U.S. patent application number 15/161246 was filed with the patent office on 2016-09-15 for device for enabling patient self-testing and treatment self-adminstration and system using the device for managing the patient's health care.
This patent application is currently assigned to Thuban, Inc.. The applicant listed for this patent is Thuban, Inc.. Invention is credited to Rana J. Arefieg.
Application Number | 20160263317 15/161246 |
Document ID | / |
Family ID | 51388825 |
Filed Date | 2016-09-15 |
United States Patent
Application |
20160263317 |
Kind Code |
A1 |
Arefieg; Rana J. |
September 15, 2016 |
DEVICE FOR ENABLING PATIENT SELF-TESTING AND TREATMENT
SELF-ADMINSTRATION AND SYSTEM USING THE DEVICE FOR MANAGING THE
PATIENT'S HEALTH CARE
Abstract
A portable unit comprises a sampling mechanism used by a patient
to take a sample of a bodily fluid or tissue that can be tested for
any property indicative of a medical condition of the patient, a
microprocessor for determining a treatment for the condition based
on a test of the sample, and an administration mechanism for
administering the treatment based on the determination by the
microprocessor. Operationally, the unit samples a bodily function,
evaluates the sample, determines from stored protocols and criteria
if treatment is required, and administers treatment. Two-way
wireless communication between the unit and one or more remote
networks enables numerous functionalities, including (i) collection
and collation of medical information and records relating to
multiple users of information stored by their units for access by
healthcare providers, regulatory agencies, insurance carriers,
pharmaceutical companies, and others, (ii) unit maintenance and
resupply of consumables, and (iii) direct user-to-user
communication.
Inventors: |
Arefieg; Rana J.;
(Ridgefield, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Thuban, Inc. |
Ridgefield |
CT |
US |
|
|
Assignee: |
Thuban, Inc.
|
Family ID: |
51388825 |
Appl. No.: |
15/161246 |
Filed: |
May 22, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13774845 |
Feb 22, 2013 |
9357961 |
|
|
15161246 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2562/0295 20130101;
A61B 5/4839 20130101; A61B 5/0004 20130101; A61M 2205/3584
20130101; A61M 2205/502 20130101; A61B 5/150022 20130101; A61B
5/150412 20130101; A61B 5/1519 20130101; A61B 5/14532 20130101;
A61B 5/157 20130101; A61B 5/150503 20130101; A61B 2560/0266
20130101; A61B 5/150358 20130101; A61M 2205/52 20130101; A61B
5/15113 20130101; A61B 5/15117 20130101; A61B 5/150954 20130101;
A61M 2205/50 20130101; A61B 5/151 20130101; A61M 2205/582 20130101;
A61B 5/15123 20130101; A61B 5/097 20130101; A61B 5/0002 20130101;
A61M 5/1723 20130101; A61M 2205/276 20130101; A61M 2205/505
20130101; A61B 5/150854 20130101; A61B 5/150328 20130101; A61B
5/1411 20130101 |
International
Class: |
A61M 5/172 20060101
A61M005/172; A61B 5/00 20060101 A61B005/00; A61B 5/157 20060101
A61B005/157; A61B 5/15 20060101 A61B005/15; A61B 5/145 20060101
A61B005/145; A61B 5/151 20060101 A61B005/151 |
Claims
1. A treatment administration unit comprising: a housing of a size
suitable for transport in a handbag or clothing pocket of a user; a
sampling module in the housing operable to take a sample of tissue
from a user and test the sample to determine a property thereof
relating to a medical condition of the user, wherein the sampling
module performs the test using a consumable part of the sampling
module and includes a sensor for determining when the consumable
part is exhausted; a microprocessor in the housing for operating
the sampling module and calculating a dosage of a medication
appropriate for treatment of the medical condition in accordance
with the property determined by the testing; an administration
module in the housing including a container for the medication and
a mechanism for administering the medication to the user from the
container under the control of the microprocessor, and a sensor for
determining when the medication in the container is exhausted; and
a wireless communication device in the housing and under the
control of the microprocessor for automatically informing a remote
supply source when at least one of the consumable part of the
sampling module and the medication is exhausted, wherein the
consumable part of the sampling module and the medication container
can be removed from the unit and replaced with a new consumable
part or a new container of medication.
2. A treatment administration unit as in claim 1, wherein the
administration unit is operable to administer a second medication
to the user.
3. A treatment administration unit as in claim 2, wherein the
administration module includes separate containers for the
medications.
4. A treatment administration unit comprising: a housing of a size
suitable for transport in a handbag or clothing pocket of a user; a
communication device in the housing for connecting to the unit a
peripheral device for providing information to the unit relating to
a medical condition of the user, wherein the sampling module is
operable to determine from the information a treatment for the
condition involving administration of a medication; a
microprocessor in the housing for operating the sampling module and
calculating a dosage of the medication appropriate for treatment of
the medical condition in accordance with the property determined by
the testing; an administration module in the housing for
administering the medication to the user under the control of the
microprocessor.
5. A treatment administration unit as in claim 4, wherein the
communication device comprises one of a connection port for
physically connecting the peripheral device to the unit and a
wireless communication circuitry for accepting the information from
a remote peripheral device.
6. A treatment administration unit comprising: a housing of a size
suitable for transport in a handbag or clothing pocket of a user;
an administration module in the housing including a container for
medication and a mechanism operable for administering the
medication to the user from the container; an input device for
enabling the user to manually input an amount of medication to be
administered; a microprocessor in the housing for operating the
administration module to administer the amount of medication input
by the user; and a sensor for determining if the unit is in place
for administering the medication to the user, wherein the
microprocessor prevents operation of the administration module if
the unit is not in place.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to monitoring a patient's
compliance with treatment protocols relating to a medical
condition, and more particularly, to a device for enabling
self-testing and medication self-administration and to a system for
communicating with the device to assist in management of the
medical condition.
[0003] 2. Description of Related Art
[0004] U.S. Pat. No. 8,206,340 ("the '340 patent") describes a
first generation device with multiple functionalities that
facilitate patient self-management of medical conditions such as
diabetes. For example, the device includes a blood glucose
monitoring function and an insulin injection mechanism integrated
into a single unit that fits in a handbag or pocket. A
microprocessor in the unit automatically calculates an insulin
dosage based on a blood glucose level detected using the unit and
controls the insulin injection mechanism to administer the
calculated dosage. The device can also download and store treatment
protocols appropriate to particular patients and monitor and report
patient compliance with the protocols by interfacing with a
healthcare provider for that patient. Information exchanges between
a healthcare provider and the device can be performed by remote
data transfer via cellular telephony, wireless cloud-based
communication, or the like. Another feature automatically notifies
an emergency service provider if the unit senses that the patient
has failed to administer an insulin dosage within a predetermined
time after the unit determines that one is necessary.
[0005] The device described in the '340 patent includes the
above-mentioned features, as well as many other many useful
functionalities that improve over prior art devices directed to
combining blood glucose monitoring and insulin injection functions
into a single unit. Examples of such prior art devices are
described in U.S. Pat. No. 5,728,074 and U.S. Patent Publ. No.
2011/0282173. The '340 patent is incorporated by reference into the
present description as if set forth in full herein, and the present
invention is capable of performing all of the functions of the
device and the systems with which it interacts as described in the
'340 patent. The manner in which the unit, systems, and methods
described herein improve over various features of the prior art in
general, and over the non-prior art '340 patent, will be apparent
from the description below of preferred embodiments of the present
invention.
SUMMARY OF THE INVENTION
[0006] It is an object of the present invention to improve various
constructional aspects of the integrated device described in U.S.
Pat. No. 8,206,340 to enhance the utility thereof and further
facilitate patient monitoring and medication administration of such
an integrated unit.
[0007] It is another object of the present invention to improve and
expand on the functionalities of the unit described in the '340
patent, and the methods of using it for patient care and for
interacting with other systems, so as further to assist patients in
managing and treating various medical conditions, and to enable
healthcare providers, medical supply manufacturers and
distributors, and regulatory agencies in performing and
coordinating their various functions to ensure that patients
receive optimum medical care.
[0008] One more specific object of the invention is to embody one
of its core concepts into a unit that includes in combination: (i)
a sampling mechanism for taking from a patient a sample that can be
tested for a property indicative of a medical condition of the
patient, (ii) circuitry such as a microprocessor for determining a
treatment for the condition based on a test of the sample, and
(iii) an administration mechanism for administering the treatment
based at least in the first instance on the determination by the
circuitry (although in another aspect of the unit a user can
override the recommended treatment). A separate but related core
concept resides in using such a unit to sample a bodily function of
an organism (human or animal), evaluate the sample, determine from
stored protocols and criteria if treatment is required based on the
evaluation, and administer treatment.
[0009] Another object of the unit is to enhance the functionality
of such a unit with the features described herein to enhance
healthcare in myriad ways by using hardware and software
implementations that enable one or more of the following additional
functions: (a) two-way communication via one or more communication
platforms connecting the unit and a healthcare provider or other
information source to enhance and optimize the quality of medical
care rendered to the patient using the unit, (b) using the forgoing
communication capability to enable a healthcare provider to
download treatment protocols and updates of same to the unit and
enable the unit to upload to the healthcare provider information on
patient compliance with the treatment protocols, (c) automatically
notify emergency services or responders if the unit detects that
the patient is in danger, with the optional capability of also
providing the patient's location, (d) communication between the
unit and a user, including a patient, physicians, other healthcare
providers, etc., via voice recognition (user-to-unit), handwriting
recognition (user-to-unit), visual displays via a display on the
unit, and any other communication device or platform for user/unit
communications, (e) transfer to a central system for collection and
collation of medical information and records relating to multiple
users of information stored by a unit, and (f) interconnection with
an ecosystem that provides a venue for one or more of unit
maintenance and resupply of consumables used by the unit, direct
user-to-user communication, access by regulatory agencies,
insurance carriers, pharmaceutical companies, public health
agencies and others.
[0010] In accordance with one variation, the administration
mechanism of the unit described above can be adapted to administer
two or more medications. In an advantageous implementation of this
variation, different medications are administered by
interchangeable administration modules.
[0011] An additional aspect of the invention the unit includes
control circuitry and at least one administration module under the
control of circuitry such as a microprocessor, but omits or
disables the sampling mechanism of the unit described above.
[0012] This Summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the Detailed Description. This Summary is not intended necessarily
to identify key or essential features of the claimed subject
matter, nor is it intended to be used in determining the scope of
the claimed subject matter
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The objects of the invention will be better understood from
the detailed description of its preferred embodiments which follows
below, when taken in conjunction with the accompanying drawings, in
which like numerals and letters refer to like features throughout.
