The present invention relates generally to a nebulizer, and more particularly but not exclusively to a compact nebulizer that efficiently utilizes medication.
The deposition efficiency in the tracheobronchial (TB) and pulmonary regions is highly dependent on particle size. Particle sizes in the range of about 1 to 5 μm, as well as the size range extending from approximately 0.005 to 0.5 μm, have a relatively high rate of deposition within the aforementioned regions. (See William Hinds, Aerosol Technology, p 241 (1999).) Various methods have typically been used to generate these therapeutic fine particles, such as air-blast nebulizers (i.e., compressed air, jet, or venturi nebulizer), pressure nebulizers, ultrasonic nebulizers, a vibrating orifice, a spinning disk, condensation devices, and inkjet technology-based nebulizers. However, despite the variety of methods used to generate therapeutic fine particles, problems remain such as wasted medication that is not dispensed and the swallowing of liquid medication by the user. Currently available nebulizers typically have residual (i.e., waste) medication of 50% or more. This waste is largely due to the fact that existing nebulizers will generate and disperse large and small particles. The large particle dispersion is not well controlled and leads to residual medication in the nebulizer and associated apparatus. Additionally, some nebulizers are relatively bulky, which unfortunately provides considerable surface area for medication deposition within the device which in turn leads to wasted unused medication. Thus, it would be an advance in the state of nebulizer art to more efficiently dispense and utilize liquid medication to reduce waste and increase patient compliance, and to protect the user of the nebulizer from swallowing liquid medication.
In one of its aspects, the present invention provides a nebulizer comprising an impactor having a curved surface and a nozzle oriented so that outflow from the nozzle engages the curved surface. The nebulizer incorporates a nebulizer tube, which may comprise a single-piece, and that may include a convergent-divergent air mixing nozzle, as well as an integral feed channel for siphoning medication. The nebulizer tube independently provides a first-level (i.e., relatively coarse) nebulization. To obtain the fine particles desired for nebulizers, the output stream from the nebulizer tube is directed towards an impactor having a curved surface at, or proximate, the impact site. When the flow strikes the impactor, very fine particles are generated. The curvature of the impactor promotes two very desirable effects. First, the portion of the flow that is not atomized into very fine particles will drain down the impactor and return to a medication reservoir disposed under the impactor, creating a “waterfall” recycling effect. Second, the impactor curvature also helps to direct the nebulized medication in a preferred direction, in this case toward the user's mouth.
In another of its aspects, the present invention also reduces the risk to the user associated with the inadvertent swallowing of unacceptably large quantities of liquid medication present in the nebulizer's reservoir. This could occur if the patient were to tilt his or her head too far back. To substantially reduce this risk, a semi-permeable membrane or other suitable material that is permeable to mist but sufficiently impermeable to liquid may be deployed to allow delivery of the nebulized mist to the user but prevent the flow of bulk liquid medication.
The present invention also provides in one of its aspects a reduction in the necessary treatment time through the generation of a dense mist of particles, in part because the particles are in the correct size range for effective deposition in the desired TB or pulmonary regions. The relatively higher density of nebulized particles may be created with the use of multiple jet impactors. Within a single nebulizer assembly, two, three, or more, high velocity jets of liquid-carrying gas may be directed at an impactor surface, creating a relatively higher density of fine droplets. Thus, the patient can inhale the full dose of medicine in a shorter time from which three benefits follow: more rapid treatment in critical situations, a financial benefit for the clinical setting (i.e., less time required from medical staff), and higher patient compliance in the home setting.
