U.S. patent application number 17/562323 was filed with the patent office on 2022-04-21 for prefilled medication device, method of making and using the same.
The applicant listed for this patent is PHD Preventative Health Care and Diagnostics, Inc.. Invention is credited to Eric R. DAINES.
Application Number | 20220117848 17/562323 |
Document ID | / |
Family ID | 1000006054248 |
Filed Date | 2022-04-21 |
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United States Patent
Application |
20220117848 |
Kind Code |
A1 |
DAINES; Eric R. |
April 21, 2022 |
PREFILLED MEDICATION DEVICE, METHOD OF MAKING AND USING THE
SAME
Abstract
The invention generally relates to prefilled disposable
medication devices, method of making, and using to store, contain
and deliver at least a diluent for allergenic extract and more
particularly to a prefilled cartridge containing a diluent for
allergenic extract for use with an injection pen for allergy
treatments.
Inventors: |
DAINES; Eric R.; (Colorado
Springs, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PHD Preventative Health Care and Diagnostics, Inc. |
Colorado Springs |
CO |
US |
|
|
Family ID: |
1000006054248 |
Appl. No.: |
17/562323 |
Filed: |
December 27, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14775714 |
Sep 13, 2015 |
11207241 |
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PCT/US2014/030756 |
Mar 17, 2014 |
|
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17562323 |
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61798328 |
Mar 15, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/31511 20130101;
A61M 2205/587 20130101; A61M 5/178 20130101; A61M 2205/3368
20130101; A61M 5/30 20130101; A61M 2205/8206 20130101; A61J 1/2096
20130101; A61M 2205/6054 20130101; A61M 5/24 20130101; A61M
2205/6081 20130101; A61M 2005/3131 20130101; A61M 2205/8243
20130101; A61K 39/35 20130101 |
International
Class: |
A61J 1/20 20060101
A61J001/20; A61M 5/315 20060101 A61M005/315; A61K 39/35 20060101
A61K039/35; A61M 5/178 20060101 A61M005/178; A61M 5/30 20060101
A61M005/30 |
Claims
1-73. (canceled)
74. A prefilled cartridge apparatus for use with an injection
device, comprising: a cap comprising an interior portion including
a self-healing material configured to allow a needle to be inserted
through the self-healing material in order to add and subtract
fluid into the prefilled cartridge, wherein the cap comprises a
color code indicative of a predetermined concentration of at least
one antigen; a prefilled cartridge comprising a first end, a second
end, and an internal lumen extending from the first end to the
second end, wherein the first end is closed with the cap and the
second end is open; and a plunger arranged within a portion of the
internal lumen of the prefilled cartridge, wherein the plunger is
configured to move from a first position to a second position upon
application of an external force provided by the injection device,
and wherein the prefilled cartridge comprises a fluid comprising a
first predetermined volume of diluent for an allergenic
extract.
75. The apparatus of claim 74, wherein the prefilled cartridge is
disposable.
76. The apparatus of claim 74, wherein the diluent comprises 0.4%
phenol.
77. The apparatus of claim 74, further comprising one or more
sensors configured to determine at least one of a temperature of
the fluid, a flow rate of an injection of the prefilled cartridge
in operation, and a characteristic indicative of use of the
prefilled cartridge.
78. The apparatus of claim 74, wherein the prefilled cartridge
comprises a material selected from the group consisting of glass,
plastic, thermoplastic, tempered glass, metal, alloy, composite,
and combinations thereof.
79. The apparatus of claim 74, wherein an internal surface of the
prefilled cartridge comprises a hydrophilic coating.
80. A prefilled cartridge apparatus for use with an injection
device, comprising: a cap comprising an interior portion including
a self-healing material configured to allow a needle to be inserted
through the self-healing material in order to add and subtract
fluid into the prefilled cartridge, wherein the cap comprises a
color code indicative of a predetermined concentration of at least
one antigen; a prefilled cartridge comprising a first end, a second
end, and an internal lumen extending from the first end to the
second end, wherein the first end is closed with the cap and the
second end is open; and a piston arranged within a portion of the
internal lumen of the prefilled cartridge, wherein the piston is
configured to move from a first position to a second position upon
application of an external force provided by the injection device,
and wherein the prefilled cartridge comprises a acrylonitrile
butadiene styrene (ABS) fluid, and wherein the prefilled cartridge
is configured to receive a predetermined volume of an allergenic
extract concentrate configured to elicit an immune response in a
patient.
81. The apparatus of claim 80, further comprising an injection
device configured to receive the prefilled cartridge.
82. The apparatus of claim 80, wherein an internal volume of the
prefilled cartridge is about 3 ml or less.
83. The apparatus of claim 80, wherein a volume of the
acrylonitrile butadiene styrene (ABS) fluid is in a range from
about ml to about 1 ml to about 3 ml.
84. The apparatus of claim 80, wherein the color code includes one
of a red color, a yellow color, a green color, a blue color and a
silver color.
85. The apparatus of claim 80, further comprising a radio frequency
identification (RFID) tag.
86. The apparatus of claim 85, wherein the radio frequency
identification RFID tag is an active tag.
87. A prefilled cartridge apparatus for use with an injection
device, comprising: a cap comprising an interior portion including
a self-healing material configured to allow a needle to be inserted
through the self-healing material in order to add and subtract
fluid into the prefilled cartridge, wherein the cap comprises a
color code indicative of a predetermined concentration of an
immunotherapy treatment; a prefilled cartridge comprising a first
end, a second end, and an internal lumen extending from the first
end to the second end, wherein the first end is closed with the cap
and the second end is open; and a stopper arranged within a portion
of the internal lumen of the prefilled cartridge, wherein the
stopper is configured to move from a first position to a second
position upon application of an external force provided by the
injection device, wherein the prefilled cartridge comprises a
acrylonitrile butadiene styrene (ABS) fluid; one or more sensors
configured to obtain a characteristic indicative of use of the
prefilled cartridge; and a wireless communication device configured
to transmit information from the one or more sensors.
88. The apparatus of claim 87, wherein the immunotherapy treatment
comprises one or more of a tree pollen vector allergen, grass
pollen vector allergen, weed pollen vector allergen, mold vector
allergen and other vector allergen.
89. The apparatus of claim 88, wherein the tree pollen vector
allergen comprises one or more of a birch allergen, oak allergen
and alder allergen.
90. The apparatus of claim 88, wherein the immunotherapy treatment
is a custom treatment for a patient.
91. The apparatus of claim 88, wherein the stopper comprises a
thermoplastic material.
92. The apparatus of claim 88, further comprising an injection
device configured to receive the prefilled cartridge.
Description
[0001] The present application claims the benefit of U.S.
Provisional Patent Application No. 61/798,328 filed on Mar. 15,
2013, the above-identified provisional patent application is fully
incorporated herein by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The invention generally relates to a prefilled disposable
medical device that is used to store, contain and deliver at least
a diluent for an allergenic extract and more particularly to a
prefilled cartridge containing a diluent for an allergenic extract
and/or an allergenic extract for use with an injection device for
allergy treatments.
SUMMARY OF THE INVENTION
[0003] Accordingly, the invention is directed to hermetic packaging
and a method of forming the same that substantially obviates one or
more of the problems due to limitations and disadvantages of the
related art.
[0004] An advantage of the invention is a device that provides a
more convenient solution for a patient to self-administer an
allergy treatment.
[0005] Another advantage of the invention is a device that
substantially decreases the chance of dosing errors.
[0006] Yet another advantage of the invention is a device that is
labeled with a label, e.g., an RFID label, that is machine readable
either optically, wirelessly and the like.
[0007] Additional features and advantages of the invention will be
set forth in the description which follows, and in part will be
apparent from the description, or may be learned by practice of the
invention. The objectives and other advantages of the invention
will be realized and attained by the structure particularly pointed
out in the written description and claims hereof as well as the
appended drawings.
[0008] To achieve these and other advantages and in accordance with
the purpose of the present invention, as embodied and broadly
described, a prefilled cartridge for use with an injection device
includes a container having a first end, configured to receive a
cap, and an open second end. A piston is configured to be arranged
within an interior portion of the container though the open second
end. The piston is operable to move from a first position to a
second position, e.g., upon operation of an injection device the
piston moves from a first position to a second position. A cap
including a color code indicative of a predetermined concentration
of at least one antigen is configured on one end of the cartridge.
The prefilled cartridge includes one or more of a diluent for an
allergenic extract, an allergenic extract and combinations of the
same.
[0009] One embodiment is directed towards a prefilled cartridge for
use with an injection device. The prefilled cartridge is configured
to work with an injection device that is needle free or includes a
needle. Any injection device configured to receive a cartridge may
be utilized. The injection device may have a pen type shape and
these devices are known in the art and described herein. In the
embodiment, the prefilled cartridge includes a container having a
first end configured to receive a cap and an open second end and a
piston or plunger configured to be arranged within an interior
portion of the container.
[0010] In one embodiment, the piston or plunger is operable to move
from a first position to a second position, e.g., upon operation of
an injection device when the cartridge is operably positioned
within the injection device. This action of the injection device
may be achieved by a mechanical action, electronic action,
pneumatic action, magnetic action, air pressure action and
combinations of the same. That is, a piston moves from a first
position to a second position to engage with the piston or plunger
of the prefilled cartridge.
