U.S. patent application number 12/686705 was filed with the patent office on 2010-05-13 for method and apparatus for measuring manual device actuation.
This patent application is currently assigned to Proveris Scientific Corporation. Invention is credited to Dino J. Farina, Donald C. Swavely.
Application Number | 20100116070 12/686705 |
Document ID | / |
Family ID | 33300001 |
Filed Date | 2010-05-13 |
United States Patent
Application |
20100116070 |
Kind Code |
A1 |
Farina; Dino J. ; et
al. |
May 13, 2010 |
Method and Apparatus for Measuring Manual Device Actuation
Abstract
An assembly that provides operational information about
operation of a device, such as a nasal spray pump or metered dose
inhaler. A linkage adapted to extend between a mounting assembly,
connected to a stationary part of the device, and an adapter
assembly, connected to a movable part of the device, is in
operational relationship with a transducer to enable the transducer
to indicate a mechanical relationship between the movable and
stationary parts of the device corresponding to the operation of
the device. A data collection and processing system may be
connected to the transducer for determining information that may be
used to program an automated actuation system.
Inventors: |
Farina; Dino J.; (Holliston,
MA) ; Swavely; Donald C.; (Norton, MA) |
Correspondence
Address: |
HAMILTON, BROOK, SMITH & REYNOLDS, P.C.
530 VIRGINIA ROAD, P.O. BOX 9133
CONCORD
MA
01742-9133
US
|
Assignee: |
Proveris Scientific
Corporation
Marlborough
MA
|
Family ID: |
33300001 |
Appl. No.: |
12/686705 |
Filed: |
January 13, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10825082 |
Apr 14, 2004 |
7658122 |
|
|
12686705 |
|
|
|
|
60462861 |
Apr 14, 2003 |
|
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|
Current U.S.
Class: |
73/865.9 |
Current CPC
Class: |
A61M 15/08 20130101;
A61M 11/02 20130101; B05B 11/3052 20130101; A61M 2209/02 20130101;
A61M 2205/3592 20130101; A61M 2205/3569 20130101; A61M 15/00
20130101; A61M 2205/52 20130101; A61M 15/009 20130101 |
Class at
Publication: |
73/865.9 |
International
Class: |
G01N 19/00 20060101
G01N019/00 |
Claims
1. An apparatus comprising: an adapter assembly configured to be
coupled to a movable part of a device; a mounting assembly
configured to be coupled to a stationary part of the device; one or
more transducers coupled to the mounting assembly or the adapter
assembly and operable to indicate a mechanical relationship between
the movable part and the stationary part of the device
corresponding to operation of the device.
2. The apparatus according to claim 1 wherein at least one
transducer is a position sensor.
3. The apparatus according to claim 2 wherein the position sensor
is a potentiometer.
4. The apparatus according to claim 3 further including a linkage,
adapted to connect the mounting assembly and the adapter assembly,
in operational relationship with the transducer.
5. The apparatus according to claim 4 wherein the linkage is a
spring loaded wire integrally associated with the
potentiometer.
6. The apparatus according to claim 1 wherein at least one
transducer is a force transducer.
7. The apparatus according to claim 1 wherein the transducers
include at least one position sensor and at least one force
transducer.
8. The apparatus according to claim 1 wherein the device is a
spring or other mechanically resistive element.
9. The apparatus according to claim 1 further including a data
processing system coupled to the transducers that captures
indications of the mechanical relationship between the movable part
and the stationary part.
10. The apparatus according to claim 9 wherein the data processing
system includes program instructions that automatically calculate
parameters in position, velocity, force, and/or acceleration
corresponding to operation of the device.
11. The apparatus according to claim 10 wherein the instructions
include a routine that calculates velocity or acceleration data
from position measurements.
12. The apparatus according to claim 10 wherein the parameters
include at least one of the following: maximum position
displacement, hold time, maximum actuation velocity, maximum return
velocity, maximum actuation acceleration, maximum return
acceleration, and maximum force.
13. The apparatus according to claim 9 wherein the data processing
system includes a signal conditioner, data sampler, and amplifier,
wherein the signal conditioner conditions a signal effected by one
or more transducers prior to the data sampler and amplifier
operating on the signal.
14. An apparatus comprising: an adapter assembly configured to be
coupled to a movable part of a spray device; a mounting assembly
configured to be coupled to a stationary part of the device; a
position sensor, a force transducer, or both a position sensor and
force transducer, coupled to the mounting assembly or the adapter
assembly and operable to indicate a mechanical relationship between
the movable part and the stationary part of the device
corresponding to operation of the spray device.
15. The apparatus according to claim 14 wherein the spray device is
any one of a nasal spray bottle; a Metered Dose Inhaler (MDI), a
pharmaceutical spray pump assembly, a glue/caulking gun, a
household spray pump, a pressurized spray can, a pharmaceutical
nasal syringe, an industrial nozzle, and or a cosmetic spray
pump.
16. The apparatus according to claim 14 further including a data
processing system coupled to the transducer that captures
indications of the mechanical relationship between the movable part
and the stationary part.
17. The apparatus according to claim 16 wherein the data processing
system includes program instructions that automatically calculate
parameters in position, velocity, force, and/or acceleration
corresponding to operation of the device.
18. The apparatus according to claim 17 wherein the instructions
include a routine that calculates velocity or acceleration data
from position measurements.
19. The apparatus according to claim 17 wherein the parameters
include at least one of the following: maximum position
displacement, hold time, maximum actuation velocity, maximum return
velocity, maximum actuation acceleration, maximum return
acceleration, and maximum force.
20. The apparatus according to claim 16 wherein the data processing
system includes a signal conditioner, data sampler, and amplifier,
wherein the signal conditioner conditions a signal effected by one
or more transducers prior to the data sampler and amplifier
operating on the signal.
Description
RELATED APPLICATION(S)
[0001] This application is a continuation of U.S. application Ser.
No. 10/825,082, filed Apr. 14, 2004, which claims the benefit of
U.S. Provisional Application No. 60/462,861, filed on Apr. 14,
2003. The entire teachings of the above applications are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] A spray pump's performance is characterized in terms of its
emitted spray pattern, plume geometry, and/or droplet size
distribution. These parameters are known to be affected by the
means in which the spray pump is actuated. For example, slow
actuation will likely cause poor atomization, producing a
stream-like flow. Fast actuation will likely produce too fine a
spray, leading to poor absorption in the nasal mucosa and unwanted
inhalation and deposition of the droplets in the throat and lungs.
