U.S. patent application number 17/500529 was filed with the patent office on 2022-05-05 for apparatus and system for diabetes management.
The applicant listed for this patent is Hygieia, Inc.. Invention is credited to Eran Bashan, Israel Hodish.
Application Number | 20220133224 17/500529 |
Document ID | / |
Family ID | 1000006082953 |
Filed Date | 2022-05-05 |
United States Patent
Application |
20220133224 |
Kind Code |
A1 |
Bashan; Eran ; et
al. |
May 5, 2022 |
Apparatus and System for Diabetes Management
Abstract
An apparatus and system diabetes management. The apparatus
comprises a body which houses: (i) at least a first memory for
storing data inputs corresponding at least to one or more
components in a patient's present insulin dosage regimen and the
patient's blood-glucose-level measurements determined at a
plurality of times; (ii) a processor operatively connected to the
at least first memory, the processor programmed at least to
determine from the data inputs corresponding to the patient's
blood-glucose-level measurements determined at a plurality of times
whether and by how much to vary at least one of the one or more
components of the patient's present insulin dosage regimen; (iii) a
display screen operatively connected to the processor; (iv) a
quantity of insulin; (v) a needle communicating with the quantity
of insulin for delivering insulin to the patient; (vi) means for
effecting delivery of a portion of the quantity of insulin to the
patient via the needle; and (vii) metering means for controlling
the portion of the quantity of insulin delivered to the patient via
the needle.
Inventors: |
Bashan; Eran; (Ann Arbor,
MI) ; Hodish; Israel; (Ann Arbor, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hygieia, Inc. |
Livonia |
MI |
US |
|
|
Family ID: |
1000006082953 |
Appl. No.: |
17/500529 |
Filed: |
October 13, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15878050 |
Jan 23, 2018 |
11172878 |
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17500529 |
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14631525 |
Feb 25, 2015 |
9907508 |
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15878050 |
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13128358 |
Jul 21, 2011 |
8992464 |
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PCT/US2009/063989 |
Nov 11, 2009 |
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14631525 |
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61257886 |
Nov 4, 2009 |
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61113252 |
Nov 11, 2008 |
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Current U.S.
Class: |
604/66 |
Current CPC
Class: |
G16H 40/63 20180101;
A61M 5/31571 20130101; A61M 2205/507 20130101; G16H 20/60 20180101;
A61M 5/1723 20130101; G16H 20/10 20180101; A61M 2205/502 20130101;
A61M 2005/14208 20130101; A61M 5/1684 20130101; G16H 10/40
20180101; A61B 5/4839 20130101; G16H 20/17 20180101; A61M 2205/52
20130101; A61B 5/14532 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/145 20060101 A61B005/145; G16H 40/63 20060101
G16H040/63; G16H 20/60 20060101 G16H020/60; A61M 5/168 20060101
A61M005/168; A61M 5/172 20060101 A61M005/172; G16H 20/17 20060101
G16H020/17; G16H 20/10 20060101 G16H020/10; G16H 10/40 20060101
G16H010/40 |
Claims
1. An apparatus for diabetes management, comprising: a body
housing: (i) at least a first memory for storing data inputs
corresponding at least to one or more components in a patient's
present insulin dosage regimen and the patient's
blood-glucose-level measurements determined at a plurality of
times; (ii) a processor operatively connected to the at least first
memory, the processor programmed at least to determine from the
data inputs corresponding to the patient's blood-glucose-level
measurements determined at a plurality of times whether and by how
much to vary at least one of the one or more components of the
patient's present insulin dosage regimen; (iii) a display screen
operatively connected to the processor; (iv) a quantity of insulin;
(v) a needle communicating with the quantity of insulin for
delivering insulin to the patient; (vi) means for effecting
delivery of a portion of the quantity of insulin to the patient via
the needle; and (vii) metering means for controlling the portion of
the quantity of insulin delivered to the patient via the
needle.
2. The apparatus of claim 1, wherein the quantity of insulin is
contained in a cartridge that is selectively removable from the
housing so as to be replaceable upon exhaustion of the quantity of
insulin therein.
3. The apparatus of claim 1, wherein the quantity of insulin cannot
be replenished upon exhaustion thereof.
4. The apparatus of claim 1, wherein the body further houses a test
strip port for receiving a test strip, and the processor is
operative to determine a patient's current blood glucose level
measurement from a sample of the patient's blood provided on a test
strip.
5. The apparatus of claim 4, wherein the display is further
operative to display a patient's current blood glucose level
measurement.
6. The apparatus of claim 3, further comprising means for
communicating data from the memory to a remote device for remote
storage.
