U.S. patent application number 17/509556 was filed with the patent office on 2022-02-10 for 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.
This patent application is currently assigned to Mallinckrodt Hospital Products IP Unlimited Company. The applicant listed for this patent is Mallinckrodt Hospital Products IP Unlimited Company. Invention is credited to Todd J. Bakken, Duncan P. Bathe, Scott I. Biba, Daniel J. Lee, Frederick J. Montgomery.
Application Number | 20220040438 17/509556 |
Document ID | / |
Family ID | 1000005925910 |
Filed Date | 2022-02-10 |
United States Patent
Application |
20220040438 |
Kind Code |
A1 |
Montgomery; Frederick J. ;
et al. |
February 10, 2022 |
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
Abstract
A valve assembly comprising a housing and a valve, the valve
being disposed within the housing, a first indexed member integral
to the housing, the first indexed member adapted to be
complementary to a second indexed member, and a radio frequency
identification device adapted to communicate with a radio frequency
receiver, the valve being configured to align with a canister, seal
the canister and open in a single movement. A drug containment
device having said valve assembly is also disclosed.
Inventors: |
Montgomery; Frederick J.;
(Sun Prairie, WI) ; Bathe; Duncan P.; (Fitchburg,
WI) ; Lee; Daniel J.; (Fremont, CA) ; Biba;
Scott I.; (Madison, WI) ; Bakken; Todd J.;
(Madison, WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Mallinckrodt Hospital Products IP Unlimited Company |
Mulhuddart |
|
IE |
|
|
Assignee: |
Mallinckrodt Hospital Products IP
Unlimited Company
Mulhuddart
IE
|
Family ID: |
1000005925910 |
Appl. No.: |
17/509556 |
Filed: |
October 25, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15899063 |
Feb 19, 2018 |
11154684 |
|
|
17509556 |
|
|
|
|
14301692 |
Jun 11, 2014 |
9895199 |
|
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15899063 |
|
|
|
|
13260505 |
Sep 26, 2011 |
8757148 |
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PCT/US2009/045266 |
May 27, 2009 |
|
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|
14301692 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F17C 2205/0382 20130101;
F17C 2221/031 20130101; F17C 2221/014 20130101; A61M 2202/0208
20130101; A61M 2202/0233 20130101; F17C 2201/058 20130101; F17C
2205/0153 20130101; A61B 90/90 20160201; F17C 2205/0188 20130101;
F17C 2201/0109 20130101; F17C 2260/028 20130101; A61M 2202/0266
20130101; A61M 16/20 20130101; A61B 90/94 20160201; F17C 2205/0323
20130101; A61M 16/209 20140204; A61M 2205/6054 20130101; A61M
2202/0275 20130101; A61M 16/14 20130101; F17C 13/003 20130101; F17C
13/04 20130101; A61M 2205/6045 20130101; F17C 2205/058 20130101;
A61B 90/98 20160201; F17C 2223/013 20130101; F17C 2223/0123
20130101; F17C 2270/025 20130101; F17C 2201/0104 20130101; F17C
2270/02 20130101; A61M 16/12 20130101; F17C 2201/032 20130101 |
International
Class: |
A61M 16/14 20060101
A61M016/14; A61M 16/12 20060101 A61M016/12; A61M 16/20 20060101
A61M016/20; A61B 90/94 20060101 A61B090/94; A61B 90/98 20060101
A61B090/98; F17C 13/04 20060101 F17C013/04; F17C 13/00 20060101
F17C013/00; A61B 90/90 20060101 A61B090/90 |
Claims
1. A valve assembly comprising: a housing and a valve, the valve
being disposed within the housing; a first indexed member integral
to the housing, the first indexed member adapted to be
complementary to a second indexed member; and a radio frequency
identification device adapted to communicate with a radio frequency
receiver, wherein the valve is configured to align with a canister,
seal the canister and open in a single movement.
2. A drug containment device comprising: a valve assembly
comprising a housing and a valve disposed within the housing, a
first indexed member integral to the housing, the first indexed
member adapted to be complementary to a second indexed member, a
canister in fluid communication with the valve assembly, the
canister containing an active pharmaceutical ingredient and, a
radio frequency identification device adapted to communicate with a
radio frequency receiver, wherein the valve is configured to align
with the canister, seal the canister and open in a single
movement.
3. The valve assembly of claim 1, wherein the radio frequency
identification device is adapted to communicate to the radio
frequency receiver identifying information of the contents of a
canister that is attachable to the valve.
4. The valve assembly of claim 1, wherein the valve assembly is
attachable to a canister comprising an active pharmaceutical
ingredient including one of nitric oxide, with a concentration in
the range of approximately 50 ppm to 10,000 ppm, carbon monoxide
with a concentration in the range of approximately 500 ppm to
20,000 ppm, or, a chalcogenide compound and an inactive carrier gas
comprising at least one of N.sub.2 and O.sub.2.
5. The valve assembly of claim 1, wherein the valve is linearly
actuated.
6. The valve assembly of claim 5, wherein the valve is configured
to align with the canister, seal the canister and open in a single
movement.
