U.S. patent application number 17/675211 was filed with the patent office on 2022-06-02 for monitoring a physiological parameter associated with tissue of a host to confirm delivery of medication.
The applicant listed for this patent is Insulet Corporation. Invention is credited to Robert W. CAMPBELL, Steven DIIANNI, Ian T. MCLAUGHLIN, Jason B. O'CONNOR, Kevin Guido SCHMID.
Application Number | 20220168507 17/675211 |
Document ID | / |
Family ID | |
Filed Date | 2022-06-02 |
United States Patent
Application |
20220168507 |
Kind Code |
A1 |
SCHMID; Kevin Guido ; et
al. |
June 2, 2022 |
MONITORING A PHYSIOLOGICAL PARAMETER ASSOCIATED WITH TISSUE OF A
HOST TO CONFIRM DELIVERY OF MEDICATION
Abstract
A physiological parameter associated with tissue of a host may
be monitored in the tissue to confirm subcutaneous delivery of
medication to the host. More particularly, such may involve
delivering medication subcutaneously to the host with a medical
device which includes a sensor used to measure the physiological
parameter, particularly within a predetermined time period after
delivery of the medication. Such may also or otherwise involve
forming a depot in the tissue with the medication, and using the
sensor to measure the physiological parameter while the sensor is
at least partially within the depot.
Inventors: |
SCHMID; Kevin Guido;
(Boxford, MA) ; DIIANNI; Steven; (Danvers, MA)
; CAMPBELL; Robert W.; (Waltham, MA) ; MCLAUGHLIN;
Ian T.; (Groton, MA) ; O'CONNOR; Jason B.;
(Acton, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Insulet Corporation |
Acton |
MA |
US |
|
|
Appl. No.: |
17/675211 |
Filed: |
February 18, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16568965 |
Sep 12, 2019 |
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17675211 |
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14253271 |
Apr 15, 2014 |
10441717 |
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16568965 |
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International
Class: |
A61M 5/172 20060101
A61M005/172; A61M 5/142 20060101 A61M005/142; A61B 5/1486 20060101
A61B005/1486; A61B 5/00 20060101 A61B005/00; G16H 20/17 20060101
G16H020/17; A61B 5/145 20060101 A61B005/145 |
Claims
1. A fluid delivery device, comprising: a fluid passage mechanism
operable to receive a fluid from a reservoir; and a transcutaneous
access tool operable to receive the fluid from the fluid passage
mechanism, the transcutaneous access tool comprising: a needle
within a first lumen of a cannula; and a sensor within a second
lumen of the cannula, wherein the cannula includes an opening
through a sidewall of the cannula for access to the sensor.
2. The fluid delivery device of claim 1, further comprising a
monitor test strip disposed within the second lumen, wherein the
sensor is coupled to the monitor test strip.
3. The fluid delivery device of claim 1, further comprising a
second opening through the sidewall of the cannula, the second
opening providing access to a second sensor within the second
lumen.
4. The fluid delivery device of claim 3, wherein the opening and
the second opening are positioned axially adjacent one another.
5. The fluid delivery device of claim 3, the cannula comprising a
proximal end opposite a distal tip, wherein the opening is
positioned closer to the distal tip than the second opening.
6. The fluid delivery device of claim 1, further comprising a
transcutaneous access tool insertion mechanism for deploying the
transcutaneous access tool.
7. The fluid delivery device of claim 1, further comprising a fluid
drive mechanism for driving the fluid out of the reservoir.
8. The fluid delivery device of claim 1, wherein the sensor is a
glucose sensor.
9. The fluid delivery device of claim 1, wherein the first lumen
has a circular profile, and wherein the second lumen has a
rectangular profile.
10. A transcutaneous access tool, comprising: a needle within a
first lumen of a cannula, the needle operable to deliver a fluid
from a reservoir to a destination; and a sensor within a second
lumen of the cannula, wherein the cannula includes an opening
through a sidewall for access to the sensor.
11. The transcutaneous access tool of claim 10, further comprising
a monitor test strip disposed within the second lumen, wherein the
sensor is coupled to the monitor test strip.
12. The transcutaneous access tool of claim 10, further comprising
a second opening through the sidewall of the cannula, the second
opening providing access to a second sensor within the second
lumen.
13. The transcutaneous access tool of claim 12, wherein the opening
and the second opening are positioned axially adjacent one
another.
14. The transcutaneous access tool of claim 12, the cannula
comprising a proximal end opposite a distal tip, wherein the
opening is positioned closer to the distal tip than the second
opening.
15. The transcutaneous access tool of claim 10, wherein the sensor
is a glucose sensor.
16. A fluid delivery device, comprising: a fluid passage mechanism
operable to receive a fluid from a reservoir; and a transcutaneous
access tool operable to receive the fluid from the fluid passage
mechanism, the transcutaneous access tool comprising: a needle
within a first lumen of a cannula, the needle operable to deliver
the fluid to a destination; and a first sensor and a second sensor
within a second lumen of the cannula, wherein the cannula includes
a first opening through a sidewall of the cannula for access to the
first sensor and a second opening through the sidewall of cannula
for access to the second sensor.
17. The fluid delivery device of claim 16, further comprising a
monitor test strip disposed within the second lumen, wherein the
first and second sensors are coupled to the monitor test strip.
18. The fluid delivery device of claim 17, the monitor test strip
comprising a planar surface exposed through the first and second
openings, wherein the first and second sensors are positioned on
the planar surface.
19. The fluid delivery device of claim 16, wherein the first
opening and the second opening are positioned axially adjacent one
another, and wherein the first opening is positioned closer to a
distal tip of the cannula than the second opening.
20. The fluid delivery device of claim 16, further comprising a
transcutaneous access tool insertion mechanism for deploying the
transcutaneous access tool.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/568,965 filed on Sep. 12, 2019, which is a
continuation of U.S. patent application Ser. No. 14/253,271 filed
Apr. 15, 2014, now 10,441,717, the teachings of which are
incorporated herein by reference.
TECHNICAL FIELD
[0002] The present disclosure relates to methods of delivering
medication to a host with a medication delivery device, and more
particularly, methods of monitoring one or more physiological
parameters associated with tissue of the host to confirm
subcutaneous delivery of medication.
BACKGROUND INFORMATION
[0003] In a patient with diabetes mellitus, ambulatory infusion
pumps have been used to deliver insulin to the patient. These
ambulatory infusion pumps have the ability to offer sophisticated
insulin delivery profiles including variable basal rates and bolus
requirements. The ability to carefully control insulin delivery can
result in better efficacy of the medication and therapy, and less
toxicity to the patient.
[0004] Some existing ambulatory infusion pumps include a reservoir
to contain insulin and use electromechanical pumping or metering
technology to deliver the insulin via tubing to a needle and/or
soft cannula that is inserted subcutaneously into the patient.
These existing devices allow control and programming via
electromechanical buttons or switches located on the housing of the
device. The devices include visual feedback via text or graphic
screens and may include alert or warning lights and audio or
vibration signals and alarms. Such devices are typically worn in a
harness or pocket or strapped to the body of the patient.
[0005] Some infusion pumps have been designed to be relatively
small, low cost, light-weight, and easy-to-use. One example of such
a pump is the OMNIPOD.RTM. insulin infusion pump available from
Insulet Corporation. Examples of infusion pumps are also described
in greater detail, for example, in U.S. Pat. Nos. 7,128,727;
7,018,360; and 7,144,384 and U.S. Patent Application Publication
Nos. 2007/0118405, 2006/0282290, 2005/0238507, and 2004/0010207,
which are fully incorporated herein by reference. These pumps
include insertion mechanisms for causing a transcutaneous access
tool, such as a needle and/or soft cannula, to be inserted into a
patient. Although such pumps are effective and provide significant
advantages over other insulin infusion pumps, there is a need for
continued improvement.
[0006] Complications arising from diabetes mellitus may be reduced
by careful management that includes regular checking of glucose
concentration levels, typically at numerous times of the day
depending on the specific type of diabetes mellitus, with Type 1
patients generally having to check glucose levels more often than
Type 2 patients.