The following is a brief identification of the drawing figures used
in the accompanying detailed description.
[0014] FIG. 1 is an isometric view of the front side of an
integrated unit used to sample bodily fluids and administer
medications, which further permits exchange of information with
other systems and databases, according to an embodiment of the
present invention.
[0015] FIG. 2 is a plan view of the rear side of the unit in FIG.
1.
[0016] FIG. 3 shows the unit in FIG. 1 with the rear half of its
housing removed to show schematically various modules included in
the unit.
[0017] FIGS. 4 to 6 taken together schematically illustrate the
construction of a bodily fluid sampling module in the unit in FIG.
1, with FIGS. 4 and 5 being partial isometric views of the sampling
module respectively illustrating extended and retracted positions
of a lancet and FIG. 6 being a cross-sectional view showing a
lancet operating mechanism.
[0018] FIG. 7 is a detail view of the unit in FIG. 1 illustrating
the manner in which a lid at a first end of the unit is rotatably
mounted to expose the sampling unit for permitting a user to take a
blood sample.
[0019] FIG. 8 shows the LCD display of the unit in FIG. 1
displaying the results of the unit's analysis of a sample of bodily
fluid after collection thereof in accordance with one aspect of the
present invention.
[0020] FIGS. 9 and 10 schematically illustrate the construction and
operation of the administration module and its associated
hypodermic needle for administering medication based on the
analysis of the bodily fluid collected by the sampling module in
accordance with the operation illustrated in FIGS. 4 to 7.
[0021] FIGS. 11 and 12 are detail views of a second end of the unit
in FIG. 1, with FIG. 11 illustrating a closure covering an aperture
for the hypodermic needle shown in FIGS. 9 and 10 and FIG. 12
showing the closure in a position covering the aperture.
[0022] FIG. 13 is a simplified block diagram showing representative
system components of the unit in FIG. 1 in accordance with the
present embodiment of the invention.
[0023] FIG. 14, comprising FIGS. 14A and 14B, is a flow chart
illustrating a testing cycle directed by the unit in accordance
with one embodiment of the invention.
[0024] FIG. 15 is a diagram of an example of a cloud-based Smart
Rep.TM. system of which the unit in FIG. 1 can form a part and
which enhances the functionality of the unit in accordance with one
of the aspects of the invention.
[0025] One skilled in the art will readily understand that the
drawings are not strictly to scale, but nevertheless will find them
sufficient, when taken with the detailed descriptions of preferred
embodiments that follow, to make and use the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0026] The embodiment of the invention chosen for illustrative
purposes is an integrated blood glucose monitor and insulin pen
unit that can collect a blood sample from a patient, analyze the
glucose level in the sample, calculate an insulin dosage based on
the insulin level, if appropriate, and administer the calculated
dosage. In essence, the described unit can perform all of the
functions of the device described in U.S. Pat. No. 8,206,340 (which
is incorporated herein in full by reference). However, it will
become apparent as the present description proceeds that the unit
has greatly enhanced functionality and improved constructional
features not suggested by the '340 patent. The description below
first describes constructional details and the operation of one
embodiment of a unit with features that exemplify aspects of the
present invention. Following that, there is a description of
various exemplary functionalities that can be effected by a unit
embodying the constructional features. Finally, there is a
description of numerous other applications of a unit according to
the present invention for that enable monitoring and treating a
variety of medical conditions.
Exemplary Constructional Features of the Unit
[0027] FIGS. 1 to 3 show basic constructional features of an
integrated unit 10 in accordance with one embodiment of the present
invention. FIG. 1 is an isometric view of the front side of an
integrated unit 10 used to sample bodily fluids and administer
medications. The unit 10 includes a housing 12, comprising a front
part 12a and a rear cover 12b, that encloses its functional
components, which are described in detail below. The unit has a
first top end 14 at which a blood sample can be taken, as described
further below, and a second bottom end 16 at which a hypodermic
needle can extend for administering insulin in a manner also
described further below. (In describing embodiments of the
invention, terms indicating direction or orientation, such as
"front," "rear," "right," "left," "top," "bottom," etc., may be
used to facilitate the description. They do not imply that the
invention is limited to a particular orientation of the unit.)
[0028] The unit 10 includes various user interface components.
These include a display 18 for displaying to the user various
prompts and informational messages as described below. The display
18 is preferably an LCD display, although other display
constructions are possible and the invention is not limited to any
particular type of display. A touch device 20 comprises another
user interface component. The touch device 20 includes directional
arrows 20a and 20b, and an input button 20c. In one form of the
unit 10, the touch device 20 is used in conjunction with the LCD
display 18 to operate the unit. For example, a menu may be
displayed on the LCD display and the user can use the arrows 20a
and 20b to scroll through the menu until reaching a desired menu
item, at which time the user touches the input button 20c to choose
that menu item. In an alternate embodiment the display itself can
enable touch screen input permitting the user to choose selected
functions and operations directly on the display, thus eliminating
the need for a separate input touch device. Other user interface
components include a speaker 22 and a microphone 24. It is
understood that the term "speaker" encompasses an optional headset
that could be plugged into a port (not shown) in the unit. The
various functions of the speaker and microphone are covered in
detail by the description that follows below. The user interface
also comprises front and rear cameras 25F and 25R (see FIG. 3)
under the control of the user via the touch device 20. The user can
operate the cameras simultaneously, or in still or video mode. The
user interface can further include a vibration device (not shown)
that provides tactile signals to a user. This option enables users
who are hearing and/or vision impaired to take advantage of the
unit's capabilities. It is particularly useful if the unit is
configured for managing medical conditions (such as diabetes) that
can cause vision impairment. The unit further includes a USB port
26 that permits attachment of a standard USB cable for purposes
described further below. It is preferable to use a mini- or
micro-size USB connection consistent with the general goal of
miniaturizing the unit to the greatest possible extent.
[0029] As seen in FIG. 1, the unit 10 has an elongated
configuration that is not only attractive, but enables its various
mechanical and electronic components to be contained in a compact
device easily carried in a pocket or handbag/purse. In addition the
unit tapers slightly toward its bottom end 16 to provide a tactile
and visual indication to the user regarding the end of the unit to
use to administer an injection. A preferred configuration will
typically be generally circular in cross section with a diameter of
about 0.75'' to 1.5'' and will be about 4'' to 6'' long, although
other configurations and dimensions can be used within the broadest
scope of the invention. FIG. 2 shows the reverse or back side of
the housing 12 with a rear cover release 30. The housing 12 is
molded in two parts that fit together along a longitudinal seam,
and the rear cover release is spring loaded into a position that
holds the two housing halves together. Pressing the rear cover
release 30 against the spring force allows the user to remove a
rear cover half 12b of the housing 12 and access the interior of
the unit. Details of the spring latch formed by the rear cover
release are omitted here since construction of a latching
arrangement consistent with the objects and uses of the unit 10 as
described herein is well within the ability of those skilled in the
art. It will also be clear that the invention is not limited to any
particular configuration or dimensions. For example, one skilled in
the art may chose to arrange the internal components of the unit
discussed below in a manner that makes it preferable to use a
different configuration or a different size housing.
[0030] FIG. 3 shows the interior of the unit 10 from the rear with
the rear cover 12b removed. The unit includes a sampling module
100, an administration module 300, and a control module 500 that
provides overall control of the unit in accordance with inputs from
the user, the sampling module 100 and the administration module
300. A battery (not shown) provides electrical power to those
components requiring it (the modules, the display, the speaker,
etc.), and is preferably a lithium polymer rechargeable battery,
although other types of battery can be used within the scope of the
invention. The control module 500 preferably comprises an
integrated circuit that includes a microprocessor for effecting
overall control of the unit and its various functionalities. In a
fashion familiar to those skilled in the art, the microprocessor
incorporates a read-only memory ROM storing an operating system and
a random access working memory RAM enabling the microprocessor to
execute programs stored in the ROM. These programs include
algorithms that use inputs to the control module to determine
medication dosages and other outputs that enable functionalities of
the unit discussed herein further below. For example, if the unit
is configured for diabetes management, the microprocessor would
include programs that enable the unit to manage a patient's
symptoms and perform the other functions and methods described in
U.S. Pat. No. 8,206,340.
[0031] The control module 500 serves several overall purposes in
achieving objects of the invention. One purpose is to accept inputs
from various sensors within the unit and from user interface
components (such as the touch device 20 and the microphone 24), and
provide operating outputs to the sampling module 100, the
administration module 300, and user interface components (such as
the display 18 and the speaker 22, or a vibration device). The
control module 500 also accepts inputs from and provides outputs to
the USB port 26 for various purposes described in the course of the
following description. The control module further includes a memory
for storing data. Many of the uses and functionalities provided by
the unit 10 are described in U.S. Pat. No. 8,206,340, and the unit
described herein is capable of providing all of those
functionalities, as well as the many others described more fully
herein.
[0032] The unit 10 further includes a communications module 700 for
enabling communications between the unit 10 and systems and
components external to the unit. The communications module can
comprise the software and firmware for enabling communication with
systems external to the unit, via either a wired connection or a
wireless connection such as Wi-Fi or cellular telephony. In that
regard, the communications module would include at least one of a
GPS, cell phone, Bluetooth, and Wi-Fi transceiver. Certain
components of the communications module can be incorporated in the
integrated circuit that also includes control module components
discussed above, this commonality being indicated by associating
both of the reference numerals 500 and 700 with the integrated
circuit and associated electronics illustrated schematically in
FIG. 3. These various components enabling communications with a
system external to the unit are of known construction and
operation, and those skilled in the art will thus be able to
incorporate them into the unit 10 without further explanation.
Functionalities of the communications module are described below in
more detail in connection with the operation and control of the
unit 10.
[0033] It will be further understood that the term "module" as used
herein does not necessarily denote a physically separate, unitary
component. The term when applied to a constructional feature is to
be understood to mean a collection of structural components that
can be more readily understood in the context of the related
functions they perform together. When applied to software or
firmware, or information, the term is to be understood in a broad
sense as information in the form of executable instructions,
storage locations, electronic circuitry, etc., that may be found in
various locations in the storage media on which they reside.
Therefore, unless specifically stated, reference to a "module" is
solely for convenience of description, in that certain
functionalities of the unit 10 and the systems with which it can
communicate, are more readily discussed by grouping them together
to aid understanding how they achieve the purposes and objects of
the subject matter claimed herein. Any parts of the unit 10 and its
various modules discussed herein that are constructed as separate,
unitary components are specifically stated as such.