[0011] The cartridge can also include a cap or other portion having
a color code indicative of a predetermined concentration of at
least one antigen contained within the cartridge. The cap also
includes a seal, e.g., a self-healing seal permitting a needle or
other device to puncture the seal and allowing it to be resealed
upon the needle or other device.
[0012] One embodiment is directed towards a method of preparing an
allergen extract for an immunotherapy treatment with a prefilled
cartridge for use with an injection device. The method includes
providing a first prefilled cartridge for use with the injection
device, the prefilled cartridge includes a container having a first
end configured to receive a cap and an open second end, a piston
arranged within an interior portion of the container where the
piston is operable to move from a first position to a second
position, and a solution contained between the piston and the first
end, the solution including a diluent for an allergenic extract.
The method further includes adding at least one allergen extract to
the prefilled cartridge to form the allergen extract for an
immunotherapy treatment at first concentration. Optionally,
additional steps may be performed to by adding a predetermined
amount of the allergen extract at a first concentration in the
prefilled cartridge to a second prefilled cartridge to form an
allergen extract for an immunotherapy treatment at a second
concentration.
[0013] One embodiment is directed towards a method of preparing an
allergen extract for an immunotherapy treatment with a prefilled
cartridge for use with an injection device. The method includes
providing a prefilled cartridge including a solution having a
diluent for an allergenic extract. Next, combining one or more
allergenic extracts into a first container to form an allergenic
extract concentrate and obtaining a predetermined volume of diluent
in the prefilled cartridge. Next, forming an allergen extract for
an immunotherapy treatment at a first concentration by combining a
predetermined volume of the concentrate into the prefilled
cartridge. Optionally, additional steps may be performed to by
adding a predetermined amount of the allergen extract at a first
concentration in the prefilled cartridge to a second prefilled
cartridge to form an allergen extract for an immunotherapy
treatment at a second concentration.
[0014] One embodiment is directed towards a method of preparing an
allergen extract for immunotherapy treatment cartridge for use with
an injection device. The method includes providing a prefilled
cartridge containing where the prefilled cartridge is empty of any
liquid. Next, combining one or more allergenic extract into a first
container to form an allergenic extract concentrate and obtaining a
predetermined volume of diluent in the prefilled cartridge. Next,
forming the allergen extract for immunotherapy treatment by
combining a predetermined volume of the concentrate into the
prefilled cartridge. Optionally, additional steps may be performed
to by adding a predetermined amount of the allergen extract at a
first concentration in the prefilled cartridge to a second
prefilled cartridge to form an allergen extract for an
immunotherapy treatment at a second concentration.
[0015] One embodiment is directed towards a method of administering
immunotherapy to a patient with an injection device and prefilled
cartridge. The method includes providing the injection device and
loading the prefilled cartridge into the injection device. The
prefilled cartridge includes an efficacious amount of allergen
extract for immunotherapy. Next, the injection is operated at a
treatment situs of the patient to administer an efficacious dosage
of the allergen extract.
[0016] One embodiment is directed towards a medical kit for
immunotherapy. The medical kit may include an injection device and
one or more prefilled cartridges include an allergen extract for
immunotherapy and instructions for use. Optionally or
alternatively, the medical kit for immunotherapy includes one or
more prefilled cartridges comprising an allergen extract for
immunotherapy or diluent without the allergen extract for
immunotherapy.
[0017] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory and are intended to provide further explanation of
the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawings, which are included to provide a
further understanding of the invention and are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention and together with the description serve to explain
the principles of the invention.
[0019] In the drawings:
[0020] FIG. 1 illustrates a perspective view of a prefilled
cartridge;
[0021] FIG. 2 illustrates a perspective view of a cap according to
an embodiment of the invention;
[0022] FIG. 3 illustrates a method of preparing an immunotherapy
treatment set with prefilled cartridges according to an embodiment
of the invention; and
[0023] FIG. 4 illustrates a method of administering immunotherapy
to a patient with an injection device and prefilled cartridge.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0024] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the exemplary embodiments illustrated in the drawing(s), and
specific language will be used to describe the same.
[0025] Appearances of the phrases an "embodiment," an "example," or
similar language in this specification may, but do not necessarily,
refer to the same embodiment, to different embodiments, or to one
or more of the figures. The features, functions, and the like
described herein are considered to be able to be combined in whole
or in part with one another as the claims and/or art may direct,
either directly or indirectly, implicitly or explicitly.
[0026] As used herein, "comprising," "including," "containing,"
"is," "are," "characterized by," and grammatical equivalents
thereof are inclusive or open-ended terms that do not exclude
additional unrecited elements or method steps unless explicitly
stated otherwise.
[0027] In order to more fully appreciate the present disclosure and
to provide additional related features, each of the following
references are incorporated herein by reference in their
entirety:
[0028] (1) U.S. Pat. No. 4,936,833 by Sams which discloses a
cartridge assembly for a syringe-type medication dispensing unit
including a cartridge having a cartridge body with first and second
ends. A pierceable membrane is mounted at the first end and a
piston is mounted at the second end, with a volume of medication
contained in the cartridge body between the membrane and the
piston. A cartridge holder receives the cartridge and defines first
and second ends. The first holder end defines a central opening and
an external thread for mounting a double-ended needle. The second
holder end defines an external thread for securing the holder to a
medication dispensing unit and an actuating shoulder. The holder
frictionally engages the cartridge to form an assembly which can be
handled as a single modular unit with the cartridge held securely
in the holder by frictional engagement.
[0029] (2) U.S. Pat. No. 5,104,380 by Holman, et al., which
discloses a generally pen-like syringe incorporating a dose
metering device provided by a cap rotatable with respect to a pen
body to a position related to the dose of medicament (for example
insulin) to be injected. The rotation compresses a coil spring,
which is prevented from unwinding by cooperating ratchet teeth.
When the dose is to be injected, a trigger slide is moved to the
left causing the ratchet teeth to come out of engagement. This
permits the spring to unwind, thereby rotating a drive sleeve,
drive gear and a drive plunger. The drive plunger is formed with a
quick pitch screw thread so that its rotational movement is
accompanied by axial movement to cause medicament to be discharged
from a cartridge and injected through a needle.
[0030] (3) U.S. Pat. No. 5,211,285 by Haber, et al. which discloses
a telescoping, pharmaceutical mixing container including outer and
inner containers telescopically mounted to one another with the
inner end of the inner container situated within the outer
container. The inner container has a piston cap mounted to it so as
to provide a piston-like seal between the inner and outer
containers, and houses a piston within its interior. The piston cap
defines a flow path between first and second variable volume
regions within the inner and outer containers respectively.
Reciprocating the inner container within the outer container causes
the pharmaceutical to pass through the flow path and between the
variable volume regions and mix. The mixing container is preferably
used with a metering assembly including a metering stop, threadably
positionable along the axis of the mixing container, and a driver
secured to the inner container. The driver includes a drive stop
which engages the metering stop once the inner container has moved
an appropriate distance towards its collapsed condition, typically
during an injection.
[0031] (4) U.S. Pat. No. 5,334,162 by Harris which discloses a
cartridge assembly for holding a lyophilized product, forming a
disposable portion of a pen injector including a cylindrical glass
cartridge adapted to receive the product, a closure cap, a
cartridge case, and a plunger mechanism. The closure cap is adapted
to retain an elastomeric disc seal during lyophilization and
includes diametrically opposed ledges. The closure cap and seal are
adapted to cover a neck portion of the ampule, the neck portion
having on its end a radially extending circumferential flange. The
ledges of the closure cap and the flange of the neck portion allow
the closure cap to remain open during lyophilization, oxygen purge
and nitrogen overlay. An oval-shaped indentation formed on the
inside of the closure cap aids in snapping the closure cap about
the flange without crimping to retain the closure cap underneath
the flange. Reconstitution of the lyophilized drug is accomplished
without foaming by use of an obliquely angled connector which
causes the diluent to indirectly impinge on the drug. The injection
device and cartridge assembly cooperate such that the length of
travel of the plunger rod during retraction is less than the axial
length of a recess in the rod tip.
[0032] (5) U.S. Pat. No. 5,454,786 by Harris which discloses a
cartridge assembly for holding a lyophilized product, forming a
disposable portion of a pen injector including a cylindrical glass
cartridge adapted to receive the product, a closure cap, a
cartridge case, and a plunger mechanism. The closure cap is adapted
to retain an elastomeric disc seal during lyophilization and
includes diametrically opposed ledges. The closure cap and seal are
adapted to cover a neck portion of the ampule, the neck portion
having on its end a radially extending circumferential flange. The
ledges of the closure cap and the flange of the neck portion allow
the closure cap to remain open during lyophilization, oxygen purge
and nitrogen overlay. An oval-shaped indentation formed on the
inside of the closure cap aids in snapping the closure cap about
the flange without crimping to retain the closure cap underneath
the flange. Reconstitution of the lyophilized drug is accomplished
without foaming by use of an obliquely angled connector which
causes the diluent to indirectly impinge on the drug. The injection
device and cartridge assembly cooperate such that the length of
travel of the plunger rod during retraction is less than the axial
length of a recess in the rod tip.
