U.S. patent application number 17/191442 was filed with the patent office on 2021-08-12 for devices, systems and methods for medicament delivery.
This patent application is currently assigned to kaleo, Inc.. The applicant listed for this patent is kaleo, Inc.. Invention is credited to Eric S. EDWARDS, Evan T. EDWARDS, Mark J. LICATA, Paul F. MEYERS, David A. WEINZIERL.
Application Number | 20210244894 17/191442 |
Document ID | / |
Family ID | 1000005540954 |
Filed Date | 2021-08-12 |
United States Patent
Application |
20210244894 |
Kind Code |
A1 |
EDWARDS; Eric S. ; et
al. |
August 12, 2021 |
DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY
Abstract
An apparatus includes a label configured to be coupled to a
medicament delivery device. The label includes a first surface and
a second surface. The first surface is configured to be coupled to
an outer surface of the medicament delivery device. The second
surface includes a textual indicia. The label further includes an
electronic circuit system configured to output an electronic
signal.
Inventors: |
EDWARDS; Eric S.; (Moseley,
VA) ; EDWARDS; Evan T.; (Charlottesville, VA)
; LICATA; Mark J.; (Doswell, VA) ; MEYERS; Paul
F.; (Fishers, IN) ; WEINZIERL; David A.;
(Andover, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
kaleo, Inc. |
Richmond |
VA |
US |
|
|
Assignee: |
kaleo, Inc.
Richmond
VA
|
Family ID: |
1000005540954 |
Appl. No.: |
17/191442 |
Filed: |
March 3, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16145974 |
Sep 28, 2018 |
10960155 |
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17191442 |
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15061462 |
Mar 4, 2016 |
10099023 |
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16145974 |
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14664426 |
Mar 20, 2015 |
9278182 |
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15061462 |
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14470165 |
Aug 27, 2014 |
9259539 |
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14664426 |
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13404699 |
Feb 24, 2012 |
8926594 |
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14470165 |
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12794020 |
Jun 4, 2010 |
8206360 |
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13404699 |
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11621236 |
Jan 9, 2007 |
7731686 |
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12794020 |
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10572148 |
Mar 16, 2006 |
7749194 |
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PCT/US2006/003415 |
Feb 1, 2006 |
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11621236 |
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60648822 |
Feb 1, 2005 |
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60731886 |
Oct 31, 2005 |
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60787046 |
Mar 29, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 15/009 20130101;
G16H 20/17 20180101; A61M 5/2046 20130101; A61M 5/14244 20130101;
A61M 5/2033 20130101; A61M 2205/581 20130101; A61M 2005/2073
20130101; A61M 5/3129 20130101; A61M 5/3204 20130101; A61M 5/19
20130101; A61M 5/3287 20130101; G16H 20/13 20180101; A61M 2205/587
20130101; A61M 5/3234 20130101; A61M 2205/583 20130101; A61M 5/2053
20130101; A61M 2205/8206 20130101; A61M 5/326 20130101; A61M
2205/50 20130101; G16Z 99/00 20190201; A61M 2205/582 20130101; A61M
35/00 20130101; A61M 2005/206 20130101; A61M 2205/502 20130101;
A61M 5/3202 20130101; A61M 5/5086 20130101 |
International
Class: |
A61M 15/00 20060101
A61M015/00; G16Z 99/00 20060101 G16Z099/00; A61M 5/20 20060101
A61M005/20; A61M 5/32 20060101 A61M005/32; A61M 5/50 20060101
A61M005/50; A61M 35/00 20060101 A61M035/00; G16H 20/17 20060101
G16H020/17; G16H 20/13 20060101 G16H020/13 |
Claims
1-16. (canceled)
17. An apparatus comprising: a housing; a medicament container
disposed within the housing; a needle configured to be placed in
fluid communication with the medicament container, the needle
configured to move between a first needle position, in which the
needle is disposed within the housing, and a second needle position
in which a portion of the needle extends from the housing; an
actuator coupled to the housing, the actuator movable relative to
the housing and configured to cause the needle to move from the
first needle position to the second needle position when actuated;
an electronic circuit system coupled to the housing, the electronic
circuit system configured to produce an output when the actuator is
actuated; and a safety lock removably coupled to the housing, the
safety lock preventing movement of the actuator and isolating the
electronic circuit system from a terminal of a power source when
the safety lock is coupled to the housing.
18. The apparatus of claim 17, wherein: the power source is a
battery coupled to the housing, in response to the safety lock
being removed from the housing, the battery is placed in electrical
communication with the electronic circuit system.
19. The apparatus of claim 17, wherein the safety lock has a first
portion disposed within the housing and a second portion disposed
outside the housing.
20. The apparatus of claim 17, wherein: the housing has a base
surface configured to contact patient, the base surface defines a
needle opening in which the needle moves through when the needle
moves from the first needle position to the second needle
position.
21. The apparatus of claim 17, wherein the apparatus is one of an
autoinjector, a pen injector and a medicament patch.
22. The apparatus of claim 17, wherein the medicament container is
configured to contain a medicament for injection into a
patient.
23. The apparatus of claim 17, further comprising: a retraction
spring coupled to the housing and configured to produce a
retraction force to move the needle from the second needle position
to the first needle position.
24. The apparatus of claim 17, further comprising: a retraction
mechanism configured to move the needle to the first needle
position after delivery of the medicament.
25. The apparatus of claim 17, wherein the medicament container is
configured to contain a medicament for delivery into a patient, the
actuator configured to cause the medicament to be expelled from the
medicament container and through the needle upon actuation.
26. An apparatus comprising: a housing; a medicament container
disposed within the housing; a needle configured to be placed in
fluid communication with the medicament container, the needle
configured to move between a first needle position, in which the
needle is disposed within the housing, and a second needle position
in which a portion of the needle extends from the housing; an
actuator coupled to the housing, the actuator movable relative to
the housing and configured to cause the needle to move from the
first needle position to the second needle position when actuated;
an electronic circuit system coupled to the housing, the electronic
circuit system configured to produce an output when the actuator is
actuated; and a safety lock coupled to the housing, the safety lock
having a first portion disposed within the housing and a second
portion disposed outside the housing such that a user can grasp the
second portion to remove the safety lock from the housing, the
first portion of the safety lock preventing the actuator from being
actuated and isolating the electronic circuit system from a
terminal of a power source when the safety lock is coupled to the
housing.
27. The apparatus of claim 26, wherein: the power source is a
battery coupled to the housing, in response to the safety lock
being removed from the housing, the battery is placed in electrical
communication with the electronic circuit system.
28. The apparatus of claim 26, wherein: the housing has a base
surface configured to contact patient, the base surface defines a
needle opening in which the needle moves through when the needle
moves from the first needle position to the second needle
position.
29. The apparatus of claim 26, wherein the apparatus is one of an
autoinjector, a pen injector and a medicament patch.
30. The apparatus of claim 26, wherein the medicament container is
configured to contain a medicament for injection into a
patient.
31. The apparatus of claim 26, further comprising: a retraction
spring coupled to the housing and configured to produce a
retraction force to move the needle from the second needle position
to the first needle position.
32. The apparatus of claim 26, further comprising: a retraction
mechanism configured to move the needle to the first needle
position after delivery of the medicament.
33. The apparatus of claim 26, wherein the medicament container is
configured to contain a medicament for delivery into a patient, the
actuator configured to cause the medicament to be expelled from the
medicament container and through the needle upon actuation.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/145,974, entitled "Devices, Systems and
Methods for Medicament Delivery," filed Sep. 28, 2018, which is a
continuation of Ser. No. 15/061,462, now U.S. Pat. No. 10,099,023,
entitled "Devices, Systems and Methods for Medicament Delivery,"
filed Mar. 4, 2016, which is a continuation of U.S. patent
application Ser. No. 14/664,426, now U.S. Pat. No. 9,278,182,
entitled "Devices, Systems and Methods for Medicament Delivery,"
filed Mar. 20, 2015, which is a continuation of U.S. patent
application Ser. No. 14/470,165, now U.S. Pat. No. 9,259,539,
entitled "Devices, Systems and Methods for Medicament Delivery,"
filed Aug. 27, 2014, which is a continuation of U.S. patent
application Ser. No. 13/404,699, now U.S. Pat. No. 8,926,594,
entitled "Devices, Systems and Methods for Medicament Delivery,"
filed Feb. 24, 2012, which is a continuation of U.S. patent
application Ser. No. 12/794,020, now U.S. Pat. No. 8,206,360,
entitled "Devices, Systems and Methods for Medicament Delivery,"
filed Jun. 4, 2010, which is a continuation of U.S. patent
application Ser. No. 11/621,236, now U.S. Pat. No. 7,731,686,
entitled "Devices, Systems and Methods for Medicament Delivery,"
filed Jan. 9, 2007, which is a continuation-in-part of U.S. patent
application Ser. No. 10/572,148, entitled "Devices, Systems and
Methods for Medicament Delivery," now U.S. Pat. No. 7,749,194,
filed Mar. 16, 2006, which is a national stage filing under 35
U.S.C. .sctn. 371 of International Patent Application No.
PCT/US2006/003415, entitled "Devices, Systems and Methods for
Medicament Delivery," filed Feb. 1, 2006, which claims priority to
U.S. Provisional Application Ser. No. 60/648,822, entitled
"Devices, Systems and Methods for Medicament Delivery," filed Feb.
1, 2005 and U.S. Provisional Application Ser. No. 60/731,886,
entitled "Auto-Injector with Feedback," filed Oct. 31, 2005, each
of which is incorporated herein by reference in its entirety. U.S.
patent application Ser. No. 11/621,236 also claims priority to U.S.
Provisional Application Ser. No. 60/787,046, entitled "Devices,
Systems and Methods for Medicament Delivery," filed Mar. 29, 2006,
which is incorporated herein by reference in its entirety.
BACKGROUND
[0002] The invention relates generally to a medical device, and
more particularly to a medicament delivery device for delivering a
medicament into a body of a patient.