[0007] Most diabetes patients rely on glucose strips along with
hand-held glucose meters that record glucose levels in blood drawn
via finger pricking, which may be referred to as user-dependent
(self-monitoring) of blood glucose. However, the pain associated
with finger pricking, together with the inability of test strips to
reflect whether the glucose level of a patient is increasing or
decreasing at any point in time with user-dependent
(self-monitoring) of blood glucose level is problematic.
[0008] Continuous glucose monitoring incorporated into an
ambulatory infusion pump may be beneficial to patients by
eliminating many of the problems associated with self monitoring,
as well as help identify glucose trends to physicians who may then
better optimize treatment plans. Furthermore, it would be
beneficial for such devices to confirm actual delivery of the
medication.
SUMMARY
[0009] The present disclosure provides devices and methods of
treating a host, such as a patient, with a medication.
[0010] In certain embodiments, the method of treating a host with a
medication may comprise providing a medication delivery device
which delivers medication into tissue of the host, wherein the
medication delivery device includes a sensor, and wherein the
sensor is used to measure a physiological parameter associated with
the tissue; introducing the medication delivery device including
the sensor into the tissue; delivering the medication into the
tissue of the host; and confirming delivery of the medication from
the medication delivery device to the host, wherein confirming
delivery of the medication comprises using the sensor to measure
the physiological parameter within a predetermined time period
after delivery of the medication.
[0011] In certain embodiments, the method may further comprise
introducing the medication delivery device including the sensor
into the tissue such that the tissue is in contact with the sensor;
and forming a depot in the tissue with the medication, wherein the
depot reduces the tissue contact with the sensor. The tissue in
contact with the sensor may comprise extracellular fluid; and the
depot reduces contact of the extracellular fluid with the sensor.
The depot may reduce contact of the extracellular fluid with the
sensor by the depot at least partially surrounding the sensor
within the depot. The predetermined time period is less than a time
required for the depot to be completely absorbed into the tissue
and the tissue reestablishes contact with the sensor where the
depot was located. The predetermined time period may be in a range
of 0.1 second to 600 seconds.
[0012] In certain embodiments, confirming delivery of the
medication from the medication delivery device to the host may
further comprise determining a value of the physiological parameter
measured within the predetermined time period after delivery of the
medication; providing a predetermined representative value for the
physiological parameter with (e.g. stored on, such as in an
electronic or memory thereof) the medication delivery device; and
determining that the measured value of the physiological parameter
within the predetermined time period after delivery of the
medication is less than the predetermined representative value for
the physiological parameter provided by (e.g. stored on) the
medication delivery device.
[0013] In certain embodiments, after introducing the medication
delivery device including the sensor into the tissue, the method
may further comprise using the sensor to measure the physiological
parameter before delivering the medication into the tissue; and
confirming delivery of the medication from the medication delivery
device to the host may further comprise determining a value of the
physiological parameter measured before delivering the medication;
determining a value of the physiological parameter measured within
the predetermined time period after delivery of the medication; and
determining that the value of the physiological parameter measured
within the predetermined time after delivery of the medication is
less than the value of the physiological parameter measured before
delivering the medication into the tissue.
[0014] In certain embodiments, after introducing the medication
delivery device including the sensor into the tissue, the method
may further comprise using the sensor to measure the physiological
parameter before delivering the medication into the tissue; and
confirming delivery of the medication from the medication delivery
device to the host may further comprise determining a value of the
physiological parameter measured before delivering the medication;
determining a value of the physiological parameter measured within
the predetermined time period after delivery of the medication;
determining a numerical difference between the value of the
physiological parameter measured before delivering the medication
into the tissue, and the value of the physiological parameter
measured within the predetermined time after delivering the
medication into the tissue; providing a predetermined
representative value for the numerical difference of the
physiological parameter with (e.g. stored on, such as in an
electronic memory thereof) the medication delivery device; and
determining the numerical difference between the two measured
values of the physiological parameter is greater than a
predetermined representative value for the numerical difference
provided by (e.g. stored on) the medication delivery device. The
physiological parameter may be interstitial glucose concentration
level; and a predetermined representative value for the numerical
difference provided by (e.g. stored on) the medication delivery
device is at least 20 mg/dL, and more particularly as least 30
mg/dL, or in a range of 20 mg/dL to 60 mg/dL.
[0015] In certain embodiments, after introducing the medication
delivery device including the sensor into the tissue, the method
may further comprise using the sensor to measure the physiological
parameter before delivering the medication into the tissue; and
confirming delivery of the medication from the medication delivery
device to the host may further comprise determining a value of the
physiological parameter measured before delivering the medication;
determining a value of the physiological parameter measured within
the predetermined time period after delivery of the medication;
determining a percentage change between the value of the
physiological parameter measured before delivering the medication
into the tissue, and the value of the physiological parameter
measured within the predetermined time after delivering the
medication into the tissue; providing a predetermined
representative value for the percentage change of the physiological
parameter with (e.g. stored on, such as in an electronic memory
thereof) the medication delivery device; and determining the
percentage change between the two measured values of the
physiological parameter is greater than a predetermined
representative value for the percentage change provided by (e.g.
stored on) the medication delivery device. The physiological
parameter may be interstitial glucose concentration level; and a
predetermined representative value for the percentage change
provided by (e.g. stored on) the medication delivery device is at
least 15%, or more particularly at least 20%, or even more
particularly at least 25%, or in a range of 15% to 75%.
[0016] In certain embodiments, delivering the medication into the
tissue of the host may further comprise delivering the medication
into subcutaneous tissue of to the host. The medication delivery
device may deliver medication into the subcutaneous tissue of the
host with a transcutaneous access tool. The transcutaneous access
tool may comprise a cannula, and the sensor is joined to the
cannula. The medication delivery device may further comprise a
pump.
[0017] The sensor may comprise a glucose sensor, and the medical
condition may be diabetes. The physiological parameter may be
glucose concentration level, and more particularly, interstitial
glucose concentration level.
[0018] In certain embodiments, the method of treating a host with a
medication may also comprise providing a medication delivery device
which delivers medication into tissue of the host, wherein the
medication delivery device includes a sensor, and wherein the
sensor is used to measure a physiological parameter associated with
the tissue; introducing the medication delivery device including
the sensor into the tissue such that the tissue is in contact with
the sensor; delivering the medication into the tissue of the host;
forming a depot in the tissue with the medication, wherein the
sensor is at least partially within the depot and the depot reduces
the tissue contact with the sensor; confirming delivery of the
medication from the medication delivery device to the host, wherein
confirming delivery of the medication comprises using the sensor to
measure the physiological parameter while the sensor is within the
depot.
[0019] In certain embodiments, confirming delivery of the
medication from the medication delivery device to the host may
further comprise determining a value of the physiological parameter
while the sensor is within the depot; providing a predetermined
representative value for the physiological parameter with the
medication delivery device; and after delivery of the medication,
determining that the measured value of the physiological parameter
while the sensor is within the depot is less than the predetermined
representative value for the physiological parameter provided by
the medication delivery device.
[0020] In other embodiments, confirming delivery of the medication
from the medication delivery device to the host may further
comprise determining a value of the physiological parameter
measured before delivering the medication; after delivery of the
medication, determining a value of the physiological parameter
measured while the sensor is within the depot; and determining that
the value of the physiological parameter measured while the sensor
is within the depot is less than the value of the physiological
parameter measured before delivering the medication into the
tissue.
[0021] In other embodiments, confirming delivery of the medication
from the medication delivery device to the host may further
comprise determining a value of the physiological parameter
measured before delivering the medication; after delivery of the
medication, determining a value of the physiological parameter
measured while the sensor is within the depot; determining a
numerical difference between the value of the physiological
parameter measured before delivering the medication into the
tissue, and the value of the physiological parameter measured while
the sensor is within the depot; providing a predetermined
representative value for the numerical difference of the
physiological parameter with the medication delivery device; and
determining the numerical difference between the two measured
values of the physiological parameter is greater than a
predetermined representative value for the numerical difference
provided by the medication delivery device.
