IE54016B1 - Apparatus for use in the diagnosis of respiratory diseases and allergies - Google Patents

Abstract

Method and apparatus for coating the airways of the lung of a patient substantially uniformly with a mist formed by aspirating a liquid which includes restricting the maximum size of the particles of the mist to about 1.2 microns with the major portion of the particles being in the range of .056 microns to 1 micron causing the mist to behave as a gas, conduits (21, 28, 29) for feeding the mist together with a gas containing oxygen to a patient to be inhaled during the normal breathing process, and valves (15, 17, 31) connected with the conduits for diverting the exhaled mist and gas through a discharge path. By radioactively tagging the liquid prior to production of the mist, the uniform deposition of the mist throughout the entire lung without encountering heavy accumulations in the large airways and at branch points, enables the production of high definition image scans of the lung.

Description

This invention relates to the diagnosis of respiratory diseases and more specifically to a novel and improved apparatus utilising an aerosolised radioactive isotope for ventilation of the lungs to enable the production of multiple images of relatively high resolution and contrast to facilitate location of emboli, tumours and the like as well as other diseases affecting the respiratory tract without the danger of hyperdeposition and loss of image clarity.

Heretofore, diagnosis of respiratory diseases was principally effected by perfusion lung scans and ventilation utilising radioactive gases. The use of radioactive aerosols was also considered but it was found that with known systems excessive deposition or rainout occurred not only in the upper respiratory tract, the oral pharynx or the trachea but also at airway intersections. Moreover, uneven deposition of the mist was observed between the central and peripheral areas of the lung.

Accordingly, when ventilation scans are deemed desirable, radioactive gases such as xenon and krypton are generally relied upon notwithstanding the relatively high cost entailed in producing the gas, patient inconvenience, extremely limited time in which to obtain even one image of the lung and the need for containment and disposition of the exhaled gas.

This invention overcomes the problems heretofore entailed in the diagnosis of lung diseases and provides apparatus utilizing a radioactive mist which avoids the difficulties entailed with gases as well as the problems heretofore encountered with aerosols. More specifically, it has been found that with the utilisation of aerosols wherein the particle size is maintained in the range of 0.056 to 1.2 microns with by far the major portion of the particles being well below 1 micron, the mist behaves much the same as a gas and does not produce material rainout or hyperdeposition in the upper respiratory tract, pharynx or trachea. Moreover, there is substantially uniform deposition throughout the entire lung without accumulation at airway branching points and the patient can be in any 2. position and is not required to hold his breath during the scanning operation and ample time is available for multiple scans. Furthermore, the isotope being in aerosol form can, upon being exhaled, be filtered out and safely stored until the radioactivity reaches a safe level for convenient disposition. Radioactive gases, however, cannot be filtered and great care is required for containment and storage, the latter requiring extended periods of time as compared to aerosols.

According to the invention, apparatus for producing a mist to be inhaled by a patient comprises means for continuously aspirating a liquid using gas pressure to produce the mist, a conduit connected at or towards one end to an outlet from said aspirator means, a first unidirectional flow valve communicating with said conduit for introduction of ambient air into said conduit on inhalation by the patient, means arranged at the other end of said conduit to facilitate inhalation by the patient and a second unidirectional flow valve communicating with said conduit and arranged to permit flow in a direction opposite to that of said first valve whereby on inhalation the patient draws ambient air through said first valve and mist from said aspirator and on exhalation exhaled air and mist are discharged through said second valve, and means for regulating the size of the mist particles inhaled by the patient so that the inhaled mist particles are of a size within the range of from 0.056 micron to 1.2 microns, with the major portion of the particles being less than 1 micron.

The invention utilises a nebuliser, wherein the maximum particle size is essentially limited to 1.2 microns with a major portion of particles less than 1 micron. A unidirectional air inlet is coupled to the output of the nebuliser and the output is also coupled through a T- or Y- connector to a mouthpiece or face mask through which the patient inhales the mist produced by the nebuliser. The third or discharge opening on the connector includes a unidirectional flow valve for the discharge of mist and air exhaled by the patient and preferably, a filter for the removal of the radioactive mist. The output from the filter is preferably fed to a suitable container for storage until the radioactivity decays to a safe level for disposal. Since the nebuliser is usually operated continuously by a compressed air supply, means are also 3. 4016 normally provided at the output of the nebuliser to prevent the development of excess pressure during the exhaling periods.

