Source: https://patents.google.com/patent/KR101899271B1/en
Timestamp: 2019-09-17 03:08:49
Document Index: 235150604

Matched Legal Cases: ['Application No. 11', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 11']

KR101899271B1 - Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery - Google Patents
Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery Download PDF
KR101899271B1
KR101899271B1 KR1020177013523A KR20177013523A KR101899271B1 KR 101899271 B1 KR101899271 B1 KR 101899271B1 KR 1020177013523 A KR1020177013523 A KR 1020177013523A KR 20177013523 A KR20177013523 A KR 20177013523A KR 101899271 B1 KR101899271 B1 KR 101899271B1
KR1020177013523A
KR20170059490A (en
프레데릭 제이. 몽고메리
던컨 피. 베이드
대니얼 주형 리
스콧 이그나티우스 비바
토드 제이. 바켄
이노 테라퓨틱스 엘엘씨
2009-05-27 Application filed by 이노 테라퓨틱스 엘엘씨 filed Critical 이노 테라퓨틱스 엘엘씨
2009-05-27 Priority to PCT/US2009/045266 priority Critical patent/WO2010138114A1/en
2017-05-30 Publication of KR20170059490A publication Critical patent/KR20170059490A/en
2018-09-14 Publication of KR101899271B1 publication Critical patent/KR101899271B1/en
The present invention relates to an indexed drug delivery device (70) comprising:
- a valve assembly (13) comprising a valve and a housing (26), the valve being arranged in the housing,
- one or more keys (34,38) integrally formed in said housing, said keys being configured to have an inter-fitting shape with respect to a corresponding opening on collar (12)
- a compression canister (28) in fluid communication with the valve assembly, the canister containing an active pharmaceutical ingredient and an inert carrier gas,
A receiving assembly including a container configured to engage with at least a portion of the housing and a seat configured to engage the valve,
A plunger assembly configured to linearly actuate the valve assembly and the canister along an axis to couple the valve to the seat, the plunger assembly including a lever having a cam configured to engage a carriage and a spring secured to the collar, The spring is configured to linearly actuate the carriage, valve assembly, canister and collar along the axis.
TECHNICAL FIELD [0001] The present invention relates to a method and apparatus for coupling an indexed valve and a compression canister assembly to a collar and linearly operating the same to a plunger assembly to establish fluid communication with a drug delivery modulating device. BACKGROUND OF THE INVENTION BY PLUNGER ASSEMBLY INTO FLUID COMMUNICATION WITH DEVICE FOR REGULATING DRUG DELIVERY}
The present invention relates to an indexed drug delivery device and method for use in an indexed drug delivery and conditioning device.
Various keying and canister or cylinder actuating devices are known. In the art of inhalation of a drug from a compression cylinder, the cylinders are large in size and are not easily portable. Also, these cylinders are not protected against the hospital environment around the cylinder, which may be physically poor. The connection between the cylinder and the regulator may be complicated.
Perhaps, however, the greatest disadvantage will be the danger of connecting the cylinder with an incorrect and false drug and / or dosing concentration or otherwise inappropriate drug and / or dosage amount to the regulating device.
Thus, it is possible to improve the connection of the cylinder to the regulating device, to better protect the cylinder, to improve the portability of the cylinder, and to ensure that the cylinder containing the correct drug and administration concentration can be connected to the drug delivery and control device It would be desirable to have a means to
One aspect of the present invention is an indexed valve assembly comprising:
- a valve and a housing, the valve being arranged in the housing,
- a first indexed member integrally formed in the housing, the first indexed member being configured to be complementary to the second indexed member;
In one exemplary embodiment of the indexed valve assembly, the assembly further includes a third indexed member integrally formed with the housing, the third indexed member having an interfitting feature on the fourth indexed member Wherein the first indexed member is configured to be non-complementary to the fourth indexed member and the third indexed member is inter-fitted to the second indexed member It is configured not to have a fit shape.
In yet another exemplary embodiment of the indexed valve assembly, the assembly further includes a plurality of indexed members, each of the indexed members having an interfitting shape for the corresponding indexed members And is configured such that it does not have an inter-fitting shape for non-corresponding indexed members.
In yet another exemplary embodiment of the indexed valve assembly, the one or more indexed members are configured to predeterminately display the canister concentration and identity of the active pharmaceutical ingredient (API).
In another exemplary embodiment of the indexed valve assembly, the API comprises nitrogen oxide and the canister concentration is in the range of about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm, or 10,000 ppm. Here, the concentration can also be expressed in mg / L, which is about 12 mg / L per 10,000 ppm.