[0033] (6) U.S. Pat. No. 5,725,500 by Micheler which discloses a
container for a liquid medicament suspension, e.g. an insulin
crystal suspension, having a tube with a sealing piston, a cap, and
a mixing element which moves along the tube to assist mixing the
suspension. The element is guided by the inner surface of the tube
and has restricted lateral movement but is free to move axially,
for example, by tilting or end to end inversion of the container.
Flow passages such as apertures and peripheral recesses are
provided in the mixing element which can serve to promote turbulent
flow. The containers are particularly suited for use as multi-dose
cartridges for pen-like injection devices or for portable infusion
devices which have piston-operating mechanisms to cooperate with
the container piston.
[0034] (7) U.S. Pat. No. 5,733,258 by Lane which discloses a closed
system for the handling of injectable biological products and
vaccines used in the treatment and prevention of livestock
diseases. This system embodies a prefilled disposable cartridge
with a disposable needle attached and a metered pistol grip
syringe. The cartridge is breech loaded into the syringe and the
product is dispensed from the cartridge by a unique drag link
mechanism as a means for advancing the plunger rod (36) and forcing
the vaccine from the cartridge into the flesh of the animal being
treated. Each prefilled cartridge is disposed of after it is
emptied and no cleaning is required. A color coding system between
the prefilled cartridges and the syringe bodies insures that proper
dosages are given and that different products are not mixed up or
confused with each other by the technicians dispensing the
biological products.
[0035] (8) U.S. Pat. No. 6,264,629 by Landau, which discloses a
gas-powered, single-use, needle-less hypodermic jet injection
device including a hand-held injector, and a drug injection
cartridge which provides a cylinder of liquid medication to be
injected, an injection orifice, and an injection piston. Forceful
movement of the injection piston in the cylinder causes an
injection jet of medication to be expelled from the injection
orifice. The injection device also includes a hermetically sealed
gas pressure capsule which remains sealed until the moment of
injection and powers the jet injection after opening of this
cartridge.
[0036] (9) U.S. Pat. No. 6,443,942 by Van Antwerp, et al., which
discloses medical devices such as medication infusion pumps having
internal surfaces that are treated to inhibit protein denaturation.
In accordance with the invention, hydrophilic internal surfaces and
related coating methods are provided to reduce or eliminate
accumulation of medication deposits which can otherwise occur when
handling complex protein-based medications. Preferred hydrophilic
pump surfaces include hydrophilic surfactants (PEO) or (PEG)
coatings which exhibit very low protein adsorption characteristics.
Several methods are disclosed for producing such treated surfaces
including the covalent attachment of hydrophilic surfactants.
[0037] (10) U.S. Pat. No. 7,104,973 by Woolston, et al. which
discloses an apparatus for patients having diabetes who take a
combination of slow and fast acting types of insulin. It is
important that the different forms of medicament do not become
confused and that the patient does not receive the incorrect
medicament. In combination, a medicament delivery apparatus and a
medicament cartridge are provided, the medicament delivery
apparatus including at least one switch and the medicament
cartridge comprising a cartridge housing within which a medicament
is provided, a displaceable piston located internally at one end of
the housing and a raised ring of material about an external
periphery of the medicament cartridge, the ring of material being
of sufficient dimensions, in use, to trip the at least one switch
of the medicament delivery apparatus.
[0038] (11) U.S. Pat. No. 7,547,293 by Williamson, et al. which
discloses a needle-free hypodermic jet injection device having an
actuation system to effect an injection from a drug delivery
system. The actuation system includes an injection force assembly
adapted to transmit a driving force to the drug delivery system.
The actuation system further includes a trigger assembly adapted to
alter the actuation system between a plurality of configurations
including a fired configuration in which the injection force
assembly transmits a driving force to the drug delivery system. In
some embodiments, the device has a recoil restriction system
including a restriction member adapted to couple the recoil
restriction system to the trigger assembly and a recoil member
coupled to the injection force assembly and movable relative to the
restriction member. The restriction member limits movement of the
recoil member once the recoil member moves a predetermined distance
relative to the restriction member.
[0039] (12) U.S. Pat. No. 7,618,393 by Bingham, et al., which
discloses a needle-less injector device for delivering a dose of
fluid intradermally, subcutaneously or intramuscularly to an animal
or human. The device includes an inner housing having opposed ends.
A syringe is disposed in one end of the inner housing. The syringe
includes a nozzle for delivering a dose of fluid held within the
syringe. A plunger is movably disposed within the syringe. A spring
powered hammer is movably disposed within the inner housing. The
hammer cooperates with the plunger to drive the dose of medicament
from the nozzle. An injection delivery spring for powering the
hammer is positioned and compressed between the other end of the
inner housing and the spring powered hammer. An outer housing
slideably supports the inner housing. A skin tensioning spring is
mounted between the inner housing and the outer housing, the skin
tensioning spring biasing the nozzle of the syringe against the
animal or human. A trigger mechanism is disposed in the outer
housing, the trigger mechanism cooperating with the spring powered
hammer to release the injection delivery spring, wherein the size
of the injection delivery spring and the length of the hammer
dictate the amount of dose delivered and whether the dose is
delivered intradermally, subcutaneously or intramuscularly to an
animal or human.
[0040] (13) U.S. Pat. No. 7,654,995 by Warren, et al. which
discloses a vial adaptor for removing liquid contents from a vial
including a piercing member and a bag. The bag can be contained
within the piercing member such that the bag is introduced to the
vial when the vial adaptor is coupled with the vial. In some
embodiments, the bag expands within the vial as liquid is removed
from the vial via the adaptor, thereby regulating pressure within
the vial. In other embodiments, a vial comprises a bag for
regulating pressure within the vial as liquid is removed therefrom.
In some embodiments, a vial adaptor is coupled with the vial in
order to remove the liquid. In some embodiments, as the liquid is
removed from the vial via the adaptor, the bag expands within the
vial, and in other embodiments, the bag contracts within the
vial.
[0041] (14) U.S. Pat. No. 7,678,073 by Griffiths, et al. which
discloses an automatic injector that separately stores liquid and
dry components in respective compartments. When the injector is
activated, a fluid-directing member between the liquid and dry
compartments causes the liquid component to form a vortex as the
liquid flows into the dry compartment. This allows the two
components to combine more thoroughly and quickly to form a liquid
solution that is delivered to an injection site.
[0042] (15) U.S. Pat. No. 7,699,802 by Steinway, et al., which
discloses a needle-less injector device that includes an outer
housing and an inner housing that is slideably supported from the
outer housing is disclosed. The inner housing supporting a vial
that includes a nozzle for delivering a fluid held within the vial.
A spring powered ram that is adapted for pushing a seal and plunger
is mounted within inner housing. A skin tensioning spring mounted
between the inner housing and the outer housing is used for pushing
the leading end of the inner housing away from the outer housing. A
trigger that cooperates with the spring-powered ram is used to
release the ram from the cocked position only when the inner
housing is in a firing position.
[0043] (16) U.S. Pat. No. 7,850,663 by Sullivan, et al. which
discloses a method and device for intradermal delivery of a
reconstituted powdered medicament. The device includes a chamber,
which is in fluid communication with a microdevice, e.g.
microabrader or one or more microneedles. A cartridge containing
the powdered medicament may be located within said chamber. At
least one burstable membrane retains a powdered medicament within
the housing. The method involves the steps of positioning the
device at a delivery site on the skin of a patient and
intradermally administering the medicament by dispensing a diluent
from a diluent source through an inlet port to rupture the
membranes, reconstitute the powdered medicament and deliver the
reconstituted medicament through the microdevice to the dermal
region of the skin.
[0044] (17) U.S. Pat. No. 7,899,528 by Miller, et al. which
discloses an automatic external defibrillator apparatus which may
be provided for use in cooperation with an intraosseous apparatus.
Apparatus and methods may also be provided to execute protocols
calling for external defibrillation and drug delivery. The
disclosure provides a medical apparatus including two electrodes, a
processor, a display, a driver, a drug delivery slot, a drug
delivery port, and a voltage source. The two electrodes may include
an attachment operable to releasably connect the two electrodes to
the patient. The processor may be operable to collect and analyze a
rhythm associated with the patient's heart from the two electrodes.
The display may be operable to communicate instructions to a user.
The driver may be operable to insert an intraosseous device into a
bone and associated bone marrow of the patient. The drug delivery
slot may be operable to receive a drug. The drug delivery port may
be operable to communicate the drug from the drug delivery slot to
the patient via the intraosseous device. The voltage source may be
operable to deliver an electric shock to the patient via the two
electrodes.
[0045] (18) U.S. Pat. No. 8,167,835 by Keller which discloses a
single chamber device for drawing in and dispensing components
comprising a syringe housing, a piston that is actuatable by a
plunger unit, and a mixing assembly whose rod is guided through the
piston and operatively connected to the plunger unit. The plunger
unit comprises a plunger rod that is articulated at the mixing rod
and provided with means that are engageable with the mixing rod. In
this manner, a mixture of different components, particularly also
bone cement, can be both created and dispensed in a simple and
inexpensive single chamber device.
