U.S. patent application number 17/517464 was filed with the patent office on 2022-04-28 for devices and methods for precision dose delivery.
This patent application is currently assigned to Regeneron Pharmaceuticals, Inc.. The applicant listed for this patent is Regeneron Pharmaceuticals, Inc.. Invention is credited to Bryan GRYGUS, Eric HOUDE, Ross KENYON, Danielle LAIACONA, Trevor LANGLEY, Jeremy McNAMARA, Sibgat ULLA, Kathryn VENUTO.
Application Number | 20220126023 17/517464 |
Document ID | / |
Family ID | 1000006075555 |
Filed Date | 2022-04-28 |
View All Diagrams
United States Patent
Application |
20220126023 |
Kind Code |
A1 |
ULLA; Sibgat ; et
al. |
April 28, 2022 |
DEVICES AND METHODS FOR PRECISION DOSE DELIVERY
Abstract
Disclosed herein are delivery devices for delivering a volume of
a drug product, placebo product, or other product including a
fluid. The devices may include a barrel having a longitudinal axis,
a proximal end region, and a distal end region. The proximal end
region may include an opening, and the barrel may be configured to
receive a drug therein. A plunger rod may be disposed at least
partially inside the barrel and protruding from the opening. The
plunger rod may include a rack having a plurality of teeth. The
device may further include a pinion having a plurality of teeth
configured to engage with the plurality of teeth of the rack, and
rotation of the pinion against the rack may move at least a part of
the plunger rod along the longitudinal axis of the barrel.
Inventors: |
ULLA; Sibgat; (Rensselaer,
NY) ; LAIACONA; Danielle; (Rexford, NY) ;
KENYON; Ross; (Saratoga Springs, NY) ; LANGLEY;
Trevor; (Rensselaer, NY) ; GRYGUS; Bryan;
(Clifton Park, NY) ; HOUDE; Eric; (Queensbury,
NY) ; McNAMARA; Jeremy; (Albany, NY) ; VENUTO;
Kathryn; (Waltham, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Regeneron Pharmaceuticals, Inc. |
Tarrytown |
NY |
US |
|
|
Assignee: |
Regeneron Pharmaceuticals,
Inc.
Tarrytown
NY
|
Family ID: |
1000006075555 |
Appl. No.: |
17/517464 |
Filed: |
November 2, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16900747 |
Jun 12, 2020 |
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17517464 |
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PCT/US2018/065192 |
Dec 12, 2018 |
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16900747 |
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62722252 |
Aug 24, 2018 |
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62676047 |
May 24, 2018 |
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62598212 |
Dec 13, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/31511 20130101;
A61M 5/31593 20130101; A61M 5/31583 20130101; A61M 5/31536
20130101 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Claims
1.-30. (canceled)
31. A method of dispensing a substance from a drug delivery device
having a plunger rod and a barrel, the method comprising: advancing
the plunger rod by a predetermined distance into the barrel until
advancement of the plunger rod is resisted by a stop; deactivating
the stop; and actuating the plunger rod to deliver the
substance.
32. The method of claim 31, wherein advancing the plunger rod
comprises rotating a pinion against a rack disposed on the plunger
rod.
33. The method of claim 32, wherein the stop comprises a shaft
removably affixed to the pinion, and wherein deactivating the stop
comprises removing the shaft from the pinion.
34. The method of claim 31, wherein deactivating the stop comprises
rotating the plunger rod.
35. The method of claim 31, wherein the plunger rod comprises a
flange, and wherein the stop comprises a lock that prevents the
flange from entering the barrel.
36. The method of claim 35, wherein deactivating the stop comprises
removing the lock.
37. The method of claim 35, wherein deactivating the stop comprises
breaking the lock.
38.-40. (canceled)
41. A drug delivery device having a dose expulsion control
mechanism, the drug delivery device comprising: a barrel including
a proximal end and a distal end; a plunger rod extending into an
interior of the barrel through an opening at the proximal end of
the barrel and along a central longitudinal axis of the drug
delivery device, the plunger rod including a depressor and a
plunger, wherein the plunger and the plunger rod are together
formed in a one-piece construction; a stop movable between a first
configuration and a second configuration, wherein the stop is
configured to prevent distal movement of the plunger rod after the
plunger rod moves a priming distance while the stop is in the first
configuration, and is configured to allow the plunger rod to move
further distally through the barrel after being transitioned from
the first configuration to the second configuration; and a flange
contacting the proximal end of the barrel, the flange including a
body and a hole that receives the plunger rod.
42. The drug delivery device of claim 41, wherein the stop (i)
includes one projection on the plunger rod, (ii) includes two
projections on the plunger rod, (iii) includes a lock or pin, (iv)
includes threads or teeth, or (v) is disposed within an interior of
the barrel.
43. The drug delivery device of claim 42, wherein the lock is
configured to be removed or broken to allow actuation of the
plunger rod relative to the barrel.
44. The drug delivery device of claim 41, wherein the plunger rod
is rotatable about the central longitudinal axis relative to the
flange.
45. The drug delivery device of claim 41, wherein the drug delivery
device is a pre-filled syringe.
46. A method of preparing the drug delivery device of claim 41 for
delivering a dose of a drug substance, the method comprising:
advancing the plunger rod distally into the barrel; and rotating
the plunger rod about the central longitudinal axis by 90 degrees,
relative to the flange.
47. The drug delivery device of claim 41, wherein the stop includes
two projections on the plunger rod that are symmetrically disposed
about the central longitudinal axis, and protrude in directions
perpendicular to the central longitudinal axis.
48. The drug delivery device of claim 47, wherein the hole has a
geometry configured to receive the projections when the drug
delivery device is in a dosage delivery configuration, wherein the
body has a one-piece construction, and the hole has a circumference
that is fully enclosed by the body.
49. A drug delivery device having a dose expulsion control
mechanism, the drug delivery device comprising: a barrel including
a proximal end and a distal end; a plunger rod extending into an
interior of the barrel through an opening at the proximal end of
the barrel and along a central longitudinal axis of the drug
delivery device; a plunger affixed to the plunger rod, wherein the
plunger and the plunger rod are defined together in a one-piece
construction where the plunger and the plunger rod are formed in a
single mold; and a stop movable between a first configuration and a
second configuration, wherein in the first configuration, the stop
is configured to prevent distal movement of the plunger rod after
the plunger rod moves a priming distance, and after being
transitioned from the first configuration to the second
configuration, the stop is configured to allow the plunger rod to
move further distally through the barrel.
50. The drug delivery device of claim 49, wherein the stop is
transitioned from the first configuration to the second
configuration by removing or breaking a lock to allow actuation of
the plunger rod relative to the barrel.
51. The drug delivery device of claim 49, wherein the stop is
transitioned from the first configuration to the second
configuration by rotating the plunger rod about the central
longitudinal axis of the drug delivery device.
52. The drug delivery device of claim 49, wherein the stop is
transitioned from the first configuration to the second
configuration by rotating a sleeve coupled to the plunger rod about
the central longitudinal axis of the drug delivery device.
53. The drug delivery device of claim 49, wherein the stop is
transitioned from the first configuration to the second
configuration by translating the plunger rod relative to the barrel
along the central longitudinal axis of the drug delivery device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Application No.
62/598,212, filed Dec. 13, 2017; U.S. Application No. 62/676,047,
filed May 24, 2018; and U.S. Application No. 62/722,252, filed Aug.
24, 2018, all of which are incorporated by reference herein in
their entireties.
FIELD OF DISCLOSURE
[0002] Aspects of the present disclosure relate to devices and
methods for priming or otherwise configuring a dose delivery
device, e.g., a syringe, to promote precision dose delivery. More
specifically, embodiments of the present disclosure relate to
devices and methods for loading, storing, transporting, and/or
delivering precise doses of a drug product, placebo product, or
other product including a fluid.
INTRODUCTION
[0003] Liquid drug products may be deliverable to patients in a
variety of ways, including via injection. In many cases, the
precision and accuracy of a liquid drug product's volume is
crucial. For example, medical professionals may have an interest in
ensuring that an approved or prescribed volume of a drug product is
consistently delivered to each patient requiring the drug.
Additionally, over- or under-dosing a patient with a drug product,
even slightly, may have an undesired (or even negative) clinical
impact on the patient. Moreover, some drug products are prescribed
at low volumes (e.g., under 100 .mu.L). At low volumes, human error
in preparing and delivering an accurate dose of a drug product for
injection may impact the drug's efficacy in a patient and the
subsequent clinical effect on the patient.
[0004] Additional aspects of liquid drug product delivery can
complicate the goal of accurate dose delivery via injection. For
example, for a correct dose of a drug product to be dispensed from
a device (e.g., a syringe), a corresponding accurate volume of the
drug product must be loaded into the device. Furthermore, handling,
storage, packaging, and/or transportation of loaded devices must
not result in inadvertent expulsion of drug product from the
devices. Additionally, prior to administration of a drug product
from a device, the device may need to be primed to remove air
bubbles from within the device's needle and barrel. Incorrectly
priming a device may result in expulsion of too much or too little
drug product from the device, which likewise may result in a
decreased dose being delivered to a patient, or air bubbles being
injected from the device into the patient.
SUMMARY
[0005] Disclosed herein are fluid delivery devices. In an aspect of
the present disclosure, the devices may include a barrel having a
longitudinal axis, a proximal end region, and a distal end region.
The proximal end region may include an opening, and the barrel may
be configured to receive a drug therein. A plunger rod (having a
piston coupled thereto) may be disposed at least partially inside
the barrel and protruding from the opening. The plunger rod may
include a rack having a plurality of teeth. The device may further
include a pinion having a plurality of teeth configured to engage
with the plurality of teeth of the rack, and rotation of the pinion
against the rack may move at least a part of the plunger rod along
the longitudinal axis of the barrel.
[0006] Various aspects of the device may include one or more of the
features below. The device may also include a shaft affixed to the
pinion, wherein rotation of the shaft rotates the pinion against
the rack. In one embodiment, a knob may be affixed to the shaft. In
another embodiment, a visualization device (e.g., a magnifier) may
be disposed on the distal end region of the barrel. In a further
embodiment, the device may include a stopper inside the barrel, and
the stopper may be affixed to a distal end of the plunger rod. In
an exemplary embodiment, the device may further include a circular
ratchet disposed coaxially with the pinion, wherein the circular
ratchet has a diameter smaller than a diameter of the pinion, a
spring-loaded pawl disposed on an internal circumference of the
pinion, wherein the pawl is configured to engage the ratchet, and a
shaft affixed to the ratchet, wherein rotation of the shaft in one
direction causes rotation of the pinion, and rotation of the shaft
in a second direction does not cause rotation of the pinion. In
some embodiments, the ratchet may be disposed inside the pinion. In
some embodiments, the pinion may include a plurality of teeth
having a first height, and a stopper tooth having a second height
greater than the first height. In further embodiments, the second
height of the stopper tooth may prevent the pinion from engaging
the plurality of teeth of the rack. In still further embodiments,
the second height of the stopper tooth may be configured to contact
one of the plunger rod and the rack to stop rotation of the pinion.
In still other embodiments, the plunger rod may include an inner
column and an outer lumen, and the rack may be disposed on the
inner column. In some embodiments, rotation of the pinion against
the rack may move the inner column of the plunger rod independently
of the outer lumen. In some embodiments, the device may also
include a shaft removably affixed to the pinion, wherein the shaft
prevents movement of the outer lumen of the plunger rod relative to
the barrel, and wherein removal of the shaft allows for movement of
the outer lumen of the plunger rod relative to the barrel.
[0007] In some embodiments, the plunger rod may further include a
body and a flange, the flange extending partially along a
longitudinal length of the body and having a width greater than a
width of the body, and the barrel may further include a plunger
lock, the plunger lock including a through hole configured to allow
the flange to pass through the second plunger lock in a specific
orientation.
[0008] In another aspect of the present disclosure, a drug delivery
device may include a barrel having a longitudinal axis, a proximal
end region, a distal end region, and an interior, the proximal end
region including an opening and the interior including a threaded
region. The device may further include a plunger rod disposed at
least partially inside the barrel and protruding from the opening,
the plunger rod having a threaded region configured to engage the
threaded region of the barrel interior. Rotation of the plunger rod
about the longitudinal axis of the drug delivery device may move
the plunger rod along the longitudinal axis.
[0009] Various aspects of the device may include one or more of the
features below. The plunger rod may further include a tab
protruding from the plunger rod in a first direction and located
proximally from the threaded region of the plunger rod, and the
threaded region in the interior of the barrel may further include a
slot sized and configured to allow for the tab to pass through the
threaded region in the interior of the barrel. In some embodiments,
the slot may include a first segment parallel to the longitudinal
axis of the drug delivery device and a second segment perpendicular
to the longitudinal axis of the drug delivery device. In some
embodiments the slot may include a third segment parallel to the
longitudinal axis of the drug delivery device, wherein the second
segment is in between the first segment and the third segment. In
other embodiments, the tab is a first tab, and the plunger rod may
further include a second tab protruding from the plunger rod in a
second direction opposite to the first direction, and the threaded
region in the interior of the barrel may further include a second
slot sized and configured to allow for the second tab to pass
through the threaded region in the interior of the barrel.
