U.S. patent application number 13/462752 was filed with the patent office on 2012-08-23 for sensing systems and methods.
This patent application is currently assigned to Medtronic MiniMed, Inc.. Invention is credited to Paul F. Bente, IV, Ian B. Hanson.
Application Number | 20120215163 13/462752 |
Document ID | / |
Family ID | 47192230 |
Filed Date | 2012-08-23 |
United States Patent
Application |
20120215163 |
Kind Code |
A1 |
Hanson; Ian B. ; et
al. |
August 23, 2012 |
SENSING SYSTEMS AND METHODS
Abstract
A fluidic media detection system for detecting a presence of
fluidic media includes a first housing portion adapted to be
carried by a user; a second housing portion configured to be
selectively operatively engaged with and disengaged from the first
housing portion, the second housing portion for supporting a
reservoir having an interior volume for containing fluidic media; a
fluid conduit supported by one of the first housing portion and the
second housing portion for providing fluid communication between
the reservoir and the user when the first housing portion and the
second housing portion are operatively engaged; and at least one
interactive element, positioned near a portion of the fluid
conduit, that interacts with the fluidic media when the fluidic
media is present in the fluid conduit.
Inventors: |
Hanson; Ian B.; (Wayne,
PA) ; Bente, IV; Paul F.; (Wayne, PA) |
Assignee: |
Medtronic MiniMed, Inc.
|
Family ID: |
47192230 |
Appl. No.: |
13/462752 |
Filed: |
May 2, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12650378 |
Dec 30, 2009 |
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13462752 |
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12650287 |
Dec 30, 2009 |
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12650378 |
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13235288 |
Sep 16, 2011 |
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12650287 |
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61561801 |
Nov 18, 2011 |
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Current U.S.
Class: |
604/67 ; 29/428;
29/592.1; 604/264 |
Current CPC
Class: |
A61M 2005/14268
20130101; G01B 7/14 20130101; Y10T 29/49002 20150115; A61M 2205/14
20130101; A61M 5/1413 20130101; A61M 2005/14252 20130101; A61M
2039/1072 20130101; Y10T 29/49826 20150115; Y10T 29/49208 20150115;
A61M 2230/201 20130101; A61M 5/1456 20130101; G01R 3/00 20130101;
A61M 5/1723 20130101; A61M 5/162 20130101; A61M 5/14244 20130101;
A61M 5/14248 20130101; A61M 2205/6054 20130101; A61M 2005/1585
20130101 |
Class at
Publication: |
604/67 ; 604/264;
29/428; 29/592.1 |
International
Class: |
A61M 5/00 20060101
A61M005/00; H05K 13/00 20060101 H05K013/00; B23P 17/04 20060101
B23P017/04 |
Claims
1. A fluidic media detection system for detecting a presence of
fluidic media, the system comprising: a first housing portion
adapted to be carried by a user; a second housing portion
configured to be selectively operatively engaged with and
disengaged from the first housing portion, the second housing
portion for supporting a reservoir having an interior volume for
containing fluidic media; a fluid conduit supported by one of the
first housing portion and the second housing portion for providing
fluid communication between the reservoir and the user when the
first housing portion and the second housing portion are
operatively engaged; and at least one interactive element,
positioned near a portion of the fluid conduit, that interacts with
the fluidic media when the fluidic media is present in the fluid
conduit.
2. The system of claim 1, wherein the fluid conduit comprises a
cannula for insertion into the skin of the user to allow the
fluidic media to flow into the body of the user.
3. The system of claim 1, wherein the fluid conduit provides fluid
communication between the reservoir and a cannula for insertion
into the skin of the user to allow the fluidic media to flow into
the body of the user.
4. The system of claim 1, wherein the fluid conduit is supported by
the first housing portion.
5. The system of claim 1, wherein the at least one interactive
element comprises at least one sensor arranged to detect a
parameter or the characteristic of the fluidic media when the
fluidic media is in the fluid conduit, the at least one sensor
configured to provide an output signal indicating that the fluidic
media is detected in the fluid conduit.
6. The system of claim 5, the system further comprising: an
indication device controlled by the output signal to notify the
user when fluidic media is detected.
7. The system of claim 5, wherein the indicator device produces one
of an audible and tactical feedback when fluidic media is
detected.
8. The system of claim 1, wherein the at least one interactive
element comprises at least one electrical component configured to
detect a change in at least one electrical characteristic of the
fluid conduit or the fluidic media when the fluidic media is
present in the fluid conduit, the at least one electrical component
configured to provide an output signal indicating that the fluidic
media is detected in the fluid conduit.
9. The system of claim 1, wherein the at least one interactive
element comprises at least one optical receiver configured to
detect a change in light when the fluidic media is in the fluid
conduit, the at least one optical receiver configured to provide an
output signal indicating that fluidic media is detected in the
fluid conduit.
10. The system of claim 1, wherein the at least one interactive
element comprises at least one reactive element, positioned near a
portion of the fluid conduit, that reacts with at least one
component within or characteristic of the fluidic media when the
fluidic media is present in the fluid conduit.
11. The system of claim 10, wherein the at least one reactive
element comprises at least one chemical, positioned near the fluid
conduit, that reacts with at least one component within the fluidic
when the fluidic media is present in the fluid conduit.
12. The system of claim 11, wherein a product of a chemical
reaction, between the at least one chemical and the at least one
component within the fluidic media, is a colored complex.
13. The system of claim 12, the system further comprising: an
optical receiver configured to detect a change in light when the
colored complex is created by the chemical reaction, the optical
receiver configured to provide an output signal indicating that
fluidic media is detected.
14. The system of claim 13, the system further comprising: a light
conducting element that guides light from a point near the fluid
conduit to the optical receiver.
15. The system of claim 14, wherein the light conducting element is
at least one fiber optic cable.
16. The system of claim 14, wherein the light conducting element is
a fluid connector in communication with the fluid conduit.
17. The system of claim 11, wherein the at least one chemical is
embedded in the fluid conduit.
18. The system of claim 11, wherein the fluid conduit is
impregnated with the at least one chemical.
19. The system of claim 1, the system further comprising: a rosette
positioned near the fluid conduit; wherein the at least one
interactive element comprises at least one electrical component
coupled to the rosette to detect a change in at least one
electrical characteristic associated with the rosette when fluidic
media is present in the fluid conduit.
20. The system of claim 19, wherein the rosette is a closed
circuit, such that impedance across the rosette decreases as
fluidic media nears the fluid conduit.
21. The system of claim 19, wherein the rosette is an open circuit,
such that the circuit is closed when fluidic media nears the fluid
conduit.
22. The system of claim 19, wherein the at least one electrical
component detects voltage across the rosette.
23. The system of claim 19, wherein the at least one electrical
component detects impedance across the rosette.
24. The system of claim 19, wherein the at least one electrical
component detects capacitance across the rosette.
25. The system of claim 19, the system further comprising: an
indication device coupled to the electrical component to notify the
user when fluidic media is detected.
26. The system of claim 25, wherein the indicator device produces
one of an audible and tactical feedback when fluidic media is
detected.
27. The system of claim 19, wherein the rosette surrounds an
exterior surface of the fluid conduit, an interior surface of the
fluid conduit in contact with fluidic media when the fluidic media
is in the fluid conduit.
28. A method of manufacturing a fluidic media detection system for
detecting a presence of fluidic media, the method comprising:
adapting a first housing portion to be carried by a user;
configuring a second housing portion to be selectively operatively
engaged with and disengaged from the first housing portion, the
second housing portion for supporting a reservoir having an
interior volume for containing fluidic media; supporting a fluid
conduit by one of the first housing portion and the second housing
portion for providing fluid communication between the reservoir and
the user when the first housing portion and the second housing
portion are operatively engaged; and positioning at least one
interactive element near a portion of the fluid conduit, that
interacts with the fluidic media when the fluidic media is present
in the fluid conduit.
29. A medical device for treating a user, the medical device
comprising: a first housing portion adapted to be carried by a
user; a second housing portion configured to be selectively
operatively engaged with and disengaged from the first housing
portion; a plurality of electrical contacts provided on at least
one of the first housing portion and the second housing portion,
the plurality of electrical contacts including a set of main
electrical contacts and at least one other electrical contact; a
shorting mechanism provided on the other of the first housing
portion and the second housing portion, the shorting mechanism for
interacting with the set of main electrical contacts; a magnetic
source having at least one of a certain magnetic field and a
certain magnetic strength provided on at least one of the first
housing portion and the second housing portion; a sensor for
detecting at least one of the certain magnetic field and the
certain magnetic strength provided on the other of the first
housing portion and the second housing portion; and electronic
circuitry configured to provide a first signal in a case where the
first housing portion and the second housing portion are brought
together and the shorting mechanism interacts with the set of main
electrical contacts of the plurality of electrical contacts; the
electronic circuitry configured to provide a second signal in a
case where the first housing portion and the second housing portion
are brought together and the shorting mechanism interacts with the
at least one other electrical contact of the plurality of
electrical contacts; the electronic circuitry configured to provide
a first sensing signal in a case where the first housing portion
and the second housing portion are brought together and the sensor
detects at least one of the certain magnetic field and the certain
magnetic strength of the magnetic source; and the electronic
circuitry configured to provide a second sensing signal in a case
where the first housing portion and the second housing portion are
brought together and the sensor detects at least one of a magnetic
field different from the certain magnetic field and a magnetic
strength different from the certain magnetic strength of the
magnetic source.
30. The device according to claim 29, the device further
comprising: a user-perceptible indicator operatively coupled to the
electronic circuitry for providing a user-perceptible indication in
response to receiving one or more of the first signal, the second
signal, the first sensing signal, and the second sensing
signal.
31. The device according to claim 30, wherein the user-perceptible
indication comprises at least one of an audible indication, a
visual indication, and a tactile indication.
32. The device according to claim 30, wherein the user-perceptible
indicator provides a first type of indication when the first
sensing signal is received from the electronic circuitry and a
second type of indication when at least one of the second signal
and the second sensing signal is received from the electronic
circuitry.
33. The device according to claim 29, the device further
comprising: a drive device supported by one of the first housing
portion and the second housing portion, the drive device for
selectively driving fluid from a reservoir; wherein the delivery
device further comprises control electronics operatively coupled to
the electronic circuitry for controlling the drive device based
upon receiving one or more of the signals from the electronic
circuitry.
34. The device according to claim 33, wherein the control
electronics is configured to inhibit operation of the drive device
unless the first sensing signal is received.
35. The device according to claim 33, wherein the control
electronics is configured to begin operation of the drive device
upon receiving the first sensing signal.
36. The device of claim 33, the electronic circuitry configured to
provide the first sensing signal for activating the control
circuitry in a case where the sensor detects a gauss level
exceeding a first pre-defined threshold value.
37. The device of claim 36, wherein the sensor comprises a magnetic
threshold switch.
38. The device of claim 29, the magnetic source having a certain
magnetic field direction; the sensor for detecting the certain
magnetic field direction; the electronic circuitry configured to
provide the first sensing signal when the sensor detects the
certain magnetic field direction.
39. The device of claim 38, the electronic circuitry configured to
provide the second sensing signal when the sensor detects a
magnetic field direction different from the certain magnetic field
direction.
40. The device of claim 29, wherein the certain magnetic field
includes a direction, the sensor configured for detecting the
direction.
41. The device of claim 29, wherein the first signal causes the
sensor to begin detecting the at least one of the certain magnetic
field and the certain magnetic strength.
42. The device of claim 29, wherein the set of main electrical
contacts interact with the shorting mechanism when the shorting
mechanism contacts the set of main electrical contacts; the
electronic circuitry configured to provide the first signal when
the shorting mechanism contacts the set of main electrical contacts
of the plurality of electrical contacts; the electronic circuitry
configured to provide the second signal when the shorting mechanism
contacts the at least one other electrical contact of the plurality
of electrical contacts.
43. The device of claim 29, the shorting mechanism having a
plurality of ends, each of the ends for interacting with a
respective main electrical contact of the set of main electrical
contacts; the electronic circuitry configured to provide the first
signal when each of the ends of the shorting mechanism interacts
with the respective main electrical contact of the set of main
electrical contacts; the electronic circuitry configured to provide
the second signal when at least one of the ends of the shorting
mechanism interacts with the at least one other electrical contact
of the plurality of electrical contacts.
44. The device of claim 43, the set of main electrical contacts
comprising a first main electrical contact and a second main
electrical contact; the plurality of ends of the shorting mechanism
including a first end and a second end for interacting with the
first main electrical contact and the second main electrical
contact; the electronic circuitry configured to provide the first
signal when the first end and the second end of the shorting
mechanism interacts with the first main electrical contact and the
second main electrical contact of the plurality of electrical
contacts; the electronic circuitry configured to provide the second
signal when at least one of the first end and the second end of the
shorting mechanism interacts with the at least one other electrical
contact of the plurality of electrical contacts.
45. The device of claim 29, wherein at least one of the at least
one other electrical contact is arranged between the set of main
electrical contacts.
46. The device of claim 29, wherein at least some of the set of
main electrical contacts are arranged to be outermost electrical
contacts of the plurality of electrical contacts.
47. The device of claim 29, wherein all of the at least one other
electrical contact is arranged in between the set of main
electrical contacts.
48. The device of claim 29, wherein the shorting mechanism is
configured to establish an electrical connection between the set of
main electrical contacts when the shorting mechanism interacts with
the set of main electrical contacts.
49. The device of claim 29, the device further comprising: a fluid
conduit supported by one of the first housing portion and the
second housing portion in a position to establish fluid
communication between a reservoir, supported by one of the first
housing portion and the second housing portion, and the user when
the first housing portion and the second housing portion are
operatively engaged; and at least one interactive element,
positioned near a portion of the fluid conduit, that interacts with
the fluidic media when the fluidic media is present in the fluid
conduit; the circuitry configured to provide a first positioning
signal in a case where the first housing portion and the second
housing portion are brought together and the at least one
interactive element interacts with the fluidic media when the
fluidic media is present in the fluid conduit.
50. The device according to claim 49, the device further
comprising: a drive device supported by one of the first housing
portion and the second housing portion, the drive device for
selectively driving fluidic media from the reservoir; wherein the
delivery device further comprises control electronics operatively
coupled to the electronic circuitry for controlling the drive
device based upon receiving one or more of the signals from the
electronic circuitry.
51. The device according to claim 50, wherein the control
electronics are configured to begin operation of the upon receiving
the first positioning signal.
52. A method of manufacturing a medical device for treating a user,
the method comprising: adapting a first housing portion to be
carried by a user; configuring a second housing portion to be
selectively operatively engaged with and disengaged from the first
housing portion; providing a plurality of electrical contacts on at
least one of the first housing portion and the second housing
portion, the plurality of electrical contacts including a set of
main electrical contacts and at least one other electrical contact;
providing a shorting mechanism on the other of the first housing
portion and the second housing portion, the shorting mechanism for
interacting with the set of main electrical contacts; providing a
magnetic source having at least one of a certain magnetic field and
a certain magnetic strength on at least one of the first housing
portion and the second housing portion; providing a sensor for
detecting at least one of the certain magnetic field and the
certain magnetic strength on the other of the first housing portion
and the second housing portion; configuring electronic circuitry to
provide a first signal in a case where the first housing portion
and the second housing portion are brought together and the
shorting mechanism interacts with the set of main electrical
contacts of the plurality of electrical contacts; configuring the
electronic circuitry to provide a second signal in a case where the
first housing portion and the second housing portion are brought
together and the shorting mechanism interacts with the at least one
other electrical contact of the plurality of electrical contacts;
configuring the electronic circuitry to provide a first sensing
signal in a case where the first housing portion and the second
housing portion are brought together and the sensor detects at
least one of the certain magnetic field and the certain magnetic
strength of the magnetic source; configuring the electronic
circuitry to provide a second sensing signal in a case where the
first housing portion and the second housing portion are brought
together and the sensor detects at least one of a magnetic field
different from the certain magnetic field and a magnetic strength
different from the certain magnetic strength of the magnetic
source.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application relates to and claims priority from U.S.
Provisional Application 61/561,801, filed Nov. 18, 2011,
incorporated herein by reference in its entirety. This application
is a Continuation-In-Part of U.S. application Ser. No. 12/650,287,
filed Dec. 30, 2009, incorporated herein by reference in its
entirety. This application is a Continuation-In-Part of U.S.
application Ser. No. 12/650,378, filed Dec. 30, 2009, incorporated
herein by reference in its entirety. This application is a
Continuation-In-Part of U.S. application Ser. No. 13/235,288, filed
Sep. 16, 2011, incorporated herein by reference in its
entirety.
BACKGROUND
[0002] 1. Field
[0003] Embodiments of the present invention relate generally to
medical device systems and methods and, in specific embodiments, to
systems and methods for detecting alignment, connection, and/or
positioning of components of medical devices.
[0004] 2. Related Art
[0005] According to modern medical techniques, certain chronic
diseases may be treated by delivering a medication or other
substance to the body of a patient. For example, diabetes is a
chronic disease that is commonly treated by delivering defined
amounts of insulin to a patient at appropriate times.
Traditionally, manually operated syringes and insulin pens have
been employed for delivering insulin to a patient. More recently,
modern systems have been designed to include programmable pumps for
delivering controlled amounts of medication to a patient.
[0006] Pump type delivery devices have been configured in external
devices, which connect to a patient, and have been configured in
implantable devices, which are implanted inside of the body of a
patient. External pump type delivery devices include devices
designed for use in a stationary location, such as a hospital, a
clinic, or the like, and further include devices configured for
ambulatory or portable use, such as devices designed to be carried
by a patient, or the like. External pump-type delivery devices may
contain reservoirs of fluidic media, such as, but is not limited
to, insulin.
[0007] External pump-type delivery devices may be connected in
fluid flow communication to a patient or user-patient, for example,
through suitable hollow tubing. The hollow tubing may be connected
to a hollow needle that is designed to pierce the skin of the
patient and to deliver fluidic media there through. Alternatively,
the hollow tubing may be connected directly to the patient as
through a cannula, or the like.
[0008] Examples of some external pump type delivery devices are
described in U.S. patent application Ser. No. 11/211,095, filed
Aug. 23, 2005, titled "Infusion Device And Method With Disposable
Portion" and Published PCT Application WO 01/70307 (PCT/US01/09139)
titled "Exchangeable Electronic Cards For Infusion Devices" (each
of which is owned by the assignee of the present invention),
Published PCT Application WO 04/030716 (PCT/US2003/028769) titled
"Components And Methods For Patient Infusion Device," Published PCT
Application WO 04/030717 (PCT/US2003/029019) titled "Dispenser
Components And Methods For Infusion Device," U.S. Patent
Application Publication No. 2005/0065760 titled "Method For
Advising Patients Concerning Doses Of Insulin," and U.S. Pat. No.
6,589,229 titled "Wearable Self-Contained Drug Infusion Device,"
each of which is incorporated herein by reference in its
entirety.
[0009] External pump-type delivery devices may be connected in
fluid-flow communication to a patient-user, for example, through
suitable hollow tubing. The hollow tubing may be connected to a
hollow needle that is designed to pierce the patient-user's skin
and deliver an infusion medium to the patient-user. Alternatively,
the hollow tubing may be connected directly to the patient-user as
or through a cannula or set of micro-needles.
[0010] In contexts in which the hollow tubing is connected to the
patient-user through a hollow needle that pierces skin of the
user-patient, a manual insertion of the needle into the
patient-user can be somewhat traumatic to the user-patient.
Accordingly, insertion mechanisms have been made to assist the
insertion of a needle into the user-patient, whereby a needle is
forced by a spring to move quickly from a retracted position into
an extended position. As the needle is moved into the extended
position, the needle is quickly forced through the skin of the
user-patient in a single, relatively abrupt motion that can be less
traumatic to certain user-patients as compared to a slower, manual
insertion of a needle. While a quick thrust of the needle into the
skin of the user-patient may be less traumatic to some
user-patients than a manual insertion, it is believed that, in some
contexts, some user-patients may feel less trauma if the needle is
moved a very slow, steady pace.
[0011] Examples of insertion mechanisms that may be used with and
may be built into a delivery device are described in: U.S. patent
application Ser. No. 11/645,435, filed Dec. 26, 2006, titled
"Infusion Medium Delivery system, Device And Method With Needle
Inserter And Needle Inserter Device And Method,"; and U.S. patent
application Ser. No. 11/211,095, filed Aug. 23, 2005, titled
"Infusion Device And Method With Disposable Portion" (each of which
is assigned to the assignee of the present invention), each of
which is incorporated herein by reference in its entirety. Other
examples of insertion tools are described in U.S. Patent
Application Publication No. 2002/0022855, titled "Insertion Device
For An Insertion Set And Method Of Using The Same" (assigned to the
assignee of the present invention), which is incorporated herein by
reference in its entirety. Other examples of needle/cannula
insertion tools that may be used (or modified for use) to insert a
needle and/or cannula, are described in, for example U.S. patent
application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled
"Auto Insertion Device For Silhouette Or Similar Products," and/or
U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and
entitled "Insertion Device For Insertion Set and Method of Using
the Same," both of which are incorporated herein by reference in
their entirety. Further examples of various insertion tools are
described in, but are not limited to, U.S. patent application Ser.