[0003] Exposure to certain substances, such as, for example,
peanuts, shellfish, bee venom, certain drugs, toxins, and the like,
can cause allergic reactions in some individuals. Such allergic
reactions can, at times, lead to anaphylactic shock, which can
cause a sharp drop in blood pressure, hives, and/or severe airway
constriction. Accordingly, responding rapidly to mitigate the
effects from such exposures can prevent injury and/or death. For
example, in certain situations, an injection of epinephrine (i.e.,
adrenaline) can provide substantial and/or complete relief from the
allergic reaction. In other situations, for example, an injection
of an antidote to a toxin can greatly reduce and/or eliminate the
harm potentially caused by the exposure. Because emergency medical
facilities may not be available when an individual is suffering
from an allergic reaction, some individuals carry a medicament
delivery device, such as, for example, an auto-injector, to rapidly
self-administer a medicament in response to an allergic
reaction.
[0004] To actuate such a medicament delivery device, however, the
user may be required to execute a series of operations. For
example, to actuate some known auto-injectors, the user must remove
a protective cap, remove a locking device, place the auto-injector
in a proper position against the body and then press a button to
actuate the auto-injector. Failure to complete these operations
properly can result in an incomplete injection and/or injection
into an undesired location of the body. In certain instances, for
example, users who have become confused in the operation of some
known auto-injectors have inadvertently injected the medicament
into their thumb by improperly positioning the auto-injector.
[0005] The likelihood of improper use of known medicament delivery
devices can be compounded by the nature of the user and/or the
circumstances under which such devices are used. For example, many
users are not trained medical professionals and may have never been
trained in the operation of such devices. Moreover, in certain
situations, the user may not be the patient, and may therefore have
no experience with the medicament delivery device. Similarly,
because some known medicament delivery devices are configured to be
used relatively infrequently in response to an allergic reaction or
the like, even those users familiar with the device and/or who have
been trained may not be well practiced at operating the device.
Finally, such devices are often used during an emergency situation,
during which even experienced and/or trained users may be subject
to confusion, panic and/or the physiological effects of the
condition requiring treatment.
[0006] Some known medicament delivery devices include printed
instructions to inform the user of the steps required to properly
deliver the medicament. Such printed instructions, however, can be
inadequate for the class of users and/or the situations described
above. Moreover, because some known medicament delivery devices,
such as, for example, auto-injectors, pen injectors, inhalers or
the like, can be compact, such printed instructions may be too
small to read and comprehend during an emergency situation.
[0007] Some known medicament delivery devices include and
electronic system to assist the user in setting the proper dosage
and/or maintaining a compliance log. Such known medicament delivery
devices and the accompanying electronic systems can be large and
therefore not conveniently carried by the user. Moreover, such
known medicament delivery devices and the accompanying electronic
systems can be complicated and/or expensive to manufacture.
[0008] Thus, a need exists for a medicament delivery device and/or
a medicament container that can be conveniently carried by a user
that provides instructions that can be easily understood by an
untrained user in any type of situation, and that can be
inexpensively manufactured.
SUMMARY
[0009] Medicament delivery devices are described herein. In one
embodiment, an apparatus includes a label configured to be coupled
to a medicament delivery device. The label includes a first surface
and a second surface. The first surface is configured to be coupled
to an outer surface of the medicament delivery device. The second
surface includes a textual indicia. The label further includes an
electronic circuit system configured to output an electronic
signal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of a medicament delivery device
according to an embodiment of the invention.
[0011] FIG. 2 is a front cross-sectional view of the medicament
delivery device shown in FIG. 1.
[0012] FIG. 3 is a schematic illustration of a portion of the
medicament delivery device shown in FIG. 1.
[0013] FIG. 4 is a schematic illustration of a medicament delivery
device according to an embodiment of the invention.
[0014] FIG. 5 is a perspective view of an auto-injector according
to an embodiment of the invention.
[0015] FIG. 6 is a front view of the auto-injector illustrated in
FIG. 5, with a portion of the auto-injector illustrated in phantom
lines for ease of reference.
[0016] FIG. 7 is a partial cut-away front view of a portion of the
auto-injector illustrated in FIG. 5.
[0017] FIG. 8 is a cross-sectional view of a portion of the
auto-injector illustrated in FIG. 5 taken along line 8-8 in FIG.
7.
[0018] FIG. 9 is a cross-sectional view of a portion of the
auto-injector illustrated in FIG. 5 taken along line 9-9 in FIG.
7.
[0019] FIG. 10 is a front view of a portion of the auto-injector
illustrated in FIG. 5.
[0020] FIG. 11 is a schematic illustration of a portion of the
auto-injector illustrated in FIG. 5.
[0021] FIG. 12 is a perspective view of a portion of the
auto-injector illustrated in FIG. 5 in a second configuration.
[0022] FIG. 13 is a perspective view of a portion of the
auto-injector illustrated in FIG. 5 in a third configuration.
[0023] FIG. 14 is a perspective view of a portion of the
auto-injector illustrated in FIG. 5 in a fourth configuration.
[0024] FIGS. 15 and 16 are front views of a portion of the
auto-injector labeled as region 15 in FIG. 10, in a first
configuration and a second configuration, respectively.
[0025] FIGS. 17 through 20 are perspective views of a portion of
the auto-injector illustrated in FIG. 10, in a first configuration,
a second configuration, a third configuration and a fourth
configuration, respectively.
[0026] FIG. 21 is a flow chart of a method according to an
embodiment of the invention.
[0027] FIG. 22 is a flow chart of a method according to an
embodiment of the invention.
[0028] FIG. 23 is a flow chart of a method according to an
embodiment of the invention.
[0029] FIGS. 24 and 25 are perspective views of a medicament
delivery device according to an embodiment of the invention.
[0030] FIG. 26 is a perspective view of the auto-injector
illustrated in FIG. 5 in a first configuration, with at least a
portion of the auto-injector illustrated in phantom lines for ease
of reference.
[0031] FIG. 27 is a front view of the auto-injector illustrated in
FIGS. 5 and 26 in a first configuration.
[0032] FIG. 28 is a perspective view of the auto-injector
illustrated in FIG. 26 showing an assembly according to an
embodiment of the invention being removed.
[0033] FIG. 29 is a front view of the auto-injector illustrated in
FIG. 26 showing a member according to an embodiment of the
invention being removed.
[0034] FIG. 29A is an exploded perspective view of a portion of the
auto-injector illustrated in FIG. 29.
[0035] FIG. 29B is a cross-sectional view of a component
illustrated in FIG. 29A.
[0036] FIG. 29C is a perspective view of a component illustrated in
FIG. 29A.
[0037] FIG. 30 is a perspective view of a member of the
auto-injector illustrated in FIG. 29.
[0038] FIG. 31 is a perspective view of a portion of the
auto-injector illustrated in FIG. 29.
[0039] FIG. 32 is a perspective view of a portion of the
auto-injector illustrated in FIG. 31.
[0040] FIG. 33 is a partially exploded perspective view of a base
of the auto-injector illustrated in FIG. 31.
[0041] FIG. 34 is a front view of the auto-injector illustrated in
FIG. 27 in a second configuration.
DETAILED DESCRIPTION
[0042] In some embodiments, an apparatus includes a label
configured to be coupled to a medicament delivery device. The label
includes a first surface and a second surface. The first surface is
configured to be coupled to an outer surface of the medicament
delivery device. In some embodiments, for example, the first
surface can include an adhesive. The second surface includes a
textual indicia, such as, for example, a description of the
medicament delivery device, a mark indicating the manufacturer or
distributor of the medicament delivery device and/or an instruction
associated with the use of the medicament delivery device. The
label further includes an electronic circuit system configured to
output an electronic signal. In some embodiments, the electronic
signal can include an instruction associated with the use of the
medicament delivery device.
[0043] In some embodiments, an apparatus includes a printed circuit
board configured to be coupled to a medicament delivery device. The
printed circuit board includes a substrate and an electrical
conductor disposed on the substrate. The substrate includes an
actuation portion configured to receive an actuator. The actuator
is configured to deform the actuation portion of the substrate,
thereby separating the electrical conductor.
[0044] In some embodiments, an apparatus includes a printed circuit
board configured to be coupled to a medicament delivery device. The
printed circuit board includes a substrate and an electrical
conductor disposed on the substrate. The substrate includes an
actuation portion configured to receive an actuator. The actuation
portion of the substrate defines an opening adjacent the electrical
conductor, the opening being configured to receive the actuator.
The actuator is configured to move substantially parallel to a
plane defined by a surface of the actuation portion of the
substrate to produce a tear in the actuation portion of the
substrate, thereby severing the electrical conductor. In some
embodiments, the opening can be configured to propagate the tear in
a predetermined direction.
[0045] In some embodiments, an apparatus includes a medicament
delivery device configured to deliver a medicament into a body. The
medicament delivery device, which can be, for example, a pen
injector, an auto-injector, an inhaler or a transdermal delivery
device, includes an electronic circuit system and a locking member.
The electronic circuit system is configured to output an electronic
signal associated with a use of the medicament delivery device. In
some embodiments, the electronic signal can be, for example,
associated with recorded speech. The locking member is configured
to prevent the medicament from being delivered into the body. The
locking member includes an actuator configured to actuate the
electronic circuit system.
[0046] In some embodiments, an apparatus includes a medicament
delivery device configured to deliver a medicament into a body. The
medicament delivery device includes an electronic circuit system
and a locking member. The electronic circuit system includes a
switch and is configured to output a signal when the switch is
moved from a first state to a second state. The locking member is
configured to prevent the medicament from being delivered into the
body when in a first position and to allow the medicament to be
delivered into the body when in a second position. A portion of the
locking member is configured to move the switch from the first
state to the second state when the locking member is moved from the
first position to the second position.
[0047] In some embodiments, an apparatus includes a housing
configured to contain a medicament, a flexible printed circuit
board, an energy storage member and a label. The flexible printed
circuit board is disposed on an outer surface of the housing and
includes a first electrical contact portion and a second electrical
contact portion. The label is coupled to the flexible printed
circuit board and the housing and is configured to maintain a first
surface of the energy storage member in electrical communication
with the first electrical contact portion and maintain a second
surface of the energy storage member in electrical communication
with the second electrical contact portion. The energy storage
member, can be, for example, a battery.
[0048] In some embodiments, a method includes assembling a
medicament delivery device, such as, for example, an auto-injector.
An electronic circuit system is then placed against an outer
surface of the medicament delivery device. A label is then coupled
to the medicament delivery device such that the label is disposed
about a portion of the electronic circuit system.
[0049] FIGS. 1 and 2 are a perspective view and a partial cutaway
front view, respectively, of an auto-injector 1002 according to an
embodiment of the invention. The auto-injector 1002 is similar to
the auto-injectors described in U.S. patent application Ser. No.