[0010] In another aspect of the present disclosure, a drug delivery
device may include a barrel having a proximal end region, a distal
end region, an opening in the proximal end region, an interior, and
a threaded region in the interior. The device may further include a
sleeve disposed partly inside the barrel and protruding from the
opening in the proximal end region of the barrel, the sleeve
including a threaded region engaged with the threaded region of the
barrel interior. The device may also include a plunger rod disposed
at least partially inside the sleeve, and a stopper inside the
barrel and located distally from the sleeve, the stopper connected
to a distal end of the plunger rod. Rotation of the sleeve in a
first direction around a longitudinal axis of the drug delivery
device may move the sleeve towards the distal end region of the
barrel.
[0011] Various aspects of the device may include one or more of the
features below. Rotation of the sleeve in the first direction may
move the stopper towards the distal end region of the barrel. In
some embodiments, the sleeve may include an inner passage, and the
stopper may have a diameter larger than a diameter of the inner
passage. In some embodiments, the sleeve may include a tab disposed
on an exterior of the sleeve, the tab may be located proximally
from the threaded region of the barrel interior, and the tab may
stop movement of the sleeve towards the distal end region of the
barrel. In further embodiments, the tab may be configured to stop
movement of the sleeve towards the distal end region of the barrel
after the drug delivery device has been primed. In additional
embodiments, the tab may be a first tab, the sleeve may further
include a second tab disposed on an exterior of the sleeve, the
second tab may be located distally from the threaded region of the
barrel interior, and the second tab may stop movement of the sleeve
towards the proximal end region of the barrel.
[0012] In a further aspect of the present disclosure, a drug
delivery device may include a barrel having a proximal end region
and a distal end region, and the proximal end region may include an
opening. The device may also include a plunger rod having a body
and a flange, the flange extending partially along a longitudinal
length of the body and having a width greater than a width of the
body, the plunger rod being disposed at least partially inside the
barrel and protruding from the opening. The device may also include
a first plunger lock disposed on the barrel, the first plunger lock
being configured to block the flange from entering the barrel, and
a second plunger lock disposed in the barrel, the second plunger
lock including a through hole configured to allow the flange to
pass through the second plunger lock in a specific orientation.
[0013] Various aspects of the device may include one or more of the
features below. In some embodiments, the first plunger lock may be
removable. In some embodiments, the first plunger lock may be
frangible. In still other embodiments, a distance between the first
plunger lock and the second plunger lock may be equivalent to the
distance that the stopper must travel to prime the drug delivery
device. In other embodiments, the plunger rod may be rotatable
around a longitudinal axis of the drug delivery device.
[0014] In a further aspect of the present disclosure, a method of
dispensing a substance from a drug delivery device having a plunger
rod and a barrel may include advancing the plunger rod by a
predetermined distance into the barrel until advancement of the
plunger rod is resisted by a stop, deactivating the stop, and
actuating the plunger rod to deliver the substance.
[0015] Various aspects of the device may include one or more of the
features below. In some embodiments, advancing the plunger rod may
comprise rotating a pinion against a rack disposed on the plunger
rod. In some embodiments, the stop may comprise a shaft removably
affixed to the pinion, and deactivating the stop may comprise
removing the shaft from the pinion. In still other embodiments,
deactivating the stop may comprise rotating the plunger rod. In
some embodiments, the plunger rod may comprise a flange, and the
stop may comprise a lock that prevents the flange from entering the
barrel. In other embodiments, deactivating the stop may comprise
removing the lock. In some embodiments, deactivating the stop may
comprise breaking the lock.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The accompanying drawings, which are incorporated into and
constitute a part of this specification, illustrate various
exemplary embodiments and, together with the description, serve to
explain principles of the disclosed embodiments. The drawings show
different aspects of the present disclosure and, where appropriate,
reference numerals illustrating like structures, components,
materials, and/or elements in different figures are labeled
similarly. It is understood that various combinations of the
structures, components, and/or elements in various embodiments,
other than those specifically shown, are contemplated and are
within the scope of the present disclosure.
[0017] There are many embodiments described and illustrated herein.
The described devices and methods are neither limited to any single
aspect nor embodiment thereof, nor to any combinations and/or
permutations of such aspects and/or embodiments. Moreover, each of
the aspects of the described inventions, and/or embodiments
thereof, may be employed alone or in combination with one or more
of the other aspects of the described inventions and/or embodiments
thereof. For the sake of brevity, certain permutations and
combinations are not discussed and/or illustrated separately
herein.
[0018] FIG. 1 depicts an exemplary delivery device (e.g., a
syringe), according to one embodiment of the present
disclosure.
[0019] FIG. 2 depicts an exemplary pawl and ratchet mechanism for a
delivery device, according to one embodiment of the present
disclosure.
[0020] FIGS. 3A and 3B depict an exemplary lock mechanism for a
delivery device, according to one embodiment of the present
disclosure.
[0021] FIGS. 3C and 3D depict an exemplary telescoping mechanism
for a delivery device, according to one embodiment of the present
disclosure.
[0022] FIGS. 4A and 4B depict exemplary rotational lock mechanisms
for a delivery device, according to embodiments of the present
disclosure.
[0023] FIGS. 4C-4E depict an exemplary delivery device with an
exemplary rotational lock mechanism in various positions, according
to an embodiment of the present disclosure.
[0024] FIG. 5 depicts an exemplary delivery device, according to
one embodiment of the present disclosure.
[0025] FIGS. 6A-6E depict an exemplary delivery device and locking
mechanism, according to one embodiment of the present
disclosure.
[0026] FIG. 7A depicts an exemplary delivery device, according to
one embodiment of the present disclosure.
[0027] FIG. 7B depicts a threaded portion of the delivery device of
FIG. 7A.
[0028] FIG. 8 depicts an alternative embodiment of the threaded
portion of FIG. 7B.
[0029] FIG. 9A depicts an exemplary delivery device, according to
one embodiment of the present disclosure.
[0030] FIGS. 9B-9D depict locking components of the delivery device
of FIG. 9A.
[0031] FIGS. 10A-10C depict further exemplary delivery devices
according to additional embodiments of the present disclosure.
[0032] FIGS. 11A and 11B depict still further exemplary delivery
devices according to additional embodiments of the present
disclosure.
[0033] FIG. 12 depicts an exemplary delivery device according to
additional embodiments of the present disclosure.
[0034] FIGS. 13A-13C depict an exemplary priming and delivery
mechanism for a delivery device according to additional embodiments
of the present disclosure.
[0035] FIGS. 14A-14C depict another exemplary priming and delivery
mechanism for a delivery device according to additional embodiments
of the present disclosure.
[0036] FIGS. 15A-15E depict another rotational lock mechanism for a
delivery device according to additional embodiments of the present
disclosure.
[0037] FIGS. 16A-16E depict another exemplary delivery device and
lock mechanism, according to additional embodiments of the present
disclosure.
[0038] FIGS. 17A-17C depict further exemplary delivery devices and
mechanisms according to additional embodiments of the present
disclosure.
[0039] FIGS. 18A-18F depict a locking and priming mechanism for a
delivery device according to additional embodiments of the present
disclosure.
[0040] FIGS. 19A-19E depict another locking and priming mechanism
for a delivery device according to additional embodiments of the
present disclosure.
[0041] FIGS. 20A-20C depict another locking and priming mechanism
for a delivery device according to additional embodiments of the
present disclosure.
[0042] As used herein, the terms "comprises," "comprising,"
"includes," "including," or any other variation thereof, are
intended to cover a non-exclusive inclusion, such that a process,
method, article, or apparatus that comprises a list of elements
does not include only those elements, but may include other
elements not expressly listed or inherent to such process, method,
article, or apparatus. The term "exemplary" is used in the sense of
"example," rather than "ideal." Notably, an embodiment or
implementation described herein as an "example" or "exemplary" is
not to be construed as preferred or advantageous, for example, over
other embodiments or implementations; rather, it is intended
reflect or indicate the embodiment(s) is/are one "example," rather
than "ideal." In addition, the terms "first," "second," and the
like, herein do not denote any order, quantity, or importance, but
rather are used to distinguish an element, a structure, a step or a
process from another. Moreover, the terms "a" and "an" herein do
not denote a limitation of quantity, but rather denote the presence
of one or more of the referenced items.
DETAILED DESCRIPTION
[0043] Embodiments of the present disclosure may be used in
addition to and/or in combination with aspects of U.S. provisional
application No. 62/598,212, which in incorporated by reference in
its entirety herein.
[0044] Embodiments of the present disclosure may be used with any
type of fluid-containing products, such as liquid drug products,
liquid placebos, or other liquids that may be dispensed in a dose
form. In some embodiments, drug products may include one or more
active ingredients, including, e.g., small or large molecules or
biologics, such as pain medications, steroids, or biologics. As
used herein, the term "biologic" may refer to a large molecule
(e.g., having a size greater than 15 kDa, greater than 30 kDa,
greater than 50 kDa, greater than 75 kDa, or greater than 100 kDa)
created in a living system such as a cell. Biologics may include
proteins (e.g., antibodies), nucleic acids, large sugars, etc.
Unlike small molecules that may have well-defined chemical
structures, biologics may have highly complex structures that
cannot be easily quantified by laboratory methods. As used herein,
the term "drug product" may refer to a volume of a formulated drug
substance apportioned into a primary packaging component for
packaging, transportation, delivery, and/or administration to a
patient.
[0045] The term "primary packaging component" refers to a packaging
component for a drug product, such as a drug container, that is
designed and manufactured to be in direct physical contact with the
formulated drug substance. (See, for example, Guidance for Industry
on Container Closure Systems for Packaging Human Drugs and
Biologics, U.S. Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research, and
Center for Biologics Evaluation and Research (May 1999), which is
incorporated by reference herein.) Examples of primary packaging
components include prefillable syringes, Luer syringes, cartridges,
and vials made of glass, plastic, and/or other materials.
[0046] Embodiments of the present disclosure may be used with
products typically having small dose volumes, such as, e.g.,
ophthalmic drug products. In some embodiments, devices of the
present disclosure may be used with drug products including an
antigen-binding molecule. In some aspects, the antigen-binding
molecule may be an antibody or antigen-binding fragment. In some
embodiments, devices of the present disclosure may be suitable for
use with drug products including ingredients such as, e.g.,
aflibercept, alirocumab, abicipar pegol, bevacizumab, brolucizumab,
conbercept, dupilumab, evolocumab, tocilizumab, certolizumab,
abatacept, rituximab, infliximab, ranibizumab, sarilumab,
adalimumab, anakinra, trastuzumab, pegfilgrastim, interferon
beta-la, insulin glargine [rDNA origin], epoetin alpha,
darbepoetin, filigrastim, golimumab, etanercept, antigen-binding
fragments of any of the above, or combinations of such binding
domains, such as a bispecific antibody to VEGF or angiopoietin-2,
among others.
[0047] For some products in particular, e.g., ophthalmic or other
drug products, dose accuracy may be particularly important.
However, it is also contemplated that embodiments of the present
disclosure may be applicable to any other liquid products or any
other context for which precise methods for setting and
administering a reliably accurate dose or delivery volume are
beneficial.
[0048] In some embodiments, devices according to the present
disclosure may be manufactured, packaged, filled, and/or otherwise
prepared according to processes relevant to the products (e.g.,
drug products) they may be used with. For example, in some
embodiments, devices according to the present disclosure may be
sterilized, either before or after being filled and/or packaged.
For example, in some embodiments, devices according to the present
disclosure may be filled and packaged in, e.g., blister packaging,
and/or may be terminally sterilized using any suitable method in
the art. For example, devices according to the present disclosure
may be terminally sterilized using a chemical sterilization method,
such as a method including ethylene oxide or hydrogen peroxide
(e.g., vaporized hydrogen peroxide). In some embodiments, devices
according to the present disclosure may be terminally sterilized
using methods described in, e.g., International Application No.
PCT/US2018/021013, filed Mar. 6, 2018, which is incorporated by
reference herein in its entirety.
[0049] Dose delivery devices available on the market, such as
prefilled syringes or syringes for use with vials, may not
necessarily assist with accurately loading a desired volume of a
product, priming the devices, expelling excessive drug product from
the devices, and/or removing air bubbles from the devices. In dose
delivery devices containing a small volume of a drug product in
particular (e.g., about 500 .mu.L or less, about 300 .mu.L or less,
about 250 .mu.L or less, about 200 .mu.L or less, about 150 .mu.L
or less, about 100 .mu.L or less, about 50 .mu.L or less, or about
25 .mu.L or less, such as between about 25 .mu.L and about 50
.mu.L, between about 50 .mu.L and about 100 .mu.L, between about 25
.mu.L and about 100 .mu.L, between about 50 .mu.L and about 150
.mu.L, between about 100 .mu.L and about 250 .mu.L, between about
100 .mu.L and about 150 .mu.L, between about 150 .mu.L and about
250 .mu.L, between about 200 .mu.L and about 250 .mu.L, between
about 200 .mu.L and about 500 .mu.L, or between about 250 .mu.L and
about 500 .mu.L), it may also be difficult to confirm the presence
of the correct dose of a drug product in the device with the naked
eye. Currently in the dose delivery device market, and specifically
in the syringe market, there is a need for mechanisms that allow a
user to set precisely for delivery a small volume of a product in a
syringe (e.g., a prefilled or fillable/refillable syringe), prime
the syringe, remove air bubbles from the syringe, and/or confirm or
be assured that the dose volume in the syringe is correct.