In these regards, the present invention provides a nebulizer for delivering a mist of liquid, comprising a housing and a reservoir disposed internally to the housing for containing liquid to be nebulized by the nebulizer. The nebulizer may include a monolithic nebulizer tube which has a gas channel having a first end for receiving a gas, such as compressed gas, and a second end for expelling the compressed gas and/or liquid. The gas channel may extend from a first end to a second end of the nebulizer tube. The monolithic nebulizer tube may also include a liquid feed channel comprising a first end in fluid communication with the reservoir for receiving liquid from the reservoir. Depending on the application the liquid may desirably be a liquid medication. The feed channel may include a second end in fluid communication with the gas channel. Alternatively, the feed channel may have an annular passageway at a second end of the feed channel with the annular passageway disposed about the second gas channel end. Application of compressed gas to the first end of the gas channel creates a siphon in the liquid feed channel to draw liquid into the feed channel and to expel the liquid and compressed gas from the second end of the nebulizer tube. To direct the flow of nebulized mist to an exit port of the nebulizer, a tortuous passageway may be provided between the second end of the gas channel and an exit port of the nebulizer. The tortuous passageway may be configured to remove nebulized particles larger than a selected therapeutic size from the flow of nebulized mist.
The nebulizer may further include an impactor disposed proximate the second end of the gas channel to nebulize the expelled liquid when the expelled liquid strikes the impactor. The impactor may be disposed sufficiently close the second end of the gas channel to assist in nebulizing the liquid expelled from the second end of the gas channel. The impactor may comprises a spherical, cylindrical, or mesa-like shape, or may include a ring disposed around the mesa to provide an annular channel between the ring and the mesa. The annular channel may be dimensioned to provide a fundamental resonant frequency of the annular channel tuned to generate particles of a preferred size.
In another configuration, the present invention provides a nebulizer for delivering a mist of liquid, comprising a housing having an inlet port for receiving compressed gas, such as compressed air for example, and an exit port for delivering a mist of nebulized liquid. A reservoir is disposed internally to the housing for containing liquid to be nebulized by the nebulizer. The nebulizer also includes a nebulizer tube in fluid communication with the liquid having an outlet from which the nebulized mist is provided. The outlet end of the nebulizer tube is disposed internally to the housing. The nebulizer also includes a tortuous passageway disposed within the housing between outlet end of the nebulizer tube and the exit port of the nebulizer for directing the flow of nebulized mist therethrough to the exit port.
In yet another configuration, the present invention provides a nebulizer for delivering a mist of liquid, comprising a two-piece housing having separate first and second housing portions, and a reservoir monolithic to the housing for containing liquid to be nebulized by the nebulizer. The nebulizer includes a nebulizer tube monolithic to the housing. The nebulizer tube includes a gas channel having a first end for receiving a gas, such as compressed air for example, and a second for expelling compressed gas and liquid. The gas channel extends from the first end to a second end of the nebulizer tube. The nebulizer tube also includes a liquid feed channel comprising a first end in fluid communication with the reservoir for receiving liquid from the reservoir and comprising a second end in fluid communication with the gas channel. Application of compressed gas to the first end of the gas channel creates a siphon in the liquid feed channel to draw liquid into the feed channel and to expel the liquid along with compressed gas from the second end of the nebulizer tube.
The foregoing summary and the following detailed description of the preferred embodiments of the present invention will be best understood when read in conjunction with the appended drawings, in which:
Referring now to the figures, wherein like elements are numbered alike throughout,
To receive a liquid, such as medication, introduced through the fill port 30, the lower housing 3 includes a reservoir 7 which may include a cylindrical sidewall 33 for containing the liquid medication within a localized region within the lower housing 3. (While any suitable liquid may be provided in the reservoir, for illustration purposes the devices of the present application are described herein as containing a medication.)
The reservoir 7 may be dimensioned to hold at least 3 ml of liquid medication, for example. In addition, to further contain the location of the liquid medication, the reservoir 7 may include a hemispherical or other suitably shaped depression 34 into which the liquid medication may pool. Maintaining the liquid medication in a specified location assists in making the medication available to the nebulizer tube 1, and thus aids in efficient use of the medication.