7. The drug containment device of claim 4, wherein the first and
second indexed members are predeterminately adapted to indicate the
identity and canister concentration of the active pharmaceutical
ingredient.
8. The valve assembly of claim 2, wherein the radio frequency
identification device is adapted to communicate to the radio
frequency receiver identifying information of the active
pharmaceutical ingredient.
9. The drug containment device of claim 2, wherein the active
pharmaceutical ingredient comprises one of nitric oxide, with a
concentration in the range of approximately 50 ppm to 10,000 ppm,
carbon monoxide with a concentration in the range of approximately
500 ppm to 20,000 ppm, or, a chalcogenide compound and the inactive
carrier gas comprises at least one of N.sub.2 and O.sub.2.
10. The drug containment device of claim 2, wherein the first and
second indexed members are predeterminately adapted to indicate the
identity and concentration of an active pharmaceutical ingredient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 15/899,063, filed on Feb. 19, 2018,
which is a continuation application of U.S. patent application Ser.
No. 14/301,692, filed on Jun. 11, 2014, now U.S. Pat. No.
9,895,199, which is a continuation application of U.S. patent
application Ser. No. 13/260,505, now U.S. Pat. No. 8,757,148, which
is the National Phase entry of PCT/US2009/045266, filed May 27,
2009, the entire content of which are incorporated herein by
reference in their entirety.
STATEMENT CONCERNING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT
[0002] Not Applicable.
BACKGROUND OF THE INVENTION
[0003] Various keying and canister or cylinder actuation devices
are known. In the technology concerning the inhalation of drugs
from pressurized cylinders, the cylinders have been large and not
easily portable. The cylinders are also unprotected to the
surrounding hospital environment, which can be physically rigorous.
The connection between the cylinder and the regulation device can
be cumbersome.
[0004] Perhaps the most significant drawback, however, is the risk
of connecting a cylinder containing an inappropriate, wrong or
otherwise unsuitable drug and/or dosing concentration to the
regulation device.
[0005] Hence, devices that provide improved connection of the
cylinder to the regulation device, improved protection of the
cylinder, enhanced portability of the cylinder, and, means for
ensuring that a cylinder containing the correct drug and dosing
concentration is connected to the drug delivery and regulation
device would be advantageous.
SUMMARY OF THE INVENTION
[0006] One aspect of the invention is an indexed valve assembly
comprising a housing and a valve, the valve disposed within the
housing, and, a first indexed member integral to the housing, the
first indexed member adapted to be complementary to a second
indexed member.
[0007] In an exemplary embodiment of the indexed valve assembly,
the assembly further comprises a third indexed member integral to
the housing, the third indexed member adapted to be complementary
to a fourth indexed 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.
[0008] In another exemplary embodiment of the indexed valve
assembly, the assembly further comprises a plurality of indexed
members, each indexed member adapted to be complementary to a
corresponding indexed member and non-complementary to a
non-corresponding indexed member.
[0009] In another exemplary embodiment of the indexed valve
assembly, one or more indexed members are predeterminately adapted
to indicate the identity and canister concentration of an active
pharmaceutical ingredient (API).
[0010] In another exemplary embodiment of the indexed valve
assembly, the API comprises nitric oxide, and, the canister
concentration is in the range of approximately 50 ppm or 100 ppm to
800 ppm, 2400 ppm, 2500 ppm or 10,000 ppm. The concentrations
herein may also be expressed in mg/L, whereby the conversion is
approximately 12 mg/L per 10,000 ppm.
[0011] In another exemplary embodiment of the indexed valve
assembly, the indexed members are further predeterminately adapted
to indicate an initial volume of approximately 32 L of compressible
gas or 0.16 L of liquid.
[0012] In another exemplary embodiment of the indexed valve
assembly, the API comprises carbon monoxide, and, the canister
concentration is in the range of approximately 500 ppm or 3000 ppm
to 5000 ppm, 10,000 ppm, 15,000 ppm or 20,000 ppm.
[0013] In another exemplary embodiment of the indexed valve
assembly, the API comprises a chalcogenide compound.
[0014] In another exemplary embodiment of the indexed valve
assembly, the valve is a spring-biased needle valve.
[0015] In another exemplary embodiment of the indexed valve
assembly, the first indexed member or second indexed member is a
key.
[0016] In another exemplary embodiment of the indexed valve
assembly, the key is a tongue, prong, post, ridge, protrusion or
rail.
[0017] In another exemplary embodiment of the indexed valve
assembly, the first indexed member or second indexed member is an
opening.
[0018] In another exemplary embodiment of the indexed valve
assembly, the opening is a groove, slot, channel, aperture or
hole.
[0019] 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 opening,
and, the fourth indexed member is a key.
[0020] In another exemplary embodiment of the indexed valve
assembly, the first indexed member is a slot, the second indexed
member is rail, the third indexed member is a slot, and, the fourth
indexed member is a rail.
[0021] Another aspect of the invention is an indexed drug
containment device for inhalation comprising a valve assembly
comprising a housing and a valve, the valve disposed within the
housing, a first indexed member integral to the housing, the first
indexed member adapted to be complementary to a second indexed
member, and, a canister in fluid communication with the valve
assembly, the canister containing an API and a inactive carrier
gas.