[0034] The Sampling Module 100
[0035] FIGS. 4 to 6 comprise enlarged views of the first top end 14
of the unit 10, with the rear cover 12b removed to show details of
the construction and operation of the sampling module 100. It will
be understood that the depictions in these figures are highly
schematic, but that taken with the rest of the description herein
they are sufficient to enable one of ordinary skill in the art to
construct a sampling module with the features and functions
described herein. Generally, the sampling module includes a housing
110 (see FIG. 3) in which is disposed a first supply reel (not
shown) around which one end of a test strip 112 (omitted from FIG.
6 for clarity) is wound and a second take-up reel (not shown)
around which the other end of the test strip is wound. As seen in
the figures (including FIG. 3), the test strip 112 extends from the
housing 110, over a slide support 114, and back into the housing
110. A micromotor (not shown) in the housing 110 drives the take-up
real to draw the test strip 112 from the supply reel and over the
slide support 114 in the direction of the arrow A in FIG. 5. The
micromotor is preferably a step motor that responds to pulses from
the control module 500 to advance the test strip a predetermined
distance set by the relevant program in the microprocessor. The
supply reel would typically be spring-loaded to resist rotation,
thus maintaining the test strip in tension as it is advanced from
the supply reel by rotation of the take-up reel.
[0036] The slide support 114 positions the test strip 112 to extend
just outside a window 12W at the first top end 14 of the unit. As
shown in more detail in FIG. 7, a lid 12L (omitted from FIGS. 4 to
6 for clarity) is mounted to the unit end 14 for rotation between
an open test position (shown in these figures) that exposes the
test strip 112 and a closed stowed position. When the user rotates
the lid 12L to the open test position, it exposes the test strip
112 through the window 12W to enable the user to place a bodily
fluid sample (in the present example, a drop of the user's blood)
on the test strip. FIG. 6 shows the sampling module with the test
strip removed to better depict a lancet mechanism 120 for drawing a
blood sample. The lancet mechanism includes a lancet 122 with a
razor-sharp point at the end of a lancet shaft 124 extending into
the unit. The lancet 122 can advantageously be coated with
Teflon.RTM. polymer and/or a suitable antimicrobial coating. A
flange 126 surrounds the shaft and provides a bearing surface for a
coil spring 128 that forcefully and rapidly drives the lancet
upward though the opening 12W (see FIGS. 5 and 6) to pierce a
location on the user's skin placed over the window 12L. A lancet
arming mechanism includes an endless retracting belt 130 that
extends around two pulleys 132a and 132b. A micromotor (not shown)
rotates the shaft of one of the pulleys 132a, 132b to move an
arming tab 134 that bears against the top of the flange 126. When
the motor rotates a pulley 132a, 132b clockwise (as seen in FIG.
6), the tab 134 pushes the flange 126 downward to compress the
spring for arming the lancet mechanism. When the lancet flange 126
reaches a predetermined position, a spring-loaded latch (not shown)
engages the flange 126 to hold the lancet mechanism in its armed
condition with the spring 128 compressed. A latch solenoid (not
shown) is energized in accordance with the operation of the unit
described below to release the latch and permit the spring 128 to
propel the lancet 122 quickly upward (as seen in FIGS. 4 and
5).
[0037] FIG. 7 is a view from outside the unit 10 at the first end
14, with the lid 12L rotated into the open position to expose the
window 12W. In this view, the test strip 112 is omitted to
illustrate that the slide support 114 includes two spaced apart
positioning rails 114a and 114b with a slot between them through
which the lancet extends when propelled upward by the spring 128.
The rails 114a and 114b are spaced apart a distance that matches
the width of the test strip 112, so that the test strip's opposing
lateral edges contact with the inner surfaces of the rails. This
captures the test strip 112 between the rails to position it
laterally as it is drawn over the slide support. The sampling
module can further include guides extending between the housing 110
and the slide support 114 to assist in maintaining the proper
position of the test strip, and sensors may be provided as well to
provide a signal to the microprocessor that will trigger an alert
(audible or otherwise) to the user that the test strip is out of
position. Further, as seen most clearly in FIG. 6, the sampling
module includes a lancet disinfectant tablet 140 through which the
lancet 122 travels before and after it pierces the user's skin. The
tablet 140 comprises a replaceable pad made of a suitable material
that sterilizes the lancet 122 as it passes through the tablet. The
tablet can have any suitable construction or composition that
achieves its purpose. A suitable tablet could be made of a surgical
sponge material impregnated with a liquid disinfectant/fungicide,
and optionally covered by silicone rubber to retard evaporation.
Broadly speaking, the tablet 140 comprises means for disinfecting
the lancet and can take any form suitable for that purpose. Some
examples of equivalent structure are a rubber or plastic container
that holds a liquid disinfectant (which in the present context is
defined as any substance that kills microbes, fungi, protozoa, and
other infectious agents), and is made of a material that reseals
after the lancet 122 is withdrawn. Other examples are a solid
material that itself disinfects the lancet as the lancet passes
through it, and a device that emits radiation in infrared and/or
ultraviolet wavelengths or other type of bactericidal/fungicidal
radiation. If the disinfectant is a separate substance, it can be
iodine or alcohol or other liquid disinfectants, either alone or in
combination.
[0038] In a preferred embodiment, various components of the
sampling module 100 form a unitary structure that can be removed
and replaced when the test strip supply in the housing has been
completely used. For example, it is contemplated that in one
embodiment the sampling module, including the housing 110, will
include a sufficient length test strip to last for several days to
a week or more, after which the entire module is discarded and
replaced with a new sampling module with a fresh test strip. In a
particularly preferred embodiment, motors used by the various
components and the solenoid-controlled lancet latch would remain in
the unit, and the unit and sampling modules would include suitable
mechanical interfaces for the motors and solenoid that form a
permanent part of the unit. In addition, the tablet 140 could be
separately replaceable independently of the replaceable sampling
module by providing a shaped opening such as that shown in FIG. 6
for the tablet.
[0039] After the sampling module 100 determines the blood glucose
level, it sends a data signal to inform the control unit 500, in
response to which the control unit causes the LCD display 18 to
show the test results to the user, as illustrated in FIG. 8. A more
detailed description of a complete test/administration cycle is
described further below after the following detailed description of
the construction of the administration module 300.
The Administration Module 300
[0040] FIGS. 9 and 10 depict the unit 10 with the rear cover 12b
removed to illustrate additional details relating to the
construction and operation of the administration sampling module
300. (See FIG. 3 also.) The administration module comprises an
injection mechanism powered by two micromotors (not shown) that
drive a hypodermic needle 302 downward (as seen in FIGS. 9 and 10)
through an opening 12O in the second end of the unit 10, to be
described in more detail just below. The needle 302 is mounted to a
syringe assembly 304 that includes a chamber 306 for medication
(insulin in this instance) that is in fluid communication with the
hypodermic needle 302. A plunger 308 moves downward (as seen in
FIGS. 9 and 10) to force the medication from the chamber 306
through the needle 302 in a conventional fashion. In the present
embodiment, a module housing 310 includes one or more micromotors
(not shown) that operate the administration module. Typically,
there will be two motors controlled in sequence by the unit
microprocessor, with the first motor operating a suitable
mechanical linkage or other mechanism (not shown) for moving the
administration module 300 bodily downward (as seen in FIGS. 9 and
10) until the chamber terminal end 312 reaches a shoulder 314
within the unit and the needle 302 extends externally from the
unit's bottom end through an opening 12O. At that time, a second
micromotor within the housing 310 operates the plunger 308 to
administer a dosage of the medication in the chamber 306.
[0041] The unit further includes a needle disinfectant tablet 316
that fits in a recess behind the opening 12O through which the
needle 302 travels before and after it pierces the user's skin. The
needle tablet 316 comprises a replaceable pad made of a suitable
material as described above in connection with the lancet
disinfectant tablet. It serves the same purposes as the lancet
disinfectant tablet 140 and can have any of the constructions and
compositions discussed in connection the tablet 140. In that
regard, the needle tablet 316 comprises means for disinfecting the
needle and can take any form and have any property suitable for
that purpose, and in particular, any of the forms, properties, and
equivalent structures discussed in connection with the tablet 140
In a preferred embodiment, the syringe assembly 304 can be removed
and replaced when the medication is depleted and replaced with a
new syringe assembly having a fresh supply of medication. In
addition, the tablet 316 could be separately replaceable
independently of the replaceable syringe assembly.
[0042] FIGS. 11 and 12 are detailed views of the bottom second end
16 of the unit 10 showing an iris-like closure 320 similar to a
camera aperture mechanism for covering the opening 12O except for
those times when an injection is to be administered. FIG. 12 shows
the closure 320 in its open position, exposing the opening 12O to
permit passage therethrough of the hypodermic needle 302. A
preferred embodiment, a medication administration cycle is
initiated when the user manually turns an actuating ring 330
encircling the unit's second end to a position that opens the iris
closure 320. This triggers a sensor to indicate to the
microprocessor that the opening 12O is exposed, at which time the
microprocessor initiates an administration cycle in accordance with
the particular protocol under which the unit is operating. The
description of a complete test/administration cycle that follows
includes additional details concerning the operation of the
administration module 300.
Operation and Control of the Unit
System Components
[0043] FIG. 13 illustrates schematically various system components
and the manner in which they cooperate to operate the unit and
carry out the various functionalities discussed herein. As already
noted, the unit 10 is under the overall control of a microprocessor
that is part of the control module 500. As described above, the
microprocessor comprises a read-only memory ROM storing an
operating system and executable programs that use algorithms and
data provided to the unit to determine medication dosages and other
parameters useful in managing a patient's medical condition, and
that control the operation of the various other components of the
unit described just below. The microprocessor also includes a
random access working memory RAM to enable the microprocessor to
execute programs stored in the ROM. Further, the microprocessor
includes a clock that, in a conventional fashion, provides the
timing pulses necessary for the microprocessor to perform its
control functions.