11/562,061, entitled "Devices, Systems and Methods for Medicament
Delivery," filed Nov. 21, 2006, which is incorporated herein by
reference in its entirety. Accordingly, only an overview of the
mechanical components and related operation of the auto-injector
1002 is included below.
[0050] The auto-injector 1002 includes a housing 1110 that defines
a gas chamber 1120. The housing 1110 has a proximal end portion
1112 and a distal end portion 1114. A base 1520 is movably coupled
to the distal end portion 1114 of the housing 1110. A safety lock
1710 is removably coupled to the base 1520. As discussed in more
detail herein, when the safety lock 1710 is coupled to the base
1520, the auto-injector 1002 cannot be actuated. When the safety
lock 1710 is removed from the base 1520, the base 1520 can be moved
relative to the housing 1110, thereby actuating the auto-injector
1002. Accordingly, to inject a medicament into the body, the distal
end portion 1114 of the housing 1110 is oriented towards the user
such that the base 1520 is in contact with the portion of the body
where the injection is to be made. The base 1520 is then moved
towards the proximal end 1112 of the housing 1110 to actuate the
auto-injector 1002.
[0051] The auto-injector 1002 includes a medicament injector 1210
and a system actuator 1510 disposed non-coaxially within the
housing 1110. The medicament injector 1210 includes multiple
medicament vials 1262, a plunger 1284 movably disposed within each
medicament vial 1262, a movable member 1312 engaged with each
plunger 1284 and a needle 1212. Retraction springs 1350 located
within a portion of the base 1520 and the housing 1110 can push the
needle 1212 back within the housing 1110 after injection. The
system actuator 1510 includes a compressed spring 1560, a
compressed gas cylinder 1412, and a puncturing mechanism 1612 to
dispel the contents of the compressed gas cylinder 1412.
[0052] In use, when the auto-injector 1002 is actuated, the
puncturing mechanism 1612 punctures the compressed gas cylinder
1412 allowing a pressurized gas to flow into the gas chamber 1120.
In response to a force produced by the pressurized gas on the
movable member 1312, the movable member 1312 moves distally within
the housing 1110. As a result, the needle 1212 is extended through
the housing 1110. The movement of the movable member 1312 also
causes the plungers 1284 to move within the vials 1262, thereby
expelling a medicament from the vials 1262.
[0053] The auto-injector 1002 includes an electronic circuit system
1920 to provide a predetermined sequence of electronic outputs
during the use of the auto-injector 1002. The electronic circuit
system 1920 is powered by a battery (not shown in FIGS. 1 and 2)
and includes a processor (not shown in FIGS. 1 and 2), a start
button 1970, two switches 1972A and 1972B, a proximity sensor 1974,
two visual output devices 1958A and 1958B and an audio output
device 1956. The components of the electronic circuit system 1920
are operatively coupled by any suitable mechanism, such as, for
example, a printed circuit board (not shown in FIGS. 1 and 2)
having conductive traces.
[0054] The start button 1970 is disposed on the proximal end of the
housing 1110 and can be manually actuated by the user to begin the
sequence of electronic outputs. The first switch 1972A is disposed
on the distal portion 1114 of the housing 1110 adjacent the base
1520 and the locking member 1710. The locking member 1710 is
configured to engage the first switch 1972A such that when the
locking member 1710 is removed, as shown in FIG. 1, the first
switch 1972A changes states. In this manner, removal of the locking
member 1710 can trigger the processor to output a predetermined
electronic output.
[0055] Similarly, the second switch 1972B is disposed on the
housing 1110 adjacent the medicament injector 1210. The medicament
injector 1210 is configured to engage the second switch 1972B such
that when the medicament injector 1210 is moved distally within the
housing 1110 the second switch 1972B changes states. In this
manner, the processor can be prompted to output a predetermined
electronic output based on the position of the medicament injector
1210.
[0056] The proximity sensor 1974 is disposed on the base 1520 and
is configured to produce an output when the base 1520 engages the
body. The proximity sensor can be, for example, a temperature
sensor, an optical sensor or the like. In this manner, the
processor can be prompted to output a predetermined electronic
output when the base 1520 is positioned against the body.
[0057] The first visual output device 1958A is disposed on the
locking member 1710. Similarly, the second visual output device
1958B is disposed on the outer surface 1111 of the housing 1110.
The visual output devices 1958A and 1958B are in electronic
communication with the processor and are configured to produce an
output in response to an electronic signal output by the processor.
The visual output devices 1958A and 1958B can be any suitable
visual indicia, such as, light-emitting diodes (LEDs),
liquid-crystal display (LCD) screens, optical polymers, fiber optic
components or the like. In some embodiments, the visual output
devices 1958A and 1958B can be coupled to the housing 1110 and/or
the locking member 1710 by a label 1910.
[0058] The audio output device 1956 is disposed within the housing
1110 such that it can project sound outside of the housing 1110.
The audio output device 1956 can be any suitable device for
producing sound, such as a micro-speaker a piezo-electric
transducer or the like. Such sound output can include, for example,
an alarm, a series of beeps, recorded speech or the like. The audio
output device 1956 is in electronic communication with the
processor and is configured to produce an output in response to an
electronic signal output by the processor.
[0059] In use, the user activates the electronic circuit system by
pushing the start button 1970 to activate the processor, thereby
causing the processor to output a predetermined sequence of
electronic outputs. In some embodiments, the start button 1970 can
activate the processor by providing an input to the processor. In
other embodiments, the start button 1970 can activate the processor
by placing the battery (not shown in FIGS. 1 and 2) in electronic
communication with the processor.
[0060] In some embodiments, upon activation, the processor can
output an electronic signal to the audio output device 1956 thereby
producing a first electronic output instructing the user in how to
use the auto-injector 1002. Such a message can state, for example,
"please remove the safety tab." Additionally, the first visual
output device 1958A can produce a flashing light to further
indicate to the user where the locking member 1710 is located. The
processor can be configured to repeat the first audible instruction
if the locking member 1710 is not removed within a predetermined
time period.
[0061] When the user removes the locking member 1710, the first
switch 1972A changes states thereby triggering the processor to
output an electronic output providing a second instruction to the
user. The second instruction can be, for example, an audible speech
output instructing the user to "please place the base of the device
on the outer portion of your thigh." The first visual output device
1958A can produce a lighted output during this audible instruction,
thereby visually indicating where the base 1520 is located and/or
what portion of the base 1520 should be placed on the thigh.
[0062] When the user places the base 1520 against the body, the
proximity sensor 1974 provides an input to the processor, thereby
triggering the processor to output an electronic output providing a
third instruction to the user. The third instruction can be, for
example, an audible speech output instructing the user to "push
down on the top of the device to activate the injector."
[0063] When the injection is completed, the medicament injector
1210 is configured to engage the second switch 1972B, thereby
triggering the processor to output an electronic output providing a
fourth instruction to the user. Such a post-use instruction can be,
for example, an audible speech output instructing the user to seek
further medical attention, providing instructions for the safe
disposal of the auto-injector 1002 or the like.
[0064] FIG. 3 is a schematic illustration of the electronic circuit
system 1920 of the auto-injector 1002. The electronic circuit
system 1920 includes a processor 1950 operatively coupled to a
memory device 1954. The memory device 1954 can be configured to
store processor-readable code 1955 instructing the processor 1950
to perform the functions described above. In some embodiments, the
processor-readable code 1955 can be modified and/or updated as
circumstances dictate. The electronic circuit system 1920 includes
an input/output device 1952 configured to receive electronic inputs
from the switches 1972A and 1972B, the proximity sensor 1974 and/or
the start button 1970. The input/output device 1952 is also
configured to provide electronic signals to the various output
devices, such as the visual output devices 1958A and 1958B and the
audio output device 1956.
[0065] The electronic circuit system 1920 also includes a network
interface 1953 configured to couple the electronic circuit system
1920 to a communications network. Such an arrangement can be used,
for example, to download replacement processor-readable code 1955
from a central network (not shown) to the memory device 1954. The
network interface 1953 can also be configured to transmit
information from the electronic circuit system 1920 to a central
network, the user's home computer, the user's cell phone or the
like.
[0066] FIG. 4 is a schematic illustration of a medical device 2002
according to an embodiment of the invention. The medical device
2002, which can be, for example, a medicament delivery device such
as an auto-injector, a pen injector, an inhaler, a transdermal
delivery system or the like, includes a housing 2110 and a label
2910. The label 2910 is coupled to an outer surface 2111 of the
housing 2110. The label 2910 includes a first surface 2912, a
second surface 2914 and an electronic circuit system 2920. The
first surface 2912 is configured to engage the outer surface 2111
of the housing 2110 to couple the label 2910 to the housing 2110.
In some embodiments, the first surface 2912 can include an adhesive
to fixedly couple the label 2910 to the housing 2110. The second
surface 2914 includes a textual indicia 2916. The textual indicia
2916 can include, for example, a description of the medicament
delivery device, a source of the medicament delivery device and/or
an instruction associated with the use of the medicament delivery
device. Although the first surface 2912 is shown as being opposite
the second surface 2914, in other embodiments, the first surface
2912 and the second surface 2914 can be adjacent each other and/or
co-planar.
[0067] The electronic circuit system 2920 is configured to output
an electronic signal. As discussed in more detail herein, the
electronic circuit system 2920 can include many components, such
as, for example, a processor, a switch, a visual output device
and/or an audio output device. The electronic signal can be, for
example, an electronic signal communicated to an output device,
such as, for example, a visual output device, an audio output
device, a haptic output device or the like. In some embodiments,
the electronic signal can be associated with an aspect of the
medical device 2002, such as an instruction associated with an
initial use of the medical device 2002. For example, in some
embodiments, the electronic circuit system 2920 can output a text
message to a display screen (not shown) disposed on the medical
device 2002 instructing the user in the use of the medical device
2002. In other embodiments, the electronic circuit system 2920 can
produce an audio output, such as recorded speech, instructing the
user in the use of the medical device 2002.
[0068] Although the electronic circuit system 2920 is shown as
being disposed on the second surface 2914 of the label 2910, in
other embodiments, the electronic circuit system can be disposed on
the first surface 2912 of the label 2910. In yet other embodiments,
the electronic circuit system 2920 can be disposed between the
first surface 2912 and the second surface 2914 of the label 2910.
