U.S. patent application number 13/684929 was filed with the patent office on 2013-12-12 for systems and methods for delivering a therapeutic agent.
This patent application is currently assigned to SPRINGLEAF THERAPEUTICS, INC.. The applicant listed for this patent is SpringLeaf Therapeutics, Inc.. Invention is credited to Glenn R. Booma, J. Richard Gyory, Alessandro Pizzochero.
Application Number | 20130331812 13/684929 |
Document ID | / |
Family ID | 44902416 |
Filed Date | 2013-12-12 |
United States Patent
Application |
20130331812 |
Kind Code |
A1 |
Booma; Glenn R. ; et
al. |
December 12, 2013 |
SYSTEMS AND METHODS FOR DELIVERING A THERAPEUTIC AGENT
Abstract
Devices, methods, and kits for delivering a therapeutic agent to
a patient are disclosed herein. In one embodiment, an apparatus
comprises a reservoir for containing a fluid, a first actuator, a
transfer structure, and a second actuator. The first actuator has a
first configuration and a second configuration and is configured to
exert a first force on the reservoir when moved from its first
configuration to its second configuration such that a first volume
of fluid within the reservoir is communicated out of the fluid
reservoir. The transfer structure is disposed between the first
actuator and the reservoir and has a surface configured to engage
the reservoir such that the first force exerted by the first
actuator is distributed across a surface of the reservoir engaged
by the transfer structure. The second actuator has a first
configuration and a second configuration and is configured to exert
a second force on the reservoir when the second actuator is moved
from its first configuration to its second configuration such that
a second volume of fluid within the reservoir is communication out
of the fluid reservoir.
Inventors: |
Booma; Glenn R.; (Natick,
MA) ; Pizzochero; Alessandro; (Chelmsford, MA)
; Gyory; J. Richard; (Sudbury, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SpringLeaf Therapeutics, Inc.; |
|
|
US |
|
|
Assignee: |
SPRINGLEAF THERAPEUTICS,
INC.
Boston
MA
|
Family ID: |
44902416 |
Appl. No.: |
13/684929 |
Filed: |
November 26, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13101749 |
May 5, 2011 |
8337457 |
|
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13684929 |
|
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|
61331763 |
May 5, 2010 |
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Current U.S.
Class: |
604/500 ;
604/131; 604/134 |
Current CPC
Class: |
A61M 5/145 20130101;
A61M 2005/14506 20130101; A61M 2005/14513 20130101; A61M 37/00
20130101; A61M 35/00 20130101; A61M 5/14248 20130101; A61M 31/00
20130101 |
Class at
Publication: |
604/500 ;
604/131; 604/134 |
International
Class: |
A61M 5/145 20060101
A61M005/145 |
Claims
1. An apparatus, comprising: a reservoir for containing a fluid; a
first actuator having a first configuration and a second
configuration, the first actuator configured to exert a first force
on the reservoir when the first actuator moves from its first
configuration to its second configuration such that a first volume
of fluid within the reservoir is communicated out of the fluid
reservoir; a transfer structure disposed between the first actuator
and the reservoir, the transfer structure having a surface
configured to engage the reservoir such that the first force
exerted by the first actuator is distributed across a surface of
the reservoir engaged by the transfer structure; and a second
actuator having a first configuration and a second configuration,
the second actuator configured to exert a second force on the
reservoir when the second actuator moves from its first
configuration to its second configuration such that a second volume
of fluid within the reservoir is communicated out of the fluid
reservoir.
2. The apparatus of claim 1, wherein the surface of the reservoir
is a first surface, the second actuator configured to exert the
second force on a second surface of the reservoir, the second
surface being different than the first surface.
3. The apparatus of claim 1, wherein the surface of the reservoir
is a first surface and the transfer structure is a first transfer
structure, further comprising: a second transfer structure disposed
between the second actuator and the reservoir, the second transfer
structure having a surface configured to engage the reservoir such
that the first force exerted upon actuation of the first actuator
is distributed across a second surface of the reservoir engaged by
the second transfer structure.
4. The apparatus of claim 1, wherein the first actuator includes a
spring configured to exert the first force.
5. The apparatus of claim 1, wherein the second actuator includes
an electrochemical actuator.
6. The apparatus of claim 1, wherein the transfer structure is
configured to activate a trigger associated with the second
actuator when the first actuator moves from its first configuration
to its second configuration.
7. The apparatus of claim 1, wherein the first actuator is
configured to exert the first force in a first direction with
respect to the reservoir upon movement of the first actuator
towards its second configuration, the second actuator is configured
to exert the second force in a second direction, different than the
first direction, with respect to the reservoir when the second
actuator moves towards its second configuration.
8. The apparatus of claim 1, wherein the first actuator is at least
partially disposed within a housing, further comprising: a
cartridge assembly including at least one of the second actuator
and the reservoir, the cartridge assembly configured to be received
in an interior region defined by the housing, the cartridge
assembly configured to displace the transfer structure when the
cartridge assembly is loaded into the interior region of the
housing such that at least one of the first actuator and the second
actuator is moved to its first configuration.
9. An apparatus, comprising: a reservoir configured to contain a
fluid; a fluid communicator configured to be in fluid communication
with the reservoir; a first actuator including a mechanical
actuator, the first actuator coupled to the reservoir and
configured to exert a first force on the reservoir to urge fluid
within the reservoir out of the reservoir through the fluid
communicator; and a second actuator including an electrochemical
actuator, the second actuator coupled to the reservoir and
configured to exert a second force on the reservoir to urge fluid
within the reservoir out of the reservoir through the fluid
communicator.
10. The apparatus of claim 9, wherein the electrochemical actuator
includes an electrode configured to deflect when the
electrochemical actuator is discharged, the deflection of the
electrode being operative to exert the second force on the
reservoir.
11. The apparatus of claim 9, wherein the electrochemical actuator
is a first electrochemical actuator, the first electrochemical
actuator defining a first stroke when the electrochemical actuator
is discharged, the second actuator including a second
electrochemical actuator, the second electrochemical actuator
defining a second stroke when the second electrochemical actuator
is discharged, a stroke of the second actuator being collectively
defined by the first stroke and the second stroke.
12. The apparatus of claim 9, wherein the second actuator includes
a first electrochemical actuator and a second electrochemical
actuator.
13. The apparatus of claim 9, wherein the first actuator is
configured to exert the first force for a first time period, the
second actuator is configured to exert the second force for a
second time period after the first time period.
14. The apparatus of claim 13, wherein the first time period at
least partially overlaps with the second time period.
15. The apparatus of claim 9, further comprising: a transfer
structure disposed between the reservoir and the first actuator,
the transfer structure configured to transmit the first force to
the reservoir upon actuation of the first actuator.
16. The apparatus of claim 9, wherein the first volume of fluid and
the second volume of fluid are collectively substantially equal to
a total volume of fluid contained in the reservoir.
17. The apparatus of claim 9, further comprising: a first transfer
structure disposed between first actuator and the reservoir, the
first transfer structure configured to transmit the first force to
the reservoir upon actuation of the first actuator; and a second
transfer structure disposed between the second actuator and the
reservoir, the second transfer structure configured to transmit the
second force to the reservoir.
18. A method for delivering a fluid, comprising: actuating a first
actuator including a mechanical actuator to exert a first force on
a fluid reservoir such that a first volume of fluid within the
fluid reservoir is communicated out of the reservoir and through a
fluid communicator; and actuating a second actuator including an
electrochemical actuator to exert a second force on the fluid
reservoir such that a second volume of fluid within the fluid
reservoir is communicated out of the reservoir and through the
fluid communicator.
19. The method of claim 18, wherein actuation of the first actuator
exerts the first force on the fluid reservoir in a first direction,
actuation of the second actuator exerts the second force on the
fluid reservoir in a second direction different than the first
direction.
20. The method of claim 18, wherein the first actuator is
configured to exert the first force for a first time period, the
second actuator is configured to exert the second force for a
second time period after the first time period.
21. The method of claim 18, wherein the first force is exerted by
the first actuator onto a transfer structure configured to transmit
the first force to the reservoir.
22. A kit, comprising: a housing including an actuator; and a
reservoir configured to contain a fluid, the reservoir having a
first configuration in which the reservoir is separate from the
housing, the reservoir having a second configuration in which at
least a portion of the reservoir is received in the housing, the
actuator configured to exert a force on the reservoir when the
reservoir is in its second configuration such that at a volume of
the fluid is communicated out of the reservoir.
23. The kit of claim 22, further comprising: a cartridge assembly
configured to be slidably inserted into an opening in the housing,
the cartridge assembly including the reservoir.
24. The kit of claim 22, wherein the actuator is configured to be
placed in a pre-loaded position when the cartridge assembly is
inserted into the opening of the housing.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to and the benefit of U.S.
Provisional Application Ser. No. 61/331,763, filed May 5, 2010,
entitled "Systems and Methods for Delivering a Therapeutic Agent,"
the disclosure of which is hereby incorporated by reference herein
in its entirety.
BACKGROUND
[0002] The invention relates generally to medical devices and
procedures, including, for example, medical devices and methods for
delivering a therapeutic agent to a patient.
[0003] Drug delivery involves delivering a drug or other
therapeutic compound into the body. Typically, the drug is
delivered via a technology that is carefully selected based on a
number of factors. These factors can include, but are not limited
to, the characteristics of the drug, such as drug dose,
pharmacokinetics, complexity, cost, and absorption, the
characteristics of the desired drug delivery profile (such as
uniform, non-uniform, or patient-controlled), the characteristics
of the administration mode (such as the ease, cost, complexity, and
effectiveness of the administration mode for the patient,
physician, nurse, or other caregiver), or other factors or
combinations of these factors.
[0004] Conventional drug delivery technologies present various
challenges. Oral administration of a dosage form is a relatively
simple delivery mode, but some drugs may not achieve the desired
bioavailability and/or may cause undesirable side effects if
administered orally. Further, the delay from time of administration
to time of efficacy associated with oral delivery may be
undesirable depending on the therapeutic need. While parenteral
administration by injection may avoid some of the problems
associated with oral administration, such as providing relatively
quick delivery of the drug to the desired location, conventional
injections may be inconvenient, difficult to self-administer, and
painful or unpleasant for the patient. Furthermore, injection may
not be suitable for achieving certain delivery/release profiles,
particularly over a sustained period of time.
