U.S. patent number RE41,946 [Application Number 10/153,081] was granted by the patent office on 2010-11-23 for portable immediate response medical analyzer having multiple testing modules.
This patent grant is currently assigned to International Technidyne Corporation. Invention is credited to Carter R. Anderson, David T. Giddings, James D. Kurkowski, Kee Van Sin, Robbi T. Thompson.
United States Patent |
RE41,946 |
Anderson , et al. |
November 23, 2010 |
Portable immediate response medical analyzer having multiple
testing modules
Abstract
A portable device that includes a plurality of test modules for
analyzing preselected concentrations of various body fluids of a
patient. The portable diagnostic device interfaces and utilizes
disposable cartridges and reagent diagnostic test strips and other
fluid sample diagnostic devices to determine the amounts of
preselected parameters in a patient's blood through either
electrochemical, electrical, optical, or mechanical analysis. The
disposable fluid sample diagnostic devices may include sample
chambers with inlet ports, electrical, physical, or chemical
sensors, in situ calibration media, a plurality of electrical
interface terminals, and temperature control elements. An
electrical interface interconnects the various test modules with
one or more corresponding integrated circuits which in turn are
electrically coupled to a common interactive display, printer,
power supply, and communication ports.
Inventors: |
Anderson; Carter R. (Inver
Grove Heights, MN), Giddings; David T. (Carmel, IN),
Kurkowski; James D. (Roseville, MN), Thompson; Robbi T.
(Lake Elmo, MN), Sin; