JP6246107B2 - Apparatus and method for engaging a pressurized container assembly having an indexed valve and a collar and for linear actuation by a plunger assembly in fluid communication with an apparatus for regulating drug delivery - Google Patents

Description

Cross-reference of related applications Not applicable

Description of research and development funded by the federal government Not applicable

  Various keying and container or cylinder actuators are known. In the technology related to the inhalation of a drug from a pressurized cylinder, the cylinder is large and is not easily carried. The cylinder is also not protected from the surrounding hospital environment, which can be physically demanding. The connection between the cylinder and the adjusting device is complicated.

  However, perhaps the most serious drawback is the risk of coupling a cylinder containing an inappropriate, incorrect or unsuitable drug and / or dose concentration to the regulator.

  Thus, improved coupling of the cylinder to the regulator, improved protection of the cylinder, improved portability of the cylinder, and a cylinder containing the proper drug and dosage concentration is coupled to the drug delivery and regulator. It would be beneficial to have an apparatus that provides a means for ensuring.

  One embodiment of the present invention is a housing and a valve, wherein the valve is disposed in the housing, the housing and the valve, and a first indexing member integrated with the housing, The indexed member is an indexed valve assembly comprising: a first indexed member adapted to be complementary to the second indexed member.

  In one exemplary embodiment of the indexed valve assembly, the assembly further comprises a third indexing member integrated into the housing, the third indexing member being complementary to the fourth indexing member. The first indexed member is non-complementary to the fourth indexed member, and the third indexed member is non-complementary to the second indexed member.

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

  In another exemplary embodiment of the indexed valve assembly, the one or more indexed members are adapted in a predetermined manner to indicate API (API) identification and container concentration.

  In another exemplary embodiment of the indexed valve assembly, the API includes nitric oxide and the container concentration ranges from about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm or 10,000 ppm. The concentration herein is also expressed in mg / L, according to which the concentration is about 12 mg / L per 10,000 ppm.

  In another exemplary embodiment of the indexed valve assembly, the indexing member is further adapted in a predetermined manner so that the initial amount represents about 32 L of compressible gas or 0.16 L of liquid.

  In another exemplary embodiment of the indexed valve assembly, the API includes carbon monoxide and the container concentration ranges from about 50 ppm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm or 20,000 ppm.

  In another exemplary embodiment of the indexed valve assembly, the API includes a chalcogenide compound.

  In another exemplary embodiment of the indexed valve assembly, the valve is a spring-loaded needle valve.

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

  In another exemplary embodiment of the indexed valve assembly, the key is a tongue, protrusion, post, ridge, protrusion, or rail.

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

  In another exemplary embodiment of the indexed valve assembly, the opening is a groove, slot, passage, hole or hole.

  In another exemplary embodiment of the indexed valve assembly, the first indexing member is an opening, the second indexing member is a key, the third indexing member is an opening, The indexed member is a key.

  In another exemplary embodiment of the indexed valve assembly, the first indexing member is a slot, the second indexing member is a rail, the third indexing member is a slot, The indexed member is a rail.

  Another aspect of the present invention is a housing and a valve, wherein the valve is disposed in the housing, the valve assembly including the housing and the valve, and a first indexed member integrated with the housing. A first indexing member adapted to be complementary to the second indexing member, the container in fluid communication with the first indexing member and the valve assembly, wherein the container Is a drug storage device with an index for inhalation comprising a container for storing an API and an inert carrier gas.

  In an exemplary embodiment of the indexed drug storage device, the device further comprises a third indexed member integrated into the housing, such that the third indexed member is complementary to the fourth indexed member. The first indexing member is non-complementary to the fourth indexing member, and the third indexing member is non-complementary to the second indexing member.

  In another exemplary embodiment of an indexed drug storage device, the device further comprises a plurality of indexed members, each indexed member being complementary to a corresponding indexed member and not complementary to a non-corresponding indexed member Adapted to fit.

  In another exemplary embodiment of the indexed drug storage device, the one or more indexing members are adapted in a predetermined manner to indicate API identification and container concentration.

In another exemplary embodiment of the indexed drug storage device, the API includes nitric oxide, the inert carrier gas includes nitrogen gas (N ₂ ), and the container concentration is about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm or The range is 10,000 ppm.

  In another exemplary embodiment of the indexed drug storage device, the indexing member is further adapted in a predetermined manner such that the initial amount represents about 32 L of compressible gas or 0.16 L of liquid.

In another exemplary embodiment of the indexed drug storage device, the API comprises carbon monoxide, the inert carrier gas comprises oxygen gas (O ₂ ), optionally the remainder comprises N ₂ and the container concentration Is in the range of about 500 pm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm or 20,000 ppm.

In another exemplary embodiment, the carrier gas includes about 30% O ₂ and 70% N ₂ .

