HK1217664B - An indexed drug containment device assembly for a drug delivery and regulation device and an indexed drug delivery system - Google Patents

Abstract

An indexed drug delivery device (70) comprising a valve assembly (13) comprising a housing (26) and a valve, the valve disposed within the housing, one or more keys (34,38) integral to the housing, the keys complementary to corresponding openings on a collar (12), a pressurized canister (28) in fluid communication with the valve assembly, the canister containing an active pharmaceutical ingredient and an inactive carrier gas, a receiving assembly comprising a receptacle adapted to engage at least a portion of the housing, a seat adapted to engage the valve, and, a plunger assembly adapted to linearly actuate the valve assembly and canister along an axis and to engage the valve and seat, the plunger assembly comprising a carriage fixed to the collar, and, a lever having a cam adapted to engage a spring, the spring adapted to linearly actuate the carriage, valve assembly, canister and collar along the axis.

Description

Indexed drug containment device assembly for drug delivery adjustment device and indexed drug delivery system

The present application is a divisional application of a patent application having an application date of 2009, 27/5, No. 200980159463.X entitled "device and method for engaging an indexing valve and a pressurized cartridge assembly with a collar and linearly actuating a fluid communication with a device for regulating drug delivery by a plunger assembly.

Background

Various key and cylinder actuators or cylinder actuators are known. In the art relating to inhalation of medication from a pressurized cylinder, the cylinder is too large and not easily portable. The cylinder is also not protected from the hospital environment, which is in fact very severe. The connection between the cylinder and the adjusting device is very cumbersome.

However, perhaps the most important drawback is the risk of connecting a cylinder containing an unsuitable, wrong or inappropriate drug and/or medicament concentration to the adjustment means.

It would therefore be beneficial to provide an improved connection of a cylinder to a regulating means, an improved protection of a cylinder, a means of enhanced portability of a cylinder and a method for ensuring that a cylinder containing the correct drug and medicament concentration is connected to a drug delivery regulating means.

Summary of The Invention

One aspect of the invention is an indexing valve assembly comprising a housing and a valve, the valve being disposed within the housing, and the indexing valve assembly comprising a first indexing member integrally formed with the housing, the first indexing member being adapted to be complementary to a second indexing member.

In an exemplary embodiment of the graduated valve assembly, the assembly further comprises a third indexing member which may be integrally formed with the assembly, the third indexing member being adapted to be complementary to a fourth indexing member, the first indexing member being non-complementary to the fourth indexing member and the third indexing member being non-complementary to the second indexing member.

In another exemplary embodiment of the indexing valve assembly, the assembly further comprises a plurality of indexing members, each indexing member being adapted to be complementary to and non-complementary to a corresponding indexing member.

In another exemplary embodiment of the indexing valve assembly, the one or more indexing members are predetermined adapted to indicate the identity and cartridge concentration of an Active Pharmaceutical Ingredient (API).

In another exemplary embodiment of the indexing valve assembly, the API comprises nitric oxide and the cartridge concentration is in the range of about 50ppm or 100ppm to 800ppm, 2400ppm, 2500ppm, or 10,000 ppm. Concentrations herein may also be expressed in mg/L, so the conversion relationship is about 12mg/L per 10,000 ppm.

In another exemplary embodiment of the indexing valve assembly, the indexing member is further predetermined adapted to represent an initial volume of about 32L of compressible gas or 0.16L of liquid.

In another exemplary embodiment of the indexing valve assembly, the API comprises carbon monoxide, and the cartridge concentration is in the range of about 500ppm or 3000ppm to 5000ppm, 10,000ppm, 15,000ppm, or 20,000 ppm.

In another exemplary embodiment of the indexing valve assembly, the API comprises a chalcogenide compound.

In another exemplary embodiment of the indexing valve assembly, the valve is a spring biased needle valve.

In another exemplary embodiment of the indexing valve assembly, the first indexing member or the second indexing member is a keyway.

In another exemplary embodiment of the indexing valve assembly, the keyway is a tongue, a fork, a post, a ridge, a protrusion, or a cross-bar.

In another exemplary embodiment of the indexing valve assembly, the first indexing member or the second indexing member is an opening.

In another exemplary embodiment of the indexing valve assembly, the opening is a groove, slit, channel, aperture or hole.

In another exemplary embodiment of the indexing valve assembly, the first indexing member is an opening, the second indexing member is a keyway, the third indexing member is an opening and the fourth indexing member is a keyway.

In another exemplary embodiment of the indexing valve assembly, the first indexing member is a slit, the second indexing member is a cross-bar, the third indexing member is a slit, and the fourth indexing member is a cross-bar.

Another aspect of the present invention is a graduated drug containment device for inhalation comprising: a valve assembly comprising a housing and a valve disposed within the housing; a first indexing member, which may be integrally formed, adapted to be complementary to a second indexing member; and a cartridge in fluid communication with the valve assembly, the cartridge housing the API and the inactive carrier gas.

In an exemplary embodiment of the indexed drug containment device, the device further comprises a third indexing member integrally formed with said housing, said third indexing member being adapted to be complementary to a fourth indexing member, said first indexing member being non-complementary to said fourth indexing member, and said third indexing member being non-complementary to said second indexing member.