7. The apparatus of claim 3, further comprising means for
communicating data from the memory to a second, like apparatus for
taking blood glucose measurements and optimizing a patient's
insulin dosage regimen over time.
8. The apparatus of claim 1, further comprising means for
preventing a patient from administering an injection when there is
an insufficient quantity of insulin remaining in the apparatus.
9. A system for diabetes management, comprising: (a) a device
including: (i) at least a first memory for storing data inputs
corresponding at least to one or more components in a patient's
present insulin dosage regimen and the patient's
blood-glucose-level measurements determined at a plurality of
times; and (ii) a processor operatively connected to the at least
first memory, the processor programmed at least to determine from
the data inputs corresponding to the patient's blood-glucose-level
measurements determined at a plurality of times whether and by how
much to vary at least one of the one or more components of the
patient's present insulin dosage regimen; (b) an apparatus, remote
from the device, comprising a body housing: (i) at least a first
memory; (ii) a processor operatively connected to the at least
first memory; (iii) a display screen operatively connected to the
processor; (iv) a quantity of insulin; (v) a needle communicating
with the quantity of insulin for delivering insulin to a patient;
(vi) means for effecting delivery of a portion of the quantity of
insulin to the patient via the needle; and (vii) metering means for
controlling the portion of the quantity of insulin delivered to the
patient via the needle; and (c) means for communicating data
between the device and the apparatus, the data including at least
data corresponding to a current recommended insulin dose.
10. The system of claim 9, wherein the quantity of insulin is
contained in a cartridge that is selectively removable from the
housing so as to be replaceable upon exhaustion of the quantity of
insulin therein.
11. The system of claim 9, wherein the quantity of insulin cannot
be replenished upon exhaustion thereof.
12. The system of claim 9, wherein the body further houses a test
strip port for receiving a test strip, and the processor of the
apparatus is operative to determine the patient's current blood
glucose level measurement from a sample of the patient's blood
provided on a test strip, and wherein further the means for
communicating between the device and the apparatus are further
operative for communicating the patient's blood glucose measurement
between the apparatus and the device.
13. The system of claim 12, wherein the display is further
operative to display a patient's current blood glucose level
measurement.
14. The system of claim 9, further comprising means for preventing
a patient from administering an injection when there is an
insufficient quantity of insulin remaining in the apparatus.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 15/878,050, filed Jan. 23, 2018, which is further a
continuation of U.S. application Ser. No. 14/631,525, filed Feb.
25, 2015, now U.S. Pat. No. 9,907,508, which is further a
continuation of U.S. application Ser. No. 13/128,358, filed Jul.
21, 2011, now U.S. Pat. No. 8,992,464, which is the U.S. National
Phase of International Application No. PCT/US2009/063989, filed
Nov. 11, 2009, which is related to both, and claims the benefit of
priority from both, U.S. Provisional Application No. 61/257,886,
filed Nov. 4, 2009, and U.S. Provisional Application No.
61/113,252, filed Nov. 11, 2008. All of the foregoing related
applications, in their entirety, are incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention pertains to apparatus and systems for
diabetes management, and more specifically to such apparatus and
systems as are operative to determine at a plurality of times
whether and by how much to vary at least one of the one or more
components of a patient's present insulin dosage regimen, and to
provide the means for administering insulin doses.
BACKGROUND OF THE INVENTION
[0003] Diabetes is a chronic disease resulting from deficient
insulin secretion by the endocrine pancreas. About 7% of the
general population in the Western Hemisphere suffers from diabetes.
Of these persons, roughly 90% suffer from Type-2 diabetes while
approximately 10% suffer from Type-1. In Type-1 diabetes, patients
effectively surrender their endocrine pancreas to autoimmune
distraction and so become dependent on daily insulin injections to
control blood-glucose-levels. In Type-2 diabetes, on the other
hand, the endocrine pancreas gradually fails to satisfy increased
insulin demands, thus requiring the patient to compensate with a
regime of oral medications or insulin therapy. In the case of
either Type-1 or Type-2 diabetes, the failure to properly control
glucose levels in the patient may lead to such complications as
heart attacks, strokes, blindness, renal failure, and even
premature death.
[0004] Insulin therapy is the mainstay of Type-1 diabetes
management and one of the most widespread treatments in Type-2
diabetes, about 27% of the sufferers of which require insulin.
Insulin administration is designed to imitate physiological insulin
secretion by introducing two classes of insulin into the patient's
body: Long-acting insulin, which fulfills basal metabolic needs;
and short-acting insulin (also known as fast-acting insulin), which
compensates for sharp elevations in blood-glucose-levels following
patient meals. Orchestrating the process of dosing these two types
of insulin, in whatever form (e.g., separately or as premixed
insulin) involves numerous considerations.
