U.S. patent application number 17/825017 was filed with the patent office on 2022-09-15 for wearable medication delivery device.
The applicant listed for this patent is Insulet Corporation. Invention is credited to David NAZZARO, Robert RIOUX.
Application Number | 20220288314 17/825017 |
Document ID | / |
Family ID | 1000006377509 |
Filed Date | 2022-09-15 |
United States Patent
Application |
20220288314 |
Kind Code |
A1 |
RIOUX; Robert ; et
al. |
September 15, 2022 |
WEARABLE MEDICATION DELIVERY DEVICE
Abstract
Systems and methods for delivering a medication to a person
experiencing an emergency medical event without requiring
intervention or action on the part of the person. A device encases
a reservoir of medication and a delivery mechanism. Sensors in the
housing sense a physical attribute of the person and circuitry
monitors information collected by the sensors to determine if the
person is experiencing a severe medical condition or event based on
the information. An input device on or in the housing, such as a
button, may be used or activated by the person if the detected
condition or event is a false positive to cancel further action. If
the system does not include the button or if the user does not
press it in time, the system activates the delivery device and
injects the medication into the person.
Inventors: |
RIOUX; Robert; (Ashland,
MA) ; NAZZARO; David; (Groveland, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Insulet Corporation |
Acton |
MA |
US |
|
|
Family ID: |
1000006377509 |
Appl. No.: |
17/825017 |
Filed: |
May 26, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16519349 |
Jul 23, 2019 |
11364341 |
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17825017 |
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15358945 |
Nov 22, 2016 |
10413665 |
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16519349 |
|
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62259706 |
Nov 25, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/581 20130101;
A61M 5/158 20130101; A61M 2205/3569 20130101; A61M 5/14526
20130101; A61M 2230/63 20130101; A61M 2230/06 20130101; A61M
2230/50 20130101; A61M 2205/276 20130101; A61M 5/1723 20130101;
A61M 2205/3368 20130101; A61M 2205/18 20130101; A61M 2205/587
20130101; A61M 2205/583 20130101; A61M 2230/20 20130101; A61M
2005/1585 20130101; A61M 2205/50 20130101; A61M 2205/8206 20130101;
A61M 2230/201 20130101; A61M 2205/52 20130101; A61M 2205/582
20130101; A61M 5/172 20130101; A61M 2230/30 20130101; A61M 5/14216
20130101; A61M 2205/502 20130101; A61M 2005/1586 20130101 |
International
Class: |
A61M 5/172 20060101
A61M005/172; A61M 5/142 20060101 A61M005/142; A61M 5/145 20060101
A61M005/145; A61M 5/158 20060101 A61M005/158 |
Claims
1. An on-body drug delivery device, comprising: a reusable first
portion including a motion sensor and a computer processor; and a
second portion including a needle, and a fluid reservoir for
storing liquid medication, wherein the first portion and the second
portion are releasably attached to one another, the motion sensor
is operable to capture acceleration information in three different
axes and to be in electrical communication with the computer
processor via a wired connection.
2. The drug delivery device of claim 1, wherein the second portion
further comprises: a power supply configured to supply power for a
minimum amount of time, wherein the adhesive member has adhesive
properties and the adhesive member is configured to lose some of
its adhesive properties over the minimum amount of time.
3. The on-body drug delivery device of claim 2, wherein the minimum
amount of time that the adhesive member loses some of its adhesive
properties is one day
4. The on-body drug delivery device of claim 1, wherein the first
portion further comprises: a power supply configured to supply
power for a minimum amount of time, wherein the adhesive member has
adhesive properties and the adhesive member is configured to lose
some of its adhesive properties over the minimum amount of
time.
5. The on-body drug delivery device of claim 3, wherein the minimum
amount of time that the adhesive member loses some of its adhesive
properties is at least 2 days.
6. The on-body drug delivery device of claim 1, wherein the second
portion is configured to be disposable and the first portion is
operable to be reusable with at least one new second portion.
7. The on-body drug delivery device of claim 1, wherein the second
portion further comprises: batteries and corresponding metal
elements coupled to the batteries, wherein the first portion
includes conducting metal elements that mate with the corresponding
metal elements in the second portion.