In yet another exemplary embodiment of the indexed valve assembly, the indexed members are configured to additionally predetermine and display an initial volume of about 32 L of compressed gas or 0.16 L of liquid.
In another exemplary embodiment of the indexed valve assembly, the API comprises carbon monoxide and the canister concentration is in the range of about 500 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 comprises a chalcogenide compound.
In another exemplary embodiment of the indexed valve assembly, the valve is a spring-biased 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, a prong, a post, a ridge, a protrusion, or a 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, a slot, a channel, an aperture, or a hole.
In another exemplary embodiment of the indexed valve assembly, the first indexed member is an opening, the second indexed member is a key, the third indexed member is an aperture and the fourth indexed member is a key.
In another exemplary embodiment of the indexed valve assembly, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, and the fourth indexed member is a rail.
Yet another aspect of the present invention is an indexed drug containment device for inhalation comprising:
- a valve assembly including a valve and a housing, the valve being arranged in the housing,
- a first indexed member integral with said housing, said first indexed member being configured to have an interfitting shape with respect to a second indexed member,
A canister in fluid communication with the valve assembly, the canister containing an API and an inactive carrier gas.
In one exemplary embodiment of the indexed drug containing device, the apparatus further comprises a third indexed member integrally formed in the housing, the third indexed member having an interfitted shape Wherein the first indexed member is configured not to have an interfitting shape with the fourth indexed member and the third indexed member has an interfitting shape with the second indexed member, .
In another exemplary embodiment of the indexed drug containing device, the device further comprises a plurality of indexed members, each of the indexed members having an interfitting shape for the corresponding indexed members And are configured such that they do not have an interfitting shape for indexed members that are configured and do not correspond.
In yet another exemplary embodiment of the indexed drug containing device, the one or more indexed members are configured to predetermine and display the canister concentration and characteristics of the API.
In another exemplary embodiment of the indexed drug containing device, the API comprises nitric oxide, the inert carrier gas comprises nitrogen gas (N 2 ), the canister concentration is about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm, or 10,000 ppm.
In another exemplary embodiment of the indexed drug containing device, the indexed members are configured to additionally predetermine and display an initial volume of about 32 L of compressed gas or 0.16 L of liquid.
In another exemplary embodiment of the indexed drug containing device, the API comprises carbon monoxide, the inert carrier gas comprises oxygen gas (O 2 ), optionally the balance comprises N 2 , The canister concentration is in the range of about 500 ppm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm, or 20,000 ppm.
In another exemplary embodiment, the carrier gas comprises about 30% O 2 and 70% N 2 .
In another exemplary embodiment of the indexed drug containing device, the API comprises a chalcogenide compound in an appropriate concentration.
In another exemplary embodiment of the indexed drug containing device, the valve is a spring-based needle valve.
In yet another exemplary embodiment of the indexed drug containing device, the first indexed member or the second indexed member is a key.
In another exemplary embodiment of the indexed drug containing device, the key is a tongue, a prong, a post, a ridge, a protrusion, or a rail.
In yet another exemplary embodiment of the indexed drug containing device, the first indexed member or the second indexed member is an opening.
In another exemplary embodiment of the indexed drug containing device, the opening is a groove, a slot, a channel, an aperture, or a hole.
In another exemplary embodiment of the indexed drug containing device, the first indexed member is an aperture, the second indexed member is a key, the third indexed member is an aperture and the fourth indexed member is a key.
In another exemplary embodiment of the indexed drug containing device, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, and the fourth indexed member is a rail.
Another form of the invention is an indexed drug actuation device, said device comprising:
A canister in fluid communication with the valve assembly, the canister containing an API and an inert carrier gas,
- a collar comprising the second indexed member, the second indexed member being integral with the collar.
In one exemplary embodiment of the indexing-type drug actuating device, the apparatus further comprises a third indexed member integrally formed with the housing and a fourth indexed member integrally formed with the collar, wherein the third indexed Member is configured to have an inter-fitting shape with the fourth indexed member, the first indexed member is configured not to have an inter-fitting shape with the fourth indexed member, and the third indexed member The second indexed member is configured not to have an interfitting shape.
In another exemplary embodiment of the indexing-type drug actuating device, the device further comprises a plurality of indexed members, each of the indexed members having an interfitting shape for the corresponding indexed members And are configured such that they do not have an interfitting shape for indexed members that are configured and do not correspond.
In yet another exemplary embodiment of the indexing-type drug actuating device, the one or more indexed members are configured to predetermine and display the canister concentration and characteristics of the API.
