U.S. patent application number 09/249666 was filed with the patent office on 2001-08-23 for incremental motion pump mechanisms druven by shape memory alloy wire or the like.
This patent application is currently assigned to MINIMED INC.. Invention is credited to NASON, CLYDE, STUTZ, WILLIAM H. JR..
Application Number | 20010016710 09/249666 |
Document ID | / |
Family ID | 22944476 |
Filed Date | 2001-08-23 |
United States Patent
Application |
20010016710 |
Kind Code |
A1 |
NASON, CLYDE ; et
al. |
August 23, 2001 |
INCREMENTAL MOTION PUMP MECHANISMS DRUVEN BY SHAPE MEMORY ALLOY
WIRE OR THE LIKE
Abstract
A drive mechanism for a medication delivery device includes a
force receiving member, a force applying member and a shape memory
alloy (SMA) actuator. The force applying member is operatively
coupled to the force receiving member to move the force receiving
member to a different position relative to the force applying
member. The shape memory alloy actuator is formed from a shape
memory alloy material and is operatively coupled to the force
applying member. The shape memory alloy actuator is heat activated
to distort the shape memory actuator from a first shape to a second
shape to activate the force applying member to act upon the force
receiving member to move the force receiving member to a different
position relative to the force applying member. Also, the shape
memory alloy actuator is returned to the first shape from the
second shape after the force receiving member is moved to a
different position relative to the force applying member. In
addition, the shape memory alloy actuator may be activated by
applying and removing an electrical current to the shape memory
element. For example, the drive mechanism may further include a
power source coupled to the shape memory actuator to provide the
electric current to the shape memory actuator. In addition, the
shape memory actuator may be formed from Nitinol material, such as
a wire.
Inventors: |
NASON, CLYDE; (VALENCIA,
CA) ; STUTZ, WILLIAM H. JR.; (EAGLE ROCK,
CA) |
Correspondence
Address: |
MINIMED INC. - PATENT DEPARTMENT
18000 DEVONSHIRE STREET
NORTHRIDGE
CA
91325-1219
US
|
Assignee: |
MINIMED INC.
|
Family ID: |
22944476 |
Appl. No.: |
09/249666 |
Filed: |
February 12, 1999 |
Current U.S.
Class: |
604/153 ;
604/531 |
Current CPC
Class: |
A61M 5/1452 20130101;
A61M 2205/0266 20130101; A61M 2005/14506 20130101; A61M 2205/106
20130101; A61M 5/148 20130101 |
Class at
Publication: |
604/153 ;
604/531 |
International
Class: |
A61M 037/00 |
Claims
What is claimed is:
1. A drive mechanism for a medication delivery device, the drive
mechanism comprising: a force receiving member; a force applying
member operatively coupled to the force receiving member to cause
relative movement to occur between the force receiving member and
the force applying member so that the force receiving member is in
a different position relative to the force applying member; and a
shape memory actuator formed from a shape memory material and which
is operatively coupled to the force applying member, and wherein
the shape memory actuator is heat activated to distort the shape
memory actuator from a first shape to a second shape to activate
the force applying member to act upon the force receiving member to
cause the relative movement between the force applying member and
the force receiving member so that the force receiving member is in
the different position relative to the force applying member, and
wherein the shape memory actuator is returned to the first shape
from the second shape after the force receiving member is in the
different position relative to the force applying member.
2. A drive mechanism in accordance with claim 1, wherein the force
applying member is stationary and the force receiving member is
moved by the force applying member.
3. A drive mechanism in accordance with claim 1, wherein the force
receiving member remains stationary and the force applying member
is moved relative to the force receiving member.
4. A drive mechanism in accordance with claim 1, wherein the force
receiving member is a guide and the force applying member is a
carriage assembly.
5. A drive mechanism in accordance with claim 4, wherein the guide
is a shaft and wherein the carriage assembly includes at least one
pawl which is actuated to incrementally move the carriage assembly
relative to the shaft.
6. A drive mechanism in accordance with claim 4, wherein the guide
is a shaft and the carriage assembly includes at least one pawl, a
lever and a cam surface on one end of the lever, and wherein the
shape memory actuator is coupled to another end of the lever and
actuated to move the cam surface of the lever against the at least
one pawl to incrementally move the carriage assembly relative to
the shaft.
7. A drive mechanism in accordance with claim 1, wherein the force
receiving member is a gear, and wherein the different position of
the gear relative to the force applying member is an angular
rotation.