[0044] In the present embodiment the unit 10 is adapted for use by
a patient with diabetes to manage the symptoms of his or her
condition in a convenient and intuitive manner. To that end, the
sampling module 100 includes a finger sensor 170 that senses when a
user's finger is in contact with the test strip 112 exposed through
the window 12W in the top end 14 of the cover 12. In a preferred
embodiment the finger sensor 170 detects a change in capacitance
caused by contact of the user's finger (or other body part) with
the test strip 112 and slide support 114 through the window 12W,
although the presence of the user's finger can be sensed by other
means, such as by using a mechanical sensing mechanism responsive
to pressure by the user. The sensor 170 is electrically connected
to the control module and the change in capacitance is interpreted
by the microprocessor to indicate that a user's finger is in
position to have a blood sample taken using the lancet 122. A test
strip micromotor 172 in the sampling module housing 110 drives a
take-up reel to draw the portion of the test strip containing the
blood sample into the housing, where a test module 174 operates in
accordance with known principles to determine the glucose level in
the blood sample, and communicates the test results to the
microprocessor. Advancing the test strip portion with the blood
sample into the housing 110 brings a fresh portion of the strip 112
into position for accepting a new blood sample in a subsequent
testing cycle. The details of the glucose level testing do not form
a part of the present invention, and are well known to those
skilled in the art. U.S. Pat. No. 5,728,074 describes various ways
of performing such testing and obtaining a corresponding electrical
signal. Any of those techniques, or variations thereof, can be used
in performing blood glucose testing with the unit 10, and those
portions of U.S. Pat. No. 5,728,074 describing such testing are
incorporated by reference as if set out in full herein.
[0045] The blood sample is automatically taken by the lancet 122
while the user's finger is on the test strip. The lancet is held in
a retracted, armed position against the force of the spring 128
(FIG. 6) by a latch. The latch is released by a signal from the
microprocessor to a solenoid-actuated latch release 176 so that the
lancet 122 will prick the user's finger (or other location) and
draw the blood sample. A lancet micromotor 178 retracts the lancet
against the force of the spring 128 as discussed above to return it
to the retracted position where it re-engages the latch to lock the
lancet in its armed condition, ready for taking the next blood
sample. Thereafter, the motor returns the arming tab 134 to a
waiting position (the position shown in FIG. 6) to await the next
sampling cycle. The sampling module further includes a sensor 180
that determines when the test strip is nearly used up, and sends a
corresponding signal indicating same to the control module.
[0046] The administration module 300 includes injection motors 370
that operate the administration module 300 to administer an
injection as discussed above. The administration module further
includes an error sensor 372 that ensures that the proper
medication dosage is administered. The error sensor has built-in
redundancy, in that it provides two signals to the control module
500. The first signal is generated by an encoder integrated into
the injection motor 370 to provide a signal indicative of the
amount of rotation of the motor shaft, and thus provide a real-time
indication of the amount of insulin being injected as the injection
motor rotates. The second signal is generated by an infrared
detector that generates a signal based on detecting the actual
location of the injection plunger as it moves in the hypodermic
syringe, and thus provides a parallel, second real-time indication
of the amount of insulin being injected. The microprocessor
compares these two signals, and if they indicate injection volumes
that differ by more than a predetermined amount, the microprocessor
generates an error signal that halts the injection process and
provides an error message to the user. Since the insulin dosage
must be precisely controlled, the predetermined amount of variation
between the two signals is typically small. For example, a suitable
limit on the amount of variation between the signals is no more
than 5%, with the limit on the variation most preferably being no
greater than about 2%. The administration module also includes an
empty sensor 374 that determines when the medication chamber 306 is
nearly empty, and sends a corresponding signal indicating same to
the control module.
[0047] The unit 10 further includes a lid switch 802 that senses
when the lid 12L has been moved to its open test position (FIG. 5)
and sends a corresponding signal indicating same to the control
module. The lid switch can be implemented in any suitable fashion,
and typically comprises a pair of electrical contacts that are
brought into juxtaposition when the lid 12L is in the open position
shown in FIG. 5. The unit also includes a ring switch 804 that
senses when the actuating ring 330 has been turned a sufficient
amount to expose the needle opening 12O (FIG. 12) and sends a
corresponding start signal to the control module indicating that a
medication administration cycle has been enabled. The unit also
includes a bottom end proximity sensor 806 similar in operation to
the finger sensor 170 that is used by the sampling module 100. That
is, the bottom end sensor is mounted within the unit 10 at the
second bottom end 16 and detects a change in capacitance caused by
contact of a body part of the user with the injection site on the
unit (that is, the bottom end 16). The sensor 806 is electrically
connected to the control module and the change in capacitance is
interpreted by the microprocessor to mean that the user has placed
the unit in position for medication administration.
[0048] In alternate embodiment, the bottom end sensor 806 could
initiate an administration cycle by first actuating an iris
micromotor (not shown) to open the iris 320, and a sensor or limit
switch or the like that is triggered when the opening 12O is fully
exposed to indicate that the control module should terminate the
actuating signal. The control module can send a closing actuating
signal to the micromotor 806 to re-cover the opening 12O when the
injection cycle is complete. Otherwise, the user will manually
re-close the iris 320. The USB port 26 enables communications
between the unit and associated peripheral devices (not shown), as
well as permitting uploading of information to the ROM and
downloading information therefrom. The control module is configured
to permit recharging the battery via a power cord attached to the
USB port.
[0049] In accordance with the discussion above, the communications
module 700 can provide one or more modalities for communications
with systems external to the unit 10. Wi-Fi circuitry 770 under the
control of the control module can enable communications with remote
locations via a broadband wireless connection to the Internet if
the unit 10 is sufficiently close to a Wi-Fi router. This enables
information to be sent and received by the unit wirelessly at very
high speeds. Another possible communication modality is provided by
cellular telephone circuitry 772 for dialing remote locations under
the control of the control module 500. The cellular telephone
circuitry can be so-called 3G or 4G circuitry for connection to the
Internet when connection to a Wi-Fi router connection cannot be
made. The unit 10 can further include GPS (Global Positioning
System) circuitry 774 that transmits signals to a GPS satellite to
indicate the global longitude and latitude of the unit. Finally,
the unit can include Bluetooth circuitry 776 for wireless
connection to a peripheral device such as a user's cellular
telephone or personal digital assistant (not shown) that itself has
Wi-Fi, cellular telephony, and/or GPS capability. These components
can perform all of the functions and achieve all of the purposes
described in U.S. Pat. No. 8,206,340, which are incorporated by
reference herein, as well as those discussed herein further
below.
[0050] The LCD display 18, the touch device 20, the speaker 22 (and
headset, if provided), the microphone 24, and the cameras 25F and
25R are all discussed above in connection with FIGS. 1 to 3. These
components comprise elements of a user interface UI by which
information can be passed between the user and the unit 20. For
example, the microprocessor can incorporate speech recognition
software that enables the user to use spoken commands to operate
the unit 10 via the microphone 24. In a more preferred embodiment,
the microprocessor can incorporate elements of artificial
intelligence to facilitate understanding of user commands and
responses thereto on the display 18 and over the speaker 22. That
is, with this feature, the commands do not have to be in a
preordained format or use particular words to be understood by the
unit microprocessor. It is anticipated that more useful embodiments
of the unit 10 will be developed as the capabilities of artificial
intelligence and speech recognition increase over time. An optional
vibration device VM is shown in FIG. 13 to indicate its functional
relationship to the other components of the unit 10, and some of
its uses are described in a moment in connection with the use of
the unit. The vibration device will typically comprise a
conventional a vibratory motor with a motor shaft that rotates a
small eccentric mass at an angular velocity between 8,000 and
16,000 rpm, which is felt as a vibration at a frequency between
about 130 to 270 Hz. Uses for the cameras 25F and 25R are discussed
further below.
Initialization of the Unit
[0051] To perform the tasks described herein, the unit 10 requires
initial set-up by inputting data from the patient's healthcare
provider. In its most basic form, this involves loading data into
the ROM in the device microprocessor that will enable the programs
stored therein to calculate insulin dosages and specify treatment
regimens based on the user-patient's tested glucose level. This
data can be input using a portable USB drive (not shown) on which
the necessary information has been stored by the healthcare
provider and which is then plugged into the USB port 26, or by
sending the information to the unit over the Internet via a
receiver included in the Wi-Fi circuitry 770 or the cellular
telephone circuitry 772 included in the unit. In addition, the
programs stored in the ROM can be loaded, updated and/or changed in
similar manners.
[0052] The necessary data is loaded into the unit's ROM by the
healthcare provider so that it is available when the patient uses
the unit. The data would typically include information such as
insulin dosages and types and amounts of glucose-producing
substances to be consumed based on tested blood glucose levels, and
any other data or parameters required by the algorithms in the ROM
used by the unit to determine a given insulin dosage or amount and
type of glucose-producing substance to be ingested appropriate to a
patient's tested blood glucose level. The exact nature of this data
does not form a part of the present invention, and literature such
as the references discussed in U.S. Pat. No. 8,206,340 illustrate
the type of data and programs that can be used in this regard.
Further details regarding exemplary patient data that can be loaded
into the unit ROM to enable it to perform its intended functions
can be found in the '340 patent, and are specifically incorporated
herein by reference.
Performing a Treatment Cycle
[0053] FIG. 14 (comprising FIGS. 14A and 14B) is a flowchart
illustrating salient points in a test cycle comprising sampling a
user's blood glucose or insulin and administering glucose, as
directed by the unit 10 as thus far described. It will be
understood as the following description proceeds that not all
functionalities of the unit are represented by entries in the
flowchart. Rather, FIG. 14 is intended to show how the unit 10
described herein effects a glucose testing/insulin administration
cycle. The unit 10 described herein can also effect some or all of
the functionalities illustrated in the flowchart in FIGS. 6A, 6B,
and 6C of U.S. Pat. No. 8,206,340 and described in the text
accompanying that flowchart. Those portions of the '340 patent are
specifically incorporated herein by reference, and those skilled in
the art will understand from the following description how such
functionalities described in the '340 patent can be incorporated
into the testing cycle described in connection with FIG. 14 hereof.
It is assumed here that the unit is in its ready condition, with
the lid 12L and the iris closure 320 in their closed positions, and
the lancet 122 in its armed condition.