In another exemplary embodiment of the indexed drug-working device, the API comprises nitrogen oxide, the inert carrier gas comprises N 2 , the canister concentration is about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm or 10,000 ppm.
In yet another exemplary embodiment of the indexing-type drug-actuating device, the indexed members are configured to additionally predetermine and display an initial volume of about 32 L of compressed gas or 0.16 L of liquid.
In another exemplary embodiment of the indexing-type drug-acting device, the API comprises carbon monoxide, the inert carrier gas comprises O 2 , optionally, the balance comprises N 2 , About 500 ppm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm, or 20,000 ppm.
In another exemplary embodiment of the indexed drug-eluting device, the API comprises a chalcogenide compound.
In another exemplary embodiment of the indexing-type drug actuating device, the valve is a spring-type needle valve.
In another exemplary embodiment of the indexing-type drug actuating device, the first indexed member or the second indexed member is a key.
In another exemplary embodiment of the indexing-type drug actuating device, the key is a tongue, a rake, a post, a ridge, a protrusion or a rail.
In another exemplary embodiment of the indexing-type drug actuating device, the first indexed member or the second indexed member is an opening.
In yet another exemplary embodiment of the indexing-type drug actuating device, the opening is a groove, slot, channel, hole or hole.
In another exemplary embodiment of the indexing-type drug actuating device, the first indexed member is an aperture, the second indexed member is a key, the third indexed member is an aperture, and the fourth indexed member is a key.
In another exemplary embodiment of the indexing-type drug actuating device, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, and the fourth indexed member is a rail.
Yet another aspect of the present invention is an indexed drug delivery device, comprising:
A canister in fluid communication with the valve assembly, the canister containing an active pharmaceutical ingredient and an inert carrier gas,
- a collar comprising the second indexed member, the second indexed member being integrally formed with the collar,
A receiving assembly including a receptacle configured to engage with at least a portion of the housing and a seat configured to engage the valve,
A plunger assembly configured to linearly actuate the valve assembly and the canister along an axis, the plunger assembly configured to engage the valve and seat, the plunger assembly including a cam configured to engage a carriage and a spring secured to the collar, wherein the spring is configured to linearly actuate the carriage, valve assembly, canister, and collar along the axis.
In one exemplary embodiment of the indexed drug delivery device, the apparatus further comprises a third indexed member integral with the housing and a fourth indexed member integrally formed with the collar, wherein the third indexed member Member is configured to have an inter-fitting shape with the fourth indexed member, the first indexed member is configured not to have an inter-fitting shape with the fourth indexed member, and the third indexed member The second indexed member is configured not to have an interfitting shape.
In another exemplary embodiment of the indexed drug delivery device, the device further comprises a plurality of indexed members, each of the indexed members having an interfitting shape for the corresponding indexed members And are configured such that they do not have an interfitting shape for indexed members that are configured and do not correspond.
In yet another exemplary embodiment of the indexed drug delivery device, the one or more indexed members are configured to predetermine and display the canister concentration and characteristics of the API.
In another exemplary embodiment of the indexed drug delivery device, the API comprises nitrogen oxide, the carrier gas comprises N 2 , the canister concentration is about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm Or 10,000 ppm.
In another exemplary embodiment of the indexed drug delivery device, the indexed members are configured to further pre-determine and display an initial volume of about 32 L of compressed gas or 0.16 L of liquid.
In another exemplary embodiment, the API comprises carbon monoxide, and and an inert carrier gas comprises O 2, optionally, the balance (balance) comprises N 2, and the canister concentration of the indexing-type drug delivery device About 500 ppm or 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-based 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, a rake, a post, a ridge, a protrusion or a rail.
In yet 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, channel, hole or hole.
In another exemplary embodiment of the indexed drug delivery device, the first indexed member is an aperture, the second indexed member is a key, the third indexed member is an aperture and the fourth indexed member is a key.
In another exemplary embodiment of the indexed drug delivery device, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, and the fourth indexed member is a rail.
In yet another exemplary embodiment of the indexed drug delivery device, the cam is configured to engage a compression spring and the compression spring is configured to engage the carriage.
Yet another aspect of the present invention is a valve assembly comprising:
- a radio frequency identification device adapted to communicate with a radio frequency receiver.
Yet another aspect of the present invention is a compressed drug containing device for inhalation comprising:
- a radio frequency identification device adapted to communicate with a radio frequency receiver,
A canister in fluid communication with the valve assembly, the canister containing an API and an inert carrier gas.