[0022] In an exemplary embodiment of the indexed drug containment
device, the device further comprises a third indexed member
integral to the housing, the third indexed member adapted to be
complementary to a fourth indexed 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.
[0023] In another exemplary embodiment of the indexed drug
containment device, the device further comprises a plurality of
indexed members, each indexed member adapted to be complementary to
a corresponding indexed member and non-complementary to a
non-corresponding indexed member.
[0024] In another exemplary embodiment of the indexed drug
containment device, one or more indexed members are
predeterminately adapted to indicate the identity and canister
concentration of the API.
[0025] In another exemplary embodiment of the indexed drug
containment device, the API comprises nitric oxide, the inactive
carrier gas comprises nitrogen gas (N.sub.2), and, the canister
concentration is in the range of approximately 50 ppm or 100 ppm to
800 ppm, 2400 ppm, 2500 ppm or 10,000 ppm.
[0026] In another exemplary embodiment of the indexed drug
containment device, the indexed members are further
predeterminately adapted to indicate an initial volume of
approximately 32 L of compressible gas or 0.16 L of liquid.
[0027] In another exemplary embodiment of the indexed drug
containment device, the API comprises carbon monoxide, the inactive
carrier gas comprises oxygen gas (O.sub.2) and, optionally, the
balance comprising N.sub.2, and, the canister concentration is in
the range of approximately 500 ppm or 3000 ppm to 5000 ppm, 10,000
ppm, 15,000 ppm or 20,000 ppm.
[0028] In another exemplary embodiment, the carrier gas comprises
around 30% O.sub.2 and 70% N.sub.2.
[0029] In another exemplary embodiment of the indexed drug
containment device, the API comprises a chalcogenide compound at a
suitable concentration.
[0030] In another exemplary embodiment of the indexed drug
containment device, the valve is a spring-biased needle valve.
[0031] In another exemplary embodiment of the indexed drug
containment device, the first indexed member or second indexed
member is a key.
[0032] In another exemplary embodiment of the indexed drug
containment device, the key is a tongue, prong, post, ridge,
protrusion or rail.
[0033] In another exemplary embodiment of the indexed drug
containment device, the first indexed member or second indexed
member is an opening.
[0034] In another exemplary embodiment of the indexed drug
containment device, the opening is a groove, slot, channel,
aperture or hole.
[0035] In another exemplary embodiment of the indexed drug
containment device, the first indexed member is an opening, the
second indexed member is a key, the third indexed member is an
opening, and, the fourth indexed member is a key.
[0036] In another exemplary embodiment of the indexed drug
containment device, the first indexed member is a slot, the second
indexed member is rail, the third indexed member is a slot, and,
the fourth indexed member is a rail.
[0037] Another aspect of the invention is an indexed drug actuation
device comprising a valve assembly comprising a housing and a
valve, the valve disposed within the housing, a first indexed
member integral to the housing, the first indexed member adapted to
be complementary to a second indexed member, a canister in fluid
communication with the valve assembly, the canister containing an
API and a inactive carrier gas, and, a collar comprising the second
indexed member, the second indexed member integral to the
collar.
[0038] In an exemplary embodiment of the indexed drug actuation
device, the device further comprises a third indexed member
integral to the housing and a fourth indexed member integral to the
collar, the third indexed member adapted to be complementary to the
fourth indexed 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.
[0039] In an exemplary embodiment of the indexed drug actuation
device, the device further comprises a plurality of indexed
members, each indexed member adapted to be complementary to a
corresponding indexed member and non-complementary to a
non-corresponding indexed member.
[0040] In another exemplary embodiment of the indexed drug
actuation device, one or more indexed members are predeterminately
adapted to indicate the identity and canister concentration of the
API.
[0041] In another exemplary embodiment of the indexed drug
actuation device, the API comprises nitric oxide, the inactive
carrier gas comprises N.sub.2 and, the canister concentration is in
the range of approximately 50 ppm or 100 ppm to 800 ppm, 2400 ppm,
2500 ppm or 10,000 ppm.
[0042] In another exemplary embodiment of the indexed drug
actuation device, the indexed members are further predeterminately
adapted to indicate an initial volume of approximately 32 L of
compressible gas or 0.16 L of liquid.
[0043] In another exemplary embodiment of the indexed drug
actuation device, the API comprises carbon monoxide, the inactive
carrier gas comprises O.sub.2 and, optionally the balance comprises
N.sub.2, and, the canister concentration is in the range of
approximately 500 ppm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000
ppm or 20,000 ppm.
[0044] In another exemplary embodiment of the indexed drug
actuation device, the API comprises a chalcogenide compound.
[0045] In another exemplary embodiment of the indexed drug
actuation device, the valve is a spring-biased needle valve.
[0046] In another exemplary embodiment of the indexed drug
actuation device, the first indexed member or second indexed member
is a key.
[0047] In another exemplary embodiment of the indexed drug
actuation device, the key is a tongue, prong, post, ridge,
protrusion or rail.
[0048] In another exemplary embodiment of the indexed drug
actuation device, the first indexed member or second indexed member
is an opening.
[0049] In another exemplary embodiment of the indexed drug
actuation device, the opening is a groove, slot, channel, aperture
or hole.
[0050] In another exemplary embodiment of the indexed drug
actuation device, the first indexed member is an opening, the
second indexed member is a key, the third indexed member is an
opening, and, the fourth indexed member is a key.
[0051] In another exemplary embodiment of the indexed drug
actuation device, the first indexed member is a slot, the second
indexed member is rail, the third indexed member is a slot, and,
the fourth indexed member is a rail.
[0052] Another aspect of the invention is an indexed drug delivery
device comprising a valve assembly comprising a housing and a
valve, the valve disposed within the housing, a first indexed
member integral to the housing, the first indexed member adapted to
be complementary to a second indexed member, a canister in fluid
communication with the valve assembly, the canister containing an
active pharmaceutical ingredient and an inactive carrier gas, a
collar comprising the second indexed member, the second indexed
member integral to the collar, a receiving assembly comprising a
receptacle adapted to engage at least a portion of the housing,
and, a seat adapted to engage the valve, and, a plunger assembly
adapted to linearly actuate the valve assembly and canister along
an axis and to engage the valve and seat, the plunger assembly
comprising a carriage fixed to the collar, and, a lever having a
cam adapted to engage a spring, the spring adapted to linearly
actuate the carriage, valve assembly, canister and collar along the
axis.
[0053] In an exemplary embodiment of the indexed drug delivery
device, the device further comprises a third indexed member
integral to the housing and a fourth indexed member integral to the
collar, the third indexed member adapted to be complementary to the
fourth indexed 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.
[0054] In another exemplary embodiment of the indexed drug delivery
device, the device further comprises a plurality of indexed
members, each indexed member adapted to be complementary to a
corresponding indexed member and non-complementary to a
non-corresponding indexed member.
[0055] In another exemplary embodiment of the indexed drug delivery
device, one or more indexed members are predeterminately adapted to
indicate the identity and canister concentration of the API.
[0056] In another exemplary embodiment of the indexed drug delivery
device, the API comprises nitric oxide, the carrier gas comprises
N.sub.2 and, the canister concentration is in the range of
approximately 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm or
10,000 ppm.
[0057] In another exemplary embodiment of the indexed drug delivery
device, the indexed members are further predeterminately adapted to
indicate an initial volume of approximately 32 L of compressible
gas or 0.16 L of liquid.
[0058] In another exemplary embodiment of the indexed drug delivery
device, the API comprises carbon monoxide, the inactive carrier gas
comprises O.sub.2 and, optionally the balance comprises N.sub.2,
and, the canister concentration is in the range of approximately
500 ppm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm or 20,000
ppm.
[0059] In another exemplary embodiment of the indexed drug delivery
device, the API comprises a chalcogenide compound.
[0060] In another exemplary embodiment of the indexed drug delivery
device, the valve is a spring-biased needle valve.
[0061] In another exemplary embodiment of the indexed drug delivery
device, the first indexed member or second indexed member is a
key.
[0062] In another exemplary embodiment of the indexed drug delivery
device, the key is a tongue, prong, post, ridge, protrusion or
rail.
[0063] In another exemplary embodiment of the indexed drug delivery
device, the first indexed member or second indexed member is an
opening.
[0064] In another exemplary embodiment of the indexed drug delivery
device, the opening is a groove, slot, channel, aperture or
hole.
[0065] In another exemplary embodiment of the indexed drug delivery
device, the first indexed member is an opening, the second indexed
member is a key, the third indexed member is an opening, and, the
fourth indexed member is a key.
[0066] In another exemplary embodiment of the indexed drug delivery
device, the first indexed member is a slot, the second indexed
member is rail, the third indexed member is a slot, and, the fourth
indexed member is a rail.
[0067] 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 the carriage.
[0068] Another aspect of the invention is a valve assembly
comprising a housing and a valve, the valve disposed within the
housing, and, a radio frequency identification device adapted to
communicate with a radio frequency receiver.
[0069] Another aspect of the invention is a pressurized drug
containment device for inhalation comprising a valve assembly
comprising a housing and a valve, the valve disposed within the
housing, a radio frequency identification device adapted to
communicate with a radio frequency receiver, and, a canister in
fluid communication with the valve assembly, the canister
containing an API and a inactive carrier gas.
[0070] Another aspect is a method of engaging the above pressurized
drug-containing canister comprising linearly actuating along an
axis the above drug containment device to engage a receptacle and
to engage the valve with a seat.
[0071] Another aspect of the invention is a method of engaging a
pressurized canister comprising linearly actuating along an axis an
indexed drug-containing pressurized canister to engage a receptacle
and to engage the valve with a seat.
[0072] Another aspect of the invention is a method of engaging a
pressurized canister comprising linearly actuating along an axis an
indexed pressurized canister to engage a receptacle and to engage
the valve with a seat.
