U.S. patent application number 17/201992 was filed with the patent office on 2021-07-01 for apparatus and methods for tracking administering of medication by medication injection devices.
The applicant listed for this patent is Verily Life Sciences LLC. Invention is credited to Benjamin David Krasnow, Russell Mirov, Brett Schleicher.
Application Number | 20210202060 17/201992 |
Document ID | / |
Family ID | 1000005459630 |
Filed Date | 2021-07-01 |
United States Patent
Application |
20210202060 |
Kind Code |
A1 |
Mirov; Russell ; et
al. |
July 1, 2021 |
APPARATUS AND METHODS FOR TRACKING ADMINISTERING OF MEDICATION BY
MEDICATION INJECTION DEVICES
Abstract
A medication injection device including a plunger, a temperature
sensor, an antenna, and a controller is described herein. The
plunger is configured to dispense medication. The temperature
sensor is to measure a temperature representative of an ambient
temperature of the medication injection device. The antenna is to
pair the medication injection device with a remote device. The
controller includes logic that when executed causes the medication
injection device to perform operations, including placing the
medication injection device into a low-power sleep mode, measuring
the temperature with the temperature sensor at a regular interval
while the medication injection in the low-power sleep mode,
detecting a temperature change with the temperature sensor while in
the low-power sleep mode, transitioning the medication injection
device into an initialization mode in response, and pairing the
medication injection device with the remote device using the
antenna while in the initialization mode.
Inventors: |
Mirov; Russell; (Los Altos,
CA) ; Krasnow; Benjamin David; (Redwood City, CA)
; Schleicher; Brett; (San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Verily Life Sciences LLC |
South San Francisco |
CA |
US |
|
|
Family ID: |
1000005459630 |
Appl. No.: |
17/201992 |
Filed: |
March 15, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15499037 |
Apr 27, 2017 |
|
|
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17201992 |
|
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62329605 |
Apr 29, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2230/201 20130101;
A61M 2205/3368 20130101; A61M 5/142 20130101; A61M 2205/6054
20130101; A61M 2205/50 20130101; A61M 2205/52 20130101; A61M
2205/6063 20130101; A61M 2205/3553 20130101; G16H 20/17 20180101;
A61M 5/315 20130101; G16H 40/63 20180101; A61M 2205/3592 20130101;
A61M 2207/00 20130101; A61M 2205/33 20130101; A61M 2205/3584
20130101; G16H 40/40 20180101; A61M 5/31568 20130101; A61M 5/31511
20130101; A61M 2205/587 20130101; A61M 2205/3375 20130101 |
International
Class: |
G16H 20/17 20060101
G16H020/17; A61M 5/315 20060101 A61M005/315; G16H 40/63 20060101
G16H040/63; G16H 40/40 20060101 G16H040/40; A61M 5/142 20060101
A61M005/142 |
Claims
1. A medication injection device, comprising: a plunger configured
to dispense medication from the medication injection device when
the plunger is depressed; a temperature sensor coupled to the
plunger to measure a temperature representative of an ambient
temperature of the medication injection device; an antenna to pair
the medication injection device with a remote device; a controller
coupled to the temperature sensor and the antenna, wherein the
controller includes logic that when executed by the controller
causes the medication injection device to perform operations
including: placing the medication injection device into a low-power
sleep mode; measuring the temperature with the temperature sensor
at a regular interval while the medication injection in the
low-power sleep mode; detecting a temperature change with the
temperature sensor while in the low-power sleep mode; transitioning
the medication injection device into an initialization mode, in
response to the temperature change; and pairing the medication
injection device with the remote device using the antenna while in
the initialization mode.
2. The medication injection device of claim 1, wherein a power
consumption of the medication injection while in the low-power
sleep mode is less than when the medication injection device is in
the initialization mode or an operational mode.
3. The medication injection device of claim 1, wherein the
controller includes additional logic that when executed by the
controller causes the medication injection device to perform
further operations including: transitioning the medication device
from the initialization mode to an operational mode in response to
a successful pairing of the medication device with the remote
device; and measuring and logging a plunger head position of the
medication injection device while the medication injection device
is in the operational mode.
4. The medication injection device of claim 3, wherein the
controller includes additional logic that when executed by the
controller causes the medication injection device to perform
further operations including: transitioning the medication
injection device to the low-power sleep mode when after a period of
inactivity.
5. The medication injection device of claim 4, wherein the period
of inactivity corresponding to no measurable change in position of
the plunger head position over a period of time.
6. The medication injection device of claim 3, wherein the
controller includes additional logic that when executed by the
controller causes the medication injection device to perform
further operations including: transitioning the medication
injection device from the operational mode to the low-power sleep
mode when a subsequent temperature change is detected, wherein the
subsequent temperature change corresponds to a decrease in the
ambient temperature.
7. The medication injection device of claim 1, wherein the
temperature change corresponds to an increase in temperature from a
storage temperature to a room temperature.
8. The medication injection device of claim 1, wherein the
controller includes additional logic that when executed by the
controller causes the medication injection device to perform
further operations including: transitioning the medication
injection device directly from the low-power sleep mode to an
operational mode if a successful pairing with the remote device has
already occurred; and measuring and logging a plunger head position
of the medication injection device while the medication injection
device is in the operational mode.
9. The medication injection device of claim 1, further comprising a
transducer coupled to the controller to measure a plunger head
position of the medication injection device.
10. The medication injection device of claim 9, wherein the
controller includes additional logic that when executed by the
controller causes the medication injection device to perform
further operations including: transitioning the medication device
from the initialization mode to an operational mode in response to
a successful pairing of the medication device with the remote
device; and measuring and logging the plunger head position of the
medication injection device while the medication injection device
is in the operational mode using the transducer.
11. The medication injection device of claim 1, wherein the
controller includes additional logic that when executed by the
controller causes the medication injection device to perform
further operations including: transitioning the medication device
from the initialization mode to an operational mode in response to
a successful pairing of the medication device with the remote
device; monitoring the temperature during each of the low-power
sleep mode, the initialization mode, and the operational mode; and
transmitting an alert when the temperature goes outside of an
acceptable range of temperature.
12. The medication injection device of claim 11, wherein the alert
corresponds to an auditory alert emitted by the medication
injection device.
13. The medication injection device of claim 11, wherein the alert
is transmitted to the remote device.
14. The medication injection device of claim 11, wherein the
medication injection device further includes a display coupled to
the controller, and wherein the transmitting of the alert
corresponds to displaying a visual indicator on the display.
15. At least one machine-accessible storage medium that provides
instructions that, when executed by a medication injection device,
will cause the medication injection device to perform operations
comprising: placing the medication injection device into a
low-power sleep mode; measuring a temperature with a temperature
sensor at a regular interval while the medication injection in the
low-power sleep mode, wherein the temperature is representative of
an ambient temperature of the medication injection device;
detecting a temperature change with the temperature sensor while in
the low-power sleep mode; transitioning the medication injection
device into an initialization mode, in response to the temperature
change; and pairing the medication injection device with the remote
device using the antenna while in the initialization mode.