These factors and others, such as drug compatibility with the spray
device, may result in the drug delivery falling outside the
criteria associated with an original clinical trial approval.
Testing the delivery or spray devices may be done to verify the
spray device actuates the drug within the criteria of the original
clinical trial approval, but operator actuation variability may
adversely affect test results.
SUMMARY OF THE INVENTION
[0003] Automated actuation of nasal spray devices subject to in
vitro bioequivalence testing may be employed to decrease
variability in drug delivery due to operator factors (including
removal of potential analyst bias in actuation) and increase the
sensitivity for detecting potential differences among drug
products. An automated actuation system may include settings for
force, velocity, acceleration, length of stroke, and other relevant
parameters. Selection of appropriate settings is relevant to proper
usage of the product by a trained patient, and, for nasal sprays,
may be available from pump suppliers for tests such as droplet size
distribution by laser diffraction or spray pattern photographic
techniques. In the absence of recommendations from the pump
supplier, settings may be documented based on exploratory studies
in which the relevant parameters are varied to simulate in vitro
performance upon hand actuation. Exploratory studies of hand
actuation of the spray pump device are useful to determine
appropriate settings for automated actuation.
[0004] Accordingly, one embodiment of the principles of the present
invention includes an assembly that provides information about
operation of a spray device. The assembly includes an adapter
assembly configured to be coupled to a movable part of the spray
device. In the ease of a nasal spray, the movable part is the nasal
tip and, in the case of a Metered Dose Inhaler (MDI), the movable
part is the canister containing the drug. The assembly also
includes a mounting assembly configured to be coupled to a
stationary part of the spray device. In the case of the nasal spray
device, the stationary part is the bottle containing the drug and,
in the ease of the MDI, the stationary part is the mouthpiece. The
assembly also includes a transducer, coupled to the mounting
assembly or the adapter assembly. The assembly also includes a
linkage that is adapted to extend between the mounting assembly and
the adapter assembly. The linkage is in operational relationship
with the transducer to enable the transducer to indicate a
mechanical relationship between the movable and stationary parts of
the spray device corresponding to the operation of the spray
device.
[0005] The mounting assembly may include a bearing and shaft
assembly coupling the adapter assembly to the mounting assembly.
The bearing and shaft assembly may substantially maintain alignment
between the adapter assembly and the mounting assembly in
non-actuation axes.
[0006] The assembly may also include a base assembly adapted to be
coupled to the mounting assembly. The base assembly may include a
foot assembly with a footprint that supports the spray device in a
vertical relationship with the foot assembly. The assembly and
spray device may have a predetermined weight for use on a weight
measuring scale sensitive enough to measure a change in fluid
ejected by the spray device in a single discharge. In one
embodiment, the total weight of the assembly and spray device is
less than or equal to 200 grams.
[0007] The transducer may be a position sensor. An example of one
such position sensor is a potentiometer. In the case of the
potentiometer, the linkage is a spring loaded wire integrally
associated with the potentiometer.
[0008] The adapter assembly may be configured to interface with an
automated actuation system that operates the spray device in an
automated manner. The transducer may indicate the mechanical
relationship in a format usable by the automated actuation
system.
[0009] The assembly may also include a data processing system
coupled to the transducer that captures indications of the
mechanical relationship between the movable part and the stationary
part of the spray device. The data processing system may include
program instructions that automatically calculate parameters in
position, velocity, or acceleration corresponding to operation of
the spray device. The instructions may include a routine that
calculates velocity or acceleration data from position measurements
using a least squares technique. The parameters may include at
least one of the following: maximum position displacement, hold
time, maximum actuation velocity, maximum return velocity, maximum
actuation acceleration, and maximum return acceleration. The
actuation direction is defined herein as the direction in which the
movable part causes atomization of the liquid drug contained in the
spray device, and the return direction is defined herein as the
direction in which the movable part returns to its state of rest.
The data processing system may also include a signal conditioner,
data sampler, and amplifier, wherein the signal conditioner
conditions a signal effected by the transducer prior to the data
sampler and amplifier operating on the signal.
[0010] The principles of the present invention include
corresponding methods related to the above-described apparatus and
alternative embodiments thereof described below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The foregoing and other objects, features and advantages of
the invention will be apparent from the following more particular
description of preferred embodiments of the invention, as
illustrated in the accompanying drawings in which like reference
characters refer to the same parts throughout the different views.
The drawings are not necessarily to scale, emphasis instead being
placed upon illustrating the principles of the invention.
[0012] FIG. 1 is an illustration of an example application in which
the principles of the present invention may be employed;
[0013] FIGS. 2A-2B are diagrams of spray devices ejecting an
atomized drug produced by actuation of the spray device containing
the drug used in the application of FIG. 1;
[0014] FIG. 3 is a diagram of an assembly connected to the spray
device of FIG. 1;
[0015] FIG. 4 is an alternative embodiment of the assembly of FIG.
3;
[0016] FIGS. 5A-5B are side views of the assembly embodiments of
FIGS. 3 and 4, respectively;
[0017] FIG. 6 is an embodiment of the assembly of FIG. 3 in which a
shaft and bearing assembly is employed;
[0018] FIG. 7 is a side view of the assembly of FIG. 6;
[0019] FIG. 8 is a diagram of an automated actuation system used in
the application of FIG. 1;
[0020] FIG. 9 is a block diagram of a data capture and processing
system adapted to be used with the assembly of FIGS. 3 and 4;
[0021] FIG. 10 is an alternative embodiment of the data capture and
processing system of FIG. 9;
[0022] FIG. 11 is a process optionally used with the data capture
and processing systems of FIGS. 9 and 10;
[0023] FIG. 12 is a user interface optionally used with the data
capture and processing systems of FIGS. 9 and 10;
[0024] FIG. 13 is a set of waveform diagrams illustrating captured
data associated with the spray devices of FIGS. 2A-2B; and
[0025] FIGS. 14-17 are actual test data associated with in vitro
testing and automated testing of the spray device of FIG. 2A.
DETAILED DESCRIPTION OF THE INVENTION
[0026] A description of preferred embodiments of the invention
follows.
[0027] FIG. 1 illustrates a spray device application in which the
principles of the present invention may be employed. A person 105
uses a spray device 100, such as a nasal spray pump or Metered-Dose
Inhaler (MDI), to receive a drug supplied in a liquid form. In the
case of a nasal spray pump, the person 105 uses his hand 115 to
actuate the spray device 100 to cause the liquid drug to be
atomized and projected into a nostril 110. In the case of an MDI,
the person 105 uses hand actuation to project an atomized drug into
his mouth 120.