Embodiments of the present disclosure may assist manufacturers,
drug product providers, medical professionals, and/or patients with
accurately filling or otherwise preparing a dose administration
device, priming the device, removing bubbles from the device,
confirming the dose, and/or administering a dose from the device to
a patient. Moreover, embodiments of the present disclosure may
assist in preventing or mitigating errors or variation in device
manufacture or use, such as errors or variation in placement of
dose lines on devices, variation in device geometry (e.g.,
variation in syringe neck geometry), and/or variation or errors in
setting a dose line prior to delivery of a product.
[0050] In some instances, embodiments of the present disclosure may
be of particular assistance to individuals who may have difficulty
setting doses with precision and accuracy. For example, embodiments
of the present disclosure may assist elderly individuals, young
children, or persons with physical or mental disabilities in
setting accurate doses.
[0051] Described herein are various embodiments for dose delivery
devices, and in particular, for syringes. In some instances,
embodiments disclosed herein may be used in conjunction with
existing syringe body parts to modify off-the-shelf products, which
may reduce the development and manufacturing time for the dose
delivery devices. In other instances, embodiments disclosed herein
may be included in devices during their manufacture. The syringes
described herein may be prefilled or may be
fillable/refillable.
[0052] Embodiments of the present disclosure may include syringes
having rotating parts, threaded parts, springs, gears, and the
like, that may allow a user to precisely control the movement of
dosage setting and delivery elements such as, e.g., plungers and/or
stoppers. In some embodiments, for example, screw and gear
mechanisms may be used to transfer rotary motion (e.g., on a knob
or dial) to linear motion of a plunger, and thus to set the plunger
rod of a syringe to a predefined position with reduced human effort
and/or relatively greater accuracy. By reducing human effort and/or
increasing accuracy, it is contemplated that embodiments of the
present disclosure may reduce human error as well.
[0053] In some embodiments, visualization devices, such as
magnifiers, may be provided with, attached to, or otherwise
disposed on, delivery devices, in order to help enhance visibility
of dose measurement markers on the devices. It is contemplated that
aspects of one embodiment (such as magnifiers, sleeves, guiding
pins, channels, screw and gear mechanisms, rotating parts, threaded
parts, grips, springs, etc.) may be combined with aspects of one or
more other embodiments, to create various combinations and
permutations of features in a single device.
[0054] In some embodiments, devices according to the present
disclosure may be depicted as including one type of plunger rod and
plunger, or as including a general schematic representation of a
plunger rod and plunger. For example, some devices according to the
present disclosure may be depicted or described as including, e.g.,
a plunger rod having a threaded end, which engages with threads on
an interior of a plunger such that the plunger rod and the plunger
may be screwed together. It is contemplated that multiple and/or
different configurations of plunger rods and plungers may be
appropriate for each of the embodiments disclosed herein. For
example, in some cases, the aforementioned threaded plunger rod and
plunger may be used with embodiments disclosed herein. In some
embodiments, a plunger rod may not be affixed to a plunger, and
instead may be disposed near, next to, or flush against a plunger
such that pressure from the plunger rod towards the plunger may
push the plunger, but withdrawal, twisting, or other movement of
the plunger rod may not cause the plunger to likewise be withdrawn,
twisted, or otherwise moved. As another example, in some
embodiments, a plunger rod may be affixed to a plunger by an
adhesive, or may be of a single piece with a plunger (e.g., may
have been manufactured in a single mold with a plunger).
[0055] In some embodiments, devices according to the present
disclosure may include various cosmetic features relevant to
intended users of the devices. For example, devices according to
the present disclosure may be manufactured and sold for use by
pediatric patients. In such cases, devices according to the present
disclosure may include child-friendly coloring, cartoon images, or
other cosmetic features to appeal to children. In some cases,
devices according to the present disclosure may include lettering,
labeling, or other features designed to be easily recognized by the
intended users. For example, lettering on a pediatric device or a
device for use by a disabled person or an elderly person may have
larger, more accessible labeling so that it may be more easily
recognized and read by the user(s) of the device.
[0056] FIG. 1 depicts a syringe 10 containing a volume of drug
product 12 and having a dose expel control mechanism. The dose
expel control mechanism may include a rack 2 and a pinion 3. Rack 2
may be formed on an inner surface of a plunger rod 1 of syringe 10
or may be otherwise attached to an inner surface of plunger rod 1.
In some embodiments, rack 2 may, e.g., be engraved, machined, or
molded onto plunger rod 1. Rack 2 may include a plurality of teeth
extending along its length.
[0057] Pinion 3 may also include a plurality of teeth that are
configured to engage with the teeth of rack 2. Pinion 3 may be
operably connected to an actuator (e.g., a dial or a knob) located
external to plunger rod 1 via a pinion rod 4. For example, as shown
in FIG. 1, rotation of a dial 5 may cause rotation of pinion rod 4
and thus rotation of pinion 3. Thus, pinion rod 4 may extend from
an interior region of syringe 10 (where it connects to pinion 3) to
an exterior region of syringe 10 (where it connects to dial 5). In
the embodiment of FIG. 1, pinion rod 4 may extend partially or
fully through a finger flange 7 (e.g., on, integral to, or affixed
to syringe 10). In other embodiments, pinion rod 4 may extend
through a body wall of plunger rod 1 and/or syringe barrel 9 of
syringe 10. Pinion rod 4 may be supported by a gasket or seal, such
as an O-ring 6, where it exits finger flange 7 (or, if appropriate,
syringe barrel 9). O-ring 6 may provide physical support to pinion
rod 4 and/or pinion 3 while pinion 3 is in motion and/or at rest.
While O-ring 6 is described as providing structural support to
pinion rod 4 and/or pinion 3, it is also contemplated that O-ring 6
may simply seal the internal region of plunger rod 1 from an
external region, or both. Additionally, other seals or gaskets, or
combinations thereof, may be used instead of, or in addition to,
O-ring 6, and these seals or gaskets may or may not provide
structural support and/or sealing. For example, such seals or
gaskets may simply provide a barrier protecting the interior region
of syringe from an exterior region or may provide structural
support and may also act as a barrier.
[0058] Teeth of pinion 3 may engage with teeth of rack 2 such that,
upon rotation of pinion 3 via dial 5, the rotational motion of
pinion 3 may cause translational motion of plunger rod 1. Thus,
rotating pinion 3 may cause plunger rod 1 to move distally and/or
proximally in syringe barrel 9, which may also move piston 8 (e.g.,
a stopper) within syringe barrel 9. By rotation of dial 5, piston 8
(which may also act as a stopper) within syringe barrel 9 may be
gradually moved towards the needle end of syringe 10, so that air
and excess drug may be pushed out through needle 13, priming needle
13 for injection of an appropriate dose of drug product 12.
[0059] Pinion 3 and rack 2 may be sized and configured such that
rotation of pinion 3 in a given direction or by a given amount
(e.g., one clockwise rotation) may cause rack 2 and pinion 3 to
disengage from one another, which may cease the ability of dial 5
to advance piston 8. In some embodiments, once dial 5 has been
rotated a predetermined amount in a clockwise or counterclockwise
direction, rack 2 and/or pinion 3 may cease to move. For example,
pinion 3 may be prevented from moving further as a result of
reaching a proximal end of rack 2, as a result of disengaging with
rack 2, as a result of disengaging with pinion rod 4, as a result
of abutting against a stopper, or dial 5 may only be rotatable for
a given amount. Accordingly, rotation of dial 5 and pinion 3 a
given amount in a given direction may serve to complete priming of
the syringe needle.
[0060] In some embodiments, when plunger rod 1 has been moved a
desired amount (at which point rotation of dial 5 and/or pinion 3
may or may not be stopped), a user may pull dial 5 outwards away
from plunger rod 1. Outwards movement of dial 5 may disengage dial
5 from pinion rod 4 and/or may disengage pinion rod 4 from pinion
3. In some embodiments, pinion rod 4 may extend through an opening
in a sidewall of plunger rod 1, and pulling dial 5 outwards may
retract pinion rod 4 out of the opening so that pinion rod 4 no
longer prohibits movement of plunger rod 1. In some embodiments,
pulling out dial 5 may lock it in place, thereby preventing further
movement of plunger rod 1 via use of dial 5. In some embodiments,
pulling dial 5 outwards may unlock the outer plunger rod, allowing
it to move freely, whether or not movement of dial 5 is locked. In
some embodiments, pulling dial 5 and/or pinion rod 4 outward may
disengage pinion 3 from rack 2. In some embodiments, a user may not
be able to depress plunger rod 1 until pinion 3 reaches its
terminal position and/or until dial 5 is pulled outwards.
[0061] Dial 5 may be the only mechanism capable of moving plunger
rod 1 until syringe 10 has been primed. For example, the
complementary teeth of rack 2 and pinion 3 may prevent a user from
depressing plunger rod 1 (and/or pulling plunger rod 1 proximally)
until pinion 3 has disengaged from rack 2. This may prohibit drug
product 12 from being dispensed until syringe 10 has been primed
and may inhibit under- or over-priming of syringe 10 and promote
accurate dispensation of drug product 12.
[0062] As shown in the embodiment of FIG. 1, syringe 10 may
optionally include a magnifier 11 attached to or embedded on
syringe barrel 9. Magnifier 11 may aid in reading measurement
indicators on syringe barrel 9, may aid in observing the presence
or absence of air bubbles in syringe barrel 9, and/or may aid in
determining whether a complete dose of drug product 12 has been
dispensed from syringe 10. Magnifier 11 may be included in a distal
region of syringe 10 and may be any suitable shape or size. For
example, magnifier 11 may have a circular or rectangular shape or
may wrap around all of or a portion of the circumference of syringe
barrel 9. In other embodiments, no magnifier 11 may be
included.
[0063] The embodiment depicted in FIG. 1 may be operated in the
following manner. Dial 5 may be rotated a given amount in a given
direction until rotation of pinion 3 stops. A user may detect
whether pinion 3 has stopped when dial 5 is unable to rotate
further and/or when movement of plunger rod 1 ceases. As discussed
above, pinion 3 may stop moving, e.g., as a result of reaching an
end region of rack 2, as a result of disengaging with rack 2, as a
result of disengaging with pinion rod 4, as a result of abutting
against a stopper, or because dial 5 may only be rotatable for a
given amount. Alternatively or additionally, in some embodiments,
dial 5 may be pulled outwards by a user to prevent further movement
of plunger rod 1 via dial 5.
[0064] Once movement of plunger rod 1 via dial 5 is complete, a
user may optionally confirm the dose level of drug product in
syringe barrel 9 and/or may optionally confirm whether any air is
trapped within syringe barrel 9. A proximal end of plunger rod 1
may then be pushed to inject a dose of drug product.
[0065] FIG. 2 depicts an exemplary variation on the pinion 3
depicted in FIG. 1. Pinion 20 of FIG. 2 may include an internal
ratchet and pawl mechanism to allow rotation of pinion 20 in a
first direction and to prevent rotation of pinion 20 in a second
direction, opposite the first direction. For example, only
clockwise rotation may be allowed and counterclockwise rotation may
be blocked, or vice versa. In some embodiments, pinion 20 may be
prevented from rotating in a direction that would cause plunger rod
1 to move proximally away from the needle end of syringe 10, while
rotation in a direction that would cause plunger rod 1 to move
distally towards the needle end of syringe 10 is allowed.
[0066] As shown in FIG. 2, ratchet 23 may be coaxial with pinion
20, and dial 5 (FIG. 1) may be connected to ratchet 23, for
example, via a pinion rod (such as pinion rod 4 depicted in FIG. 1)
through a center 25 of ratchet 23. Ratchet 23 may include angled
teeth 24. An interior region of pinion 20 may include a
spring-loaded pawl 22 operably coupled to the interior region. Pawl
22 may be positioned at an angle complementary to the angles of
ratchet teeth 24 and close enough so that a free end of pawl 22
engages ratchet teeth 24. Each ratchet tooth 24 may include a
rounded surface, over which the free end of each pawl 22 can slide,
and a projecting face against which the free end of each pawl 22
may engage and be stopped. Rotation of dial 5 of FIG. 1 in one
direction (e.g., a direction that would cause plunger rod 1 to move
away from the needle end of syringe 10) may cause rotation of
ratchet 23 such that ratchet teeth 24 do not engage pawls 22, and
ratchet 23 may rotate independently of pinion 20. Rotation of dial
5 in the opposite direction, however, may cause ratchet 23 to
engage with pawls 22 and to rotate pinion 20 such that plunger rod
1 and piston 8 may move distally towards the needle end of the
device, allowing for priming of needle 13 and expulsion of air.
