U.S. patent application number 11/705814 was filed with the patent office on 2007-12-27 for infusion device with dosage dial control.
This patent application is currently assigned to Seattle Medical Technologies. Invention is credited to John M. Adams, Clifton A. Alferness, Daniel Hawkins.
Application Number | 20070299399 11/705814 |
Document ID | / |
Family ID | 39226666 |
Filed Date | 2007-12-27 |
United States Patent
Application |
20070299399 |
Kind Code |
A1 |
Alferness; Clifton A. ; et
al. |
December 27, 2007 |
Infusion device with dosage dial control
Abstract
A disposable infusion device comprises a base arranged to adhere
to a patient's skin, a cannula arranged to extend from the base to
beneath the patient's skin to deliver a liquid medicament to the
patient, and a source arranged to provide the cannula with a liquid
medicament. The device further includes an actuator that actuates
the source to provide the liquid medicament to the cannula. The
source is arranged to provide, with each actuation, a fixed volume
of medicament to the cannula. A control sets the fixed volume.
Inventors: |
Alferness; Clifton A.; (Port
Orchard, WA) ; Adams; John M.; (Kirkland, WA)
; Hawkins; Daniel; (Newcastle, WA) |
Correspondence
Address: |
Richard O. Gray, Jr.
Suite. 350
155-108th Avenue N.E.
Bellevue
WA
98004-5973
US
|
Assignee: |
Seattle Medical
Technologies
|
Family ID: |
39226666 |
Appl. No.: |
11/705814 |
Filed: |
February 12, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60782941 |
Mar 16, 2006 |
|
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|
Current U.S.
Class: |
604/151 |
Current CPC
Class: |
A61M 5/1408 20130101;
A61M 2005/1587 20130101; A61M 2005/1405 20130101; A61M 2005/1426
20130101; A61M 5/16881 20130101; A61M 2025/0266 20130101; A61M
5/14526 20130101; A61M 5/1454 20130101; A61M 2005/1585 20130101;
A61M 5/1452 20130101; A61M 5/14248 20130101 |
Class at
Publication: |
604/151 |
International
Class: |
A61M 5/142 20060101
A61M005/142 |
Claims
1. A disposable infusion device comprising: a base arranged to
adhere to a patient's skin; a cannula arranged to extend from the
base to beneath the patient's skin to deliver a liquid medicament
to the patient; a source arranged to provide the cannula with a
liquid medicament; an actuator that actuates the source to provide
the liquid medicament to the cannula, the source being arranged to
provide, with each actuation, a fixed volume of medicament to the
cannula; and a control that sets the fixed volume.
2. The device of claim 1, wherein the source includes a reservoir
that holds the liquid medicament.
3. The device of claim 1, wherein the control comprises a rotatable
dial.
4. The device of claim 1, wherein the source includes a pump,
wherein the pump has a liquid medicament holding capacity, and
wherein the control varies the amount of the pump holding capacity
to be pumped to the cannula upon each actuation.
5. The device of claim 4, wherein the pump comprises a compressible
tube and wherein the control controls the portion of the
compressible tube that is compressed with each actuation.
6. The device of claim 5, wherein the pump further includes a disk
having a circumferential surface that supports the compressible
tube, a strap coupled to the actuator that compresses a portion of
the compressible tube against the disk circumference, wherein the
disk has a groove within its circumferential surface, the groove
having a depth that increases along the disk circumference, the
groove being arranged to receive the compressible tube, and the
disk being rotatable to vary the length of the groove receiving the
compressible tube to adjust the portion of the tube that is
compressed and the volume of liquid medicament pumped to the
cannula with each actuation of the actuator.
7. The device of claim 6, wherein the control comprises a rotatable
dial and wherein the disk is arranged to be rotated by the
rotatable dial.
8. The device of claim 5, wherein the source further includes a
reservoir that holds the liquid medicament and wherein the
compressible tube communicates with the reservoir.
9. A disposable infusion device comprising: a base arranged to
adhere to a patient's skin; a cannula arranged to extend from the
base to beneath the patient's skin to deliver a liquid medicament
to the patient; a source arranged to provide the cannula with a
liquid medicament, the source including a reservoir that holds the
liquid medicament and a pump that pumps the liquid medicament from
the reservoir to the cannula; an actuator that actuates the pump to
cause the pump to provide the liquid medicament to the cannula, the
pump being arranged to provide, with each actuation, a fixed volume
of medicament to the cannula; and a control that varies the fixed
volume.
10. The device of claim 9, wherein the control comprises a
rotatable dial.
Description
CLAIM OF PRIORITY
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 60/782,941, filed on Mar. 16, 2006, which is
incorporated by reference.
BACKGROUND
[0002] Tight control over the delivery of insulin in both type I
(usually juvenile onset) and type II (usually late adult onset),
has been shown to improve the quality of life as well as the
general health of these patients. Insulin delivery has been
dominated by subcutaneous injections of both long acting insulin to
cover the basal needs of the patient and by short acting insulin to
compensate for meals and snacks. Recently, the development of
electronic, external insulin infusion pumps has allowed the
continuous infusion of fast acting insulin for the maintenance of
the basal needs as well as the compensatory doses for meals and
snacks. These infusion systems have shown to improve control of
blood glucose levels, however, they suffer the drawbacks of size,
cost, and complexity, which prevents many patients from accepting
this technology over the standard subcutaneous injections. These
pumps are electronically controlled and must be programmed to
supply the desired amounts of basal and bolus insulin.
SUMMARY
[0003] In one embodiment, the invention provides a disposable
infusion device comprising a base arranged to adhere to a patient's
skin, a cannula arranged to extend from the base to beneath the
patient's skin to deliver a liquid medicament to the patient, a
source arranged to provide the cannula with a liquid medicament, an
actuator that actuates the source to provide the liquid medicament
to the cannula, the source being arranged to provide, with each
actuation, a fixed volume of medicament to the cannula, and a
control that sets the fixed volume.
[0004] The source may include a reservoir that holds the liquid
medicament. The control may comprise a rotatable dial. The source
may include a pump, the pump having a liquid medicament holding
capacity, and the control may vary the amount of the pump holding
capacity to be pumped to the cannula upon each actuation. The pump
may comprise a compressible tube and the control may be arranged to
control the portion of the compressible tube that is compressed
with each actuation.
[0005] The pump may include a disk having a circumferential surface
that supports the compressible tube and a strap coupled to the
actuator that compresses a portion of the compressible tube against
the disk circumference. The disk may be provided with a groove
within its circumferential surface, the groove having a depth that
increases along the disk circumference. The groove may be arranged
to receive the compressible tube, and the disk being rotatable to
vary the length of the groove receiving the compressible tube to
adjust the portion of the tube that is compressed and the volume of
liquid medicament pumped to the cannula with each actuation of the
actuator. The disk may be rotated by a rotatable dial. The source
may further include a reservoir that holds the liquid medicament
and the compressible tube communicates with the reservoir.
[0006] In another embodiment, a disposable infusion device
comprises a base arranged to adhere to a patient's skin, a cannula
arranged to extend from the base to beneath the patient's skin to
deliver a liquid medicament to the patient and a source arranged to
provide the cannula with a liquid medicament. The source includes a
reservoir that holds the liquid medicament and a pump that pumps
the liquid medicament from the reservoir to the cannula. The device
further comprises an actuator that actuates the pump to cause the
pump to provide the liquid medicament to the cannula. The pump is
arranged to provide, with each actuation, a fixed volume of
medicament to the cannula, The device still further comprises a
control that varies the fixed volume.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further features and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like reference numerals
identify identical elements, and wherein:
[0008] FIG. 1 is a side view of an infusion port that may be used
in practicing the invention;
[0009] FIG. 2 is a side view of an infusion port, loading membrane,
and insulin reservoir according to one embodiment of the
invention;
[0010] FIG. 2A is a schematic diagram illustrating one potential
manner of operation of the system of FIG. 2;
[0011] FIG. 2B a schematic diagram illustrating another potential
manner of operation of the system of FIG. 2;
[0012] FIG. 3 is a side view, with portions cut away, of a
disposable insulin infusion system including a mechanical timer
according to another embodiment of the invention;
[0013] FIG. 4 is a perspective view of a disposable insulin
infusion system that provides for both basal delivery and bolus
delivery of insulin according to an embodiment of the
invention;
[0014] FIG. 4A is a side view, with portions cut away, showing more
particulars of the operation of the system of FIG. 4;
[0015] FIG. 5 is a perspective view of a disposable insulin
infusion system providing user basal delivery rate adjustment and
bolus delivery of insulin;
[0016] FIG. 6 is a side view of a disposable insulin infusion
system including constant insulin delivery device and a separate
mating bolus delivery device according to an embodiment of the
invention;
[0017] FIG. 7 is a top view, with portions cut away, of an insulin
infusion system according to another embodiment of the invention
having insulin delivery rate determined by a chamber pressure;
[0018] FIG. 7A is a schematic diagram illustrating one potential
manner of operation of the system of FIG. 7;
[0019] FIG. 8 is a side view of an insulin infusion system having
insulin bolus delivery volume controlled by peristaltic action
according to an embodiment of the invention;
[0020] FIG. 9 is an end view of the system of FIG. 8;
[0021] FIG. 10 is a schematic diagram of a further system embodying
the invention;
[0022] FIG. 11 is a side view, with portions cut away, of a bolus
pump embodying the invention prior to insulin delivery; and
[0023] FIG. 12 is a side view, with portions cut away, of the bolus
pump of FIG. 11 embodying the invention after insulin delivery.
