U.S. patent application number 15/094886 was filed with the patent office on 2016-08-04 for portable medicine injection device and analyte metering system.
The applicant listed for this patent is YOFIMETER, LLC. Invention is credited to Marc Goldman, Gad Shaanan.
Application Number | 20160220754 15/094886 |
Document ID | / |
Family ID | 48481589 |
Filed Date | 2016-08-04 |
United States Patent
Application |
20160220754 |
Kind Code |
A1 |
Shaanan; Gad ; et
al. |
August 4, 2016 |
PORTABLE MEDICINE INJECTION DEVICE AND ANALYTE METERING SYSTEM
Abstract
Methods, systems, and devices are described for setting a dose
of medicine and injecting the medicine. In one aspect, a method to
dispense a medicine includes inserting a cartridge containing a
medicine into a cartridge holder coupled to a housing of a medicine
injection device, positioning a spine component of the device to
make contact with the cartridge in the cartridge holder, selecting
a dose of the medicine for injection, in which the selecting
includes rotating an injection component of the device to a setting
corresponding to the selected dose, and linearly advancing the
injection component to rotate a drive gear coupled to the injection
component to drive the spine component so as to push the end of the
cartridge to dispense the medicine in the amount of the selected
dose.
Inventors: |
Shaanan; Gad; (La Jolla,
CA) ; Goldman; Marc; (La Jolla, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
YOFIMETER, LLC |
La Jolla |
CA |
US |
|
|
Family ID: |
48481589 |
Appl. No.: |
15/094886 |
Filed: |
April 8, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14371401 |
Jul 9, 2014 |
9308324 |
|
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PCT/US2013/062048 |
Sep 26, 2013 |
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15094886 |
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61706071 |
Sep 26, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2005/2407 20130101;
A61M 2205/3592 20130101; A61M 5/20 20130101; A61M 5/1454 20130101;
G08B 21/02 20130101; A61M 5/31543 20130101; A61M 5/14244 20130101;
A61M 5/1723 20130101; A61M 2005/14506 20130101; A61M 5/31528
20130101; A61M 5/31551 20130101; A61M 5/31575 20130101; A61M
2205/50 20130101; A61M 2205/52 20130101; A61M 5/28 20130101; A61M
5/1452 20130101; A61M 5/3158 20130101; G06F 19/3468 20130101; A61M
2230/201 20130101; A61M 2005/31518 20130101; A61M 2205/6063
20130101; A61M 2205/3584 20130101; A61M 5/24 20130101; A61M 5/31561
20130101; A61M 2205/581 20130101; A61M 5/31558 20130101; A61M
5/31585 20130101; G16H 20/17 20180101 |
International
Class: |
A61M 5/145 20060101
A61M005/145; G08B 21/02 20060101 G08B021/02; A61M 5/172 20060101
A61M005/172 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 6, 2013 |
CA |
2808738 |
Claims
1. A health management system, comprising: an analyte monitoring
device configured to determine a concentration level of an analyte;
a computing system in communication with the analyte monitoring
device, the computing system comprising: (a) a memory unit; and (b)
a processor configured to process data; and a medicine injection
device in communication with at least one of the analyte monitoring
device or the computing system.
2. The system of claim 1, wherein the computing system is further
configured to transmit and/or receive at least one of: (a) data
obtained from the analyte monitoring device, (b) data obtained from
the medicine injection device, or (c) information derived from data
from a user-operated computing device, based on a wireless or wired
communication protocol.
3. The system of claim 1, wherein the processor is configured to
keep track of inventory of lancets and analyte sensors in the
analyte monitoring device.
4. The system of claim 3, wherein the processor is configured to
reorder the inventory of one or both of the lancets and the analyte
sensors from a lancet or analyte sensor manufacturer.
5. The system of claim 1, wherein the processor is configured to
produce a prompt to direct a user to use one or both of the analyte
monitoring device and the medicine injection device at a
predetermined time or time interval.
6. The system of claim 1, wherein the computing system is
configured to process and store user input data selected from the
group consisting of: supplies used, supplies ordered, food eaten,
duration, type and/or intensity of an exercise, type, dosage,
and/or time of medication taken, and estimated calories burned.
7. The system of claim 1, wherein the medicine injection device
comprises: (a) a housing; (b) a cartridge holder coupled to the
housing, the cartridge holder including a chamber structured to
encase a cartridge containing a medicine and having an opening
configured to receive a cartridge containing a medicine; and (c) an
injecting mechanism including: (i) a component configured to push
against the cartridge for dispensing a selected amount of the
medicine; (ii) a gear mechanism including a drive gear and one or
more other gears, wherein the drive gear has at least one
engagement mechanism for engaging to at least one of the one or
more other gears, wherein the drive gear is configured to advance
the component configured to push against the cartridge; and (iii) a
button coupled to the gear mechanism and disposed at least in part
outside of the housing, wherein linear advancement of the button
moves the drive gear.
8. The system of claim 1, wherein the medicine injection device
comprises: (a) a housing; (b) a cartridge holder coupled to the
housing, the cartridge holder including a chamber structured to
encase a cartridge containing a medicine and having an opening
configured to receive a cartridge containing a medicine; (c) a
component configured to push against the cartridge for dispensing a
selected amount of the medicine; (d) a sliding button coupled to
the component configured to push against the cartridge and disposed
at least partially outside of the housing such that movement of the
sliding button is configured to move the component configured to
push against the cartridge.
9. The system of claim 1, wherein the medicine injection device
further comprises a data processing unit, comprising: a processor;
and a memory coupled to the processor, wherein at least one of a
selected amount of medicine or a dispensed amount of medicine is
processed as data by the processor and stored in the memory.
10. The system of claim 9, wherein the medicine injection device
further comprises an optical scanner coupled to the data processing
unit and configured to scan an identification code located on an
external surface of a cartridge containing medicine when the
cartridge is engaged to the medicine injection device, wherein the
identification code corresponds to information about the medicine
contained in the cartridge.
11. The system of claim 9, wherein one or more of the medicine
injection device and the analyte monitoring device further comprise
a display unit to display data.
12. The system of claim 9, wherein the medicine injection device
further comprises injection sensors configured to measure at least
one of rotation or linear movement to indicate the selected dose,
wherein the injection sensors are in communication with the data
processing unit.
13. The system of claim 11, wherein the injection device comprises
a display unit to display data, wherein the display unit is
configured to display one or more of: a current dose setting that
the device is dialed to inject, an amount of medicine previously
injected from a medicine cartridge engaged to the injection device,
a type of medicine in the cartridge, instructions for when to
perform a medical injection, instructions about the use of the
injection device, or instructions about the status of the injection
device.
14. The system of claim 12, wherein the injection sensors include
at least one of an optical linear encoder, a magnetic linear
encoder, or a capacitive linear encoder.
15. The system of claim 1, wherein one or more of the analyte
monitoring device, the computing system, and the medicine injection
device include a user identification mechanism that permits only
authorized users to operate the device and access data.
16. The system of claim 1, wherein the processor is configured to
correlate data with one or more of time stamps, threshold values,
alerts, and user entered information.
17. The system of claim 1, wherein the processor is configured to
store voice recordings.
18. The system of claim 1, wherein the analyte monitoring device
further comprises a temperature sensor module.
19. The system of claim 1, further comprising a pedometer, wherein
the pedometer is communicatively coupled to the processor, wherein
the processor is configured to calculate one or more: distance
traveled, speed of travel, or an amount of calories associated with
distance traveled.
20. The system of claim 1, wherein the analyte monitoring device
further comprises an emergency response system, wherein the
emergency response system is configured to perform one or more of:
contacting a third party, identifying the analyte monitoring
device, providing health data associated with a user of the analyte
monitoring device, notifying a third party of an urgency level of
an emergency, and determining an identity of a third party to be
contacted.
21. The system of claim 1, further comprising a user interface
configured to provide health information and allow user input,
wherein the user interface can be accessed by one or more of: a
patient, a caregiver, and a payer.
22. The system of claim 21, wherein the user interface includes one
or more modules, the one or more modules including one or more of:
analyte monitoring, medicine dispensing, lifestyle tracking, and
user information.
23. A method for operating a medicine injection device to dispense
medicine comprising: inserting a cartridge containing a medicine
into a cartridge holder coupled to a housing of a medicine
injection device; selecting a dose of the medicine for injection;
linearly advancing a button coupled to at least one gear and
disposed at least in part outside of the housing, wherein linear
advancement of the button moves the at least one gear; and rotating
the at least one gear to drive a movable component so as to push
the end of the cartridge to dispense the medicine in the amount of
the selected dose.
24. The method of claim 23, further comprising displaying on a
display of the device the corresponding dose during the
selecting.
