Note: Descriptions are shown in the official language in which they were submitted.
CA 02565956 2006-11-17
COST-SENSITIVE APPLICATION INFUSION DEVICE
FIELD OF THE INVENTION
This invention relates to external infusion devices and, in particular
embodiments to external infusion devices that control the rate that a fluid is
infused
into an individual's body.
BACKGROUND OF THE INVENTION
Portable personal infusion devices and systems are relatively well-known in
the medical arts, for use in delivering or dispensing a prescribed medication
to a
patient. Many pharmaceutical agents are delivered into the subcutaneous tissue
and
the most common is insulin. Currently, more than 70,000 patients in the U. S.
and
30,000 more patients worldwide use continuous subcutaneous infusion of insulin
(CSII) for the treatment of diabetes mellitus. However, other medications that
are
infused include HIV drugs, drugs to treat pulmonary hypertension, iron
chelation
drugs, pain medications, and anti-cancer treatments.
Traditionally, low cost infusion devices have used an elastomeric diaphragm,
sponge rubber, balloon or gas generator to expel fluid to be infused into a
patient
over a period of time at a single, relatively constant rate. A drawback to
these
devices is that they are only filled with fluid once. When the infusion of
fluid is
complete, the infusion device is disposed of. Thus, the infusion device must
be
made at an extremely low cost. Another drawback is that the low cost may not
allow
for the high quality needed to have sufficient flow rate control accuracy for
the
delivery of dosage sensitive drugs.
To obviate these drawbacks, infusion devices have been designed with more
accurate dosage control, but at a significantly higher cost. To compensate for
the
relatively high cost, the more accurate infusion devices are designed to be
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refilled and reused.
In one form, refillable infusion devices comprise a relatively compact
housing adapted to receive a syringe or reservoir carrying a prescribed
medication
for administration to the patient through infusion tubing and an associated
catheter
or infusion set. Such infusion devices are utilized to administer insulin and
other
medications, with exemplary infusion device constructions being shown and
described in U. S. Patent Nos. 4,562,751; 4,678,408; 4,685,903 ; 5,080,653 and
5,097,122.
While the sophisticated electronics and robust mechanics of the more
expensive refillable infusion devices provide a more reliable and accurate
infusion
device, the cost of manufacturing may make the refillable infusion device too
expensive for some users or medications. On the other hand, the low cost, one-
time-
use, constant flow rate infusion devices may not have sufficient flow rate
accuracy
or the adjustments needed to control the dosage for some users.
SUMMARY OF THE DISCLOSURE
According to an embodiment of the invention, a reusable external infusion
device with a predetermined usage life for infusing a fluid into a body
includes a
replaceable reservoir, a power supply, a drive system, an electronics system,
and
a housing. The housing contains the reservoir, power supply, drive system and
electronics system. The replaceable reservoir contains the fluid before
infusing and
has a usage life substantially shorter than the predetermined usage life of
the
infusion device. The power supply provides power to the drive system and the
electronics system to force fluid from the reservoir. The electronics system
regulates
the power from the power supply to control the drive system.
In particular embodiments of the present invention, the infusion device
includes a control system operatively coupled to the electronics system that
adjusts
one or more control parameters. In more particular embodiments, the control
system
is a supplemental device. In additional embodiments, the supplemental device
establishes two way communication with the electronics system. In particular
embodiments, the supplemental device has a display.
In preferred embodiments, after the infusion device's predetermined usage
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life has expired, the infusion device may be refurbished at least once to
function
for another predetermined usage life. In particular embodiments, when the
predetermined usage life for the infusion device expires, the infusion device
ceases to infuse fluid. In further particular embodiments, the predetermined
usage life for the infusion device is programmed into a software program as a
number of times that the replaceable reservoir is replaced in the infusion
device.
In preferred embodiments, the drive mechanism of the infusion device
contains a DC motor in the drive system. In alternative embodiments, the drive
mechanism of the infusion device contains a stepper motor, solenoid motor, a
shape memory alloy driven motor, or the like. According to another
embodiment of the present invention, a reusable external infusion device is
for
infusing a fluid into an individual. In preferred embodiments, the infusion
device
includes a housing and a replaceable fluid containing reservoir that is
inserted
into the housing. In preferred embodiments, the housing contains only one
electronics module to control the infusion device. In particular embodiments,
the
electronics module contained within the housing is produced using chip-on-
board
construction. In other particular embodiments, the electronics module
contained
within the housing is produced using ball grid array construction. In further
embodiments, the electronics module a flex circuit to control the infusion
device.
2 0 In preferred embodiments, the housing contains a detection device that
detects
the presence or absence of the replaceable reservoir. In further preferred
embodiments, the reusable external infusion device further includes a drive
mechanism coupled to an electronics system and the housing includes a button
coupled to the electronics system that an individual may push to cause the
drive
2 5 mechanism to deliver a bolus of fluid into the individual.