In yet other embodiments, the label 2910 can include multiple
discrete layers coupled together, within which portions of the
electronic circuit system can be disposed.
[0069] FIG. 5 is a perspective view of an auto-injector 4002
according to an embodiment of the invention. The auto-injector 4002
is similar to the auto-injectors described in U.S. patent
application Ser. No. 11/562,061, entitled "Devices, Systems and
Methods for Medicament Delivery," filed Nov. 21, 2006, which is
incorporated herein by reference in its entirety. Accordingly, the
mechanical components and operation of the auto-injector 4002 are
not described in detail herein.
[0070] The auto-injector 4002 includes a housing 4110 having a
proximal end portion 4112 and a distal end portion 4114. The distal
end portion 4114 of the housing 4110 includes a protrusion 4142 to
help a user grasp and retain the housing 4110 when using the
auto-injector 4002. Said another way, the protrusion 4142 is
configured to prevent the auto-injector 4002 from slipping from the
user's grasp during use. A base 4520 is movably coupled to the
distal end portion 4114 of the housing 4110. A needle guard
assembly 4810 is removably coupled to the base 4520. Similarly, a
safety lock 4710 is removably coupled to the base 4520. To inject a
medicament into the body, the distal end portion 4114 of the
housing is oriented towards the user such that the base 4520 is in
contact with the portion of the body where the injection is to be
made. The base 4520 is then moved towards the proximal end 4112 of
the housing 4110 to actuate the auto-injector 4002.
[0071] FIG. 26 is a perspective view of the auto-injector 4002
showing the housing 4110 in phantom lines so that the components
contained within the housing 4110 can be more clearly seen.
Similarly, FIG. 27 is a front view of the auto-injector 4002
showing the housing 4110 in phantom lines. For clarity, the
auto-injector 4002 shown in FIGS. 26 and 27 show the auto-injector
4002 without the needle guard assembly 4810', the safety lock 4710'
and the electronic circuit system 4920. Additionally, the
auto-injector 4002 shown and described with reference to FIGS.
26-34 is presented to describe the mechanical components and
operation of the device. Accordingly, the auto-injector 4002 shown
and described with reference to FIGS. 26-34 includes a needle guard
assembly 4810' that does not include a battery isolation tab 4860
(see e.g. FIG. 12), a safety lock 4710' that does not include an
actuator 4732 (see e.g., FIG. 13), and a base 4520' that does not
include an actuator 4538 (see e.g., FIG. 14).
[0072] The auto-injector 4002 includes a medicament injector 4210
and a movable member 4312 engaged with the medicament injector
4210, each of which are disposed within the housing 4110. The
auto-injector 4002 also includes a system actuator 4510, a
compressed gas container 4412 and a gas release mechanism 4612. The
medicament injector 4210 includes a carrier 4250 that is movable
within the housing 4110, a medicament container 4262 and a needle
4212. The medicament container 4262 is coupled to the carrier 4250.
The needle 4212 is disposed within a needle hub portion of the
carrier to allow the needle 4212 to be placed in fluid
communication with the medicament container 4262 during an
injection event.
[0073] The movable member 4312 includes a proximal end portion 4316
and a distal end portion 4318. The proximal end portion 4316
includes a surface 4322 that, together with the housing 4110,
defines a gas chamber 4120. Said another way, the surface 4322
defines a portion of a boundary of the gas chamber 4120. The distal
end portion 4318 is disposed within the medicament container 4262.
In use, the movable member 4312 moves towards the distal end
portion 4114 of the housing 4110, as indicated by arrow C in FIG.
26, in response to a force produced by a pressurized gas on the
surface 4322 of the movable member 4312. As a result, the movable
member 4312 and the medicament injector 4250 are moved towards the
distal end portion 4114 of the housing 4110, thereby exposing the
needle 4212 from the housing 4110. The movable member 4312 then
continues to move within the medicament container 4262 to expel a
medicament from the medicament container 4262 through the needle
4212.
[0074] The auto-injector 4002 is actuated by the system actuator
4510, which is configured to move the compressed gas container 4412
into contact with the gas release mechanism 4612. The gas release
mechanism 4612 punctures a portion of the compressed gas container
4412 to release the pressurized gas contained therein into the gas
chamber 4120 defined by the housing 4110. The system actuator 4510
includes a rod 4540, a spring 4560 and a spring retainer 4570. The
rod 4540 has a proximal end portion 4542 and a distal end portion
4544. The proximal end portion 4542 of the rod 4540 is coupled to
the compressed gas container 4412. The distal end portion 4544 of
the rod 4540 is coupled to the spring retainer 4570 by two
projections 4548, which can be moved inwardly towards each other to
decouple the rod 4540 from the spring retainer 4570, as discussed
below.
[0075] The spring 4560 is disposed about the rod 4540 in a
compressed state such that the spring 4560 is retained by the
proximal end portion 4542 of the rod 4540 and the spring retainer
4570. In this manner, the rod 4540 is spring-loaded such that when
the distal end portion 4544 of the rod 4540 is decoupled from the
spring retainer 4570, the force of the spring 4560 causes the rod
4540, and therefore the compressed gas container 4412, to move
proximally as indicated by arrow D in FIG. 26 and into contact with
the gas release mechanism 4612.
[0076] The base 4520' defines an opening 4522 configured to receive
a portion of the projections 4548 when the base is moved towards
the proximal end 4112 of the housing 4110, as indicated by arrow E
in FIG. 26. When the projections 4548 are received within the
opening 4522, they are moved together causing the distal end
portion 4544 of the rod 4540 to be released from the spring
retainer 4570.
[0077] As shown in FIGS. 26 and 27, the medicament injector 4210
defines a longitudinal axis Lm that is non-coaxial with the
longitudinal axis Le defined by the compressed gas container 4412.
Accordingly, the medicament injector 4210, the compressed gas
container 4412 and the system actuator 4510 are arranged within the
housing 4110 such that the housing has a substantially rectangular
shape. Moreover, the non-coaxial relationship between the
medicament injector 4210 and the compressed gas container 4412
allows the auto-injector 4002 to be actuated by manipulating the
base 4520', which is located at the distal end portion 4114 of the
housing 4110.
[0078] Prior to use, the auto-injector 4002 must first be enabled
by first removing the needle guard 4810' and then removing the
safety lock 4710'. As illustrated by arrow G in FIG. 28, the needle
guard 4810' is removed by pulling it distally. As described in more
detail below, removal of the needle guard 4810' also removes the
isolation tab 4860 (see FIG. 12), thereby placing the batteries
4962 into electrical connection with the electronic circuit system
4910 (not shown in FIGS. 26-34, for purposes of clarity).
Similarly, as illustrated by arrow H in FIG. 29, the safety lock
4710' is removed by pulling it substantially normal to the
longitudinal axis Le of the compressed gas container 4412. Said
another way, the safety lock 4710' is removed by moving it in a
direction substantially normal to the direction that the needle
guard 4810' is moved. As described below, removal of the safety
lock 4710' also actuates the electronic circuit system 4920 (not
shown in FIGS. 26-34, for purposes of clarity). The needle guard
4810' and the safety lock 4710' are cooperatively arranged to
prevent the safety lock 4710' from being removed before the needle
guard 4810' has been removed. Such an arrangement prevents the
auto-injector 4002 from being actuated while the needle guard 4810'
is in place.
[0079] As illustrated in FIG. 29A, the needle guard 4810 includes a
sheath 4820 and a sheath retainer 4840. The sheath 4820 has a
proximal end portion 4822 and a distal end portion 4824 and defines
an opening 4826 configured to receive a portion of the needle 4212
when the needle guard 4810 is in a first (or installed) position.
The sheath 4820 further defines a recessed portion 4828 within the
opening 4826 that engages a corresponding protrusion 4238 defined
by an outer surface 4236 of the needle hub 4223. In this manner,
when the needle guard 4810 is in its first position, the sheath
4820 is removably coupled to the needle hub 4223. In some
embodiments, the recessed portion 4828 and the protrusion 4238 form
a seal that is resistant to microbial penetration.
[0080] The sheath retainer 4840 has a proximal portion 4842 and a
distal portion 4844. The proximal portion 4842 of the sheath
retainer 4840 includes a protrusion 4856 that engages a
corresponding recess 4526 in the base 4520' (see FIG. 33) to
removably couple the sheath retainer 4840 to the base 4520'. The
distal portion 4844 of the sheath retainer 4840 defines an opening
4846 through which the distal end portion 4824 of the sheath 4820
is disposed. The distal portion 4844 of the sheath retainer 4840
includes a series of retaining tabs 4852 that engage the distal end
portion 4824 of the sheath 4820 to couple the sheath 4820 to the
sheath retainer 4840. In this manner, when the sheath retainer 4840
is moved distally away from the base 4520' into a second (or
removed) position, as shown in FIG. 28, the sheath 4820 is removed
from the needle 4412. Moreover, this arrangement allows the sheath
4820 to be disposed about the needle 4412 independently from when
the sheath retainer 4840 is coupled to the sheath 4820. As such,
the two-piece construction of the needle guard provides flexibility
during manufacturing. The distal portion 4844 of the sheath
retainer 4840 also includes a protrusion 4848 to aid the user when
grasping the needle guard 4810.
[0081] When the needle guard 4810 is in its first position, the
sheath retainer 4840 is disposed within a recess 4720 defined by
one of the extended portions 4716 of the safety lock 4710 (see FIG.
30). This arrangement prevents the safety lock 4710 from being
removed when the needle guard 4810 is in its first position, which
in turn, prevents the auto-injector 4002 from being actuated when
the needle guard 4810 is in its first position.
[0082] The outer surface of the sheath retainer 4840 includes an
indicia 4850 to instruct the user in operating the auto-injector
4002. As shown in FIG. 29C, the indicia 4850 includes a numeral to
indicate the order of operation and an arrow to indicate the
direction in which the needle guard 4810 should be moved. In some
embodiments, the indicia 4850 can include different colors,
detailed instructions or any other suitable indicia to instruct the
user. In other embodiments, the indicia 4850 can protrude from the
sheath retainer 4840 to aid the user when grasping the needle guard
4810.
[0083] In some embodiments, the sheath 4820 can be constructed from
any suitable material, such as, for example polypropylene, rubber
or any other elastomer. In some embodiments, the sheath 4820 can be
constructed from a rigid material to reduce the likelihood of
needle sticks during the manufacturing process. In other
embodiments, the sheath 4820 can be constructed from a flexible
material.