[0005] In addition, the immediate delivery of a full dose of a drug
may cause undesirable side effects related to the very high peak
plasma concentration resulting from the bolus injection. If this
peak concentration is blunted by delivering the dose over an
extended period of time, the side effects may be ameliorated and
make the treatment much more tolerable, and in some cases, it may
allow higher doses to be delivered, thus increasing the efficacy of
the drug. If a high bolus dose is required in order to attain
extended efficacy of the drug as it is eliminated from the body
(i.e., to maintain a minimum trough level of drug), then by
extending the delivery time, the trough level may be maintained
with a lower total dose of drug. Thus, the same efficacy may be
achieved at a lower total dose of the drug and result in a larger
margin of safety.
[0006] Passive transdermal technology, such as a conventional
transdermal patch, may be relatively convenient for the user and
may permit relatively uniform drug release over time. However, some
drugs, such as highly charged or polar drugs, peptides, proteins
and other large molecule active agents, may not penetrate the
stratum corneum for effective delivery. Furthermore, a relatively
long start-up time may be required before the drug takes effect.
Thereafter, the drug release may be relatively continuous, which
may be undesirable in some cases. Also, a substantial portion of
the drug payload may be undeliverable and may remain in the patch
once the patch is removed.
[0007] Active transdermal systems, including iontophoresis,
sonophoresis, and poration technology, may be expensive and may
yield unpredictable results. Only some drug formulations, such as
aqueous stable compounds, may be suited for active transdermal
delivery. Further, modulating or controlling the delivery of drugs
using such systems may not be possible without using complex
systems.
[0008] Some infusion pump systems may be large and may require
tubing between the pump and the infusion set, which can impact the
quality of life of the patient. Further, infusion pumps may be
expensive and may not be disposable. From the above, it would be
desirable to provide new and improved drug delivery systems and
methods that overcome some or all of these and other drawbacks.
SUMMARY OF THE INVENTION
[0009] Devices, methods, and kits for delivering a therapeutic
agent to a patient are disclosed herein. In one embodiment, an
apparatus comprises a reservoir for containing a fluid, a first
actuator, a transfer structure, and a second actuator. The first
actuator has a first configuration and a second configuration and
is configured to exert a first force on the reservoir when moved
from its first configuration to its second configuration such that
a first volume of fluid within the reservoir is communicated out of
the fluid reservoir. The transfer structure is disposed between the
first actuator and the reservoir and has a surface configured to
engage the reservoir such that the first force exerted by the first
actuator is distributed across a surface of the reservoir engaged
by the transfer structure. The second actuator has a first
configuration and a second configuration and is configured to exert
a second force on the reservoir when the second actuator is moved
from its first configuration to its second configuration such that
a second volume of fluid within the reservoir is communication out
of the fluid reservoir.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a schematic illustration of a delivery system
according to an embodiment.
[0011] FIG. 2(a) is side view of a schematic illustration of an
electrochemical actuator shown in a charged state; and FIG. 2(b) is
a schematic illustration of a side view of the electrochemical
actuator of FIG. 2(a) shown in a discharged state.
[0012] FIG. 3 is a schematic illustration of a portion of a
delivery system according to an embodiment illustrating an
electrochemical actuator in a charged state.
[0013] FIG. 4 is a schematic illustration of the portion of the
delivery system of FIG. 3 illustrating the electrochemical actuator
as it discharges.
[0014] FIG. 5 is a perspective view of a delivery device according
to an embodiment.
[0015] FIG. 6 is a front perspective view of a portion of the
delivery device of FIG. 5.
[0016] FIG. 7 is a front perspective view of a cover member of the
delivery device of FIG. 5.
[0017] FIG. 8A is a side view of the delivery device of FIG. 5.
[0018] FIG. 8B is a cross-sectional view of the delivery device of
FIG. 5, taken along line 5B-5B of FIG. 5.
[0019] FIG. 9 is a front perspective view of a portion of the
delivery device of FIG. 5 showing the spring actuator in a biased
natural state.
[0020] FIG. 10 is a front view of the portion of the delivery
device shown in FIG. 9.
[0021] FIG. 11 is a front perspective view of the portion of the
delivery device of FIG. 9 showing the spring actuator in a
pre-loaded state.
[0022] FIG. 12 is a front view of the portion of the delivery
device shown in FIG. 11.
[0023] FIG. 13 is a front perspective view of a portion of the
delivery device of FIG. 5 shown with the spring actuator in a
pre-loaded state.
[0024] FIG. 14 is a front perspective view of a cartridge assembly
of the delivery device of FIG. 5.
[0025] FIG. 15 is a front perspective view of a portion of the
cartridge assembly of FIG. 14.
[0026] FIG. 16 is a top view of the fluid reservoir of the delivery
device of FIG. 5.
[0027] FIG. 17 is a bottom perspective view of a portion of the
cartridge assembly of FIG. 14.
[0028] FIG. 18 is a front perspective view of a transfer structure
of the delivery device of FIG. 5.
[0029] FIG. 19 is a side view of a portion of the delivery device
of FIG. 5.
[0030] FIG. 20 is a top view of a portion of the delivery device of
FIG. 5.
[0031] FIG. 21 is a partial cut-away view of a portion of the
delivery device of FIG. 5.
[0032] FIG. 22A is a schematic illustration of the delivery device
of FIG. 5 showing the forces exerted by a first actuator; and FIG.
22B is a schematic illustration of the delivery device of FIG. 5
showing the forces exerted by a second actuator.
[0033] FIG. 23 is a schematic illustration of an embodiment of a
delivery device showing the forces exerted by a first actuator and
the forces exerted by a second actuator.
[0034] FIG. 24 is a schematic illustration of an embodiment of a
delivery device showing the forces exerted by a first actuator and
the forces exerted by a second actuator.
[0035] FIG. 25 is a schematic illustration of an embodiment of a
delivery device showing the forces exerted by a first actuator and
the forces exerted by a second actuator.
DETAILED DESCRIPTION
[0036] Devices, systems, methods and kits are described herein that
are configured for use in the delivery of therapeutic agents to a
patient's body. Such therapeutic agents can be, for example, one or
more drugs and can be in fluid form of various viscosities. In some
embodiments, the devices and methods can include a pump device that
includes an actuator, such as, for example, an electrochemical
actuator, which can have characteristics of both a battery and a
pump. Specifically, an electrochemical actuator can include an
electrochemical cell that produces a pumping force as the cell
discharges. Thus, the pump device can have relatively fewer parts
than a conventional drug pump, such that the pump device is
relatively more compact, disposable, and reliable than conventional
drug pumps. Such drug delivery devices are desirable, for example,
for use in delivery devices that are designed to be attached to a
patient's body (e.g., a wearable device). These attributes of the
pump device may reduce the cost and the discomfort associated with
infusion drug therapy.
[0037] In some embodiments, such a pump device can be operated
with, for example, a controller and/or other circuitry, operative
to regulate drug or fluid flow from the pump device. Such a
controller may permit implementing one or more release profiles
using the pump device, including release profiles that require
uniform flow, non-uniform flow, continuous flow, discontinuous
flow, programmed flow, scheduled flow, user-initiated flow, or
feedback responsive flow, among others. Thus, the pump device may
effectively deliver a wider variety of drug therapies than other
pump devices.
[0038] In some embodiments, a drug delivery system can include one
or more actuators. For example the delivery system can include one
or more electrochemical actuators or one or more electrochemical
actuators and one or more mechanical actuators employing a
mechanical energy storage mechanism, such as springs or elastomeric
members. In some embodiments, a first actuator can be actuated to
provide a first phase of pumping at a first rate, and then a second
actuator can be actuated to provide a second phase of pumping at a
second rate, which may be the same as, or different than, the first
rate. In alternative embodiments, the first and second actuators
can be actuated at the same time or at different times. The first
actuator can be, for example, a mechanical actuator (e.g.,
spring-based) and the second actuator can be, for example, an
electrochemical actuator, or vice versa. In some embodiments, a
mechanical actuator can provide a faster rate of delivery than the
delivery provided by an electrochemical actuator. Thus, a
combination of fast and slow delivery rates can be achieved. In
some embodiments, an electrochemical actuator may provide a faster
rate of delivery than a mechanical, spring-based actuator.
Mechanical actuators can also be configured to apply a greater
force on the fluid reservoir containing the drug to be delivered.
In some embodiments, one or more electrochemical actuators can be
used in sequence or simultaneously.
[0039] The multi-phase drug delivery systems described herein can
be used to deliver medications and provide treatments at different
rates within the same device such as a bolus followed by a uniform
slow delivery over a specified time period. The delivery systems
can be used to deliver larger doses than other known delivery
systems, providing enhanced treatment options.
[0040] FIG. 1 is a schematic block diagram illustrating an
embodiment of a fluid delivery system 100 (also referred to herein
as "delivery device" or "drug delivery device"). The fluid delivery
system 100 can include a first actuator 118, a second actuator 102,
a first transfer structure 116, a second transfer structure 130, a
fluid source 104 and a fluid communicator 106. The first actuator
118 can be for example, a mechanical actuator, such as one using a
spring as a source of stored mechanical energy, and the second
actuator 102 can be, for example, an electrochemical actuator, as
described in more detail below. The fluid source 104 can contain a
fluid (i.e., a therapeutic agent) to be delivered into a target 108
via the fluid communicator 106. The target 108 can be, for example,
a human or other mammalian body in need of a drug therapy or
prophylaxis.
[0041] The second actuator 102 (also referred to herein as
"electrochemical actuator 102") can actuate or otherwise create a
pumping force to deliver the fluid from the fluid source 104 into
the fluid communicator 106 as described in more detail below. In
some embodiments, the electrochemical actuator 102 can be a device
that experiences a change in volume or position in response to an
electrochemical reaction that occurs therein. For example, the
electrochemical actuator 102 can include a charged electrochemical
cell, and at least a portion of the electrochemical cell can
actuate as the electrochemical cell discharges. Thus, the
electrochemical actuator 102 can be considered a self-powered
actuator or a combination battery and actuator. In some
embodiments, more than one electrochemical actuator can be
included.
