Patent Grant
7841342
The present invention relates to inhalation equipment and more particularly, relates to aerosol inhalation systems including an interface (accessory) for use in the system between a conventional part of the inhalation equipment, such as a generator and the patient to provide in a number of applications a completely closed system that ensures that the medication delivered to the patient has a fixed concentration over time.
Aerosol inhalation equipment is commonly used as a means to deliver medication in all aerosolized form to a patient. Aerosolized medication is typically used to treat patients with respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD). For example, inhalation equipment is a common means for delivering, medication to counter certain aliments of a patient population, including reactive airway disease, asthma, cystic fibrosis, etc.
It is generally accepted that effective administration of medication as aerosol depends on the delivery system and its position in relation to the patient. Aerosol particle deposition is influenced by particle size, ventilatory pattern, and airway architecture and effective medication response is also influenced by the dose of the medication used.
An aerosol delivery system includes three principal elements, namely a generator, a power source, and an interface. Generators include small volume nebulizers (SVN), large volume nebulizers (LVN), metered dose inhalers (MDI), and dry powder inhalers (DPI). The power source is the mechanism by which the generator operates or is actuated and includes compressed gas for SVN and LVN and self-contained propellants for MDI. The interface is the conduit between the generator and the patient and includes spacer devices/accessory devices with mouthpieces or face masks. Depending on the patient's age (ability) and coordination, various interfaces are used in conjunction with SVN and MDI in order to optimize drug delivery.
A SVN is a jet nebulizer that is powered by a compressed gas source. The medication is displaced tip a capillary tube from the nebulizer's reservoir and is dispersed continuously as aerosolized particles. The aerosolized particles are spontaneously inhaled by the patient or delivered in conjunction with positive-pressure breaths. Typically, for patients greater than 3 years who are spontaneously breathing without an artificial airway and are able to cooperate, a mouthpiece with an extension reservoir should be used. For patients unable to negotiate a mouthpiece, typically children under 3 years, a face mask should be used.
An MDI is essentially a pressurized canister that contains a medication and propellant. Actuation of the MDI results in the ejection of one dose of medication as aerosolized particles, which can be spontaneously inhaled by the patient or delivered in conjunction with positive-pressure breaths. A spacer device/accessory device should be used with an MDI. A spacer device enhances delivery by decreasing the velocity of the particles and reducing the number of large particles. A spacer device with a one-way valve, i.e., holding chamber, eliminates the need for the patient to coordinate actuation and inhalation and optimizes drug delivery. A spacer device without valves requires coordination between inhalation and actuation. The MDI with spacer device and face mask is appropriate for patients, typically less than 3 years, unable to use a mouthpiece.
A DPI is a breath-actuated device that uses a gelatin capsule containing, a single dose of medication and a carrier substance to aid in the dispersion of the drug. The capsule is inserted into the device and punctured. The patient's inspiratory flow disperses the dry particles and draws them into the lower airways. In spontaneously breathing patients, this device is appropriate in patients who are able to achieve a certain inspiratory flow, such as equal to or greater than 50 L/min. This will typically correspond to children about 6 years or greater.
A LVN can be used to deliver a dose of medication continuously over a period of time. A LVN is powered by a compressed gas source, and a face mask is typically used as the interface.
The two primary means for delivering aerosolized medication to treat a medical condition is an MDI or a nebulizer. MDI medication (drug) canisters are typically sold by manufacturers with a boot that includes a nozzle, an actuator, and a mouthpiece. Patients can self-administer the MDI medication using the boot alone but the majority of patients have difficulty in synchronizing the actuation of the MDI canister and patient inhalation and improve the delivery and improve the delivery of medication by decreasing oropharynigeal deposition of the aerosol drug.
Many valved chambers of this type are commercially available. Examples of such spacers include but are not limited to those structures disclosed in U.S. Pat. Nos. 4,470,412; 5,012,803; 5,385,140; 4,637,528; 4,641,644; 4,953,545; and U.S. patent application publication No. 2002/0129814. These devices are expensive and may be suitable for chronic conditions that require frequent use of MDI inhalers provided the cost and labor involved in frequent delivery of medication is acceptable to the patient. However, under acute symptoms, such devices may fail to serve the purpose and lead to an inadequate delivery of medication.
Aerosol delivery systems that use standard small volume nebulizers are commonly used in acute conditions as they are cheap and overcome the inhalation difficulties associated with actuation of MDI and synchronization of inhalation by the patient. Nebulizers are fraught with numerous problems as well. The medication dose used is about 10 times of that used with an MDI and hence the increased cost without any added proven clinical benefit. Secondly, the majority of the nebulized medication is wasted during exhalation. Thirdly, the time taken to deliver the medication is several times that of an MDI and the labor cost of respiratory therapist may outweigh the benefits of nebulizers compared with MDIs. Breath actuated nebulizers(s) with reservoir have been designed to overcome the medication waste. An example of this type of device is found in U.S. Pat. No. 5,752,502. However, these devices are expensive and still have all the other problems associated with nebulizer use alone. Other examples of aerosol inhalation devices can be found in U.S. Pat. No. 4,210,155, in which there is a fixed volume mist accumulation chamber for use in combination with a nebulizer and a TEE connection.