In additional preferred embodiments, the housing and internal contents are
assembled together without screws. In more preferred embodiments, the housing
includes at least one feature that is fused using ultrasonic vibrations. In
other
preferred embodiments, the housing includes a drive mechanism that contains at
30 least one non-metallic gear.
In preferred embodiments, the housing includes a slidable key that
provides access to remove and/or replace the replaceable reservoir inside the
housing. In particular embodiments, the housing accepts a key that includes a
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communication device for communicating with a supplemental device. In
alternative embodiments, the housing accepts a tab that includes a
communication
device for communicating with a supplemental device. In further alternative
embodiments, the housing accepts a tab/key that includes a communication
device for communicating with a supplemental device.
In further preferred embodiments, the housing includes an opening to
insert a removable tab that includes a programmable chip that contains at
least
one control parameter to control the infusion device. In further embodiments,
the
housing includes an opening to insert a tab that includes at least one
electrical
terrriinal that establishes electrical contact between at least one set of
electrical
terminals inside the housing. In particular embodiments, the housing is
adapted
to receive at least one of at least two different tabs that are insertable
into the
housing, and the at least two different tabs each have different electrical
terminal
configurations that establish electrical contact between different electrical
terminals inside the housing, and connects different electrical terminals to
cause
the external infusion device to dispense fluid at different rates. In still
fiirther
embodiments, the housing is adapted to receive at least one tab with an
optically
readable pattern, and the housing includes an optical reader to read the
optically
readable pattern on the at least one tab to control at least one control
parameter of
2 0 the reusable external infusion device. In alternative embodiments, the
housing is
adapted to receive at least one tab that includes magnetically stored
information,
and the housing includes a magnetic reader to read the magnetically stored
information from the at least one tab to control at least one control
parameter of
the reusable external infusion device.
2 5 In preferred embodiments, the reusable external infusion device includes
at least one lithium magnesium oxide (LiMnO2) battery. In particular
embodiments, the reusable external infusion device includes a battery that
lasts at
least 10 weeks, measured while the reusable external infusion device dispenses
up to 40 milliliters of fluid per day and while the alarms draw substantially
no
30 power from at least one battery.
In additional particular embodiments, an alarm is activated when the
reusable external infusion device needs to be refurbished. In preferred
embodiments, the reusable external infusion device has a predetermined usage
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life and when the predetermined usage life has expired, the reusable external
infusion device may be refurbished at least once to function for another
predetermined usage life. In particular embodiments, the reusable external
infusion device has a predetermined usage life and when the predetermined
usage
life expires, the reusable external infusion device ceases to infuse fluid.
In further particular embodiments, the reusable external infusion device
has a predetermined usage life and the predetermined usage life for the
reusable
external infusion device is programmed into a software program as a number of
times that the replaceable reservoir is replaced in the housing, as a number
of
days that the reusable external infusion device is in use, as the number of
times
the battery is replaced in the reusable external infusion device, and/or as
the
number of times that a key is removed from the reusable external infusion
device.
In other embodiments, the reusable external infusion device has a
predetermined
usage life and the predetermined usage life for the reusable external infusion
device is expired when the amount of electrical power consumed to empty a
reservoir exceeds a predetermined amount programmed into a software program.
Other features and advantages of the invention will become apparent from
the following detailed description, taken in conjunction with the accompanying
drawings which illustrate, by way of example, various features of embodiments
of
2 0 the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
A detailed description of embodiments of the invention will be made with
reference to the accompanying drawings, wherein like numerals designate
corresponding parts in the several figures.
Fig. 1 is a block diagram, illustrating an infusion device and a
supplemental device according to an embodiment of the present invention.
Fig. 2 is a perspective view of an infusion device connected to a tube, an
infusion set and an individual's body according to an embodiment of the
present
invention.
Fig. 3 is a perspective view of an electronics module in accordance with
an embodiment of the present invention.
Fig. 4 is a perspective view of a flex circuit in accordance with an
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embodiment of the present invention.
Fig. 5 is a partial perspective view of an infusion device drive system in
accordance with an embodiment of the present invention.
Fig. 6 is a cross-sectional view showing "Tinnerman" style retaining rings
holding gear hubs in accordance with an embodiment of the present invention.
Fig. 7 is a partial perspective view of internal components of an infusion
device with multiple batteries in accordance with another embodiment of the
present invention.
Fig. 8 is a perspective view of an infusion device with a key slid out of the
housing in accordance with an embodiment of the present invention.
Fig. 9 is a partial perspective view of an infusion device with a[cey that
has electrical traces in accordance with another embodiment of the present
invention.