[0028] It has been observed that different age groups apply
different forces to the spray devices 100. Therefore, a drug
development company and/or spray device manufacturer cannot always
predict the amount of drug that will reach the intended nasal
rnucosa. A regulatory body, such as the Food and Drug
Administration (FDA), may approve a given drug for a predetermined
dose. However, spray device manufacturers rarely, if ever, know
what the appropriate settings should be for automated actuation
testing. This is primarily due to the fact that the device
manufacturers rarely have the requisite knowledge of the physical
properties of the drug formulation (e.g., viscosity and surface
tension) because the formulations are proprietary to the drug
company. Thus, the spray device manufacturers generally do not know
how these properties will affect the characteristics of the spray
the spray device produces when actuated by hand or by an automated
actuation system. Additionally, the spray device manufacturer may
not have the same automated actuation system as the drug company,
thereby further reducing their ability to supply the appropriate
actuation settings to the automated actuation system. Moreover, in
practice, based on a person's age group, the amount of drug ejected
(i.e., dosage) from the spray device 100 may be different from
expected. Therefore, the amount absorbed by the person 105 may be
different from what the regulatory body approved in clinical
trials, thereby causing concern that a person's response to the
drug may be different from the criteria determined to be safe and
effective in the clinical trials. Some other factors that affect
the amount of drug discharged by the spray device 100 are
atomization rate of the drug, droplet size, spray pattern, plume
geometry, priming and re-priming rates, and environmental
conditions.
[0029] FIGS. 2A and 2B illustrate spray patterns 200a and 200b,
respectively, produced by the same or different spray devices 100.
In FIG. 2A, the spray pattern 200a is projected in a relatively
conical pattern. In FIG. 2B, the drug is more atomized than in FIG.
2A as evidenced by a broader spray pattern 200b.
[0030] Spray pattern studies characterize a spray either during the
spray prior to impaction or following impaction on an appropriate
target, such as a thin-layer chromatography (TLC) plate. Spray
patterns for certain nasal spray products may be spoked or
otherwise irregular in shape.
[0031] Spray patterns can be characterized and quantified by either
manual or automated image analysis. Both analyses allow shape and
size to be determined. Automated analysis systems may also allow
determination of Center of Mass (COM) and/or Center of Gravity
(COG) within the pattern to be determined.
[0032] Plume geometry describes a side view of the aerosol cloud
parallel to the axis of the plume. High-speed photography, laser
light sheet, and high speed digital camera or other suitable
methods are generally used to determine plume geometry.
[0033] Priming and re-priming data also ensure delivery of a dosage
of drug and are taken into account when measuring spray patterns
200a and 200b to accurately model in vitro operation.
[0034] FIG. 3 is an illustration of an example assembly that may be
adapted to interface with the spray device 100. In accordance with
the principles of the present invention, the assembly is adapted to
indicate a mechanical relationship between a movable part 305 and a
stationary part of the spray device 100 corresponding to operation
of the spray device 100. In a nasal spray pump application, the
movable part 305 may be referred to as a nasal tip since it is
inserted into the nostril 110. The stationary part 310 may be
referred to as a nasal spray pump bottle in this application.
[0035] Components that are connected to the spray device 100
include (a) an adapter assembly 315a, which connects to the movable
part 305, (b) a mounting assembly 320a, which connects to the spray
device 100, (c) a transducer 335, which is connected to the
mounting assembly 320a in this embodiment but may be connected to
the adapter assembly 315a in other embodiments, and (d) a linkage
330, which may be a spring loaded draw wire that is adapted to
extend between the mounting assembly 320a and adapter assembly
315a. The linkage 330 is in operational relationship with the
transducer 335 to enable the transducer 335 to indicate the
mechanical relationship between the movable part 305 and the
stationary part 310 of the spray device 100 corresponding to
operation of the spray device 100.
[0036] The transducer 335 may be a position sensor, such as a
potentiometer. Extending from the potentiometer is a transducer
cable 340 providing a transducer output. The transducer cable 340
connects at the other end (not shown) to a data acquisition (DAQ)
circuit board (not shown) or other electronics to capture and/or
process the transducer output.
[0037] The mounting assembly 320a may be connected to the
stationary part 310 through use of flexible tie straps 325. Other
connection means may also be used, such as Velcro.RTM. straps,
adhesive, or other suitable attachment means. A rubber or other
suitable material may be used to form a solid connection between
the adapter assembly 315a and the movable part 305. Securing of the
adapter assembly 315a or the mounting assembly 320a to the
respective parts 305, 310 of the spray device 100 may be completed
through screw means, latching mechanism, or other suitable
mechanism.
[0038] In this particular embodiment, the draw wire 330 is kept
taut enough by the spring in the transducer 335 to prevent
sluggishness without deflecting the movable part 305 of the spray
device 100 or the adapter assembly 315a. The lateral location of
the transducer 335 relative to the mounting assembly 320a is then
adjusted and tightened against the mounting assembly 320a so that
the draw wire 330 is parallel to the actuation axis of the spray
device 100.
[0039] In operation, a person 105 operates the spray device 100 in
a typical manner by placing his fingers on the adapter assembly
315a and drawing it toward the mounting assembly 320a to cause the
movable part 305 to move. The motion produces a "shot" or dosage to
the expelled from the spray device 100. When the spray device 100
is actuated, the linkage 330 causes the transducer 335 to change
its state. A change in state of the transducer 335 causes the
transducer output to change state in a proportional manner. The
data acquisition circuit board (not shown) captures the change in
state of the transducer 335 and provides the captured data to a
processor for further processing. Prior to testing, the transducer
335 may be calibrated and used during the processing.
[0040] FIG. 4 is an illustration of the components applied to a
metered-dose inhaler (MDT) 400. The spray bottle 100 and MDI 400
are interchangeably referred to herein as "spray devices". In the
case of the MDI 400, a pressurized canister 405 is the movable
part, and a mouthpiece 410 is the stationary part. A person's hand
115 squeezes the pressurized canister 405 toward the mouthpiece 410
to actuate the MDI 400 and cause a "shot" to be expelled from the
MDI 400.
[0041] Similar to its usage with the spray bottle 100, the linkage
330 extends between the adapter assembly 315b and mounting assembly
320b. The linkage 330 causes the transducer 335 to change states,
which is transmitted by way of the transducer cable 340 to a data
acquisition system or other processor (not shown).