Problems with prior art devices include that the devices significantly waste medication, they provide a non-uniform concentration of delivered medication, they are expensive, and they are difficult to use. Many of these devices are commercially available in which the nebulizer is directly attached to the TEE connector without any mixing chamber. All of the aforementioned devices can be used with either an MDI or a nebulizer but not both, and hence, face the difficulty associated with either system alone. Other devices have tried to overcome the above problems by incorporating a mixing chamber in the device with adaptability to be used with an MDI or standard nebulizer. U.S. patent application publication No. 2002/0121275 disclosed a device having the above characteristics, however, this device is plagued with problems that are typical to those types of devices. As with other conventional devices, the disclosed device, like the other ones, fails to incorporate some of the key features necessary for enhanced aerosol delivery.
In general, each of the prior art devices suffers from the following deficiencies: (1) the entrained airflow in the device interferes with the MDI plume as well as the plume generated by a nebulizer resulting in increased impaction losses of aerosol generated by either an MDI or nebulizer; (2) the device does not have the ability to deliver a desired precise fraction of inspired oxygen to a hypoxic patient and simultaneously deliver aerosol medication with either a metered dose inhaler (MDI) or a nebulizer; (3) the device can not deliver a (as with a desired density to improve aerosol delivery and a desired fraction of inspired oxygen to a hypoxemic patient; (4) the device does not have the ability to deliver different density gases with a desired fraction of inspired oxygen simultaneously while retaining the ability to deliver aerosol medication at the same time with either an MDI or a nebulizer; (5) the device does not have the ability to deliver a mixture of multiple gases to a patient and simultaneously maintain a desired fraction of inspired oxygen; (6) the device does not serve as a facemask for delivering varying concentrations of inspired oxygen from room air to 100% but serves solely as an aerosol delivery device; (7) the device does not have a reservoir chamber—either as a bag or as a large volume tubing to store nebulized medication that is otherwise wasted during exhalation (The holding chamber of this type of device varies from 90 cc to 140 cc and is not enough to serve as a reservoir for the volume of nebulized medication generated during exhalation is wasted); (8) there is no mechanism in the device to prevent entrainment of room air which forms the bulk of volume during inhalation (the fraction of inspired oxygen and the density of the gas mixture inhaled by the patient may vary with every breath with the device depending on the volume of entrained room air which may vary with each breath); (9) the device does not have any valve system to prevent exhaled carbon dioxide from entering the holding chamber—rebreathing of carbon dioxide from the holding chamber on subsequent inhalation can be extremely detrimental to a patient and extremely dangerous under certain clinical conditions; (10) the device does not have the capability of delivering medication with an MDI and a nebulizer simultaneously; and (11) the device has a fixed volume-holding chamber which makes the device extremely large and cumbersome to deliver medication.
What is needed in the art and has heretofore not been available is a system that overcomes the above deficiencies and incorporates functionality to make the device a compacts user friendly, economical, and multipurpose aerosol device for both acute and chronic use with either an MDI or a nebulizer or with both devices simultaneously as warranted by the patient's clinical circumstances.
According to one embodiment, an aerosol inhalation system includes a single source of gas and a Y-connector having a first port in fluid communication with the gas source via a first conduit and second and third ports. The system also has an accessory having a main conduit body that includes a first leg, a second leg, and a third leg, all of which are in fluid communication with the main conduit section. The first leg, is fluidly connected to the second port of the Y-connector via a second conduit to permit gas from the single source to flows though the first leg, the accessory including a patient interface conduit that delivers aerosolized medication to a mouth of the patient.
A nebulizer is sealingly and removably disposed within the third leg and includes a gas inlet port that is fluidly connected to the third port of the Y-connector to permit gas from the single source to flow into the nebulizer to create the aerosolized medication that is delivered into the main conduit body and to the patient through the patient interface conduit.
According to another embodiment, an aerosol inhalation system includes a single source of gas and a Y-connector having a first port in fluid communication with the gas source via a first conduit and second and third ports. The system further includes an accessory having a main conduit body that includes a first leg, a second leg, and a third leg, all of which are in fluid communication with the main conduit section. The first leg is fluidly connected to the second port of the Y-connector via a second conduit that is connected to the second port and a gas port associated with the first leg to permit gas from the single source to enter and flow through the first leg. The accessory also includes a patient interface conduit that delivers aerosolized medication to a mouth of the patient.
A nebulizer is sealingly and removably disposed within the third leg and includes a gas inlet port that is fluidly connected to the third part of the Y-connector to permit gas from the single source to flow into the nebulizer to create the aerosolized medication that is delivered into the main conduit body and to the patient through the patient interface conduit. The gas port has a first inner diameter and the gas inlet port of the nebulizer has a second inner diameter which is greater than the first inner diameter.
Further aspects and features of the exemplary aerosol inhalation system disclosed herein can be appreciated from the appended Figures and accompanying written description.
The foregoing and other features of the present invention will be more readily apparent from the following detailed description and drawings of the illustrative embodiments of the invention wherein like reference numbers refer to similar elements and in which:
Now turning to FIGS. 1 and 3-5 in which an accessory or interface element 100 according to one exemplary embodiment and for use in an aerosol delivery system is illustrated. As described below, the accessory 100 is intended for use with a nebulizer or an MDI or another piece of aerosol inhalation equipment. The accessory 100 is defined by a body 110 that can be formed of any, number of different materials, including a plastic material or a metal. The accessory 100 is essentially a hollow body 110 that has a first end (inlet end) 112 and an opposing second end (outlet end) 114. The accessory 100 is intended to act as a fluid connector in that it is fluidly attached to another piece of equipment, such as a facemask, that is directly coupled to the patients mouth, as well as being fluidly attached to an actuatable device that generates the aerosol particles (aerosolized medication) that are delivered to the patient.