DETAILED DESCRIPTION
[0024] FIG. 1 shows an infusion port 10 into which a liquid
medicament, such as insulin or incretins, can be injected manually
using a standard syringe. The port 10 includes a funnel port 12, an
insertion needle 14, and an injection membrane 16. The port 10 may
be adhered to the skin 18 with adhesive tape 20. This system
obviates the need for multiple daily percutaneous needle sticks to
accomplish the provision of insulin dosage.
[0025] The port 10 further includes a cannula 15. The cannula 15 is
carried by the funnel port 12. As known in the art, once the needle
14 and cannula 15 are positioned beneath the skin 18 as shown, the
needle 14 is removed leaving the cannula 15 in a deployed position
and ready to deliver insulin to the patient.
[0026] FIG. 2 shows a system 30 according to one embodiment of the
invention. The system includes an infusion port 32 similar to port
10 for delivery of either long acting or short acting insulin. The
port 32 is shown prior to the needle 39 being withdrawn from the
cannula 41. The system includes a first source 31 including a
reservoir 34 which may be filled with a fast acting insulin through
a port 36 and a pump 38. A further reservoir may be provided as
will be seen subsequently. The port allows for reservoir 34 to
internally hold a first liquid medicament, such as a fast acting
insulin, for delivery at meals, for example, while the funnel port
33 of the port 32 forms a second source 43 and allows for a second
liquid medicament, such as a slow acting insulin to be delivered
as, for example, in the morning after awakening. The fast acting
insulin may be delivered by the pump 38 which may be squeezed with
the fingers.
[0027] In the case when the system 30 includes multiple reservoirs,
the system may have a mechanism for the selection of which insulin
is infused at any given time. It also may provide control over how
much of each particular insulin is determined to be delivered by
having the patient depress the actuator 38 a desired number of
times. For example, each activation might deliver 0.5 units of
insulin. Therefore, if 3 units of insulin are desired, 6
depressions will deliver the desired amount.
[0028] FIG. 2A shows one manner of operation of the system 30. Fast
acting insulin may be loaded into reservoir 34 through loading port
36. The pump 38 may be a piston pump and more particularly, a fixed
stroke piston pump which provides a predetermined volume of insulin
upon each actuation. The number of depressions of pump 38 thus
determines the amount of the fast acting insulin delivered from
reservoir 34 to port 32 and cannula 41. When a slow acting insulin
is to be delivered, such as in the morning upon awakening, the slow
acting insulin may be delivered through funnel port 33. In that
regard, it will be noted that the port 33 permits the slow acting
insulin to be received from an instrument, such as syringe 39, from
external to the system 30. It may further be noted that the
infusion system 30 further includes one-way valves 45 and 47. Valve
45 is between the pump 38 and reservoir 34 and valve 47 is between
port 32 and pump 38.
