This application is a continuation in part of my applicatio titled Pulmonary Sampling Chamber filed September 14, 1992. SN 07/944,350

BACKGROUND OF THE INVENTION

Sputum induction [SI] is a technique for obtaining a deep sample of secretions from the Jungs in a non-invasive manner for diagnostic purposes from patients who are unable to spontaneous¬ ly expectorate such material on demand.

The sputum can be examined in a vari ty of ways, according to the judgment of the clinician, for bacteria, fungi, viruses, parasites, or malignant cells. Alternatively, in recent years, patients undergo an invas ye procedure known as fiber optic bronchoscopy in which a thin, flexible tube is guided into the patients lungs allowing for suctioning of material. Bronchoscopy is somewhat uncomfortable, costly, occasionally hazardous, time consuming and usually requires a hospital environment to be accomplished safely.

Sputum induction is a long standing procedure traditionally used to obtain material to confirm the diagnoses of pulmonary tuberculosis, a bacterial infection of the lungs. It is also used to follow, in a serial manner, the effectiveness of therapy for this condition.

The technique of sputum induction essentially comprises having the subject breathe a nebulized mist or aerosol of a liquid which acts as a cough inducing agent, for example

hyper-l.onic saline solution. The inhaled saline aerosol or mist humidifies and also irritates the subject's airways, thus promoting and facil itating expectoration of a deep sputum sample.

Sputum induction (SI) has historically been confined to the hospital environment and, more specificall , to institutions with special units for tuberculosis patients. Ordinarily a special space is designated exclusively for sputum induction, since deep coughing can result in the aerosolizati on of potentially infectious droplet nuclei containing tubercle bacilli , which can be carried by air currents to other areas of a hospital. The prior practice in hospitals has utilized a small room, usually isolated by closing off the outflow ducting of the central air system. In addition, a large exhaust fan is placed in a window of the isolated room to provide for 20 to 30 total room air exchanges per hour. The isolated room has to be located so that contaminated exhaust air will not be pulled into adjacent rooms or buildings from outside. Ultraviolet light fixtures are placed in the SI room in a manner to sterilize the air and kill aerosolized microorganisms. Even with these precautions, however, it has been estimated that the number of viable organisms released into the air has been reduced by on y about 50%. An additional problem has been that of maintaining a com ortable room temperature, since inflowing heated or cooled air is rapidly vented outside.

Sputum induction has, therefore, never gained acceptance as an office procedure due to the cost and inconvenience of dedicating and modifying a separated and isolated space just for SI, and also due to the small but finite hazard of transmission of tuberculosis or other airborne infectious diseases to susceptible persons in the area.

Therapeutic patient enclosures have been known for at least one hundred years. Such patient enclosures are frequently used, for example, to treat patients who must inhale aerosolized medication. Aerosol pentamidine treatment has been administered in this fashion to HIV infected patients to prevent or delay the occurrence of Pneumocystis pneumonia.

Inhaling medication of whatever composition, often induces coughing. Active pulmonary tuberculosis occurs frequently in immunosuppression HIV+ patients. Thus control of sputum droplets exhaled or resulting from coughing in HIV i-nfected patients is well advised to prevent possible spreading of tuberculosis infection. Pentamidine treatment is regularly given to patients in an outpatient setting such as a clinic or doctor's office, to accommodate outpatient treatment of HIV patients. Commercial patient enclosures offering protection from contamination of ambient office or clinic air space with tubercle bacilli have been developed. Such enclosures provide for rapid and therefore multiple air exchanges between the patient enclosure interior and the ambient air in the medical office. This rapid exchange is achieved by means of a high

volume blower ¹ . Infectious particles are trapped within highly efficient i il ers. (For instance, a 0.3 micron filter is adequate to entrap most airborne pathogens.)

A problem with patient enclosures which have been used to administer inhaled pentamidine and other drugs Ls that they are not adapted for sputum induction. ST requires the de ivery of a large volume of nebulized mist of externally generated aerosol particles. For instance, an aerosol of hypertonic saline solution has been successfull used for the purpose. Existing commerci l enclosures provide some type of smal 1 -aperture nozzle mounted to the wall of the chamber. Through such a nozzle a quantity of air with aerosol mi t must be generated and delivered to inside the chamber and then to an enclosed patient. The aerosol is thus diffused throughout the chamber, the concentra ion of the aerosol reaching the patient is relatively low. By providing a frequent change of air within the chamber the aerosol mist is further diluted preventing the patient from receiving a sufficient amount. Alternatively, aerosolized medication may be administered with a small hand h ld nebulizer held by the patient within the chamber. Available hand held nebulizers are sufficient to aerosolize only small quantities of medication in l quid droplet form. Thus, wi h either of these methods of supplying the aerosol mist the patient fails to receive a sufficient quantity for SI.