[0073] Another aspect of the invention is a drug delivery device
for regulating delivery of an API to a patient comprising a valve
assembly comprising a housing and a valve, the valve disposed
within the housing, a first indexed member integral to the housing,
the first indexed member adapted to be complementary to a second
indexed member, a canister in fluid communication with the valve
assembly, the canister containing the API and an inactive carrier
gas, a collar comprising the second indexed member, the second
indexed member integral to the collar, a receiving assembly
comprising a receptacle adapted to engage at least a portion of the
housing, and, a seat adapted to engage the valve, a plunger
assembly adapted to linearly actuate the valve assembly and
canister along an axis and to engage the valve and seat, the
plunger assembly comprising a carriage fixed to the collar, and, a
lever having a cam adapted to engage a spring, the spring adapted
to linearly actuate the carriage, valve assembly, canister and
collar along the axis, and, a controllable drug delivery and
regulation device adapted to regulate the delivery of the API to
the patient.
[0074] In an exemplary embodiment of the drug delivery device, the
device further comprises a third indexed member integral to the
housing and a fourth indexed member integral to the collar, the
third indexed member adapted to be complementary to the fourth
indexed 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.
[0075] In another exemplary embodiment of the drug delivery device,
the device further comprises a plurality of indexed members, each
indexed member adapted to be complementary to a corresponding
indexed member and non-complementary to a non-corresponding indexed
member.
[0076] In another exemplary embodiment of the drug delivery device,
one or more indexed members are predeterminately adapted to
indicate the identity and canister concentration of the API.
[0077] In another exemplary embodiment of the drug delivery device,
the API comprises nitric oxide, the inactive carrier gas comprises
N.sub.2, and, the canister concentration is in the range of
approximately 50 ppm or 100 ppm to 800 ppm, 2400 ppm, 2500 ppm or
10,000 ppm.
[0078] In another exemplary embodiment of the drug delivery device,
the indexed members are further predeterminately adapted to
indicate an initial volume of approximately 32 L of compressible
gas or 0.16 L of liquid.
[0079] In another exemplary embodiment of the drug delivery device,
the API comprises carbon monoxide, the inactive carrier gas
comprises O.sub.2 and, optionally a balance comprising N.sub.2,
and, the canister concentration is in the range of approximately
500 ppm or 3000 ppm to 5000 ppm, 10,000 ppm, 15,000 ppm or 20,000
ppm.
[0080] In another exemplary embodiment of the drug delivery device,
the API comprises a chalcogenide compound.
[0081] In another exemplary embodiment of the drug delivery device,
the valve is a spring-biased needle valve.
[0082] In another exemplary embodiment of the drug delivery device,
the first indexed member or second indexed member is a key.
[0083] In another exemplary embodiment of the drug delivery device,
the key is a tongue, prong, post, ridge, protrusion or rail.
[0084] In another exemplary embodiment of the drug delivery device,
the first indexed member or second indexed member is an
opening.
[0085] In another exemplary embodiment of the drug delivery device,
the opening is a groove, slot, channel, aperture or hole.
[0086] 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 opening, and, the fourth
indexed member is a key.
[0087] In another exemplary embodiment of the drug delivery device,
the first indexed member is a slot, the second indexed member is
rail, the third indexed member is a slot, and, wherein the indexed
member is a rail.
[0088] 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 the carriage.
[0089] Another aspect of the invention is a method of producing
pulmonary vasodilation in a patient in need thereof comprising
providing any of the above drug delivery devices for delivering
nitric oxide, and, delivering a controlled and regulated
pharmaceutical dose or dose rate of nitric oxide to the
patient.
[0090] Another aspect of the invention is a method of treating a
disease or disorder selected from the group consisting of outcomes
in organ transplant, delayed graph function associated with organ
transplant, cystic fibrosis, ileus, necrotizing enterocolitis,
vascular restenosis, hepatitis, acute liver failure associated with
hepatitis and hemorrhagic shock, in a patient in need thereof
comprising providing any of the above drug delivery devices for
delivering a controlled and regulated pharmaceutical dose or dose
rate of carbon monoxide to the patient.
[0091] Another aspect of the invention is a drug delivery device
for regulating delivery of an API to a patient comprising a
receiving assembly comprising a receptacle adapted to engage at
least a portion of an indexed drug containment device, a seat
adapted to engage the valve of the indexed drug containment device,
a plunger assembly adapted to linearly actuate the valve assembly
and canister along an axis and to engage the valve and seat, the
plunger assembly comprising a carriage fixed to the collar, and, a
lever having a cam adapted to engage a spring, the spring adapted
to linearly actuate the carriage, valve assembly, canister and
collar along the axis, and, a controllable drug delivery and
regulation device adapted to regulate the delivery of the API to
the patient.
BRIEF DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0092] FIG. 1 shows a partial perspective view of the collar
canister assembly.
[0093] FIG. 2 shows several partial front views illustrating
interfaces between the collar and the canister.
[0094] FIG. 3 shows a side sectional view of the collar canister
assembly of FIG. 1 illustrating the receptacle before engaging the
assembly.
[0095] FIG. 4 shows a side sectional view of the collar canister
assembly of FIG. 1 illustrating the receptacle engaging the
assembly.
[0096] FIG. 5 shows a partial perspective view of the collar
canister assembly including a radio frequency identification
device.
[0097] FIG. 6 shows a partial sectional front view of the collar
canister assembly positioned in a pressurized gas drug delivery
device. FIG. 6 also shows a cover and a lever of the delivery
device in an open position.