In the illustrated embodiment, the body 110 has a main section 116 that includes a number of arms or feet that extend outwardly therefrom, with the inlet end 112 being formed at the end of a first leg 120 that is formed at a right angle to the main section 116. The main section 116 includes a second leg 130 that extends outwardly therefrom between the first leg 120 and the outlet end 114 and a third leg 140 that is located between tile outlet end 114 and the second leg 130. The third leg 140 is located proximate the outlet end 114, while the second leg 130 is closer to the first leg 120. The first, second and third legs 120, 130, 140 are thus tubular structures that are in fluid communication with the interior of the tubular main section 116 and are open at their opposite distal ends to receive an object (such as a conduit or connector) or a fluid, etc.
The main section 116 includes a fourth leg 150 that extends outwardly from the main section 116 and is in fluid communication with the interior of the main section 116. Like the other legs, the fourth leg 150 is a tubular structure that is open at its distal end for an attachment to an object (conduit). In the illustrated embodiment, the first, second and third legs 120, 130, 140 extend outwardly from all underside of the tubular main section 116, while the fourth lea 150 extends outwardly from the opposite top side of the tubular main section 116. The fourth leg 150 is located between the second and third legs 130, 140.
The main section 116 is the part of the accessory 100 that is intended to be connected to equipment that is placed over the patient's nose and mouth. Thus, the main section 116 (main conduit) is the principal pathway for fluid, such as air and the aerosol particles, to either enter the patient in the case of aerosol particles and air or to be discharged from the patient as in the case of exhaled gases, such as carbon dioxide.
The first leg 120 serves as a poll or connector for mating with a device 200 that generates a gas flow that is intended to be breathed in by the patient. For example, the device 200 can be in the form of a nebulizer or even an MDI or the like. In the illustrated embodiment, the device is in the form of a nebulizer 200 that is fluidly connected to a gas source via a nebulizer conduit 215. The nebulizer 200 is fluidly and sealingly connected to the first leg 120 so that the gas and aerosolized particles generated by the nebulizer 200 are delivered into the interior of the main section 116 of the accessory 100. Any number of techniques call be used to couple the nebulizer 200 to the first leg 120, such as threadingly, snap-fittingly, functionally, etc., the two together.
In one embodiment, the accessory 100 is intended for use with a nebulizer, generally indicated at 200, and therefore includes a holding, chamber 300 into which the aerosol particles can be stored prior to the patient inhaling. The holding chamber 300 is preferably formed as a member that is collapsible and expandable depending upon whether gas is being delivered thereto or being evacuated therefrom. The holding chamber 300 thus can have a number of different structures that have a variable dimension, such as a variable length or a variable width. In one embodiment, the holding chamber 300 is defined by a bellows-type structure that can either expand or collapse/constrict depending upon the force applied. As with other accessories of this type, the holding chamber 300 is intended to receive and store the aerosol particles prior to the patient inhaling them by means of the accessory 100 and the facemask.
In the illustrated embodiment, the holding chamber 300 is in the form of an expandable/collapsible bag (reservoir bag) or similar type structure. According to one aspect of the present invention, the holding chamber 300 is in the form of a bi-furcated bag or the like 310 as shown in
The first port 340 includes a complementary fastening feature that permits it to be sealingly attached to the third leg 140 of the accessory 100, and similarly, the second port 350 includes a complementary fastening feature that permits it to be sealingly attached to the second leg 130. For example, the first and second fastening features can be in the form of threads that mate with complementary threads that are part of the legs 140, 130, respectively. Other fastening, means, such as locking means or mechanical fits, such as a frictional fit, can likewise be used so long as the accessory 100, and in particular, the second and third legs 130, 140, are sealingly attached to the bag 310. While, the fastening features can be in the form of threads, it still be appreciated that in many applications and embodiments, the third and second legs 140, 130 and the first and second ports 340, 350 simply mate with one another via a frictional interface fit between two complementary stems.
The first port 340 of the bag 310 also preferably includes a gas inlet port 342 that extends outwardly therefrom and is constructed to attach to a gas source 370. More specifically, the gas inlet port 342 is in fluid communication with and provides an entrance into the first port 340 and is in the form of a tubular structure that has a distal end 344. The end 344 is meant to be attached to the gas source 370 by any number of techniques, including using a gas conduit, such as tubing or the like, that extends from the gas source 370 to the gas inlet port 342. The gas source 370 is preferably connected to a control system or regulator or the like that permits the flow rate of the gas source 370 to be carefully controlled and varied by means, such as valve assemblies and the like that are associated therewith (e.g., valve assembly within the gas conduit).
The gas source 370 can hold any number of different types of gases that are intended for inhalation by the patient through the accessory 100.
The accessory 100 includes a number of different valve assemblies that are positioned within the body 110. More specifically, a first valve assembly 400 is disposed within the open second end 114 of the main section 116 and in the illustrated embodiment the first valve assembly 400 functions as an exhalation valve. The first valve assembly 400 includes a valve element 402 which is positionable between an open position and a closed position and which can be any number of different types of valve structures so long as they function in the intended manner and provide the desired results. The valve 402 typically seats against a valve seat 404 that is formed at the second end 114 when the valve 402 is closed. The illustrated valve 402 is a one-way flap valve that presses against the valve seat 404 on inhalation and completely occludes the open second end 114 to prevent any room air entrainment (i.e., not allowing, the air from the atmosphere to enter into the main section 116 on inhalation). On exhalation, the flap valve 402 moves away from the flap valve seat 404 for the air exhaled by the patient to escape into the atmosphere from the main section 116 by flowing through the fourth leg 150 from a mask or the like and then through the main section 116 and through the opening formed at the second end 104. The open second end 104 is the only means for the exhaled air to escape as will be appreciated below since the four legs 120, 130, 140, 150 are connected to devices, are capped or otherwise not open.