25. The method of claim 23, further comprising optically scanning
an identification code that includes a plurality of bars wrapped
radially around the external surface of the cartridge when the
cartridge is inserted in the cartridge holder, wherein the
identification code corresponds to information about the medicine
contained in the cartridge.
26. The method of claim 23, further comprising wirelessly
communicating information related to the dispensed dose to another
device or system.
27. A device to dispense a medicine, comprising: a housing; a
cartridge holder coupled to the housing, the cartridge holder
including a chamber structured to encase a cartridge containing a
medicine and having an opening configured to receive a cartridge
containing a medicine; an injecting mechanism including: (i) a
component configured to push against the cartridge for dispensing a
selected amount of the medicine; (ii) a gear mechanism including a
drive gear and one or more other gears, wherein the drive gear has
at least one engagement mechanism for engaging to at least one of
the one or more other gears, wherein the drive gear is configured
to advance the component configured to push against the cartridge;
and (iii) a button coupled to the gear mechanism and disposed at
least in part outside of the housing, wherein linear advancement of
the button moves the drive gear; and a data processing unit,
comprising: a processor; and a memory coupled to the processor,
wherein at least one of a selected amount of medicine or a
dispensed amount of medicine is processed as data by the processor
and stored in the memory.
28. The device of claim 27, further comprising an optical scanner
coupled to the data processing unit and configured to scan an
identification code located on an external surface of a cartridge
containing medicine when the cartridge is engaged to the medicine
injection device, wherein the identification code corresponds to
information about the medicine contained in the cartridge.
29. The device of claim 27, further comprising a wireless
transmitter unit to transmit the data to a computing device.
30. The device of claim 27, further comprising sensors configured
to measure at least one of rotation or linear movement to indicate
the selected dose, wherein the injection sensors are in
communication with the data processing unit.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent document is a continuation of U.S. patent
application Ser. No. 14/371,401, entitled "PORTABLE MEDICINE
INJECTION DEVICE AND ANALYTE METERING SYSTEM" filed Jul. 9, 2014,
which is a 35 U.S.C. .sctn.371 National Stage Application of
International Application No. PCT/US2013/062048 filed Sep. 26,
2013, which claims the benefit of priority from Canadian Patent
Application No. 2,808,738, entitled "PORTABLE MEDICINE INJECTION
DEVICE AND ANALYTE METERING SYSTEM" filed Mar. 6, 2013, now granted
as Canadian Patent No. 2,808,738, on Mar. 18, 2014, and U.S.
Provisional Application No. 61/706,071, entitled "PORTABLE MEDICINE
INJECTION DEVICE" filed on Sep. 26, 2012. The entire disclosure of
the above-referenced applications is incorporated by reference as
part of the specification of this application.
FIELD
[0002] This patent document relates to medicine injection devices
technologies, including portable medicine injection devices such as
portable insulin injection devices for self-administration by
diabetic patients.
BACKGROUND
[0003] Diabetes mellitus is a group of metabolic diseases
associated with high blood sugar, e.g., which may be due to
insufficient production of insulin by the body or inadequate
response by cells to the insulin that is produced. There are three
main types of diabetes mellitus (diabetes). Type 1 diabetes results
from the body's failure to produce insulin, and presently requires
the person to inject insulin (e.g., manually or using a wearable
insulin pump). Type 2 diabetes results from insulin resistance, in
which cells fail to use insulin properly, sometimes combined with
an absolute insulin deficiency. Types 1 and 2 diabetes are
considered chronic conditions that cannot be cured. The third main
form, referred to as gestational diabetes, can occur when pregnant
women without a previous history of diabetes develop a high blood
glucose level, e.g., which can develop into type 2 diabetes, but
often resolves after the pregnancy. Other forms of diabetes include
congenital diabetes (e.g., due to genetic defects of insulin
secretion), cystic fibrosis-related diabetes, steroid diabetes
(e.g., due to high doses of glucocorticoids), and other forms of
monogenic diabetes.
[0004] For example, diabetes, without proper treatment, may cause
acute complications, e.g., including hypoglycemia, diabetic
ketoacidosis, or nonketotic hyperosmolar coma, or in some
instances, may cause serious long-term complications, e.g.,
cardiovascular disease, chronic renal failure, and/or diabetic
retinopathy (retinal damage). Adequate treatment of diabetes is
thus important, as well as controlling blood pressure and managing
lifestyle factors such as nonsmoking and healthy body weight.
Insulin is used to treat the many of the forms of diabetes,
including type 1 diabetes. Other medications are used to treat type
2 diabetes.
SUMMARY
[0005] Systems, devices, and techniques are described for injecting
a medicine using a mechanical dose setting and dispensing mechanism
with built in intelligence to track the use of the medicine and
communicate the data in a closed loop system.
[0006] In one aspect of the disclosed technology, a method to
dispense a medicine includes inserting a cartridge containing a
medicine into a cartridge holder coupled to a housing of a medicine
injection device, positioning a spine component of the device to
make contact with the cartridge in the cartridge holder, selecting
a dose of the medicine for injection, in which the selecting
includes rotating an injection component of the device to a setting
corresponding to the selected dose, and linearly advancing the
injection component to rotate a drive gear coupled to the injection
component to drive the spine component so as to push the end of the
cartridge to dispense the medicine in the amount of the selected
dose.
[0007] In another aspect, a device to dispense a medicine includes
a housing configured to include a curved channel, a cartridge
holder coupled to the housing via a pivot joint, the cartridge
holder including a chamber structured to encase a cartridge
containing a medicine and having a first opening that aligns with
one end of the curved channel and a second opening at the opposite
end of the chamber, and a dose setting and injecting mechanism. The
dose setting and injection mechanism includes (i) a spine component
housed in the curved channel of the housing, the spine component
including a plurality of link structures linked together to allow
curved movement of the spine component within the curved channel,
in which the one end of the curved channel includes a channel
opening interlaced with the first opening to enable the spine
component to push against the cartridge for dispensing a selected
amount of the medicine through the second opening, (ii) a shaft
component structured to include a threaded cylindrical section
encased at least in part within the housing and a knob disposed at
least in part outside of the housing, (iii) a gear mechanism
including a rod having a first gear and a second gear which is
coupled to the spine component, and a drive gear having a first
gear engagement for engaging to the first gear and a second gear
engagement for engaging to threads of the threaded cylindrical
section of the shaft component, in which, upon engaging the first
gear and the drive gear to each other, a linear movement of the
shaft component moves the spine component, and (iv) a disengagement
button coupled to the rod to disengage the first gear and the drive
gear from each other, e.g., to allow the spine component to move
independent of the shaft component. The device can be operated such
that a rotation of the shaft component moves the shaft component to
a distance from the housing that corresponds selected amount of the
medicine.
[0008] In another aspect, a health management system includes an
analyte monitoring device to determine a concentration level of an
analyte; a computing system in communication with the analyte
monitoring device, in which the computing system includes a memory
unit and a processor configured to process data; and a medicine
injection device in communication with at least one of the analyte
monitoring device or the computing system. The medicine injection
device includes a housing configured to include a curved channel, a
cartridge holder coupled to the housing via a pivot joint, the
cartridge holder including a chamber structured to encase a
cartridge containing a medicine and having a first opening that
aligns with a first end of the curved channel and a second opening,
and a dose setting and injecting mechanism. The dose setting and
injection mechanism includes (i) a spine component housed in the
curved channel of the housing, the spine component including a
plurality of link structures linked together to allow curved
movement of the spine component within the curved channel, in which
the first end of the curved channel includes a channel opening
interlaced with the first opening to enable the spine component to
push against the cartridge for dispensing a selected amount of the
medicine through the second opening, (ii) a shaft component
structured to include a threaded cylindrical section encased at
least in part within the housing and a knob disposed at least in
part outside of the housing, (iii) a gear mechanism including a rod
having a first gear and a second gear, the second gear coupled to
the spine component, and a drive gear having a first gear
engagement mechanism for engaging to the first gear and a second
gear engagement mechanism for engaging to threads of the threaded
cylindrical section of the shaft component, in which, upon
engagement of the first gear and the drive gear to each other, a
linear movement of the shaft component moves the spine component,
and (iv) a disengagement button coupled to the rod to disengage the
first gear and the drive gear from each other, thereby allowing the
spine component to move independent of the shaft component, in
which a rotation of the shaft component moves the shaft component
to a distance from the housing that corresponds to the selected
amount of the medicine.