[0098] FIG. 7 shows a partial sectional front view of the collar
canister assembly positioned in the pressurized gas drug delivery
device. FIG. 7 also shows the cover and the lever of the delivery
device in an operating position.
[0099] FIG. 8 is a perspective view of a pressurized gas drug
delivery device including the collar canister assembly.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0100] The embodiments and aspects of the invention, as described
herein, may be used to deliver a medical pharmaceutical gas to a
patient in need of treatment for multiple diseases or disorders.
For example, the drug delivery devices, as described herein may be
used to deliver nitric oxide to a patient for the treatment of
reversible pulmonary hypertension as described in U.S. Pat. Nos.
("USPN's") 5,873,359 and 5,485,827; or, sickle cell disease as
described in U.S. Pat. No. 5,885,621, all of which are incorporated
herein by reference in their entirety.
[0101] In addition, the drug delivery devices, as described herein
may be used to deliver carbon monoxide to a patient for the
treatment of the following: Organ transplant outcomes as described
in U.S. patent application Ser. No. ("USSN") 11/401,722 (US
2007/02020083); cystic fibrosis as described in U.S. Ser. No.
10/053,535 (US 2002/0155166); ileus as described in U.S. Ser. No.
10/371,666 (US 2003/0219497); necrotizing enterocolitis as
described in U.S. Ser. No. 10/413,817 (US 2004/0005367); vascular
disease including vascular restenosis as described in U.S. Ser. No.
10/367,277 (US 2003/0219496) and U.S. Ser. No. 12/050,826 (US
2008/0167609); or, hepatitis including acute liver failure as
described in U.S. Ser. No. 10/439,632 (US 2004/0052866), all of
which are incorporated herein by reference in their entirety.
[0102] As used herein, the term "key" (and variations thereof)
means a structure adapted to engage a corresponding opening, such
as a tongue, prong, post, rail, ridge or protrusion.
[0103] As such, as used herein, the term "opening" (and variations
thereof) means a structure defined by one or more adjacent or
surrounding structures that is adapted to engage a key, such as a
slot, groove, channel, aperture or hole.
[0104] As used herein, the term "member" (and variations thereof)
includes both keys and openings.
[0105] As used herein, the term "indexed" (and variations thereof)
means that one or more members are designed to predeterminately
indicate the identity and/or dosing concentration of the API.
[0106] As used herein, the term "complementary" (and variations
thereof) means that an indexed member and a corresponding indexed
member engage to form an interface, whereby, upon engagement
sufficient for actuation, the interface is flush.
[0107] As used herein, the term "non-complementary" (and variations
thereof) means that two indexed members are not complementary.
[0108] As used herein, the term "interface" (and variations
thereof) means the flush surfaces of two complementary indexed
members.
[0109] Shown in FIG. 1 is an indexed drug actuation device 10 for
use in an indexed drug delivery and regulation device 70 (FIG. 8).
The indexed drug actuation device 10 provides indexing features
that permit specific drug delivery devices to dispense a
predetermined concentration of an API contained in a
pharmaceutically inactive carrier gas. The indexed device 10
includes a collar 12 and an indexed drug containment device 24. The
device 24 includes an indexed valve assembly 13 threaded to a
canister 28.
[0110] In an exemplary embodiment, the indexed device 10 contains
100 ppm or 800 ppm of nitric oxide in accordance with the current
drug label insert for INOmax.RTM. (nitric oxide) for inhalation
(SPC-0303 V:3.0), which is incorporated herein by reference in its
entirety. It may also be used in connection with other formulations
of INOmax.RTM. at higher concentrations such as 2400 ppm of nitric
oxide. For example, the indexing features may permit only
engagement of the device 10 containing nitric oxide and/or a
specific concentration of nitric oxide.
[0111] The API may be carbon monoxide, nitric oxide, or a
chalcogenide compound. The API concentration may be any
concentration within the range of 100 ppm to 15,000 ppm. The
inactive carrier gas may comprise O.sub.2, N.sub.2 and/or another
pharmaceutically suitable inactive carrier gas. The canister 28 may
have sufficient capacity to store 30 L to 35 L at a pressure in the
range of 2000 psig to 3000 psig. Other sized canisters with
different pressures and capacities may also be utilized.
[0112] As shown in FIG. 1, the indexed drug actuation device 10
includes a collar 12 configured to transversely engage 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 12 transversely engages the housing 26. 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, 20 are elongated in a transverse direction
19 to provide rail structures.
[0113] As used herein, the term "transverse direction" (and
variations thereof, such as "transversely") means a direction in
which the indexed valve assembly 13 is engagable and removable from
the collar 12, that is, perpendicular to the longitudinal axis
21.
[0114] As used herein, the term "longitudinal axis" (and variations
thereof, such as simply "axial") means an axis longitudinally
aligned with canister 28.
[0115] The first and second collar keys 18, 20 may differ in shape
(such as cross-sectional shape, axial position, axial width, or
orientation) to provide the indexing features and functionality.