[0084] As shown in FIG. 30, the safety lock 4710' is a U-shaped
member having a first end 4712 and a second end 4714. The second
end 4714 of the safety lock 4710' includes two extended portions
4716, each of which includes an inwardly facing protrusion 4718.
When the safety lock 4710' is in its first (or locked) position,
the extended portions 4716 extend around a portion of the base
4520' to space the base 4520' apart from the distal end portion
4114 of the housing 4110. As shown in FIG. 31, the protrusions 4718
are configured engage a portion of the base 4520' to removably
couple the safety lock 4710' in its first position. Additionally,
one of the extended portions 4716 defines a recess 4720 that
receives the sheath retainer 4840 when the needle guard 4810' is in
its first position.
[0085] The first end 4712 of the safety lock 4710' includes a
locking protrusion 4722 that extends inwardly. As shown in FIG. 31,
when the safety lock 4710' is in its first position, the locking
protrusion 4722 extends between the projections 4548 of the rod
4540 and obstructs the opening 4522 of the base 4520'. In this
manner, when the safety lock 4710' is in its first position, the
base 4520' cannot be moved proximally to allow the projections 4548
to be received within the opening 4522. The arrangement of the
locking protrusion 4722 also prevents the projections 4548 from
being moved inwardly towards each other. Accordingly, when the
safety lock 4710' is in its first position, the auto-injector 4002
cannot be actuated.
[0086] The outer surface 4724 of the first end 4712 of the safety
lock 4710' includes a series of ridges 4726 to allow the user to
more easily grip the safety lock 4710'. The outer surface 4724 of
the first end 4712 of the safety lock 4710' also includes an
indicia 4728 to instruct the user in operating the auto-injector
4002. As shown in FIG. 30, the indicia 4728 includes a numeral to
indicate the order of operation and an arrow to indicate the
direction in which the safety lock 4710' should be moved. In some
embodiments, the indicia 4728 can include different colors,
detailed instructions or any other suitable indicia to instruct the
user. In other embodiments, the indicia 4728 can protrude from the
safety lock 4710' to aid the user when grasping the safety lock
4710'.
[0087] After being enabled, the auto-injector 4002 can then be
actuated by moving the base 4520' proximally towards the housing
4110, as indicated by arrow I in FIG. 32. Additionally, as
described below, movement of the base 4520' actuates the electronic
circuit system 4920 (not shown in FIGS. 26-34, for purposes of
clarity).
[0088] As shown in FIG. 33, the base 4520' defines two openings
4536 that receive corresponding attachment protrusions 4150
disposed on the distal end portion 4114 of the housing 4110. In
this manner, the movement and/or alignment of the base 4520'
relative to the housing 4110 is guided by the attachment
protrusions 4150 and the openings 4536. Each attachment protrusion
4150 is secured within its corresponding opening 4536 by a lock
washer 4534. The lock washers 4534 each define an opening 4535 that
receives a portion of the attachment protrusion 4150. The lock
washers 4534 are disposed within slots 4533 defined by the base
4520' so that the openings 4535 are aligned with the attachment
protrusions 4150. The openings 4535 are configured to allow the
lock washers 4534 to move proximally relative to the attachment
protrusions 4150, but to prevent movement of the lock washers 4534
distally relative to the attachment protrusions 4150. In this
manner, when the attachment protrusions 4150 are disposed within
the openings 4535 of the lock washers 4534, the base 4520' becomes
fixedly coupled to the housing 4110. Moreover, after the base 4520'
is moved proximally relative to the housing 4110, the lock washers
4534 prevent the base 4520' from returning to its initial
position.
[0089] The base 4520' also defines a needle opening 4532, a recess
4526 and two retraction spring pockets 4531. The needle opening
4532 receives a portion of the needle guard 4810' when the needle
guard is in its first position. Additionally, when the
auto-injector 4002 is actuated, the needle 4212 extends through the
needle opening 4532. The retraction spring pockets 4531 receive a
portion of the retraction springs.
[0090] As shown in FIG. 33, the base 4520' includes two opposing
tapered surfaces 4524 that define an opening 4522 configured to
receive a corresponding tapered surface 4550 of the projections
4548 when the base 4520' is moved proximally towards the housing
4110. When the projections 4548 are received within the tapered
opening 4522, they are moved together as indicated by arrows J in
FIG. 32. The inward movement of the projections 4548 causes the rod
4540 to become disengaged from the spring retainer 4570, thereby
allowing the rod 4540 to be moved proximally along its longitudinal
axis as the spring 4560 expands.
[0091] Because the rod 4540 is coupled to the compressed gas
container 4412, when the rod 4540 is moved from its first (engaged)
position to its second (actuated) position, the compressed gas
container 4412 is moved proximally within the housing 4110 into
engagement with the gas release mechanism 4612. FIG. 34 shows the
auto-injector in a second configuration, in which the compressed
gas container 4412 is engaged with the gas release mechanism 4612.
When in the second configuration, the compressed gas contained
within the compressed gas container 4412 is released to actuate the
medicament injector 4210.
[0092] The pressurized gas produces a force that causes the movable
member 4312 and the medicament injector 4210 to move distally
within the housing 4110. The movement of the medicament injector
4210 causes the needle 4212 to extend from distal end portion 4114
of the housing 4110 and the base 4520. This operation can be
referred to as the "needle insertion" operation. When the
medicament injector 4210 has completed its movement (i.e., the
needle insertion operation is complete), the movable member 4312
continues to move the medicament container 4262 distally within the
carrier 4250. The continued movement of the medicament container
4262 places the needle 4212 in fluid communication with the
medicament container 4262, thereby allowing the medicament to be
injected. The force from the pressurized gas also causes the
movable member 4312 to move within the medicament container 4262,
thereby expelling the medicament through the needle 4212. This
operation can be referred to as the "injection operation." Upon
completion of the injection, the pressurized gas is released from
the gas chamber 4120, thereby allowing the medicament injector 4210
and the movable member 4312 to be moved proximally within the
housing. This operation can be referred to as the "retraction
operation."
[0093] The auto-injector 4002 includes a label 4910 coupled to an
outer surface 4111 of the housing 4110. The label 4910 includes an
outer layer 4911, an intermediate layer 4980 and an electronic
circuit system 4920 (see FIGS. 7-9). FIG. 6 is a front view of the
auto-injector 4002 showing the outer layer 4911 of the label 4910
in phantom lines so that the intermediate layer 4980 and an
electronic circuit system 4920 can be more clearly seen. As shown
in FIGS. 7-9, the outer layer 4911, which, in some embodiments, can
be constructed from paper, has a first surface 4912 and a second
surface 4914 opposite the first surface 4912. Multiple indicia 4916
are disposed on the first surface 4912. The indicia 4916 include a
textual indicia 4916A and two symbolic indicia 4916B. The textual
indicia 4916B can be written text describing the medicament
delivery device, indicating a source of the medicament delivery
device and/or instructing a user in the use of the medicament
delivery device. The symbolic indicia 4916B can include, for
example, arrows, pointers, trademarks, symbols describing the use
of the medicament delivery device or the like. The label 4910 is
coupled to the outer surface 4111 of the housing 4110 such that the
portion of the first surface 4912 including the indicia 4916 is
visible.
[0094] A portion of the second surface 4914 of the outer layer 4911
can be coupled to the outer surface 4111 of the housing 4110 by any
suitable method. For example, in some embodiments, the second
surface 4914 of the outer layer 4911 includes an adhesive
configured to bond the outer layer 4911 to the outer surface 4111
of the housing 4110. Other portions of the second surface 4914 of
the outer layer 4911 are adjacent the intermediate layer 4980 and
portions of the electronic circuit system 4920. In this manner, the
outer layer 4911 of the label 4910 retains the intermediate, or
spacer, layer 4980 and the electronic circuit system 4920 in a
predetermined position against the outer surface 4111 of the
housing 4110.
[0095] The outer layer 4911 of the label 4910 includes multiple
openings 4917 adjacent the audio output device 4956. In this
manner, sound waves produced by the audio output device 4956 can be
transmitted to an area outside of the housing 4110. Similarly, the
outer layer 4911 of the label 4910 includes openings 4918 adjacent
the light emitting diodes (LEDs) 4958A and 4958B to allow the user
to see the visual output. In some embodiments, the outer layer 4911
of the label 4910 can include a transparent portion adjacent the
LEDs 4958A and 4958B to allow the user to see the visual
output.
[0096] The electronic circuit system 4920 includes a printed
circuit board 4922 upon which a microprocessor 4950, two LEDs 4958A
and 4958B, two switches 4972A and 4972B and various electronic
components 4951, such as, for example, resistors, capacitors and
diodes, are mounted. The electronic circuit system 4920 also
includes an audio output device 4956, such as, for example, a
micro-speaker, coupled to the outer surface 4111 of the housing
4110 adjacent the printed circuit board 4922. The printed circuit
board 4922 includes a substrate 4924 upon which a series of
electrical conductors 4934, such as for example, copper traces, are
etched. The substrate 4924 can be constructed from any material
having suitable electrical properties, mechanical properties and
flexibility, such as, for example Mylar.RTM., Kapton.RTM. or
impregnated paper.
[0097] A mask layer (not shown) is disposed over the substrate 4924
to electrically isolate selected portions of the electrical
conductors 4934 from adjacent components. The electrical conductors
4934 operatively couple the above-mentioned circuit components in a
predetermined arrangement. In this manner, the electronic circuit
system 4920 can be configured to output, via the LEDs 4958A and
4958B and/or the audio output device 4956, a predetermined sequence
of electronic outputs during the use of the auto-injector 4002.
[0098] Power is supplied to the electronic circuit system 4920 by
two batteries 4962 connected in series. The batteries can be, for
example, three volt, "watch-style" lithium batteries. As shown in
FIG. 9, each of the batteries 4962 has a first surface 4964 and a
second surface 4966 opposite the first surface. The first surface
4964 can be, for example, an electrically negative terminal.
Similarly, the second surface 4966 can be an electrically positive
terminal. As discussed in more detail herein, the batteries 4962
are positioned such that a first electrical contact portion 4936 of
the printed circuit board 4922 can be placed in contact with the
first surface 4964 of the battery 4962 and a second electrical
contact portion 4938 of the printed circuit board 4922 can be
placed in contact with the second surface 4966 of the battery 4962.