  In another exemplary embodiment of an indexed drug storage device, the API includes a suitable concentration of a chalcogenide compound.

  In another exemplary embodiment of the indexed drug storage device, the valve is a spring-loaded needle valve.

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

  In another exemplary embodiment of the indexed drug storage device, the key is a tongue, protrusion, post, ridge, protrusion, or rail.

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

  In another exemplary embodiment of the indexed drug storage device, the opening is a groove, slot, passage, hole or hole.

  In another exemplary embodiment of the indexed drug storage device, the first indexed member is an opening, the second indexed member is a key, the third indexed member is an opening, The indexed member is a key.

  In another exemplary embodiment of the indexed drug storage device, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, The indexed member is a rail.

  Another aspect of the present invention is a housing and a valve, wherein the valve is disposed in the housing, the valve assembly including the housing and the valve, and a first indexed member integrated with the housing. A first indexing member adapted to be complementary to the second indexing member, the container in fluid communication with the first indexing member and the valve assembly, wherein the container Is a collar containing an API and an inert carrier gas, and a collar provided with a second indexing member, the second indexing member being integrated with the collar; It is an attached drug actuator.

  In another exemplary embodiment of the indexed drug actuating device, the apparatus further comprises a third indexing member integrated into the housing and a fourth indexing member integrated into the collar, The index member is adapted to be complementary to the fourth index member, the first index member is non-complementary to the fourth index member, and the third index member is the second index Non-complementary to the attached member.

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

  In another exemplary embodiment of the indexed drug actuator, the one or more indexing members are adapted in a predetermined manner to indicate API identification and container concentration.

In another exemplary embodiment of indexed drug actuator, API includes nitric oxide, inert carrier gas comprises _{N 2,} from the container concentration is about 50ppm or 100 ppm 800 ppm, 2400 ppm, of 2500ppm or 10,000ppm It is a range.

  In another exemplary embodiment of the indexed drug actuator, the indexing member is further adapted in a predetermined manner so that the initial amount represents about 32 L of compressible gas or 0.16 L of liquid.

In another exemplary embodiment of the indexed drug actuator, the API comprises carbon monoxide, the inert carrier gas comprises O ₂ , optionally the remainder comprises N ₂ and the container concentration is about 500 pm or It is in the range of 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm or 20,000 ppm.

  In another exemplary embodiment of the indexed drug actuator, the API includes a chalcogenide compound.

  In another exemplary embodiment of the indexed drug actuator, the valve is a spring-loaded needle valve.

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

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

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

  In another exemplary embodiment of the indexed drug actuator, the opening is a groove, slot, passage, hole 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, the third indexing member is an opening, The indexed member is a key.

  In another exemplary embodiment of the indexed drug actuation device, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, The indexed member is a rail.

  Another aspect of the present invention is a housing and a valve, wherein the valve is disposed in the housing, the valve assembly including the housing and the valve, and a first indexed member integrated with the housing. A first indexing member adapted to be complementary to the second indexing member, the container in fluid communication with the first indexing member and the valve assembly, wherein the container Is a collar portion containing a drug substance and an inert carrier gas, and a collar portion having a second indicator member, the second indicator member being integrated with the collar portion, and a housing A receiving assembly comprising a receptacle adapted to engage at least a portion of the seat, a seat adapted to engage the valve, and linearly actuating the valve assembly and the container along an axis. A plunger assembly adapted to engage the valve and seat, the plunger assembly being secured to the collar. A lever assembly with a plunger assembly and a cam adapted to engage a spring, the spring acting linearly along the carriage, valve assembly, container and collar An indexed drug delivery device comprising a lever adapted to cause

  In an exemplary embodiment of the indexed drug delivery device, the device further comprises a third indexing member integrated into the housing and a fourth indexing member integrated into the collar, the third indexing The member is adapted to be complementary to the fourth index member, the first index member is non-complementary to the fourth index member, and the third index member is the second index member. Non-complementary to the member.

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

  In another exemplary embodiment of the indexed drug delivery device, the one or more indexing members are adapted in a predetermined manner to indicate API identification and container concentration.

In another exemplary embodiment of indexed drug delivery device, API includes nitric oxide, inert carrier gas comprises _{N 2,} from the container concentration is about 50ppm or 100 ppm 800 ppm, 2400 ppm, of 2500ppm or 10,000ppm It is a range.

  In another exemplary embodiment of the indexed drug delivery device, the indexing member is further adapted in a predetermined manner such that the initial amount represents about 32 L of compressible gas or 0.16 L of liquid.

In another exemplary embodiment of the indexed drug delivery device, the API comprises carbon monoxide, the inert carrier gas comprises O ₂ , optionally the remainder comprises N ₂ and the container concentration is about 500 pm or It is in the range of 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm 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-loaded needle valve.