The reservoir 7 may include shapes other than cylindrical. For example, the reservoir 7″ may have a generally rectangular shape being bounded at the inlet and outlet end of the lower housing 3″ by front and rear reservoir walls 13a, 13b,
For example, a foam sponge material may be used as the membrane 4 to permit mist flow while deterring liquid medication flow therethrough. In the nebulizers of the present invention, the flow of small droplets from the nebulizer 100 operates in a very low Reynold's number flow regime. The Reynold's number is a dimensionless number, a ratio of the momentum forces acting on a body to that of the viscous forces. In a low Reynold's number flow, particles tend to follow the path of the gas flow and are not likely to impact upon the solid surfaces that restrain the flow. This holds true even when that flow path is a circuitous one through the pores of a thickness of sponge material. The droplets are carried through with the flowing gas stream, and so the sponge remains dry.
Thus, in one embodiment of the present invention, the membrane 4 is provided in the form of a layer of sponge material that covers the flow through the exit port 10 and permits the nebulized mist to flow out. The sponge could comprise either a wettable or non-wettable material for the given liquid medication. (The determination of whether a material is “wetting” or “non-wetting” depends on the liquid being used. As used herein, we are most interested in the wettability of materials mainly as it pertains to the use of aqueous solutions.) If the sponge were non-wettable, a sufficiently small pore size would have enough capillary pressure to prevent the liquid medication from progress through the sponge membrane 4. (A simple, well known equation can be used to calculate the “capillary pressure.” Capillary pressure is the pressure that would be required to force the liquid through a given-sized circular hole in a non-wetting material. The capillary pressure is dependent upon: the contact angle, the surface tension of the liquid, and the diameter of the hole.) However, most readily available sponge materials are comprised of wettable materials. If a wettable sponge material were employed as the membrane 4, the wettable sponge material should be located so that it is not typically in contact with the bulk liquid medication in the nebulizer 100. Otherwise, the liquid medication would undesirably be wicked into the sponge and would not be available to be delivered to the user. Nonetheless, a wettable sponge can provide useful functionality when it is strategically located so that, if the nebulizer 100 is tilted too much, the sponge acts as a barrier wicking up the large liquid drops or liquid that has sloshed due to rapid gross motions of the nebulizer 100. For example, a 2 mm thick layer of polyethylene wettable foam having about 80% open space and pore sizes of about 0.8 mm may be used as the membrane 4. In addition, a foam layer in the flow exit path proximate the exit port 10 provides an additional feature: a very slight back-pressure in the flow path of the gas and liquid mixture (i.e. the airborne droplets). This slight back-pressure gives the effect of a diffuser by evening out the velocity profile at the nebulizer exit port 10 so that the nebulized mist exits the nebulizer 100 at a slower average velocity and more uniform distribution across the exit port 10. (The diffuser effect causes the velocity to be more uniform. The slight flow restriction or back pressure, due to the presence of the foam layer, will tend to slow the flow.)
Further exemplary materials for use as the membrane 4 would include films comprised of fluoropolymers (PTFE, etc.), such as DuPont Teflon® PTFE, having very small pore sizes. Films such as these are currently being produced by W. L. Gore Company under the Gore-Tex® trademark. Teflon® PTFE has a very low surface energy as it is essentially a non-polar molecule. Water is a polar molecule, and liquid water does not “wet” a Teflon® PTFE surface. Instead, liquid water forms “beaded” drops on the surface of the Teflon® PTFE; each drop has a contact angle much greater than 90 degrees. In the case of liquid water and Teflon® PTFE, a very high pressure is required to force water through small holes in the material. However, gases and water mist flow through the pores with little trouble. Gore-Tex® films are specifically created to exploit this phenomena in a number of applications. (One example is a “T” fitting that has one port covered by Gore-Tex® film. This assembly is used in some intravenous tubing, which allows gases to vent out of the tube but prevents the IV fluid from leaking through.)