In another exemplary embodiment of the indexed drug containment device, the device further comprises a plurality of indexing members, each indexing member being adapted to be complementary to and non-complementary to a corresponding indexing member.

In another exemplary embodiment of the indexed drug containment device, the one or more indexing members are predetermined adapted to represent the identity of the API and the cartridge concentration.

In another embodiment of the indexed medicament containment deviceIn an exemplary embodiment, the API comprises nitric oxide and the inactive carrier gas comprises nitrogen (N)₂) And the cartridge concentration is in the range of about 50ppm or 100ppm to 800ppm, 2400ppm, 2500ppm, or 10,000 ppm.

In another exemplary embodiment of the indexed drug containment device, the indexing feature is further predetermined adapted to represent an initial volume of about 32L of compressible gas or 0.16L of liquid.

In another exemplary embodiment of the indexed drug containment device, the API comprises carbon monoxide and the inactive carrier gas comprises oxygen (O)₂) And optionally N₂The cylinder concentration is in the range of about 500ppm or 3000ppm to 5000ppm, 10,000ppm, 15,000ppm or 20,000 ppm.

In another exemplary embodiment, the carrier gas comprises about 30% O₂And 70% of N₂。

In another exemplary embodiment of the indexed drug containment device, the API comprises a chalcogenide compound at an appropriate concentration.

In another exemplary embodiment of the indexed drug containment device, the valve is a spring biased needle valve.

In another exemplary embodiment of the indexed drug containment device, the first or second indexing member is a key slot.

In another exemplary embodiment of the indexed drug containment device, the keyway is a tongue, a prong, a post, a ridge, a protrusion, or a cross-bar.

In another exemplary embodiment of the indexed drug containment device, the first indexing member or the second indexing member is an opening.

In another exemplary embodiment of the indexed drug containment device, the opening is a groove, slit, channel, aperture or hole.

In another exemplary embodiment of the indexed drug containment device, the first indexing member is an opening, the second indexing member is a keyway, the third indexing member is an opening and the fourth indexing member is a keyway.

In another exemplary embodiment of the indexed drug containment device, the first indexing member is a slit, the second indexing member is a crossbar, the third indexing member is a slit, and the fourth indexing member is a crossbar.

Another aspect of the invention is an indexed drug actuation device comprising: a valve assembly comprising a housing and a valve disposed within the housing; a first indexing member integrally formed with the housing, the first indexing member being adapted to be complementary to a second indexing member; a cartridge in fluid communication with the valve assembly, the cartridge housing an API and an inactive carrier gas; and a collar including a second indexing member integrally formed with the collar.

In an exemplary embodiment of the indexed drug actuation device, the device further comprises a third indexing member integrally formed with the housing and a fourth indexing member integrally formed with the collar, the third indexing member being adapted to be complementary to the fourth indexing member, the first indexing member being non-complementary to the fourth indexing member, the third indexing member being non-complementary to the second indexing member.

In an exemplary embodiment of the indexed drug actuation device, the device further comprises a plurality of indexing members, each indexing member being adapted to be complementary to and non-complementary to a corresponding indexing member.

In an exemplary embodiment of the indexed drug actuation device, the one or more indexing members are predetermined adapted to represent the identity of the API and the cartridge strength.

In an exemplary embodiment of the indexed drug actuation device, the API comprises nitric oxide and the inactive carrier gas comprises N₂Cartridge concentrations range from about 50ppm or 100ppm to 800ppm, 2400ppm, 2500ppm, or 10,000 ppm.

In an exemplary embodiment of the indexed drug actuation device, the indexing member is further pre-determined adapted to represent an initial volume of about 32L of compressible gas or 0.16L of liquid.

In an exemplary embodiment of the indexed drug actuation device, the API comprises carbon monoxide and the inactive carrier gas comprises O₂Optionally balancing the gas to include N₂Cartridge concentrations range from about 500ppm or 3000ppm to 5000ppm, 10,000ppm, 15,000ppm, or 20,000 ppm.

In another exemplary embodiment of the indexed drug actuation device, the API comprises a chalcogenide compound.

In another exemplary embodiment of the indexed drug actuation device, the valve is a spring biased needle valve.

In another exemplary embodiment of the indexed drug actuation device, the first or second indexing member is a key slot.

In another exemplary embodiment of the indexed drug actuation device, the key is a tongue, a fork, a post, a ridge, a protrusion or a cross-bar.

In another exemplary embodiment of the indexed drug actuation device, the first indexing member or the second indexing member is an opening.

In another exemplary embodiment of the indexed drug actuation device, the opening is a groove, slit, channel, aperture or hole.

In another exemplary embodiment of the indexed drug actuation device, the first indexing member is an opening, the second indexing member is a key slot, the third indexing member is an opening and the fourth indexing member is a key slot.

In another exemplary embodiment of the indexed drug actuation device, the first indexing member is a slit, the second indexing member is a crossbar, the third indexing member is a slit, and the fourth indexing member is a crossbar.