[0009] The subject matter described in this patent document can be
implemented in specific ways that provide one or more of the
following features. For example, the disclosed medicine dispensing
device can be configured to have a small, compact size enabling
convenient portability of the device, e.g., in which a user can
store within one's pocket, purse, handbag, etc. For example, the
disclosed medicine dispensing device can include an electronic
display that provides the user with information including, but not
limited to, a current dose setting that the device is dialed to
inject, the amount of medicine previously injected from the
existing loaded medicine cartridge in the device, the type of
medicine in the loaded cartridge (e.g., such as the name of the
drug, manufactured lot number, etc.), when to perform medicine
injections, and instructions for the user about the use of the
device or status of the device. For example, the disclosed medicine
dispensing device can include a cartridge holder that opens and
closes in a manner that provides ease of loading and removal of a
medicine cartridge. For example, the disclosed medicine dispensing
device can include an optical scanner that can scan an
identification code located on the medicine cartridge and detect
the type of medicine contained in the cartridge, e.g., which can be
processed as data in the device. For example, the disclosed
medicine dispensing device can be implemented as a reusable
medicine dispensing pen that communicates wirelessly with other
devices, e.g., such as a blood glucose monitor, mobile phone or
computing device including a user interface for health management
(e.g., including glucose monitoring and insulin treatments),
creating a closed loop system that provides convenience and ease of
use for a user to monitor analyte levels and perform drug-related
treatments. For example, the closed loop system can enable the
information stored on the disclosed medicine injection device to be
relayed (e.g., such as the type, amount, and injection time of a
medicine) to other device(s), which can store the reported
information as data and utilize the stored data with other user
data that can be used in health management, e.g. in real time).
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIGS. 1A-1F show schematics of an exemplary medicine
injection device based on the disclosed technology.
[0011] FIGS. 2A and 2B show block diagrams of processes to operate
the exemplary medicine injection device.
[0012] FIG. 3A shows a schematic illustrating a process to load a
medicine cartridge into an exemplary medicine injection device.
[0013] FIGS. 3B and 3C show schematics showing an exemplary torsion
spring mechanism configured to enable loading/unloading of a
medicine cartridge into the exemplary medicine injection
device.
[0014] FIGS. 4A and 4B show schematics illustrating a process to
prepare the exemplary medicine injection device for an
injection.
[0015] FIG. 5 shows a schematic illustrating a process to select a
dose of medicine to dispense using the exemplary medicine injection
device.
[0016] FIGS. 6A and 6B show schematics illustrating a process to
dispense the dose of medicine using the exemplary medicine
injection device.
[0017] FIGS. 7A-7C show schematics illustrating a process to reset
the exemplary medicine injection device.
[0018] FIG. 8 shows a schematic illustrating a process to remove
the used medicine cartridge from the exemplary medicine injection
device.
[0019] FIG. 9 shows a diagram of an exemplary system for health
management including an exemplary medicine injection device,
analyte monitoring device, and a cloud-based computing device.
[0020] Like reference symbols and designations in the various
drawings indicate like elements.
DETAILED DESCRIPTION
[0021] The technologies and technical features described in this
document can be implemented to provide portable insulin injection
devices for self-administration by diabetic patients. The described
technologies and technical features can be implemented in various
medicine injection devices including portable medicine injection
devices other than the portable insulin injection devices.
[0022] A portable insulin injection device can be configured as a
compact insulin pen for injecting insulin as part of treatment
and/or management of diabetic conditions in a patient. For example,
an insulin pen device can include an insulin cartridge holder and
mechanisms to dial to measure a dose of the insulin and to dispense
the measured dose. The insulin pen 5 device can include a housing
structure which can be shaped like a pen or other suitable
geometries for encasing or holding the insulin contained in a
cartridge, which can also be referred to as a container or vial.
The insulin pen device also includes a mechanism that uses
disposable needles to inject the dose into the patient's body.
Insulin pens can be configured as disposable pens that do not
replace vials of insulin after use or as reusable pens that allow
for replaceable insulin cartridges to be loaded into the cartridge
holder of the pen device. For example, insulin pens can be
configured to provide advantages over vial and syringe modalities
that include greater convenience in portability for daily use and
transport, increased accuracy in doses, improved ease to implement
(e.g., particularly among those with visual or fine motor skills
impairments), and reduced pain caused by injection.
[0023] Yet, some existing modalities of insulin treatments for
diabetic patients suffer certain problems and inefficiencies. For
example, in some existing insulin injection devices, unless a pump
is used, an insulin dose for injection needs to be tracked and
recorded manually. For example, some existing insulin injection
devices do not provide an insulin pen that is integrated with a
blood glucose monitor device to track test results and insulin
dosage. For example, various existing insulin injection devices
have designs that render it difficult to accurately administer
using insulin pens, e.g., various features associated with the
mechanics of the pen devices to set a dose, prime the injection,
and replace the insulin cartridge may cause the above mentioned
difficulty. Additionally, for example, some existing insulin pen
devices include large physical dimensions that are inconvenient for
a user to portably carry and store. In some existing insulin
injection devices, spent cartridges of reusable insulin pens are
difficult to remove, making it inconvenient for the patient to
reset the pen for next use. Disposable insulin injection pens may
provide convenient features in some regards but they tend to be
expensive on a per use basis and also do not include tracking and
reporting functionalities.
[0024] Disclosed are systems, devices, and techniques for injecting
a medicine including insulin using a precise mechanical dose
setting and a convenient and accurate dispensing mechanism with
built in intelligence to track the use of the medicine and
communicate the data in a closed loop system. While the disclosed
embodiments described in this patent document are primarily based
on systems, devices and techniques to inject insulin, e.g., in
order to facilitate understanding of the underlying concepts, it is
understood that the disclosed embodiments can also be used for
injection of other medicines.
[0025] In one embodiment of the disclosed technology, a device can
include a mechanical dose setting and dispensing mechanism with
integrated electronics to monitor and display the use of the
medicine and communicate the data in a closed loop system. For
example, the exemplary medicine injection device can include a
housing configured to include a curved channel, a medicine
cartridge holder coupled to the housing (e.g., via a pivot joint),
in which the cartridge holder includes a chamber structured to
encase a cartridge containing a medicine and having a first opening
that aligns with one end of the curved channel and a second opening
at the opposite end of the chamber, and a dose setting and
injecting mechanism. The dose setting and injection mechanism can
include (i) a spine component housed in the curved channel of the
housing, the spine component including a plurality of link
structures linked together to allow curved movement of the spine
component within the curved channel, in which the one end of the
curved channel includes a channel opening interlaced with the first
opening to enable the spine component to push against the medicine
cartridge for dispensing a selected amount of the medicine through
the second opening, (ii) a shaft component structured to include a
threaded cylindrical section encased at least in part within the
housing and a knob disposed at least in part outside of the
housing, (iii) a gear mechanism including a rod having a first gear
and a second gear which is coupled to the spine component, and a
drive gear having a first gear engagement for engaging to the first
gear and a second gear engagement for engaging to threads of the
threaded cylindrical section of the shaft component, in which, upon
engaging the first gear and the drive gear to each other, a linear
movement of the shaft component moves the spine component, and (iv)
a disengagement button coupled to the rod to disengage the first
gear and the drive gear from each other, e.g., to allow the spine
component to move independent of the shaft component. The exemplary
medicine injection device can be operated such that a rotation of
the shaft component moves the shaft component to a distance from
the housing that corresponds selected amount of the medicine.
[0026] In some examples, the drive gear of the gear mechanism can
be structured to include external threads that couple to the shaft
component between threads of the threaded cylindrical section and
internal threads located within a hole through the center of the
drive gear, in which the drive gear moves in response to a movement
of the shaft component. For example, the rod can intersect through
the drive gear via the hole and be structured to include a threaded
gear (e.g., the first gear) and an indentation, in which the
threaded gear is capable of coupling to the drive gear between
internal threads when the gear mechanism is in an engaged position.
The rod can also include a second gear located between the threaded
gear and the indentation. For example, the second gear of the rod
can be structured to include outer threads that couple between
threads of the link structures of the spine component. For example,
an advancement of the disengagement button advances the rod from
the engaged position to a disengaged position that disengages the
drive gear from the threaded gear of the rod, e.g., allowing the
spine component to move independent of the shaft component.
[0027] For example, the exemplary medicine injection device can
also include a data processing unit that includes a processor and a
memory unit, in which the selected dose for an injection and
dispensed dose are processed as data by the processor and stored in
the memory unit. For example, the exemplary medicine injection
device can also include a wireless transmitter unit to transmit the
data to another mobile and/or computing device or system. For
example, the exemplary medicine injection device can also include
an electronic display that provides the user with information
including, but not limited to, a current dose setting that the
device is dialed to inject, the amount of medicine previously
injected from the existing loaded medicine cartridge in the device,
the type of medicine in the loaded cartridge (e.g., such as the
name of the drug, manufactured lot number, etc.), when to perform
medicine injections, and instructions for the user about the use of
the device or status of the device. For example, exemplary medicine
injection device can also include an optical scanner located within
the housing and coupled to the data processing unit, in which the
optical scanner includes an optical sensor (e.g., a laser scanner)
that can scan an identification code located on a cartridge of
medicine and detect the type of medicine contained in the
cartridge, e.g., which can be processed as data in the device. For
example, the identification code can be configured to include bars
(e.g., of varying thicknesses, spacing, opacity, color, or other
parameters) that radially wrap around the cylindrical casing of the
medicine cartridge. In this exemplary configuration, the optical
scanner can detect the identification code in any orientation that
the cartridge is placed within the cartridge holder, e.g., such
that the cartridge position (rotationally) is not critical to the
ability to detect the identification code.