8. A drive mechanism in accordance with claim 7, wherein the force
applying member is a wire pawl that includes the shape memory
actuator to pull upon the gear to cause the angular rotation.
9. A drive mechanism in accordance with claim 7, wherein the force
applying member is a bar that includes the shape memory actuator to
push upon the gear to cause the angular rotation.
10. A drive mechanism in accordance with claim 1, wherein the shape
memory actuator is heat activated by applying and removing an
electric current to the shape memory element.
11. A drive mechanism in accordance with claim 10, wherein the
drive mechanism further includes a power source coupled to the
shape memory actuator to provide the electric current to the shape
memory actuator.
12. A drive mechanism in accordance with claim 10, wherein the
shape memory actuator is formed from Nitinol material.
13. A drive mechanism in accordance with claim 12, wherein the
Nitinol material is formed as a wire.
14. A drive mechanism in accordance with claim 1, wherein the drive
mechanism utilizes less than three shape memory actuators, three
force receiving members and three force applying members.
15. A drive mechanism in accordance with claim 1, wherein the drive
mechanism utilizes less than three shape memory actuators.
16. A drive mechanism for a medication delivery device, the drive
mechanism comprising: a guide; a carriage member to move relative
to the guide; and a shape memory actuator formed from a shape
memory material and which is operatively coupled to the carriage
member, and wherein the shape memory actuator is heat activated to
distort the shape memory actuator from a first shape to a second
shape to move the carriage member relative to the guide, and
wherein the shape memory actuator is returned to the first shape
from the second shape after the carriage has moved relative to the
guide.
17. A drive mechanism in accordance with claim 16, wherein the
shape memory actuator is heat activated by applying and removing an
electric current to the shape memory actuator.
18. A drive mechanism in accordance with claim 17, wherein the
drive mechanism further includes a power source coupled to the
shape memory actuator to provide the electric current to the shape
memory actuator.
19. A drive mechanism in accordance with claim 17, wherein the
shape memory actuator is formed from Nitinol material.
20. A drive mechanism in accordance with claim 19, wherein the
Nitinol material is formed as a wire.
21. A drive mechanism for a medication delivery device, the drive
mechanism comprising: a shaft; a carriage coupled to the shaft to
move relative to the shaft, wherein the carriage includes: a first
pawl having a first end and a second end with a first bore defining
an opening between the first and second ends, wherein edges of the
first bore grasp the shaft when the first pawl is tilted; a first
resilient member coupled between the carriage and the first pawl to
bias the first pawl to a first position relative to the shaft; a
second pawl having a first end and a second end with a second bore
defining an opening between the first and second ends, wherein
edges of the second bore grasp the shaft when the second pawl is
tilted; a second resilient member coupled between the carriage and
the second pawl to bias the second pawl to resist relative rearward
movement of the carriage; and a shape memory element to activate
the first pawl to move between the first position and a second
position to move the carriage relatively forward, as the shaft is
grasped by the edges of the first bore, when the first pawl is
moved from the first position to the second position, wherein the
first resilient member moves the first pawl back to the first
position after the carriage has moved relative to the shaft.
22. A drive mechanism in accordance with claim 21, wherein the
shape memory element is activated by applying and removing an
electric current to the shape memory element.
23. A drive mechanism in accordance with claim 22, wherein the
drive mechanism further includes a power source coupled to the
shape memory element to provide the electric current to the shape
memory element.
24. A drive mechanism in accordance with claim 22, wherein the
shape memory element is formed from Nitinol material.
23. A drive mechanism in accordance with claim 22, wherein the
Nitinol material is formed as a wire.
Description
FIELD OF THE INVENTION
[0001] This invention relates to drive mechanisms for medical
devices and, in particular embodiments, to a drive mechanism for a
medication infusion pump that utilizes shape memory alloy wire to
activate the drive motion.
BACKGROUND OF THE INVENTION
[0002] Traditionally, drive mechanisms for medication infusion
pumps have used a motor that rotates a lead screw that is connected
to a carriage, and the carriage is advanced by rotation of the lead
screw. For example, as the motor rotates the threads of the lead
screw, corresponding threads on the carriage that are engaged with
the lead screw threads, advance the carriage forward along the lead
screw. Generally, the carriage is connected to a nut, or other
engagement member, that is connected to a piston in a medication
cartridge, which is advanced with the carriage to dispense
medication through a catheter.