Another aspect of the invention is an indexed drug delivery device comprising: a valve assembly comprising a housing and a valve disposed within the housing; a first indexing member integrally formed with the housing, the first indexing member being adapted to be complementary to the second indexing member; a cartridge in fluid communication with the valve assembly, the cartridge containing an active pharmaceutical ingredient and an inactive carrier gas; a collar comprising a second indexing member integrally formed with the collar; a receiver assembly including a receptacle adapted to engage at least a portion of the housing and a valve seat adapted to engage the valve; and a plunger assembly linearly actuating the valve assembly and the barrel along an axis and engaging the valve and the valve seat, the plunger assembly including a carriage fixed with a collar and a lever having a cam adapted to engage a spring adapted to linearly actuate the carriage, valve assembly, barrel and collar along the axis.

In an exemplary embodiment of the indexed drug delivery device, the device further comprises a third indexing member integrally formed with the housing and a fourth indexing member integrally formed with the collar, the third indexing member being adapted to be complementary to the fourth indexing member, the first indexing member being non-complementary to the fourth indexing member, the third indexing member being non-complementary to the second indexing member.

In another exemplary embodiment of the indexed drug delivery device, the device further comprises a plurality of indexing members, each indexing member being adapted to be complementary to and non-complementary to a corresponding indexing member.

In another exemplary embodiment of the indexed drug delivery device, the one or more indexing members are predetermined adapted to represent the identity of the API and the cartridge concentration.

In another exemplary embodiment of the indexed drug delivery device, the API comprises nitric oxide and the carrier gas comprises N₂Cartridge concentrations range from about 50ppm or 100ppm to 800ppm, 2400ppm, 2500ppm, or 10,000 ppm.

In another exemplary embodiment of the indexed drug delivery device, the indexing member is further pre-determined adapted to represent an initial volume of about 32L of compressible gas or 0.16L of liquid.

In another exemplary embodiment of the indexed drug delivery device, the API comprises carbon monoxide and the inactive carrier gas comprises O₂Optionally balancing the gas to include N₂Cartridge concentrations range from about 500ppm or 3000ppm to 5000ppm, 10,000ppm, 15,000ppm, or 20,000 ppm.

In another exemplary embodiment of the indexed drug delivery device, the API comprises a chalcogenide compound.

In another exemplary embodiment of the indexed drug delivery device, the valve is a spring biased needle valve.

In another exemplary embodiment of the indexed drug delivery device, the first or second indexing member is a key slot.

In another exemplary embodiment of the indexed drug delivery device, the keyway is a tongue, a prong, a post, a ridge, a protrusion, or a cross-bar.

In another exemplary embodiment of the indexed drug delivery device, the first or second indexing member is an opening.

In another exemplary embodiment of the indexed drug delivery device, the opening is a groove, slit, channel, aperture or hole.

In another exemplary embodiment of the indexed drug delivery device, the first indexing member is an opening, the second indexing member is a keyway, the third indexing member is an opening and the fourth indexing member is a keyway.

In another exemplary embodiment of the indexed drug delivery device, the first indexing member is a slit, the second indexing member is a crossbar, the third indexing member is a slit and the fourth indexing member is a crossbar.

In another exemplary embodiment of the indexed drug delivery device, the cam is adapted to engage the compression spring, and the compression spring is adapted to engage the carriage.

Another aspect of the invention is a valve assembly comprising a housing and a valve disposed within the housing, the valve assembly comprising a radio frequency identification device adapted to communicate with a radio frequency receiver.

Another aspect of the present invention is a pressurized medicament containment device for inhalation comprising: a valve assembly comprising a housing and a valve disposed within the housing; a radio frequency identification device adapted to communicate with a radio frequency receiver; and a cartridge in fluid communication with the valve assembly, the cartridge housing an API and an inactive carrier gas.

Another aspect is a method of engaging the pressurized medicament containing cartridge described above, comprising linearly actuating the medicament containing device described above along an axis to engage the receptacle and engage the valve with the valve seat.

Another aspect of the invention is a method of engaging a pressurized cartridge comprising linearly actuating an indexed drug containing pressurized cartridge along an axis to engage a receptacle and engage a valve with a valve seat.

Another aspect of the invention is a method of engaging a pressurized cartridge comprising linearly actuating an indexed pressurized cartridge along an axis to engage a receiver and engage a valve with a valve seat.

Another aspect of the invention is a drug delivery device for regulating API delivery to a patient, comprising: a valve assembly comprising a housing and a valve disposed within the housing; a first indexing member integrally formed with the housing, the first indexing member being adapted to be complementary to the second indexing member; a cartridge in fluid communication with the valve assembly, the cartridge housing an API and an inactive carrier gas; a collar comprising a second indexing member integrally formed with the collar; a receiver assembly including a receptacle adapted to engage at least a portion of the housing and a valve seat adapted to engage the valve; a plunger assembly adapted to linearly actuate the valve assembly and the barrel along an axis to engage the valve and the valve seat, the plunger assembly including a carriage fixed with a collar and a lever having a cam adapted to engage a spring adapted to linearly actuate the carriage, the valve assembly, the barrel and the collar along the axis; and a controllable drug delivery regulating device adapted to regulate the delivery of the API to the patient.

In an exemplary embodiment of the drug delivery device, the device further comprises a third indexing member integrally formed with the housing and a fourth indexing member integrally formed with the collar, the third indexing member being adapted to be complementary to the fourth indexing member, the first indexing member being non-complementary to the fourth indexing member, the third indexing member being non-complementary to the second indexing member.