[0042] For illustration and discussion purposes, the first actuator
118 is also referred to herein as "spring-based actuator 118." As
discussed above, the spring-based actuator 118 can be used in
conjunction with the electrochemical actuator 102 to provide
variable or multi-phase delivery rates. Thus, distinct delivery
rates can be achieved that may not otherwise be available with a
single actuator without the use of complex valve/control systems to
meter flow-rate outputs. Various delivery rates and delivery
sequences can be customized to meet the particular drug delivery
need. For example, in some embodiments, a drug delivery system can
be configured to deliver a drug at a first delivery rate during
actuation of the first actuator 118 that is different than (e.g.
greater than) a second delivery rate during actuation of the
electrochemical actuator 102. In some embodiments, a drug delivery
system can be configured to deliver a drug at a first rate that is
slower than a second rate or at a first rate that is faster than a
second rate. In some embodiments, a mechanical actuator can be
configured to deliver a loading dose at a relatively fast rate
during a start-up phase of an electrochemical actuator until the
electrochemical actuator arrives at a steady-state delivery rate.
The electrochemical actuator alone or in combination with the
mechanical actuator can then complete delivery of the remaining
dose at a relatively lower basal delivery rate. Specific
embodiments of a spring-based actuator and electrochemical actuator
are described in more detail below.
[0043] The fluid source 104 can be a reservoir, pouch, chamber,
barrel, bladder, or other known device that can contain a drug in
fluid form therein. The fluid communicator 106 can be in, or can be
moved into, fluid communication with the fluid source 104. The
fluid communicator 106 can be, for example, a needle, catheter,
cannula, infusion set, or other known drug delivery conduit that
can be inserted into or otherwise associated with the target body
for drug delivery.
[0044] In some embodiments, the fluid source 104 can be any
component capable of retaining a fluid or drug in fluid form. In
some embodiments, the fluid source 104 may be disposable (e.g., not
intended to be refillable or reusable). In other embodiments, the
fluid source 104 can be refilled, which may permit reusing at least
a portion of the device and/or varying the drug or fluid delivered
by the device. In some embodiments, the fluid source 104 can be
sized to correlate with the electrochemical potential of the
electrochemical actuator 102 and the stroke of the spring-based
actuator 118. For example, the size and/or volume of the fluid
source 104 can be selected so that the fluid source 104 becomes
about substantially empty at about the same time that the aggregate
actuation of the spring-based actuator 118 and electrochemical
actuator 102 is complete. By optimizing the size of the fluid
source 104 and the amount of drug contained therein to correspond
to the driving potential of the electrochemical actuator 102 and
the stroke of the spring-based actuator 118, the size and/or cost
of the device may be reduced. In other embodiments, the
electrochemical actuator 102 and/or the spring-based actuator 118
may be oversized with reference to the fluid source 104. In some
embodiments, the delivery system 100 can include more than one
fluid source 104. Such a configuration may permit using a single
device to deliver two or more drugs or fluids. The two or more
drugs or fluids can be delivered discretely, simultaneously,
alternating, according to a program or schedule, or in any other
suitable manner. In such embodiments, the fluid sources 104 may be
associated with the same or different electrochemical actuators
102, the same or different spring-based actuators 118, the same or
different fluid communicators 106, the same or different
operational electronics, or the same or different portions of other
components of the delivery system.
[0045] The first transfer structure 116 can be disposed such that a
surface of the transfer structure 116 can contact the fluid source
104 when the first actuator (e.g., spring-based actuator) 118 is
actuated. For example, the spring-based actuator 118 can include
one or more springs that are coupled to the transfer structure 116
and when the spring-based actuator 118 is actuated, the springs can
apply a pulling force (if extension springs are used) or a pushing
force (if compression springs are used) on the first transfer
structure 116, which in turn will act upon the fluid source 104, as
described in more detail below. The first transfer structure 116
can include one or more components. For example, the transfer
structure 116 can be a single component having a surface configured
to contact the fluid source 104. In some embodiments, the transfer
structure 116 can include one or more members having a surface
configured to contact the fluid source 104 upon activation of the
spring-based actuator 118. In some embodiments, the transfer
structure 116 is a substantially planar or flat plate.
[0046] The second transfer structure 130 can be disposed between
the electrochemical actuator 102 and the fluid source 104. In some
embodiments, the second transfer structure 130 includes a surface
configured to contact a side of the fluid source 104 opposite to
the side contacted by the first transfer structure 116 upon
actuation of the electrochemical actuator 102 such that a force
exerted by the electrochemical actuator 102 is transferred from the
transfer structure 130 to the fluid source 104. The transfer
structure 130 can include one or more components. For example, the
transfer structure 130 can be a single component having a surface
configured to contact the fluid source 104. In some embodiments,
the transfer structure 130 can include one or more members having a
surface configured to contact the fluid source 104 upon activation
of the electrochemical actuator 102. In some embodiments, the
transfer structure 130 is a substantially planar or flat plate.
[0047] In some embodiments, the fluid delivery system 100 can be
used to deliver a drug formulation which comprises a drug,
including an active pharmaceutical ingredient. In other
embodiments, the fluid delivery system 100 may deliver a fluid that
does not contain a drug. For example, the fluid may be a saline
solution or a diagnostic agent, such as a contrast agent. Drug
delivery can be subcutaneous, intravenous, intraarterial,
intramuscular, intracardiac, intraosseous, intradermal,
intrathecal, intraperitoneal, intratumoral, intratympnic,
intraaural, topical, epidural, and/or peri-neural depending on, for
example, the location of the fluid communicator 106 and/or the
entry location of the drug.
[0048] The drug (also referred to herein as "a therapeutic agent"
or "a prophylactic agent") can be in a pure form or formulated in a
solution, a suspension, or an emulsion, among others, using one or
more pharmaceutically acceptable excipients known in the art. For
example, a pharmaceutically acceptable vehicle for the drug can be
provided, which can be any aqueous or non-aqueous vehicle known in
the art. Examples of aqueous vehicles include physiological saline
solutions, solutions of sugars such as dextrose or mannitol, and
pharmaceutically acceptable buffered solutions, and examples of
non-aqueous vehicles include fixed vegetable oils, glycerin,
polyethylene glycols, alcohols, and ethyl oleate. The vehicle may
further include antibacterial preservatives, antioxidants, tonicity
agents, buffers, stabilizers, or other components.
[0049] Although the fluid delivery system 100 and other systems and
methods described herein are generally described as communicating
drugs into a human body, such systems and methods may be employed
to deliver any fluid of any suitable biocompatibility or viscosity
into any object, living or inanimate. For example, the systems and
methods may be employed to deliver other biocompatible fluids into
living beings, including human beings and other animals. Further,
the systems and methods may deliver drugs or other fluids into
living organisms other than human beings, such as animals and plant
life. Also, the systems and methods may deliver any fluids into any
target, living or inanimate.
[0050] The systems and methods described herein are generally
systems and methods of delivering fluids using a delivery device
100 that includes an electrochemical actuator 102, such as a
self-powered actuator and/or combined battery and actuator. Example
embodiments of such electrochemical actuators are generally
described in U.S. Pat. No. 7,541,715, entitled "Electrochemical
Methods, Devices, and Structures" by Chiang et al., U.S. Patent
Pub. No. 2008/0257718, entitled "Electrochemical Actuator" by
Chiang et al., and U.S. Patent Pub. No. 2009/0014320, entitled
"Electrochemical Actuator" by Chiang et al., and U.S. Pat. No.
7,828,771, entitled "Systems and Methods for Delivering Drugs" by
Chiang et al. (the '771 patent"), the disclosure of each of which
is incorporated herein by reference. Such electrochemical actuators
can include at least one component that responds to the application
of a voltage or current by experiencing a change in volume or
position. The change in volume or position can produce mechanical
work that can then act on a fluid source (e.g., fluid source 104)
or may be transferred to a fluid source, such that a fluid can be
delivered out of the fluid source.
[0051] In some embodiments, the electrochemical actuator 102 can
include a positive electrode and a negative electrode, at least one
of which is an actuating electrode. These and other components of
the electrochemical actuator can form an electrochemical cell,
which can in some embodiments initially be charged. For example,
the electrochemical cell may begin discharging when a circuit
between the electrodes is closed, causing the actuating electrode
to actuate. The actuating electrode can thereby perform work upon
another structure, such as the fluid source, or a transfer
structure associated with the fluid source, as described in more
detail below. The work can then cause fluid to be pumped or
otherwise dispensed from the fluid source into the target 108.
[0052] More specifically, the actuating electrode of the
electrochemical actuator 102 can experience a change in volume or
position when the closed circuit is formed, and this change in
volume or position can perform work upon the fluid source or
transferring structure. For example, the actuating electrode may
expand, bend, buckle, fold, cup, elongate, contract, or otherwise
experience a change in volume, size, shape, orientation,
arrangement, or location, such that at least a portion of the
actuating electrode experiences a change in volume or position. In
some embodiments, the change in volume or position may be
experienced by a portion of the actuating electrode, while the
actuating electrode as a whole may experience a contrary change or
no change whatsoever. It is noted that the delivery device 100 can
include more than one electrochemical actuator 102. For example, in
some embodiments, the delivery device 100 can include one or more
electrochemical actuators 102 arranged in series, parallel, or some
combination thereof. In some embodiments, a number of such
electrochemical actuators 102 may be stacked together. As another
example, concurrent or sequenced delivery of multiple agents can be
achieved by including one or more electrochemical actuators 102
acting on two or more fluid sources.