A second valve assembly 410 is provided and functions as an inhalation valve in that the valve moves between an open position and a closed position depending upon whether the patient is inhaling or exhaling. The second valve assembly 410 is disposed within the body 110 and in particular, the second valve assembly 410 is disposed within the main section 116 at a location between the second leg 130 and the fourth leg 150 such that when the second valve assembly 410 is in an open position, fluid can flow from both the first leg 110 and the nebulizer 200, as well as from the second leg 130 and the second compartment 330 of the bag 310, and into the fourth leg 150 where it can flow into the patient's mask and into the patient's respiratory system.
The second valve assembly 410 includes a valve element 412 that can be any number of different types of valve structures so long as they function in the intended manner and provide the desired results. As shown in
As in
The third valve assembly 420 includes a valve element 422 that can be any number of different types of valve structures so long as they function in the intended manner and provide the desired results. The valve 422 typically seats against a valve seat 424 that is formed within either the third leg 140 or first port 340 when the valve 422 is closed. The illustrated valve 422 is a one-way flap valve that presses against the valve seat 424 on exhalation and completely occludes the third leg 140 or first port 340 to prevent any exhaled air to flow from the mask and fourth leg 150 and into either the first compartment 320 of the bag 310. On inhalation, the flap valve 422 moves away from the flap valve seat 424 to permit the gas from the first compartment 320 of the bag 310 to flow into and through the main section 116 and into the fourth leg 150 where it flows into the mask to the patient.
While the two compartments 320, 330 of the bag 310 are illustrated as having equal or about equal volumes it will be appreciated that the bag 310 can be constructed so that one of the compartments 320, 330 has a greater volume. For example, the first compartment 320 that serves as the nebulizer holding compartment can have a greater volume than the second compartment 330 which receives the supplemental gas to backup the nebulized medication holding chamber.
The first leg 120 is intended to be fluidly attached to the device that generates the aerosol particles (medication) that is delivered to the patient and preferably, as illustrated, the first leg 120 is fluidly connected to the nebulizer 200. More specifically, a connector 212 of a conduit (tube) 210 of the nebulizer 200 is sealingly attached to the first leg 120 so that tile nebulized medication is delivered thoroughly the conduit 210 and into the interior of the first leg 120 and when the second valve element 412 is open, the nebulized medication (aerosol particles) travels the length through the first leg 120 and a portion of the main section 516 and through the opening defined by the valve seat 414 and into the fourth leg 150 and then into the equipment (facemask) that delivers the medication to the patient. This is the sequence of events when the patient inhales. Conversely, when the patient exhales, the second valve element 412 closes; however, the nebulizer 200 continues to deliver the nebulized medication through the first leg 120 into the interior of the main section 116. Since the second valve element 412 is closed when the patient exhales prior to the next inhalation the nebulized medication can not flow past the valve assembly 410 and into the fourth leg 150 but instead flows through the second leg 130 through the second port 350 and into the second compartment 330 of the bag 310.
The second compartment 330 of the bag 310 is therefore intended to act as a main reservoir bag in that the second compartment 330 receives and holds the nebulized medication until the patient inhales. The second compartment 330 of the bag 310 thus expands until the patient inhales at which time the second valve element 412 opens and the inhalation of the patient draws the nebulized medication out of the second compartment 330 into the main section 116 and then into the fourth leg 150 where it is delivered to the patient.
There are some circumstances where an insufficient amount of nebulized medication is present in the second compartment 330 of the bag 310. This may result because the flow rate of the nebulizer 200 is insufficient for the patient as when the patient has a greater body weight than the flow rate setting of the nebulizer 200. When this does occur, the patient experiences a very uncomfortable feeling in that the patient will experience an insufficient air flow to the lungs and therefore will begin to breathe more deeply and rapidly. In other words, the patient may begin feeling as though they need to gasp for air to breathe.
The present invention overcomes such potential deficiency in air flow to the patient by providing the first compartment 320 in the bag 310 which acts as a supplemental air source for the patient due to the first compartment 320 being attached to a supplemental gas source, generally indicated at 370. Preferably, the gas source 370 connects to the stern of the first port 340 as shown in the figures; however, it is possible for the gas source 370 to be directly connected to the first compartment 320 of the bag 310. In any event, the gas source 370 is directly and fluidly connected to the first compartment 320 and therefore, the gas is delivered into the first compartment 320. As with the flow of nebulized medication into the second compartment 330, the flow of the gas source 370 into the first compartment 320 causes the first compartment 320 to expand as the bag 310 is filled with gas.
It will be appreciated that the gas source 370 serves as a supplemental gas since gas stored in the first compartment 320 is in selective fluid communication with the main section 116 and therefore, can flow to the patient under certain circumstances as discussed below. In other words, if there is insufficient gas in the form of nebulized gas in the second compartment 330, when the patient inhales, then the patient will not experience the above described breathing problems since the first compartment 320 is open to the patient through, the main section 116 and therefore the patient can inhale the supplemental gas that is present in the first compartment 320 to make up for any shortfall in gas in the second compartment 330.