[0046] (19) U.S. Pat. No. 8,267,913 by Fangrow which discloses a
vial adaptor for removing liquid contents from a vial including a
piercing member and a bag. The bag can be contained within the
piercing member such that the bag is introduced to the vial when
the vial adaptor is coupled with the vial. In some embodiments, the
bag expands within the vial as liquid is removed from the vial via
the adaptor, thereby regulating pressure within the vial. In other
embodiments, a vial comprises a bag for regulating pressure within
the vial as liquid is removed therefrom. In some embodiments, a
vial adaptor is coupled with the vial in order to remove the
liquid. In some embodiments, as the liquid is removed from the vial
via the adaptor, the bag expands within the vial, and in other
embodiments, the bag contracts within the vial.
[0047] (20) U.S. Pat. No. 8,529,500 by Bingham, et al., which
discloses a needle-less injector device for delivering a dose of
fluid intradermally, subcutaneously or intramuscularly to an animal
or human. The device includes an inner housing having opposed ends.
A syringe is disposed in one end of the inner housing. The syringe
includes a nozzle for delivering a dose of fluid held within the
syringe. A plunger is movably disposed within the syringe. A spring
powered hammer is movably disposed within the inner housing. The
hammer cooperates with the plunger to drive the dose of medicament
from the nozzle. An injection delivery spring for powering the
hammer is positioned and compressed between the other end of the
inner housing and the spring powered hammer. An outer housing
slideably supports the inner housing. A skin tensioning spring is
mounted between the inner housing and the outer housing, the skin
tensioning spring biasing the nozzle of the syringe against the
animal or human. A trigger mechanism is disposed in the outer
housing, the trigger mechanism cooperating with the spring powered
hammer to release the injection delivery spring, wherein the size
of the injection delivery spring and the length of the hammer
dictate the amount of dose delivered and whether the dose is
delivered intradermally, subcutaneously or intramuscularly to an
animal or human.
[0048] (21) U.S. Patent Application Publication No. 2004/0176728 by
Fischer, et al. which discloses a prefilled injection apparatus for
multiple dosings of medication. The protective housing element into
which is installed the mechanical drive mechanism used to force the
medication from the apparatus extends forward to provide a volume
in which is directly contained a multi-dose quantity of medicine,
and the medicine is sealed between a movable piston and a septum
each in fluid tight engagement with the protective housing element.
This design advantageously eliminates the need for using a separate
cartridge within the apparatus. A method of making a
cartridge-free, multi-dose injection apparatus is also
disclosed.
[0049] (22) U.S. Patent Application Publication No. 2005/0124941 by
Panchula, et al., which discloses cartridges provided for storing
and facilitating the delivery of pharmaceutical formulations. In
one preferred embodiment, the cartridge comprises a body including
a bore extending through the body, and a plunger movably disposed
in the bore. The bore has a transverse dimension at a distal end
that is equivalent to that at a midpoint. The plunger has a planar
contact surface that is transversely coextensive with the bore for
applying a force to a pharmaceutical formulation contained in the
bore. This configuration helps to eliminate dead volume, and
therefore enables filing by volume rather than weight to ensure
accurate dosing.
[0050] (23) U.S. Patent Application Publication No. 2007/0027428 by
Bingham, et al., which discloses a needle-free or needle-less
intradermal injection device that is capable of delivering an agent
of interest to only the intradermal space. The intradermal device
can deliver lower volumes of an agent than commonly used with
present devices. In one aspect of the invention, the intradermal
device is useful for delivering one or more agents to the
intradermal space for eliciting immune responses particular to the
dermal layer. In other aspects of the invention, the intradermal
device is useful for delivering one or more agents to the
intradermal space for treating, delaying development of delaying
the progression of preventing, and/or ameliorating symptoms of
various diseases, disease states, and conditions.
[0051] (24) U.S. Patent Application Publication No. 2008/0027007 by
Benner, et al. which discloses drug development against acute
radiation injury caused by exposure to high-energy electromagnetic
waves (X-rays, gamma rays) or particles (alpha particles, beta
particles, neutrons). To date, there is no effective drug to
ameliorate radiation injury after accidental exposure to ionizing
irradiation. The invention provides a method of treating radiation
injury of a subject in need thereof comprising administering to the
subject a peptide, or functional analogue or derivative thereof, of
smaller than 30 amino acids. Furthermore, the invention provides
use of a peptide, or functional analogue or derivative thereof, of
smaller than 30 amino acids for the production of a pharmaceutical
composition for the treatment of a subject suffering from or
believed to be suffering from radiation injury. In particular, the
invention provides anti-radiation peptides having a dose reduction
factor (DRF) against acute gamma irradiation of at least 1.10, said
DRF determinable by testing which dose of radiation results in 50%
mortality at 30 days (LD50/30) after whole body radiation (WBI) in
a test group of mice treated with said peptide at 72 hours after
WBI and, testing which dose of radiation results in 50% mortality
at 30 days (LD50/30) after whole body radiation (WBI) in a control
group of mice treated only with the vehicle of said peptide at 72
hours after WBI and wherein the DRF is calculated by dividing the
LD50/30 of the peptide-treated animals by the LD50/30 of the
vehicle-treated animals.
[0052] (25) U.S. Patent Application Publication No. 2013/0035634 by
Cappello, et al., which discloses a needle-free injection device
having an outer housing and an inner housing. The inner housing is
configured to receive a needle-free syringe in one end. In
addition, the inner housing is movable within the outer housing
between a syringe loading position and a firing position. The
device also includes an activation button operatively associated
with the inner and outer housings and a housing lock engaged by the
activation button to prohibit movement of the inner housing from
the syringe loading position to the firing position when the
activation button is activated with the inner housing in the
syringe loading position. Methods and apparatus for using, filing
and operating the needle-free injection device are also
disclosed.
[0053] (26) U.S. Patent Application Publication No. 2013/0150820 by
Cappello, et al., which discloses a needle-free injection device
suitable for delivering a therapeutic substance into the
intradermal space of a patient. The needle-free injection device
includes a main spring which can be compressed using one or more
handles attached to the device to place the needle-free injection
device into an armed configuration. Device embodiments may
optionally include an injector tube and associated apparatus which
may be moved relative to other device structures when the injector
is pressed against the skin of a patient with sufficient force. The
disclosed operational switches and release mechanisms cooperate to
prevent injection unless the device is properly positioned for an
injection. Needle-free injection systems and methods of operating a
needle-free injection device are also disclosed.
[0054] (27) U.S. Patent Application Publication No. 2014/0005632 by
Bingham, et al., which discloses a needle-less injector device for
delivering a dose of fluid intradermally, subcutaneously or
intramuscularly to an animal or human. The device includes an inner
housing having opposed ends. A syringe is disposed in one end of
the inner housing. The syringe includes a nozzle for delivering a
dose of fluid held within the syringe. A plunger is movably
disposed within the syringe. A spring powered hammer is movably
disposed within the inner housing. The hammer cooperates with the
plunger to drive the dose of medicament from the nozzle. An
injection delivery spring for powering the hammer is positioned and
compressed between the other end of the inner housing and the
spring powered hammer. An outer housing slideably supports the
inner housing. A skin tensioning spring is mounted between the
inner housing and the outer housing, the skin tensioning spring
biasing the nozzle of the syringe against the animal or human. A
trigger mechanism is disposed in the outer housing, the trigger
mechanism cooperating with the spring powered hammer to release the
injection delivery spring, wherein the size of the injection
delivery spring and the length of the hammer dictate the amount of
dose delivered and whether the dose is delivered intradermally,
subcutaneously or intramuscularly to an animal or human.
[0055] One embodiment is directed towards a prefilled cartridge for
use with an injection device. The prefilled cartridge is configured
to work with an injection device that is needle free or includes a
needle. Any injection device configured to receive a cartridge may
be utilized. The injection device may have a pen type shape and
these devices are known in the art and described herein. In the
embodiment, the prefilled cartridge includes a container having a
first end configured to receive a cap and an open second end and a
piston or plunger configured to be arranged within an interior
portion of the container.
[0056] In one embodiment, the piston or plunger is operable to move
from a first position to a second position, e.g., upon operation of
an injection device when the cartridge is operably positioned
within the injection device. This action of the injection device
may be achieved by a mechanical action, electronic action,
pneumatic action, magnetic action, air pressure action and
combinations of the same. That is, a piston moves from a first
position to a second position to engage with the piston or plunger
of the prefilled cartridge.
[0057] The cartridge can also include a cap or other portion having
a color code indicative of a predetermined concentration of at
least one antigen contained within the cartridge. The cap also
includes a seal, e.g., a self-healing seal permitting a needle or
other device to puncture the seal and allowing it to be resealed
upon the needle or other device.
[0058] One embodiment is directed towards a method of preparing an
allergen extract for an immunotherapy treatment with a prefilled
cartridge for use with an injection device. The method includes
providing a first prefilled cartridge for use with the injection
device, the prefilled cartridge includes a container having a first
end configured to receive a cap and an open second end, a piston
arranged within an interior portion of the container where the
piston is operable to move from a first position to a second
position, and a solution contained between the piston and the first
end, the soluton including a diluent for an allergenic extract. The
method further includes adding at least one allergen extract to the
prefilled cartridge to form the allergen extract for an
immunotherapy treatment at first concentration. Optionally,
additional steps may be performed to by adding a predetermined
amount of the allergen extract at a first concentration in the
prefilled cartridge to a second prefilled cartridge to form an
allergen extract for an immunotherapy treatment at a second
concentration.