16. The at least one machine-accessible storage medium of claim 15,
that provides additional instructions that, when executed by the
medication injection device, will cause the medication injection
device to perform further operations including: transitioning the
medication device from the initialization mode to an operational
mode in response to a successful pairing of the medication device
with the remote device, and wherein a power consumption of the
medication injection while in the low-power sleep mode is less than
when the medication injection device is in the initialization mode
or the operational mode; and measuring and logging a plunger head
position of the medication injection device while the medication
injection device is in the operational mode.
17. The at least one machine-accessible storage medium of claim 15,
wherein the medication injection device enters the low-power sleep
mode as part of a manufacturing and testing process for the
medication injection device.
18. The at least one machine-accessible storage medium of claim 15,
that provides additional instructions that, when executed by the
medication injection device, will cause the medication injection
device to perform further operations including: transitioning the
medication injection device to the low-power sleep mode when after
a period of inactivity, wherein the period of inactivity
corresponding to no measurable change in position of the plunger
head position over a period of time.
19. The at least one machine-accessible storage medium of claim 15,
that provides additional instructions that, when executed by the
medication injection device, will cause the medication injection
device to perform further operations including: transitioning the
medication injection device directly from the low-power sleep mode
to an operational mode if a successful pairing with the remote
device has already occurred; and measuring and logging a plunger
head position of the medication injection device while the
medication injection device is in the operational mode.
20. The at least one machine-accessible storage medium of claim 15,
that provides additional instructions that, when executed by the
medication injection device, will cause the medication injection
device to perform further operations including: transitioning the
medication device from the initialization mode to an operational
mode in response to a successful pairing of the medication device
with the remote device; measuring and logging a plunger head
position of the medication injection device while the medication
injection device is in the operational mode; monitoring the
temperature during each of the low-power sleep mode, the
initialization mode, and the operational mode; and transmitting an
alert when the temperature goes outside of an acceptable range of
temperature.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 15/499,037, filed on Apr. 27, 2017, which
claims the benefit of U.S. Provisional Application No. 62/329,605,
filed Apr. 29, 2016, the contents of all of which are hereby
incorporated by reference in its entirety.
BACKGROUND
Technical Field
[0002] The present disclosure relates generally to the field of
tracking the administration of medication, and more particularly,
apparatus and methods for tracking the administration of medication
by medication injection devices.
Background Description
[0003] Measuring the quantity and recording the timing of a drug's
administration is an integral part of many disease treatments. For
many treatments, to achieve the best therapeutic effect, specific
quantities of a drug may need to be injected specific times of day.
For example, individuals suffering from diabetes may be required to
inject themselves regularly throughout the day in response to
measurements of their blood glucose. The frequency and volume of
insulin injections must be carefully tracked and controlled to keep
the patient's blood glucose level within a healthy range.
Currently, there are a limited number of methods or devices for
automatically tracking the drug administration without requiring
the user to manually measure and record the volume, date, and time.
A variety of glucose injection syringes/pens have been developed,
but there is much room for significant advancement in the
technology in order to reduce the size, lower the cost, and
enhanced the functionality thus making them a more viable long term
solution. For example, current insulin pens are often disposable,
but do not include dosage tracking. A smaller portion of the market
is composed of reusable pens which are more expensive, and still
don't include good dosage tracking capabilities.
SUMMARY
[0004] The present disclosure is directed to apparatuses and
methods of drug administration using a medication injection
device.
[0005] In one aspect, the present disclosure is directed to a
plunger head for a medication injection device. The plunger head
may include a first component that houses electronic components and
a second component that couples to the first component to form the
plunger head. When the plunger head is installed within a barrel of
the medication injection device the second component may separate
the first component from medication contained within the
barrel.
[0006] In another aspect, the present disclosure is directed to a
method of manufacturing a plunger head for a medication injection
device. The method may include assembling a first component of the
plunger head, which houses electronic components, using lower
temperature assembly steps. The method may also include sterilizing
the first component using a lower temperature sterilization method.
The method may further include molding a second component of the
plunger head from an elastomer to define a bucket shape. The method
may also include sterilizing the first component using a higher
temperature sterilization method. The method may further include
attaching the first component to the second component to form the
plunger head.
[0007] In another aspect, the present disclosure is directed to
another plunger head for a medication injection device. The plunger
head may include a transducer that sends and receives ultrasonic
signals, an antenna, and a microcontroller that interfaces with the
transducer and the antenna. The plunger head may also include a
power source that powers the microcontroller and the transducer.
The microcontroller may be programmed with instructions to
calculate data representative of the quantity of medication
dispensed from the barrel and transmit the data to a remote device
via the antenna and to automatically differentiate an air shot of
medication versus an injection of medication.
[0008] In another aspect, the present disclosure is directed to a
method of tracking injections of a medication delivered by a
medication injection device. The method may include depressing a
plunger of the medication injection device. The method may also
include sending and receiving ultrasonic signals from a plunger
head installed within a barrel of the medical injection device. The
method may further include measuring the time it takes for the
signals to travel through the medication to an end of the barrel
and return to the plunger head. The method may also include
calculating the distance the plunger head travels based on a change
in the time. The method may further include calculating a quantity
of the medication dispensed based on the distance the plunger head
travels. The method may also include automatically differentiating
an air shot of medication versus an injection of medication using
an algorithm, wherein the algorithm is programmed to recognize an
air shot based on one or more conditional states. The method may
also include selectively transmitting wirelessly the quantity of
the medication dispensed to a remote device.
[0009] In another aspect, the present disclosure is directed to
another plunger head for a medication injection device. The plunger
head may include a transducer that sends and receives ultrasonic
signals, an antenna, and a microcontroller that interfaces with the
transducer and the antenna. The plunger head may also include a
power source that powers the microcontroller and the transducer.
The microcontroller may be programmed with instructions to
calculate a quantity of medication dispensed from a barrel of the
medication injection device based on a plurality of logged data
samples and transmit the quantity of medication dispensed to a
remote device via the antenna. The microcontroller may also be
programmed with instructions to log each data sample in order to
generate the plurality of logged data samples at an approximately
regular interval. After the quantity of medication is transferred
to the remote device, the time and date maintained by the remote
device may be used to back-interpolate the time corresponding to
each data sample in order to determine the approximate time the
quantity of medication was dispensed.
[0010] In another aspect, the present disclosure is direction to
another method of tracking injections of a medication delivered by
a medication injection device. The method may include depressing a
plunger of the medication injection device and sending and
receiving ultrasonic signals from a plunger head installed within a
barrel of the medical injection device. The method may also include
measuring the time it takes for the signals to travel through the
medication to an end of the barrel and return to the plunger head
and determining a position of the plunger head based on the travel
time of the signals and logging a data sample representative of the
position. The method may further include logging a plurality of the
data samples representative of the position of the plunger at an
approximately regular interval. The method may also include
calculating the distance the plunger head travels based on a change
in the position and calculating a quantity of the medication
dispensed based on the distance the plunger head travels. The
method may further include selectively transmitting wirelessly the
quantity of the medication dispensed to a remote device. The method
may also include back-interpolating the time corresponding to each
data sample logged in order to determine the approximate time the
quantity of medication was dispensed, using the time and date
maintained by the remote device as a reference time.