[0053] The spring-based actuator 118 can include one or more
springs (not shown in FIG. 1) that are operatively coupled to the
first transfer structure 116. A variety of different types of
springs can be used, for example, compression, extension, spring
washers, Belleville, tapered, or other types of springs to achieve
a desired delivery rate. In addition, a variety of elastomeric
structures can be used in a variety of configurations to provide
either a "pulling" or "pushing" force on the fluid source 104. The
spring-based actuator 118 can be configured to apply a force on the
first transfer structure 116 such that when the actuator 118 is
activated the force is transferred from the first transfer
structure 116 to the fluid source 104. For example, the springs can
initially be moved to a pre-loaded state and then allowed to move
back towards an un-biased state. During this transition, the
springs can apply a force (e.g., a pulling force or a pushing
force) on the first transfer structure 116. The details and
function of the spring-based actuator 118 are described in more
detail below with reference to specific embodiments.
[0054] The delivery system 100 can also include a housing (not
shown in FIG. 1) that can be removably or releasably attached to
the skin of the patient. The various components of the delivery
system 100 can be fixedly or releasably coupled to the housing. To
adhere the delivery device 100 to the skin of a patient, a
releasable adhesive can at least partially coat an underside of the
housing. The adhesive can be non-toxic, biocompatible, and
releasable from human skin. To protect the adhesive until the
device is ready for use, a removable protective covering can cover
the adhesive, in which case the covering can be removed before the
device is applied to the skin. Alternatively, the adhesive can be
heat or pressure sensitive, in which case the adhesive can be
activated once the device is applied to the skin. Example adhesives
include, but are not limited to, acrylate based medical adhesives
of the type commonly used to affix medical devices such as bandages
to skin. However, the adhesive is not necessary, and may be
omitted, in which case the housing can be associated with the skin,
or generally with the body, in any other manner. For example, a
strap or band can be used.
[0055] The housing can be formed from a material that is relatively
lightweight and flexible, yet sturdy. The housing also can be
formed from a combination of materials such as to provide specific
portions that are rigid and specific portions that are flexible.
Example materials include plastic and rubber materials, such as
polystyrene, polybutene, carbonate, urethane rubbers, butene
rubbers, silicone, and other comparable materials and mixtures
thereof, or a combination of these materials or any other suitable
material can be used.
[0056] In some embodiments, the housing can include a single
component or multiple components. In some embodiments, the housing
can include two portions: a base portion and a movable portion. The
base portion can be suited for attaching to the skin. For example,
the base portion can be relatively flexible. An adhesive can be
deposited on an underside of the base portion, which can be
relatively flat or shaped to conform to the shape of a particular
body part or area. The movable portion can be sized and shaped for
association with the base portion. In some embodiments, the two
portions can be designed to lock together, such as via a locking
mechanism. In some cases, the two portions can releasably lock
together, such as via a releasable locking mechanism, so that the
movable portion can be removably associated with the base portion.
To assemble such a housing, the movable portion can be movable with
reference to the base portion between an unassembled position and
an assembled position. In the assembled position, the two portions
can form a device having an outer shape suited for concealing the
device under clothing. Various example embodiments of a housing are
described in the '771 patent.
[0057] The delivery system 100 can also include a cartridge (not
shown in FIG. 1) that can be coupled to the housing. The cartridge
can define an interior region to contain various components of the
delivery device 100. For example, in some embodiments, the
electrochemical actuator 102 and/or transfer plate 130 are disposed
within the cartridge. In some embodiments, the fluid source 104 can
also be contained within the cartridge. For example, in some
embodiments, a housing can define an interior region and contain
the transfer structure 116 and a spring actuator 130. A cartridge
containing an electrochemical actuator 102, a transfer plate 130
and the fluid source 104 can be sized and configured to be received
within the interior region of the housing such that the fluid
source is adjacent the transfer structure 116. Specific embodiments
of such a delivery system 100 are described in more detail below.
An insertion mechanism for inserting the fluid communicator 106
into a patient's body can also be contained within an interior
region of the housing or the cartridge.
[0058] The size, shape, and weight of the delivery device 100 can
be selected so that the delivery device 100 can be comfortably worn
on the skin after the device is applied via the adhesive. For
example, the delivery device 100 can have a size, for example, in
the range of about 1.0''.times.1.0''.times.0.1'' to about
5.0''.times.5.0''.times.1.0'', and in some embodiments in a range
of about 2.0''.times.2.0''.times.0.25'' to about
4.0''.times.4.0''.times.0.67''. The weight of the delivery device
100 can be, for example, in the range of about 5 g to about 200 g,
and in some embodiments in a range of about 15 g to about 100 g.
The delivery device 100 can be configured to dispense a volume in
the range of about 0.1 ml to about 1,000 ml, and in some cases in
the range of about 0.3 ml to about 100 ml, such as between about
0.5 ml and about 5 ml. The shape of the delivery device 100 can be
selected so that the delivery device 100 can be relatively
imperceptible under clothing. For example, the housing can be
relatively smooth and free from sharp edges (see, for example, FIG.
11). However, other sizes, shapes, and/or weights are possible.
[0059] As mentioned above, a first actuator 118 (e.g., a
spring-based actuator) and a second actuator 102 (e.g., an
electrochemical actuator) can be used to cause the fluid delivery
device 100 to deliver a drug-containing or non-drug containing
fluid into a human patient or other target 108. Such a fluid
delivery system 100 can be embodied in a relatively small,
self-contained, and disposable device, such as a patch device that
can be removably attached to the skin of a patient as described
above. The delivery device 100 can be relatively small and
self-contained, in part, because the electrochemical actuator 102
serves as both the battery and a pump and the spring-based actuator
118 can be sized to occupy a relatively small area of the device.
The small and self-contained nature of the delivery device 100
advantageously may permit concealing the device beneath clothing
and may allow the patient to continue normal activity as the drug
is delivered. Unlike conventional drug pumps, external tubing to
communicate fluid from the fluid reservoir into the body can be
eliminated. Such tubing can instead be contained within the
delivery device, and a needle or other fluid communicator can
extend from the device into the body. The small and inexpensive
nature of the components of the device may, in some embodiments,
permit disposing of the entire device after a single use. The
delivery device 100 can permit drug delivery, such as subcutaneous
or intravenous drug delivery, over a time period that can vary from
several minutes to several days. Subsequently, the delivery device
100 can be removed from the body and discarded.
[0060] In use, the delivery device 100 can be placed in contact
with the target 108 (e.g. placed on the surface of a patient's
body), such that the fluid communicator 106 (e.g., a needle,
cannula, etc.) is disposed adjacent to a desired injection site.
The fluid communicator 106 can be activated such that it is
inserted into the patient's body. The spring-based actuator 118 can
be actuated such that it applies a force on the transfer structure
116 moving the transfer structure in a direction toward the fluid
source 104. The force is then transferred from the transfer
structure 116 to the fluid source 104, causing fluid in the fluid
source 104 to be delivered through the fluid communicator 106 and
into the target 108 at a first rate during a first time period. The
actuation of the spring-based actuator 118 can continue, for
example, until the transfer structure 116 reaches a mechanical stop
within the delivery device 100. The electrochemical actuator 102
can then be actuated to apply a force on the fluid source 104,
causing the fluid to be delivered through the fluid communicator
106 into the target 108 at a second rate during a second time
period. For example, as the electrochemical actuator 102 is
actuated, the actuator 102 can be displaced in a direction toward
the fluid source 104 and apply a force to the transfer structure
130. This force will in turn be transferred to the fluid source 104
to pump the fluid out of the fluid source 104, through the fluid
communicator 106, and into the target 108. In alternative
embodiments, the delivery system 100 may not include a second
transfer structure 130 and instead the actuator 102 can act
directly on the fluid source 104.
[0061] The fluid communicator 106 can be actuated with the
actuation of the spring-based actuator 118 and/or the
electrochemical actuator 102, whichever is actuated first in a
particular embodiment. Activation of the fluid communicator 106 can
include, for example, insertion of the fluid communicator 106 into
the patient's body. Alternatively, the fluid communicator 106 can
be actuated prior to actuation of the spring-based actuator 118
and/or the electrochemical actuator 102. For example, the fluid
communicator 106 can be actuated using an insertion mechanism that
is separate from the delivery device 100 or a mechanism that is
incorporated within the delivery device 100. Example embodiments
illustrating various configurations for actuation of a fluid
communicator are also described in the '771 patent.
[0062] Having described above various general principles, several
exemplary embodiments of these concepts are now described. These
embodiments are only examples, and many other configurations of a
delivery system and/or the various components of a delivery system,
are contemplated.
[0063] FIGS. 2A and 2B are schematic illustrations of an embodiment
of an electrochemical actuator 202 that can be used in a delivery
device as described herein. As shown, in this embodiment, the
electrochemical actuator 202 can include a positive electrode 210,
a negative electrode 212, and an electrolyte 214. These components
can form an electrochemical cell that can initially be discharged
and then charged before use, or can be initially charged, as shown
in FIG. 2A. The positive electrode 210 can be configured to expand
or displace in the presence of the electrolyte 214. When a circuit
between the electrodes 210, 212 is closed, current can travel from
the positive electrode 210 to the negative electrode 212. The
positive electrode 210 can then experience a change in volume or
shape, resulting in longitudinal displacement of at least a portion
of the positive electrode 210, as shown in FIG. 2B. For example,
the actuator 202 can have an overall height h.sub.1 when it is
charged (prior to actuation), as shown in FIG. 2A, and an overall
height of h.sub.2 when it is discharged or actuated, such that the
actuator 202 has a displacement or stroke that is equal to
h.sub.2-h.sub.1. Said another way, the actuator 202 can have a
first end portion 215, a second end portion 219 and a medial
portion 217 disposed between the first end portion 215 and the
second end portion 219. The actuator prior to actuation (prior to
discharge) can be supported on a surface S of the delivery device
in which the actuator 202 is disposed, and when the actuator 202 is
discharged at least the medial portion 217 can displace (e.g., bend
or flex) a non-zero distance from the surface S. The stroke of the
actuator 202 can be substantially equal to that non-zero distance.
As the actuator 202 is displaced, the actuator 202 can exert a
pumping force or pressure on a fluid reservoir (not shown) and/or
an associated transfer structure (not shown) coupled thereto. The
pumping force or pressure exerted by the actuator 202 can cause a
volume of fluid (e.g., a therapeutic agent) to be pumped out of the
fluid reservoir. Thus, the electrochemical actuator 202 can be
considered a self-powered electrochemical pump.