[0022] In other embodiments, confirming delivery of the medication
from the medication delivery device to the host may further
comprise determining a value of the physiological parameter
measured before delivering the medication; after delivery of the
medication, determining a value of the physiological parameter
measured while the sensor is within the depot; determining a
percentage change between the value of the physiological parameter
measured before delivering the medication into the tissue, and the
value of the physiological parameter measured while the sensor is
within the depot; providing a predetermined representative value
for the percentage change of the physiological parameter with the
medication delivery device; and determining the percentage change
between the two measured values of the physiological parameter is
greater than a predetermined representative value for the
percentage change provided by the medication delivery device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] These and other features and advantages will be better
understood by reading the following detailed description, taken
together with the drawings wherein:
[0024] FIG. 1 is a top perspective view of a fluid delivery device
with a transcutaneous access tool insertion mechanism in a
pre-deployment position, consistent with the present
disclosure;
[0025] FIG. 2 is a bottom perspective view of a needle and cannula
retracted into the fluid delivery device in the pre-deployment
position shown in FIG. 1;
[0026] FIG. 3 is a top perspective view of the fluid delivery
device shown in FIG. 1 with the insertion mechanism in an
intermediate position;
[0027] FIG. 4 is a bottom perspective view of the needle and
cannula extending from the fluid delivery device in the
intermediate position shown in FIG. 3;
[0028] FIG. 5 is a top perspective view of the fluid delivery
device shown in FIG. 1 with the insertion mechanism in a
post-deployment position;
[0029] FIG. 6 is a bottom perspective view of the cannula extending
from the fluid delivery device in the post-deployment position
shown in FIG. 5;
[0030] FIG. 7 is a side perspective view of another embodiment of
the insertion mechanism, consistent with the present disclosure, in
a pre-deployment position;
[0031] FIG. 8 is a side perspective view of the insertion mechanism
shown in FIG. 7 in an intermediate position;
[0032] FIG. 9 is a side perspective view of the insertion mechanism
shown in FIG. 7 in a post-deployment position;
[0033] FIG. 10 is a top perspective view of the second sliding
member of the insertion mechanism shown in FIG. 7 locked in the
pre-deployment and post-deployment positions;
[0034] FIG. 11 is a top perspective view of a fluid driving
mechanism of the fluid delivery device shown in FIG. 1 with a
clutch mechanism in a disengaged position prior to filling;
[0035] FIG. 12 is a side cross-sectional view of the fluid driving
mechanism shown in FIG. 11;
[0036] FIG. 13 is a top perspective view of the fluid driving
mechanism shown in FIG. 11 with the clutch mechanism in a
disengaged position after filling;
[0037] FIG. 14 is a top perspective view of the fluid driving
mechanism shown in FIG. 11 with the clutch mechanism being released
to the engaged position; and
[0038] FIGS. 15 and 16 are top perspective views of the fluid
driving mechanism shown in FIG. 11 with the clutch mechanism in the
engaged position.
[0039] FIGS. 17-23 are views of a bi-lumen cannula used in the
fluid delivery device shown in FIGS. 1-6 to insert a monitor test
strip transcutaneously;
[0040] FIGS. 24-29 are views of another embodiment of a fluid
delivery device including a cannula with a D-shaped lumen for
inserting a monitor test strip transcutaneously;
[0041] FIGS. 30-32 are views of the D-lumen cannula used in the
fluid delivery device of FIGS. 24-29;
[0042] FIGS. 33 and 34 are views of a semi-circular trocar used
with the D-lumen cannula in the fluid delivery device of FIGS.
18-23;
[0043] FIGS. 35-41 are views of another embodiment of a fluid
delivery device including an oval trocar for inserting a monitor
test strip transcutaneously;
[0044] FIG. 42 is a side view of the oval trocar for use in the
fluid delivery device shown in FIGS. 35-41;
[0045] FIG. 43 is a top perspective view of a second sliding member
for use in the fluid delivery device shown in FIGS. 35-41.
[0046] FIG. 44 is a perspective view of a fluid delivery device
according to the present disclosure in conjunction with a remote
control device; and
[0047] FIG. 45 is a side view of a cannula according to the present
disclosure within tissue before delivery of medication; and
[0048] FIG. 46 is a side view of a cannula according to the present
disclosure within tissue after delivery of medication.
DETAILED DESCRIPTION
[0049] A physiological parameter associated with tissue of a host
may be monitored in tissue subcutaneously to confirm subcutaneous
delivery of medication to the host. More particularly, such may
involve delivering medication subcutaneously to the host with a
medical device which includes a sensor used to measure the
physiological parameter, particularly within a predetermined time
period after delivery of the medication. Such may also or otherwise
involve forming a depot in the tissue with the medication, and
using the sensor to measure the physiological parameter while the
sensor is at least partially within the depot.
[0050] Methods for monitoring consistent with the present
disclosure may be performed using a medication delivery device as
disclosed herein to deliver the medication to the host
subcutaneously. The medication delivery device may more
particularly be referred to herein as a fluid delivery device,
particularly as the medication disclosed herein is in liquid
form.
[0051] The fluid delivery device may particularly deliver a
therapeutic fluid to the host via a transcutaneous access tool,
such as a needle/trocar and/or a cannula. A transcutaneous access
tool insertion mechanism may be used to deploy the transcutaneous
access tool, for example, by inserting and retracting a
needle/trocar in a single, uninterrupted motion. The insertion
mechanism may also provide an increasing insertion force as the
needle/trocar moves in the insertion direction. The fluid delivery
device may also include a clutch mechanism to facilitate filling a
reservoir and engagement of a drive mechanism for driving fluid out
of the reservoir. In certain embodiments, the fluid delivery device
may comprise an ambulatory insulin infusion device.
[0052] In other embodiments, a fluid delivery device may be used to
deliver a therapeutic fluid to a host with integrated monitoring,
such as continuous glucose monitoring (CGM). In these embodiments,
the fluid deliver device may include a transcutaneous access tool
configured to introduce a monitoring test strip through the skin of
the host, for example, using one or more needles, cannulas and/or
trocars.
[0053] Referring to FIGS. 1-6, one embodiment of a fluid delivery
device 100 is shown and described. In the exemplary embodiment, the
fluid delivery device 100 is used to subcutaneously deliver a
fluid, such as a liquid medicine (e.g. insulin), to a person or an
animal. Those skilled in the art will recognize that the fluid
delivery device 100 may be used to deliver other types of fluids,
such as saline. The fluid delivery device 100 may be used to
deliver fluids in a controlled manner, for example, according to
fluid delivery profiles accomplishing basal and bolus requirements,
continuous infusion and variable flow rate delivery.
[0054] As such, the fluid may by a liquid dosage form including one
or more active pharmaceutical ingredients which may include
analgesic drugs; anesthetic drugs; anti-arthritic drugs;
anti-bacterial drugs; anti-biotic drugs; anti-cholesterol drugs;
anti-coagulant drugs; anti-cancer drugs; anti-convulsant drugs;
anti-depressant drugs; anti-diabetic drugs; anti-gastrointestinal
reflux drugs; anti-hypertension drugs; anti-infection drugs;
anti-inflammatory drugs; anti-migraine drugs; anti-muscarinic
drugs; anti-neoplastic drugs; anti-obesity; anti-parasitic drugs;
anti-protozoal drugs; anti-psychotic drugs; anti-stroke; anti-ulcer
drugs; anti-viral drugs; cardiovascular drugs; central nervous
system drugs; digestive tract drugs; diuretic drugs; fertility
drugs; gastrointestinal tract drugs; genitourinary tract drugs;
hormonal drugs; immunologic agents; metabolic drugs;
psychotherapeutic drugs; pulmonary drugs; radiological drugs;
respiratory drugs; and sedative drugs.
[0055] According to one embodiment, the fluid delivery device 100
may include one or more batteries 110 for providing a power source,
a fluid reservoir 130 for holding a fluid, a fluid drive mechanism
150 for driving the fluid out of the reservoir 130, a fluid passage
mechanism 170 for receiving the fluid from the reservoir 130 and
passing the fluid to a destination via a transcutaneous access tool
172, and a transcutaneous access tool insertion mechanism 180 for
deploying the transcutaneous access tool 172. The fluid delivery
device 100 may include a circuit board 101 including a
microcontroller (processor), with control circuitry and a
communication element for remotely controlling the device and a
chassis 102 that provides mechanical and/or electrical connections
between components of the fluid deliver device 100. The fluid
delivery device 100 may also include a housing 104 to enclose the
circuit board 101, the chassis 102, and the components 110, 130,
150, 170, 180.