[0028] The disclosed medicine injection device can be configured to
have a small, compact size enabling convenient portability of the
device, e.g., in which a user can store within one's pocket, purse,
handbag, etc. For example, the cartridge holder of the disclosed
device can be configured to open and close in a manner that
provides ease of loading and removal of a medicine cartridge. For
example, the disclosed device can be implemented as a reusable
medicine dispensing pen that communicates wirelessly with other
devices, e.g., such as a blood glucose monitor or mobile phone or
computing device including a user interface for health management
(e.g., including glucose monitoring and insulin treatments),
creating a closed loop system that provides convenience and ease of
use for a user to monitor analyte levels and perform drug-related
treatments. For example, the closed loop system can enable the
information stored on the disclosed medicine injection device to be
relayed (e.g., such as the type, amount, and injection time of a
medicine) to other device(s), which can store the reported
information as data and utilize the stored data with other user
data that can be used in health management, e.g. in real time).
[0029] FIGS. 1A-1F show schematics of an exemplary medicine
injection device 100 based on the disclosed technology. FIGS. 1A
and 1B show different three dimensional cross sectional views of
the components that make up the dose setting and injecting
mechanism in the medicine injection device 100. It is noted that
some components included in the medicine injection device 100 may
not necessarily be shown in the schematics of FIGS. 1A and 1B.
[0030] As shown in FIGS. 1A and 1B, the dose setting and injecting
mechanism is encased in a housing structure 101 that can be used to
provide positioning and/or structural support to various
mechanisms, modules and components contained with the housing of
the medicine injection device 100. The device 100 includes a
cartridge holder 121 that is coupled to the housing structure 101
and includes a chamber structured to encase and hold a cartridge
120 containing a medicine, e.g., insulin. The cartridge holder 121
has one end that is engaged to a rotational pivot joint structure
121b to enable the cartridge holder 121 to be in a latched position
in the housing structure 101 or in an open position that exposes
the chamber after being released from the latched position in the
housing structure 101 for removing or replacing the cartridge 120.
The rotational pivot joint structure 121b can include a spring
mechanism having a torsional spring that pushes the cartridge
holder 121 to an open position, as shown later in FIGS. 3A-3C. The
cartridge 120 can be loaded into the chamber of the cartridge
holder 121 and can be removed and replaced after the medicine in
the cartridge 120 is used up or otherwise needs to be disposed or
replaced. The exterior of the cartridge holder 121 at the distal
end adjacent to the rotational pivot joint structure 121b includes
an opening between the chamber and an attachment structure (e.g.,
such as a protruding or receding threading for screwing a needle
on) to attach a detachable needle structure 125 with a protruding
needle 124, e.g., for injecting the medicine into the patient. For
example, the detachable needle structure 125 includes a cap region
that attaches to the attachment structure of the cartridge holder
121. For example, the protruding needle 124 can be configured as a
single needle that protrudes internally within the cap of the
detachable needle structure 125 and externally from the exterior of
the detachable needle structure 125. For example, the cartridge 120
can be structured as a hollowed tube (e.g., of a non-fouling,
biocompatible material) with one end configured as a medicine
dispensing tip having a dispensing aperture, e.g., in which the tip
region of the cartridge 120 tapers from the body of the tube
structure, e.g., such that the diameter of the aperture is smaller
than that of the tube body. The dispensing aperture can be covered
with a membrane that seals the aperture to prevent leakage or
contamination of the stored medicine in the cartridge 120. The
other end of the tube structure of the cartridge 120 can be
configured to include a moveable piston or plunger (e.g., of a
rubber or plastic material, which can be of coated by a
non-fouling, biocompatible material) initially positioned at the
end within the hollowed tube. For example, the piston or plunger
can function as a pliable stopper that can be pushed into the tube
interior in the direction of the dispensing aperture, e.g., to push
the medicine through the dispensing aperture and the protruding
needle 124. For example, when the cartridge 120 is loaded into the
chamber of the cartridge holder 121, the inner protruding region of
the protruding needle 124 of the detachable needle structure 125
punctures through the membrane at the dispensing aperture, e.g.,
thereby allowing the medicine to flow through the protruding needle
124 to be dispensed from the device 100. The device 100 includes a
latch mechanism 126 that can include a sliding button configured on
the exterior of the housing structure 101 to move in a linear
direction to unlock the latch mechanism 126 from the cartridge
holder 121 to allow the cartridge holder 121 to move to the open
position. The device 100 includes an electronics unit 185 including
display electronic components (e.g., liquid crystal display (LCD)
electronics) that can display information related to the medicine,
medicine injection dose, and the device.
[0031] The device 100 can include a data processing unit 186
including a processor and a memory coupled to the processor. The
data processing unit 186 in this example is shown to be a separate
unit from the electronics unit 185 and is positioned underneath of
the electronics unit 185. In other implementations, the electronics
unit 185 and data processing unit 186 may be integrated into one
module as a single unit. The data processing unit 186 can be
configured to continuously monitor data provided by sensors
configured along a travel path of a push spine component 110 of the
dose setting and injecting mechanism to determine the movement of
the push spine component 110 and process the data as an
administered or dispensed dose of the medicine. For example, the
processing unit 186 can report the dispensed dose data and/or
provide alarms regarding the dose to a user on a display (e.g., via
the display electronics of the electronics unit 185) on the
exterior of the device 100, e.g., which can confirm to the user
that a complete injection dose was administered. The data
processing unit 186 can be configured to continuously monitor data
provided by sensors configured along a travel path of an injection
shaft component 102 of the dose setting and injecting mechanism to
determine the movement of the injection shaft component 102 and
process the data as a selected or set dose of the medicine to be
dispensed. The sensors configured within the travel path of the
injection shaft component 102 can measure the rotation and/or
related (linear) translation of the injection shaft component 102
to indicate the selected dose. Exemplary sensors can include a
linear encoder that can be optical, magnetic, or capacitive to
perform the dose volume metering. For example, the processing unit
186 can report the selected dose data and/or provide alarms
regarding the dose to a user on the display of the device 100,
which can confirm to the user that the desired dose was dialed. For
example, the data processing unit 186 can be in wired or wireless
communication with a mobile device (e.g., such as a cell phone) or
a computing device that includes a application portal featuring a
user interface that the user of the device 100 can use for various
functions, including, but not limited to, monitoring the status of
the device 100 (e.g., such as if the device is ready to dispense
the medicine, a setting value of the medicine to be dispensed,
etc.), the presence of a cartridge in the cartridge holder 121, or
the amount of medicine contained in the cartridge 120. Some
examples for wireless communications of the device 100 include 3G
wireless communication standards, 4G wireless communication
standards including, LTE, WiFi, Blue tooth, Bluetooth LE, and other
suitable wireless communications via radio frequency waves and
other electromagnetic waves.
[0032] The dose setting and injecting mechanism can include a push
spine component 110 encased in a curved channel 101a of the housing
structure 101, an injection shaft component 102 having a threaded
cylindrical section 102b at least partially encased within the
housing structure 101 and a knob section 102a disposed at least
partially outside of the housing structure 101, and a button 111
partially encased within a button casing structure 112 structured
to expose a top surface of the button 111 outside of the housing
structure 101. The dose setting and injecting mechanism can also
include a gear mechanism to interact with the push spine component
110, the injection shaft component 102, and the button 111 and can
be encased within a mechanism encasement structure 116 located
within the housing structure 101. The mechanism encasement
structure 116 can include multiple sections having to two joined
chambers, in which one chamber includes a hollowed cylindrical
chamber structured to encase at least a portion of the threaded
cylindrical section 102b of the shaft component 102 and in which
the other chamber is structured to fit the components of the gear
mechanism.
[0033] Referring to FIG. 1B, the housing structure 101 can include
a recess 101b along one side of the device 100, in which an opening
track 101c is structured between the straight region of the curved
channel 101a and the outside of the device 100. The opening track
101c provides an aperture that enables a sliding button 187
positioned within the recess 101b and coupled to the push spine
component 110 (e.g., encased in the curved channel 101a) to move
along the recess 101b in response to a movement of the push spine
component 110.
