Modular aerosol delivery system

Information

  • Patent Grant
  • 9242057
  • Patent Number
    9,242,057
  • Date Filed
    Thursday, November 7, 2013
    11 years ago
  • Date Issued
    Tuesday, January 26, 2016
    8 years ago
Abstract
In a modular medicament delivery system, a dispenser housing has a support block with a well and an orifice communicating with the well. A first container assembly includes a valve stem shaped to be received by the well in the support block. The first container assembly has a first exterior shape. A second container assembly includes a valve stem shaped to be received by the well in the support block. The second container assembly has a second exterior shape that is different than the first exterior shape. An insert member is adapted for mounting to the dispenser housing in the cavity and defines an interior space shaped to receive the second exterior shape of the second container. Methods of assembling the system, a system kit and a device are also provided. A medication delivery device includes first and second end pieces and a collapsible chamber disposed therebetween.
Description
BACKGROUND

The present invention relates generally to an aerosol delivery system, and in particular to a modular aerosol delivery system configured to adapt and support medicament container assemblies having different configurations.


Pressurized Metered Dose Inhalers (PMDI's) are an important delivery mechanism for various medicaments. For example, patients have certain conditions that can be treated with medicaments dispersed in an aerosol and administered to the patient by inhalation. In one format, the aerosol with medicaments is maintained under pressure in a container, and is dispensed in metered, or measured, dosages with an inhalation device, such as an actuator boot. In other arrangements and configurations, the aerosol with medicaments is administered by way of a holding chamber, which can be further incorporated into a ventilator system.


In some circumstances, it can be important for the patient or caregiver to be able to ascertain the number of metered doses remaining in the container, either by an indication of the number remaining therein or by knowledge of the number already dispensed therefrom, such that the patient or caregiver is not caught unaware with an empty container when in need of the medicament. As a result, it is known to secure various indicating devices to the container and/or to the dispenser housing interfacing with the canister. The indicating devices are configured to count and display indicia informing the patient or caregiver about the number of doses used or remaining in the container.


In one example of such a device, as shown for example and without limitation in U.S. Pat. No. 6,431,168, the dose indicator is secured to the container. As such, the corresponding dispenser housing must be shaped to receive a container assembly, which includes the container and dose counter secured thereto. One problem with such a configuration, however, is that the dispenser housing may not be suitably shaped and/or configured to receive and properly actuate a different container assembly, for example a container having a different medication, and which may or may not be equipped with a dose counter or a differently shaped dose counter. This can be particularly troublesome, for example, where the dispenser housing is incorporated into a ventilator circuit and cannot be easily removed therefrom. As such, it may be difficult to administer different types of medication through the same dispenser housing, but instead requires the caregiver to disassemble and reconfigure the ventilator circuit for each type of medication.


For at least these reasons, an improved medication delivery assembly, which can accommodate and actuate different medicament container assemblies, is desirable.


SUMMARY

In a first aspect of the invention, a kit for assembling a medication delivery device includes a dispenser housing having a support block with a well and an orifice communicating with the well. The dispenser housing includes a peripheral wall defining a cavity. A first container assembly includes a valve stem shaped to be received by the well in the support block. The first container assembly has a first exterior shape and is reciprocally moveable along a longitudinal axis defined by the valve stem. The first exterior shape is shaped to be received in the cavity. A second container assembly includes a valve stem shaped to be received by the well in the support block. The second container assembly has a second exterior shape and is reciprocally moveable along a longitudinal axis defined by the valve stem. The second exterior shape is different than the first exterior shape. An insert member is adapted for mounting to the dispenser housing in the cavity and defines an interior space shaped to receive the second exterior shape of the second container. Both the first container assembly and the second container assembly, the latter in combination with the insert member, are adapted to be mounted in the dispenser housing. The first container assembly in combination with the insert member is not adapted to be mounted in the dispenser housing.


In another aspect, a medication delivery device includes a dispenser housing having a support block with a well and an orifice communicating with the well. The dispenser housing includes a first peripheral wall defining a cavity. An insert member is disposed in the cavity of the dispenser housing. The insert member has a second peripheral wall nesting with the first peripheral wall, and a floor defining an interior space. The floor has an opening aligned with the well of the dispenser housing. A medicament container includes a canister and a valve stem, which extends through the opening in the floor and is received in the well in the support block. The canister is reciprocally moveable relative to the valve stem along a longitudinal axis defined by the valve stem.


In yet another aspect, a method for assembling a medication delivery device includes providing first and second identical dispenser housings each having a support block with a well and an orifice communicating with the well. Each of the dispenser housings has a peripheral wall defining a cavity. The method further includes providing a first container assembly having a valve stem shaped to be received by the well in the support block of the first dispenser housing. The first container assembly has a first exterior shape shaped to be received in the cavity of the first dispenser housing, and includes a dose counter. The method further includes inserting the first container assembly in the cavity of the first dispenser housing and disposing the valve stem in the support block of the first dispenser housing. The method also includes providing a second container assembly having a valve stem shaped to be received by the well in the support block of the second dispenser housing. The second container assembly has a second exterior shape different than the first exterior shape. The method further includes disposing an insert member in the cavity of the second dispenser housing. The insert member includes an interior space shaped to receive the second exterior shape of the second container. The method further includes inserting the second container assembly in the interior space of the insert member and disposing the valve stem of the second container assembly in the support block of the second dispenser housing.


In yet another aspect, a ventilator system includes a dispenser housing in fluid communication with an oxygen intake line and a patient interface. The dispenser housing includes a support block having a well and an orifice communicating with the well. The dispenser housing has a peripheral wall defining a cavity. An insert member is adapted for mounting to the dispenser housing in the cavity and defines an interior space. The insert member has a floor with an opening adapted to be aligned with the well of the dispenser housing when the insert member is mounted to the dispenser housing.


In yet another aspect, a method for assembling a medication delivery device includes providing a dispenser housing having a support block with a well and an orifice communicating with the well. The dispenser housing includes a peripheral wall defining a cavity. A first container assembly is inserted in the cavity of the dispenser housing. The method includes removing the first container assembly from the cavity of the dispenser housing, disposing an insert member in the cavity of the dispenser housing, and inserting a second container assembly in the insert member.


In yet another aspect, a medication delivery device includes a first end piece having an input port and a first quick release connector component and a second end piece having an exit port and a second quick release connector component. The first and second quick release connector components are releasably engageable with the first and second end pieces defining an interior space therebetween. A collapsible chamber has opposite ends connected to the first and second end pieces. The collapsible chamber is moveable between a collapsed position and an extended position, wherein an entirety of the collapsible chamber is received in the interior space defined by the first and second pieces when in the collapsed position.


The various aspects and embodiments of the present invention provide significant advantages relative to the prior known devices. In particular, a single dispenser housing can be used to accommodate differently shaped and configured medicament container assemblies. As such, there is no need to manufacture and inventory multiple, complicated and expensive dispenser housings. Instead, a simple and inexpensive insert member can be used to reconfigure the dispenser housing. In addition, this allows the user, such as the caregiver, to use the same dispenser housing to dispense different types of medication, or medications coming in different types of containers. This can be important, for example and without limitation, when the dispenser housing is difficult to remove from a delivery system such as a ventilator system. The collapsible chamber permits the chamber to be collapsed, so as to minimize the size of the device while protecting the chamber from tampering or other damage.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a cross-sectional, side view of a first embodiment of a dispenser housing including a holding chamber.



FIG. 2 is a cross-sectional, side view of a second embodiment of a dispenser housing.



FIG. 3 is a perspective view of a portion of the dispenser housing shown in FIG. 1.



FIG. 4 is a front view of the dispenser housing portion shown in FIG. 3.



FIG. 5 is a cross-sectional side view of the dispenser housing portion taken along line 5-5 of FIG. 4.



FIG. 6 is a top view of the dispenser housing portion shown in FIG. 3.



FIG. 7 is a perspective view of an insert member shaped to be received in the dispenser housing shown in FIG. 1.



FIG. 8 is a top view of the insert member shown in FIG. 7.



FIG. 9 is a cross-sectional side view of the insert member taken along line 9-9 of FIG. 8.



FIG. 10 is an exploded perspective view of an insert member and a portion of a dispenser housing.



FIG. 11 is an exploded perspective view of a first container assembly and dispenser housing.



FIG. 12 is an exploded perspective view of a second container assembly and a dispenser housing configured with an insert member.



FIG. 13 is a cross-sectional view of the first container assembly and dispenser housing in an assembled configuration.



FIG. 14 is a cross-sectional view of the second container assembly and dispenser housing in an assembled configuration.



FIG. 15 is a perspective view of a medication delivery device including a resuscitation bag.



FIG. 16 is a partial, perspective view of a medication delivery device shown in FIG. 15.



FIG. 17 is a partially exploded perspective view of an alternative embodiment of a medication delivery device.



FIG. 18 is an assembled perspective view of the medication delivery device shown in FIG. 17.



FIG. 19 is view of a medication delivery device incorporated into a ventilator circuit.



FIG. 20 is a cross-sectional view of the delivery device shown in FIG. 19 taken along line 20-20.



FIG. 21 is a cross-sectional view of the delivery device shown in FIG. 19 taken along line 21-21.



FIG. 22 is a side cross-sectional view of a delivery device shown in a collapsed position.