[0003] However, a drawback to lead screw mechanisms is that they
require a complicated motor assembly and drive parts, making them
costly to produce. In addition, the lead screw and drive motor
contribute to a substantial portion of the weight and volume in a
medical infusion pump.
SUMMARY OF THE DISCLOSURE
[0004] It is an object of an embodiment of the present invention to
provide an improved drive mechanism for a medication infusion pump,
which obviates for practical purposes, the above mentioned
limitations.
[0005] According to an embodiment of the invention, a drive
mechanism for a medication delivery device includes a force
receiving member, a force applying member and a shape memory
actuator. The force applying member is operatively coupled to the
force receiving member to cause relative movement to occur between
the force receiving member and the force applying member so that
the force receiving member is in a different position relative to
the force applying member. The shape memory actuator is formed from
a shape memory material and is operatively coupled to the force
applying member. Preferably, the shape memory actuator is heat
activated to distort the shape memory actuator from a first shape
to a second shape to activate the force applying member to act upon
the force receiving member to cause the relative movement between
the force applying member and the force receiving member so that
the force receiving member is in the different position relative to
the force applying member. Also, the shape memory actuator is
returned to the first shape from the second shape after the force
receiving member is in the different position relative to the force
applying member. In particular embodiments, the force applying
member is stationary and the force receiving member is moved by the
force applying member. In other embodiments, the force receiving
member remains stationary and the force applying member is moved
relative to the force receiving member. In preferred embodiments,
the shape memory actuator is activated by applying and removing an
electrical current to the shape memory element. For example, the
drive mechanism may further include a power source coupled to the
shape memory actuator to provide the electrical current to the
shape memory actuator. Preferably, the preferred the shape memory
actuator is formed from Nitinol material, with the preferred
structure being a wire. In some embodiments, the drive mechanism
utilizes less than three shape memory actuators, three force
receiving members and/or three force applying members. In still
other embodiments, the drive mechanism utilizes less than three
shape memory actuators.
[0006] In a first embodiment of the present invention, the force
receiving member is a guide and the force applying member is a
carriage assembly. For instance, the guide is a shaft and the
carriage assembly includes at least one pawl that is actuated to
incrementally move the carriage assembly relative to the shaft. In
further embodiments, the carriage assembly includes at least one
pawl, a lever and a cam surface on one end of the lever, and the
shape memory actuator is coupled to another end of the lever and
actuated to move the cam surface of the lever against the at least
one pawl to incrementally move the carriage assembly relative to
the shaft. In another embodiment, the force receiving member is a
gear, and the different position of the gear relative to the force
applying member is an angular rotation. For example, the force
applying member is a wire pawl that includes the shape memory
actuator to pull upon the gear to cause the angular rotation.
Alternatively, the force applying member is a bar that includes the
shape memory actuator to push upon the gear to cause the angular
rotation.
[0007] In another embodiment, the drive mechanism includes a guide,
a carriage member and a shape memory actuator. The carriage member
moves relative to the guide. The shape memory actuator is formed
from a shape memory material and is operatively coupled to the
carriage member. In addition, the shape memory actuator is
activated to distort the shape memory actuator from a first shape
to a second shape to move the carriage member relative to the
guide. Further, the shape memory actuator is returned to the first
shape from the second shape after the carriage has moved relative
to the guide.
[0008] In further embodiment of the present invention, a drive
mechanism for a medication delivery device includes a shaft, a
carriage and a shape memory element. The carriage is coupled to the
shaft to move relative to the shaft. The carriage includes a first
pawl, a first resilient member, a second pawl and a second
resilient member. The first pawl has a first end and a second end
with a first bore. The first bore defines an opening between the
first and second ends, and the edges of the first bore grasp the
shaft when the first pawl is tilted. The first resilient member is
coupled between the carriage and the first pawl to bias the first
pawl to a first position relative to the shaft. The second pawl has
a first end and a second end with a second bore. The second bore
defines an opening between the first and second ends, and the edges
of the second bore grasp the shaft when the second pawl is tilted.
The second resilient member is coupled between the carriage and the
second pawl to bias the second pawl to resist relative rearward
movement of the carriage. The shape memory element activates the
first pawl to move between the first position and a second position
to move the carriage relatively forward, as the shaft is grasped by
the edges of the first bore, when the first pawl is moved from the
first position to the second position. The first resilient member
is used to move the first pawl back to the first position after the
carriage has moved relative to the shaft.