Another embodiment of the present invention is the above-mentioned compressed drug-containing canister bonding method comprising the step of linearly operating the above-mentioned drug-containing device along the axis to bind to a container and to a valve having a sheet.
Another aspect of the present invention is a compression canister bonding method comprising: linearly operating an indexable drug-containing compression canister along an axis to couple to a container and to a valve having a seat.
Another aspect of the present invention is a method of combining a compression canister comprising linearly operating an indexed compression canister along an axis to couple to a container and to a valve having a seat.
Another embodiment of the present invention is a drug delivery device for regulating delivery of an API to a patient, the device comprising:
A plunger assembly configured to linearly actuate the valve assembly and the canister along an axis to couple the valve to the seat, the plunger assembly including a lever having a cam configured to engage a carriage and a spring secured to the collar, Wherein the spring is configured to linearly actuate the carriage, valve assembly, canister and collar along the axis,
- an adjustable drug delivery and conditioning device configured to regulate delivery of the API to the patient.
In one exemplary embodiment of the drug delivery device, the apparatus further comprises a third indexed member integral with the housing and a fourth indexed member integrally formed with the collar, the third indexed member The first indexed member is configured to have an inter-fitting shape with the fourth indexed member, the first indexed member is configured not to have an inter-fitting shape with the fourth indexed member, 2 &lt; / RTI &gt; indexed member.
In yet another exemplary embodiment of the drug delivery device, the device further comprises a plurality of indexed members, each of the indexed members being configured to have an interfitting shape for the corresponding indexed members And is configured so as not to have an interfitting shape for non-corresponding indexed members.
In yet another exemplary embodiment of the drug delivery device, the one or more indexed members are configured to predetermine and display the canister concentration and characteristics of the API.
In another exemplary embodiment of the drug delivery device, the API comprises nitrogen oxide, the inert carrier gas comprises N 2 , and the canister concentration is about 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm, 10,000 ppm.
In yet another exemplary embodiment of the drug delivery device, the indexed members are configured to additionally predetermine and display an initial volume of about 32 L of compressed gas or 0.16 L of liquid.
In yet another exemplary embodiment of the drug delivery device, wherein the API comprises carbon monoxide, and an inert carrier gas comprises an O 2, optionally, the balance (balance) is the canister concentration is about 500, and containing the N 2 ppm or 3000 ppm to 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-like needle valve.
In another exemplary embodiment of the drug delivery device, the first indexed member or the second indexed member is a key.
In another exemplary embodiment of the drug delivery device, the key is a tongue, a rake, a post, a ridge, a protrusion or a rail.
In yet another exemplary embodiment of the drug delivery device, the first indexed member or the second indexed member is an opening.
In another exemplary embodiment of the drug delivery device, the opening is a groove, slot, channel, hole or hole.
In another exemplary embodiment of the drug delivery device, the first indexed member is an opening, the second indexed member is a key, the third indexed member is an aperture and the fourth indexed member is a key.
In another exemplary embodiment of the drug delivery device, the first indexed member is a slot, the second indexed member is a rail, the third indexed member is a slot, and the fourth indexed member is a rail.
In another exemplary embodiment of the drug delivery device, the cam is configured to engage a compression spring and the compression spring is configured to engage the carriage.
Another aspect of the invention is a method of forming pulmonary vasodilation in a patient as needed, the method comprising:
- providing any of the aforementioned drug delivery devices for delivery of nitric oxide, and
- delivering the rate of administration of nitric oxide or the amount of controlled and adjusted drug to the patient.
Another aspect of the present invention is to provide a method of treating an organ transplant, outcomes in a delayed graph function on organ transplantation, cystic fibrosis, a disease selected from the group consisting of ileus, necrotizing enterocolitis, vascular restenosis, hepatitis, hemorrhagic shock, and acute liver failure associated with hepatitis or The method comprising the step of providing any of the above mentioned drug delivery devices for delivering carbon monoxide doses or adjusted and adjusted medicament doses to the patient.
- a receiving assembly comprising a container configured to engage with at least a portion of an indexable drug containing device,
- a seat configured to engage a valve of the indexed drug containing device,
1 is a perspective view of a portion of a color canister assembly;
Figure 2 is a front view of a portion of the interface between the collar and the canister.
Figure 3 is a side cross-sectional view of the collar canister assembly of Figure 1 showing a receptacle prior to coupling the assembly.
FIG. 4 is a side cross-sectional view of the collar canister assembly of FIG. 1 showing the container in engagement with the assembly; FIG.
5 is a perspective view illustrating a portion of a color canister assembly including a radio frequency identification device.
