U.S. patent application number 12/572136 was filed with the patent office on 2010-03-04 for device and method employing shape memory alloy.
This patent application is currently assigned to ABBOTT DIABETES CARE, INC.. Invention is credited to Christopher V. Reggiardo, Benjamin M. Rush.
Application Number | 20100057007 12/572136 |
Document ID | / |
Family ID | 37087707 |
Filed Date | 2010-03-04 |
United States Patent
Application |
20100057007 |
Kind Code |
A1 |
Rush; Benjamin M. ; et
al. |
March 4, 2010 |
Device and Method Employing Shape Memory Alloy
Abstract
A system for the metering and delivery of small discrete volumes
of liquid is comprised of a small or minimal number of inexpensive
components. One such component is a movable member, such as a
miniature precision reciprocating displacement pump head, which is
driven by an actuator that comprises a shape memory alloy material.
The operating mechanism of the system is of little or minimal
complexity. The system facilitates the precise metering and
delivery of the small discrete volumes of liquid. Potential
applications for the system include subcutaneous, long-term,
automated drug delivery, for example, the delivery of insulin to a
person with diabetes. In such an application, the small, simple and
inexpensive nature of the invention would allow for its use as both
a portable and a disposable system.
Inventors: |
Rush; Benjamin M.; (Oakland,
CA) ; Reggiardo; Christopher V.; (Castro Valley,
CA) |
Correspondence
Address: |
FULWIDER PATTON LLP
HOWARD HUGHES CENTER, 6060 CENTER DRIVE, TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Assignee: |
ABBOTT DIABETES CARE, INC.
Alameda
CA
|
Family ID: |
37087707 |
Appl. No.: |
12/572136 |
Filed: |
October 1, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12163944 |
Jun 27, 2008 |
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12572136 |
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11106256 |
Apr 13, 2005 |
7399401 |
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12163944 |
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10683659 |
Oct 9, 2003 |
6916159 |
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11106256 |
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60424613 |
Nov 6, 2002 |
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60424414 |
Nov 6, 2002 |
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60417464 |
Oct 9, 2002 |
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Current U.S.
Class: |
604/153 |
Current CPC
Class: |
A61M 2205/0288 20130101;
A61M 2205/3317 20130101; A61M 5/14216 20130101; A61M 5/14244
20130101; F04B 51/00 20130101; G01F 1/708 20130101; G01F 1/64
20130101; A61M 5/16886 20130101; A61M 2205/3569 20130101; G01F
1/7088 20130101; A61M 2005/1726 20130101; F04B 2205/09 20130101;
F05C 2251/08 20130101; F04B 49/065 20130101; A61M 2205/702
20130101; A61M 2205/3592 20130101; F04B 43/043 20130101; G01F
25/0007 20130101 |
Class at
Publication: |
604/153 |
International
Class: |
A61M 5/152 20060101
A61M005/152 |
Claims
1. A device for pumping a predetermined volume of fluid,
comprising: a reservoir enclosure for holding the fluid; a
displacement cavity; a fluid inlet and a fluid outlet via fluid
paths that are discrete from but in communication with the
reservoir enclosure and displacement cavity; a plunger acting on
the displacement cavity; a biasing element linked to the plunger
moving the plunger to a first position compressing the fluid in the
displacement cavity; a shape memory actuator, having a first
transition temperature to a high temperature phase with a
remembered configuration and a second transition temperature to a
low temperature phase with a malleable configuration, linked to the
plunger; an electrical source providing a current to the shape
memory actuator, wherein a current on state transforms the shape
memory actuator to the high temperature phase and moves the plunger
against the biasing element to a second position decompressing the
displacement cavity, and a current off state allows the shape
memory actuator to cool to the low temperature phase so that the
biasing element biases the plunger to the first position; and
wherein the reservoir enclosure is disposable and detachable from a
housing containing at least one of the displacement cavity,
plunger, actuator, and biasing element.
2. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the reservoir enclosure includes a resilient
collapsible material.
3. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the fluid includes insulin.
4. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the fluid paths are defined by tubing.
5. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the reservoir enclosure includes a resilient
balloon.
6. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the shape memory actuator includes a NiTi
wire.
7. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the first transition temperature is about
70.degree. C. above an ambient temperature and the second
transition temperature is about at the ambient temperature.
8. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the shape memory actuator while in the
malleable configuration is stretched elastically by the biasing
element.
9. A device for pumping a predetermined volume of fluid according
to claim 1, wherein the electrical source includes a battery and a
capacitor, and at least the battery is contained within the
reservoir enclosure.
10. A device for pumping a predetermined volume of insulin,
comprising: a reservoir enclosure for holding the insulin; a
displacement cavity in communication with the reservoir enclosure;
inlet and outlet valves and respective conduits that are physically
discrete from the cavity but in communication with the cavity; a
plunger acting on the cavity to compress or decompress the cavity;
a biasing element acting on the plunger to bias the plunger to a
first position compressing the cavity; a shape memory actuator,
having a first transition temperature to a high temperature phase
with a remembered configuration and a second transition temperature
to a low temperature phase with a malleable configuration, linked
to the plunger; an electrical source providing a current to the
shape memory actuator, wherein a current on state thermally
transforms the shape memory actuator to the high temperature phase
and moves the plunger against the biasing element to a second
position decompressing the cavity, and a current off state
thermally transforms the shape memory actuator to the low
temperature phase so that the biasing element urges the plunger to
the first position; and wherein the enclosure is physically
discrete and detachable from a housing containing the cavity,
plunger, actuator, and biasing element.
11. A device for pumping a predetermined volume of fluid according
to claim 10, wherein the electrical source includes a battery and a
capacitor, and at least the battery is contained within the
reservoir enclosure.
12. A device for pumping a predetermined volume of fluid according
to claim 10, wherein the electrical source includes a timing
circuit controlling a field effect transistor (FET) that are
powered by an electrochemical capacitor and a battery.
13. A device for pumping a predetermined volume of fluid according
to claim 12, wherein the timing circuit controlling the field
effect transistor (FET) generate one of a single pulse and a
sequence of discrete smaller pulses.