The nebulizer tube 1 includes a liquid feed channel 6 having an inlet end 42 disposed in fluid communication with the reservoir 7 to receive liquid medication disposed within the lower housing 3,
The inlet end 41 of the nebulizer tube 1 may include a barb 18 to assist in securing attachment of a compressed air hose to the inlet end 41 of the nebulizer tube 1,
The nozzle 8 is oriented so that the output flow from the nozzle 8 strikes a curved impactor 9, which may be provided as part of the upper housing 2. This energetic collision generates the very fine, therapeutic particles required of nebulizers. It has been determined that a sufficiently small spacing is required between the nozzle 8 and impactor 9 to generate a fine mist. A suitable nozzle to impactor spacing is 10 to 20 thousandths of an inch. The location of the nozzle 8 relative to the curved impactor 9 may be specified by an alignment boss 21 provided on the nebulizer tube 1 that mates with a complementary positioning feature 11 of the lower housing 3 to locate the nebulizer tube 1 within the housing 40. In addition, the nebulizer tube mates with an nozzle capture feature 15 of the upper housing 2 to stabilize the tube 1 within the nebulizer 100,
The impactor 9, 209 may have a generally cylindrical shape, such as a substantially full cylinder,
In addition to creating a fine mist, the curved impactor 9 also provides at least two other desirable functions: (I) it helps direct the nebulized mist towards the user's mouth, and (ii) it facilitates a waterfall-like recycling effect. The waterfall effect arises because part of the mixture exiting the nebulizer tube 1 will strike the impactor 9 and simply drain back down into the region containing the pool of liquid, i.e., reservoir 7. In this regard, the impactor 9 may be positioned above the reservoir 7. Of course, a significant portion of the air/liquid mixture will exit via port 10 of the nebulizer as a mist directed toward the user's mouth. An air baffle 20 may be provided on the nebulizer tube 1 proximate the feed channel inlet end 42, so that the high-velocity mixture striking the impactor 9 does not blow liquid away from the feed channel inlet 42 which could lead to a feed channel starvation condition. In addition, inclusion of the air baffle 20 can deter unwanted formation of large airborne droplets that might result from the surface of the liquid being agitated.
Additionally, the impactor 9, 209 can be shaped to create a scavenging flow within the nebulizer 100, 200. The scavenging flow would be directed throughout the housing interior and would help prevent the accumulation of medication on the internal walls of the nebulizer 100, 200. In addition, curtain walls 261 may be provided in the upper housing 2, 202 to redirect any accumulation of liquid on the upper surface of the upper housing 2, 202 downward into the reservoir 7, 207. The presence of curtain walls 261 can avoid the situation of liquid running down the interior sidewall of the upper housing 2, 202 to encounter and potentially leak out through the seam between the upper housing 2, 202 and the lower housing 3, 203. The curtain walls 261 may also be positioned sufficiently close to the impactor 209 to permit fine particles to travel around the impactor 209 to the exit port 210 and to cause larger particles to strike the curtain walls 261 and then drip down into the reservoir 207. Additionally, a filter-type material may be positioned in the nebulizer 100, 200 to give a preferential flow direction for the nebulized mist toward the user's mouth without creating an excessive flow resistance to inhalation. Furthermore, the housing 40, 240 and/or other components of the nebulizer 100, 200 may be fabricated from materials that possess surface tension properties characteristic of wetting materials to create a sheeting action that will facilitate the flow of recycled materials to the reservoir 7, 207. For example, the material of the housing 40 may comprise plastics that are non-wetting in their original condition. Polyethylene (PE) and polypropylene (PP) are two examples. If the reservoir 7 is constructed of one of these materials, and has sufficiently steep internal shape, the liquid medication will roll down to the lowest point, which would presumably be the location from which the liquid medication is being siphoned. Many times however, in practical applications, after having been used, a surface that started out as non-wetting, can become fully or partially wetting due to the deposition of a very thin layer of dirt, minerals, or other contaminants on the surface. The surface might then act as a wettable one. For this reason, it is important to design the reservoir 7 to work well as a wettable material to start with.
