Abstract:
An adaptor for providing fluid communication between a counter equipped measured dose inhaler (MDI) canister and a ventilator circuit includes a housing, a receiver tube for engaging the valve stem of the canister, and a tab for engaging the counter mechanism. The housing defines a primary lumen which extends between an input limb and an output limb. The limbs are configured to mate with the tubing of a ventilator circuit. The receiver tube defines a receiver lumen therethrough and extends from the exterior of the housing and into the primary lumen. The receiver lumen provides fluid communication between the exterior of the housing and the primary lumen.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    None. 
       BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    Embodiments of the invention are directed to ventilator systems and more particularly to ventilator systems and/or their components adapted to interface with a metered dose inhaler (MDI). 
         [0004]    2. Description of the Related Art 
         [0005]    Ventilators are automatic mechanical devices designed to provide all or part of the work the body must produce to move gas into and out of the lungs. Though many types of ventilators are known in the art, features common to nearly all conventional types include a number of working components that cooperate with one another to ensure the desired ventilation of the patient&#39;s lungs is realized. More specifically, a conventional ventilator includes a stable attachment (also called an interface or accessory) of the device to the patient; a source of energy to drive the device; a control system to make it perform appropriately; and a means of monitoring the performance of the device and the condition of the patient. 
         [0006]    Conventional ventilators deliver gas to the patient through a set of flexible conduits or tubes called a patient circuit. Typically, the ventilator includes two tubes: one associated with exhalation and the other associated with inhalation (there are some ventilator systems which include only a single tube). The circuit connects the ventilator to either an endotracheal or tracheostomy tube that extends into the patient&#39;s throat (in the case of an invasive ventilation), or a mask covering the mouth and nose or just the nose (in the case of a noninvasive ventilation). 
         [0007]    Often when a patient is connected to a ventilator, it is necessary to deliver therapeutic agents (drugs, medicine, etc) into the lungs. A common way to do this is to include in the circuit pathway a mechanism that will receive the valve stem of a canister of medicine, such as those canisters typically associated with a metered dose inhaler (MDI). Such a receiver mechanism provides a convenient and user friendly way to directly inject medicine into the lungs of the patient by utilizing the inhalation event of the ventilator. 
         [0008]    MDIs are well known devices, and are often referred to simply as inhalers. They are devices that help deliver a predetermined amount (dose) of medication to the pulmonary system, and particularly the lungs. They are commonly used to treat asthma, chronic obstructive pulmonary disease (COPD), and/or other respiratory problems. 
         [0009]    A hand held inhaler or MDI often comprises two major components: a canister and a mouth piece body. The canister itself includes a metering dose valve with an actuating stem, and contains the aerosol propellant and medication or medications. The mouth piece body contains a valve stem receptor that defines a port to engage the stem of the canister, and the mouth piece itself, to which the user places to their mouth to receive the medication contained in the canister. The mouth piece commonly includes a dust cap to prevent contamination. 
         [0010]    Once assembled the patient or care provider uses the inhaler by pressing down on the top of the canister while supporting lower portion of the body or mouthpiece, thus releasing a mist of medication that is then inhaled into the lungs. When utilized in a ventilator circuit, such as described above, the valve stem of the canister is typically mated directly to a receiver (without the mouth piece body) on the inhalation tube of the circuit. Direct compression of the canister against the receiver expels medicine into the circuit and then into the lungs of the patient. 
         [0011]    A recent trend in the make-up of MDIs is to include a counter device that is incorporated directly into assembly of the canister and/or valve stem. The counter is provided in order to enable the user to see the number of doses expelled from, or remaining in, the canister. An example of an MDI equipped with a counter mechanism is illustrated in PRIOR ART  FIGS. 1   a .- 1   e.    
         [0012]    As shown, the counter equipped MDI includes the canister assembly  10  and the mouth piece body  20 . The mouth piece body  20  defines a canister receiving region  21  and a valve stem neck  22 , which receives the valve stem  11 . The canister  10  includes a counter mechanism  12  which at least partially surrounds the valve stem  11 . The counter  10  includes a display mechanism  13  such as a gear and/or spindle driven wheel or wheels that display the number of doses remaining in the canister. The display mechanism  13  is configured to be repeatedly engaged and actuated by a tab, protrusion, or other device  23  within the mouth piece  20 . Each time the engagement mechanism  12  is engaged by protrusion  23 , the display  13  progressively displays each dose expelled from the canister  10  when the MDI is used in the manner described above. 
