U.S. patent application number 12/744268 was filed with the patent office on 2010-10-07 for analyte monitoring and fluid dispensing system.
Invention is credited to Ruthy Kaidar, Ofer Yodfat.
Application Number | 20100256593 12/744268 |
Document ID | / |
Family ID | 40329047 |
Filed Date | 2010-10-07 |
United States Patent
Application |
20100256593 |
Kind Code |
A1 |
Yodfat; Ofer ; et
al. |
October 7, 2010 |
Analyte Monitoring and Fluid Dispensing System
Abstract
Disclosed is a skin adherable device for delivering therapeutic
fluid into a body of a patient. The device includes a monitoring
apparatus, a dispensing apparatus, and a tip for delivering the
therapeutic fluid into the body of the patient and for monitoring
bodily analyte in the body of the patient. The dispensing apparatus
may continuously deliver the therapeutic fluid to the body of the
patient and the monitoring apparatus may continuously monitor
bodily analytes of the patient.
Inventors: |
Yodfat; Ofer;
(Maccabim-Reut, IL) ; Kaidar; Ruthy; (Haifa,
IL) |
Correspondence
Address: |
MINTZ LEVIN COHN FERRIS GLOVSKY & POPEO
ONE FINANCIAL CENTER
BOSTON
MA
02111
US
|
Family ID: |
40329047 |
Appl. No.: |
12/744268 |
Filed: |
November 20, 2008 |
PCT Filed: |
November 20, 2008 |
PCT NO: |
PCT/IL08/01521 |
371 Date: |
May 21, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61004047 |
Nov 21, 2007 |
|
|
|
Current U.S.
Class: |
604/504 ;
600/345; 600/347; 604/151; 604/66 |
Current CPC
Class: |
A61M 2205/50 20130101;
A61M 5/14248 20130101; A61M 2210/04 20130101; A61M 5/1723 20130101;
A61M 2005/1726 20130101; A61M 2230/201 20130101; A61M 2205/8206
20130101; A61M 2205/3592 20130101; A61M 2005/14268 20130101 |
Class at
Publication: |
604/504 ; 604/66;
604/151; 600/345; 600/347 |
International
Class: |
A61M 5/168 20060101
A61M005/168; A61M 5/142 20060101 A61M005/142; A61B 5/145 20060101
A61B005/145; A61B 5/1486 20060101 A61B005/1486 |
Claims
1.-28. (canceled)
29. A system for delivering a therapeutic fluid into the body of a
patient and for sensing one or more body analytes, the system
comprising: a subcutaneously insertable tip including: a cannula
configured for subcutaneous placement within a body of a patient,
at least one electrode for interacting with one or more body
analytes in subcutaneous tissue of a patient and generating a
signal representative of a concentration of the one or more body
analytes in the body, the at least one electrode being coupled to
the cannula, and at least one cannula electrical connector being in
electrical communication with the at least one electrode; a
reusable part including: at least a portion of a pump, a processor
capable of processing the signal for determining the concentration
of the one or more body analytes, and at least one reusable part
electrical connector being in electrical communication with the
processor; a disposable part including: a reservoir containing a
therapeutic fluid, and an outlet port for enabling flow of the
therapeutic fluid from the reservoir to the cannula; and a skin
securable cradle having a well for receiving the subcutaneously
insertable tip; wherein: upon coupling of the reusable part to the
disposable part and connection thereof to the cradle: electrical
communication is established between the at least one electrode and
the processor via the at least one cannula electrical connector and
the at least one reusable part electrical connector, and the pump
delivers the therapeutic fluid from the reservoir to the body
through the cannula.
30. The system of claim 29, wherein the cradle further comprises: a
first cradle electrical connector coupleable to the at least one
cannula electrical connector, and a second cradle electrical
connector coupleable to the at least one reusable part electrical
connector and in electrical communication with the first cradle
electrical connector.
31. The system of claim 29, wherein the disposable part further
comprises: a first disposable part electrical connector coupleable
to the at least one cannula electrical connector, and a second
disposable part electrical connector coupleable to the at least one
reusable part electrical connector and in electrical communication
with the first disposable part electrical connector.
32. The system of claim 29, wherein the subcutaneously insertable
tip includes current conducting elements for establishing
electrical communication between the at least one electrode and the
cannula electrical connector.
33. The system of claim 30, wherein the cradle includes current
conducting elements for establishing electrical communication
between the first cradle electrical connector and the second cradle
electrical connector.
34. The system of claim 31, wherein the disposable part includes
current conducting elements for establishing electrical
communication between the first disposable part electrical
connector and the second disposable part electrical connector.
35. The system of claim 29, wherein coupling of the reusable part
to the disposable part form a unit and the unit is releasably
connected to the cradle enabling repeated establishment of
electrical communication between the at least one electrode and the
processor.
36. The system of claim 29, wherein the at least one electrode
being coated with an enzyme layer that electrochemically interacts
with the one or more body analytes.
37. The system of claim 29, wherein the cannula includes a proximal
portion and a distal portion, the proximal portion including the
cannula electrical connector and being securable to the well, and
the distal portion including the at least one electrode and being
configured for subcutaneous placement within the body of the
patient.
38. The system of claim 37, wherein the at least one electrode is
in close proximity to an opening at the distal portion, the
therapeutic fluid being delivered though the opening.
39. The system of claim 29, wherein the at least one electrode is
disposed on an outer surface of the cannula.
40. The system of claim 29, wherein the at least one electrode is
provided on an inner surface of the cannula and at least part of
the cannula comprises a permeable or a semi-permeable wall.
41. The system of claim 29, wherein the at least one electrode is
provided along at least one of a part of a circumferential axis of
the cannula and a part of a longitudinal axis of the cannula.
42. The system of claim 29, wherein the therapeutic fluid comprises
insulin and the one or more body analytes comprises glucose.
43. The system of claim 29, wherein the processor controls each of
the pump for continuously delivering the therapeutic fluid to the
body of the patient and also the at least one electrode for
continuously monitoring the concentration level of the one or more
body analytes in the subcutaneous tissue.
44. The apparatus of claim 29, wherein the pump is configured to
deliver the therapeutic fluid to the body of the patient based on
the concentration of the one or more body analytes determined by
the processor.
45. The system of claim 29, wherein the system is operable in a
mode selected from the group consisting of: an open loop mode, a
closed loop mode, and a semi-closed loop mode.
46. The system of claim 29, wherein the cradle includes an adhesive
layer for adhering the cradle to the skin of the patient.
47. The system of claim 29, wherein the system further comprises a
remote control, the remote control being configured for at least
one of controlling, programming and managing data related to
delivery of the therapeutic fluid and/or monitoring of the one or
more body analytes.
48. The system of claim 47, wherein the remote control includes a
glucose monitoring apparatus.
49. The system of claim 33, wherein at least one of the current
conducting elements, the first cradle electrical connector and the
second cradle electrical connector, is embedded with the
cradle.
50. The system of claim 29, wherein the cradle and the
subcutaneously insertable tip are disposable.
51. A system for delivering a therapeutic fluid into the body of a
patient and for sensing one or more body analytes, the system
comprising: a subcutaneously insertable tip including: a cannula
configured for subcutaneous placement within a body of a patient,
at least one electrode for interacting with one or more body
analytes in subcutaneous tissue of a patient and generating a
signal representative of a concentration of the one or more body
analytes in the body, the at least one electrode being coupled to
the cannula, and at least one cannula electrical connector being in
electrical communication with the at least one electrode; a
therapeutic fluid delivery device having a processor capable of
processing the signal for determining the concentration of the one
or more body analytes, and at least one electrical connector being
in electrical communication with the processor; and a skin
securable cradle having a well for receiving the subcutaneously
insertable tip; wherein: electrical communication is established
between the at least one electrode and the processor via the at
least one cannula electrical connector and the at least one
electrical connector of the device upon connection thereof to the
cradle, and the pump delivers the therapeutic fluid from the
reservoir to the body through the cannula.
52. A method for delivering a therapeutic fluid into the body of a
patient and for sensing one or more body analytes, the method
comprising: providing a system for delivering a therapeutic fluid
into the body of a patient and for sensing one or more body
analytes, the system comprising: a subcutaneously insertable tip
including: a cannula configured for subcutaneous placement within a
body of a patient, at least one electrode for interacting with one
or more body analytes in subcutaneous tissue of a patient and
generating a signal representative of a concentration of the one or
more body analytes in the body, the at least one electrode being
coupled to the cannula, and at least one cannula electrical
connector being in electrical communication with the at least one
electrode; a therapeutic fluid delivery device having a processor
capable of processing the signal for determining the concentration
of the one or more body analytes, and at least one electrical
connector being in electrical communication with the processor; and
a skin securable cradle having a well for receiving the
subcutaneously insertable tip; establishing electrical
communication between the at least one electrode and the processor
via the at least one cannula electrical connector and the at least
one electrical connector of the device upon connection thereof to
the cradle, and delivering therapeutic fluid from the reservoir to
the body through the cannula by action of the pump.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Patent Application No. 61/004,047, entitled "Analyte Monitoring and
Fluid Dispensing System," filed on Nov. 21, 2007, the disclosure of
which is incorporated herein by reference in its entirety.
FIELD
[0002] Systems, devices, and methods for continuous monitoring of
bodily analyte and continuous dispensing of therapeutic fluid are
described herein. More particularly, a system comprising a
continuous glucose monitor and insulin dispenser is described
herein. Even more particularly, a device that is configured as a
miniature, portable, single unit that can be adhered to a patient's
skin and connected to at least one subcutaneous tip to continuously
monitor glucose levels and dispense insulin is described
herein.
[0003] The systems, devices and methods are not limited strictly to
delivering insulin and monitoring glucose but, rather, apply to
delivering any other drug and concomitantly monitoring any analyte.