[0059] One embodiment is directed towards a method of preparing an
allergen extract for an immunotherapy treatment with a prefilled
cartridge for use with an injection device. The method includes
providing a prefilled cartridge including a solution having a
diluent for an allergenic extract. Next, combining one or more
allergenic extracts into a first container to form an allergenic
extract concentrate and obtaining a predetermined volume of diluent
in the prefilled cartridge. Next, forming an allergen extract for
an immunotherapy treatment at a first concentration by combining a
predetermined volume of the concentrate into the prefilled
cartridge. Optionally, additional steps may be performed to by
adding a predetermined amount of the allergen extract at a first
concentration in the prefilled cartridge to a second prefilled
cartridge to form an allergen extract for an immunotherapy
treatment at a second concentration.
[0060] One embodiment is directed towards a method of preparing an
allergen extract for immunotherapy treatment cartridge for use with
an injection device. The method includes providing a prefilled
cartridge containing where the prefilled cartridge is empty of any
liquid. Next, combining one or more allergenic extract into a first
container to form an allergenic extract concentrate and obtaining a
predetermined volume of diluent in the prefilled cartridge. Next,
forming the allergen extract for immunotherapy treatment by
combining a predetermined volume of the concentrate into the
prefilled cartridge. Optionally, additional steps may be performed
to by adding a predetermined amount of the allergen extract at a
first concentration in the prefilled cartridge to a second
prefilled cartridge to form an allergen extract for an
immunotherapy treatment at a second concentration.
[0061] One embodiment is directed towards a method of administering
immunotherapy to a patient with an injection device and prefilled
cartridge. The method includes providing the injection device and
loading the prefilled cartridge into the injection device. The
prefilled cartridge includes an efficacious amount of allergen
extract for immunotherapy. Next, the injection is operated at a
treatment situs of the patient to administer an efficacious dosage
of the allergen extract.
[0062] One embodiment is directed towards a medical kit for
immunotherapy. The medical kit may include an injection device and
one or more prefilled cartridges include an allergen extract for
immunotherapy and instructions for use. Optionally or
alternatively, the medical kit for immunotherapy includes one or
more prefilled cartridges comprising an allergen extract for
immunotherapy or diluent without the allergen extract for
immunotherapy.
[0063] In one embodiment, the injection device is a needle-free
injector as described with reference to any patent and patent
application publication herein including but not limited to U.S.
Pat. Nos.: 5,104,380; 7,547,293; 7,618,393; 7,699,802; 8,529,500
and U.S. Patent Application Publication Nos.: 2007/0027428;
2013/0035634; 2013/0150820; and 2014/00632, each of which are
hereby incorporated by reference as if fully set forth herein.
Optionally, the cartridge includes a chamber as described with
reference to any patent described herein including but not limited
to U.S. Pat. Nos.: 5,104,380; 7,547,293; 7,618,393; 7,699,802;
8,529,500 and U.S. Patent Application Publication Nos.:
2007/0027428; 2013/0035634; 2013/0150820; and 2014/00632, each of
which are hereby incorporated by reference as if fully set forth
herein. Moreover, the geometry of the cartridge may be configured
to fit within any injection device as known in the art. The
cartridge may include any materials, e.g., glass, plastic, metal,
alloy, composite materials, thermoplastic, tempered glass and
combinations thereof. The cartridge may also be transparent,
semitransparent or not transparent to light.
[0064] Alternately and/or optionally, the container includes a
material selected from the group consisting of glass, plastic,
thermoplastic, tempered glass, metal, alloy, composite, and
combinations thereof.
[0065] Alternately and/or optionally, the cartridge, cap, plunger
or piston, injection device and combinations of the same may
include a radio frequency identification (RFID) tag or other device
configured to contain or transmit data indicative of at least one
of a concentration of at least one antigen, a patient identifier, a
manufacturer of the antigen, a lot number, a lot date, a diluent
identification, an antigen identifier and a manufacturer of the
diluent, antigen or both. The RFID tag can be an active tag or
passive tag.
[0066] Alternately and/or optionally, the cartridge, cap, plunger
or piston, injection device and combinations of the same may
include a one or more sensors configured to determine at least one
of a temperature of the solution, a flow rate of the injection
device in operation, a concentration of at least one antigen, a
concentration of the injection diluent, a volume of the solution, a
characteristic indicative of use of the injection device, a
characteristic indicative of a time of use of the injection device,
and a characteristic indicative of an angle of orientation of the
injection device when used. The sensors may further communicate
wirelessly with a receiver/transmitter as known in the art, e.g., a
wireless communication unit configured to output information from
the one or more sensors
[0067] Alternately and/or optionally, the cartridge, cap, plunger
or piston, injection device and combinations of the same may
include a light emitting diode or light source. The light emitting
diode or light source is configured to emit a colored light
indicative of one or more of a concentration of the solution,
temperature of the solution, predetermined time of treatment,
volume of solution, and incorrectly loading of the cartridge into
the injection device.
[0068] Alternately and/or optionally, the cartridge, cap, plunger
or piston, injection device and combinations of the same may
include a power source. The power source can include a battery
configured to be inductively or remotely charged.
[0069] In one embodiment, the diluent include broadest definition.
In a preferred embodiment, the diluent includes one of glycerin,
Phenol, saline, and acrylonitrile butadiene styrene (ABS). In
another embodiment, the diluent can include 0.9% NaCl, 0.03% human
albumin, and 0.4% phenol in water. In yet another embodiment, the
diluent can include about 50% glycerin and phenol. In still yet
another embodiment, the diluent includes 0.4% phenol and/or saline.
In yet another embodiment, the diluent includes 0.03% HSA, 0.4%
phenol, and saline.
[0070] In one embodiment, the cartridge includes an allergenic
extract configured to elicit an immune response. Optionally, the
allergen extract includes one or more of a tree pollen vector
allergen, grass pollen vector allergen, weed pollen vector
allergen, mold vector allergen and other vector allergen.
[0071] In one embodiment, the increased concentration utilized in
immunotherapy is based on a predetermined algorithm or mathematical
function, e.g., a linear line with a positive slope, for a
predetermined amount of time, e.g., a six week basis. In a
preferred embodiment, the immunotherapy treatment includes
administering two shots per week for six weeks at a first
concentration, e.g., 5000 dilution for six weeks. The volume of
each shot changes as a linear function, e.g., 0.03 mL increments.
That is, the first shot, week one, concentration of 5000 dilution
would be at a starting amount, e.g., in a range from about 0.02 mL
to about 0.04. The second shot that week would be adjusted by about
0.03 mL with the same dilution amount. The maximum volume would be
in week six and would not exceed 0.39 mL. Moreover, the shots
should be given at least 48 hours apart in each week. It is noted
this would be considered a first round of treatment at the first
concentration of allergen extract. The treatments may be provided
by either a provider or a patient with an injection device. In
addition, it is understood that this treatment may be adjusted
based on adverse reactions from the patients. In one embodiment,
the method is adjusted by a predetermined criteria by reducing the
volume to one or more previously successfully administered
treatment without adverse reactions.
[0072] By way of example, one embodiment is directed towards a six
week treatment of increased dosage or volume also called a ramp
over a predetermined time frame, which may be administered with a
prefilled cartridge utilizing an injection device. Optionally, a
pretreatment prior to the treatment set being is utilized in order
to reduce adverse reactions, preferably, the pretreatment is
configured as one injection at a dosage or volume configured to
prevent any next increase from being higher than fifty percent. In
preferred embodiment, the dosage or volume of the pretreatment is
in a range from about 0.01 ml to about 0.04 ml, and more preferably
about 0.04 ml.
[0073] Ramping may be a predetermined time frame from about 1 week
to 6 weeks or greater, preferably 6 weeks. In one ramping
embodiment, a pretreatment injection of about 0.04 ml was
administered with the injection device or other instrument and
prefilled cartridge. Next, the ramp started at a 1:5000 dilution
according to the following schedule could be used as follows: Week
1: shot 1--0.06 mL, 5000 dilution, shot 2--0.09 mL, 5000 dilution;
Week 2: shot 1--0.12 mL, 5000 dilution, shot 2--0.15 mL, 5000
dilution; Week 3: shot 1--0.18 mL, 5000 dilution, shot 2--0.21 mL,
5000 dilution; Week 4: shot 1--0.24 mL, 5000 dilution, shot 2--0.27
mL, 5000 dilution; Week 5: shot 1--0.30 mL, 5000 dilution, shot
2--0.33 mL, 5000 dilution; Week 6: shot 1--0.36 mL, 5000 dilution,
shot 2--0.39 mL, 5000 dilution. Next, the concentration is
increased to a mixture with a concentration of 1:500 vol/vol or 500
dilution and a six week treatment set is repeated, however, the
starting point is not 0.03 mL, but 0.06 mL, therefore the ending
point in week six is 0.39 mL. This is repeated for the rest of the
concentrations in six week increments until the 1.5 vol/vol or 5
dilution is given in the six week ramp treatment. Next a
maintenance schedule is given for about six months or longer. The
maintenance schedule is linear and two shots per week at 0.30 mL to
0.39 mL are given. There is no change in volume from week to week
or concentration from week to week or shot to shot. The amount of
volume change between shots and durations of schedules is dependent
on the efficacy and safety of the immunotherapy and may be adjusted
to stay within the efficacy and safety bounds.