8. The on-body drug delivery device of claim 1, further comprises:
if the first portion and the second portion are separated, the
on-body drug delivery device is configured to be inoperable.
9. The on-body drug delivery device of claim 1, wherein the fluid
reservoir of the second portion is operable to dispense a quantity
of liquid medication through the needle.
10. The on-body drug delivery device of claim 1, wherein when the
first portion and the second portion are releasably attached to one
another, the first portion and the second portion are held together
by a friction fit or by tabs.
11. The on-body drug delivery device of claim 1, wherein when the
first portion and the second portion are releasably attached to one
another, one or both of the first portion.
12. The on-body drug delivery device of claim 1, wherein the first
portion and the second portion include a signal path then enables
the computer processor of the first portion to communicate with the
second portion.
13. The on-body drug delivery device of claim 1, further
comprising: a needle actuator configured to deploy the needle.
14. The on-body drug delivery device of claim 1, further
comprising: a plunger disposed in the fluid reservoir at an end of
the reservoir opposite the needle and configured to advance within
the reservoir toward the needle.
15. The on-body drug delivery device of claim 13, further
comprising: an electrochemical operable to exert a force on the
plunger, wherein the force causes the plunger to advance toward the
needle.
16. The on-body drug delivery device of claim 1, wherein the
reservoir further comprises: an elastic member that is configured
to exert a force on any liquid medication stored in the
reservoir.
17. The on-body drug delivery device of claim 1, wherein the
reservoir further comprises: a propellant that is configured to
exert a force on any liquid medication stored in the reservoir.
18. The on-body drug delivery device of claim 1, wherein: the
needle is disposed within the on-body drug delivery device.
19. The on-body drug delivery device of claim 1, further
comprising: a spring positioned proximal to the needle and
configured to force the needle into a body of a person upon
activation.
20. The on-body drug delivery device of claim 19, wherein the
spring is compressed against a surface within the on-body housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 16/519,349, filed on Jul. 23, 2019, which is a
Continuation of U.S. patent application Ser. No. 15/358,945, filed
on Nov. 22, 2016 (now U.S. Pat. No. 10,413,665), which claims
priority to U.S. Provisional Patent Application No. 62/259,706,
filed on Nov. 25, 2015, the entire contents of all applications are
incorporated herein by reference in their entirety.
TECHNICAL FIELD
[0002] Embodiments herein generally relate to medication delivery
and, more particularly, to wearable medication delivery devices for
providing medication to a user experiencing a severe medical
event.
BACKGROUND
[0003] Some medical situations require rapid delivery of a
medication to a person to avoid death or serious injury. For
example, if a person is exposed to a chemical warfare agent, such
as sarin gas, the person may require the administration of an
antidote such as atropine within a very short period of time.
Similarly, for someone having a bee-sting allergy, epinephrine must
be administered soon after a bee sting occurs. Other such medical
conditions or events that may require urgent attention can include
episodes caused by food allergies or epileptic attacks. Often,
there is not enough time to transport the afflicted person to a
care facility or even to bring a medical professional to the
person.
[0004] As a result, people required to be in zones in which
chemical warfare is a possibility, such as soldiers, and people who
are known to have medical conditions such as allergic reactions to
substances or events such as bee stings or foods are encouraged to
carry self-injector devices that permit the quick delivery of a
needed medication. These devices are typically about five inches
long, cylindrical, and resemble a large pen or magic marker. The
user holds one end of the self-injector on an injection site (e.g.,
the thigh of a leg) and a predetermined amount of medication is
automatically injected. One such device is sold under the trade
name EPIPEN.
[0005] Use of these devices presents a number of drawbacks,
however. The user is required to know both how to operate the
device and when to operate the device. Improper operation may
result in little or no medication actually injected and improper
timing may result in injection occurring too late. Furthermore, the
user must be conscious and capable of performing the
self-injection. Because some chemical agents and allergic reactions
cause seizures, the user may be incapable of performing the
self-injection due to seizing before the person even realizes that
an attack or allergen exposure has occurred. A need therefore
exists for a system and method to deliver antidotes and other
medication even if or when a user is incapable of doing so.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] In the drawings, like reference characters generally refer
to the same parts throughout the different views. In the following
description, various embodiments of the present invention are
described with reference to the following drawings, in which:
[0007] FIG. 1 illustrates a first exemplary wearable device for
delivering medication.