The wetting angle of a wettable material is less than 90 degrees. The contact angle can be a very small angle as the edge of a liquid is pulled along a solid surface. Several characteristics of a wettable surface, together with intentional geometric features, can be used to help the functionality of the nebulizer design. An ideal nebulizer would have the capability to utilize every bit of the liquid medication contained therein. Achievement of this goal may be attempted by pulling the liquid medication from a location that is the lowest point in a depression of the reservoir 7. The inner walls of the reservoir 7 may be sloped as much as possible, because as the liquid medication level goes down, droplets of water can remain stuck in random locations on the walls of a reservoir 7 that is made from a wettable material. These droplets would be counted as wasted medication that the nebulizer 100 is unable to use as residual content. The nebulizer design can cause the air flow to move generally downward along the walls of the reservoir 7, which is generally a turbulent action. However the shear action downward along the reservoir wall will scrub the liquid down toward the pick up location.
The geometry of the reservoir walls, together with the wetting characteristics of the reservoir can also help to reduce the amount of residual unused medication. Internal angles or grooves that run in a direction down the side walls of the reservoir 7 can also be included. The dimensions of the angles or grooves can be relatively small as compared with the dimensions of the reservoir 7, in which case the liquid will “wick” along the angles or grooves. Further, the design can be made to cause the liquid to preferentially move in one direction along the length of these features by gradually changing the size or shape of the groove along its length. For example, if the internal angle of the groove becomes more acute, the liquid will be preferentially pulled in that direction. Another technique for pulling the liquid toward the feed channel inlet 42 of the feed channel 6 is by make the gap between the bottom surface of the reservoir 7 and the feed channel inlet 42 sufficiently small to wick into this gap (if the surfaces are wetting materials). A further aid is to have the gap reduce in size (taper, or converge) as the liquid moves in the flow-wise direction, towards the feed channel inlet 42. A gap that becomes smaller as it approaches the inlet to the feed channel 42 can encourage the liquid to flow in that direction.
Turning next to
Referring to the cross-sectional view of
The air accelerates until it reaches the throat 343 (a location of minimum cross-sectional area) of the nebulizer tube 301. By virtue of the Bernoulli effect, as the flow velocity increases, its static pressure decreases. As a result, the static pressure at the throat 343 of the nebulizer tube 301 is below that of the local atmospheric pressure. An integral liquid feed channel 306 of the nebulizer tube 301 is disposed in communication with the medication located in the reservoir 307 of the lower housing 303. Since the static pressure of the liquid is higher than the static pressure at the throat 343 of the nebulizer tube 301, liquid is siphoned upward though the feed channel 306 as a result of this venturi effect. Subsequent to siphoning, the liquid/air mixture is rapidly expanded in the divergent section of the nozzle 314. This rapid expansion encourages turbulent mixing and creates an effective first-level of nebulization.
After exiting the nozzle 314, the mixture strikes an impactor 309 which may be provided as a monolithic part of the upper housing 302. This energetic collision generates very fine, therapeutic particles. The spacing between the nozzle 314 and the impactor 309 is selected to be sufficiently small, e.g., 20 to 40 thousandths of an inch, to generate a suitably fine mist. The impactor 309 also provides the waterfall-like recycling effect. An air baffle 320 of the nebulizer tube 301 is provided near the bottom of the feed channel 306 so that after the high-velocity mixture strikes the impactor 309 the deflected stream does not disturb the liquid near the feed channel inlet. Without the baffle 320, it is possible that a feed tube starvation condition could be created due to liquid being blown away from the feed channel 306. In addition, the surface of the liquid might be agitated to an extent that would produce unwanted formation of large airborne droplets. Note also, that in the event that the nebulizer is tilted forward beyond some critical angle during use, the adjoining walls 313, 350 of the upper and lower housings 302, 303 block the flow of medication into the user's mouth.