In another exemplary embodiment of the drug delivery device, the device further comprises a plurality of indexing members, each indexing member being adapted to be complementary to and non-complementary to a corresponding indexing member.

In another exemplary embodiment of the drug delivery device, the one or more indexing members are predetermined adapted to represent the identity of the API and the cartridge concentration.

In another exemplary embodiment of the drug delivery device, the API comprises nitric oxide, the inactive carrier gas comprises N2, and the cartridge concentration is in a range of about 50ppm or 100ppm to 800ppm, 2400ppm, 2500ppm, or 10,000 ppm.

In another exemplary embodiment of the drug delivery device, the index member is further predetermined adapted to represent an initial volume of about 32L of compressible gas or 0.16L of liquid.

In another exemplary embodiment of the drug delivery device, the API comprises carbon monoxide and the inactive carrier gas comprises O₂Optionally balancing the gas to include N₂Cartridge concentrations range from about 500ppm or 3000ppm to 5000ppm, 10,000ppm, 15,000ppm, or 20,000 ppm.

In another exemplary embodiment of the drug delivery device, the API comprises a chalcogenide compound.

In another exemplary embodiment of the drug delivery device, the valve is a spring biased needle valve.

In another exemplary embodiment of the drug delivery device, the first indexing member or the second indexing member is a keyway.

In another exemplary embodiment of the drug delivery device, the keyway is a tongue, a fork, a post, a ridge, a protrusion or a cross-bar.

In another exemplary embodiment of the drug delivery device, the first index member or the second index member is an opening.

In another exemplary embodiment of the drug delivery device, the opening is a groove, slit, channel, aperture or hole.

In another exemplary embodiment of the drug delivery device, the first indexing member is an opening, the second indexing member is a keyway, the third indexing member is an opening and the fourth indexing member is a keyway.

In another exemplary embodiment of the drug delivery device, the first indexing member is a slit, the second indexing member is a cross bar and the third indexing member is a slit, wherein the indexing member is a cross bar.

In another exemplary embodiment of the drug delivery device, the cam is adapted to engage a compression spring, said compression spring being adapted to engage the carriage.

Another aspect of the invention is a method for producing pulmonary vasodilation in a patient's body in need thereof, comprising: providing any one of the above drug delivery devices for delivering nitric oxide; and delivering a controlled and adjusted dose of the pharmaceutical agent or nitric oxide to the patient.

Another aspect of the invention is a method of treating a disease or condition selected from the group consisting of: the outcome of an organ transplant, delayed pattern function associated with organ transplantation, cystic fibrosis, ileus, necrotizing enterocolitis, vascular restenosis, hepatitis, acute liver failure associated with hepatitis and hemorrhagic shock, the method comprising: there is provided any of the above drug delivery devices for delivering a controlled and adjusted dose of medicament or carbon monoxide to a patient.

Another aspect of the present invention is a drug delivery device for regulating API delivery to a patient, comprising: a receptacle assembly comprising a receptacle adapted to engage at least a portion of an indexed drug containment device and a valve seat adapted to engage a valve of the indexed drug containment device; a plunger assembly adapted to linearly actuate the valve assembly and the barrel along an axis and engage the valve and the valve seat, the plunger assembly including a carriage fixed with a collar and a lever having a cam adapted to engage a spring adapted to linearly actuate the carriage, the valve assembly, the barrel and the collar along the axis; and a controllable drug delivery regulating device adapted to regulate the delivery of the API to the patient.

Drawings

FIG. 1 shows a partial perspective view of a collar cartridge assembly.

Fig. 2 shows a partial front view of several sets illustrating the interface between the collar and the cartridge.

FIG. 3 shows a side cross-sectional view of the collar cartridge assembly of FIG. 1 illustrating the receiver prior to engaging the assembly.

FIG. 4 shows a side cross-sectional view of the collar cartridge assembly of FIG. 1 illustrating a receptacle of the engagement assembly.

FIG. 5 illustrates a partial perspective view of a collar cartridge assembly including a radio frequency identification device.

Fig. 6 shows a partial cross-sectional front view of a collar cartridge assembly located in a pressurized gas drug delivery device. Fig. 6 also shows the lid and lever of the delivery device in an open position.

Fig. 7 shows a partial cross-sectional front view of a collar cartridge assembly located in a pressurized gas drug delivery device. Figure 7 also shows the lid and lever of the delivery device in the working position.

Fig. 8 is a perspective view of a pressurized gas drug delivery device including a collar cartridge assembly.

Detailed Description

Embodiments and aspects of the invention described herein may be used to deliver drug gases to a patient in need of treatment for a variety of diseases or conditions. For example, the drug delivery devices described herein may be used to deliver nitric oxide to a patient for the treatment of reversible pulmonary hypertension as described in U.S. patent nos. ("USPN") 5,873,359 and 5,485,827, or sickle cell disease as described in USPN 5,885,621, which are incorporated herein by reference in their entirety.