[0054] A test cycle can be initiated in various ways. In the
example illustrated in FIG. 14, the unit ROM stores information
regarding scheduled glucose testing for the user, and generates a
prompt to the user at step S100. This prompt can take one or
several forms, including one or more of actuating the vibration
device VM, displaying a prompt on the LCD display 18, and/or
providing a verbal prompt using the speaker ("It is time for a
glucose test"). In step S102 the user opens the lid 12L on the
device by rotating it to expose the testing window 12W. This
triggers the lid switch 802, which causes the microprocessor to
start a timer in step S104. The process line between steps 100 and
102 is dotted to indicate that the user can initiate a test cycle
manually by opening the lid 12L in the absence of a prompt from the
unit (step S100). The unit can be programmed to audibly prompt the
user to place his or her finger over the window 12W in position for
piercing by the lancet ("Place your finger on the tester"), and/or
display the same or similar prompt on the LCD display 18. In step
S106 the unit waits for a signal from the finger sensor 170
indicating that the user has placed his or her finger over the
window 12W. The unit can also display any of the same prompts,
messages, and/or signals discussed in connection with the display
box D102 in FIG. 6A of the '340 patent. The timer is typically set
for between 10 seconds to one minute, and more preferably for 30
seconds. If the timer times out in step S108 before the ROM
receives a signal from the finger sensor 170, and the test cycle
was initiated by a prompt from the microprocessor (step S100), the
unit will record this fact and can, under certain circumstances
(say, if several prompts have been ignored) notify the user's
healthcare provider or an emergency service provider such as the
public 911 system or a private system such as the Alert One.RTM.
medical alert service provided by Alert One Services, Inc., of
Williamsport, Pa.
[0055] If the finger sensor 170 does sense the presence of the
user's finger at the top first end of the unit before the timer
times out, the process proceeds to step S112, in which the unit
begins an audible countdown over the speaker of the time by the
second ("5, 4, 3, 2, 1") until release of the lancet 122, with an
optional display of the countdown on the LCD display 18. At the end
of the countdown, the ROM checks at step S114 to see if there is
still a finger on the window 12L. If not, the process returns to
step S106, and in the absence of a signal from the sensor 170, the
unit proceeds through the time out step S108. If the timer has by
now timed out, the process proceeds to step S110, which ends the
process as discussed above. If the sensor 170 detects the presence
of a finger on the window 12W, the process proceeds to step S112 as
before and a new countdown starts.
[0056] If the signal from the sensor 170 is present at the end of
the countdown (step S114), the microprocessor actuates the lancet
release solenoid 174 in step S116 to draw blood from the user's
finger and onto the test strip 112. After a brief pause, the test
strip motor 172 is actuated in step S118 and the test strip with
the blood sample is moved into the housing 110 where the test
module 174 determines the blood glucose level in step S120.
Thereafter, the lancet motor 178 is actuated in step S122 to
retract the lancet 122 and re-latch it in its armed condition, as
described above. At the same time display status box D102 displays
the blood glucose level on the display 18 as shown in FIG. 8. It
will be appreciated that the unit can also announce the blood
glucose level over the speaker 22 (or headset), which is a
particularly useful feature for visually impaired users. If the
user is hypoglycemic as determined in step S124, the process will
display instructions to the user at display status box D104 and set
a timer in step S126. The timer waits for an appropriate response
from the user in step S128, and if the user responds the process
terminates at step S130. If the user does not respond before the
timer times out in step S132, the unit takes appropriate action,
which can be an automatic call to 911 in step S134 if the user's
blood glucose level is so low that the user might be in danger. It
will be appreciated here that the unit 10 can perform all of the
steps in the process described in the '340 patent if the blood test
reveals a hypoglycemic condition. For example, the unit 10 can
store the threshold levels L1 and L2 as shown in FIG. 6 of the '340
patent, and the process performed by the unit 10 herein can include
some or all of the steps described in '340 patent when the user
tests hypoglycemic.
[0057] If the user is not hypoglycemic, the process proceeds to
step S136, where the tested glucose level is compared to the user's
hyperglycemic threshold as stored in the unit's ROM. If the user is
not hyperglycemic the process ends at step S138. If the user is
hyperglycemic, the protocol followed by the unit 10 is comparable
to that described in the '340 patent and illustrated in FIG. 6
thereof. For example, as was the case if the user tested
hypoglycemic, the unit herein can also perform all of the
corresponding functions described in the '340 patent if the blood
test determines that the user is hyperglycemic. This would include
storing threshold levels L3 and L4 as described in the '340 patent
and performing some or all of the warning, displaying, and
prompting steps described there when the user tests hyperglycemic.
The description of those steps is truncated here for the sake of
simplicity and to highlight the functions of the present unit that
are not explicitly disclosed in the '340 patent.
[0058] If the user is hyperglycemic, the unit calculates the
insulin dosage in step S140, and displays the results in display
status box D106, preferably in the same general fashion as in the
'340 patent (see FIG. 7 and column 15), and sets a timer in step
S142. The display can then request that the user confirm the
calculated dosage amount (using the input device 20 or by a speech
command such as "OK"). As in the device described in the '340
patent, the user can also set a different dosage. The unit then
prompts the user to turn the actuating ring 330 to expose the
opening 12O for the needle 302. This can be done audibly ("Please
prepare for insulin injection"), by a message or graphic on the LCD
display 18, or both, indicating the action required. The timer is
typically set in step S142 for a first predetermined time of
between 10 seconds to one minute, and more preferably for 30
seconds. The amount of time should be sufficient to enable the user
to perform the necessary action. In an alternate embodiment, the
unit includes a motor that automatically opens the iris 320 and
informs the user when it is ready for the insulin injection.
[0059] Once the timer is set, the microprocessor waits in step S144
for a start signal from the ring switch 804 indicating that the
iris closure 320 has been opened to expose the opening 12O for the
hypodermic needle. If the timer times out in step S146 before the
iris closure has been opened, the unit takes appropriate action,
such as calling 911 in step S148 in cases of severe hyperglycemia.
As already noted, in the case of a user that has tested
hyperglycemic, the unit can take any of the actions or operate in a
fashion that incorporates some or all of the features of the device
discussed in the '340 patent and the flowchart in FIG. 6 thereof.
If the microprocessor receives a start signal from the ring switch
804 before the timer times out, it prompts to the user to place the
unit at the intended injection site. This can be done audibly using
the speaker 22 ("Please place the unit end on the injection site"),
or by a message or a graphic on the LCD display, or both. In step
S150 the unit begins an audible countdown by the second ("5, 4, 3,
2, 1") over the speaker of a second predetermined time until
injection, with an optional display of the countdown on the LCD
display 18. At the end of the countdown, the ROM checks at step
S152 for a sensing signal from the bottom contact sensor 806 to
determine if the unit is in place for the insulin injection. If
not, the process takes appropriate action. This can take the form
of repeating instructions to the user or requesting some other user
response, which can be made audibly in a louder or more insistent
tone. The unit can accompany these audible warnings by displaying a
warning on the LCD display as indicated in display status box D108.
The display can be made on a flashing red background on the display
18. The unit can also provide an audible alarm over the speaker 22,
accompanied by a spoken message that a call will be made to an
emergency service provider if the alarm is not disarmed within a
predetermined time (typically no more than 45 seconds). The user
can disarm the alarm and re-start the injection process at step
S150, by providing a predetermined input to the unit using the
touch device 20 or speaking a predetermined phrase into the
speaker, or both. The predetermined input and/or phrase are
designed to ensure that the user has not become disoriented or lost
consciousness. Instructions for restarting the injection process
can be shown on the display, as indicated in display status box
D108.
[0060] If a signal from the contact sensor 806 is present at the
end of the countdown in step S150, the process proceeds to step
S154, where the injection motors 370 are actuated to administer the
microprocessor-calculated or user-set insulin dosage, as the case
may be. Step S156 indicates that the error sensor 372 monitors the
progress of the injection and if it detects an error or
malfunction, it terminates the injection, displays a message ("An
error has occurred during injection") and instructions to the user
("please contact your healthcare provider immediately"). In a
preferred embodiment, the unit automatically sends a notice of the
malfunction and its nature using the unit's the communications
module 700 to the unit manufacturer and the user's primary
healthcare provider. This can be done wirelessly, and can include
information on the location of the user. It can advantageously be
provided via cloud-based ecosystems, such as the Smart Rep.TM.
system discussed further below. In fact, such malfunctions
exemplify advantages of integration of the unit into an ecosystem
with components like the Smart Rep.TM. system, to allow automatic
replacement of defective units, compilation of a database of
malfunctions and their nature for manufactures and regulatory
agencies.
[0061] If the injection is completed successfully, the
sampling/administration cycle terminates at step S158. At this
time, the unit can audibly inform the user that the injection was
successful and confirm the dosage administered. It can also state,
and display on the LCD display, a message informing the user of the
next scheduled blood sampling scheduled in accordance with the
treatment protocol stored in the unit's ROM. The termination
procedure will preferably include notification to one or more of
the remote systems discussed below (such as the Smart Rep.TM.
system and/or the Global EMR.TM. system discussed below) of a
successful treatment cycle and particulars thereof, such as the
date and time of administration, whether the user was hypo- or
hyperglycemic, the amount of insulin injected, if any, and whether
the amount of insulin injected was calculated by the microprocessor
or set by the patient, just to name a few examples.
Variations, Modifications, and Enhancements
[0062] Those skilled in the art will recognize that many variations
and modifications of the disclosed embodiments would fall within
the scope of the invention. In one variation on the techniques
described above, the testing/treatment history of a user can be
downloaded via a bar code displayed on the LCD display 18 rather
than by using an external USB drive or an Internet connection. In
this variation, the unit's software can include an algorithm that
converts recorded data into a bar code format that is then
displayed on the LCD display. Scanning the bar code transfers the
information to the scanning device. If necessary, the information
can be contained in multiple bar code displays, which are then
scanned in turn.
[0063] In another variation, the unit can include a removable USB
storage device on which the data is recorded. This will facilitate
manipulation and transportation of the recorded information. For
example, such a storage device could be employed to eliminate an
intermediate step in which the unit must be connected to a computer
through a USB port, as discussed. It will also enable a user to
mail or otherwise transport the recorded data to a healthcare
provider, for those users not comfortable with transmitting data
over the Internet, as well as eliminating the need to visit the
healthcare provider simply to have the recorded data downloaded
onto a computer at the provider's location. If a removable USB
storage device is used, the unit can be provided with multiple such
devices so that the user has a supply on hand.
[0064] In emergency situations, the unit's location sensing
circuitry (for example, via GPS or a cellular network) can locate
the closest medical facilities such as a hospital, ambulatory
center, clinic or standalone emergency rooms. It can also permit
communication directly with such facilities to find the one that is
best equipped for the ongoing emergency. The unit's alerting
function can further be programmed to notify nearby relatives or
caregivers (within, say, a predetermined distance from the user's
location) of an ongoing emergency situation and the medical
facility where the user is going.