The upper housing 302 includes a nebulization chamber 334 in which the nebulized mist is generated,
Specifically, with reference to
To further assist in directing airflow through the nebulizer to the patient, upper and lower housings 402, 403 may be provided which have a geometry that includes a flow path for external air to be drawn in by the patient,
Each of the nebulizer configurations discussed so far may also utilize multi-channel nebulizer tubes 401, 501, rather than a single channel nebulizer tube 1, 201, 301, to reduce the treatment time. For example, as shown in
In addition, still further configurations of nebulizers and nebulizer tubes are provided by the present invention. For instance, with reference to
In operation, a high pressure gas (typically air) enters the nebulizer tube 801 through the inlet end 841 and is accelerated to sonic velocity. The air expands as it leaves the nozzle 811. Since the feed channel 806 is in communication with a reservoir 811 of liquid (typically medication), under the proper conditions, liquid medication is siphoned through the feed channel 806 and exits the nebulizer tube 801 via annular medication exit port 808. Whether siphoning occurs depends on the spacing between the exterior face of the nozzle 811 and the impactor 809. Provided that the spacing between the exterior face of the nozzle 811 and the impactor 809 is sufficiently small (for example, 20 to 80 mils, with 30 mils representing a preferred spacing), a low-pressure air zone will be formed proximal to the annular medication exit port 808. This creates a pressure differential across the liquid that will siphon fluid from the reservoir 807 and direct it towards the impactor 809. The energy imparted to the liquid from the gas, as well as the impaction on the impactor 809, generates fine particles from the liquid.
Further, alternative impactor structures in addition to the spherical impactor 809 of
In yet another aspect of the present invention, a nebulizer configuration is provided in which the nebulizer body comprises only two parts, with the nebulizer tube 601 monolithically formed as a part of either the upper or the lower housing 602, 603,
The upper housing 602 may include a “living hinge” 622 that allows the impactor half of the upper housing 602 to open as a lid 620 to permit the introduction of liquid medication into a reservoir 607 of the lower housing 603,
The integral nebulizer tube 601 may also include a convergent channel 605 through which compressed air is introduced to the nebulizer 600. The air accelerates until it reaches the throat 643 (minimum cross-sectional area) of the tube. By virtue of the Bernoulli effect, as the flow velocity increases, its static pressure will decrease. As a result, the static pressure at the throat 643 of the nebulizer tube 601 is below that of the local atmospheric pressure. Since the static pressure of the liquid is higher than the static pressure at the throat 643 of the nebulizer tube 601, liquid is siphoned upward as a result of this Venturi effect. Subsequent to siphoning, the liquid/air mixture is rapidly expanded in the divergent section of a nozzle 608 of the nebulizer tube 601. This rapid expansion encourages turbulent mixing and creates an effective first-level of nebulization. After exiting the nozzle 608, the mixture strikes an impactor 609 which is also monolithic to the upper housing 602,
As with the nebulizer configuration of
In addition, the nebulizer 600 may also include one or more make-up air channels 672, which may be provided as a monolithic part of the upper housing 602,
The various nebulizer configurations presented above may have a compact size permitting the nebulizers to substantially fit within the user's mouth which contributes to minimizing the amount of residual medication. The compact size is not just a matter of design choice—it has an effect on all other aspects of the nebulizer's functionality. A higher nebulization rate, within a small volume, can have negative aspects. For example, there can be interaction between the multiple jets leading to an increased probability of particle agglomeration to a size larger than that desired for effective patient treatment. However, there can be substantial benefits of making the nebulizer very compact, such as high efficiency use of the medication, which is partially dependent upon having a compact nebulizer. A compact nebulizer has a smaller wettable surface area. Thus, the inner surfaces of the nebulizer will hold less residual medicine. The location and geometry of the liquid reservoir and intake, together with the gas flow path, are also important factors affecting the amount of residual. Thus, the designs strike a balance between nebulization rate and compactness.
These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as set forth in the claims.
This application claims the benefit of priority of U.S. Provisional Applications Nos. 60/891,892 filed on Feb. 27, 2007 and 60/999,755 filed on Aug. 9, 2007, the entire contents of which application are incorporated herein by reference.
Number | Date | Country | |
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60891892 | Feb 2007 | US |