Fig. 10 is a perspective view of the infusion device of Fig. 8 with the
housing removed to show the internal components and the key.
Fig. 11 is a perspective diagram of an infusion device connected to a
computer in accordance with an embodiment of the present invention.
Fig. 12 is a perspective diagram of an infusion device connected to a
personal digital assistant in accordance with an embodiment of the present
2 0 invention.
Fig. 13 is a perspective diagram of an infusion device communicating
with a dedicated programming device in accordance with an embodiment of the
present invention.
Fig. 14 is a partial perspective view of an infusion device with a tab that
2 5 has electrical traces in accordance with a further embodiment of the
present
invention.
Fig. 15 is a perspective view of two tabs with different electrical traces in
accordance with an embodiment of the present invention.
Fig. 16 is a perspective view of two keys with different electrical traces in
30 accordance with an embodiment of the present invention.
Fig. 17 is a partial perspective view of an infusion device with a tab that
has a programmable chip in accordance with an embodiment of the present
invention.
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Fig. 18 is a partial perspective view of an infusion device with a key that
is that has a programmable chip in accordance with an embodiment of the
present
invention.
Fig. 19(a) is a perspective view of a communication key with a slot to
accept a connector in accordance with an embodiment of the present invention.
Fig. 19(b) is a perspective view of a communication key with a connector
and wire attached in accordance with an embodiment of the present invention.
Fig. 20 is a perspective view of a communication key for RF
communication in accordance with an embodiment of the present invention.
Fig. 21 is a perspective view of a communication key for IR
communication in accordance with an embodiment of the present invention.
Fig. 22 is a plan view of the internal components of an infusion pump in
accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in the drawings for purposes of illustration, the invention is
embodied in a reusable external infusion device for infusing a fluid into an
individual's body and methods of manufacturing the same. The infusion device
controls the rate that fluid flows from a reservoir inside a housing, through
an
2 0 external tube, and into the individual's body. In preferred embodiments,
the
infused fluid is insulin. In alternative embodiments, many other fluids may be
administered through infusion such as, but not limited to, HIV drugs, drugs to
treat pulmonary hypertension, iron chelation drugs, pain medications, anti-
cancer
treatments, vitamins, hormones, or the like.
2 5 In preferred embodiments, as shown in Fig. 1, an infusion device 10
includes a reservoir 12, a drive system 14, an electronics system 16, a
control
system 18, and a power supply 20, all contained within a housing 22. The fluid
is
pushed from the reservoir 12 by the drive system 14 when commanded by the
electronics system 16. The power supply 20 provides power to both the drive
30 system 14 and the electronics system 16. A user or another qualified
person, such
as a doctor, parent, or spouse interfaces with the electronics system 16
through
the control system 18. In preferred embodiments, fluid flows from the infusion
device 10, through the external tube 24, into an infusion set 26, and then
into the
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individual's body 28, as shown in Fig. 2. Infusion sets 26 that may be used in
conjunction with
the infusion device 10 are described in, but not limited to, U. S. Patents;
4,723,947; 4,755,173;
5,176,662; and 5,584,813; and disclosed in U. S. Patent No. 6,056,718 entitled
"Medication
Infusion Set".
The control system 18 provides a method for the user or another qualified
person to adjust
one or more control parameters that the electronics system 16 uses to
calculate and issue
commands to the drive system 14. Control parameters include, for example, one
or more basal
rates, one or more bolus rates, maximum and minimum delivery rates, one or
more alarm criteria,
or the like.
In preferred embodiments, the electronics system 16 is a compilation of one or
more
electrical elements designed to carryout commands as specified by the control
parameters.
Electrical elements may include, but are not limited to, resistors,
capacitors, amplifiers, diodes,
semiconductor circuits, traces, wires, antennae, buttons, sound emanating
devices, light emitting
devices, receivers, transmitters, switches, or the like. In preferred
embodiments, the electrical
elements are attached to a single electronics board to form an electronics
module. In particular
embodiments, an electronics module 30 is a "popsickle stick" design, as shown
in Figs. 3, 5, 10
and 22. The term "popsickle stick" refers to the electronics module's long
thin layout that
optimizes the usage of space within the housing 22. With the "popsickle stick"
design, the
electronics module 30 stretches the length of the housing 22 so that only
short leads are needed to
extend from the electronics module 30 to any component that uses electricity
or signals from the
electronics. The use of a "popsickle stick" design also facilitates ease of
assembly and integrat-
ing for the infusion device 10.
