Abstract:
Some embodiments and aspects presented herein provide methods and apparatus for vaporizing and/or mixing medication with air or other gases for oral delivery to a patient. Some methods and apparatus may include breaking liquid medications down to particle sizes no larger than about 1.0 to 3.0 micrometers in diameter. Such small particle diameters can be introduced directly to a patient&#39;s bloodstream via the lungs by crossing the alveoli membranes.

Description:
FIELD OF THE INVENTION  
       [0001]     This invention relates to fluid vaporizing and homogenizing devices and methods. More particularly, this invention relates to medical devices, systems, and methods for producing finely homogenized or vaporized gas-phase fluid mixtures.  
       BACKGROUND OF THE INVENTION  
       [0002]     Many types of devices have been developed over the years for the purpose of converting liquids or aerosols into gas-phase fluids. Some such devices have been developed, for example, to discharge small droplets from an inhaler-type medicinal administration apparatus.  
         [0003]     Typical inhalers include a pressurized canister with measured doses of medication inside. Squeezing the top of the canister converts liquid medication into an inhalable mist. Inhalers enable children and adults to deliver medicine directly to their lungs. Typical aerosol inhalers usually comprise a diverging nozzle at an outlet to the pressurized liquid, which tends to vaporize the liquid medicine to a droplet volume median diameter on the order of 50 μm.  
         [0004]     50 μm particles produced by typical inhalers can effectively treat certain lung ailments. For example, bronchodilators such as albuterol treat acute asthma by causing the lung passages to open or dilate. Similarly, nebulizers typically vaporize liquid medications to a droplet volume median diameter on the order of 50 μm. However, in addition to direct lung treatments, applicant notes that liquid medicinal drugs could also be delivered directly to the bloodstream through the lungs.  
         [0005]     The lungs include groups of tiny air sacs called alveoli. The alveoli have very thin walls or membranes, and small blood vessels called capillaries run through these membranes. Oxygen molecules are small enough to pass through the membranes and into the blood in the capillaries. Other particles having diameters of approximately 1 to 3 μm or smaller may also pass through the alveoli membranes and directly into the blood stream. Nevertheless, there are currently no efficient methods of reducing liquids to particle sizes small enough to pass through the alveoli membranes.  
         [0006]     In addition, typical aerosol inhalers produce a wide range of particle droplet sizes, and much of the metered medication tends to simply impinge the mouth or the back of the throat of a user. Consequently, sometimes only a fraction of the medication is deeply inhaled.  
       SUMMARY OF THE INVENTION  
       [0007]     The principles described herein may address some of the above-described deficiencies and others. Specifically, some of the principles described herein relate to liquid processor apparatuses and methods, some embodiments of which may be suited for medical applications.  
         [0008]     One aspect provides a method comprising introducing a supply of liquid into a vortex, and breaking down the supply of liquid to a particle size of approximately 20 μm in diameter or smaller. According to one aspect, the method comprises breaking down a majority of the supply of liquid to a particle size of approximately 10 μm in diameter or smaller. According to one aspect, the method comprises breaking down a majority of the supply of liquid to a particle size of approximately 2 μm in diameter or smaller. In one aspect, the method comprises delivering the supply of liquid orally to a patient.  
         [0009]     According to one aspect, introducing the supply of liquid comprises introducing a supply of liquid medication into the vortex. One aspect may further comprise supplying a pressurized air supply into a vortex chamber, where introducing the supply of liquid comprises pressurizing the liquid above a threshold pressure needed to open a biased valve leading to the vortex chamber. One aspect of the method may further comprise adjusting flow rate capacity of the supply of liquid into the vortex by changing a position of a needle valve stop. According to one aspect, breaking down the supply of liquid comprises processing at least 0.8 ml of fluid medicine per minute at an air flow rate of approximately five cubic feet per minute.  
         [0010]     One aspect comprises a method of delivering liquid medication to a patient. The method comprises providing a mass of liquid medication, introducing the mass of liquid medication to a vortex, and breaking down a majority of the mass of liquid medication to a particle size of approximately 1-3 μm in diameter or smaller, and inhaling the mass of liquid medication. Introducing the liquid medication may comprise inserting the mass of liquid medication at a pressure sufficient to open a needle valve leading to the vortex. According to one aspect, the method may further comprise passing at least a portion of the mass of liquid medication directly into a patient&#39;s bloodstream by crossing an alveoli membrane of a patient&#39;s lungs.  