[0067] FIGS. 3A and 3B depict another variation of the pinion 3
depicted in FIG. 1. In this embodiment, plunger rod 30 may include
a rack 32 extending along at least a portion of its length. Rack 32
may include a plurality of teeth 34 configured to engage with teeth
36 on pinion 33. In addition to teeth 36, pinion 33 may include a
stopper tooth in the form of protrusion 35. Protrusion 35 may
extend radially further out from pinion 33 than teeth 36 and may
have a height that is greater than a height of teeth 36. Pinion 33
may rotate along rack 32 (FIG. 3A) until protrusion 35 on pinion 33
contacts rack 32 or plunger rod 30 (FIG. 3B), halting rotation of
pinion 33. In this way, protrusion 35 may prevent more than one
rotation of pinion 33. Halting rotation of pinion 33 may
consequently halt advancement of plunger rod 30 and piston 38
beyond a predetermined point. The predetermined point may
correspond to, e.g., a point at which excess air and dosage of a
drug product may be expelled from syringe 10 (see FIG. 1),
resulting in accurate priming of syringe 10. In some embodiments,
when protrusion 35 contacts plunger rod 30 and pinion 33 assumes
the position shown in FIG. 3B, protrusion 35 may be free of rack
32, and plunger rod 30 may slide freely against it. Accordingly, in
the embodiment of FIGS. 3A and 3B, instead of the rack length
controlling the amount of movement of plunger rod 30 is allotted to
prime the syringe, the circumference of pinion 33 may control this
movement.
[0068] The physical cessation of further pinion movement caused by
protrusion 35 on pinion 33 may also provide tactile feedback to a
user to indicate that a proper dose has been set and that syringe
10 has been primed. Inclusion of protrusion 35 on pinion 33 may
additionally prevent over- or under-rotation of pinion 33 in an
undesirable direction (e.g., that would allow movement of plunger
rod in a proximal direction). Protrusion 35 may be useful to
prevent overfilling of syringe 10 or intake of air into syringe 10
during handling, packaging, storage, and/or transport. In further
embodiments, a protrusion 35 may be located on rack 32 instead of,
or in addition to, pinion 33 to control movement of pinion 33.
[0069] FIGS. 3C and 3D depict another variation of plunger rod 1
depicted in FIG. 1. Plunger rod 40 of FIGS. 3C and 3D may include a
locking mechanism configured to prevent accidental depression of
piston 48, e.g., when the syringe is being packaged, stored,
handled, and/or filled. In some embodiments, plunger rod 40 may
include a telescoping inner portion 49 (e.g., an inner tubular
portion or a column) having a rack 42. Inner portion 49 of plunger
rod 40 may include piston 48 connected to a distal end thereof.
Inner portion 49 may move relative to a stationary outer portion 41
(e.g., an outer lumen). Rotation of dial 45 may extend inner
portion 49 distally out from outer portion 41 so that inner portion
49 moves independently from outer portion 41.
[0070] Dial 45 may be operably connected to the telescoping inner
portion 49 by pinion rod 44 (e.g., a shaft) and pinion 43. Rotation
of dial 45 may in turn rotate piston rod 44 and pinion 43. Teeth on
pinion 43 may engage with teeth on rack 42 of inner portion 49,
moving inner portion 49 distally out from outer portion 41. FIG. 3C
depicts inner portion 49 of telescoping plunger rod 40 retracted
within outer portion 41, and FIG. 3D depicts inner portion 49 of
telescoping plunger rod 40 extending out from outer portion 41.
Turning dial 45 may thus move piston 48 distally towards the needle
end of the syringe to prime the needle and remove air bubbles.
[0071] While inner portion 49 of plunger rod 40 may extend from
outer portion 41 during priming of the needle, outer portion 41 may
not move during dose preparation. In such an exemplary embodiment,
dial 45 and/or pinion rod 44 may optionally interfere with outer
portion 41 of plunger rod 40 so that plunger rod 40 can't move
relative to the syringe barrel and can't be depressed by pressing
on thumbpad 47 of plunger rod 40 during dose preparation. For
example, to connect pinion 43 to dial 45, pinion rod 44 may extend
through an opening of telescoping outer portion 41 of plunger rod
40. Thus, when pinion rod 44 is connected to pinion 43, extension
of pinion rod 44 through a sidewall of outer portion 41 may prevent
movement of outer portion 41. Because outer portion 41 cannot be
moved, plunger rod may not be able to be depressed. Pulling out
dial 45 may disengage pinion rod 44 from pinion 43, so that pinion
rod 44 no longer extends through outer portion 41. As a result,
once dial 45 is pulled out, pinion rod 44 may be removed from
engagement with the telescoping portions and may no longer extend
through the telescoping portions, allowing plunger rod 40 may to
move freely within the syringe barrel. Movement of plunger rod 40
in a distal direction by pressing thumbpad 47 may allow for
administration of the dose.
[0072] In the embodiment of FIGS. 3C and 3D, when thumbpad 47 is
depressed, telescoping inner portion 49 of plunger rod 40 may be
fixed in place relative to outer portion 41 so that depressing
thumbpad 47 and moving plunger rod 40 does not cause telescoping
inner portion 49 to collapse back within outer portion 41. Outer
portion 41 and inner portion 49 of plunger rod 40 may, for example,
be coupled to each other with positive locking teeth (e.g., teeth
46 of outer portion 41), which may allow inner portion 49 to extend
distally from outer portion 41 but may prohibit backwards movement
of inner portion 49 into outer portion 41. This may prevent the two
telescoping portions from collapsing one into the other when
thumbpad 47 is depressed and plunger rod 40 moves distally to expel
the dose. This may also prevent proximal movement of inner portion
49 during priming.
[0073] In use, dial 45 may be rotated to prime a syringe as
depicted in FIGS. 3C and 3D and may allow for finer and/or more
controlled movements of plunger rod 40 for such priming. As
described above, the inclusion of dial 45 may prevent discharge of
any product volume intended for dosage until priming is complete
and, e.g., dial 45 has been pulled outwards to unlock movement of
plunger rod 40. Although one type of locking mechanism associated
with dial 45 is described, it is contemplated that any suitable
type of locking mechanism may be incorporated, and that such a
locking mechanism may be activated and/or deactivated by pulling,
depressing, sliding, or otherwise manipulating dial 45.
[0074] For example, other variations of a locking mechanism are
depicted in cross section in FIGS. 4A and 4B. The locking
mechanisms of FIGS. 4A and 4B may be used instead of, or in
addition to, dial 45 of FIGS. 3C and 3D. In the embodiment of FIG.
4A, the entirety of plunger rod 50 or a proximal region of plunger
rod 50 (e.g., a telescoping outer portion of the plunger rod) may
include a physical stop (e.g., an interfering bump or projection)
to prevent depression of plunger rod 50 during dose preparation and
priming--or to allow only enough depression to prepare and prime
the dose. In the embodiment of FIG. 4A, an interfering projection
51 (shown in top-down cross-section) may prevent plunger rod 50
from moving distally until plunger rod 50 and/or the portion of
plunger rod 50 having projection 51 is rotated relative to other
portions of the syringe, e.g., a finger flange (not shown), a
stopper 53 located at a mouth of a syringe barrel 58, and/or
syringe barrel 58. In the embodiment of FIG. 4B, plunger rod 50 as
a whole may have a cross-sectional shape that is not radially
symmetrical, such that the shape of plunger rod 50 may prevent it
from moving distally until plunger rod 50 is rotated relative to
other portions of the syringe, e.g., a finger flange, stopper 53,
and/or syringe barrel 58. In order to depress plunger rod 50,
plunger rod 50, stopper 53, and/or barrel 58 may be rotated
relative to other portions of the syringe in order to be able to
depress plunger rod 50 enough to fully dispense the drug dose.
[0075] In some embodiments, plunger rod 50 may not be capable of
moving past, e.g., a finger flange or stopper 53 in the syringe
barrel until plunger rod 50 is rotated a certain number of degrees
(e.g., 90 degrees) in relation to the finger flange or the stopper.
In some embodiments, the finger flange or stopper 53 may be rotated
(e.g., 90 degrees) in relation to plunger rod 50. For example,
plunger rod 50 may have a particular cross-sectional shape (e.g., a
generally rectangular shape and/or projections 51), and syringe
barrel 58 and/or stopper 53 may include a blocking component and/or
may be sized and shaped so that projections 51 of plunger rod 50
cannot fit through until the relevant parts have been rotated
sufficiently so that the complementary shapes align and plunger rod
50 can pass through.
[0076] In some embodiments, an opening 52 in stopper 53 and/or
syringe barrel 58 (and/or a finger flange, not shown), and a
cross-section of plunger rod 50 may have complementary shapes but
may be offset from each other unless one or the other is rotated
until the shapes align. In FIGS. 4A and 4B, projections 51, or the
general shape of plunger rod 50, do not align with opening 52 until
the finger flange or plunger rod 50 is rotated sufficiently. While
two projections 51 from plunger rod 50 and a corresponding shape of
opening 52 are depicted in FIG. 4A, and while a given
cross-sectional shape of plunger rod 50 is depicted in FIG. 4B, it
is contemplated that any suitable number, size, and shaped openings
and projections and/or cross-sectional shapes may be used.
Additionally, while the exemplary embodiments show the required
rotation as being 90 degrees, it is contemplated that any suitable
amount of rotation (less than or greater than) 90 degrees may be
needed.
[0077] FIGS. 4C-4E depict a side view of a syringe 54 having
plunger rod 50, with projections 51, in three different positions.
Syringe 54 may include stopper 53, through which projections 51
cannot fit until projections 51 and stopper 53 have been rotated
relative to one another such that the shape of projections 51 fits
a complementary opening in stopper 53 (see, e.g., dotted lines in
FIG. 4A). Plunger rod 50 may be coupled to a plunger 56, which may
be configured to fit snugly within a barrel 58 of syringe 54.
Syringe 54 may include a volume of a drug product 12 suitable for
dispensing from syringe 54. In FIG. 4C, syringe 54 is depicted in a
first, un-actuated position. Projections 51 are positioned about
plunger rod 50 in a first orientation. In FIG. 4D, syringe 54 is
depicted in a second, partially actuated position. Projections 51
in the first orientation are blocked from passing through stopper
53, and thus the further depression of plunger rod 50 is also
blocked. In FIG. 4E, syringe 54 is depicted in a fully actuated
position. Upon rotation of plunger rod 50 (e.g., in the manner
indicated by the curved arrow, or alternately in the opposite
direction), projections 51 may be moved into a second orientation
about plunger rod 50. In the second orientation, projections 51 may
pass through stopper 53, allowing for further depression of plunger
rod 50 and plunger 56.
[0078] In some embodiments, projections 51 may be positioned on
plunger rod 50 such that they do not protrude from the general
profile of syringe 54. For example, projections 51 may be located
inside, e.g., barrel 58 before syringe 54 is actuated (e.g., in
FIG. 4C). In such embodiments, projections 51 may be located, e.g.,
inside a portion of stopper 53 before syringe 54 is actuated. In
some such embodiments, stopper 53 may have a greater thickness so
as to accommodate projections 51, and may have a proximal cavity
sized and configured to house projections 51 in a first
orientation, and a more distal cavity configured to accommodate
projections 51 in a second orientation, such that rotation of
plunger rod 50 and/or projections 51 may allow for movement of
plunger rod 50 in a distal direction.
[0079] In some embodiments, a second set of projections may be
incorporated in plunger rod 50 either proximally or distally from
projections 51. The second set of projections may have similar
geometry to projections 51, but may be radially offset from
projections 51, such that additional rotation of plunger rod 50 is
required for the second set of projections to pass through an
opening in, e.g., stopper 53 (e.g., opening 52). Alternately, a
second set of projections may have a geometry that cannot fit
through an opening, such that plunger rod 50 is inhibited from
moving in a given direction by their geometry. Such a second set of
projections may be useful in, e.g., limiting movement of plunger
rod 50 either before or after projections 51 have passed through
the opening. In some embodiments, limiting of movement in this
manner may be used in controlling an amount of movement of plunger
rod 50 allowed for priming syringe 10, prior to further rotation of
plunger rod 50 to allow for dispensing a dosage amount from syringe
10. In further embodiments, limiting of movement in this manner may
be used to control a dosage volume that may be dispensed from
syringe 50. See, for example, FIGS. 15A-E described further below.
As is the case with all embodiments depicted and described herein,
this embodiment may be combined with aspects of other embodiments
described herein.
[0080] In some embodiments, the syringe may be configured to
provide feedback to the user to indicate when rotation of plunger
rod 50 and projections 51 and/or the finger flange is complete and
plunger rod 50 is aligned with openings 52 (see FIGS. 4A-4B). For
example, a "clicking" noise or other audio or tactile feedback
mechanism may be incorporated into the syringe.
[0081] Referring now to FIG. 5, another exemplary syringe 60 is
pictured having a dose expel control mechanism. In the embodiment
of FIG. 5, the dose expel control mechanism includes two sets of
angled helical threads. A first set of helical threads 62 is
included on an exterior surface of plunger rod 61. Threads 62 may
extend around the entire circumference of plunger rod 61 or around
a portion of the circumference. A second set of helical threads 63,
complementary to external helical threads 62 of plunger rod 61, are
included on an internal circumference of syringe barrel 69 and/or
finger flange 64 through which plunger rod 61 passes. Threads 62
may extend around the entire circumference of syringe barrel 69
and/or finger flange 64 or around a portion of the circumference.
Threads 62, 63 may be engraved, molded, machined, attached, or
otherwise included to the surfaces of plunger rod 61 and syringe
barrel 69 or finger flange 64, respectively.