[0064] In this embodiment, the electrochemical actuator 202 has a
positive electrode 210 selected to have a lower chemical potential
for the working ion when the electrochemical actuator 202 is
charged, and is thereby able to spontaneously accept working ions
from the negative electrode 212 as the actuator is discharged. In
some embodiments, the working ion can include, but is not limited
to, the proton or lithium ion. When the working ion is lithium, the
positive electrode 210 can include one or more lithium metal oxides
including, for example, LiCoO.sub.2, LiFePO.sub.4, LiNiO.sub.2,
LiMn.sub.2O.sub.4, LiMnO.sub.2, LiMnPO.sub.4,
Li.sub.4Ti.sub.5O.sub.12, and their modified compositions and solid
solutions; oxide compound comprising one or more of titanium oxide,
manganese oxide, vanadium oxide, tin oxide, antimony oxide, cobalt
oxide, nickel oxide or iron oxide; metal sulfides comprising one or
more of TiSi.sub.2, MoSi.sub.2, WSi.sub.2, and their modified
compositions and solid solutions; a metal, metal alloy, or
intermetallic compound comprising one or more of aluminum, silver,
gold, boron, bismuth, gallium, germanium, indium, lead, antimony,
silicon, tin, or zinc; a lithium-metal alloy; or carbon comprising
one or more of graphite, a carbon fiber structure, a glassy carbon
structure, a highly oriented pyrolytic graphite, or a disordered
carbon structure. The negative electrode 212 can include, for
example, lithium metal, a lithium metal alloy, or any of the
preceding compounds listed as positive electrode compounds,
provided that such compounds when used as a negative electrode are
paired with a positive electrode that is able to spontaneously
accept lithium from the negative electrode when the actuator is
charged. These are just some examples, as other configurations are
also possible.
[0065] In some embodiments, the electrochemical actuator can
include an anode, a cathode, and a species, such as a lithium ion.
In some embodiments, a source of lithium ion is the electrolyte
which is made up an organic solvent such as PC, propylene
carbonate, GBL, gamma butyl lactone, dioxylane, and others, and an
added electrolyte. Some example electrolytes include LiPF.sub.6,
LiBr, LiBF.sub.4. At least one of the electrodes can be an
actuating electrode that includes a first portion and a second
portion. The portions can have at least one differing
characteristic, such that in the presence of a voltage or current,
the first portion responds to the species in a different manner
than the second portion. For example, the portions can be formed
from different materials, or the portions can differ in thickness,
dimension, porosity, density, or surface structure, among others.
The electrodes can be charged, and when the circuit is closed,
current can travel. The species can, intercalate, de-intercalate,
alloy with, oxide, reduce, or plate with the first portion to a
different extent than the second portion. Due to the first portion
responding differently to the species than the second portion, the
actuating electrode can experience a change in one or more
dimensions, volume, shape, orientation, or position.
[0066] Another example of an electrochemical actuator is shown in
the embodiment illustrated in FIGS. 3 and 4. As shown in FIG. 3, an
electrochemical actuator 302 can include a negative electrode 312
in electrical communication with a positive electrode 310
collectively forming an electrochemical cell. Positive electrode
310 may include a first portion 320 and a second portion 322. In
some embodiments, first portion 320 and second portion 322 are
formed of different materials. Portions 320 and 322 may also have
different electrical potentials. For example, first portion 320 may
include a material that can intercalate, de-intercalate, alloy
with, oxidize, reduce, or plate a species to a different extent
than second portion 322. Second portion 322 may be formed of a
material that does not substantially intercalate, de-intercalate,
or alloy with, oxidize, reduce, or plate the species. In some
embodiments, first portion 320 may be formed of a material
including one or more of aluminum, antimony, bismuth, carbon,
gallium, silicon, silver, tin, zinc, or other materials which can
expand upon intercalation or alloying or compound formation with
lithium. In one embodiment, first portion 320 is formed with
aluminum, which can expand upon intercalation with lithium. Second
portion 322 may be formed of copper, since copper does not
substantially intercalate or alloy with lithium. In some instances,
second portion 322 may act as a positive electrode current
collector, and may extend outside the electrochemical cell, e.g.,
to form a tab or current lead. In other embodiments, second portion
322 may be joined to a tab or current lead that extends outside the
cell. Negative electrode 312 may also include a current collector.
Electrochemical actuator 302 may include a separator 323. The
separator 323 may be, for example, a porous separator film, such as
a glass fiber cloth, or a porous polymer separator. Other types of
separators, such as those used in the construction of lithium ion
batteries, may also be used. The electrochemical actuator 302 may
also include an electrolyte 314, which may be in the form of a
liquid, solid, or a gel. The electrolyte may contain an
electrochemically active species, such as that used to form the
negative electrode. Electrochemical actuator 302 may also include
an enclosure 336, such as a polymer packaging, in which negative
electrode 312, positive electrode 310 and separator 323 can be
disposed.
[0067] As illustrated in FIG. 4, the electrochemical cell may have
a voltage 333, such that, when a closed circuit is formed between
the negative electrode 312 and the positive electrode 310, an
electric current may flow between the negative electrode 312 and
the positive electrode 310 through the external circuit. If
negative electrode 312 is a lithium metal electrode and the
electrolyte contains lithium ions, lithium ion current can flow
internally from the negative electrode 312 to the positive
electrode 310. The intercalation of first portion 320 with lithium
can result in a dimensional change, such as a volume expansion. In
some instances, this volume expansion may reach at least 25%, at
least 50%, at least 75%, at least 100%, at least 150%, at least
200%, at least 250%, or at least 300% compared to the initial
volume. High volume expansion may occur, for example, when first
portion 320 is saturated with lithium. As first portion 320
increases in volume due to intercalation of lithium, second portion
322 to which first portion 320 may be bonded, may not substantially
expand due to minimal or no intercalation of lithium. First portion
320 thus provides a mechanical constraint. This differential strain
between the two portions causes positive electrode 310 to undergo
bending or flexure. As a result of the dimensional change and
displacement of the positive electrode 310, electrochemical
actuator 302 can be displaced from a first orientation to a second
orientation. This displacement can occur whether the volumetric or
dimensional change (e.g., net volume change) of the electrochemical
cell, due to the loss of lithium metal from the negative electrode
312 and formation of lithium intercalated compound or lithium alloy
at the positive electrode 310, is positive, zero, or negative. In
some cases, the actuator displacement may occur with a volumetric
or dimensional change (e.g., net volume change) of the
electrochemical actuator 302, or portion thereof that is positive.
In some cases, the actuator displacement may occur with a
volumetric or dimensional change (e.g., net volume change) of the
electrochemical actuator 302, or portion thereof that is zero. In
some cases, the actuator displacement may occur with a volumetric
or dimensional change (e.g., net volume change) of the
electrochemical actuator 302, or portion thereof that is
negative.
[0068] As used herein, "differential strain" between two portions
can refer to the difference in response (e.g., actuation) of each
individual portion upon application of a voltage or current to the
two portions. That is, a system as described herein may include a
component including a first portion and a second portion associated
with (e.g., may contact, may be integrally connected to) the first
portion, wherein, under essentially identical conditions, the first
portion may undergo a volumetric or dimensional change and the
second portion does not undergo a volumetric or dimensional change,
producing strain between the first and second portions. The
differential strain may cause the component, or a portion thereof,
to be displaced from a first orientation to a second orientation.
In some embodiments, the differential strain may be produced by
differential intercalation, de-intercalation, alloying, oxidation,
reduction, or plating of a species with one or more portions of the
actuator system.
[0069] For example, the differential intercalation,
de-intercalation, alloying, oxidation, reduction, or plating of
first portion 320 relative to second portion 322 can be
accomplished through several means. In one embodiment, first
portion 320 may be formed of a different material than second
portion 322, wherein one of the materials substantially
intercalates, de-intercalates, alloys with, oxidizes, reduces, or
plates a species, while the second portion interacts with the
species to a lesser extent. In another embodiment, first portion
320 and second portion 322 may be formed of the same material. For
example, first portion 320 and second portion 322 may be formed of
the same material and may be substantially dense, or porous, such
as a pressed or sintered powder or foam structure. In some cases,
to produce a differential strain upon operation of the
electrochemical cell, first portion 320 or second portion 322 may
have sufficient thickness such that, during operation of the
electrochemical cell, a gradient in composition may arise due to
limited ion transport, producing a differential strain. In some
embodiments, one portion or an area of one portion may be
preferentially exposed to the species relative to the second
portion or area of the second portion. In other instances,
shielding or masking of one portion relative to the other portion
can result in lesser or greater intercalation, de-intercalation, or
alloying with the masked or shielded portion compared to the
non-masked or shielded portion. This may be accomplished, for
example, by a surface treatment or a deposited barrier layer,
lamination with a barrier layer material, or chemically or
thermally treating the surface of the portion to be masked/shielded
to either facilitate or inhibit intercalation, de-intercalation,
alloying, oxidation, reduction, or plating with the portion.
Barrier layers can be formed of any suitable material, which may
include polymers, metals, or ceramics. In some cases, the barrier
layer can also serve another function in the electrochemical cell,
such as being a current collector. The barrier layer may be
uniformly deposited onto the surface in some embodiments. In other
cases, the barrier layer may form a gradient in composition and/or
dimension such that only certain portions of the surface
preferentially facilitate or inhibit intercalation,
de-intercalation, alloying, oxidation, reduction, or plating of the
surface. Linear, step, exponential, and other gradients are
possible. In some embodiments a variation in the porosity across
first portion 320 or second portion 322, including the preparation
of a dense surface layer, may be used to assist in the creation of
an ion concentration gradient and differential strain. Other
methods of interaction of a species with a first portion to a
different extent so as to induce a differential strain between the
first and second portions can also be used. In some embodiments,
the flexure or bending of an electrode is used to exert a force or
to carry out a displacement that accomplishes useful function.
[0070] In some embodiments, the electrical circuit can include
electrical contacts (not shown) that can open or close the
electrical circuit. For example, when the electrical contacts are
in communication with each other, the electrical circuit will be
closed (as shown in FIG. 4) and when they are not in contact with
each other, the electrical circuit can be opened or broken, as
shown in FIG. 3.