Figure 6 is a front sectional view showing a portion of a color canister assembly positioned within a compressed gas drug delivery device. Figure 6 also shows the lever and cover of the delivery device in the open position.
7 is a front sectional view illustrating a portion of a color canister assembly positioned within a compressed gas drug delivery device. Figure 7 also shows the lever and cover of the delivery device in the operative position.
8 is a perspective view of a compressed gas drug delivery device including a color canister assembly.
As described herein, aspects and embodiments of the present invention can be used to deliver a medical pharmaceutical gas to a patient when it is necessary to treat a complex disease or disorder. For example, a drug delivery device as described herein may be used to treat sickle cell disease, as described in U.S. Patent No. 5,885,621, or in U.S. Patent Nos. 5,873,359 and 5,485,827 Can be used to deliver nitric oxide to a patient to treat reversible pulmonary hypertension as described in U. S. Patent No. 5,102, 607, which is incorporated herein by reference.
Also, as described herein, a drug delivery device can be used to treat or prevent the following diseases: an organ transplant outcome such as that described in U.S. Patent Application No. 11 / 401,722 (US 2007/02020083); Cystic fibrosis as described in U.S. Patent Application No. 10 / 053,535 (US 2002/0155166); Ileus (ileus) as described in U.S. Patent Application No. 10 / 371,666 (US 2003/0219497); Necrotizing enterocolitis as described in U.S. Patent Application No. 10 / 413,817 (US 2004/0005367); Vascular diseases including vascular restenosis as described in U.S. Patent Application Nos. 10 / 367,277 (US 2003/0219496) and 12 / 050,826 (US 2008/0167609); Alternatively, it may be used to deliver carbon monoxide to the patient to treat hepatitis, including acute liver failure as described in U.S. Patent Application No. 10 / 439,632 (US 2004/0052866) All patents are incorporated herein by reference.
As used herein, the term " key " (and variations thereof) refers to a tongue, a prong, a post, a rail, a ridge, protrusion &lt; / RTI &gt; and the like.
As used herein, the term " opening " (and variations thereof) refers to a key, such as a slot, a groove, a channel, an aperture or a hole, Quot; means a structure formed by one or more adjacent or surrounding structures configured to engage.
As used herein, the term " member " (and variations thereof) includes both a key and an opening.
As used herein, the term " indexed " (and variations thereof) means that the dosing concentration and / or identity of the active pharmaceutical ingredient (API) Which means that it is designed to display.
As used herein, the term " complementary " (and variations thereof) means that the indexed member and the corresponding indexed member form an interface to form an interface It means that the interface flushes to be sufficient.
As used herein, the term " non-complementary " (and variations thereof) means that the two indexed members do not have an interfitting shape.
As used herein, the term " interface " (and variations thereof) means a flat surface of an indexed member having two interfitting shapes.
An indexed drug actuating device 10 for use in the indexed drug delivery and conditioning device 70 (FIG. 8) is shown in FIG. The indexing-type drug actuating device 10 can be used to indexing a specific drug delivery device that allows a particular drug delivery device to dispense APIs with a predetermined concentration contained within a pharmaceutically inactive carrier gas. features. The indexed device 10 includes a collar 12 and an indexed drug containing device 24. [ The device 24 includes an indexed valve assembly 13 threaded to the canister 28.
In one exemplary embodiment, the indexed device 10 contains 100 ppm or 800 ppm nitric oxide according to the current drug label insert for INOmax (R) (Nitric Oxide) for inhalation (SPC-0303 V: 3.0), which is incorporated herein by reference. This indexed device 10 may also be used in conjunction with other formulations of INOmax® at higher concentrations, such as 2400 ppm nitrogen oxide. For example, the indexing properties may only allow binding of the device 10 containing nitric oxide and / or a certain concentration of nitric oxide.
The API may be carbon monoxide, nitrogen oxide, or a chalcogenide compound. The API concentration may be any concentration within the range of 100 ppm to 15,000 ppm. The inert carrier gas may include O 2 , N 2, and / or another pharmaceutically suitable inert carrier gas. The canister 28 may have sufficient capacity to store 30 L to 35 L at pressures between 2000 psig and 3000 psig. Other canisters of different sizes with different pressures and capacities may also be used.
1, the indexing-type drug actuating device 10 includes a collar 12 configured transversely engageable with a valve housing 26 of an indexed valve assembly 13. The collar 12 is generally U-shaped and includes a first arm 14 and a second arm 16. The collar 12 engages the housing 26 in a transverse direction. The inner faces 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 and second collar keys 18 and 20 are elongated in a transverse direction 19 to provide a rail structure.