No. 11/645,972, filed Dec. 26, 2006, "Infusion Medium Delivery
System, Device And Method With Needle Inserter And Needle Inserter
Device And Method"; U.S. patent application Ser. No. 11/646,052,
filed Dec. 26, 2006, "Infusion Medium Delivery System, Device And
Method With Needle Inserter And Needle Inserter Device And Method";
U.S. patent application Ser. No. 11/646,000, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method," all of which are
herein incorporated by reference in their entirety.
[0012] Pump-type delivery devices can allow accurate doses of
insulin to be calculated and delivered automatically to a
patient-user at any time during the day or night. Furthermore, when
used in conjunction with glucose sensors or monitors, insulin pumps
may be automatically controlled to provide appropriate doses of
infusion medium at appropriate times of need, based on sensed or
monitored levels of blood glucose.
[0013] Pump-type delivery devices have become an important aspect
of modern medical treatments of various types of medical
conditions, such as diabetes. As pump technologies improve and as
doctors and patient-users become more familiar with such devices,
the popularity of external medical infusion pump treatment
increases and is expected to increase substantially over the next
decade.
SUMMARY OF THE DISCLOSURE
[0014] A fluidic media detection system for detecting a presence of
fluidic media includes (but is not limited to) a first housing
portion, a second housing portion, a fluid conduit, and at least
one interactive element. The first housing portion is adapted to be
carried by a user. The second housing portion is configured to be
selectively operatively engaged with and disengaged from the first
housing portion. The second housing portion for supporting a
reservoir having an interior volume for containing fluidic media.
The fluid conduit supported by one of the first housing portion and
the second housing portion for providing fluid communication
between the reservoir and the user when the first housing portion
and the second housing portion are operatively engaged. The at
least one interactive element positioned near a portion of the
fluid conduit, that interacts with the fluidic media when the
fluidic media is present in the fluid conduit.
[0015] In various embodiments, the fluid conduit comprises a
cannula for insertion into the skin of the user to allow the
fluidic media to flow into the body of the user.
[0016] In various embodiments, the fluid conduit provides fluid
communication between the reservoir and a cannula for insertion
into the skin of the user to allow the fluidic media to flow into
the body of the user.
[0017] In various embodiments, the fluid conduit is supported by
the first housing portion.
[0018] In various embodiments, the at least one interactive element
comprises at least one sensor arranged to detect a parameter or the
characteristic of the fluidic media when the fluidic media is in
the fluid conduit. The at least one sensor configured to provide an
output signal indicating that the fluidic media is detected in the
fluid conduit.
[0019] In some embodiments, the system further includes an
indication device controlled by the output signal to notify the
user when fluidic media is detected.
[0020] In some embodiments, the indicator device produces one of an
audible and tactical feedback when fluidic media is detected.
[0021] In various embodiments, the at least one interactive element
comprises at least one electrical component configured to detect a
change in at least one electrical characteristic of the fluid
conduit or the fluidic media when the fluidic media is present in
the fluid conduit. The at least one electrical component configured
to provide an output signal indicating that the fluidic media is
detected in the fluid conduit
[0022] In various embodiments, the at least one interactive element
comprises at least one optical receiver configured to detect a
change in light when the fluidic media is in the fluid conduit. The
at least one optical receiver configured to provide an output
signal indicating that fluidic media is detected in the fluid
conduit.
[0023] In various embodiments, the at least one interactive element
comprises at least one reactive element, positioned near a portion
of the fluid conduit, that reacts with at least one component
within or characteristic of the fluidic media when the fluidic
media is present in the fluid conduit.
[0024] In some embodiments, the at least one reactive element
comprises at least one chemical, positioned near the fluid conduit,
that reacts with at least one component within the fluidic when the
fluidic media is present in the fluid conduit.
[0025] In further embodiments, a product of a chemical reaction,
between the at least one chemical and the at least one component
within the fluidic media, is a colored complex.
[0026] In yet further embodiments, the system further includes an
optical receiver configured to detect a change in light when the
colored complex is created by the chemical reaction. The optical
receiver configured to provide an output signal indicating that
fluidic media is detected.
[0027] In even further embodiments, the system further includes a
light conducting element that guides light from a point near the
fluid conduit to the optical receiver.
[0028] In even further embodiments, the light conducting element is
at least one fiber optic cable.
[0029] In even further embodiments, wherein the light conducting
element is a fluid connector in communication with the fluid
conduit.
[0030] In further embodiments, the at least one chemical is
embedded in the fluid conduit.
[0031] In further embodiments, the fluid conduit is impregnated
with the at least one chemical.
[0032] In various embodiments, the system further includes a
rosette positioned near the fluid conduit. The at least one
interactive element comprises at least one electrical component
coupled to the rosette to detect a change in at least one
electrical characteristic associated with the rosette when fluidic
media is present in the fluid conduit.
[0033] In some embodiments, the rosette is a closed circuit, such
that impedance across the rosette decreases as fluidic media nears
the fluid conduit.
[0034] In some embodiments, the rosette is an open circuit, such
that the circuit is closed when fluidic media nears the fluid
conduit.
[0035] In some embodiments, the at least one electrical component
detects voltage across the rosette.
[0036] In some embodiments, the at least one electrical component
detects impedance across the rosette.
[0037] In some embodiments, the at least one electrical component
detects capacitance across the rosette.
[0038] In some embodiments, the system further includes an
indication device coupled to the electrical component to notify the
user when fluidic media is detected.
[0039] In further embodiments, the indicator device produces one of
an audible and tactical feedback when fluidic media is
detected.
[0040] In some embodiments, the rosette surrounds an exterior
surface of the fluid conduit. An interior surface of the fluid
conduit is in contact with fluidic media when the fluidic media is
in the fluid conduit.
[0041] A method of manufacturing a fluidic media detection system
for detecting a presence of fluidic media may include, but is not
limited to, any one or combination of: (i) adapting a first housing
portion to be carried by a user; (ii) configuring a second housing
portion to be selectively operatively engaged with and disengaged
from the first housing portion, the second housing portion for
supporting a reservoir having an interior volume for containing
fluidic media; (iii) supporting a fluid conduit by one of the first
housing portion and the second housing portion for providing fluid
communication between the reservoir and the user when the first
housing portion and the second housing portion are operatively
engaged; and (iv) positioning at least one interactive element near
a portion of the fluid conduit, that interacts with the fluidic
media when the fluidic media is present in the fluid conduit.
[0042] A medical device for treating a user includes, but is not
limited to, a first housing portion, a second housing portion, a
plurality of electrical contacts, a shorting mechanism, a magnetic
source, a sensor, and electronic circuitry. The first housing
portion adapted to be carried by a user. The second housing portion
configured to be selectively operatively engaged with and
disengaged from the first housing portion. The plurality of
electrical contacts provided on at least one of the first housing
portion and the second housing portion. The plurality of electrical
contacts includes a set of main electrical contacts and at least
one other electrical contact. The shorting mechanism provided on
the other of the first housing portion and the second housing
portion. The shorting mechanism for interacting with the set of
main electrical contacts. The magnetic source having at least one
of a certain magnetic field and a certain magnetic strength
provided on at least one of the first housing portion and the
second housing portion. The sensor for detecting at least one of
the certain magnetic field and the certain magnetic strength
provided on the other of the first housing portion and the second
housing portion. The electronic circuitry configured to provide a
first signal in a case where the first housing portion and the
second housing portion are brought together and the shorting
mechanism interacts with the set of main electrical contacts of the
plurality of electrical contacts. The electronic circuitry
configured to provide a second signal in a case where the first
housing portion and the second housing portion are brought together
and the shorting mechanism interacts with the at least one other
electrical contact of the plurality of electrical contacts. The
electronic circuitry configured to provide a first sensing signal
in a case where the first housing portion and the second housing
portion are brought together and the sensor detects at least one of
the certain magnetic field and the certain magnetic strength of the
magnetic source. The electronic circuitry configured to provide a
second sensing signal in a case where the first housing portion and
the second housing portion are brought together and the sensor
detects at least one of a magnetic field different from the certain
magnetic field and a magnetic strength different from the certain
magnetic strength of the magnetic source.
[0043] In various embodiments, the device further includes a
user-perceptible indicator operatively coupled to the electronic
circuitry for providing a user-perceptible indication in response
to receiving one or more of the first signal, the second signal,
the first sensing signal, and the second sensing signal.
[0044] In some embodiments, the user-perceptible indication
comprises at least one of an audible indication, a visual
indication, and a tactile indication.
[0045] In some embodiments, the user-perceptible indicator provides
a first type of indication when the first sensing signal is
received from the electronic circuitry and a second type of
indication when at least one of the second signal and the second
sensing signal is received from the electronic circuitry.
[0046] In various embodiments, the device further includes a drive
device supported by one of the first housing portion and the second
housing portion, the drive device for selectively driving fluid
from a reservoir. The delivery device further comprises control
electronics operatively coupled to the electronic circuitry for
controlling the drive device based upon receiving one or more of
the signals from the electronic circuitry.
[0047] In some embodiments, the control electronics is configured
to inhibit operation of the drive device unless the first sensing
signal is received.
[0048] In some embodiments, the control electronics is configured
to begin operation of the drive device upon receiving the first
sensing signal.
[0049] In some embodiments, the electronic circuitry configured to
provide the first sensing signal for activating the control
circuitry in a case where the sensor detects a gauss level
exceeding a first pre-defined threshold value.
[0050] In further embodiments, the sensor comprises a magnetic
threshold switch.
[0051] In various embodiments, the magnetic source has a certain
magnetic field direction. The sensor for detecting the certain
magnetic field direction. The electronic circuitry configured to
provide the first sensing signal when the sensor detects the
certain magnetic field direction.
[0052] In some embodiments, the electronic circuitry configured to
provide the second sensing signal when the sensor detects a
magnetic field direction different from the certain magnetic field
direction.
[0053] In various embodiments, the certain magnetic field includes
a direction, the sensor configured for detecting the direction.
[0054] In some embodiments, the first signal causes the sensor to
begin detecting the at least one of the certain magnetic field and
the certain magnetic strength.
[0055] In some embodiments, the set of main electrical contacts
interact with the shorting mechanism when the shorting mechanism
contacts the set of main electrical contacts. The electronic
circuitry configured to provide the first signal when the shorting
mechanism contacts the set of main electrical contacts of the
plurality of electrical contacts. The electronic circuitry
configured to provide the second signal when the shorting mechanism
contacts the at least one other electrical contact of the plurality
of electrical contacts.
[0056] In various embodiments, the shorting mechanism has a
plurality of ends. Each of the ends for interacting with a
respective main electrical contact of the set of main electrical
contacts. The electronic circuitry configured to provide the first
signal when each of the ends of the shorting mechanism interacts
with the respective main electrical contact of the set of main
electrical contacts. The electronic circuitry configured to provide
the second signal when at least one of the ends of the shorting
mechanism interacts with the at least one other electrical contact
of the plurality of electrical contacts.
[0057] In some embodiments, the set of main electrical contacts
comprising a first main electrical contact and a second main
electrical contact. The plurality of ends of the shorting mechanism
including a first end and a second end for interacting with the
first main electrical contact and the second main electrical
contact. The electronic circuitry configured to provide the first
signal when the first end and the second end of the shorting
mechanism interacts with the first main electrical contact and the
second main electrical contact of the plurality of electrical
contacts. The electronic circuitry configured to provide the second
signal when at least one of the first end and the second end of the
shorting mechanism interacts with the at least one other electrical
contact of the plurality of electrical contacts.
[0058] In various embodiments, at least one of the at least one
other electrical contact is arranged between the set of main
electrical contacts.
[0059] In various embodiments, at least some of the set of main
electrical contacts are arranged to be outermost electrical
contacts of the plurality of electrical contacts.
[0060] In various embodiments, all of the at least one other
electrical contact is arranged in between the set of main
electrical contacts.
[0061] In various embodiments, the shorting mechanism is configured
to establish an electrical connection between the set of main
electrical contacts when the shorting mechanism interacts with the
set of main electrical contacts.
[0062] In various embodiments, the device further includes a fluid
conduit and at least one interactive element. The fluid conduit
supported by one of the first housing portion and the second
housing portion in a position to engage a reservoir, supported by
the other of the first housing portion and the second housing
portion, to establish fluid communication between the reservoir and
the user when the first housing portion and the second housing
portion are operatively engaged. The at least one interactive
element, positioned near a portion of the fluid conduit, interacts
with the fluidic media when the fluidic media is present in the
fluid conduit. The circuitry configured to provide a first
positioning signal in a case where the first housing portion and
the second housing portion are brought together and the at least
one interactive element interacts with the fluidic media when the
fluidic media is present in the fluid conduit.
[0063] In some embodiments, the device further includes a drive
device supported by one of the first housing portion and the second
housing portion, the drive device for selectively driving fluidic
media from the reservoir. The delivery device further comprises
control electronics operatively coupled to the electronic circuitry
for controlling the drive device based upon receiving one or more
of the signals from the electronic circuitry.
[0064] In further embodiments, the control electronics are
configured to begin operation of the upon receiving the first
positioning signal.
[0065] A method of manufacturing a medical device for treating a
user may include, but is not limited to, any one or combination of:
(i) adapting a first housing portion to be carried by a user; (ii)
configuring a second housing portion to be selectively operatively
engaged with and disengaged from the first housing portion; (iii)
providing a plurality of electrical contacts on at least one of the
first housing portion and the second housing portion, the plurality
of electrical contacts including a set of main electrical contacts
and at least one other electrical contact; (iv) providing a
shorting mechanism on the other of the first housing portion and
the second housing portion, the shorting mechanism for interacting
with the set of main electrical contacts; (v) providing a magnetic
source having at least one of a certain magnetic field and a
certain magnetic strength on at least one of the first housing
portion and the second housing portion; (vi) providing a sensor for
detecting at least one of the certain magnetic field and the
certain magnetic strength on the other of the first housing portion
and the second housing portion; (vii) configuring electronic
circuitry to provide a first signal in a case where the first
housing portion and the second housing portion are brought together
and the shorting mechanism interacts with the set of main
electrical contacts of the plurality of electrical contacts; (viii)
configuring the electronic circuitry to provide a second signal in
a case where the first housing portion and the second housing
portion are brought together and the shorting mechanism interacts
with the at least one other electrical contact of the plurality of
electrical contacts; (ix) configuring the electronic circuitry to
provide a first sensing signal in a case where the first housing
portion and the second housing portion are brought together and the
sensor detects at least one of the certain magnetic field and the
certain magnetic strength of the magnetic source; and (x)
configuring the electronic circuitry to provide a second sensing
signal in a case where the first housing portion and the second
housing portion are brought together and the sensor detects at
least one of a magnetic field different from the certain magnetic
field and a magnetic strength different from the certain magnetic
strength of the magnetic source.
BRIEF DESCRIPTION OF THE DRAWINGS
[0066] FIG. 1 illustrates a generalized representation of a system
in accordance with an embodiment of the present invention;
[0067] FIG. 2 illustrates an example of a system in accordance with
an embodiment of the present invention;
[0068] FIG. 3 illustrates an example of a delivery device in
accordance with an embodiment of the present invention;
[0069] FIG. 4 illustrates a delivery device in accordance with an
embodiment of the present invention;
[0070] FIG. 5A illustrates a durable portion of a delivery device
in accordance with an embodiment of the present invention;
[0071] FIG. 5B illustrates a section view of a durable portion of a
delivery device in accordance with an embodiment of the present
invention;
[0072] FIG. 5C illustrates a section view of a durable portion of a
delivery device in accordance with an embodiment of the present
invention;
[0073] FIG. 6A illustrates a disposable portion of a delivery
device in accordance with an embodiment of the present
invention;
[0074] FIG. 6B illustrates a section view of a disposable portion
of a delivery device in accordance with an embodiment of the
present invention;
[0075] FIG. 6C illustrates a section view of a disposable portion
of a delivery device in accordance with an embodiment of the
present invention;
[0076] FIG. 7 illustrates portions of a medical device in
accordance with an embodiment of the present invention;
[0077] FIG. 8 illustrates a medical device in accordance with an
embodiment of the present invention;
[0078] FIG. 9 illustrates a medical device in accordance with an
embodiment of the present invention;
[0079] FIG. 10 illustrates a medical device in accordance with an
embodiment of the present invention;
[0080] FIG. 11 illustrates a medical device in accordance with an
embodiment of the present invention;
[0081] FIG. 12 illustrates a medical device in accordance with an
embodiment of the present invention;
[0082] FIG. 13 illustrates a medical device in accordance with an
embodiment of the present invention;
[0083] FIG. 14 illustrates a medical device in accordance with an
embodiment of the present invention;
[0084] FIG. 15 illustrates a medical device in accordance with an
embodiment of the present invention;
[0085] FIG. 16 illustrates cross-section of a needle-inserting
device in accordance with an embodiment of the present
invention;
[0086] FIGS. 17A-17C illustrate various rosettes in accordance with
an embodiment of the present invention;
[0087] FIGS. 18A-18C illustrate a portion of a medical device
system in accordance with an embodiment of the present
invention;
[0088] FIG. 19 illustrates a portion of a medical device system in
accordance with an embodiment of the present invention;
[0089] FIGS. 20A and 20B illustrate a portion of a medical device
system in accordance with an embodiment of the present
invention;
[0090] FIGS. 21A and 21B illustrate a portion of a medical device
system in accordance with an embodiment of the present
invention;
[0091] FIGS. 22A and 22B illustrate a portion of a medical device
system in accordance with an embodiment of the present
invention;
[0092] FIG. 23 illustrates a block diagram of an electrical
configuration of a medical device system in accordance with an
embodiment of the present invention;
[0093] FIG. 24 illustrates an alignment verification process S2400
in accordance with an embodiment of the present invention; and
[0094] FIG. 25 an alignment monitoring process S5400 in accordance
with an embodiment of the present invention.
DETAILED DESCRIPTION
[0095] FIG. 1 illustrates a generalized representation of a system
10 in accordance with an embodiment of the present invention. The
system 10 may include a delivery device 12. The system 10 may
further include a sensing device 14, a command control device (CCD)
16, and a computer 18. In various embodiments, the delivery device
12 and the sensing device 14 may be secured at desired locations on
the body 5 of a patient or user-patient 7. The locations at which
the delivery device 12 and the sensing device 14 are secured to the
body 5 of the user-patient 7 in FIG. 1 are provided only as
representative, non-limiting, examples.
[0096] The system 10, the delivery device 12, the sensing device
14, the CCD 16, and computer 18 may be similar to those described
in the following U.S. Patent Applications that were assigned to the
assignee of the present invention, where each of following patent
applications is incorporated herein by reference in its entirety:
(i) U.S. patent application Ser. No. 11/211,095, filed Aug. 23,
2005, "Infusion Device And Method With Disposable Portion"; (ii)
U.S. patent application Ser. No. 11/515,225, filed Sep. 1, 2006,
"Infusion Medium Delivery Device And Method With Drive Device For
Driving Plunger In Reservoir"; (iii) U.S. patent application Ser.
No. 11/588,875, filed Oct. 27, 2006, "Systems And Methods Allowing
For Reservoir Filling And Infusion Medium Delivery"; (iv) U.S.
patent application Ser. No. 11/588,832, filed Oct. 27, 2006,
"Infusion Medium Delivery Device And Method With Drive Device For
Driving Plunger In Reservoir"; (v) U.S. patent application Ser. No.
11/588,847, filed Oct. 27, 2006, "Infusion Medium Delivery Device
And Method With Compressible Or Curved Reservoir Or Conduit"; (vi)
U.S. patent application Ser. No. 11/589,323, filed Oct. 27, 2006,
"Infusion Pumps And Methods And Delivery Devices And Methods With
Same"; (vii) U.S. patent application Ser. No. 11/602,173, filed
Nov. 20, 2006, "Systems And Methods Allowing For Reservoir Filling
And Infusion Medium Delivery"; (viii) U.S. patent application Seri.