In alternative embodiments, the electrical elements of the electronics module
are mounted
on a flex circuit. Preferably, the flex circuit has one or more flex circuit
leads 34 that run to
various locations within the housing 22 to minimize or eliminate the need for
wires. An example
of one embodiment of a flex circuit 32 is shown in Fig. 4. Flex circuit leads
34 may run to a
motor 36, an antenna 38, one or more LEDs 40, one or more buttons 42, a
battery 44, electrical
elements 46, or the like. In additional embodiments, the flex circuit 32 may
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connect to other devices or components such as a transmitter, a receiver, a
display, an
alarm, a tab, a communication port, a power port, or the like. In additional
embodi-
ments, one or more semiconductor circuits are wire bonded to the flex circuit
32.
In preferred embodiments, the electronics module 30 includes chip-on- board
construction. In alternative embodiments, the electronics module 30 includes
ball grid
array (BGA) packages or leaded chip construction.
In preferred embodiments, the electronics system 16 includes one or more
LEDs 40 to indicate specific conditions about the infusion device 10, such as
whether
the fluid is being dispensed, the battery power level, the fluid level in the
reservoir 12,
whether the electronics system 16 is functioning, warnings regarding how soon
the
infusion device 10 will require servicing, or the like. In preferred
embodiments, the
electronics system 16 includes one or more alarms. Preferably, an alarm is a
piezo
electric sound device. In alternative embodiments, the one or more alarms
includes a
vibrator, a light, a sound emanating device, or the like.
In preferred embodiments, as shown in Figs. 5 and 22, the drive system 14
includes a motor/gear box 48 with a drive shaft 50 that extends out of the
motor/gear
box 48, one or more gears 52 external to the motor/gear box 48 that transfers
motion
from the drive shaft 50 to a lead screw 54, and a piston 56 that is coupled to
the lead
screw 54, such that as the lead screw 54 rotates, the piston 56 moves a
plunger 58
inside the reservoir 12. The angular rotation of a motor shaft 136 is measured
with
an optical encoder 138 attached to an end of a motor shaft 136 protruding from
the
motor/gear box 48. In particular embodiments, the motor/gear box 48 includes a
stepper motor. In alternative embodiments, the motor/gear box 48 uses a direct
current (DC) motor, a solenoid motor or a shape memory alloy (SMA) driven
motor.
The SMA motor may
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include a ratchet/pawl mechanism actuated by a SMA component.
In preferred embodiments, the one or more gears 52 external to the
motor/gear box 48 have a one-to-one gear ratio. However, in alternative
embodiments, the gears may have different gear rations such as 1.5:1, 2:1,
3:1,
5:1, or the like depending on the motor control resolution and the minimum
dosage requirement for the fluid. In particular embodiments, the gears 52 are
made of molded plastic. In alternative embodiments, the gears 52 are made of
metal, epoxy, laminates, or other suitably strong materials. In alternative
embodiments, mechanical power is transferred from the motor/gear box 48 to the
lead screw 54 using one or more of a belt, timing belt, chain, gears, rack or
the
like.
As shown on Fig. 6, in preferred embodiments, each of the gears 52 have
a gear hub 60 that fits through one of the openings 62 in a wall 64 contained
within the housing 22. A"Tinnerman" style retaining ring 66 slips over the
gear
hub 60 of each gear 52 to secure the gear 52 to the wall 64. In alternative
embodiments, each gear hub 60 is held in place with a snap ring, a rivet, a
threaded nut, a press-on nut, or the like. In preferred embodiments, each gear
52
has a "D" shaped hole 68 passing entirely through the gear 52 that is located
generally at the center of rotation. The drive shaft 50, with a mating "D"
shaped
2 0 end 51, fits into the "D" shaped hole 68 in a gear 52. In addition, a "D"
shaped
end 55 of the lead screw 54 fits into a "D" shaped hole 68 in a gear 52. The
"D"
shaped holes 68 function to transmit torque from the drive shaft 50 to the
gears 52
and on to the lead screw 54 without the need for a fixed attachment of the
drive
shaft 50 and the lead screw 54 to the gear hubs 60. In alternative
embodiments,
2 5 other shaped holes are used such as hexagonal, square, rectangular,
polygonal,
triangular, oval, star, clover, round, notched, or the like along with a drive
shaft
and a lead screw with mating ends that fit into the holes.
As shown in Fig. 5, in preferred embodiments, the piston 56 has a
threaded bore 70 that is generally centered with the piston's longitudinal
axis, and
30 the threads 72 on the lead screw 54 mate with the threaded bore 70 on the
piston
56. Preferably only the first half of an inch of the piston bore 70 is
threaded and
the remainder of the bore through the rest of the piston is smooth with a
large
enough diameter to allow the lead screw to pass through unobstructed.
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Alternatively, the length of the piston bore that is threaded may be increased
or
decreased depending on the number of threads needed to apply force to the
plunger and the amount of friction generated between the piston bore 70 and
the
lead screw 54. Preferably, the piston 56 includes a flange 74 with a notch 76
that
fits over a rail 78. The rail 78 runs generally parallel to the lead screw 54.