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

  In another exemplary embodiment of the indexed drug delivery device, the key is a tongue, protrusion, post, ridge, protrusion, or rail.

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

  In another exemplary embodiment of the indexed drug delivery device, the opening is a groove, slot, passage, hole 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 key, the third indexing member is an opening, The indexed member is a key.

  In another exemplary embodiment of the indexed drug delivery device, the first indexing member is a slot, the second indexing member is a rail, the third indexing member is a slot, The indexed member is a rail.

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

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

  Another aspect of the present invention is a housing and a valve, wherein the valve is disposed within the housing, the valve assembly comprising the housing and the valve, and a radio adapted to communicate with the radio frequency receiver. A pressurized drug storage device for inhalation comprising an automatic identification device and a container in fluid communication with a valve assembly, the container comprising an API and an inert carrier gas.

  Another aspect engages with the pressurized drug container including activating the drug container device linearly along an axis to engage a receptacle and a valve having a seat. It is a method to do.

  Another aspect of the present invention includes actuating linearly along an axis to engage an indexed drug containing pressurized container with a receptacle and with a valve having a seat. A method of engaging with a container.

  Another aspect of the present invention relates to a pressurized container that includes actuating linearly along an axis to engage an indexed pressure container with a receptacle and with a valve having a seat. It is a method to match.

  Another aspect of the present invention is a housing and a valve, wherein the valve is disposed in the housing, the valve assembly including the housing and the valve, and a first indexed member integrated with the housing. A first indexing member adapted to be complementary to the second indexing member, the container in fluid communication with the first indexing member and the valve assembly, wherein the container Is a collar that contains an API and an inert carrier gas, and a collar that includes a container and a second indexing member, the second indexing member being integrated with the collar, A receiving assembly comprising a receptacle adapted to engage at least a portion; a seat adapted to engage a valve; and actuating the valve assembly and container linearly along an axis; A plunger assembly adapted to engage a valve and a seat, the plunger assembly being attached to the collar A lever assembly having a defined carriage and a cam having a cam adapted to engage with the spring, the spring linearly along the axis of the carriage, valve assembly, container and collar A drug delivery device for regulating API delivery to a patient comprising a lever adapted to actuate and a controllable drug delivery and adjustment device adapted to regulate API delivery to the patient It is.

  In one exemplary embodiment of the drug delivery device, the device further comprises a third indexing member integrated into the housing and a fourth indexing member integrated into the collar, the third indexing member comprising: It is adapted to be complementary to the fourth index member, the first index member is non-complementary to the fourth index member, and the third index member is the second index member. It is non-complementary.

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

  In another exemplary embodiment of the drug delivery device, the one or more indexing members are adapted in a predetermined manner to indicate API identification and container concentration.

In another exemplary embodiment of the drug delivery device, API includes nitric oxide, inert carrier gas comprises _{N 2,} containers concentration 800ppm of about 50ppm or 100 ppm, 2400 ppm, in the range of 2500ppm or 10,000ppm is there.

  In another exemplary embodiment of the drug delivery device, the indexing member is further adapted in a predetermined manner to indicate an initial amount of about 32 L of compressible gas or 0.16 L of liquid.

In another exemplary embodiment of the drug delivery device, the API comprises carbon monoxide, the inert carrier gas comprises O ₂ , optionally the remainder comprises N ₂ , and the container concentration is from about 500 pm or 3000 ppm. The range is 5000 ppm, 10,000 ppm, 15,000 ppm 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-loaded needle valve.

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

  In another exemplary embodiment of the drug delivery device, the key is a tongue, protrusion, post, ridge, protrusion, or rail.

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

  In another exemplary embodiment of the drug delivery device, the opening is a groove, slot, passage, hole or hole.

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

  In another exemplary embodiment of the drug delivery device, the first indexing member is a slot, the second indexing member is a rail, and the third indexing member is a slot, and is indexed. The member is a rail.

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

  Another aspect of the present invention is to provide any of the above drug delivery devices for delivering nitric oxide and to deliver nitric oxide controlled and coordinated drug administration and dosage rate to a patient. A method of providing pulmonary vasodilation to a patient in need thereof.

  Another aspect of the present invention is in a patient in need thereof, including providing any of the above drug delivery devices for delivering controlled drug delivery and dosage rates to a patient with controlled and regulated carbon monoxide. Prognosis of organ transplant, selected from the group consisting of delayed graph function related to organ transplant, cystic fibrosis, bowel obstruction, necrotizing enterocolitis, vascular restenosis, hepatitis, acute liver failure related to hepatitis and hemorrhagic shock Is a method of treating a disease or disorder.