[0034] FIG. 1C shows a schematic of one example of the push spine
component 110 of the dose setting and injecting mechanism. In this
example, the push spine component 110 can include multiple link
structures 110a formed of a rigid body that are linked together at
a rotational joint 110c. The location of the rotational joint 110c
on each link structure 110a can be configured near one side of the
link structure 110a having threads such that the alignment of the
link structures 110a positions the threads 110b on one side of the
push spine component 110. For example, the rotational joint 110c
can include a pin that can pass through an opening in two
overlapping sections of two adjacent link structures 110a to
provide a pivot in which one link structure can rotate about the
other. The rotational joint 110c enables the push spine component
110 to bend in the curved section while traveling in the curved
channel 101a.
[0035] FIG. 1D shows a schematic of one example of the gear
mechanism of the dose setting and injecting mechanism. In this
example, the gear mechanism can include a rod shaft 118 coupled to
the lower region of the button 111 at one end of the rod shaft 118
and intersecting through a roller clutch 113 and a drive gear 114
of the gear mechanism via a hole through the center of the roller
clutch 113 and drive gear 114. The rod shaft 118 includes a
threaded gear 118b and an indentation 118c (shown in FIGS. 1E and
1F), in which the threaded gear 118b is capable of coupling to the
drive gear 114 between internal threads of the drive gear 114 when
the gear mechanism is in an engaged position. For example, when the
gear mechanism is in the engaged position, the push spine component
110 can move in response to a movement (e.g., a linear advancement)
by the injection shaft component 102. The drive gear 114 can be
structured to include external threads that couple to the injection
shaft component 102 between the threads of the threaded cylindrical
section 102b. The drive gear 114 can be structured to include
internal threads located within the hole through its center (shown
in FIG. 1F), such that the drive gear 114 rotates in response to a
movement of the shaft component 102. The gear mechanism can include
a gear 115 connected to the rod shaft 118 and located at a fixed
position on the rod shaft 118 between the threaded gear 118b and
the indentation 118c. In some exemplary configurations, the gear
115 can be configured as part of the rod shaft 118. The gear 115
can be structured to include outer threads that couple between the
threads 110b of the link structures 110a of the spine component 110
so that the rotation of the drive gear 115 (e.g., resulting from a
rotation of the drive gear 114 when in the gear mechanism is in the
engaged position) can be translated into the movement of the link
structures 110a of the spine component 110 which, in turn, pushes
the piston or plunger in the cartridge 120 to press a determined
amount of the medicine in the cartridge 120 out of the cartridge
120 and device, e.g., through the detachable needle structure 125
and into the patient's body (e.g., via the protruding needle 124
that can penetrate into the patient's body to dispense the
medicine). The gear mechanism can include a spring 117 surrounding
the rod shaft 118 and located under the gear 115, in which the
spring 117 provides a compressive force when compressed. The roller
clutch 113 is configured to prevent the drive gear 115 from
rotating in more than one direction.
[0036] FIG. 1E shows a schematic of the gear mechanism in the
engaged position, and FIG. 1F shows a schematic of the gear
mechanism in the disengaged position. For example, the advancement
of the button 111 advances the rod shaft 118 from the engaged
position to the disengaged position that disengages the drive gear
114 from the threaded gear 118b of the rod shaft 118, e.g.,
allowing the push spine component 110 to move independent of the
injection shaft component 102. In this example, the button casing
structure 112 can include a recessed cavity 112a that permits the
button 111 to travel (e.g., linearly advance into the recessed
cavity 112a) when the button 111 is pressed. For example, the
advancement of the button 111 advances the rod shaft 118 through a
channel formed by the holes through the center of the button casing
112 and the drive gear 114, an actuator chamber 116a of the
mechanism encasement structure 116, and a housing chamber 101d of
the housing structure 101. The advancement of the rod shaft 118
displaces the threaded gear 118b of the rod shaft 118 from its
engaged alignment with the internal threads of the drive gear 114.
The displacement of the threaded gear 118b of the rod shaft 118
from the internal threads of the drive gear 114 uncouples the two
components such that a movement of the injection shaft component
102 no longer affects the movement of the push spine component 110,
and the injection shaft component 102 and the push spine component
110 are free to move independent of each other. For example, the
gear mechanism can be maintained in the disengaged position using a
clasp component 109 that is encased within the housing structure
101 and structured to include a notch 109a capable of coupling to
the indentation 118c of the rod shaft 118 to lock the rod shaft 118
in the disengaged position, as shown later in FIG. 4B.
[0037] FIG. 2A shows a block diagram of an exemplary process 200 to
operate a medicine injection device of the disclosed technology.
The process 200 can include a process 210 to insert a cartridge
containing a medicine into the cartridge holder of the medicine
injection device. The process 200 can include a process 220 to
preset the push spine of the medicine injection device, e.g., by
moving the push spine component in a position to make contact with
the abutting end of the cartridge in the cartridge holder. The
process 200 can include a process 230 to select a dose amount of
the medicine for injection, e.g., by rotating an injection
component of the device to a dose setting position corresponding to
the selected dose amount, e.g., in which the injection component is
rotated from its initial or home position corresponding to a zero
dose. The process 200 can include a process 240 to dispense the
medicine in the amount of the selected dose from the device, e.g.,
by linearly advancing the injection component from the dose setting
position to the home position of the injection component, which can
rotate a drive gear coupled to the injection component to drive the
movement of the spine component. The process 200 can optionally
include repeating the processes 230 and 240, e.g., while the
inserted cartridge contains medicine in an amount greater than a
desired dose. The process 200 can include a process 250 to return
the push spine component to its initial position in the device,
e.g., such that the push spine component is not positioned within
the cartridge holder. The process 200 can include a process 260 to
remove the cartridge from the cartridge holder of the device. For
example, after the implementation of the process 260, the process
200 can be repeated by implementing the process 210. In some
examples, the process 200 can further include displaying on a
display of the device at least one of the dose setting or the
corresponding dose amount during and/or after the process 230. The
process 200 can further include scanning an identification code on
the exterior of the medicine cartridge with an optical scanner of
the device.
[0038] FIG. 2B shows a block diagram of the process 220 to preset
the push spine of the medicine injection device. For example, the
process 220 can include a process 221 to disengage the injection
component from the push spine, e.g., by implementing a
disengagement actuator (e.g., pressing the disengagement button on
the exterior of the device) to advance the rod shaft from the
engaged position to the disengaged position such that the threaded
region of the rod shaft is not coupled to the internal threads of
the drive gear, thereby allowing the spine component to move
independent of the shaft component. For example, the process 220
can include a process 222 to move the push spine through the curved
channel of the housing of the device to make contact with the
abutting end of the cartridge in the chamber of the cartridge
holder. For example, the process 220 can include a process 223 to
reengage the injection component with the push spine, e.g., by
implementing a reengagement actuator (e.g., pressing a release
button on the slide button of the push spine component 110) to
unlatch the notch of a clasping component from the indentation of
the rod shaft 118 such that the gear mechanism returns to the
engaged position.
[0039] FIGS. 3A-8 show schematics that illustrate the
implementation of the exemplary process 200 using the exemplary
medicine injection device 100. FIG. 3A shows a schematic
illustrating the process 210 to load a cartridge containing
medicine into the device 100. The process can include implementing
the latch mechanism 126 to open the cartridge holder 121, e.g., by
actuating the button of the latch mechanism 126 to unlock the
cartridge holder 121 from the housing structure 101. The process
can include inserting the cartridge 120 into the cartridge holder
121 while in the open position. The cartridge holder 121 can be
configured to hold the cartridge 120 such that an opening at the
end of the cartridge (for dispensing the contained medicine) is
aligned with an opening at the distal end of the cartridge holder
121 having the detachable needle structure 125 with a protruding
needle 124. The process can include returning the cartridge holder
121 to the closed position (e.g., which aligns the end of the
cartridge 120 with the exit end of the curved channel 101a). For
example, upon returning the cartridge holder 121 to the closed
position, the latch mechanism 126 can be automatically engaged to
lock the cartridge holder 121 in the position. The process can
include attaching the needle structure 125 to the distal end of the
cartridge holder 121.
[0040] FIGS. 3B and 3C show schematics showing an exemplary torsion
spring mechanism configured to couple the cartridge holder 121 to
the housing structure 101 and enables the cartridge holder 121 to
rotate to a load position upon unlocking of the latch mechanism 126
that allows for the loading/unloading of a medicine cartridge
(e.g., the cartridge 120). As shown in FIG. 3B, the exemplary
torsion spring mechanism of the rotational pivot joint structure
121b is implemented to rotate the cartridge holder 121 to the load
position at a particular angle (e.g., which can be configured to 13
degrees from the closed position aligned with the terminal link of
the push spine component 110, or to another angle based on design
preference). FIG. 3C shows a cross section of the exemplary
rotational pivot joint structure 121b that includes a torsion
spring 321 which can be embedded in a spring housing component 322
of the cartridge holder 121 and the housing structure 101. The
cartridge holder 121 is shown in the closed position in FIG. 3C, in
which the torsion spring 221 of the rotational pivot joint
structure 121b is compressed and the latch mechanism 126 locks the
cartridge holder 121 in the closed position.