[0011] In another aspect, the present disclosure is directed to
another plunger head for a medication injection device. The plunger
head may include a transducer that sends and receives ultrasonic
signals, an antenna, and a microcontroller that interfaces with the
transducer and the antenna. The plunger head may also include a
power source that powers the microcontroller and the transducer and
a temperature sensor that measures a temperature associated with
the plunger head. The plunger head may be stored in a low-power
sleep mode prior to use during which the plunger head periodically
wakes up to measure the temperature.
[0012] In another aspect, the present disclosure is directed to a
method of operation for a medication injection device that has a
temperature sensor associated with the device that measures an
ambient temperature. The method may include entering the medication
injection device into a low-power sleep mode. The method may also
include periodically measuring the ambient temperature while in the
low-power sleep mode and detecting a temperature change and then
transitioning the medication injection device into an
initialization mode. The method may further include pairing the
medication injection device with a remote device while in the
initialization mode. The method may also include entering an
operational mode after a successful pairing of the medication
device with the remote device. The method may further include
measuring and logging a plunger head position of the medication
injection device once in the operational mode.
BRIEF DESCRIPTION OF DRAWINGS
[0013] FIG. 1 is a perspective view of a medication injection
device, which includes a plunger head according to an exemplary
embodiment.
[0014] FIG. 2 is a schematic of the plunger head of FIG. 1.
[0015] FIG. 3 is a cross-sectional schematic illustrating another
embodiment of the plunger head of FIG. 1
[0016] FIG. 4 is a flow chart illustrating a method of
manufacturing the plunger head of FIG. 3.
[0017] FIG. 5 is a schematic illustrating the behavior of
ultrasonic signals transmitted by the plunger head of FIG. 2 or
3.
[0018] FIG. 6 is a perspective view of a medication injection
device, which includes a plunger head and a cuff according to an
exemplary embodiment.
[0019] FIG. 7 is a flow chart illustrating a method of tracking
administering of medication by a medication injection device,
according to an exemplary embodiment.
DETAILED DESCRIPTION
[0020] Reference will now be made in detail to embodiments of the
present disclosure, examples of which are illustrated in the
accompanying drawings. Where possible, the same reference numbers
will be used throughout the drawings to refer to the same or like
parts.
[0021] FIG. 1 shows a perspective view of a medication injection
device in the form of a syringe
[0022] 10 designed for ejecting a fluid. Syringe 10 may include a
barrel 12, a plunger 14, a needle 16, and a hub 18 connecting
needle 16 to barrel 12. Barrel 12 may be configured to contain a
fluid, for example, a medication 20 and syringe 10 may be
configured to dispense medication 20 from needle 16 when plunger 14
is depressed. A standard syringe usually contains a plunger head at
the end of the plunger that seals the top of the barrel and forces
the fluid out the needle when the plunger is depressed. The plunger
head for a standard syringe is usually just a piece of molded
rubber.
[0023] For syringe 10 shown in FIG. 1, the standard plunger head
has been replaced with a smart or intelligent plunger head 22 that
is configured to measure and register the quantity of medication 20
administered and the time and date of administration. Plunger head
22 may be installed in a standard syringe by withdrawing plunger 14
and removing the standard plunger head and installing smart plunger
head 22. In some embodiments, syringe 10 may be manufactured and
supplied with a smart plunger head 22 preinstalled. Smart plunger
head 22 may be referred herein as either smart plunger head 22 or
plunger head 22.
[0024] Plunger head 22 may be sized to correspond with the size of
barrel 12. For example, plunger head 22 may be formed to fit any
size syringe. For example, plunger head 22 may be sized to fit a 1
ml, 2 ml, 3 ml, 5 ml, 10 ml, 20 ml, 30 ml, or 50 ml syringe.
[0025] FIG. 2 shows a schematic of plunger head 22, according to an
exemplary embodiment. Plunger head 22 may include a transducer 24,
a microcontroller 26, a power source 28, and an antenna (e.g., for
near field communication (NFC) or a transceiver 30 (e.g., for
BLUETOOTH low energy (BLE) communication). In some embodiments,
plunger head 22 may also include a temperature sensor 36.
Temperature sensor 36 may be configured to measure the ambient
temperature, which may be generally representative of a temperature
of plunger head 22 and/or medication 20.
[0026] Transducer 24 may be configured to send and receive
ultrasonic signals. Microcontroller 26 may be programmed with
instructions to control the overall operation of the plunger head.
Transceiver 30 may be configured to wirelessly communicate with a
remote device (e.g., a smart phone, a glucose monitor, an insulin
pump, or a computer) using one or more wireless communication
methods. The one or more wireless communication methods may
include, for example, radio data transmission, Bluetooth, BLE, near
field communication (NFC), infrared data transmission,
electromagnetic induction transmission, and/or other suitable
electromagnetic, acoustic, or optical transmission methods. Power
source 28 may be configured to power transducer 24, microcontroller
26, transceiver 30, temperature sensor 36, and other electronic
components of plunger head 22.
[0027] In some embodiments, as shown in FIG. 2, the components of
plunger head 22 may be at least partially encapsulated in an
elastomer 21 (e.g., rubber, ethylene propylene (EPM), Nitrile
(NBR), ethylene propylene diene (EPDM), polybutadiene, or
polisoprene) that is shaped to define plunger head 22.
[0028] In some embodiments, plunger head 22 may formed of a
plurality of components. For example, plunger head 22 may be formed
of a first component 31 and a second component 33 that may be
fixedly or releasably coupled together such that first component 31
and second component 33 may form plunger head 22, as shown in FIG.
3. First component 31 and second component 33 may each take a
variety of shapes. FIG. 3 shows a cross-section of one illustrative
example where first component 31 may be shaped to define a plug
shape while second component 33 may be shaped to define a bucket
shape configured to receive the plug shaped first component 31.
When installed in barrel 12, plunger head 22 may be oriented such
that second component 33 sits below first component 31 such that
second component 33 may separate first component 31 from medication
20 contained within barrel 12. As a result, contact with medication
20 within barrel 12 may be limited to second component 33 (i.e.,
first component 31 may be prevented from contacting medication 20).
Such an arrangement may be advantageous because first component 31
and second component 33 may be manufactured from different
materials if desired and the available options of materials for
first component 31 may be greater because compatibility with
medication 20 may be eliminated as a consideration. Second
component 33 may be manufactured from elastomers or other materials
commonly used to manufacture plunger heads thus reducing or
eliminating compatibility concerns, which may reduce and simplify
regulatory hurdles and testing. First component 31 may be
manufactured from the same material as second component 33 or from
different materials including those which may not be compatible
with medication 20. For example, second component may be formed of
an elastomer (e.g., butyl rubber) while first component may be
formed of another plastic, elastomer, or rubber (e.g., silicone
rubber).