         [0011]     One aspect comprises a method of delivering a medicinal liquid drug to a patient. The method comprises passing the medicinal liquid drug directly into a patient&#39;s bloodstream by crossing an alveoli membrane of the patients&#39; lungs. According to one aspect, passing the medicinal liquid drug directly into a patient&#39;s bloodstream comprises introducing the medicinal liquid drug to an air vortex, vaporizing the medicinal liquid drug with the air vortex, diffusing the vaporized medicinal liquid drug, and causing the vaporized medicinal liquid drug to be inhaled into the patient&#39;s lungs.  
         [0012]     One embodiment comprises a medicinal liquid drug delivery device. The medicinal liquid drug delivery device comprises a body, a mouthpiece attached directly or indirectly to the body, a vortex chamber disposed inside the body, a medicinal liquid drug port, and a valve between the medicinal liquid drug port and the vortex chamber. The valve may comprise a biased needle valve for allowing and preventing fluid communication between the vortex chamber and the medicinal liquid drug port. The apparatus may further comprise a linearly adjustable stop abutting the biased needle valve. The stop may comprise a micrometer abutting the biased needle valve, the micrometer adjustably limiting a range of linear travel of the biased needle valve.  
         [0013]     According to one embodiment, the vortex chamber comprises an vertex, and the valve comprises a needle valve at and opposite of the vertex. According to one embodiment, the apparatus further comprises a diverging nozzle disposed in the body, and the vortex chamber is defined by a tapering annulus between the body and the diverging nozzle. The vortex chamber may comprise a stepped outer surface. One embodiment of the apparatus further comprises an air ring arranged around the body, an air ring conduit between the air ring and the body, and a plurality of angled flow passages disposed in the body and leading to the vortex chamber. The apparatus may include a compressed air port disposed in the air ring.  
         [0014]     According to one embodiment, the apparatus further comprises a pressurized air supply in fluid communication with the vortex chamber, and the valve is biased to open at a pressure of no less than approximately five to twenty PSI above a pressure of the pressurized air supply.  
         [0015]     One aspect provides a vortex system for nebulizing a liquid for inhalation. The vortex system comprises a vortex chamber for mixing the liquid with a gas in a vortex, the vortex chamber comprising a vertex. The vortex system may also comprise a liquid inlet arranged at the vertex of the vortex chamber, and a diffuser arranged interior to and in fluid communication with the vortex chamber for receiving a mixture of liquid and gas from the vortex. According to one embodiment, the vortex system includes a valve for selectively allowing the liquid through the liquid inlet. One embodiment of the vortex system may further comprise a gas ring around the vortex chamber, the vortex chamber comprising a plurality of angled passages in fluid communication with the gas ring. The gas ring may be in fluid communication with a gas supply pressurized to at least fifty PSI.  
         [0016]     Another embodiment provides a medicinal drug delivery device comprising an inner nozzle having an axis, a vortex chamber jacketing at least a portion of the inner nozzle (the vortex chamber being coaxial with the axis), a mouthpiece at least partially housing the inner nozzle, a linear valve at a common vertex of the inner nozzle and the vortex chamber, and a drug introduction port in fluid communication with the linear valve. One embodiment of the medicinal drug delivery device further comprises an adjustable stop to the linear valve. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]     The accompanying drawings illustrate certain embodiments discussed below and are a part of the specification.  
         [0018]      FIG. 1  is an assembled cross sectional view of a medical drug delivery apparatus according to one aspect.  
         [0019]      FIG. 2A  is a side view of an internal nozzle of the medical shown in  FIG. 1 .  
         [0020]      FIG. 2B  is a cross section of the internal nozzle of  FIG. 2A .  
         [0021]      FIG. 3A  is a perspective view of a body of the medical drug delivery shown in  FIG. 1 .  
         [0022]      FIG. 3B  is a side view of the body shown in  FIG. 3A .  
         [0023]      FIG. 3C  is a cross-section of the body shown in  FIG. 3B , taken along line  3 C- 3 C.  
         [0024]      FIG. 3D  is a cross-section of the body shown in  FIG. 3B , taken along line  3 D- 3 D. 
     
    
       [0025]     Throughout the drawings, identical reference characters and descriptions indicate similar, but not necessarily identical elements.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0026]     Illustrative embodiments and aspects are described below. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers&#39; specific goals, such as compliance with system-related and business-related constraints, that will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.  