[0009] 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 the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] 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.
[0011] FIG. 1 is a partial perspective view of a carriage assembly
and stationary shaft for a drive mechanism in accordance with a
first embodiment of the present invention.
[0012] FIG. 2 is an enlarged, partial cross-sectional diagram of
the drive mechanism as shown within the dashed circle 2-2 in FIG.
1.
[0013] FIG. 3 is a cross-sectional diagram of a medical device
using the drive mechanism shown in FIGS. 1 and 2 in accordance with
an embodiment of the present invention.
[0014] FIG. 4 is a cross-sectional diagram of a medical device
using a drive mechanism in accordance with another embodiment of
the present invention.
[0015] FIG. 5 is a cross-sectional diagram of a medical device
using a drive mechanism in accordance with a further embodiment of
the present invention.
[0016] FIG. 6 is a side perspective view of a carriage assembly
using a pulley arrangement to support the shape memory material in
accordance with an embodiment of the present invention.
[0017] FIG. 7 is a top perspective view of a carriage assembly
using a pulley arrangement to support the shape memory material in
accordance with an embodiment of the present invention.
[0018] FIG. 8 is a side perspective view of a carriage assembly
using a lever and cam assembly to support the shape memory material
in accordance with an embodiment of the present invention.
[0019] FIG. 9 is a perspective view of a drive mechanism in
accordance with a second embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] As shown in the drawings for purposes of illustration, the
invention is embodied in a drive mechanism for a medication
infusion pump. In preferred embodiments of the present invention,
shape memory alloy wire, or the like, is used to activate an
incremental motion drive mechanism for pumping liquids, such as
medications, drugs, vitamins, vaccines, peptides or the like.
However, it will be recognized that further embodiments of the
invention may be used in other devices that require compact and
accurate drive mechanisms. In addition, other shape altering
materials, such as piezo-electric materials, or the like, may be
used.
[0021] Preferred embodiments of the present invention utilize the
shape memory material with the principle of an "inching" type
motion, which is similar in some aspects to the friction type
motion used in car jacks and "squeeze grip" types of woodworking
clamps. However, instead of hand action, these embodiments use
shape memory material, such as "Nitinol" shape memory alloy wire,
or the like, and a small low voltage battery to power the device
and activate the inching motion. In alternative embodiments, shape
memory material structures, other than wire, such as sheets, bars,
plates, rods, laminates, or the like, may be used. In addition,
other shape memory alloys, or materials may be used. Relative
simplicity and low cost make these types of drive mechanisms
suitable for very inexpensive or disposable pumps.
[0022] FIGS. 1 and 2 illustrate a drive mechanism 10 in accordance
with a first embodiment of the present invention. The drive
mechanism includes a stationary shaft 12 and a carriage assembly 14
that travels along the stationary shaft 12. In preferred
embodiments, the stationary shaft 12 is a metal rod having a smooth
surface. However, in alternative embodiments, the metal rod may be
formed out of other materials, such as glass, ceramics, plastics or
the like. In addition, the round metal rod may be formed with other
cross-section shapes, such as rectangles, squares, triangles or the
like, and the surface may be roughened or include teeth to
facilitate movement of the carriage assembly 14. In other
alternative embodiments, the rod may be replaced with a track,
guide, recessed groove or the like. In still other alternative
embodiments, the carriage assembly 14 may be fixed (or stationary)
to a housing and the shaft may be moved (rather than being
stationary) by the carriage assembly to depress a plunger (not
shown) or the like.
[0023] In preferred embodiments, the carriage assembly 14 includes
two pawls 16 and 18 that are used to "inch" (or incrementally move)
along the stationary shaft 12. The forward pawl 16 is used to
produce the forward "inching" movement of the carriage assembly 14
along the stationary shaft 12. The backstop (or anti-backtrack)
pawl 18 is used to prevent (or substantially inhibit) backward
movement of the carriage assembly 14 along the stationary shaft 12.