FIG. 23 is a top cross-sectional view of a delivery device shown in a collapsed position.



FIG. 24 is a plan view of a plug member.



FIG. 25 is a side, cross-sectional view of the plug member shown in FIG. 24.



FIG. 26 is a side view of an insert member.



FIG. 27 is a top view of an insert member.





DETAILED DESCRIPTION OF THE DRAWINGS

The present disclosure is directed to medication delivery devices, including ventilator circuit aerosol delivery systems. The disclosed ventilator circuit aerosol delivery systems include implementations to be used with intermittent flow ventilators and implementations to be used with continuous flow ventilators. As described in more detail below, by implementing systems to separate an inspired gas flow from an expired gas flow at the entrance to an endotracheal tube, or a tracheotomy tube, and integrating a Wye connector into an MDI ventilator assembly, the MDI ventilator assembly may be moved from the inspired limb and connected directly to the endotracheal tube, or a tracheotomy tube. By connecting the MDI ventilator assembly directly to the endotracheal tube, or tracheotomy tube, aerosolized drugs may be more effectively administered to a patient without “dead space area” where gases exhaled from a patient remain between each breath such that the same gases are inhaled by the patient upon their next breath. Various delivery systems are disclosed for example and without limitation in U.S. Publication No. US 2005-39746A1, entitled Ventilator Circuit and Method for the User Thereof and filed Feb. 9, 2004, U.S. Publication No. US 2006-0254579A1, entitled Ventilator Circuit and Method for the Use Thereof and filed Apr. 24, 2006, and U.S. application Ser. No. 12/105,881, entitled Aerosol Delivery System and filed Apr. 18, 2008, the entire disclosures of which are hereby incorporated herein by reference.


Now referring to the embodiment of FIGS. 1, 15 and 16, a dispenser housing 2 includes three primary components. A housing component 4 includes a patient port 10. It should be understood that the housing component 4 can be configured with different patient ports to accommodate various patient interface components, including for example and without limitation endotracheal (ET) tubes, masks, mouthpieces, etc. A second housing component 6 includes an exterior wall 12 and an interior wall 14, or shelf, which separates the chamber into the inhalation and exhalation interior spaces 16, 18. In one embodiment, the spaces 16, 18 communicate with each other at a vestibule area 20 formed in front of and communicating with the patient port. A receptacle 40 is formed on the housing and includes a support block 42 having a well 44 with an orifice 46 that communicates directly with the inhalation interior space 16, as shown in FIGS. 3-10.


Referring again to FIGS. 1, 15 and 16, a third housing component 8 is formed as a connector and defines a ventilator port 32. The connector has first and second passageways separated by a wall, with the first and second passageways communicating with inhalation and exhalation interior spaces 16, 18. Additional walls 30 form a valve seat for the inhalation valve 22. The first and third components 4, 8 are secured to respective ends of the second component 6 to form the dispenser housing. An integrally formed inhalation/exhalation valve 22, 24 is disposed between the connector 8 and the second component 6. The second component 6 has a valve seat 26 for the exhalation valve 24. The valve includes a base portion 28, and inhalation/exhalation flaps 22, 24 extending in opposite directions from the base portion 28. The inhalation valve 22 moves off of the first seat 30 of the connector 8 during inhalation, while the exhalation valve 24 moves off of the second seat 26 during exhalation. In one embodiment, the surface area of the inhalation valve 22 is greater than the surface area of the exhalation valve 24, although it should be understood that the surface areas can be the same, or that the surface area of the inhalation valve is less than the area of the exhalation valve. It should be understood that the inhalation and exhalation valves 22, 24 can be formed separately, again with the same or differential surface areas.


In operation, the system is pressurized to inflate the lungs of the patient, such as a neonate. The positive pressure comes from an oxygen supply 34 connected to a resuscitation bag 36. Manual resuscitation, for example and without limitation bagging, can begin immediately after birth, for example, to maintain a neonate's breathing. A pressurized metered dose inhaler (pMDI) 50 is actuated or fired in between breaths, with the drug being held in the inhalation interior space 16 of the chamber until the next breath. As the resuscitation bag is squeezed, the flow through the inhalation valve 22 and increase in pressure forces the drug from the inhalation interior space 16 of the chamber through the patient port 10 to the patient, for example through the endotracheal tube 51. As the resuscitation bag 36 reinflates, it creates a negative pressure that pulls air through the exhalation interior space 18 as the exhalation valve 24 is opened, with any drug remaining in the inhalation interior space 16 staying there due to the separation of the inhalation and exhalation interior spaces 16, 18. The next breath forces the remaining drug through the patient port 10 to the patient through the patient interface component. The dispenser housing can be used with a flow inflating resuscitation bag, as described hereinabove, or with a self-inflating resuscitation bag. The self-inflating resuscitation bag includes a non-rebreathing valve that prevents the bag from pulling exhaled gases from the patient, and in particular from the chamber. Instead, the patient exhales into the device and the expiratory gases exit to the atmosphere through the non-breathing valve. With this device, the dispenser housing still separates the exhaled gases because a pressure differential is maintained with a higher pressure at the patient end of the device.


While the embodiments of FIGS. 1, 15 and 16 may still be used with a Wye connector, it should be understood that because inspired gas flow and expired gas flow are separated at the entrance to the endotracheal breathing tube, or tracheotomy tube, the MDI ventilator assembly may be moved from the inspired limb and connected directly to the endotracheal breathing tube or tracheotomy tube.


The disclosed ventilator circuit aerosol delivery system is suitable for use with intermittent flow ventilators and continuous flow ventilators, and including without limitation both mechanical and manual ventilators such as resuscitation bags. As used herein throughout, the term “including” does not means limited to, but rather is without limitation. Implementations of the disclosed ventilator circuit aerosol delivery systems provide the ability to connect the MDI ventilator assembly directly to the endotracheal tube, or a tracheotomy tube, due to an integrated Wye connector or the ability to separate inhalation flow and exhalation flow at the entrance to an endotracheal breathing tube or a tracheotomy tube. Connecting the MDI ventilator assemblies directly to the endotracheal tube, or tracheotomy tube, provides the ability to more efficiently administer aerosolized drugs to a patient without “dead space area” where gases exhaled from a patient remain between each breath such that the same gases are inhaled by the patient upon their next breath. For this reason, the MDI ventilator assembly may be left in a ventilator circuit even when the MDI ventilator assembly is not being used to administer an aerosolized drug to a patient so that it is no longer necessary to break a ventilator circuit each time an aerosolized drug is administered to a patient.


Preferably, the housing 2, or it various components 4, 6, 8 individually or in combination, are made of a clear plastic, although it can be non-transparent in certain embodiments. In one implementation, the housing 2, or its various components individually or in combination, may be made from an antistatic material such that a surface resistivity of the housing 2 is less than about 10E12 ohm/sq., and preferably between about 10E10 and about 10E12 ohm/sq. Examples of antistatic housings are disclosed in U.S. patent application Ser. No. 10/821,260, filed Apr. 8, 2004, the entirety of which is hereby incorporated by reference. Further examples of housings used in MDI ventilator assemblies are disclosed in U.S. patent application Ser. No. 10/774,751, filed Feb. 9, 2004 and published as U.S. Publication No. US 2005-39746A1 (entitled Ventilator Circuit and Method for the User Thereof), and U.S. patent application Ser. No. 11/410,270, filed Apr. 24, 2006 U.S. and published as U.S. Publication No. US 2006-0254479A1 (entitled Ventilator Circuit and Method for the User Thereof), the entire disclosures of which are hereby incorporated herein by reference.


It should be appreciated that the housing 2 may additionally define a temperature probe port, a pressure port, and a holder. In one implementation, both the temperature probe port and the pressure port are positioned on the inhalation port. However, in other implementations, one or both of the temperature probe port and the pressure port may be positioned on other portions of the housing such as the exhalation port. It should be understood that the ports, including without limitation the temperature and pressure ports, can be used to monitor other parameters, such as the presence of CO2 or other gases.


Referring to FIGS. 17-23, another embodiment of a medication delivery device includes a housing 202 having a port 232 and a patient port 210, 304. The port 232 can be configured as a ventilator port as described above with respect to the first embodiment. Indeed, as shown in the embodiment of FIG. 19, a WYE-connector 300 is connected to the patient port 304, with a ventilator supply conduit 320 connected to the port 232. As shown in FIGS. 19, 21 and 23, in one embodiment, the patient port 304 is offset from a central, longitudinal axis 334 defined by the chamber, while the orifice 46 is in line with the longitudinal axis 334. A receptacle 40 is configured on a conduit 234 communicating between the port and the housing. The housing includes first and second end pieces 236, 238, with the first end piece including the patient port 210, 304. As shown in FIGS. 21-23, the patient port 304 includes a curved portion 306. A collapsible chamber 240 is disposed between and coupled to the end pieces. U.S. Pat. No. 4,938,210, which is hereby incorporated herein by reference, discloses one embodiment of a collapsible chamber. The chamber defines an interior space. When extended, the chamber has a volume of less than about 150 cc in one embodiment, less than about 130 cc in another embodiment, and less than about 125 cc in another embodiment. The chamber is expandable between a collapsed, stored position (FIGS. 22 and 23) and an extended, use position (FIGS. 17-21). In the stored position, the chamber is collapsed and disposed in spaces 242, and in particular annular grooves 412, 414, formed by the end pieces, which are coupled for example with a quick-release mechanism 244 that can be snapped together. In the stored position, the collapsible chamber is protected from tampering, with the size of the overall device being reduced. In one embodiment, the quick release mechanism includes first and second connector components, which may be interchanged on the first and second end pieces. In one embodiment, the quick release mechanism includes a pair of tabs 246 releasably engaging a corresponding pair of receivers 248 configured with abutment surfaces 252. The tabs are depressed, inserted through openings 250 in the receivers and then released to engage the surfaces. The tabs include grippable portions 254 allowing them to be engaged by the user and thereafter deflected for engagement/insertion and disengagement/withdrawal with the receivers. In the collapsed position, an entirety of the collapsible chamber is received in the interior space 242, 412, 414 defined by the first and second pieces. In one embodiment, each of the first and second end pieces include an annular wall 460, 462 defining the interior space 242, 412, 414, with the annular walls 460, 462 overlapping when the collapsible chamber is moved to the collapsed position as shown in FIGS. 22 and 23. The discharge orifice 46 is in fluid communication with the interior of the collapsible chamber.