[0008] FIGS. 2A and 2B illustrate a second exemplary wearable
device for delivering medication.
[0009] FIGS. 3A and 3B illustrate a third exemplary wearable device
for delivering medication.
[0010] FIGS. 4A and 4B illustrate first and second views of a first
exemplary needle deployment system.
[0011] FIGS. 4C and 4D illustrate first and second views of a
second exemplary needle deployment system.
[0012] FIG. 5 is a block diagram of an exemplary medication
delivery device.
[0013] FIG. 6 illustrates a first method for delivering
medication.
[0014] FIG. 7 illustrates a second method for delivering
medication.
DETAILED DESCRIPTION
[0015] Various embodiments described herein include systems and
methods for delivering a medication to a person exposed or
subjected to an emergency medical event without requiring
intervention or action on the part of the person. The event may be
a chemical-weapon attack, bee sting, allergic reaction, epileptic
attack, or any other event. In some embodiments, a pod or housing
encases a reservoir of medication and a delivery device, such as a
hypodermic needle. The housing is held in contact with or in close
proximity to a body part of a person, such as the person's thigh,
via an adhesive, strap, pouch, or any similar means. Sensors in the
housing, such as motion sensors, accelerometers, biosensors, or any
other type of sensor, sense a physical attribute of the person,
such as the motion and/or biochemistry of the person, and a
computer processor (and associated circuitry) monitor information
collected by the sensors and determine if the person is
experiencing a medical event, such as a seizure or allergic attack,
based on the information. The housing may further include an output
communications device, such as a loudspeaker, vibration generator,
thermal indicator, or electric-shock dispenser, that signals to the
person that a seizure or other severe medical condition or events
has been detected. An input device on or in the housing, such as a
button, may be used or activated by the person in response to the
signal if the detected condition or event is a false positive to
cancel further action. If the system does not include the button or
if the user does not press it in time, the system activates the
delivery device and injects the medication into the person.
[0016] FIG. 1 illustrates a wearable device 100 for delivering
medication to a wearer or user of the wearable device 100. A
housing 102 may be used to enclose a hypodermic needle, needle
actuator, medication reservoir, motion sensor, medical condition
sensor, environmental sensor, computer processor, and/or other
elements, components, or devices described herein. The housing 102
may be made of metal, plastic, or any other material or any
combination thereof. In some embodiments, the housing 102 can
include a detachable portion 104 that includes one or more enclosed
components, as described in greater detail below. The housing 102
may further, in some embodiments, be attached on one side to an
adhesive member 106 that facilitates attachment to a person's body.
The adhesive member 106 may be made of one or more flexible
materials such as gauze, fabric, rubber, latex, or any other
material, which may be arranged in one or more layers. An adhesive
substance may be disposed on one side of the adhesive member 106. A
person may, for example, first remove a non-adhesive layer affixed
to the adhesive substance to thereby expose the adhesive substance
and then adhere the adhesive member 106 to his or her body. In
other embodiments, the housing 102 can be held in place touching or
adjacent to a person's body via use of a strap, pouch, or similar
means, and the adhesive member 106 may not be present or
needed.
[0017] FIGS. 2A and 2B illustrate a wearable device 200 configured
in two parts. The wearable device 200 can represent a particular
implementation of the wearable device 100 of FIG. 1. The wearable
device 200 can include a first portion 202 (shown in FIG. 2A) and a
second portion 204 (shown in FIG. 2B). The first portion 202 can
include a number of components such as, for example, a motion
sensor and a computer processor. In various embodiments, the first
portion 202 can further include a medical condition sensor and/or
an environmental sensor. The second portion 204 can include an
adhesive member 206, batteries 208, a needle unit 210, and a needle
212. The adhesive member 206 can represent an implementation of the
adhesive member 106 depicted in FIG. 1. In some embodiments,
however, the first portion 202 can be a cover to protect the
components disposed in the second portion 204 and does not itself
house any components. The components may be apportioned such that
one portion (e.g., the first portion 202) is re-usable, while some
or all of the perishable components (e.g., the medication and
batteries) are in the second portion 204. The person using the
system may therefore need to replace only the second portion 204
upon expiration of the medication and/or battery.
[0018] The first and second portions 202 and 204 may be configured
to releasably attach to each other, as shown in FIG. 2. The first
and second portions 202 and 204 may be held in place together by
friction (e.g., friction fit), by tabs, by screws, or by any other
means of attachment. In some embodiments, the first and second
portions 202 and 204 are configured to allow any person to separate
them. In other embodiments, the first and second portions 202 and
204 are configured to allow only qualified persons (e.g., medical
professionals) to separate them by using, for example, a locking
mechanism, screws or bolts with specially-shaped heads, or similar
means. In some embodiments, the first and second portions 202 and
204 include a sticker, thread, or similar tell-tale that indicates
whether the first and second portions 202 and 204 have been
separated by snapping, breaking, or moving (e.g., one or more of
the first and second portions 202 and 204 may include a tamper
evident device or mechanism indicating when the first and second
portions 202 and 204 have been separated). The first and second
portions 202 and 204 may further include a self-destruct or
disabling mechanism that can be triggered if the first and second
portions 202 and 204 are separated or separated improperly.
[0019] The batteries 208 may be used to provide power to the needle
unit 210 and may be AA or AAA cell batteries, watch batteries,
rechargeable batteries, or any other type or number of batteries
(including a single cell battery). In some embodiments, the
batteries 208 also or instead provide power to components within
the first portion 202. For example, the first portion 202 may have
conducting metal elements that mate with corresponding metal
elements in the second portion 204 when the first and second
portions 202 and 204 are attached to each other, thereby enabling
power from the batteries 208 to be provided to components in the
first portion 202. The first portion 202 may also or instead have
conducting metal elements that contact the batteries 208 themselves
(e.g., directly) to thereby supply power to components therein. In
other embodiments, the first portion 202 includes another power
supply (e.g., one or more additional batteries).
[0020] The first and second portions 202 and 204 may similarly have
data or signal connectors that form a data or signal path when the
first and second portions 202 and 204 are attached together to
thereby permit the transmission of data or signals there between.
For example, the first portion 202 may have a connector with pins
that mates with a socket on the second portion 204 when the first
and second portions 202 and 204 are attached to each other. This
data or signal path may be used to, for example, communicate
between a processor disposed in the first portion 202 and the
needle unit 210 in the second portion 204.
[0021] The needle unit 210 may include a fluid reservoir for
storing and/or dispensing a quantity of liquid medication or drug.
In some embodiments, the fluid reservoir can be a cylinder or
similar shape having a cross-sectional shape of a circle, oval,
rectangle, square, or any other shape. In these embodiments, the
needle 212 can be fluidly connected to one end of the cylinder, and
a plunger can be disposed at the other end of the cylinder. The
medicine or drug may be dispensed through the needle 212 via
mechanical or electro-mechanical means, such as an electric motor
that turns a gear that advances the plunger. The plunger may
alternatively be driven by electrochemical means, such as by
causing the creation or expansion of a gas by applying an electric
current to a substance to thereby exert a force on the plunger. In
other embodiments, the fluid reservoir can exert a force on the
liquid medicine disposed therein. For example, one or more inner
walls of the fluid reservoir may include an elastic member that is
stretched such that it exerts a force on the liquid (e.g., an
elastic bladder). A propellant may alternatively be added to the
fluid reservoir to exert force on the liquid. In these embodiments,
instead of or in addition to a plunger, the needle unit 210 can
include a valve that, once open, permits the liquid under pressure
to exit the fluid reservoir and travel through the needle 212.
[0022] FIGS. 3A and 3B illustrate a wearable device 300. The
wearable device 300 can represent another embodiment of a
medication delivery device of the present invention. In this
embodiment, as shown in FIG. 3A, a needle 302 can be part of a
first portion 304 of the wearable device 300 (as opposed to being
part of the second portion 204 as shown in the embodiment of FIG.
2B). A second portion 306 of the wearable device 300 can include
batteries 308 and an adhesive member 310. The present invention is
not limited to any particular division of components between the
two portions 302 and 306 as any division or placement of any
constituent components is within the scope of the wearable devices
described. In addition, other embodiments of the present invention
can include additional portions (e.g., more than two portions) or
fewer portions (e.g., a single portion such that the housing/entire
wearable device is provided as a single piece).