[0082] Plunger rod 61 may be rotated to move threads 62 of plunger
rod 61 through threads 63, converting the twisting motion of
plunger rod 61 into translational (or linear) motion of plunger rod
61 (and thus, piston 68) in syringe barrel 69. The linear motion of
piston 68 may push air bubbles and excess drug out through syringe
needle 66. Thus, needle 66 may be primed and readied for injection
by twisting of plunger rod 61. Both threads 62, 63 may be sized and
configured such that, once threads 62 are moved entirely through
threads 63, air is removed from within syringe barrel 69, and a
predetermined volume of drug product is expelled from syringe
needle 66 to prime needle 66.
[0083] Threads 62, 63 may also prevent plunger rod 61 from being
depressed before priming of needle 66 occurs. For example, in order
to depress plunger rod 61 to dispense the drug product, plunger rod
61 must first be twisted--i.e., needle 66 must first be primed.
Once threads 62 are rotated through threads 63 and priming is
complete, a user may be able to depress plunger rod 61 to deliver
the dosage.
[0084] As discussed above in relation to FIG. 1, the embodiment of
FIG. 5 may also optionally include a magnifier 65. Magnifier 65 may
aid in reading magnified volume measurements of the drug product in
syringe barrel 69, may aid in observing the presence or absence of
air bubbles in syringe barrel 69, and/or may aid in determining
whether a complete dose of drug product has been dispensed from
syringe 60. Magnifier 65 may be included in a distal region of
syringe 60 and may be any suitable shape or size. For example,
magnifier 65 may have a circular or rectangular shape or may wrap
around all of or a portion of the circumference of syringe barrel
69. In other embodiments, no magnifier 65 may be included.
[0085] To operate syringe 60, a user may first rotate plunger rod
61. Plunger rod 61 may need to be rotated a partial rotation, one
complete rotation, or more than one complete rotation in order to
pass threads 62 through threads 63 and disengage threads 62 from
threads 63. At this time, a user may optionally confirm the dose
level in syringe barrel 69. The user may use magnifier 65 to
perform this step, if magnifier 65 is included. The user may then
push plunger rod 61 to dispense the dose of drug product.
[0086] In some embodiments, syringe 60 may provide feedback to the
user to indicate when rotation of plunger rod 61 is complete and
the dose is ready for injection. For example, a "clicking" noise or
other audio or tactile feedback mechanism may be incorporated into
syringe 60.
[0087] The embodiment of FIGS. 6A-6E may operate in a similar
manner to the embodiment of FIG. 5, but may further include a
locking mechanism to prevent accidental depression of plunger rod
71 when priming of the needle is complete. For example, like FIG.
5, the embodiment of FIGS. 6A-6E includes threads 72 on plunger rod
71, which must be twisted through corresponding threads 73 of
syringe barrel 75. However, plunger rod 71 may also include a stop
74 located on an outer surface of plunger rod 71, proximal to
threads 72.
[0088] Stop 74 may be sized and shaped to fit within a slot 76
extending through threads 73. For example, stop 74 may enter a
vertical portion of slot 76 passing through some of internal
threads 73 of syringe barrel 75 (depicted in, e.g., section A-A in
FIGS. 6B and 6C). Slot 76 may also include a horizontal section
(e.g., along section B-B depicted in FIGS. 6B and 6D). Once stop 74
slides fully into the vertical section of slot 76, the user must
rotate plunger rod 71 in the direction opposite the direction of
threads 72 of plunger rod 71 in order to slide stop 74 through the
horizontal portion of slot 76 and to advance plunger rod 71 further
distally. Because of the need for an opposing direction of
rotation, the risk of accidental advancement of plunger rod 71 may
be reduced. Finally, the plunger may be depressed downwards to move
stop 74 through a second vertical section of slot 76 (e.g., section
C-C depicted in FIGS. 6B and 6E), to expel a volume of the drug
product.
[0089] Slot 76 may be shaped to require clockwise or
counterclockwise rotation, depending on the relative locations of
the horizontal and vertical sections. Additionally, although slot
76 is shown and described as including one horizontal portion
requiring rotation of rod 71, it is contemplated that multiple
horizontal portions may be included, requiring rod 71 to be rotated
addition times in the same direction or in multiple directions.
Further, although stop 74 is depicted as including two projections
on plunger rod 71, it is contemplated that one projection or more
than two projections may be included as part of stop 74, and slot
76 may be shaped and sized to accommodate the different
configurations of stop 74.
[0090] Although threads 73 are described as being on an internal
surface of syringe barrel 75, it is contemplated that threads 73
and slot 76 may be located on an internal surface of a finger
flange instead of, or in addition to, syringe barrel 75. Moreover,
as is the case with all embodiments depicted and described herein,
the above-described embodiment may be combined with aspects of
other embodiments described herein. For example, rod 71 may include
additional projections and/or geometries, such as those shown in
FIGS. 4A-4E and FIGS. 15A-15E, to provide a hard stop to the
movement of rod 71.
[0091] Referring now to FIGS. 7A and 7B, another embodiment of a
dose expel control mechanism is depicted. In FIG. 7A, syringe 80
includes complementary helical threads 82 and 83. External threads
82 in this embodiment are located on a sleeve 87 surrounding
plunger rod 81 instead of directly on plunger rod 81. A close-up of
the threaded portions of syringe 80 is depicted in FIG. 7B. Sleeve
87 may allow for free distal movement of plunger rod 81 (towards
the needle end of syringe 80), but may block undesirable proximal
movement of piston 88. Before depression of plunger rod 81,
rotation of sleeve 87 (e.g., via twisting of dial rod 85 located at
a proximal end of sleeve 87) may be transformed into a controlled
sliding movement of sleeve 87 into syringe barrel 89 via threads 82
on sleeve 87 and corresponding threads on finger flange 84 and/or
syringe barrel 89. The controlled sliding movement of sleeve 87 may
gradually push plunger rod 81 and stopper 88 towards the distal
needle end of the device. Movement of plunger rod 81 through the
threaded region may allow for controlled expulsion of air and
priming of needle 86.
[0092] As in previous embodiments, the embodiment of FIG. 7A may
also optionally include a magnifier 90. Magnifier 90 may magnify
volume measurements of the drug product in syringe barrel 89, may
aid in observing the presence or absence of air bubbles in syringe
barrel 89, and/or may aid in determining whether a complete dose of
drug product has been dispensed from syringe 80. Magnifier 90 may
be included in a distal region of syringe 80 and may be any
suitable shape or size. For example, magnifier 90 may have a
circular or rectangular shape or may wrap around all of or a
portion of the circumference of syringe barrel 89. In other
embodiments, no magnifier 90 may be included.
[0093] To operate syringe 80, dial rod 85 may be rotated a partial
rotation, one complete rotation, or more than one complete rotation
in order to pass threads 82 of sleeve 87 through threads 83 until
threads 82 are disengaged from threads 63. At this time, a user may
optionally confirm the dose level in syringe barrel 89. The user
may use magnifier 90 to perform this step, if magnifier 90 is
included. The user may then push plunger rod 81 to dispense the
dose of drug product.
[0094] In some embodiments, syringe 80 may provide feedback to the
user to indicate when rotation of plunger rod 81 is complete and
the dose is ready for injection. For example, a "clicking" noise or
other audio or tactile feedback mechanism may be incorporated into
syringe 80. In some embodiments, a user may know that priming is
complete because dial rod 85 may not rotate any further, plunger
rod 81 may not move any further when twisting, and/or dial rod 85
may abut a portion of finger flange 84 and/or syringe barrel 89,
preventing further distal movement of dial rod 85.
[0095] In some embodiments, a locking mechanism like the one
discussed above in reference to FIGS. 6A-6E may be incorporated
into plunger rod 81. By requiring that plunger rod 81 be turned
(e.g., 90 degrees, although turning plunger rod 81 more or less is
than 90 degrees is also contemplated) prior to administration to
allow plunger rod 81 to move freely, plunger rod 81 may be
prevented from being pressed in a distal direction during needle
priming.
[0096] In further embodiments, a locking or stopping mechanism may
be incorporated into sleeve 87 of FIGS. 7A and 7B. Such a mechanism
is depicted in FIG. 8. By incorporating stops 91 and/or 92 (e.g.,
tabs or projections) onto sleeve 87 (e.g., at positions above
and/or below threads 82 on sleeve 87 and threads 83 in the syringe
barrel), over-rotation of the sleeve in either direction (and thus
over-priming or unwanted removal of sleeve 87) may be prevented.
Stop 91 may be located proximal of threads 82 and may be configured
to stop movement of sleeve 87 towards the distal end region of the
syringe barrel. Stop 92 may be located distally from threads 82 and
may be configured to stop movement of sleeve 87 towards the
proximal end region of the syringe barrel.
[0097] Referring now to FIGS. 9A-9D, another syringe 100 is
pictured with a further embodiment of a dose expel control
mechanism. This embodiment may include, for example, a key 103 to
act as a removable stop at a junction between syringe barrel 109
and plunger rod 101. Key 103 may obstruct movement of plunger rod
101 when it is in place between syringe barrel 109 and a proximal
region of plunger rod 101. Key 103 may be placed between plunger
rod 101 and syringe barrel 109, e.g., during packaging, filling, or
preparation of syringe 100. Key 103 may snap-fit, friction-fit,
twist-fit, or otherwise be set in place in any suitable manner. A
user may then remove key 103 just prior to use of syringe 101. To
remove key 103, a user may pull a tab included on key 103, may snap
off a tab, may break a frangible portion, may twist key 103, or may
remove key 103 in any suitable manner. Syringe 100 is depicted as
having a magnifier 105 disposed at a distal end portion of syringe
barrel 109, which may assist in, e.g., visualizing a level of
product in barrel 109.
[0098] It is contemplated that the key and/or locking mechanisms
described above may be useful in the context of fillable syringes
as well as pre-filled syringes, which may undergo sterilization,
packaging, storage, and/or shipment after being filled. In
pre-filled syringes, key 103 may prevent the accidental depression
of plunger rod 101 prior to its intended use, thus preserving the
sterility, safety, and dose volume of the drug product. Variations
of key 103 may include, for example, a frangible stop that may be
broken by applying a certain amount of force to plunger rod
101.
[0099] In addition to key 103, the embodiment depicted in FIG. 9A
may include a locking mechanism similar to that discussed with
respect to, e.g., FIGS. 4A-4E, above, or FIGS. 15A-E, described
further herein. For example, as is shown in FIG. 9D, a slot 107 may
be included in a stopper 104 of syringe 100. Stopper 104 may have
an open portion 110 through which plunger rod 101 may move without
being rotated to a set position. The open portion 110 may allow the
plunger to move a distance suitable for priming needle 106. Slot
107 may be sized and shaped to fit the cross-sectional area of
plunger rod 101 in a particular orientation. For example, plunger
rod 101 may include a flange 102 sized and shaped to pass through
slot 107 when aligned with slot 107. Stopper 104 may be disposed at
a proximal region of syringe barrel 109, such that plunger rod 101
must be rotated to a set position to align flange 102 with slot 107
prior to being depressed through at least part of stopper 104.
Although flange 102 and corresponding slot 107 are depicted, slot
107 and plunger rod 101 may have any suitable complementary
cross-sectional shapes. Moreover, plunger rod 101 may have multiple
cross-sectional geometries along its length, to either provide a
hard stop to distal movement of plunger rod 101 or require
additional turning of plunger rod 101 relative to stopper 104 to
further move plunger rod 101 (see, e.g., FIGS. 15A-15E). As is the
case with all embodiments depicted and described herein, this
embodiment may be combined with aspects of other embodiments
described herein.
[0100] Once key 103 is removed, plunger rod 101 may be allowed to
move distally from its original position down through open portion
110 of stopper 104. This distal movement of plunger rod 101 may
move piston 108 just enough to prime needle 106 and to remove any
air bubbles. Stopper 104 may halt additional distal movement of
plunger rod 101 when flange 102 hits the inner portion of stopper
104, where slot 107 begins. At that time, plunger rod 101 may need
to be rotated to align flange 102 with slot 107 in stopper 104
before rod 101 can be pushed distally through the rest of stopper
104 to move piston 108 and discharge the drug dose.
[0101] In some embodiments, syringe 100 may be configured to
provide feedback to the user to indicate when plunger rod 101 and
flange 102 are aligned with slot 107 and/or when priming of syringe
100 is complete. For example, a "clicking" noise or other audio or
tactile feedback mechanism may be incorporated into syringe
100.
[0102] Referring now to FIGS. 10A-10C, a cross-sectional image of a
syringe 200 is depicted, with various embodiments of a further dose
expel control mechanism. Syringe 200 may include a barrel 240 and a
plunger rod 220. Plunger rod 220 may be coupled to a first plunger
222, which may be configured to fit into an opening in a flange 210
positioned at a proximal plunger rod end of barrel 240. Flange 210
may be configured to fit securely within barrel 240, and may be,
e.g., sealed against an interior of barrel 240 with an O-ring 208.
The interior of barrel 240 may include a second plunger 260
configured to fit snugly within the interior of barrel 240. A first
fluid 244 may be disposed inside barrel 240 to a proximal side of
plunger 260, and a second fluid, e.g., a drug product 212, may be
disposed inside barrel 240 to a distal side of plunger 260. A
needle, cannula, tube, or other attachment may be coupled to a
distal end of barrel 240, through which a fluid, e.g., drug product
212, may be expelled or withdrawn.
[0103] The opening of flange 210 may have a cross-sectional width a
into which plunger 222 may be configured to securely fit. In some
embodiments, plunger 222 may be configured to form a seal against
flange 210, e.g., with the use of an O-ring 224. The portion of
flange 210 having width a may also have a depth c. As shown in FIG.