The gas source 370 typically has an associated valve assembly (not shown) that is external to the system and is typically at the gas source 370 for controlling the flow rate of the gas source 370 into the first compartment 320. The valve assembly is preferably an adjustable valve that controls the flow rate of the supplemental gas into the first compartment 320. Any number of different valve mechanisms are suitable for this type of application and typically include an adjustable part, such as a dial, that permits the physician to easily alter and change the flow characteristics. For example, the valve mechanism can include an adjustable member that when manipulated either sequentially closes or opens the opening, formed in the conduit that delivers the supplemental gas to the first compartment 320.
Thus, the physician can initially set the valve at one setting which the physician believes will provide a sufficient supplemental gas flow into the first compartment 320 based on the physicians past experiences and based on certain characteristics of the patient, such as the size and weight of the patient. For example, when the patient is a large adult or even a large child, the flow rate of the nebulized medication into the second compartment 330, even when it is set at a maximum flow rate, may not be sufficient and therefore, this could result in the patient receiving a low level of air and feeling the above noted discomfort. The gas source 370 thus supplements the gas flow of the nebulizer 200 and makes up for any deficiency so that the patient breaths smoothly throughout the procedure.
When setting the valve, the physician will keep in mind that it may not be desirable to set the flow rate of the supplemental gas at too high a value since this will result in the first bag compartment 320 expanding and also, results in the supplemental gas source 370 nixing with the nebulized medication as the patient inhales, thereby causing a decrease in the inhaled concentration of the medication. As mentioned before, it is desirable to try to keep as fixed as possible the concentration of the inhaled medication. Since the first compartment 320 is fluidly connected to the main section 116 via the third leg 140 and is fluidly connected to the first valve assembly 400, any excess build up of supplemental gas in the first compartment 320 can be vented through the first valve 402 each time the patient exhales since the second valve assembly 410 closes when the patient exhales and the supplemental gas can not flow past the second valve assembly 410 toward the other legs and the second compartment 330 of the bag 310.
In the event that the initial setting of the valve is not optimal in that the too much supplemental gas is being delivered to the first bag compartment 320 or too little supplemental gas is being delivered to the first bag compartment 320, the physician simply needs to make the necessary adjustment to the valve to either immediately reduce or increase, respectively, the supplemental gas flow into the first bag compartment 320. This can be done by simply turning or otherwise manipulating the valve. It is also very easy for the physician to determine whether the flow rate of the supplemental gas source 370 is optimal since the physician can observe the bag 310 and more particularly, can observe whether either the first bag compartment 320, the second compartment 330 or both compartments 320, 330 appear to be excessively collapsed (thus indicating an increase in flow rate is needed) or excessively expanded or extended (thus indicating a decrease in flow rate is needed). The physician can simply and immediately alter the flow rate and thus, the accessory 100 is tailored to be used with a whole range of different types of patients, from small infants up to large adults.
A supplemental gas valve assembly is preferably provided for controlling the flow of the supplemental gas out of the first compartment 320 and into the third leg 140 and more particularly, to permit flow of the supplemental gas from the first bag compartment 320 into the third leg 140, through the main section 116 and ultimately to the patient when the patient inhales and conversely, preventing the flow of supplemental gas from the first bag compartment 320 into the third leg 140 when the patient exhales. It will also be appreciated that when valve assembly closes during exhalation, the exhaled air that includes waste gases is not permitted to flow into the first bag compartment 320 where it could then be drawn into the patient at the next annihilation movement of the patient.
Now referring to
Since the first leg 120 is not formed at the end of the main section 116 in this embodiment, the main section 116 has an open end 117 and a closed end 119. The second leg 130 is located proximate the open end 117.
As shown the first leg 120 is disposed between the second valve assembly 410 and the second leg 130 and in particular, the first leg 120 communicates with the interior of the main section 116 at a location that is near the second valve element 412. It will be appreciated that in this embodiment, the nebulizer 200 is located in front of/downstream from the gas flow from the second compartment 330 of the bag 310 and the present applicants have discovered that the placement of the nebulizer 200 in this location results in improved performance and improved drug delivery since the aerosolized medication is located closer to the face mask as measured along the gas flow path. In addition, this location for the nebulizer 200 permits the gas flow from the second compartment 330 of the bag 110 to assist in carrying the aerosolized medication to the fourth leg 150 and into the patient's mask or the like. In other words, the gas flow from the second compartment 330 acts to entrain the aerosolized medication that is flowing, through the first leg 120 from the nebulizer 200.
The first valve 400 is located in the open end 117 of the section 116.
The operation of the components is the same in this embodiment as in the other embodiments. For example, the valve assemblies 400, 410, 420 operate the same or similar in both embodiments. The first leg 120 is positioned close to the second valve assembly 410 such that once the valve element 412 opens upon inhalation, the gas and aerosolized medication from the nebulizer 200 flows through the valve element 412 and into the fourth leg 150 to the patient.
It will also be appreciated that in each of the embodiments of
Referring now to
As with the other accessories, the accessory 500 is intended for use with a nebulizer or an MDI or another piece of aerosol inhalation equipment. The accessory 500 is defined by a body 510 that can be formed of a number of different materials, including plastics or even metals. The accessory 500 is essentially a hollow body 510 that has a first end 512 and an opposite closed second end 514. The accessory 500 is intended to act as a fluid connector in that it is fluidly connected to another piece of equipment, such as a facemask, that is directly coupled to the patient's mouth, as well as being fluidly attached to an actuatable device that generates the aerosol particles (aerosolized medication) that are delivered to the patient.