No. 11/602,052, filed Nov. 20, 2006, "Systems And Methods Allowing
For Reservoir Filling And Infusion Medium Delivery"; (ix) U.S.
patent application Ser. No. 11/602,428, filed Nov. 20, 2006,
"Systems And Methods Allowing For Reservoir Filling And Infusion
Medium Delivery"; (x) U.S. patent application Ser. No. 11/602,113,
filed Nov. 20, 2006, "Systems And Methods Allowing For Reservoir
Filling And Infusion Medium Delivery"; (xi) U.S. patent application
Ser. No. 11/604,171, filed Nov. 22, 2006, "Infusion Medium Delivery
Device And Method With Drive Device For Driving Plunger In
Reservoir"; (xii) U.S. patent application Ser. No. 11/604,172,
filed Nov. 22, 2006, "Infusion Medium Delivery Device And Method
With Drive Device For Driving Plunger In Reservoir"; (xiii) U.S.
patent application Ser. No. 11/606,703, filed Nov. 30, 2006,
"Infusion Pumps And Methods And Delivery Devices And Methods With
Same"; (xiv) U.S. patent application Ser. No. 11/606,836, filed
Nov. 30, 2006, "Infusion Pumps And Methods And Delivery Devices And
Methods With Same"; U.S. patent application Ser. No. 11/636,384,
filed Dec. 08, 2006, "Infusion Medium Delivery Device And Method
With Compressible Or Curved Reservoir Or Conduit"; (xv) U.S. patent
application Ser. No. 11/645,993, filed Dec. 26, 2006, "Infusion
Medium Delivery Device And Method With Compressible Or Curved
Reservoir Or Conduit"; U.S. patent application Ser. No. 11/645,972,
filed Dec. 26, 2006, "Infusion Medium Delivery System, Device And
Method With Needle Inserter And Needle Inserter Device And Method";
(xvi) U.S. patent application Ser. No. 11/646,052, filed Dec. 26,
2006, "Infusion Medium Delivery System, Device And Method With
Needle Inserter And Needle Inserter Device And Method"; (xvii) U.S.
patent application Ser. No. 11/645,435, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; (xviii) U.S.
patent application Ser. No. 11/646,000, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; (xix) U.S. patent
application Ser. No. 11/759,725, filed Jun. 7, 2007, "Infusion
Medium Delivery Device And Method With Drive Device For Driving
Plunger In Reservoir"; (xx) U.S. patent application Ser. No.
11/606,837, filed Nov. 30, 2006, "Method And Apparatus For
Enhancing The Integrity Of An Implantable Sensor Device"; (xxi)
U.S. patent application Ser. No. 11/702,713, filed Feb. 5, 2007,
"Selective Potting For Controlled Failure And Electronic Devices
Employing The Same"; (xxii) U.S. patent application Ser. No.
11/843,601, filed Aug. 22, 2007, "System And Method For Sensor
Recalibration"; (xxiii) U.S. patent application Ser. No.
11/868,898, filed Oct. 8, 2007, "Multilayer Substrate"; (xxiv) U.S.
patent application Ser. No. 11/964,649, filed Dec. 26, 2007,
"System And Methods Allowing For Reservoir Air Bubble Management";
(xxv) U.S. patent application Ser. No. 12/111,751, filed Apr. 29,
2008, "Systems And Methods For Reservoir Filling"; (xxvi) U.S.
patent application Ser. No. 12/111,815, filed Apr. 29, 2008,
"Systems And Methods For Reservoir Air Bubble Management"; (xxvii)
U.S. patent application Ser. No. 11/924,402, filed Oct. 25, 2007,
"Sensor Substrate And Method Of Fabricating Same"; (xxviii) U.S.
patent application Ser. No. 11/929,428, filed Oct. 30, 2007,
"Telemetry System And Method With Variable Parameters"; (xxix) U.S.
patent application Ser. No. 11/965,578, filed Dec. 27, 2007,
"Reservoir Pressure Equalization Systems And Methods"; (xxx) U.S.
patent application Ser. No. 12/107,580, filed Apr. 22, 2008,
"Automative Filling Systems And Methods"; (xxxi) U.S. patent
application Ser. No. 11/964,663, filed Dec. 26, 2007, "Medical
Device With Full Options And Selective Enablement/Disablement";
(xxxii) U.S. patent application Ser. No. 10/180,732, filed Jun. 26,
2002, "Communication Station And Software For Interfacing With An
Infusion Pump, Analyte Monitor, Analyte Meter, Or The Like";
(xxxiii) U.S. patent application Ser. No. 12/099,738, filed Apr. 8,
2008, "Systems And Methods Allowing For Reservoir Air Bubble
Management"; (xxxiv) U.S. patent application Ser. No. 12/027,963,
filed Feb. 7, 2008, "Adhesive Patch Systems And Methods"; (xxxv)
U.S. patent application Ser. No. 12/121,647, filed May 15, 2008,
"Multi-Lumen Catheter"; (xxxvi) U.S. Patent Provisional Application
Ser. No. 61/044,269, filed Apr. 11, 2008, "Reservoir Plunger Head
Systems And Methods"; (xxxvii) U.S. patent application Ser. No.
61/044,292, filed Apr. 11, 2008, "Reservoir Barrier Layer Systems
And Methods"; (xxxviii) U.S. Patent Provisional Application Ser.
No. 61/044,322, filed Apr. 11, 2008, "Reservoir Seal Retainer
Systems And Methods"; (xxxix) U.S. patent application Ser. No.
12/179,502, filed Jul. 24, 2008, "Method For Formulating And
Immobilizing A Matrix Protein And A Matrix Protein For Use In A
Sensor"; (xl) U.S. patent application Ser. No. 12/336,367, filed
Dec. 16, 2008, "Needle Insertions Systems And Methods"; (xli) U.S.
patent application Ser. No. 12/166,210, filed Jul. 1, 2008,
"Electronic Device For Controlled Failure"; (xlii) U.S. patent
application Ser. No. 12/271,134, filed Nov. 14, 2008, "Multilayer
Circuit Devices And Manufacturing Methods Using Electroplated
Sacrificial Structures"; (xliii) U.S. patent application Ser. No.
12/171,971, filed Jul. 11, 2008, "Infusion Medium Delivery System,
Device And Method With Needle Inserter And Needle Inserter Device
And Method"; (xliv) U.S. patent application Ser. No. 12/189,077,
filed Aug. 8, 2008, "Packaging System"; (xlv) U.S. patent
application Ser. No. 12/179,536, filed Jul. 24, 2008, "Real Time
Self-Adjusting Calibration Algorithm"; (xlvii) U.S. patent
application Ser. No. 12/277,186, filed Nov. 24, 2008, "Infusion
Medium Delivery System, Device And Method With Needle Inserter And
Needle Inserter Device And Method"; (xlviii) U.S. patent
application Ser. No. 12/211,783, filed Sep. 16, 2008, "Implantable
Sensor Method And System"; (xlix) U.S. patent application Ser. No.
12/247,945, filed Oct. 8, 2008, "Infusion Medium Delivery Device
And Method With Drive Device For Driving Plunger In Reservoir"; (1)
U.S. patent application Ser. No. 12/360,077, filed Jan. 26, 2009,
"Reservoir Barrier Layer Systems And Methods"; (1i) U.S. patent
application Ser. No. 12/345,362, filed Dec. 29, 2008, "Reservoir
Seal Retainer Systems And Methods"; (lii) U.S. patent application
Ser. No. 12/353,181, filed Jan. 13, 2009, "Systems And Methods
Allowing For Reservoir Filling And Infusion Medium Delivery";
(liii) U.S. patent application Ser. No. 12/360,813, filed Jan. 27,
2009, "Multi-Position Infusion Set Device And Process"; (liv) U.S.
Patent Pub. No. US 2007/0142776 (application Ser. No. 10/314,653),
filed Dec. 9, 2002, "Insertion Device For An Insertion Set and
Methods Of Using The Same." In other embodiments, the system 10,
delivery device 12, sensing device 14, CCD 16, and computer 18 may
have other suitable configurations.
[0097] The delivery device 12 may be configured to deliver fluidic
media to the body 5 of the user-patient 7. In various embodiments,
fluidic media may include a liquid, a fluid, a gel, or the like. In
some embodiments, fluidic media may include a medicine or a drug
for treating a disease or a medical condition. For example, fluidic
media may include insulin for treating diabetes, or may include a
drug for treating pain, cancer, a pulmonary disorder, HIV, or the
like. In some embodiments, fluidic media may include a nutritional
supplement, a dye, a tracing medium, a saline medium, a hydration
medium, or the like.
[0098] The sensing device 14 may include a sensor, a monitor, or
the like, for providing sensor data or monitor data. In various
embodiments, the sensing device 14 may be configured to sense a
condition of the user-patient 7. For example, the sensing device 14
may include electronics and enzymes reactive to a biological
condition, such as a blood glucose level, or the like, of the
user-patient 7.
[0099] In various embodiments, the sensing device 14 may be secured
to the body 5 of the user-patient 7 or embedded in the body 5 of
the user-patient 7 at a location that is remote from the location
at which the delivery device 12 is secured to the body 5 of the
user-patient 7. In various other embodiments, the sensing device 14
may be incorporated within the delivery device 12. In other
embodiments, the sensing device 14 may be separate and apart from
the delivery device, and may be, for example, part of the CCD 16.
In such embodiments, the sensing device 14 may be configured to
receive a biological sample, analyte, or the like, to measure a
condition of the user-patient 7.
[0100] In further embodiments, the sensing device 14 and/or the
delivery device 12 may utilize a closed-loop system. Examples of
sensing devices and/or delivery devices utilizing closed-loop
systems may be found at, but are not limited to, the following
references: (i) U.S. Pat. No. 6,088,608, entitled "Electrochemical
Sensor And Integrity Tests Therefor"; (ii) U.S. Pat. No. 6,119,028,
entitled "Implantable Enzyme-Based Monitoring Systems Having
Improved Longevity Due To Improved Exterior Surfaces"; (iii) U.S.
Pat. No. 6,589,229, entitled "Implantable Enzyme-Based Monitoring
Systems Adapted for Long Term Use"; (iv) U.S. Pat. No. 6,740,072,
entitled "System And Method For Providing Closed Loop Infusion
Formulation Delivery"; (v) U.S. Pat. No. 6,827,702, entitled
"Safety Limits For Closed-Loop Infusion Pump Control"; (vi) U.S.
Pat. No. 7,323,142, entitled "Sensor Substrate And Method Of
Fabricating Same"; (vii) U.S. patent application Ser. No.
09/360,342, filed Jul. 22, 1999, entitled "Substrate Sensor"; and
(viii) U.S. Provisional patent application Ser. No. 60/318,060,
filed Sep. 7, 2001, entitled "Sensing Apparatus and Process", all
of which are incorporated herein by reference in their
entirety.
[0101] In such embodiments, the sensing device 14 may be configured
to sense a condition of the user-patient 7, such as, but not
limited to, blood glucose level, or the like. The delivery device
12 may be configured to deliver fluidic media in response to the
condition sensed by the sensing device 14. In turn, the sensing
device 14 may continue to sense a new condition of the
user-patient, allowing the delivery device 12 to deliver fluidic
media continuously in response to the new condition sensed by the
sensing device 14 indefinitely. In some embodiments, the sensing
device 14 and/or the delivery device 12 may be configured to
utilize the closed-loop system only for a portion of the day, for
example only when the user-patient is asleep or awake.
[0102] Each of the delivery device 12, the sensing device 14, the
CCD 16, and the computer 18 may include transmitter, receiver, or
transceiver electronics that allow for communication with other
components of the system 10. The sensing device 14 may be
configured to transmit sensor data or monitor data to the delivery
device 12. The sensing device 14 may also be configured to
communicate with the CCD 16. The delivery device 12 may include
electronics and software that are configured to analyze sensor data
and to deliver fluidic media to the body 5 of the user-patient 7
based on the sensor data and/or preprogrammed delivery
routines.
[0103] The CCD 16 and the computer 18 may include electronics and
other components configured to perform processing, delivery routine
storage, and to control the delivery device 12. By including
control functions in the CCD 16 and/or the computer 18, the
delivery device 12 may be made with more simplified electronics.
However, in some embodiments, the delivery device 12 may include
all control functions, and may operate without the CCD 16 and the
computer 18. In various embodiments, the CCD 16 may be a portable
electronic device. In addition, in various embodiments, the
delivery device 12 and/or the sensing device 14 may be configured
to transmit data to the CCD 16 and/or the computer 18 for display
or processing of the data by the CCD 16 and/or the computer 18.
[0104] In some embodiments, the sensing device 14 may be integrated
into the CCD 16. Such embodiments may allow the user-patient to
monitor a condition by providing, for example, a sample of his or
her blood to the sensing device 14 to assess his or her condition.
In some embodiments, the sensing device 14 and the CCD 16 may be
for determining glucose levels in the blood and/or body fluids of
the user-patient without the use of, or necessity of, a wire or
cable connection between the delivery device 12 and the sensing
device 14 and/or the CCD 16.
[0105] In some embodiments, the CCD 16 may be for providing
information to the user-patient that facilitates the user-patient's
subsequent use of a drug delivery system. For example, the CCD 16
may provide information to the user-patient to allow the
user-patient to determine the rate or dose of medication to be
administered into the body of the user-patient. In other
embodiments, the CCD 16 may provide information to the delivery
device 12 to control the rate or dose of medication administered
into the body of the user-patient
[0106] Examples of the types of communications and/or control
capabilities, as well as device feature sets and/or program options
may be found in the following references: (i) U.S. patent
application Ser. No. 10/445,477, filed May 27, 2003, entitled
"External Infusion Device with Remote Programming, Bolus Estimator
and/or Vibration Alarm Capabilities"; (ii) U.S. patent application
Ser. No. 10/429,385, filed May 5, 2003, entitled "Handheld Personal
Data Assistant (PDA) with a Medical Device and Method of Using the
Same"; and (iii) U.S. patent application Ser. No. 09/813,660, filed
Mar. 21, 2001, entitled "Control Tabs for Infusion Devices and
Methods of Using the Same," all of which are incorporated herein by
reference in their entirety.
[0107] FIG. 2 illustrates an example of the system 10 in accordance
with an embodiment of the present invention. The system 10 in
accordance with the embodiment illustrated in FIG. 2 includes the
delivery device 12 and the sensing device 14. The delivery device
12 in accordance with an embodiment of the present invention may
include a disposable housing 20, a durable housing 30, and a
reservoir system 40. The delivery device 12 may further include an
infusion path 50.
[0108] Elements of the delivery device 12 that ordinarily contact
the body of a user-patient or that ordinarily contact fluidic media
during operation of the delivery device 12 may be considered as a
disposable portion of the delivery device 12. For example, a
disposable portion of the delivery device 12 may include the
disposable housing 20 and the reservoir system 40. The disposable
portion of the delivery device 12 may be recommended for disposal
after a specified number of uses.
[0109] On the other hand, elements of the delivery device 12 that
do not ordinarily contact the body of the user-patient or fluidic
media during operation of the delivery device 12 may be considered
as a durable portion of the delivery device 12. For example, a
durable portion of the delivery device 12 may include the durable
housing 30, electronics (not shown in FIG. 2), a drive device
having a motor and drive linkage (not shown in FIG. 2), and the
like. Elements of the durable housing portion of the delivery
device 12 are typically not contaminated from contact with the
user-patient or fluidic media during normal operation of the
delivery device 12 and, thus, may be retained for re-use with
replaced disposable portions of the delivery device 12.
[0110] In various embodiments, the disposable housing 20 may
support the reservoir system 40 and has a bottom surface (facing
downward and into the page in FIG. 2) configured to secure to the
body of the user-patient. An adhesive may be employed at an
interface between the bottom surface of the disposable housing 20
and the skin of the user-patient to adhere the disposable housing
20 to the skin of the user-patient. In various embodiments, the
adhesive may be provided on the bottom surface of the disposable
housing 20, with a peelable cover layer covering the adhesive
material. In this manner, the cover layer may be peeled off to
expose the adhesive material, and the adhesive side of the
disposable housing 20 may be placed against the user-patient, for
example against the skin of the user-patient. Thus in some
embodiments, the delivery device 12 may be attached to the skin of
the user-patient.
[0111] In other embodiments, the disposable housing 20 and/or the
remaining portions of the delivery device 12 may be worn or
otherwise attached on or underneath clothing of the user-patient.
Similarly, the delivery device 12 may be supported by any suitable
manner, such as, but not limited to, on a belt, in a pocket, and
the like. Representative examples of such delivery devices 12, and
delivery devices in general, may include, but is not limited to,
the MiniMed Paradigm 522 Insulin Pump, MiniMed Paradigm 722 Insulin
Pump, MiniMed Paradigm 515 Insulin Pump, MiniMed Paradigm 715
Insulin Pump, MiniMed Paradigm 512R Insulin Pump, MiniMed Paradigm
712R Insulin Pump, MiniMed 508 Insulin Pump, MiniMed 508R Insulin
Pump, and any other derivatives thereof.
[0112] The reservoir system 40 may be configured for containing or
holding fluidic media, such as, but not limited to insulin. In
various embodiments, the reservoir system 40 may include a hollow
interior volume for receiving fluidic media, such as, but not
limited to, a cylinder-shaped volume, a tubular-shaped volume, or
the like. In some embodiments, the reservoir system 40 may be
provided as a cartridge or canister for containing fluidic media.
In various embodiments, the reservoir system 40 can be refilled
with fluidic media. In further embodiments, the reservoir system 40
is pre-filled with fluidic media.
[0113] The reservoir system 40 may be supported by the disposable
housing 20 in any suitable manner. For example, the disposable
housing 20 may be provided with projections or struts (not shown),
or a trough feature (not shown), for holding the reservoir system
40. In some embodiments, the reservoir system 40 may be supported
by the disposable housing 20 in a manner that allows the reservoir
system 40 to be removed from the disposable housing 20 and replaced
with another reservoir. Alternatively, or in addition, the
reservoir system 40 may be secured to the disposable housing 20 by
a suitable adhesive, a strap, or other coupling structure.
[0114] In various embodiments, the reservoir system 40 may include
at least one port 41 for allowing fluidic media to flow into and/or
flow out of the interior volume of the reservoir system 40. In some
embodiments, the infusion path 50 may include a connector 56, a
tube 54, and a needle apparatus 52. The connector 56 of the
infusion path 50 may be connectable to the port 41 of the reservoir
system 40. In various embodiments, the disposable housing 20 may be
configured with an opening near the port 41 of the reservoir system
40 for allowing the connector 56 of the infusion path 50 to be
selectively connected to and disconnected from the port 41 of the
reservoir system 40.
[0115] In various embodiments, the port 41 of the reservoir system
40 may be covered with or supports a septum (not shown in FIG. 2),
such as a self-sealing septum, or the like. The septum may be
configured to prevent fluidic media from flowing out of the
reservoir system 40 through the port 41 when the septum is not
pierced. In addition, in various embodiments, the connector 56 of
the infusion path 50 may include a needle for piercing the septum
covering the port 41 of the reservoir system 40 to allow fluidic
media to flow out of the interior volume of the reservoir system
40.
[0116] Examples of needle/septum connectors can be found in U.S.
patent application Ser. No. 10/328,393, filed Dec. 22, 2003,
entitled "Reservoir Connector," which is incorporated herein by
reference in its entirety. In other alternatives, non-septum
connectors such as Luer locks, or the like may be used. In various
embodiments, the needle apparatus 52 of the infusion path 50 may
include a needle that is able to puncture the skin of the
user-patient. In addition, in various embodiments, the tube 54
connects the connector 56 with the needle apparatus 52 and may be
hollow, such that the infusion path 50 is able to provide a path to
allow for the delivery of fluidic media from the reservoir system
40 to the body of a user-patient.
[0117] The durable housing 30 of the delivery device 12 in
accordance with various embodiments of the present invention
includes a housing shell configured to mate with and secure to the
disposable housing 20. The durable housing 30 and the disposable
housing 20 may be provided with correspondingly shaped grooves,
notches, tabs, or other suitable features that allow the two parts
to connect together easily, by manually pressing the two housings
together, by twist or threaded connection, or other suitable manner
of connecting the parts that is well known in the mechanical
arts.
[0118] In various embodiments, the durable housing 30 and the
disposable housing 20 may be connected to each other using a twist
action. The durable housing 30 and the disposable housing 20 may be
configured to be separable from each other when a sufficient force
is applied to disconnect the two housings from each other. For
example, in some embodiments the disposable housing 20 and the
durable housing 30 may be snapped together by friction fitting. In
various embodiments, a suitable seal, such as an o-ring seal, may
be placed along a peripheral edge of the durable housing 30 and/or
the disposable housing 20 to provide a seal against water entering
between the durable housing 30 and the disposable housing 20.
[0119] The durable housing 30 of the delivery device 12 may support
a drive device (not shown in FIG. 2), including a motor and a drive
device linkage portion, for applying a force to fluidic media
within the reservoir system 40 to force fluidic media out of the
reservoir system 40 and into an infusion path, such as the infusion
path 50, for delivery to a user-patient. For example, in some
embodiments, an electrically driven motor may be mounted within the
durable housing 30 with appropriate linkage for operatively
coupling the motor to a plunger arm (not shown in FIG. 2) connected
to a plunger head (not shown in FIG. 2) that is within the
reservoir system 40 and to drive the plunger head in a direction to
force fluidic media out of the port 41 of the reservoir system 40
and to the user-patient.