14. A device for pumping a predetermined volume of fluid,
comprising: a fluid reservoir contained within an enclosure,
wherein the enclosure is resilient and collapsible; a displacement
cavity in communication with the enclosure; a fluid inlet and a
fluid outlet in communication with the displacement cavity; a
plunger acting on the displacement cavity; a biasing element linked
to the plunger moving the plunger to a first position compressing
the displacement cavity; a shape memory actuator, having a first
transition temperature to a high temperature phase with a
remembered configuration and a second transition temperature to a
low temperature phase with a malleable configuration, linked to the
plunger; an electrical source providing a current to the shape
memory actuator, wherein a current on state thermally transforms
the shape memory actuator to the high temperature phase and moves
the plunger against the biasing element to a second position
decompressing the displacement cavity, and a current off state
allows the shape memory actuator to cool to the low temperature
phase so that the biasing element moves the plunger to the first
position; and wherein the enclosure is disposable and detachable
from a housing holding the plunger, displacement cavity, actuator,
and biasing element.
15. A device for pumping a predetermined volume of fluid according
to claim 14, wherein the enclosure includes a resilient balloon and
the fluid includes insulin.
16. A device for pumping a predetermined volume of fluid according
to claim 14, wherein the electrical source provides current pulses
to the shape memory actuator.
17. A device for pumping a predetermined volume of fluid according
to claim 14, wherein the current on and current off states define
one cycle, which cycle dispenses a predetermined volume of
fluid.
18. A device for pumping a predetermined volume of fluid according
to claim 14, wherein the electrical source includes a programmable
pulse generating circuit.
19. A device for pumping a predetermined volume of fluid according
to claim 18, wherein the device includes an energy storage cell
powering the programmable pulse generating circuit.
20. A device for pumping a predetermined volume of fluid,
comprising: a fluid reservoir contained within an enclosure,
wherein the enclosure is resilient and collapsible; a displacement
cavity in fluid communication with the fluid reservoir; a plunger
acting on the displacement cavity; a biasing element linked to the
plunger biasing the plunger to a first position compressing the
displacement cavity; a shape memory actuator, having a first
transition temperature to a high temperature phase with a
remembered configuration and a second transition temperature to a
low temperature phase with a malleable configuration, linked to the
plunger; an electrical source providing a current to the shape
memory actuator, wherein a current on state transforms the shape
memory actuator to the high temperature phase and moves the plunger
against the biasing element to a second position decompressing the
displacement cavity, and a current off state allows the shape
memory actuator to cool to the low temperature phase so that the
biasing element moves the plunger to the first position; and
wherein the enclosure is disposable and detachable from a housing
holding the plunger, displacement cavity, actuator, and biasing
element.
21. A device for pumping a predetermined volume of fluid according
to claim 20, wherein the enclosure includes a resilient balloon
holding the fluid therein.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a divisional application of co-pending parent
application having U.S. application Ser. No. 12/163,944, filed Jun.
27, 2008, which is a continuation of U.S. application Ser. No.
11/106,256, filed Apr. 13, 2005, now U.S. Pat. No. 7,399,401, which
is a continuation-in-part (CIP) of U.S. application Ser. No.
10/683,659, filed Oct. 9, 2003, now U.S. Pat. No. 6,916,159, which
claims benefit and priority based on U.S. Provisional Application
No. 60/417,464, entitled "Disposable Pump For Drug Delivery
System," filed on Oct. 9, 2002, U.S. Provisional Application No.
60/424,613, entitled "Disposable Pump And Actuation Circuit For
Drug Delivery System," filed on Nov. 6, 2002, and U.S. Provisional
Application No. 60/424,414, entitled "Automatic Biological Analyte
Testing Meter With Integrated Lancing Device And Methods Of Use,"
filed Nov. 6, 2002, each of which is incorporated herein in its
entirety by this reference. This non-provisional application is
also related to U.S. Pat. No. 6,560,471, entitled "Analyte
Monitoring Device and Methods of Use," issued May 6, 2003, which is
incorporated herein in its entirety by reference.
FIELD OF INVENTION
[0002] This invention generally relates to fluid delivery devices,
systems, and methods. This invention further relates to small
volume, disposable medical devices for the precision delivery of
medicines or drugs such as insulin, and associated systems and
methods.
BACKGROUND OF THE INVENTION
[0003] Insulin pumps are widely available and are used by diabetic
people to automatically deliver insulin over extended periods of
time. All currently available insulin pumps employ a common pumping
technology, the syringe pump. In a syringe pump, the plunger of the
syringe is advanced by a lead screw that is turned by a precision
stepper motor. As the plunger advances, fluid is forced out of the
syringe, through a catheter to the patient. The choice of the
syringe pump as a pumping technology for insulin pumps is motivated
by its ability to precisely deliver the relatively small volume of
insulin required by a typical diabetic (about 0.1 to about 1.0
cm.sup.3 per day) in a nearly continuous manner. The delivery rate
of a syringe pump can also be readily adjusted through a large
range to accommodate changing insulin requirements of an individual
(e.g., basal rates and bolus doses) by adjusting the stepping rate
of the motor. While the syringe pump is unparalleled in its ability
to precisely deliver a liquid over a wide range of flow rates and
in a nearly continuous manner, such performance comes at a cost.
Currently available insulin pumps are complicated and expensive
pieces of equipment costing thousands of dollars. This high cost is
due primarily to the complexity of the stepper motor and lead screw
mechanism. These components also contribute significantly to the
overall size and weight of the insulin pump. Additionally, because
of their cost, currently available insulin pumps have an intended
period of use of up to two years, which necessitates routine
maintenance of the device such as recharging the power supply and
refilling with insulin.
[0004] U.S. Pat. No. 6,375,638 of Clyde Nason and William H. Stutz,
Jr., entitled "Incremental Motion Pump Mechanisms Powered by Shape
Memory Alloy Wire or the Like," issued Apr. 23, 2002, and naming
Medtronic MiniMed, Inc. as the assignee, which patent is
incorporated herein in its entirety by this reference, describes
various ratchet type mechanisms for incrementally advancing the
plunger of a syringe pump. The ratchet mechanisms are actuated by a
shape memory alloy wire. The embodiments taught by Nason et al.
involve a large number of moving parts, and are mechanically
complex, which increases size, weight and cost, and can reduce
reliability.