[0056] The fluid delivery device 100 may also include integrated
monitoring such as continuous glucose monitoring (CGM). A monitor
test strip 120 coupled to a monitor (not shown) of the device 100
may be introduced by the transcutaneous access tool 172
subcutaneously. One example of the monitor test strip is a CGM test
strip (such as the type available from Nova Biomedical) which may
be understood as a glucose sensor configured to test for a
concentration level of glucose in the interstitial fluid (ISF)
and/or blood of a host. The fluid delivery device 100 may be
configured to receive data from the monitoring test strip
concerning a glucose concentration level of the host, and
determining an output of insulin from the reservoir based on the
glucose concentration level.
[0057] The transcutaneous access tool 172 includes an introducer
trocar or needle 174 at least partially positioned within a lumen
175 of a cannula 176 (e.g., a soft flexible cannula), which is
capable of passing the fluid into the host. In particular, the
introducer needle/trocar 174 may initially penetrate the skin such
that both the introducer needle/trocar 174 and the cannula 176 are
introduced (inserted) into the host, and the introducer
needle/trocar 174 may then be retracted within the cannula 176 such
that the cannula 176 remains inserted. A fluid path, such as tubing
178, fluidly couples the reservoir 130 to the lumen 175 of cannula
176 of the transcutaneous access tool 172. The transcutaneous
access tool 172 may also be used to introduce a monitoring test
strip subcutaneously into the host for monitoring purposes, as
described in greater detail below.
[0058] The transcutaneous access tool insertion mechanism 180 is
coupled to the transcutaneous access tool 172 to deploy the
transcutaneous access tool 172, for example, by inserting the
needle/trocar 174 and cannula 176 through the skin of a host and
retracting the needle/trocar 174. In the illustrated embodiment,
the insertion mechanism 180 includes a spring-biased linkage
mechanism 182 and sliding members 184, 186 coupled to the
needle/trocar 174 and cannula 176, respectively, for moving the
needle/trocar 174 and cannula 176 in the insertion direction and
for moving the needle/trocar 174 in the retraction direction. In a
single, uninterrupted motion, the spring-biased linkage mechanism
182 moves from a pre-deployment position (FIG. 1) with both
needle/trocar 174 and cannula 176 retracted (FIG. 2) to an
intermediate position (FIG. 3) with both needle/trocar 174 and
cannula 176 inserted (FIG. 4) to a post-deployment position (FIG.
5) with the needle/trocar 174 retracted and the cannula 176
inserted (FIG. 6).
[0059] One embodiment of the spring-biased linkage mechanism 182
includes a helical torsion spring 181 and first and second linkages
183a, 183b coupled between the torsion spring 181 and the first
sliding member 184. Energy stored in the torsion spring 181 applies
a force to the linkages 183a, 183b, which applies a force to the
first sliding member 184 to move the first sliding member 184 in
both the insertion direction and in the retraction direction. In
the pre-deployment position (FIG. 1), the torsion spring 181 is
loaded and the sliding members 184, 186 are locked and prevented
from moving. When the sliding members 184, 186 are released, the
energy stored in the torsion spring 181 causes the first linkage
183a to rotate (e.g., clockwise as shown), which applies a force to
the first sliding member 184 through the second linkage 183b
causing the first sliding member 184 with the needle/trocar 174 to
move (with the second sliding member 186) in the insertion
direction. In the intermediate position (FIG. 3), the linkages
183a, 183b are fully extended with the needle/trocar 174 and
cannula 176 being inserted, the second sliding member 186 is
locked, and the remaining energy stored in the torsion spring 181
causes the first linkage 183a to continue to rotate, which applies
an opposite force to the first sliding member 184 through the
second linkage 183b causing the first sliding member 184 with the
needle/trocar 174 to move in the retraction direction to the
post-deployment position (FIG. 5). In the illustrated embodiment,
the second sliding member 186 is locked against retraction by one
or more latches 187. Thus, in the foregoing manner, the continuous
uninterrupted clockwise rotation of first linkage 183a via the
energy of torsion spring 181 provides the transcutaneous access
tool insertion mechanism 180 with the ability to insert and retract
the needle/trocar 174 in a single, uninterrupted motion.
[0060] The spring-biased linkage mechanism 182 allows a single
spring and motion to achieve both the insertion and retraction and
has a relatively small size. The spring-biased linkage mechanism
182 also reduces the static stresses caused by locking and holding
back the sliding members 184, 186 and provides a smoother and more
comfortable needle/trocar insertion because of the way the linkages
183a, 183b vector the forces applied to the sliding members 184,
186. The static forces on the sliding members 184, 186 are
relatively small in the pre-deployment position when the linkages
183a, 183b are fully retracted. When the deployment starts and the
linkages 183a, 183b start to become extended, the insertion forces
increase because the force vectors increase in the insertion
direction as the linkages extend 183a, 183b until a maximum
insertion force is reached at the fully extended, intermediate
position. By gradually increasing the insertion forces, the
needle/trocar insertion and retraction is smoother, quieter and
less painful.
[0061] Another embodiment of an insertion mechanism 280 is shown in
greater detail in FIGS. 7-10. The sliding members 284, 286 are
slidably received in a frame 290 and moved by a spring-biased
linkage mechanism 282 including torsion spring 281 and linkages
283a, 283b. In this embodiment, a cam finger 292 (e.g., extending
from the frame 290) engages beneath one or both of the sliding
members 284, 286 to lock the sliding members in the retracted or
pre-deployment position (FIG. 7). In this pre-deployment position,
the cam finger 292 is held against the sliding members 284, 286 by
a release bar 296, which may be moved (rotated) to allow the cam
finger 292 to move and release the sliding members 284, 286 (FIG.
8). The cam finger 292 may be biased in a downward direction and/or
the second sliding member 286 may include a cam surface 287 to help
facilitate movement along the cam finger 292 over locking mechanism
293 upon actuation.
[0062] The release bar 296 includes a lever 297 for pivoting the
release bar 296 between an engaged position against the cam finger
292 (FIG. 7) and a disengaged position releasing the cam finger 292
(FIG. 8). The release bar 296 may be biased toward the disengaged
position and held against the cam finger 292 in the engaged
position until the lever 297 is released allowing the release bar
296 to move to the disengaged position. In the illustrated
embodiment, the lever 297 engages a rotating surface 257 of a drive
wheel 256 of the fluid drive mechanism 150 such that the lever 297
is held in the engaged position for part of the rotation and is
released at a certain point during the rotation (e.g., when a flat
portion of the rotating surface 257 allows the lever 297 to
move).
[0063] As shown in FIGS. 9 and 10, the cam finger 292 may also be
used to lock the second sliding member 286 in the insertion
position. A locking portion 288 of the second sliding member 286
engages a locking portion 293 of the cam finger 292 when the
linkage mechanism 282 is fully extended in the intermediate
position and prevents the second sliding member 286 from retracting
such that the cannula remains inserted. As discussed above, the
second sliding member 286 may also be locked by one or more latches
(not shown) extending from a top of the frame 290.
[0064] Referring to FIGS. 11-16, one embodiment of the fluid drive
mechanism 150 uses a clutch mechanism 160 to facilitate filling of
the reservoir 130 and engagement of the fluid drive mechanism 150
for driving fluid out of the reservoir 130. The fluid drive
mechanism 150 includes a first threaded member in the form of an
elongated shaft such as a threaded drive rod or leadscrew 152, with
external threads extending from a plunger 136 received in the
reservoir 130 and sealed with an o-ring 137 against the inside
surface of the reservoir 130. The leadscrew 152 and plunger 136 may
be an inseparable, insert-molded assembly. A second threaded member
in the form of an elongated shaft such as a tube nut 154 with
internal threads threadably engages the leadscrew 152 and may be
driven by a drive wheel 156 via a clutch mechanism 160.