[0029] In some embodiments, as shown in FIG. 3, the electronic
components (e.g., transducer 24, microcontroller 26, power source
28, transceiver 30, and temperature sensor 36) may be housed in
first component 31 while second component 33 may be a simple
elastomer mold or liner designed to separate first component 31
from medication 20. In other words, the electronic components may
be isolated from medication 20 within first component 31. In some
embodiments, transducer 24, transceiver 30, microcontroller 26, and
power source 28 may be plate cylindrically shaped and arranged in a
pancake stack configuration within first component 31.
[0030] The thickness of second component 33 may vary. For example,
in some embodiments, the thickness of second component may be about
0.5 millimeters, about 0.6 millimeters, about 0.7 millimeters,
about 0.8 millimeters, about 0.9 millimeters, about 1 millimeter,
about 1.1 millimeter, greater than about 1.1 millimeter, or less
than about 0.5 millimeters.
[0031] In some embodiments, as shown in FIG. 3, first component 31
may include, among other things, a structural support system 35.
Structural support system 35 may be designed to prevent unintended
deformation of first component 31 so that mechanical tolerances may
be maintained with desired ranges. In addition, structural support
system 35 may be designed to protect (e.g., prevent damage) of the
electronic components due to compressive forces applied to plunger
head 22 by plunger 14 when medication 20 is being injected. An
upper surface of structural support system 35 may be designed to
function as a "push plate" for plunger 14 and may be designed to
uniformly distribute the compressive forces applied by plunger
14.
[0032] Structural support system 35 may be, for example, a rigid
skeleton, cylinder, container, or frame work that surrounds or
encloses one or more of the electronic components. Although FIG. 3
shows structural support system 35 surrounding all the electronic
components, it is contemplated that in some embodiments, less than
all or a portion of the electronic components may be contained
within or surrounded by a boundary of structural support system 35.
In some embodiments, first component 31 may be encapsulated,
over-molded, or sealed within a coating (e.g., elastomer, silicone,
plastic, or rubber coating).
[0033] In some embodiments, one or more of the electronic
components may be exposed from first component 31. For example, in
some embodiments, a portion of transducer 24 may be exposed from
the bottom of first component 31 so that when first component 31 is
inserted within second component 33, it mates flush with second
component 33.
[0034] In some embodiments, first component 31 may also be designed
to facilitate proper positioning and orientation of one or more of
the electronic components. For example, the shape of first
component 31 and second component 33 may be such that when first
component 31 is inserted into second component 33, transducer 24
may be pointed generally down a center of barrel 12 when installed.
In some embodiments, second component 33 may also be designed to
facilitate proper orientation of antenna/transceiver 30 when
receiving first component 31.
[0035] Structural support system 35 may be made generally semi
rigid or rigid and may be formed of a variety of different
materials, for example, plastic, elastomers, composites, metals, or
combinations thereof.
[0036] In some embodiments, first component 31 may also be arranged
to provide additional functionality including, for example, power
source 28 (e.g., battery). For example, power source 28 may be
positioned such that when no compressive forces are applied to
first component 31, then there is no electrical contact between
power source 28 and the electronic components, thereby keeping the
other electronic components powered down (i.e., conserving power).
But when compressive forces are applied to first component 31,
power source 28 or one or more of the other electronic components
may be moved and brought into electrical contact thereby powering
up. In other words, in some embodiments, power source 28 may be
positioned within first component 31, such that the compressive
force applied by plunger 14 acts as an off/off switch, which
initiates (e.g., wakes up or powers up) the electronic components
of plunger head 22.
[0037] Separating plunger head 22 into first component 31 (that
house the electronic components and second component 33 (that
contacts the medication) may provide additional advantages. For
example, a challenge with monolithic encapsulating or overmolding
of electronic components is that the process usually exposes the
electronic components to higher temperatures during both the
molding step and later sterilization step(s), which may damage the
electronic components, in particular, power source 28 (e.g., the
battery). By splitting plunger head 22 into separate components
(i.e., first component 31 and second component 33), a lower
temperature (e.g., about 60 degrees Celsius or less) series of
steps for manufacturing and sterilization can be employed for first
component 31, which houses the electronic components, while a
higher temperature (e.g., greater than about 60 degrees Celsius)
series of steps for manufacturing and sterilization can be employed
for second component 33, which contacts medication 20. The first
component 31 and second component 33 may then be attached (e.g., by
adhesive, bonding, or friction), or another attachment means to
form a completed sealed and sterile plunger head 22.
[0038] Although the multiple component arrangements (e.g., first
component 31 and second component 33) is described herein with
reference to plunger head 22, it is contemplated that this multiple
or separate component arrangement may be utilized in other
applications where electronic components are being packaged (e.g.,
encapsulated or over-molded) for applications of use where they are
alongside sensitive materials (e.g., liquids, medications,
chemicals, etc.).
[0039] A method 200 of manufacturing plunger head 22 formed of
first component 31 and second component 33 will now be explained
with reference to FIG. 4. Method 200 may include, at step 202,
assembling first component 31 of plunger head 22, which houses the
electronic components, using a lower temperature assembly method.
Method 200 may also include, at step 204, sterilizing first
component 31 using a lower temperature sterilization method. Method
200 may also include, at step 206, molding second component 33 of
plunger head 22 from an elastomer to define, for example, a bucket
shape). Method 200 may also include, at step 208, sterilizing a
second component 33 using a higher temperature sterilization
method. Method 200 may also include, at step 210, attaching first
component 31 to second component 33 to form plunger head 22. First
component 31 and second component 33 may then be attached (e.g., by
adhesive, bonding, or friction), or another attachment means to
form a completed seal and sterile plunger head 22.
[0040] Transducer 24 may be an actuator, piezoelectric element, or
speaker-like voice coil configured to generate and send a pressure
wave or ultrasonic signal. Transducer 24 may be sized to be
slightly smaller than the inner diameter of barrel 12. As shown in
FIG. 5, transducer 24 may be configured to generate ultrasonic
signals 25 (e.g., radiated sound energy waves) and send the
ultrasonic signals 25 down barrel 12 toward hub 18 and needle 16.
The ultrasonic signals can travel through medication 20 along the
length of barrel 12 and bounce or reflect off an end 27 of barrel
12 and travel back through medication 20 to plunger head 22. The
reflected ultrasonic signals can be received and detected by
transducer 24. The speed of sound in medication 20 may be a known
value and thus a distance D can be calculated very accurately based
on the time it takes for a ultrasonic signal to travel down and
back from transducer 24. As plunger head 22 is moved down barrel 12
distance D will change and by knowing the diameter of barrel 12
then the volume of medication 20 dispensed may be calculated based
on the change in distance D.
[0041] As shown in FIG. 5, in some embodiments, a porous membrane
29 may be placed within barrel 12 at end 27. Porous membrane 29 may
be designed to allow medication 20 to pass through while providing
a surface with good reflective properties for the ultrasonic
signals 25 to reflect from. Utilizing porous membrane 29 may
improve the accuracy of the reflective wave detection and thereby
the distance and volume calculations. It is contemplated that other
materials may be used besides a porous membrane. It is also
contemplated that the geometry of barrel 12 at end 27 may dictate
whether a porous membrane is needed. For example, in some
embodiments the geometry of end 27 may be designed to produce the
desired reflective properties avoiding the need to porous membrane
29.