Preferably, movement of the carriage assembly 14 is limited to a
predetermined limit by a limit stop 20 to provide precise control
over the increment of movement. In additional embodiments, the
limit stop 20 may include a set screw, or the like, (not shown) to
facilitate accurate adjustment of the movement of the carriage
assembly 14 to refine the movement increment after assembly. As
shown in FIGS. 1 and 2, preferably, the backstop pawl 18 is held
loosely captive in a corresponding pivot groove 22 in a base plate
19 of the carriage assembly 14. The pivot groove 22 maintains the
captive end of the backstop pawl 18 allowing it to pivot relative
to the base plate 19 of the carriage assembly 14. Also, each of the
pawls 16 and 18 is forwardly biased toward the direction of travel
of the carriage assembly 14 by corresponding bias springs 24 and 26
to place a forward load against the pawls 16 and 18.
[0024] As shown in FIG. 2, a slight rearward canting (or tilting)
of the forward pawl 16 relative to the stationary shaft 12 results
in a binding condition (or contact) at points A and B between the
edges of a bore 28 in the forward pawl 16 and the stationary shaft
12 that inhibits sliding motion from occurring. When the forward
pawl 16 is oriented substantially perpendicular to the stationary
shaft 12, the forward pawl 16 is free to slip along the stationary
shaft 12. However, when the forward pawl 16 is oriented away from
perpendicular, by shrinkage of the shape memory alloy wire 30, such
that contact at points A and B occurs, the forward pawl 16 firmly
grasps the stationary shaft 12 to inhibit relative movement between
the forward pawl 16 and the stationary shaft 12. With the contact
between A and B establishing an anchor point, the shape memory
alloy wire 30 becomes effectively tied (or locked or connected) to
the stationary shaft 12, and any further shrinkage of the shape
memory alloy wire 30 can only result in the advancing (or pulling
or sliding) of the carriage assembly 14 along the stationary shaft
12. The carriage assembly 14 will continue to advance (or pull or
slide) until the limit stop 20 contacts the forward pawl 16.
[0025] The bias spring 26 biases the backstop pawl 18 slightly
forward to prevent rearward movement of the carriage assembly 14.
However, the forward motion of the carriage assembly 14 relative to
the stationary shaft 12 moves the pivot groove 22, allowing the
backstop pawl 18 to overcome the bias force from the bias spring
26. Overcoming the bias tends to tilt the backstop pawl 18
rearward, which allows the stationary shaft 12 to slide rearward
relative to the backstop pawl 18 and the forward moving carriage
assembly 14. Conversely, the backstop pawl 18 does not permit
backward motion of the carriage assembly 14, since the bias spring
26 tilts the backstop pawl 18 slightly forward and any rearward
motion of the carriage assembly 14 would provide additional force
to the backstop pawl 18 (which would tend to tilt the backstop pawl
18 further forward) to increase the grasp of the backstop pawl 18
on the stationary shaft 12. This inhibits rearward movement of the
carriage assembly 14 relative to stationary shaft 12. Using an
alternating binding and sliding position of the forward pawl 16, an
incremental inching motion along the stationary shaft 12 is
accomplished.
[0026] In preferred embodiments, the carriage assembly 14 of the
drive mechanism 10 may be returned to the starting position, by
tilting both pawls 16 and 18 to a generally perpendicular
orientation relative to the stationary shaft 12. In this
orientation, there is sufficient clearance between the pawls 16 and
18 and the stationary shaft 12 to permit the carriage assembly 14
to be slid backwards to the starting point or home position. In
preferred embodiments, when the shape memory alloy material 30 is
in the lengthened condition, the forward pawl 16 is biased in the
perpendicular orientation relative to the stationary shaft 12 by
the bias spring 24 and the front wall 17 of the carriage assembly
14. Thus, the backstop pawl 18 is the only pawl that needs to be
adjusted to permit resetting of the carriage assembly. The backstop
pawl 18 could be adjusted manually, using a lever, or even another
piece of shape memory alloy wire may be used to tilt the backstop
pawl 18 back. It should be noted that it is preferred that the
drive mechanism 10 remain inoperative until the pawls 16 and 18 are
released again.