[0023] FIGS. 4A and 4B illustrate top and side views, respectively,
of an exemplary system 400 for deploying a needle disposed within a
wearable device of the present invention (such as one of the
wearable devices 100, 200, or 300) into the body of a person for
subsequent dispensing of a medication or drug there through. In
this embodiment, a needle driver 402 is under load of a spring 404
that is compressed between the needle driver 402 and another
surface 406. The surface 406 may be part of a housing, attached to
a housing, or may be any other surface of a wearable device as
described herein. One or more keys 408 can hold the needle driver
402 in place and prevent the spring 404 from expanding to propel
the needle driver 402 forward. Protrusions 410 in the keys 408 can
mate with corresponding notches 412 in the needle driver 402. The
needle driver 402, the spring 404, the surface 406, and the keys
408 may be constructed using any material, such as metal or
plastic. The needle driver 402 may be a medication reservoir or act
as a fluid conduit between a separate medication reservoir and the
needle.
[0024] The keys 408 may be moved to thereby release the needle
driver 402 and allow the spring 404 to move it, thereby propelling
a needle 414 attached to the needle driver 402 forward in response
to a signal. Additional support members may be included to guide
the needle driver 402 and/or keys 408 such that they move only in
one dimension or direction (or otherwise restrict the movement of
the needle driver 402 and/or keys 408). As explained in greater
detail below, an actuation signal may be generated by a processor
that, in response to data collected by a sensor (such as a motion
sensor or biosensor), determines that the person wearing the device
is experiencing a medical event such as a seizure or allergic
attack. In various embodiments, an electrically deformable material
416, such as shape-memory wire made from, for example,
copper-aluminum-nickel or nickel-titanium alloys, can be disposed
around the needle driver 402 and through holes 418 in the one or
more keys 408. Any other type of electrically deformable material,
such as magnetic-shape memory, piezoelectric materials, or
shape-memory polymer, is within the scope of the present invention.
When the signal to release the keys 408 is received, an electric
current can be provided to run through electrically deformable
material 416, thereby causing it to change shape. For example, the
diameter of the electrically deformable material 416 may increase
when the current is applied, thereby causing the keys 408 to move
away from the needle driver 402 such that the protrusions 410 no
longer mate with the notches 412. In other embodiments, the
electrically deformable material 416 may be configured to decrease
in length when current is applied. In these embodiments, the
electrically deformable material 416 can be positioned to pull the
keys 408 away from the needle driver 402 to thereby release it. Any
configuration of electrically deformable material and keys is
within the scope of the present invention as will be understood by
one of skill in the art. Further, any other system and method of
mechanically actuating a needle to extend into the body of the
person in response to a received electric or electronic signal is
similarly within the scope of the present invention.
[0025] FIGS. 4C and 4D illustrate top and side views, respectively,
of a second exemplary system 450 for deploying a needle disposed
within a wearable device of the present invention (such as one of
the wearable devices 100, 200, or 300) into the body of a person
for subsequent dispensing of a medication or drug there through. In
this embodiment, an electrically deformable material 452 can be
connected to keys 454 and can run over pulleys 456. When the
electrically deformable material 452 is shortened (e.g., in
response to an actuation signal), the electrically deformable
material 452 can exert a force on each key 454 in a radial outward
direction with respect to needle driver 458. By doing so, the keys
454 can be moved away from the needle driver, thereby no longer
restricting movement of the needle drive 458. As a result, the
needle driver can move as described above in relation to needle
driver 402. As shown in FIG. 4D, a hook 460 may be used to connect
the electrically deformable material 452 to a power source. The
hook 460 may also be used to anchor the electrically deformable
material 452 such that, when power is applied to the electrically
deformable material 452, both of the keys 454 separate away from
the needle driver 458. If, for example, the electrically deformable
material 452 were unanchored and if one key 454 were subject to a
greater frictional force with respect to the needle driver 408 than
the other key 454, contracting the electrically deformable material
452 might move only one key 454, and the needle driver 408 might
not be free to move. In other embodiments, separate, unconnected
electrically deformable materials 452 can be provided for each key
454. The systems 400 and 450 depicted in relation to FIGS. 4A-4D
can include any number of keys (e.g., as few as a single key or two
or more keys).