Other shapes, arrangements, configurations, and combinations of the
collar keys 18, 20 are described in further detail below. The first
and second collar keys 18, 20 also provide an arcuate key 22
between the first and second arms 14, 16, which may also provide
indexing for API identification.
[0116] The sides of the valve housing 26 also include structures
that engage the collar keys 18, 20. Specifically, one side of the
valve housing 26 includes an upper key ridge 34 that extends
outwardly in a radial direction 29 relative to a first valve
opening 36 that accommodates the first collar key 18.
[0117] As used herein, the term "radial direction" (and variations
thereof, such as "radial") means a direction perpendicular to the
longitudinal axis 21.
[0118] The term "radially inwardly" (and variations thereof) means
toward the longitudinal axis 21 in a radial direction.
[0119] The term "radially outwardly" (and variations thereof) means
away from the longitudinal axis 21 in a radial direction.
[0120] The first valve opening 36 may also engage a portion of the
arcuate key 22. This side of the valve housing 26 also includes a
lower key ridge 38 longitudinally opposite the upper key ridge 34
that extends radially outwardly relative to the first valve opening
36.
[0121] As shown in FIGS. 1, 3 and 4, the opposite side of the valve
housing 26 also includes upper and lower key ridges 34, 38 that
extend radially outwardly relative to a second valve opening 36'.
The second valve opening 36' accommodates the second collar key 20.
The valve openings 36, 36' are complementary to the collar keys 18,
20, respectively.
[0122] The valve openings 36, 36' and the collar keys 18, 20 have
rectangular cross-sections. However, other cross-sectional shapes
may be used, such as semi-circular, triangular, trapezoidal,
pentagonal, an so on.
[0123] Alternatively, the cross-sectional shapes of the set of
indexed members 18, 36 and 20/36' may differ from each other. For
example, the indexed members 18, 36 may have rectangular
cross-sections and the indexed members 20, 36' may have trapezoidal
cross-sections. The cross-sectional shapes and/or other structural
features of the sets of indexed members 18, 36 and 20, 36' provide
the aforementioned indexing of the API and/or dosing
concentration.
[0124] As a result, the indexed collar 12 engages only an indexed
drug containment device 24, whereby the indexing provides fully
complementary members identified for the predetermined API and/or
dosing concentration. The cross-sectional shapes and/or other
structural features of the sets of indexed members 18, 36 and 20,
36' may also provide for non-complementary indexed members on the
collar 12 and the valve housing 26 when the valve housing is turned
by 180 degrees relative to the collar 12. That is, the first collar
key 18 is non-complementary with the second valve opening 36' and
the second collar key 20 is non-complementary with the first valve
opening 36 such that the canister 28 can only be inserted into the
collar 12 one way. The relief valve 32 that includes a relief
outlet 33 may also provide structure preventing incorrect
engagement of the collar 12 and valve housing 26. Even without the
relief valve 32 if the valve housing doesn't have an opening in the
relief valve location that will allow the arcute key of the collar
to mate with the opening, it will not be possible for the valve
housing to fully engage with the collar.
[0125] The valve housing 26 may also include additional keys and
the collar 12 may include additional openings. The valve housing 26
and the 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 include different types of openings. For
example, the collar 12 may include rails along the first and second
arms 14, 16 and one or more posts instead of the arcuate key 22.
The valve housing 26 may include slots that accommodate the rails
and one or more apertures that accommodate the posts.
[0126] 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 threadably engages the
neck 30 of the canister 28. The canister 28 is aligned along
longitudinal axis 21. Alternatively, the valve housing 26 may
communicate with the canister 28 through a conduit or hose (not
shown).
[0127] The connection between the valve housing 26 and the canister
28 also includes an o-ring 31 (see FIGS. 3 and 4) adapted to
prevent leaking of API and carrier gas from the canister 28. The
valve housing 26 also includes an optional relief valve 32 threaded
into the valve housing 26. The relief valve 32 includes a relief
outlet 33. The relief valve 32 may be any suitable valve known in
the art that prevents over-pressurization of the contents of the
canister 28 due to for example high temperatures due to fire or
overfilling of the canister during production.
[0128] As shown in FIG. 2, the indexing features that correspond to
the identity and/or dosing concentration of the API may be provided
by one or more of different axial width, axial juxtaposition,
different cross-sectional shape, and the like, of the interfaces
18/36 and 20/36'.
[0129] As used herein, the term "axial juxtaposition" means that
the mid-planes of the interfaces 18/36 and 20/36' are offset (i.e.,
not in alignment).
[0130] As used herein, the term "mid-plane" (and variations
thereof) means a plane perpendicular to the longitudinal axis that
bisects an interface.
[0131] As used herein, the term "aligned" (and variations thereof
such as "alignment") means that the mid-planes of two or more
interfaces are coplanar.
[0132] As used herein, the term "offset" (and variations thereof)
means that the mid-planes of two or more interfaces are not
coplanar.
[0133] Several exemplary embodiments of the interfaces are shown in
FIG. 2. 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 axially juxtaposed below the
mid-plane of the first interface 118/136.
[0134] 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 mid-planes of the interfaces 218/236 and 220/236'
are aligned.
[0135] 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' is axially juxtaposed
above the mid-plane of the first interface 318/336.