Additionally, the drug delivery devices described herein may be used to deliver carbon monoxide to a patient for the treatment of the following diseases: organ transplant results as described in U.S. patent application serial No. (USSN ") 11/401,722(US 2007/02020083); cystic fibrosis as described in USSN 10/053,535(US 2002/0155166); ileus as described in USSN 10/371,666(US 2003/0219497); necrotizing enterocolitis as described in USSN 10/413,817(US 2004/0005367); vascular diseases including restenosis of blood vessels as described in USSN 10/367,277(US 2003/0219496) and 12/050,826(US 2008/0167609); or hepatitis including acute liver failure as described in USSN 10/439,632(US 2004/0052866), the entire contents of which are incorporated herein by reference.

The term "keyway" (and variations thereof) as used herein refers to a structure adapted to engage a corresponding opening such as a tongue, prong, post, rail, ridge or protrusion.

Thus, the term "opening" (and variations thereof) as used herein refers to a structure defined by one or more adjacent or surrounding structures adapted to engage a keyway, such as a slit, groove, channel, aperture or hole.

The term "member" (and variations thereof) as used herein includes both keyways and openings.

The term "indexing" (and variations thereof) as used herein means that one or more members are designed to predestinably represent the identity and/or medicament concentration of an API.

The term "complementary" (and variations thereof) as used herein means that the indexing members and corresponding indexing members engage to form an interface, and thus are sufficiently actuatable when engaged, that the interface is flush.

The term "non-complementary" (and variations thereof) as used herein means that the two indexing members are not complementary.

The term "interface" (and variations thereof) as used herein refers to the flush surfaces of two complementary indexing members.

Fig. 1 shows an indexed drug actuation device 10 for indexing a drug delivery adjustment device 70 (fig. 8). The indexing drug actuation device 10 provides an indexing feature that allows a particular drug delivery device to formulate a predetermined concentration of an API contained in a pharmaceutically inactive carrier gas. The indexing device 10 comprises a collar 12 and an indexing medicament containing device 24. The device 24 comprises an indexing valve assembly 13 in threaded connection with a barrel 28.

In an exemplary embodiment, the indexing device 10 is adapted for inhalation(nitric oxide) (SPC-0303V:3.0) to contain 100ppm or 800ppm nitric oxide, the instrument being incorporated by reference in its entirety. The device may also be used with nitric oxide at higher concentrations, such as 2400ppmIn combination with other formations. For example, the indexing features may only allow engagement of a device 10 containing nitric oxide and/or a particular concentration of nitric oxide.

The API may be carbon monoxide, nitric oxide or a chalcogenide compound. The API concentration may be any concentration within the range of 100ppm to 15,000 ppm. The non-reactive carrier gas may include O₂、N₂And/or appropriate inactivity of the additional agentAnd (4) a carrier gas. The cartridge 28 may have sufficient capacity to store 30L to 35L at pressures in the range of 2000psig to 3000 psig. Other sized cartridges having different pressures and capacities may also be used.

As shown in fig. 1, the indexing drug actuation device 10 includes a collar 12 configured to transversely engage a valve housing 26 of the indexing valve assembly 13. The collar 12 is generally U-shaped and includes a first arm member 14 and a second arm member 16. The collar 12 transversely engages the housing 26. The inner faces of the first and second arm members 14, 16 include first and second collar keyways 18, 20, respectively. The first and second collar keyways 18, 20 are elongated in the transverse direction 19 to provide a crossbar structure.

The term "transverse direction" (and variations thereof, such as "transversely") as used herein refers to the direction in which the indexing valve assembly 13 can be engaged and disengaged from the collar 12, i.e., the direction perpendicular to the longitudinal axis 21.

The term "longitudinal axis" (and variations thereof, such as the abbreviated "axial") as used herein refers to an axis that is longitudinally aligned with the barrel 28.

The first and second collar keyways 18, 20 may have different shapes (e.g., cross-sectional shapes, axial positions, axial widths, or orientations) in order to provide indexing features and functions. Other shapes, arrangements, configurations and combinations of collar keyways 18, 20 will be described in detail below. The first and second collar keyways 18, 20 also provide an arcuate keyway 22 between the first and second arms 14, 16, which also provides indexing for API identification.

The side of the valve housing 26 also includes structure that engages the collar splines 18, 20. Specifically, a side face of valve housing 26 includes an upper key land 34 extending outwardly in radial direction 29 relative to a first valve opening 36 that receives first collar keyway 18.

The term "radial direction" (and variations thereof, such as "radial") as used herein refers to a direction perpendicular to longitudinal axis 21.

The term "radially inward" (and variations thereof) refers to a direction toward longitudinal axis 21 in a radial direction.

The term "radially outward" (and variations thereof) refers to a direction radially away from longitudinal axis 21.

The first valve opening 36 may also engage portions of the arcuate keyway 22. The side of the valve housing 26 also includes a lower key land 38 longitudinally opposite the upper key way ridge 34, which extends radially outward relative to the first valve opening 36.

As shown in fig. 1, 3 and 4, the opposite side of the valve housing 26 also includes upper and lower keyway ridges 34, 38 that extend radially outward relative to the second valve opening 36'. The second valve opening 36' receives the second collar keyway 20. Valve openings 36, 36' are complementary to collar splines 18, 20, respectively.

The valve openings 36, 36' and collar keyways 18, 20 have a rectangular cross-section. However, other cross-sectional shapes may be used, such as semi-circular, triangular, trapezoidal, pentagonal, etc.