[0042] FIGS. 5A and 5B include indications of axes associated with
the spray devices 100 and 400. Referring to FIG. 5A, an actuation
axis 505a extends from the movable part 305, and a draw wire axis
510a extends along the linkage 330. Also indicated in FIG. 5A is a
pair of adjustment slots 520 and corresponding adjustment screws
515 that hold the transducer 335 (hidden by the mounting assembly
320a).
[0043] In FIG. 5B, the actuation axis 505b extends vertically from
the pressurized canister 405, and the draw wire axis 510b extends
along the linkage 330.
[0044] In both cases of spray devices 100, 400, rotation of the
linkage 330 about the actuation axis 505a, 505b causes the
transducer 335 to change state much faster than normal operation of
the spray device 100 (i.e., actuation along the actuation axis
505a, 505b). Such a rotation of the linkage 330 is possible if the
adapter assembly 315a, 315b slips (i.e., spins about the actuation
axis). Similarly, pivoting of the adapter assemblies 315a and 315b
causes the linkage 330 to rapidly affect the state of the
transducer 335. Rapid changes in the output of the transducer 335
affects in vitro measurements. Therefore, the assembly described
may be improved by having a more rigid connection between the
mounting assembly 320a and the adapter assembly 315a. An assembly
providing a more rigid connection and, therefore, less measurement
error, is illustrated in FIG. 6.
[0045] FIG. 6 illustrates an embodiment of an assembly 600 that
employs a bearing 610 and shaft 605 assembly that substantially
maintains alignment between the adapter assembly 315c and the
mounting assembly 320c. The linkage 330 is extended through the
shaft 605 and connects to a shaft head 615 by extending through a
center hole in the shaft head 615. The linkage 330 may be held in
place through use of a slot 630 designed for this purpose.
[0046] By using the bearing 610 and shaft 605 assembly, the
pivoting of the movable part 305 of the spray device 100 is
dramatically reduced over the embodiment of FIG. 3. Further, the
assembly 600 may be constructed of lightweight materials, such as
aluminum, to allow a person 105 to operate the spray device 100 in
an unimpeded manner to simulate typical use of the spray bottle
100. The shaft 605 may be a hardened precision shaft constructed of
1/4'' O.D. stainless steel. The bearing 610 may be lined with
various materials to allow the shaft 605 to travel smoothly and
freely, thereby facilitating unimpeded in vitro motion.
[0047] In this embodiment, the mounting assembly 320c is connected
to a foot assembly 620 via a bracket assembly 625. Screws or other
connection means are used to connect the bracket assembly 625 to
the mounting assembly 320c and the foot assembly 620. The foot
assembly 620 is adapted to allow the entire assembly 600 to stand
in a vertical arrangement such that the spray device 100 is held in
a vertical relationship with the foot assembly 620 and suspended
above a surface (e.g., weight measuring scale platform or table
top) on which the foot assembly 620 rests.
[0048] The assembly 600 and spray device 100 may have a
predetermined weight for use on a weight measuring scale that is
sensitive enough to measure a change in fluid ejected by the spray
device in a single discharge. Accordingly, if the foot assembly 620
is frame-like, weight can be minimized to meet a lightweight
criterion. For example, the total weight of the assembly 600 and
spray device 100 may be required to be less than 200 grams. If even
more weight need be removed from the assembly 600, the bracket
assembly 625 can also be formed in a frame-like manner, as
shown.
[0049] FIG. 7 is a side view of the assembly 600 with the spray
device 100. The mounting assembly 320e includes adjustment screws
515 and slots 520 to accommodate spray devices 100 having different
diameters. Similar adjustment means may be provided on the adapter
assembly 315c. Various types of alignment means may be provided to
remove motion in a cross-axis to the actuation axis 505a (FIG.
5A).
[0050] The MDI 400 generally maintains alignment in the actuation
axis 505b. Therefore, the shaft 605 and bearing 610 design is
generally unnecessary for allowing the transducer 335 to indicate
the mechanical relationship between the movable part 405 and the
stationary part 410 of the MDI 400 without having errors caused by
rapid changes in length of the linkage 330.
[0051] FIG. 8 is an illustration of an automated actuation system
800 that operates the spray device 100 in an automated manner. The
automated actuation system 800 includes a compression plate
assembly 805 that travels vertically along a pair of passive,
parallel, guide bars 810. In one embodiment, a drive motor assembly
(not shown) drives a belt and pulley assembly (not shown) that
drives a drive plate assembly 835 along a drive rod 830. The drive
plate assembly 835 is connected to the compression plate assembly
805 in this embodiment. In response to upward force by the drive
plate assembly 835, the compression plate assembly 805 presses
upward on the stationary part 310 of the spray device 100 to
actuate the spray device 100. Alternatively, a clamp (not shown) or
other attachment means may be used to attach the stationary part
310 of the spray device 100 to the compression plate assembly 805.
Embodiments of automated actuation systems 800 are further
described in co-pending U.S. patent application Ser. No. 10/176,930
(Attorney Docket No. 3558.1005-001) entitled, "Precise Position
Controlled Actuating Method and System", filed on Jun. 21, 2002;
the entire teachings of which are incorporated herein by reference
in their entirety.
[0052] To facilitate engagement of the assembly 600 with the
automated actuation system 800, the adapter assembly 315c may be
configured to fit into a predefined cut-out 823 in the top 825 of
the automated actuation system 800. Also, in this embodiment, the
bracket assembly 625 is disconnected from the foot assembly 620 to
allow for the proper interfacing of the assembly 600 with the
automated actuation system 800.
[0053] The motor assembly and a portion of the belt and pulley
assembly may be deployed in a housing 820 of the automated
actuation system 800. At least one processor (not shown) and
voltage or current drive amplifier(s) (not shown) may also be
deployed in the housing 820. The drive amplifier(s) may be used to
control drive motor(s) in the drive motor assembly.
[0054] In one embodiment of the automated actuation system 800, the
compression plate assembly 805 includes a force transducer (not
shown), such as a piezoelectric transducer, that is positioned to
sense actuation force of the spray device 100 caused by upward
force applied by the compression plate assembly 805. The force
transducer may convert force to an output signal (e.g., voltage,
current, or charge) in a proportional manner and transmit the
output signal on a cable 815 to a sense amplifier (not shown). The
sense amplifier is adapted to receive the output signal and convert
it to a signal, with minimal additional noise, that can be sampled
and processed by the processor.