As the
lead screw 54 rotates, an edge of the notch 76 in the piston flange 74 rests
against
the rail 78 and prevents the piston 56 from rotating. Therefore, as the lead
screw
54 rotates, the piston 56 moves along the length of the lead screw 54
substantially
free of rotational movement. In alternative embodiments, the threaded bore 70
in
the piston 56 is not generally centered with the piston's centerline. For
example,
the lead screw 54 may pass through the piston's flange 74.
In preferred embodiments, the power supply is a battery 44. In particular
embodiments, the power supply is a lithium magnesium oxide (Li Mn OZ) battery
44, as shown in Figs. 4, 5 and 10. Some of the factors that influence the size
of
the battery 44 are, the amount of power needed to drive the motor/gear box 48,
the amount of friction through out the drive system 14, the size of the
reservoir 12
(and therefore the amount of piston 56 displacement needed to empty the
reservoir 12), the dosage resolution required, the dosage volume, whether or
not
alarms are set off, how frequently lights or displays are used, and the number
of
2 0 days desired between battery 44 replacement. In preferred embodiments, the
battery 44 lasts at least 10 weeks, while the reusable infusion device 10
dispenses
fluid at a rate of up to 40 milliliters per day without alarms. At greater
fluid
dispensing rates and/or when the alarms are active, the battery duration may
be
diminished. In preferred embodiments, with a 3 ml reservoir 12, the battery
capacity is generally 2.1 amp-hours at 3 volts. In other embodiments, with a
1.5
ml reservoir 12', such as shown in Fig. 7, the combined capacity of a pair of
batteries 80, shown in Fig. 7, is generally 1.1 amp-hours at 3 volts. In
alternative
embodiments, the battery 44 may last as little as 3 days (a common time to
empty
a reservoir 12) with a battery capacity as low as 0.035 amp-hours. Or, the
battery
44 may last as long as a year (a likely time to have the infusion device 10
serviced) with a better battery capacity as large as 12.6 amp-hours. And in
other
alternative embodiments, the battery voltage may be as low as 0.5 volts and as
large as 9 volts depending on the power needed for the drive system 14 and
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electronics system 16. In further alternative embodiments, two or more
batteries
(Fig. 7) may be used to supply the voltage and capacity needed to operate the
infusion device 10.
In preferred embodiments, the battery 44 and reservoir 12 are removable
through an opening 82 in the housing 22, and the opening 82 may be closed by
sliding a key 84 into a slot 83 formed in the housing 22 so that the key 84
covers
the battery 44 and slides over the shoulder 86 of the reservoir 12, as shown
in
Figs. 8, and 10. In this embodiment, the key 84 may be slid part way out of
the
slot 83 of the housing 22 to a detent position that provides a sufficient
opening to
remove the reservoir 12 from the housing 22 while retaining the battery 44 in
place within the housing 22. The battery 44 and the reservoir 12 may both be
removed from the housing 22 by entirely removing the key 84 from the slot 83
to
fully expose the opening 82. In alternative embodiments, two different sliding
keys (not shown) are used, one to slide over the battery 44 and another to
slide
over the shoulder 86 of the reservoir 12.
In preferred embodiments, the key 84 has a conductive trace 85 that
connects a battery terminal 88 of the battery 44 to a power lead 87 on the
electronics module 30 (see Fig. 8). Alternatively, the entire back of the key
84
could be conductive. Therefore, if the key 84 is removed, battery power is
2 0 removed from the electronics system 16. In preferred embodiments, a
capacitor,
or other charge storage device, maintains electrical power for at least 15
seconds
and up to 3 minutes after the battery 44 is disconnected from the electronics
system 16. This allows an individual time to replace the battery 44 without
losing
electrically stored information in the electronics system 16. In alternative
2 5 embodiments, a commonly known DC converter is used to convert AC wall
current into the appropriate DC current and a DC jack is plugged into the
infusion
device 10 to keep the infusion device 10 powered whenever battery power is low
or the battery 44 is removed. In additional embodiments, the battery 44 is
rechargeable by supplying a DC current to the infusion device 10 such as by
30 plugging in a DC converter. Alternatively, the infusion device 10 may be
placed
on a cradle to recharge the battery 44 using induction, solar cells, or use
other
methods of supplying current to a battery. In additional alternatives the
infusion
device 10 may be powered directly using solar cells, a DC power supply such as
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an exterior battery or a DC converter plugged into an AC outlet, and the like.