Alternatively, the cross-sectional shapes of a set of indexing members 18, 36 and 20/36' may be different from one another. For example, the indexing members 18, 36 may have a rectangular cross-section, while the indexing members 20, 36' may have a trapezoidal cross-section. The cross-sectional shape and/or other structural features of one set of indexing members 18, 36 and 20, 36' provide the aforementioned indexing of API and/or medicament concentration.

As a result, the indexing collar 12 only engages the indexing drug containment device 24, thus indexing provides a fully complementary member that is identified for a predetermined API and/or medicament concentration. The cross-sectional shape and/or other structural features of the set of indexing members 18, 36 and 20, 36' may also provide non-complementary indexing members on the collar 12 and valve housing 26 when the valve housing is rotated 180 degrees relative to the collar 12. That is, the first collar keyway 18 is non-complementary to the second valve opening 36' and the second collar keyway 20 is non-complementary to the first valve opening 36, such that the cartridge 28 can only be inserted one way into the collar 12. The relief valve 32 including the relief outlet 33 may also provide structure to prevent improper engagement of the collar 12 and the valve housing 26. Even if the relief valve 32 is not provided, if the valve housing does not have an opening at the relief valve position that allows the arcuate keyway of the collar to mate with the opening, the valve housing may not be fully engaged with the collar.

The valve housing 26 may also include additional splines and the collar 12 may include additional openings. The valve housing 26 and the collar 12 may each include one or more keyways and one or more openings. The collar 12 may include different types of keyways. The valve housing 26 may include different types of openings. For example, rather than including the arcuate keyways 22, the collar 12 may include a cross-bar along the first and second arms 14, 16 and one or more posts. The valve housing 26 may include a slot to receive the cross-bar and one or more apertures to receive the post.

As shown in fig. 1, 3 and 4, the collar 12 engages the valve housing 26. The valve housing 26 includes a first end defining an inlet 27. The valve housing 26 threadably engages the neck 30 of the cartridge 28. The barrel 28 is aligned along the longitudinal axis 21. Alternatively, the valve housing 26 may communicate with the barrel 28 through a conduit or hose (not shown).

The connection between the valve housing 26 and the canister 28 also includes an o-ring 31 (see fig. 3 and 4) adapted to prevent leakage of API and carrier gas from the canister 28. The valve housing 26 also includes an optional relief valve 32 threaded into the valve housing 26. The pressure relief valve 32 includes a pressure relief outlet 33. The pressure relief valve 32 may be any suitable valve known in the art that prevents over-pressurization of the contents of the canister 28 due to high temperatures, for example, due to a fire or overfill of the canister during production.

As shown in fig. 2, indexing features corresponding to the API's identification and/or medicament concentration may be provided by one or more of different axial widths, axial juxtapositions, different cross-sectional shapes, etc. of the interfaces 18/36 and 20/36'.

The term "axially juxtaposed" as used herein means that the midplanes of the ports 18/36 and 20/36' are offset (i.e., not aligned).

The term "midplane" (and variations thereof) as used herein refers to a plane perpendicular to the longitudinal axis bisecting the interface.

The term "align" (and variations thereof, such as "alignment") as used herein means that the midplanes of two or more interfaces are coplanar.

The term "offset" (and variations thereof) as used herein means that the midplanes of two or more interfaces are not coplanar.

A number of exemplary embodiments of interfaces are shown in fig. 2. In one embodiment, the second header 120/136 'has a smaller axial width than the first header 118/136, the second header 120/136' also being axially juxtaposed below the mid-plane of the first header 118/136.

In another embodiment shown in fig. 2, the second header 220/236 'has a smaller axial width than the first header 218/236, the midplanes of the headers 218/236 and 220/236' are aligned.

In another embodiment shown in fig. 2, the second header 320/336 'has a smaller axial width than the first header 318/336, and the second header 320/336' is axially juxtaposed above the mid-plane of the first header 318/336.

In another embodiment shown in fig. 2, the first header 418/436 has a smaller axial width than the second header 420/436 ', and the first header 418/436 is axially juxtaposed above the mid-plane of the second header 420/436'.

In another embodiment shown in fig. 2, the first header 518/536 has a smaller axial width than the second header 520/536 ', the midplanes of the headers 518/536 and 520/536' are aligned.

In another embodiment shown in fig. 2, the first header 618/636 has a smaller axial width than the second header 620/636 ', and the first header 618/636 is axially juxtaposed below the mid-plane of the second header 620/636'.

The embodiment of interfaces 118/136 and 120/136' and other embodiments shown in fig. 2 may each represent an API identification and/or a medicament concentration. For example, one embodiment may indicate that the drug containment device 24 contains nitric oxide at a concentration of 100ppm and that the collar requires indexing of the complementary members.

As shown in fig. 1, 3 and 4, the valve housing 26 further includes a second end adjacent the ports 18/36 and 20/36' and opposite the cartridge 28. The second end defines a valve outlet 40 that includes an o-ring 41 that in some cases seals against the valve assembly 13, as will be described below.