[0005] First, patients measure their blood-glucose-levels (using
some form of a glucose meter) on average about 3 to 4 times per
day. The number of such measurements and the variations
therebetween complicates the interpretation of these data, making
it difficult to extrapolate trends therefrom that may be employed
to better maintain the disease. Second, the complexity of human
physiology continuously imposes changes in insulin needs for which
frequent insulin dosage regimen adjustments are warranted.
Presently, these considerations are handled by a patient's
endocrinologist or other healthcare professional during clinic
appointments. Unfortunately, these visits are relatively
infrequent--occurring once every 3 to 6 months--and of short
duration, so that the physician or other healthcare professional is
typically only able to review the very latest patient medical data.
In consequence, it has been shown that more than 60% of patients
control their diabetes at sub-optimal levels, leading to unwanted
complications from the disease.
[0006] Indeed, one of the major obstacles of diabetes management is
the lack of availability of a patient's healthcare professional and
the relative infrequency of clinic appointments. Studies have, in
fact, established that more frequent insulin dosage regimen
adjustments--e.g., every 1 to 2 weeks--improves diabetes control in
most patients. Yet as the number of diabetes sufferers continues to
expand, it is expected that the possibility of more frequent
insulin dosage regimen adjustments via increased clinic visits
will, in fact, decrease. And, unfortunately, conventional diabetes
treatment solutions do not address this obstacle.
[0007] The device most commonly employed in diabetes management is
the blood glucose meter. Such devices come in a variety of forms,
although all are characterized by their ability to provide patients
near instantaneous readings of their blood-glucose-levels. This
additional information can be used to better identify dynamic
trends in blood-glucose-levels. However, all conventional glucose
meters are designed to be diagnostic tools rather than therapeutic
ones. Therefore, by themselves, even state-of-the-art glucose
meters do not lead to improved glycemic control.
[0008] One conventional solution to the treatment of diabetes is
the insulin pump. Insulin pumps are devices that continuously
infuse short acting insulin into a patient at a predetermined rate
to cover both basal needs and meals. As with manual insulin
administration therapy, a healthcare professional sets the pump
with the patient's insulin dosage regimen during clinic visits. In
addition to their considerable current expense, which prohibits
their widespread use by patients with Type-2 diabetes, insulin
pumps require frequent adjustment by the physician or other
healthcare professional to compensate for the needs of individual
patients based upon frequent blood-glucose-level measurements.
[0009] An even more recent solution to diabetes treatment seeks to
combine an insulin pump and near-continuous glucose monitoring in
an effort to create, in effect, an artificial pancreas regulating a
patient's blood-glucose-level with infusions of short-acting
insulin. According to this solution, real-time patient information
is employed to match insulin dosing to the patient's dynamic
insulin needs irrespective of any underlying physician-prescribed
treatment plan. While such systems address present dosing
requirements, they are entirely reactive and not instantaneously
effective. In consequence of these drawbacks, such combined systems
are not always effective at controlling blood glucose levels. For
instance, such combined units cannot forecast unplanned activities,
such as exercise, that may excessively lower a patient's
blood-glucose level. And when the hypoglycemic condition is
detected, the delay in the effectiveness of the insulin occasioned
not only by the nature of conventional synthetic insulin but also
the sub-dermal delivery of that insulin by conventional pumps
results in inefficient correction of the hypoglycemic event.
[0010] While the foregoing solutions are beneficial in the
management and even treatment of diabetes in some patients, or at
least hold the promise of being so, there continues to exist the
need for an apparatus that is easy to use so as to facilitate
improved diabetes control in patients.
SUMMARY OF THE INVENTION
[0011] The present invention comprehends an apparatus and system
for diabetes management. In one embodiment, the inventive apparatus
comprises a body which houses:
[0012] (i) at least a first memory for storing data inputs
corresponding at least to one or more components in a patient's
present insulin dosage regimen and the patient's
blood-glucose-level measurements determined at a plurality of
times;
[0013] (ii) a processor operatively connected to the at least first
memory, the processor programmed at least to determine from the
data inputs corresponding to the patient's blood-glucose-level
measurements determined at a plurality of times whether and by how
much to vary at least one of the one or more components of the
patient's present insulin dosage regimen;
[0014] (iii) a display screen operatively connected to the
processor and operative to display at least the recommended insulin
dose;
[0015] (iv) a quantity of insulin;
[0016] (v) a needle communicating with the quantity of insulin for
delivering insulin to the patient;
[0017] (vi) means for effecting delivery of a portion of the
quantity of insulin to the patient via the needle; and
[0018] (vii) metering means for controlling the portion of the
quantity of insulin delivered to the patient via the needle.