While the desirability of utilising radioactive aerosols or mists for the diagnosis of lung diseases had been suggested because of convenience and relatively low cost, the procedure has not heretofore been utilised because of excessive deposition of the aerosols in large airways, posterior pharynx, trachea, stomach and the like. It was also generally considered that a satisfactory radioactive mist must merely not include particles larger than 2 microns in mean mass aerodynamic diameter. The applicants have found that particle sizes not only should not exceed 1.2 microns but that the particles of the aerosol should be in the range of .056 micron to 1.2 microns with the major proportion, especially approximately 90% of the particles being under 1 micron. Under these conditions, the aerosol behaves as a gas and the desired objectives can be achieved.

In preparation of the aerosol for the production of radioactive scans, either ”* technetium-sulphur colloid or ” technetiumdiethylene triamine penta-acetate functioned satisfactorily and have half lives of about 6 hours which provides adequate time for multiple image scans and yet a short enough half life to provide for convenient disposal. Gases not only require the patient to hold his breath during an image scan which affords time for only a single scan but known satisfactory gases such as krypton has a half life of less than 30 seconds making it difficult to provide time for even the single scan and forms of tagged xenon have half lives of from 4 to 30 days making disposal difficult. The radioactive technetium compounds referred to above are generally available in Nuclear Medicine Departments for routine clinical diagnostic procedures and accordingly constitute a relatively inexpensive and available aerosol for the conduct of ventilation scans.

The invention will now be described in greater detail by way of example with reference to the drawings in whichs4. 5401 6 Figure 1 is a side elevational view in partially diagrammatic form of one embodiment of apparatus in accordance with the invention; and Figure 2 is a side elevational view in partially diagrammatic form of a modification of the invention shown in Figure 1.

Referring now to Figure 1 showing a partially diagrammatic elevational view of one form of apparatus in accordance with the invention, the nebuliser is generally denoted by the numeral 10 and includes a compressed gas inlet 11 and an outlet 12. The nebuliser may take any desired form through in the illustrated embodiment, the housing would include a suitable reservoir, an aspirator for producing the mist and the gas such as oxygen or air should be supplied at the rate of the order of 6 to 10 litres per minute. In the instant embodiment of the invention, a four-way connector generally denoted by the numeral 13 is coupled to the outlet 12 of the nebuliser 10 by the tubular leg 14. A unidirectional air inlet valve 15 is connected to a second tubular leg 16 of the four-way connector 13, a second unidirectional outlet valve 17 and particle filter 18 are connected to a third leg 19 of the four-way connector 13 and a fourth leg 20 of the connector 13 is connected to flexible tubing 21 having a bellows configuration for delivery of the aerosol to the patient. It is preferable to enclose the nebuliser 10 together with the four-way connector 13 within a container 22 formed of lead or other radiation shielding material since the nebuliser will contain a radioactive liquid.

The outlet end of the tubing 21 is connected to a third unidirectional valve 23 which may be contained within a second container 24 also formed of lead or other radiation shielding material. The outlet of the one-way valve 23 is coupled to one leg 25 of a Y- connector 26 disposed within the container 24 and the second leg 27 of the Y- connector is coupled to a flexible tube 28 similar to that of the tube 21. A mouthpiece 29 for the patient is secured to the end of the tube 28 so that the patient can conveniently inhale the mist generated by the nebuliser 10 together with air entering the one-way valve 15. While a simple mouthpiece 29 has been illustrated, a suitable facemask may replace the .

S4G 16 mouthpiece if so desired. The unidirectional flow valve 23 may take any desired form and may preferably be adjusted to prevent flow during the presence of atmospheric pressure on the downstream side of the valve and provide for free flow when the downstream pressure is reduced during the time the patient is in the process of inhaling.

When utilising aerosols for ventilation scans, the patient may inhale and exhale several times in order to be certain that the radioactive mist has been uniformly deposited throughout the entire lung. During the exhaling periods, the patient will exhale through the mouthpiece or facemask, as the case may be, and through the tube 28.

Since the one-way valve 23 will prevent reverse flow of mist, the exhaled aerosol will pass outwardly through the leg 30 of the Y- connector 26, a one-way valve 31 and a filter 32 and the exhaled air and/or gas will be discharged through the tube 33. The filter 32 retains the aerosol exhaled by the patient and contains the filtered aerosol until the level of radioactivity has decreased to a safe level for convenient disposal. During the exhaling period, the valve 23 will remain closed and it is therefore desirable to prevent development of excessive pressure within the tube 21 caused by compressed air entering the inlet 11 of the nebuliser 10. For this purpose, the tubing 21, being in the form of a bellows, will tend to expand and thus limit the pressure. If desired, the one-way valve 17 may be utilised and adjusted to act as a relief valve to limit the maximum pressure in the tube 21. When the relief valve 17 is utilised, an aerosol filter 18 is provided to filter out and contain the aerosol and the remaining gas is discharged through the pipe 34. If desired, pipes 33 and 34 may be coupled together and fed to a holding container which will retain the gaseous material until the radioactivity has decreased to a level permitting normal disposal.