As shown in fig. 3 and 4, the valve outlet 40 is also in fluid communication with a needle valve 42 disposed within the passage of the valve housing 26. The needle valve 42 comprises an inlet subsection 43 which is connected by a thread to the valve housing 26 close to the valve inlet 27. The needle valve 42 further comprises a movable outlet subsection 46 which is held in a normally closed position by a compression spring 44. The compression spring 44 presses the outlet subsection 46 (and optionally the sealing ring 48) against the inner wall within the valve housing 26, thereby preventing flow between the canister 28 and the valve outlet 40. When the movable outlet subsection 46 is in the open position (fig. 4), gas from the container can pass through the outlet port 49 and exit the needle valve 42. The seal 48 may be constructed of conventional materials such as rubber or polytetrafluoroethylene. The needle valve 42 has a coaxial internal passage where the gas exits through a central passage outlet.

As shown in fig. 3, 4 and 7, the valve receiving assembly 80 includes a receiver 84 that axially engages the valve housing 26 in the operating position. The receiver 84 includes a side wall 86 that surrounds the valve housing 26 and ensures good alignment before the valve is engaged. The receiver 84 also includes an elongated valve seat 88 that engages the needle valve 42 and forms a seal with the o-ring 41. In the operating position, the valve seat 88 axially displaces or actuates the needle valve 42. Actuation of needle valve 42 allows fluid communication between cartridge 28 and valve seat 88 and receiver passage 90 in receiver assembly 80. The collar 12 is fixed to the carriage 73.

After actuation, the dispensing of the composition from the receptor channel 90 and cartridge 28 may be controlled by the drug delivery modulation device 70 and may be guided by the keyway area 72 and/or an automated procedure (see fig. 8). Device 70 may be in USPN 5,885,621; 5,558,083, respectively; 5,732,693, respectively; 5,752,504, respectively; 5,699,790, respectively; 5,732,694, respectively; 6,089,229, respectively; 6,109,260, respectively; 6,125,846, respectively; 6,164,276, respectively; 6,581,592, respectively; 5,918,596, respectively; 5,839,433, respectively; 7,114,510, respectively; 5,417,950, respectively; 5,670,125, respectively; 5,670,127, respectively; 5,692,495, respectively; 5,514,204, respectively; 5,885,621, respectively; 6,125,846, respectively; and 7,523,752, and USSN 11/355,670(US 2007/0190184); 11/401,722, respectively; 10/053,535, respectively; 10/367,277, respectively; 10/439,632, respectively; and 10/520,270(US 2006/0093681), the entire contents of which are incorporated herein by reference, or any suitable combination of devices or devices and/or components, API, or formation thereof. Related methods of treatment and drug formations and dosage forms thereof for use in conjunction with the present invention are also contemplated.

As shown in fig. 6-8, drug delivery regulating device 70 includes a key slot area 72 to allow a user to control and/or manage the delivery of APIs from cartridge 28. The pressurized gas drug delivery device 70 further comprises a carriage 73, the collar 12 being fixedly mounted to the carriage 73. The pivotable cover 74 is secured to a lever 76. Both the cover 74 and the lever 76 pivot between an open position (see fig. 6 where the indexed drug containment device 24 may be inserted into the collar 12 or removed from the collar 12) and an active/closed position (see fig. 7 where the collar 12 and the device 24 are secured). Once in the working/closed position, the device 24 is advantageously protected from the external environment, which is particularly advantageous in a hospital environment.

As shown in fig. 6 and 7, the lever 76 includes a cam surface 78 that, in the operating position, moves a valve receiving assembly 80 to engage the indexing valve assembly 13. Conversely, in the open position, receiver assembly 80 is urged upward by rod/compression spring assembly 82 to disengage from valve assembly 24. The lever 76, cam 78, rod/compression spring assembly 82 and carriage 73 constitute a plunger assembly for axially actuating the containment device 24 into the receptacle 84.

As shown in fig. 5, the cartridge assembly may include a Radio Frequency Identification (RFID) device 50 disposed about the neck 30 of the cartridge 28. The RFID device 50 transmits radio frequencies to an RFID reader (not shown) disposed within the delivery device to provide further identification features. That is, the RFID reader may be used to determine whether a proper or improper cartridge has been inserted.

It is apparent from the above disclosure that the present invention provides any combination of the following advantages: a linearly actuated cartridge assembly capable of tool-less installation; a single movement means to align, seal and open the valve; and the graduation of various drugs (e.g., nitric oxide, carbon monoxide, etc.).

Exemplary embodiments of the present invention have been described in considerable detail. Various modifications and alterations to the illustrative embodiments will be apparent to those skilled in the art. Accordingly, the invention should not be limited to the described embodiments, but should be defined by the appended claims.

Claims (16)

1. An indexed drug containment device assembly for a drug delivery regulating device, comprising:

a cartridge containing an active pharmaceutical ingredient and an inactive carrier gas for delivery to a patient in need thereof by a drug delivery regulating device;

a housing and a spring biased needle valve, at least a portion of the spring biased needle valve disposed within the housing and regulating fluid flow from the gas cylinder by actuation along a longitudinal axis of the gas cylinder; and

a first indexing member integrally formed with the housing, including first and second arcuate openings arcuately extending about the longitudinal axis of the cartridge and on at least portions of opposite sides of the cartridge, the first and second arcuate openings having at least one of different axial widths and non-aligned mid-planes, the first indexing member adapted to complementarily engage with a second indexing member of a drug delivery regulating device to provide sufficient engagement for actuation of the spring biased needle valve so that the indexing drug containment device assembly can be inserted into and removed from the drug delivery regulating device upon alignment therewith by relative movement perpendicular to the longitudinal axis, and

wherein when complementarily engaged, the indexed drug containment device assembly aligns, seals and opens the drug delivery modulation device and is secured therein with a single movement.