[0065] In one enhancement, configuring the unit with a two-way
communication platform such as Apple-like Face Time, Skype.TM., or
any other like communication service that permits using the camera
25 for remote consultations with healthcare providers. These
consultations can be provided as part of a general healthcare
routine, or in connection with a current situation for which the
user needs specialized guidance (analogous to the subscription
OnStar.RTM. service provided to automobile drivers). In that
connection, the same service can function as an emergency service
provider as discussed above, in which someone at the service
provider can provide real-time advice during an emergency. Of
course, this enhancement can be provided without a video link (that
is by audio only), as well. Cameras on the front and the rear of
the unit provide flexibility of use to patients and healthcare
providers who might from time to time be users of the unit. (It
should be understood that throughout this description, the term
"user" is not restricted to a patient using the unit for
monitoring, administration, or communication purposes, and
references to a "user" will be clear from the context in which the
term is used herein.)
[0066] In still another variation, medications can be administered
by any means that serves the purpose of delivering them to the user
in any appropriate manner. For example, instead of a hypodermic
needle, a medication can be administered with a jet injector
syringe that uses a high-pressure narrow jet of the injection
liquid instead of a hypodermic needle to penetrate the epidermis.
This type of device is powered by compressed air or gas, either by
a pressure hose from a large cylinder, or from a built-in gas
cartridge or small cylinder.
[0067] In yet another variation, the administration module of the
unit described above can be adapted to administer two or more
medications. Many individuals have co-morbid diseases for which
they are being treated and for which they are prescribed multiple
medications. It is not unusual for a person to be taking four or
more different medications, usually on a different schedule for
each. This can cause confusion leading to medication errors, which
can cause avoidable side effects and negative outcomes. A unit
according to this variation could take many forms. For example, the
administration module could include a revolving chamber for
dispensing different medications, or incorporate interchangeable
administration modules for different treatments. The unit could be
programmed to provide instructional prompts (audible, text, video,
or any combination) tailored to an individual's particular
treatment protocol. In that regard, individual administration
modules can have electronic identifying indicia that the unit can
read and match with prestored instructions to provide instructional
prompts appropriate to particular medications. All activity of the
user related to a given administration module is stored for upload
to a healthcare provider of an ecosystem (as described below) for
the purposes discussed below.
[0068] The following are a few examples of multi-medication
treatment regimens possible with this type of unit: [0069] HIV
cocktail therapy: [0070] HAART (Highly Active Anti Retro Viral
therapy) cocktail (administered orally or by injection, for
example) [0071] Multi drug resistance combinations (administered
orally or by injection, for example) [0072] Treatment for HIV or
AIDS opportunistic conditions such as sarcomas, pneumonia,
influenza, tuberculosis, hepatitis, etc. (administered orally, by
injection, in ointment form, intravenously, to name some examples)
[0073] Vitamin assortment of vitamins for wellness programs
(administered orally or by injection, for example) [0074] Multiple
medications to manage diabetes: [0075] Metformin tablets [0076]
Sulfonylureas--treatment of type-2 diabetes (administered orally)
[0077] GLP1 (administered orally or by injection, for example)
[0078] Insulin injections.
[0079] Another variation of the unit described above is adapted for
use independent of a sampling module, and may be constructed
without a sampling module at all. This type of "smart injector"
could alternatively be constructed with a switch or other means
(voice activated, for example) to disable the sampling module 100.
It could also permit a user to install different administration
modules with electronic identification indicia to enable a user to
interface with the administration module using a suitable input
device like the touch device 20 and/or display, or by voice
activation using voice recognition software as discussed above. In
one mode of operation, the user can set a dosage amount to
substitute for step S140 in the flowchart in FIG. 14B, after which
an exemplary process would proceed by incorporating some or all of
the subsequent steps described above in connection with FIG. 14B.
Of course, such a unit could be used for medications other than
insulin in accordance with the discussion further below of other
applications of the unit 10.
[0080] Further, a comparable unit could be adapted for use without
an administration module, or constructed without an administration
module at all. Such a unit could perform some or all of the steps
described in FIG. 14A, tailored to a specific medical condition
(that is, conditions other than diabetes; see discussion below of
other applications of the unit). Such a unit would provide a way of
monitoring medical conditions that are not necessarily life
threatening, but as to which it would be advantageous to permit a
patient to periodically check some bodily condition using a
portable unit and communicate the results to the patient's
healthcare provider. It would also provide a way of keeping an
individual's healthcare provider apprised of the status of his or
her medical condition without requiring an office visit. And it
would provide all of the data recording and utilization features
described in the next section.
Data Recording/Utilization--Integration with Companion Systems
[0081] Another aspect of the invention involves storage in the
microprocessor's ROM of complete information regarding the timing
and results of the blood glucose testing, times and amounts of
ingestion of blood glucose producing substances, times and amounts
of insulin injections, calls to 911 and/or a private subscriber
service, or any other aspect of the process just described. Many of
the instances where recording is performed are noted specifically
in the above description, and others will be apparent to those
skilled in the art. The recording capabilities of the unit enable
compilation of a complete history of a patient's monitoring and
management of his or her condition that various entitles can access
for numerous uses. As described more fully in U.S. Pat. No.
8,206,340, one such entity is the patient's healthcare provider,
which can download stored information and employ it for various
reasons, such as making adjustments to the patient's treatment
protocol, which can then be uploaded to the unit as discussed
above. The same information, collected from numerous patients, can
be used for public health purposes by converting it to statistical
information on treatment of diabetes or other conditions as
described further below. All of the uses described in U.S. Pat. No.
8,206,340 for data stored by the unit described there are also
available in connection with the unit 10 described here.
[0082] The recording and storage of information concerning the use
of the unit for the purpose of monitoring and managing a single
patient's medical condition also enables the unit to be integrated
as part of an entire healthcare "ecosystem." Such an ecosystem
could have a multitude of functionalities and embodies concepts
that are independent of the medical condition the unit is used to
monitor and treat. (Specific applications of the unit for other
than diabetes monitoring and treatment are discussed in the
following section.) This ecosystem can have numerous parts that
interact with a unit according to the present invention and with
each other to realize multiple advantages, including enhancing
patient outcomes, improving public health data gathering, providing
information required by regulatory agencies, and facilitating the
exchange of information with insurance carriers, just to name a
few.
[0083] Parts of such an ecosystem have already been described above
in connection with the usage of the unit 10 and in the '340 patent.
These include the notification of emergency service providers such
as the public 911 system or private systems such as the Alert
One.RTM. medical alert service. Another possible part of such an
ecosystem could be specialized healthcare knowledge centers that
offer medical advice to a patient-user of the device or his or her
physician. Such advice would thus be adapted to specific aspects of
the patient's condition as reflected by the monitoring and
treatment history stored in the unit ROM and sent to the knowledge
center by the unit's communication module. The knowledge center
could download information to the unit regarding matters such as
treatment protocols, recent developments in treatments for the
patient's condition, and oral advice from a specialist physician to
be recorded and played back by the user, just to name a few
possibilities. The downloaded information, if in text form, can be
automatically displayed on the unit's LCD display, or a prompt
could be displayed indicating that a message (oral or text) is
waiting. The healthcare knowledge centers can be existing
organizations that specialize in certain medical conditions, such
as Joslin Diabetes Center of Boston, Mass., or specialists at other
organizations such as the Cleveland Clinic, Harvard Medical School,
the Mayo Clinic, Johns Hopkins Hospital, or the like. Organizations
such as these and others could offer their services to users of the
unit, whether patients or physicians, either as a public service or
on a subscription basis.
[0084] An ecosystem incorporating a unit as described herein could
also comprise one or more components of a multi-purpose healthcare
system such as that described in U.S. provisional patent
application No. 61/705,961, entitled "Smart Rep System Healthcare
Provider/Supplier Interface," which is incorporated by reference
into the present description as if set forth in full herein. FIG.
15 is a schematic diagram of various components of an exemplary
Smart Rep.TM. system that uses a cloud-based server to track,
monitor, store, and report interactions among numerous parties to
coordinate myriad activities relating to individual medical care of
individuals participating in the system via the unit 10 with the
capabilities already discusses and to public health. The footnotes
referenced in FIG. 15 explain the functions that the system
components perform and how the components interact with each other:
[0085] (A) "Representative" comprises any pharmaceutical, device,
and over the counter sales, marketing and medical representative
from the manufactures identified in footnote G. [0086] (B) "Smart
Closet.TM." comprises the physical repository or storage area with
sensors that monitor, record, and track the flow of items taken
from or introduced to "inventory." This includes not only
traditional health care items such as pharmaceuticals and medical
devices, but also educational materials, inventory reports,
marketing reports, etc., either printed or transmitted
electronically from the Smart Closet.TM. repository. [0087] (C)
"Healthcare provider" includes doctors, dentists, nurses, and
administrative personnel supporting care providers in all care
centers, including hospitals, acute care centers, physician
offices, hospices, pharmacies, etc. One feature of the system is
that doctors can prescribe electronically (E-Prescribing), and
patients (footnote I) can obtain prescriptions by accessing the
server (footnote E). Patients can also physically receive items
from a Provider. [0088] (D) "Products" include all items identified
in footnote G and all educational, sample voucher, and marketing
materials. [0089] (E) "Smart Rep.TM." is the preferably cloud-based
server system that tracks, monitors, stores, and reports
interactions between the parties in FIG. 15. Access is typically
available to subscribers (and patients of subscribers), and
regulatory agencies. Available information and/or services can
include data interchanges incorporated into electronic medical
record (EMR) systems. If the unit 10 is integrated with this type
of system, a user would typically connect to the Smart Rep.TM.
system server represented here, preferably using one or more of its
wireless communication devices. [0090] (F) "Inventory" includes all
Smart Closet information and product movement and stocking
information for the use and replenishment of supplies. [0091] (G)
"Manufacturer" includes any producer of branded or generic
pharmaceutical products and devices, as well as a provider of
services to the healthcare industry. It can also include
manufacturers and sellers of consumer products, such as
over-the-counter, non-prescription medications, wound care
products, and other consumer healthcare products. [0092] (H)
"Regulators" comprise federal, state, and national regulatory and
auditing agencies involved in monitoring the healthcare industry.
It can also include a payer of healthcare expenses, such as a
private insurance company, Medicare, Medicaid, etc. These parties
can use the system for purposes such as detecting fraudulent
activity, identity theft, or other kinds of misrepresentation.