[0071] The discharge of the electrochemical actuator can be
relatively proportional to the current traveling through the
electrical circuit (i.e., the electrical resistance of the
resistor). Because the electrical resistance of the resistor can be
relatively constant, the electrochemical actuator can discharge at
a relatively constant rate. Thus, the discharge of the
electrochemical actuator, and thus the displacement of the
electrochemical actuator can be relatively linear with the passage
of time.
[0072] In some embodiments, an electrical circuit can be used that
includes a variable resistor. By varying the resistance, the
discharge rate of the electrochemical actuator and the
corresponding displacement of the electrochemical actuator can be
varied, which in turn can vary the fluid flow rate from the fluid
source. An example of such an embodiment is described in the '771
patent. In some embodiments, an electrical circuit can be used that
uses a switch to open or close the electrical circuit. When the
switch is closed, the electrochemical actuator can discharge and
when the switch is opened, the electrochemical actuator can be
prevented from discharging. An example of such an embodiment is
described in the '771 patent incorporated by reference above.
[0073] FIGS. 5-21 illustrate a delivery device according to an
embodiment. A delivery device 500 includes a housing 526, a first
transfer structure 516, a spring-based actuator 518 and a cartridge
assembly 532 configured to be received within an interior region
528 (see, e.g., FIG. 6) defined by the housing 526. The cartridge
assembly 532 includes a cartridge housing 534, an electrochemical
actuator 502, a second transfer structure 530 and a fluid source
504 (see, e.g., FIG. 14). An activation mechanism 574 is also
provided as described in more detail below.
[0074] The housing 526 includes a base member 536 (see e.g., FIG.
6) and a cover member 538 (see e.g., FIG. 7) that collectively
define the interior region 528 when coupled together. The base
member 536 includes a floor 540 and upper walls 542. The floor 540
of the base member 536 defines a fluid communicator access opening
552. The cover member 538 is configured to be placed over the upper
walls 542 of the base member 536. For example, the cover member 538
defines a lower opening 544 (see e.g., FIG. 7) configured to
receive the base member 536.
[0075] As shown in FIG. 8B, the cover member 538 includes a
protrusion 580 that can be snap-fitted into a corresponding recess
582 in the base member 536. In this embodiment, the protrusion 580
extends about (or substantially about) a lower edge portion of the
cover member 538 (see e.g., FIG. 7), and the recess 582 extends
about (or substantially about) a lower portion of the upper wall
542 of the base member 536 (see e.g., FIG. 6). A seal member (not
shown) can also be provided to seal the internal component of the
device. For example, a gasket can be positioned between the base
member 536 and the cover member 538 and an additional gasket can be
placed on the end of the cartridge so that upon insertion, the
device is fully sealed. In some embodiments, the base member 536
and cover member 538 can be coupled together with other types of
mechanical attachments, which can be a fixed or removable
attachment. For examples tabs or clips that interlock between the
base member 536 and cover member 538 can be used. In some
embodiments, the base member 536 and cover member 538 can be bonded
together with epoxies/glues or via processes that can establish a
permanent bond.
[0076] The cover member 538 of the housing 526 and the base member
536 of the housing 526 can be coupled together, for example, with
adhesive, bonding, mechanical fasteners, or other known coupling
methods. In some embodiments, a snap-fit coupling can be used. The
cover member 538 can optionally include a guide pin 548 (shown in
FIGS. 7 and 8A) configured to be received in an opening (not shown)
defined in the base member 536 that can be used to help align the
cover member 538 to the base member 536. The cover member 538 also
defines a front opening 546 as shown, for example, in FIG. 7. The
cartridge assembly 532 (shown e.g., in FIG. 14) can be inserted
through the opening 546 and into the interior region 528 of the
housing 526.
[0077] FIGS. 9 and 10 illustrate the delivery device 500 without
the cartridge assembly 532 disposed within the housing 526. FIG. 9
is a front perspective view and FIG. 10 is a front view. The
spring-based actuator 518 includes four extension springs 554, one
disposed in each corner of the housing 526 (only two are visible in
FIGS. 9 and 10). The springs 554 are coupled on one end to the base
member 536 of the housing 526 at mounting supports 556 as shown,
for example, in FIG. 10 (see also FIG. 6). The springs 554 are
coupled on an opposite end to the transfer structure 516 at similar
mounting supports 558 (see e.g., FIG. 18). As shown in FIGS. 9 and
10, prior to the cartridge assembly 532 being inserted into the
housing 526, the springs 554 are in an unbiased or relaxed state
(un-extended), and hold the transfer structure 516 elevated at a
spaced distance from the floor 540 of the base member 536. The
cartridge assembly 532 can be inserted through the opening 546 and
into the housing 526 above the transfer structure 516. As the
cartridge assembly 532 is being inserted, the transfer structure
516 is pushed downward, and the springs 554 are moved to an
extended state, as shown in FIGS. 11-13. For illustration purposes,
FIGS. 11-13 illustrate the movement or repositioning of the
transfer structure 516 and the extension of the springs 554 without
the cartridge being shown. FIG. 11 is a front perspective view,
FIG. 12 is a front view and FIG. 13 is a front perspective view
with the cover member 536 also removed for illustration
purposes.
[0078] Also shown in FIG. 13, the transfer structure 516 defines a
cut-out 576 (see also FIG. 18) to provide clearance for an
insertion mechanism 550. The insertion mechanism 550 can be
disposed within the interior region 528 of the housing 526. The
insertion mechanism 550 can be configured to insert a fluid
communicator (not shown) through the opening 552 in the base member
536 of the housing 526 and into a target (e.g., a patient's body).
The insertion mechanism 550 can also be configured to puncture the
fluid source 504 and provide fluid communication between the fluid
source 504 and the fluid communicator.
[0079] As stated above, and as shown in FIGS. 14 and 15, the
cartridge assembly 532 includes the cartridge housing 534, the
electrochemical actuator 502, the transfer structure 530 and the
fluid source 504 containing a volume of fluid to be delivered to a
target (e.g., patient). The electrochemical actuator 502 can be
configured to function in the same or similar manner as described
above for other embodiments. FIG. 15 illustrates the transfer
structure 530 disposed between the electrochemical actuator 502 and
the fluid source 504 (without the cartridge housing 532), and FIG.
16 is a top view of the fluid source 504.
[0080] As shown in FIG. 17, the cartridge housing 534 defines a
front access opening 578 and an opening 560 defined in a bottom
face of the cartridge housing 534. The cartridge housing 534 also
includes legs 562 with hooks 564, and a rear hub portion 566. The
legs 562 are used to couple the cartridge assembly 532 to the
transfer structure 516 when the cartridge assembly 532 is inserted
into the housing 526. The hooks provide a snap-fit coupling between
the cartridge assembly 532 and the transfer structure 516. As shown
in FIG. 18, the transfer structure 516 defines tracks 568 and slots
570 in which the legs 562 can be received when inserting the
cartridge assembly 532 into the interior region 528 of the housing
526. The tracks 568 also include ramped portions 572 to help
facilitate insertion of the cartridge assembly 532. Specifically,
as the cartridge assembly 532 is being inserted in the direction of
arrow A (shown in FIGS. 18 and 19), the legs 562 of the cartridge
housing 534 can slide within the tracks 568 until the cartridge
assembly 532 is positioned above the slots 570. This aligns the
cartridge assembly 532 to properly move the transfer structure 516
downward. As the cartridge assembly 532 is moved downward, it
pushes the transfer structure 516 into the housing 526 to a
pre-actuation position, which in turn extends the springs 554 of
the actuator 518 from their natural state (un-extended) to an
extended state. This places the springs 554 in a pre-loaded
position, and places a bottom surface 507 of the fluid source 504
(see, e.g., FIG. 15) in contact with a top surface 571 of the
transfer structure 516. The transfer structure 516 is then pulled
upward by the springs 554 such that the cartridge legs 562 are
inserted into the slots 570 of the transfer structure 516, and the
hooks 562 are snap-fitted to the transfer structure 516.
[0081] FIG. 20 is a top view of the delivery device 500 with the
cover member 536 and cartridge housing 534 removed for illustration
purposes. As shown in FIG. 20, the fluid source 504 is disposed
such that it can contact the insertion mechanism 550. With the
cartridge assembly 532 coupled to the transfer structure 516, the
activation mechanism 574 (see also FIG. 5) can be moved to a hold
position to maintain the transfer structure 516 in its
pre-actuation position and the delivery device 500 in a ready
position. The activation mechanism 574 can be, for example, a
pull-tab with pin member. Other types of mechanisms, such as a
button, switch, electrical activation mechanism, etc., can
alternatively be used. In some embodiments, a separate mechanism
can be used to move the transfer structure 516 to its pre-actuation
position. For example, a delivery device can include a mechanism
configured to move the transfer structure 516 to its pre-actuation
position prior to the cartridge assembly 532 being inserted into
the housing 526. In some embodiments, a separate device external to
the delivery device can be used to move the transfer structure 516
to its pre-actuation position.
[0082] In use, with the delivery device 500 in the ready position,
the delivery device 500 can be placed in contact with a target
(e.g. placed on the surface of a patient's body), such that the
opening 552 in the base member 536 is disposed adjacent to a
desired injection site. The delivery device 500 can be activated by
moving the activation mechanism 574 to a start position, releasing
the transfer structure 516 from its pre-actuation position. This
starts a first actuation of the delivery device 500. Specifically,
when the delivery device 500 is activated, the springs 554 of the
actuator 518 will be free to move upward back to their biased
natural or relaxed state (un-extended), pulling the transfer
structure 516 upward with them. As the transfer structure 516 is
moved upward, it exerts a first force F1 (see the partial cut-away
view of FIG. 21) on the bottom surface 507 of fluid source 504,
thereby compressing the fluid source 504 and causing a first volume
of fluid to be expelled out of the fluid source 504 (through a
fluid communicator) and into the target (e.g., patient). As shown
in FIG. 21, when the transfer structure 516 is moved upward by the
pulling force of the springs 554, the cartridge assembly 532 is
also moved upward due to its attachment to the transfer structure
516. The actuation of the spring-based actuator 518 (e.g., springs
554) can continue, for example, until the transfer structure 516
reaches a mechanical stop 535 within the cartridge housing 534. As
such, the mechanical stop 535 can be positioned within the
cartridge assembly 534 to help limit the amount of fluid (e.g., to
the first volume) expelled from the fluid source 504 during
actuation of the spring-based actuator 518. The travel of the
cartridge assembly 532 is also limited by the height of the inside
of the cover member 538. The coupling of the legs 562 of the
cartridge housing 534 to the transfer structure 516 limits the
transfer structure 516 from reversing its motion (e.g., moving
downward after the spring-based actuator is actuated).