In the illustrated embodiment, the body 510 has a main section 520 that includes a number of arms or feet that extend outwardly therefrom. More specifically, a first leg 530 is formed at or proximate the first end 512 of the body 510, a second leg 540 is formed in an intermediate region of the body 510 and a third leg 550 is formed at or proximate the second end 514. In other words, the second leg 540 is formed between the first and third legs 530, 550. The first, second and third legs 530, 540, 550 are tubular structures that are in fluid communication with the interior of the tubular main section 520 and are open at their opposite distal ends to receive an object (such as a conduit or connector, etc.) or a fluid, etc.
The main section 520 also includes a fourth leg 560 that extends outwardly from the main section 520 and is also in fluid communication with the interior of the main section 520. Like the other legs, the fourth leg 560 is a tubular structure that is open at its distal end for attachment to an object, such as a mask or mouthpiece or the like, generally indicated at 561. In the illustrated embodiment, the first, second and third legs 530, 540, 550 extend from an underside of the main section 520, while the fourth leg 560 extends front a top side of the main section; however, this is merely an exemplary arrangement, and the relative positions of the legs can be varied, including having the legs be disposed at less than 90 degrees from one another. The fourth leg 560 is located between the first and second legs 530, 540.
The main section 520 is part of an accessory that is intended to be connected to equipment that is placed over the patient's nose and mouth, thus, the main section 520 (main conduit) is the principal pathway for fluid to either enter the patient in the case of aerosol particles and air (or other fluid) or to be discharged from the patient as in the case of exhaled gases, such as carbon dioxide.
Unlike the embodiments shown in
In addition to having a compartment for holding the medication to be aerosolized, the nebulizer body 610 has a conduit 620 that is intended to be fluidly connected to a source of gas for creating the aerosolized medication. For example, a gas conduit (tube) can be connected to a flee end of the conduit 620 for providing gas to the nebulizer 600.
The cap 701 can be attached to the third leg 550 by means of a flexible strap 703 or the like so that when the cap 701 is removed from the third leg 550, the cap 701 can simply hang from the third leg 550, thereby reducing the chances that it might be misplaced, etc. The cap 701 has a nipple 705 or the like that is a hollow conduit that includes a bore or thorough hole that extends completely thorough the cap 701, thereby permitting fluid communication between the exterior and the interior of the third leg 550, and thus, the interior of the main section 520.
As with the other embodiments, the accessory 500 is intended for use with the nebulizer 600 and therefore includes a holding chamber 700 into which the aerosol particles can be stored prior to the patient inhaling. The holding chamber 700 is preferably formed as a member that is collapsible and expandable depending upon whether gas is being delivered thereto or being evacuated therefrom. The holding chamber 700 thus can have a number of different structures that have a variable dimensions such as a variable length or a variable width. In one embodiment the holding chamber 700 is defined by a bellows-type structure that can either expand or collapse/constrict depending upon the force applied. As with other accessories of this type, the holding chamber 700 is intended to receive and store the aerosol particles prior to the patient inhaling them by means of the accessory 500 and the facemask.
In the illustrated embodiment, the holding chamber 700 is in the form of an expandable/collapsible bag (reservoir bag) or similar type structure. According to one aspect of the present invention, the holding chamber 700 is in the form of a bi-furcated bag or tile like 710 as shown in
The first connector 740 includes a complementary fastening feature that permits it to be sealingly attached to the first leg 530 of the accessory 500, and similarly, the second connector 750 includes a complementary fastening feature that permits it to be sealingly attached to the second leg 540. For examples the first and second fastening features can be in the form of threads that mate with complementary threads that are part of the legs 530, 540, respectively. Other fastening means, such as locking means or mechanical fits, such as a frictional fit, can likewise be used so long as the accessory 500, and in particular, the second and third legs 530, 540, are sealingly attached to the bag 710. While, the fastening features can be in the form of threads, it will be appreciated that in many applications and embodiments, the third and second legs 530, 540 and the first and second connectors 740, 750 simply mate with one another via a frictional interface fit between two complementary stems.
The first con hector 740 of the bag 710 also preferably includes a gas inlet port 742 that extends outwardly therefrom and is constructed to attach to a gas source. More specifically, the gas inlet port 742 is in fluid communication with and provides an entrance into the first connector 740 and is in the form of a tubular structure that has a distal end 744. The end 744 is meant to be attached to the gas source by any number of techniques, including using a gas conduit, such as tubing or the like, that extends from the gas source to the gas inlet port 742. The gas source is preferably connected to a control system or regulator or the like that permits the flow rate of the gas source to be carefully controlled and varied by means, such as valve assemblies and the like that are associated therewith (e.g., valve assembly within the gas conduit).
The gas source can hold any number of different types of gases that are intended for inhalation by the patient through the accessory 500.
In addition, the first leg 530 can contain a supplemental gas inlet port or connector 751 that extends outwardly therefrom and can be fluidly attached to a supplemental gas source. The gas inlet port 751 is formed so that it is above the first connector 740 when the first connector 740 is inserted into the first leg 530 so that the gas inlet port 751 does not interfere with the reception of the first connector 740 into the first leg 530.
The second connector 750 is similar to the first connector 740 and is in the form of a tubular connector that is both sized and shaped to fit intimately within the second leg 540. For example, the second connector 750 can be frictionally fit into and held within the second leg 540 as by slidingly engaging the second connector 750 within the second leg 540. The lengths of the first and second connectors 740, 750 are preferably the same.