[0093] (I) "Patient" is the actual patient or his/her family
members and/or caregiver. It can also include other care providers
and/or organizations requiring access to information about the
patient's medical care. Patients have access to the Smart Rep.TM.
server to schedule appointments, obtain test results, access
medical information, etc. It will be appreciated that the term
"patient" is used broadly in this context, and will include any
user of a unit with some or all of the capabilities of a unit as
described herein. It will also be clear that it is contemplated
that myriad users will be part of a Smart Rep.TM. system as
described herein.
[0094] For example, the unit described herein can communicate with
the server of the Smart Rep.TM. system to upload stored information
regarding any aspect of the testing and medication administration
protocol performed by the unit (whether relating to diabetes care
or other applications discussed further below). For example, the
unit 10 could communicate to the server that the testing cartridge
or the injection cartridge is empty and needs to be replaced. The
Smart Rep.TM. system can automatically arrange to send to the user
replacement cartridges, new test strips (which may be separately
replaceable in certain embodiments), or any other consumable part
of the sampling module or administration module item. The system
can further keep track of the central inventory of such items (via
the Smart Closet.TM. inventory control feature of the Smart Rep.TM.
system) to ensure that an adequate supply of replacement cartridges
and other consumable items is always on hand. Information on the
testing and medication administration history of numerous patients
can be collected by other Smart Rep.TM. system participants for use
by public health agencies, healthcare providers, medical supply
distributors and manufactures, regulatory agencies, and insurance
companies, to name just some of the possibilities.
[0095] It will be appreciated that a supporting infrastructure like
the Smart Rep.TM. system can be provided with almost countless ways
of assisting the user in managing a medical condition. Examples
include the ability to write or refill prescriptions and
communicate them to the unit or a pharmacy or both. For example,
information recorded and sent to the Smart Rep.TM. system by the
unit can be analyzed by a healthcare professional participating in
the system, who might determine that a patient's medication should
be changed, or that the patient's condition requires treatment
other than medication administered by the unit. In such a case, a
prescription for the new medication could be sent directly to a
pharmacy that the patient has previously designated to the Smart
Rep.TM. system (possibly by using the unit). An optional feature
would send a prompt for display on the unit or a voice message to
indicate that a prescription has been sent to the user's
pharmacy.
[0096] It will be recognized by those skilled in the art that the
ecosystem could also include a separate cloud-based system for
supplying replacements of consumable components of the unit
described herein. That is, the ecosystem incorporating the unit can
include a resupply system rather than or in addition to relying on
a similar capability in the Smart Rep.TM. system for consumables,
such as the administration module, the sampling module, the alcohol
tablet, batteries, and any other item in a particular unit that
needs to be periodically replaced. Depending on the capabilities
and the application for which the unit is adapted (see further
below), this resupply aspect of the system could monitor usage
and/or performance of various components of a unit and arrange for
automatic ordering of replacements (or for prompting the user that
replacements are necessary) for items such as (a) oral medications,
inhalers, nasal sprays, nebulizers or other mist-related medication
devices, drops and other types of inner ear medications, dermal or
intradermal treatments, ointments, vaccines, elixirs, and powders,
whether administered by the unit or are used in connection with the
condition monitored using the unit, (b) other consumables, such as
lancets, testing strips, assays, dyes, and reagents, that are used
in connection with the sampling and testing function of a unit and
that are depleted as the unit is used over time, and (c) hardware
components such as computer memory, application chip sets,
telecommunication devices, and the like that can fail and require
replacement. Supplies could further be color coded, bar coded,
and/or be provided with an RF tag or the like, for identification
by a reader/detection device that cooperates with software in the
unit and can read or detect the identification information to
verify that the item is intended for that particular user. The unit
could be programmed to display information about the item to enable
further confirmation by the user that it is intended for his or her
use.
[0097] Another part of such an ecosystem can be the IMOS.TM.
platform and operating system, which provides integrated medical
information system software and services that in one aspect enable
communications between a unit as described herein and one or more
peripheral ancillary devices such as an electronic
sphygmomanometer, weight scale, spirometer, electrocardiogram,
stethoscope, digital signals representing the results of diagnostic
tests such as ultrasound, X-ray, CAT, and MRI examinations (or from
any other diagnostic testing technique), pupillometer, calorimeter,
dosimeter, thermometer, or any other device that provides
information in digital form indicative of some condition of a
person or animal. These and other types of ancillary devices can
communicate with the unit either by a wired connection, such as via
the USB port, or wirelessly to periodically or continuously monitor
a patient's condition, and in the typical case would take the place
of the sampling module. The IMOS.TM. operating system provides the
platform for sharing the results of such tests with the unit in a
form that the unit can utilize for all of the purposes described
herein. The unit can also store this information in its ROM and
upload it to a healthcare provider or healthcare knowledge center
of the type discussed above participating in the IMOS.TM. platform,
and then be used to provide treatment instructions or other
information to the patient via a download to the unit for display
or voice communication over the unit's speaker. The IMOS.TM.
platform can also be integrated with systems and organizations that
collect information capable of providing information and support in
connection with the use of units like those described herein. These
can include organizations that collect information for medical and
healthcare purposes such as universities, research labs,
information service companies, philanthropies, insurance carriers,
regulatory agencies, and the like.
[0098] The supporting ecosystem of which the unit is a part can
also include a universal health record system that integrates all
aspects of the user's current and past treatment history for use by
healthcare providers granted access by the user. This Global
EMR.TM. electronic medical record system would be a cloud-based
service that could store the entire medical and dental records of
an individual (whether human or animal), including information
recorded, stored, and uploaded to a server by a unit as described
herein and by other components of the ecosystem already described.
The user would control access to the records with a secure password
and authentication scheme and the entire system would use firewalls
in a known manner to comply with governmental regulations
concerning privacy.
[0099] Some or all of these parts of the ecosystem can make uses of
data that a unit as described herein can record and store, or that
can be collated using information provided from plural such units:
[0100] Assemble statistics (global, national, regional or local)
relating to healthcare issues such as correlations between
diagnoses and prescribed treatments, costs of particular services
provided to users and benefits realized from them, correlations
between treatments and outcomes, correlations between life
expectancies and the prevalence of particular diseases and cures,
and between the provision of healthcare samples and outcomes (for
example, determining the correlation, if any, on a person-to-person
basis between samples of medications given to individuals in
certain demographics--for example native Americans--and control of
blood glucose levels) [0101] Identify subgroup populations
benefiting from a particular clinical trial or drug [0102] Gather
data regarding exclusion patient populations due to reported
adverse events as associated with and correlated to bodily fluids,
DNA/RNA biomarkers, enzyme, etc., such as patients with biomarkers,
blood types genes, etc., that exclude them from taking certain
medications. [0103] Allow commercial entities such as
pharmaceutical companies or vendors participating in the ecosystem
to do many tasks based on data heretofore difficult to collect,
such as: [0104] Devise mass marketing approaches that target
marketing information and education programs for patients with
certain medical conditions and required treatment protocols [0105]
Organize global distribution and branding platforms to provide
logistical and sales support based on the prevalence of certain
kinds of diseases in various geographical areas or among certain
demographic groups [0106] Correlate the volume of sales or
prescriptions for a particular product with the number of
promotional samples that were given away [0107] Determine how many
of a vendor's customers have reordered products as they are
consumed by users of the unit, including determining numbers of
products per order [0108] Compile users' satisfaction ratings of
physicians, diagnostic devices, products, or services [0109]
Compile and collate into categories types of questions or concerns
users have communicated to healthcare providers or other
suppliers.
[0110] The IMOS.TM. operating system platform for the unit and the
ecosystem components facilitates the communications and operations
discussed above. For example, it enables participants in the Smart
Rep.TM. system to sync information on all parts of the system,
while providing controlling or restricting access to certain
information, either designated confidential or protected by
government regulations. Syncing information across the various
components of a system such as the Smart Rep.TM. system will enable
calendars of various participants to be synchronized to facilitate
tasks such as meeting planning and patient visits to various
healthcare providers. Another example of the functionality provided
by the IMOS.TM. operating system platform would be to enable
various participants in the Smart Rep.TM. system and in the Global
EMR.TM. medical record system to share medical records of a patient
that includes data and information provided via the units as
described herein being used by multiple users.
[0111] The ecosystem can also include Healthmart.TM., a cloud-based
supplier of programs designed to help the user perform specific
tasks ("apps") related to healthcare issues of interest or
importance to the user. These apps could include programs
downloaded to the unit from a Healthmart.TM. app supplier. The
following are examples of tasks that such apps could perform:
[0112] Direct users to information on health care, nutritional
supplements, wellness, price comparisons of healthcare products and
services, and/or other health or veterinary related subject matter
[0113] Provide an avenue for users to suggest directly to providers
such as the unit manufacturer, pharmaceutical companies, or any
other participant in the Smart Rep.TM. system ideas for new
products or product improvements or additional services or
improvements in existing services [0114] Provide either via the
Healthmart.TM. app or a separate HealthRank.TM. app a mechanism for
users to grade service providers (such as physicians and
hospitals); users' rankings could be uploaded to the Smart Rep.TM.
system for access by participating insurance companies, government
agencies, etc., or shared among users [0115] Enable direct audio or
video communication between a physician and patient, or access to
physician narrated instruction/informational videos using
DOKTOK.TM. two-way communication software [0116] Provide an avenue
by which a user can report directly to providers such as the unit
manufacturer, pharmaceutical companies, or healthcare providers
adverse events or side effects such as fainting, dizziness, rashes,
nausea, headaches, pain, or other difficulties [0117] Provide an
avenue for a user to submit questions to the customer service
department of products or services used with a unit [0118] Permit a
user to download coupon vouchers or special offers on consumer
healthcare products or over the counter medications [0119] Provide
direct interunit communications so users of units can communicate
with each other directly (either in person, by e-mail, via social
media, text messages, or otherwise) in groups or on a one-to-one
basis.
[0120] A further feature of the ecosystem can include notification
of severe patient adverse events to ecosystem participants, such as
one or more of a patient's healthcare providers and emergency
medical first responders. In addition, family members and/or
caregivers can be notified each time the unit provides an emergency
notification. As already discussed, the unit can use its GPS
circuitry or position information gathered by other means to
determine the user's location and upload this information
periodically to the ecosystem, so that a failure to update at the
appointed time can be detected by appropriate software in the
ecosystem server to fix the last known location of dementia
patients or children if a predetermined number of updates are
missed. In general, the types of synchronized communication among
various participants in the ecosystem can avoid errors and
omissions, and resultant poor patient outcomes, that have plagued
healthcare rendered using known technology.