[0019] In one embodiment, the apparatus may be for single-use only,
meaning that the quantity of insulin cannot be replenished upon
exhaustion thereof.
[0020] In another embodiment, the apparatus is for multiple-use and
the quantity of insulin is therefore able to be replenished.
According to this embodiment, the quantity of insulin may be
contained in a cartridge that is selectively removable from the
housing so as to be replaceable upon exhaustion of the quantity of
insulin therein.
[0021] In one embodiment, the body may further house a test strip
port for receiving a test strip. Per this embodiment, the processor
is operative to determine a patient's current blood glucose level
measurement from a sample of the patient's blood provided on a test
strip. Also per this embodiment, the display may, optionally, be
operative to display a patient's current blood glucose level
measurement.
[0022] According to one feature of the invention, means may be
provided for communicating data from the memory to a remote device
for remote storage. Such means are particularly, though not
exclusively, suited to employment of the apparatus for single-use
only, according to which data stored in the apparatus may be
remotely stored, including, for example, for later transfer to a
second, like apparatus.
[0023] Per another feature, means may be provided communicating
data from the memory of the apparatus directly to a second, like
apparatus for diabetes management. Such means are particularly,
though not exclusively, suited to employment of the apparatus for
single-use only.
[0024] Per yet another feature of the invention, the apparatus may
further comprise means for preventing a patient from administering
an injection when there is an insufficient quantity of insulin
remaining in the apparatus.
[0025] The present invention further comprehends a system for
diabetes management, comprising:
[0026] (a) a device including: [0027] (i) at least a first memory
for storing data inputs corresponding at least to one or more
components in a patient's present insulin dosage regimen and the
patient's blood-glucose-level measurements determined at a
plurality of times; and [0028] (ii) a processor operatively
connected to the at least first memory, the processor programmed at
least to determine from the data inputs corresponding to the
patient's blood-glucose-level measurements determined at a
plurality of times whether and by how much to vary at least one of
the one or more components of the patient's present insulin dosage
regimen;
[0029] (b) an apparatus, remote from the device, comprising a body
housing: [0030] (i) at least a first memory; [0031] (ii) a
processor operatively connected to the at least first memory;
[0032] (iii) a display screen operatively connected to the
processor; [0033] (iv) a quantity of insulin; [0034] (v) a needle
communicating with the quantity of insulin for delivering insulin
to a patient; [0035] (vi) means for effecting delivery of a portion
of the quantity of insulin to the patient via the needle; and
[0036] (vii) metering means for controlling the portion of the
quantity of insulin delivered to the patient via the needle;
and
[0037] (c) means for communicating data between the device and the
apparatus, the data including at least data corresponding to a
current recommended insulin dose.
[0038] In one embodiment, the apparatus may be for single-use only.
Accordingly, the quantity of insulin cannot be replenished.
[0039] In another embodiment, the apparatus is for multiple-use and
the quantity of insulin is therefore able to be replenished.
According to this embodiment, the quantity of insulin may be
contained in a cartridge that is selectively removable from the
housing so as to be replaceable upon exhaustion of the quantity of
insulin therein.
[0040] According to one feature of the invention, the body further
houses a test strip port for receiving a test strip, and the
processor of the apparatus is operative to determine the patient's
current blood glucose level measurement from a sample of the
patient's blood provided on a test strip, and wherein further the
means for communicating between the device and the apparatus are
further operative for communicating the patient's blood glucose
measurement between the apparatus and the device.
[0041] Per yet another feature of the invention, the apparatus may
further comprise means for preventing a patient from administering
an injection when there is an insufficient quantity of insulin
remaining in the apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] For a better understanding of the invention, and to show
more clearly how it may be carried into effect according to one or
more embodiments thereof, reference will now be made, by way of
example, to the accompanying drawings, showing exemplary
embodiments of the present invention and in which:
[0043] FIG. 1 is perspective view of the apparatus for diabetes
management according to an exemplary embodiment;
[0044] FIG. 2 is a perspective view of the apparatus for diabetes
management according to a second exemplary embodiment;
[0045] FIG. 3 is a diagrammatic depiction of the inventive system
according to a first exemplary embodiment thereof;
[0046] FIG. 4 is a diagrammatic depiction of the inventive system
according to a second exemplary embodiment thereof; and
[0047] FIG. 5 is a diagrammatic depiction of the inventive system
according to a third exemplary embodiment thereof.