The accessory 500 includes a number of different valve assemblies that are positioned within the body 510. More specifically, a first valve assembly 800 is disposed within the open first end 512 of the main section 520 and in the illustrated embodiment, the first valve assembly 800 functions as an exhalation valve. The first valve assembly 800 includes a valve element 802 which is positionable between an open position and a closed position and which can be any number of different types of valve structures so long as they function in the intended manner and provide the desired results. The valve 802 typically seats against a valve seat that is formed at the first end 512 when the valve 802 is closed, the illustrated valve 802 is a one-way flap valve that presses against the valve seat on inhalation and completely occludes the open first end 512 to prevent any room air entrainment (i.e., not allowing the air from the atmosphere to enter into the main section 520 on inhalation). On exhalation, the flap valve 802 moves away from the flap valve seat for the air exhaled by the patient to escape into the atmosphere from the main section 520 by flowing through the fourth leg 560 from a mask or the like and then through the main section 520 and through the opening formed at the first end 512. The open first end 512 is the only means for the exhaled air to escape as will be appreciated below.
A second valve assembly 810 is provided and functions as a first inhalation valve in that the valve moves between an open position and a closed position depending upon whether the patient is inhaling or exhaling. The second valve assembly 810 is disposed within the first leg 530 when the holding chamber is attached thereto and in particular, the second valve assembly 810 includes a valve element 812 that is disposed at the free distal end of the connector 740.
The second valve assembly 810 includes a valve element 812 that can be any number of different types of valve structures so long as they function in the intended manner and provide the desired results. The valve 812 typically seats against a valve seat that is formed at the distal end of the connector 740. The illustrated valve 812 is a one-way flap valve that presses against the valve seat on exhalation and completely occludes the first leg 530 to prevent any exhaled air to flow from the mask through the main section 520 and into the first compartment 710. The valve element 612 is thus positioned so that the gas inlet port 742 is disposed between the valve element 812 and the first compartment 710. Thus, the closing of the valve element 812 prevents exhaled gas from flowing into the gas inlet poll 742.
It will be appreciated that instead of incorporating the valve element 812 into the connector 740, the valve element 812 can be directly incorporated into the first leg 530 such that it still selectively permits fluid flow from the first compartment 710 and from the gas inlet port 742.
The valve element 812 is thus positioned so that the gas inlet port 742 is disposed between the valve element 812 and the first compartment 710. Thus, the closing of the valve element 812 prevents exhaled gas from flowing, into the gas inlet port 742.
A third valve assembly 820 is provided and functions as a second inhalation valve in that the valve moves between an open position and a closed position depending upon whether the patient is inhaling or exhaling. The third valve assembly 820 is disposed within the main section 520 and in particular, the third valve assembly 820 is disposed within the main section 520 between the first and second legs 530, 540. In addition, the third valve assembly 820 is disposed between the fourth leg 560 and the second leg 540.
The third valve assembly 820 includes a valve element 822 that can be any number of different types of valve structures so long as they function in the intended manner and provide the desired results. The valve 822 typically seats against a valve seat 824 that is formed within the main section 520. The illustrated valve 822 is a one-way flap valve that presses against the valve seat 824 on exhalation and completely occludes the main section 530 to prevent any exhaled air to flow from the mask through the main section 520 and into the first compartment 710.
Both the first and second inhalation valves 812, 822 close when the patient exhales and conversely open when the patient inhales. Thus, when the patient exhales and the valves 812, 822 close, the exhaled gas travels down the fourth leg 560 into the main section 520; however none of the first, second and third legs 530, 540, 550 are accessible and therefore, the exhaled gas must flow to the exhalation valve 802, which is open and thus, the exhaled gas flows out of the main section 820.
While the two compartments 720, 730 of the bag 710 are illustrated as having equal or about equal volumes, it will be appreciated that the bag 710 can be constructed so that one of the compartments 720, 730 has a greater volume. For example, the first compartment 720 that serves as the nebulizer holding compartment can have a greater volume than the second compartment 730 which receives the supplemental gas to backup tile nebulized medication holding chamber.
In this embodiment, there is a single main gas source as opposed to the two gas sources of the previous embodiments. A single main gas source 900 is provided and a first conduit section 910 is connected at a first end 912 to the gas source 900, while an opposite second end 914 is connected to a conduit adapter or connector 920. The connector 920 is a Y connector in that it has a first leg 922 that is connected to the second end 914 of the conduit 910, as well as second and third legs 924, 926, respectively. Fluid flow (gas from source 900) is thus delivered into the first leg 922 and then split into two flow paths, namely, those defined by the second and third legs 924, 926. A second conduit section 930 is connected at a first end 932 to the second leg 924 and a separate third conduit section 940 is connected at a first end 942 to the third leg 926. An opposite second end 934 of the second conduit section 900 is connected to the gas inlet port 742 to deliver (as from the source 900 into the first compartment 710 and/or into the main section 520 by traveling through the first leg 530. An opposite second end 944 of the third conduit section 940 is connected to either the nipple 705 that is part of the cap 701 or the conduit 620 of the nebulizer body 610 depending upon whether the nebulizer 600 is installed in the third leg 550 or whether the cap 701 is installed in the third leg 550. In either instance, gas flows through the second conduit section 930 and into the third leg 530. When it is desired to deliver aerosolized medication to the patient, then the nebulizer 600 is installed in the third leg 550 and the second conduit section 930 is connected to the conduit 620 to permit gas to flow from main gas source 900 to the nebulizer 600 where the medication is aerosolized.