Referring to FIGS. 1, 3-6, 10, 15 and 16, the MDI receptacle 40 is typically located on a top of the housing 2, but the MDI receptacle 40 may be located at other positions on the housing 2, for example on the conduit as shown in FIGS. 17 and 18. FIGS. 3-6 and 10-14 presently show only the downstream portion of the housing component 6, and it should be understood that this portion can be made separately or integrally with the remaining portions of housing component 6, or components 4 and 8. The MDI receptacle 40 is positioned away from the patient port 10 such that when an aerosolized drug is dispensed into the interior space 16 via the MDI receptacle 40, the aerosolized drug may expand before being inhaled by a patient via the patient port 10. In particular, it will be appreciated that during inhalation, when gases flow from the interior space 16 to the endotracheal breathing tube, or tracheotomy tube, the aerosolized drug expands and flows to the patient. If any portion of the aerosolized drug is not inhaled during an initial breath, the remaining aerosolized drug is inhaled during subsequent breaths.


Referring to FIGS. 3-6, 10-14 and 17, the MDI receptacle 40 includes a peripheral wall 48 that defines a socket or recess 52 to receive an end of a MDI container 122 such that when the MDI container 50 is placed in the MDI receptacle 40, an actuator nozzle 42 or support block in the recess of the MDI receptacle 40 engages a stem 54 extending from the MDI container 50 and causes the aerosolized drug within the MDI container 50 to be dispensed into the interior space 16 of the housing 2. A plurality of longitudinal ribs 49 are formed along the interior surface of the wall 48. In particular, the stem 52 is received in the well 44 formed in the actuator nozzle or support block 42. The well 44 communicates with the discharge orifice 46, which opens into the interior space 16. It should be understood that the receptacle can be configured to connect to and support medication containers, aerosol dispersal devices, or systems other than the disclosed MDI container 50.


In an alternative embodiment, shown in FIG. 2, a dispenser housing 102 is formed as an actuator boot, with a mouthpiece 110 and a peripheral wall 148 defining a cavity 152 or interior space. Again, the housing includes a support block 142 configured with a well 144 and discharge orifice 146.


Referring to the embodiment of FIGS. 17 and 18, the receptacle is configured with two laterally extending tabs or wings 260. In this embodiment, the user positions two fingers (e.g., first and second) underneath the wings 260 and actuates the container with a thumb. As such, the fingers and thumb do not have to span as great a distance as the other embodiments, for example engaging the bottom of the housing component 8 opposite the container. The wings may also be incorporated into the other embodiments, including for example and without limitation the embodiment of FIGS. 1 and 2. The wings are sized and shaped to provide sufficient surface area to grip. For example and without limitation, in one embodiment, the wings have a depth of about 6 mm and a width of about 18 mm.


Referring to FIGS. 11, 13 and 17, a first container assembly 70 includes a dose counter 60 secured to a container 50. The dose counter 60 includes a counting mechanism, mechanical or electrical, including for example and without limitation mechanisms disclosed in U.S. Pat. Nos. 6,997,349 and 6,729,330 (the entire disclosures of which are hereby incorporated herein by reference), with a viewing window 64 displaying various dosage indicia, whether mechanical or electrical/digital. The peripheral wall 48 of the dispenser housing is also configured with a viewing window 62 or opening shaped and positioned to be aligned with the viewing window 64 of the dose counter when the valve stem 54 of the first container assembly is secured in the well 44 of the dispenser housing. Alternatively, the viewing window may be omitted from the dispenser housing as shown in FIGS. 17 and 18, although it should be understood that a viewing window may be incorporated into the embodiment of FIGS. 17 and 18. As shown in FIGS. 2, 13 and 17, an upright member 66 or finger is configured as an actuator. The actuator is positioned such that reciprocal movement of the first container assembly relative to the dispenser housing causes the dose counter to advance and record a dispersement of medication. The first container assembly 70, including the dose counter 60, has a first exterior shape 72 defined by the exterior surface of the dose counter 60, including the viewing window 64. For example, in a cross-section substantially perpendicular to a longitudinal axis defined by the valve stem 54, the cross section substantially mates with the interior space of the socket 52 as shown in FIG. 6, and includes a circular portion 90 and a protuberance 92 extending outwardly from a diameter of the circular portion, thereby forming a “keyhole” shape. The circular portion 90 and protuberance 92 mate with a circular portion 94 of the socket and a recess 96 extending laterally outwardly therefrom respectively.


Referring to FIGS. 12 and 14, a second container assembly 80 is configured as a canister 50 with an end portion 82, including a ferrule, and a valve stem 54 extending therefrom. The second container assembly 80 has a second exterior shape 84 defined by the exterior surface 86 of the end portion of the canister. For example, as shown in FIG. 12, the second exterior shape 84 in cross section is substantially circular defined by the diameter of the end portion. As shown in FIGS. 11 and 12, the second exterior shape 84 of the second container assembly is different than the first exterior shape 72 of the first container assembly. It should be understood that other container assemblies may have further additional, different exterior shapes defined for example and without limitation by differently sized and shaped canisters, e.g., with end portions having different diameters, with or without differently configured and shaped dose counters.


Since the second exterior shape 84 of the second container assembly is different than the first exterior shape 72 of the first container assembly, and in particular has a smaller overall cross-sectional area taken perpendicular to the longitudinal axis defined by the valve stem 54, the second container assembly 80 may feel sloppy relative to the socket 52 when mounted to the support block 42 due to the excess room between the exterior surface of the canister 50, and the end portion in particular, and the interior surface of the peripheral wall 48 of the dispenser housing.


To improve the fit of the second container assembly 84, an insert member 98, 398 is provided, as show in FIGS. 6-10, 12, 14, 22, 26 and 27. The insert member has a peripheral wall 100, 500 that is nested inside the peripheral wall of the dispenser housing and has an exterior shape 130 that mates with the interior profile of the dispenser housing wall. As shown in FIGS. 26 and 27, the wall 500 may include slots 508, as well as ribs 510 that engage the container. In one embodiment, the exterior shape includes a circular portion 132 and a protuberance 134. The insert member further includes an upper peripheral rim 136, 502 that extends outwardly from the peripheral wall and engages a top edge 138 of the dispenser housing wall. The insert member 98, 398 is configured with a floor 140 having an opening 142 aligned with and positioned above the support block and well and shaped to receive the valve stem 54 of the canister. Alternatively, the support block can extend through the floor, as long as the discharge orifice is located beneath the floor and in communication with the holding chamber or mouthpiece. The floor 140 also includes a second opening 144 shaped to receive or accommodate the upright finger 66 or actuator, which may not have any function relative to a second container assembly not configured with a dose counter. The insert member 98, 398 supports the canister 50 during insertion and use, and prevents the valve stem 54 from missing the well 44 during insertion. The floor 140, with its opening 142, further helps locate and align the valve stem 54 with the support block 42 and well 44. In connection with the embodiment of FIG. 2, the insert member may be longer with an upper rim engaging the top of the actuator, or the insert member may not be configured with a peripheral rim.


As shown in FIGS. 19, 22, 26 and 27, the insert member 398 includes a flexible tether 402 having an end portion 450 with an opening that is secured over a button 308 extending from the exterior surface of the receptacle 40. It should be understood that the tether can be integrally formed with the insert member, or can be configured as a separate member, whether formed as a cord, chain, retractable member, or other similar device. In this way, the insert member 398 can be removed, for example when a first container assembly 70 with a dose counter 60 is being used with the dispenser system, but with it remaining connected to the dispenser system with the tether 402 such that it is not lost or otherwise displaced. As shown in FIGS. 19, 22, 24 and 25, a plug member 310, having wings 332 for gripping by the user, can be inserted into the insert member 398 when the system is not in use, or when the insert member is disconnected from the receptacle, so as to prevent contaminants from entering the insert member or receptacle. The plug member 310 includes a tether 302 having an end portion with an opening, which can be secured over the button. It should be understood that the tether can be integrally formed with the insert member, or can be configured as a separate member, whether formed as a cord, chain, retractable member, or other similar device. The plug member 310 includes an orifice insert 312 that is disposed in the well of the support block to plug the well and prevent contamination thereof. The insert 312 extends through the opening 142 in the bottom of the insert member 398.