As used herein, the term " transverse direction " (and variants such as transversely) may be used to refer to the fact that indexed valve assembly 13 may engage collar 12, 12, which direction is perpendicular to the longitudinal axis 21.
As used herein, the term " longitudinal axis " (and the term " longitudinal axis " Axis. &Lt; / RTI &gt;
The first and second color keys 18,20 may be different in shape to provide indexing characteristics and functions (such as cross-sectional shape, axial position, axial width, or alignment direction). Other forms, arrangement states, shapes, and combinations thereof of the color keys 18 and 20 are described in further detail below. The first and second color keys 18,20 also provide an arcuate key 22 between the first and second arms 14,16 which can also be displayed for API identification It is.
The sides of the valve housing 26 include a structure that engages the collar keys 18,20. Specifically, one side of the valve housing 26 has an upper key ridge 34 extending outwardly in a radial direction 29 relative to the first opening 36 that receives the first collar key 18 .
As used herein, the term "radial direction" (and the term "radial" as the term "radial") refers to a direction perpendicular to the longitudinal axis 21 do.
The term " radially inwardly " (and its variants) refers to the radial direction of the longitudinal axis 21.
The term " radially outwardly " (and its variants) means to be away from the longitudinal axis 21 in the radial direction.
The first opening 36 may also engage a portion of the arcuate key 22. The face of the valve housing 26 includes a lower key ridge 38 longitudinally opposite the upper key ridge 34 extending radially outwardly with respect to the first opening 36.
As shown in FIGS. 1, 3 and 4, the opposite side of the valve housing 26 also includes upper and lower key ridges 34, 34 extending radially outwardly with respect to the second opening 36 ' 38). The second opening (36 ') receives the second collar key (20). The openings 36 and 36 'have mutually-fitting shapes with respect to the collar keys 18 and 20, respectively.
The 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. may also be used.
Alternatively, the cross-sectional shapes of the indexed members 18,36 and 20/36 'sets may be different. For example, the indexed members 18, 36 may have a rectangular cross-section and the indexed members 20, 36 'may have a trapezoidal cross-section. The cross-sectional shape and / or other structural characteristics of the set of indexed members 18, 36 and 20, 36 'provide indexing and / or dosing concentration of the aforementioned API.
As a result, indexed collar 12 is only associated with indexed drug containing device 24 and indexing properties are provided to members having a fully interfitted shape that is identified for a predetermined API and / or dosage concentration . The cross-sectional shape and / or other structural features of the indexed member 18, 36 and 20, 36 'set may be adjusted by the collar 12 and the valve housing 26 For example, for indexed members that do not have an interfitting shape on the base plate. This is so that the first collar key 18 does not have an inter-fitting shape with the second opening 36 and the second collar key 20 does not have an inter-fitting shape with the first opening 36, 28 can be inserted into the collar 12 only in one direction. It is possible to provide a structure in which the relief valve 32 including the relief outlet 33 is prevented from being inadvertently engaged with the collar 12 and the valve housing 26. Even if there is no relief valve 32, it is possible for the valve housing to be fully engaged with the collar if the valve housing does not have an opening in the relief valve position that will cause the arched key of the collar to mate with the opening I will not.
The valve housing 26 may also include additional keys and the collar 12 may also include additional openings. The valve housing 26 and collar 12 may each include one or more keys and one or more openings. The collar 12 may include different types of keys. The valve housing 26 may also include openings of different types. For example, the collar 12 may include one or more posts instead of the arcuate keys 22 and a rail along the first and second arms 14,16. The valve housing 26 may include one or more apertures for receiving the posts and a slot for receiving the rails.
As shown in Figures 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 is threadably engaged with the neck portion 30 of the canister 28. The canisters 28 are aligned side-by-side along the longitudinal axis 21. Alternatively, the valve housing 26 may communicate with the canister 28 via a conduit or hose (not shown).
The connection between the valve housing 26 and the canister 28 includes an o-ring 31 configured to prevent the API and carrier gas from escaping from the canister 28 (see Figures 3 and 4) . The valve housing 26 also includes an optional relief valve 32 threaded within the valve housing 26. The relief valve 32 includes a relief discharge portion 33. The relief valve 32 is designed to prevent over-pressurization of the contents of the canister 28 due to overfilling or overheating of the canister during manufacture, for example, Or any suitable valve known to those skilled in the art.
As shown in FIG. 2, the characteristics of the API and / or the characteristics of the interface 18/36 and / or 20/36 'may be modified by one or more different axial widths, axial juxtaposition, different cross- Indexing properties corresponding to the administration concentration can be provided.