In this manner, the batteries 4962 can be operatively coupled to
the electronic circuit system 4920.
[0099] As shown in FIGS. 7 and 9, a battery isolation tab 4860 is
movably disposed between the first electrical contact portion 4936
of the printed circuit board 4922 and the first surface 4964 of one
of the batteries 4962. The battery isolation tab 4860 can be
constructed from any electrically isolative material, such as, for
example, Mylar.RTM.. As discussed in more detail herein, in this
manner, the batteries 4962 can be selectively placed in electronic
communication with the electronic circuit system 4920.
[0100] The intermediate, or spacer, layer 4980 is disposed between
the outer layer 4911 and the electronic circuit system 4920. The
intermediate layer 4980 includes openings (not shown) within which
various components of the electronic circuit system, such as, for
example, the batteries 4962 are disposed. The intermediate layer
4980 is sized to maintain a predetermined spacing between the
various components included in the label 4910. The intermediate
layer can be constructed from any suitable material, such as, for
example, flexible foam having an adhesive surface, polycarbonate or
the like.
[0101] FIG. 10 is a front view of the electronic circuit system
4920 showing the arrangement of the various components (i.e., the
microprocessor 4950, LEDs 4958A and 4958B, switches 4972A and
4972B, audio output device 4956 or the like). FIG. 11 is a
schematic illustration of the electronic circuit system 4920.
[0102] The operation of the auto-injector 4002 and the electronic
circuit system 4920 is now discussed with reference to FIGS. 12-14.
The actuation of the electronic circuit system 4920 includes
several operations that are incorporated into the standard
procedures for using the auto-injector 4002. In this manner, the
user can actuate the electronic circuit system 4920 without
completing any additional operations.
[0103] Prior to use, the auto-injector 4002 is first enabled by
removing the needle guard 4810 and the safety lock 4710 (see FIGS.
12 and 13). As illustrated by arrow AA in FIG. 12, the needle guard
4810 is removed by moving it distally. The needle guard 4810
includes a sheath retainer 4840 and a sheath 4820. The sheath 4820
is configured to receive a portion of the needle (not shown) when
the needle guard 4810 is in a first (or installed) position. The
sheath retainer 4840 is coupled to the sheath 4820 such that when
the sheath retainer 4840 is moved distally away from the base 4520
into a second (or removed) position, the sheath 4820 is removed
from the needle.
[0104] The sheath retainer 4840 includes an actuator 4864 that is
received by an opening 4862 in the isolation tab 4860. Accordingly,
when the sheath retainer 4840 is moved distally away from the base
4520, the isolation tab 4860 is removed from the area between the
first electrical contact portion 4936 of the printed circuit board
4922 and the first surface 4964 of one of the batteries 4962. In
this manner, the batteries 4962 can be operatively coupled to the
electronic circuit system 4920 when the needle guard 4810 is
removed, thereby actuating the electronic circuit system 4920.
[0105] When actuated, the electronic circuit system 4920 can output
one or more predetermined electronic outputs. For example, in some
embodiments, the processor 4950 can output an electronic signal
associated with recorded speech to the audible output device 4956.
Such an electronic signal can be, for example, associated with a
.WAV file that contains a recorded instruction instructing the user
in the operation of the auto-injector 4002. Such an instruction can
state, for example, "remove the blue safety tab near the base of
the auto-injector." The processor can simultaneously output an
electronic signal to the first LED 4958A, thereby causing the first
LED 4958A, which is located near the safety lock 4710, to flash a
particular color. In this manner, the electronic circuit system
4920 can provide both audible and visual instructions to assist the
user in the initial operation of the auto-injector 4002.
[0106] In other embodiments, the electronic circuit system 4920 can
output an electronic output associated with a description and/or
status of the auto-injector 4002 and/or the medicament contained
therein. For example, in some embodiments, electronic circuit
system 4920 can output an audible message indicating the type of
medicament contained in the auto-injector, the expiration date of
the medicament, the dosage of the medicament or the like.
[0107] As illustrated by arrow BB in FIG. 13, the safety lock 4710
is removed by moving it substantially normal to the longitudinal
axis of the housing 4110. The safety lock 4710 has a first end 4712
and a second end 4714. When the safety lock 4710 is in its first
(or locked) position, the second end 4714 extends around a portion
of the base 4520 to space the base 4520 apart from the distal end
portion 4114 of the housing 4110. Additionally, the first end 4714
includes a locking protrusion (not shown) that obstructs portions
of the system actuator (not shown) further preventing the base 4520
from being moved proximally towards the housing 4110. Accordingly,
when the safety lock 4710 is in its first position, the
auto-injector 4002 cannot be actuated.
[0108] In some embodiments, the safety lock 4710 includes an
actuator 4732 that actuates the electronic circuit 4920 to trigger
a predetermined output or sequence of outputs when the safety lock
4710 is moved from the first position to a second (or unlocked)
position, as shown in FIG. 13. More particularly, as shown in FIGS.
10, 15 and 16, the actuator 4732 includes a protrusion 4730 that is
received within a first opening 4928A defined by an actuation
portion 4926 of the substrate 4924 when the safety lock 4710 is in
the first position. The boundary 4929 of the first opening 4928A
has a discontinuous shape, such as, for example, a teardrop shape,
that includes a stress concentration riser 4930. The discontinuity
and/or the stress concentration riser 4930 of the boundary 4929 can
be of any suitable shape to cause the substrate 4924 to deform in a
predetermined direction when the protrusion 4730 is moved relative
to the first opening 4928A.
[0109] As shown in FIGS. 15 and 16, the first opening 4928A is
defined adjacent an electrical conductor 4934 that, as discussed
above, electronically couples the components included in the
electronic circuit system 4920. The electrical conductor 4934
includes a first switch 4972A, which can be, for example a
frangible portion of the electrical conductor 4934. In use, when
the safety lock 4710 is moved from the first position to the second
position, the actuator 4732 moves in a direction substantially
parallel to a plane defined by a surface of the actuation portion
4926 of the substrate 4924. The movement of the actuator 4732
causes the protrusion 4730 to move within the first opening 4928A,
as indicated by the arrow DD in FIG. 16. The movement of the
protrusion 4730 tears the actuation portion 4926 of the substrate
4924, thereby separating the portion of the electrical conductor
4934 including the first switch 4972A. Said another way, when the
safety lock 4710 is moved to the second position, the actuator 4732
moves irreversibly the first switch 4972A from a first state (e.g.,
a state of electrical continuity) to a second state (e.g., a state
of electrical discontinuity).
[0110] When the actuator 4732 actuates the electronic circuit
system 4920 as described above, the electronic circuit system 4920
can output one or more predetermined electronic outputs. For
example, in some embodiments, the processor 4950 can output an
electronic signal associated with recorded speech to the audible
output device 4956. Such an electronic signal can be, for example,
associated with a recorded message notifying the user of the status
of the auto-injector 4002. Such a status message can state, for
example, "The auto-injector is now enabled." The processor can also
simultaneously output an electronic signal to the first LED 4958A,
thereby causing the first LED 4958A to stop flashing, change color
or the like.
[0111] In some embodiments, the electronic circuit system 4920 can
be configured to output the status message for a predetermined time
period, such as, for example, five seconds. After the predetermined
time period has elapsed, the electronic circuit system 4920 can
output an audible message further instructing the user in the
operation of the auto-injector 4002. Such an instruction can state,
for example, "Place the base of the auto-injector against the
patient's thigh. To complete the injection, press the base firmly
against the patient's thigh." In some embodiments, the processor
can simultaneously output an electronic signal to the second LED
4958B, thereby causing the second LED 4958B, which is located near
the base 4520, to flash a particular color. In this manner, the
electronic circuit system 4920 can provide both audible and visual
instructions to assist the user in the placement and actuation of
the auto-injector 4002. In some embodiments, the electronic circuit
system 4920 can be configured to repeat the instructions after a
predetermined time period has elapsed.
[0112] After the auto-injector 4002 is enabled and placed against
the body of the patient, the auto-injector 4002 is actuated by
moving the base 4520 proximally towards the housing 4110, as
illustrated by arrow CC in FIG. 14. The base 4520 includes an
actuator 4538 that actuates the electronic circuit 4920 to trigger
a predetermined output or sequence of outputs when the base 4520 is
moved from a first position to a second position, as shown in FIG.
13. The actuator 4538 includes a protrusion 4539 that is received
within a second opening 4928B (see FIG. 10) defined by the
substrate 4924 when the base 4520 is in the first position. The
configuration and operation of the protrusion 4539, the second
opening 4928B and the second switch 4972B are similar to the
configuration and operation of the protrusion 4730, the first
opening 4928A and the first switch 4972A, and are therefore not
described in detail.
[0113] When the actuator 4538 actuates the electronic circuit
system 4920, the electronic circuit system 4920 can output one or
more predetermined electronic outputs. For example, in some
embodiments, the processor 4950 can output an electronic signal
associated with recorded speech to the audible output device 4956.
Such an electronic signal can be, for example, associated with a
recorded message notifying the user that the injection is complete,
instructing the user on post-injection disposal and safety
procedures, instructing the user on post-injection medical
treatment or the like. Such a status message can state, for
example, "The injection is now complete. Please seek further
medical attention from a doctor." The processor can also
simultaneously output an electronic signal to the first LED 4958A,
thereby causing the first LED 4958A to stop flashing, change color
or the like, to provide a visual indication that the injection is
complete.
[0114] As described above, the batteries 4962 are positioned such
that the first electrical contact portions 4936 of the printed
circuit board 4922 can be placed in contact with the first surface
4964 of each battery 4962 and the second electrical contact portion
4938 of the printed circuit board 4922 can be placed in contact
with the second surface 4966 of each battery 4962. As shown in
FIGS. 10 and 17, the first electrical contact portions 4936 each
include a pair of electrical contacts 4937 that are operatively
coupled to the electronic circuit system 4920. Similarly, the
second electrical contact portion 4938 includes a pair of
electrical contacts 4939 that is operatively coupled to the
electronic circuit system 4920.
[0115] The first electrical contact portions 4936 and the second
electrical contact portion 4938 are monolithically constructed from
the printed circuit board 4922. FIGS. 17-20 are perspective views
showing the printed circuit board 4922 in various stages of
manufacture. FIG. 21 is a flow chart illustrating a method 5000 for
manufacturing a flexible printed circuit board according to an
embodiment of the invention. The illustrated method includes
disposing a copper layer on the top surface 4925 of the flexible
substrate 4924 and etching the desired series of electrical
conductors (not shown in FIGS. 17-20) at 5002. A mask layer (not
shown) is disposed on portions of the top layer 4925 of the
substrate 4924 to electrically isolate selected portions of the
electrical conductors from adjacent components at 5004. During this
operation, the electrical contacts 4937, 4939 are constructed.