10A, in some embodiments depth c may correspond to a distance
between a distal side of plunger 222 and a distal side of flange
210. Distal movement of plunger 222 for, e.g., a distance
corresponding to depth c (e.g., caused by depression of plunger rod
220 towards flange 210) may cause a first volume of fluid 244 in
the opening of flange 210 to be displaced distally by a distance
corresponding to depth c. Displacement of the first volume of fluid
244 may in turn push plunger 260, causing a second volume of drug
product 212 to be expelled from syringe 200. Barrel 240 may have a
cross-sectional width b located distally from flange 210, where
width b is greater than width a. Due to the differences between
widths a and b (and thus the differences in fluid volume capacity
in the portions of syringe 200 having widths a and b), distal
movement of plunger 222 by, e.g., a distance corresponding to depth
c may cause plunger 260 to move distally by a smaller distance d.
In this manner, a movement of, e.g., plunger rod 220 in the distal
(or proximal) direction may be converted into a proportionally
smaller, and thus more controllable, movement of plunger 260 and
thus a more controllable expulsion (or withdrawal) of a volume of
drug product 212.
[0104] The embodiments depicted in FIGS. 10B and 10C may differ
somewhat from the embodiment of FIG. 10A. Referring to FIG. 10B,
cross-sectional widths a and b may both be widths of an opening in
flange 210. In such embodiments, a second plunger rod 262 may be
disposed within the barrel, such that a portion of plunger rod 262
is disposed within, and extends across an interior of, the portion
of flange 210 having width b. Plunger rod 262 may be coupled to,
and may extend proximally from, plunger 260. Moreover, plunger rod
262 may have a proximal side that extends across the area of the
opening in flange 210 having width b, such that distal movement of
fluid 244 may cause distal movement of plunger rod 262, which in
turn may push plunger 260 distally. Referring to FIG. 10C,
cross-sectional width b may refer to the internal cross-sectional
width of barrel 240, as with the embodiment depicted in FIG. 10A,
and second plunger rod 262 may be disposed within, and may extend
across an interior of, barrel 240. Similarly to the embodiment
depicted in FIG. 10B, plunger rod 262 may have a proximal side that
extends across the internal area of barrel 240 having width b, such
that distal movement of fluid 244 may cause distal movement of
plunger rod 262, which in turn may push plunger 260 distally. As
with the embodiment of syringe 200 depicted in FIG. 10A, a movement
of, e.g., plunger rod 220 in the distal direction may be converted
into a proportionally smaller, and thus more controllable, movement
of plunger 260 and thus a more controllable expulsion of a volume
of drug product 212.
[0105] With respect to the embodiments depicted in FIGS. 10B and
10C, plunger rod 262 may form a seal with adjacent parts of syringe
200, such that fluid 244 may not travel distally through/past
plunger rod 262. This may result in the need for less fluid 244,
and may allow for a region of "empty" space between fluid 244 and
drug product 212, which may aid in preventing leakage or mixture of
fluid 244 with drug product 212. The "empty" spacy may include a
vacuum, or may include, e.g., dry or sterile air. In some
embodiments, the "empty" space may include additional fluid 244 (or
another fluid) to provide additional structural support to the
syringe. In any of the embodiments depicted in FIGS. 10A-10C, fluid
244 may be any suitable liquid or gaseous fluid, such as, e.g.,
water for injection, dry gas, sterile air, or the like.
[0106] Referring now to FIG. 11A, a cross-section of another
syringe 300 is depicted with a further embodiment of a dose expel
control mechanism. Syringe 300 may include a barrel 340, a plunger
360, and a drug product 312. A plunger rod 320 may extend into
barrel 340, and may include several ratchet-type teeth 321 that may
engage with pinions 328, which in turn may engage with ratchet type
teeth 326 on an interior of barrel 340. Each of pinions 328 may be
coupled to one of rods 330, which may be coupled to plunger 360. A
needle, cannula, tube, or other attachment (not pictured) may be
coupled to a distal end of barrel 340, through which a fluid (e.g.,
drug product 312) may be expelled or withdrawn.
[0107] Movement of plunger rod 320 in the proximal or distal
direction may translate, via pinions 328 and teeth 326, to
proportionally smaller movement of plunger 360. In this manner,
controlled movement of plunger 360 in the distal direction may,
e.g., expel drug product 312 distally at a controlled rate. The
sizes and shapes of the teeth, ratchets, and pinions in syringe 300
may be selected so as to create a desired controlled speed of
movement of plunger 360.
[0108] FIG. 11B depicts, in cross-section, a further embodiment of
syringe 300, in which teeth 321 of plunger 320 may engage with
pinions 328, which may each be coupled with, and may rotate
coaxially and in tandem with, relatively smaller pinions 329, which
in turn may engage with teeth 326 on the interior of barrel 340.
Pinions 328 may pass adjacent to teeth 326, such that only pinions
329 engage with teeth 326. Each of pinions 328, 329 may be coupled
to one of rods 330, which may be coupled to plunger 360.
[0109] Due to the relatively smaller diameter of pinions 329 as
compared to pinions 328, movement of plunger 320 in the proximal or
distal direction may translate, via pinions 328, pinions 329, and
teeth 326, to proportionally smaller movement of plunger 360. In
this manner, controlled movement of plunger 360 in the distal
direction may, e.g., translate to relatively smaller movement of
plunger 360 and controlled expulsions of drug product 312 distally.
As with FIG. 11A, the sizes and shapes of the teeth, ratchets, and
pinions in syringe 300 may be selected so as to create a desired
controlled speed of movement of plunger 360.
[0110] Although the embodiments depicted in FIGS. 11A and 11B each
show a symmetrical arrangement including teeth 321 on two sides of
plunger rod 321, two of pinions 328, two of pinions 329 (with
respect to the embodiment of FIG. 11B), and two of rods 330, a
single arrangement, e.g., teeth 321 engaged with one pinion 328,
which may be coupled to one pinion 329 (with respect to the
embodiment of FIG. 11B), which may be coupled to one rod 330, is
also contemplated. One of ordinary skill in the art will understand
that more or fewer pinions, and/or rods may be incorporated into
embodiments of the present disclosure, to achieve controlled
delivery of the contents of syringe 300.
[0111] Referring now to FIG. 12, a cross-sectional side view of
another syringe 400 is depicted with a further embodiment of a dose
expel control mechanism. Syringe 400 may include a barrel 402, an
inner sleeve 404, and a plunger rod 406. Plunger rod 406 may extend
into barrel 402 and into an opening 410 defined by inner sleeve
404, where opening 410 is narrower than a general inner width of
barrel 402. Opening 410 may receive or contain a drug product
408.
[0112] Generally, syringe 400 may be configured to provide a
relatively narrow channel or path (e.g., in opening 10) through
which drug product 408 may be pushed by plunger rod 406, such that
distal movement by plunger rod 406 may be translated into
relatively gradual and controllable expulsion or delivery of drug
product 408 through a distal end of syringe 400 (e.g., via a
needle, cannula, tube, or other attachment coupled to syringe 400),
as compared to a syringe having a relatively wider channel or path
for drug product 408.
[0113] As shown, a distal portion of plunger rod 406 may be
configured to fit within opening 410 of inner sleeve 404. Inner
sleeve 404 may be of a piece with barrel 402 (e.g., may be
contiguous with, or may be made in a single mold with, barrel 402),
or may be a separate piece inserted into barrel 402. Inner sleeve
404 may extend partly or fully through an interior of barrel 402.
In some embodiments, as shown, inner sleeve 404 may be disposed in
a distal portion of the interior of barrel 402.
[0114] Plunger rod 406 may be fitted with, coupled to, or may
otherwise contact a plunger configured to enclose a volume of drug
product 408 within opening 410 and/or between plunger rod 406 and a
distal end of syringe 400. Plunger rod 406 and/or a plunger coupled
to plunger rod 406 may be configured to fit snugly within barrel
402, so as to contain drug product 408 without leakage of drug
product 408 into the general interior of barrel 402 (e.g.,
proximally from inner sleeve 404). Opening 410 and plunger rod 406
may be configured to have relatively narrow widths, thus creating
the relatively narrow channel through which drug product 408 may be
expelled from syringe 400.
[0115] In some embodiments, barrel 402 may be marked with
measurement indicators, so as to visually indicate a volume of
fluid left in, and/or dispensed from, syringe 400. Moreover, as
shown or described with respect to other embodiments, syringe 400
may optionally include a magnifier attached to or embedded on
syringe barrel 402, which may aid in reading measurement indicators
on syringe barrel 102, may aid in observing the presence or absence
of air bubbles in syringe barrel 102, and/or may aid in determining
whether a complete dose of drug product 408 has been dispensed from
syringe 400. Such a magnifier may be included in a distal region of
syringe 10 and may be any suitable shape or size. In other
embodiments, no magnifier 11 may be included.
[0116] In further embodiments, the narrow channel of syringe 400
may be achieved in a manner that does not require inner sleeve 400.
For example, a syringe barrel (e.g., barrel 402) may be
manufactured to itself have a relatively narrow interior configured
to receive plunger rod 406, such that no narrowing insert need be
disposed inside the barrel. The narrow interior of the syringe
barrel may be sized and configured to house a volume of a drug
product (e.g., drug product 408) that will result in a desired or
suitable amount of the drug product being dispensed from syringe
400 upon its use.
[0117] Aspects of the embodiment depicted in FIG. 12 may be
particularly suited to being combined with aspects of other
embodiments discussed herein. For example, any embodiment of the
present disclosure may also incorporate a relatively narrow (or
narrowed) interior to allow for more gradual and controlled
delivery of a drug product.
[0118] Referring now to FIGS. 13A-13C, cross-sectional side views
of another syringe 420 are depicted, with a further embodiment of a
dose expel control mechanism. Syringe 420 may include a barrel 422,
a plunger rod 424, and a plunger 426. An interior 428 of barrel 422
may house or receive a drug product 430 and an insert 432.
[0119] Insert 432 may include a compressible portion, such that
insert 432 may be compressed by a predetermined distance or volume.
In some embodiments, for example, insert 432 may be a spring, such
as a wave spring, a coiled spring, or any other spring known in the
art. In further embodiments, for example, insert 432 may be made
from a compressible material, such as rubber, silicone, or plastic.
In some embodiments, insert 432 may be affixed to, or otherwise
held in place within, a particular location/orientation in barrel
422.
[0120] An initial configuration of a filled syringe 420 is depicted
in FIG. 13A. In this configuration, a quantity of drug product 430
is located between plunger 246 and insert 432, as is an empty space
(e.g., an air bubble) in interior 428. As depicted in FIG. 13B,
when plunger rod 424 is depressed distally, the quantity of drug
product 430 between plunger 426 and insert 432 may be expelled
distally from syringe 420, along with the air bubble (e.g., via a
needle, cannula, tube, or other attachment coupled to a distal end
of syringe 420). Upon contacting plunger 426, insert 432 may offer
some resistance against further distal movement of 426. This may
provide, e.g., a tactile, auditory, and/or visual feedback to a
user of syringe 420 indicating that syringe 420 is primed and the
air bubbles have been removed.
[0121] A distance a by which insert 432 may be compressed may be
proportional to a volume of drug product 430 suitable for a dosage
contained within barrel 422. For example, in some embodiments, a
volume defined by insert 432 may correspond to a volume of drug
product 430 suitable for a dosage contained within barrel 422.
Thus, as shown in FIG. 13C, when plunger 426 is moved further
distally so as to compress insert 432 by distance a, a quantity of
drug product 430 suitable for a dosage may be dispensed from the
distal end of syringe 420. For example, plunger 426 may be moved
distally so that a volume of drug product 430 corresponding to the
volume defined by insert 432 is dispensed. Insert 432 may be
configured to prevent its compression or movement beyond distance
a, thus ensuring that only a quantity of drug product 430 suitable
for dosage is dispensed. A leftover quantity of drug product 430
may remain inside barrel 422 after a dosage amount is dispensed. In
some cases, this may allow for increased dosage accuracy, as
plunger 426 need not interact with any tapering of the diameter of
barrel 422 that may occur near a distal end portion of syringe
420.
[0122] Referring now to FIGS. 14A-14C, cross-sectional side views
of another syringe 440 with a further embodiment of a dose expel
control mechanism are depicted in three stages. Syringe 440 may
include a barrel 442, a plunger having an outer plunger rod 444 and
an inner plunger rod 446, both of which may be actuated by a knob
or depressor 448. Inner plunger rod 446 may be disposed inside, and
coaxially with, outer plunger rod 444. Inner plunger rod may
protrude proximally and/or distally from outer plunger rod 444. A
plunger 450 may be coupled to either or both of inner plunger rod
446 and outer plunger rod 444. Specifically, plunger 450 may be
movably coupled to inner plunger rod 446. A volume of drug product
454 may be received or housed within barrel 442 between plunger 450
and a distal end of syringe 440. An insert 456 may be disposed
distally from plunger 450, e.g., at a distal end portion of the
interior of barrel 442. Insert 456 may include a channel 458, sized
and configured to accommodate inner plunger rod 446 (but not
plunger 450 or outer plunger rod 444).