[0042] In some embodiments, microcontroller 26 may be configured to
use the temperature of medication 20 to compensate for variations
in the temperature that would affect the speed of sound within the
medication, thus improving the accuracy of the distance and volume
calculations.
[0043] In some embodiments, microcontroller 26 (or simply a
controller) may be attached to a printed circuit board and may
include one or more processors, including for example, a central
processing unit (CPU). The processors may include any suitable type
of commercially available processor or may be a custom design.
Microcontroller 26 may include additional components, for example,
non-volatile memory (e.g., a flash memory), volatile memory (e.g.,
a random access memory (RAM)), and other like components,
configured to store information). In some embodiments,
microcontroller or controller may include logic that can be
dynamically updated in software or the like or may have static
logic that is implemented in hardware.
[0044] Microcontroller 26 may be programmed with instructions to
control the operation of transducer 24. Microcontroller 26 may be
programmed with instructions to calculate data representative of
the quantity of medication 20 dispensed. For example, in some
embodiments, microcontroller 26 may be programmed to detect and
record the reflection times of the ultrasonic signals 25. Based on
the reflection times, microcontroller 26 may track and produce a
time profile of the position of transducer 24 (i.e., plunger head
22). Based on the time profile of the position, microcontroller 26
may be able to identify a first distance D.sub.1 or starting
position (e.g., before medication 20 is dispensed), which may
correspond with barrel 12 being filed and a second distance D.sub.2
or ending position (e.g., after medication 20 is dispensed), which
may correspond with barrel 12 being empty. Microcontroller 26 may
then calculate the change in distance between D.sub.1 and D.sub.2
and based off of the change in distance may calculate the volume
(i.e., amount or quantity) of medication 20 dispensed.
[0045] In some embodiments, microcontroller 26 may be programmed to
automatically differentiate a portion of the volume dispensed as
part of an air shot versus the portion of volume injected into a
patient. An air shot may be defined as priming of the medication
injection device by dispensing a small quantity (e.g., 2 units) of
medication 20 into the air prior to injection. An air shot is a
common practice associated with medication injection devices and
the primary purposes are to remove bubbles from the medication,
fill the needle, and clear any potential debris from the needle
(e.g., when a needle is reused). Failure to differentiate the
volume disposed as part of an air shot could lead to more
medication than was actually injected being recorded and this can
lead to inaccurate medication injection records. By recognizing and
air shot, microcontroller 26 can subtract the volume of medication
dispensed during the air shot from the total volume of medication
20 dispensed to determine the actual volume of medication 20
injected in a patient. In some embodiments, the volume of the air
shot and the volume of the actual injection may be logged and
recorded so a caregiver may monitor if recommended procedures
(e.g., an air shot) are being followed.
[0046] Microcontroller 26 may be programmed to recognize an air
shot using an algorithm based on one or more conditional states.
The algorithm may be programmed to recognize a dispensed volume of
medication as an air shot when there is a short gap (e.g., about 5
seconds, about 4 seconds, about 3 seconds, about 2 seconds) between
a first volume and a second volume of medication being dispensed.
In other words, a first volume of medication dispensed when there
is a sequence of at least two or more dispensing events in a row
may be recognized as an air shot. In some embodiments, the
algorithm may also be programmed to incorporate and recognize an
air shot base on the volume of the amount disposed. For example,
the algorithm may be programmed to recognize a dispensed volume
that is about equal to a recommend air shot volume (e.g., 2 units)
as an air shot. In some embodiments, the algorithm may also be
programmed to incorporate and recognize an air shot based on an
orientation of the medical injection device or plunger head 22. For
example, in some embodiments plunger head 22 may include an
accelerometer that microcontroller 26 may utilize to determine
orientation. In some embodiments, the algorithm may also be
programmed to incorporate and recognize an air shot based on a rate
of pressure decline of medication 20 within barrel 12 after an
initial movement of plunger head 22. For example, transducer 24 may
function as a piezoelectric element and measure pressure of
medication 20. Further it may be determined that a faster pressure
decline may correspond with an air shot because for an air shot
medication 20 is just being shot in the air against no back
pressure. In comparison, when medication 20 is being injected into
a patient there is a back pressure caused by the tissue.
[0047] In some embodiments, medication 20 may include an active
medication ingredient and a buffer solution. The concentration of
the active medication ingredient may be known or programmed into
microcontroller 26 enabling the specific volume of the active
medication ingredient to be calculated. In some embodiments, for
example, the concentration of the active medication ingredient may
be stored in the non-volatile memory of microcontroller 26. In some
embodiments, additional information regarding the medication 20 may
also be stored, for example, ultrasonic velocity vs. temperature
data.
[0048] Transducer 24 and/or microcontroller 26 may be programmed to
perform various forms of signal conditioning in order to detect the
time of the reflected ultrasonic signals 25. The signal
conditioning may include, for example, amplification, filters, and
envelope detection. Transducer 24 and/or microcontroller 26 may use
the signal conditioning to determine for example, time to first
rising edge or time to maximum reflective value in order to
determine the reflection time.
[0049] Plunger head 22 may transmit data (e.g., the amount of
medication 20 dispensed and time and date it was dispensed) to a
remote device (e.g., a smart phone, a glucose monitor, an insulin
pump, or a computer) via one or more of the wireless communication
methods. Plunger head 22 may have a unique identifier so the remote
device may be able to identify and process the information received
properly. Plunger head 22 may transmit this information to the
remote device immediately or shortly after the medication is
administered or plunger head 22 may store the information until the
remote device is paired and within range. The information may be
stored, for example, in memory of microcontroller 26. In some
embodiments, plunger head 22 may wait to initiate transmitting of
the information to the remote device until initiated by the remote
device. For example, a user may initiate information retrieval on
the remote device. In some embodiments, the remote device may
transmit the information to a caregiver (e.g., a doctor) or upload
the information to the cloud so it may be saved to the patient's
medical history and may be accessed by the caregiver. The ability
of a caregiver or a patient to access and review the dose history
may improve treatment. For example, the ability of a caregiver to
review a diabetic insulin injection history and continuous glucose
measurement data may enable the caregiver to adjust the prescribed
treatment to improve the therapeutic effect, for example, by better
stabilizing the patient's glucose levels.
[0050] In some embodiments, plunger head 22 may also include a
crystal oscillator 32 configured to keep a real time clock (RTC) so
that the date and time of each injection may be accurately recorded
and stored in memory of microcontroller 26. Crystal oscillator may
be, for example, a 32 KHZ crystal oscillator. In some embodiments,
microcontroller 26 may include an internal oscillator (e.g., RC
oscillator), which may be calibrated using crystal oscillator 32.
The internal RC oscillator may be, for example, a 10 MHZ RC
oscillator. Internal RC oscillator may provide sufficient time
accuracy to measure the position (e.g., distance D) of plunger head
22 to within, for example, about 150 microns. In some embodiments,
transducer 24 may be used as an oscillator or as a calibrator for
the internal RC oscillator. In some embodiments, the frequency of
the RC oscillator may be up-converted on microcontroller 26 to a
higher frequency. For example, the RC oscillator may be used to
drive a higher-frequency phase-locked loop.