SUMMARY OF THE INVENTION
[0005] A fluid delivery system constructed according to the present
invention can be utilized in a variety of applications. As
described in detail below, it can be used to deliver medication to
a person or animal. The invention can be applied in other medical
fields, such as for implantable micro-pump applications, or in
non-medical fields such as for small, low-power, precision
lubricating pumps for precision self-lubricating machinery.
[0006] In its preferred embodiment, the present invention provides
a mechanical insulin delivery device for diabetics that obviates
the above-mentioned limitations of the syringe pump namely size,
weight, cost and complexity. By overcoming these limitations, a
precise and reliable insulin delivery system can be produced with
sufficiently low cost to be marketed as a disposable product and of
sufficiently small size and weight to be easily portable by the
user. For example, it is envisioned that such a device can be worn
discretely on the skin as an adhesive patch and contain a three-day
supply of insulin after the use of which the device is disposed of
and replaced.
[0007] The present invention relates to a miniature precision
reciprocating displacement pump head driven by a shape memory alloy
actuator. Shape memory alloys belong to a class of materials that
undergo a temperature induced phase transition with an associated
significant dimensional change. During this dimensional change,
shape memory alloys can exert a significant force and can thus
serve as effective actuators. The shape memory alloy actuator
provides an energy efficiency about one thousand times greater than
that of a conventional electromechanical actuator, such as a
solenoid, and a force to mass ratio about ten thousand times
greater. Additionally, the cost of shape memory alloy materials
compares favorably to the cost of electromechanical devices with
similar capabilities.
[0008] The device of the present invention is intended to be
operated in a periodic dosing manner, i.e., liquid is delivered in
periodic discrete doses of a small fixed volume rather than in a
continuous flow manner. The overall liquid delivery rate for the
device is controlled and adjusted by controlling and adjusting the
dosing period. Thus the device employs a precision timing mechanism
in conjunction with a relatively simple mechanical system, as
opposed to a complex mechanical system, such as that embodied by
the syringe pump.
[0009] A precision timing device is an inherently small, simple and
inexpensive device. It is an underlying assumption of the invention
(and a reasonable conclusion of process control theory) that in the
treatment of diabetes, there is no clinical difference between
administering insulin in periodic discrete small doses and
administering insulin in a continuous flow, as long as the
administration period of the discrete dose is small compared to the
interval of time between which the blood glucose level is measured.
For the present invention, a small dose size is regarded as on the
order of 0.10 units of insulin (1 microliter) assuming a standard
pharmaceutical insulin preparation of 100 units of insulin per ml
(U100). A typical insulin dependent diabetic person uses between 10
and 100 units of insulin per day, with the average diabetic person
using 40 units of insulin. Thus the present invention would deliver
the daily insulin requirements of the average diabetic person in
400 individual discrete doses of 1 .mu.l each with a dosing period
that can be programmed by the user. A pump constructed according to
the present invention can have a predetermined discrete dosage
volume that is larger or smaller than 1 .mu.l, but preferably falls
within the range of 0.5 to 5 .mu.l, and more preferably falls
within the range of 1 to 3 .mu.l. The smaller the discrete dose is
of a particular pump design, the more energy required by the device
to deliver a given amount of fluid, since each pump cycle consumes
roughly the same amount of energy regardless of discrete dosage
size. On the other hand, the larger the discrete dosage is, the
less precise the pump can mimic the human body in providing a
smooth delivery rate. A device constructed according to the present
invention is also suitable for delivery of other drugs that might
be administered in a manner similar to insulin.
[0010] It is further intended that the present invention could be
used as a disposable component of a larger diabetes management
system comprised of additional disposable and non-disposable
components. For example, the present invention could be coupled
with a continuous blood glucose monitoring device and remote unit,
such as a system described in U.S. Pat. No. 6,560,471, entitled
"Analyte Monitoring Device and Methods of Use," issued May 6, 2003.
In such an arrangement, the hand-held remote unit that controls the
continuous blood glucose monitoring device could wirelessly
communicate with and control both the blood glucose monitoring unit
and the fluid delivery device of the present invention. The monitor
and pump could be physically separate units, or could share one or
more disposable and/or non-disposable components. For example, a
disposable pump constructed according to the present invention and
charged with a 3-day supply of insulin, a small battery and a
disposable glucose sensor could be integrated into a single housing
and releasably coupled with non-disposable components such as
control electronics, a transmitter/receiver and a user interface to
comprise a small insulin delivery device that could be worn on the
skin as an adhesive patch. Alternatively, the battery (or
batteries) and/or sensor could be replaced separately from the
disposable pump. Such arrangements would have the advantage of
lowering the fixed and recurring costs associated with use of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] A detailed description of various embodiments of the
invention is provided herein with reference to the accompanying
drawings, which are briefly described below.
[0012] FIG. 1A shows a schematic representation of a most general
embodiment of the invention.
[0013] FIG. 1B shows a schematic representation of an alternative
general embodiment of the invention.
[0014] FIG. 2A shows a schematic representation of a preferred
embodiment of the invention.
[0015] FIGS. 2B and 2C show enlarged details of a preferred
embodiment of the invention.
[0016] FIG. 3 shows a schematic representation of a preferred
embodiment of a check valve to be used in the invention.
[0017] FIG. 4 shows a schematic representation of a preferred
embodiment of a pulse generation circuit to be used with the
invention.
[0018] FIG. 5 shows data from the experimental characterization of
the reproducibility of a functional model of the invention.
[0019] FIG. 6 shows data from the experimental characterization of
the energy utilization of a functional model of the invention.
[0020] FIG. 7 shows a schematic representation of a first
alternative embodiment of the invention.
[0021] FIG. 8 shows a schematic representation of a second
alternative embodiment of the invention.