[0120] Also, in some embodiments, the motor may be controllable to
reverse direction to move the plunger arm and the plunger head to
cause fluid to be drawn into the reservoir system 40 from a
patient. The motor may be arranged within the durable housing 30
and the reservoir system 40 may be correspondingly arranged on the
disposable housing 20, such that the operable engagement of the
motor with the plunger head, through the appropriate linkage,
occurs automatically upon the user-patient connecting the durable
housing 30 with the disposable housing 20 of the delivery device
12. Further examples of linkage and control structures may be found
in U.S. patent application Ser. No. 09/813,660, filed Mar. 21,
2001, entitled "Control Tabs for Infusion Devices and Methods of
Using the Same," which is incorporated herein by reference in its
entirety.
[0121] In various embodiments, the durable housing 30 and the
disposable housing 20 may be made of suitably rigid materials that
maintain their shape, yet provide sufficient flexibility and
resilience to effectively connect together and disconnect, as
described above. The material of the disposable housing 20 may be
selected for suitable compatibility with skin. For example, the
disposable housing 20 and the durable housing 30 of the delivery
device 12 may be made of any suitable plastic, metal, composite
material, or the like. The disposable housing 20 may be made of the
same type of material or a different material relative to the
durable housing 30. In some embodiments, the disposable housing 20
and the durable housing 30 may be manufactured by injection molding
or other molding processes, machining processes, or combinations
thereof
[0122] For example, the disposable housing 20 may be made of a
relatively flexible material, such as a flexible silicone, plastic,
rubber, synthetic rubber, or the like. By forming the disposable
housing 20 of a material capable of flexing with the skin of a
user-patient, a greater level of user-patient comfort may be
achieved when the disposable housing 20 is secured to the skin of
the user-patient. In addition, a flexible disposable housing 20 may
result in an increase in site options on the body of the
user-patient at which the disposable housing 20 may be secured.
[0123] In the embodiment illustrated in FIG. 2, the delivery device
12 is connected to the sensing device 14 through a connection
element 17 of the sensing device 14. The sensing device 14 may
include a sensor 15 that includes any suitable biological or
environmental sensing device, depending upon a nature of a
treatment to be administered by the delivery device 12. For
example, in the context of delivering insulin to a diabetes
patient, the sensor 15 may include a blood glucose sensor, or the
like.
[0124] In some embodiments, the sensor 15 may include a continuous
glucose sensor. The continuous glucose sensor may be implantable
within the body of the user-patient. In other embodiments, the
continuous glucose sensor may be located externally, for example on
the skin of the user-patient, or attached to clothing of the
user-patient. In such embodiments, fluid may be drawn continually
from the user-patient and sensed by the continuous glucose sensor.
In various embodiments, the continuous glucose sensor may be
configured to sense and/or communicate with the CCD 16
continuously. In other embodiments, the continuous glucose sensor
may be configured to sense and/or communicate with the CCD 16
intermittently, for example sense glucose levels and transmit
information every few minutes. In various embodiments, the
continuous glucose sensor may utilize glucose oxidase.
[0125] The sensor 15 may be an external sensor that secures to the
skin of a user-patient or, in other embodiments, may be an
implantable sensor that is located in an implant site within the
body of the user-patient. In further alternatives, the sensor may
be included with as a part or along side the infusion cannula
and/or needle, such as for example as shown in U.S. patent
application Ser. No. 11/149,119, filed Jun. 8, 2005, entitled "Dual
Insertion Set," which is incorporated herein by reference in its
entirety. In the illustrated example of FIG. 2, the sensor 15 is an
external sensor having a disposable needle pad that includes a
needle for piercing the skin of the user-patient and enzymes and/or
electronics reactive to a biological condition, such as blood
glucose level or the like, of the user-patient. In this manner, the
delivery device 12 may be provided with sensor data from the sensor
15 secured to the user-patient at a site remote from the location
at which the delivery device 12 is secured to the user-patient.
[0126] While the embodiment shown in FIG. 2 may include a sensor 15
connected by the connection element 17 for providing sensor data to
sensor electronics (not shown in FIG. 2) located within the durable
housing 30 of the delivery device 12, other embodiments may employ
a sensor 15 located within the delivery device 12. Yet other
embodiments may employ a sensor 15 having a transmitter for
communicating sensor data by a wireless communication link with
receiver electronics (not shown in FIG. 2) located within the
durable housing 30 of the delivery device 12. In various
embodiments, a wireless connection between the sensor 15 and the
receiver electronics within the durable housing 30 of the delivery
device 12 may include a radio frequency (RF) connection, an optical
connection, or another suitable wireless communication link.
Further embodiments need not employ the sensing device 14 and,
instead, may provide fluidic media delivery functions without the
use of sensor data.
[0127] As described above, by separating disposable elements of the
delivery device 12 from durable elements, the disposable elements
may be arranged on the disposable housing 20, while durable
elements may be arranged within a separable durable housing 30. In
this regard, after a prescribed number of uses of the delivery
device 12, the disposable housing 20 may be separated from the
durable housing 30, so that the disposable housing 20 may be
disposed of in a proper manner. The durable housing 30 may then be
mated with a new (un-used) disposable housing 20 for further
delivery operation with a user-patient.
[0128] FIG. 3 illustrates an example of the delivery device 12 in
accordance with another embodiment of the present invention. The
delivery device 12 of the embodiment of FIG. 3 is similar to the
delivery device 12 of the embodiment of FIG. 2. While the delivery
device 12 in the embodiment illustrated in FIG. 2 provides for the
durable housing 30 to cover the reservoir system 40, the delivery
device 12 in the embodiment of FIG. 3 provides for the durable
housing 30 to secure to the disposable housing 20 without covering
the reservoir system 40. The delivery device 12 of the embodiment
illustrated in FIG. 3 includes the disposable housing 20, and the
disposable housing 20 in accordance with the embodiment illustrated
in FIG. 3 includes a base 21 and a reservoir retaining portion 24.
In one embodiment, the base 21 and reservoir retaining portion 24
may be formed as a single, unitary structure.
[0129] The base 21 of the disposable housing 20 may be configured
to be securable to a body of a user-patient. The
reservoir-retaining portion 24 of the disposable housing 20 is
configured to house the reservoir system 40. The
reservoir-retaining portion 24 of the disposable housing 20 may be
configured to have an opening to allow for the port 41 of the
reservoir system 40 to be accessed from outside of the
reservoir-retaining portion 24 while the reservoir system 40 is
housed in the reservoir-retaining portion 24. The durable housing
30 may be configured to be attachable to and detachable from the
base 21 of the disposable housing 20. The delivery device 12 in the
embodiment illustrated in FIG. 3 includes a plunger arm 60 that is
connected to or that is connectable to a plunger head (not shown in
FIG. 3) within the reservoir system 40.
[0130] FIG. 4 illustrates another view of the delivery device 12 of
the embodiment of FIG. 3. The delivery device 12 of the embodiment
illustrated in FIG. 4 includes the disposable housing 20, the
durable housing 30, and the infusion path 50. The disposable
housing 20 in the embodiment of FIG. 4 includes the base 21, the
reservoir-retaining portion 24, and a peelable cover layer 25. The
peelable cover layer 25 may cover an adhesive material on the
bottom surface 22 of the base 21. The peelable cover layer 25 may
be configured to be peelable by a user-patient to expose the
adhesive material on the bottom surface 22 of the base 21. In some
embodiments, there may be multiple adhesive layers on the bottom
surface 22 of the base 21 that are separated by peelable
layers.
[0131] The infusion path 50 in accordance with the embodiment of
the present invention illustrated in FIG. 4 includes the needle 58
rather than the connector 56, the tube 54, and the needle apparatus
52 as shown in the embodiment of FIG. 2. The base 21 of the
disposable housing 20 may be provided with an opening or pierceable
wall in alignment with a tip of the needle 58, to allow the needle
58 to pass through the base 21 and into the skin of a user-patient
under the base 21, when extended. In this manner, the needle 58 may
be used to pierce the skin of the user-patient and deliver fluidic
media to the user-patient.
[0132] Alternatively, the needle 58 may be extended through a
hollow cannula (not shown in FIG. 4), such that upon piercing the
skin of the user-patient with the needle 58, an end of the hollow
cannula is guided through the skin of the user-patient by the
needle 58. Thereafter, the needle 58 may be removed, leaving the
hollow cannula in place, with one end of the cannula located within
the body of the user-patient and the other end of the cannula in
fluid flow connection with fluidic media within the reservoir
system 40, to convey pumped infusion media from the reservoir
system 40 to the body of the user-patient.
[0133] FIG. 5A illustrates a durable portion 8 of the delivery
device 12 (refer to FIG. 3) in accordance with an embodiment of the
present invention. FIG. 5B illustrates a section view of the
durable portion 8 in accordance with an embodiment of the present
invention. FIG. 5C illustrates another section view of the durable
portion 8 in accordance with an embodiment of the present
invention. With reference to FIGS. 5A, 5B, and 5C, in various
embodiments, the durable portion 8 may include the durable housing
30, and a drive device 80. The drive device 80 may include a motor
84 and a drive device linkage portion 82.
[0134] In various embodiments, the durable housing 30 may include
an interior volume for housing the motor 84, the drive device
linkage portion 82, other electronic circuitry, and a power source
(not shown in FIGS. 5A, 5B, and 5C). In addition, in various
embodiments, the durable housing 30 may be configured with an
opening 32 for receiving a plunger arm 60 (refer to FIG. 3). In
addition, in various embodiments, the durable housing 30 may
include one or more connection members 34, such as tabs, insertion
holes, or the like, for connecting with the base 21 of the
disposable housing 20 (refer to FIG. 3).
[0135] FIG. 6A illustrates a disposable portion 9 of the delivery
device 12 (refer to FIG. 3) in accordance with an embodiment of the
present invention. FIG. 6B illustrates a section view of the
disposable portion 9 in accordance with an embodiment of the
present invention. FIG. 6C illustrates another section view of the
disposable portion 9 in accordance with an embodiment of the
present invention. With reference to FIGS. 6A, 6B, and 6C, in
various embodiments, the disposable portion 9 includes the
disposable housing 20, the reservoir system 40, the plunger arm 60,
and a plunger head 70. In some embodiments, the disposable housing
20 may include the base 21 and the reservoir-retaining portion 24.
In various embodiments, the base 21 may include a top surface 23
having one or more connection members 26, such as tabs, grooves, or
the like, for allowing connections with the one or more connection
members 34 of embodiments of the durable housing 30 (refer to FIG.
5B).
[0136] In various embodiments, the reservoir system 40 may be
housed within the reservoir retaining portion 24 of the disposable
housing 20, and the reservoir system 40 may be configured to hold
fluidic media. In addition, in various embodiments, the plunger
head 70 may be disposed at least partially within the reservoir
system 40 and may be moveable within the reservoir system 40 to
allow fluidic media to fill into the reservoir system 40 and to
force fluidic media out of the reservoir system 40. In some
embodiments, the plunger arm 60 may be connected to or is
connectable to the plunger head 70.
[0137] Also, in some embodiments, a portion of the plunger arm 60
may extend to outside of the reservoir-retaining portion 24 of the
disposable housing 20. In various embodiments, the plunger arm 60
may have a mating portion for mating with the drive device linkage
portion 82 of the drive device 80 (refer to FIG. 5C). With
reference to FIGS. 5C and 6C, in some embodiments, the durable
housing 30 may be snap fitted onto the disposable housing 20,
whereupon the drive device linkage portion 82 automatically engages
the mating portion of the plunger arm 60.
[0138] When the durable housing 30 and the disposable housing 20
are fitted together with the drive device linkage portion 82
engaging or mating with the plunger arm 60, the motor 84 may be
controlled to drive the drive device linkage portion 82 and, thus,
move the plunger arm 60 to cause the plunger head 70 to move within
the reservoir system 40. When the interior volume of the reservoir
system 40 is filled with fluidic media and an infusion path is
provided from the reservoir system 40 to the body of a
user-patient, the plunger head 70 may be moved within the reservoir
system 40 to force fluidic media from the reservoir system 40 and
into the infusion path, so as to deliver fluidic media to the body
of the user-patient.
[0139] In various embodiments, once the reservoir system 40 has
been sufficiently emptied or otherwise requires replacement, the
user-patient may simply remove the durable housing 30 from the
disposable housing 20, and replace the disposable portion 9,
including the reservoir system 40, with a new disposable portion
having a new reservoir. The durable housing 30 may be connected to
the new disposable housing of the new disposable portion, and the
delivery device including the new disposable portion may be secured
to the skin of a user-patient, or otherwise attached to the
user-patient.
[0140] In various other embodiments, rather than replacing the
entire disposable portion 9 every time the reservoir system 40 is
emptied, the reservoir system 40 may be refilled with fluidic
media. In some embodiments, the reservoir system 40 may be refilled
while remaining within the reservoir retaining portion 24 (refer to
FIG. 6B) of the disposable housing 20. In addition, in various
embodiments, the reservoir system 40 may be replaced with a new
reservoir (not shown), while the disposable housing 20 may be
re-used with the new reservoir. In such embodiments, the new
reservoir may be inserted into the disposable portion 9.
[0141] With reference to FIGS. 3, 5A, 6B, and 6C, in various
embodiments, the delivery device 12 may include reservoir status
circuitry (not shown), and the reservoir system 40 may include
reservoir circuitry (not shown). In various embodiments, the
reservoir circuitry stores information such as, but not limited to,
at least one of (i) an identification string identifying the
reservoir system 40; (ii) a manufacturer of the reservoir system
40; (iii) contents of the reservoir system 40; and (iv) an amount
of contents in the reservoir system 40. In some embodiments, the
delivery device 12 may include the reservoir status circuitry (not
shown), and the reservoir status circuitry may be configured to
read data from the reservoir circuitry (not shown) when the
reservoir system 40 is inserted into the disposable portion 9.
[0142] In various embodiments, the reservoir status circuitry (not
shown) may be further configured to store data to the reservoir
circuitry after at least some of the contents of the reservoir
system 40 have been transferred out of the reservoir system 40 to
update information in the reservoir circuitry (not shown) related
to an amount of contents still remaining in the reservoir system
40. In some embodiments, the reservoir status circuitry (not shown)
may be configured to store data to the reservoir circuitry (not
shown) to update information in the reservoir circuitry (not shown)
related to an amount of contents remaining in the reservoir system
40 when the reservoir system 40 is inserted into the disposable
portion 9. In some embodiments, the delivery device 12 may include
the reservoir status circuitry (not shown) and the reservoir system
40 may include the reservoir circuitry (not shown), and the
reservoir status circuitry (not shown) may selectively inhibit use
of the delivery device 12 or may selectively provide a warning
signal based on information read by the reservoir status circuitry
(not shown) from the reservoir circuitry (not shown).
[0143] In addition, embodiments may be configured to establish a
contiguous fluid flow passage for fluid transfer between a
reservoir and the user-patient when the hollow needle or cannula is
inserted into the user-patient. Needle-inserting devices according
to embodiments of the present invention may be used with,
connectable to and disconnectable from, or incorporated in a
portion of an infusion medium delivery system. For example, a
needle-inserting device may be connectable to a base structure of a
pump-type delivery device for insertion of a needle, after which
the needle-inserting device may be removed from the base structure,
whereupon a further housing portion of the delivery device
(containing components such as, but not limited to, a reservoir and
pump or drive device) may be coupled to the base structure for
operation.
[0144] Alternatively, the needle-inserting device may be
incorporated into the further housing portion that contains other
components as described above. In yet other embodiments, the
needle-inserting device may be connectable to (and releasable from)
or incorporated within an injection site module or other housing
that connects, for example, by flexible tubing, to other components
of a medical device (such as, but not limited to an infusion medium
delivery device). In yet other embodiments, needle inserter devices
may be configured for use with systems other than infusion medium
delivery systems, such as, but not limited to sensor and monitor
systems, or the like.
[0145] The structures and methods described with respect to FIGS.
7-25 may be employed in any suitable device or system in which two
members that, at some period of time, are not connected in fluid
flow communication, are to be connected together in a manner that
allows fluid to flow from one member to the other. In some
embodiments, the structure and method is described with respect to
a first member, which is in fluid flow with a fluid reservoir for
containing an infusion medium, that may be connectable to a second
member including an injection site structure in which a hollow
needle or cannula is or may be inserted into a user-patient, for
conveying fluid media to the user-patient. However, a connection
structure according to embodiments of the present invention may be
employed to connect any two (or more) members together for fluid
flow communication with each other.
[0146] In FIGS. 7-12, an example of a structure 100 and method for
connecting two members in fluid flow communication is described
with reference to a first member 102 and a second member 103. The
first member 102 may include a housing 104 on a base 106. The
housing 104 may be formed integral with the base 106 or may be
formed as a separate structure connected to the base 106 in a fixed
relation to the base 106. The housing 104 and the base 106 each may
be made of any suitably rigid material, including, but not limited
to plastic, metal, ceramic, composite material, or the like.
[0147] The housing 104 may include an injection site section 105
containing an injection site structure in which a hollow needle or
cannula may be inserted into a user-patient for conveying fluidic
media to or from the user-patient. The housing 104 may be made of a
material of suitable strength and durability such as, but not
limited to, plastic, metal, glass, or the like. In other
embodiments, instead of or in addition to an injection site, the
housing 104 may contain, be part of, or be operatively connected to
any other suitable structure for conveying, containing, and/or
processing fluidic media.
[0148] The second member 103 may also include a housing 108. In
some embodiments, the housing 108 may include a reservoir 107 for
containing fluidic media. The reservoir 107 may be configured
and/or made of materials as previously described with respect to
reservoir system 40 (e.g., FIGS. 1-6C). The second member 103 may
be held within or otherwise be covered by an outer housing 109
configured to attach to the base 106. The outer housing 109 may be
configured to connect to the base 106 of the first member 102 by
any suitable connection structure. In other embodiments, the second
member 103 and/or the housing 108 is a fluid conduit that may be in
fluid flow with the reservoir 107 or the like, for example when
coupled to the reservoir 107.
[0149] In particular embodiments, at least one of the outer housing
109 and the base 106 may include one or more flexible pawls,
protrusions, indentations, or the like for engaging and/or
receiving one or more corresponding pawls, protrusions,
indentations, or the like on the other of the base 106 and the
outer housing 109 to provide a suitable connection structure.
Alternatively or in addition, the connection structure may include
adhesive material or other suitable connectors.
[0150] In other embodiments, the housing 108 may be or be connected
to a sensor housing (not shown) containing sensor components. In
yet other embodiments, the housing 108 may contain, be part of, or
be operatively connected to any other suitable structure for
conveying, containing, and/or processing fluidic media. The housing
108 may be made of any suitably rigid material, including, but not
limited to, plastic, metal, ceramic, composite material, or the
like.
[0151] The housing 104 may have or be connected to a receptacle
structure 110. The receptacle structure 110 may have an opening 112
leading into a chamber 114 within the receptacle structure 110. In
some embodiments, the receptacle structure 110 may be part of the
housing 104 adjacent a section of the housing 104 containing the
injection site section 105. In other embodiments, the receptacle
structure 110 may include a further housing connected to the
housing 104.
[0152] The receptacle structure 110 may include a first septum 116
located within the chamber 114 and may be moveable within the
chamber 114 toward and away from the opening 112. The receptacle
structure 110 may also include a bias mechanism 118, which may
apply a bias force on the first septum 116 in a direction toward
the opening 112. The bias mechanism 118 may be arranged for forcing
the first septum 116 against the opening 112. One or more annular
protrusions or one or more appropriately shaped or positioned
protrusions 120 adjacent the opening 112 may be provided to inhibit
the first septum 116 from being forced out of the chamber 114
through the opening 112 by the force of the bias mechanism 118.
[0153] The first septum 116 may have a front surface 116a that is
at least partially exposed through the opening 112 when the first
septum 116 is urged against the opening 112 by the bias mechanism
118. The first septum 116 may have a back surface 116b facing
toward an interior of the chamber 114. The first septum 116 may be
made of any suitable material that may be pierceable by a needle,
such as, but not limited to, a natural or synthetic rubber
material, silicon, or the like. In some embodiments, the first
septum 116 may be made of a self-sealing material capable of
sealing itself after a needle has pierced the first septum 116 and
was subsequently withdrawn from the first septum 116.
[0154] In some embodiments, the bias mechanism 118 may be a coil
spring located within the chamber 114 on an opposite side of the
first septum 116 with respect to the front surface 116a. In other
embodiments, the bias mechanism 118 may be provided in any suitable
manner for biasing the first septum 116 toward the opening 112.