         [0027]     As used throughout the specification and claims, the terms “medicine” or “medication” refer to a drug that treats, prevents, or alleviates the symptoms of disease and also includes dietary supplements and nutraceuticals. The words “including” and “having,” as used in the specification, including the claims, have the same meaning as the word “comprising.” 
         [0028]     Turning now to the figures, and in particular to  FIG. 1 , one embodiment of a vortex system is shown. The vortex system may comprise, for example, a liquid delivery device. The liquid delivery device may prepare a variety of liquids for inhalation. For example, the liquid delivery device may prepare liquids including, but not limited to, medicinal drugs, supplements, nutraceuticals, or other liquids. According to one aspect, the liquid delivery device is a medicinal drug delivery device  100 . The medicinal drug delivery device  100  may be used, for example, to vaporize or nebulize and deliver a fluid or liquid, such as a liquid drug, directly to a bloodstream of a patient without an injection. The medicinal drug delivery device  100  may generate a gaseous, homogenous mixture of medication and air that can be inhaled, with medication particles small enough pass through the membranes of the patient&#39;s alveoli and directly into the bloodstream.  
         [0029]     The medicinal drug delivery device  100  may create the gaseous, homogenous mixture of medication and air by introducing fluid or liquid medication to a vortex. The vortex pulverizes and vaporizes liquid medication into very small particles or droplets that can pass through alveoli membranes. However, the vortex of the medicinal drug delivery device  100  may also create larger particles that will not pass though the alveoli membranes of a patient, depending on the configuration and/or parameters of the medicinal drug delivery device  100 .  
         [0030]     As shown in the embodiment of  FIG. 1 , the medicinal drug delivery device  100  includes a body  102 . The body  102  may comprise any rigid material, including, but not limited to, plastic, metal, composites, and ceramics. The body  102  may comprise any shape, such as the generally cylindrical shape shown. The body is shown in detail in  FIGS. 3A-3D . As shown in  FIGS. 3A-3C , the body  102  may comprise a head portion  104  and a tail portion  106 . The tail portion  106  may be elongated and cylindrical, with a first internal cavity  108 . According to one embodiment, the first internal cavity  108  comprises multiple diameters. For example, the first internal cavity  108  may include a tapered dish portion  110  leading to an internal cylindrical recess  112 . The internal cylindrical recess  112  may lead to a converging cone  114  that may comprise a fluid or liquid inlet. A vertex  116  of the cone  114  may be open to a second internal cavity  118  of the body  102 .  
         [0031]     The second internal cavity  118  of the body  102  may comprise a generally cylindrical inner wall  120  and a tapered inner wall  122 . The tapered inner wall  122  may comprise a plurality of stairs as shown in  FIG. 3C  that step inward toward the vertex  116  of the cone  114 .  
         [0032]     According to one embodiment, the body  102  includes a side or angled port  124  disposed in the tail portion  106 . The angled port  124  may comprise a medicinal liquid drug port which is in fluid communication with the first internal cavity  108 . In one embodiment, a liquid passageway  126  of the angled port  124  is open to the converging cone  114  of the first internal cavity  108 . Although the angled port  124  forms an acute angle with the body  102  in  FIGS. 1 and 3 C, this is not necessarily so. The angled port  124  may take on any shape, angle, and form, including, for example, an orientation normal to the body  102 .  
         [0033]     The head portion  104  of the body  102  may include a number of features. For example, one embodiment includes a pair of external protruding rings  130 ,  132  flanking a recess  134 . The rings  130 ,  132  and the recess  134  may facilitate attachment of the body  102  to other components.  
         [0034]     According to one embodiment, the head portion  104  includes a plurality of angled passages  136  extending from the exterior of the body  102  into the second internal cavity  118 . As shown in  FIG. 3D , the angled passages  136  are angled from normal, and are not perfectly tangential. The angled passages  136  may be angled, for example, between five and seventy-five degrees from tangent. Air or other fluid flowing into the angled passages  136  may create a vortex inside the body  102  as described below.  
         [0035]     According to one embodiment, the first internal cavity  108  of the body  102  receives a valve. For example, as shown in  FIG. 1 , a biased linear or needle valve  138  extends from the internal cylindrical recess  112  ( FIG. 3C ) into the converging cone  114 . A tapered tip  140  of the needle valve  138  is sized to provide an annulus  142  between the converging cone  114  and the tapered tip  140 , and the annulus  142  is in fluid communication with the with the angled port  124 . The tapered tip  140  is biased into the converging cone  114  to seal off the vertex  116  and close fluid communication through the cone  114 . A spring  144  may bias the needle valve  138  into a closed position.  