[0051] In some embodiments, plunger head 22 may be designed to
back-interpolate the time of each injection enabling crystal
oscillator 32 to be eliminated. In order to maintain the RTC,
crystal oscillator 32 may consume a significant amount of power,
thus eliminating the crystal oscillator 32 can save a significant
amount of power as well as save space.
[0052] Plunger head 22 may back-interpolate the time of each
injection by relying on the real time clock of the remote device.
The method of back-interpolating may start with plunger head 22
taking and logging a series of data samples (e.g., plunger head 22
positions). Plunger head 22 may be programmed to take and log the
data samples at an approximately regular interval. The data
samples, may be stored, for example in a memory of microcontroller
26 in the order measured. The data samples may be logged and stored
into memory with other data values (e.g., calculated injection
volume, temperature, etc.). The collection of logged data samples
may be transferred/transmitted (e.g., uploaded) to a remote device,
which will receive the data samples in the same order. The remote
device may rely on the approximately regular interval of the data
sample logging to back-interpolate from the actual time at time of
transfer, as determined by the RTC of the remote device. By
back-interpolating the approximate time of each data sample logged
may be determined. For example, if there were six samples
transferred to the remote device and they were known to have been
captured at about 60 minute intervals then the remote device may
determine the time of each of the six samples were logged working
backwards from the time of data transfer. However, this example
produces about a 60 minute uncertainty in the calculated time of
the data sample points because the time of transfer may not be
synchronized with the time of data sample logging. However, plunger
head 22 may be programmed to log data samples at a faster frequency
to reduce the uncertainty or increase the accuracy. For example,
data samples may be logged every 30 minutes, 15 minutes, 10
minutes, 5 minutes, 1 minute, or less than 1 minute.
[0053] The approximately regular interval may be determined or
maintained by a less accurate, less power consuming, smaller timing
device (e.g., an oscillator). It is noted that the reduce accuracy
of the timing device may result in the approximately regular
interval drifting due to a variety of factors, for example,
temperature, voltage, or factory determined offsets. However, in
some embodiments, plunger head 22 may store the factory determined
offsets and be programmed with instructions to measure and log the
temperature and/or voltage. Microcontroller 26 may be programmed
with instructions to use the factory determined offsets and the
logged temperatures and voltages to generate a model to correct
drift (i.e., change in interval) between the approximately regular
intervals caused by variability in the temperature and the voltage.
This same method may also be used in other embodiments to correct
drift even in a more accurate time tracking system (e.g., a quartz
referenced system).
[0054] Although the above described back-interpolation and drift
correction method is described in reference to plunger head 22, it
is contemplated that this method could be used in other sensor or
sampling systems to provide timestamps of useful accuracy for a
sequence of sensor samples that do not contain an accurate time
reference. This method provides cost, power, and space savings
while providing an accurate time reference for a sensor system.
[0055] Antenna or transceiver 30 may be used to communicate with a
variety of remote devices (e.g., smart phones, glucose monitors,
insulin pumps, computers, etc.). Plunger head 22 may transmit the
information via any suitable wireless communication method. For
example, in some embodiments, plunger head 22 may utilize radio
data transmission, BLUETOOTH or (BLE), near field communication
(NFC), infrared data transmission or other suitable method. In some
embodiments, information may also be wirelessly transmitted from a
remote device to plunger head 22 via antenna 30. For example, the
date and time may be set by writing to microcontroller 26 via the
wireless communication.
[0056] In some embodiments, plunger head 22 may also include a
force sensor 34. Force sensor 34 may be configured to detect when a
force is applied to plunger head 22 via plunger 14. Force sensor 34
may be, for example, a simple spring-loaded switch that is molded
into the plunger head 22. In some embodiments, transducer 24 may be
configured to function as a force sensor thereby eliminating the
need for a separate force sensor 34. For example, transducer 24 may
have a piezoelectric element that may detect the dynamic changes in
pressure when a user depresses plunger 14.
[0057] Power source 28 may be any suitable power source. For
example, power source 28 may be a battery, a capacitor, or the
like. In some embodiments, power source 28 may be rechargeable via
wireless energy transmission, for example, inductive coupling,
resonant inductive coupling, radio frequency (RF) link, or the
like. In some embodiments, power source 28 may be a
non-rechargeable battery that is configured to last the storage and
operational life of plunger head 22, for which the combined storage
and operational life may be about 1 year, about 2 years, about 3
years, or more. For example, in some embodiments, power source 28
may be a watch battery. In some embodiments, where plunger head 22
is a passive device as described herein, power source 28 may be
eliminated.
[0058] It is common for goods, including medical injection devices,
to have a long storage life between the time of manufacture and
time of use/sale. Products that include embedded electronics, in
particular a battery, it can be a challenge to conserve battery
power while the products are in storage. Some products have no
on/off switch, buttons, or removable/rechargeable batteries, so the
traditional approach of disconnecting or turning off the device
while in storage may not be feasible. Also, certain products (e.g.,
medical injection devices) that include perishable goods (e.g.,
medication) it may be advantageous to have the product monitor the
storage environment (e.g., temperature, light, etc.) and log or
store this data and this can't be done if the battery is
disconnected.
[0059] To address this challenge, plunger head 22 may be designed
to enter a low-power sleep mode while in storage. Plunger head 22
may be programmed to enter low-power sleep mode as part of the
manufacturing and testing process for plunger head 22 or the
medication injection device. When in low-power sleep mode the rate
of power consumption may be a fraction of the rate of power
consumption for normal operation. While in low-power sleep mode,
microcontroller 26 may be programmed with instructions to
periodically wake up to measure the temperature. Microcontroller 26
may also log the temperature to create a temperature history.
Alternatively, in some embodiments microcontroller 26 may be
programmed to log the temperature only when there is a change in
temperature, thus saving on data storage. The efficacy of some
medications is affected by temperature. For example, insulin is
sensitive to hot and cold temperatures. Plunger head 22 thus may
monitor the temperature medication 20 through storage and up
through use to ensure it stays within an acceptable range. If the
temperature of the medication 20 goes outside the acceptable range
then plunger head 22 may be configured to send an alert. The type
of alert may vary. In some embodiments, plunger head 22 may include
a display (not shown in FIG. 2) and the alert may be a flashing
light or a visual indicator. In some embodiments, plunger head 22
may include a speaker and the alert may be auditory, for example, a
beeping sound. In some embodiments, the alert may be transmitted to
a remote device and the remote device may display a visual alert
and/or play an auditory alert.
[0060] In some embodiments, plunger head 22 may also be designed to
utilize the temperature measurement to transition between modes.
For example, a medication injection device that includes plunger
head 22 and medication 20 may often be stored at a lower
temperature (e.g., below a normal room temperature of about 20 to
about 22 degrees Celsius). Subsequently, prior to use, often the
temperature will be the medication device, including plunger head
22 and in particular medication 20 will be raised to room
temperature because injection of cold fluids can be painful. Thus,
usually there will be a transition from a lower temperature to a
higher temperature shortly before use thereby triggering a change
in the mode of plunger head 22.