In preferred embodiments, a switch 89 (shown in Figs. 4, 5 and 10) is
located in the housing 22 so that when the reservoir 12 is inserted far enough
into
the housing 22, an end of the reservoir 12 contacts the switch 89 causing the
switch 89 to toggle. The switch 89 is also spring loaded to return to its
original
position when the reservoir 12 is removed. Thus, the switch 89 detects when
the
reservoir 12 is removed from the housing 22. In alternative embodiments, the
infusion device 10 may include an optical reader that optically detects when a
reservoir is present. In preferred embodiments, when the reservoir 12 is
removed
from the housing 22, the motor/gear box 48 is automatically triggered to run
in
reverse to fully retract the piston 56 in preparation for a new reservoir 12
to be
installed. In a(ternative embodiments, the motor/gear box 48 retracts the
piston
56 when the key 84 is removed far enough to permit removal of the reservoir
12.
In preferred embodiments, the infusion device 10 is disabled by the
electronics system 16 when a predetermined usage life is expired. For
instance,
the electronics system 16 keeps track of the number of times the reservoir 12
is
replaced and compares that number to a specified number that is programmed
into a software program in the electronics system 16. Thus, the electronics
system 16 will shut down the infusion device 10, stopping the flow of fluid,
after
2 0 the reservoir 12 is replaced a specified number of times. In preferred
embodiments, the predetermined life of the infusion device 10 is expired when
the reservoir 12 has been replaced sixty times. In alternative embodiments,
the
number of times that the reservoir 12 may be replaced before the predetermined
life of the infusion device 10 is expired may be as many as one hundred and
fifty
2 5 times or as few as twenty times due to the durability of the components
that might
wear, how carefully individuals handle the infusion device 10, the types of
climates the infusion device 10 is subjected to, or the like. In additional
alternative embodiments, other measurements are used to detect when the
infusion device's predetermined life is expired such as, the number of days of
3 0 use, the number of times the battery 44 is replaced, an increase in the
amount of
battery power consumed to empty a reservoir 12, the number of times a key 84
is
removed from the infusion device 10, or the like.
In preferred embodiments, the infusion device 10 may be refurbished and
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returned to the user to be used again after the electronics system 16 has
disabled
the infusion device 10 due to exceeding its predetermined life. In particular
embodiments, the infusion device 10 can be refurbished at least once before
its
total life is expired. In particular embodiments, the predetermined life may
increase or decrease after refurbishing due to a change in the quality of a
replacement part, a new lubrication method, new information about the
durability
of the infusion device 10, how well the user cares for the particular infusion
device, or the like. In alternative embodiments, the infusion device 10 is not
refurbishable. In other alternative embodiments, the infusion device 10 may be
refurbished at least 2 times and up to an indefinite number of times before
its total
life is expired and it can no longer be used. In particular embodiments,
measurements are taken to determine if the total life of the infusion device
10 has
expired such as, a significant physical shock detected by an accelerometer
(perhaps a shock greater than 2.5 gs, depending on the amount of shock the
infusion device 10 can handle), an increase in the amount of battery power
consumed to empty a reservoir 12, a maximum temperature such as 120 degrees F
has been exceeded, the reservoir has been replaced too many times (such as
1,000
times), or the like.
In preferred embodiments, the electronics system 16 stores the control
2 0 parameters, and default control parameters are programmed into the
electronics
system 16 during manufacturing. Preferably, the control parameters may be
changed by an individual using the control system 18. In preferred
embodiments,
the control system 18 of the infusion device 10 has buttons 42 accessible
through
the housing 22. In particular embodiments, a button 42 is used to command a
2 5 bolus. In other particular embodiments, additional buttons 42 may provide
additional control features such as to undo a previous command, confirm a
command, activate a function, initialize a software program, initialize a new
reservoir 12, reset one or more control parameters to a default value, modify
a
control parameter, withdraw the piston 56, or the like. In preferred
embodiments,
30 LEDs indicate that control parameters have been modified by turning on or
off,
flashing, changing color, sequencing, or the like, In alternative embodiments,
the
electronics system includes a LCD, LED display, or other displays to show the
status of control parameters and /or indicate to the user which control
parameters
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are being modified. In other alternative embodiments, other feedback methods
such as sounds, vibrations, or the like are used to indicate the status of
control
parameters.
In other embodiments, a supplemental device 90 is used as, or is used in
addition to, the control system 18 to adjust, change, modify, program, input,
or
the like, one or all of the control parameters. The supplemental device 90
interfaces with the electronics system 16 as shown in Fig.1. Preferably, the
supplemental device 90 includes a display 98, an input system 100 and a
communication system 102 that interfaces with the infusion device 10. The
communication system 102 provides an initiating signal to the infusion device
10
to cause the control system 18 to go into a programming mode. Alternatively,
no
initiating signal is needed. Preferably the communication system 102 provides
2-
way communication between the supplemental device 90 and the infusion device
10, as shown in Fig. 1. Alternatively the communication system 102 may be one
way.