[0027] Spanning the distance between the forward pawl 16 and a back
wall 29 of the carriage assembly 14 is a shape memory alloy wire 30
composed of a Nickel Titanium alloy known as Nitinol. In
alternative embodiments, other shape memory alloys or materials,
such as piezoelectric materials or the like may be used. Also,
structures, other than wire, such as rods, bars, sheets or the like
may be used. Electrically connected to each end of the shape memory
alloy wire 30 are conductive wires 32 that are connected to a
battery 34 and control electronics 36. Nitinol wire is preferred,
due to its unique properties of temporarily shrinking in length
when heated to about 70.degree. C. above ambient temperature and
then returning to its original length when cooled. Passage of a
small electric current, from the battery 34 via the conductive
wires 32, through the shape memory allow wire 30 is sufficient to
heat the shape memory alloy wire 30. The heating shrinks the length
of the shape memory alloy wire 30. For example, Nitinol wire can
shrink in length by as much as 6%, but this amount of shrinkage
tends to reduce the life of the Nitinol element. However, the use
of different materials, structures, heating energy, or the like may
be used to increase or decrease the amount of shrinkage of the
shape memory alloy wire. A typical conservative shrinkage
percentage is generally 3% or less.
[0028] The shrinking of the shape memory alloy wire 30 is used as a
pulling motion against the forward pawl 16 to tilt it backwards to
grasp the stationary shaft 12 as shown in FIG. 2, and to cause a
minute forward motion of the carriage assembly 14 along the
stationary shaft 12. Pulsing the current to the shape memory alloy
wire 30, to incrementally heat and cool, provides a series of
incremental motions that propel the carriage assembly 14 along the
stationary shaft for cumulative travel that delivers liquid from a
reservoir in a medication infusion pump.
[0029] FIG. 3 shows a medication infusion pump 100 in accordance
with an embodiment of the present invention that utilizes the drive
mechanism 10 shown in FIGS. 1 and 2. The medication infusion pump
100 includes a housing 102 for holding a reservoir 104 that is
operatively coupled to the drive mechanism 10. The stationary shaft
12 is also secured to the housing 102 to provide support for the
carriage assembly 14 of the drive mechanism 10. The reservoir 104
includes a plunger 106 that is coupled to a piston 108 that slides
along a reservoir housing 110. The reservoir housing 110 forms a
liquid chamber 112 for holding medication or the like, and has a
piston receiving end 114 and an outlet end 116. The piston
receiving end 114 is adapted to receive the plunger 106 and piston
108. The outlet end 116 provides an outlet for the liquid in the
liquid chamber and may be configured to attach to catheters,
needles, luers, infusion sets or the like. In preferred
embodiments, the reservoir 104 is a disposable syringe. However, in
alternative embodiments, the reservoir 104 may be a prefilled
cartridge or a reusable reservoir.
[0030] In this embodiment, the carriage assembly 14 includes a
drive tab 40 that is connected to the back wall 29 of the carriage
assembly 14 and extends down to engage and push against an end 118
of the plunger. As the carriage assembly 14 moves along the
stationary shaft 12, as discussed above, it pushes in the plunger
106 by a corresponding amount. Therefore, incremental movement of
the drive mechanism 10 results in incremental advancement of the
plunger 106, which pushes on the piston 108 to expel liquid from
the liquid chamber 112 through the outlet end 116 of the reservoir
104. In preferred embodiments, each incremental movement of the
carriage assembly is a distance that is set at the factory to
provide a set amount of liquid. However, in alternative
embodiments, the carriage assembly may include the capability to be
adjusted to move along with different increments to provide
different amounts of liquid with each movement of the carriage
assembly 14.
[0031] FIG. 4 shows a medication infusion pump 200 in accordance
with another embodiment of the present invention that utilizes the
drive mechanism 10 shown in FIGS. 1 and 2. The medication infusion
pump 200 includes a housing 202 for holding a collapsible reservoir
204 that is operatively coupled to the dive mechanism 10. The
stationary shaft 12 is also secured to the housing 202 to provide
support for the carriage assembly 14 of the drive mechanism 10. The
collapsible reservoir 204 includes flexible walls 206 that are
secured together at a sealed end 208 to form a liquid chamber 210
to hold liquids such as medications or the like. The sealed end 208
is also secured to the housing 202 to prevent it from slipping. The
other end of the flexible walls 206 terminate in an outlet end 212.
The outlet end 212 provides an outlet for the liquid in the liquid
chamber and may be configured to attach to catheters, needles,
luers, infusion sets or the like. In preferred embodiments, the
collapsible reservoir 204 is a disposable sack (or tube). However,
in alternative embodiments, the reservoir 204 may be a prefilled
sack (or tube) or a reusable, refillable reservoir.