[0061] As described above, in lower power sleep mode plunger head
22 can periodically measure the temperature, thus microcontroller
26 may be programmed to detect the temperature change that is
expect prior to use and when detected microcontroller 26 may be
programmed to transition plunger head 22 from low-power sleep mode
into an initialization mode. Microcontroller 26 may be programmed
to pair with a remote device while in the initialization mode.
After a successful pairing, microcontroller 26 may be programmed to
transition plunger head 22 to an operational mode and start sending
and receiving ultrasonic waves and measuring the position of
transducer 24. In some embodiments, microcontroller 26 may be
programmed to reenter the low-power sleep mode if it is unable pair
with a remote device within a certain period of time (e.g., if no
remote device is present). Microcontroller 26 may also be
programmed to reenter the low-power sleep mode after a period of
inactivity (e.g., no measurable change in transducer 24 position
after a programmed period of time). Microcontroller 26 may also be
programmed to reenter the low-power sleep mode if a subsequent
temperature change (e.g., a decrease in temperature from normal
room temperature) is detected. Microcontroller 26 may be programmed
to transition directly from the low-power sleep mode back to the
operational mode if a successful pairing with a remote device has
already occurred.
[0062] In some embodiments, plunger head 22 may also be configured
to detect air bubbles in medication 20. Air bubbles if injected can
be deadly so detection of air bubbles is advantageous. In order to
detect air bubbles, transducer 24 of plunger head 22 may be
configured to detect small ultrasonic echoes created by the
reflection of the ultrasonic waves off the air bubbles in addition
to the main echo caused by the end of barrel 12. Plunger head 22
may be configured to transmit an alert if air bubbles are detected.
The alert may be communicated in the same ways as the temperature
alert described above.
[0063] In some embodiments, plunger head 22 may also be configured
to differentiate, verify, and/or identify medication 20 contained
in syringe 10. For example, when barrel 12 is loaded with
medication 20, plunger 14 and plunger head 22 may be pulled all the
way back to its stopping point and the distance from plunger head
22 to end 27 of barrel 12 may be known enabling microcontroller 26
to solve for the speed of sound of the fluid, which depends on
temperature and density. The temperature may be measured by
temperature sensor 36 so the density may be determined and based on
the density the amount of solids dissolved in the fluid may also be
determined. In addition, the viscosity of the medication 20 may be
measured based on the amplitude of the reflected ultrasonic signals
25 because more viscous fluids dissipate more energy. In some
embodiments, plunger head 22 may also include electrodes 38
connected to microcontroller 26 configured to measure the
conductivity of medication 20. In some embodiments, the electrodes
38 may protrude out from the surface of plunger head 22 into barrel
12 where the electrodes 38 may contact medication 20. With the
density, conductivity, and viscosity of medication 20 determined,
microcontroller 26 may have a sufficient number of properties to
profile medication 20. In some embodiments, the profiling may be
configured to differentiate medication 20 in order to determine if
it from a prescribed class of medication. In some embodiments, the
profiling may be configured to verify that medication 20 is the
same as the medication that is prescribed for the patient. In some
embodiments, the profiling may be configured to identify the
medication 20.
[0064] According to an exemplary embodiment, plunger head 22 as
described herein may be combined with a syringe that has been
modified to include a piezo linear motor. The piezo linear motor
may be incorporated into the wall of the barrel of the syringe and
a piezo element may be incorporated into plunger head 22. The piezo
linear motor may be configured to drive or "walk" the plunger head
22 down the barrel of the syringe by driving the piezo element,
thereby forcing the medication from the syringe. This embodiment
may enable the piezo linear motor to control medication dispensing
while plunger head 22 may simultaneously track the amount of
medication being dispensed. In some embodiments, plunger head 22
may control the piezo linear motor or plunger head 22 can
communication with a remote device that can control the piezo
linear motor such that it dispenses a set amount of medication.
[0065] FIG. 6 shows a smart syringe system 40, according to an
exemplary embodiment. System 40 may be designed for use with a
standard disposable syringe 10 or other medication injection
devices. Similar to plunger head 22, smart syringe system 40 may be
configured to measure and register the quantity of medication 20
administered and the date and time of administration. Smart syringe
system 40 may include a smart or intelligent plunger head 42,
similar to plunger head 22, and a cuff 44. In some embodiments,
plunger head 42 may be designed to be disposable after a single use
while cuff 44 is reusable. Embodiments of plunger head 42 designed
to be disposable after a single use may houses only the minimum
number of components to carry out its function while any optional
or ancillary components may be housed in cuff 44 to minimize
manufacturing cost of plunger head 42. The manufacturing cost of
plunger head 42 may also be minimized by using lower cost
components (e.g., transducers, antennas, and microcontrollers) and
materials (e.g., rubbers, polymers, plastics) that are less robust
and durable, and instead may be designed for shorter operational
life spans.
[0066] Plunger head 42 may be designed to be supplied with or
installed into a disposable syringe 10 and after administering a
dose of medication 20, syringe 10 along with plunger head 42 may be
disposed of or recycled. In contrast, cuff 44 may be designed to be
reused numerous times. For example, a disposable syringe 10 may be
inserted through cuff 44 and after medication 20 is administered;
cuff 44 may be removed from the used syringe 10 and be saved for
later use.
[0067] In some embodiments, both plunger head 42 and cuff 44 may be
reusable. For example, after medication 20 is administered by
syringe 10, both plunger head 42 and cuff 44 may be removed and
saved for later use.
[0068] Plunger head 42 and cuff 44 can come in different sizes so
they may be used with any size syringe. For example, plunger head
42 may be sized to fit within the barrel 12 of any size syringe 10
while cuff 44 may be configured to have a passage 46 configured to
receive any size barrel 12 of syringe 10.
[0069] Plunger head 42 and cuff 44 (i.e., the smart syringe system
40) in combination may be configured to have some or all of the
same components (e.g., a transducer 24, a microcontroller 26, a
power source 28, an antenna 30, crystal oscillator 32, force sensor
34, and a temperature sensor 36) as plunger head 22 and perform at
least all the same operations as plunger head 22. Some of the
components may be housed in plunger head 42 while some of the
components may be housed in cuff 44. To reduce the manufacturing
cost of plunger head 42, as described above, plunger head 42 may be
designed to house the minimum number of components to carry out its
functions. For example, system 40 may be configured such that all
the components that can be housed in cuff 44 are, rather than
plunger head 42. In some embodiments, such components may include a
form of memory for data storage.
[0070] According to an exemplary embodiment, plunger head 42 may
include the transducer 24, antenna 30, and a microcontroller 26
while cuff 44 may also include a separate microcontroller, a power
source, and a separate antenna. To reduce complexity, plunger head
42 may be passive (e.g., battery-free) and configured to be
controlled and powered by cuff 44 via wireless energy transmission.
Cuff 44 may also be configured to communicate with a remote device
(e.g., a smart phone, a glucose sensor, an insulin pump, or a
computer) thereby enabling the volume of medication and the time
and date of administering to be uploaded to another device or the
cloud.