[0116] The printed circuit board 4922 is then populated with the
microprocessor, switches, output devices and/or other electronic
components to form the electronic circuit system 4920 at 5006. For
clarity, the circuit components are not shown in FIGS. 17-20. After
the printed circuit board 4922 is populated, the portion of the
flexible substrate 4924 forming the second electrical contact
portion 4938 is separated from the remainder of the substrate 4924
at 5008. As shown in FIG. 17, during this operation, a portion 4923
of the boundary between the second electrical contact portion 4938
and the remainder of the substrate 4924 is left intact.
[0117] As shown by the arrow EE in FIG. 18, the second electrical
contact portion 4938 is then moved upwardly away from the remainder
of the substrate 4924 at 5010. In this manner, the second
electrical contact portion 4938 is spaced apart from the first
electrical contact portions 4936. As shown by the arrow FF in FIG.
19, the portion of the second electrical contact portion 4938
containing the electrical contacts 4939 is then folded so that the
electrical contacts 4939 on the second electrical contact portion
4938 are facing the electrical contacts 4937 on the first
electrical contact portions 4936, at 5012. In this manner, opposing
electrical contacts 4937, 4939 are constructed on the printed
circuit board 4922 without disposing electrical conductors on
and/or etching multiple surfaces of the printed circuit board
4922.
[0118] The batteries 4962 are then disposed between the first
electrical contact portions 4936 and the second electrical contact
portion 4938 at 5014. Although not shown in FIG. 19, in some
embodiments, a battery isolation tab of the type discussed above
can be disposed between one of the batteries and the printed
circuit board 4922. Once the batteries 4962 are in place, the top
layer 4911 of the label 4910 is disposed about the printed circuit
board 4922 (see FIG. 20) to maintain the position of the batteries
4962 within the printed circuit board 4922, at 5016. The label
assembly 4910 is then coupled to the outer surface of the housing
(not shown) at 5018. The label 4910 is coupled to the housing with
sufficient tension and/or stretch to maintain the electrical
contacts 4937 in electrical communication with the first surface
4964 of each battery 4962 and to maintain the electrical contacts
4939 in electrical communication with the second surface 496 of
each battery 4962. In this manner, the batteries 4962 can be held
in place in a printed circuit board 4922 devoid of springs, clips
or other rigid members.
[0119] As described above, the audio output device 4956, can
include, for example, a micro-speaker. In some embodiments, for
example, the audio output device 4956 can include an RS-1511A
micro-speaker manufactured by Regal Electronics, Inc.
[0120] Similarly, the microprocessor 4950 can be a
commercially-available processing device dedicated to performing
one or more specific tasks. For example, in some embodiments, the
microprocessor 4950 can be a commercially-available microprocessor,
such as the Sonix SNC 12060 voice synthesizer. Alternatively, the
microprocessor 4950 can be an application-specific integrated
circuit (ASIC) or a combination of ASICs, which are designed to
perform one or more specific functions. In yet other embodiments,
the microprocessor 4950 can be an analog or digital circuit, or a
combination of multiple circuits.
[0121] The microprocessor 4950 can include a memory device (not
shown) configured to receive and store information, such as a
series of instructions, processor-readable code, a digitized
signal, or the like. The memory device can include one or more
types of memory. For example, the memory device can include a read
only memory (ROM) component and a random access memory (RAM)
component. The memory device can also include other types of memory
suitable for storing data in a form retrievable by the
microprocessor 4950, for example, electronically-programmable read
only memory (EPROM), erasable electronically-programmable read only
memory (EEPROM), or flash memory.
[0122] FIG. 22 is a flow chart illustrating a method 5040 for
manufacturing a medical device according to an embodiment of the
invention. The medical device can be any medicament delivery device
of the type discussed above, such as, for example, an
auto-injector, a pen injector, an inhaler, or a transdermal
delivery device. The medical device can also be a medicament
container, such as, for example, a pill bottle, a blister pack an
intravenous solution bag or the like. The illustrated method
includes assembling the medical device, 5042. After the medical
device is assembled, an electronic circuit system is placed on an
outer surface of the medicament delivery device, 5044. The
electronic circuit system can by any electronic circuit system of
the type shown and described above. In some embodiments, the
electronic circuit system is placed on the outer surface of the
medical device in a predetermined orientation. For example, in some
embodiments, the electronic circuit system can include openings,
such as openings 4928 that are aligned with mating portions of the
medical device, such as, for example, protrusions 4730, 4538. In
other embodiments, however, the electronic circuit system can be
placed on the outer surface of the medical device in any
orientation.
[0123] After the electronic circuit system is placed on an outer
surface of the medical device, a label is coupled to the medical
device, 5046. The label, which can be, for example, a label
containing a textual indicia, is coupled to the medical device such
that a portion of the label is disposed about the electronic
circuit system. In this manner, the coupling of the label to the
medical device also serves to maintain the electronic circuit
system in its position against the outer surface of the medicament
delivery device.
[0124] FIG. 23 is a flow chart illustrating a method 5060 for
manufacturing a medical device according to an embodiment of the
invention. The medical device can be any medicament delivery device
of the type discussed above, such as, for example, an
auto-injector, a pen injector, an inhaler, or a transdermal
delivery device. The medical device can also be a medicament
container, such as, for example, a pill bottle, a blister pack, an
intravenous (IV) bag or the like. The illustrated method includes
assembling the medical device, 5062. The medical device is then
sterilized using any suitable sterilization process, 5064. In some
embodiments, for example, such as those embodiments in which the
medicament is epinephrine, the medical device can be sterilized by
exposure to ethylene oxide (EtO) gas. In other embodiments, the
medical device can be sterilized by exposure to gamma radiation. In
yet other embodiments, the medical device can be sterilized by
exposure to heat, such as for example, by placing the medicament
delivery device into an autoclave.
[0125] In parallel with the manufacture of the medical device, the
illustrated method includes constructing an electronic circuit
system of the type shown and described above, 5066. The electronic
circuit system is then coupled to a label, 5068, to form a label
assembly. Because the circuit construction is done apart from the
manufacture of the medicament delivery device, it is not subjected
the sterilization process, which, in some instances, may damage the
circuit components.
[0126] The illustrated method then includes placing the label
assembly on the outer surface of the medical device, 5070. The
label assembly is then coupled to the outer surface of the medical
device, 5072. In some embodiments, the label assembly can be
coupled to the medicament delivery device by an adhesive, an
elastic fastener, a shrink wrap or any other suitable method.
[0127] While various embodiments of the invention have been
described above, it should be understood that they have been
presented by way of example only, and not limitation. Where methods
described above indicate certain events occurring in certain order,
the ordering of certain events may be modified. Additionally,
certain of the events may be performed concurrently in a parallel
process when possible, as well as performed sequentially as
described above.
[0128] For example, although the first surface 4912 of the top
layer 4911 of the label 4910 is shown and described as being
opposite the second surface 4914 of the top layer 4911 of the label
4910, in other embodiments, the first surface 4912 and the second
surface 4914 can be adjacent each other and/or co-planar.
Similarly, although the top layer 4911 of the label 4910 is shown
and described as covering substantially all of the housing 4110, in
some embodiments, the top layer 4911 of the label 4910 can cover
only a portion of the housing.
[0129] Although the label 4910 is shown and described as including
a top layer 4911, an intermediate layer 4980 and a printed circuit
board 4922, in some embodiments, the layers comprising the label
4910 can be arranged in any suitable order. For example, in some
embodiments, a multi-layered label can include a printed circuit
board as an intermediate layer. In other embodiments, a
multi-layered label can include a printed circuit board as the
outer layer. Moreover, in yet other embodiments, the label need not
include multiple layers. For example, in some embodiments, a label
can include a single layer that includes an electronic circuit
system and textual indicia.
[0130] Although the indicia 4916 are shown and described as being
visible (e.g., textual indicia and/or symbolic indicia), in some
embodiments, a label can include indicia that are haptic. For
example, in some embodiments a label can include Braille. In other
embodiments, a label can include indicia having a distinct feel,
such as for example, a particularly rough or smooth surface.
[0131] Although the electronic circuit system 4920 is shown and
described as including a printed circuit board 4922 having a
flexible substrate 4924, in other embodiments, an electronic
circuit system can include a rigid printed circuit board. In yet
other embodiments, an electronic circuit system can include a
printed circuit board having a substrate having at least a rigid
portion.
[0132] Moreover, in some embodiments, an electronic circuit system
need not include a printed circuit board. For example, in some
embodiments, an electronic circuit system can include electronic
components operatively coupled by any suitable method other than by
a printed circuit board.
[0133] Similarly, although the components included in the
electronic circuit system 4920 (e.g., the microprocessor 4950, the
LEDs 4958A and 4958B or the like) are shown and described as being
operatively coupled by electrical conductors 4934, in other
embodiments, the components can be operatively coupled without
being physically connected. For example, in some embodiments, at
least a portion of the components included in an electronic circuit
system can be inductively coupled. In other embodiments, at least a
portion of the components included in an electronic circuit system
can be evanescently coupled.
[0134] Although the switches 4972A and 4972B are shown and
described as being "tear-through" switches that are monolithically
formed from the electrical conductors 4934, in other embodiments, a
switch can be formed separately from the electrical conductors
4934. For example, in some embodiments, an electrical circuit
system can include a series of first electrical conductors having a
first set of characteristics (e.g., the width, height, material
from which the conductor is fabricated or the like) and a switch
constructed from a second electrical conductor having a second set
of characteristics different than the first set of characteristics.
In other embodiments, a switch can be a separate component, such
as, for example, a microswitch, that is mounted to the printed
circuit board. In yet other embodiments, an electrical circuit
system can include a "pop-out" switch that includes a biasing
member to bias the switch in a predetermined state. In yet other
embodiments, an electrical circuit system can include a switch that
is disposed at a location other than on a printed circuit
board.
[0135] Similarly, although the switches 4972A and 4972B are shown
and described as being irreversibly movable from a first state to a
second state, in other embodiments, a switch can be reversibly
movable between a first state and a second state. Moreover, in yet
other embodiments, a switch can have more than two distinct
states.