When used in the following description the term "analyte" means any
solute composed of specific molecules dissolved in an aqueous
medium.
BACKGROUND
Continuous Subcutaneous Insulin Injection (SCII)
[0004] Medical treatment of several illnesses requires continuous
drug infusion into various body compartments, such as subcutaneous
and intra-venous injections. Diabetes mellitus (DM) patients, for
example, require the administration of varying amounts of insulin
throughout the day to control their glucose levels. In recent
years, ambulatory portable insulin infusion pumps have emerged as a
superior alternative to multiple daily syringe injections of
insulin, initially for Type 1 diabetes patients (Diabetes Medicine
2006; 23(2):141-7) and consecutively for Type 2 diabetes patients
(Diabetes Metab 2007 Apr. 30, Diabetes Obes Metab 2007 Jun. 26).
These pumps, which deliver insulin at a continuous basal rate as
well as in bolus volumes, were developed to liberate patients from
repeated self-administered injections, and allow them to maintain a
near-normal daily routine. Both basal and bolus volumes must be
delivered in precise doses, according to individual prescription,
since an overdose or under-dose of insulin could be fatal.
[0005] The first generation of portable infusion pumps concerns
"pager-like" devices with a reservoir contained within the device's
housing. These devices are provided with a long tube for delivering
insulin from the pump attached to a patient's belt to a remote
insertion site. Both basal and bolus volumes deliveries in these
"pager-like" devices are controlled via a set of buttons provided
on the device. A human interface screen is provided on the device
housing for advising the user about fluid delivery status, for
programming flow delivery, for alerts and alarms. Such devices are
disclosed, for example, in U.S. Pat. Nos. 3,771,694, 4,657,486 and
4,498,843. These devices represent a significant improvement over
multiple daily injections, but nevertheless, they all suffer from
several major drawbacks, among which are the large size and weight,
long delivery tubing and lack of discreetness.
[0006] To avoid the consequences of a long delivery tube, a new
concept on which a second generation pumps are based, was proposed.
As described in prior art, the new concept concerns a remote
controlled skin adherable device with a housing having a bottom
surface adapted for contact with the patient's skin, a reservoir
disposed within the housing, and an injection needle adapted for
communication with the reservoir. In these devices, the user
interface means is configured as a separate remote control unit
that contains operating buttons and screen providing fluid delivery
status, programming flow delivery, alerts and alarms, as described,
for example, in U.S. Pat. Nos. 5,957,895, 6,589,229, 6,740,059,
6,723,072, and 6,485,461. These second generation devices also have
several limitations, such as being heavy, bulky, and expensive
because the device should be replaced every 2-3 days. Another major
drawback of these second generation skin adherable devices is
associated with the remote controlled drug administration. The user
is totally dependent on the remote control unit and cannot initiate
bolus delivery or operate the device if the remote control unit is
not at hand, or it is lost or malfunctions (practically, this means
that the patient cannot eat).
[0007] A third generation of skin adherable infusion devices was
devised to avoid the price limitation and to extend patient
customization. An example of such a device was described in
co-pending/co-owned patent applications U.S. patent application
Ser. No. 11/397,115 and International Patent Application No.
PCT/IL06/001276. This third generation device contains a remote
control unit and a skin adherable device/patch unit that can be
comprised of two parts: [0008] Reusable part--containing the
metering portion, electronics, and other relatively expensive
components. [0009] Disposable part--containing the reservoir and in
some embodiments batteries. This concept provides a cost-effective,
skin adherable infusion device and allows diverse usage such as
various reservoir sizes, various needle and cannula types.
[0010] In a co-pending/co-owned International Application No.
PCT/IL07/001,578 and U.S. Patent Application No. PCT/IL07/001,578
and U.S. patent application Ser. No. 12/004,837, claiming priority
to U.S. Provisional Patent Application No. 60/876,679, a fourth
generation patch unit that can be disconnected and reconnected from
and to a skin adherable cradle unit was disclosed.
[0011] The fourth generation detachable skin adherable patch can be
remotely controlled or can be operated by a dedicated control
buttons that are located on the patch housing as disclosed in the
co-owned/co-pending U.S. Provisional Patent Application No.
60/691,527 By virtue of the fourth generation patch the user can
deliver a desired bolus dose by repetitive pressing of control
buttons.
Continuous Glucose Monitoring (CGM)
[0012] Most diabetic patients currently measure their own glucose
levels several times during the day by obtaining finger-prick
capillary samples and applying the blood to a reagent strip for
analysis in a portable meter. While glucose level self-monitoring
has had a major impact on improving diabetes care in the last few
decades, the disadvantages of this technology are substantial and
consequently leading to non-compliance. Blood sampling is
associated with the discomfort of multiple skin pricking, testing
cannot be performed during sleeping and when the subject is
occupied (e.g., during driving a motor vehicle), and intermittent
testing may miss episodes of hyper- and hypoglycemia. The ideal
glucose monitoring technology should therefore employ automatic and
continuous testing.
[0013] Currently there are three techniques for continuously
monitoring of glucose in the subcutaneous interstitial fluid (ISF):
[0014] 1. The first technique is based on use of glucose oxidase
based sensors as described in U.S. Pat. Nos. 6,360,888 to Mclvor et
al. and 6,892,085 to Mclvor et al., both assigned to Medtronic
MiniMed Inc. (CGMS, Guardian.TM. and CGMS Gold), and 6,881,551 to
Heller et al., assigned to Abbott Laboratories, formerly
TheraSense, Inc., (Navigator.TM.). These sensors consist of a
subcutaneously implantable, needle-type amperometric enzyme
electrode, coupled with a portable logger. [0015] 2. The second
technique is based on use of reverse iontophoresis-based sensors as
detailed in U.S. Pat. No. 6,391,643 to Chen et al., assigned to
Cygnus, Inc. (GlucoWatch.TM.). A small current passed between two
electrodes located on the skin surface draws ions and (by
electro-endosmosis) glucose-containing interstitial fluid to the
surface and into hydrogel pads incorporating a glucose oxidase
biosensor (JAMA 1999; 282: 1839-1844). [0016] 3. The third
commercial technology in current clinical use is based on
microdialysis (Diab Care 2002; 25: 347-352), as detailed in U.S.
Pat. No. 6,091,976 to Pfeiffer et al., assigned to Roche
Diagnostics. There exists also marketable device (Menarini
Diagnostics, GlucoDay.TM.). Here, a fine, hollow dialysis fiber is
implanted in the subcutaneous tissue and perfused with isotonic
fluid. Glucose from the tissue diffuses into the fiber and is
pumped outside the body for measurement by a glucose oxidase-based
electrochemical sensor. Initial reports (Diab Care 2002; 25:
347-352) show good agreement between sensor and blood glucose
readings, and good stability with a one-point calibration over one
day.
Closed Loop Systems
[0017] In an artificial pancreas, sometimes referred to as a
"closed loop" system, an insulin pump delivers appropriate dosage
of insulin according to continuous glucose monitor readings. An
artificial pancreas voids human interface and is expected to
eliminate debilitating episodes of hypoglycemia, particularly
nighttime hypoglycemia. An intermediate step in the way to achieve
a "closed loop" system is an "open loop" (or "semi-closed loop")
system also called "closed loop with meal announcement." In this
model, user intervention is required, in a way similar to using of
today's insulin pumps by keying in the desired insulin before they
eat a meal. A closed loop system is discussed in U.S. Pat. No.
6,558,351 to Steil et al., assigned to Medtronic MiniMed. The
system is comprised of two separate devices, a glucose monitor and
an insulin pump which are adherable to two remotely body sites and
the loop is closed by an RF communication link. This closed loop
system has some major drawbacks: [0018] 1. The glucose monitor and
insulin pump are two discrete components, thus there are required
two insertion sites and two skin-pricking sites for every
replacement of the insulin pump and the sensor, usually every 3
days. [0019] 2. Being separated apart, the two system components
should be connected either by radio communication link or by wires.
[0020] 3. The pump is heavy and bulky with long tubing making the
system non-discreet. [0021] 4. The system is extremely expensive
because the pump infusion set and the monitor sensor should be
disposed every 3 days.
SUMMARY OF THE INVENTION
[0022] Systems, devices, and methods for continuous monitoring of
bodily analyte and continuous dispensing of therapeutic fluid are
provided. Some embodiments relate to a device that includes both a
monitoring apparatus and a dispensing apparatus. The dispensing
apparatus may be used for infusing fluid into the body and the
monitoring apparatus may be used for monitoring analytes within the
body. The monitoring apparatus and the dispensing apparatus can
share a single subcutaneously insertable tip, designed to allow
both the concomitantly monitoring of analyte levels and the
dispensing of fluid. In some embodiments, the apparatus can have a
plurality of insertable tips that can be connected to the
monitoring and dispensing apparatuses to perform monitoring of
analyte(s) and dispensing of fluid(s). The tip functions as a probe
for monitoring analyte levels within the body, for example, within
the interstitial fluid ("ISF") and at the same time as a cannula
through which fluid is delivered to the body (hereinafter "tip").
The dispensing apparatus and the monitoring apparatus may work
independently of each other, or may work together as a closed loop
or semi-closed loop system. In some embodiments, the dispensing
fluid is insulin to be used with diabetic patients and the analyte
is glucose. The monitoring apparatus and dispensing apparatus may
comprise a fluid delivery device, which may be configured as a skin
adherable device (hereinafter "patch unit").