[0071] In some embodiments, cuff 44 may include a display. Cuff 44
may be configured to display any alerts (e.g., high temperature or
improper medication) to the user. Cuff 44 may also display the
volume, date, and time after medication has been dispensed. The
display may also be configured to allow user input (e.g., touch
screen). For example, the user may program in the date, the time,
the type of medication or other information.
[0072] Plunger head 22 and system 40 described herein may be
utilized for a variety of methods for tracking administering of a
medication to a patient delivered by syringe. Various methods of
utilizing plunger head 22 and system 40 will now be explained with
reference to FIG. 7. In some embodiments, the methods as described
herein may be performed by a caregiver (e.g., a doctor or nurse) in
a hospital or other inpatient setting. In some embodiments, the
methods as described herein may be performed by a caregiver (e.g.,
a doctor, nurse, or parent) at home or outside a hospital. In some
embodiments, the methods as described herein may be performed by
the patient. It is contemplated that the methods described herein
may be performed in other settings by other individuals.
[0073] Plunger head 22 may be utilized for a method 100 of tracking
administering of a medication to a patient delivered by a
medication injection device (e.g., a syringe), according to an
exemplary embodiment. In some embodiments, at step 102, method 100
may begin by installing plunger head 22 into barrel 12 of syringe
10 (e.g., a disposable syringe). In some embodiments, syringe 10
may be supplied with plunger head 22 already installed. For
embodiments corresponding to other medication injection devices
(e.g., insulin pen), plunger head 22 may be installed as part of
the original manufacturing process, which may also include loading
of medication 20 (e.g., insulin)
[0074] Optionally, at step 104, the barrel 12 of the syringe may be
filled with the medication 20. This step may be eliminated for
embodiments were the medication 20 comes prefilled. The barrel 12
may be completely filled or only partially with medication 20.
[0075] At step 106, the syringe may then be positioned for
administration. For example, the needle may be inserted into the
skin of the patient or into a drug delivery port connected to the
patient. Once in position, the plunger 14 of the syringe 10 may be
depressed, which forces plunger head 22 down the barrel 12 and
forces the medication 20 out the needle 16. Optionally, prior to
step 106, method 100 may also include performing an air shot which
may be automatically differentiated from the actual injection.
[0076] In some embodiments, the initial position of plunger head 22
(e.g., the distance between plunger head 22 and end 27) may be
known by plunger head 22. For example, syringe 10 may be full and
plunger head 22 may know the distance between plunger head 22 and
end 27 when filled. In some embodiments, if syringe 10 is used
multiple times to deliver a medication 20, the previous position of
plunger head 22 may be known from the last measurement stored. In
some embodiments, the initial position of plunger head 22 may be
measured using plunger head 22 prior to any medication 20 being
delivered, as described below.
[0077] Prior to and while plunger 14 is being depressed, plunger
head 22 may send and receive ultrasonic signals 25 via transducer
24, at step 108. Plunger head 22 may send and receive ultrasonic
signals 25 the duration of the time the plunger is being depressed.
Plunger head 22 may measure a time it takes for each of the
ultrasonic signals to travel through the medication to an end of
the barrel and return to the transducer, at step 110. In some
embodiments, at least a portion of the ultrasonic signals 25 may be
sent and received before any medication 20 is dispensed enabling
the initial position of plunger head 22 and initial volume of
medication 20 to be calculated.
[0078] As described herein, at step 112, plunger head 22 may
calculate the position of plunger head 22 and a distance plunger
head 22 travels over the course of dispensing medication 20. At
step 114, the quantity of medication 20 dispensed may be calculated
based on the calculated distance the plunger head 22 traveled. As
described herein, in some embodiments plunger head 22 may
automatically differentiate an air shot and if an air shot is
performed may subtract the volume of medication 20 dispensed as
part of the air shot from the total volume dispensed in order to
determine the actual volume of medication 20 injected.
[0079] For some embodiments of method 100, the calculation of the
quantity of medication dispensed may be performed by a remote
device (e.g., a smart phone, a glucose sensor, an insulin pump, or
a computer). In some embodiments, method 100 may also include
transmitting the quantity of the medication dispensed and the time
and date the quantity was dispensed to a remote device. In some
embodiments, method 100 may also include uploading the quantity of
the medication dispensed and the time and date the quantity was
dispensed to the cloud. In some embodiments, method 100 may also
include sending the quantity of the medication dispensed and the
time and date the quantity was dispensed to a caregiver.
[0080] For some embodiments, method 100 may also include logging a
plurality of data samples (e.g., position of plunger head 22) at an
approximately regular interval and then back-interpolating the time
corresponding to each data sample logged to determine the
approximate time the quantity of medication 20 was disposed using
the RTC maintained by the remote device as a reference time.
[0081] Although method 100 is described with reference to plunger
head 22, it may also be performed by system 40, as described
herein.
[0082] The foregoing description has been presented for purposes of
illustration. It is not exhaustive and is not limited to precise
forms or embodiments disclosed. Modifications and adaptations of
the embodiments will be apparent from consideration of the
specification and practice of the disclosed embodiments. For
example, the described embodiments of plunger head 22, 42 and cuff
44 may be adapted for used with a variety of other medication
injection devices, including for example, auto-injectors,
auto-syringes, injector pens (e.g., insulin pens), or other drug or
medication injection devices.
[0083] Moreover, while illustrative embodiments have been described
herein, the scope includes any and all embodiments having
equivalent elements, modifications, omissions, combinations (e.g.,
of aspects across various embodiments), adaptations and/or
alterations based on the present disclosure. The elements in the
claims are to be interpreted broadly based on the language employed
in the claims and not limited to examples described in the present
specification or during the prosecution of the application, which
examples are to be construed as nonexclusive. Further, the steps of
the disclosed methods can be modified in any manner, including
reordering steps and/or inserting or deleting steps.
[0084] The features and advantages of the disclosure are apparent
from the detailed specification, and thus, it is intended that the
appended claims cover all systems and methods falling within the
true spirit and scope of the disclosure. As used herein, the
indefinite articles "a" and "an" mean "one or more." Similarly, the
use of a plural term does not necessarily denote a plurality unless
it is unambiguous in the given context. Words such as "and" or "or"
mean "and/or" unless specifically directed otherwise. Further,
since numerous modifications and variations will readily occur from
studying the present disclosure, it is not desired to limit the
disclosure to the exact construction and operation illustrated and
described, and accordingly, all suitable modifications and
equivalents may be resorted to, falling within the scope of the
disclosure.
[0085] Computer programs, program modules, and code based on the
written description of this specification, such as those used by
the microcontrollers, are readily within the purview of a software
developer. The computer programs, program modules, or code can be
created using a variety of programming techniques. For example,
they can be designed in or by means of Java, C, C++, assembly
language, or any such programming languages. One or more of such
programs, modules, or code can be integrated into a device system
or existing communications software. The programs, modules, or code
can also be implemented or replicated as firmware or circuit
logic.
[0086] Other embodiments will be apparent from consideration of the
specification and practice of the embodiments disclosed herein. It
is intended that the specification and examples be considered as
example only, with a true scope and spirit of the disclosed
embodiments being indicated by the following claims.
* * * * *