In operation, the user, such as caregiver, can use different container assemblies 70, 80, having different exterior shapes 72, 84, with the same dispenser housing 2, 102. For example and without limitation, the caregiver can first dispose the first container assembly 70 with dose counter 60 in the dispenser housing 2, 102, and in particular the socket 52, and actuate the first container assembly a predetermined number of times, including for example a single actuation. The dose counter 60 records the predetermined number of actuations. The caregiver can then remove the first container assembly 70 without having to remove the dispenser housing 2, for example, from a ventilator circuit, or alternatively without having locate another actuator 102 for use with another container assembly. Subsequently, for example if a different medication is required, the caregiver can install an insert member 98, 398 into the dispenser housing 2, 102 and then insert a second container assembly 80, for example a canister 50 without a dose counter, into the insert member 98, 398 and engage the support block 42 of the dispenser housing with the valve stem 54 of the canister. The insert member 98 can be installed in the dispenser housing with a snap-fit, a press fit or any other suitable mechanism for securing the insert member. For example, as shown in FIG. 9, one embodiment of the insert member 98 includes a tab 150 that engages the upper edge of the viewing window 62 with a snap fit as shown in FIG. 12. This same operation can be carried out with the actuator boot shown in FIG. 2, with the insert member configured as needed to be fitted in the boot (e.g., without a rim). In this way, it should be understood that the system and method may be incorporated into systems other than ventilator circuits, including the actuator boot of FIG. 2 and/or a spacer configuration.


It is intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.

Claims
  • 1. A medication delivery device comprising: a collapsible holding chamber defining and moveable along a first longitudinal axis between an extended position and a collapsed position, wherein said collapsible holding chamber comprises an input port and a patient port located at opposite ends of said collapsible holding chamber, and a release mechanism holding said collapsible holding chamber in said collapsed position, wherein said release mechanism comprises a tab and a receiver moveable relative to each other in a longitudinal direction between a disengaged position and an engaged position as said collapsible holding chamber is moved between said extended and collapsed positions, wherein said tab is deflectable transverse to said longitudinal direction between an insertion position and said engaged position, wherein said tab is moveable in said longitudinal direction through an opening in said receiver when said tab is in said insertion position, and wherein said tab engages an abutment surface of said receiver and prevents said tab and said receiver from being moved relative to each other in said longitudinal direction when said tab is in said engaged position, and wherein said tab comprises a grippable end portion accessible to, and engageable by, a user when said tab is in said engaged position; anda metered dose inhaler receptacle coupled to and in fluid communication with said collapsible holding chamber, wherein said metered dose inhaler receptacle is in fluid communication with said collapsible holding chamber at a location spaced apart from and downstream of said input port, wherein separate first and second flow paths are defined respectively from and through said metered dose inhaler receptacle and said input port and into said collapsible holding chamber, and wherein at least a portion of said second flow path from said input port to said collapsible holding chamber remains unobstructed by said metered dose inhaler receptacle.
  • 2. The medication delivery device of claim 1 further comprising a conduit communicating between said input port and said collapsible holding chamber, wherein said metered dose inhaler receptacle is coupled to said conduit and comprises a discharge orifice disposed in said conduit.
  • 3. The medication delivery device of claim 2 wherein said orifice is aligned with said first longitudinal axis.
  • 4. The medication delivery device of claim 1 wherein said patient port defines a second longitudinal axis laterally spaced from said first longitudinal axis.
  • 5. The medication delivery device of claim 4 wherein said first and second longitudinal axes are parallel.
  • 6. The medication delivery device of claim 1 wherein said collapsible holding chamber comprises first and second end pieces, and a collapsible chamber member coupled to and disposed between said first and second end pieces, wherein said tab is disposed on one of said first or second end pieces, and said receiver is disposed on the other of said first or second end pieces.
  • 7. The medication delivery device of claim 6 wherein said first and second end pieces define an interior space therebetween when said collapsible holding chamber is in said collapsed position, wherein said collapsible chamber member is disposed in said interior space.
  • 8. The medication delivery device of claim 7 wherein said first and second end pieces each comprise an annular wall, said annular walls of said first and second end pieces defining said interior space when said collapsible holding chamber is in said collapsed position.
  • 9. The medication delivery device of claim 7 wherein said first and second end pieces comprise first and second grooves respectively, wherein said collapsible chamber member is received in said first and second grooves when said collapsible holding chamber is in said collapsed position.
  • 10. The medication delivery device of claim 1 further comprising a medicament container disposed in said metered dose inhaler receptacle.
  • 11. A medication delivery device comprising: a collapsible holding chamber defining and moveable along a first longitudinal axis between an extended position and a collapsed position, wherein said collapsible holding chamber comprises an input port and a patient port located at opposite ends of said collapsible holding chamber, wherein said patient port defines a second longitudinal axis laterally spaced from said first longitudinal axis;a release mechanism holding said collapsible holding chamber in said collapsed position, wherein said release mechanism comprises a tab and a receiver moveable relative to each other in a longitudinal direction between a disengaged position and an engaged position as said collapsible holding chamber is moved between said extended and collapsed positions, wherein said tab is deflectable transverse to said longitudinal direction between an insertion position and said engaged position, wherein said tab is moveable in said longitudinal direction through an opening in said receiver when said tab is in said insertion position, and wherein said tab engages an abutment surface of said receiver and prevents said tab and said receiver from being moved relative to each other in said longitudinal direction when said tab is in said engaged position, and wherein said tab comprises a grippable end portion accessible to, and engageable by, a user when said tab is in said engaged position; anda metered dose inhaler receptacle coupled to and in fluid communication with said collapsible holding chamber, wherein said metered dose inhaler receptacle is in fluid communication with said collapsible holding chamber at a location spaced apart from and downstream of said input port, wherein separate first and second flow paths are defined respectively from and through said metered dose inhaler receptacle and said input port and into said collapsible holding chamber, and wherein at least a portion of said second flow path from said input port to said collapsible holding chamber remains unobstructed by said metered dose inhaler receptacle.
  • 12. The medication delivery device of claim 11 further comprising a conduit communicating between said input port and said collapsible holding chamber, wherein said metered dose inhaler receptacle is coupled to said conduit and comprises a discharge orifice disposed in said conduit.
  • 13. The medication delivery device of claim 12 wherein said orifice is aligned with said first longitudinal axis.
  • 14. The medication delivery device of claim 11 wherein said first and second longitudinal axes are parallel.
  • 15. The medication delivery device of claim 11 wherein said collapsible holding chamber comprises first and second end pieces, and a collapsible chamber member coupled to and disposed between said first and second end pieces, wherein said tab is disposed on one of said first or second end pieces, and said receiver is disposed on the other of said first or second end pieces.
  • 16. The medication delivery device of claim 15 wherein said first and second end pieces define an interior space therebetween when said collapsible holding chamber is in said collapsed position, wherein said collapsible chamber member is disposed in said interior space when said collapsible holding chamber is in said collapsed position.
  • 17. The medication delivery device of claim 16 wherein said first and second end pieces each comprise an annular wall, said annular walls of said first and second end pieces defining said interior space when said collapsible holding chamber is in said collapsed position.
  • 18. The medication delivery device of claim 16 wherein said first and second end pieces comprise first and second grooves respectively, wherein said collapsible chamber member is received in said first and second grooves when said collapsible holding chamber is in said collapsed position.
  • 19. The medication delivery device of claim 11 further comprising a medicament container disposed in said metered dose inhaler receptacle.
  • 20. A medication delivery device comprising: a collapsible holding chamber comprising first and second end pieces and a collapsible chamber member coupled to said first and second end pieces, said collapsible chamber member defining a first longitudinal axis, wherein said first and second end pieces are moveable along said longitudinal axis between a use position and a stored position, wherein said first and second end pieces define an interior space therebetween when said first and second end pieces are in said stored position, wherein said collapsible chamber member is disposed in said interior space when said first and second end pieces are in said stored position, wherein said collapsible holding chamber comprises a release mechanism holding said first and second end pieces in said stored position, wherein said release mechanism comprises a tab disposed on one of said first or second end pieces and a receiver disposed on the other of said first or second end pieces, wherein said tab and said receiver are moveable relative to each other in a longitudinal direction between a disengaged position and an engaged position as said first and second end pieces are moved between said use and stored positions, wherein said tab is deflectable transverse to said longitudinal direction between an insertion position and said engaged position, wherein said tab is moveable in said longitudinal direction through an opening in said receiver when said tab is in said insertion position, and wherein said tab engages an abutment surface of said receiver and prevents said tab and said receiver from being moved relative to each other in said longitudinal direction when said tab is in said engaged position, wherein said tab comprises a grippable end portion accessible to, and engageable by, a user when said tab is in said engaged position, and wherein said first end piece comprises an input port; anda metered dose inhaler receptacle coupled to and in fluid communication with said collapsible holding chamber, wherein said metered dose inhaler receptacle is in fluid communication with said collapsible holding chamber at a location spaced apart from and downstream of said input port, wherein separate first and second flow paths are defined respectively from and through said metered dose inhaler receptacle and said input port and into said collapsible holding chamber, and wherein at least a portion of said second flow path from said input port to said collapsible holding chamber remains unobstructed by said metered dose inhaler receptacle.
  • 21. The medication delivery device of claim 20 wherein said metered dose inhaler receptacle is coupled to said first end piece.
  • 22. The medication delivery device of claim 21 wherein said metered dose inhaler receptacle comprises a discharge orifice aligned with said first longitudinal axis.
  • 23. The medication delivery device of claim 20 wherein said second end piece comprises a patient port defining a second longitudinal axis laterally spaced from said first longitudinal axis.
  • 24. The medication delivery device of claim 23 wherein said first and second longitudinal axes are parallel.
  • 25. The medication delivery device of claim 20 wherein said first and second end pieces each comprise an annular wall, said annular walls of said first and second end pieces defining said interior space when said first and second end pieces are in said stored position.
  • 26. The medication delivery device of claim 25 wherein said first and second end pieces comprise first and second grooves respectively, wherein said collapsible chamber member is received in said first and second grooves when said first and second end pieces are in said stored position.
  • 27. The medication delivery device of claim 20 further comprising a medicament container disposed in said metered dose inhaler receptacle.
Parent Case Info

This application is a continuation of U.S. application Ser. No. 12/603,700, filed Oct. 22, 2009, which application claims the benefit of U.S. Provisional Application Ser. No. 61/107,435, filed Oct. 22, 2008, the entire disclosures of which are hereby incorporated herein by reference.