[0022] FIG. 9 shows a schematic representation of a first
alternative embodiment of a pulse generation circuit to be used
with the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] A device of the present invention includes a miniature
precision reciprocating displacement pump driven by a shape memory
alloy wire linear actuator and controlled by a programmable pulse
generating circuit. For purposes of description, the device is
divided into three subcomponents, a precision miniature
reciprocating displacement pump head, a shape memory alloy linear
actuator, and a programmable pulse generating circuit. Each
subcomponent is comprised of multiple elements. A schematic
representation of a most general embodiment of the invention is
shown in FIG. 1A and is described below.
[0024] The miniature precision pump head is comprised of the
following elements: a rigid substrate 101 to which other components
may be attached so as to fix their orientation and position
relative to one another, a fluid reservoir 102 for storing the
fluid to be pumped 103 and a small cavity, henceforth referred to
as the displacement cavity 104, whose volume can be varied between
precisely defined limits. The limit corresponding to a state of
maximum volume for the displacement cavity 104 is defined as the
first limit 105 and the limit corresponding to a state of minimum
volume for the displacement cavity 104 is defined as the second
limit 106. An inlet conduit 107 connects the displacement cavity
104 to the fluid reservoir 102 and thus permits fluid flow between
the two. An inlet check valve 108 is situated within the inlet
conduit 107 such that fluid flow is restricted to flowing from the
fluid reservoir 102 to the displacement cavity 104. An outlet
conduit 109 connects the displacement cavity 104 to some point 111
to which it is desired to deliver the fluid. An outlet check valve
110 is situated within the outlet conduit 109 such that fluid flow
is restricted to flowing from the displacement cavity 104 to the
point 111 to which it is desired to deliver the fluid.
[0025] The shape memory alloy actuator is comprised of a shape
memory allow material, such as a nickel-titanium alloy material,
sometimes referred to as "nitinol." The shape memory alloy material
is sensitive to temperature or heat. For example, the material
temporarily shrinks at a certain temperature, or shrinkage
temperature, such as about 70.degree. C. above ambient temperature
for nitinol, and expands at a relatively lower temperature to
return to its original condition. In response to being heated to
the above-described shrinkage temperature, the shape memory alloy
undergoes a dimensional change, such as a change in its length. In
this way, a wire composed of a material such as nitinol, can
undergo a change in length and a return toward its original length
one or more times via temperature treatment or repeated temperature
cycling. It is contemplated that a material that expands by going
through a phase transition at a certain temperature and shrinks at
a different temperature to return toward its original condition
could be used.
[0026] In the process of undergoing a dimensional change, as
described above, the shape alloy material goes through a reversible
phase transition or transformation, or a reversible structural
phase transition, upon a change in temperature. Generally, such a
transition represents a change in the material from one solid phase
of the material to another, for example, by virtue of a change in
the crystal structure of the material or by virtue of a reordering
of the material at a molecular level. In the case of nitinol, for
example, the superelastic alloy has a low temperature phase, or
martensitic phase, and a high temperature phase, or austenitic
phase. These phases can also be referred to in terms of a stiff
phase and a soft and malleable phase, or responsive phase. The
particular phase transition associated with a particular alloy
material may vary.
[0027] The shape memory alloy actuator is also comprised of the
following elements. A movable member is referred to as a plunger
112 and is fixed by a rigid restraint 113 such that it is
constrained to a periodic motion of precisely fixed limits. The
plunger 112 is situated in relation to and/or attached to the
displacement cavity 104 such that movement of the plunger 112
within the limits of its constrained motion will cause the volume
of the displacement cavity 104 to be varied between its limits 105,
106. A biasing spring 115 is situated relative to the rigid
restraint 113 and the plunger 112 such that at equilibrium, the
biasing spring 115 exerts a force on the plunger 112 whose
direction is that which would induce the displacement cavity 104
toward a state of minimum volume, i.e., toward its second limit
106. A length of shape memory alloy wire 114 is connected at one
end to the plunger 112 and at another end to the rigid substrate
101. The shape memory alloy wire 114 is situated such that its
dimensional change will give rise to motion of the plunger 112. The
shape memory alloy wire 114 and the biasing spring 115 are both of
sufficient dimension such that when the shape memory alloy wire 114
is heated so as to induce phase transition and associated
dimensional change, the wire will move the plunger 112 against the
force of the biasing spring 115 "in one generally uninterrupted
motion" to its second limit 105 so as to create a state of maximum
volume within the displacement cavity 104, whereas when the shape
memory alloy is allowed to cool to ambient temperature, the force
imparted by the biasing spring 115 will stretch the shape memory
alloy wire 114 until the point where the displacement cavity 104 is
in a state of minimum volume.
[0028] The programmable pulse generating circuit is comprised of a
source of electric power 116, an electrical connection 117 from the
source of electric power 116 to each end of the shape memory alloy
wire 114 and a programmable pulse generating circuit 118 situated
along the electrical connection 117 such that pulses of electricity
from the electric power source 116 may be applied to the shape
memory alloy wire 114 automatically in a preset regular periodic
manner.
[0029] Operation of the device proceeds in a cyclic manner. For
purposes of description the beginning of the cycle is defined as
the following state. All void space within the fluid reservoir 102,
inlet 107 and outlet 109 conduit, inlet 108 and outlet 110 check
valves and displacement cavity 104 are completely filled with the
fluid 103 to be pumped. The shape memory alloy wire 114 is at
ambient temperature and thus in a state of maximum length.
Correspondingly, the position of the plunger 112 is such that the
volume of the displacement chamber 104 is at its minimum value. The
biasing spring 115 is in a compressed state such that it exerts a
force on the plunger 112 consistent with a state of minimum volume
of the displacement cavity 104. Operation of the device involves
first a heating of the shape memory alloy wire 114 to a temperature
and for a period of time sufficient to induce phase transition and
an associated dimensional change. Heating of the shape memory alloy
wire 114 is accomplished by passing an electric current though it.