[0055] Alternative embodiments of the automated actuation system
800 may also be employed. For example, the compression plate
assembly 805 may include the drive motor assembly, which may employ
linear voice coil motor(s), and the drive amplifier(s) may be in
the housing 820. In such an embodiment, the cable 815 carries
electrical power signals between the drive amplifier(s) and
motor(s) (not shown) in the compression plate assembly 805. The
cable 815 may also include feedback wires to allow for closed-loop
control. Alternatively, the compression plate assembly 805 may
include all the processing and drive amplifiers necessary for
driving the spray device 100, in which case, the cable 815 carries
power and trajectory signals to the motor(s) and processor(s).
Other combinations of electronics locations and wiring are also
possible.
[0056] Forms of control that the automated actuation system 800 may
use to operate the spray device 100 are open-loop control,
closed-loop control, or combination thereof. A Proportional,
Integration and Differentiation (PID) controller (not shown) may be
employed to provide smooth operation of the compression plate
assembly 805. Alternatively, a digital controller may be employed.
The output from the transducer 335 may be used for closed-loop
control of the spray device 100 since the transducer 335 directly
measures the effect of the compression plate assembly 805 actuating
the spray device 100. Use of open- or closed-loop control may be
based on at least one parameter, such as an error budget associated
with force, acceleration, velocity, position, length of stroke, or
other relevant parameters.
[0057] A trajectory input (i.e., an actuation profile) to the
compression plate assembly 805 is preferably as close to in vitro
actuation of the spray device 100 as possible to test the
performance of the spray device 100. In this way, the automated
actuation system 800 can actuate the spray device 100 in a manner
that allows for near in vitro test conditions. Such testing allows
a drug development company or spray device manufacturer to test the
performance of the spray device 100. The automated actuation system
800 may be used in conjunction with an automated spray
characterization (i.e., spray pattern measurement) system that
measures spray pattern, plume geometry, priming and repriming
metrics, and/or other metrics associated with actuation of the
spray device 100.
[0058] FIGS. 9-17 illustrate a processing system and signals
captured or generated thereby. The data processing system 900
captures data produced by the transducer 335. The data processing
system 900 is typically distinct from control electronics
associated with the automated actuation system 800, but data
captured, processed, and/or produced by the data processing system
900 may be transferred to the automated actuation system 800 for
use in automated actuation of the spray device 100. Data may be
transferred between the data processing system 900 and the
automated actuation system 800 via a local area network (LAN),
magnetic disk, optical disk, infrared signals, a Wide Area Network
(WAN) such as the Internet, or other signal or data transfer
means.
[0059] Referring first to FIG. 9, the data processing system 900
includes the transducer 335, which receives stimuli via the linkage
330 as a function of the mechanical relationship between the
movable part 305 and the stationary part 310. In turn, the
transducer 335 indicates the mechanical relationship.
[0060] A signal conditioner 905 is connected to the transducer 335
and provides an output signal to an amplifier 910. The amplifier is
connected to and provides an output to a data sampler 915. The data
sampler 915 is connected to a processor 920. The processor 920 may
output information related to the indication of the mechanical
relationship between the movable and stationary parts of the spray
device 100 on a display 925 and/or transfer data or parameters
associated with the data to the automated actuation system 800.
[0061] In operation, the signal conditioner 905 provides low-level
signal conditioning of signals affected by a change of state of the
transducer 335. The signal conditioner 905 may have predetermined
knowledge of the type of transducer 335 with which it is in
communication. For example, the signal conditioner 905 may provide
a consistent current to the transducer 335 if the transducer 335 is
a potentiometer. In this example, the signal conditioner 905 may
have internal circuitry (not shown) that measures voltage across
the potentiometer to provide a measurement as a function of a
change of state of the potentiometer caused by a change in length
of the linkage 330 resulting from motion of the movable part 305
with respect to the stationary part 310.
[0062] The signal conditioner 905 outputs a smooth representation
of the voltage to the amplifier 910 corresponding to the indication
of the mechanical relationship between the movable and stationary
parts of the spray device 100. A waveform 902 represents an example
signal indicating motion of the movable part as indicated by the
transducer 335. An output from the signal conditioner 905 is shown
as a signal 907 that the amplifier 910 amplifies for capture by a
data sampler 915. The data sampler, in turn, produces a digitized
waveform 917, which is received by the processor 920. The processor
920 may process the digitized signal 917 for determining, for
example, parameters associated with in vitro operation of the spray
device 100.
[0063] FIG. 10 is an alternative embodiment of the data processing
system 9005. The transducer 335 receives an input of +5VDC 1005 and
an output of 0-5VDC 1010. A data acquisition (DAQ) circuit board
1015 captures the output generated by the transducer 335, which in
this case is a position transducer. Therefore, the output from the
transducer 335 directly relates to the position of the movable part
305 with respect to the stationary part 310. The DAQ board 1015 may
be in communication with a general purpose computer in a
daughterboard arrangement. The information captured by the DAQ
board 1015 may be displayed on a monitor 1020 and controlled via a
Graphical User Interface (GUI) by either a keyboard 1025 or mouse
1030. In this way, a user may provide various parameters and other
forms of control to cause the DAQ board 1015 to collect the output
1010 from the transducer 335 in a customized manner.
[0064] FIG. 11 is a flow diagram of a process that may be employed
by the data processing systems 900a, 900b. The process 1100 may
start by initializing the software variables in the DAQ board 1015
(step 1105). The process 1100 continues and checks for a status
change in user input parameters (step 1110). Examples of user input
parameters are sampling frequency, scale factors, and voltage
output levels from the DAQ board 1015 to the transducer 335 (i.e.,
the input 1005 to the transducer 335). If the input value has not
changed (step 1115), the process 1100 checks again for a status
change in user input parameters (step 1110). If the input value has
changed (step 1115), the process 1100 continues to operate as
specified by the user.
[0065] The process 1100 may acquire sensor response data and
compute actuation parameters (step 1120). The process 1100 may also
save a report of response histories, acquisition parameters, and
sensor information (step 1125). Saving the information may include
saving information to a server, local memory, or portable computer
readable medium. The process 1100 may also reset all parameters to
initial conditions (step 1130). The process 1100 may also quit the
program (step 1135) in response to user input. Other processes may
also be executed by the process 1100 that are different from the
examples listed.