[0026] FIG. 5 is a block diagram of a medication delivery device
500 in accordance with embodiments of the present invention. The
medication delivery device 500 can represent an implementation of
the wearable devices 100, 200, and 300 described herein. A housing
502 can include a needle 504 that can be configured to extend into
the body of a wearer and dispense medication from a reservoir 506.
An adhesive material or substance 508 can be attached to one side
of the housing 502. The adhesive 502 may be used to attach the
housing 502 to the body of a person.
[0027] A computer processor 510 may execute software instructions
stored in a memory 512. The processor 510 may be, for example, a
general-purpose processor, a digital-signal processor, an
application specific integrated circuit (ASIC), or any other type
of digital logic. The processor 510 may also or instead include
analog or mixed-signal circuitry that does not require the
execution of software instructions to carry out the methods
described herein. The memory 512 may volatile or non-volatile and
may be a random access memory (RAM), read only memory (ROM), flash
memory, solid-state storage, and/or magnetic storage. The software
instructions may include assembly code written directly or compiled
from a higher-level language, such as C or JAVA. The computer
processor 510 can be considered to be a controller for directing
operations and functionality of the medication delivery device 500
overall and the constituent components thereof.
[0028] A movement sensor 514 detects movement of the housing 502
and, by extension, movement of the person to whom the housing 502
is attached. Any type of movement sensor is within the scope of the
present invention, and the movement sensor 514 may detect position,
velocity, acceleration, jerk, orientation, rotation, or any other
similar movement type. In some embodiments, the movement sensor 514
can include three microelectromechanical systems (MEMS) capacitors
oriented to capture acceleration information on x, y, and z axes.
The movement sensor 514 can be in electrical communication with the
processor 510 via, for example, wires or a bus. The processor 510,
memory 512, and the movement sensor 514 are depicted as separate
components but are not so limited. The present invention is not
limited to only this arrangement of components as two or more of
these components may be combined, such as in a system-on-a-chip
arrangement.
[0029] A power supply 516 supplies power to the processor 510,
memory 512, movement sensor 514, and/or any other components in or
on the housing 502 that require power. As mentioned above, the
power supply 516 may include one or more cells or batteries, which
may be single-use or rechargeable. The power supply 516 may be
configured to supply power to the system 500 for a certain minimum
amount of time, e.g., one day, two days, or three days. The
adhesive 508 may be configured or selected such that it loses some
or all of its adhesive properties before this minimum power-supply
time, thus prompting the person to replace the system 500 with a
new one.
[0030] As mentioned above, the processor 510 can determine whether
the person is having a seizure by monitoring data received from the
movement sensor 514. Any method of seizure detection is within the
scope of the present invention. In some embodiments, the processor
510 executes software instructions that calculate the direction,
velocity, duration, and/or frequency of the person's movements and
compares these factors against thresholds. If the factors exceed
one or more thresholds, the processor 510 determines that the
person is having a seizure or experience some other serious medical
event and sends a signal to a needle actuator 518 to deploy the
needle 504 and dispense the medication in the reservoir 506. In
some embodiments, for example, if the processor 510 detects a
certain number of rapid, back-and-forth movements made by the
person within a certain period of time, the processor can determine
that the person is having a seizure. The processor 510 may further
detect if the person falls to the ground before, during, or after
the back-and-forth movements as further evidence of a seizure.
[0031] The housing may further include devices for the input of
information, such as a button 520, or the output of information,
such as speaker/vibrator 522. In some embodiments, if the processor
510 detects a seizure, before signaling the needle actuator 518 to
activate, the processor can determine to alert the person using the
output device 522 by sounding an alarm and/or causing vibrations.
In other embodiments, the output device 522 delivers heat or an
electric shock to the body of the person to thereby alert the
person. If the person is not having a seizure and presses the
button 520 within a certain amount of time (e.g., ten seconds), the
processor 510 can cancel deployment of the needle 504. In such
instances, the button 520 can operate as an override or false alarm
input. In some embodiments, the processor 510 adjusts one or more
thresholds in response to the pressing of the button to thereby
reduce or prevent false positives in the future.