The duration of the electric heating period is preset and is
controlled by the timing and switching circuit 118. The dimensional
change of the shape memory alloy wire 114 will result in the
movement of the plunger 112 against the opposing force of biasing
spring 115 so as to vary the volume of the displacement chamber 104
toward its first limit 105 and a state of maximum volume. As the
volume of the displacement cavity 104 is increased, fluid 103 is
drawn into the displacement cavity 104 from the fluid reservoir 102
through the inlet conduit 107 and inlet check valve 108. Fluid 103
is not drawn into the displacement cavity 104 through the outlet
conduit 109 due to the one-way flow restriction of the outlet check
valve 110. After the preset duration, the current is then switched
off by the timing and switching circuit 118 allowing the shape
memory alloy wire 114 to cool below its phase transition
temperature. Cooling proceeds via natural convection to the ambient
environment. When the shape memory alloy wire 114 cools below its
phase transition temperature, the force exerted by the biasing
spring 115 stretches the shape memory alloy wire 114 to its
original maximum length. This allows the movement of the plunger
112 so as to vary the volume of the displacement cavity 104 toward
its second limit 106 and a state of minimum volume. As the volume
of the displacement cavity 104 is decreased, fluid 103 is pushed
out of the displacement cavity 104 through the outlet conduit 109
and outlet check valve 110. Fluid 103 is not pushed out of the
displacement cavity 104 through the inlet conduit 107 due to the
one-way flow restriction of the inlet check valve 108. Thus one
complete heating and cooling cycle of the shape memory alloy wire
114 results in the delivery of a volume of fluid 103 from the fluid
reservoir 102 to the end of the outlet conduit 111. The volume of
fluid delivered with each cycle is precisely equal to the
difference between the maximum and minimum volumes of the
displacement cavity 104 as determined by the precisely defined
limits 105, 106. The overall rate of fluid delivery is controlled
by varying the period of time between actuations of the shape
memory alloy actuator 104.
An Alternative General Embodiment of the Invention
[0030] A schematic representation of an alternative general
embodiment of the invention is shown in FIG. 1B. The alternative
general embodiment includes all of the same components and elements
as the general embodiment shown in FIG. 1A with the following
exceptions. In this embodiment of the invention, heating of the
shape memory alloy material 114 so as to cause a phase transition
associated shortening of its length results in a minimum volume
condition for the displacement cavity 104. This may be achieved,
for example, through the use of a pivoting linkage assembly 119
connecting the biasing spring 115 to the plunger 112.
Detailed Description of a Preferred Embodiment of the Invention
[0031] As stated previously, it is an intention of the present
invention that it be sufficiently small and sufficiently
inexpensive to be practically used as both a portable device and as
a disposable device. For example, a device that can be comfortably
worn on the skin as an adhesive patch and can be disposed of and
replaced after 3 days of use. A preferred embodiment of the
invention includes specific embodiments of the various elements and
components of the general embodiment that are consistent with this
intention.
[0032] A preferred embodiment of the invention is diagrammed
schematically in FIGS. 2A, 2B and 2C and is comprised of all of the
same elements and components of the general embodiment of the
invention shown in FIGS. 1A and 1B with the following exceptions.
In a preferred embodiment of the invention the displacement cavity
is comprised of an elastomeric diaphragm pump head 201. An enlarged
view of the details of the diaphragm pump head 201 is shown by FIG.
2B with pump head 201 in a state of minimum volume and by FIG. 2C
with pump head 201 in a state of maximum volume. The diaphragm pump
head is comprised of an elastomeric diaphragm 202 set adjacent to a
rigid substrate 203 and scaled about a perimeter of the elastomeric
diaphragm 202. The displacement cavity 204 is then comprised of the
volume in between the adjacent surfaces of the rigid substrate 203
and the elastomeric diaphragm 202 within the sealed perimeter.
[0033] Separate inlet 205 and outlet 206 conduits within the rigid
substrate 203 access the displacement volume of the elastomeric
diaphragm pump head 201 with the inlet conduit 205 connecting the
displacement cavity 204 with a fluid reservoir 207 and the outlet
conduit 206 connecting the displacement cavity 204 to the point to
which it is desired to deliver fluid 208. An inlet check valve 209
and an outlet check valve 210 are situated within the inlet conduit
205 and outlet conduit 206 respectively, oriented such that the net
direction of flow is from the fluid reservoir 207 to the point to
which it is desired to deliver fluid 208.
[0034] The plunger 211 is comprised of a cylindrical length of
rigid dielectric material. The plunger 211 is situated within a
cylindrical bore 212 of a rigid restraint 213 such that the axis of
the plunger 211 is oriented normal to surface of the elastomeric
diaphragm 202. The flat head of the plunger 211 is functionally
attached to the non-wetted surface of elastomeric diaphragm 202
opposite the displacement cavity 204 such that movement of the
plunger 211 along a line of motion coincident with its axis will
cause the concomitant variation in the volume of the displacement
cavity 204. The biasing spring 214 is situated within the
cylindrical bore 212 of the rigid restraint 213, coaxial with the
plunger 211. The relative positions and dimensions of the plunger
211, the rigid restraint 213 and the biasing spring 214 are such
that at equilibrium the biasing spring 214 exerts a force on the
plunger 211 along a line coincident with its axis such that the
displacement cavity 204 is in a state of minimum volume (FIG.
2A).
[0035] A straight length of shape memory alloy wire 215 is situated
in a position coincident with the axis of the plunger 211. One end
of the shape memory alloy wire 215 is fixed to the rigid restraint
203 and electrically connected by connection 216 to the
programmable pulse generating circuit 217 and the electric power
source 218. The other end of the shape memory alloy wire 215 along
with an electrical connection 219 to that end is connected to the
end of the plunger 211. The shape memory alloy wire 215 and the
biasing spring 214 are both of sufficient dimension such that when
the shape memory alloy wire 215 is heated so as to induce phase
transition and associated dimensional change, it will pull the
plunger 211 against the force of the biasing spring 214 so as to
create a state of maximum volume within the displacement cavity
204, whereas when the shape memory alloy is allowed to cool to
ambient temperature, the force imparted by biasing spring 214 will
stretch the shape memory alloy wire 215 until the point where the
displacement cavity 204 is in a state of minimum volume.