In particular embodiments, the supplemental device 90 is a computer
system 200 that communicates with an infiision device 210. The computer
system 200 has a monitor 202 as the display, a key board 204 as the input
system,
and the computer 206 and wires 208 as the communication system, as shown in
2 0 Fig. 11. In preferred embodiments, the wires 208 are detachable at the
infusion
device 210. In alternative embodiments, the wires 503 carry information
between
the supplemental device 90 to a communication key 501, shown in Figs. 19(a)
and 19(b). The wires 503 connect to the communication key 501 through a
connector 505 that mates with slot 507 in the key 501. The communication key
501 carries the information signals through electrical traces (not shown) to
electrical terminals 114 on the infusion device, such as shown in Fig. 9. In
particular embodiments, the wires 503 are detachable from the communication
key 501 as shown in Figs. 19(a) and 19(b). In other embodiments, the wires 503
do not detach from the communication key. In further embodiments, the
supplemental device 90 is a personal digital assistant (PDA) 300 or a hand
held
computer such as a Palm Pilot that communicates with an infusion device 310.
The PDA 300 has a touch screen LCD 302 that performs the duties of both the
display and the input system, while the cradle 304 and wire 306 serve as the
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communication system, as shown in Fig. 12. In still further embodiments, the
PDA may communicate using a wireless connection, such as by IR, RF, or the
like. In still other embodiments, the supplemental device 90 is a dedicated
programming device 400, that communicates with an infusion device 410 as
shown in Fig. 13. The dedicated programming device 400 has a LCD 402 for its
display, buttons 404 as the input system and a radio transmitter 406 and
receiver
408 as the communication system.
In alternative embodiments, the communication system 102 in the
supplemental device 90 uses IR signals, optical signals, direct electrical
contact,
laser signals, combinations of carrier frequencies, or the like. In further
alternative embodiments, the display 98 is monitor, a touch screen, LEDs,
lights,
or the like. In more alternative embodiments, the input system 100 includes a
keyboard, a button, a touch screen, a touch pad, a dial, a switch, a
microphone, a
joystick, a computer mouse, a roller ball, or the like.
In particular alternative embodiments, a communication key is used that
includes portions of the communication system. For example, a communication
key 601 has a radio frequency transmitter 603 and receiver 605, shown in Fig.
20.
Alternatively, a communication key 701 has a infra red transmitter 703 and
receiver 705, shown in Fig. 21. Other communication devices may be included in
2 0 the communication key that use other carriers such as, ultrasonic, visual
light,
video frequencies, ultra violet, laser, microwave, or the like. In alternative
embodiments, installation of the communication key into the infusion device
causes the control system of the infusion device to go into a programming
mode.
In particular alternative embodiments, the infusion device enters a
programming
2 5 mode when the communication key contacts a switch (not shown), contacts
electrical terminals 114, is detected by a sensor such as an optical or
magnetic
proximity sensor, pushes a button, or the like.
In another embodiment, control parameters such as the basal and/or bolus
levels, maximum or minimum basal rate or the like, are set in an infusion
device
30 103 when a tab 104, with at least one conductive trace 108, is inserted
into a slot
106 on the housing 107, such as shown in Fig. 14. The conductive trace 108
establishes connections between some of the electrical terminals (not shown)
in
the infusion device 103. Different patterns of conductive traces 108 and 108'
on
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different tabs 104 and 104' (shown as examples in Fig, 15) connect different
electrical terminals (not shown) in the infusion device 103. As different
electric
terminals (not shown) are connected to each other, different control
parameters,
such as basal rates, are set and then used by the electronics system 16. The
number of electrical terminals (not shown) and the number of conductive traces
108 may vary depending on the number of control parameters that are controlled
using the tabs 104. The number of different patterns of unique conductive
traces
108, and therefore different tabs 104, is dependent on the number of control
parameters that are controlled with the tabs 104 and the number of variations
needed for each command parameter. As an example of an application using tabs
104 to control the infusion device 103, a doctor may prescribe a particular
basal
rate and therefore insert a particular tab 104 into the infusion device 103.
Later, if
a patient's needs have changed, the doctor may remove the originally
prescribed
tab 104 and insert a different tab 104 that causes the infusion device 103 to
dispense the fluid at a different rate. In alternative embodiments, the tabs
may
include an optical pattern that is read by an optical reader in the housing.
For
instance, the optical pattern may be similar to that shown in Fig. 15.
Alternatively, other patterns or a bar codes may be used. In further
alternative
embodiments, the tabs may include information stored on a magnetic media. And
the information may be read by a magnetic reader contained within the housing.