US Referenced Citations (471)
Number Name Date Kind
165054 Baldwin Jun 1875 A
498851 Jones Jun 1893 A
1219858 Patterson Mar 1917 A
2417759 Johnson Mar 1947 A
2455962 Wheeler et al. Dec 1948 A
2580292 Geary et al. Dec 1951 A
2587147 Guion et al. Feb 1952 A
2630027 Wunderlich Mar 1953 A
2644452 Brown Jul 1953 A
2767680 Lermer Oct 1956 A
2770711 Baranowski Nov 1956 A
2841190 Scheck Jul 1958 A
2883086 Davison et al. Apr 1959 A
2939597 Greene Jun 1960 A
2943730 Tregilgas Jul 1960 A
2953242 Shaw Sep 1960 A
3001524 Maison et al. Sep 1961 A
3028873 Kindred Apr 1962 A
3073468 Arneson Jan 1963 A
3085745 Auberger Apr 1963 A
3119557 Chapman Jan 1964 A
3120318 Rigor Feb 1964 A
3148801 Radeloff et al. Sep 1964 A
3151599 Livingston Oct 1964 A
3170597 Reichenberger Feb 1965 A
3183906 Moyat May 1965 A
3187963 Anderson Jun 1965 A
3189232 Joffe Jun 1965 A
3191867 Helms Jun 1965 A
3240389 Genua Mar 1966 A
3334731 Dale Aug 1967 A
3344951 Gervais Oct 1967 A
3361306 Grim Jan 1968 A
3402863 Green Sep 1968 A
3419187 Bazarnic Dec 1968 A
3446179 Bender May 1969 A
3477561 Espinal Nov 1969 A
3495567 Hayes et al. Feb 1970 A
3511409 Huck May 1970 A
3549057 Perez Dec 1970 A
3568629 Porter Mar 1971 A
3572282 Trump et al. Mar 1971 A
3589563 Carragan et al. Jun 1971 A
3612349 Thomas Oct 1971 A
3654890 Rigney et al. Apr 1972 A
3655952 Johnson et al. Apr 1972 A
3667475 Venturelli et al. Jun 1972 A
3688945 Harman, Jr., et al. Sep 1972 A
3726274 Bird et al. Apr 1973 A
3753417 Garby Aug 1973 A
3766882 Babbitt, III Oct 1973 A
3789843 Armstrong et al. Feb 1974 A
3792242 Hanson Feb 1974 A
3796348 Zipper Mar 1974 A
3797748 Nozawa et al. Mar 1974 A
3802608 Gullett Apr 1974 A
3831808 Bender Aug 1974 A
3831812 Dolan Aug 1974 A
3842828 Bird Oct 1974 A
3845883 Johnson et al. Nov 1974 A
3848774 Schimke Nov 1974 A
3886879 Frost et al. Jun 1975 A
3887099 Gillman et al. Jun 1975 A
3921568 Fish Nov 1975 A
3926326 Grau Dec 1975 A
3950939 Meisner Apr 1976 A
3960713 Carey Jun 1976 A
3977554 Costa Aug 1976 A
3994421 Hansen Nov 1976 A
4011829 Wachsmann et al. Mar 1977 A
4029033 Kerwin et al. Jun 1977 A
4034757 Glover Jul 1977 A
4037719 Perlmutter Jul 1977 A
4069935 Hampel Jan 1978 A
4069942 Marshall et al. Jan 1978 A
4074831 Roach Feb 1978 A
4078661 Thomas Mar 1978 A
4094408 Ford Jun 1978 A
4117952 Grimes Oct 1978 A
4162746 Anderson et al. Jul 1979 A
4164301 Thayer Aug 1979 A
4171753 Vreede Oct 1979 A
4188984 Lyall Feb 1980 A
4220247 Kramer Sep 1980 A
4240417 Holever Dec 1980 A
4291688 Kistler Sep 1981 A
4300548 Jones Nov 1981 A
4319128 Dow, Jr. et al. Mar 1982 A
4345541 Villa-Real Aug 1982 A
4347804 Villa-Real Sep 1982 A
4347853 Gereg et al. Sep 1982 A
4350265 Griffiths et al. Sep 1982 A
4354621 Knickerbocker Oct 1982 A
4357192 Moser Nov 1982 A
4365722 Kramer Dec 1982 A
4368381 Ishiyama Jan 1983 A
4405045 Villa-Real Sep 1983 A
4417574 Talonn et al. Nov 1983 A
4419016 Zoltan Dec 1983 A
4432300 Lyss Feb 1984 A
4436223 Wilson Mar 1984 A
4440306 Van Buskirk et al. Apr 1984 A
4457305 Shanks et al. Jul 1984 A
4489834 Thackrey Dec 1984 A
4500005 Forrester Feb 1985 A
4501370 Kelley Feb 1985 A
4511150 Seguenot Apr 1985 A
4523933 Laush et al. Jun 1985 A
4528933 Allen Jul 1985 A
4534343 Nowacki et al. Aug 1985 A
4534345 Wetterlin Aug 1985 A
4538744 Weissenborn Sep 1985 A
4548157 Hevoyan Oct 1985 A
4562933 Dennis Jan 1986 A
4565302 Pfeiffer et al. Jan 1986 A
4599508 Smetaniuk Jul 1986 A
4627432 Newell et al. Dec 1986 A
4634012 Kelley Jan 1987 A
4637528 Wachinski et al. Jan 1987 A
4641759 Kelley Feb 1987 A
4646936 Frazier et al. Mar 1987 A
4662520 Griffin May 1987 A
4664107 Wass May 1987 A
4666051 Trick May 1987 A
4668218 Virtanen May 1987 A
4677975 Edgar et al. Jul 1987 A
4693399 Hickman et al. Sep 1987 A
4705182 Newel-Lewis Nov 1987 A
4722729 Dettbarn et al. Feb 1988 A
4723673 Tartaglia et al. Feb 1988 A
4727886 Conrardy et al. Mar 1988 A
4736871 Luciani et al. Apr 1988 A
4749093 Trick Jun 1988 A
4753189 Mastman et al. Jun 1988 A
4756423 Holtsch Jul 1988 A
4782966 Thackrey Nov 1988 A
4792664 Schwab Dec 1988 A
4803977 Kremer, Jr. Feb 1989 A
4815459 Beran Mar 1989 A
4817822 Rand et al. Apr 1989 A
4823784 Bordoni et al. Apr 1989 A
4828844 Rontgen-Odenthal et al. May 1989 A
4890572 Huang Jan 1990 A
4934358 Nilsson et al. Jun 1990 A
4934568 Fuchs Jun 1990 A
4938210 Shene Jul 1990 A
4947875 Brooks et al. Aug 1990 A
4953545 McCarty Sep 1990 A
4955371 Zamba et al. Sep 1990 A
4969578 Gander et al. Nov 1990 A
4973250 Milman Nov 1990 A
4984158 Hillsman Jan 1991 A
5002048 Makiej, Jr. Mar 1991 A
5005572 Raemer et al. Apr 1991 A
5006343 Benson et al. Apr 1991 A
5009338 Barker Apr 1991 A
5011032 Rollman Apr 1991 A
5012804 Foley et al. May 1991 A
5020527 Dessertine Jun 1991 A
5027806 Zoltan et al. Jul 1991 A
5027808 Rich et al. Jul 1991 A
5038972 Muderlak et al. Aug 1991 A
5044361 Werner et al. Sep 1991 A
5049388 Knight et al. Sep 1991 A
5056454 Turner Oct 1991 A
5060643 Rich et al. Oct 1991 A
5069204 Smith et al. Dec 1991 A
5082129 Kramer Jan 1992 A
5082130 Weinstein Jan 1992 A
5115929 Buono May 1992 A
5131387 French et al. Jul 1992 A
5164369 Cochrane et al. Nov 1992 A
5174473 Marelli Dec 1992 A
5178138 Walstrom et al. Jan 1993 A
5184761 Lee Feb 1993 A
5188251 Kusz Feb 1993 A
5190643 Duncan et al. Mar 1993 A
5209375 Fuchs May 1993 A
5215079 Fine et al. Jun 1993 A
5217004 Blasnik et al. Jun 1993 A
5224474 Bloomfield Jul 1993 A
5226539 Cheng Jul 1993 A
5227764 Umemoto Jul 1993 A
5228436 Parkin Jul 1993 A
5228586 Fuchs Jul 1993 A
5230884 Evans et al. Jul 1993 A
5242067 Garby et al. Sep 1993 A
5243970 Ambrosio et al. Sep 1993 A
5260273 Cochrane et al. Nov 1993 A
5261548 Barker et al. Nov 1993 A
5262405 Girod-Vaquez et al. Nov 1993 A
5263475 Altermatt et al. Nov 1993 A
5284133 Burns et al. Feb 1994 A
5289946 Fuchs Mar 1994 A
5292499 Evans et al. Mar 1994 A
5297543 Larson et al. Mar 1994 A
5299566 Davis et al. Apr 1994 A
5299701 Barker et al. Apr 1994 A
5300042 Kossoff et al. Apr 1994 A
5301873 Burke et al. Apr 1994 A
5309903 Long May 1994 A
5318016 Mecikalski Jun 1994 A
5320096 Hans Jun 1994 A
5328597 Boldt, Jr. et al. Jul 1994 A
5331953 Andersson et al. Jul 1994 A
5335823 Fuchs et al. Aug 1994 A
5349944 Chippendale et al. Sep 1994 A
5349945 Wass et al. Sep 1994 A
5355872 Riggs et al. Oct 1994 A