[0066] FIG. 12 is an example Graphical User Interface (GUI) 1200 in
which a user may program input conditions, acquisition parameters,
and view captured waveforms and associated parameters. A set of
input fields 1205 includes information related to materials being
tested, and personnel involved in the testing, such as
manufacturer, drug name, lot/device ID, experiment type (e.g., hand
or automated actuation), starting dose number, operator, and report
path to which the captured data is stored. A second set of inputs
1210 relates to the transducer 335, including serial number and a
calibration table, where the calibration table allows for input
such as gain, de offset, scale factor, or other parameters related
to the calibration of the transducer 335. Another set of parameters
input by the use of the GUI 1200 is a set of acquisition
parameters, such as data acquisition collection time span (e.g.,
one second) and sampling frequency (e.g., 1 kHz).
[0067] The GUI 1200 also include a graphics area displays a
position plot 1220 of the position versus time of the movable part
305 with respect to the stationary part 310. The GUI 1200 displays
multiple parameters 1225 associated with the position plot 1220.
The parameters 1225 in this embodiment include a hold time of 98
msec, stroke length of 0.50 mm, actuation stroke velocity of 38.49
mm/s, acceleration of 2961.13 mm/s.sup.2, return stroke velocity of
-35.45 mm/s, and return stroke acceleration of -1772.30 mm/s.sup.2.
In one embodiment, the measured parameters 1225 are automatically
calculated based on the data captured and displayed in the position
plot 1220.
[0068] FIG. 13 provides graphical representations of position,
velocity, and acceleration. The representations are representative
of motion of the movable part 305 with respect to the stationary
part 310 in a typical spray device 100, 400 by in vitro actuation
or automated actuation. A position curve 1305 is similar to the
position curve in the position plot 1220 of FIG. 12. The position
curve 1305 rises during an actuation time, remains at a position
(P.sub.ACT) during a hold time 1325, and decreases from P.sub.ACT
during a return time 1330. A corresponding velocity curve 1310
rises to a maximum velocity V.sub.ACT halfway during the actuation
time and decreases back to a zero velocity during the hold time
1325. The velocity decreases to a maximum negative velocity
(V.sub.RTN) and returns to zero during the return time 1330.
[0069] An acceleration curve 1315 illustrates the corresponding
acceleration curve 1315 to the position curve 1305 and velocity
curve 1310. During the actuation time 1320, the acceleration
increases and decreases to maximum accelerations (A.sub.ACT).
Similarly, during the (+/-A.sub.ACT) return time 1330, the
acceleration decreases and increases to maximum accelerations
(+/-A.sub.RTN). The maximum accelerations may be calculated as an
average of the magnitude of +/-A.sub.ACT levels, and the maximum
return accelerations may be calculated as an average of the
magnitude of +/-A.sub.RTN levels.
[0070] Processing to calculate the velocity and acceleration curves
from captured position data may be performed in an automated
manner. For example, a software routine that calculates velocity or
acceleration data from position measurements may use a least
squares technique. An example of such a routine may use a
Savitzky-Golay smoothing and differentiation filter that optimally
fits a set of data points to polynomials of different degrees. This
type of filter is useful for substantially reducing noise in a
manner better than a point-to-point differentiation technique does.
Other smoothing filters and processes may also or alternatively be
employed.
[0071] It should be understood that if the transducer 335 is an
acceleration or velocity transducer, integration and/or
differentiation techniques may be used to provide the other motion
data, plots, and parameters.
[0072] FIGS. 14-17 are plots that were produced by a method to
measure hand actuation parameters for nasal spray pumps that can be
used for automated actuation. Actuation parameters were measured
for representative commercially available spray pumps filled with
water. The average actuation parameters were then checked to
confirm that the automation actuation system 800 accurately
duplicated the ergonomics of hand actuation. The actuation
parameters were optimized within a working range of the hand
actuation parameters to obtain shot weight delivery closest to the
delivery target (e.g., label claim by the pump manufacturer).
[0073] Methods for producing the plots of FIGS. 14-17 include a
hand actuation portion, a congruency test portion, and an optimized
automated actuation portion.
[0074] Referring first to the hand actuation test portion of the
method, three patients were trained on the method for hand
actuation. Three primed nasal spray pumps were actuated by hand ten
times each by the three patients. The actuation parameters were
measured using a data processing system, such as the systems 900a
and 900b of FIGS. 9 and 10, respectively, and the assembly 600 of
FIG. 6. After each actuation, expelled shot weight (i.e., liquid
expelled during actuation) was measured and is shown in FIG. 14. A
curve for each of the three bottles was recorded and displayed in
the plot 1400 in FIG. 14.
[0075] The shot weight performance by hand actuation of the three
nasal spray pumps is shown. The shot weight average was 92.6 mg
compared to a design delivery target of 100.2 mg. The standard
deviation associated with shot weight was 9.2 mg across all
actuations. Bottle 1 (curve 1405) had the highest standard
deviation of 10.6 mg across all actuations.
[0076] In the congruency test portion of the method, the average
actuation parameters from hand actuation were programmed into the
automated actuation system 800 of FIG. 8. Three primed spray
devices 100 were actuated ten times. A quantitative comparison of
the position versus time curves measured by each method is shown in
FIG. 15, where the hand measurements are shown in the heavy-lined
curve 1505 and the automated measurements are shown in the
light-lined curve 1510 in the plot 1500. Shot weight delivery
performance for the three units obtained by automated actuation is
shown in FIG. 16, with each of the curves 1605, 1610, and 1615
corresponding to spray bottles 1, 2, and 3, respectively, in the
plot 1600.
[0077] The shot weight performance by automated actuation of three
bottles using average actuation parameters (not optimized) is
shown. The shot weight average was 76.0 mg. The standard deviation
associated with shot weight decreased from 9.2 mg with hand
actuation to 5.9 mg across all actuations, using automated
actuation, a 35.9% reduction. Bottle 1 (represented by curve 1605)
had the highest standard deviation of 4.12 mg across all
actuations.