WRITTEN DESCRIPTION OF THE INVENTION
[0048] As required, detailed embodiments of the present invention
are disclosed herein. However, it is to be understood that the
disclosed embodiment is merely exemplary of the invention that may
be embodied in various and alternative forms. Therefore, specific
structural and functional details disclosed herein are not to be
interpreted as limiting, but merely as a representative basis for
teaching one skilled in the art to variously employ the present
invention.
[0049] The accompanying drawings are not necessarily to scale, and
some features may be exaggerated or minimized to show details of
particular components or elements. [31] As used herein, the term
"insulin dose" means and refers to the quantity of insulin taken on
any single occasion, while the term "insulin dosage regimen" refers
to and means the set of instructions (typically defined by the
patient's physician or other healthcare professional) defining when
and how much insulin to take in a given period of time and/or under
certain conditions. One conventional insulin dosage regimen
comprises several components, including a long-acting insulin
dosage component, a plasma glucose correction factor component, and
a carbohydrate ratio component. Thus, for instance, an exemplary
insulin dosage regimen for a patient might be as follows: 25 units
of long acting insulin at bedtime; 1 unit of fast-acting insulin
for every 10 grams of ingested carbohydrates; and 1 unit of
fast-acting insulin for every 20 mg/dL by which a patient's blood
glucose reading exceeds 120 mg/dL. In the context of this
disclosure, a "current" insulin dose equates to the number of
insulin units the patient needs to administer on the basis of the
latest blood-glucose-level measurement and his or her prevailing
insulin dosage regimen.
[0050] Referring now to the drawings, wherein like numerals refer
to like or corresponding parts throughout the several views, the
present invention is generally characterized as an apparatus 10 for
diabetes management, the apparatus comprising a body 11 which
houses:
[0051] (i) at least a first computer-readable memory (not shown)
for storing data inputs corresponding at least to one or more
components in a patient's present insulin dosage regimen and the
patient's blood-glucose-level measurements determined at a
plurality of times;
[0052] (ii) a processor (not shown) operatively connected to the at
least first memory, the processor programmed at least to determine
from the data inputs corresponding to the patient's
blood-glucose-level measurements determined at a plurality of times
whether and by how much to vary at least one of the one or more
components of the patient's present insulin dosage regimen;
[0053] (iii) a display screen 12 operatively connected to the
processor;
[0054] (iv) a quantity of insulin (not visible) disposed in an
internal opening 13 in the body 11;
[0055] (v) a needle 14 communicating with the quantity of insulin
for delivering insulin to the patient;
[0056] (vii) means for effecting delivery of a portion of the
quantity of insulin to the patient via the needle; and
[0057] (vi) metering means for controlling the portion of the
quantity of insulin delivered to the patient via the needle (FIGS.
1 and 2).
[0058] The data inputs corresponding at least to one or more
components in a patient's present insulin dosage regimen and the
patient's blood-glucose-level measurements determined at a
plurality of times stored in the at least first memory may, by way
of non-limiting example, comprise those data inputs described in
the inventions as set forth in US Published Applications
20090253970 and 20090253973, the disclosures of which published
patent applications are incorporated herein by reference in their
entireties. Relatedly, operation of the processor to at least
determine from the data inputs whether and by how much to vary at
least one of the one or more components of the patient's present
insulin dosage regimen may, by way of non-limiting example,
correspond to operation of the inventions as set out in the
aforesaid US Published Applications 20090253970 and 20090253973. As
explained more fully therein, the operation of the exemplary
embodiments of those inventions is characterized by the
determination of whether and by how much to vary one or more
components of a patient's insulin dosage regimen based upon the
determined efficacy of that regimen in view of blood glucose level
measurements recorded as of the time of the determination. As a
non-limiting example, determination of whether and by how much to
vary a patient's present insulin dosage regimen is undertaken both
on the basis of evaluations conducted at predefined time intervals
(every 7 days, for example) as well as asynchronously to such
intervals. The asynchronous determinations will evaluate the
patient's blood-glucose-level data for safety each time a new
blood-glucose-level measurement is received to determine whether
any urgent action, including any urgent variation to the patient's
present insulin dosage, is necessary. More particularly, each time
a new patient blood glucose-level measurement is received into the
memory it is accessed by the processor and sorted and tagged
according to the time of day the measurement was received and
whether or not it is associated with a certain event, e.g.,
pre-breakfast, bedtime, nighttime, etc. Once so sorted and tagged,
the new and/or previously recorded blood-glucose-level measurements
are subjected to evaluation for the need to update on the basis of
the passage of a predefined period of time measured by a counter,
as well as the need to update asynchronously for safety. For
instance, a very low blood glucose measurement representing a
severe hypoglycemic event or the accumulation of several low
measurements in the past few days may lead to an update in the
patient's insulin dosage regimen, while an update to that regimen
may otherwise be warranted if a predefined period of time (e.g., 7
days) has elapsed since the patient's insulin dosage regimen was
last updated. If an excessive number of such hypoglycemic events is
not indicated, then the algorithm queries whether or not it is time
to update the patient's insulin dosage regimen irrespective of the
non-occurrence of hypoglycemic events, and based instead upon the
passage of a predefined interval of time (e.g., 7 days) since the
need to update the patient's insulin dosage regimen was last
assessed. If such an update is not indicated, i.e., because an
insufficient time interval has passed, then no action is taken with
respect to the patient's insulin dosage and the algorithm ends
until the next blood glucose-level measurement data are input.