5356012 Tang et al. Oct 1994 A
5356406 Schraga Oct 1994 A
5357946 Kee et al. Oct 1994 A
5363842 Mishelevich et al. Nov 1994 A
5370267 Schroeder Dec 1994 A
5378233 Haber et al. Jan 1995 A
5379804 Dunn et al. Jan 1995 A
5382243 Mulholland Jan 1995 A
RE34847 Muderlak et al. Feb 1995 E
5388572 Mulhauser et al. Feb 1995 A
5392768 Johansson et al. Feb 1995 A
5394866 Ritson et al. Mar 1995 A
5397028 Jesadanont Mar 1995 A
5407914 Cochrane et al. Apr 1995 A
5411173 Weinstein May 1995 A
5421482 Garby et al. Jun 1995 A
5433195 Kee et al. Jul 1995 A
5437270 Braithwaite Aug 1995 A
5447150 Bacon Sep 1995 A
5448042 Robinson et al. Sep 1995 A
5468233 Schraga Nov 1995 A
5471979 Psaros et al. Dec 1995 A
5474058 Lix Dec 1995 A
5474759 Fassberg et al. Dec 1995 A
5479920 Piper et al. Jan 1996 A
5482030 Klein Jan 1996 A
5482163 Hoffman Jan 1996 A
5498243 Vallelunga et al. Mar 1996 A
5505192 Samiotes et al. Apr 1996 A
5505195 Wolf et al. Apr 1996 A
5509905 Michel Apr 1996 A
5519197 Robinson et al. May 1996 A
5520166 Ritson et al. May 1996 A
5522378 Ritson et al. Jun 1996 A
5524613 Haber et al. Jun 1996 A
5544647 Jewett et al. Aug 1996 A
5546930 Wikefeldt Aug 1996 A
5549101 Trofast et al. Aug 1996 A
5564414 Walker et al. Oct 1996 A
5571246 Alldredge Nov 1996 A
5574268 Herman et al. Nov 1996 A
5577335 Tucker Nov 1996 A
5584815 Pawelka et al. Dec 1996 A
5590644 Rosenkoetter Jan 1997 A
5611444 Garby et al. Mar 1997 A
5616158 Biendarra et al. Apr 1997 A
5617844 King Apr 1997 A
5622163 Jewett et al. Apr 1997 A
5625334 Compton Apr 1997 A
5625659 Sears Apr 1997 A
5626566 Petersen et al. May 1997 A
5638970 Garby et al. Jun 1997 A
5657748 Braithwaite Aug 1997 A
5657750 Colman et al. Aug 1997 A
5666946 Langenback Sep 1997 A
5676129 Rocci, Jr. et al. Oct 1997 A
5687710 Ambrosio et al. Nov 1997 A
5692492 Bruna et al. Dec 1997 A
5693944 Rich Dec 1997 A
5694882 Marshall Dec 1997 A
5697916 Schraga Dec 1997 A
5701886 Ryatt Dec 1997 A
5718355 Garby et al. Feb 1998 A
5720282 Wright Feb 1998 A
5724957 Rubsamen et al. Mar 1998 A
5732836 Barker et al. Mar 1998 A
5740792 Ashley et al. Apr 1998 A
5743251 Howell et al. Apr 1998 A
5758638 Kreamer Jun 1998 A
5772074 Dial et al. Jun 1998 A
5789381 Cochrane et al. Aug 1998 A
5794612 Wachter et al. Aug 1998 A
5799651 Garby et al. Sep 1998 A
5803283 Barker et al. Sep 1998 A
5809996 Alldredge Sep 1998 A
5809997 Wolf Sep 1998 A
5816240 Komesaroff Oct 1998 A
5826571 Casper et al. Oct 1998 A
5829428 Walters et al. Nov 1998 A
5829434 Ambrosio et al. Nov 1998 A
5845777 Najmi Dec 1998 A
5848587 King Dec 1998 A
5852590 De La Huerga Dec 1998 A
5853003 Faithfull et al. Dec 1998 A
5871007 Clark, Jr. Feb 1999 A
5873995 Huang et al. Feb 1999 A
5882507 Tanner et al. Mar 1999 A
5896855 Hobbs Apr 1999 A
5896990 Barzana Apr 1999 A
5899201 Schultz et al. May 1999 A
5904139 Hauser May 1999 A
5925334 Rubin et al. Jul 1999 A
5957896 Bendek et al. Sep 1999 A
5961495 Walters et al. Oct 1999 A
5988496 Bruna Nov 1999 A
6000159 Hornung Dec 1999 A
6001082 Dair et al. Dec 1999 A
6012450 Rubsamen Jan 2000 A
6014972 Sladek Jan 2000 A
6029659 O'Connor Feb 2000 A
6039042 Sladek Mar 2000 A
6059133 Lai May 2000 A
6062214 Howlett May 2000 A
6076521 Lindahl et al. Jun 2000 A
6082358 Scarrott et al. Jul 2000 A
6085742 Wachter et al. Jul 2000 A
6089180 Nichols, Jr. Jul 2000 A
6096010 Walters et al. Aug 2000 A
6119684 Nohl et al. Sep 2000 A
6138669 Rocci, Jr. et al. Oct 2000 A
6142339 Blacker et al. Nov 2000 A
6148815 Wolf Nov 2000 A
6149054 Cirrillo Nov 2000 A
6155251 Hauser Dec 2000 A
6161724 Blacker et al. Dec 2000 A
6164494 Marelli Dec 2000 A
6182655 Keller et al. Feb 2001 B1
6186364 Dobbs Feb 2001 B1
6202642 McKinnon et al. Mar 2001 B1
6221053 Walters et al. Apr 2001 B1
6223744 Garon May 2001 B1
6234168 Bruna May 2001 B1
6269810 Brooker et al. Aug 2001 B1
6279574 Richardson et al. Aug 2001 B1
6283365 Bason Sep 2001 B1
6309623 Weers et al. Oct 2001 B1
6309624 Sapsford et al. Oct 2001 B1
6315983 Eistetter Nov 2001 B1
6318600 Winnett et al. Nov 2001 B1
6328037 Scarrott et al. Dec 2001 B1
6336453 Scarrott et al. Jan 2002 B1
6360739 Rand et al. Mar 2002 B1
6390091 Banner et al. May 2002 B1
6405727 MacMichael et al. Jun 2002 B1
6415785 Stage Jul 2002 B1
6425392 Sosiak Jul 2002 B1
6431168 Rand et al. Aug 2002 B1
6435177 Schmidt et al. Aug 2002 B1
6435372 Blacker et al. Aug 2002 B1
6446627 Bowman et al. Sep 2002 B1
6451339 Patel et al. Sep 2002 B2
6463929 Scheuch et al. Oct 2002 B1
6474331 Rand et al. Nov 2002 B1
6481438 Gallem et al. Nov 2002 B1
6484717 Dagsland et al. Nov 2002 B1
6494203 Palmer Dec 2002 B1
6503481 Thurston et al. Jan 2003 B1
6516799 Greenwood et al. Feb 2003 B1
6524557 Bäckström et al. Feb 2003 B1
6527011 Mantz Mar 2003 B1
6529446 De La Huerga Mar 2003 B1
6550476 Ryder Apr 2003 B1
6561384 Blacker et al. May 2003 B2
6572841 Mautone Jun 2003 B1
6575944 McNary et al. Jun 2003 B1
6579254 McNary et al. Jun 2003 B1
6581600 Bird Jun 2003 B2
6601582 Rand et al. Aug 2003 B2
6613734 Cochrane et al. Sep 2003 B2
6615824 Power Sep 2003 B2
6615827 Greenwood et al. Sep 2003 B2
6622725 Fisher et al. Sep 2003 B1
6635283 Edwards et al. Oct 2003 B2
6645467 Mautone Nov 2003 B2
6659307 Stradella Dec 2003 B1
6660715 Klibanov Dec 2003 B2
6679251 Gallem et al. Jan 2004 B1
6701917 O'Leary Mar 2004 B2
6718972 O'Leary Apr 2004 B2
6729330 Scarrott et al. May 2004 B2
6737044 Dickinson et al. May 2004 B1
6752153 Eckert Jun 2004 B1
6761161 Scarrott et al. Jul 2004 B2
6766799 Edwards et al. Jul 2004 B2
6769601 Haikarainen et al. Aug 2004 B2
6770619 Larsson et al. Aug 2004 B2
6805118 Brooker et al. Oct 2004 B2
6886561 Bayron et al. May 2005 B2
6907876 Clark et al. Jun 2005 B1
6921527 Platz et al. Jul 2005 B2
6938796 Blacker et al. Sep 2005 B2
6997349 Blacker et al. Feb 2006 B2
7040314 Nguyen et al. May 2006 B2
7137391 Bruna Nov 2006 B2
7143764 Dagsland et al. Dec 2006 B1
7143908 Blacker et al. Dec 2006 B2
7156258 Eckert Jan 2007 B2
7201164 Grychowski et al. Apr 2007 B2
7201167 Fink et al. Apr 2007 B2
7207329 Bowden Apr 2007 B2
7219668 Flynn May 2007 B2
7360537 Snyder et al. Apr 2008 B2
7360541 Dhuper et al. Apr 2008 B2
7407066 Ouyang et al. Aug 2008 B2
7555995 Stump et al. Jul 2009 B1
7575130 Blacker et al. Aug 2009 B2
7743764 Dhuper et al. Jun 2010 B2
7793798 Stradella et al. Sep 2010 B2