[0074] Reference will now be made in detail to an embodiment of the
present invention, example of which is illustrated in the
accompanying drawings.
[0075] FIG. 1 illustrates a perspective view of a prefilled
cartridge.
[0076] Referring to FIG. 1, the prefilled cartridge is generally
depicted with reference to number 100. The prefilled cartridge 100
can be utilized with a delivery apparatus, e.g., an injection
device or other automatic delivery system. The cartridge 100 is
configured for a single disposable use and is also configured to
receive an additive of liquids or gels, e.g., a diluent for an
allergenic extract, an allergenic extract, and combinations of the
same.
[0077] In this embodiment, the prefilled cartridge 100 is utilized
for immunotherapy. The cartridge 100 includes a stopper or plunger
102 or piston and a cap 104. The cap 104 includes seal 106 which is
configured to be self-healing and is made of a thermoplastic
material, e.g., an integral cap and seal such as a rubber disk. The
self-healing of the seal allows for a needle to be inserted through
the seal to add and subtract fluid or gel in the cartridge 100.
Upon removal of the needle the seal 106 is sealed automatically
with the self-healing material to prevent fluid from escaping.
Optionally, the seal 106 may include more than one layer to enhance
the self-healing ability, e.g., a dual layer seal including a first
layer resistant to chemical and a second layer to aid in sealing or
self-healing after a predetermined used, e.g., 5 or more uses or
penetrations. The first layer includes at least one of a
thermoplastic material, polymer material, and combinations of the
same and the second layer includes thermoplastic material, polymer
material, and combinations of the same. Optionally, the seal may
include additional layers for other functionality or performance
criteria. In one embodiment, the seal 106 is a hermetic seal.
Optionally, the seal may be semi-permeable such that it is
configured to prevent fluid from exiting the cartridge, but allows
a gas to pass through at a pressure greater than atmospheric
pressure. This type of semi-permeable seal may be useful in adding
and removing fluids to the prefilled cartridge 100. For example,
with reference to FIG. 3 disclosed herein, the volume of the
prefilled cartridge is configured to work the injection device. In
a preferred embodiment, the volume is about 3.0 ml. Alternatively
or optionally, the piston 102 may include one or more sensors 107
and a power source 105 integral with the piston 102. Moreover, the
sensor 107 may be configured as described herein and also be an
RFID tag.
[0078] Referring now to FIG. 2, which illustrates a cross-sectional
view of an integral cap according to an embodiment of the
invention. The cap 104 in this embodiment includes a dual layer
seal 106. The first layer 120 includes at least one of a
thermoplastic material, polymer material, and combinations of the
same and the second layer 122 includes thermoplastic material,
polymer material, and combinations of the same. One end 108 of the
cartridge 100 is open and the other end may also be open prior to
applying the cap. Moreover, the cap may be integrated with the end
of the cartridge. In such a case, the end 112 would not include a
cap, but would have a self-healing plug to close the end. The plug
(not shown) could be made with thermoplastic material.
[0079] The cap may be a pressure fit cap, a threaded cap, or
include another fastening mechanism and combinations of the same
configured to hold it place. The cap may be constructed from a
metal material, alloy material, plastic material, composite
material, and combinations of the same. In a preferred embodiment,
the cap includes an aluminum material. Optionally, the aluminum
material is color coated.
[0080] Referring again to FIG. 1, the stopper or plunger 102 is
operationally coupled to a plunger or piston of the pen and the
plunger 102 is configured to move from a first position to second
position upon application of linear force to the stopper 102. The
stopper 102 may be configured to be removable from the end of the
cartridge 100. This removability may be advantageous for prefilling
the cartridge with the desired liquid. Moreover, the stopper 102
can be constructed of thermoplastic material and is configured to
provide a fluid seal to the liquid between the cap 106 and the
stopper 102. In one embodiment, the stopper 102 may be
self-sealable similar to the seal 106 as described herein with
respect to the seal 106, thereby allowing a needle to penetrate the
stopper 102 and permit the addition and removal of liquid in the
cartridge 100.
[0081] In a preferred embodiment, the cartridge includes a glass
material, e.g., borosilicate glass. Other materials may also be
used, e.g., metal, alloy, composite, glass and combinations of the
same. Optionally, the edges of the cartridge are buffered to remove
any type of sharp edges. Moreover, a circular protective ring (not
shown) can be placed on the edges to prevent any exposure to sharp
edges. In addition, the interior walls 110 of the cartridge may be
coated with an anti-frictional material, e.g., silicon, PTFE and/or
the like. For example, one or more internal surface may include a
hydrophilic coating that substantially reduces or eliminates
accumulation of medication deposits as described in U.S. Pat. No.
6,443,942, which is hereby incorporated by reference. Other types
of coatings may be used such a hydrophobic coating and/or
siliconization. In one embodiment, the at least a portion of an
interior of the cartridge is treated with a material that is a
lubricant, a hydrophobic coating or hydrophilic coating that is
resistant to corrosive or other negative effects from phenol and/or
antigens. In addition, the prefilled cartridge is sterilized as
known in the art.
[0082] The cap 104, plug, and/or cartridge 100 may be color coded
with any color. In one embodiment, the color coding includes a red
cap, a yellow cap, a green cap, a blue cap and a silver cap to
indicate predetermined concentrations of extracts in the container.
The color coding may be achieved with a plastic covering or
integrated fully with the cap 104. The cap may include a solid
color or a line of color or other mechanism or element configured
to be indicative of a concentration of allergen extract. The color
coding may also be achieved with a second plastic cap (not shown)
that is coded cap and configured to fit around an existing cap on
the prefilled cartridge.
[0083] In one embodiment, the cap uses predetermined colors to
indicate a specific concentration. For example, the cap colors
chosen may be red, yellow, blue, green, and silver. A red cap is
indicative of a concentrate 1:1 vol/vol, a yellow cap is indicative
of a 10 fold dilution 1:10 vol/vol, a blue cap is indicative of a
1:100 vol/vol, a green is indicative of a 1000 fold dilution
1:1,000 vol/vol, and a silver cap is indicative of a 10,000 fold
dilution 1:10,000 vol/vol. Of course in other embodiments other cap
colors may by indicative of other concentrations, e.g., a red cap
may be indicative of a concentrate 1:1 vol/vol, a yellow cap is
indicative of a 5 fold dilution 1:5 vol/vol, a blue cap is
indicative of a 50 fold dilution 1:50 vol/vol; a green cap is
indicative of a 500 fold dilution 1:500 vol/vol; and a silver cap
is indicative of a 5,000 fold dilution 1:5,000 vol/vol.
[0084] Also, the cap colors may simply be indicative of a hierarchy
of concentrations, e.g., from more to less and vice versa. In one
embodiment, there are five colors, red, yellow, blue, green and
silver and the hierarchy of concentration from higher to lower is
from red to silver where red is the highest concentration and
silver is the lowest concentration.
[0085] The cartridge may be prefilled with a diluent for an
allergenic extract, allergen, antigen, allergen extract and
combination of the same. An allergen is any substance that is
configured to elicit an immune response. The extracts are used in
an immunotherapy treatment include one more allergens also called
an antigen configured to elicit an immune response. In a preferred
embodiment, the allergens are classified into broad categories
based on a transmission or other functional characteristics of the
allergens. For example, the first category is called a vector
group, and includes a pollen vector group, an animal vector group,
a control vector group and an environment vector group.
[0086] In addition, these vector groups can have a further
classification of allergens into sub-vector groups below each
vector group. For example, the pollen vector group includes a tree
sub-vector group, a grass sub-vector group, a weed sub-vector
group, a plant sub-vector group and other pollen transmitting
sub-vector groups. The animal vector group includes an indoor
animal sub-vector group and an outdoor animal sub-vector group. The
control vector group includes a saline control sub-vector group and
histamine control sub-vector group. The environmental vector group
includes a mold sub-vector group and cockroach allergens.
Optionally and/or alternatively, the allergens within each
sub-vector group may be further classified into one or more of
seasons, amount of pollen produced per a predetermined time of one
or more plant, tree, weed, or grass associated with each a specific
vector group, sub-vector group or both, a cross-reactivity
designation of one or more antigens in each sub-vector group, a
frequency designation of one or more plant, tree, weed, or grass
associated with each a specific vector group, sub-vector group or
both per a predetermined area, and a meteorological factors
associated with one or more plant, tree, weed, or grass associated
with each a specific vector group, sub-vector group.