Applications for the Unit
[0121] In the description of the constructional details and
operation of the unit 10, diabetes management and treatment was
used as an exemplary application. However, there are many other
applications for such a unit, and there are many systems with which
it can coordinate and communicate. The unit can be adapted for
sampling and testing a wide variety of bodily fluids depending on
the condition to be treated/monitored. Examples of such bodily
fluids in addition to blood include sweat, urine, and saliva. It
will also be appreciated that the unit can test for many properties
other than blood glucose level and administer treatments based on
the test results. Broadly speaking, the invention includes
measuring and/or analyzing all types of assays across multiple
analytes and sample types, including tissue samples, breath
samples, light sensors, and the like for use in testing based on
properties of one or more of DNA/RNA, proteins, enzymes,
biomarkers, gene mutations, gene sequencing, oxygen levels,
CO.sub.2 levels, or any other measurable substance or genetic
indicator in a living organism. It can also integrate information
from other sources, such as the ancillary devices discussed above,
to take samples and determine appropriate treatment regimens. In
that regard, it will be appreciated that the unit can be in the
form of a mobile device as described herein that administers
medications using a delivery system that can take any suitable form
such as an administration mechanism of the type already described.
It can also include combinations of medication delivery mechanisms,
such as one or more of an administration mechanism like that
described further above, an inhaler, an oral dispenser, a liquid
dispenser, a nasal spray, a nebulizer, a mist generator, a respimat
soft mist inhaler, and others.
[0122] Given that broad range of sampling/testing/treatment
possibilities, it will be apparent to those skilled in the art that
there are myriad applications for treatment of a wide variety of
medical conditions using a unit in accordance with one of its core
concepts of the invention, namely a unit that includes in
combination: (i) a mechanism for taking from a patient a sample,
which is defined for present purposes as measuring a bodily
condition of the patient, (ii) circuitry such as a microprocessor
for determining a treatment based on a test for a particular
property of the sample, and (iii) a mechanism for administering a
treatment based at least in the first instance on the determination
by the circuitry (although in another aspect of the unit a user
could override the recommended treatment). The following are some
exemplary applications other than diabetes control for a unit in
accordance with the present invention.
Opiate Overdoses and Pain Medication Misuse
[0123] This application involves using a protocol that includes
injecting nalaxone opioid inverse agonist to counter the effects of
an overdose of an opiate such as heroin or morphine. A key
indicator of such a condition is respiratory depression, which can
be measured using a unit in accordance with the invention
constructed with a sampling mechanism incorporating an oximeter for
measuring blood oxygen levels. Another indicator of an opiod
overdose is a change in normal chest wall movement, which can be
measured by incorporating an accelerometer into the unit in
addition to or instead of an oximeter. The unit would already have
stored therein the patient's baseline blood oxygen level and chest
movement data.
[0124] Using the results of tests based on samples taken by the
oximeter or accelerometer, the unit microprocessor can calculate an
appropriate dosage of nalaxone in accordance with stored
information relating to a stored profile of the user, including
information such as the user's age, weight, allergies, etc.
Nalaxone can be administered in three different modalities,
intravenously, intramuscular injection, or as a nasal spray, and a
unit is accordance with the present invention could incorporate an
administration mechanism capable of nalaxone treatment using one or
more of the three modalities. In emergency situations an emergency
service provider (911) can be automatically notified of the user's
condition and location (using the GPS or cellular telephone
capabilities).
Pain Management
[0125] Pain from cancer (carcinoma) can be managed using a unit in
accordance with the invention that samples blood CO.sub.2 levels,
which correlate to tachycardia and tachypnea, and/or changes in
chest wall movement using an accelerometer as discussed above, all
of which are indicators that a person is experiencing pain.
Treatments would include opiates (such as morphine, with or without
one or more adjuvants) and other types of analgesics such as
non-steroidal anti-inflammatory medications.
[0126] A unit according to the invention would store the history of
administrations of such medications, including information such as
the time from the last administration, the frequency of
administration, the amounts and types of medication administered in
the past, the manner of administration, and the patient's
responsiveness to previous administrations. These data could then
be used by the unit's microprocessor to calculate a recommended
dosage in accordance with established protocols based on a
patient's age and weight.
[0127] The unit can include an administration mechanism that
injects a dosage of pain medication in accordance with the
calculated amount, or an amount set by the patient manually by
overriding the calculated recommended dosage. The ability of the
unit to cooperate with an ecosystem as described in the examples
given above that provides patient support would be an important
component for this application. For example, a healthcare
professional participating in the ecosystem could monitor patient
information such as heart rate, respiratory rate, blood pressure,
and pCO.sub.2 to adjust treatment protocols and download them to
the unit for use in calculating recommended amounts and frequencies
of administration of analgesic medications.
Anticoagulant Therapy
[0128] This application involves the testing of blood clotting
parameters such as prothrombin time (PT) and its derived measures
of prothrombin ratio (PR) and international normalized ratio (INR),
which are commonly used to measure the extrinsic pathway of blood
coagulation. The sampling module of the unit can be adapted to
measure this or other blood clotting parameters and calculate an
appropriate dosage of an anticoagulant such as enoxaparin (a low
molecular weight heparin marketed under the trade names
Lovenox.RTM., Xapari, and Clexane.RTM., among others). This
medication prevents and treats conditions such as deep vein
thrombosis or pulmonary embolism, and is administered as a
subcutaneous injection.
Summary of Additional Applications for Unit
[0129] There are many other possible applications for a unit in
accordance with the invention. Some others in addition to those
already discussed in detail are described in tabular form in the
following Table I, which constitutes just a partial list of the
types of conditions that can be monitored and treated using such a
unit, with the nature of the sample, the substance or property
tested, and the treatment administered for each.
TABLE-US-00001 TABLE I Medication/ Method of Condition Sample
Administration Comment HIV Blood or Stribild .TM. Test determines
saliva (elvitegravir presence of cobicistat HIV antigen
emtricitabine tenofovir)/oral Choles- Blood Lipitor .RTM. Test
determines terol (atorvastatin lipid panel or calcium)/oral lipid
profile; veterinary therapy may differ Prostate Blood Luteinizing
hormone- Test for cancer releasing prostate specific hormone
agonists/ antigen (PSA) subcutaneous injection, orally,
cream/ointment, nasal spray, inhaler Allergies Blood/skin
Loratadine (e.g.)/oral, Medication depends test ointment, nasal
spray, on the allergy inhaler, injection Thyroid Blood/
Levothyroxine/oral or Suspension of Disease tissue/ suspension
crushed oral peroxidase Levothyroxine (TPO) used in pediatric
antibody treatment test Osteo- Blood Teriparatide Test for presence
porosis (rDNA origin)/ one or more of subcutaneous rheumatoid
factor, injection ESR, C-reactive protein, anti- CCP, ANA, HLAB27,
anti- CPT, creatine phosphor kinase, and anti-DNA Breast Blood/
Traztuzumab/ New technology Cancer biomarkers/ intravenous enables
biopsy/ infusion, detection of many DNA-RNA, injection, oral
cancers by gene test identifying biomarkers such as BRCA1 and HER2
Kidney Blood/urine Epoetin alfa/injection, Microalbumin test
Disease intravenous Liver Blood interferon and Liver function
Function ribavirin/oral tests use (tablets or liquid), groups of
clinical injection biochemistry laboratory blood assays to provide
information on liver condition Hyper- blood Rosuvastatin Test with
electronic tension pressure calcium/oral sphygmomanometer (see note
1 below) Autoimmune Blood Adalimunab/injection Test for antinuclear
diseases: antibody c-reactive Rheumatoid protein (CRP), Arthritis
rheumatoid factor, Juvenile and complete blood Arthritis count CBC)
Psoriatic Arthritis Ankylosing Spondylitis note 1: The
sphygmomanometer can be a peripheral device connected to the unit
via the USB port; see further above.
[0130] It will be appreciated that the applications discussed in
this section relate to known testing methods, medications,
treatment protocols, and administration methods. The invention of
course can be adapted to use tests, medications, protocols,
medication administration methods developed in the future. For
example, the invention contemplates including any later developed
administration method involving technologies using nebulizer
devices, misters, inhalers, ear drops, radiation, and intravenous
administration, to name some possible examples.
Pediatric and Veterinary Uses
[0131] Pediatric care is generally defined as healthcare and
medication for children generally under the age of 18 and include
neonate, premature neonate, full term neonate, infant (one month to
one year), child or children (1 to 12 years of age), adolescent (13
to 18 years of age), postnatal age, gestational age, and
postmenstrual age. Pediatric care using the unit described herein
has to consider the implications on smaller, younger people and
bodies, taking into consideration growth, hormonal and other
issues. To that end, the unit can be adapted to monitor, measure,
and treat conditions for pediatric patients. This would include
adjusting testing and measurement criteria, treatment protocols,
communication methods, methods of administering medications, and
methods of monitoring treatment. For example, on liquid injections,
the amount of units administered and the needle size may vary for
pediatric patients.
[0132] For veterinary purposes, the sampling, measuring, and
administration functions will be similar in terms of operation,
although different medications, dosing levels, and administration
methods and frequency may be used in particular instances. The test
portion of the unit's operation will of course measure different
data points and use different algorithms to determine the
appropriate treatment for the animal. For example, normal
temperature and blood sugar level of a dog are different for
different breeds and by age and weight for a particular breed.
Accordingly, a unit for treatment of dogs could permit the human
user to input the breed, age, and weight, and incorporate a ROM
with algorithms that determine appropriate treatment protocols
depending on that input. Similarly, the unit can be part of and
supported by an ecosystem with features and aspects corresponding
to those discussed above, but adapted to the veterinary application
of the unit.
SUMMARY AND CONCLUSION
[0133] The above description relates to a universal
testing/administration unit and system that can increase the
probability of positive outcomes for patients with serious medical
conditions. The unit and system in one broad aspect involve patient
self-testing and/or self-administration of a treatment agent. The
invention frees patients with such conditions to follow more normal
lifestyles while enabling effective monitoring of their conditions
and also providing for alerting healthcare and/or emergency
providers if and when intervention may be necessary. The unit can
integrate with wide coverage healthcare, business, and leadership
networks, which in turn can interface with medical supply
distributors and manufactures, public health agencies and
regulatory bodies, among others, as part of "global" management of
healthcare for a large portion of a given population.
[0134] Those skilled in the art will readily recognize that only
selected preferred embodiments of the invention have been depicted
and described, and it will be understood that various changes and
modifications can be made other than those specifically mentioned
above without departing from the spirit and scope of the invention,
which is defined solely by the claims that follow.
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