[0032] In this embodiment, the carriage assembly 14 includes a
drive hub 44 that is connected to the base plate 19 of the carriage
assembly 14. The drive hub 44 also holds a rotatable wheel (or
roller) 46 that extends down to engage and push against the
flexible walls 206 to collapse the flexible walls 206 together. As
the carriage assembly 14 moves along the stationary shaft 12, as
discussed above, it collapses the flexible walls 206 as it moves
over and above the collapsible reservoir 204 by a corresponding
amount. In preferred embodiments, the rotatable wheel 46 provides
sufficient compression to prevent the liquid in the liquid chamber
210 from passing back into the portion of the liquid chamber 210
that has been previously compressed. In other words, the motion of
the carriage assembly 14 operates to squeeze the tube in a manner
analogous to squeezing toothpaste from a tube. Therefore,
incremental movement of the drive mechanism 10 results in
incremental collapsing of the flexible walls 206, which compressed
the liquid chamber 210 to expel liquid through the outlet end 212
of the collapsible reservoir 204. In preferred embodiments, each
incremental movement of the carriage assembly is a distance that is
set at the factory to provide a set amount of liquid. However, in
alternative embodiments, the carriage assembly may include the
capability to be adjusted to move along with different increments
to provide different amounts of liquid with each movement of the
carriage assembly 14.
[0033] This incremental motion can be used to move along either a
straight or a curved path. For example, FIG. 5 illustrates a
variation of the medical device and drive mechanism embodiment
shown in FIG. 4. The medical device 300 has a housing 302 that is
generally in the shape of a disk. The housing 302 contains a
substantially circular stationary guide 304 and carriage assembly
306 that operate in a manner similar to that described above. The
carriage assembly includes a drive hub 308 for holding a rotatable
wheel 310 that bears against a collapsible fluid reservoir 312
having flexible walls 314. The carriage assembly 306 advances along
the stationary guide 304 and collapses the flexible walls 314 of
the liquid reservoir 312 to expel liquid, such as medication or the
like, though an outlet opening 316.
[0034] FIGS. 6 and 7 illustrate a carriage assembly 400, which is
an alternative embodiment of the carriage assembly 14 shown in
FIGS. 1 and 2. The carriage assembly 400 utilizes a pulley
structure 402, such as a half pulley or the like, rotatably mounted
on a pin 404, or the like, to support a shape memory material
element 406. The use of a pulley structure 402 allows the use of a
longer shape memory material element 406, as compared to the
earlier embodiments, or to use the same length and have a smaller
carriage assembly size. The use of a longer shape memory element
406 allows for larger contractions, which can pull the forward pawl
408 back further, reducing the number of incremental movements.
Alternatively, a longer pull reduces the required shrinkage or
shape change and resulting shrinkage stress on the shape memory
material element 406. In other alternative embodiments, the shape
memory material element 406 may be wrapped around the exterior
surface of the carriage assembly 400, if the contact will not
unduly stress the shape memory material element 406 and will not
produce too much friction that would inhibit contraction of the
shape memory material element 406. In addition, caution must be
exercised that contact between the shape memory material element
406 and the carriage assembly 400 (and/or pulley structure 402)
will not impede heating and/or cooling of the shape memory material
element, since this can effect power requirements and activation
speed (or rate of shape change) for the shape memory material
element 406.
[0035] Also, as shown in FIG. 6, a modified pivot groove 410,
having extended contact members 412 on either side of the pivot
groove 410, is used to control the rotational motion of the second
pawl 414. The extended contact members provide sufficient contact
with the sides of the second pawl 414 to permit easy insertion and
pivoting of the second pawl 414 within the pivot groove 410.
However, use of the extended contact members 412 reduce, or
eliminate, play, twisting, shifting, or the like, when the second
pawl 414 is rotated during movement of the carriage assembly 400
along the shaft 416. The second pawl (or backstop pawl) 414 needs a
precise pivot point to minimize lost motion, which would impede its
ability to prevent backward movement. For instance, if there was a
lot of lost motion, the carriage assembly could move forward one
increment and back some fraction of an increment--resulting in
inefficiencies and inaccuracies. Thus, the use of extended contact
members provide for greater accuracy in delivery of the liquid or
medication from the drive mechanism. Preferably, the extended
contact members are formed as partial arcs. However, in alternative
embodiments, other shapes, such as ramps, points, or the like, may
be used.