  Another aspect of the invention is adapted to engage a receiving assembly comprising a receptacle adapted to engage at least a portion of an indexed drug storage device and a valve of the indexed drug storage device. A plunger assembly adapted to actuate a seat and a valve assembly and container linearly along an axis to engage the valve and seat, the plunger assembly being secured to the collar A lever assembly having a plunger assembly and a cam having a cam adapted to engage a spring, the spring actuating the carriage, valve assembly, container and collar linearly along an axis A drug delivery device for coordinating API delivery to a patient comprising a lever and a controllable drug delivery and coordinator adapted to regulate API delivery to the patient .

It is a fragmentary perspective view of a collar part container assembly. FIG. 3 is a partial front view showing the interface between the collar and the container. 2 is a side cross-sectional view of the collar container assembly of FIG. 1 showing the receptacle prior to engagement with the assembly. FIG. FIG. 2 is a side cross-sectional view of the collar container assembly of FIG. 1 showing the receptacle engaging the assembly. FIG. 6 is a partial perspective view of a collar container assembly including a wireless automatic identification device. FIG. 4 is a partial cross-sectional front view of a collar container assembly disposed within a pressurized gas drug delivery device and showing the delivery device cover and lever in an open position. FIG. 4 is a partial cross-sectional front view of a collar container assembly disposed within a pressurized gas drug delivery device and showing the delivery device cover and lever in an activated position. 1 is a perspective view of a pressurized gas drug delivery device including a collar container assembly. FIG.

  Embodiments and aspects of the present invention can be used to deliver a medical drug gas to a patient in need of treatment for a number of diseases or disorders, as described herein. For example, the drug delivery device may be reversible as described in US Pat. No. 5,873,359 or US Pat. No. 5,485,827 (hereinafter “USPN”), as described herein. May be used to deliver to patients for the treatment of pulmonary hypertension or sickle cell disease described in USPN 5,885,621, all of which are hereby incorporated by reference in their entirety. Embedded in the book.

  In addition, the drug delivery device can be used to deliver carbon monoxide to a patient for the following treatments as described herein: US Patent Application (hereinafter “USSN”) 11 / Prognosis of organ transplantation described in US 401/722 (US2007 / 0202083); Cystic fibrosis described in USSN 10 / 053,535 (US2002 / 0155166); USSN 10 / 371,666 (US2003) Intestinal obstruction described in USSN 10 / 413,817 (US2004 / 0005367); USSN 10 / 367,277 (US2003 / 0219496) and 12/050, Vascular disease including vascular restenosis as described in 826 (US2008 / 0167609); USSN No. 10 / 439,632 (US2004 / 0052866) liver inflammation, including acute liver failure as described in, all of which are incorporated by reference in their entirety herein.

  As used herein, the term “key” (and variations thereof) means a structure adapted to engage a corresponding opening, such as a tongue, protrusion, post, rail, ridge or protrusion. To do.

  Thus, as used herein, the term “opening” (and variations thereof) includes one or more adjacent or perimeters adapted to engage a key such as a slot, groove, passage, hole or hole. Means a structure defined by the structure of

  As used herein, the term “member” (and variations thereof) includes both keys and openings.

  As used herein, the term “indexed” (and variations thereof) means one or more members designed to indicate the API's identity and / or dose concentration as predetermined.

  As used herein, the term “complementary” (and variations thereof) refers to an engagement of an indexing member and a corresponding indexing member so as to form an interface, thereby providing sufficient engagement for operation. Below, it means that the interface is coplanar.

  As used herein, the term “non-complementary” (and variations thereof) means that the two indexed members are not complementary.

  As used herein, the term “interface” (and variations thereof) means the same surface of two complementary indexed members.

  An indexed drug actuator 10 for use in indexed drug delivery and adjustment device 70 (FIG. 8) is shown in FIG. The indexed drug actuation device 10 provides for indexing the property that a particular drug delivery device can dispense a predetermined concentration of API contained in a drug inert carrier gas. The indexing device 10 includes a collar 12 and an indexed drug storage device 24. The device 24 includes an indexed valve assembly 13 threaded into the container 28.

  In an exemplary embodiment, the indexing device 10 is 100 ppm or 800 ppm, depending on the current drug label inserted into the INOmax® (nitrogen monoxide) for inhalation (SPC-0303 V: 3.0). Contains nitric oxide, which is incorporated herein by reference in its entirety. The indexing device 10 can also be used in conjunction with other formulations of INOmax® at higher concentrations, such as 2400 ppm nitric oxide. For example, the indexing characteristic may only allow engagement of the device 10 containing nitric oxide and / or a particular concentration of nitric oxide.

The API can be carbon monoxide, nitric oxide, or a chalcogenide compound. The concentration of API can be any concentration within the range of 100 ppm to 15,000 ppm. The inert carrier gas may include a suitable inert carrier gas of O ₂ , N ₂ and / or another agent. Container 28 may have sufficient capacity to store 30 L to 35 L in the pressure range of 2000 psig to 3000 psig. Other sized containers having different pressures and capacities can also be utilized.