[0065] When the reservoir 130 is empty (FIGS. 11 and 12), the
plunger 136 is positioned at one end of the reservoir 130 such that
the plunger 136 is extended and the clutch mechanism 160 is
disengaged. In certain embodiments, the reservoir 130 may be filled
with fluid, particularly insulin, by opening an inlet port to the
reservoir 130 and pumping in the insulin under sufficient hydraulic
pressure to retract the plunger 136 within the reservoir 130.
Thereafter, the inlet port may be closed. When the reservoir 130 is
filled and the plunger 136 moves to the opposite (retracted) end of
the reservoir 130 (FIG. 13), the clutch mechanism 160 remains
disengaged to allow the tube nut 154 to pass into an elongated
cylindrical bore (along the drive axis) of a hub of the drive wheel
156. The clutch mechanism 160 may then be engaged (FIGS. 14-16)
such that rotation of the drive wheel 156 causes the clutch
mechanism 160 to rotate the tube nut 154, which causes the
leadscrew 152 to advance the plunger into the reservoir 130 to
deliver the fluid from the reservoir 130. In alternative
embodiments, the reservoir 130 may be filled when the plunger 136
is already retracted.
[0066] In the illustrated embodiment, the clutch mechanism 160
includes a clutch spring 162 (e.g., a helical torsion spring)
located in a counterbore at one end of the drive wheel 156,
adjacent the reservoir 130. The inside diameter of the clutch
spring 162 is larger than the outside diameter of the tube nut 154
when the clutch spring 162 is loaded, thereby disengaging the
clutch spring 162 from the tube nut 154 and allowing the tube nut
154 to pass through the center aperture of the spring 162 and into
the elongated bore of the drive wheel 156. Alternatively, the
inside diameter of the clutch spring 162 is smaller than the
outside diameter of the tube nut 154 when the clutch spring 162 is
unloaded, thereby engaging or gripping the tube nut 154 and
allowing the drive wheel 156 to rotate the tube nut 154. In the
illustrated embodiment, prior to filing the reservoir 130, the
clutch spring 162 is held in the loaded, disengaged position by a
spring latch 164 engaged with the drive wheel 156 (FIGS. 11-13).
After the reservoir 130 has been filled, the clutch spring 162 may
thus be engaged by rotating the drive wheel 156 until the spring
latch 164 releases the clutch spring 162 (FIG. 14) allowing the
clutch spring 162 to unload and grip the tube nut 154 (FIGS. 15 and
16), at which time fluid may be dispensed from the reservoir 130
with continued rotation of the drive wheel 156.
[0067] As shown, the spring latch 164 may be biased by the clutch
spring 162 such that as the drive wheel 156 rotates the spring
latch 164 moves rotationally against a surface of a reservoir cap
132 until clutch spring 162 deflects the spring latch 164 into a
window 133 in the reservoir cap 132. When the spring latch 164
moves into the window 133, the end of the clutch spring 162 held by
the spring latch 164 is released, thus engaging the clutch
mechanism 160. When the clutch spring 162 is engaged, the drive
wheel 156 contacts an end 163 of the clutch spring 162 to create a
thrust on the clutch spring 162 that causes the clutch spring 162
to rotate the tube nut 154. The fluid drive mechanism 150 may also
use other clutch mechanisms capable of allowing the tube nut 154 or
other type of nut or threaded member to pass through the clutch
mechanism and then being activated to engage the nut or threaded
member.
[0068] In the illustrated embodiment, the drive wheel 156 includes
ratchets 157 that are engaged by an actuator 158 to incrementally
drive the wheel 156 and advance the plunger 136 into the reservoir
130. Examples of this actuation mechanism are described in greater
detail in U.S. Patent Application Publication No. 2005/0238507,
which is fully incorporated herein by reference.
[0069] By using a clutch mechanism, the engagement between the
leadscrew and the nut occurs at assembly, and thus no rotation is
needed for the nut to engage the leadscrew by operation of the
device. This reduces the number of fluid path prime pulses to prime
the pump and assures a full and proper priming of the fluid path
before placement on the body. The clutch mechanism also enables the
changing of thread pitch for other drug applications without a need
to redesign the tilt nut used in fluid driving mechanisms in other
existing pumps. The components of the clutch mechanism are also
more easily inspected than the tilt nut assembly.
[0070] According to one embodiment, as shown in FIGS. 17-23, the
cannula 176 providing the transcutaneous access for delivery the
fluid may also be used to introduce the monitor test strip 120. In
this embodiment, the cannula 176 includes a first lumen 175 for
receiving the needle/trocar 174 and a second lumen 177 for
receiving the test strip 120. As shown, the first lumen 175 has a
circular (cylindrical) profile and the second lumen 177 has a
rectangular profile. The cannula 176 may also include one or more
windows 179a, 179b providing access to one or more sensors 122a,
122b on the test strip 120. As shown, the plurality of windows
179a, 179b of the cannula 176 may be arranged on a same side of the
sidewall of cannula 176, with the first window 179a arranged at a
distance from the distal end tip of the cannula 176 which is less
than the distance of the second window 179b from the distal end tip
of the cannula 176.
[0071] To insert the test strip 120 into second lumen 177, the test
strip 120 passes into second lumen 177 at the head 178 of the
cannula 176 and extends to the window(s) 179a, 179b. Thus, at least
one window 179a, 179b exposes a sensor 122a, 122b of the monitoring
test strip 120. In the example embodiment, two windows 179a, 179b
are provided with the window 179a closest to the tip of the cannula
176 providing access to the main sensor area and the window 179b
farthest from the tip providing a reference. Although a specific
shape and configuration of a bi-lumen cannula is shown, other
configurations of a cannula with first and second lumens may also
be used to both deliver a therapeutic fluid and introduce a test
strip subcutaneously.
[0072] According to another embodiment, as shown in FIGS. 24-34, a
fluid delivery device 300 may include a transcutaneous access tool
372 with a first cannula 376 for delivering fluid and a second
cannula 377 for introducing a test strip 320. The first cannula 376
receives a first needle/trocar 374 (shown as a circular needle) to
facilitate insertion of the first cannula 376 and the second
cannula 377 receives a second needle/trocar 375 (shown as a
semi-circular trocar) to facilitate insertion of the second cannula
377. The fluid deliver device 300 includes an insertion mechanism
380, similar to the first described embodiment above, but with
sliding members 384, 386 coupled to both the needle 374 and the
trocar 375 and both cannulas 376, 377. The insertion mechanism 380
inserts the second cannula 377 and the trocar 375 and then retracts
the trocar 375 in the same manner as described above. The test
strip 320 remains inserted after the trocar 375 is retracted. Thus,
both the first needle/trocar 374 and the second needle/trocar 375
may be introduced into the host simultaneously, particularly to
reduce the pain of sequential insertions.
[0073] Similar to the above described embodiment, first cannula 376
includes a circular (cylindrical) lumen 376a. As shown in greater
detail in FIGS. 30-32, the second cannula 377 includes a
semi-circular (D-shaped) lumen 377a to allow the monitor strip to
sit relatively flat within the cannula 377. The second cannula 377
also includes one or more windows 379a, 379b providing access to
one or more sensors 320a, 320b on the test strip 320 (see FIGS. 27
and 29). As shown, similar to the prior embodiment, the plurality
of windows 379a, 379b, of the cannula 377 may be arranged on a same
side of the sidewall of the cannula 377, with the first window 379a
arranged at a distance from the distal end tip of the cannula 377
which is less than the distance of the second window 379b from the
distal end tip of the cannula 377. Thus, at least one window 379a,
379b exposes a sensor 320a, 320b of the monitoring test strip 320.
In the example embodiment, two windows 379a, 379b are provided with
the window 379a closest to the tip of the cannula 377 providing
access to the main sensor area and the window 379b farthest from
the tip providing a reference. As shown in greater detail in FIGS.
33 and 34, the trocar 375 has a shape corresponding to the D-shaped
lumen 377a to allow the trocar 375 to be retracted leaving the test
strip 320 inserted (see FIG. 29). As shown, the trocar includes a
planar side surface 373 which corresponds to a planar test strip
320 such that, when assembled, the planar test strip 320 may be
located adjacent the planar side surface 373 of the trocar 375 in
the second cannula 377.