The use of a single main gas source 900 compared to two separate gas sources (as in the other embodiments) provides a number of advantages. First, the use of a single source is more economical and simpler in design since only one supply of gas is needed. Consequently, less space is consumed since only one gas tank is needed. In addition, since only one gas is used, the flow rates and the formulations for the patient can be more easily controlled and monitored.
When operating the accessory 500 with the nebulizer 600, the nebulizer 600 is inserted into the third leg 550. The second leg 540 remains capped for most applications and the gas input (conduit 620) of the nebulizer 600 becomes the third port of the accessory 600. The second and third legs 540, 550 are constructed as gas inlet ports that utilize gas tubing.
In accordance with one aspect of the present invention the dimensions of the gas inlet port 742 and the conduit 620 of the nebulizer 600 are carefully selected to optimize the performance of the nebulizer 600. In particular, the gas inlet port 742 is constructed so that it has dimensions (e.g., diameter) less than the dimensions of the conduit 620 of the nebulizer 600. For example, the spray hole for commercially available nebulizers 600 ranges from about 0.022 inches to about 0.025 inches. The resultant flows in the tubing (port 742 and conduit 620) are as follows when using 15 LPM (liters per minute) Ox (the maximal measurable flow for commercially available flowmeters for air and oxygen). For example, the diameter for port 742 is identified as P1 and can have a diameter of between about 0.020 inches and 0.025 inches and the diameter for conduit 620 (nebulizer spray hole) is identified as P3 and can have a diameter of between about 0.022 inches and 0.025 inches. However, in the various exemplary embodiments, the size of the port 742 is less than the size of the conduit 620 (nebulizer spray hole). The ratio for the two openings determines the ratio of the two gas flows through the port 742 and conduit 620.
If P1>P3, then more than half of the flow will go through the gas tubing to the gas inlet port 742. The nebulizer 1100 will receive less than 7.5 LPM of flow. If P1 is substantially greater than P3, then the flow to the nebulizer 1100 will be much less than 7.5 LPM. Since most single treatment nebulizers require 8 LPM to 12 LPM to work optimally, this condition is less than ideal. If P1=P3, then half of the flow will go through the tubing to the port 742. The nebulizer 1100 will receive 7.5 LPM of flow. Since most single treatment nebulizers require 8 LPM to 12 LPM to work optimally, this condition is less than ideal although the nebulizer 600 will be useable.
If P1<P3, then more than half of the flow will go through the tubing to port (conduit) 620. This nebulizer receive more than 7.5 LPM of low. Since most single treatment nebulizers 600 require 8 LPM to 12 LPM to work optimally, this condition is ideal as long as P1>P3 but not when P1 is substantially greater than P3 since the flow to the nebulizer will approach 15 LPM and the tubing disconnect from port 620 due to back pressure. For the case, where P1>P3 within about 20%, we observe that the nebulizer 600 will see approximately 20% more than half the flow. Thus, the nebulizer 600 would receive a flow of about 9 LPM which is within most nebulizer optimal operating parameters.
Thus, for the given total flow to the system, the ratios of the flows through P1 and P3 are dependent on the ratios of the (r4) of the two holes, where r is the radius of the opening. Thus, the flow through port 742/the flow through port 620 is equal or approximately equal to [(radius port 742)4]/[(radius port 620)4]. The spray hole (conduit 620) for commercially available nebulizers range from about 0.022 inches to about 0.025 inches. So, if port 742 has a radius of about 0.020 inches, this allows for flow ranging from 8.5 LPM to about 11 LPM. It will also be appreciated that the above optimization techniques for the sizing of the ports 742, 620 is not limited to the situation where the (as is air, but instead, other gases, such as helix which is very much less dense, can be used. If the port 742 had the same dimensions as the conduit 620, the greater part of the gas would flow through port 742 and consequently, the nebulizer 600 would not get sufficient gas flow. Since the gas is lighter than Ox, even less gas would go to the nebulizer 600. When helix is used, the flow rate can be set at 16.5 LPM using a flow meter designed for use with helix. Since helix gas requires a higher flow rate than oxygen to nebulize the same dose output, higher flows have to be set up with the helix flow meters. Otherwise, correction factors have to be used in order to determine the correct reading that corresponds to 16.5 LPM. Flows of 10 LPM to 14 LPM are recommended for nebulizer operation.
Flows through the second and third conduit sections 930, 940 to the ports 742, 620, respectively, determine the resultant flow to the nebulizer 600. This is in part due to ratios of the hole sizes stated above. Once the flow window for port 610 (the nebulizer 600) has been determined to be within about 8 LPM to about 12 LPM, optimal operation for mobilization is assured. Port 742 can be used to dilute a given gas used (such as oxygen or premixed helix, through ports 742, 620). This is done by using the original gas with the Y tubing and then opening port 742 to outside air or by using a second gas source to deliver air at a fixed rate. Alternatively, another gas could be used through port 742 and in one embodiment, anesthesia gas can be introduced into the port 742.
It will be appreciated that the above dimensions are merely exemplary and the components can have dimensions that lie outside the above ranges so long as the desired results, as discussed above, are achieved.
Having described embodiments of the invention with reference to the accompanying drawings it is to be understood that the invention is not limited to those precise embodiments, and that various changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims.
The present application is a continuation-in-part of U.S. patent application Ser. No. 11/414,737 filed Apr. 27, 2006, which is a continuation-in-part of U.S. patent application Ser. No. 11/121,688, filed May 3, 2005, (now U.S. Pat. No. 7,445,006, issued on Nov. 4, 2008), each of which is hereby incorporated by reference in its entirety.
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