  As shown in FIG. 1, the indexed drug actuation device 10 includes a collar 12 configured to engage laterally with a valve housing 26 of the indexed valve assembly 13. The collar 12 is generally U-shaped and includes a first arm 14 and a second arm 16. The collar portion 12 engages with the housing 26 in the lateral direction. The inner surfaces of the first arm 14 and the second arm 16 include a first collar key 18 and a second collar key 20, respectively. The first collar key 18 and the second collar key 20 are extended in the lateral direction 19 to provide a rail structure.

  As used herein, the term “lateral” (and variations thereof, such as “laterally”) is used herein to indicate that the indexed valve assembly 13 is engageable with the collar 12 and the collar 12 means a direction that can be removed from the direction 12, that is, a direction perpendicular to the longitudinal axis 21.

  As used herein, the term “vertical axis” (and variations thereof, such as simply “axially”) means an axis that is longitudinally aligned with the container 28.

  The first collar key 18 and the second collar key 20 may be different in shape (such as cross-sectional shape, shaft position, shaft width, or direction) to provide indexed properties and functions. Other shapes, arrangements, structures, and combinations of the collar keys 18, 20 are described in further detail below. The first collar key 18 and the second collar key 20 may also provide an arcuate key 22 between the first arm 14 and the second arm 16 and may also provide an indicator for API identification.

  The side of the valve housing 26 also includes structures that engage the collar keys 18, 20. Specifically, one side of the valve housing 26 includes an upper key ridge 34 that extends outward in the radial direction 29 with respect to the first valve opening 36 that houses the first collar key 18.

  As used herein, the term “radially” (and variations thereof, such as “radial”) means a direction that is perpendicular to the longitudinal axis 21.

  The term “radially inward” (and variations thereof) means radially toward the longitudinal axis 21.

  The term “radially outward” (and variations thereof) means radially away from the longitudinal axis 21.

  The first valve opening 36 may also engage a portion of the arcuate key 22. This side of the valve housing 26 also includes an upper key ridge 34 that extends radially outward with respect to the first valve opening 36 and a lower key ridge 38 that is longitudinally opposed.

  As shown in FIGS. 1, 3 and 4, the opposing sides of the valve housing 26 also have an upper key ridge 34 and a lower key ridge 38 that extend radially outward with respect to the second valve opening 36 ′. Including. The second valve opening 36 ′ houses the second collar key 20. The valve openings 36, 36 'complement the collar keys 18, 20, respectively.

  The valve openings 36, 36 'and the collar keys 18, 20 have a rectangular cross section. However, other cross-sectional shapes such as semicircular, triangular, trapezoidal, pentagonal, etc. can be used.

  Alternatively, the cross-sectional shape of the set of indexed members 18, 36 and 20/36 'may be different from each other. For example, the indexing members 18, 36 may have a rectangular cross section, and the indexing members 20, 36 'may have a trapezoidal cross section. The cross-sectional shape and / or other structural characteristics of the set of indexing members 18, 36 and 20, 36 'provide the above-described indicators of API and / or dose concentration.

  As a result, the indexed collar 12 engages only with the indexed drug storage device 24 so that the index provides a completely complementary member identified with a predetermined API and / or dosage concentration. The cross-sectional shape and / or structural characteristics of the set of indexing members 18, 36 and 20, 36 'can also cause the non-complementary indexing member to be in the collar when the valve housing is rotated 180 degrees relative to the collar 12. 12 and valve housing 26 may be provided. That is, the first collar key 18 is non-complementary to the second valve opening 36 ', and the second collar key 20 is non-complementary to the first valve opening 36, so that the container 28 has a collar portion. Only one direction inserted into 12 is possible. The safety valve 32 including the discharge port 33 may also provide a structure that prevents misengagement of the collar 12 and the valve housing 26. Even without the safety valve 32, if the valve housing does not have an opening at the position of the safety valve that allows the arcuate key of the collar to mate with the opening, the valve housing is completely with the collar. It is not possible to engage.

  The valve housing 26 may also include additional keys and the collar 12 may include additional openings. The valve housing 26 and collar 12 may each include one or more keys and one or more openings. Collar 12 may include different types of keys. The valve housing 26 may include different types of openings. For example, the collar 12 may include rails along the first arm 14 and the second arm 16 and one or more posts instead of the arcuate key 22. The valve housing 26 may include a rail and a slot that houses one or more holes that house the posts.

  As shown in FIGS. 1, 3 and 4, the collar 12 engages the valve housing 26. The valve housing 26 includes a first end that defines an inlet 27. The valve housing 26 engages with the neck portion 30 of the container 28 so as to be screwable. The container 28 is aligned along the longitudinal axis 21. Alternatively, the valve housing 26 can communicate with the container 28 through a conduit or hose (not shown).