[0041] FIGS. 4A and 4B show a schematic illustrating the process
220 to preset the position the push spine component 110 of the
device 100 to make contact with the cartridge 120 in the cartridge
holder 121. FIG. 4A shows a schematic illustrating the process 221
to disengage the injection shaft component 102 from the push spine
component 110 to allow the push spine component 110 to move
independent of the injection shaft component 102. For example, the
button 111 can be actuated to move the gear mechanism from the
engaged position to the disengaged position, e.g., by pressing the
button 111 into the recess of the button casing 112 to advance the
rod shaft 118. For example, the advancement of the rod shaft 118
displaces the threaded gear 118b of the rod shaft 118 from its
engaged alignment with the internal threads of the drive gear 114,
such that a movement of the injection shaft component 102 no longer
affects the movement of the push spine component 110.
[0042] The schematic in FIG. 4A also illustrates the process 222 to
move the push spine component 110 through the curved channel 101a
of the housing 101 to contact the abutting end of the cartridge 120
in the chamber of the cartridge holder 121. For example, while the
gear mechanism is in the disengaged position, the push spine
component 110 can be moved by sliding the button 187 along the
recess 101b until the push spine component 110 abuts the cartridge
120.
[0043] FIG. 4B shows a schematic illustrating the process 223 to
reengage the injection component with the push spine component,
e.g., by implementing a reengagement actuator that releases the
gear mechanism from the disengaged position. For example, the
reengagement actuator can include the clasp component 109 that,
when the gear mechanism is in the disengaged position, couples the
notch 109a to the indentation 118c of the rod shaft 118 to lock the
rod shaft 118 in the disengaged position and prevent its return to
the engaged position. In one example, the clasp component 109 can
be encased within an internal linear channel within the housing
structure 101 that permits translational motion of the clasp
component 109. In this example, the clasp component 109 can include
a spring 109b that creates a force to drive the notch 109a into the
housing chamber 101d to latch to the indentation 118c of the rod
shaft 118 when the rod shaft 118 has been advanced far enough to
align the indentation 118c with the notch 109a. In this example of
the clasp component 109, a release structure can be configured to
the clasp component 109 to pull the clasp component 109 back to an
unlatched position, e.g., thereby releasing the rod shaft 118 to
return gear mechanism to the engaged position. In another example
of the clasp component 109, the clasp component 109 can be encased
within an internal chamber within the housing structure 101 that
permits rotational motion of the clasp component 109 about a pivot
to rotate into the housing chamber 101d to latch to the indentation
118c of the rod shaft 118 when the rod shaft 118 has been advanced
far enough to align the indentation 118c with the notch 109a. In
this alternate example, the clasp component 109 can be coupled to a
bar connected to a terminal link structure 110a of the push spine
component 110 that protrudes out of the sliding button 187 when the
push spine component 110 has been moved to abut the cartridge 120
in the cartridge holder 121. The bar can be actuated to retract the
clasp component 109 in the opposite rotational motion such that the
clasp component 109 releases the rod shaft 118 to return the gear
mechanism to the engaged position. For example, the bar can be
actuated by pressing the bar into the sliding button 187.
[0044] FIG. 5 shows a schematic illustrating the process 230 to
select a dose of medicine to dispense using the exemplary medicine
injection device 100. The process can include rotating the
injection shaft component 102 to a dose setting position from the
home position to the select a dose amount corresponding to the dose
setting position. In the disclosed embodiment of the medicine
injection device 100, the dose setting and injection mechanism is
configured to set a dose by rotating the injection shaft component
102 and to inject the selected dose by translationally advancing
the injection shaft component 102. For example, the dose setting
functionality of dose setting and injection mechanism can be
configured such that rotation of the injection shaft component 102
does not actuate a motion of the gear mechanism. The injection
shaft component 102 can be configured to rotate in both directions,
e.g., such that the dose amount can be reduced prior to injection,
for example, in an instance where the dose was set to high and the
desired dose is a lesser amount. In some examples, the injection
shaft component 102 can be rotated such that a clicking sound is
produced to correspond to a dose setting (e.g., such as clicking
for each 100 .mu.L set by the rotation).
[0045] FIGS. 6A and 6B show schematics illustrating the process 240
to dispense the dose of medicine using the exemplary medicine
injection device 100. The cartridge 120, which can be loaded into
and removed from the chamber of the cartridge holder 121, includes
a first end structured to interface with a cap of the detachable
needle structure 125 to deliver the medicine to the injection
needle 124 and a second end (e.g., an abutment end) with a movable
plunger which interfaces with the terminal end of the link
structure of the spine component 110. In operation, the spine
component 110 is moved to cause a responding movement of the
plunger in the cartridge 120 to dispense the properly selected
amount of the medicine from the device 100, e.g., into the
patient's body. This process includes linearly advancing the
injection shaft component 102 from the dose setting position to the
home position such that the advancement of the injection shaft
component 102 actuates the rotation of the drive gear 114 of the
gear mechanism to actuate the rotation of the rod shaft 118, which
in turn rotates the gear 115, and thus drives the movement of the
push spine component 110 to push the abutment end of the cartridge
120 into the body of the cartridge to dispense the medicine from
the detachable needle structure 125 via the injection needle 124.
The roller clutch 113 of the gear mechanism can be configured to
allow the drive gear 114 to rotate in only one direction (e.g.,
counterclockwise), e.g., which can prevent a pulling movement of
the push spine component 110. For example, the advancement of the
injection shaft component 102 actuates the push spine component 110
to push the abutment end to plunge the medicine in the cartridge
120 by a volume of corresponding to the selected dose. For example,
after the implementation of the process 240, the push spine
component 110 remains in contact with the abutment end of the
cartridge 120 (e.g., within the chamber of the cartridge holder
121) for any subsequent medicine dose setting and dispensing
implementations. FIG. 6B shows the push spine component 110 in the
curved channel 101a in which the leading portion of the curved
channel 101a is advanced within the chamber of the cartridge holder
121.
[0046] FIGS. 7A-7C show schematics illustrating a process 250 to
reset the exemplary medicine injection device. The schematic of
FIG. 7 A illustrates the process 250 can include implementing the
process 221 to disengage the injection shaft component 102 from the
push spine component 110, e.g., by pressing the button 111 to
advance the rod shaft 118 from the engaged position to the
disengaged position. Subsequently, the push spine component 110 can
be moved back to its initial position by pulling it through the
curved channel 101a by sliding the sliding button 187 along the
opening track 101c of the recess 101b, as illustrated in the
schematics in FIGS. 7B and 7C.
[0047] FIG. 8 shows a schematic illustrating the process 260 to
remove a used medicine cartridge from the exemplary device 100 and
load a new medicine cartridge into the device 100. The process can
include implementing the latch mechanism 126 to open the cartridge
holder 121, e.g., unlocking the latch mechanism 126 such that the
spring mechanism of the rotational pivot joint structure 121b
rotates the cartridge holder 121 to the open position. The process
can include removing the cartridge 120 from the cartridge holder
121 in the open position. The process can include inserting a new
medicine cartridge into the cartridge holder 121 while in the open
position. The process can include returning the cartridge holder
121 to the closed position (e.g., which aligns the end of the
loaded new cartridge with the exit end of the curved channel 101a).
For example, upon returning the cartridge holder 121 to the closed
position, the latch mechanism 126 can be automatically engaged to
lock the cartridge holder 121 in the position. In some examples,
the process can include returning the cartridge holder 121 to the
closed position and locking the cartridge holder 121 to the housing
structure 101 without reloading a new medicine cartridge into the
cartridge holder 121.
[0048] In another aspect of the disclosed technology, an integrated
analyte monitoring and medicine treatment system is described for
health management. In some exemplary embodiments, the system
includes the disclosed medicine injection device and an analyte
monitoring device (e.g., such as a glucose meter) that wirelessly
communicate with a remote computerized system (e.g., server in the
cloud), as well as with each other.