[0036] A preferred embodiment of an inlet and outlet check valve is
shown in cross-section in FIG. 3 and is comprised of a molded
one-piece elastomeric valve which can be press-fit into the inlet
or outlet conduit. An important feature for a check valve
appropriate for use in the present invention is that it possesses a
low cracking pressure and provides a tight seal in the absence of
any back pressure. A preferred embodiment of such a check valve is
comprised of a thin-walled elastomeric dome 301 situated on top of
a thick elastomeric flange 302. The top of the dome has a small
slit 303 cut through it that is normally closed. A fluid pressure
gradient directed toward the concave side 304 of the dome will
induce an expansion of the dome 301 forcing the slit 303 open so as
to allow fluid to flow through the valve in this direction. A fluid
pressure gradient directed toward the convex side 305 of the dome
will induce a contraction of the dome 301 forcing the slit 303 shut
so as to prohibit fluid to flow through the valve in this
direction.
[0037] A preferred embodiment of a pulse generating circuit is
shown in FIG. 4 and is comprised of a 200 milliamp-hour,
lithium-manganese oxide primary battery 401, a high capacitance,
low-equivalent series resistance (ESR) electrochemical capacitor
402, a programmable digital timing circuit 403, and a
low-resistance field effect transistor switch 404. The shape memory
alloy wire is indicated in FIG. 4 symbolically as a resistor 405.
The battery 401 and electrochemical capacitor 402 are electrically
connected to each other in parallel and are connected to the shape
memory alloy wire 405 through the transistor switch 404. The
programmable timing circuit 403, also powered by the battery 401,
sends a gating signal to the transistor switch 404, as programmed
by the user in accordance with the user's pumping requirements.
During the period of time for which the transistor switch 404 is
open, the battery 401 will keep the electrochemical capacitor 402
at a state of full charge. During the period of time for which the
transistor switch 404 is closed, power will be delivered to the
shape memory alloy wire 405, primarily from the electrochemical
capacitor 402 rather than from the battery 401, owing to the
substantially lower ESR associated with the electrochemical
capacitor 402. As such, the battery 401 is substantially isolated
from the high current draw associated with the low resistance of
the shape memory alloy wire 405 and the useful life of the battery
401 is significantly extended.
[0038] A preferred embodiment of a fluid reservoir 207 appropriate
for use with the present invention is one for which the volume of
the fluid reservoir diminishes concomitantly as fluid is withdrawn
such that it is not necessary to replace the volume of the
withdrawn fluid with air or any other substance. A preferred
embodiment of a fluid reservoir 207 might comprise a cylindrical
bore fitted with a movable piston, for example, a syringe, or a
balloon constructed of a resilient material.
[0039] Operation of the preferred embodiment of the invention
proceeds in a manner analogous to that described for the most
general embodiment. In addition to its simplicity, the preferred
embodiment has the advantage of physically blocking any fluid flow
from the fluid reservoir to the point to which it is desired to
deliver the fluid when there is no power being supplied to the
system. This provides additional protection against an overdose
caused by fluid expanding or being siphoned through the check
valves when the system is inactive.
Detailed Description of a Functional Model of the Invention
[0040] A functional model of a preferred embodiment of the
invention has been constructed and its performance has been
characterized. The functional model is similar in appearance to the
preferred embodiment of the invention shown in FIGS. 2, 3 and 4 and
is described in more detail below. The fixed rigid components of
the pump including the rigid restraint and the rigid substrate of
the diaphragm pump head are each machined from a monolithic block
of acetal. Inlet and outlet conduits are additionally machined out
of the same block. Check valves are commercially available
one-piece elastomeric valves (for example, Check Valve, Part #
VA4914, available from Vernay Laboratories Inc. of Yellow Springs,
Ohio). A length of shape memory alloy actuator is 40 mm long and
125 .mu.m in diameter (for example, Shape Memory Alloy Wire,
Flexinol 125 LT, available from Mondo-tronics, Inc. of San Rafael,
Calif.). Electrical connections to the ends of the shape memory
alloy actuator are made with 30 AWG copper wire. The copper wire is
twisted to the shape memory alloy wire to effect a good electrical
connection. A plunger is machined out of acetal and has an overall
length of 10.0 mm and a shaft diameter of 3.2 mm. An elastomer
diaphragm is comprised of 0.025 mm thick silicon rubber film (for
example, Silicon Rubber Film, Cat. # 86435K31, available from
McMaster Carr, of Los Angeles, Calif.). The flat head of the
plunger is secured to the elastomer diaphragm with epoxy (for
example, Epoxy, Stock #14250, available from ITW Devcon, of
Danvers, Mass). The ends of the shape memory alloy wire-copper
conductor assembly are connected to the plunger and to the rigid
restraint with epoxy. A stainless steel biasing spring has an
overall length of 12.7 mm, an outside diameter of 3.0 mm, a wire
diameter of 0.35 mm and a spring constant of 0.9 N/mm (for example,
Biasing Spring, Cat. #C0120-014-0500, available from Associated
Spring, of Dallas, Tex.).
[0041] A pulse generating circuit is comprised of an adjustable
analog timing circuit based on a 556 dual timing integrated circuit
(for example, 556 Dual Timing Circuit, Part # TS3V556, available
from ST Microelectronics, of San Jose, Calif.). Power is supplied
by a 3 V lithium-manganese dioxide primary cell (for example,
Li/MgO.sub.2 Battery, Part # DL2032, available from Duracell, of
Bethel, Conn.). Power load leveling is facilitated by the use of an
electrochemical supercapacitor (for example, Electrochemical
Supercapacitor, Part # B0810, available from PowerStor Inc., of
Dublin, Calif.) in parallel with the battery. High-power switching
is achieved with a field effect transistor (for example, Field
Effect Transistor Switch, Part # IRLZ24N, available from
International Rectifier, of El Segundo, Calif.).