Specifically, the hooks 564 of the legs 562 limit the travel of the
transfer structure 516 in the downward direction. Furthermore,
because the springs 554 are in their natural, un-extended, state,
the springs also help to limit travel of the transfer structure 516
in the downward direction (e.g., towards its original
position).
[0083] When the spring-based actuator 518 has completed its
actuation, the electrochemical actuator 502 can then be actuated to
provide a second phase of delivery of a volume of fluid from the
fluid source 504. Specifically, when the transfer structure 516
reaches the mechanical stop 535, it can also activate a trigger
(not shown) associated with the electrochemical actuator 502. For
example, such a trigger can complete the electric circuit (as
described above) and cause the electrochemical actuator 502 to
start discharging. As the electrochemical actuator 502 discharges,
it will displace and exert a second force F2 (see FIG. 21) on a top
surface 509 (see e.g., FIG. 16) of the fluid source 504, thereby
compressing the fluid source 504 and causing a second volume of
fluid within the fluid source 504 to be expelled into the target
(e.g., patient). As stated above, and as shown in FIG. 21, the legs
562 of the cartridge housing 534 that are secured within the slots
570 of the transfer structure 516 limit the movement of the
transfer structure 516 to prevent it from being forced downward
away from the fluid source 504 as the electrochemical actuator 502
is being actuated. Specifically, the hooks 564 limit the downward
motion of the transfer structure 516 as the electrochemical
actuator 502 is actuated.
[0084] In some embodiments, the insertion mechanism 550 can be
activated upon insertion of the cartridge assembly 532. For
example, as the cartridge assembly 532 is being inserted, a trigger
(not shown) on the insertion mechanism 550 can be activated to
puncture the fluid source 504 and insert a fluid communicator (not
shown) through the opening 552 and into the target (e.g., patient).
In some embodiments, the insertion mechanism 550 can be actuated
when the delivery device 500 is actuated. For example, the
activation mechanism 574 can also be configured to activate the
insertion mechanism 550 when activated to start the actuators as
described above. In some embodiments, a separate button, tab,
switch, etc. (not shown) can be used to cause the insertion
mechanism 550 to puncture the fluid source 550, insert a fluid
communicator, or both. In some embodiments, the puncturing of the
fluid source and insertion of the fluid communicator can be
simultaneous or sequential. In addition, although not shown, in
some embodiments, an insertion mechanism can alternatively be
provided in the cartridge assembly 532. For example, an insertion
mechanism can be disposed within an interior region defined by the
rear hub portion 566 of the cartridge housing 534.
[0085] FIGS. 22A and 22B are schematic illustrations of the forces
exerted by the spring-based actuator 518 and the electrochemical
actuator 502 in the above-described embodiment. As shown in FIG.
22A, the spring-based actuator 518 exerts a first force F1 in a
first direction. The force F1 is a pulling force (from the
extension springs 554) applied to the transfer structure 516, which
in turns transfers to the fluid source 504. FIG. 22B illustrates a
second force F2 in a second direction exerted by the
electrochemical actuator 502 to the transfer structure 530, which
in turn is transferred to the fluid source 504.
[0086] The electrochemical actuator 502 can be configured to be
actuated for a specific time period after the actuation of the
spring-based actuator 518 to deliver a desired volume of fluid to
the target. For example, the electrochemical actuator 502 can be
configured to correspond to the particular size of the fluid source
504 and the volume of fluid contained therein such that the
activation will be complete when the fluid in the fluid source 504
has been completely expelled from the fluid source 504. The rate of
actuation of the spring-based actuator 516 can be faster than the
rate of activation of the electrochemical actuator 502. Thus, the
delivery device 500 can be actuated to deliver a volume of fluid
from the fluid source 504 at a first rate during a first time
period using the spring-based actuator 518, and a second volume of
fluid at a second rate during a second time period using the
electrochemical actuator 502.
[0087] In alternative embodiments, a delivery device as described
herein can be configured with alternative dispensing scenarios. For
example, the delivery device can be configured such that the
electrochemical actuator is activated first, and the spring-based
actuator is actuated second by activating a button, switch,
pull-tab, electrical activation mechanism, etc. at a desired time
after the electrochemical actuator has been activated. In some
embodiments, activation of the electrochemical actuator and the
spring-based actuator can overlap for some or all of their
respective activation durations. In some embodiments, additional
controls can be included to release the spring-based actuator 518
(i.e., springs 554) at a desired time either before after or during
the activation of the electrochemical actuator 502. For example, a
mechanical and/or electrical mechanism (e.g., button, switch) can
be used.
[0088] In some embodiments, compression springs can be used instead
of extension springs. For example, in such an embodiment, the
compression springs can apply a pushing force on the transfer
structure rather than a pulling force. FIG. 23 is a schematic
illustration of the forces associated with such an embodiment. As
shown in FIG. 23, a spring-based actuator 618 including compression
springs can exert a first force F1 in a first direction. In this
example, the force F1 is a pushing force applied to a transfer
structure 616, which in turns transfers to a fluid source 604. A
second force F2 in a second direction can be exerted by an
electrochemical actuator 602 to a transfer structure 630, which in
turn is transferred to the fluid source 604. The order of actuation
can be reversed as described herein.
[0089] The spring-based actuators described herein can be selected
based in part, on two extreme points of operation: a starting point
and an end point. For example, for a delivery device such as
delivery device 500 having a spring-based actuator 518 using
extension springs configured to be activated first, and an
electrochemical actuator 502 configured to be activated second, the
starting point is where the springs are in their most extended
state. The end point can be an intermediate extension of the
springs that provides the necessary force to still push fluid out
of the fluid source 504 at the point where the electrochemical
actuator starts. If compression springs are used, the starting
point is when the springs are in a most compressed state and an end
point can be an intermediate compression of the springs that
provides the necessary force to still push fluid out of the fluid
source at the point where the electrochemical actuator starts.
Certain types of springs (e.g., discs) also have relatively
constant profiles, which can provide further benefits as they can
provide more efficient use of volume.
[0090] Although delivery device 500 was described as having one
electrochemical actuator, in alternative embodiments, more than one
electrochemical actuator can be included. For example, two (or
more) electrochemical actuators can be provided. The
electrochemical actuators can be configured to be actuated
simultaneously or sequentially to increase the amount of force
and/or displacement applied to the fluid source. For example, a
spring-based actuator can be actuated, a first electrochemical
actuator can be actuated, and a second electrochemical actuator can
be actuated, in any order and/or combination.
[0091] FIG. 24 is a schematic illustration of an embodiment of a
delivery device having two electrochemical actuators 702 and 703,
and a spring-based actuator 718 and the forces associated with such
an embodiment. As shown in FIG. 24, the spring-based actuator 718
can exert a first force F1 in a first direction applied to a
transfer structure 716, which in turns transfers to a fluid source
704. A second force F2 in a second direction can be exerted by the
two electrochemical actuators 702 and 703 to a transfer structure
730, which in turn is transferred to the fluid source 704. The
order of actuation can be reversed as described herein.
[0092] FIG. 25 is a schematic illustration of another embodiment of
a delivery device having two electrochemical actuators 802 and 803,
and a spring-based actuator 818 and the forces associated with such
an embodiment. In this example embodiment, the spring-based
actuator 818 can be used in conjunction with one of the
electrochemical actuators to exert a force in one direction and the
other electrochemical actuator can exert a force in a second
direction. As shown in FIG. 25, a first force F1 in a first
direction is applied by the spring-based actuator 818 together with
the electrochemical actuator 803 to a transfer structure 816, which
in turns transfers to a fluid source 804. A second force F2 in a
second direction can be exerted by the electrochemical actuator 802
to a transfer structure 830, which in turn is transferred to the
fluid source 804. The order of actuation can be reversed as
described herein.
[0093] In some embodiments of a delivery device, a first actuator
(e.g., an electrochemical actuator or a mechanical actuator) can be
actuated for a first time period and a second actuator (e.g., an
electrochemical actuator or a mechanical actuator) can be actuated
for a second time period, and the first time period and the second
time period can at least partially overlap. For example, the first
actuator may be actuated and during its actuation, the second
actuator is actuated. In some embodiments, both actuators can be
actuated at the same time, but provide different rates of
actuation. For example, a first actuator can be configured to
actuate at a first rate that is faster than the actuation of the
second actuator. Thus, the first actuator and the second actuator
can start at the same time, but the second actuator will actuate
for a longer duration.
[0094] Example strokes and operating forces for an electrochemical
actuator can be, for example, in the range of 2 mm-5 mm and 5N-50N
respectively. In some embodiments, the stroke and operating force
is greater than 5 mm and 50 N, respectively. In some embodiments,
the force provided by an extension spring used in a spring-based
actuator can be, for example, from 30 N-50 N at peak extension and
down to, for example about 10 N-15 N at mid-stroke of approximately
2 mm-3 mm.
[0095] A delivery device (e.g., 100, 500) as described herein may
be used to deliver a variety of drugs according to one or more
release profiles. For example, the drug may be delivered according
to a relatively uniform flow rate, a varied flow rate, a
preprogrammed flow rate, a modulated flow rate, in response to
conditions sensed by the device, in response to a request or other
input from a user or other external source, or combinations
thereof. Thus, embodiments of the delivery device may be used to
deliver drugs having a short half-life, drugs having a narrow
therapeutic window, drugs delivered via on-demand dosing,
normally-injected compounds for which other delivery modes such as
continuous delivery are desired, drugs requiring titration and
precise control, and drugs whose therapeutic effectiveness is
improved through modulation delivery or delivery at a non-uniform
flow rate. These drugs may already have appropriate existing
injectable formulations.