[0032] The needle actuator 518 may represent the system 400 or 450
described above with reference to FIGS. 4A-4D or may be any other
system for deploying the needle 504 and/or dispensing the
medication in the reservoir 506. The needle 504, reservoir 506, and
needle actuator 518 are depicted as separate components in this
embodiment, but in other embodiments two or more of these
components may be integrated together as the present invention is
not limited to any particular arrangement or combination of
components.
[0033] Embodiments of the present invention are not limited to only
the above-described components as other components and features are
within its scope. For example, a network interface 524 may be used
to communicate between the system 500 and other systems, such as
remote computing devices, servers, or cellular phones. For example,
a remote system may transmit a message to the device 500 via any
wired or wireless networking protocol, such as WI-FI, ETHERNET,
BLUETOOTH, NFC, GSM/CDMA or other cellular networks/standards, that
is received using the network interface 524. The message may cause
the processor 510 to automatically deploy the needle 504 and
medication, cause an output device 522 to beep or vibrate, disable
the device 500, or perform any other action.
[0034] An environment sensor 526 may be used instead of or in
addition to the movement sensor 514. The environment sensor 526 may
sample air, water, particles, or other characteristics in a
surrounding environment of the device 500 for potentially harmful
substances, such as sarin gas. If the environment sensor 526
detects such a substance, it sends a signal to the processor 510,
which may deploy the needle 504 in response as described above.
[0035] The medication delivery device 500 may also include one or
more medical condition sensors (not shown in FIG. 5). The medical
condition sensors can measure characteristics of the user such as,
for example, pulse rate, blood pressure, temperature, glucose
levels, and oxygen levels. Separately, or in conjunction with
movement sensor 514 and/or the environmental sensor 526, a medical
condition sensor can send a signal to the processor 510, which may
deploy the needle 504 in response to a severe medical condition
being experienced by the user. In general, the medication delivery
device 500 can include any number and any type of sensors including
sensors for collecting information regarding one or more physical
attributes of a user (e.g., motion of a user, etc.), one or more
medical conditions of a user (e.g., heart rate, blood pressure,
temperature, etc.), and/or one or more conditions of an environment
of a user (e.g., presence of a gas or other toxin, temperature,
oxygen level, etc.). Such sensors can be, for example, biosensors
(e.g., for collecting biochemical data), environmental sensors,
motions sensors, or a medical condition sensor.
[0036] The output device 522 can provide a visual or audible alarm
to a user. For example, the output device 522 can include one or
more visual device--e.g., light emitting diodes (LEDs)--for
indicating an alarm. Under such a scenario, the output device 522
can flash one or more LEDs to indicate an alarm and/or can indicate
an alarm by a particular color provided by one or more LEDs. The
output device 522 can also include a speaker for providing an
audible alarm. Further, the output device 522 can include a
vibrator for vibrator all or a portion of the medication delivery
device 500. As the medication delivery device 500 is directly in
physical contact with a user, a vibrational alarm can be quickly
detected by the user in a discrete manner. The output device 522
can be or include other components for providing an alarm
including, for example, thermal actuator or electrical
stimulator.
[0037] The reservoir 506 can contain one or more medications or
drugs stored in one or more reservoir chambers such that the
medication delivery device 500 can respond to one or more different
medical events that can be experienced by a user. In various
embodiments, the reservoir 506 can store is firazyr, icatibant,
epinephrine, atropine, biperiden, and/or pralidoxime. In various
embodiments, the medication delivery device 500 can determine a
user is experiencing a severe medical event such as exposure to a
chemical warfare weapon (e.g., a gas or other toxin), a seizure, an
allergic reaction, and an epileptic attack (with any such condition
or event caused by exposure to one or more conditions of an
environment occupied by the user).
[0038] In various embodiments, the medication delivery device 500
can use one or more sensors (e.g., the sensors 514 and/or sensors
526) to sense or detect a physical attribute of a person (e.g., a
motion of a user and/or a medical condition such as heart rate of a
user) and/or a condition of an environment occupied by a user
(e.g., a temperature of the environment and/or the presence of a
chemical warfare weapon or gas or other toxin). A controller of the
medication delivery device 500 (e.g., the processor 510) can use
information collected and provided by the one or more sensors to
determine if the user is experiencing a severe medical event. If
so, the controller can direct or cause a medication to be
automatically delivered to a user (e.g., by way of the needle
actuator 518 in conjunction with the needle 504 and reservoir 506).