As used herein, the term "axial juxtaposition" means that the mid-planes of the interfaces 18/36 and 20/36 'are offset (ie, But are not aligned side by side).
As used herein, the term " mid-plane " (and variations thereof) means a plane perpendicular to the longitudinal axis dividing the interface.
As used herein, the term " aligned " (and variations thereof, such as " alignment ") means that the center-plane of two or more interfaces is coplanar It means coplanar.
As used herein, the term " offset " (and its variants) means that two or more center-planes are not in a plane.
Several representative 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' has a first interface 118/136 ' Axially juxtaposed axially underneath the mid-plane of the rotor.
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 interfaces 218/236 and 220/236' Are arranged side by side.
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' Are arranged in parallel in the axial direction on the center-plane of the interfaces 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 has a smaller axial width than the second interface 420/436' (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 interfaces 518/536 and 520/536' Are arranged side by side.
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 has a smaller axial width than the second interface 620/636' (620/636 ') in the axial direction.
Embodiments of interfaces 118/136 and 120/136 'shown in FIG. 2 and other embodiments may each indicate an API characteristic and / or a dose concentration. For example, one embodiment of these embodiments would require member indexing wherein the drug-containing device 24 contains nitric oxide at a concentration of 100 ppm and the collar has an interfitting shape.
As shown in Figures 1, 3 and 4, the valve housing 26 is opposite the canister 28 and further includes a second end adjacent the interface 18/36 and 20/36 ' . The second end forms a valve discharge portion 40 including an o-ring 41 for sealing the valve assembly 13 in some cases, as described below.
3 and 4, the valve outlet 40 is in fluid communication with a needle valve 42 arranged in a passageway within the valve housing 26. As shown in FIG. The needle valve 42 includes an inlet portion 43 which is connected in a threaded manner to a valve housing 26 near the valve inlet 27. The needle valve 42 also includes a movable discharge portion 46 secured in a normally closed position by a compression spring 44. The compression spring 44 urges the canister 28 and the valve outlet 40 in such a manner that the outlet portion 46 (and optionally the seal ring 48) is pushed against the inner wall within the valve housing 26, Thereby preventing the flow between them. When the movable discharge portion 46 is in the open position (FIG. 4), the gas from the canister can be discharged through the outlet 49 and out of the needle valve 42. The seal ring 48 may be made of conventional materials such as rubber or Teflon. The needle valve 42 has a co-axial internal passageway through which gas exits through the central passage outlet.
3, 4 and 7, the valve-receiving assembly 80 includes a container 84 which axially engages the valve housing 26 in the operative position. The vessel 84 includes sidewalls 86 surrounding the valve housing 26 and allows for alignment prior to valve engagement. The vessel 84 also includes an elongate seat 88 which forms a seal against the o-ring 41 and which engages the needle valve 42. The seat 88 moves in the axial direction or actuates the needle valve 42 in the operative position. When the needle valve 42 is actuated, the receptacle assembly 80 and the canister 28 in the seat 88 can be in flow communication between the canister passage 90 and the canister 28. The collar 12 is fixed to the carriage 73.
After operation, the process of dispensing compositions from the canister 28 and the container passageway 90 may be controlled by an automated program and / or keypad 72 and controlled by the drug delivery and regulating device 70 (Fig. 8). The device 70 is described in U.S. Patent Nos. 5,885,621; 5,558,083; 5,732,693; 5,752,504; 5,699,790; 5,732,694; 6,089,229; 6,109,260; 6,125,846; 6,164,276; 6,581,592; 5,918,596; 5,839,433; 7,114,510; 5,417,950; 5,670,125; 5,670,127; 5,692,495; 5,514,204; 5,885,621; 6,125,846; And 7,523,752, as well as U.S. Patent Application No. 11 / 355,670 (US 2007/0190184); 11 / 401,722; 10 / 053,535; 10 / 367,277; 10 / 439,632; And 10 / 520,270 (US 2006/0093681), API or compositions thereof and / or corresponding devices or any suitable combination of these devices, all of which are incorporated herein by reference. Which is incorporated herein by reference. Drug formulations and dosage forms of the formulations and related treatment methods are contemplated for use with the present invention.