[0049] FIG. 9 shows a diagram of an exemplary system 900 including
an exemplary analyte monitoring device 950 and the medicine
injection device 100 in communication with one or more cloud-based
computing devices 910, e.g., such as a server 911. For example, the
exemplary analyte monitoring device 950, the medicine injection
device 100, and the cloud-based computer device 910 can be in
communication through wired or wireless communications. Some
examples for wireless communications include 3G wireless
communication standards, 4G wireless communication standards
including, LTE, WiFi, Bluetooth, and other suitable wireless
communications via radio frequency waves and other electromagnetic
waves. In some implementations, the cloud-based computing device
910 is in communication with other peripheral computing devices
including a mobile device 920 (e.g., including, but not limited to
a smart phone, tablet, laptop computer, etc.) and a computer device
930 (e.g., including, but not limited to a desktop, laptop,
terminal or other computer, tablet or other computer medium).
[0050] The cloud-based computing device 910 can include a database
to store and organize data received from devices of the system 900,
e.g., such as the analyte monitoring device 950, the medicine
injection device 100, or a user input terminal such as the computer
930 or mobile communication device 920, among others. For example,
the information stored in the database of the cloud-based computing
device 910 can be shared between any or all of the devices of the
system 900. In some implementations, the database can exist on
other the devices of the system 900 in addition or as an
alternative to residing on the cloud-based computing device
910.
[0051] In some implementations, the system 900 includes the analyte
monitoring device 950 and the medicine injection device 100 in
communication with each other, in which the analyte monitoring
device 950 communicates with the one or more cloud-based computing
devices 910. In this example, the medicine injection device 100
communicates solely with the analyte monitoring device 950, which
can relay the raw data or process the data and relay the processed
data from the device 100 to the cloud-based computing device 910.
For example, this exemplary configuration can permit the device 100
to operate with a scaled down communication system, e.g., which may
reduce the number of components included in the device 100 and
improve the overall power consumption rate of the device 100.
[0052] In some implementations, the system 900 includes multiple
analyte monitoring devices 950 and/or multiple medicine injection
device 100 in communication with the one or more cloud-based
computing devices 910. For example, it may be desirable for a user
to possess multiple medicine injection devices 100 that can be kept
in various locations that a user may be frequently located, e.g.,
such as a user's home, car, workplace, gym, etc., while keeping a
single analyte monitoring device 950 on the user's person.
Additionally, the user may possess multiple analyte monitoring
devices 950 in various desired locations. For example, since both
the analyte monitoring devices 950 and medicine injection device
100 can include a user identification mechanism that permits only
authorized users to operate the device, the user's data, settings,
and other features personalized to the user remain secure on the
devices.
[0053] The analyte monitoring device 950 can be configured as a
blood analyte meter having a compact, all-in-one lancet/strip/meter
structure that enables a user to perform a test using one hand. The
analyte monitoring device 950 can be configured to be cassette
based, e.g., enabling a user to easily change test strip and lancet
cartridges. The analyte monitoring device 950 can be configured to
include web-based tracking services and wireless communication
devices and components. In some implementations, the analyte
monitoring device 950 includes a plurality of analyte sensors
(e.g., housed in an analyte sensor cartridge) and a plurality of
lancets (e.g., housed in a lancet cartridge), in which a one-handed
operation of an actuator mechanism can be implemented to ready the
device for a test, prick the user to extract blood to be analyzed
in the test, and reset the device for another use. For example, the
actuator mechanism of the analyte monitoring device can be
implemented to ready the device for a test by moving an analyte
sensor (e.g., a test strip) forward to expose the sensor and
advancing a firing component to a position for projection of a
lancet. The actuator mechanism can subsequently be implemented to
project (or fire) the lancet to prick a user to draw blood for
analysis in the test. The actuator mechanism can be implemented to
reset the device by ejecting the test strip and returning the
components of the actuator mechanism to an initial position.
[0054] For example, in one exemplary embodiment, the analyte
monitoring device 950 includes an analyte sensor module configured
to hold a sensor cartridge structured to store analyte sensors, the
analyte sensor module including an opening from which an analyte
sensor advances to a testing position to expose at least a portion
of the analyte sensor to outside of the analyte testing device. The
analyte monitoring device 950 includes a lancet module configured
to hold a lancet cartridge structured to store lancets. And, the
analyte monitoring device 950 includes an actuator, in which the
actuator includes: (i) a button; (ii) a first linking component
coupled to the button and the analyte sensor module, in which the
first linking component moves in response to a movement of the
button including a movement between a first position and a second
position or a movement between the second position and a third
position; (iii) a second linking component coupled to the button
and the lancet module, in which the second linking component moves
in response to a movement of the button between the first position
and the second position; (iv) a third linking component coupled to
the second linking component and moveable in response to a movement
of the second linking component; and (v) a lancet projecting
component coupled to the third linking component. The analyte
monitoring device 950 can be implemented such that a single
operation of the button moves the analyte sensor to the testing
position and moves the lancet projecting component from an initial
position to a cocked position for projecting a lancet.
[0055] This exemplary embodiment of the analyte monitoring device
950 can be implemented in ways that provide one or more of the
following features. For example, the analyte monitoring device 950
can include a processing unit coupled to a memory unit configured
to store data, in which the processing unit is configured to
evaluate data obtained from the analyte sensor module, lancet
module, or information derived from data out of the analyte
monitoring device 950. The processing unit can be configured to
send a notification to a recipient based on the evaluated data. In
some implementations, the processing unit can correlate individual
instances of the data with time stamps, threshold values, alerts
and user-entered information, e.g., including user-entered speech
and text. The analyte monitoring device 950 can include a facility
configured to transmit data obtained using a wireless protocol, or
in other examples, a wired path, to other devices of the system
900. For example, the processing unit can be configured to keep
track of inventory of lancets and analyte sensors, both within the
device 950 and outside the device 950, e.g., such as test strip and
lancet cartridges previously ordered and received by the user not
in use within the device. For example, the processing unit can be
configured to reorder inventory of lancets and analyte sensors. In
some implementations, the processing unit can be configured to
store voice recordings of diary information, e.g., for supplies
used or ordered, food eaten, exercise, medication taken, and
estimated calories burned. For example, the processing unit can be
configured to produce a prompt to direct a user to use the device
950 according to at least one of a selected time or a selected time
interval. The analyte sensor module of the analyte monitoring
device 950 can include a temperature sensor to monitor temperature
in the analyte sensor module. The analyte monitoring device 950 can
also include an LCD touch screen display, e.g., to display a user
interface for the user to interact with the device. Additionally,
for example, the analyte monitoring device 950 can include a work
light positioned to illuminate a lancet exit hole, as well as a
work light positioned to illuminate an analyte sensor exit slot. In
some implementations, the analyte monitoring device 950 can include
a pedometer communicatively coupled with the processing unit
configured to calculate, for example, the distance a user travels,
speed of travel, and/or an amount of calories burned associated
with the distance traveled. In some implementations, the analyte
monitoring device 950 can be docked in a docking station that
provides power and data connectivity to the device. In some
implementations, the analyte monitoring device 950 can include a
personal emergency response system (PERS) that includes a button
for alerting a third party. For example, the PERS can be configured
to perform the following functions, including, but not limited to,
contact a third party, identify the device, provide health data
associated with a user of the device, automatically contact a third
party in response to health data associated with a user of the
device, notify a third party as an urgency level of an emergency,
and determine identity of a third party to be contacted.
[0056] The system 900 includes a data management and interface
application that can be operated to manage the data stored in the
database and associated with the medicine dispensing device 100 and
the analyte monitoring device 950, as well as other forms of data
inputted into the system 900 (e.g., by the user). The application
can be operated on any of the devices of the system 900 with the
same or varying amount of controls or functionalities, for example,
based on a user interface presented to the devices, e.g., such as
the analyte monitoring device 950, the cloud-based computing
devices 910, the mobile device 920, the computer 930, and the
medicine injection device 100. In some examples, the exemplary
mobile device 920 operates a mobile application including a mobile
user interface that is adapted for the particular mobile
device.
[0057] The user interface of the data management and interface
application in the system 900 is configured to provide a functional
interface for a user to manage health information. For example, the
application provides a health information and management interface
that includes several interactive features that display
information, e.g., including analyzed health information, and allow
a user to input data. For example, the exemplary user health
information and management interface can include a presentation of
the data from the analyte monitor device 950 (e.g., raw data,
analyzed data, and/or summary data), data from the medicine
injection device 100 (e.g., raw data, analyzed data, and/or summary
data), and data received as input from a user of the application
interface.