         [0013]    Unfortunately, the valve stems of canister assemblies that include counters will not effectively mate with the receiver mechanisms or other known adaptors of ventilator circuits (an example of which is illustrated in PRIOR ART  FIG. 2 ). Moreover, attempts to modify counter equipped MDI canisters, so that they may be utilized with current receivers, will often result in significant damage to either or both structures, rendering the canister (and the medicine contained therein) un-useable. 
         [0014]    It is recognized that counter equipped MDI canisters are becoming more common place, and will most likely replace non-counter equipped canisters. As a result, care givers and individual vented patients are forced to adopt the counter equipped MDI canisters despite having no way of conveniently injecting the medicine of the canister into the ventilator circuit. Thus, a need exists to provide an adaptor mechanism for conveniently mating a counter equipped MDI canister, or the MDI itself, directly to the circuit of a ventilator. 
         [0015]    The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists. 
         [0016]    All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. 
         [0017]    Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below. 
         [0018]    A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims. 
       BRIEF SUMMARY OF THE INVENTION 
       [0019]    In light of the above, at least some embodiments of the present invention are directed to a mechanical interface which allows a counter equipped MDI canister to interface into a ventilator circuit without the need to modify or remove the counter from the canister. 
         [0020]    In at least one embodiment of the invention an interface mechanism is provided that will adaptively mate to the valve stem of a counter equipped MDI. 
         [0021]    These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for further understanding of the invention, its advantages and objectives obtained by its use, reference should be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there are illustrated and described further embodiments of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0022]    A detailed description of the invention is hereafter described with specific reference being made to the drawings. 
           [0023]      FIG. 1   a  is a side view of a PRIOR ART MDI device. 
           [0024]      FIG. 1   b  is a diagrammatic view of the PRIOR ART canister assembly shown in PRIOR ART  FIG. 1   a.    
           [0025]      FIG. 1   c  is a top down internal view of the PRIOR ART mouth piece shown in PRIOR ART  FIG. 1   a.    
           [0026]      FIG. 1   d  is a side view of the canister assembly shown in PRIOR ART  FIGS. 1   a  and  1   b.    
           [0027]      FIG. 1   e  is an alternate side view of the canister assembly shown in PRIOR ART  FIGS. 1   a  and  1   b.    
           [0028]      FIG. 2  is a partial perspective view of a PRIOR ART ventilator circuit. 
           [0029]      FIG. 3  is a solid perspective view of an embodiment of the invention. 
           [0030]      FIG. 4  is a solid cross-sectional perspective view of the embodiment shown in  FIG. 3 . 
           [0031]      FIG. 5  is a perspective component (see-through) view of the embodiment shown in  FIG. 3 . 
           [0032]      FIG. 6  is a cross-sectional component perspective view of the embodiment shown in  FIG. 3   
           [0033]      FIG. 7  is a top down view of the embodiment shown in  FIG. 3 . 
           [0034]      FIG. 8  is a front component view of the embodiment shown in  FIG. 3 . 
           [0035]      FIG. 9  is a side component view of the embodiment shown in  FIG. 3 . 
           [0036]      FIG. 10  is a rear component view of the embodiment shown in  FIG. 3 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0037]    While this invention may be embodied in many different forms, there are described in detail herein specific embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. 
         [0038]    For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated. 
         [0039]    Turning to the embodiment of the present invention, illustrated in  FIGS. 3-10  a unique line ventilator circuit adaptor, or t-connector  100  is shown. Adaptor  100  is configured to be inserted directly into a ventilator circuit and allow a direct interface with of a counter equipped MDI canister  10  therein. 
         [0040]    Circuit adaptor  100  is a substantially T-shaped housing  102  of material such as plastic, metal, etc., which defines a primary lumen  104  through which the fluid (e.g. breathable air, oxygen and/or oxygen mixtures, etc.) of the ventilator circuit can freely flow. The housing of the primary lumen  104  is divided into an input limb  106  and an output limb  108 . The external diameter of each limb may be the same, however in at least one embodiment, at least a portion of the exterior of the input limb  106  has a narrower diameter than the exterior of the output limb  108 . In the embodiment shown herein the input limb  106  is narrower to allow the ventilator tubing to be engaged over or on the outside surface of the housing, whereas the output limb  108  engages the exterior of the ventilator circuit tubing. 