[0078] In the optimized automated actuation portion of the method,
three primed units were each actuated ten times in a series of
tests that independently varied stroke length, hold time, and Intra
Actuation Delay (IAD) within the working ranges previously measured
during the hand actuation portion of the method. The stroke length
was varied from the average value minus one standard deviation
("-1.sigma.") to the maximum stroke length that did not damage the
bottle. The hold time was varied from the average value -1.sigma.
to the point where the shot weight did not increase more than 10%
from previous actuations. The IAD was varied from 30, 15, 5, to 1
second(s). The data were analyzed to find the optimum levels for
stroke length, hold time, and IAD, where the optimum was defined as
the level which obtained shot weight closest to the nominal
specified value (i.e., label claim of the manufacturer). Using the
optimum values, three primed units were actuated ten times each to
confirm shot weight delivery. A stroke length of 5.11 mm, hold time
of 45.55 ms, and IAD of 30 sec provided shot weight delivery
performance closest to the nominal specified value (i.e., label
claim of the manufacturer) as shown in FIG. 17. Three curves 1705,
1710, and 1715 represent shot weights from bottles 1, 2, and 3,
respectively, in the plot 1700.
[0079] Shot weight performance using optimized, automated actuation
settings was measured. The shot weight average was 101.9 mg
compared to a design delivery target of 100.2 mg. The standard
deviation associated with shot weight decreased from 9.2 mg with
hand actuation to 4.5 mg across all actuations using automated
actuations, a 51.5% reduction. Bottle 3 (represented by curve 1715)
has the highest standard deviation of 6.19 mg across all
actuations.
[0080] The results of this process indicates that the automated
actuation system 800 (FIG. 8) can be used to accurately measure
actuation parameters during hand actuation of three nasal spray
pumps. Average hand actuation parameters were programmed into the
automated actuation system 800, and the position versus time curves
show that the actuator accurately reproduced the ergonomics of hand
actuation. Using the automated actuation system 800 reduced the
standard deviation associated with shot weight performance from 9.2
mg to 5.9 mg, a 35.9% reduction compared to hand actuation. Within
the range of hand actuation parameters, the parameters were varied
to optimize the shot weight delivery. The standard deviation
associated with shot weight performance was further reduced from
9.2 mg to 4.5 mg, a 51.1% reduction compared to hand actuation. The
average shot weight delivery was within 1.7 mg of the target
designed delivery value. Determining the actuation parameters may
be done prior to conducting any other in vitro measurements, such
as spray pattern, plume geometry, or droplet size distribution, to
ensure that the automated actuation system 800 consistently
simulates hand actuation during these tests.
[0081] Below are Steps 1, 2, 3, and 4 and subparts thereof that may
be used to determine congruency between hand and automated
actuation of a spray device 100, 400.
[0082] Step 1. Determine the minimum number of priming strokes by
hand actuation.
[0083] 1.1. Procure the required number of spray pump units filled
with drug formulation.
[0084] 1.2. Select one of the units randomly.
[0085] 1.3. Measure the weight of the unit on an appropriate
balance or scale, and tare the balance with the unit.
[0086] 1.4. Actuate the unit by hand.
[0087] 1.5. Record the shot weight data (weight of formulation
released during actuation) for each actuation and tare the balance
between actuations.
[0088] 1.6. Repeat steps 1.2-1.5 for the remaining units.
[0089] 1.7. Analyze the shot weight data from each unit and
determine the minimum number of actuations required to obtain
stable shot weight performance (e.g., the shot weight being within
95-105% of label claim.)
[0090] Step 2. Determine the actuation parameter ranges by hand
actuation.
[0091] 2.1. Procure the required number of spray pump units filled
with drug formulation from the same lot(s) used in Step 1,
above.
[0092] 2.2. Select a representative group of people to actuate the
units by hand. These people should be trained on how to actuate the
units properly, and they should be from a population that
corresponds to the age and gender group range for which the product
is targeted.
[0093] 2.3. Have each person actuate each unit by hand a
representative number of times and record the position vs. time and
shot weight data for each actuation. The position vs. time data may
be generated with an appropriate sensor and will be used to
determine the settings required by the automated actuation system.
The shot weight of each actuation may be measured by an appropriate
analytical balance or scale.
[0094] 2.4. Calculate the minimum, maximum, average, relative
standard deviation ("RSD"), and standard deviation (u) values for
each of the automated actuation system parameters plus shot weight,
based on the individual actuation recordings. Additionally, compare
the calculated shot weight values to the manufacturer's
specifications, if available.
[0095] Step 3. Determine an initial estimation of delivery
performance congruency between hand and automated actuation.
[0096] 3.1. Procure the required number of spray pump units filled
with drug formulation from the same lot(s) used in Step 1.
[0097] 3.2. Set the actuation parameters on the automated actuation
system to the average values determined in Step 2.
[0098] 3.3. Prime the units using the minimum number of shots
determined in Step 1.
[0099] 3.4. Actuate each unit with the automated actuation system a
representative number of times.
[0100] 3.5. Record the position vs. time profile and shot weight
data for each automated actuation and tare the balance between
shots.
[0101] 3.6. Compile the overall average shot weights and RSD's for
the units and compare with those from Step 2.
[0102] 3.7. Qualitatively compare the position vs. time profiles
from hand and automated actuation. Additionally, statistically
compare shot weights from hand and automated actuation. If
statistical differences appear, investigate the scope and make
recommendations as appropriate.
[0103] 3.8. The definition for delivery performance congruence will
be that the measured shot weight values will be within .+-.1.sigma.
of the values specified by the pump manufacturer.
[0104] Step 4. Adjust the automated actuation parameters to achieve
desired shot weight and determine acceptable ranges.
[0105] 4.1. Procure the required number of spray pump units filled
with drug formulation from the same lot(s) used in Step 1.
[0106] 4.2. Set the actuation parameters on the automated actuation
system to the average values determined in Step 2.
[0107] 4.3. Prime the units using the minimum number of shots
determined in Step 1.
[0108] 4.4. Automatically actuate each unit a representative number
of times using the average parameters determined in Step 2.
[0109] 4.5. Record the position vs. time profile and shot weight
data for each automated actuation and tare the balance between
shots.
[0110] 4.6. Adjust a single actuation parameter (starting with
stroke length) in continuous increments of 10% of the average value
and repeat Steps 4.4-4.5 until a plateau is reached (10 shot
average does not change by more than .+-.10% of the previous 10
shot average) or until the adjusted actuation parameter is equal to
its average value +2.sigma..
[0111] 4.7. Compile the overall average shot weights and determine
the adjusted actuation parameter range as follows:
[0112] Minimum Minimum value to produce shot weight levels within
.+-.1.sigma. of the average from Step 2.
[0113] Maximum Maximum value to produce shot weight levels within
.+-.1.sigma. of the average from Step 2, up to the average
+2.sigma..
[0114] 4.8. Repeat the above steps for the other parameters and
compile all of the results.