[0029] FIG. 2B shows another manner in which the system 30 may
operate. Here, in addition to the reservoir 34 for the fast acting
insulin, the system includes another reservoir 35 to contain slow
acting insulin. The fast acting insulin is loaded into reservoir 34
through port 36. The slow acting insulin may be loaded into the
reservoir 35 through port 37. A valve 40 controls which reservoir
is selected as well as the rate in which the selected insulin is
delivered. The pump 38, which again may be a fixed stroke piston
pump, is used for pumping the selected insulin out to the patient
through port 32. Valves 45 and 47 remain on opposite sides of the
pump 38.
[0030] FIG. 3 shows a system 50 for the constant delivery of a
fixed amount of insulin per unit time. The insulin delivered over
time is fast acting insulin, to meet the basal needs. This insulin
is contained in a reservoir 52. An adjunctive port 54 for the
injection of fast acting insulin for meals and snacks is also
provided.
[0031] The insulin in reservoir 52 is constantly delivered under
the control of a mechanical timer pump 56. The timer pump is of the
type known in the art to include a winder 58, a wind-up spring 60,
and gears 62. The gears 62 drive a worn gear 63 and lead screw 65
to drive a piston 67. The piston 67 thus pressurizes the reservoir
52 to provide a constant flow of insulin to the cannula 66. When a
bolus of fast acting insulin is required, such as at meals, the
port 54 is used to inject the fast acting insulin into the
reservoir 52. When the reservoir is full, further injected insulin
will displace a like quantity of insulin from reservoir 52 thereby
injecting the same into and out of the cannula 66.
[0032] FIG. 4 shows a device embodiment 70 with an infusion port
for the delivery of a fixed amount of fast acting insulin per unit
time plus the mechanisms for delivery of boluses for meals and
snacks. A slide 72 is provided to pressurize the insulin chamber
(not shown). A filling membrane 74 permits the chamber to be
filled. A trigger 76 may be depressed for each measured bolus of
insulin to be delivered.
[0033] Referring now to FIG. 4A, here it may be seen that the slide
72 performs an additional function after the patient has deployed
the cannula 73. More specifically, the needle 71 may be retracted
from the cannula 73 to leave the cannula 73 in a fully deployed
position for delivering insulin to the patient. To this end, the
slide 72 is coupled to the device needle 71 housed in the infusion
tube 73. As the slide is slid back in the direction of the arrow
75, the needle 71 is retracted. Eventually, the needle is captured
by a needle capture chamber 77. Further backward movement of slide
72 eventually causes the needle head 71a to be caught by a needle
ejector 79. Upon further backward movement of slide 72, the needle
ejector 79 is acted upon by a ramp 81 that causes the needle head
to be displaced in the direction of arrow 79a. Such needle head
displacement forces the needle off of the slide 72. At this point,
the needle is dropped within the device 70 and cannot be reused.
The device is now safe and ready for disposal after it has been
fully used.
[0034] FIG. 5 shows a similar device 80 having a dial for the
delivery of a user adjusted variable amount of fast acting insulin
per unit time. This embodiment is particularly helpful for patients
who may need a different amount of basal insulin support at
different times during the day. The device 80 further includes
mechanisms including a wind-up 84 and trigger 86 for delivery of
boluses for meals and snacks. A filling membrane 88 is provided to
facilitate filling of the insulin reservoir (not shown) with the
fast acting insulin.
[0035] FIG. 6 shows an embodiment of infusion port 90 with an
internal reservoir 92 to hold fast acting insulin for constant
delivery of a fixed amount per unit time to meet the basal needs of
the patient with an adjunctive bolus module 94 to provide separate
bolus delivery. The module 94 is mated to the internal reservoir
for the needs of meals and snacks. The module 94 may contain enough
insulin to last considerably longer than the insulin contained in
the reservoir 92. When reservoir 92 is exhausted, the module 94 may
simply be mated with another reservoir like that of reservoir 92.
Both the constantly fed insulin and the boluses may be delivered
through the infusion tube 96. The device may be adhered to the skin
with adhesive tape 98.
[0036] FIG. 7 shows a disposable insulin infusion device 100 for
delivery of a constant flow of insulin utilizing a substantially
constant pressure source and a small, flow control orifice. More
specifically, the device 100 includes a reservoir 101 including a
chamber 102 for containing a fast acting insulin. A wall 104 of the
chamber 102 includes a small orifice 106. Another wall 109 of the
chamber 102 is moveable under the influence of a spring 110 within
an expanding chamber 112. This pressurizes the reservoir 102 to
control the flow of insulin through the orifice 106 and into the
infusion tube or cannula 108. Hence, the device 100 of FIG. 7 is
similar to the device of FIG. 3 in that a reservoir of insulin is
pressurized to deliver a constant flow of insulin to a cannula.