[0087] In one embodiment, the tree sub-vector group includes one or
more allergens, e.g., an Acacia, Golden (Acacia longifolia); Alder,
Red (alnus rubra (oregona)); Ash, White (Faxinus grandifolia);
Beech, American (Fagus grandifolia); Birch Mix (Paper, River/Red
& White Birch); Boxelder/Maple Mix (Boxelder, Hard Maple &
Red Maple); Cedar, Mountain (Juniperus ashei); Cedar, Red
(Juniperus virginiana); Cottonwood, Common (Populus deltoides);
Cypress, Arizona (Curpressus arizonica); Cypress, Bald (Taxodium
distichum); Elm, American (Ulmus americana); Elm, Chinese (Ulmus
parvifolia); Eucalyptus/Blue Gum (Eucalyptus globulus); Gum, Sweet
(Liquidambar styraciflua); Hackberry (Celtis occidentalis);
Hickory, Shagbark (Carya ovata); Linden/Basswood (Tilia americana);
Maple, Hard/Sugar (Acer saccharum); Mesquite (Prosopis juliflora
(glandulosa)); Mulberry Mix (Red & White Mulberry); Oak, Red
(Quercus rubra); Oak Mix (Red, Virginia Live & White Oak);
Olive Tree (Olea europaea); Bottlebrush Tree (Callistemon
citrinus); Melaleuca (Melaleuca quinquenervia); Palm, Queen (Cocos
plumose); Pecan Tree (Carya pecan (illinoensis); Pepper Tree,
California (Schinus molle); Pine Mix (Lodgepole & Western
Yellow Pine); Privet, Common (Lingustrum vulgare); Russian Olive
(Elaeagnus angustifolia); Sycamore, American (Platanus
occidentalis); Tree Mix (Pecan, Maple, Oak, American Sycamore,
Black Willow); Tree Mix (White Ash, American Beech, Birch, Black
Walnut, Common Cottonwood, American Elm); Tree Mix (White Ash,
American Beech, River/Red Birch, Black Walnut, Common Cottonwood,
American Elm, Shagbark Hickory, Hard Maple, Red Oak, American
Sycamore, Black Willow); Walnut, Black (Juglans nigra); Willow,
Black (Salix nigra); and the like.
[0088] There are a number of different allergens configured in the
grass sub-vector group. In one embodiment, the allergens in this
grass sub-vector group include one or more of Acacia, Bahia Grass
(Paspalum notatum); Bermuda Grass (Cynodon dactylon); Bluegrass,
Kentucky (Poa pratensis); Brome, Smooth (Bromus inermis); Corn,
Cultivated (Zea mays); Fescue, Meadow (Festuca elatior (pratensis);
Grass Mix (Kentucky Bluegrass, Orchard, Redtop, Timothy); Grass Mix
(Kentucky Bluegrass, Orchard, Redtop, Timothy, Sweet Vernalgrass);
Grass Mix (Kentucky Bluegrass, Orchard, Redtop, Timothy, Sweet
Vernalgrass, Meadow Fescue, Perennial Ryegrass); Grass Mix
(Kentucky Bluegrass, Bermuda, Johnson, Redtop, Timothy); Johnson
Grass (Sorghum halepense); Oats, Common Cultivated (Avena sativa);
Orchard Grass (Dactylis glomerata); Redtop (Agrostis gigantea
(alba)); Ryegrass, Perennial (Lolium perenne); Southern Grass Mix
(Kentucky Bluegrass, Orchard, Redtop, Timothy, Sweet Vernalgrass,
Bermuda, Johnson); Sweet Vernalgrass (Anthoxanthum odoratum);
Timothy (Phleum pratense); and the like.
[0089] There are a number of different allergens configured in the
weed sub-vector group. In one embodiment, the allergens the weed
sub-vector group include one or more of Acacia, Careless Weed
(Amaranthus palmeri); Careless/Pigweed (Careless Weed & Rough
Redroot Pigweed); Cocklebur, Common (Xanthium strumarium);
Dock/Sorrel Mix (Yellow Dock & Sheep Sorrel); Goldenrod
(Solidago canadensis); Kochia (Kochia scoparia); Lamb's Quarters
(Chenopodium album); Marshelder/Poverty Mix (Burwee, Povertyweed
& True Marshelder); Nettle (Urtica dioica); Dog Fennel, Eastern
(Eupatorium capillifolium); Pigwee, Rough Redroot (Amaranthus
retroflexus); Plantain, English (Plantago lanceolata); Ragweed,
Giant (Ambrosia trifida); Ragweed, Short (Ambrosia
artemisilifolia); Ragweed, Western (Ambrosia psilostachya); Ragweed
Mix (Giant & Short Ragweed); Ragweed (Giant, Short &
Western Ragweed); Russian Thistle (Salsola kali); Sagebrush,
Mugwort (Artemisia vulgaris Heterophylla (douglasiana)); Scale,
Wing (Atriplex canescens); Sheep Sorrel (Rumex acetosella); Weed
Mix 2630 (Common Cocklebur, Lamb's Quarters, Rough Redroot Pigweed,
Dock/Sorrel); and the like.
[0090] There are a number of different allergens configured in the
mold sub-vector group. In one embodiment, the allergens the mold
sub-vector group include one or more of Alternaria-Hormodendrum Mix
(Alternaria tenuis, Hormodendrum cladosporioides); Alternaria
tenuis; Aspergillus fumigatus; Aspergillus niger; Botrytis cinerea;
Candida albicans; Cephalosporium acremonium; Curvularia spicifera;
Epicoccum nigrum; Epidermophyton floccosum; Fusarium vasinfectum;
Helminthosporium interseminatum; Hormodendrum cladosporioides;
Mucor racemosus; Penicillium Mix (p.digitatum, expansum, glaucum,
roseum, notatum); Penicillium notatum; Phoma herbarum; Pullularia
pullulans; Rhizopus nigricans; Stemphylium botryosum; Trichopyton
Mix (T. tonsurans, rubrum, mentagrophytes); Mold Mix (Alternaria
tenuis, Aspergillus Mix (A. fumigatus, nidulans, niger, terreus),
Hormodendrum cladosporioides, Penicillium Mix (P. digitatum,
expansum, glaucum, notatum, roseum); Mold Mix Alternaria tenuis,
Aspergillus Mix (A. fumigatus, nidulans, niger, terreus), Fusarium
vasinfectum, Helminthosporium interseminatum, Hormodendrum
cladosporioides, Mucor racemosus, Penicillium Mix (P. digitatum,
expansum, glaucum, notatum, roseum), Phoma herbarum, Pullularia
pullulans, Rhizopus nigricans; and the like.
[0091] There are a number of different allergens configured in the
animal vector group. In one embodiment, the allergens in this
animal vector includes one or more of Dog Hair and Dander (Mixed
breeds); Feather Mix (Chicken, Duck and Goose); Guinea Pig Hair and
Dander; Cat Pelt; Cat Hair; Cattle Hair and Dander; Horse Hair and
Dander; House Dust Mix (Feather and Mattress dust), DP Mite and DF
Mite (even though not an animal); and the like.
[0092] There are a number of different allergens configured in the
mold sub-vector group. In one embodiment, the allergens in this
mold sub-vector group includes one or more of Alternaria tenuis;
Aspergillus fumigatus; Aspergillus niger; Candida albicans;
Cephalosporium acremonium; Curvularia spicifera; Epidermophyton
floccosum; Fusarium vasinfectum; Mucor racemosus; Hormodendrum;
Helminthosporum; Penicillium Mix; Phoma herbarum; Pullularia
pullulans; Rhizopus nigricans; Stemphylium botryosum; Trichopylton
Mix; Epicoccum nigrum; Botrytis cinerea, cockroach mix (even though
not a mold), and the like.
[0093] In another embodiment, allergen extract treatment sets are
made from prefilled cartridges or with empty cartridges. In a
preferred embodiment, the prefilled cartridges include a diluent
for an allergenic extract.
[0094] In one embodiment, a patient treatment set may be formed at
a provider's office or other predetermined location. The treatment
set is configured to provide a predetermined course of
immunotherapy to a patient for a predetermined amount of time. In a
preferred embodiment, five allergen extracts of predetermined
concentrations are combined to provide the predetermined course of
allergy treatments. The number of different allergen extracts may
vary, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20 or more. The selection of these allergen extracts
are as desired by the clinician, patient, other provider and any
combination of the same.
[0095] In this embodiment, an immunotherapy treatment set is
formed. Allergen extracts are combined into a single container,
e.g., five or more different allergen extracts are combined into
one container. The container may be 10 mL or greater. In container
now contains a concentrate or immunotherapy concentrate. The
container may also be a cartridge of adequate volume. In this
embodiment, the concentration of each of the five different
allergen extracts is similar such that the effective concentration
for treatment of each of the five different allergen extracts is
similar. This concentrate is now 1:1 vol/vol and is utilized to
create the immunotherapy treatment set. This concentrate is now a
mixture of all of the five or more different allergen extracts into
one container.
[0096] Next, a second container, e.g. a 10 mL container, containing
8 mL of a diluent for an allergenic extract is mixed with 2 mL of
the concentrate (1:1 vol/vol) to create a 1:5 vol/vol mixture (5
dilution). Next, a third container, e.g., a 10 mL container,
containing 9 mL of diluent for an allergenic extract is mixed with
1 mL of the 1:5 vol/vol mixture (5 dilution) to create a 1:50
vol/vol mixture (50 dilution). Next, a fourth container, e.g., a 10
mL container, containing 9 mL of diluent for an allergenic extract
is mixed with 1 mL of the of 1:50 vol/vol mixture (50 dilution) to
create a 1:500 vol/vol mixture (500 dilution). Next, a fifth
container, e.g., a 10 mL container, containing 9 mL of diluent for
an allergenic extract is mixed with 1 mL of the 1:500 vol/vol
mixture (500 dilution) to create a 1:5000 vol/vol mixture (5000
dilution).
[0097] In this embodiment, the different dilutions can now be
transferred to empty cartridges to create an immunotherapy
treatment for use with an injection device, e.g., an injection pen.