6-8, the drug delivery and conditioning device 70 includes a keypad 72 that allows the user to control and / or program the delivery of the API from the canister 28. [ The compressed gas drug delivery device 70 includes a carriage 73 having a collar 12 fixedly mounted thereon. And the pivotal swivel cover 74 is fixed to the lever 76. The cover 74 and the lever 76 both operate in an open position (see FIG. 6; the indexable drug containing device 24 may be inserted into or removed from the collar 12) / Closed position (see FIG. 7; the collar 12 and the drug-containing device 24 are fixed). Once in the activated / closed position, the drug-containing device 24 is preferably protected from the external environment and is particularly preferably in a hospital environment.
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 an operative position. On the other hand, the receiving assembly 80 is pushed upwards by the rod / compression spring assembly 82 and disengaged from the valve assembly 24 in the open position. The lever 76, the cam 78, the rod / compression spring assembly 82 and the carriage 73 can be moved to a plunger assembly to axially actuate the drug- .
As shown in FIG. 5, the canister assembly may include a radio frequency identification (RFID) device 50 arranged around the neck portion 30 of the canister 28. The radio frequency identification device 50 transmits radio frequencies to an RFID reader (not shown) arranged in the delivery device to provide more identification features. This means that the RFID reader can be used to determine whether a correct canister is inserted or an improper canister is inserted.
From the foregoing, it can be seen that the present invention provides the following advantages: a linear-actuated canister assembly that can be installed without tools; A device in which a single movement aligns the valve, seals the valve and opens the valve; It will also be clear that it provides any combined advantage of indexing properties of the combined drug (e.g., nitric oxide, carbon monoxide, and the like).
Representative embodiments of the invention have been described in great detail. Various modifications and improvements to the above described exemplary embodiments will be apparent to those skilled in the art. Accordingly, the invention is not to be limited to the embodiments described above, but should be defined by the following claims.
An indexed drug-containing device assembly for a drug delivery regulator,
A canister containing a gas containing an active pharmaceutical ingredient, the canister having a valve for regulating gas flow from the canister by operating along a longitudinal axis of the canister, and
A housing surrounding a portion of the valve, the housing having a first indexed member integral with the housing,
Wherein the first indexed member comprises a first opening and a second opening arcuately extending in and around a portion of the opposite side of the longitudinal axis of the canister, the first and second openings having different axial widths An indexed drug-containing device assembly having a central plane that is different from each other.
2. The drug delivery device of claim 1, wherein the first indexed member is configured to have an interdigitated configuration with respect to the second indexed member of the drug delivery control device, such that the indexed drug containing device assembly has a relative motion perpendicular to the longitudinal axis An indexed drug containing device assembly that is seated within and removable from a drug delivery control device when aligned.
The assembly of claim 1 or 2, wherein the active pharmaceutical ingredient comprises nitric oxide.
3. The pharmaceutical composition according to claim 1 or 2, wherein the active pharmaceutical ingredient is
Nitrogen oxides having a concentration ranging from 50 ppm to 10,000 ppm,
Carbon monoxide having a concentration ranging from 500 ppm to 20,000 ppm and
At least one of the chalcogenide compounds,
Wherein the canister further comprises an inert carrier gas comprising at least one of N 2 or O 2 .
3. The assembly as claimed in claim 1 or 2, wherein the first opening is directly opposite the second opening.
3. The indexing-type drug-containing device assembly according to claim 1 or 2, wherein the first indexed member is configured to have an inter-fitting shape with respect to the second indexed member to permit operation of the valve.
3. The indexing-type drug-containing device assembly according to claim 1 or 2, further comprising a radio frequency identification device arranged around the neck of the canister for transmitting radio frequency to an RFID reader arranged in the drug delivery regulator.
KR1020177013523A 2009-05-27 2009-05-27 Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery KR101899271B1 (en)
PCT/US2009/045266 WO2010138114A1 (en) 2009-05-27 2009-05-27 Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery
KR20170059490A KR20170059490A (en) 2017-05-30
KR101899271B1 true KR101899271B1 (en) 2018-09-14
ID=41383489
KR1020177013523A KR101899271B1 (en) 2009-05-27 2009-05-27 Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery
KR1020167026301A KR101740209B1 (en) 2009-05-27 2009-05-27 Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery
KR1020117031109A KR101567125B1 (en) 2009-05-27 2009-05-27 Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery
KR1020157031346A KR101661872B1 (en) 2009-05-27 2009-05-27 Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery
US (4) US8757148B2 (en)
EP (3) EP3210644B1 (en)
JP (1) JP5639645B2 (en)
KR (4) KR101899271B1 (en)
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CA (1) CA2763111A1 (en)
CY (1) CY1120440T1 (en)
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HK (1) HK1217664A1 (en)
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WO (1) WO2010138114A1 (en)
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