[0023] Some embodiments of the device include at least one of the
following units and elements: [0024] 1. A patch unit that includes
the monitoring apparatus and the dispensing apparatus. The
monitoring apparatus includes sensing means and connecting wires;
and, the dispensing apparatus includes a reservoir, driving
mechanism, and pumping mechanism. The patch unit further includes a
printed circuit board ("PCB"), which includes a processor and can
include a transceiver. The processor controls operation of the
dispensing and monitoring apparatuses (hereinafter
"processor-controller"). For programming and data presentation, the
device can be provided with a remote control unit and/or with one
or more operating buttons on the patch unit. The device further can
be provided with a skin adherable cradle unit. The patch unit can
be connected or disconnected to the cradle unit. The dispensing
apparatus of the patch unit may employ different dispensing
mechanisms, such as a syringe with a propelling plunger/piston
(syringe type) mechanism or a peristaltic mechanism. The patch unit
further includes a reservoir and an outlet port which allows fluid
communication between the reservoir and the tip when the patch unit
is connected to the cradle unit. The patch unit may be configured
as a single part or consist of two parts, which include: [0025] a.
A reusable part--contains relatively expensive components, e.g.,
pumping mechanism, electronics. [0026] b. A disposable
part--contains relatively non-expensive and disposable components,
e.g., reservoir. The patch unit further includes a power source
which can be contained either in the reusable part or in the
disposable part. [0027] 2. A cradle unit, which is provided with a
flat bottom covered by a sheet with an adhesive for adhering the
cradle unit to the skin, with a passageway (hereinafter "well") and
at least one anchors for the tip. The cradle unit further includes
at least one connector, e.g., latches for connection and
disconnection of the patch unit to and from the cradle unit. [0028]
3. A cartridge unit--includes the following: [0029] a. A tip, which
is insertable into the body for both fluid delivery and for analyte
monitoring. Upon insertion, the tip is rigidly connected to the
well. [0030] b. A penetrating member, which is a sharpened piece
used for skin pricking during tip insertion. It is removed upon
insertion of the tip. [0031] c. A protector, which shields the
cannula/probe and the penetrating member. [0032] In some
embodiments, the tip insertion can be done automatically by virtue
of a spring loaded inserter. [0033] 4. A remote control unit for
controlling the patch unit.
[0034] In some embodiments, a system for infusing a therapeutic
fluid into a body of a patient is provided and includes a skin
adherable device comprising a dispensing apparatus, a multi-purpose
tip for delivering the therapeutic fluid to the body of the patient
and for monitoring bodily analyte in the body of the patient, and a
remote control unit, including a blood glucose monitoring
apparatus. The system optionally comprises a cradle which receives
the skin adherable device and which includes an adhesive on a
skin-facing surface.
[0035] The monitoring apparatus may employ a conventional analyte
sensing means, including without limitation, such as optical,
electrochemical, acoustic, or photo-acoustic.
[0036] In some embodiments, the device includes an external glucose
monitoring and insulin dispensing unit which contains means to
dispense insulin according to glucose levels in a closed or
semi-closed loop system.
[0037] In some embodiments, the device includes one unit for
continuous insulin delivery and continuous glucose monitoring using
one common insertion site and one tip.
[0038] In some embodiments, the device includes an external single
glucose monitoring and insulin dispensing unit that can be
comprised of one part or two parts and can be connected and
disconnected from the body at user's discretion.
[0039] In some embodiments, a stand alone tip can be inserted into
the body, having a proximal end that remains out of the body and
that can be connected and reconnected both to an insulin dispenser
and glucose monitor.
[0040] In some embodiments, the device includes an external glucose
monitoring and insulin dispensing unit that can be disconnected and
reconnected to a tip inserted in the body.
[0041] In some embodiments, the device includes an external glucose
monitoring and insulin dispensing unit that is highly
cost-effective for the patient.
[0042] It is an object of some of the embodiments to provide a
device that includes a unit for frequent or continuous measurements
of bodily analyte levels and a unit for frequent or continuous
delivery of therapeutic fluid into the body.
[0043] It is another object of some of the embodiments to provide a
device that includes a unit for frequent or continuous measurements
of glucose levels and a unit for frequent or continuous delivery of
insulin.
[0044] It is another object of some of the embodiments to provide a
device that includes a unit for frequent or continuous measurements
of glucose levels and a unit for frequent or continuous delivery of
insulin according to the monitored glucose levels.
[0045] It is another object of some of the embodiments to provide a
device that is configured as a skin adherable unit which includes a
glucose monitoring apparatus and an insulin dispensing
apparatus.
[0046] It is another object of some embodiments to provide a single
patch unit, in which the monitoring and dispensing apparatuses can
concomitantly use a common insertion site and one tip that serves
as a probe for monitoring glucose levels and as a cannula for
delivering insulin. The glucose level may be monitored within the
ISF in the subcutaneous tissue, and the insulin may be delivered
into the subcutaneous tissue.
[0047] It is another object of some embodiments to provide a patch
unit that includes monitoring and dispensing apparatuses and has
two-parts--a reusable part and a disposable part. The reusable part
may include relatively expensive components, e.g., electronics, a
driving mechanism, and the disposable part may include relatively
inexpensive components, e.g., a reservoir.
[0048] It is another object of some of the embodiments to provide a
device that is configured as a patch unit and contains both a
continuous glucose monitoring apparatus and insulin dispensing
apparatus. The patch unit can be controlled by a remote control
unit or by buttons provided anywhere on the patch unit.
[0049] It is another object of some embodiments to provide a patch
unit capable both of analyte monitoring and fluid dispensing and
that is thin, miniature, can be hidden under the clothes, can be
attached to the patient's body at any desired location, avoid long
tubing, and does not interfere with normal daily activities.
[0050] It is another object of some embodiments to provide a patch
unit which includes both monitoring and dispensing apparatuses,
where the patch unit can be connected to a tip insertable within
various bodily tissue, including, for example, subcutaneous tissue,
blood vessels, peritoneal cavity, muscles, and adipose tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0051] FIGS. 1a-c show a device which can include a single-part
monitoring and dispensing patch unit and a remote control unit.
FIG. 1b shows a single-part monitoring and dispensing patch
unit.
[0052] FIG. 1c shows a two-part monitoring and dispensing patch
unit.
[0053] FIG. 2a shows an embodiment of a single-part monitoring and
dispensing patch unit.
[0054] FIG. 2b shows an embodiment of a two-part monitoring and
dispensing patch unit with a remote control unit and a cradle
unit.
[0055] FIGS. 3a-b show respectively a cross-sectional view and a
top view of an embodiment of the cradle unit.
[0056] FIGS. 4a-d illustrate tip insertion, according to some
embodiments of the provided systems, devices and methods. FIG. 4a
shows the inserter with the loaded cradle unit before loading the
cartridge unit. FIG. 4b shows the inserter adherable to the skin
loaded with the cradle unit and cartridge unit. FIG. 4c shows the
insertion of the tip through the cradle unit and skin into the
subcutaneous tissue. FIG. 4d shows the retraction of the
penetrating member into the cartridge.
[0057] FIG. 5 shows a cross-sectional view of an embodiment of the
two-part patch unit and the cradle unit before connection.
[0058] FIGS. 6a-c show a connection of the patch unit to the cradle
unit.
[0059] FIGS. 7a-c show a direct adhesion of the patch unit to
skin.
[0060] FIG. 8 shows an embodiment of the device that includes the
patch unit and a remote control unit, where the patch unit is
connected to a single tip.
[0061] FIG. 9 shows an embodiment of the device including the
remote control unit and the patch unit, where the patch unit is
connected to two tips.
[0062] FIGS. 10a-b show an embodiment of the device that includes a
patch unit and a remote control unit, where the dispensing
apparatus employs a peristaltic pumping mechanism. FIG. 10a shows a
single-part patch unit and FIG. 10b shows a two-part patch
unit.
[0063] FIGS. 11a-b show an embodiment of the device that includes a
patch unit and a remote control unit, where the dispensing
apparatus employs a plunger/piston pumping mechanism. FIG. 11a
shows a single-part patch unit and FIG. 11b shows a two-part patch
unit.
[0064] FIGS. 12a-b show an embodiment of a two-part patch unit
employing an electrochemical monitoring apparatus, where the patch
unit is connected to the tip that has electrodes on its outer
surface. FIG. 12b shows a transverse cross sectional view of the
electrodes on the outer surface of the tip.
[0065] FIGS. 13a-c show an embodiment of a two-part patch unit
employing an electrochemical monitoring apparatus, where the patch
unit is connected to the tip that has ring-like electrodes on its
outer surface. FIG. 13b shows a longitudinal cross-sectional view
of the electrodes on the outer surface of the tip. FIG. 13c shows a
spatial view of the electrodes.
[0066] FIG. 14 illustrates in detail an embodiment of a two-part
patch unit connected to the tip and employing an electrochemical
monitoring apparatus.
[0067] FIG. 15 illustrates in detail an embodiment of the two-part
patch unit connected to the tip and employing an optical monitoring
apparatus.
[0068] FIGS. 16a-c show, respectively a top view, cross-sectional
view, and enlarged view of an embodiment of a two-part patch unit
employing optical monitoring apparatus.
[0069] FIGS. 17a-c show, respectively a top view, cross-sectional
view, and enlarged view of an exemplary two-part patch unit
employing optical monitoring apparatus having two optical
windows.
[0070] FIG. 18 shows the patch unit being connected to a
semi-permeable cannula and the diffusion process.
[0071] FIG. 19 shows the patch unit being connected to a permeable
cannula and the diffusion process.
[0072] FIGS. 20a-b show the patch unit being provided,
respectively, with a tip for Microdialysis or for
Microperfusion.
[0073] FIGS. 21a-b show an embodiment of a two-part patch unit
employing electro-chemical monitoring apparatus with either
extrinsic or intrinsic sensing means.
[0074] FIGS. 22a-c show an embodiment of a two-part patch unit
containing an electro-chemical monitoring apparatus that employs an
intrinsic sensing means.