7984826 Blacker et al. Jul 2011 B2
8528543 Barney et al. Sep 2013 B2
20020000225 Schuler et al. Jan 2002 A1
20020069870 Farmer Jun 2002 A1
20020104531 Malone Aug 2002 A1
20020108614 Schultz Aug 2002 A1
20020153005 Scarrott et al. Oct 2002 A1
20030131844 Kumar et al. Jul 2003 A1
20030136399 Foley et al. Jul 2003 A1
20030183225 Knudsen Oct 2003 A1
20030200964 Blakley et al. Oct 2003 A1
20030205227 Hodson et al. Nov 2003 A1
20030209239 Rand et al. Nov 2003 A1
20040003808 Fuhrman et al. Jan 2004 A1
20040011364 Dhuper et al. Jan 2004 A1
20040065326 MacMichael et al. Apr 2004 A1
20040069301 Bacon Apr 2004 A1
20040089296 Bowden May 2004 A1
20040094147 Schyra et al. May 2004 A1
20040144798 Ouyang et al. Jul 2004 A1
20040149772 Ouyang Aug 2004 A1
20040149773 Ouyang et al. Aug 2004 A1
20040187864 Adams Sep 2004 A1
20040221840 Stockman-Lamb Nov 2004 A1
20040255935 Bruna Dec 2004 A1
20040255936 Urbanus Dec 2004 A1
20050005929 Snyder et al. Jan 2005 A1
20050011514 Power et al. Jan 2005 A1
20050011515 Lee et al. Jan 2005 A1
20050039746 Grychowski et al. Feb 2005 A1
20050056276 Schuler et al. Mar 2005 A1
20050061314 Davies et al. Mar 2005 A1
20050066964 Bathe Mar 2005 A1
20050139211 Alston et al. Jun 2005 A1
20050172954 Smith et al. Aug 2005 A1
20050178383 Mackie et al. Aug 2005 A1
20050199236 Fink et al. Sep 2005 A1
20050205089 Fink et al. Sep 2005 A1
20050217666 Fink et al. Oct 2005 A1
20050217667 Dhuper et al. Oct 2005 A1
20050229926 Fink et al. Oct 2005 A1
20050229927 Fink et al. Oct 2005 A1
20050229928 Ivri et al. Oct 2005 A1
20050247312 Davies Nov 2005 A1
20050268905 Rasmussen et al. Dec 2005 A1
20050274378 Bonney et al. Dec 2005 A1
20050284471 Bruna Dec 2005 A1
20060000471 Klein Jan 2006 A1
20060060192 Lu et al. Mar 2006 A1
20060078506 Niven et al. Apr 2006 A1
20060107947 Rist May 2006 A1
20060120968 Niven et al. Jun 2006 A1
20060254579 Grychowski et al. Nov 2006 A1
20060254581 Genova et al. Nov 2006 A1
20060260608 Armstrong et al. Nov 2006 A1
20070056581 Obuz Mar 2007 A1
20070074718 Austin Apr 2007 A1
20070084462 Allen Apr 2007 A1
20070277817 Innocenzi Dec 2007 A1
20080000470 Minocchieri et al. Jan 2008 A1
20080017198 Ivri Jan 2008 A1
20080066741 LeMahieu et al. Mar 2008 A1
20080264412 Meyer et al. Oct 2008 A1
20090025722 Pieper et al. Jan 2009 A1
Foreign Referenced Citations (110)
Number Date Country
598250 Jun 1990 AU
535 518 Jan 1957 CA
2 152 088 Jul 1994 CA
2 181 789 Jun 1996 CA
2 210 721 Jul 1996 CA
2 486 892 Dec 1998 CA
2 315 777 Jul 1999 CA
2 329 126 Oct 1999 CA
2 331 179 Nov 1999 CA
2 354 561 Jun 2000 CA
2 383 425 Mar 2001 CA
2 388 958 Mar 2001 CA
2 414 118 Jan 2002 CA
2 420 171 Mar 2002 CA
2 493 078 Feb 2004 CA
2 515 593 Aug 2004 CA
2 424 731 Oct 2004 CA
6 603 758 Jul 1969 DE
27 02 539 Jan 1977 DE
33 36 486 Apr 1984 DE
86 02 238 Apr 1986 DE
85 90 143 Apr 1987 DE
0 028 929 May 1981 EP
0 098 939 Jan 1984 EP
0 114 617 Aug 1984 EP
0 063 599 Jun 1986 EP
0 230 323 Jul 1987 EP
0 236 871 Sep 1987 EP
0 242 790 Oct 1987 EP
0 269 496 Jun 1988 EP
0 280 104 Aug 1988 EP
0 281 650 Sep 1988 EP
0 284 227 Sep 1988 EP
0 460 731 Dec 1991 EP
0 488 609 Jun 1992 EP
0 549 266 Jun 1993 EP
0 559 757 Sep 1993 EP
0 949 584 Oct 1999 EP
0 972 534 Jan 2000 EP
0 972 534 Jan 2000 EP
1 036 569 Sep 2000 EP
1 222 940 Jul 2002 EP
1 369 139 Dec 2003 EP
1 220 802 Feb 2004 EP
1 416 169 Oct 1965 FR
2 743 055 Jul 1997 FR
750 152 Jun 1953 GB
998 148 Jul 1965 GB
1 058 636 Feb 1967 GB
1 290 484 Sep 1972 GB
1 317 315 May 1973 GB
2 036 695 Jul 1980 GB
2 063 075 Jun 1981 GB
2 092 991 Aug 1982 GB
2 104 393 Mar 1983 GB
2 191 032 Dec 1987 GB
2 195 544 Apr 1988 GB
2 267 936 Dec 1993 GB
2 272 745 May 1994 GB
2 301 040 Nov 1996 GB
2 348 928 Oct 2000 GB
2 414 187 Nov 2005 GB
61-055759 Apr 1986 JP
62-121670 Aug 1987 JP
04-050059 Apr 1992 JP
06-026891 Apr 1994 JP
WO 8602275 Apr 1986 WO
WO 8704354 Aug 1987 WO
WO 9010470 Sep 1990 WO
WO 9106334 May 1991 WO
WO 9204065 Mar 1992 WO
WO 9207600 May 1992 WO
WO 9209324 Jun 1992 WO
WO 9215353 Sep 1992 WO
WO 9217231 Oct 1992 WO
WO 9324167 Dec 1993 WO
WO 9411272 May 1994 WO
WO 9414492 Jul 1994 WO
WO 9534874 Dec 1995 WO
WO 9616686 Jun 1996 WO
WO 9616687 Jun 1996 WO
WO 9639337 Dec 1996 WO
WO 9712638 Apr 1997 WO
WO 9801822 Jan 1998 WO
WO 9856444 Dec 1998 WO
WO 9856445 Dec 1998 WO
WO 9936115 Jul 1999 WO
WO 9957019 Nov 1999 WO
WO 0009187 Feb 2000 WO
WO 0045884 Aug 2000 WO
WO 0059806 Oct 2000 WO
WO 0128887 Apr 2001 WO
WO 0129765 Apr 2001 WO
WO 0137909 May 2001 WO
WO 0178819 Oct 2001 WO
WO 02072183 Sep 2002 WO
WO 03013340 Feb 2003 WO
WO 03047674 Jun 2003 WO
WO 03101514 Dec 2003 WO
WO 03103759 Dec 2003 WO
WO 2004011071 Feb 2004 WO
WO 2004018026 Mar 2004 WO
WO 2004071549 Aug 2004 WO
WO 2004089451 Oct 2004 WO
WO 2006026237 Mar 2006 WO
WO 2006110080 Oct 2006 WO
WO 2006114699 Nov 2006 WO
WO 2007030162 Mar 2007 WO
WO 2008028092 Mar 2008 WO
WO 2008042912 Apr 2008 WO
Non-Patent Literature Citations (45)
Entry
Spirale DDS Product Information Sheet, Armstrong Medical, [online] [retrieved from the Internet: URL http://wwvv.amsorbplus.com/products/spirale/spirale-main.htm] [retrieved on Oct. 21, 2009], 1 page.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)—Clinical, “Guidance for Industry: Integration of Dose-Counting Mechanisms into MDI Drug Products—Draft Guidance,” dated Nov. 2001, 6 pages.
Extended European Search Report for European Application No. 09173845.0, dated Jun. 25, 2010, 18 pages.
Translation of Japanese Office Action from Japanese Application No. 2008019458, dated Sep. 29, 2009, 2 pages.
Office Action from counterpart Japanese Application No. 2008-189362, dated Jun. 14, 2011, 4 pages (with translation).
Office Action from co-pending U.S. Appl. No. 13/397,284, dated Sep. 6, 2012, 10 pages.
Amirav, I. et al., “Nebuliser hood compared to mask in wheezy infants: aerosol therapy without tears!,” Arch. Dis. Child, vol. 88, 2003, pp. 719-723.
Ballard, Julie et al., “A survey of albuterol administration practices in intubated patients in the neonatal intensive care unit,” Respiratory Care, Jan. 2002, 47(1), pp. 31-38.
Bambang, Sidarto Oetomo et al., “Surfactant Nebulization does not Alter Airflow Obstruction and Bronchial Responsiveness to Histamine in Asthmatic Children,” Am. J. Respir. Crit. Care Med., vol. 153, 1996, pp. 1148-1152.
