handling cost and facilitates use by the physician. An additional advantage is that due to the fact that the present mouthpiece is completely encased in the interface wall container during manufacture the likelihood of contamination thereof is significantly reduced since the mouthpiece is not completely uncovered until ready for use by the patient.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a spirometer having an interface device in accordance with the present invention;
FIG. 2 is a cross section of a mouthpiece according to the present invention with a portion of the flexible interface wall shown;
FIG. 3 is a perspective view of the mouthpiece being inserted into a flexible plastic container which will form the interface wall;
FIG. 4 is a perspective view of the tubular mouthpiece within the flexible container;
FIG. 5 is a perspective view of the mouthpiece being shifted to a corner of the flexible container;
FIG. 6 is a perspective view of the mouthpiece and container being inserted within a die for the purpose of holding the container against the sides of the mouthpiece;
FIG. 7 is a perspective view of the container being inserted within the mouthpiece;
FIG. 8 is a perspective view of the container with a major portion thereof being inserted within the tubular member;
FIG. 9 is a perspective view of the mouthpiece and container in its form ready to be shipped to the physician;
FIG. 10 is a fragmentary section showing the mouthpiece and container inserted within a rigid interface chamber;
FIG. 11 is a partial fragmentary view showing the portion of the container within the mouthpiece being forced therefrom into the rigid interface chamber; and
FIG. 12 is a perspective view showing a patient exhaling into the mouthpiece with the container expanding within the rigid interface chamber.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The cycle of the spirometer is generally initiated by the application of fluid under pressure through conduit ll into the bellows (not shown). As the patient exha'les, air is forced through conduit 11 into the bellows expanding the bellows and at the same time the record 18 is moved with respect to a stylus carried by the bellows providing a tracing 19 on the record representing the air volume per unit time during the expiratory cycle of the patient. As is well known, this information is useful in the diagnosis of many diseases.
The primary purpose of the interface device 13 is to prevent contamination of the bellows within the spirometer by isolating the patients air from the air delivered to the bellows through conduit 11.
Toward this end the interface device 13 is seen to include a spheroid shaped rigid plastic container 22 defining an interface chamber 24 as seen more clearly in FIG. 12. Handles 26 and 27 may be provided on the opposite sides of the container to facilitate patient use. The mouthpiece and interface wall combination 16 is adapted to be manufactured as a separate disposable item, shipped to the physician, used for one patient and then discarded. Since the interface wall itself is disposed of along with the mouthpiece, contamination of the bellows in the spirometer as well as cross contamination between patient are minimized.
As seen in FIG. 2 the mouthpiece and interface wall combination 16 is seen to include a stepped tubular mouthpiece 30 of cylindrical construction which may be constructed of a suitable plastic material, such as polyethylene. The tubular mouthpiece 30 has an enlarged portion 32 insertable within the interface chamber 22 and an elongated reduced portion 33 which projects from the interface chamber 22 and is adapted to be inserted within the patients mouth.
An important aspect of the present invention is the method of manufacture of the disposable mouthpiece and interface wall 16 shown in its completed form in FIG. 9 ready for shipment to the using physician. Referring to FIG. 3 the tubular mouthpiece 30 is inserted into a three closed side generally rectangular, flexible, plastic container 36. The open end of the container, represented generally at 37 in FIGS. 3 and 4 is then heat sealed thereby completely encasing the mouthpiece 30 within the container.
The mouthpiece 30 is then manipulated within the container 36 so that the reduced end 33 opens toward one corner represented generally at 39 in FIG. 5.
Thereafter, the portion of the container 36 adjacent the mouthpiece 30 is held against the outside of the mouthpiece. At this time several pin holes are punched into the corner of the bag adjacent the reduced portion opening as indicated at 46 in FIG. 7. The purpose of these pin holes is to permit evacuation of the container 36 but they are small enough to minimize the possibility of any contamination of the mouthpiece 30 during shipment to the physician. The mouthpiece 30 surrounded by the container 36 is then inserted, reduced end first, into an assembly fixture 42 having an opening therein 43 approximately the diameter of the enlarged portion 32 of tubular mouthpiece 30. As the mouthpiece is forced into the opening 43 the container is pulled up around the periphery of and in contiguous engagement with the outside of the mouthpiece 30.
With the mouthpiece 30 and the container 36 projecting through fixture 42 a vacuum is applied to the reduced portion 33 of the mouthpiece in a manner to evacuate substantially all the air from container 36. With the assistance of a suitable plunger mechanism (not shown) the large overhanging portion of the container 36 is inserted within the interior of the mouthpiece through the opening of the enlarged portion 32. Upon removal of mouthpiece and container combination 16 from the fixture 42 it is ready for packaging and shipment in its form shown in FIG. 9.
When received by the using physician, the mouthpiece and container combination 16 is still in the form shown in FIG. 9 and remains so until ready for use by a patient. When it is desired that the spirometer be used a mouthpiece and interface wall combination 16 is inserted within opening in the rigid interface housing 22 with the enlarged portion 32 of the mouthpiece projecting into the chamber 24 and the reduced portion 33 projecting from the interface housing 22. The end of the container covering the opening of the reduced portion 33 is punctured and stripped back to expose a clean mouthpiece tube portion. As shown in FIG. 11 a finger, or alternatively, a plunger or a quick breath of air, is used to force the bag or the container 36 from within the mouthpiece 30 and thereafter the interface device is ready for use.
As seen in FIG. 12 a patient is exhaling into the mouthpiece portion 33 expanding the container 36 within the chamber 24. The container 36 defines a flexible interface wall for interface device 13, forcing air in the left side of the chamber 24 through flexible conduit 11 into the bellows associated with spirometer 10. After use the mouthpiece 30 is withdrawn from the interface housing 22 bringing with it the container 36 and both are then discarded.
1. A disposable mouthpiece for use with either a spirometer or a spirometer interface chamber having an outlet adapted to be connected to a spirometer, comprising an elongate tubular mouthpiece, one end of which is adapted to be inserted into an inlet opening of the spirometer or interface chamber and the other end of which is adapted to be received in the mouth ofa patient, and a flexible gas impervious bag completely surrounding said tubular mouthpiece, a major portion of said bag being inserted within the bore of said tubular mouthpiece.
2. A disposable mouthpiece as defined in claim 1 wherein said bag has at least one small aperture therein, said aperture being located in a portion of said bag adjacent the end of said tubular mouthpiece adapted to be received in the mouth of a patient.
3. A disposable mouthpiece as defined in claim 1 wherein said bag is of generally rectangular configuration and the tubular mouthpiece is within the bag at one corner thereof, said one corner having at least one small aperture therein to facilitate air removal from said bag.
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