[0074] According to another embodiment, as shown in FIGS. 35-43, a
fluid delivery device 400 may include a transcutaneous access tool
472 with a cannula 476 for delivering fluid and a needle or trocar
475 (shown as a semi-circular trocar) for introducing a test strip
420. The cannula 476 receives a needle/trocar 474 (shown as
circular needle) to facilitate insertion of the cannula 476 and the
trocar 475 is inserted with the test strip 420. The fluid deliver
device 400 includes an insertion mechanism 480, similar to the
first described embodiment above, but with sliding members 484, 486
coupled to both the needle 474 and the trocar 475. The insertion
mechanism 480 inserts the trocar 475 (FIGS. 37 and 38) and then
retracts the trocar 475 (FIGS. 39 and 40) in the same manner as the
needle/trocar described above. The test strip 420 remains inserted
after the trocar 475 is retracted (FIG. 41). In contrast to the
prior embodiment, the needle/trocar 475 introduces the monitoring
test strip 420 subcutaneously solely (i.e. without the monitoring
test strip 420 being introduced with a cannula).
[0075] The trocar 475 is shown in greater detail in FIG. 42. The
second sliding member 486 is shown in greater detail in FIG. 43. In
this embodiment, the second sliding member 486 is designed to
capture the cannula 476 and to receive and allow the trocar 475 to
pass through.
[0076] Accordingly, various embodiments of the fluid delivery
device may use the transcutaneous access tool both to deliver fluid
and to introduce a test strip subcutaneously to provide integrated
monitoring.
[0077] As shown in FIG. 44, fluid delivery device 100, 300 or 400
as disclosed herein may be operable, and more particularly
controlled, with a separate remote control device 900. The
microprocessor of fluid delivery device 100, 300 or 400, which may
be hereinafter referred to as a local processor, may be programmed
to cause the transcutaneous access tool insertion mechanism 180,
380 or 480 of each fluid delivery device 100, 300 or 400,
respectively, to deploy the transcutaneous access tool 172, 372 or
472 therein based on instructions (signals) received from the
remote control device 900. The local processor may also be
programmed to control delivery of the medication from the fluid
reservoir 130 based on instructions (signals) received from the
remote control device 900.
[0078] The fluid delivery device 100, 300 or 400 may receive the
instructions via the wireless communication element, which
thereafter provides the instructions to the local processor. In the
foregoing manner, the fluid delivery device 100, 300 or 400 may be
free of input components for providing instructions to the local
processor, such as electromechanical switches or buttons on the
housing 104, or interfaces otherwise accessible to a host to
locally operate the fluid delivery device 100, 300 or 400. The lack
of input components allows the size, complexity and costs of the
fluid delivery device 100, 300 or 400 to be substantially reduced
so that the fluid delivery device 100, 300 or 400 lends itself to
being small and disposable in nature.
[0079] Referring to FIG. 44, the remote control device 900 has
input components, including an array of electromechanical switches,
such as the membrane keypad 920 as shown. The remote control device
900 also includes output components, including a visual display,
such as a liquid crystal display (LCD) 910. Alternatively, the
remote control device 900 can be provided with a touch screen for
both input and output. Although not shown in FIG. 44, the remote
control device 900 has its own processor (hereinafter referred to
as the"remote" processor) connected to the membrane keypad 920 and
the display 910. The remote processor may receive the inputs from
the membrane keypad 920 and provide instructions to the fluid
delivery device 100, 300 or 400, as well as provide information to
the display 910. Since the remote control device 900 includes a
visual display 910, the fluid delivery device 100, 300 or 400 can
be void of an information screen, further reducing the size,
complexity and costs of the fluid delivery device 100, 300 and
400.
[0080] The communication element of fluid delivery device 100, 300
or 400 may particularly transmit and receive electronic
communication from the remote control device 900 using radio
frequency or other wireless communication standards and protocols.
As such, it should be understood that the communication element may
particularly be a two-way communication element for allowing the
fluid delivery device 100, 300 or 400 to communicate with the
remote control device 900. In such an embodiment, the remote
control device 900 also includes a two-way communication element
which may also comprise a receiver and a transmitter, such as a
transceiver, for allowing the remote control device 900 to transmit
and receive the information sent by the fluid delivery device 100,
300 or 400. Specific instructions communicated to the sensors 122a,
122b of the test strip 120 may include a time schedule for taking
samples and determining specific levels of glucose concentration of
the host that warrant either a warning or an infusion of
medication, or both.
[0081] Thus, in addition to being programmed to receive
instructions from the remote control device 900, the fluid delivery
device 100, 300 or 400 may transmit data (signals) via the
transceiver back to the remote control device 900, particularly
from the one or more sensors 122a, 122b of the glucose test strip
120. Accordingly, the fluid delivery device 100, 300 or 400 may be
used to measure glucose concentration level, in situ, and,
optionally, to control the delivery of the medication to the host
based on the data.
[0082] Alternatively, the fluid delivery device 100, 300 or 400 may
include an interface, including various input and information
displaying components built into the housing 104, thus providing a
unitary sensing device which does not require the use of a separate
remote control device.
[0083] Thus, fluid delivery device 100, 300 or 400 and/or the
remote control device 900 may contain all the computer programs and
electronic circuitry needed to allow a host to program the desired
flow patterns and rates, and adjust the program(s) as necessary.
Such circuitry may include one or more microprocessors, digital and
analog integrated circuits, resistors, capacitors, transistors and
other semiconductors and other electronic components known to those
skilled in the art. Furthermore, fluid delivery device 100, 300 or
400 and/or the remote control device 900 may contain all the
computer programs and electronic circuitry needed to allow a host
to activate one or more sensors 122a, 122b of the glucose test
strip 120.
[0084] Thus, with the incorporation of glucose test strip 120, the
fluid delivery device 100, 300, 400 may be programmed to monitor
glucose concentration level of a host at particular times during
the day, without the finger pricking associated with host dependent
(self monitoring) of glucose concentration level.
[0085] Fluid delivery device 100, 300 or 400 may also apply a host
specific insulin diffusion profile for a predetermined time period
during which time the device 100, 300 or 400 is programmed to
operate with an algorithm which may be specifically configured to
the specific host. Device 100, 300 or 400 may be programmed to
compare a measured glucose value, as determined with the sensors
122a, 122b, to a targeted glucose concentration level provided by
the algorithm. The algorithm may provide a predetermined tolerance
range for the glucose concentration level as a function a time. If
at any given time the glucose concentration level has measured by
the sensors 122a, 122b is outside the tolerance range established
by the algorithm, the device 100, 300 or 400 may emit a warning to
the host that the glucose concentration level is too low or too
high.
[0086] In addition, with fluid delivery devices 100, 300 or 400
disclosed herein, it may be confirmed that the medication has been
actually delivered to the host of the device 100, 300 or 400 by
measuring a physiological parameter associated with the tissue into
which the medication is delivered, particularly within a
predetermined time period after delivery of the medication.
[0087] Referring now to FIG. 45, there is shown cannula 176
inserted in tissue 950 after being delivered by needle 174. As
shown, the tissue 950, and more particularly the fluid thereof, is
adjacent and in contact with sensors 122a, 122b.
[0088] Thereafter, before device 100 is to inject insulin, and/or
another therapeutic fluid, sensors 122a, 122b may be used to
measure a physiological parameter, here glucose concentration
level, associated with the tissue 950 adjacent thereto, which may
provide a predetermined measured value of the glucose concentration
level before delivering the medication. Such may be determined at a
predetermined time prior to injection of the medication by the
programming of device 100. For convenience and the potential for
increased accuracy, measurement of the glucose concentration level
may be performed within a few minutes (e.g. less than 5 minutes)
prior to injection of the medication, such as within 2 minutes
before injection and more particularly within 1 minute before
injection. Even more particularly, measurement of the glucose
concentration level may be performed within 30 seconds before
injection.
[0089] Sensors 122a, 122b may particularly be enzymatic sensors.