The nebuliser 10 may take any desired form provided, however, that the aerosol particles generated thereby are within the ranges set forth above. One such nebuliser which will generate a mist meeting the requirements outlined above is illustrated and described in United States Patent No. 4,116,387. 6.

Figure 2 illustrates a modified embodiment of the invention wherein a large particle trap is included in the event the specific nebuliser 10 utilised may produce an excess number of large particles.

In the figures, like numerals have been used to denote corresponding elements in each figure.

In Figure 2, it will be observed that the leg 20 extending from the four-way connector 13 is curved upwardly and receives the vertical leg of an elbow 35 having a plurality of inclined baffles 36. The horizontal output leg of the elbow 35 is then coupled to the bellows-shaped tubing 21 for delivery of the mist to a patient.

The baffle arrangement contained within the elbow 35 provides a circuitous path for the mist with the result that the larger particles, because of their greater mass, will tend to collide with one of the baffles and he removed from the remainder of the aerosol. These larger particles upon reconversion to a liquid will automatically drain back into the nebuliser and enter the liquid reservoir therein. If desired, a separate drain may be employed for returning this liquid directly to the reservoir or to an individual receiver.

The apparatus when used for the production of lung scans utilising an aerosol has been found to be exceedingly effective not only from the standpoint of reduced costs and convenience for the patient but vastly improved image scans have been obtainable which greatly facilitate diagnosis of precise difficulties involving the entire lung.

While the invention is particularly useful for the production of image scans of the lung, it is also useful for medication of the lung in the treatment of disease. For instance, the apparatus would be useful in the treatment of the lung with antimicrobials, antifungals, tagged anticancer drugs. The apparatus is also useful in provocative allergy testing to determine the body reaction, for instance, to histamines and antigens such as ragweed.

Claims (9)

1. Apparatus for producing a mist to be inhaled by a patient comprising means for continuously aspirating a liquid using gas pressure to produce the mist, a conduit connected at or towards one end to an outlet from said 5 aspirator means, a first unidirectional flow valve communicating with said conduit for introduction of ambient air into said conduit on inhalation by the patient, means arranged at the other end of said conduit to facilitate inhalation by the patient and a second unidirectional flow valve communicating with said conduit and arranged to permit flow in a direction 10 opposite to that of said first valve whereby on inhalation the patient draws ambient air through said first valve and mist from said aspirator and on exhalation exhaled air and mist are discharged through said second valve, and means for regulating the size of the mist particles inhaled by the patient so that the inhaled mist particles are of a size within the 15 range of from 0.056 micron to 1.2 microns, with the major portion of the particles being less than 1 micron.

2. Apparatus according to claim 1, wherein a third unidirectional flow valve is arranged in said conduit between said first and second unidirectional flow valves and allowing flow in a direction the same as 20 that of the first flow valve.

3. Apparatus according to claim 1 or claim 2, which also includes pressure limiting means connected at one end to said outlet from said aspirator means.

4. Apparatus as claimed in claim 3, wherein said pressure limiting 25 means comprises a bellows-like wall portion of said conduit.

5. Apparatus according to claim 3, wherein said pressure limiting means comprises a pressure relief valve.

6. Apparatus according to claim 5, for the production of radioactive mist, wherein said pressure relief valve is connected to a filter for 30 filtering out any radioactive particles passing through the pressure relief valve. 8.

7. Apparatus according to any one of claims 1 to 6 for the production of a radioactive mist, wherein the second unidirectional valve is connected to a filter to filter out radioactive particles from the mist exhaled by the patient. 5 8. Apparatus according to any one of claims 1 to 7, wherein the mist particle regulator means comprises a plurality of baffles within the conduit providing a circuitous path for the mist such that the larger particles are prevented from passing to the patient and are returned to the aspirator means.

8. 10 9. Apparatus according to claim 1, substantially as described herein with reference to the drawings. 10. Apparatus for producing a mist to be inhaled by a patient substantially as described herein with reference to Figure 1, or Figure 1 as modified by Figure 2, as shown in the accompanying drawings.

9. 15 11. Use of apparatus according to any one of the preceding claims in the diagnosis of respiratory diseases and allergies.