Sputum i duction requires that the aerosol mist be provided in a copious and continuous supply to the patient. Accordingly,

the patient's air supply must be heavily laden with nebulized aerosol . To be effective for sputum induction the necessary quantity of aerosol is most conveniently generated exterior to the chamber and delivered into the chamber and ultimately directly to the patient through a mouthpiece. A significantly large ventilator tubing specially connected for the purpose is required for delivering directly to the patient an adequate copious volume of externally generated aerosal mist for an effective sputum induction procedure.

The central purpose of my invention is to provide means whereby a patient may inhale an air and aerosol agent mixture generated externally of an airtight secure chamber having a controlled negative pressure therein with respect to the ambient atmospheric pressure. In addition, the chamber must be constructed so that substantially all potentially pathogenic airborne particles exhaled or expectorated by the patient while seated within the chamber are entrapped in -a disposable air filter mounted at an exhaust port of the closed chamber.

Earlier therapeutic patient enclosures include those such as U.S. Patent 360,773 issued to Hosford. Hosford's device provided a vapor bath for a human patient; however, it did not enclose the patient's head and thus did not control exhaled, airborne infectious particles.

U.S. Patent 3,902,488 issued to Sheppard related to inducing patient hypothermia. Sheppard, too, failed to control escape of infectious airborne particles in his teaching.

U.S. Patent 859,156 issued to Warnken describes a pressure-controllable enclosure into which purified air is supplied to treat an enclosed pneumonia patient. However, the disclosure does not address sputum induction, as by a breathable mist. Nor does it address the isolation of pathogens through maintenance of lower-than-ambient interior pressure.

U.S. Patent 3,565,072 issued to Gauthier is directed to an atmosphere-controlling device embodied by an enclosed chamber. Thi invention has openings wh ch are not sealed and has a hi gher-than-ambi erit interior pressure, thereby allowing the escape of infectious agents.

U.S. Patent 3,665,917 issued to Jensen provides a console with a hood in which a cough inducing spray or aerosol may be administered to a patient who places his head within the interior of the hood. In addition, the console is equipped with suction means provided to draw air and pathogens from the interior of the hood and the environment about the hood into a filter for safe removal. The Jensen device discloses a combination of features which may induce sputum induction in a patient and partial recovery of pathogens from the environment resulting from the patients coughing. However, the Jensen device is not secure with respect to recovering all the pathogen material from the air surrounding the patient. Jensen does not disclose a chamber which encloses the patient in a negative pressure environment which securely prevents spread of pathogen material into the surrounding environment.

U.S. Patent 3,703,173 issued to Dixon discloses a disposable canopy supported by a frame which partially encloses a patient. A nebulizer mounted within the canopy may provide an aerosol for treatment of the patient. The disposable canopy provides partial protection from spread of pathogens exhaled by the patient.

U.S. Patent 5,233,975 issued to Choate discloses respiratory filter apparatus comprised of a face mask through which the patient inhales and exhales. The patient is also partially enclosed within a disposable plastic enclosure designed to restrict spread of pathogens from the patients exhalations or coughing. The patients exhalations are conducted through the face mask into a filter system for safely disposing of pathogens. Choate, however, does not enclose the patient in a negative pressure chamber to securely control spread of all pathogen material .

U.S. Patent 4,881 ,542 issued to Schmidt, et al . is directed toward a tubular flexible trachea! sampling probe, and as such teaches invasive pulmonary sampling.

U.S. Patent 4,981,466 to Lumbert is directed to a medical ventilating and venting apparatus and methods in which a catheter tube is used to evacuate lung secretions. Lumbert teaches an invasive medical procedure for obtaining deep lung secretion samples. The present invention, on the other hand, is directed to an entirely noninvasive technique for diagnostic deep pulmonary sampling.

U.S. Patent No. 426,609 issued to Tucken is directed to a hand-held device to deliver an irritant through a patient mouthpiece. However, there is no provision in the Tucken patent for trapping exhaled infectious particles.

U.S. Patent 310,568 issued to Emery, is directed to a medical vapor generator, but discloses no means for entrapping infectious particles exhaled by a patient.

Viewing together the aforementioned U.S. Patents, none describes an invention such as the present one, which provides for a novel combination of elements for safely inducing sputum induction in potentially or actively infectious patients. With respect to currently commercially available patient enclosures none are known which provide the combination of necessary conditions and structures for conducting safe sputum induction ,. procedures .

OBJECTS OF THE INVENTION

It is an object of the present invention to provide an appa¬ ratus for sputum induction pulmonary sampling which is safe, mobile, convenient, compact, sanitary in operation and thus economically and professionally attractive to clinical practitioners in outpatient health facilities.