These may include, but are not limited to, other types of springs,
pressurized fluid within the chamber 114, a collapsible skirt
structure extending from the first septum 116 with a natural or
built-in spring force, chemical, substance that expands upon
contact with another chemical or substance, or upon application of
energy from an energy source such as a heat, laser, or other
radiation source, or the like. For example, in some embodiments,
the first septum 116 may have a flexible accordion-like
configuration to allow expansion and contraction of the skirt
structure.
[0155] A needle 124 may be supported within the chamber 114. The
needle 124 may be hollow and may have a sharp end 124a directed
toward the back surface 116b of the first septum 116. In some
embodiments, the needle 124 may be supported within the bias
mechanism 118 such that a longitudinal axial dimension of the
needle 124 extends generally parallel to a longitudinal axial
dimension of the bias mechanism 118.
[0156] The needle 124 may be supported by a supporting structure
located within the receptacle structure 110. In some embodiments,
the supporting structure may be a wall integral with the receptacle
structure 110. The supporting structure may be located, for
example, on an opposite end of the chamber 114 relative to the end
of the chamber 114 at which the opening 112 is located. In other
embodiments, the supporting structure may be any suitable structure
that is generally fixed relative to the receptacle structure 110
and is able to support the needle 124 in a generally fixed relation
to the receptacle structure 110.
[0157] The needle 124 may be made of any suitably rigid material,
including, but not limited to metal, plastic, ceramic, or the like,
and may have a hollow channel extending in a lengthwise dimension
of the needle 124. The hollow channel in the needle 124 may be open
on the sharp end 124a of the needle 124 and may be open at another
location 124b along the lengthwise dimension of the needle 124,
such as, but not limited to, the needle end opposite the sharp end
124a. The hollow channel in the needle 124 may provide a fluid flow
path between the sharp end 124a of the needle 124 and the opening
124b of the needle 124. In some embodiments, the opening 124b of
the needle 124 may be connected in fluid flow communication with a
manifold 128 in the injection site section 105.
[0158] The housing 108 of the second member 103 may include a
connection portion 130 having a hollow interior chamber 132 and an
opening 134 into the interior chamber 132. A second septum 136 may
be supported by the housing 108 to seal the opening 134. The second
septum 136 may be supported in a fixed relation to the housing 108,
for example, within the housing 108 at one end of the interior
chamber 132.
[0159] The connection portion 130 of the housing 108 may have a
suitable shape and size to fit at least partially within the
opening 112 of the receptacle structure 110 in the first member 102
when the first member 102 and the second member 103 are connected
together. In the drawings of FIGS. 7 and 8, the first member 102
and the second member 103 are shown in a separated, disconnected
relation, wherein the connection portion 130 of the housing 108 is
outside of the opening 112 of the receptacle structure 110. By
moving the first member 102 and the second member 103 together to
insert the connection portion 130 into the opening 112 of the
housing 108 an end surface of the connection portion 130 may be
urged against the first septum 116. This may cause the moveable
first septum 116 to move relative to the housing 108 against the
force of the bias mechanism 118 toward the interior of the chamber
114. As the first septum 116 is moved toward the interior of the
housing 108, the sharp end 124a of the needle 124 may pierce the
first septum 116. Continued relative movement of the first member
102 and the second member 103 together may cause the sharp end 124a
of the needle 124 to pass through the first septum 116 in the first
member 102, then pierce, and pass through the second septum 136 in
the second member 103.
[0160] When the first member 102 and the second member 103 are
brought together (e.g., FIG. 9), at least a portion of the
connection portion 130 may extend inside of the receptacle
structure 110. With reference to FIGS. 8 and 9, the needle 124 may
pierce the first septum 116 and the second septum 136 to form a
fluid flow path between the interior chamber 132 of the connection
portion 130 and the manifold 128 or other structure at the opening
124b of the needle 124. The receptacle structure 110 and the
connection portion 130 may be provided with mating connectors that
provide, for example, a snap or friction connection upon the first
member 102 and the second member 103 being brought together as
shown in FIG. 9. In some embodiments, the mating connectors may
include a protrusion (not shown) on one or the other of the
receptacle structure 110 and the connection portion 130. The other
of the receptacle structure 110 and the connection portion 130 may
include a groove or indentation (not shown) arranged to engage each
other in a snap-fitting manner upon the connection portion 130
being extended into the receptacle structure 110 a suitable
distance.
[0161] As mentioned above, in some embodiments, the opening 124b of
the needle 124 may be connected in fluid flow communication with
the manifold 128 in the injection site section 105. The injection
site section 105 may include a channel 140 extending through the
housing 104 and the base 106. The channel 140 may have an open end
140a on a bottom surface (relative to the orientation shown in FIG.
8) of the base 106. The channel 140 may have another open end 140b
at an upper surface (relative to the orientation shown in FIG. 8)
of the injection site section 105 of the housing 104.
[0162] The manifold 128 may be located along a length of the
channel 140 and may be in fluid flow communication with the channel
140. Accordingly, the needle 124 may be arranged in fluid flow
communication with the interior of the channel 140 through the
manifold 128. The channel 140 may include a channel section 142
having a larger radial dimension relative to a remaining portion of
the channel 140 and may have a suitable shape and size to receive a
needle and/or cannula, as will be described later. The manifold 128
may be made of a material of suitable strength and durability such
as, but not limited to, plastic, metal, glass, or the like.
[0163] A needle-inserting device 144 may be located adjacent the
open end 140b of the channel 140 and arranged to selectively extend
a needle and/or cannula into the open end 140b of the channel 140
and at least partially through the channel 140 as will be
described. In various embodiments, the needle-inserting device 144
may be configured to be integral with or otherwise fixed to the
section 105 of the housing 104 of the first member 102. In other
embodiments, the needle-inserting device 144 may be a separate
device from the housing 104 and may be selectively engaged or
connected to, for example in alignment with the channel 140 (e.g.,
FIG. 8), and disengaged or disconnected from the injection site
section 105 of the housing 104.
[0164] In embodiments in which the needle-inserting device 144 is a
separate structure that connects to and disconnects from the
injection site section 105, a suitable connection structure may be
provided on the needle-inserting device 144 and/or the injection
site section 105 to provide a manually releasable connection
between those components. For example, the connection structure may
include, but is not limited to, a threaded extension on one or the
other of the needle-inserting device 144 and the injection site
section 105 and a corresponding threaded receptacle on the other of
the injection site section 105 and the needle-inserting device 144
for receiving and mating with the threaded extension in threaded
engagement. In other embodiments, other suitable connection
structures may be employed, including, but not limited to, flexible
pawls or extensions on one or the other of the needle-inserting
device 144 and the injection site section 105 and a corresponding
aperture, stop surface, or the like on the other of the other of
the injection site section 105 and the needle-inserting device 144
or friction fitting engageable portions on each of the section 105
and needle-inserting device 144.
[0165] In the drawing of FIG. 8, the needle-inserting device 144 is
shown as connected to the injection site section 105 with a needle
146 and a cannula 148 in a retracted state. With reference to FIGS.
7-16, the needle-inserting device 144 may be operated to
selectively move the needle 146 and the cannula 148 from the
retracted state (e.g., FIG. 8) to an extended state (e.g., FIG. 13)
in which the needle 146 and the cannula 148 extend through the
opening 140b of the channel 140 and at least partially through the
channel 140 such that a sharp end 146a of the needle 146 and at
least a portion of the length of the cannula 148 extend out the
opening 140a of the channel 140.
[0166] Various examples of suitable structures for needle-inserting
devices are described in U.S. patent application Ser. No.
11/645,435, filed Dec. 26, 2006, entitled "Infusion Medium Delivery
System, Device And Method With Needle Inserter And Needle Inserter
Device And Method," which is assigned to the assignee of the
present invention and is incorporated herein by reference in its
entirety. Further examples of various needle-inserting devices are
described in, but are not limited to, U.S. patent application Ser.
No. 11/645,972, filed Dec. 26, 2006, "Infusion Medium Delivery
System, Device And Method With Needle Inserter And Needle Inserter
Device And Method"; U.S. patent application Ser. No. 11/646,052,
filed Dec. 26, 2006, "Infusion Medium Delivery System, Device And
Method With Needle Inserter And Needle Inserter Device And Method";
U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; U.S. patent
application Ser. No. 11/646,000, filed Dec. 26, 2006, "Infusion
Medium Delivery System, Device And Method With Needle Inserter And
Needle Inserter Device And Method,", all of which are herein
incorporated by reference in its entirety. Other examples of
suitable structures for needle-inserting devices are described
herein.
[0167] The cannula 148 may have a hollow central channel 148c
extending along a longitudinal length of the cannula 148 and open
at one end 148a that may be adjacent the sharp end 146a of the
needle 146. An end 148b of the cannula 148 opposite the open end
148a may have a head 150 having a larger radial dimension than a
shaft portion 148d of the cannula 148. The cannula head 150 may
have a suitable shape and size to fit into the channel section 142
of the channel 140 when the needle 146 and the cannula 148 are
moved to the extended state by the needle-inserting device 144.
[0168] In particular embodiments, the cannula head 150 may include
one or more protrusions and/or indentations for engaging one or
more corresponding indentations and/or protrusions in the channel
section 142 of the injection site section 105 to provide a friction
fit, snap fit, or the like. Accordingly, the cannula 148 may be
locked or retained within the injection site section 105 upon the
needle 146 and cannula 148 being moved to the extended state by the
needle-inserting device 144. In further embodiments, instead of or
in addition to engaging protrusions and indentations, one or more
other mechanical structures may be employed to provide a suitable
retaining function for retaining the cannula 148 in place within
the injection site section 105, including, but not limited to, a
friction fit structure, snap fit, or the like.
[0169] The cannula 148 may have a connection channel 152 provided
in fluid flow communication with the hollow central channel 148c of
the cannula 148. The connection channel 152 may be provided along
the longitudinal length of the cannula 148 at a location at which
the connection channel 152 aligns with the manifold 128 (i.e., in
fluid flow communication with an interior of the manifold 128) when
the needle 146 and the cannula 148 have been moved to the extended
state by the needle-inserting device 144. In this manner, upon the
cannula 148 being moved to the extended state, the hollow central
channel 148c of the cannula 148 may be arranged in fluid flow
communication with the reservoir 108 through the manifold 128 and
the connection channel 152.
[0170] Thus, according to some embodiments, in operation, a first
member 102, which may include, for example, a housing 104 having a
receptacle 110 and an injection site section 105, may be coupled
together with a second member 103, which may include, for example,
a housing 108 having a reservoir 107. The first member 102 may be
coupled or otherwise operatively connected, by inserting a
connection portion 130 of the second member 103 into a receptacle
110 of the first member 102. Upon coupling the first member 102 and
the second member 103, fluid flow communication may be provided
between the second member 103 and the injection site section 105 in
the first member 102.
[0171] In various embodiments, the needle-inserting device 144 may
be coupled to the injection site section 105 of the housing 104 of
the first member 102 or may be provided as part of a single,
unitary structure (i.e., integral) with the injection site section
105 of the housing 104. In some embodiments, the base 106 of the
first member 102 may be secured to skin of a user-patient at a
suitable injection location with, for example, but not limited to,
adhesive material as described in U.S. patent application Ser. No.
11/645,435, filed Dec. 26, 2006, entitled "Infusion Medium Delivery
system, Device And Method With Needle Inserter And Needle Inserter
Device And Method," and/or as described herein. Alternatively or in
addition, the base 106 may be secured to the user-patient by one or
more other suitable structures, including, but not limited to,
straps, or the like.
[0172] Once the base 106 is suitably secured to the skin of the
user-patient at a suitable injection location, the inserting device
144 may be actuated to move the needle 146 and the cannula 148 from
a retracted state (e.g., FIG. 8) to an extended state. In the
extended state, the needle 146 and/or the cannula 148 may pierce
the skin of the user-patient adjacent the base 106. The cannula 148
may be locked into its extended state by engagement of the cannula
head 150 and the channel section 142, as previously described.
[0173] With the cannula 148 locked in the extended state, the
needle 146 may be retracted, for example, by automatic operation of
the needle-inserting device 144 and/or by manual removal of the
needle-inserting device 144 from the injection site section 105.
Once the needle 146 is removed, the cannula 148 may be held in
place by the injection site section 105 with a portion of the
cannula 148 extending into the user-patient. As such, the cannula
148 may be connected in fluid-flow communication with the needle
124. Accordingly, by connecting the first member 102 and the second
member 103, as described above, then a fluid-flow connection may be
provided from the reservoir 107 to the cannula 148 through the
needle 124 and the manifold 128.
[0174] A connection sequence (e.g., the sequence of connecting the
needle-inserting device 144 to the injection site section 105 of
the housing 104, connecting the receptacle 110 of the housing 104
to the connection portion 130 of the housing 108 having the
reservoir 107, and connecting the base 106 of the first member 102
to the skin of the user-patient) for connecting various components
may be different for different embodiments. In some embodiments,
the user-patient may be provided with a first member 102 having a
base 106, a housing 104, and an injection site section 105 in a
pre-connected state with the needle-inserting device 144. In this
manner, a user-patient need not have to connect the
needle-inserting device 144 to the housing 104 as those parts are
supplied to the user in a pre-connected state, for example, from a
manufacturing or assembly facility. In such embodiments, the base
106 of the first member 102 may be secured to skin of the
user-patient at a suitable injection location. After securing the
base 106 to the skin of the user-patient, the needle-inserting
device 144 may be activated to cause the needle 146 and the cannula
148 to be moved to the extended state and pierce the skin of the
user-patient.
[0175] After activation of the needle-inserting device 144, the
needle-inserting device 144 may be removed from the injection site
section 105, thus leaving the cannula 148 in place within the
injection site section 105 and partially extended into the
user-patient. With the base 106 of the first member 102 secured to
the skin of the user-patient and the cannula 148 inserted at least
partially into the user-patient and arranged in fluid-flow
communication with the needle 124, the second member 103 may be
connected to the first member 102. In particular, the connection
portion 130 of the housing 108 of the second member 103 may be
inserted into the receptacle 110 of the housing 104 of the first
member 102 to provide a fluid-flow connection between the interior
of the housing 108 and the needle 124 and, thus, the cannula 148.
Accordingly, the housing 108, which may include the reservoir 107,
for example, may be coupled in fluid-flow communication with the
cannula 148 that has been extended into the user-patient for
delivering fluid from the reservoir 107 to the user-patient. In
other embodiments, such a connection may be for conveying fluid
from the user-patient to the reservoir 107.
[0176] While the connection sequence in some of the above
embodiments involve securing the base 106 of the first member 102
to the user-patient prior to connection of the second member 103 to
the first member 102, in other embodiments, the second member 103
may be connected to the first member 102, as described above, prior
to securing the base 106 of the first member 102 onto the skin of
the user-patient. In such embodiments, the first member 102 and the
second member 103 may be connected together and, thereafter, may be
secured to the user-patient, for example, by adhering one or both
of the first member 102 and the second member 103 to the skin of
the user-patient. In addition, while the connection sequence in the
above embodiments involve activating the needle-inserting device
144 prior to the connection of the second member 103 to the first
member 102, in other embodiments, the second member 103 may be
connected to the first member 102, as described above, prior to
activating the needle-inserting device 144.
[0177] In some embodiments, such as the embodiments shown in FIGS.
7 and 8, the receptacle 110 may be in the first member 102 and the
connection portion 130 may be in the second member 103. In other
embodiments, the receptacle 110 may be in the second member 103,
for example, in or associated with a housing for a reservoir and
the connection portion 130 may be in the first member 102, for
example, in or associated with a housing containing an injection
site structure.
[0178] In some embodiments, such as the embodiments shown in FIGS.
7 and 8, the receptacle 110 may be arranged to allow the connection
portion 130 of the second member 103 to be inserted in a direction
substantially parallel to a plane of an upper-facing (in the
orientation of FIG. 7) surface of the base 106. For example, in the
orientation of FIG. 7, the direction of insertion is shown as a
horizontal direction of relative motion between the first member
102 and the second member 103.
[0179] Again referring to FIGS. 7 and 8, in other embodiments, the
receptacle 110 may be arranged in other suitable orientations,
including, but not limited to, an orientation allowing an insertion
direction (i.e., relative motion of the first member 102 and the
second member 103) to be substantially perpendicular to the plane
of the upper-facing surface of the base 106. In yet other
embodiments, the receptacle 110 may be arranged to allow any other
suitable insertion direction at a non-perpendicular angle
transverse to the plane of the upper-facing surface of the base
106.
[0180] An example arrangement shown in FIGS. 13-16 provides an
insertion direction (i.e., relative motion of the first member 102
and the second member 103) that may be substantially perpendicular
to the plane of the upper-facing (in the orientation of FIG. 8)
surface of the base 106. Components in FIGS. 13-16 are identified
by reference numbers that are the same as reference numbers used in
FIGS. 7-12 for components having similar structure and function. In
FIGS. 13 and 14, the injection site section 105 in the housing 104
is shown in a state after a needle-inserting device has been
operated to move a cannula 148 to the extended position.
[0181] FIGS. 15 and 16 show the base 106 of the first member 102
(of the embodiment of FIGS. 13 and 14) with a needle-inserting
device 144 attached to the housing 104. The needle-inserting device
144 may include a housing 160 adapted to be securable to the base
106 in any suitable manner, such as, but not limited to the manners
of connecting a needle-inserting device 144 to the injection site
structure 105 discussed above with respect to the embodiment of
FIGS. 7-12. Returning to FIGS. 15 and 16, the housing 160 may
contain an internal chamber having a longitudinal dimension L and a
moveable plunger 162 located within the housing 160 and moveable
along the longitudinal dimension L from a retracted position (shown
in solid lines in FIG. 16) to an extended position (in which the
plunger 162 is moved to a position E shown in broken lines in FIG.
16).
[0182] A bias member 164, such as, but not limited to, a coil
spring arranged within the housing 160 may be configured to impart
a bias force on the plunger 162 when the plunger 162 is in the
refracted position to urge the plunger 162 toward the extended
position E. A locking mechanism (not shown) may be provided such
as, but not limited to, a manually moveable projection, lever,
slider, or the like, connected to or extending through the housing
160 and engages the plunger 162 or other structure holding the
plunger 162 in a releasable manner to selectively hold the plunger
162 in its refracted state against the bias force of the bias
member 164 and to allow a user-patient to selectively release the
plunger 162 to move in the longitudinal direction L under the force
of the bias member 164.
[0183] An insert structure 166 may be arranged within the housing
160 for movement in the longitudinal direction L by action of
movement of the plunger 162. The insert structure 166 may include,
for example, a cup-shaped body 168. The cup-shaped body 168 may be
made of a material of suitable strength and durability such as, but
not limited to, plastic, metal, glass, or the like. The cup-shaped
body 168 may hold a first septum 116. The septum 116 may be made of
a material such as silicone, rubber, plastic, a resealable
membrane, or the like.
[0184] A hollow cannula 148 may have one open end 148a and a sharp
tip arranged adjacent the first septum 116 or at least partially
within the first septum 116. The hollow cannula 148 may extend
through the cup-shaped body 168 and may have a second open end
148b. The hollow cannula 148 may be fixed to the cup-shaped body
168 to move with movement of the cup-shaped body 168. A needle 170
may be secured to the plunger 162 and may extend through the first
septum 116 and cannula 148 when the plunger 162 is in the retracted
position.
[0185] In operation, the user-patient (or medical practitioner) may
secure the base 106 to skin of the user-patient, for example, as
previously described. Once the base 106 is secured to the skin of
the user-patient, the user-patient (or medical practitioner) may
activate the needle-inserting device 144 to cause the plunger 162
to move from the retracted position to the extended position E and,
as a result of such movement, to cause the insert structure 166 to
be moved into an opening into the interior of the housing 104. Upon
movement of the insert structure 166 into the housing 104, the
insert structure 166 may connect to the housing 104 by any suitable
connection structure.
[0186] As discussed above, in particular embodiments, one or the
other of the cup-shaped body 168 of the insert structure 166 and
the housing 104 may include one or more flexible pawls,
protrusions, indentations, or the like, for engaging and receiving
one or more corresponding pawls, protrusions, indentations, or the
like, on the other of the housing 104 and the insert structure 166
to provide a suitable connection structure. Alternatively or in
addition, the connection structure may include adhesive material or
other suitable connectors.
[0187] In particular embodiments, the housing 160 of the
needle-inserting device 144 may automatically release from the base
106 upon movement of the plunger 162 and the insert structure 166
from the retracted position to the extended position E. For
example, the housing 160 of the needle-inserting device 144 may be
made of a material that has sufficient rigidity to operate as
described herein, but also has a suitable flexibility (at least at
the portion of the device 144 that connects to the housing 104) to
bend away from and release from the housing 104 upon movement of
the insert structure 166 to the extended position E.
[0188] In some embodiments, such as the embodiment shown in FIG.