[0059] Where, as in the embodiment of FIGS. 1 and 2, the memory and
processor are housed in the body 11 of the apparatus, data entry
means, such as the illustrated single or multi-function buttons or
keys 17, are provided to facilitate the entry of, for example and
without limitation, one or more of the data inputs corresponding at
least to one or more components in a patient's present insulin
dosage regimen.
[0060] Power to operate the apparatus, including the display and
processor, may be provided by one or more batteries (not shown)
disposed in the body 11. These one or more batteries may be
rechargeable or single-use, replaceable or irreplaceable.
[0061] The means for effecting delivery of a portion of the
quantity of insulin may take the form of a plunger 15 operative in
known fashion to dispense a portion of insulin through the needle
14 upon actuation of the plunger. Such means are found in
conventional insulin pens. Of course, any other means employed to
dispense insulin in conventional insulin pens may be
substituted.
[0062] In order to control the portion of the quantity of insulin
delivered to the patient via the needle 14, metering means are
provided. In one form, such metering means may comprise any
mechanism employed in conventional insulin pens, for instance, to
ensure that actuation of the plunger 15 effectuates delivery of
only a defined portion of insulin. According to such construction
of the apparatus, unlimited actuation of the plunger 15 dispenses a
predefined portion of insulin via the needle 14. The metering means
preferably, though not necessarily, include a dial or other
mechanism the selective movement of which would limit actuation of
the plunger 15 in predefined increments corresponding to predefined
measurements of insulin. A display 16 provided on the apparatus 10
indicates the current setting of the metering means so that the
patient can know how much insulin will be dispensed upon actuation
of the plunger 15. Of course, such display may be provided on the
display screen 12 in the alternative. Thus, by actuation of the
metering means, a patient can, as desired, modify the apparatus so
that actuation of the plunger will dispense a portion of the
quantity of insulin corresponding to a recommended insulin dose
corresponding to the processor's determination of a recommended
insulin dosage regimen (which may be the patient's existing regimen
or a regimen modified according to the algorithm employed by the
processor).
[0063] In an alternative embodiment, the delivery means may
comprise an electromechanical device disposed in the body 11 and
operative to automatically effect delivery of a portion of the
quantity of insulin via the needle 14 upon actuation of one of a
plurality of single-purpose or multi-function buttons 17 provided
on the apparatus. Further according to this embodiment, the
metering means are likewise automatic. Once a recommended insulin
dosage regimen has been determined by the processor (whether that
regimen is an existing or modified regimen), the electro-mechanical
device is automatically adjusted by the processor so that the
subsequent actuation of the delivery means (such as, for instance,
via on ore more of the buttons 17) delivers to the patient a dose
of insulin corresponding to a recommended current insulin dose,
determined by the processor, that may be displayed on the display
screen 12.
[0064] According to a still further embodiment, the delivery means
may comprise the manually actuated plunger heretofore described,
while the metering means may be an electro-mechanical device the
operation of which is automatically effected by the processor. In
this fashion, the amount of insulin dispensed by a patient's manual
actuation of the plunger would automatically correspond to the
recommended current insulin dose that may be displayed on the
display screen 12.
[0065] As shown in FIG. 1, the quantity of insulin may be capable
of replenishment upon exhaustion. To this end, the quantity of
insulin may be contained in cartridges (not depicted) that are
selectively removable from the body 11 so as to be replaceable upon
exhaustion of the insulin supply therein. In order to permit access
to the cartridges, body 11 comprises, in the exemplary embodiment,
a removable cap 11a permitting access to the internal opening 13.
The cartridges may be, for instance, in the form of compressible
capsules (made, for instance, of plastic) acted upon by the plunger
15 during administration of a dose of insulin. It is also
contemplated that such cartridges may take any form employed in
conventional insulin pens.