The sensors 122a, 122b may be connected by wire to a memory of
device 100 to record data that can be stored and/or sent to remote
control device 900. The tip of the sensors 122a, 122b may be made
of a membrane selectively permeable to glucose. Without being bound
to a particular theory, once the glucose passes through the
membrane, it may be oxidized by the enzyme glucose oxidase. Reduced
glucose oxidase may then be oxidized by reacting with molecular
oxygen, forming hydrogen peroxide as a by-product. At the electrode
surface, hydrogen peroxide may be oxidized into water, generating a
current which can be measured and correlated to the glucose
concentration outside the membrane.
[0090] Thereafter, when insulin/therapeutic fluid is delivered from
cannula 176 into the tissue 950 of the host, the sensors 122a, 122b
may be used to detect a change of the measured glucose
concentration level by sensors 122a, 122b.
[0091] As shown in FIG. 46, when insulin/therapeutic fluid is
delivered from cannula 176 of fluid device 100, the
insulin/therapeutic fluid may form a temporary depot 960 (i.e.
storage) in the tissue 950 at the injection site. The size of the
temporary depot 960 and the duration it will exist may be
understood to depend at least on the rate of injection, the
injection quantity, the type of medication (e.g. fast acting,
intermediate acting, long lasting) and the type of tissue.
[0092] As shown, due to the sensors 122a, 122b being within the
injection site and, more particularly, within the injection path
defined by the needle 174 and cannula 176, the temporary depot 960
forms around the tip of the cannula 176, inclusive of sensors 122a,
122b.
[0093] Due to the injection pressure of the insulin/therapeutic
fluid pushing the insulin/therapeutic fluid into the body, and
overcoming the resistance (hydrostatic) pressure of the tissue 950,
the insulin/therapeutic fluid may be understood to physically
displace the tissue 950 in contact with the sensors 122a, 122b, and
more particularly the fluids of the tissue 950 in contact with the
sensors 122a, 122b. In doing so, the insulin/therapeutic fluid will
at least partially, and more particularly completely surround and
engulf the sensors 122a, 122b within the depot 960.
[0094] As the insulin/therapeutic fluid physically displaces and
"washes away" the fluids in contact with the sensors 122a, 122b,
the glucose concentration level being detected by the sensors 122a,
122b may be understood to change, and more particularly decrease
from the pre-medication delivery measured glucose concentration
level to a post-medication delivery measured glucose concentration
level.
[0095] Even more particularly, when the insulin/therapeutic fluid
surrounds and engulfs the sensors 122a, 122b, the glucose
concentration level being detected by the sensors 122a, 122b may
substantially decrease towards zero, or even may drop to zero,
depending on the size of the temporary depot 960 and/or the ability
of the depot 960 to displace the tissue 950 in contact with the
sensors 122a, 122b.
[0096] As such, the change in glucose concentration level being
detected by the sensors 122a, 122b is indicative that a temporary
depot 960 has formed around the tip of the cannula 176 inclusive of
sensors 122a, 122b, which has effectively displaced the glucose
concentration previously detected by the sensors 122a, 122b and, as
such, may be understood to confirm delivery of the
insulin/therapeutic fluid from the medication delivery device to
the host.
[0097] However, as set forth above, the size of the temporary depot
960 and the duration it will exist may be understood to depend on
the rate of injection, as well as the injection quantity, the type
of medication (e.g. fast acting, intermediate acting, long lasting)
and the type of tissue. As such, the post-medication delivery
measured glucose concentration level to confirm insulin/therapeutic
fluid delivery must be measured within a predetermined time period,
particularly after injection has terminated, by the programming of
device 100.
[0098] The length of the predetermined time period will depend on
how long the temporary depot 960 may exist before the temporary
depot 960 is completely absorbed into tissue 950 and the tissue 950
(e.g. extracellular fluid such as interstitial fluid) reestablishes
contact with the sensors 122a, 122b where the depot 960 was
located. In other words, immediately following injection of the
insulin/therapeutic fluid, the injected insulin/therapeutic fluid
may be expected to begin to be absorbed and dissipate into the
interstitial space between the adjacent cells of the tissue 950.
Such may also involve displacing extracellular fluid, such as the
interstitial fluid, in the interstitial space between the cells. As
the insulin/therapeutic fluid flows and dissipates into the
interstitial space, the insulin/therapeutic fluid and the size of
the depot 960 will decrease. As such, the existence of the
temporary depot 960, and the corresponding time period for
measuring the post-medication delivery measured glucose
concentration level, may only last for several minutes, or for less
than a minute, depending on the foregoing factors.
[0099] Thus, the time period to detect and measure the
post-medication delivery measured glucose concentration level may
be in a range between 0.1 second to 10 minutes (600 seconds),
particularly after injection has terminated. In other embodiments,
the time period may be in a range between 0.1 second to 9 minutes
(540 seconds); 0.1 second to 8 minutes (480 seconds); 0.1 second to
7 minutes (420 seconds); 0.1 second to 6 minutes (360 seconds); 0.1
second to 5 minutes (300 seconds); 0.1 second to 4 minutes (240
seconds); 0.1 second to 3 minutes (180 seconds); 0.1 second to 2
minutes (120 seconds); 0.1 second to 1 minute (60 seconds); 0.1
second to 55 seconds; 0.1 second to 50 seconds; 0.1 second to 45
seconds; 0.1 second to 40 seconds; 0.1 second to 35 seconds; 0.1
second to 30 seconds; 0.1 second to 25 seconds; 0.1 second to 20
seconds; 0.1 second to 15 seconds; 0.1 second to 10 seconds; and
0.1 second to 5 seconds. It should also be realized that the time
to detect and measure the post-medication delivery measured glucose
concentration level may also be determined using the beginning of
injection as the reference point for starting the relevant time
period as an alternative to the time period beginning after
injection has terminated.
[0100] For convenience (to reduce waiting time) and the potential
for increased accuracy, the post-medication delivery measured
glucose concentration level may be particularly detected and
measured in a time period in a range of 0.1 second to 2 minutes
(120 seconds) and more particularly in a range of 0.1 second to 1
minute (60 seconds) after injection has terminated. Even more
particularly, measurement of the glucose concentration level may be
performed in a range of 0.1 second to 30 seconds after injection
has terminated. Such may provide confirmation that the
insulin/therapeutic fluid has been delivered to the host in light
of a change in glucose concentration level as measured by the
sensors 122a, 122b.
[0101] In other embodiments, a response from the sensors 122a, 122b
may be turned off or otherwise discarded for a short time period
after obtaining the pre-medication delivery measured glucose
concentration level, and more particularly during or after delivery
of the insulin/therapeutic fluid from cannula 176 of fluid device
100. Such may be performed during the transient period while the
insulin/therapeutic fluid physically displaces and "washes away"
the fluids in contact with the sensors 122a, 122b. As such, a delay
period for obtaining the post-medication delivery measured glucose
concentration level, either after obtaining the pre-medication
delivery measured glucose concentration level or after delivery of
the insulin/therapeutic fluid from cannula 176 of fluid device 100,
maybe in a range between 0.1 second to 1 minute (60 seconds); 0.1
second to 55 seconds; 0.1 second to 50 seconds; 0.1 second to 45
seconds; 0.1 second to 40 seconds; 0.1 second to 35 seconds; 0.1
second to 30 seconds; 0.1 second to 25 seconds; 0.1 second to 20
seconds; 0.1 second to 15 seconds; 0.1 second to 10 seconds; and
0.1 second to 5 seconds. After the delay period has expired, the
sensors 122a, 122b may then be used to detect and measure the
post-medication delivery measured glucose concentration level
within the timer period as set forth above.
[0102] Once a post-medication delivery measured glucose
concentration level has been obtained which is indicative that the
insulin/therapeutic fluid has been delivered to the host, the
sensors 122a, 122b may be used to continue to monitor glucose
concentration level as the glucose concentration level rises back
towards normal ranges, or the sensors 122a, 122b may be turned off
for a predetermined period of time during which the depot 960 may
be expected to have been absorbed.