[0075] FIG. 23 shows an embodiment of a two-part patch unit
containing an electro-chemical monitoring apparatus that employs an
extrinsic sensing means.
[0076] FIG. 24 shows an embodiment of a two-part patch unit
employing an optically-based monitoring apparatus and intrinsic
configuration of sensing means.
[0077] FIG. 25 shows an embodiment of a two-part patch unit
employing an optical monitoring apparatus and extrinsic sensing
means.
[0078] FIGS. 26a-b show an embodiment of a two-part patch unit
employing extrinsic sensing means of the monitoring apparatus and
means for transporting the fluid rich analyte from the tip distal
end (within the subcutaneous tissue) towards the proximal end
within the patch unit. FIG. 26a shows a peristaltic mechanism and
FIG. 26b shows a plunger/piston mechanism.
[0079] FIGS. 27a-b show an embodiment of a two-part patch unit
employing an electrochemical monitoring mechanism and two
embodiments of electrical current passage. FIG. 27a shows wiring
and connectors within the patch unit. FIG. 27b shows wiring and
connectors within the cradle unit.
[0080] FIG. 28 shows an embodiment of a patch unit in which the
monitoring and dispensing apparatuses work together as a closed
loop or semi-closed loop system.
DETAILED DESCRIPTION
[0081] FIG. 1a shows the device which includes a patch unit (10).
The patch unit contains a dispensing apparatus and a monitoring
apparatus. The device also includes a remote control unit (40) for
controlling the patch unit (10). In some embodiments, the patch
unit (10) can be configured to include a single part (shown in FIG.
1b) or two parts (shown in FIG. 1c). In some embodiments, the patch
unit (10) can be configured to include a reusable part (100) and a
disposable part (200).
[0082] FIG. 2a shows a single-part patch unit (10), as well as a
skin adherable cradle unit (20) and a remote control unit (40). The
patch unit (10) may be connected to or disconnected from the cradle
unit (20) upon user discretion. Upon connection of the patch unit
(10) to cradle unit (20) fluid communication is established between
the reservoir provided in the patch unit (10) (not shown in FIG.
2a) and a subcutaneously insertable tip (330). As can be understood
by one skilled in the art, even though it is not specifically shown
in FIG. 2a, a suitable electrical wiring connection can be provided
between the tip (330) and the patch unit (10). Fluid delivery from
the patch unit can be programmed by the remote control unit (40) or
manually by at least one button (15) provided on the patch unit
(10). The remote control unit (40) may also be used for user
inputs, monitoring, programming and user feedback.
[0083] FIG. 2b shows a device which is configured as a two-part
patch unit (10) having a reusable part (100) and a disposable part
(200). The device further includes the cradle unit (20) and the
remote control unit (40). The reusable part (100) is contained
within one housing and the disposable part (200) is contained
within another separate housing. The reusable and disposable parts
housings are connected to each other before operation of the patch
unit (10). Connection of the patch unit (10) to the cradle unit
(20) provides fluid communication between the reservoir (not shown
in FIG. 2b) located in the disposable part (200) and the tip (330).
An electrical wiring connection is also established (not shown in
FIG. 2b) between the tip (330) and the disposable part (200) of the
patch unit (10). Fluid delivery can be programmed by the remote
control unit (40) and/or manually by at least one button (15)
provided on the reusable part housing. The remote control unit (40)
may also be used for user inputs, monitoring, programming, and user
feedback. In some embodiments, data acquisition and monitoring can
be performed by a processing unit located in the reusable part's
housing. The results of such monitoring can be shown on a screen
located on the reusable part's housing.
[0084] FIGS. 3a-b show a cross-sectional view (FIG. 3a) and a top
view (FIG. 3b) of the cradle unit (20) and the subcutaneously
insertable tip (330). The downwardly facing surface of the cradle
unit (20) is covered by a flat sheet with an adhesive layer facing
the skin (5). The cradle unit (20) is also provided with a
connector for connecting and disconnecting the patch unit (10). An
example of a suitable connector could be two latches. The cradle
unit (20) further includes a well (310), which is an opening used
as a passageway for the tip (330). The well (310) includes
protrusions extending upwardly (21, 21') for anchoring the tip
(330) to the cradle unit (20) after tip insertion. The tip (330) is
provided with an opening at its distal end and with a self sealable
rubber septum (320) at its proximal end. The septum (320) can be
pierced by a connecting lumen provided in the patch unit (10) (not
shown in FIGS. 3a-b). The tip (330) can be inserted automatically
using an inserter or manually.
[0085] In the following discussion, the term "cannula" will also be
used to refer to the tip (330). Detailed discussion of cannula
insertion is provided in the co-owned/co-pending U.S. Provisional
Patent Application No. 60/876,679, the disclosure of which is
incorporated herein by reference in its entirety. FIGS. 4a-d show
an embodiment of the cannula insertion and cradle unit (20)
adherence. Insertion of the tip (330) can be carried out manually
(not shown in FIGS. 4a-d), or automatically with an insertion
device (800), which is preloaded with a dedicated cannula cartridge
unit (700). FIG. 4a shows the insertion device ("inserter") (800)
before it is loaded with the cannula cartridge unit (700) depicted
on the right side of the FIG. 4a. The cannula cartridge unit (700)
includes a soft cannula (330) surrounded by penetrating member
(702). The cannula has a grip portion (704), rubber septum (402),
and cannula hub (401) for anchoring. The cannula cartridge unit
(700) is enclosed within a protector (701) that maintains
sterility, avoids unintentional pricking, and facilitates inserter
loading. The cannula cartridge unit (700) is discussed in the
co-owned/co-pending U.S. Provisional Patent Application No.
60/937,155, and the insertion method is discussed in the
co-owned/co-pending U.S. Provisional Patent Application No.
60/937,214, the disclosures of which are each incorporated herein
by reference in their entireties.
[0086] The insertion device (800) includes a housing (804) in which
the cradle (20) can be loaded. The housing has also a slot (806)
into which the cannula cartridge unit (700) can be loaded, and a
button (802) which initiates the insertion operation.
[0087] FIG. 4b shows the insertion device (800) after it has been
loaded with the cannula cartridge unit (700) and with the cradle
unit (20) already adhered to the skin but the cannula (330) not yet
inserted. FIG. 4c shows schematically the insertion of the cannula
(330) into the patient's skin (5) by pressing the button (802).
FIG. 4d shows the retraction of the penetrating member (702) by
gripping the grip portion (704). The cannula (330) is left
positioned within the subcutaneous compartment. The cannula hub
(401) is secured in the well by the anchors (21 and 21').
[0088] FIG. 5 shows a cross-sectional view of the two-part patch
unit (10) having a reusable part (100) and a disposable part (200).
The patch unit (10) contains a dispensing apparatus (1005) and a
monitoring apparatus (1006), each including at least one component
residing within the disposable or the reusable parts. The reusable
part (100) further includes electronics (130), which contains a
processor-controller (not shown) and may include an energy supply
(240). The disposable part (200) contains a reservoir (220),
delivery tube (230), and outlet port (213), to which is connected
the delivery tube (230). In some embodiments, the energy supply
(240) can be provided in the disposable part (200). At the outlet
port (213), there is provided a connecting lumen (214) which is
adapted to pierce the rubber septum (320) of the cannula (330)
after connection of the patch unit (10) to the cradle unit (20).
The distal end of the cannula (330) is seen being located within
the subcutaneous tissue below the skin (5). The proximal end of the
cannula is secured at the well (310). Manual operation buttons (15)
may be provided on the housing of the reusable part (100).
[0089] FIGS. 6a-c show the connection of the patch unit (10) to the
body via the cradle unit (20). FIG. 6a shows the cradle unit (20)
being adhered to the skin of a user. FIG. 6b shows the connection
of the patch unit (10) to the cradle unit (20). FIG. 6c shows the
patch unit (10) after it has been connected to cradle unit
(20).
[0090] FIGS. 7a-c show adhesion of the patch unit (10) directly to
the body and not via the cradle unit (20). In this embodiment, the
adhesive is attached to the disposable part (200) and there is no
cradle unit (20). FIG. 7a shows the peeling of the adhesive (101)
from the bottom surface of the patch unit (10). FIG. 7b shows
adhesive connection of the patch unit (10) to the skin. FIG. 7c
shows the patch unit (10) after it has been connected to the user's
body.
[0091] FIG. 8 shows a patch unit (10) that is provided with a
single tip (330). In this configuration, the same cannula which is
used for fluid delivery serves also as a probe for the analyte
monitoring. The patch unit (10) includes the dispensing apparatus
(1005), the monitoring apparatus (1006), electronics (130), and an
energy supply (240). All these components are disposed within a
single unit which can be attached to the user's skin (5) either
directly or via the cradle unit (20). A single tip (330), which can
be configured with any cross-sectional shape, including without
limitation, circular, oval, rectangular, or triangular, is inserted
into the subcutaneous tissue to provide for fluid delivery to the
user's body (thus, serving as a cannula) and monitoring of analytes
within the user's body (thus serving as a probe). The remote
control unit (40) may be used for remote or direct programming
and/or data handling.
[0092] In some embodiments, the dispensed fluid is insulin, the
monitored analyte is glucose and the subcutaneous compartment
includes ISF. Insulin may be continuously (or in short intervals,
such as every 3-10 minutes) dispensed into the subcutaneous
compartment by the dispensing apparatus (1005) through the tip
(330). Glucose levels can be measured continuously, or periodically
in short intervals, by the monitoring apparatus (1006), using the
tip (330).