It is a further object of the present invention to provide a sputum induction apparatus within an enclosure adapted to securely entrap substantially all airborne pathogenic particles. The present invention provides a disposable

mouthpiece terminal tubing connection permitting introduction of an aerosol generated externally to the enclosure leading to the patient's airways, while permitting the patient to breath normally and confining all patient exhalations and airborne droplets from the patient's coughing to the interior of the chamber where any pathogenic particles may be safely filtered from the air within the chamber before it is returned to the environment in the medical office..

DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view, partly cutaway, illustrating a preferred embodiment of my invention.

Figure 2 is a detailed view of tubing arrangement in the embodiment of my invention shown in Figure 1 for introducing a mixture of air and aerosol mist to a patient within an enclosure while confining the patients exhalations to the interior of the enclosure .

Figure 3 is a schematic view of the component parts of the embodiment of my invention illustrated Ln Figure 1 which further illustrates the control means for regulating a negative pressure within an enclosure, the flow of incoming air, the aerosol mist, the patients exhalation of cough induced particles, and the filtered air exhausted into the ambient atmosphere external of the enclosure.

SUMMARY OF THE INVENTION The present invention provides for a sputum induction apparatus for safely and noni nvasivel y collecting deep pulmonary samples from a patient without risk of spreading infectious microbes into the ambient air surrounding the apparatus. The present invention combines the features of a conventionally ventilated chamber resembling a telephone booth in size and shape, the chamber being equipped with air inflow and forced air exhaust means to maintain a negative atmospheric pressure when in use. An externally positioned compressor-driven nebulizer is connected to the interior of the chamber through flexible ventilator tubing which delivers aerosol mist from the nebulizer through a tubing arrangement directly to a patient enclosed within the chamber.

An important part of the novelty of the present inventipn resides in the tubing arrangement with a replaceable mouthpiece which provides for a large release of aerosol mist to be delivered to the patient through means which enables the patient to breathe normally while inhaling aerosol mist generated externally of the chamber, and exhaling only into the air confined within the chamber. With this apparatus substantially all of the patients exhaled and cough induced pathogens are securely retained within the chamber interior and are filtered out of the chamber air before it is exhausted from the interior of the chamber.

DETAILED DESCRIPTION OF THE INVENTION Referring to the illustrations, Figure 1 is a partly cutaway perspective view of my invention. An enclosed airtight chamber 10 comprised of a rear panel, front panel 12; side panels 14, 16, top panel 18 and floor 20. A door 22 is mounted in the front panel 12 to permit a patient entrance into and from the interior of the chamber 10. The door 22 is equipped with an airtight sealing gasket 24 about its perimeter. A sealed window 26 is mounted in the side panel 14. Other transparent windows, such as window 28 mounted in door 22, are provided for the comfort and observation of a patient seated in the closed chamber.

The top panel 18 is fitted with an intake air filter 30 positioned within an aperture within the top panel 18. The intake air filter 30 provides significant air flow resistance to the incoming air. Accordingly, a negative air pressure less than ambient atmospheric pressure may be maintained within the chamber when a forced exhaust air flow is maintained. Description of the exhaust air flow blower means and filter means is provided below.

Interior of the chamber 10, a seat 34 is situated upon which a patient may be comfortably seated. It is convenient to position the air exhaust filters and exhaust blower beneath and behind the seat 34. A readily replaceable exhaust air prefilter 36 is shown mounted below the seat 34. An electric powered high volume blower air pump 38 is mounted downstream adjacent to the

exhaust prefilter 36 in the exhaust air stream. The exhaust blower provides a flow rate of between 150 and 270 cubic feet of air per minute. The exhaust air blower is capable of completely exchanging the air within the chamber between 250 and 460 times per hour. Thus a continuous supply of fresh air at a negative pressure is provided within the chamber. The exhaust air is cleared by the filters of pathogens and returned to the exterior of the chamber without temperature change.

A readily replaceable main exhaust filter 40 is shown mounted in the side panel 16, airtight ducting confines the exhaust air stream from the prefilter 36 through blower 38 and into the main filter 40.

The exhaust prefilter 36 and the main filter 40 entrap all particulate matter larger than 0.3 microns. Commercial disposable filters of such fine porosity are readily available and assure substantially total removal of pathogens from the exhaust airstream.

The negative air pressure within the chamber is achieved with selecting the filters 30, 36 and 40 with respect to size, resistance to passage of air therethrough and the relative positioning of the exhaust filters 36 and 40 with respect to the blower 38.