16, a portion 172 of the internal surface of the housing 160 may
include a ramped, wedge-shaped, or angled (relative to an axial
direction of the housing 144, cannula 148, and needle 170)
cross-sectional shape that engages an outer peripheral surface of
the insert structure 166 and/or the plunger 162 as the insert
structure 166 and plunger 162 are moved toward the extended
position E. By engaging the angled, ramped, or wedge-shaped portion
172 of the internal surface of the housing 160, the plunger 162
and/or the insert structure 166 may cause the wall(s) of the
housing 160 to flex outward as the plunger 162 and/or insert
structure 166 are moved into the extended position. One or more
slots, grooves, or the like 174 may be formed in the housing 166 to
enhance the ability of the wall(s) of the housing 160 to flex
outward. One or more protrusions 176 and/or indentations may be
provided on one or the other of the interior surface of the housing
166 and the exterior surface of the housing 104 for engaging one or
more corresponding indentations 178 and/or protrusions in the other
of the housing 104 and housing 166 when the plunger 162 and insert
structure 166 are in the retracted state shown in FIG. 16.
[0189] The one or more protrusions 176 and the one or more
indentations 178, when engaged, may lock the housing 160 of the
needle-inserting device 144 to the housing 104. The one or more
protrusions 176 and/or indentations 178 may disengage from each
other when the wall(s) of the housing 160 are flexed outward by the
movement of the plunger 162 and the insert structure 166 to the
extended position E. As a result, the housing 160 of the
needle-inserting device 144 may be automatically disengaged and
released from the housing 104 upon movement of the plunger 162 and
insert structure 166 to the extended position E.
[0190] After movement of the plunger 162 and insert structure 166
from the refracted position (shown in FIG. 16) to the extended
position E at which the insert structure 166 may be locked into the
housing 104, while the housing 160 of the needle-inserting device
144 is released from the housing 104, the bias member 164 (or a
second bias member (not shown)) may act on the needle 170 to move
the needle 170 toward the retracted position and, thus, withdraw
the needle 170 from the cannula 148. For example, a return motion
of the coil spring after moving from the retracted position to the
extended position E may provide sufficient force to withdraw the
needle 170 from the cannula 148.
[0191] Once the insert structure 166 has been locked into place
within the housing 104 and the needle-inserting device 144 has been
removed from the housing 104, the cannula 148 may be connected in
fluid-flow communication with a connection portion 130 of a second
member such as, but not limited to, a reservoir, in a manner
similar to the manner in which the first member 102 and the second
member 103 are connectable in the embodiments of FIGS. 7-12. More
specifically, the housing 104 may form a receptacle (similar to the
receptacle 110 described above for FIGS. 7-12) and may contain the
first septum 116.
[0192] Similar to the embodiment of FIGS. 7-12, the connection
portion 130 may also include a second septum 136. In particular,
the connection portion 130 may be inserted into the receptacle
formed by the housing 104 to connect the interior of the reservoir
in fluid-flow communication with the cannula 148. The cannula 148
in FIG. 13 may include a sharp end 148a adjacent the first septum
116. As the connection portion 130 is inserted into the housing
104, the connection portion may push the first septum 116 against
the sharp end 148a of the cannula 148 to cause the sharp end 148a
of the cannula 148 to pierce the first septum 116. Further
insertion motion of the connection portion 130 into the housing 104
may cause the sharp end 148a of the cannula 148 to pierce the
second septum 136 in the connection portion 130 to form a flow path
from or to the connection portion 130 through the cannula 148.
Other examples of fluid connections are disclosed in (but not
limited to) U.S. patent application Ser. No. 12/553,308, filed Sep.
2, 2009; U.S. patent application Ser. No. 12/649172, filed Dec. 29,
2009; U.S. patent application Ser. No. 13/015028, filed Jan. 27,
2011; U.S. patent application Ser. No. 13/015051, filed Jan. 27,
2011, all of which are herein incorporated by reference in their
entirety.
[0193] In various embodiments, a medical device may be configured
to detect a connecting or otherwise positioning of one or more
fluid conduits, such as but not limited to, the cannula 148, the
needle 124, and/or the like in a predetermined manner. It should be
noted that reference to a specific fluid conduit (e.g., cannula
148, needle 124, etc.) is merely illustrative and that the
conduit-positioning systems/methods may be implemented with any
other fluid conduit. The medical device may be configured to detect
a presence of fluidic media to be delivered into a patient's body
that is in the one or more fluid conduits. The presence of fluidic
media in a particular fluid conduit may indicate, for instance,
that the fluid conduit (and/or fluid conduits connecting the
particular fluid conduit and a source of the fluidic media) is
properly connected and/or primed.
[0194] In some embodiments the fluidic media is insulin. In other
embodiments, the fluidic media may be, but not limited to, HIV
drugs, drugs to treat pulmonary hypertension, iron chelation drugs,
pain medications, anti-cancer treatments, vitamins, hormones,
and/or the like
[0195] Most fluids designed for parenteral administration (and/or
infusion) contain a preservative. The most commonly used
preservatives are based either on a phenol system or a benzyl
alcohol system 34. Examples of these systems are disclosed in U.S.
Pat. No. 6,461,329, which is herein incorporated by reference in
its entirety. Accordingly, an approach to detecting whether a fluid
conduit has been primed is to trigger a chemical reaction that is
observable by an individual or detectable by the medial device when
any of these preservatives are present in the fluid conduit.
[0196] In various embodiments, the cannula 148 may include a
chemical or the like for triggering the chemical reaction. For
instance, the chemical may be applied to or otherwise provided to
the cannula 148. In other cases, the cannula 148 may be impregnated
with the chemical. In some embodiments, the chemical may include at
least one of 4-amino-antipyrine and potassium ferricyanide
(K.sub.3Fe(CN).sub.6), as described for example in U.S. Pat. No.
6,461,329, which is herein incorporated by reference in its
entirety.
[0197] In particular embodiments, the medical device is an infusion
device with transparent parts or portions that allow an individual
to see through the transparent parts and observe the chemical on or
near the cannula 148 or portion thereof. In various embodiments,
the medical device may include other clear (optically transparent)
materials, such as glass, creams, crystal, laminates, or the like
for the individual to see through the medical device and observe
the chemical on or near the cannula 148. In yet other embodiments,
the medical device may include an opening or the like to allow the
individual to observe the chemical on or near the cannula 148.
[0198] In other embodiments, the cannula 148 may be configured to
direct the fluidic media to an observation portion of the medical
device. Accordingly, a chemical reaction at the observation portion
can be observed. In other embodiments, portions of the cannula 148
may extend to a observation portion of the medical device.
Accordingly, a chemical reaction at the observation portion can be
observed. In such embodiments, portions of the medical device or
the entire medical device may be opaque since the chemical reaction
does not have to be observed through the medical device.
[0199] When fluidic media is present in the cannula 148, the
preservative in the parenteral fluid reacts with the
4-amino-antipyrine and potassium ferricyanide. The resulting
product is a bright blue colored complex. Thus, the chemicals, seen
through the medical device (or at another observable location),
change from clear to bright blue, serving as a visual indicator to
the individual that fluidic media is present in the cannula 148.
The time required to detect presence of fluidic media may range
from a few minutes (or less) to several hours due to the
concentrations of the reactants, 4-amino-antipyrine and potassium
ferricyanide, the concentration of the preservative in the fluidic
media, the flow rate of the fluidic media, the rate at which the
fluidic media spreads and comes in contact with the reactants, the
method used to deposit the chemicals on or near the cannula 148,
the temperature near the cannula 148, and/or the like. In
alternative embodiments, the chemical may be some other color, such
as white, cream, off white, or the like, or a contrasting color to
make the color change noticeable. In other embodiments, the colored
product is a different color, such as red, yellow, orange, pink,
green, purple, or the like.
[0200] In alternative embodiments, an enzymatic system is used to
amplify the chemical color change signal. An enzyme, such as horse
radish peroxidase (HRP), is added to the chemical
(4-aminoantipyrine and potassium ferricyanide. When fluidic media
is present, water in the fluidic media dissolves the HRP. The HRP
then acts as a catalyst to, in essence, create an enzymatic
amplification of the signal. For instance, a deep blue colored
complex is formed due to the phenol or benzyl alcohol preservatives
in the fluidic media reacting with the 4-aminoantipyrine and the
potassium ferricyanide. The advantage of the HRP system is that
only very small amounts of the fluidic media need to be present to
be detected. In such embodiments, the time required to detect
presence of fluidic media may range from less than 20 seconds to
over 4 hours depending on the concentration of HRP, the
concentration of the reactants 4-aminoantipyrine and potassium
ferricyanide, the flow rate of the fluidic media, the rate at which
the fluidic media spreads and comes in contact with the reactants,
the method used to deposit the chemicals on or near the cannula
148, the temperature near the cannula 148, and/or the like.
[0201] In other embodiments, the 4-aminoantipyrine and potassium
ferricyanide are encapsulated in micro-spheres. In particular
embodiments, the micro-spheres dissolve in the presence of an
ingredient contained in the fluidic media, such as water, alcohol,
or the like, which then sets the reactants free to react with the
preservative in the fluid as described above. Additional
embodiments include HRP encapsulated in micro-spheres along with
4-aminoantipyrine and potassium ferricyanide.
[0202] In other embodiments, where the fluidic media to be
delivered into a patient's body includes a protein, such as an
insulin formulation, other reactants may be located or near the
cannula 148 to produce a color change that signifies presence of
fluidic media. In particular embodiments, ninhydrin, Coomassie
Brilliant Blue, and/or the like reacts with the protein in the
fluidic media resulting in a brightly colored product. While
chemical reactions are effective at displaying a visual signal (a
color change) when fluidic media is present, the individual must
visually inspect around the medical device to see the visual
signal. Thus, alternative methods of fluidic media detection
utilize an audible or tactile notification of fluidic media
presence in addition to, or instead of, a visual only signal.
[0203] In particular embodiments, optical or electrical detection
methods provide a signal to electronics contained the medical
device or remote from the medical device. When fluidic media is
detected, the electronics activate an indicator, such as a
vibrator, flashing lights or LEDs, an LCD message displaying the
cause for the indicator, a small scintillating electric shock to
the individual, a heating element, or the like. In other
alternative embodiments, the indicator generates at least one
notification signal such as by telemetry, radio frequency, optical,
infra-red, ultrasonic, laser, telephone, pager, Wi-Fi, or the like.
Infusion pump communication apparatuses and methods are disclosed
in, but are not limited to, U.S. Pat. No. 6,936,029; U.S. Pat. No.
6,551,276; U.S. Pat. No. 6,554,798; U.S. Pat. No. 7,815,602, all of
which are herein incorporated by reference in their entirety. In
particular embodiments, an indicator notification is stored in a
memory device such as an on-board memory chip, a computer memory, a
PDA, computer disks, compact disks, a telephone message, a pager,
or the like. In other embodiments, the indicator notifies a person
other than the individual using the medical device (e.g., a doctor,
a nurse, a parent, a spouse, a friend, a relative, a workmate, or
the like.)
[0204] Some embodiments employ an electro-optical detection system
in combination with any of the chemical reactions that result in a
colored chemical product like those previously described. In such
embodiments, the medical device may include an optical receiver
that receives light from near the cannula 148. When chemical
reactants produce a colored product, the optical receiver detects a
change in the light indicating presence of fluidic media. The
optical receiver provides an output signal to the electronics.
[0205] In particular embodiments, a miniature optical transmitter
and receiver are located near the cannula 148. The exterior surface
of either the transmitter, or the receiver, or both, are coated
with reactants that will produce a colored complex 40 in the
presence of fluidic media. When fluidic media triggers the color
change, the optical signal between the optical transmitter and
optical receiver is altered. The optical signal may be carried to
the electronics by a fiber optical cable (or the like), converted
to an electrical signal and carried to the electronics by
electrical wire, or the like. Accordingly, chemically activated
color changes may be detected by the optical receiver through the
fiber optic cable or the like.
[0206] In alternative embodiments, more than one fiber optic cable
may be used to carry light from more than one location near the
cannula 148 to the optical receiver. In particular embodiments, the
optical receiver and an optical transmitter are both located inside
the medical device. A first fiber optic cable runs from the optical
transmitter to a point near the cannula 148 and a second fiber
optic cable runs from the optical receiver to a point near the
cannula 147. The ends of the fiber optic cables near the infusion
site 30 may be positioned with respect to each other so that light
emitted by the optical transmitter is detected by the optical
receiver. A gap may exists between the ends of the fiber optic
cables near the cannula 148. The reactants or carrier media
containing the reactants may be placed in the gap between the ends
of the fiber optic cables. When a fluidic media triggers a reaction
producing a chemical color change, a change in the light signal is
detected by the optical receiver.
[0207] In some embodiments, the optical receiver is located within
the medical device and is positioned with respect to the cannula
148 such that light coming from the cannula 148 is detected by the
receiver to provide an indication that the cannula 148 is or is not
properly positioned.
[0208] Other leak detection methods are based on electrical
measurements. A medical device battery or the like may be an
available source for the electrical power required to operate an
electrically based detection apparatus. Electronics contained
within the medical device may evaluate the signals from the
electrically based detection apparatus.
[0209] In various embodiments, a rosette, which is a pattern of one
or more conducting elements, is provided in the medical device to
substantially surround the cannula 148. Examples of rosettes for
detecting fluid presence are disclosed in, but are not limited to,
U.S. Pat. No. 6,461,329, which is herein incorporated by reference
in its entirety.
[0210] Conducting elements may be wires, sputtered carbon, plastics
doped with conductive fillers, epoxies doped with conductive
fillers, or the like. Particular embodiments employ an active
electronic signal to detect changes in impedance across the
rosette. For instance, a voltage is supplied across the rosette by
running conductive leads from a medical device battery (or other
power source) to different points on the rosette, such as opposite
or adjacent endpoints. Then the impedance is measured across the
rosette. When fluidic media interacts (e.g., comes in contact) with
the rosette, the impedance changes and the electronics measure the
change in impedance to detect presence of fluidic media.
[0211] In some embodiments, as shown for example in FIG. 17A, an
uninterrupted rosette 246 is used such that when fluidic media is
present near the cannula 148, portions of the rosette 246 are
shorted providing additional or shorter conductive paths across
portions of the rosette, and the total impedance across the rosette
246 is decreased. The reduction in impedance across the rosette 246
is detected by the electronics which indicates presence of fluidic
media. Many other uninterrupted rosette patterns will work as long
as fluidic media presence near the cannula 148 will short out a
sufficient portion of the rosette 246 for a measurable change in
impedance to be detectable. Uninterrupted rosettes have a
continuous conductive path so that the voltage drop across the
rosette is measurable, and is not zero. Thus, a test voltage may be
used to confirm that there are no disconnects or opens in the
circuit leading from the electronics to the rosette and back.
[0212] In some embodiments, the impedance of the fluidic media to
be detected, and the impedance of the conductive leads leading from
the electronics to the rosette are low compared to the impedance
across the rosette. Thus, the high impedance of the rosette
decreases rapidly as relatively highly conductive fluidic media
spreads across the rosette. In other embodiments, the impedance of
the fluidic media and/or the leads is not low compared to the
impedance of the rosette, and therefore the electronics are tuned
to detect small shifts in the change of the impedance across the
rosette.
[0213] In other embodiments, portions of the rosette are designed
to dissolve away in the presence of the fluidic media being
infused. An example of a particular embodiment of an uninterrupted
rosette 248 with a dissolvable portion 250 near the cannula 148 is
shown in FIG. 17C. When fluidic media is present, at least a part
of the dissolvable portion 250 of the rosette 248 dissolves, and
the impedance across the rosette 248 increases. Indeed, if enough
of the rosette 248 dissolves, the rosette 248 may become an open
circuit. This increased impedance is detected by the medical device
electronics. In yet other embodiments, many different continuous
rosette patterns may be used so long as the dissolvable portion of
the rosette substantially surrounds the cannula 148. These
embodiments function even if the fluidic media is not
conductive.
[0214] In other embodiments, the rosette is discontinuous. The
conductive path is interrupted and fluidic media near the cannula
148 is required to close the open circuit. Although many designs of
discontinuous rosettes may be used, one embodiment is shown in FIG.
17B. The normal voltage reading across the discontinuous rosette
252 may be zero. Fluidic media present near the cannula 148 shorts
portions of the rosette 252 and closes the circuit. The conductive
leads, the rosette 252, and the fluidic media near the cannula 148
must have sufficiently high conductivity compared to an open
circuit for the fluidic media to be detected. In yet other
embodiments, a change in capacitance is measured to detect the
presence of fluidic media.
[0215] In alternative embodiments, the rosette may be in contact
with a material that wicks fluidic away from the cannula 148 and
spreads the fluidic across the rosette for an accelerated response.
In further embodiments, a wicking material may be used with the
chemical reactions described above, to accelerate the reaction or
make the resulting product of the reaction more visible.
[0216] In other embodiments, electrical power is not supplied to
the rosette. Instead, fluidic media reacts with one or more
chemical compounds in contact with the rosette. The electrochemical
reaction generates an electrical charge, and the voltage measured
across a discontinuous rosette increases from zero to a detectable
voltage level indicating that the fluidic media is present. In
particular embodiments, two unconnected electrodes 256 and 258 of
rosette 252 (as shown in FIG. 17B) are made of different metals and
coated with different chemicals. The electrodes 256 and 528 are
separated by a material such as a hydrogel or other material that
is dry before fluidic media presence, yet after fluidic media has
wet the hydrogel or other material conducts electricity. For
example, either of the electrodes (e.g., 256) may be made of
platinum and is coated with HRP and 4-aminoantipyrine. The other
electrode (e.g., 258) may be made of silver that is chloridized.
When the electrodes 256 and 258 are dry, there is no voltage across
the electrodes 256 and 258. Once fluidic media is present, the
phenol or other preservative within the fluidic media begins to
react with the HRP and 4-aminoantipyrine. The voltage across the
electrodes 256 and 258 will be about 650 mV or less.
[0217] In particular embodiments, the voltage is applied across an
LED (not shown) included as part of the medical device, causing the
LED to flash when fluidic media is present. In alternative
embodiments, the resulting voltage generated across the electrodes
256 and 258 is applied to other notification devices included as
part of the medical device, such as a piezo electric sound
emanating device, another sound emanating device, a piezo electric
vibration device, another vibration device, a LED that lights up or
changes color when the voltage is supplied, a RF transmitting
device that signals the medical device, or the like. In other
alternative embodiments, the voltage across the electrodes 256 and
258 is carried by a wire to the medical device and the medical
device triggers the notification (as discussed above). In other
particular embodiments, other concentrations or other reactants may
be used to generate a greater or lesser voltage differential across
the electrodes 256 and 258. In other embodiments, electrode 258 is
made of platinum and is coated with HRP and 4-aminoantipyrine, and
the other electrode 256 is made of silver that is chloridized. In
additional embodiments, other discontinuous rosettes are used.
[0218] In further embodiments, a change in impedance is detected if
the fluid conduit becomes dislodged. For instance, a change in
impedance may be detected if the medical device lifts off the
patient's skin and the cannula 148 becomes dislodged from the
subcutaneous tissue. A change in impedance may indicate that the
cannula 148 is not in the patient's body, and therefore the system
is not primed or otherwise not ready for delivery of fluidic media.
In particular embodiments, a pair of electrodes are mounted on the
medical device to measure impedance across the patient's skin. When
one or both electrodes lose contact with the patient's skin, the
increased impedance between the electrodes is sensed by medical
device electronics indicating that the system is not primed or
otherwise not read for delivery of fluidic media. Alternatively, a
change in capacitance between the electrodes may be measured to
detect when the medical device lifts off the patient's skin. The
relative capacitance increases when one or more electrodes lose
touch with the patient's skin.
[0219] Other embodiments use electrodes located on an exterior of
the cannula 148 to detect whether the cannula 148 is inserted in
the patient's body. Body fluid in the subcutaneous tissue is
substantially more conductive than infused fluidic media. When the
cannula is pulled from the body, the measured impedance across the
electrodes on the cannula 148 increases indicating that the system
is not primed or otherwise not ready for delivery of fluidic media.
Conversely, when the cannula 148 is inserted into the body, the
measured impedance across the electrodes on the cannula 148
decreases indicating that the cannula 148 has been inserted. This
may further indication that the system is now primed or otherwise
ready for delivery of fluidic media.
[0220] In yet other embodiments, electrodes may be located on an
exterior of any suitable fluid conduit, such as the needle 124 to
detect whether the needle 124 is properly connected or otherwise
position (e.g., in fluid communication with the reservoir 108).
Fluidic media has a certain conductance that be measured against an
expected value to determine if fluidic media is present or not
present.