[0093] FIG. 9 shows another embodiment of the patch unit (10) which
can be connected to the body via cradle unit (20). In the shown
embodiment, the cradle unit (20) is provided with two passageways,
one for cannula (330) and the second for a probe (3330). The patch
unit includes a dispensing apparatus (1005), a monitoring apparatus
(1006), electronics (130), and an energy supply (240). In some
embodiments, the dispensing apparatus (1005) includes one or more
components of an insulin pump (e.g., a reservoir, driving
mechanism, and pumping mechanism). The dispensing apparatus (1005)
also has an outlet port that can be connected to the cannula (330).
In some embodiments, the monitoring apparatus (1006) can include
one or more components of a continuous glucose monitor, and it can
be connected to a probe (3330). The remote control unit (40) may be
used for remote programming and/or data handling of both the
dispensing apparatus (1005) and monitoring apparatus (1006).
[0094] The single patch unit (10) containing the dispensing
apparatus (1005) and monitoring apparatus (1006) can be a
single-part or a two-part (reusable and disposable) patch unit
(10). The patch unit (10) can be contained in one or two housings.
Further, the patch unit (10) can be operated by a remote control
unit (40) and/or by manual buttons (not shown in FIG. 9) located on
the patch housing. In some embodiments, each one of the cannula
(330) and probe (3330) can be similar to the tip (330) shown in
FIG. 8.
[0095] FIG. 10a shows an embodiment of a one-part patch unit (10)
that includes a monitoring apparatus (1006) and dispensing
apparatus (1005) which employs a peristaltic pumping mechanism
(116). Fluid is delivered from reservoir (220) through delivery
tube (230) to the outlet port (213) by means of a peristaltic
pumping mechanism (116). There is provided a sensing means (2000)
situated near the outlet port (213) and having access to the
interior of the delivery tube (230). The sensing means (2000) is
electrically connected by wires (2100) to a processor-controller
(2200). Subcutaneous analyte concentration levels are measured by
the sensing means (2000) and signals are transported through wires
(2100) to be analyzed by the processor-controller (2200). The
pumping mechanism (116) can be activated by a driving mechanism
(114). In some embodiments, the driving mechanism (114), which
actuates the pumping mechanism (116), can include without
limitation a stepper motor, DC motor, or SMA actuator. An energy
supply (240) can also be provided, which can be one or more
batteries. The dispensing apparatus (1005) and the monitoring
apparatus (1006) are configured to be controlled by a PCB having
electronics (130), which may also contain the processor-controller
(2200). Programming can be done by the remote control unit (40)
and/or by at least one button (15) provided on the patch unit
(10).
[0096] FIG. 10b shows an embodiment of a two-part patch unit (10)
that includes a monitoring apparatus (1006) and a dispensing
apparatus (1005) which employs a peristaltic pumping mechanism
(116). The two-part patch unit (10) includes a reusable part (100)
and a disposable part (200), wherein each part can be contained in
a separate housing. The reusable part (100) includes the relatively
expensive components of the monitoring and dispensing apparatuses,
including without limitation, a driving mechanism (114), a pumping
mechanism (116), electronics (130), and a processor-controller
(2200). At least one manual operating button (15) can be provided
for operating the patch unit (10) and can be located on the
reusable part (100). The disposable part (200) includes an outlet
port (213) and relatively cheap components of the dispensing
apparatus, including without limitation, a reservoir (220), a
delivery tube (230), energy supply (240), and relatively cheap
components of the monitoring apparatus (1006), including without
limitation, wires (2100) and connectors (405). The monitoring
apparatus' sensing means (2000) can be located within the
disposable part (200) (extrinsic configuration) or on the tip
(intrinsic configuration), as discussed below in connection with
FIGS. 20a and 20b, respectively. In some embodiments, the energy
supply (240) can be contained in the reusable part (100). Analyte
monitoring and fluid dispensing can be done after connecting and
pairing the reusable part (100) to the disposable part (200) and
after connecting the two paired parts to the cradle unit (20) (not
shown) and to the tip (330). A detailed discussion of the fluid
dispensing can be found in the co-owned/co-pending U.S. patent
application Ser. No. 11/397,115 and International Patent
Application No. PCT/IL06/001276, the disclosures of which are
incorporated herein by reference in their entireties. A detailed
discussion of analyte monitoring can be found in the
co-owned/co-pending U.S. patent application Ser. No. 11/706,606,
U.S. Provisional Patent Application No. 60/876,945 and
International Patent Applications Nos. PCT/IL07/001,096 and
PCT/IL07/001,177, the disclosures of which are each incorporated
herein by reference in their entireties.
[0097] In some embodiments, programming can be done by the remote
control unit (40) and/or by at least one button (15) provided at
the patch unit (10). As can be understood by one skilled in the
art, the dispensing apparatus can include various types of pumping
mechanisms (e.g., peristaltic pump or plunger movement within a
syringe) and various driving mechanisms (e.g., DC or stepper
motors, SMA derived motors, piezo, or bellow). As can also be
understood by one skilled in the art, the monitoring apparatus
(1006) can include various types of monitoring mechanisms (e.g.,
electrochemical, optical, acoustic, or any combination of known
methods for analyte monitoring).
[0098] FIG. 11a illustrates an embodiment of the one-part patch
unit (10) that includes a monitoring apparatus and dispensing
apparatus, which employs a plunger/piston pumping mechanism. Fluid
is delivered from reservoir (220) to the outlet port (213) by means
of a plunger/piston pumping mechanism (116). Sensing means (2000)
is electrically connected by wires (2100) to processor-controller
(2200). Subcutaneous analyte concentration levels are measured by
the sensing means (2000) and signals are transported through wires
(2100) to be analyzed by the processor-controller (2200). The
pumping mechanism (116) can be actuated by driving mechanism (114).
In some embodiments, the driving mechanism (114), which actuates
the pumping mechanism (116), can include without limitation, a
stepper motor, DC motor, or SMA actuator. An energy supply (240)
can also be provided, which can be one or more batteries. The
dispensing apparatus and the monitoring apparatus are configured to
be controlled by a PCB having electronics (130), which may contain
processor-controller (2200). Programming can be done by the remote
control unit (40) and/or by at least one button (15) provided at
the patch unit (10).
[0099] FIG. 11b illustrates an exemplary embodiment of a two-part
patch unit (10) that includes a monitoring apparatus and dispensing
apparatus, which employs a plunger/piston pumping mechanism (116).
The two-part patch unit (10) includes a reusable part (100) and a
disposable part (200), where each part can be contained in a
separate housing. The reusable part (100) includes the relatively
expensive components of the monitoring and dispensing apparatuses,
which may include without limitation, a driving mechanism (114),
pumping mechanism (116), electronics (130), and
processor-controller (2200). At least one manual operating button
(15) can be provided on the reusable part (100). The disposable
part (200) includes outlet port (213), relatively cheap components
of the dispensing apparatus, which may include without limitation,
a reservoir (220), energy supply (240), and relatively cheap
components of the monitoring apparatus, which may include wires
(2100) and electrical connectors (405, 405'). The monitoring
apparatus sensing means (2000) can be located within the disposable
part (200) (extrinsic configuration) or on the tip (intrinsic
configuration) as will be detailed further, for example, in FIGS.
20a and 20b, respectively. In some embodiments, the energy supply
(240) can be contained in the reusable part (100). Analyte
monitoring and fluid dispensing can be done after connecting and
pairing the reusable part (100) to the disposable part (200),
connecting connectors (405,405'), and connecting the two paired
parts to the cradle unit (20) (not shown) and tip (330).
[0100] FIGS. 12-14 illustrate an embodiment of the two-part patch
unit (10), which includes a dispensing apparatus (1005) employing a
piston-plunger pumping mechanism (116) and a monitoring apparatus
(1006) employing an electrochemical sensing mechanism. The
dispensing apparatus (1005) includes driving mechanism (114) and
pumping mechanism (116), which are contained in the reusable part
(100), and reservoir (220), delivery tube (230), energy supply
(240) and the outlet port (not shown), which are contained in the
disposable part (200). The electronic components (130) are located
in the reusable part (100) and can be used both by the dispensing
and monitoring apparatuses. Power is supplied to the reusable part
(100) from the energy supply (240) located in the disposable part
(200), by wires (2400) and connectors (410) that close the
electrical circuit after pairing with the disposable part (200). In
some embodiments, the energy supply (240) can be located in the
reusable part (100). The patch unit (10) is connectable to tip
(330), which can be inserted in the subcutaneous tissue.
[0101] As illustrated in FIGS. 12a and 12b, the single tip (330)
has electrodes (120, 121, 122) longitudinally deployed on its outer
surface. One of the electrodes is a working electrode, the other is
a counter electrode and the third electrode is a reference
electrode. The monitoring apparatus (1006) includes sensing means
(2000) having electrodes (120, 121, 122), wires (2100), connectors
(405), and controller-processor (2200). At least the working
electrode is coated by an enzyme-coated sensing layer. Upon contact
of the enzyme-coated layer with the surrounding fluid which
contains glucose, electrons are generated within the sensing layer
by virtue of an enzyme-catalyzed electrochemical reaction. The
electrons are transferred by the electrodes and wires (2100),
through the connectors (405), to the processor-controller (2200)
and are detected therein as an electrical signal, the intensity of
which is proportional to the glucose concentration. The sensing
means (2000) and the tip (330) can be deployed in the disposable
part (200) and the processor-controller (2200) can be located in
the reusable part (100). In some embodiments, the
electron-transferring wires and connectors can be embedded within
the cradle unit (20) as will be further explained with reference to
FIG. 26b.