[0036] FIG. 8 illustrates a carriage assembly 450, which is another
alternative embodiment of the carriage assembly 14 shown in FIGS. 1
and 2. The carriage assembly 450 utilizes a lever 452 and a cam
surface 454 attached to the lever 452 that rotates on a pivot pin
456, and a return bias spring 458 to transform a large shrinkage
(or distortion) of the shape memory element 460, which would cause
a large incremental movement of the carriage assembly, to a small
high force incremental movement of the carriage assembly 450.
Although possible to adapt the lever 452 and the cam surface 454 to
provide a larger increment than the corresponding shrinkage of the
shape memory element 460; this tends to stress and shorten the life
of the shape memory element 460.
[0037] As illustrated the shape memory element 460 is connected to
one end of the lever 452 (rather than the first pawl 462 as
illustrated in FIGS. 1 and 2), which is moved from a first position
(A) to a second position (B as shown in dotted lines) when the
shape memory element 460 is shrunk (or distorted) by heat
activation. The other end of the lever 452 passes through a lever
bore 464 and is connected to the carriage assembly by the pivot pin
456 to permit rotation of the lever 452 about the pivot pin 456.
The end of the lever 452 with the cam surface 456 contacts and
bears against the first pawl 462 to incline the first pawl 462. As
described above in the earlier embodiments, as the rotation of the
cam surface 454 displaces the first pawl 462 to cause an
incremental movement of the carriage assembly 450. The cam surface
454 is shaped to cause the movement of the first pawl in a way that
provides more control over the setting of the movement increment of
the carriage assembly 450. This allows for accurate dispensing of
the fluid and makes the incremental movement of the drive mechanism
less sensitive to variations in the shrinkage (or distortion) of
the shape memory element 460, either from variations over time or
due to variations in manufacturing. For instance, the cam surface
454 may be shaped to have an increased displacement of the first
pawl 462 only up to a certain point, after which the curvature of
the cam surface 454 is maintained so that further rotations of the
lever 452 and cam surface 454 do not produce any further
inclination (or movement) of the first pawl 462. Thus, if lever is
set to provide a maximum tilt of the first pawl 462 under the
minimum expected shrinkage of the shape memory element 460, any
extra shrinkage due to extra heat, change in properties over time,
differences in manufacturing lots, or the like, will have no effect
on the incremental movement of the carriage assembly 450. Preferred
embodiments also use a limit stop 20, as described above, to more
accurately control the movement increment of the carriage
assembly.
[0038] As illustrated the carriage assembly 450 also includes a
rest stop 466 to prevent the lever 452 from rotating to far
backwards as the shape memory element 460 is restored to its
original shape and the lever 452 is pushed back by the bias spring
458. The use of the rest stop 466 prevents, the first pawl 462 from
also inclining to far back after incremental movement of the
carriage assembly 450. The rest stop 466 may also serve the purpose
of minimizing stress on the shape memory element 460 due to the
lever 452 being under constant tension from the bias spring 458,
which could distort the shape memory element 460. In further
embodiments, the rest stop 466 may include a set screw, or the
like, (not shown) that permits the rest position of the lever 452
to be adjusted, calibrated and/or controlled, which would permit
the incremental motion of the carriage assembly 450 to be further
fine tuned after the assembly of the drive mechanism.
[0039] As discussed above, embodiments of the present invention use
shape memory materials as the actuator for the drive mechanism.
However, the above-described embodiments are not the only way to
use shape memory materials for actuation of a drive mechanism. For
example, FIG. 9 illustrates a drive mechanism 500 in accordance
with second embodiment of the present invention. The drive
mechanism 500 includes a shape memory material pull 502 that is
actuated to contract and pull on teeth 504 of a gear 506, which in
turn rotates and/or ratchets the gear 506 to drive the medication
infusion pump mechanism. After the gear 506 is rotated, the shape
memory material 502 is allowed to expand and slide over the next
tooth 504 on the gear 506. Preferably, the gear 506 is rotatably
mounted to a pin 508 that is secured to a support housing 510. The
shape memory material is activated by a power supply 512 that is
connected to control electronics 514 to adjust the shape of the
shape memory material 502. To keep the gear from rotating
backwards, a backstop pawl 516 engages with the teeth 504 of the
gear 506 in a ratchet manner. In an alternative embodiment, the
shape memory material may be a bar structure, or the like, that
pushes on the teeth 504 of the gear, as opposed to pulling, to
rotate the gear 506 and actuate the drive mechanism 500.
[0040] 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.
[0041] 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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