[0115] While this invention has been particularly shown and
described with references to preferred embodiments thereof, it will
be understood by those skilled in the art that various changes in
form and details may be made therein without departing from the
scope of the invention encompassed by the appended claims.
[0116] For example, the assembly 600 of FIG. 6 illustrates the
spray device 100 being held in vertical relationship with a foot
assembly 620. However, it should be understood that alternative
support techniques may be employed for drug device applications and
other applications. For example, the spray device 100 may be held
at an angle or horizontally, or even up side down. Further, other
embodiments of a shaft 605 and bearing 610 assembly may be
employed. For example, the shaft and bearing may be mounted to the
spray device 100 as opposed to being in a parallel, off-actuation
axis arrangement as shown in FIG. 6. Similarly, the linkage 330
described above as extending through the shaft 605 and locking to
the shaft head 615 by way of passing through the central hole 635
through the shaft head 615, may also be clipped onto the bottom of
the shaft 605 closest to the transducer 335.
[0117] The motor(s) that drive the compression plate assembly 805
in FIG. 8 may be external from the guide bars 810 or drive rod 830,
as described above, or integral with the guide bars 810 or drive
rod 830. For example, one or more of the guide bars 810 or drive
rod 830 may be a threaded screw and be driven by a motor in a
worm-gear arrangement with the compression plate assembly 805,
which has a complementary thread in such an embodiment. Another
example includes a slot in the guide bars 810 or drive rod 830 with
a drive mechanism located inside that is connected to a mating
assembly on the compression plate assembly 805. Further, the
automated actuation system 800 may include a mechanism that
connects to the mounting assembly 320c in a manner adapted to
actuate the spray device 100 absent the compression plate assembly
805.
[0118] Also, although electrical components (e.g., potentiometer)
for measuring displacement or motion of the adapter assembly 315
with regard to the mounting assembly 320 is described herein, other
embodiments of transducers may be employed, such as optical sensors
(e.g., interferometers) or non-contact electrical sensors, such as
hall effect sensors or capacitive probe sensors, where the sensors
function in a manner essentially equivalent to a transducer 335.
Similarly, although a transducer cable 340 is illustrated in the
embodiment of FIG. 6, it should be understood that infrared or
Radio Frequency (RF) means for transmitting transducer data
indicating position or motion between the adapter assembly 315 and
mounting assembly 320 may be employed.
[0119] With regard to the data collection and processing system of
FIG. 9, alternative embodiments may be employed. For example, the
system 900a may not use a signal conditioner 905; instead, the
system 900a may use an amplifier 910 that provides minimal noise or
has a signal conditioner 905 integral in the amplifier 910. Also,
various forms of data samplers 915 may be employed. For example, a
traditional 12- or 16-bit data sampler 915 may be employed. It
should be understood that other data samplers, including
non-traditional data samplers may also be used.
[0120] The transducer 335 may have a draw wire with a stroke
length/displacement range of 0-1.5 inches. The electrical output
circuitry for the transducer 335 may form a simple voltage divider
with the output voltage signal scaling linearly with the absolute
position of the draw wire. In addition, the DAQ board 1015 may have
a 5 volt DC output that can be used as the input voltage for the
transducer 335, and this sets the 2.5 output range of the sensor to
be 0-5 volts DC, corresponding to 0-1.5 inches of displacement,
respectively. In addition, this output range is preferably
compatible with the input measurement range of the DAQ board 1015.
This DAQ board 1015 may be able to read and record the analog
voltage signal 902 from the transducer 335 up 10 kHz or more. In
addition, the DAQ board 1015 may be designed to operate in a
standard personal computer.
[0121] A portable or desktop computer system is typically suitable
for use with the present invention. The computer system preferably
works with the DAQ board 1015 and associated control software.
[0122] The processor 920 may be a general purpose processor or a
specialized signal processor. Similarly, the data acquisition board
1015 of FIG. 10 may be a specialized data acquisition board
operating in a computer or a microprocessor adapted to work within
the environment to receive analog or digital information from the
transducer 335. For example, the transducer may be a digital
encoder or resolver and provide the information directly as a
digital word or data stream.
[0123] The graphical user interface 1200 of FIG. 12 may be a text
based interface or other form of interface, such as a touch screen.
The user may be allowed to select various points along the curve(s)
alone or in combination with automated data capture and processing
techniques, which include selection of various parameters
associated with position, velocity, or acceleration.
[0124] Control software associated with the present invention may
be designed to perform the following functions: (i) record the
position vs. time history of the compression and return stroke
trajectories; (ii) verify the proper operation of the transducer
335 and DAQ board 1015; and (iii) automatically determine the
stroke length of the spray device 100, 400, the velocity and
acceleration achieved during the compression and return strokes,
and the hold time of the stroke (the time spent at the fully
compressed position).
[0125] The curves of FIGS. 14-17 are indicated for three users.
However, it should be understood that many more users of the spray
device 100, 400 may be involved in the testing to make more
accurate measurements and determine accurate parameters. Further,
persons of multiple age groups, sizes, hand sizes, health, hand
impairments (e.g., carpal tunnel syndrome), and other criteria may
be used in the testing and actuation characterization process.
[0126] Image Therm Engineering, Inc.'s (Sudbury, Mass.) SprayVIEW
NSx, MDx, and OSx automated actuation systems are examples of
automated actuation systems 800 of FIG. 8 suitable for use with the
present invention. These systems allow programming of stroke
length, compression and return stroke velocity and acceleration,
and hold time levels. The output from the processor 920 may be used
directly as inputs to these systems, thus allowing a simple
transition from the required exploratory studies to automated
actuation to be achieved and documented. In addition, the assembly
600 could be used simultaneously with these automated systems to
verify their proper operation.
[0127] It should be understood that any of the data collecting or
processing may be implemented in hardware, firmware, or software.
If implemented in software, instructions may be stored on
computer-readable media, such as magnetic disk, optical disk, read
only memory (ROM), random access memory (RAM), loaded on a server
and transmitted across a computer network, or stored on any other
form of computer readable medium. A processor loads the software
instructions from the computer-readable medium and executes the
instructions to perform the processes described herein.
[0128] The assembly 600 may be used to record the position vs. time
trajectories achieved during actuation of pharmaceutical spray pump
assemblies and also for other applications. Examples of other
applications include the following: characterization of
glue/caulking guns, household spray pumps, pressurized spray cans,
and pharmaceutical nasal syringes; testing of robotic actuation of
industrial nozzles; and/or actuation of cosmetic spray pumps.
* * * * *