[0103] Thus, the foregoing description provides a method of
treating a host with a medication, with the method comprising
providing a medication delivery device (e.g. 100) which delivers
medication into tissue (e.g. 950) of the host, wherein the
medication delivery device includes a sensor (e.g. 122a, 122b), and
wherein the sensor is used to measure a physiological parameter
(e.g. glucose concentration level) associated with the tissue;
introducing the medication delivery device including the sensor
into the tissue; delivering the medication into the tissue of the
host; and confirming delivery of the medication from the medication
delivery device to the host, wherein confirming delivery of the
medication comprises using the sensor to measure the physiological
parameter within a predetermined time period after delivery of the
medication.
[0104] Furthermore, in certain embodiments confirming delivery of
the medication from the medication delivery device (e.g. 100) to
the host may further comprise determining a value of the
physiological parameter measured before delivering the medication;
determining a value of the physiological parameter measured within
the predetermined time period after delivery of the medication; and
determining that the value of the physiological parameter measured
within the predetermined time after delivery of the medication is
less than the value of the physiological parameter measured before
delivering the medication into the tissue. Thus, based on such
methodology, confirming delivery of the medication from the
medication delivery device to the host would merely require the
value of the physiological parameter measured within the
predetermined time after delivery of the medication being less than
the value of the physiological parameter measured before delivering
the medication into the tissue.
[0105] In other embodiments, in addition to determining a value of
the physiological parameter measured before delivering the
medication, and determining a value of the physiological parameter
measured within the predetermined time period after delivery of the
medication, confirming delivery of the medication from the
medication delivery device (e.g. 100) to the host may further
comprise determining a numerical difference between the value of
the physiological parameter measured before delivering the
medication into the tissue, and the value of the physiological
parameter measured within the predetermined time after delivering
the medication into the tissue; providing a predetermined
representative value for the numerical difference of the
physiological parameter with (e.g. stored on, such as in an
electronic memory thereof) the medication delivery device; and
determining the numerical difference between the two measured
values of the physiological parameter is greater than a
predetermined representative value for the numerical difference
provided by (e.g. stored on) the medication delivery device.
[0106] Thus, based on such methodology, confirming delivery of the
medication from the medication delivery device to the host may
require a numerical difference between the two measured values of
the physiological parameter to reach a predetermined threshold of a
predetermined representative value for the numerical difference
provided by (e.g. stored on, such as in an electronic memory
thereof) the medication delivery device before confirming delivery
of the medication from the medication delivery device to the host.
In such manner, confirming delivery of the medication from the
medication delivery device to the host is not merely performed
based on a value of the physiological parameter measured within the
predetermined time after delivery of the medication being less than
a value of the physiological parameter measured before delivering
the medication into the tissue, but rather a magnitude of a
numerical difference between the two measured values of the
physiological parameter being significant enough to reach a
predetermined threshold. In certain embodiments, the predetermined
representative value for the numerical difference provided by (e.g.
stored on) the medication delivery device is at least at least 20
mg/dL, and more particularly as least 30 mg/dL, or in a range of 20
mg/dL to 60 mg/dL.
[0107] In other embodiments, in addition to determining a value of
the physiological parameter measured before delivering the
medication, and determining a value of the physiological parameter
measured within the predetermined time period after delivery of the
medication, confirming delivery of the medication from the
medication delivery device (e.g. 100) to the host may further
comprise determining a percentage change between the value of the
physiological parameter measured before delivering the medication
into the tissue, and the value of the physiological parameter
measured within the predetermined time after delivering the
medication into the tissue; providing a predetermined
representative value for the percentage change of the physiological
parameter with (e.g. stored on, such as in an electronic memory
thereof) the medication delivery device; and determining the
percentage change between the two measured values of the
physiological parameter is greater than a predetermined
representative value for the percentage change provided by (e.g.
stored on) the medication delivery device.
[0108] Thus, based on such methodology, confirming delivery of the
medication from the medication delivery device to the host may
require a percentage change between the two measured values of the
physiological parameter to reach a predetermined threshold of a
predetermined representative value for the percentage change
provided by (e.g. stored on, such as in an electronic memory
thereof) the medication delivery device before confirming delivery
of the medication from the medication delivery device to the host.
In such manner, confirming delivery of the medication from the
medication delivery device to the host is not merely performed
based on a value of the physiological parameter measured within the
predetermined time after delivery of the medication being less than
a value of the physiological parameter measured before delivering
the medication into the tissue, but rather a magnitude of a
percentage change between the two measured values of the
physiological parameter being significant enough to reach a
predetermined threshold. In certain embodiments, the predetermined
representative value for the percentage change provided by (e.g.
stored on) the medication delivery device is at least 15%, or more
particularly at least 20%, or even more particularly at least 25%,
or in a range of 15% to 75%.
[0109] In other embodiments, it may not be necessary to determining
a value of the physiological parameter measured before delivering
the medication. Confirming delivery of the medication from the
medication delivery device (e.g. 100) to the host may comprise
determining a value of the physiological parameter measured within
the predetermined time period after delivery of the medication;
providing a predetermined representative value for the
physiological parameter with (e.g. stored on, such as in an
electronic memory thereof) the medication delivery device; and
determining that the measured value of the physiological parameter
within the predetermined time period after delivery of the
medication is less than the predetermined representative value for
the physiological parameter provided by (e.g. stored on) the
medication delivery device.
[0110] The foregoing description also provides a method of treating
a host with a medication, with the method comprising providing a
medication delivery device which delivers medication into tissue of
the host, wherein the medication delivery device includes a sensor,
and wherein the sensor is used to measure a physiological parameter
associated with the tissue; introducing the medication delivery
device including the sensor into the tissue such that the tissue is
in contact with the sensor; delivering the medication into the
tissue of the host; forming a depot in the tissue with the
medication, wherein the sensor is at least partially within the
depot and the depot reduces the tissue contact with the sensor;
confirming delivery of the medication from the medication delivery
device to the host, wherein confirming delivery of the medication
comprises using the sensor to measure the physiological parameter
while the sensor is within the depot.
[0111] In certain embodiments, confirming delivery of the
medication from the medication delivery device to the host may
further comprise determining a value of the physiological parameter
while the sensor is within the depot; providing a predetermined
representative value for the physiological parameter with the
medication delivery device; and after delivery of the medication,
determining that the measured value of the physiological parameter
while the sensor is within the depot is less than the predetermined
representative value for the physiological parameter provided by
the medication delivery device.
[0112] In other embodiments, confirming delivery of the medication
from the medication delivery device to the host may further
comprise determining a value of the physiological parameter
measured before delivering the medication; after delivery of the
medication, determining a value of the physiological parameter
measured while the sensor is within the depot; and determining that
the value of the physiological parameter measured while the sensor
is within the depot is less than the value of the physiological
parameter measured before delivering the medication into the
tissue.
[0113] In other embodiments, confirming delivery of the medication
from the medication delivery device to the host may further
comprise determining a value of the physiological parameter
measured before delivering the medication; after delivery of the
medication, determining a value of the physiological parameter
measured while the sensor is within the depot; determining a
numerical difference between the value of the physiological
parameter measured before delivering the medication into the
tissue, and the value of the physiological parameter measured while
the sensor is within the depot; providing a predetermined
representative value for the numerical difference of the
physiological parameter with the medication delivery device; and
determining the numerical difference between the two measured
values of the physiological parameter is greater than a
predetermined representative value for the numerical difference
provided by the medication delivery device.
[0114] In other embodiments, confirming delivery of the medication
from the medication delivery device to the host may further
comprise determining a value of the physiological parameter
measured before delivering the medication; after delivery of the
medication, determining a value of the physiological parameter
measured while the sensor is within the depot; determining a
percentage change between the value of the physiological parameter
measured before delivering the medication into the tissue, and the
value of the physiological parameter measured while the sensor is
within the depot; providing a predetermined representative value
for the percentage change of the physiological parameter with the
medication delivery device; and determining the percentage change
between the two measured values of the physiological parameter is
greater than a predetermined representative value for the
percentage change provided by the medication delivery device.
[0115] While the principles of the invention have been described
herein, it is to be understood by those skilled in the art that
this description is made only by way of example and not as a
limitation as to the scope of the invention. Other embodiments are
contemplated within the scope of the present invention in addition
to the exemplary embodiments shown and described herein.
Modifications and substitutions by one of ordinary skill in the art
are considered to be within the scope of the present invention,
which is not to be limited except by the following claims.
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