  The connection between the valve housing 26 and the container 28 also includes an O-ring 31 (see FIGS. 3 and 4) adapted to prevent the API and carrier gas from leaking out of the container 28. The valve housing 26 also includes an optional safety valve 32 that is screwed into the valve housing 26. The safety valve 32 includes a discharge port 33. The safety valve 32 may be any suitable valve known to those skilled in the art that prevents over-pressurization of the contents of the container 28 due to overfilling of the container during combustion or production, for example due to high temperatures.

  As shown in FIG. 2, the indicator characteristics corresponding to the API identification and / or dose concentration are one or more different axial widths of the interfaces 18/36 and 20/36 ′, axis parallel, different cross-sectional shapes. , Etc.

  As used herein, the term “axial alignment” means that the midplanes of interfaces 18/36 and 20/36 'are misaligned (ie, not aligned).

  As used herein, the term “middle plane” (and variations thereof) means a plane that is perpendicular to the longitudinal axis that bisects the interface.

  As used herein, the term “aligned” (and variations thereof, such as “alignment”) means that the central planes of two or more interfaces are coplanar.

  As used herein, the term “offset” (and variations thereof) means that the central planes of two or more interfaces are not coplanar.

  Several exemplary embodiments of the interface are shown in FIG. In one embodiment, the second interface 120/136 ′ has a smaller axial width than the first interface 118/136, and the second interface 120/136 ′ is also the center of the first interface 118/136. Parallel to the axis below the plane.

  In another embodiment shown in FIG. 2, the second interface 220/236 ′ has a smaller axial width than the first interface 218/236, and the central planes of the interfaces 218/236 and 220/236 ′ are , Have been aligned.

  In another embodiment shown in FIG. 2, the second interface 320/336 ′ has a smaller axial width than the first interface 318/336, and the second interface 320/336 ′ Parallel to the axis above the center plane of interface 318/336.

  In another embodiment shown in FIG. 2, the first interface 418/436 has a smaller axial width than the second interface 420/436 ′, and the first interface 418/436 is the second interface. Parallel to the axis above the center plane of 420/436 ′.

  In another embodiment shown in FIG. 2, the first interface 518/536 has a smaller axial width than the second interface 520/536 ′, and the central planes of the interfaces 518/536 and 520/536 ′ are , Have been aligned.

  In another embodiment shown in FIG. 2, the first interface 618/636 has a smaller axial width than the second interface 620/636 ′, and the first interface 618/636 is the second interface. Parallel to the axis below the center plane of 620/636 '.

  The embodiments of interfaces 118/136 and 120/136 'shown in FIG. 2 and other embodiments may indicate API identification and / or dosage concentrations, respectively. For example, one embodiment may indicate that the drug containment device 24 contains nitric oxide at a concentration of 100 ppm and the collar should require a complementary member index.

  As shown in FIGS. 1, 3 and 4, the valve housing 26 further includes a second end adjacent to the interface 18/36 and 20/36 ′ and facing the container 28. The second end defines a valve outlet 40 that includes an O-ring 41 for sealing the valve assembly 13 in some circumstances as described below.

  As shown in FIGS. 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. Needle valve 42 includes an injection surface 43 that is threadably coupled to valve housing 26 near injection port 27. Needle valve 42 also includes a movable discharge surface 46 that is maintained in a normally closed position by a compression spring 44. The compression spring 44 presses the discharge surface 46 (and optionally the sealing ring 48) against the inner wall in the valve housing 26, thereby preventing flow between the container 28 and the valve outlet 40. When the movable outlet surface 46 is in the open position (FIG. 4), gas from the container can exit the needle valve 42 via the outlet port 49. The sealing ring 48 may be constructed from conventional materials such as rubber or Teflon. The needle valve 42 has a coaxial internal passage through which gas flows out from the central passage outlet.

  As shown in FIGS. 3, 4, and 7, the valve receiving assembly 80 includes a receptacle 84 that axially engages the valve housing 26 in the operative position. The receptacle 84 includes a sidewall 86 that surrounds the valve housing 26 and ensures good alignment before the valve is engaged. The receptacle 84 also includes an elongated seat 88 that engages the needle valve 42 and forms a seal with the O-ring 41. The seat 88 moves or actuates the needle valve 42 in the actuated position in the axial direction. Actuation of the needle valve 42 allows fluid communication between the container 28 and the seat 88 and the receptacle passage 90 in the receiving assembly 80. The collar portion 12 is fixed to the carriage 73.