[0042] The functional model was characterized with respect to
reproducibility, insulin stability and energy consumption. The
model was operated by heating the shape memory alloy wire with a
short pulse of current and then allowing the shape memory alloy
wire to cool. Each heating pulse and subsequent cooling period
comprised a single actuation cycle.
[0043] A device that is used to automatically deliver a drug to an
individual over an extended period of time should do so with
extreme precision. This is particularly critical when the drug
being delivered is one that might have dangerous health
consequences associated with an inappropriate dose. Insulin is one
such drug. An excessive dose of insulin can result in dangerously
low blood glucose level, which in turn can lead to coma and death.
Thus any device to be used for automatically delivering insulin to
a diabetic person must be able to demonstrate a very high level of
precision. To characterize the precision with which the invention
can deliver insulin, the functional model was repeatedly cycled at
a constant period of actuation and the total quantity of liquid
delivered was measured as a function of the number of actuation
cycles. FIG. 5 shows typical results. The data in FIG. 5 were
obtained with an actuation period of 28 seconds and a pulse
duration of 0.15 seconds. In FIG. 5 markers show actual data points
and the line represents a least squares fit of the data points.
Data were collected over 8500 cycles at which point the measurement
was stopped. The fit to the data has a slope of 1.997 mg/cycle and
a linear correlation coefficient of 0.999 indicating that the
functional model delivered extremely consistent volumes of liquid
with each actuation over the course of the measurement.
[0044] Another important requirement for any medical device that
handles insulin is that the device does not damage the insulin.
Insulin is a large and delicate biomolecule that can readily be
damaged by the mechanical action (e.g., shear stress) of a pumping
device. Three common modes of insulin destruction which result in a
loss of bioactivity are aggregation, where individual insulin
molecules bond together to form various polymer structures,
degradation, where individual insulin molecules are broken apart,
and denaturing, where individual molecules remain intact but lose
their characteristic conformation. All three modes of insulin
destruction are exacerbated by elevated temperatures. Thus, in the
development of a practical insulin pumping device, preferably, it
should be demonstrated that the device does not damage insulin. To
characterize the insulin stability associated with the invention, a
quantity of insulin (Insulin, Humalog U100, available from Eli
Lilly, of Indianapolis, Ind.) was set up to recycle continuously
through the functional model over the course of several days at
37.degree. C. Samples of the insulin were collected each day for
evaluation. This resulted in a series of pumped insulin samples
with an increasing amount of pump stress. The insulin samples were
then analyzed by reverse-phase high performance liquid
chromatography. The chromatography indicated a 2% loss of insulin
concentration after a single pass through the pump and a further
loss of another 5% of the insulin concentration after 3 days of
recycling.
[0045] It is desirable for a small and inexpensive insulin delivery
device to be able to execute its maximum intended term of use with
the energy from a single small inexpensive primary battery. Based
on a 0.1 unit dose size and a maximum insulin consumption of 100
units per day for 3 days, a maximum term of use for the inventive
device might be considered to be 3000 cycles. To characterize the
energy consumption of the invention, the functional model was
operated continuously for several days at an actuation period of 85
seconds while the voltage of a 200 milliamp-hour, 2032
lithium/manganese dioxide battery was monitored. FIG. 6 shows
typical results. A typical voltage vs. capacity curve for the
lithium/manganese dioxide battery is characterized by an initial
drop in voltage from about 3.2 V to a plateau voltage of about 2.8
V. The voltage of the battery remains at this plateau level for the
duration of its useful life. The battery voltage will then drop
precipitously to a value below 2 V when its capacity expires. The
data in FIG. 6 indicate that the battery is still at its plateau
voltage after 4000 pump cycles and thus the 200 milliamp-hour,
lithium/manganese dioxide battery is more than adequate to power
the device of the present invention for its intended term of
use.
Alternative Embodiments of the Invention
[0046] A first alternative embodiment of the invention is
diagrammed schematically in FIG. 7 and is comprised of all of the
same subcomponents and elements of the most general embodiment of
the invention shown in FIG. 1 with the following exceptions. In a
first alternative embodiment of the invention, the displacement
cavity, as well as the inlet and outlet conduit, are all comprised
of a single length of small-diameter flexible and resilient tubing
701. The tubing 701 is situated within a restraining fixture 702
secured to a rigid base 703 so as to fix the position and
orientation of the tubing 701 relative to the other elements of the
device. Inlet 704 and outlet 705 check valves are located within
the bore of the tubing 701 such that they have a common orientation
for flow direction and such that a length of empty tubing 701
exists in between the two check valves 704, 705. The volume within
the inner diameter of the tubing 701 and in between the two check
valves 704, 705 comprises a displacement cavity 706. The volume of
the displacement cavity 706 is varied by compressing the resilient
tubing 701 with a plunger 707 (described below) at a position
midway between the two check valves 704, 705. The volume within the
inner diameter of the tubing 701 and in between the two check
valves 704, 705 when the tubing 701 is uncompressed defines the
maximum volume of displacement cavity 706. The volume within the
inner diameter of the tubing 701 and in between the two check
valves 703, 704 when the tubing 701 is fully compressed by the
plunger 707 defines the minimum volume of the displacement cavity
705.
[0047] The plunger 707 is comprised of a cylindrical length of
rigid dielectric material and includes a flange 708 and a tapered
end 709. The plunger 707 is situated within a cylindrical bore 710
of a rigid restraint 711 such that the axis of the plunger 707 is
oriented normal to the axis of the resilient tubing 701 and such
that the tapered head 709 of the plunger 707 may be alternately
pressed against the resilient tubing 701 and removed from contact
with the resilient tubing 701 with movement of the plunger 707
along a line of motion coincident with the its axis. A biasing
spring 712 is fitted around the shaft of the plunger 707 in between
the rigid restraint 711 and the plunger flange 708. The relative
positions and dimensions of the plunger 707, the rigid restraint
711 and the biasing spring 712 are such that at equilibrium the
biasing spring 712 exerts a force on the plunger 707 along a line
coincident with its axis that is sufficient to fully collapse the
resilient tubing 701 and thus create a state of minimum volume of
the displacement cavity 706.