[0221] Particular embodiments include a needle (e.g., 146) centered
inside the cannula 148 as one electrode and a metal sheath on the
external surface of the cannula 148 as the other electrode. In
alternative embodiments, the electrodes are conductive strips on
the external surface of the cannula 148. Other embodiments include
a first electrode attached to the cannula and a second electrode
touching the surface of the patient's skin. This method is easier
to use if the cannula 148 inserted in the patient's body is
conductive, such as a steel needle, a cannula with a conductive
coating, a cannula with conductors on the exterior surface, or the
like. Again, impedance increases when the cannula 148 is removed
from the patient's body and impedance decreases when the cannula
148 is inserted in the patient's body. Alternatively, capacitance
is measured instead of impedance. In this case, capacitance
increases when the cannula 148 is removed from the patient's body,
and decreases when the cannula 148 is inserted in the patient's
body.
[0222] In alternative embodiments, the presence of fluidic media
and/or the cannula 148 may trigger an exothermic chemical reaction.
Accordingly, the patient may feel their skin near the cannula 148
become warm when the cannula 148 and/or fluidic media (in the
cannula 148) is present. In such embodiments, visual inspection of
the cannula 148 is replaced by a tactile temperature change. In
other embodiments, both the color change method and an exothermic
reaction are used.
[0223] Although various embodiments relate to a cannula, other
embodiments may relate to any fluid conduit--in addition to or in
alternative of the cannula--such as, but not limited to, the needle
124 that connects the cannula 148 with the reservoir 108, the
connection portion 130, the needle 146, and/or the like.
[0224] Although various embodiments relate to one or more fluid
conduits, other embodiments may relate to other components--in
addition to or in alternative of the one or more fluid
conduits--such as, but not limited to, the second septum 136 and/or
the like. Accordingly, the medical device may detect the presence
of the second septum 136, as shown, for example, in FIG. 9. For
instance, the medical device may be configured, for example in a
manner described above, to detect the second septum 136 (or a
reaction occurring therein) when the connection portion 130 of the
reservoir 108 is inserted in the receptacle structure 110 to allow
the needle 124 to pierce the second septum 136, which places the
needle 124 in fluid communication with the reservoir 108.
[0225] Further examples of component connection and/or alignment
verification structures are described with reference to FIGS.
18A-20B, wherein a medical device system 900 may incorporate two
parts: a first housing portion 901 and a second housing portion
902. Other embodiments may include medical device systems with more
than two parts.
[0226] The medical device system 900 may be similar to or employed
as (but not limited to) an embodiment of the one or more of the
medical device systems (e.g., FIGS. 7A-17C) discussed in the
disclosure. Although the medical device system 900 may include
features similar or used with the embodiments of FIGS. 7A-17C, it
should be understood that the medical device system 900 may also
include some or all of the same features and operate in a manner
similar to that shown and described in the embodiments of FIGS.
1-6C and/or any of the other embodiments described in the
disclosure (e.g., FIGS. 21A-22B). In addition, some or all of the
features shown in FIGS. 1-17C (and/or any of the other embodiments
described in the disclosure) may be combined in various ways and
included in the embodiments shown in FIGS. 18A-20B. Likewise, it
should be understood that any of the features of the embodiments of
FIGS. 18A-20B may be combined or otherwise incorporated into any of
the other embodiments of FIGS. 18A-20B as well as any other
embodiment herein discussed.
[0227] In various embodiments, the first housing portion 901 may
be, but is not limited to, any of the housing portions described,
such as the durable portion 30 (e.g., FIGS. 1-6C). In other
embodiments, the first housing portion 901 may be, but is not
limited to, the disposable portion 20 (e.g., FIGS. 1-6C).
[0228] Moreover in various embodiments, the second housing portion
902 may be, but is not limited to, any of the housing portions
described, such as the base 21 (in FIGS. 1-6C). In such
embodiments, for example, the second housing portion 902 may be
secured to skin of a patient-user or otherwise carried by the
patient-user (e.g., secured on a belt, clothing, or the like)
during operation of the medical device system 900. In other
embodiments, the second housing portion 902 may be, but is not
limited to, the durable housing portion 30, the disposable housing
portion 20, and/or the like.
[0229] The first housing portion 901 may include a plurality of
electrical contacts 910 including a first main electrical contact
912 and a second main electrical contact 916. The plurality of
electrical contacts 910 may also include one or more other
electrical contact 914. The electrical contacts 910 may me made of
any suitable material such as metal, a rubber conductive pad, as
well as any other electrical conductor.
[0230] In some embodiments, the other electrical contact 914 may be
arranged between the first main electrical contact 912 and the
second main electrical contact 916. However, the other electrical
contact 914 may be arranged at any suitable location. The other
electrical contact 914 may be made of the same material as the
first main electrical contact 912 and/or the second main electrical
contact 914. In other embodiments, the other electrical contact 914
may be made of a different material (e.g., a different conductive
material, or a non-conductive material) from the first main
electrical contact 912 and/or the second main electrical contact
914.
[0231] The second housing portion 902 may include a shorting
mechanism 920 or the like configured to establish a short or
electrical connection with at least some of the electrical contacts
910 upon connecting the first housing portion 901 and the second
housing portion 902. In some embodiments, the shorting mechanism
920 may establish an electrical connection with at least some of
the electrical contacts 910 in a case where the first housing
portion 901 and the second housing portion 902 are connected
properly or otherwise brought into a pre-defined, sufficiently
aligned position and/or in a pre-defined, sufficiently close
proximity. The predefined aligned position and/or proximity, for
example, may correspond to a properly aligned and mutually
proximate position for connection of the first housing portion 901
and the second housing portion 902 for operation. In other
embodiments, the shorting mechanism 920 may be a known resistance
or the like.
[0232] The shorting mechanism 920 may have a first end 922 and a
second end 924 for contacting respective electrical contacts 910 on
the first housing portion 901. In some embodiments, the first end
922 and the second end 924 may be arranged to contact the first
main electrical contact 912 and the second main electrical contact
916 respectively when the first housing portion 901 and the second
housing portion 902 are connected properly, for example, as shown
in FIG. 41B. As such, the shorting mechanism 920 may contact the
first main electrical contact 912 and the second main electrical
contact 916, but not the other electrical contact 914. Suitable
circuitry (not shown) connected to the electrical contacts 910 may
be configured to detect an electrical connection or short between
the first main electrical contact 912 and the second main
electrical contact 916 (via the shorting mechanism 920) indicating
a proper connection of the first housing portion 901 and the second
housing portion 902.
[0233] Furthermore, the electrical contacts 910 and/or the shorting
mechanism 920 may be arranged on their respective parts such that
in a case where the first housing portion 901 and the second
housing portion 902 are not properly connected, such as in FIG.
18C, an electrical connection between the first main electrical
contact 912 and the second main electrical contact 916 is not
established. Accordingly, this may indicate that the first housing
portion 901 and the second housing portion 902 have not been
connected properly.
[0234] Returning to FIGS. 18A-18C, some embodiments in which at
least one other electrical contact 914 is arranged between the
first main electrical contact 912 and the second main electrical
contact 916 may prevent a false detection of a proper connection of
the first housing portion 901 and the second housing portion 902.
For example, the circuitry may be able to distinguish between a
case where a stray metal object (e.g., a metal key, paper clip,
coin) or other electrical conductor contacts the first main
electrical contact 912, the second main electrical contact 916, and
the other contact 914 as opposed to a proper connection where only
the first main electrical contact 912 and the second main
electrical contact 912 are contacted (by the shorting
mechanism).
[0235] In some embodiments, an electrical connection will only be
established when the first end 922 contacts the first main
electrical contact 912 and the second end 924 contacts the second
main electrical contact 916. In other embodiments, an electrical
connection may be established in a case where the first end 922 and
the second end 924 contact the first main electrical contact 912
and the second main electrical contact 916 respectively or in a
case where the first end 922 and the second end 924 contact the
second main electrical contact 916 and the first main electrical
contact 912 respectively. Such embodiments, may allow for a
detection of a proper connection of the first housing portion 901
and the second housing portion 902 in more than one
orientation.
[0236] In the embodiments shown in FIGS. 18A-18C, there are three
electrical contacts: the first main electrical contact 912, the
second main electrical contact 916, and the other electrical
contact 914 arranged between the first main electrical contact 912
and the second main electrical contact 916. However, in various
other embodiments, any suitable number of electrical contacts 910
may be provided on the first housing portion 901 as required. In
some embodiments, the main electrical contacts (e.g., 912, 916) are
arranged as the outermost electrical contacts; however, in other
embodiments, the main electrical contacts may be arranged anywhere
relative to the other electrical contact(s) 914.
[0237] Similarly, the other electrical contacts need not be limited
to being arranged in between main electrical contacts, but may also
be arranged to be the outermost electrical contact in some
embodiments. As such, the electrical contacts 910 (e.g., main
electrical contacts and other electrical contacts) may be arranged
or otherwise provided on the first housing portion 901 in any
suitable manner, for example linearly/non-linearly,
equidistant/non-equidistant, similar/varying heights, arranged on
similar/varying surfaces, same/different resistances,
same/different materials, and/or the like. For instance, as shown
in FIG. 19, seven electrical contacts 910 could be provided
including two first main electrical contacts 912, a first other
electrical contact 914, a second main electrical contact 916, a
second other electrical contact 914, and two third main electrical
contacts 918.
[0238] In the embodiments shown in FIGS. 18A-18C, the shorting
mechanism 920 has two ends 922, 924 for contacting the first main
electrical contact 912 and the second main electrical contact 916,
respectively. However, in various other embodiments, the shorting
mechanism 920 may be provided with any suitable number of ends or
contact surfaces for contacting the electrical contacts 910 as
required. Similarly, the ends (e.g., 922, 924) may be arranged on
shorting mechanism 920 in any suitable manner.
[0239] In various embodiments, the electrical contacts 910 may be
provided on the first housing portion 901 and the shorting
mechanism 920 may be provided on the second housing portion 902. In
other embodiments, the electrical contacts 910 may be provided on
the second housing portion 902 and the shorting mechanism 920 may
be provided on the first housing portion 901. In further
embodiments, each of the first housing portion 901 and the second
housing portion 902 may be provided with a shorting mechanism 920
and complementing electrical contacts 910.
[0240] In some embodiments, such as the embodiments shown in FIGS.
20A and 20B, a bias member 919, such as a spring, or the like, may
be provided to bias the electrical contacts 910 either
individually, partially (e.g., some, but not all), or collectively
toward a first position (e.g., an extended position as shown in
FIG. 20A). As such, the electrical contacts 910 may be moveable
toward a second position (e.g., a retracted position as shown in
FIG. 20B), for example, as the first housing portion 901 and the
second housing portion 902 are brought together. Thus, while in the
second position, an electrical connection may be established
between the first main electrical contact 912 and the second main
electrical contact 916 via the shorting mechanism 910 in a similar
manner to that previously described. The bias member 919 may be
located at least partially within a recess of the first housing
portion 901. In some embodiments, the bias member 919 may be
supported on the first housing portion 901, for example, between
the electrical contacts 910 and the first housing portion 901.
[0241] In addition or in alternative to the above, in some
embodiments, a bias member, such as a spring, or the like, may be
provided to bias the shorting mechanism or portion thereof (e.g.,
ends 922, 924) toward a first position (e.g., an extended
position). As such, shorting mechanism or portion thereof may be
moveable toward a second position (e.g., a retracted position), for
example, as the first housing portion 901 and the second housing
portion 902 are brought together. Thus, while in the second
position, an electrical connection may be established between the
first main electrical contact 912 and the second main electrical
contact 916 via the shorting mechanism 910 in a similar manner to
that previously described.
[0242] In various embodiments, the electrical contacts 920 and/or
the shorting mechanism 910 may be or otherwise comprise a bias
member like that previously described. For example, the electrical
contacts 920 may be metal springs or the like that may be moveable
from the first position to the second position as the first housing
portion 901 and the second housing portion 902 are brought
together.
[0243] Further examples of component connection and/or alignment
verification structures are described with reference to FIGS.
21A-22B, wherein a medical device system 1100 may incorporate two
parts: a first housing portion 1101 and a second housing portion
1102. Other embodiments may include medical device systems with
more than two parts.
[0244] The medical device system 1100 may be similar to or employed
as (but not limited to) an embodiment of the one or more of the
medical device systems (e.g., FIGS. 7A-20B) discussed in the
disclosure. Although the medical device system 1100 may include
features similar or used with the embodiments of FIGS. 7A-20B, it
should be understood that the medical device system 1100 may also
include some or all of the same features and operate in a manner
similar to that shown and described in the embodiments of FIGS.
1-6C and/or any of the other embodiments described in the
disclosure. In addition, some or all of the features shown in FIGS.
1-20B (and/or any of the other embodiments described in the
disclosure) may be combined in various ways and included in the
embodiments shown in FIGS. 21A-22B. Likewise, it should be
understood that any of the features of the embodiments of FIGS.
21A-22B may be combined or otherwise incorporated into any of the
other embodiments of FIGS. 21A-22B as well as any other embodiment
herein discussed.
[0245] In various embodiments, the first housing portion 1101 may
be, but is not limited to, any of the housing portions described,
such as the durable portion 30 (e.g., FIGS. 1-6C). In other
embodiments, the first housing portion 1110 may be, but is not
limited to, the disposable portion 20 (e.g., FIGS. 1-6C).
[0246] Moreover in various embodiments, the second housing portion
1102 may be, but is not limited to, any of the housing portions
described, such as the base 21 (FIGS. 1-6C). In such embodiments,
the second housing portion 1102 may be secured to skin of a
patient-user during operation of the medical device system 1100. In
other embodiments, the second housing portion 1102 may be, but is
not limited to, the durable housing portion 30, the disposable
housing portion, and/or the like.
[0247] The first housing portion 1101 may include a sensor 1110 for
sensing a magnetic field, and in specific embodiments, for sensing
at least a direction (i.e., vector) of a magnetic field. Such
sensors 1110 may allow for detecting a presence of a magnetic field
or magnetic source independent of magnetic strength. Furthermore,
sensing a direction of a magnetic field may increase the
probability that the sensor 1110 is sensing the appropriate the
magnetic source. The sensor 1110 may be similar to the sensors
described in, but is not limited to, U.S. patent application Ser.
No. 12/649,619, filed Dec. 30, 2009, entitled "Alignment Systems
and Methods," herein incorporated by reference in its entirety. The
sensor 1110 may be disposed in the first housing portion 1101 or be
provided on the first housing portion 1101.
[0248] Suitable electronics may be connected to the sensor 1110 to
provide a controlled power signal to selectively activate or
otherwise control one or more of the sensor 1110 and/or other
components as described in the disclosure. For example, the sensor
1110 may be controlled to activate upon a manual activation of a
control button, switch, or other manual operator on one of the
connectable components or on a remote-controller device (not shown)
connected in wireless communication with the sensor 1110 through
suitable control electronics. As another example, the sensor 1110
may be controlled to activate automatically after a certain action,
such as activation of a button, and/or the like or after a certain
amount of time. In some embodiments, the sensor 1110 may be
controlled to activate upon activation or insertion of a particular
component or device, such as, but not limited to, a needle inserter
to insert a needle or cannula.
[0249] Examples of various needle insertion tools are described in,
but are not limited to, U.S. patent application Ser. No.
11/645,972, filed Dec. 26, 2006, "Infusion Medium Delivery System,
Device And Method With Needle Inserter And Needle Inserter Device
And Method"; U.S. patent application Ser. No. 11/646,052, filed
Dec. 26, 2006, "Infusion Medium Delivery System, Device And Method
With Needle Inserter And Needle Inserter Device And Method"; U.S.
patent application Ser. No. 11/645,435, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; U.S. patent
application Ser. No. 11/646,000, filed Dec. 26, 2006, "Infusion
Medium Delivery System, Device And Method With Needle Inserter And
Needle Inserter Device And Method," all of which are herein
incorporated by reference in their entirety. Thus, in such
examples, the sensor 1110 may be activated, for example, before or
after, the first housing portion 1101 and the second housing
portion 1102 are brought operatively engaged.
[0250] The second housing portion 1102 may include a magnetic
source 1120 or the like for providing a magnetic field having a
direction. The magnetic source 1120 may be arranged on or in the
second housing portion 1102 at a location to allow the magnetic
field and/or the direction of the magnetic field of the magnetic
source 1120 to be detectable by the sensor 1110 in a case where the
first housing portion and the second housing portion 1102 are
connected properly or otherwise brought into a pre-defined,
sufficiently aligned position and/or in a pre-defined, sufficiently
close proximity. The predefined aligned position and/or proximity,
for example, may correspond to a properly aligned and mutually
proximate position for connection of the first housing portion 1101
and the second housing portion 1102 for operation. Detection of the
magnetic field and/or the direction of the magnetic field of the
magnetic source 1120 may indicate that the first housing portion
1101 and the second housing portion 1102 have been connected
properly.
[0251] In some embodiments, the magnetic source 1120 may be in
contact with the sensor 1110 to allow the sensor 1120 to detect the
magnetic field and/or direction of the magnetic field of the
magnetic source 1120. In other embodiments, the magnetic source
1120 need not be in contact with the sensor 1110 to allow the
sensor 1110 to detect the magnetic field and/or direction of the
magnetic field of the magnetic source 1120. For example, a portion
of one or both of the first housing portion 1101 and the second
housing portion 1102 may be arranged between the sensor 1110 and
the magnetic source 1120.
[0252] Furthermore, the sensor 1110 and the magnetic source 1120
may be arranged such that in a case where the first housing portion
1101 and the second housing portion 1102 are not been properly
connected, the sensor 1110 will not be able to detect the magnetic
field and/or the direction of the magnetic field, for example,
because the sensor 1110 and the magnetic source 1120 are too far
apart. Accordingly, this may indicate that the first housing
portion 1101 and the second housing portion 1102 have not been
connected properly.
[0253] In some embodiments, the magnetic source 1120 may provide
more than one magnetic fields and/or directions of magnetic fields.
As shown for example in FIGS. 21A and 21B, a first field 1122, a
second field 1124, and a third field 1126 are provided in which the
first field 1122 and the third field 1126 have a direction
different from a direction of the second field 1124. In such an
example, the sensor 1110 may be configured to detect only the
second field 1124 and/or the direction (e.g., North) of the second
field 1124 in a manner previously described. Thus, detection of the
second field 1124 and/or the direction of the second field 1124 may
indicate that the first housing portion 1101 and the second housing
portion 1102 have been connected properly.
[0254] In further embodiments, the sensor 1110 may be configured to
detect other fields (e.g., first field 1122 and second field 1126)
and/or directions of the other fields such that detection of the
other fields and/or directions of the other fields may indicate an
improper connection of the first housing portion 1101 and the
second housing portion 1102. The electronics may employ an
algorithm for processing information relating to the various fields
and/or other related information (e.g., magnetic field strength,
gauss level, and/or the like).
[0255] In some embodiments, such as the embodiments shown in FIGS.
22A-22B, the first housing portion 1101 may have a sensor 1111 for
sensing a gauss level or the like of a magnetic source. The sensor
1111 may be similar to the sensor 1110 previously described or any
of the sensors described in, but is not limited to, U.S. patent
application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled
"Alignment Systems and Methods," herein incorporated by reference
in its entirety. The sensor 1111 may be disposed in the first
housing portion 1101 or be provided on the first housing portion
1101.
[0256] Suitable electronics may be connected to the sensor 1111 to
provide a controlled power signal to selectively activate or
otherwise control one or more of the sensor 1111 and/or other
components as described in the disclosure. For example, the sensor
1111 may be controlled to activate upon a manual activation of a
control button, switch, or other manual operator on one of the
connectable components or on a remote-controller device (not shown)
connected in wireless communication with the sensor 1111 through
suitable control electronics. As another example, the sensor 1111
may be controlled to activate automatically after a certain action,
such as activation of a button, and/or the like or after a certain
amount of time. In some embodiments, the sensor 1111 may be
controlled to activate upon activation or insertion of a particular
component or device, such as, but not limited to, a needle inserter
to insert a needle or cannula.
[0257] Examples of various needle insertion tools are described in,
but are not limited to, U.S. patent application Ser. No.
11/645,972, filed Dec. 26, 2006, "Infusion Medium Delivery System,
Device And Method With Needle Inserter And Needle Inserter Device
And Method"; U.S. patent application Ser. No. 11/646,052, filed
Dec. 26, 2006, "Infusion Medium Delivery System, Device And Method
With Needle Inserter And Needle Inserter Device And Method"; U.S.
patent application Ser. No. 11/645,435, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; U.S. patent
application Ser. No. 11/646,000, filed Dec. 26, 2006, "Infusion
Medium Delivery System, Device And Method With Needle Inserter And
Needle Inserter Device And Method," all of which are herein
incorporated by reference in their entirety. Thus, in such
examples, the sensor 1111 may be activated, for example, before or
after, the first housing portion 1101 and the second housing
portion 1102 are brought operatively engaged.