In alternative embodiments, the tab is in the form of a tab/key I 10 that
slides into slot 83 on an infusion device 111 to hold the battery 44 and/or
reservoir 12 in place as shown in Fig. 9. Conductive traces 112 on the tab/key
110 establish connections between some of electrical terminals 114. Different
patterns of conductive traces 112 and 112' on different tab/keys 110 and I 10'
(shown as examples in Fig. 16) connect different electrical terminals 114.
Again,
as different electrical terminals 114 are connected to each other, different
control
parameters such as basal rates, or the like, are set and used by the
electronics
system 16.
In other embodiments, a tab 116 has a programmable chip 118, such as
shown in Fig. 17, that is programmed with different control parameters before
insertion into a slot 122 in a housing 124 of a infusion device 126. One or
more
conductive traces 120 on the tab 116 connect the chip 118 to the electronics
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system 16 through electrical terminals (not shown) in the housing 124. In
particular embodiments, different tabs 116 have chips 118 that are programmed
with different basal rates. Therefore, to change the basal rate for an
infusion
device 10, an individual may remove the existing tab 116 from the housing 124
and install a different tab 116 that includes a chip 118 that is programmed to
command a different basal rate. In particular embodiments, the tabs 116 are
removed from the infusion device 126, and the chips 118 are re-programmed with
different control parameters, and then the tab 116 is re-installed into the
infusion
device 126. In alternative embodiments, the chips 118 are not re-programmable,
and a new tab 116 with a new chip 118 is used when control parameters must be
changed.
In alternative embodiments, the tab is in the form of a tab/key 128 and has
a programmable chip 130 such as shown in Fig. 18, that is programmed with
different control parameters before insertion into slot 83 of the housing 22
of
infusion device 132. One or more conductive traces 134 on the tab/key 128
connect the chip 130 to the electronics system 16 through electrical terminals
114.
In additional alternative embodiments, a tab/key, normally used to
establish control parameters as described above, may be a communication key.
The communication key enables the infusion device to communicate with a
supplemental device 90 to change control parameters or transfer data. In
particular embodiments, a tab/key that is not a communication key is
reinserted
into the infusion device for normal operation after the communication key has
completed the communication with the supplemental device 90. In other
particular embodiments, the communication key is left in the infusion device
or a
different tab/key is used after the communication device is removed.
In other particular embodiments, the tab/key includes communication
devices. For example, a tab/key with a computer chip (such as tab/key 128
described above) may include a slot to accept a connector such as
communication
key 501 shown in Figs. 19(a) and 19(b). Other communication devices such as
IR, RF, ultrasonic, or the like may be included on a tab/key. In particular
embodiments, the supplemental device 90 can reprogram computer chips
included on the tab/key. In alternative embodiments, a communication device is
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included on a tab that does not serve as the key that covers the battery 44
and the
reservoir 12.
In preferred embodiments, the tabs are color coded to identify the basal rate,
or other control parameters, they are programmed to command. In alternative
embodiments, other identification methods may be used to indicate the basal
rate,
and/or other control parameters, associated with a particular tab such as, a
code
number, a serial number, a lot number, a batch number, a name, or the like.
Methods
of applying the identification include, stamping, silk-screening, printing,
typing,
labels, embossing, imprinting, molding, or the like. In additional alternative
embodiments, other means are used to identify tabs that have different control
parameters from each other such as, surface textures, flexibility, materials,
a raised
patterns, printed patterns, or the like.
Tabs may be used to modify characteristics of other infusion devices as well,
such as those described in U.S. Patents 4,562,751; 4,685,903; 5,080,653;
5,505,709;
5,785,688; 5,814,020 and 5,097,122. Tabs may also be used to calibrate or
control
various features of characteristic or analyte monitor systems.
In preferred embodiments, substantially all parts of the infusion device 10
are
designed to slide or snap together during assembly. In particular embodiments,
no
screws are used on the infusion device 10. In preferred embodiments, the
housing 22
is plastic and is sealed using ultrasonic fusing. In
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alternative embodiments, other methods are used to seal the housing 22 such as
gluing, bonding, fusing, melting, snapping, pressing, or the like. In other
alternative embodiments, the housing 22 is made of other materials such as
metal,
rubber, resin, foam, or the like. Refurbishing of the infusion pump 10 may
require destruction of the housing 22.
While the description above refers to particular embodiments of the
present invention, it will be understood that many modifications may be made
without departing from the spirit thereof. The accompanying claims are
intended
to cover such modifications as would fall within the true scope and spirit of
the
present invention.
The presently disclosed embodiments are therefore to be considered in all
respects as illustrative and not restrictive, the scope of the invention being
indicated by the appended claims, rather than the foregoing description, and
all
changes which come within the meaning and range of equivalency of the claims
are therefore intended to be embraced therein.
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