[0136] 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 axially juxtaposed
above the mid-plane of the second interface 420/436'.
[0137] 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 mid-planes of the interfaces 518/536 and
520/536' are aligned.
[0138] 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 axially juxtaposed
below the mid-plane of the second interface 620/636'.
[0139] The embodiments of the interfaces 118/136 and 120/136' shown
in FIG. 2 and other embodiments may each indicate the API identity
and/or dosing concentration. For example, one of the embodiments
may indicate that the drug containment device 24 contains nitric
oxide at a concentration of 100 ppm, and the collar would require
complementary member indexing.
[0140] As shown in FIGS. 1, 3, and 4, the valve housing 26 further
includes a second end adjacent the interfaces 18/36 and 20/36' and
opposite the canister 28. The second end defines a valve outlet 40
that includes an o-ring 41 to seal the valve assembly 13 in some
situations, as described below.
[0141] As shown in FIGS. 3 and 4, the valve outlet 40 is also in
fluid communication with a needle valve 42 disposed within a
passageway in the valve housing 26. The needle valve 42 includes an
inlet section 43 that threadably connects to the valve housing 26
near the valve inlet 27. The needle valve 42 also includes a
movable outlet section 46 that is held in a normally closed
position by a compression spring 44. The compression spring 44
forces the outlet section 46 (and, optionally, a seal ring 48)
against an internal wall within the valve housing 26 thereby
preventing flow between the canister 28 and the valve outlet 40.
When the moveable outlet section 46 is in the open position (FIG.
4) the gas from the container can pass through the outlet port 49
and out of the needle valve 42. The seal ring 48 may be constructed
from conventional materials, such as rubber or teflon. The needle
valve 42 has a co-axial internal passageway where the gas flows out
through the center passage outlet.
[0142] As shown in FIGS. 3, 4 and 7, a valve-receiving assembly 80
includes a receptacle 84 that axially engages the valve housing 26
in the operating position. The receptacle 84 includes side walls 86
that surround 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
against the o-ring 41. The seat 88 axially displaces or actuates
the needle valve 42 in the operating position. Actuation of the
needle valve 42 permits fluid communication between the canister 28
and a receptacle passageway 90 within the seat 88 and the receiving
assembly 80. The collar 12 is fixed to a carriage 73.
[0143] After actuation, dispensing of the composition from the
receptacle passageway 90 and the canister 28 may be controlled by
the drug delivery and regulation device 70 and as directed by the
keypad 72 and/or an automated program (see FIG. 8). The device 70
may be a corresponding device or any suitable combination of
devices and/or components, API or formulations thereof disclosed in
U.S. Pat. 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. Ser. No. 11/355,670 (US 2007/0190184);
U.S. Ser. Nos. 11/401,722; 10/053,535; 10/367,277; 10/439,632; and,
10/520,270 (US 2006/0093681), all of which are incorporated herein
by reference in their entirety. The associated methods of treatment
and drug formulations and dosage forms thereof are also
contemplated for use in conjunction with this invention.
[0144] As shown in FIGS. 6-8, the drug delivery and regulation
device 70 includes a keypad 72 to permit a user to control and/or
program delivery of the API from the canister 28. The pressurized
gas drug delivery device 70 also includes a carriage 73 having the
collar 12 fixedly mounted thereon. A pivotable cover 74 is fixed to
a lever 76. Both the cover 74 and the lever 76 pivot between an
open position (see FIG. 6 whereby the indexed drug containment
device 24 may be inserted or removed from the collar 12) and an
operating/closed position (see FIG. 7 whereby the collar 12 and the
device 24 are secured). Once in the operating/closed position, the
device 24 is advantageously protected from the exterior
environment, which is particularly advantageous in a hospital
environment.
[0145] As shown in FIGS. 6 and 7, the lever 76 includes a cam
surface 78 that moves a valve-receiving assembly 80 to engage the
indexed valve assembly 13 in the operating position. In contrast,
the receiving assembly 80 is forced upward by a rod/compression
spring assembly 82 to disengage the valve assembly 24 in the open
position. The lever 76, cam 78, rod/compression spring assembly 82
and carriage 73 make up a plunger assembly for axially actuating
the drug containment device 24 into the receptacle 84.
[0146] As shown in FIG. 5, the canister assembly may include a
radio frequency identification (RFID) device 50 disposed about the
neck 30 of the canister 28. The RFID device 50 transmits a radio
frequency to an RFID reader (not shown) disposed within the
delivery device to provide further identification features. That
is, the RFID reader may be used to determine if appropriate or
inappropriate canisters have been inserted.
[0147] From the above disclosure it should be apparent that the
present invention provides any combination of the following
advantages: a linearly actuated canister assembly that can be
installed without tools; a device in which a single movement
aligns, seals and opens the valve; and indexing of multiple drugs
(e.g., nitric oxide, carbon monoxide, and the like).
[0148] An exemplary embodiment of the invention has been described
in considerable detail. Many modifications and variations to the
exemplary embodiment described will be apparent to a person of
ordinary skill in the art. Therefore, the invention should not be
limited to the embodiment described, but should be defined by the
claims that follow.
* * * * *