[0258] The second housing portion 1102 may include a magnetic
source 1121 or the like for providing a certain gauss level. The
magnetic source 1121 may be similar to the magnetic source 1120
previously described or any of the magnetic sources described in,
but is not limited to, U.S. patent application Ser. No. 12/649,619,
filed Dec. 30, 2009, entitled "Alignment Systems and Methods,"
herein incorporated by reference in its entirety.
[0259] The magnetic source 1121 may be arranged on or in the second
housing portion 1102 at a location to allow the gauss level of the
magnetic source 1121 to be detectable and/or measurable by the
sensor 1110 in a case where the first housing portion and the
second housing portion 1102 are connected properly. Detection of
gauss level of the magnetic source 1121 may indicate that the first
housing portion 1101 and the second housing portion 1102 have been
connected properly. In further embodiments, the sensor 1111 and/or
associated electronics may be configured to detect a gauss level
that is within a specified range. In such embodiments, a gauss
level that is below or exceeds the specified range may indicate an
improper connection.
[0260] In some embodiments, the magnetic source 1121 may be in
contact with the sensor 1111 to allow the sensor 1111 to detect the
gauss level of the magnetic source 1121. In other embodiments, the
magnetic source 1121 need not be in contact with the sensor 1111 to
allow the sensor 1111 to detect the gauss level of the magnetic
source 1121. For example, a portion of one or both of the first
housing portion 1101 and the second housing portion 1102 may be
arranged between the sensor 1111 and the magnetic source 1121.
[0261] Furthermore, the sensor 1111 and the magnetic source 1121
may be arranged such that in a case where the first housing portion
1101 and the second housing portion 1102 are not been properly
connected, the sensor 1111 will not be able to detect the gauss
level (or the gauss level is not within a detectable range) of the
magnetic source 1121, for example, because the sensor 1111 and the
magnetic source 1121 are too far apart. Accordingly, this may
indicate that the first housing portion 1101 and the second housing
portion 1102 have not been connected properly.
[0262] In further embodiments, electronics (not shown), such as a
magnetic threshold switch (e.g., hall switch, reed switch, and/or
the like), or the like, associated with the sensor 1111 may be
configured to provide a signal or the like upon the sensor 1111 (or
other sensor) sensing a signal outside a second range, which in
some embodiments may be the same the specified range. In other
embodiments, the second range may be different from the specified
range. For example, the electronics may provide a signal to the
control electronics of the medical device system 1100 to disable
the medical device system 1100 or certain portions thereof if a
gauss level beyond the second range is detected. Such embodiments
may protect the various electronics of the medical device system
1100 in a case where the medical device system 1100 is in operation
and is exposed to a strong external magnetic influence, such as an
MRI (magnetic resonance imaging) machine, or the like.
[0263] In some embodiments, the magnetic source 1121 may provide
more than one gauss level. In such embodiments, the sensor 1111 may
be configured to detect only a particular gauss level corresponding
to a proper connection of the first housing portion 1101 and the
second housing portion 1102 similar to a manner previously
described. Thus, detection of the particular gauss level may
indicate that the first housing portion 1101 and the second housing
portion 1102 have been connected properly. In further embodiments,
the sensor 1111 may be configured to detect other gauss levels such
that detection of the other gauss levels may indicate an improper
connection of the first housing portion 1101 and the second housing
portion 1102. The electronics may employ an algorithm for
processing information relating to the various gauss levels and/or
other related information (e.g., magnetic field strength, direction
of a field, and/or the like).
[0264] With reference to FIGS. 22A-22B, in various embodiments, the
sensor 1110 and the sensor 1111 may be the same sensor and thus may
be configured to sense both a direction of magnetic field and a
gauss level from a magnetic source. In some embodiments, the sensor
1110 and the sensor 1111 may both provided for sensing a magnetic
source (e.g., 1120, 1121) as previously described. The sensor 1110
and the sensor 1111 may be arranged to sense the same magnetic
source or respective magnetic sources. In further embodiments, the
electronics may employ an algorithm for processing information
relating to the various gauss levels, field directions, and/or
other related information.
[0265] In various embodiments, the sensor 1110, 1111 may be
provided on the first housing portion 1101 and the magnetic source
1120, 1121 may be provided on the second housing portion 1102. In
other embodiments, the sensor 1110, 1111 may be provided on the
second housing portion 1102 and the magnetic source 1120, 1121 may
be provided on the first housing portion 1101. In further
embodiments, each of the first housing portion 1101 and the second
housing portion 1102 may be provided with a sensor (e.g., 1110,
1111) and complementing magnetic source (e.g., 1120, 1121).
[0266] With reference to FIGS. 18A-22B and 23, the sensors and/or
the electrical contacts may be in electrical communication with
electronics (not shown). The electronics may be incorporated within
control electronics for controlling a drive device 44 (e.g., FIG.
4) such as, but not limited to, control electronics 52 (e.g., FIG.
4) for controlling the drive device 44. Alternatively, the
electronics may be separate from and in addition to the control
electronics 52, but connected in electrical communication with the
control electronics 52 and/or the drive device 44 to provide a
drive control signal to the drive device 44. More specifically, the
electronics may be configured to inhibit operation of the drive
device 44, unless a signal or a change in state is received by the
control electronics 52.
[0267] For instance, as previously discussed, a signal or a change
in state may be provided upon the first end 922 and the second end
924 interacting with the first main contact 912 and the second main
contact 916, for example, in a case where the first housing portion
901 and the second housing portion 902 are in proper alignment and
sufficiently close in proximity to connect for operation. In other
words, the drive device 44 may be inoperable unless the first
housing portion 901 and the second housing portion 902 are
operatively engaged properly (i.e., aligned and/or connected
properly).
[0268] The electronics and/or the control electronics 52 (e.g.,
FIG. 4) may be configured to control the drive device 44 (e.g.,
FIG. 4) in various manners in accordance with various embodiments
of the invention. Examples are discussed in, but are not limited
to, U.S. patent application Ser. No. 11/759,725, entitled "Infusion
Medium Delivery Device and Method with Drive Device for Driving
Plunger in Reservoir"; and U.S. patent application Ser. No.
12/649,619, filed Dec. 30, 2009, entitled "Alignment Systems and
Methods," both of which are herein incorporated by reference in
their entirety.
[0269] For example, the drive device 44 may be controlled to stop
pumping (delivery) operation upon a detection of an interruption of
a fluid-flow path or a disconnection of a critical component in the
medical device system (e.g., 900, 1100). These may include, but are
not limited to, a disconnection of a housing portion from another
housing portion or from a base portion, a disconnection of a
conduit from another conduit or from a reservoir, a disconnection
of a reservoir from a housing portion or a base, and/or the
like.
[0270] In yet further embodiments, additional sensors may be
provided within the medical device system and connected for
electrical communication with the electronics 414. Such additional
sensors may comprise magnetically and/or electronically actuating
switches, magnetic and/or electric field magnitude and direction
sensors, inductive sensors, other proximity sensors, contact
sensors, and/or the like for providing a detectable signal or
change in a state upon proper connection of other components in the
medical device system. Such proper connection of other components
may comprise, for example, one or more of a proper connection of a
reservoir into a housing portion or base, a proper connection of a
conduit to a reservoir, a proper connection of two conduits
together, a proper setting of a needle or cannula in an inserted
state, a proper connection of a conduit to a cannula or needle, or
a proper connection of other components of or to the medical device
system.
[0271] In alternative or in addition, the electronics and/or the
control electronics 52 (e.g., FIG. 4) may be configured to detect a
first-time connection of a first housing portion (e.g., 901) and a
second housing portion (e.g., 902) or a first-time connection of
other components, as compared to a re-connection after previous or
partial usage. In this manner, the drive device 44 may be
controlled to provide a priming operation or other suitable
first-time operation(s) upon detection of a first-time connection
of the first part 401 and the second part 402.
[0272] In various embodiments, the sensors, electrical contacts,
and/or associated circuitry may allow for, but is not limited to,
tracking a number of times a component has been connected to and/or
disconnected from other components, verifying proper connection
and/or alignment of components in a medication delivery system
prior to each delivery step, checking, sensing, and/or measuring
parameters, such as ambient parameters (e.g., ambient magnetic
fields), operating parameters, and/or the like, alerting users to
conditions, such as conditions outside operating parameters of the
delivery system, and/or the like.
[0273] Various embodiments may allow for verification between two
(or more) distinct and separate components, verification of correct
positioning between the two (or more) distinct and separate
components, verification that the two (or more) distinct and
separate components have been connected in the correct order, a
safety mechanism to provide notification of separation (intentional
or accidental) of any individual component in a multi-component
system, and/or the like.
[0274] In alternative or in addition, the electronics and/or the
control electronics 52 (e.g., FIG. 4) may be configured to provide
a user-perceptible indication of a proper alignment and/or
connection of the first housing portion and the second housing
portion or of other components. For example, upon detection of a
proper alignment and/or connection of the first housing portion and
the second housing portion 402, the electronics 414 and/or the
control electronics 52 may provide a suitable control signal to
activate an indicator device 420, as shown in FIG. 36.
[0275] The indicator device 420 may be operated by a processor 422.
The processor 422 may be configured to execute various programs
and/or to process various information, such as data received from
one or more sensors, responsive devices, and/or other interactive
elements. The processor 422, for example, may be configured to
compare detected signals with thresholds and/or pre-stored values
in memory 424.
[0276] With reference to FIGS. 18A-22B and 23, the indicator device
420 may include, but is not limited to, an audible indicator, an
optical indicator, a tactile indicator, combinations of one or more
those indicators, and/or the like. For example, upon a proper
alignment or connection of components as described above, an
audible beeping sound or other suitable sound may be generated by a
sound generating device in or associated with one or both of the
first housing portion and the second housing portion. For example,
upon a proper alignment or connection of components as described
above, a flashing light or other suitable visual indicator may be
generated by an LED or other light source or a display device on or
associated with one or both of the first housing portion and the
second housing portion. For example, upon a proper alignment or
connection of components as described above, a vibration and/or the
like may be generated by a vibration device and/or the like in or
associated with one or both of the first housing portion and the
second housing portion. Examples of indicator devices are discussed
in, but are not limited to, U.S. patent application Ser. No.
11/759,725, entitled "Infusion Medium Delivery Device and Method
with Drive Device for Driving Plunger in Reservoir"; and U.S.
patent application Ser. No. 12/649,619, filed Dec. 30, 2009,
entitled "Alignment Systems and Methods," both of which are herein
incorporated by reference in their entirety.
[0277] Throughout various embodiments, a medical device system
includes multiple housing portions that must be put together. The
medical device system must be able to verify presence of the
housing portions and alignment of the housing portions relative to
each other. In particular embodiments, the medical device system is
configured to detect proper alignment between one or more housings,
for example between the base 21 (refer to FIGS. 1-6C) and the
durable housing portion 30 (refer to FIGS. 1-6C). FIG. 24
illustrates an alignment verification process S2400 implemented by
a medical device system having the structures 900 and 1100 of FIGS.
18A-22B for detecting proper alignment between a first housing
portion (e.g., durable housing portion 901, 1101) and a second
housing portion (e.g., base portion 902, 1102).
[0278] With reference to FIGS. 18A-24, the process S2400 typically
(but not necessarily) takes place when the medical device system is
in a monitoring state, waiting for confirmation of a fully
assembled medical device system to begin normal operation.
[0279] The process S2400 algorithm is triggered by an interrupt
(S2410), which is detected when the electrical contacts (e.g., 912
and 916) switch states (e.g., from high to low or low to high)
(S2412). To account for system instability and reduce false
interrupts, the medical device system continues to monitor the
interrupt line (BP_INT) for a period of time (S2414). This ensures
that the electrical contacts remain in the states for a minimum
specified duration (e.g., 100 ms). Any intermediate interrupt will
reset the timer.
[0280] Next, the system determines whether the interrupt (BP_INT)
was triggered by the base housing portion and not, for example, by
a short from an ionic solution, partial short, or a disconnection
of the base housing portion from the durable housing portion. In
particular, in step S2420, state of the other electrical contact
(e.g., 914) is monitored. In a case where the states of the
electrical contacts 912 and 916 are HIGH, if the state of the other
electrical contact 914 is HIGH (i.e., a same state as that of the
electrical contacts) (S2422: NO), a partial short, ionic solution
presence, or disconnection of the housing portion may have
occurred, which may indicate that the medical device system
components are disconnected or otherwise not in a state for
operation (S2424). Accordingly, the medical device system, in step
S2426, may provide an alarm or other indication of such, for
example via the indicator 420.
[0281] In a case where the states of the electrical contacts 912
and 916 are HIGH, if the state of the other electrical contact 914
is NO (i.e., an opposite or different state as the electrical
contacts) (S2422: YES), the system determines whether the interrupt
(BP_INT) was triggered by the base housing portion and not, for
example, a metallic short. In particular, in step S2430, a voltage
pulse may be applied. Then in step S2432, a reference state is
detected. If the reference state is LOW (i.e., an opposite or
different state as the electrical contacts) (S2434: NO), a metallic
short may have occurred, which may indicate that the medical device
system components are disconnected or otherwise not in a state for
operation (S2436). Accordingly, the medical device system, in step
S2438, may provide an alarm or other indication of such, for
example via the indicator 420.
[0282] If the reference state is HIGH (i.e., a same state as the
electrical contacts) (S2434: YES), the magnetic sensor (e.g., 1110,
1111) is queried to verify alignment of the connected housing
portions. In particular, in step S2440, the magnetic sensor samples
(e.g., 16.times.@1 kHz) the magnetic source (e.g., 1120, 1121). In
some embodiments, in step S2442, an averaging filter may be
implemented to adjust the sampled sensor data, for example to
mitigate spurious signals, attenuate noise, adjust sampled sensor
data to mitigate anomalous data points, and/or the like. In step
S2444, the sampled sensor data (or adjusted sampled sensor data) is
compared to a table or predetermined range of values to determine
whether the sensor and the magnetic source (and thus the durable
housing portion and the base housing portion, respectively) are
aligned in the predetermined manner. If the sensor data is not
within the range of values (S2446: NO), this may indicate that the
medical device system components are disconnected or otherwise not
in a state for operation (S2447). Accordingly, the medical device
system, in step S2448, may provide an alarm or other indication of
such, for example via the indicator 420. If the sensor data is
within the range of value (S2446: YES), this may indicate that the
housing portions are connected and aligned in the predetermined
manner (S2450) to allow the medical device system to begin normal
operation (e.g., begin delivery of insulin).
[0283] In particular embodiments, the magnetic sensor is a magnetic
angle sensor that measures a magnetic angle of the magnetic source
to determine whether the measured magnetic angle is within a
predetermined range, which would indicate that housing portions are
aligned in the predetermined manner. When the measured magnetic
angle is outside the predetermined range, this may indicate that
the base portion is not present or that the housing portions are
not otherwise aligned. In other embodiments, a reed switch may be
used in place of the magnetic angle sensor. The reed switch may
generate an interrupt any time the base portion is moved to act as
a signal for change in base proximity.
[0284] In various embodiments, one or more of the steps of the
process S2400 may be omitted, added to, or replaced. For instance,
in some embodiments, the triggered interrupt (S2410) may trigger
programmed sampling of the contact potential (or the like) at one
or more specified intervals. If sample n does not match the
original detected interrupt, the triggered interrupt is cleared,
and the process waits for a new interrupt. In other embodiments,
the algorithm may be triggered (e.g., steps S2410-S2414) through
use of the magnetic sensor. For instance, the sensor may
continuously monitor the magnetic field of the magnetic source, and
may trigger the algorithm whenever the sensor data is within the
predetermined range of values. In some embodiments, the
verification steps (e.g., steps S2420-S2446) may be omitted. In
other embodiments, only one or two of the ionic solution check,
metallic short check, and magnetic sensor check may be performed.
In various embodiments, upon each failure, the system may alert the
user of the corresponding failure and end the process S2400. In
other embodiments, the system may continue some or all of the steps
of the process S2400 after a failure has been determined, and then
issue one or more alerts corresponding the failure and any other
failures. In various embodiments, a failure alert is issued more or
less immediately after occurring. In other embodiments, the failure
alerts are delayed until some later event. For instance, the alert
may be issued at a later time when the user attempts to operate a
motor of the medical device system.
[0285] In various embodiments, the process 2400 verifies that the
base portion is presented (i.e., that the components are properly
aligned). In other embodiments, the process 2400 may be used (and
modified accordingly) in a similar manner to determine that the
base portion is not present. This may be useful when ensuring
engagement of the drive system to the delivery system, resetting
drive components, or otherwise calibrating the medical device
system.
[0286] FIG. 25 illustrates an alignment monitoring process S5400
implemented by a medical device system having the structures 900
and 1100 of FIGS. 18A-22B for detecting proper alignment between a
first housing portion (e.g., durable housing portion 901, 1101) and
a second housing portion (e.g., base portion 902, 1102).
[0287] With reference to FIGS. 18A-25, the process S2500 typically
(but not necessarily) begins with a system request (S2510) that
takes place after the components of the medical device system have
been properly aligned, for example (but not limited to), upon
completion of step S2450. The system request may occur immediately
upon completion of step S2450, periodically (e.g., every 5 minutes)
thereafter, or upon the occurrence of an event (e.g., an interrupt
on the other electrical contact is triggered).
[0288] Next, the magnetic sensor (e.g., 1110, 1111) is queried to
verify alignment of the connected housing portions, for example as
described in S2400. In particular, in step S2520, the magnetic
sensor samples (e.g., 16.times.@1 kHz) the magnetic source (e.g.,
1120, 1121). In some embodiments, in step S2522, an averaging
filter may be implemented to adjust the sampled sensor data, for
example to adjust sampled sensor data to mitigate anomalous data
points, attenuate noise, mitigate spurious signals, and/or the
like. In step S2524, the sampled sensor data (or adjusted sampled
sensor data) is compared to a table or predetermined range of
values to determine whether the sensor and the magnetic source (and
thus the durable housing portion and the base housing portion,
respectively) are aligned in the predetermined manner. If the
sensor data is within the range of value (S2426: YES), this may
indicate that the housing portions are connected and aligned in the
predetermined manner (S2450) to allow the medical device system to
begin normal operation (e.g., begin delivery of insulin).
[0289] If the sensor data is not within the range of values (S2426:
NO), the system may wait a period of time (S2530) (e.g., 500 ms) to
determine if an interrupt is triggered (S2532), after which the
interrupt behavior may be followed. If the interrupt is triggered
(S2532: YES), this may indicate that the medical device system
components have become disconnected or are otherwise not in a state
for operation (S2534). Accordingly, the medical device system, in
step S2536, may provide an alarm or other indication of such, for
example via the indicator 420. If no interrupt occurs (S2532: NO),
the check may be repeated at least one more time (S3538: NO). If
the check continues to fail (S2538: YES), normal operation is
halted and the user is notified (S2534, S2536).
[0290] In various embodiments, the medical device system implements
process S2400 to verify an initial connection and/or alignment of
the durable housing portion and the base portion (or between other
suitable housing portions), and then implements the process S2500
to continuously monitor that the housing portions remain connected
and/or aligned. In other embodiments, one of these processes may be
omitted. For instance, once the process S2400 is complete, the
medical device system need not execute the process S2500.
[0291] In some embodiments, a single failure of the sensor (e.g.,
S2526: NO) may be sufficient to indicate a failure. Thus, in some
embodiments, at least steps S2532 and S2538 and/or any other
verification steps may be omitted.
[0292] In some embodiments, the verification steps using the
magnetic sensor (steps S2520-S2526) may in the alternative (or
additionally) poll the sensor at one or more specified intervals.
If sample n does not match an expected reading, steps S2530-S2538
may follow. If the same sample does match, the process proceeds to
step S2528.
[0293] In some embodiments, a reed switch may be used in place of
the magnetic angle sensor. The reed switch may generate an
interrupt any time the base portion is moved to act as a signal for
change in base proximity.
[0294] In various embodiments, the process S2500 (and/or the
process S2400) may verify that a fluid connector (e.g., cannula 148
in FIGS. 7-17C) is properly positioned, as described (but not
limited to) any one of the structures and/or methods described with
respect to FIGS. 7-17C. For instance, an optical receiver
positioned to detect light (and/or other parameters) from the
cannula may provide a signal or other indication as part of the
process S2500 to indicate whether the cannula is properly
positioned.
[0295] The embodiments disclosed herein are to be considered in all
respects as illustrative, and not restrictive of the invention. The
present invention is in no way limited to the embodiments described
above. Various modifications and changes may be made to the
embodiments without departing from the spirit and scope of the
invention. The scope of the invention is indicated by the attached
claims, rather than the embodiments. Various modifications and
changes that come within the meaning and range of equivalency of
the claims are intended to be within the scope of the
invention.
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