[0066] Alternatively, the apparatus 10' may, as shown in FIG. 2, be
for "single use," meaning that the quantity of insulin contained
therein would suffice for a limited number of doses and would
thereafter be incapable of replenishment. For instance, it is
typically the case that conventional insulin pens contain about 300
insulin units [IU]. A similar amount could, without limitation,
constitute the quantity of insulin contained in the apparatus 10'.
For some patients, such an amount may last for 10 or more days,
while for others this can represent a daily consumption of
insulin.
[0067] Needle 14 is preferably, though not necessarily, removably
connected to the body 11 so as to be disposable following use and
thereafter replaceable with a sanitary needle. Such removable
connection, typical of conventional insulin pens, may be
accomplished in any conventional fashion.
[0068] According to any of the foregoing, it is further
contemplated that the apparatus 10, 10' may include means for
preventing a patient from administering an injection when there is
no or an insufficient amount of insulin remaining in the apparatus.
Such means may take the form of a visual warning, provided for
instance on the display 12, 12'. Alternatively, or in addition, the
apparatus may be programmed to physically prevent operation of the
delivery means. Such may comprise an electro-mechanical device
(which may be the same as or separate from those described in
connection with the delivery and/or metering means), the operation
of which is effected by the processor, which precludes actuation of
the delivery means when it is determined by the processor (for
instance, by calculation from the known initial quantity of insulin
provided, the number of times the delivery means are actuated, and
the dose/portion of insulin delivered each time the delivery means
are actuated) that an insufficient amount of insulin remains to
deliver a recommended dose of insulin or another, predefined
dose.
[0069] Optionally, the apparatus 10 may, as shown in FIG. 1,
further comprise a test strip port of known construction housed in
the body 11 for receiving a test strip 20, such that the apparatus
is capable of acting also as a blood glucose meter. To this end,
the processor is operative to determine a patient's current blood
glucose level measurement from a sample of the patient's blood
provided on a test strip 20. Per this embodiment, display 12 may,
optionally, provide a visual indication of the patient's current
blood-glucose-level reading (e.g., "189 mg/dL" as shown in FIG. 1).
According to this embodiment, the blood-glucose-level readings so
determined comprise data inputs stored in the at least one memory
and employed by the processor at least to determine whether and by
how much to vary at least one of the one or more components of the
patient's present insulin dosage regimen (such as, for instance,
according to the manner of operation of the inventions as disclosed
in the aforesaid US Published Applications 20090253970 and
20090253973).
[0070] Display screen 12 may, by way of non-limiting example,
comprise an LCD screen, the apparatus being programmed, according
to convention, to display thereon such information displays as
described herein (e.g., a recommended insulin dose corresponding to
the processor-determined insulin dosage regimen). Where the
apparatus 10 is operative to determine blood glucose level
measurements, and further includes data entry means such as the
buttons 17 herein described to permit the patient and/or other
user's to input data corresponding at least to one or more
components in a patient's present insulin dosage regimen and data
inputs related to the patient's blood glucose measurements, the
display screen 12 may be operative so as to display information
displays corresponding to at least the following: a patient's
current blood glucose level measurement; an event associated with
the said current blood glucose level measurement; a measurement for
the number of carbohydrates associated with the said event; and a
recommended insulin dose corresponding to the processor-determined
insulin dosage regimen.
[0071] Optionally, the display screen 12 may further be operative
to successively display a summary screen displaying simultaneously
information corresponding to that provided on each of two or more
of the foregoing information displays, including: a patient's
current blood glucose level measurement, an event associated with
the said current blood glucose level measurement, a measurement for
the number of carbohydrates associated with the said event, and the
recommended insulin dose.
[0072] According to the foregoing embodiment of the invention, the
patient and/or other user is able to enter, in addition to, for
instance, such other data as corresponds to one or more components
in a patient's present insulin dosage regimen, data related to a
particular blood glucose level measurement as determined by the
processor from a sample of the patient's blood. These data include,
for instance and without limitation, an appropriate event (e.g.,
breakfast, lunch, dinner) associated with a current blood glucose
measurement as displayed on display 12, as well as the number of
carbohydrates associated with the event.
[0073] Optionally, the apparatus 10 is programmed to enable a
patient and/or other user to selectively override, such as by using
one or more of the plurality of buttons 17, a recommended current
insulin dose displayed on the display screen 12. To the extent that
the metering means are automatically adjusted to effect delivery of
the recommended insulin dose, it is contemplated that the metering
means would be further adjusted in response to any change in the
recommended current insulin dose made by the patient and/or other
user.