[0102] FIGS. 12a-b shows an embodiment of a two-part patch unit
(10) employing electrochemical-sensing when the electrodes are
placed on the outer periphery of the tip (330). FIG. 12a shows a
two-part patch unit (10) that is connected to cradle (20) which is
adherable to the skin (5). The patch unit (10) includes the
reusable part (100) and the disposable part (200). The monitoring
apparatus (1006) includes processor-controller (2200) and
connectors (405) in the reusable part (100), wiring (2100) and
connectors (405) in the disposable part (200), and a tip (330) with
electrodes (120, 121, and 122). In this embodiment, the electrodes
(120, 121, 122) extend along the entire or partial outer periphery
of the tip (330). FIG. 12b shows a cross-sectional view of the tip
(330) with longitudinal electrodes (120, 121, 122) on its outer
periphery.
[0103] FIGS. 13a-c shows an embodiment of a two-part patch unit
(10) employing electrochemical sensing, in which the electrodes are
located on the outer periphery of the tip (330) transversally, in a
concentric, ring-like, manner. FIG. 13a shows the two-part patch
unit (10) that is connected to cradle unit (20) which is adherable
to the skin (5). The patch unit (10) comprises reusable (100) and
disposable (200) part. The monitoring apparatus (1006) includes
processor-controller (2200) and connectors (405) in the reusable
part (100), wiring (2100) and connectors (405) in the disposable
part (200) and tip (330) with electrodes (120, 121, 122). In this
embodiment, the electrodes (120, 121, 122) are located on the outer
periphery side of the tip (330) concentrically, in a ring-like
manner. FIGS. 13b and 13c show longitudinal cross-sectional and
isometric views, respectively, of the tip (330) with ring-like
electrodes (120, 121, 122) transversally located on its outer
periphery, and the electrical current transfer wiring (2100).
[0104] FIG. 14 shows a two-part patch unit (10) which includes the
dispensing apparatus (1005) and the monitoring apparatus (1006),
employing electrochemical monitoring. FIG. 14 shows the details of
the monitoring apparatus (1006) within the reusable part (100) and
disposable part (200). The patch unit (10) is connected to cradle
unit (20) which is adherable to skin (5). The monitoring apparatus
(1006) is shared between the reusable part (100) and disposable
part (200) and employs an electrochemical sensing means (2000). The
reusable part (100) includes processor-controller (2200) and an
electric circuit (400). The circuit (400) contains necessary
components to provide a potential or current to the electrodes for
the electrochemical reaction that occurs on the electrodes, and to
measure the electrical current or potential produced by the
electrodes due to this electrochemical reaction. Wires (2100) and
connectors (405) are provided to electrically connect between the
disposable (200) and reusable (100) parts. The disposable part
(200) is connected to a tip (330) which contains the sensing means
(2000), located subcutaneously.
[0105] The dispensing apparatus (1005) can also be contained within
the reusable part (100) and the disposable part (200), where the
reusable part (100) includes the driving mechanism (114) and
pumping mechanism (116), and the disposable part (200) includes
reservoir (220) and delivery tube (230). Upon connection of the
patch unit (10) to the tip (330), fluid can be delivered from the
reservoir through the tip (330) into the body, and analytes within
the body can be monitored.
[0106] FIGS. 15-17 show embodiments of a two-part patch unit (10)
which includes a dispensing apparatus (1005) employing a pumping
mechanism (116) and a monitoring apparatus (1006) employing an
optical sensing mechanism. The dispensing apparatus (1005) includes
driving mechanism (114) and pumping mechanism (116), which are
contained in the reusable part (100). The dispensing apparatus
(1005) further includes reservoir (220), delivery tube (230),
energy supply (240), and outlet port (not shown) contained in the
disposable part (200). The electronics (130) and
processor-controller (2200) are located in the reusable part (100)
and can be used by both the dispensing apparatus (1005) and
monitoring apparatus (1006). In some embodiments, the energy supply
(240) can be located in the reusable part (100).
[0107] The monitoring apparatus (1006) in the shown embodiment
includes at least one light-emitting source (101), at least one
detector (102), and at least one optical deflecting means (109).
The path of light propagating from the light-emitting source (101)
into the body is shown as a solid line and the path of light
propagating from the body to the detector (102) is shown as a
dashed line. Emitted light (300) from the light-emitting source
(101) is deflected by deflecting means (109) to the body and the
returned light reaches the detector (102) and is analyzed by the
processor-controller (2200). The light-emitting source (101),
detector (102), and processor-controller (2200) can be located in
the reusable part (100) and the deflecting means (109) can be
located in the reusable part (100). Windows (111, 112) are provided
in the reusable part (100) and disposable part (200). The windows
(111, 112) are aligned and maintain passing of the light along the
above paths after the reusable part (100) and disposable part (200)
are paired.
[0108] FIG. 15 shows the two-part patch unit (10), connected to a
cradle unit (20) which is adherable to skin (5) and the components
of the optical-based monitoring apparatus (1006) which is divided
between the reusable part (100) and disposable part (200). Light
emitted from the source (101) is deflected by the deflecting means
(109) to a tip (330) and into the ISF of the subcutaneous tissue.
Spectra of the emitted light can be varied depending on the
measured analyte (13). For example, if the analyte is glucose, a
spectra in the near-infrared (NIR), mid infrared, or visible light
range can be used (altogether or separately). The light (300)
propagating towards the tip's (330) distal end returns to the tip
(330), and then, via the deflecting means (109), to the detector
(102). The reflected light spectra are analyzed by the
processor-controller (2200) to obtain analyte concentration levels.
Embodiments of patch units (10) with various configurations for
directing light from the light-emitting source (101) through the
tip (330) to the body and then back to the detector (102), are
discussed in U.S. Provisional Patent Application No. 61/004,039,
the disclosure of which is incorporated herein by reference in its
entirety.
[0109] FIGS. 16a-17c illustrate embodiments of the two-part patch
unit (10) having a dispensing apparatus (1005) and a monitoring
apparatus (1006). The dispensing apparatus (1005) includes the
driving and pumping mechanisms (not shown in FIGS. 16a-17c) in the
reusable part (100), and reservoir (220) and delivery tube (230) in
the disposable part (200). The dispensing apparatus (1005) delivers
fluid from the reservoir (220) through the delivery tube (230) via
the pumping mechanism (not shown in FIGS. 16a-17c) through the tip
(330) to the body. The monitoring apparatus (1006) contains
light-emitting source (101) and detector (102) located in the
reusable part (100), optical fiber (106) and lens (105) which can
be located in the reusable part (100) or disposable part (200).
Deflecting means (109) can include a reflecting mirror (108), which
directs the light (300) to and from the body. In some embodiments,
an additional optical coupler (190) may be present between the
reusable (100) and disposable (200) parts, and/or at the distal end
of the tip (330). The optical coupler (190) may include without
limitation a window inclined at a certain angle (e.g., 8 degrees)
to ensure that reflected light is not coupled back from the tissue
to the optical fiber (106).
[0110] FIGS. 16a-c show an embodiment of the two-part patch unit
(10) comprising dispensing apparatus (1005) and monitoring
apparatus (1006). The monitoring apparatus (1006) includes lens
(105), for focusing the light (300) passing between the reusable
part (100) and disposable part (200). In some embodiments, the
optical lens (105) serves as collimating means, or focusing means,
for narrowing down the scattering of the emitted and returning
light. The lens may be made from a variety of suitable materials,
including without limitation, plastic, glass, or crystal. Use of a
plastic lens may be more cost-effective; however, glass and crystal
have superior optical properties.
[0111] FIG. 16a and FIG. 16b show a side-view and a top-view,
respectively, of the patch unit (10) with the lens (105) located
between the reusable and disposable parts (100, 200). FIG. 16c
shows an enlarge view of the contact surfaces between the reusable
part (100) and disposable part (200) and the passage of light (300)
between the two parts via the lens (105).
[0112] FIGS. 17a-c show a side-view (FIG. 17a) and a top-view (FIG.
17b) of the two-part patch unit (10) having a dispensing apparatus
(1005) and a monitoring apparatus (1006). The light path through
the monitoring apparatus (1006) includes two aligned optical
windows (110, 111) located in the reusable part (100) and
disposable part (200), respectively, and enabling passage of light
(300) between the two parts. The optical windows (110, 111) serve
as means for allowing the passage of light (300) between the
reusable (100) and disposable (200) parts. FIG. 17c shows direction
(300) of light passing between the reusable part (100) and
disposable part (200) and going through optical fibers (106) and
the two optical windows (110, 111). In some embodiments, the two
windows (110, 111) may be, both or separately, inclined by for
example, about an eight-degree angle to prevent backwards optical
reflection into the optical fiber (106). In other embodiments, the
two optical windows (110, 111) are made of material, which is
translucent to light in the wavelengths relevant for detecting
analyte concentration levels, allowing for light to pass through
the windows (110, 111). The windows (110, 111) can be made from a
variety of suitable materials, including without limitation,
plastic, glass, or crystal. In some embodiments, the optical
windows (110, 111) serve as focusing means, so that when the
emitted or returned light passes through them, they narrow down any
possible scattering of the light.