[0096] For example, the delivery devices may be useful in a wide
variety of therapies. Representative examples include, but are not
limited to, opioid narcotics such as fentanyl, remifentanyl,
sufentanil, morphine, hydromorphone, oxycodone and salts thereof or
other opioids or non-opioids for post-operative pain or for chronic
and breakthrough pain; NonSteroidal Antinflamatories (NSAIDs) such
as diclofenac, naproxen, ibuprofin, and celecoxib; local
anesthetics such as lidocaine, tetracaine, and bupivicaine;
dopamine antagonists such as apomorphine, rotigotine, and
ropinerole; drugs used for the treatment and/or prevention of
allergies such as antihistamines, antileukotrienes,
anticholinergics, and immunotherapeutic agents; antispastics such
as tizanidine and baclofin; insulin delivery for Type 1 or Type 2
diabetes; leutenizing hormone releasing hormone (LHRH) or follicle
stimulating hormone (FSH) for infertility; plasma-derived or
recombinant immune globulin or its constituents for the treatment
of immunodeficiency (including primary immunodeficiency),
autoimmune disorders, neurological and neurodegenerative disorders
(including Alzheimer's Disease), and inflammatory diseases;
apomorphine or other dopamine agonists for Parkinson's disease;
interferon A for chronic hepatitis B, chronic hepatitis C, solid or
hematologic malignancies; antibodies for the treatment of cancer;
octreotide for acromegaly; ketamine for pain, refractory
depression, or neuropathic pain; heparin for post-surgical blood
thinning; corticosteroid (e.g., prednisone, hydrocortisone,
dexamethasone) for treatment of MS; vitamins such as niacin;
Selegiline; and rasagiline. Essentially any peptide, protein,
biologic, or oligonucleotide, among others, that is normally
delivered by subcutaneous, intramuscular, or intravenous injection
or other parenteral routes, may be delivered using embodiments of
the devices described herein. In some embodiments, the delivery
device can be used to administer a drug combination of two or more
different drugs using a single or multiple delivery port and being
able to deliver the agents at a fixed ratio or by means enabling
the delivery of each agent to be independently modulated. For
example, two or more drugs can be administered simultaneously or
serially, or a combination (e.g. overlapping) thereof.
[0097] In some embodiments, the delivery device may be used to
administer ketamine for the treatment of refractory depression or
other mood disorders. In some embodiments, ketamine may include
either the racemate, single enantiomer (R/S), or the metabolite
(wherein S-norketamine may be active). In some embodiments, the
delivery devices described herein may be used for administration of
Interferon A for the treatment of hepatitis C. In one embodiment, a
several hour infusion patch is worn during the day or overnight
three times per week, or a continuous delivery system is worn 24
hours per day. Such a delivery device may advantageously replace
bolus injection with a slow infusion, reducing side effects and
allowing the patient to tolerate higher doses. In other Interferon
A therapies, the delivery device may also be used in the treatment
of malignant melanoma, renal cell carcinoma, hairy cell leukemia,
chronic hepatitis B, condylomata acuminata, follicular
(non-Hodgkin's) lymphoma, and AIDS-related Kaposi's sarcoma.
[0098] In some embodiments, a delivery device as described herein
may be used for administration of apomorphine or other dopamine
agonists in the treatment of Parkinson's Disease ("PD"). Currently,
a bolus subcutaneous injection of apomorphine may be used to
quickly jolt a PD patient out of an "off" state. However,
apomorphine has a relatively short half-life and relatively severe
side effects, limiting its use. The delivery devices described
herein may provide continuous delivery and may dramatically reduce
side effects associated with both apomorphine and dopamine
fluctuation. In some embodiments, a delivery device as described
herein can provide continuous delivery of apomorphine or other
dopamine agonist, with, optionally, an adjustable baseline and/or a
bolus button for treating an "off" state in the patient.
Advantageously, this method of treatment may provide improved
dopaminergic levels in the body, such as fewer dyskinetic events,
fewer "off" states, less total time in "off" states, less cycling
between "on" and "off" states, and reduced need for levodopa; quick
recovery from "off" state if it occurs; and reduced or eliminated
nausea/vomiting side effect of apomorphine, resulting from slow
steady infusion rather than bolus dosing.
[0099] In some embodiments, a delivery device as described herein
may be used for administration of an analgesic, such as morphine,
hydromorphone, fentanyl or other opioids, in the treatment of pain.
Advantageously, the delivery device may provide improved comfort in
a less cumbersome and/or less invasive technique, such as for
post-operative pain management. Particularly, the delivery device
may be configured for patient-controlled analgesia.
[0100] In some embodiments, all or some of the components of a
delivery system can be included in a kit. For example, a kit can
include at least a housing (e.g., housing 526) with an actuator and
a reservoir (e.g., fluid source 504). The reservoir has a first
configuration in which the reservoir is separate from the housing
and a second configuration in which at least a portion of the
reservoir is received in the housing. Upon actuation, the actuator
is configured to exert a force on the reservoir when the reservoir
is in its second configuration such that at a volume of the fluid
is communicated out of the reservoir. In some embodiments, the
reservoir is included in a cartridge assembly. The cartridge
assembly is configured to be slidably inserted into an opening in
the housing. In some embodiments, when the cartridge assembly is
inserted into the housing, the actuator is placed in a pre-loaded
position (such as described above with respect to cartridge
assembly 532).
[0101] The reservoir and/or the cartridge assembly can be
maintained separately from the housing and its components within
the kit packaging. For example, the reservoir and/or the cartridge
assembly can be disposed within a first portion of the kit such
that a temperature, humidity, or other environmental factor is
controlled or maintained independent of a temperature, humidity, or
other environmental factor of a section portion of the kit in which
other delivery system components (e.g., the housing) are disposed.
For example, the reservoir can be insulated (e.g., by enclosure in
an insulated material or compartment). In another example, the
reservoir can be disposed in a temperature controlled compartment
(e.g., in a refrigerated or heated compartment) within the kit. As
such, the kit is contemplated to include a reservoir containing one
or more of a variety of temperature-sensitive fluids, whether such
fluids are temperature-sensitive based on the fluid medium or a
drug, contrast agent, diagnostic agent, or other therapeutic agent
included therein. Additionally, because the reservoir and any
therapeutic fluid or agent contained therein can be
temperature-controlled, the shelf-life of the therapeutic fluid or
agent can be extended (or at least not be undesirably shortened).
In other words, the reservoir can be packaged within the kit in a
manner to limit degradation, deterioration, or reduced efficacy of
a drug, contrast agent, diagnostic agent, or other therapeutic
agent or fluid contained within the reservoir, such as may
otherwise occur in at an undesirable temperature.
[0102] In some embodiments, the reservoir is separately maintained
within the kit packaging in a manner to limit exposure of the
reservoir to undesirable movement, friction, or other displacement
that may otherwise occur during transportation of the kit (e.g.,
from a manufacturer). For example, because the reservoir can be in
the form of a flexible bladder or membrane, in some embodiments, a
kit includes a protective shell disposed about at least a portion
of the reservoir. The shell is configured to limit exertion of a
compressive force on the reservoir that could otherwise cause
premature release of the fluid contained therein. In another
example, the kit can include a cushion disposed about at least a
portion of the reservoir, or another component of the delivery
system, to absorb a shock from an impact that may occur during
transportation of the kit, e.g., from a manufacturer. In some
embodiments, at least one of the shell or cushion is removable
prior to placement of the reservoir within the housing (i.e., in
its second configuration). In other embodiments, at least one of
the shell or the cushion can remain disposed about at least a
portion of the reservoir when the reservoir is placed in its second
configuration.
[0103] Although the kit is described herein as including a housing
with an actuator and a cartridge assembly with a reservoir, in some
embodiments, a kit can include any combination of delivery system
components described herein. For example, in some embodiments, a
kit can also include at least one of a second actuator, a fluid
communicator, and one or more transfer structures. In some
embodiments, the kit can include the housing in an assembled
configuration (e.g., with coupled base and cover members), or in an
unassembled configuration (e.g., with uncoupled base and cover
members). Additionally, a kit can include more than one of any
delivery system component, including those components described
herein. For example, in some embodiments, a kit can include two or
more housings, two or more reservoirs, multiple actuators, and/or
two or more cartridge assemblies.
[0104] 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
and steps described above indicate certain events occurring in
certain order, those of ordinary skill in the art having the
benefit of this disclosure would recognize that the ordering of
certain steps may be modified and that such modifications are in
accordance with the variations of the invention. Additionally,
certain of the steps may be performed concurrently in a parallel
process when possible, as well as performed sequentially as
described above. The embodiments have been particularly shown and
described, but it will be understood that various changes in form
and details may be made.
[0105] For example, although various embodiments have been
described as having particular features and/or combinations of
components, other embodiments are possible having any combination
or sub-combination of any features and/or components from any of
the embodiments described herein. The specific configurations of
the various components can also be varied. For example, the size
and specific shape of the various components can be different than
the embodiments shown, while still providing the functions as
described herein. For example, in some embodiments, the first
transfer structure 516 can have a differently shaped cut-out 576 or
be differently sized such that no cut-out is needed. In another
example, although the electrochemical actuator 502 has been
illustrated and described herein as being included in the cartridge
assembly 532, in some embodiments, the electrochemical actuator can
be included in a different portion of the delivery device 500. For
example, the electrochemical actuator 502 can be coupled to the
housing (e.g., to the cover member 538) independent of the
cartridge assembly 532. As such, the cartridge assembly 532 can be
reconfigured (e.g., with an opening in its housing 534) to permit
the electrochemical actuator 502 to engage or otherwise exert its
force upon at least one of the second transfer structure 530 or the
fluid source 504 during actuation. In some embodiments, the second
transfer structure 530 can similarly be included in a different
portion of the delivery device 500, such as being coupled to the
housing 526 independent of the cartridge assembly 532.
* * * * *