[0037] FIG. 7A is a schematic representation of the operation of
another device 115 similar to the device 100 of FIG. 7. Here it may
be seen that the insulin is pressurized by gas within the
pressurized reservoir 102. The orifice 106 restricts the flow of
insulin by a controlled amount to the infusion tube or cannula 108.
In addition, the device 115 includes a bolus pump 114 to pump
boluses of fast acting insulin from another reservoir (or the same
reservoir) to the infusion tube or cannula 108. Again, the pump 114
may be a fixed stroke piston pump. Also, one-way valves 45 and 47
are positioned on opposite sides of the pump 114 as in previous
embodiments.
[0038] FIGS. 8 and 9 show another disposable insulin infusion
device 120 embodying the invention. Here, a volume adjustment
mechanism is provided to control the volume of insulin delivered
with each actuation. This actuation may be manual to adjust boluses
for meals and snacks or at specific timed intervals for an
adjustable effective basal rate.
[0039] More specifically, the device 120 includes a reservoir 122
for containing a fast acting insulin. The device further includes
disk 124 having a groove 126 that increases in depth along the
circumference of the disk 124. A flexible tube 130 extends from the
reservoir 122 around the disk 124 and within the groove 126. A
strap 132 extends from a fixed tie point 134 along the tube 130 to
an actuator 136. As the disk is rotated in the clockwise direction,
an increasing length of the tube 130 will reside in the groove 126.
Conversely, counter-clockwise rotation of disk 124 will cause a
decreased length of the tube 130 to reside in the groove 126. When
the actuator 136 is moved in the direction of arrow 138, the strap
132 acts upon (compresses) the portion of the tube 130 not in the
groove 126 to cause a measured bolus of insulin to be delivered to
the infusion tube 140. Hence, as more tubing is acted upon by the
strap 132, a larger volume bolus is delivered by peristaltic
action. The disk 124 may be rotated by a dial, such as the dial 82
of the device 86 of FIG. 5.
[0040] FIG. 10 schematically illustrates the operation of another
disposable insulin infusion device 150 embodying the invention.
Here there are separate reservoirs 152 and 154 for fast acting
insulin and slow acting insulin respectively. Each reservoir is
associated with its own respective pump. Reservoir 152 is
associated with pump 156 and reservoir 154 is associated with pump
158. The pumps 156 and 158 may be fixed stroke piston pumps as
shown. The reservoirs 152 and 154 deliver under the pumping action
of pumps 156 and 158 their respective insulin to a common port 160
coupled to a cannula 162. Again, one-way valves 145 and 147 are on
opposite sides of pump 156, and one-way valves 141 and 143 are on
opposite sides of pump 158.
[0041] FIGS. 11 and 12 show a bolus pump 170 embodying the
invention. The pump 170 takes the form of a dome pump as
illustrated. FIG. 11 shows the pump 170 prior to being depressed by
the patient's finger 172 and FIG. 12 shows the pump after being
depressed and insulin delivery. The pump 170 may be arranged to
deliver 0.5 units of insulin with each actuation and provide
tactile feedback with each actuation of the pump.
[0042] As may be noted, the pump includes a resilient membrane 174
sealed to a base 176 by a sealing ring 178. The base may be adhered
to the patient's skin by adhesive tape (not shown). The pump 170
also includes an intake valve 180 which permits insulin to enter
the inner cavity 184 formed by the membrane 174 and base 176 when
the membrane returns to the configuration shown in FIG. 11. An
output valve 182 permits insulin to flow from the cavity 184 when
the membrane is depressed as shown in FIG. 12. The inner cavity may
be arranged to displace a volume of 0.5 units of insulin for each
depression of the pump 170. Hence, if 3 units of insulin are
required for a meal, for example, the pump 170 may be depressed 6
times to deliver the desired amount of insulin to the patient.
[0043] While particular embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention as defined by those claims.
* * * * *