Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas
Reexamination Certificate
2001-09-10
2003-11-11
Lo, Weilun (Department: 3761)
Surgery
Respiratory method or device
Means for mixing treating agent with respiratory gas
C128S203120, C128S203150, C128S203280, C604S058000, C604S187000, C604S200000, C604S244000
Reexamination Certificate
active
06644309
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to medicament respiratory delivery devices, including pulmonary, intranasal and buccal respiratory delivery devices, which releases and delivers on demand a controlled unit dose of aerosolized medicament to the respiratory system of a patient and method of delivery.
BACKGROUND OF THE INVENTION
Inhalers and atomizers are now commonly used primarily to deliver various liquid medicaments via the patient's or user's nose or mouth. As used herein, “medicament” includes any powder or liquid medicament, drug or vaccine or combinations thereof which may be administered from an respiratory delivery device through the user's nose or mouth, sometimes referred to herein as a medicament respiratory delivery device. More recently, the prior art has proposed unit dose disposable powder medicament delivery devices, such as disclosed in U.S. Pat. No. 5,215,221, wherein a predetermined quantity or unit dose of a powder medicament is sealed in a reservoir formed between opposed thermoplastic sheets and expressed or delivered by application of manual force to a thermoformed blister which, upon activation, breaks a burstable seal between the sheets at the entrance to the reservoir and fluidizes the powder medicament in the reservoir through a delivery tube. The sealed delivery tube is cut prior to use.
There are several considerations affecting the design and efficacy of medicament respiratory delivery devices. First, it is important to ensure that a predetermined quantity or dose of medicament is consistently delivered to the user with each application. Second, because respiratory therapy often requires numerous applications, the cost of providing the dosage should also be considered. Thus, it is desirable that the medicament respiratory delivery device consistently express substantially all of the medicament to the user and that the delivery device is not susceptible to user error in operation. Third, it is important that the medicament be properly disbursed or entrained in the conveying fluid. Further considerations include the operating complexity, cost of the device, portability and size of the delivery device. It would also be desirable in certain applications to provide a reusable delivery device with a disposable standard medicament cartridge containing a unit dose of medicament which can be easily handled and replaced in the delivery device by the user without error. In other applications, a disposable delivery device is desirable.
Further, it would be desirable for a respiratory delivery device to deliver a controlled unit dose of an aerosolized medicament on demand. That is, it would be desirable to be able to charge or pressurize the medicament respiratory delivery device prior to use, such that the patient does not have to simultaneously manipulate the pressure delivery means, as by compressing a bulb or syringe, with the mouth or nosepiece in the patient's mouth or nose, while inhaling the aerosolized medicament. This can be difficult for some patients to accomplish and may result in poor or partial delivery of the medicament.
The medicament respiratory delivery device of this invention provides a reproducible, high level of clearance of medicament or emitted dose from a replaceable cartridge, wherein a manually actuatable fluid pressure delivery device may be charged prior to use and then released on demand to deliver a controlled unit dose of an aerosolized medicament to the respiratory system of the patient.
SUMMARY OF THE INVENTION
As set forth above, the medicament respiratory delivery device of this invention may be utilized for pulmonary, intranasal, and buccal respiratory delivery of medicaments, drugs or vaccines and various combinations thereof. The medicament respiratory delivery device of this invention includes a medicament housing including a chamber having a chamber inlet and preferably a generally coaxially aligned chamber outlet, a medicament cartridge is preferably located within the housing chamber having opposed ends, a passage through the cartridge through the opposed ends generally coaxially aligned with the chamber inlet and outlet of the housing, a medicament in the cartridge passage and a burstable membrane sealing the passage preferably at both ends of the cartridge having a burst pressure of less than 10 atmospheres. The medicament respiratory delivery device further includes a manually actuatable fluid delivery device having an outlet in fluid communication with the chamber inlet for delivery of fluid under pressure to the chamber and a valve located between the outlet of the fluid delivery device and the chamber inlet including a valve inlet in fluid communication with the outlet of the fluid delivery device and an outlet in fluid communication with the chamber inlet of the medicament housing.
Upon actuation of the manually actuatable fluid delivery device, fluid is delivered under pressure to the valve, thereby charging the medicament respiratory delivery device for use. Then, upon opening of the valve, fluid is delivered under pressure to the inlet of the chamber containing the cartridge, thereby rupturing the burstable membranes of the cartridge and expressing the medicament through the chamber outlet. In the preferred embodiment, the manually actuatable fluid delivery device is actuatable to maintain the fluid pressure at the outlet, prior to opening of the valve, to permit the user to release the manually actuatable fluid delivery device and insert the housing outlet into the nose or mouth.
The medicament respiratory delivery device of this invention thereby separates the charging or pressurizing function from the use function. That is, the medicament aerosol delivery device of this invention may be utilized by a patient to first “arm” or pressurize the valve inlet and then deliver fluid under pressure to the housing chamber containing the cartridge by opening the valve. Thus, for example, the patient may first arm the medicament respiratory delivery device of this invention by manipulating the pressure delivery device to pressurize a chamber at the valve inlet, then turn the device to receive the mouthpiece or nosepiece in the user's mouth or nose and then open the valve to deliver a controlled unit dose of an aerosolized medicament to the respiratory system of the patient through the nose or mouth. This simplifies the operation and use of the device to minimize user error and consistently deliver a predetermined quantity or dose of medicament to the patient's respiratory system.
As will be understood by those skilled in this art, various fluid delivery devices and valves may be utilized in the medicament respiratory delivery device of this invention. For example, the fluid delivery device may include a collapsible bulb which communicates with a pressure chamber through a one way valve having an outlet in communication with the valve inlet. However, in a preferred embodiment of the medicament respiratory delivery device of this invention disclosed herein, the manually actuatable fluid delivery device includes a tubular pressure member having an outlet and a plunger or stopper received in the tubular pressure member in sealed relation which is manually reciprocable in the tubular pressure member toward the pressure member outlet. The manually actuatable fluid delivery device may be a conventional syringe preferably having finger grips and a plunger and stopper assembly, such that the patient can hold the barrel and manipulate the plunger with the patient's thumb. Thus, upon movement of the plunger, the stopper is moved in sealed relation toward the syringe outlet, pressurizing the fluid, preferably air, at the syringe outlet. Opening of the valve at the pressure member outlet thus releases or expresses the fluid into the housing chamber containing the cartridge, rupturing the burstable membrane and delivering the medicament to the outlet of the housing as described. In the preferred embodiment, the plunger and stopper assembly and tubular barrel include cooperative stop
Casper Robert A.
Gardner David L.
Knors Christopher J.
Monahan Lawrence A.
Snow John M.
Becton Dickinson and Company
Lo Weilun
Mendoza Michael
West Robert E.
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