The delivery of the responsive medication is intended to offset the
medical event being experienced by the user. Further, the
medication is provided automatically such that a user need not
actively take steps to ensure delivery of the medication (e.g., to
ensure delivery of the medication in situations where the user is
unable or incapable of physically manipulating a medication
delivery system).
[0039] Once a determination is made by the controller that a user
is experiencing a medical event, the controller can provide an
alarm as discussed above to the user. Within a predetermined amount
of time after the determination is made and/or the alarm is
provided, the controller can cause or direct the needle actuator
518 to inject the user. The predetermined amount of time (e.g., the
wait time or delay time) can vary for different determined medical
conditions and/or determined severity of any particular medical
event. During this delay or wait time, a user can press a button
520 or other input device to cancel or prevent the automatic
injection of the user. If no input is received by the medication
delivery device 500 during the delay time, then injection of the
user can occur at the end of the predetermined amount of time.
[0040] If a user overrides automatic injection and delivery of the
medication (e.g., for a false alarm event), then the controller 510
can adjust one or more thresholds associated with detection and
determination of medical events. That is, a relatively higher
threshold can be required for medical events in order to trigger
the automatic response. These higher thresholds could include more
motion, more severe motion, more jerky motion, higher levels of
detected toxins, and/or higher medical condition readings (e.g.,
higher heart rates, higher blood pressure) which would need to be
met or exceeded before determining any subsequent medical event
after false alarm reporting by the user. In essence, thresholds
associated with determining instances of a medical event based on
information collected by the sensors can be adjusted in response to
a false reporting by a user (e.g., so as to reduce the likelihood
of a false alarm event in the future). In various embodiments, any
override by the user can itself be overridden based on a signal
received remotely over the network interface 524. For example, an
accidental cancellation of an automatic injection of the user can
be overridden by remote observation and direction provide through
the network interface 524.
[0041] Each of the components shown in the medication delivery
device 500 can be physically and/or electrically coupled together.
For example, the controller 510 can be coupled electrically to the
sensors 514 and 526, the network interface 524, the button 520, the
output device 522, the memory 512, and the needle actuator 518 to
enable communication and/or control information, signals, and
instructions to be provided therebetween. Further, the needle
actuator 518 can be physically coupled to the needle 504 and the
reservoir 506.
[0042] FIG. 6 illustrates a method 600 for delivering a medication
in accordance with embodiments of the present invention. The method
600 can be implemented by the wearable devices 100, 200, and 300
described above or by the medication delivery device 500 described
above. In a first step 602, input from a sensor representing a
position, velocity, acceleration, or jerk of the person is
received. In a second step 604, it is computationally determined
that the patient is experiencing a seizure (or other severe medical
event) based on the received input. In an optional third step 606,
the person is prompted to identify a false positive prior to
triggering mechanical actuation. In a fourth step 608, mechanical
actuation of the medication delivery is triggered based on the
determination.
[0043] FIG. 7 illustrates a method 700 for delivering a medication
in accordance with embodiments of the present invention. The method
700 can be implemented by the wearable devices 100, 200, and 300
described above or by the medication delivery device 500 described
above. In a first step 702, input from a sensor representing a
physical attribute of the person is received. In a second step 704,
it is computationally determined that the patient is experiencing a
medical event based on the received input. As an example, the
received input can include inputs received remotely, or inputs from
an environment sensor, a movement sensor, and/or a medical
condition sensor. In an optional third step 706, the person is
prompted to identify a false positive prior to triggering
mechanical actuation. In a fourth step 708, mechanical actuation of
the medication delivery is triggered based on the
determination.
[0044] Certain embodiments of the present invention were described
above. It is, however, expressly noted that the present invention
is not limited to those embodiments, but rather the intention is
that additions and modifications to what was expressly described
herein are also included within the scope of the invention.
Moreover, it is to be understood that the features of the various
embodiments described herein were not mutually exclusive and can
exist in various combinations and permutations, even if such
combinations or permutations were not made express herein, without
departing from the spirit and scope of the invention. In fact,
variations, modifications, and other implementations of what was
described herein will occur to those of ordinary skill in the art
without departing from the spirit and the scope of the invention.
As such, the invention is not to be defined only by the preceding
illustrative description.
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