         [0041]    On the exterior  101  of the primary lumen housing  102  is positioned an MDI receiver collar  110 . The collar has an interior diameter sufficient to removeably receive a counter equipped MDI canister  10 , such as of the type previously shown and described above. The collar is further configured to removeably receive a cap or cover  112  which overlays the collar opening  114  when the canister  10  is not in use or present. 
         [0042]    In some embodiments the cap and collar interface includes threads to allow the cap to be screwed into place. In some embodiments the cap and collar interface includes one or more flanges, indentations and/or protrusions to allow the cap and collar to frictionally engage one another with a “snap-fit”. Regardless of the particular mechanism used to engaged the cap  112  to the collar  110 , the interface between the two desirably forms an air tight seal. 
         [0043]    Within the collar  110  is positioned an external portion  121  of valve stem receiver  120 . In at least one embodiment, at least the exterior portion  121  of the receiver  120  is centrally positioned within the collar  110 , though in some embodiments the receiver can be offset if desired. 
         [0044]    The receiver  120  is an elongate tube of the same or different material as the housing  102  and defines a receiver lumen  122 . An exterior portion  121  of the receiver  120  includes an opening  123  in communication with the receiver lumen  122 . The opening  123  has an inner diameter sized to receive and engaged the valve stem  11  of a counter equipped MDI canister  10  of the type previously shown and described. In some embodiments the exterior portion  121  of the receiver  120  is sized and configured such that the external surface of the receiver lumen  122  engages the internal surface of the canister valve stem  11 . 
         [0045]    The receiver tube  120  has a length that extends from within the collar  110 , through the housing  102 , and into the primary lumen  104 . The portion of the receiver  120  within the primary lumen is referred to as the interior portion  125  of the receiver  120 . The receiver  120  terminates at an interior end  124  within the primary lumen  104 . Adjacent to the interior end  124 , the receiver  120  defines an interior opening or port  126 . Port  126  may be defined by any portion of the receiver  120 , but in at least one embodiment port  126  is defined by the region of the tube generally facing the output limb  108  of the primary lumen  104 . By facing in this direction, drug or other therapeutic agent delivered from canister  10  (through opening  123  and lumen  122 ) will enter the primary lumen  104  and be directed into the ventilator circuit in the same direction of the inhalant flowing to the patient. 
         [0046]    In some embodiments the receiver tube  120  includes at least one unidirectional valve. Such a valve is positioned within or adjacent to the receiver lumen  122  to allow a therapeutic agent to enter the primary lumen  104  (via the receiver lumen  122 ) but prevents the therapeutic agent or other fluid (breathable air, etc.) present in the ventilator circuit from escaping back through the receiver lumen  122 . 
         [0047]    In order for the present circuit adapter  100  to be fully effective with counter equipped MDI canisters, the adaptor must include an engagement tab  130  configured to engage and actuate the counter mechanism  12  of the canister  10 . Such a tab  130  is positioned on the external surface  101  of the primary lumen housing  102 , adjacent to receiver tube  120  and with the perimeter of the collar  110 . 
         [0048]    The particular orientation, spacing from the receiver tube, size, shape, length, and other physical characteristics of the tab  130  are selected depending on the type of canister  10  to be utilized. For example, in at least one embodiment the tab  130  includes along one lateral face  132  a plurality of engagement teeth  134 . These teeth are numbered, sized and arranged to engage the gear/spindle (not shown) of the counter mechanism  12  of the type of canister  10  shown in the PRIOR ART figures. 
         [0049]    In at least one embodiment the tab  130  is identical in size and shape to the engagement device  23  of the mouth piece  20  depicted in the PRIOR ART figures. 
         [0050]    In use adaptor  100  is inserted into the inspiratory limb of a ventilator circuit with the output limb  108  proximal to the patient. Once in position, a counter equipped MDI canister  10  is inserted within the collar  110 . The canister valve stem  11  engages the valve stem receiver  120  of the adaptor  100  and the canister&#39;s counter mechanism  12  engages the tab  130 . When positioned in this manner the canister  10  can be compressed toward the adaptor  100  causing the valve stem  11  to release a single dose of medication from the canister, while the tab  130  simultaneously engages and actuates the particular gear/spindle or other system of the counter mechanism  12 . This actuation will result in the display mechanism  13  advancing to visually display that a medication dose has been expelled from the canister. 
         [0051]    This completes the description of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto. 
         [0052]    The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. The various elements shown in the individual figures and described above may be combined or modified for combination as desired. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. 
         [0053]    Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim  1  should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.