         [0036]     According to one embodiment, the needle valve  138  abuts a stop, which limits the linear travel range of the needle valve  138 . The stop may be adjustable, and may comprise, for example, a micrometer  146 . The micrometer  146  may extend through a flange  145  mounted in the dish portion  110  of the first internal recess  108  ( FIG. 3C ). Rotation of a knob  148  of the micrometer  146  causes linear movement of a pin  150  of the micrometer  146 . The pin  150  of the micrometer  146  provides a surface abutting the spring  144 , and also provides a hard stop against further valve opening when an end  152  of the needle valve  138  comes into contact therewith. Therefore, the micrometer  146  may be adjusted to precisely limit the travel extents of the needle valve  138 . It may be desirable to finely adjust the linear travel limits of the needle valve  138  to control the amount of fluid that may pass through the cone  114  when the needle valve  138  opens.  
         [0037]     According to one embodiment, the angled port  124  in the body  102  may be receptive of a fitting, such as a quick touch fitting  128  illustrated in  FIG. 1 . The quick touch fitting  128  is connected to a medicine supply conduit  154 . The spring  144  of the needle valve  138  may be biased to remain closed until a predetermined pressure threshold is reached. Accordingly, a certain pressure level from, for example, the medicine supply conduit  154 , must be reached to inject a mass of medicine out through the cone  114 . According to some embodiments, a pressure of at least five to fifty PSI above normal conditions (the pressure the tapered tip  140  is normally exposed to, which may be above atmospheric) may be selectively supplied from the medicine supply conduit  154  to open the needle valve  138 .  
         [0038]     According to one embodiment, the second internal cavity  118  ( FIG. 3C ) of the body  102  may receive a diffuser such as a nozzle  156 . The nozzle  156  is at least partially disposed inside the second internal cavity  118  ( FIG. 3C ). The nozzle  156  is shown in a side view in  FIG. 2A  and in cross-section in FIGS. I and  2 B. The nozzle  156  includes an axis  157  and an outer rim  158  that may bear against and attach to an end wall  160  ( FIG. 3A ) of the body  102  ( FIG. 3A ). A step down diameter  162  of the nozzle  156  may be sized to fit snugly within the cylindrical inner wall  120  ( FIG. 3C ) of the body  102  ( FIG. 3C ). The step down diameter  162  does not, however, insert past the angled passages  136  ( FIGS. 1 and 3 C) and may be approximately tangent with the angled passages  136  ( FIGS. 1 and 3 C). As shown in  FIG. 1 , the outer surface of the nozzle  156  may neck down to create an annulus  164  with the cylindrical inner wall  120  and the tapered inner wall  122 .  
         [0039]     According to one embodiment, the annulus  164  between the body  102  and the nozzle  156  defines a vortex chamber with a vertex at the approximate same location as the vertex  116  of the cone  114 . The vortex chamber may thus jacket at least a portion of the nozzle  156  and be coaxial with the nozzle  156 . The angled passages  136  in the body  102  lead to the vortex chamber comprising the annulus  164 . A supply of air or other fluid entering through the angled passages  136  in the body  102  tends to create a vortex in the vortex chamber.  
         [0040]     The inside of the nozzle  156  may comprise a continuous or discontinuous diffuser. For example, as shown in  FIGS. 1 and 2 B, the inside of the nozzle  156  may comprise taper  166  with a discontinuity  168 . At the discontinuity  168 , the inside of the nozzle  156  may comprise a passage  169  of generally constant diameter. The passage  169  is adjacent to the vertex  116  of the cone  114 , and is open to the vertex  116 . The passage  169  is thus in fluid communication with the vortex chamber or annulus  164 . According to one embodiment, there is a gap of approximately 0.067 inches between the nozzle  156  and the cone  114 .  
         [0041]     According to one embodiment, there is a gas or air ring  170  arranged around the head portion  104  ( FIG. 3A ) of the body  102 . The air ring  170  may include a flange or lip  171  that fits into the recess  134  of the body  102 . One or more O-rings  172  may seal between the body  102  and the air ring  170 . An annulus between the air ring  170  and body  102  forms an air ring conduit  174  in fluid communication with the angled passages  136  and thus the vortex chamber. The air ring  170  may include a pressurized air port  176  connected to a pressurized air or gas source.  