[0123] As shown in FIG. 14A, inner plunger rod 446 may protrude
both proximally and distally from outer plunger rod 444. A seal
(not shown) may exist between inner plunger rod 446 and outer
plunger rod 444, to prevent leakage of any fluid between the
plunger rods. In some embodiments, inner plunger rod 446 may only
protrude distally or may only protrude proximally from outer
plunger rod 444. For example, inner plunger rod 446 may be a
telescoping plunger rod, which may be configured to extend only
distally from outer plunger rod 444. In some embodiments, inner
plunger rod 446 may be configured to optionally telescope, slide,
or otherwise move through outer plunger rod 444 and plunger 450. In
some embodiments, for example, inner plunger rod 446 may include a
threaded portion on its exterior (not shown), configured to mate
with complementary threads on an interior of outer plunger rod 444
(not shown). When inner plunger rod 446 and outer plunger rod 444
are engaged via these threads or by any other mechanism, inner
plunger rod 446 and outer plunger rod 444 may move proximally and
distally within barrel 442 in tandem. Upon rotation of inner
plunger rod 446 (e.g., by turning knob or depressor 448) relative
to outer plunger rod 444, inner plunger rod 446 may be configured
or allowed to move proximally or distally independently of outer
plunger rod 444, and in particular may be allowed to move distally
through outer plunger rod 444 and plunger 450. In some embodiments,
plunger 450 may be affixed to a distal end of outer plunger rod
444, so that inner plunger rod 446 may move through both outer
plunger rod 444 and plunger 450 without causing separation between
outer plunger rod 444 and plunger 450. In further embodiments, a
distal end of outer plunger rod 444 may simply contact or press
against plunger 450.
[0124] An initial configuration of syringe 440 is depicted in FIG.
14A. As shown, inner plunger rod 446, outer plunger rod 444, and
plunger 450 are all located proximally from a volume of drug
product 454 contained within barrel 442. As shown in FIG. 14B, upon
depression of depressor or knob 448, both inner plunger rod 446 and
outer plunger rod 444 may move distally through barrel 442,
consequently pushing plunger 450 through barrel 442. This may serve
to prime the syringe, removing air and an excess quantity of drug
product 454 from barrel 442 by expelling it through, e.g., a distal
end of barrel 442 (via, e.g., a needle, cannula, tube, or other
attachment at the distal end of barrel 442). Distal movement of the
plunger rods 444, 446 and plunger 450 may eventually be halted by
contact between plunger 450 and insert 456. This may provide, e.g.,
a user with tactile, auditory, and/or visual feedback indicating
that priming is complete.
[0125] As shown in FIG. 14C, inner plunger rod 446 may then be
allowed to move distally independently from outer plunger rod 444,
e.g., by rotation of inner plunger rod 446 such that inner plunger
rod 446 disengages from outer plunger rod 444. Such rotation may,
for example, cause threads on an exterior of inner plunger rod 446
to disengage from threads on an interior of outer plunger rod 444.
In some embodiments, such rotation may allow for inner plunger rod
446 to expand (e.g., telescope) distally. Inner plunger rod 446 may
then be moved distally through channel 458, which may contain a
volume of drug product 454 suitable for a dosage amount. In this
manner, inner plunger rod 446 may be configured to expel a desired
dosage amount of drug product 454 through the distal end of barrel
442. In some embodiments, a distal end of inner plunger rod 446 may
include, be attached to, or be affixed to an inner plunger, which
may be sized and configured to move distally through channel 458,
and push a volume of drug product 454 suitable for a dosage amount
towards and through the distal end of barrel 442.
[0126] Referring now to FIGS. 15A-15E, views of another syringe 500
with a further embodiment of a dose expel control mechanism are
depicted. Syringe 500 may include a barrel 502 and a plunger rod
503 having a knob or depressor 504 and projections 506, 508 which
extend in directions that are offset from one another. Plunger rod
503 also includes a stopper 510. A proximal end of barrel 502 is
capped by a keyhole-shaped flange 512 (a top-down view of which is
depicted in FIG. 5E). Plunger 514 is disposed in an interior of
barrel 502 such that it may be contacted and pushed distally by
plunger rod 503. The interior of barrel 502 may also house a volume
of a drug product 516 located distally from plunger 514.
[0127] An initial configuration of syringe 500 is depicted in FIG.
15A. As shown, the plunger rod and plunger 514 are located
proximally from the volume of drug product 516. Projections 506,
which extend to a distal end portion of plunger rod 503, are
positioned so as to fit through the keyhole shape in flange 512,
allowing plunger rod 503 to move distally until flange 512 contacts
projections 508 (FIG. 15B). The extent of the distal movement
allowed in this configuration may be sufficient to prime syringe
500 and remove air between plunger 514 and drug product 516. As
shown in FIG. 15B, plunger rod 503 may be prevented from moving
further by the contact between flange 512 and projections 508,
which may be of a similar shape and size to projections 506, but in
a different configuration from projections 506 (e.g., a
rotationally offset configuration).
[0128] FIG. 15C depicts syringe 500 upon the rotation of plunger
rod 503 by 90 degrees. In this configuration, projections 508 may
now fit through flange 512, as shown in FIG. 15D. Plunger rod 503
may then move distally until its movement is stopped by stopper
510, which may have a shape and/or size that is not configured to
fit through flange 512 in any orientation. Movement of plunger rod
503 as shown from FIG. 15C to FIG. 15D may dispense a volume of
drug product 516 equivalent to a suitable or desired dose for a
patient (e.g., by a needle, cannula, tube, or other attachment to
the distal end of syringe 500). While plunger rod 503 is depicted
as rotation 90 degrees between FIGS. 15C and 15D, it is understood
that projections 506 and 508 may be rotationally offset by any
suitable amount.
[0129] In some embodiments, as shown in FIG. 15D, upon dispensing
the desired or suitable volume of drug product 516, plunger 514 may
not be flush with a distal end of the interior of barrel 502 and a
volume of drug product 516 may remain in barrel 502. In some
embodiments, this may allow for increased accuracy in the volume of
dose delivered from syringe 500, as discrepancies in size or shape
between stopper 514 and the distal end of barrel 502 will not
prevent the desired or suitable dose volume from being dispensed.
Moreover, this (and other embodiments herein) may eliminate the
need for a dose line on syringe 500, which may reduce or eliminate
inaccuracies that may occur when placing a dose line on barrel 502
during manufacturing, and/or when visually gauging whether a volume
of drug product 516 is aligned with a dose line on barrel 502.
[0130] It should be noted that while projections 506, 508 are
depicted as having a particular shape and size, it is contemplated
that they and the corresponding opening in flange 512 may have any
suitable shape and size allowing for passage of projections 506,
508 through flange 512. Moreover, it should be noted that while an
opening is being shown in flange 512, any suitably shaped opening
may be incorporated in any part of syringe 500 suitable to regulate
movement of plunger rod 503 (e.g., into a finger flange, a stopper
fixed at a proximal end portion of barrel 502, a proximal side of
barrel 502, or any other suitable portion of syringe 500).
[0131] Referring now to FIGS. 16A-16E, views of another syringe 600
with a further embodiment of a dose expel control mechanism are
depicted. Syringe 600 may include a barrel 602 and a plunger rod
603 having a depressor 604 and a projection 606. A plunger 608 is
disposed in an interior of barrel 602. A removable key 610 is
disposed at a proximal end of barrel 602. The interior of barrel
602 may also house a volume of a drug product 612. A proximal end
of barrel 602 may be closed or closed off in any suitable manner,
having an opening configured to allow passage of the thin portion
of plunger rod 603.
[0132] In some aspects of this embodiment, projection 606 may be
sized and configured such that it is unable to pass beyond key 610.
Thus, plunger rod 603 may only be depressed distally until
projection 606 contacts key 610. Projection 606 may be affixed to
plunger rod 603 in any suitable manner, or may be of a piece with
(e.g., molded as a part of) plunger rod 603.
[0133] In some embodiments, key 610 may be made as a separate
structure from other aspects of syringe 600. In further
embodiments, key 610 may be of a piece with another component of
syringe 600, such as, e.g., a removable finger flange (not
shown).
[0134] An initial configuration of syringe 600 is depicted in FIG.
16A. As shown, plunger rod 603 and plunger 608 are located
proximally from the volume of drug product 612 disposed in the
interior of barrel 602. Projection 606 is located a distance
proximally from key 610. As shown in FIG. 16B, plunger rod 603 may
be allowed to move distally (e.g., via depression of depressor 604)
until projection 606 contacts key 610. The extent of the distal
movement allowed in this configuration may be sufficient to prime
syringe 600 and remove air between plunger 608 and drug product
612. As shown in FIG. 16B, plunger rod 603 may be prevented from
moving further by the contact between key 610 and projection
606.
[0135] FIG. 16C depicts syringe 600 upon removal of key 610. A
height of key 610 may be proportional to a desired or suitable
dosage volume of drug product 612, such that once key 610 is
removed, plunger rod 603 and projection 606 are free to move
further distally until projection 606 contacts, and is obstructed
by, a proximal end of barrel 602 (FIG. 16D) or other component of
syringe 600 located at a distal end portion of barrel 602 (e.g., a
flange, lid, or stopper). This movement of plunger rod 603 allows
for plunger 608 to likewise expel a desired or suitable dosage
volume of drug product 612 (e.g., via needle, cannula, tube, or
other mechanism connected to a distal end of syringe 600).
[0136] Referring now to FIGS. 17A-17B, two schematic views of
additional embodiments of delivery devices with dose expel control
mechanisms are depicted. FIG. 17A depicts a syringe 700a, having a
body 702, a plunger rod 704 with a plurality of teeth, a plunger
706, and a volume of drug product 708. The teeth of plunger rod 704
may be configured to engage with complementary teeth on an
intermediate gear 712, which may in turn be configured to engage
with teeth on a driving gear 714a. Driving gear 714a is depicted
with two longer teeth, which are configured to engage with tabs on
an offset actuator 710a.
[0137] Priming and dispensing of a dose from syringe 700a may both
be accomplished by depression of offset actuator 710a (e.g., to a
first depressed position and a second depressed position). The tabs
of offset actuator 710a may be sized and configured to interact
with (e.g., push on) the long teeth of driving gear 714a at desired
intervals corresponding to priming of syringe 700a (the lower tab
and a first of the long teeth of driving gear 714a and dispensing
of a desired dosage amount of drug product 708 (the upper tab of
actuator 710a and a second of the long teeth of driving gear 714a.
FIG. 17A depicts, for example, a position of driving gear 714a and
actuator 710a after syringe 700a has been primed (e.g., a first
depressed position). In some embodiments, driving gear 714a,
intermediate gear 712, or plunger rod 704 may be configured to
provide audio, visual, or tactile feedback upon movement of
actuator 710a to a first or second depressed position (e.g., by
providing a clicking sound, or by resisting movement beyond the
depressed position). In some embodiments, the interaction between
actuator 710a and driving gear 714a may resemble that of a Geneva
drive. In some embodiments, rotation of driving gear 714a may be
stopped by contact between a long tooth of driving gear 714a and
intermediate gear 712.
[0138] Multiple configurations of a driving gear and an actuator
are possible in order to achieve priming and/or drug dispensing
steps by depression of the actuator. For example, FIG. 17B depicts
a second syringe 700b with a driving gear 714b having three long
teeth, instead of two, and an actuator 710b having three tabs,
instead of two. In such an embodiment, it is contemplated that
actuator 710b may be depressed multiple times (e.g., to a first
depth, a second depth, and a third depth) to achieve a desired
result (e.g., priming of syringe 700b). Each contact between a tab
of actuator 710b and a long tooth of driving gear 714b may be
accompanied by tactile, audio, or visual feedback, and may
correspond with partially or fully priming syringe 700b, removing
air bubbles from syringe 700b, or dispensing a desired dose volume
from syringe 700b. In some embodiments, an actuator may have only
one tab configured to interact with the long tooth or teeth of a
driving gear (See, e.g., actuator 710c and driving gear 714c
depicted in FIG. 17C).
[0139] In some embodiments, an actuator may be spring-loaded, such
that after depressing the actuator to a predetermined extent (e.g.,
enough for a tab of the actuator to push, contact, rotate, and/or
otherwise interact with a single long tooth of the driving gear),
the actuator may be returned to its pre-depressed location by,
e.g., a spring return or other return mechanism. Such an embodiment
is schematically depicted in FIG. 17C, where depression of actuator
710c may compress spring 716, which may in turn cause actuator 710c
to return to its pre-depressed location upon release. When actuator
710c is depressed again to a predetermined extent, the tab on
actuator 710c may push, contact, rotate, and/or otherwise interact
with another single long tooth of the driving gear. Each depression
of the actuator may serve a separate function (e.g., to prime
and/or remove air from a syringe, or to dispense a suitable dosage
volume from a syringe).
[0140] While FIGS. 17A-17C depict potential versions of embodiments
including a driving gear and an actuator, many more permutations
and combinations of driving gears having longer teeth and actuators
having tabs are contemplated. Additional variations on these
embodiments include that the actuator (e.g., actuator 710c) may be
spring-loaded or otherwise configured in any suitable manner to
return to an initial position after, e.g., completing a priming or
dispensing step.