[0113] The monitoring apparatus (1006) can use any one of the
following optical means: [0114] Near-Infrared (NIR) spectroscopy:
NIR transmission and reflectance measurements of glucose are based
on the fact that glucose-specific properties are embedded within
the NIR spectra and can be extracted by using multivariate analysis
methods (Diab Tech Ther 2004; 6(5): 660-697, Anal. Chem. 2005, 77:
4587-4594). [0115] Mid-IR spectroscopy: This range contains
absorbance fingerprints generated by the highly specific and
distinctive fundamental vibrations of biologically important
molecules such as glucose, proteins, and water. Two strong bands of
glucose are found at 9.25 .mu.m and 9.65 .mu.m. [0116] Light
scattering: Light scattering is measured by a localized reflectance
(spatially resolved diffuse reflectance) or NIR frequency domain
reflectance techniques. In the localized reflectance, a narrow beam
of light illuminates a restricted area on the surface of a body
part, and reflected signals are measured at several distances from
the illumination point. Both localized reflectance measurements and
frequency domain measurements are based on changes in glucose
concentration, which affects the refractive index mismatch between
the ISF and tissue fibers. [0117] Raman spectroscopy: The Raman
Effect is a fundamental process in which energy is exchanged
between light and matter. In Raman spectroscopy, the incident
light, often referred to as `excitation` light, excites the
molecules into vibration motion. Since light energy is proportional
to frequency, the frequency change of this scattered light must
equal the vibration frequency of the scattering molecules. This
process of energy exchange between scattering molecules and
incident light is known as the Raman Effect. The Raman scattered
light can be collected by a spectrometer and displayed as a
`spectrum`, in which its intensity is displayed as a function of
its frequency change. Since each molecular species has its own
unique set of molecular vibrations, the Raman spectrum of a
particular species will consist of a series of peaks or `bands`,
each shifted by one of the characteristic vibration frequencies of
that molecule. Thus, Raman spectroscopy can be employed to
accurately measure tissue and blood concentrations of glucose
(Phys. Med. Biol. 2000 45 (2) R1-R59). [0118] Fluorescence energy
transfer (FRET)-based assay: Concanavalin A is labeled with the
highly NIR-fluorescent protein allophycocyanin as donor and dextran
labeled with malachite green as the acceptor (J Photochem Photobiol
2000; 54: 26-34; Anal Biochem 2001; 292: 216-221). Competitive
displacement of the dextran from binding to the lectin occurs when
there are increasing glucose concentrations, leading to a reduction
in FRET, measured as intensity or lifetime (time-correlated
single-photon counting). [0119] Photoacoustic method:
Photoacoustics ("PA") involves ultrasonic waves created by the
absorption of light. A medium is excited by a laser pulse at a
wavelength that is absorbed by a particular molecular species in
the medium. Light absorption and subsequent radiation-less decay
cause microscopic localized heating in the medium, which generates
an ultrasound pressure wave that is detectable by a hydrophone or a
piezoelectric device. Analysis of the acoustic signals can map the
depth profile of the absorbance of light in the medium. Glucose
trends can be tracked by the photoacoustic technique which can work
as a noninvasive instrument for the monitoring of blood glucose
concentrations (Clin Chem 1999 45(9): 1587-95).
[0120] FIGS. 18-19 show embodiments of the two-part patch unit (10)
having a reusable part (100) and a disposable part (200). The patch
unit (10) is connected to cradle unit (20) which is adherable to
the skin (5). The patch unit (10) contains dispensing and
monitoring apparatuses (not shown in FIGS. 18-19) that use tip
(330). In the shown embodiments, the tip (330) issemi-permeable or
permeable, allowing for diffusion of analyte molecules into the tip
(330) across its membrane wall. The dispensed fluid (e.g., insulin)
is used as a solution within the tip (330) into which molecules
from the surrounding ISF can diffuse. Diffusion of analyte
molecules across the semi-permeable or permeable membrane follows
the direction of the concentration gradient. The analyte
concentration within the tip (330) is proportional or equal to the
analyte concentration in the surrounding ISF depending on the
recovery time, which is defined as the time for achieving
concentration equilibrium.
[0121] FIG. 18 shows an embodiment of the patch unit (10) that is
connected to the single subcutaneously insertable tip (330). The
tip (330) includes a semi-permeable membrane allowing diffusion of
low molecular weight molecules (13) (e.g., glucose) while providing
a barrier for high molecular weight molecules (14).
[0122] FIG. 19 shows an embodiment in which the tip (330) includes
a permeable membrane which is permeable for both small molecular
weight molecules (13) and large molecular weight (14) molecules.
The permeable tip can be cheaper and allows rapid recovery time but
renders specific analyte (usually consisting of small molecular
weight molecules) monitoring less accurate.
[0123] In some embodiments, the tip (330) that is used for
monitoring analyte concentration levels and for delivering fluid is
a microdialysis ("MD") or a microperfusion ("MP") probe, as known
in the art. The probe may be perfused with the dispensed fluid
(e.g., insulin), or with an additional/alternative perfusion fluid
(e.g., saline). The tip membrane may be either semi-permeable or
permeable. MD probes are known in the art and examples of their
description can be found in U.S. Pat. No. 4,694,832 to Ungerstedt,
as well as from the document of CMA/Microdialysis AB Company, under
the name "CMA 60 Microdialysis Catheter" or "CMA 70 Brain
Microdialysis Catheters". An MD probe coupled with a cannula for
insertion is also discussed in the published U.S. Pub. No.
2005/0119588 to Model et al.
[0124] FIGS. 20a-b show embodiments of the tip (330), in which the
MD tip (FIG. 20a) or the MP tip (FIG. 20b) is used and which is
similar to MD or MP probes known by those of ordinary skill in the
art, apart from the fact that it contains an opening at the bottom
(331), or on its side (332), allowing for fluid entering the tip
(33) to be delivered via the tip (330) from the patch unit (10) to
the user's body. Thus, the tip (330) in this embodiment, serves
both as a means for dispensing fluid into the body and as a MD or
MP probe for monitoring analyte concentrations.
[0125] In embodiments which are based on molecular diffusion and
the tip (330) is semi-permeable or permeable, the analyte sensing
means can be configured in one of the following configurations:
[0126] 1. Intrinsic configuration--the sensing means reside at the
tip and is located in the subcutaneous compartment. [0127] 2.
Extrinsic configuration--the sensing means reside within the patch
unit being located outside the subcutaneous compartment. The
analyte-rich fluid can be transferred to the patch unit, where
analyte concentration sensing can be performed outside the body. In
this configuration, the dispensing apparatus contains means for
transferring of analyte rich fluid from the distal end of the tip,
which is located subcutaneously to the proximal end of the tip that
is located within the patch (e.g., by reversing the direction of
fluid delivery).
[0128] Analyte sensing means can be based on electrochemical,
optical, acoustic, or any other analyte sensing means known by
those of ordinary skill in the art.
[0129] FIGS. 21a-b show a two-part patch unit (10) having reusable
(100) and disposable (200) parts. The patch unit (10) contains a
dispensing apparatus and a electrochemical monitoring apparatus,
and is connected to a cradle unit (20). The patch unit (10) can be
connected to tip (330) having a membrane which is semi-permeable or
permeable. The monitoring apparatus is provided with sensing means
(2000). FIGS. 21a and 21b show two configurations of the sensing
means (2000) within the tip (i.e., intrinsic) (FIG. 21a) and within
the patch (i.e., extrinsic) (FIG. 21b).
[0130] FIG. 21a shows an embodiment of a two-part patch unit (10)
that includes dispensing and monitoring apparatuses (not shown in
FIGS. 21a-b), which employs an intrinsic sensing means (2000). The
patch unit (10) is connected to cradle (20) that is adherable to
skin (5). The monitoring apparatus includes processor-controller
(2200) located in the reusable part (100), wires (2100) located in
reusable and disposable parts (100 and 200), and tip (330) with
sensing means (2000). The sensing means (2000) is located within
the tip (330) (intrinsic configuration). The tip (330) has a
permeable or semi-permeable membrane that allows analyte to diffuse
in the direction of the concentration gradient (illustrated by
arrows).
[0131] FIG. 21b shows an embodiment of a two-part patch unit (10)
that includes dispensing and monitoring apparatuses (not shown in
FIG. 21b) which employs an extrinsic sensing means. The patch unit
(10) is connected to cradle unit (20) that is adherable to skin
(5). The monitoring apparatus includes processor-controller (2200)
located in the reusable part (100), wires (2100) located in the
disposable part (200), and tip (330). The sensing means (2000) is
located within the patch (10), preferably in the disposable part
(200) (extrinsic configuration). The tip (330) has permeable or
semi-permeable membrane that allows analyte molecules to diffuse in
the direction of the concentration gradient (shown by arrows). The
dispensing apparatus contains means (not shown) for transferring
analyte-rich fluid from the tip (330) into the patch unit (10). One
method of such transfer includes reversing the direction of fluid
delivery, as disclosed in the co-owned, co-pending International
Patent Application No. PCT/US08/062,928 and U.S. patent application
Ser. No. 12/116,546, both of which claim priority to U.S.
Provisional Patent Application No. 60/928,054, the disclosures of
which are incorporated herein by reference in their entireties.
[0132] FIGS. 22a-c and 23 show embodiments of a two-part patch unit
(10) that includes a dispensing apparatus (1005) and an
electrochemical monitoring apparatus (1006). The patch unit (10)
includes a reusable part (100) and a disposable part (200) and is
connected to cradle unit (20), which is adherable to the skin (5).
The dispensing apparatus (1005) includes processor-controller
(2200), driving mechanism (114) and pumping mechanism (116),
located in the reusable part (100), and reservoir (220) and
delivery tube (230), located in the disposable part (200). The
monitoring apparatus (1006) includes the processor-controller
(2200) located in the reusable part (100), wires (2100), connectors
(405), and electrochemical sensing means, which can be intrinsic or
extrinsic.
[0133] FIG. 22a shows an exemplary embodiment of an
electrochemical-based monitoring apparatus (1006) that contains an
intrinsic configuration of a sensing means. The sensing means is
located on the tip (330) in the subcutaneous compartment and
includes a working electrode (120), counter electrode (121), and
reference electrode (122). The electrodes can be located
longitudinally on the outer or inner side of the tip. Current is
transferred from electrodes by wires (2100) and connectors (405) to
the processor-controller (2200).