Beck, Jennifer et al., “Prolonged Neural Expiratory Time Induced by Mechanical Ventilation in Infants,” Pediatric Research, vol. 55, No. 5, 2004, pp. 747-754.
Becquemin, M.H. et al., “Particle deposition and resistance in the nose of adults and children,” Eur. Respir. J., vol. 4, 1991, pp. 694-702.
Berggren, Acta Paediatr, Pilot study of nebulized surfactant therapy for neonatal respiratory distress syndrome, 2000, vol. 89, pp. 460-464.
Cheifetz, Ira M. MD, “Invasive and Noninvasive Pediatric Mechanical Ventilation,” Respiratory Care, vol. 48, No. 4, Apr. 2003, pp. 442-458.
Cole, Cynthia H., M.D., M.P.H., “The Use of Aerosolized Medicines in Neonates,” Neonatal Respiratory Diseases, vol. 10, No. 4; Associates in Medical Marketing Co., Inc., Newtown, PA.; 2000, 6 pages.
Dijk, P.H. et al., “Surfactant nebulisation: safety, efficiency and influence on surface lowering properties and biochemical composition,” Intensive Care Med., vol. 23, 1997, pp. 456-462.
Dolovich, M., “Influence of inspiratory flow rate, particle size, and airway caliber on aerosolized drug delivery to the lung,” Respiratory Care, 2000, vol. 45(6): pp. 597-608.
Dubus, Jean C. et al., “Aerosol Deposition in Neonatal Ventilation,” Pediatric Research, vol. 58, No. 1, 2005, pp. 10-14.
Fink, J.B. et al. “Device and equipment evaluations,” Respir. Care, 2004, 49(10), pp. 1157-1164.
Fink, James B., “Aerosol Delivery to Ventilated Infant and Pediatric Patients,” Respiratory Care, vol. 49, No. 6, Jun. 2004, pp. 653-665.
Fink, J.B. et al., “Can high efficiency aerosol delivery continue after extubation?” Critical Care, 2005, 9(Suppll ): p. P129.
Foust, Gregory N. et al., “Shortcomings of Using Two Jet Nebulizers in Tandem with an Aerosol Face Mask for Optimal Oxygen Therapy,” Chest, vol. 99, 1991, pp. 1346-1351.
Gaon, P. et al., “Assessment of effect of nasal continuous positive pressure on laryngeal opening using fibre optic laryngoscopy,” Arch. Dis. Child Fetal Neonatal Ed., vol. 80, 1999, pp. F230-F232.
Geller, David E. et al., “Efficiency of Pulmonary Administration of Tobramycin Solution for Inhalation in Cystic Fibrosis Using an Improved Drug Delivery System,” Chest, vol. 123, 2003, pp. 28-36.
Glasser, Stephan W. et al., “cDNA and deduced amino acid sequence of human pulmonary surfactant-associated proteolipid SPL(Phe),” Proc. Natl. Acad. Sci. USA, vol. 84, Biochemistry, Jun. 1987, pp. 4007-4011.
Hopp, Thomas P. et al., “Prediction of protein antigenic determinants from amino acid sequences,” Proc. Natl. Acad. Sci. USA, vol. 78, No. 6, Immunology, Jun. 1981, pp. 3824-3828.
Kattwinkel, John MD et al., “Technique for Intrapartum Administration of Surfactant without Requirement for an Endotracheal Tube,” Original Article, Journal of Perinatology, vol. 24, 2004, pp. 360-365.
Ma, Jingwen et al., “Effects of a Cationic and Hydrophobic Peptide, KL4, on Model Lung Surfactant Lipid Monolayers,” Biophysical Journal, vol. 74, Apr. 1998, pp. 1899-1907.
Richardson, C. et al., “Effect of continuous positive airway pressure on pulmonary function and blood gases of infants with respiratory distress syndrome,” Pedial. Res., 1978, vol. 12, pp. 771-774.
Rosenfeld, Warren N. et al., “Water intoxication: A complication of nebulization with nasal CPAP,” The Journal of Pediatrics, vol. 89, No. 1, Jul. 1976, pp. 113-114.
Salmon, B. et al., “How much aerosol reaches the lungs of wheezy infants and toddlers?,” Archives of Disease in Childhood, vol. 65, 1990, pp. 401-403.
Drs. Vibhuti Shah and Edmond Kelly, Mount Sinai Hospital, and Dr. Michael Dunn, Sunnybrook and Women's College Health Sciences Center, “A Dose-ranging study to assess the effect of inhaled corticosteroids in ventilated preterm neonates.,” published prior to at least Oct. 22, 2009, 27 pages.
Smedsaas-Löfvenberg A. et al., “Nebulization of drugs in a nasal CPAP system,” Acta. Pediatr., vol. 88, 1999, pp. 89-92.
Nguyen, Tung et al., “Generation and Characterization of Soft-Mist Aerosols from Aqueous Formulations Using the Capillary Aerosol Generator,” J. Aerosol Med., vol. 16(2), Poster Presentations, Therapeutic Aerosols, Jul. 2004, p. 189.
Thomson, Merran A. et al., “Treatment of Immature Baboons for 28 Days with Early Nasal Continuous Positive Airway Pressure,” Am. J. Respir. Crit. Care Med., vol. 169, 2004, pp. 1054-1062.
Trevisanuto, Daniele et al., “Laryngeal Mask Airway Used as a Delivery Conduit for the Administration of Surfactant to Preterm Infants with Respiratory Distress Syndrome,” Biology of the Neonate, vol. 87, 2005, pp. 217-220.
Verder, Henrik et al., “Surfactant Therapy and Nasal Continuous Positive Airway Pressure for Newborns with Respiratory Distress Syndrome,” Danish-Swedish Multicenter Study Group, N. Eng. J. Med., vol. 331, No. 6, 1994, pp. 1051-1055.
Verder, Henrik et al., “Nasal Continuous Positive Airway Pressure and Early Surfactant Therapy for Respiratory Distress Syndrome in Newborns of Less Than 30 Weeks' Gestation,” Pediatrics, Official Journal of the American Academy of Pediatrics, vol. 103(2), 1999, pp. 1-6.
International Search Report for International Application No. PCT/IB2004/000333 filed Feb. 10, 2004, 8 pages.
Written Opinion of the International Searching Authority for International Application No. PCT/IB2004/000333 filed Feb. 10, 2004, 9 pages.
International Search Report for International Application No. PCT/IB2006/001027, dated Sep. 21, 2006, 6 pages.
Written Opinion of the International Searching Authority for International Application No. PCT/IB2006/001027, dated Sep. 21, 2006, 8 pages.
International Search Report and Written Opinion of the International Searching Authority for International Application No. PCT/US2009/037409, dated May 12, 2009, 6 pages.
International Preliminary Report on Patentability for International Application No. PCT/US2009/037409, dated Sep. 21, 2010, 6 pages.
Final Office Action for U.S. Appl. No. 10/774,751, dated Jun. 24, 2009, 8 pages.
Reply to Oct. 6, 2008 Office Action filed Jan. 5, 2009 for U.S. Appl. No. 10/774,751, 14 pages.
Related Publications (1)
Number Date Country
20140130795 A1 May 2014 US
Provisional Applications (1)
Number Date Country
61107435 Oct 2008 US
Continuations (1)
Number Date Country
Parent 12603700 Oct 2009 US
Child 14074432 US