[0074] Referring next to FIG. 3, it is further contemplated that
the apparatus 10' be capable (particularly, though not exclusively,
where fashioned for single use) of communicating remotely (shown by
the dashed line 50) with a device 100, such as a general-purpose
computer (shown), cell phone, IPHONE, IPOD, PDA, etc., to which
patient data, such as, for instance, blood-glucose-level data, may
be transferred and stored for later use. Such remote communication
may be accomplished via a communication cable, for instance a USB
cable, connectable to the apparatus and the remotely positioned
device. Alternatively, such remote communication may be
accomplished wirelessly, such as, for instance, via any
conventional wireless transmission protocol.
[0075] In similar fashion, it is further contemplated that the
apparatus of the present invention (especially, although again not
exclusively, where fashioned for single-use) include means to
communicate with like apparatus via a communication cable,
wirelessly, or any other conventional communication means. This may
be necessary, for instance, to transfer the patient's present
insulin dosage regimen data, as well as historical
blood-glucose-level measurement data from the apparatus 10' the
insulin supply of which is exhausted to a second, unspent
apparatus. It will be appreciated that while such utility may be
particularly desired where the apparatus 10' is of "single-use"
design, it may also be desired in order to transfer such data as is
stored in a first apparatus to a second, like apparatus upon, or
prior to, failure of the first.
[0076] Referring next to FIG. 4, there is depicted an alternative
embodiment of the apparatus 10'' according to which a memory for
storing data inputs corresponding at least to one or more
components in a patient's present insulin dosage regimen and/or the
patient's blood-glucose-level measurements determined at a
plurality of times, as well as a processor operatively connected to
memory and programmed at least to determine from the data inputs
corresponding to the patient's blood-glucose-level measurements
determined at a plurality of times whether and by how much to vary
at least one of the one or more components of the patient's present
insulin dosage regimen, are disposed in a device 100' remote from
the apparatus 10''. Device 100', which may be a general-purpose
computer (as depicted), cell phone, IPHONE, IPOD, PDA or a
purpose-built unit, is adapted to communicate remotely (shown by
dashed lines 50') with the apparatus 10'' so that data may be
transferred between the device 100' and the apparatus 10'' (which
includes a processor and at least a first memory for storing such
data but which is not, as indicated, itself operative to determine
from the data inputs corresponding to the patient's
blood-glucose-level measurements determined at a plurality of times
whether and by how much to vary at least one of the one or more
components of the patient's present insulin dosage regimen). Such
remote communication may be accomplished via a communication cable,
for instance a USB cable, connectable to the apparatus 10'' and the
remotely positioned device 100'. Alternatively, such communication
may be accomplished wirelessly, such as, for instance, via any
conventional wireless transmission protocol.
[0077] According to this embodiment, data corresponding to the
patient's insulin dosage regimen and the patient's
blood-glucose-level measurements are stored in the memory of the
device 100', the processor of which is operative to access these
data and determine at least whether and by how much to vary at
least one of the one or more components of the patient's present
insulin dosage regimen. Upon completion of this determination,
information corresponding to at least a recommended current insulin
dose may be transferred to the apparatus 10'' to be displayed on
display 12 to be acted upon in any manner as heretofore
described.
[0078] Per this embodiment of the invention, the data corresponding
to the patient's insulin dosage regimen may be input on one or more
occasions by the patient's physician or other healthcare
professional. The patient's blood-glucose-level measurements may be
transferred to the memory of the device 100' via a separate blood
glucose meter or, to the extent that such functionality is provided
in the apparatus 10'' according to the embodiment as described
herein, may be provided directly from the apparatus 10''.
[0079] Referring next to FIG. 5, it is further contemplated that
the embodiment of FIG. 4 may be augmented by the provision of one
or more additional devices 110 in communication (shown by dashed
line 51, which represents either a wireless or wired connection)
with the device 100' to facilitate remote entry of data, such as,
for instance, data corresponding to the patient's insulin dosage
regimen. Per this embodiment of the invention, data corresponding
to the patient's insulin dosage regimen may be input on one or more
occasions by the patient's physician or other healthcare
professional via the device 110 and these data thereafter
transferred, such as, for instance and without limitation, via the
internet, to the memory of the device 100'.
[0080] The foregoing description of the exemplary embodiment of the
invention has been presented for purposes of illustration and
description. It is not intended to be exhaustive of, or to limit,
the invention to the precise form disclosed, and modification and
variations are possible in light of the above teachings or may be
acquired from practice of the invention. The embodiment shown and
described in order to explain the principles of the invention and
its practical application to enable one skilled in the art to
utilize the invention in various embodiments and with various
modifications as are suited to the particular application
contemplated. Accordingly, all such modifications and embodiments
are intended to be included within the scope of the invention.
Other substitutions, modifications, changes and omissions may be
made in the design, operating conditions, and arrangement of the
exemplary embodiments without departing from the spirit of the
present invention.
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