         [0042]     According to one embodiment, the body  102  is attached directly or indirectly to a mouthpiece  178 . According to the embodiment of  FIG. 1 , the mouthpiece  178  attaches to the air ring  170  and/or the nozzle  156 . The mouthpiece  178  may enclose a portion of the nozzle  156  that extends outside of the body  102 . The mouthpiece  178  may comprise a converging section  180  to direct flow to a patient or other user. However, according to some embodiments, the mouthpiece  178  is omitted and the nozzle  156  may comprise a mouthpiece.  
         [0043]     According to one aspect, embodiments described herein and others may be used to prepare liquids for users. For example, embodiments may be used to prepare liquid medication for a patient. Accordingly, a supply of fluid or liquid medicine may be introduced into a vortex to create a gaseous, homogenous liquid or liquid medicine supply having a very small particle diameter. According to one aspect, compressed or pressurized air is introduced into the air ring conduit  174  through the pressurized air port  176 . The pressurized air in the air ring conduit  174  is forced through the angled passages  136  into the vortex chamber (defined, for example, by the annulus  164 ). The angled passages  136  cause the pressurized air to form a high speed vortex in the vortex chamber. The energy level of the vortex in the vortex chamber may be adjusted by adjusting the pressure and/or flow rate of gas into the air ring conduit  174 . According to one aspect, air pressurized to approximately fifty to one hundred PSI is supplied to the air ring  170 .  
         [0044]     According to one aspect, pressurized air enters the vortex chamber and creates a vortex. Further, a supply of liquid medication is introduced to the vortex. In one aspect, liquid such as liquid medication is pressurized to a predetermined threshold level higher than the pressure of the pressurized air. For example, the spring  144  of the needle valve  138  may be set to open upon the application of fifty-five to seventy five PSI. Accordingly, the medication may be pressurized five to twenty-five PSI greater than the pressurized air. The pressure of the liquid medication opens the needle valve  138  and allows the liquid medication to exit the cone  114  into the vortex chamber. The vortex of the vortex chamber quickly breaks down and pulverizes the liquid medication into small, gaseous particles. According to one embodiment, the vortex breaks part or a majority of the liquid medication down to a particle size of no more than ten to twenty μm. A particle size of no more than ten μm can be deeply inhaled to treat lung ailments. The supply of vaporized medication mixed with air exits the vortex chamber through the nozzle  156 , where it is diffused for oral inhalation by a patient through the mouthpiece  178 .  
         [0045]     According to some aspects, it may be desirable to pass a mass of liquid medication directly into a patient&#39;s bloodstream by crossing the alveoli membrane of a patient&#39;s lungs. Therefore, according to some aspects, the vortex in the vortex chamber may be sufficiently energized to break down liquid medication to particle sizes of no greater than approximately 1.0 to 3.0 μm in diameter. According to some aspects, providing a supply of air to the vortex chamber at approximately fifty to one hundred PSI and delivering the air at approximately five CFM breaks down a majority of liquid medicines provided at a rate of approximately 0.8 ml/min to a particle diameter of no more than 1.0 to 3.0 μm. According to some aspects, 95% of liquid medicine supplied to the vortex chamber is broken down to a particle diameter of no more than 1.0 to 3.0 μm. Particles having a diameter of no more than approximately 1.0 to 3.0 μm can pass through the alveoli membranes of the lungs and directly into the patient&#39;s blood stream. Accordingly, inhalation of liquid medicine processed according to the principles described herein effectively delivers liquid medication to a patient without needles or digestion. Therefore, one can deliver medication to a patient according to principles described herein by passing a medicinal liquid drug directly into a patient&#39;s bloodstream by crossing the membrane of the alveoli of the lungs. Flow rates of the vortex air and the fluid or liquid medicine supply may be adjusted by those of skill in the art having the benefit of this disclosure to generate any desired medicine particle size. The flow rate of the liquid medicine introduced to the vortex may be adjusted, for example, by changing the position of the micrometer  146 , which in turn control how far the needle valve  138  opens.  
         [0046]     The preceding description has been presented only to illustrate and describe certain aspects, embodiments, and examples of the principles claimed below. It is not intended to be exhaustive or to limit the described principles to any precise form disclosed. Many modifications and variations are possible in light of the above teaching. Such modifications are contemplated by the inventor and within the scope of the claims. The scope of the principles described is defined by the following claims.