[0141] Referring now to FIGS. 18A-18F, views of another embodiment
of a dose expel control mechanism are depicted. FIGS. 18A and 18B
depict a front view and an angled view, respectively, of a sleeve
800. Sleeve 800 may be configured to surround and/or attach to,
e.g., a syringe barrel, and may include a body 801, a channel 802,
a flange 804, and an offset portion 806 of channel 802. Sleeve 800
may be configured to be used in conjunction with a plunger rod 820,
depicted in, e.g., FIG. 18C. Plunger rod 820 may include a primary
body 822 extending from a cap 826. Primary body 822 may be
configured to extend into a body of a syringe barrel. Plunger rod
pin arm 824, which may extend from cap 826 separately from primary
body 822, may be configured to extend adjacent to a syringe barrel
into which primary body 822 is extending. Plunger rod end 828 may
be configured to contact, affix to, or otherwise attach to a
plunger (not shown).
[0142] FIG. 18D depicts a syringe assembly 830 including sleeve 800
and plunger rod 820 surrounding a syringe 832. As shown, plunger
rod pin arm 824 may be sized and configured to slide through
channel 802. As plunger rod 820 is depressed distally into the body
of syringe 832, plunger rod pin arm 824 may move distally through
channel 802. When plunger rod pin arm 824 reaches the offset
portion 806 of channel 802, the shape of channel 802 may stop
further progress of plunger rod 820 distally. FIG. 18E depicts
that, upon rotation of plunger rod 820 (e.g., turning of cap 826)
or separate movement or rotation of plunger rod pin arm 824,
plunger rod pin arm 824 may move laterally into offset portion 806
of channel 802, after which further distal movement of plunger rod
pin arm 824, and thus plunger rod 820, may be possible.
[0143] Syringe 832 may include a volume of a drug product that may
be greater than or equal to a desired dose for a patient. Initial
distal movement of plunger rod 820 (e.g., prior to plunger rod pin
arm 824 approaching offset portion 806 of channel 802) may be used
to prime syringe 832. Contact of plunger rod pin arm 824 with the
change in shape of channel 802 near offset portion 806 of channel
802 (shown in, e.g., FIG. 18E) may signify that the syringe is
primed and that air has been removed from an interior of syringe
832. A length of offset portion 806 of channel 802 may be
proportional to a desired dosage volume of a drug product inside
syringe 832 after syringe 832 has been primed. Thus, rotation of
plunger rod 820 to align plunger rod pin arm 824 with offset
portion 806 of channel 802, and subsequent depression of plunger
rod 802 such that plunger rod pin arm 824 slides through off set
portion 806, may result in delivery of the desired dose of a drug
product through the distal end of syringe 832 (depicted in, e.g.,
FIGS. 18E and 18F as being coupled to a needle).
[0144] FIG. 18F depicts a detail cross-sectional side view of
assembly 830. Plunger rod pin arm 824 is shown as having contacted
the portion of channel 802 where offset portion 806 begins. As
such, assembly 830 may be in the "primed" position. The interior
834 of syringe 832 indicated in FIG. 18F may correspond to a
desired dose volume of a drug product for delivery to a
patient.
[0145] Referring now to FIGS. 19A-19E, views of another embodiment
of a dose expel control mechanism are depicted. Assembly 900 may
include a syringe body 902, a plunger rod 904a, a plunger 906, a
plunger rod pin arm 908, and a sleeve 910a, which may be connected
to a sleeve flange 912. Syringe body 902 may house a volume of drug
product 914 located distally from plunger 906. Operation of this
embodiment may be similar to operation of assembly 830 depicted in
FIGS. 18A-18F. Notably, sleeve 910a need not extend along a full
length of syringe body 902, allowing for visibility of syringe body
902, or into syringe body 902 if syringe body 902 is transparent. A
length of sleeve 910a (and/or other parts of assembly 900) may be
chosen to, e.g., help with ease of handling of assembly 900.
[0146] As depicted in FIGS. 19A-D, various configurations of a
sleeve and a channel in the sleeve may be used in conjunction with
assembly 900, to allow for priming and dispensing of a desired dose
of a drug product from assembly 900. For example, sleeve 910a
depicted in FIG. 19A includes a channel 909a which does not extend
through the entirety of sleeve 910a. In this embodiment, the upper
portion of channel 909a may correspond to a distance that plunger
rod pin arm 908, and thus that plunger rod 904a, may travel in
order to prime assembly 900, and the offset lower portion of
channel 909a may be proportional to a desired dosage volume of drug
product 914 that may be dispensed from a distal end of assembly 900
by rotation and distal movement of plunger rod 904a until plunger
rod pin arm 908 is stopped from further distal movement by the end
of channel 909a. The closed end of channel 909a ensures that more
than the desired dosage volume is not delivered, and may mitigate
variance in, e.g., a desired dosage volume by preventing plunger
906 from moving distally into a tapered distal end portion of
syringe body 902. Such variance may be caused by, e.g., variability
in geometries of plunger 906 and syringe body 902.
[0147] In alternative embodiments, the sleeve may have different
configurations such as those depicted in FIGS. 19B-19D. Each of
FIGS. 19B-19D depict a cross section of a sleeve having a variation
of a channel through which plunger rod pin arm 908 may travel, thus
guiding movement of plunger rod 904a within syringe body 902. For
example, FIG. 19B depicts a front view of a half-sleeve 910b.
Half-sleeve 910b may not wrap around syringe body 902 to create a
narrow channel through which plunger rod pin arm 908 may travel;
instead, plunger rod pin arm 908 may be guided by the "open" wall
of half-sleeve 910b, and may travel in area 909b adjacent to the
open wall of half-sleeve 910b. Sleeve 910c, depicted in FIG. 19C,
provides a configuration similar to that of sleeve 910a, except for
the open end of channel 909c, as opposed to the closed end of
channel 909a. Such a configuration may allow for, e.g., bottoming
out of plunger 906 in syringe body 902, in embodiments in which
such bottoming out would allow for dispensing a desired dose of a
drug product from assembly 900. Sleeve 910d, depicted in FIG. 19D,
depicts a channel 909d having a bend in a direction opposite to the
bend of sleeves 910a, 910b, and 910c.
[0148] FIGS. 19A-19D depict exemplary configurations of channels
through which a plunger rod pin arm may travel. It is contemplated,
however, that many more embodiments of sleeves and/or channels are
possible. It is also contemplated that while channel 909a is
depicted as being disposed distally from sleeve flange 912, a
channel (e.g., channel 909a, 909b, 909c, or 909d) may be
incorporated into a sleeve on or near any portion of a syringe body
(e.g., syringe body 902), and/or may be incorporated into the
syringe body itself (e.g., via embossing, engraving, molding, or
other method).
[0149] FIG. 19E depicts sleeve 910C and an exemplary method or
mechanism by which a sleeve (e.g., sleeve 910c) may connect to a
flange portion 912 during assembly. As shown, sleeve 910c may
include one or more tabs 915 that may interface with complementary
slots, holes, or indents 913 in flange 912. The interface between
tabs 915 and slots, holes, or indents 913 in flange 912 may be any
suitable interface allowing for flange 912 and sleeve 910c to
connect (e.g., a dovetail connection, a dowel connection, a mortise
and tenon connection, or any other now-known or future-developed
type of connection). In alternative embodiments, flange 912 may
connect to sleeve 910c without the use of tabs, slots, holes, or
indents (e.g., using an adhesive, a heat connection, etc.).
[0150] Attachment of the flange and sleeve in this manner may allow
for one of the two components to be added to syringe body 902
first, followed by the other. For example, flange 912 may be
configured to slide, surround, snap on, or otherwise combine with
syringe body 902, and the sleeve (e.g., sleeve 910a, 910b, 910c or
910d) may subsequently be slid onto syringe body 902 and connected
to flange 912. As a further example, the sleeve may be added to
syringe body 902 first, followed by flange 912. In yet another
example, the sleeve and flange 912 may first be connected, and then
may slide, surround, snap on or otherwise combine with syringe body
902.
[0151] In further embodiments, a sleeve (e.g., sleeve 910a, 910b,
910c or 910d) and flange (e.g., flange 912) may be a unitary body
(e.g., may be manufactured or molded together), instead of
comprising two attached pieces. In some embodiments, the sleeve
and/or flange may be made from, or may include, a material rigid
enough to allow for a channel in the sleeve to restrict and/or
control movement of a plunger rod pin arm, and flexible enough to
allow for the sleeve and/or flange to snap onto or otherwise
combine with syringe body 902. In some embodiments, for example,
the sleeve and/or flange may include polypropylene. In some
embodiments, for example, the sleeve and/or flange may include two
different materials combined in an overmolding technique (e.g.,
polypropylene and a second material).
[0152] Referring now to FIGS. 20A-20C, views of another embodiment
of a dose expel control mechanism are depicted. All three are
discussed in tandem herein. As shown primarily in the
cross-sectional side view of FIG. 20A and the cross section
indicated by "A-A" depicted in FIG. 20B, assembly 1000 may include
a plunger rod 1002, a plunger 1003, a syringe body 1004, a volume
of a drug product 1005 disposed within syringe body 1004, a plunger
rod arm 1006 configured to extend from the plunger rod cap
separately from, and parallel to, plunger rod 1002, a sleeve 1008,
a sleeve pin 1010, a spring-loaded pin casing 1012, a sleeve cavity
1014, a plunger rod arm cavity 1016, a pin protrusion 1018, and a
sleeve pin slot 1020 (depicted in the view of sleeve 1008 shown in
FIG. 20C).
[0153] As with the embodiments depicted in FIGS. 19A-19E, sleeve
1008 may include a flange, and may be configured to wrap around a
circumference of syringe body 1004. Assembly 1000 differs from,
e.g., assembly 900 in that plunger rod arm 1006 does not include a
pin; instead, plunger rod arm 1006 may include a cavity 1016 into
which sleeve pin 1010 may extend. Sleeve pin 1010 may be slidably
connected to sleeve 1008 such that it extends through pin slot
1020. In some embodiments, pin casing 1012, which may be spring
loaded, may exert a force on sleeve pin 1010 in a direction outward
from sleeve 1008, while pin protrusion 1018 (depicted in, e.g.,
FIG. 20B) may prevent sleeve pin 1010 from being pulled out of pin
slot 1020. In the configuration depicted in FIG. 20A, sleeve pin
1010 may be pushed distally (e.g., towards the expulsion end of
assembly 1000) along the length of pin slot 1020 in order to move
plunger rod arm 1006 distally (i.e., so that plunger rod 1002 also
moves distally), because sleeve pin 1010 extends into plunger rod
arm cavity 1016 (depicted in, e.g., FIG. 20B). This movement of
sleeve pin 1010, and the corresponding movement of plunger rod
1002, may serve to prime assembly 1000.
[0154] Upon movement of sleeve pin 1010 to the distal end of pin
slot 1020, pin protrusion 1018 may become aligned with sleeve
cavity 1014, which may be sized and configured to house pin
protrusion 1018. The force exerted upon sleeve pin 1010 by pin
casing 1012 may cause pin protrusion 1018 to be pulled into sleeve
cavity 1014, thus causing sleeve pin 1010 to disengage from plunger
rod arm cavity 1016.
[0155] After sleeve pin 1010 has become disengaged from plunger rod
arm cavity 1016, plunger rod 1002 may be pushed distally
independently of sleeve pin 1010 (e.g., by a user) to dispense a
desired dosage of drug product 1005.
[0156] With respect to any embodiment in the present disclosure
that includes a sleeve and a pin that may travel through a channel
or slot in the sleeve, it is contemplated that the channel or slot
need not necessarily be located within a sleeve. For example, in
embodiments where a sleeve wraps fully or partially around a
syringe or syringe body, the sleeve may be replaced by, e.g., a
channel or slot being imprinted, molded, or otherwise disposed
directly upon the syringe or syringe body.
[0157] Features enumerated above have been described within the
context of particular embodiments. However, features and aspects of
the embodiments may be combined, added to other embodiments,
subtracted from embodiments, etc. in any manner to assist with
controlled preparation and/or delivery of a drug.
[0158] Aspects of the embodiments above have been described with
respect to priming doses and removing excess air bubbles from
within syringes. However, aspects of these embodiments may also be
employed for use with fillable syringes and multi-dose vials. For
example, syringes according to the present disclosure may provide a
more precise method for transferring drug product from a vial to a
syringe. Precision during this syringe loading step may reduce or
minimize overfilling of syringes from, e.g., vials of drug product.
Inhibiting overfilling may in turn decrease wastage of a drug
product and may increase or maximize the number of doses that may
be administered from one vial.
[0159] For example, to fill syringe 10 depicted in FIG. 1, dial 5
may be rotated in the reverse direction to withdraw piston 8 into
syringe barrel 9 away from the distal needle end to fill syringe 10
through needle 13.
[0160] As a further example, to fill syringe 60 depicted in FIG. 5,
plunger rod 61 may be rotated in the direction opposite to the
direction needed to prime needle 66 to withdraw piston 68 into
syringe barrel 69 away from the distal needle end to fill syringe
60 through needle 66.
[0161] While a number of embodiments are presented herein, multiple
variations on such embodiments, and combinations of elements from
one or more embodiments, are possible and are contemplated to be
within the scope of the present disclosure. Moreover, those skilled
in the art will appreciate that the conception upon which this
disclosure is based may readily be used as a basis for designing
other devices, methods, and systems for carrying out the several
purposes of the present disclosure.
* * * * *