The intake air filter 30 is substantially smaller in area and has substantially greater resistance to passage of air therethrough than either, respectively, that of the prefilter 36 or the exhaust filter 40. The prefilter 36 has an area smaller

than that of the exhaust filter 40. Moreover the resistance of air passage through the prefilter 36 i s greater than that through the exhaust filter 40. The prefilter 36 is mounted at the intake port of the high volume blower 38. The high volume blower 38 draws air through the prefilter 36 in part due to reduced pressure resulting from the action of the high volume exhaust blower 38 intake air stream. Thus, a region of slightly lower air pressure than that inside the chamber proper is maintained in the exhaust ducting in the space between the exhaust side of the prefilter 36 and the intake port of blower 38. Thus, flow of air in the exhaust direction is maintained through the prefilter 36.

In order to maintain the required volume exhaust flow through the exhaust filter 40, the ducted space between the output port of the blower 38 and the inner surface of the exhaust filter 40 is maintained at a positive or greater than atmospheric pressure, thus providing the pressure differential to sustain volume flow of air through the filter 40 into the ambient atmosphere.

A negative differential of between 4 and 20 millibars of air pressure with respect to ambient atmosphere air pressure may be readily maintained within the sealed chamber when the high volume blower is in operation and the filters having the resistance, respective y, as described above are mounted in place .

A conventional compressor driven aerosol nebulizer 44 is

positioned exteriorly to the chamber 10. Aerosol nebulizers are commercially available; a Ultra Neb 99 device manufactured by the DeVilbiss Company of Medford, Pennsylvania has been used successfully in my sputum induction system. The aerosol mist is generated by gravity feeding hypertonic saline or other appropriate liquid solution from a reservoir 46 connected through plastic tubing 48 to the inlet orifice of the aerosol nebulizer 44. A hypertonic saline solution in the reservoir 46 when mixed with a rapidly moving air stream within the nebulizer produces an aerosolized air mixture well adapted to sputum induction .

The output port (not shown in the illustrations) of the aerosol nebulizer 44, feeds a mixture of aerosol and air generated within the nebulizer into a flexible ventilator tube 50. The tube of approximately one inch diameter provides sufficient flow and therefore volume of aerosol and air mixture. The ventilator tube 50 is passed through an aperture 52 located in the chamber side panel 14. Packing material 54 may be placed around the ventilator tube 50 at the aperture 52 to prevent leakage.

The ventilator tube 50 terminates within the chamber. A connector section 60 is mounted to the end of the ventilator tube 50. A replaceable mouthpiece 66 is inserted over the connector section 60. By this arrangement a voluminous continuous supply of aerosol and air mixture flows to the patient through the ventilator tube 50 and through the

mouthpiece 66. While some portion of the aerosol mist is introduced into the interior of the chamber, the patients inhalations through the mouthpiece 66 absorb the largest portion of the aerosol flowing through the ventilator tube 50. This favorable proportional utilization of the aerosol mist is readily achieved by adjusting the rate of flow of aerosol from the nebulizer 44 and instructing the patient to breathe in deeply through the mouthpiece 66 and to exhale quickly while the mouthpiece 66 is held partially or entirely out of his mouth.

The ventilator tube 50 carries aerosol mist at a slight positive pressure above ambient atmospheric pressure from the nebulizer 44 into the interior of the chamber 10. The chamber 10 when in use is maintained at a negative pressure with respect the ambient atmospheric pressure. The air and aerosol mixture entering the chamber through the ventilator tube 50 add only a small portion of the volume of air flowing into the chamber.

When the patient is seated within the closed and sealed chamber and the air pressure within the chamber is slightly reduced by means as described above, the sputum induction procedure may be commenced. The patient then places the mouth piece 66 within his mouth. Nebulized aerosol is then fed through the ventilator tube 50 into the connector 60. The patient then breathes by inhaling through the mouthpiece 66, and exhaling into the enclosure chamber 10.

Exhalation by the patient back into the ventilator tube 50, is prevented by the pressure gradient created by the positive

air pressure within the ventilator tube 50. Due to the reduced or negative pressure within the interior of the chamber 10, the aerosol flows into the tubing connector 60 and through the mouthpiece 66 directly to the patient. Particulate matter exhaled by the patient or spray of sputum droplets resulting from coughing by the patient are securely contained within the chamber and safely collected in the disposable exhaust filters 36 and 40.

The forgoing description is of one of the preferred embodiments of my invention. Other means to facilitate the different functions of my novel apparatus may be suggested and the whole apparatus still will be within the intended scope of my invention. For instance, the negative pressure within the closed chamber of my invention could readily be maintained with means different than that described in the aforesaid preferred embodiment without altering the scope or intended function of my invention. The full scope of my invention i-s more fully defined in the claims set forth below.

I claim:

1. An apparatus for safely conducting non-invasive sputum induction procedures comprising a hollow tubing means, a source of aerosol for inducing a patient to cough, a sealabl e enclosure adequate to fully enclose a patient, air intake and air exhaust means for retaining a negative atmospheric pressure within the enclosure while continuously changing the air within the