[0136] Although the actuators 4732, 4539 are shown and described as
being configured to move in a direction substantially parallel to
the surface of the substrate 4924, in other embodiments, an
actuator can be configured to actuate an electronic circuit system
by moving in any direction. For example, in some embodiments a
circuit actuator can be moved in a direction substantially normal
to a portion of an electronic circuit system.
[0137] Similarly, although the actuators 4732, 4539 are shown and
described as actuating the switches 4972A and 4972B by tearing
and/or deforming a portion of the substrate 4924, in other
embodiments, a switch can be moved from a first state to a second
state without deforming the substrate. For example, in some
embodiments, an electronic circuit system can include a printed
circuit board having a substrate and a frangible switch tab
disposed on the substrate. An electrical conductor and/or a switch
can be disposed on the frangible switch tab, such that when the
switch tab is removed from the substrate the switch is moved from a
first state to a second state. In this manner, the switch can be
actuated without tearing and/or deforming a portion of the
substrate.
[0138] Although the actuators 4732, 4539 are shown and described as
being included on the safety lock 4710 and the base 4520,
respectively, in other embodiments, the actuators can be included
on any component of a medicament delivery device. For example, in
some embodiments, an auto-injector can include a start button
having an actuator configured to actuate an electronic circuit
system. In other embodiments, an auto-injector can include a
movable member configured to move a medicament container and/or a
needle within a housing of the auto-injector, the movable member
including an actuator configured to actuate an electronic circuit
system.
[0139] Although the safety lock 4710 is shown and described as
being removed from the housing 4110 of the auto-injector 4002 when
in its second position, in other embodiments, a safety lock can
remain coupled to the housing of an auto-injector when in its
second position. For example, in some embodiments, a safety lock
can be moved from its first position to its second position by
rotating a portion of the safety lock.
[0140] Certain components of the auto-injector 4002 are shown and
described as being coupled together via protrusions and mating
openings. The protrusions and/or openings can be disposed on any of
the components to be coupled together and need not be limited to
only a certain component. For example, the safety lock 4710 is
shown and described as including an actuator 4732 having a
protrusion 4730 configured to be received within an opening 4928A
defined by the substrate 4924. In some embodiments, however, the
protrusions can be disposed on the substrate 4924 and the mating
openings can be defined by the actuator 4732. In other embodiments,
such components can be coupled together in any suitable way, which
need not include protrusions and mating openings. For example, in
some embodiments, an actuator can be operatively coupled to an
actuation portion of a substrate via mating shoulders, clips,
adhesive or the like.
[0141] Similarly, although certain components of the auto-injector
4002 are shown and described as being constructed from multiple
separate components, in some embodiments, such components can be
monolithically constructed. For example, the needle guard 4810 and
the battery isolation tab 4860 are shown and described as being
constructed separately and then coupled together. In other
embodiments, a needle guard and a battery isolation tab can be
constructed monolithically.
[0142] Although the electronic circuit systems are shown and
described above as being configured to output primarily audible and
visual outputs, in other embodiments, an electronic circuit system
can be configured to produce any suitable output. For example, in
some embodiments, an electronic circuit system can produce a haptic
output, such as a vibratory output produced by a piezo-electric
actuator. In other embodiments, an electronic circuit system can
produce a thermal output, produced by a heating or cooling
element.
[0143] Similarly, the visual output devices shown and described
above can include any suitable type of visual output device, such
as, for example, a liquid crystal display, an organic polymer
display, a fiber optic display. In this manner, the visual output
produced by an electronic circuit system can include text messages,
numerical indications of the dosage or the like.
[0144] Although the electronic circuit systems are shown and
described above as outputting recorded speech in English, in other
embodiments, the electronic circuit system can output recorded
speech in any language. In yet other embodiments, the electronic
circuit system can output recorded speech in multiple
languages.
[0145] Although the electronic circuit systems are shown and
described above as including a proximity sensor, in other
embodiments, an electronic circuit system can include any suitable
sensor for providing feedback to the electronic circuit system. For
example, in some embodiments, the electronic circuit system can
include a pressure sensor configured to sense the internal gas
pressure within a gas-powered auto-injector. In this manner, the
electronic circuit system can output an instruction and/or a status
message when the internal gas pressure crosses a predetermined
threshold. For example, in some embodiments, when the internal gas
pressure rapidly increases, the electronic circuit system can
output a message, such as, for example, "Internal gas chamber has
been successfully punctured --injection is in process."
[0146] Similarly, in some embodiments, the electronic circuit
system can include a temperature sensor configured to sense the
temperature of the medicament contained within the medicament
delivery device. In this manner, the electronic circuit system can
output an instruction and/or a status message when the medicament
is too cold for effective delivery. For example, in some
embodiments, when the medicament is too cold for effective delivery
(this may occur, for example, if the medicament delivery device has
been left outside overnight), the electronic circuit system can
output a message, such as, for example, "Medicament is too
cold--please briskly rub the auto-injector between your hands."
[0147] Although the batteries 4962 are shown and described as
having a first surface 4964 (an electrically negative terminal) and
a second surface 4966 (an electrically positive terminal) opposite
the first surface, in other embodiments the batteries can include a
first surface and a second surface that are adjacent each other
and/or co-planar. In other embodiments, an electronic circuit
system can be powered by a battery having any shape and/or any
number of surfaces. In yet other embodiments, an electronic circuit
system can be powered by any suitable energy storage device, such
as, for example, a capacitor, solar cell, spring actuated
generator, or the like.
[0148] Although the medicament delivery devices have been shown and
described above as being primarily single-use medical injectors, in
some embodiments a medicament delivery device can include any
suitable device for delivering one or more doses of a medicament
into a patient's body. For example, in some embodiments, a
medicament delivery device can be a pen injector containing
multiple doses of a chronic-care medicament, such as, for example,
insulin. In such embodiments, an electronic circuit system can
output instructions associated with not only an initial use of the
medicament delivery device, but also associated with repeated uses,
dosage monitoring or the like. In other embodiments, a medicament
delivery device can include a transdermal medicament delivery
device, an inhaler or a nasal medicament delivery device.
[0149] FIGS. 24 and 25 show an inhaler 6002 according to an
embodiment of the invention. The inhaler 6002 includes a housing
6110 and a medicament container 6262 movably disposed within the
housing 6110. The medicament container 6262 includes a metering
mechanism (not shown in FIGS. 24 and 25) configured to discharge a
predetermined volume of medicament when the inhaler 6002 is
actuated.
[0150] The housing 6110 has a proximal end portion 6112 and a
distal end portion 6114. A label 6910, which includes at least a
portion of an electronic circuit system 6920, is disposed on an
outer surface 6111 of the housing 6110. As described above, a
portion of the label 6910 can include a textual indicia 6916.
Similar to the electronic circuit systems shown and described
above, the electronic circuit system 6920 is configured to output
at least one electronic signal associated with the user of the
inhaler 6002. The electronic circuit system 6920 includes a
microprocessor (not shown), a microspeaker 6956 and an LED 6958.
The electronic circuit system 6920 also includes a motion sensor
6976, the function of which is discussed in more detail below.
[0151] The distal end portion 6114 of the housing 6110 includes a
mouthpiece 6212 about which a protective cap 6710 is disposed.
Prior to use, the inhaler 6002 is first enabled by removing the
protective cap 6710, as shown by the arrow GG in FIG. 25. The
protective cap 6710 includes an actuator 6732 that actuates the
electronic circuit system 6920 to trigger a predetermined output or
sequence of outputs when the protective cap 6710 is removed. In
some embodiments, the actuator 6732 can include a protrusion that
is received by an actuation portion of the electronic circuit
system 6920, in a similar manner as described above. In other
embodiments, the actuator 6732 can be configured to engage a
microswitch that can be repeatedly moved between a first state and
a second state.
[0152] When actuated, the electronic circuit system 6920 can output
one or more predetermined electronic outputs. For example, in some
embodiments, the electronic circuit system 6920 can output an
audible message via the microspeaker 6956 instructing the user to
"vigorously shake the inhaler for five seconds." The processor can
simultaneously enable the motion sensor 6976.
[0153] Upon receiving a predetermined input from the motion sensor
6976, which can be any sensor suitable for detecting the rapid
motion of the inhaler 6002, the processor can then send an
electronic signal to produce a second audible message. Such a
message can state, for example, "the inhaler is now sufficiently
shaken and is ready for use." In some embodiments, the electronic
circuit system 6920 can also output an instruction associated with
the correct placement of the inhaler 6002. For example, the
electronic circuit system 6920 can output an audible message
stating "please place the mouthpiece in your mouth and firmly press
down on the medicament container." The electronic circuit system
6920 can also simultaneously output a signal to the LED 6958 to
provide a visual indication of where the mouthpiece 6212 is
located.
[0154] After the inhaler 6002 is enabled and placed within the
mouth of the patient, the inhaler 6002 is actuated by moving the
medicament container 6262 distally within housing 6110, as
illustrated by arrow HH in FIG. 25. In some embodiments, the
medicament container 6262 can include an actuator (not shown) that
actuates the electronic circuit 6920, in a manner similar to those
described above, to trigger a predetermined output or sequence of
outputs. For example, in some embodiments, the processor can output
an electronic signal associated with recorded speech to the
microspeaker 6956. Such an electronic signal can be, for example,
associated with a recorded message notifying the user that the
injection is complete, instructing the user on post-injection
procedures, instructing the user on post-injection medical
treatment or the like. Such a status message can state, for
example, "The injection is now complete."
[0155] In other embodiments, a medicament delivery device can
include a transdermal medicament delivery device, such as for
example, a medicament patch. In such embodiments, an electronic
circuit system can be configured, for example, to output
instructions associated with the enablement, placement and/or
removal of the transdermal medicament delivery device. For example,
in some embodiments, the electronic circuit system can be actuated
by removing a protective barrier that seals the portion of the
device that contacts the skin.
[0156] Although the medical devices are shown and described above
as being medicament delivery devices, such as, for example, medical
injectors, inhalers or the like, in other embodiments, a medical
device can include a medicament container, such as, for example, a
pill bottle, a blister pack or the like.
[0157] Although various embodiments have been described as having
particular features and/or combinations of components, other
embodiments are possible having a combination of any features
and/or components from any of embodiments where appropriate.
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