[0048] A straight length of shape memory alloy wire 713 is situated
in a position coincident with the axis of the plunger 707. One end
of the shape memory alloy wire 713 is attached to the rigid base
703 and electrically connected by connection 716 to the pulse
generating circuit 714 and the electric power source 715. The other
end of the shape memory alloy wire 713 along with an electrical
connection 717 to that end is attached to the shaft of the plunger
707. The shape memory alloy wire 713 is of sufficient length and
strength that when heated so as to induce phase transition and
associated dimensional change it will pull the plunger 707 away
from contact with the resilient tubing 701 against the opposing
force of the biasing spring 713.
[0049] A second alternative embodiment of the invention is
diagrammed schematically in FIG. 8 and is comprised of all of the
same subcomponents and elements of the most general embodiment of
the invention shown in FIG. 1 with the following exceptions. A
displacement cavity 801 is comprised of a cylindrical shell 802 and
tube 803 arrangement where the tube 803 is coaxial with the shell
802 and can move freely within the shell 802 along a line
coincident with that axis. The volume of the displacement cavity
801 is varied by moving the tube 803 relative to the shell 802.
Movement of the tube 803 into the shell 802 reduces the volume of
the displacement cavity 801 whereas movement of the tube out of the
shell increases the volume of the displacement cavity 801. A
dynamic seal 804, for example and elastomer o-ring, seals the
displacement cavity 801 while not interfering adversely with the
relative motion of the shell 802 and tube 803. Outlet 805 and inlet
806 conduits access the displacement cavity 801 through the ends of
the shell 802 and tube 803 respectively. Outlet 807 and inlet 808
check valves are situated within the shell 802 and tube 803
respectively. A biasing spring 809 is situated within the
displacement cavity 801 so as to resist the motion of the
displacement cavity 801 toward a state of reduced volume. A shape
memory alloy wire 810 is attached between the shell 802 and the
tube 803 along the outside of the assembly such that when the shape
memory alloy wire 810 is heated so as to induce phase transition
and associated dimensional change it will incline the displacement
cavity 801 toward a state of reduced volume. The shape memory alloy
wire 810 is electrically connected by connector 811 to a
programmable pulse generating circuit 812 and a source of electric
power 813. Hard stops (not shown) on the limits of the relative
positions of the shell 802 and tube 803 define the maximum and
minimum volumes of the displacement volume 801.
[0050] Operation of both the first and second alternative
embodiments of the invention proceed in a manner analogous to that
described for the most general embodiment and preferred embodiment
of the invention.
[0051] In all of the embodiments described above, a shape memory
alloy wire acts as an actuator to drive a movable member to
increase or decrease the fluid volume in the pump head, and once
the wire cools a spring is used to return the movable member back
to its original position. Those of reasonable skill in this field
will appreciate that a multitude of other biasing means exist, one
or more of which can be used in place of or in addition to the
spring. In fact, a shape memory alloy can be constructed in such a
way that it drives the movable member in both directions to act as
both an actuator and a return biasing element. For example, the
shape memory alloy can be coiled much like a spring to drive the
movable member in one direction when heated and in the other
direction when cooled.
[0052] A first alternative embodiment of a pulse generating circuit
is diagrammed schematically in FIG. 9 and is comprised of a 200
milliamp-hour lithium-manganese dioxide primary battery 901, a DC
to DC converter 902, a capacitor 903, a low-resistance field effect
transistor switch 904, a programmable digital timing circuit 905,
an inductor 906 and a diode 908. The shape memory alloy wire is
indicated in FIG. 9 symbolically as a resistor 907. The objective
of this embodiment of a pulse generating circuit is that the pulses
of power delivered to the shape memory alloy wire 907 can be of a
higher voltage, and thus higher current, than that associated with
the preferred embodiment of a pulse generating circuit diagrammed
in FIG. 4 and described previously. A high voltage, high current
power pulse has the advantage that it can actuate the circuit in a
shorter more efficient time period. Additionally, the alternative
embodiment of a pulse generating circuit allows the useful life of
the battery 901 to be extended to a lower voltage and can prevent
other circuitry powered by the battery from resetting when the
battery voltage drops as is likely to happen in the preferred
embodiment. The battery 901 and capacitor 903 are electrically
connected to each other in parallel through the DC to DC converter
902. The capacitor 903 is further connected to the shape memory
alloy wire 907 through the transistor switch 904. The programmable
timing circuit 905, also powered by the battery 901 sends a gating
signal to the transistor switch 904 as programmed by the user in
accordance with their pumping requirements. During the period for
which the transistor switch 904 is open, the DC to DC converter 902
draws energy from the battery 901 and stores it in the capacitor
903. Use of the DC to DC converter 902 allows the voltage of the
capacitor 903 to be charged to a significantly higher value than
that associated with the battery 901 and to be charged to the same
voltage throughout the life of the battery 901 regardless of the
battery voltage. It is intended that the transistor switch 904 may
be modulated to send an overall energy pulse as a single pulse or
as a sequence of discrete smaller pulses. It is intended that these
smaller pulses may be sequenced so as to tailor a custom profile
for the overall energy pulse. The custom profile would ensure
optimal energy delivery to the shape memory alloy without exceeding
its fusing characteristics. The inclusion of the inductor 906 and
diode 908 allows current to continue to flow through the shape
memory alloy wire 907 after the transistor switch 904 is opened
when the pulse is modulated. This allows further control of the
energy delivered to the shape memory alloy.
[0053] Various references, publications, provisional and
non-provisional United States patent applications, and/or United
States patents, have been identified herein, each of which is
incorporated herein in its entirety by this reference. Various
aspects and features of the present invention have been explained
or described in relation to beliefs or theories or underlying
assumptions, although it will be understood that the invention is
not bound to any particular belief or theory or underlying
assumption. Various modifications, processes, as well as numerous
structures to which the present invention may be applicable will be
readily apparent to those of skill in the art to which the present
invention is directed, upon review of the specification. Although
the various aspects and features of the present invention have been
described with respect to various embodiments and specific examples
herein, it will be understood that the invention is entitled to
protection within the full scope of the appended claims.
* * * * *