[0134] FIGS. 22b and 22c show a transverse cross-sectional view
(FIG. 22b) and isometric view (FIG. 22c) of concentrically,
ring-like, electrodes (120, 121, 122) located transversally on the
inner side of the tip (330). In the shown embodiment, the tip (330)
is either permeable or semi-permeable. In some embodiments, the
electrodes can be located on the outer side of the tip (330). The
tip (330) may be circular, oval, rectangular, have a flat outer
contour, or any other shape. The tip (330) may be non-permeable or
semi-permeable and the electrodes can be located on the outer or
inner surface of the tip (330).
[0135] FIG. 23 shows an embodiment of an electrochemical-based
monitoring apparatus (1006) that contains extrinsic sensing means.
Sensing means (2000) is located on the tip (330) within the patch
unit (10) and can include at least one working electrode (120),
counter electrode (121) or reference electrode (122). The
electrodes can be located on the outer or inner surface of the tip
(330). Current is transfer from electrodes by wires (2100) and
connectors (405) to the processor-controller (2200). Analyte-rich
solution from the subcutaneous tip portion (distal end of the tip)
can reach the sensing means (proximal end of the tip) by diffusion
along the tip (following the concentration gradient within the tip)
or by forcible fluid transfer (e.g., due to reverse flow of the
fluid within the tip created by reversing the pumping mechanism
direction).
[0136] FIGS. 24-25 show embodiments of a two-part patch unit (10)
that includes a dispensing apparatus (1005) and an optical-based
monitoring apparatus (1006). The patch unit (10) includes reusable
part (100) and disposable part (200) and is connected to cradle
unit (20), which is adherable to the skin (5). The dispensing
apparatus (1005) includes processor-controller (2200), driving
mechanism (114) and pumping mechanism (116) located in the reusable
part (100), and reservoir (220) and delivery tube (230) located in
the disposable part (200). The monitoring apparatus (1006) includes
light-emitting source (101), detector (102), and
processor-controller (2200), located in the reusable part (100),
wires (2100) and connectors (405) located in both parts. The tip
(330) can be permeable or semi-permeable. The optical sensing means
can be either intrinsic (FIG. 24) or extrinsic (FIG. 25). Optical
means, e.g., windows, lens, may be deployed between the reusable
(100) and disposable (200) parts for more efficient passage of
light (300) between the two parts.
[0137] FIG. 24 shows an embodiment of two-part patch unit (10) that
includes a dispensing apparatus (1005) and monitoring apparatus
(1006). The dispensing apparatus (1005) includes
processor-controller (2200), driving mechanism (114) and pumping
mechanism (116) located in the reusable part (100), and reservoir
(220) and delivery tube (230) located in the disposable part (200).
The optical-based monitoring apparatus (1006) contains an intrinsic
sensing means (2002). The sensing mechanism, including the
light-emitting source (101) and detector (102), is located within
the patch unit (10), and the sensing means (2000) is located in the
tip (330). The sensing means (2000) resides in the subcutaneous
compartment and includes at least one reflecting mirror (190).
Direction (300) of light emitted from the source (101) is deflected
by deflecting means (109) into tip (330) and the light is reflected
by mirror (190) towards the deflecting means (109) and detector
(102), to be analyzed by the processor-controller (2200). The tip
(330) can be permeable or semi-permeable, thus the analyte of
interest (i.e., glucose) can flow in the direction of the
concentration gradient. Optical spectral analysis can be achieved
when light passes through the analyte-rich solution within the tip
(330).
[0138] FIG. 25 shows an embodiment of a two-part patch unit (10)
that includes a dispensing apparatus (1005) and a monitoring
apparatus (1006). The dispensing apparatus (1005) includes
processor-controller (2200), driving mechanism (114) and pumping
mechanism (116), located in the reusable part (100), and reservoir
(220) and delivery tube (230), located in the disposable part
(200). The optical-based monitoring apparatus (1006) contains an
extrinsic sensing means. Some elements of the sensing means,
including the light-emitting source (101) and detector (102) are
located within the patch unit (10). Direction (300) of light (300)
emitted from source (101) is directed towards the analyte-rich
fluid, and is reflected by mirror (109) back to detector (102), to
be analyzed by the processor-controller (2200). The tip (330) can
be permeable or semi-permeable, thus the analyte of interest (e.g.,
glucose) can flow in direction of the concentration gradient.
Optical spectral analysis can be achieved when light passes through
the analyte-rich solution within the tip (330). Analyte-rich
solution from the subcutaneous tip portion (distal end of tip) can
reach the sensing means within the patch unit (10) for sensing
(proximal end of cannula) either by diffusion along the tip (330)
(following the concentration gradient) or by active fluid transfer
(e.g., due to backward flow of the fluid within the tip created by
reversing the direction of movement of the pumping mechanism).
[0139] FIG. 26a shows an embodiment of a patch unit (10) that
contains a dispensing apparatus and monitoring apparatus. The
monitoring apparatus contains an extrinsic sensing means (2000)
wired to a processor-controller (2200) connected to the electronic
components (130). The dispensing apparatus employs driving
mechanism (114) and a peristaltic pumping mechanism composed of a
rotary wheel (112), which dispenses fluid in the direction of
rotation (clockwise or counter clockwise) from the reservoir (220)
via a delivery tube (230). Accordingly, flow can be delivered
forward (from patch unit (10) to tip (330)) and backward (form tip
(330) to patch unit (10)). The monitoring apparatus can employ
electrochemical or optical sensing. Delivery of analyte-rich fluid
from the distal end of the tip (330) to the proximal end within the
patch unit (10) brings to the sensing means (2000) within the patch
unit (10) a solution which contains analyte concentration identical
(or at a known ratio) to that in the ISF.
[0140] FIG. 26b shows an embodiment of a patch unit (10) that
contains both dispensing and monitoring apparatuses. The monitoring
apparatus contains extrinsic sensing means (2000) wired via
connectors (410) to processor-controller (2200) connected to the
electronics (130) residing in the reusable part (100). The
dispensing apparatus employs, for example, a syringe type pumping
mechanism (116). The driving mechanism (114) can push or pull the
piston rod (118) which is paired with a plunger (119). Accordingly,
flow can be delivered forward via the reservoir (220) in the
disposable part (200) (from patch unit (10) to tip (330)) and
backward (from tip (330) to patch unit (10)). Delivery of
analyte-rich fluid from the distal end of the tip (330) to the
proximal end within the patch unit (10) brings to the sensing means
(2000) within the patch unit (10) a solution which contains analyte
concentration identical (or at a known ratio) to that in the
ISF.
[0141] FIGS. 27a-b shows embodiments of the patch unit (10) having
dispensing and monitoring apparatuses and configurations of
electrical wires (2100). The monitoring apparatus (1006) includes
intrinsic electrochemical sensing means. The dispensing apparatus
(1005) includes electronics (130), processor-controller (2200),
driving mechanism (114) and pumping mechanism (116), located in the
reusable part (100), and reservoir (220) and delivery tube (230),
located in the disposable part (200).
[0142] In FIG. 27a, electrical current generated on the electrodes
(120, 121, 122) are delivered by wires (2100) to a set of contacts
(406) at the proximal end of the tip (330). A set of contacts (405)
transfer the electrical current from the disposable part (200) to
the reusable part (100) and to the processor-controller (2200).
[0143] In FIG. 27b, electrical current generated on the electrodes
(120, 121, and 122) are delivered by wires (2100) to a set of
contacts (407) at the proximal end of the tip (330). An additional
set of contacts (408) transfer the electrical current from the
cradle unit (20) to the reusable part (100) and to the
processor-controller (2200).
[0144] FIG. 28 shows one embodiment of the device that includes
patch unit (10) and can include remote control unit (40). The patch
unit (10) can be connected to cradle unit (20) and to tip (330).
The patch unit (10) contains dispensing apparatus (1005) and
monitoring apparatus (1006). The dispensing apparatus delivers
fluid according to analyte concentration levels that are monitored
by the monitoring apparatus (1006). The device can function as a
closed loop or semi-closed loop system.
[0145] In some embodiments, insulin is dispensed according to
bodily glucose levels and thus the system functions as closed loop
system and is known in the art as an "artificial pancreas." In some
embodiments, the patch unit (10) can include two parts--reusable
part (100) and disposable part (200) --and can include buttons for
inputting flow programs.
[0146] In the semi-closed loop system, additional inputs from the
user (e.g., meal times, changes in basal insulin delivery rates, or
boluses before meals) are used within a specific algorithm, to
calculate the amount of insulin to be delivered by the dispensing
apparatus (1005), as well as inputs from the monitoring apparatus
(1006). User inputs can be done with the remote control unit (40)
or with the buttons (not shown) on the patch unit (10).
[0147] In some embodiments, the patch unit (10) may be connected to
a remote control unit (40) that controls the patch unit (10), where
the remote control unit (40) further includes a blood glucose
monitoring component that allows monitoring and controlling blood
glucose levels in the body of the patient. Similar to the
embodiments described above, the patch unit (10) may include a
dual-purpose tip (330) and can be a one-part or a two-part patch
unit. Further, the patch unit (10) may include the cradle unit
(20), which can be adhered to the skin of the patient and
accommodate insertion of the tip (330). In some embodiments, the
patch unit (10) can be configured not to include the cradle unit
(20).
[0148] Although particular embodiments have been disclosed herein
in detail, this has been done by way of example for purposes of
illustration only, and is not intended to be limiting with respect
to the scope of the appended claims, which follow. In particular,
it is contemplated that various substitutions, alterations, and
modifications may be made without departing from the spirit and
scope of the invention as defined by the claims. Other aspects,
advantages, and modifications are considered to be within the scope
of the following claims. The claims presented are representative of
the inventions disclosed herein. Other, unclaimed inventions are
also contemplated. The applicant reserves the right to pursue such
inventions in later claims.
[0149] Any patents, patent applications, articles and published and
non-published documents referred to above are herein incorporated
by reference in their entirety.
* * * * *