  After actuation, dispensing of the composition from the receptacle passageway 90 and the container 28 is controlled by the drug delivery and adjustment device 70 and as directed by the key operator 72 and / or automatic program (see FIG. 8). obtain. Apparatus 70 is described in USPN 5,885,621; 5,558,083; 5,732,693; 5,752,504; 5,699,790; No. 694; No. 6,089,229; No. 6,109,260; No. 6,125,846; No. 6,164,276; No. 6,581,592; No. 5,918,596 No. 5,839,433; No. 7,114,510; No. 5,417,950; No. 5,670,125; No. 5,670,127; No. 5,692,495; 5,514,204; 5,885,621; 6,125,846; and 7,523,752; and USSN 11 / 355,670 (US2007 / 0190184); 401,722; No. 10/05 No. 535; No. 10 / 367,277; No. 10 / 439,632; and No. 10 / 520,270 (US 2006/0093681), corresponding devices or devices and / or components, API or There can be any suitable combination of the formulations, all of which are hereby incorporated by reference in their entirety. Related methods of treatment and drug formulations and dosage forms thereof are also contemplated for use in connection with the present invention.

  As shown in FIGS. 6-8, the drug delivery and adjustment device 70 includes a key operation 72 to allow a user to control and / or program API delivery from the container 28. Pressurized gas drug delivery device 70 also includes a carriage 73 having a collar 12 fixedly mounted thereon. A pivotable cover 74 is fixed to the lever 76. Both the cover 74 and the lever 76 are in the open position (the indexed drug storage device 24 can be inserted into or removed from the collar 12, see FIG. 6) and the activated / closed position (collar Pivot between the part 12 and the device 24 (see FIG. 7). Once in the activated / closed position, the device 24 is advantageously protected from the external environment, which is particularly advantageous in a hospital environment.

  As shown in FIGS. 6 and 7, the lever 76 includes a cam surface 78 that moves the valve receiving assembly 80 to engage the indexed valve assembly 13 in the activated position. On the other hand, the receiving assembly 80 is pushed upward by the rod / compression spring assembly 82 to disengage the valve assembly 24 in the open position. Lever 76, cam 78, rod / compression spring assembly 82 and carriage 73 create a plunger assembly for axially actuating drug containment device 24 within receptacle 84.

  As shown in FIG. 5, the container assembly may include a wireless automatic identification (RFID) device 50 disposed about the neck 30 of the container 28. The RFID device 50 transmits radio frequencies to an RFID reader (not shown) located within the delivery device to further provide identification characteristics. That is, an RFID reader can be used to determine whether an appropriate container is inserted or an inappropriate container is inserted.

  From the above disclosure, it should be clear that the present invention provides any combination of the following advantages: a linearly actuated container assembly that can be installed without tools; a single movement of the valve therein A device that aligns, seals and opens with; and indicators of multiple drugs (eg, nitric oxide, carbon monoxide, etc.).

  One exemplary embodiment of the invention has been described in considerable detail. Many modifications and variations of the described exemplary embodiments will become apparent to those skilled in the art. Accordingly, the invention is not limited to the described embodiments but is to be defined by the scope of the following claims.

Claims (17)