[0058] In some exemplary embodiments, the application includes a
user interface that can be accessed by each of a variety of users,
e.g., including a patient (e.g., a diabetic person), a caregiver
(e.g., a nurse or doctor or family member), and a payer (e.g., an
insurance company) to facilitate the sharing of information and to
enhance the quality of care. For example, the UI of the application
can be configured differently for each type of user. The
application of the system 900 can be configured in a variety of
modules, e.g., in which each module can include a distinct user
interface or include an inclusive user interface for some or all of
the modules. For example, in some implementations, the application
includes a UI for analyte monitoring (e.g., glucose level
monitoring), a UI for medicine dispensing (e.g., insulin dose
injections), a UI for lifestyle tracking (e.g., diet, exercise,
etc.), and a UI for user information. In one example, an analyte
monitoring user interface can be presented on any of the devices of
the system 900 to enable the user to identify individual patterns
and changes in the level of analytical substances found in a bodily
fluid (e.g., blood, saliva, or urine) of a patient, as well as
guide (e.g., provide pertinent info/test data to support guidance)
the user (e.g., patient, care taker, doctor, etc.) as to what
actions to take based on the analyte level, e.g., such as the
timing and dosage of a medication, meal planning, physical
activities, or other interventions. For example, the application
can include an inclusive UI with viewable information to the user
providing the analyzed analyte level and/or dispensed medicine
data, tags and details, user goal information, selectable sub
categories (e.g., including, but not limited to, nutrition
information such as carbohydrates, steps, exercise, and goal
information), selectable data history information, personalized
settings, and flagging/data storing/questions settings.
[0059] The exemplary health management application of the system
900 can be used to identify a pattern (or patterns) or a threshold
(e.g., maximum or minimum) that are analyzed from the analyte
monitoring data or obtained as input from the user. For example,
such data patterns and thresholds can include an analyte testing
regime pattern, a medicine injection regime pattern, a hypo- or
hyper-blood analyte level pattern or threshold, a pattern of
variability in analyzed or input data, and a comparative pattern to
a particular standard. For example, the inclusion of such a variety
of information can be displayed on a single display of any of the
devices of the system 900, which greatly enhances the user's
experience and provides functionalities that would not have been
possible, or readily discernible, from data that is dispersed
throughout multiple plots, or lists, etc. Based on an identified
pattern or threshold, alerts or messages can be generated by the
exemplary health management system 900 and displayed on a screen of
any of the devices of the system 900, e.g., such as the analyte
monitoring device 950, the cloud-based computing devices 910, the
mobile device 920, the computer 930, and the medicine injection
device 100. Other types of messages can also be generated for the
user, e.g., including, but not limited to, reminders, encouraging
messages, factoids, etc.
[0060] For example, actual analyte levels and fluctuations therein
can be easily correlated to one or more of the factors presented to
the user using the UL For example, fluctuations in analyte levels
can be correlated to a variety of factors, e.g., including, but not
limited to, consumption of nutrients, injection of a particular
medicine and other medications taken by the patient for other
conditions outside the condition being monitored, a patient's
exercise schedule, a patient's stress, sickness, and other factors
that may be inputted health information and management interface.
By providing such a detailed and comprehensive picture on a single
display screen, e.g., with a properly selected granularity, the
system 900 enables a user to determine the effects of a particular
factor on the patient's analyte levels. Further, such correlations
can be further analyzed to set alerts (or alarms or reminders) to
predict, prevent and/or mitigate adverse effects of such factors
before the analyte levels reach a critical limit. In some
embodiments, a caregiver is alerted to a particular analyte level
fluctuations through a text message, a phone call, an email or
other communication methods.
[0061] The application of the system 900 provide the following
exemplary features that are operated on and/or displayed on, for
example, the analyte monitoring device 950 and/or the medicine
injection device 100. The exemplary features include, but are not
limited to: (1) event time stamping and updating to database (e.g.,
including time stamping data associated with an analyte level test,
injection, status of devices, or user inputted data such as
exercise, meals, moments of stress, illness, or other types of
data); (2) event displaying to the user through the UI, in which
the events are stored in a running log in the database; (3)
displaying motivational messages and images before and/or after
test results; (4) temperature checking of the analyte test module
(e.g., to confirm safe exposure of the analyte test strips, as
extreme high or low temperatures can damage stored strips); (5)
comparative data checking with control results data; (6)
consumables/disposables monitoring, e.g., of the test strips and
lancets of the analyte monitoring device 950 and/or the medicine
level in the medicine cartridge loaded in the cartridge holder of
the medicine injection device 100; (7) providing tutorials (e.g.,
such as animations educating the user on testing/injecting
procedure); (8) authenticating a user prior to any or certain
operations of the device; and (9) providing emergency contact
information (e.g., such as 911, emergency respondents, and
user-identified contacts, such as family), as well as, in some
implementations, alerting identified persons or entities in case of
emergency. For example, the application can keep track of unused
and used consumables/disposables by the device 950 and/or the
device 100, keep track of ordered (and unused)
consumables/disposables in the user's possession, as well as keep
track of remaining stock (e.g., packages) by manufacturers that the
application is in communication with (e.g., using the internet).
For example, the application can contact the manufacturers of such
consumables/disposables when the user's remaining stock is low and
re-order the consumables/disposables, e.g., by communicating using
links to e-commerce.
[0062] Implementations of the subject matter and the functional
operations described in this patent document can be implemented in
various systems, digital electronic circuitry, or in computer
software, firmware, or hardware, including the structures disclosed
in this specification and their structural equivalents, or in
combinations of one or more of them. Implementations of the subject
matter described in this specification can be implemented as one or
more computer program products, i.e., one or more modules of
computer program instructions encoded on a tangible and
non-transitory computer readable medium for execution by, or to
control the operation of, data processing apparatus. The computer
readable medium can be a machine-readable storage device, a
machine-readable storage substrate, a memory device, a composition
of matter effecting a machine-readable propagated signal, or a
combination of one or more of them. The term "data processing
apparatus" encompasses all apparatus, devices, and machines for
processing data, including by way of example a programmable
processor, a computer, or multiple processors or computers. The
apparatus can include, in addition to hardware, code that creates
an execution environment for the computer program in question,
e.g., code that constitutes processor firmware, a protocol stack, a
database management system, an operating system, or a combination
of one or more of them.
[0063] A computer program (also known as a program, software,
software application, script, or code) can be written in any form
of programming language, including compiled or interpreted
languages, and it can be deployed in any form, including as a
standalone program or as a module, component, subroutine, or other
unit suitable for use in a computing environment. A computer
program does not necessarily correspond to a file in a file system.
A program can be stored in a portion of a file that holds other
programs or data (e.g., one or more scripts stored in a markup
language document), in a single file dedicated to the program in
question, or in multiple coordinated files (e.g., files that store
one or more modules, sub programs, or portions of code). A computer
program can be deployed to be executed on one computer or on
multiple computers that are located at one site or distributed
across multiple sites and interconnected by a communication
network.
[0064] The processes and logic flows described in this
specification can be performed by one or more programmable
processors executing one or more computer programs to perform
functions by operating on input data and generating output. The
processes and logic flows can also be performed by, and apparatus
can also be implemented as, special purpose logic circuitry, e.g.,
an FPGA (field programmable gate array) or an ASIC (application
specific integrated circuit).
[0065] Processors suitable for the execution of a computer program
include, by way of example, both general and special purpose
microprocessors, and any one or more processors of any kind of
digital computer. Generally, a processor will receive instructions
and data from a read only memory or a random access memory or both.
The essential elements of a computer are a processor for performing
instructions and one or more memory devices for storing
instructions and data. Generally, a computer will also include, or
be operatively coupled to receive data from or transfer data to, or
both, one or more mass storage devices for storing data, e.g.,
magnetic, magneto optical disks, or optical disks. However, a
computer need not have such devices. Computer readable media
suitable for storing computer program instructions and data include
all forms of nonvolatile memory, media and memory devices,
including by way of example semiconductor memory devices, e.g.,
EPROM, EEPROM, and flash memory devices. The processor and the
memory can be supplemented by, or incorporated in, special purpose
logic circuitry.
[0066] While this patent document contains many specifics, these
should not be construed as limitations on the scope of any
invention or of what may be claimed, but rather as descriptions of
features that may be specific to particular embodiments of
particular inventions. Certain features that are described in this
patent document in the context of separate embodiments can also be
implemented in combination in a single embodiment. Conversely,
various features that are described in the context of a single
embodiment can also be implemented in multiple embodiments
separately or in any suitable subcombination. Moreover, although
features may be described above as acting in certain combinations
and even initially claimed as such, one or more features from a
claimed combination can in some cases be excised from the
combination, and the claimed combination may be directed to a
subcombination or variation of a subcombination.
[0067] Similarly, while operations are depicted in the drawings in
a particular order, this should not be understood as requiring that
such operations be performed in the particular order shown or in
sequential order, or that all illustrated operations be performed,
to achieve desirable results. Moreover, the separation of various
system components in the embodiments described in this patent
document should not be understood as requiring such separation in
all embodiments.
[0068] Only a few implementations and examples are described and
other implementations, enhancements and variations can be made
based on what is described and illustrated in this patent
document.
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