A 1:5 vol/vol mixture (5 dilution) treatment is made by
transferring the 1:5 vol/vol mixture into an empty cartridge, e.g.,
a 10 mL cartridge. This cartridge is labeled with a cap having a
color, e.g., yellow, that is preexisting or added to the cap to
indicate the concentration of the immunotherapy. Moreover, a label,
e.g., an RFID label (active or passive), may be added to the
cartridge containing the mixture to indicate one or more of the
concentration, specific allergen extracts in the mixture, age of
the mixture, origin of the allergen extracts, and other parameters.
This can be repeated to obtain multiple 1:5 vol/vol mixture
treatments.
[0098] A 1:50 vol/vol mixture (50 dilution) treatment is made by
transferring the 1:50 vol/vol mixture into an empty cartridge,
e.g., a 10 mL cartridge. A 1:500 vol/vol mixture (500 dilution)
treatment is made by transferring the 1:5 vol/vol mixture into an
empty cartridge, e.g., a 10 mL cartridge. A 1:5000 vol/vol mixture
(5000 dilution) treatment is made by transferring the 1:5000
vol/vol mixture into an empty cartridge, e.g., 10 mL cartridge.
These cartridges are labeled to indicate the concentration of the
mixture, e.g., a preexisting blue cap or added cap can be used for
the 1:50 vol/vol mixture, a preexisting green cap or added cap can
be used for the 1:500 vol/vol mixture, and a preexisting silver cap
or added cap can be used form the 1:5000 vol/vol mixture. Moreover,
an RFID label as described herein can be added to the cartridges.
This method can be repeated to obtain multiple mixture
treatments.
[0099] Next these labeled cartridges are placed in a treatment box
or container. In a preferred embodiment, the box or container is
configured to hold two or more cartridges of each treatment
dilution concentration and all treatment dilutions are in one
container. This treatment set is used by a patient for
immunotherapy and may be called an immunotherapy treatment set. In
a preferred embodiment, these treatments sets are formed in a
medical office, hospital or other medical center.
[0100] FIG. 3 illustrates a method of preparing an immunotherapy
treatment set with prefilled cartridges according to an embodiment
of the invention.
[0101] The treatment set is configured for treating a patient for
six weeks at each treatment concentration. In this embodiment, the
treatment set includes two immunotherapy prefilled cartridges at
each of the following concentrations is indicative of a 5 fold
dilution 1:5 vol/vol, a 50 fold dilution 1:50 vol/vol, a 500 fold
dilution 1:500 vol/vol, and a 5,000 fold dilution 1:5,000 vol/vol.
The prefilled cartridges are color coded with as described
herein.
[0102] Referring to FIG. 3, in step 302 allergen extracts are
combined into a single container, e.g., five or more predetermined
allergen extracts are combined into one container. The container
may be 10 mL or greater. The container now contains a concentrate
or immunotherapy concentrate of the predetermined allergen
extracts. In this embodiment, the concentration of each of the five
different allergen extracts is similar such that the effective
concentration for treatment of each of the five different allergen
extracts is similar. This concentrate is now 1:1 vol/vol and is
utilized to create the immunotherapy treatment set. This
concentrate is now a mixture of all of the five or more different
allergen extracts into one container.
[0103] In step 304, a predetermined amount of diluent is obtained
in the prefilled cartridge. This may be accomplished by either
adding or subtracting diluent to the prefilled cartridge to obtain
the predetermined volume of diluent. Specifically, the prefilled
cartridge may include 3.0 ml of diluent, so 0.3 ml is removed to
obtain a 2.7 ml volume of diluent in the prefilled cartridge. In
step 306, forming the 1:5 vol/vol (5 dilution) can be accomplished
by mixing 0.3 ml of the concentrate (from Step 302) into the
prefilled cartridge containing 2.7 mL (from Step 304). Steps 304
and 306 are repeated to obtain a second prefilled cartridge at 1:5
vol/vol mixture (5 dilution) and may be repeated additional times
as well. These prefilled cartridges are labeled as described
herein.
[0104] In step 308, a predetermined amount of diluent is obtained
in the prefilled cartridge. This may be accomplished by either
adding or subtracting diluent to the prefilled cartridge to obtain
the predetermined volume of diluent. Specifically, the prefilled
cartridge may include 3.0 ml of diluent, so 0.3 ml is removed to
obtain a 2.7 ml volume of diluent in the prefilled cartridge. In
step 310, forming the 1:50 vol/vol (50 dilution) can be
accomplished by mixing 0.3 ml of the 1:5 vol/vol (5 dilution)
concentrate (from Step 306) into the prefilled cartridge containing
2.7 mL (from Step 308). Steps 308 and 310 are repeated to obtain a
second prefilled cartridge at 1:50 vol/vol mixture (50 dilution)
and may be repeated additional times as well. These prefilled
cartridges are labeled as described herein.
[0105] In step 312, a predetermined amount of diluent is obtained
in the prefilled cartridge. This may be accomplished by either
adding or subtracting diluent to the prefilled cartridge to obtain
the predetermined volume of diluent. Specifically, the prefilled
cartridge may include 3.0 ml of diluent, so 0.3 ml is removed to
obtain a 2.7 ml volume of diluent in the prefilled cartridge. In
step 314, forming the 1:500 vol/vol (500 dilution) can be
accomplished by mixing 0.3 ml of the 1:50 vol/vol (50 dilution)
concentrate (from Step 310) into the prefilled cartridge containing
2.7 mL (from Step 312). Steps 312 and 314 are repeated to obtain a
second prefilled cartridge at 1:500 vol/vol mixture (500 dilution)
and may be repeated additional times as well. These prefilled
cartridges are labeled as described herein.
[0106] In step 316, a predetermined amount of diluent is obtained
in the prefilled cartridge. This may be accomplished by either
adding or subtracting diluent to the prefilled cartridge to obtain
the predetermined volume of diluent. Specifically, the prefilled
cartridge may include 3.0 ml of diluent, so 0.3 ml is removed to
obtain a 2.7 ml volume of diluent in the prefilled cartridge. In
step 318, forming the 1:5000 vol/vol (5000 dilution) can be
accomplished by mixing 0.3 ml of the 1:500 vol/vol (500 dilution)
concentrate (from Step 314) into the prefilled cartridge containing
2.7 mL (from Step 316). Steps 316 and 318 are repeated to obtain a
second prefilled cartridge at 1:5000 vol/vol mixture (5000
dilution) and may be repeated additional times as well. These
prefilled cartridges are labeled as described herein.
[0107] The treatment set includes two immunotherapy prefilled
cartridges at each of the following concentrations is indicative of
a 5 fold dilution 1:5 vol/vol, a 50 fold dilution 1:50 vol/vol, a
500 fold dilution 1:500 vol/vol, and a 5,000 fold dilution 1:5,000
vol/vol. The prefilled cartridges are color coded with as described
herein. Optionally, more or less cartridges can be utilized. In
addition, the treatment set may also include instructions for home
use immunotherapy and an injection pen.
[0108] In the methods described herein a needle and syringe or
other device may be used to transfer liquid from one container
(prefilled cartridge) to another container. Moreover, caps on the
prefilled cartridges may be removable or non-removable. In a
preferred embodiment, the needle is inserted through a resealable
membrane on the cap of the cartridge to add or subtract diluent for
an allergenic extract or allergen extract. After removing the
needle the resealable membrane closes automatically. Resealable and
self-healing are used interchangeably herein.
[0109] FIG. 4 illustrates a method of administering immunotherapy
to a patient with an injection pen and prefilled cartridge.
[0110] In step 402, a cartridge with an immunotherapy treatment is
loaded into the pen. In step 404, the pen is utilized to administer
an efficacious amount of allergen extract preferably in a range
from about 0.4 ml to about 0.27 ml. For example, using an injection
pen to administer to the patient an effective dosage of an allergen
extract.
[0111] While various embodiments of the present disclosure have
been described in detail, it is apparent that modifications and
alterations of those embodiments will occur to those skilled in the
art. However, it is to be expressly understood that such
modifications and alterations are within the scope and spirit of
the present disclosure, as set forth in the following claims.
[0112] The foregoing discussion of the disclosure has been
presented for purposes of illustration and description. The
foregoing is not intended to limit the disclosure to the form or
forms disclosed herein. In the foregoing Detailed Description for
example, various features of the disclosure are grouped together in
one or more embodiments for the purpose of streamlining the
disclosure. This method of disclosure is not to be interpreted as
reflecting an intention that the claimed disclosure requires more
features than are expressly recited in each claim. Rather, as the
following claims reflect, inventive aspects lie in less than all
features of a single foregoing disclosed embodiment. Thus, the
following claims are hereby incorporated into this Detailed
Description, with each claim standing on its own as a separate
preferred embodiment of the disclosure.
[0113] Moreover, though the present disclosure has included
description of one or more embodiments and certain variations and
modifications, other variations and modifications are within the
scope of the disclosure, e.g., as may be within the skill and
knowledge of those in the art, after understanding the present
disclosure. It is intended to obtain rights which include
alternative embodiments to the extent permitted, including
alternate, interchangeable and/or equivalent structures, functions,
ranges or steps to those claimed, whether or not such alternate,
interchangeable and/or equivalent structures, functions, ranges or
steps are disclosed herein, and without intending to publicly
dedicate any patentable subject matter.
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