2. An indexed drug containment device assembly for a drug delivery regulating device, comprising:

a cartridge containing an active pharmaceutical ingredient and an inactive carrier gas for delivery to a patient in need thereof by a drug delivery regulating device; the gas cylinder having a valve that regulates fluid flow from the gas cylinder by actuation along a longitudinal axis of the gas cylinder;

a housing encasing at least a portion of the valve, the housing having a first indexing member integrally formed therewith;

the first indexing member includes first and second arcuate openings extending arcuately about the longitudinal axis of the cartridge and on at least portions of opposite sides of the cartridge, the first and second arcuate openings having at least one of different axial widths and non-aligned mid-planes, the first indexing member being adapted to complementarily engage with a second indexing member of a drug delivery regulating device to provide sufficient engagement for actuation of the valve such that the indexing drug containment device assembly is insertable into and removable from the drug delivery regulating device upon alignment therewith by relative movement perpendicular to the longitudinal axis, and

wherein when complementarily engaged, the indexed drug containment device assembly aligns, seals and opens the drug delivery modulation device and is secured therein with a single movement.

3. An indexed drug containment device assembly for a drug delivery regulating device, comprising:

a gas cartridge for delivering a drug component to a patient in need thereof by actuating and drug delivery adjustment means along a longitudinal axis of said gas cartridge, said gas cartridge having a valve for adjusting a flow of active drug component within said gas cartridge;

a housing enclosing at least a portion of the valve, the housing having a first indexing member;

the first indexing member includes first and second arcuate openings extending arcuately about the longitudinal axis of the cartridge and on at least portions of opposite sides of the cartridge, the first and second arcuate openings having at least one of different axial widths and non-aligned mid-planes, the first indexing member adapted to complementarily engage a second indexing member of a drug delivery adjustment device when aligned.

4. The assembly of any of claims 1-3, wherein the active pharmaceutical ingredient comprises at least one of nitric oxide at a concentration in a range of 50ppm to 10,000ppm, carbon monoxide at a concentration in a range of 500ppm to 20,000ppm, and a chalcogenide compound,

wherein the cartridge further contains an inactive carrier gas comprising N₂And O₂At least one of (1).

5. The assembly of any of claims 1-3, wherein the first arcuate opening is frontally opposed to the second arcuate opening.

6. The assembly of any of claims 1-3, wherein the first and second arcuate openings have different axial widths or non-aligned midplanes.

7. The assembly of any one of claims 1-3, wherein the indexed drug containment device assembly is removable from the drug delivery modulation device by relative movement perpendicular to the longitudinal axis.

8. The assembly of any one of claims 1-3, further comprising a radio frequency identification device adapted to communicate with a radio frequency receiver.

9. The assembly according to any of claims 1-3, wherein the first indexing member is configured as a support to enable the indexing of the drug containment device assembly for vertical suspension in the drug delivery regulating device.

10. The assembly of any one of claims 1-3, wherein the first indexing member is configured as a support that allows actuation of the valve along the longitudinal axis of the cartridge.

11. The assembly of any one of claims 1-3, wherein the first indexing member is configured as a support to enable the indexing of the drug containment device assembly vertically suspended in the drug delivery adjustment device and a support to allow actuation of the valve along the longitudinal axis of the cartridge.

12. The assembly of any one of claims 1-3, wherein one or more of the first indexing member and the second indexing member has a surface configured as at least one of a support that enables insertion of the indexed drug containment device assembly into a drug delivery modulation device and a support that allows actuation of a valve along the longitudinal axis of the gas cartridge.

13. A graduated drug delivery system comprising: the assembly of any one of claims 1-12; and

the drug delivery modulation device includes a second indexing member.

14. An indexed drug containment device assembly for a drug delivery regulating device, comprising:

a gas cartridge having a valve for regulating the flow of active pharmaceutical ingredient within the gas cartridge for delivery of the pharmaceutical ingredient to a patient in need thereof by actuation along the longitudinal axis of the gas cartridge and a drug delivery regulating device;

a housing at least partially enclosing the valve and having a first indexing member adapted to complementarily engage a second indexing member of the drug delivery adjustment device to (i) ensure that the cartridge is at least one of a desired cartridge and contains a desired therapeutic gas drug, (ii) suspend the indexed drug containment device assembly in the drug delivery adjustment device, and (iii) provide sufficient engagement for allowing actuation of the valve.

15. The assembly of claim 14, wherein the first and second indexing members are adapted to complementarily engage when aligned by relative movement perpendicular to the longitudinal axis.

16. The assembly of claim 14 or 15, wherein the first indexing member comprises first and second arcuate openings extending arcuately about and on at least partially opposite sides of a longitudinal axis of the portable gas cylinder, the first and second arcuate openings having at least one of different axial widths and non-aligned mid-planes.