An indexed drug storage device assembly for a drug delivery and adjustment device, the indexed drug storage device assembly comprising:
A gas container containing the drug substance and an inert carrier gas for delivery to the patient in need via the drug delivery and conditioning device;
A housing and a spring-biased needle valve, wherein at least a portion of the spring-biased needle valve is disposed within the housing and operates along a longitudinal axis of the gas container A housing and a spring-biased needle valve for adjusting a flow of fluid from the gas container; and a first indexing member integrated with the housing, wherein the first indexing member is: A first arcuate opening extending in an arc around the longitudinal axis of the gas container and extending over at least a portion of the gas container facing the longitudinal axis; and Two arcuate openings, the first and second arcuate openings having at least one of different axial widths or unaligned central planes, the first indexing member Engages complementarily with the second indexing member of the drug delivery and adjustment device The indexed when adapted to provide sufficient engagement for operation of the spring-loaded needle valve and aligned via relative movement perpendicular to the longitudinal axis. A first indexing member characterized in that the assembly of the drug storage device is housed in and removable from the drug delivery and adjustment device, and is complementarily engaged An assembly of an indexed drug storage device, wherein the indexed drug storage device assembly aligns the spring-biased needle valve within the drug delivery and adjustment device in a single movement. An indexed drug storage device assembly for a drug delivery and adjustment device, the indexed drug storage device assembly comprising:
A gas container containing a drug substance and an inert carrier gas for delivery to a patient in need via the drug delivery and conditioning device, the gas container being actuated along a longitudinal axis of the gas container A gas container having a valve for regulating a flow of fluid from the gas container;
A housing that houses at least a portion of the valve, the housing having a first indexed member integrated with the housing;
The first index member extends in a bow shape around the longitudinal axis of the gas container, and extends on at least a part of the gas container facing the longitudinal axis. An arcuate opening and a second arcuate opening, wherein the first and second arcuate openings have at least one of different axial widths or unaligned midplanes; The first indexing member is adapted to complementarily engage the second indexing member of the drug delivery and adjustment device to provide sufficient engagement for operation of the valve; and The indexed drug storage device assembly is housed in and removable from the drug delivery and adjustment device when aligned via relative motion perpendicular to the longitudinal axis And a pair of the indexed drug storage devices when complementarily engaged. An assembly of an indexed drug storage device characterized in that the valve is aligned within the drug delivery and adjustment device in a single movement. An indexed drug storage device assembly for a drug delivery and adjustment device, the indexed drug storage device assembly comprising:
A gas container, wherein the gas container is contained within the gas container for delivery to a patient in need via the drug delivery and conditioning device by operating along a longitudinal axis of the gas container. A gas container having a valve to regulate the flow of active drug substance;
A housing that houses at least a portion of the valve, the housing having a first index member; and
The first indexing member extends in a bow shape around the longitudinal axis of the gas container, and extends on at least a part of the side facing the longitudinal axis of the gas container. A shaped opening and a second arcuate opening, wherein the first and second arcuate openings have at least one of different axial widths or unaligned midplanes; A pair of indexed drug storage devices, wherein when aligned, the first indexed member is adapted to complementarily engage with a second indexed member of the drug delivery and adjustment device Solid.   The first indexing member is adapted to complementarily engage a second indexing member of the drug delivery and adjustment device to provide sufficient engagement for operation of the valve; and When aligned via relative movement perpendicular to the longitudinal axis, the drug storage device assembly is received in and removable from the drug delivery and adjustment device. The assembly of the drug storage device with an index according to claim 3. The indexed drug storage device of claim 3, wherein the complementary drug storage device assembly aligns the valve within the drug delivery and adjustment device in a single movement when complementarily engaged. Assembly of drug storage device. The drug substance is
Nitric oxide having a concentration range of 50 ppm to 10000 ppm,
Carbon monoxide having a concentration in the range of 500 ppm to 20000 ppm, and
Comprising at least one of the chalcogenide compounds,
The assembly of an indexed drug storage device according to claim 3, wherein the gas container also contains an inert carrier gas containing at least one of nitrogen and oxygen.   4. The assembly of an indexed drug storage device according to claim 3, wherein the first arcuate opening directly faces the second arcuate opening.   4. The indexed drug container assembly according to claim 3, wherein the first and second arcuate openings have different axial widths and unaligned central planes.   4. The indexed drug storage device assembly of claim 3, wherein the complementary engagement of the first and second indexing members provides sufficient engagement to enable the valve to operate. .   4. The indexed drug storage device assembly of claim 3, wherein the indexed drug storage device assembly is detachable from the drug delivery and adjustment device via a relative motion perpendicular to the longitudinal axis. Assembly of drug storage device.   4. The indexed drug storage device assembly according to claim 3, further comprising a wireless automatic identification device adapted to communicate with a radio frequency receiver.   The indexed member according to claim 3, wherein the first indexed member is configured to be supported so as to enable operation of the valve along the longitudinal axis of the gas container. Assembly of drug storage device.   The first indexing member allows the assembly of the indexed drug storage device to be retained in the drug delivery and adjustment device and allows the valve to operate along the longitudinal axis of the gas container. 4. The assembly of an indexed drug storage device according to claim 3, wherein the assembly is supported.   One or more of the first indexed member and the second indexed member are supported so that an assembly of the indexed drug storage device can be accommodated in the drug delivery and adjustment device, and the gas container 4. The set of indexed drug storage devices according to claim 3, comprising a surface that constitutes at least one of the supports that are supported so as to enable operation of the valve along the longitudinal axis. Solid. An indexed drug delivery system comprising: the assembly according to claim 3; and the drug delivery and adjustment device including the second indexed member. An indexed drug storage device assembly for a drug delivery and adjustment device, the indexed drug storage device assembly comprising:
A gas container in the gas container for delivery to a patient in need via the drug delivery and conditioning device by actuating along the longitudinal axis of the gas container. A gas container having a valve to regulate the flow of contained drug substance;
A housing that houses at least a part of the valve and has a first indexed member,
The first indexing member is adapted to complementarily engage a second indexing member of the drug delivery and adjustment device; (i) the gas container is at least one desired gas container; Enough to ensure that it contains the desired therapeutic gas drug, (ii) retain the indexed drug storage device assembly in the drug delivery and adjustment device, and (iii) enable the valve to be actuated Provide
The first indexed member is in a bow shape around the vertical axis of the portable gas container, and is present on at least a part of the portable gas container on the opposite side of the vertical axis. An arcuate opening and a second arcuate opening, the first and second arcuate openings having at least one of different axial widths or unaligned midplanes An assembly of an indexed drug storage device.   The first and second indexing members are adapted to complementarily engage when aligned via relative movement perpendicular to the longitudinal axis of the gas container. An assembly of an indexed drug storage device according to claim 16.

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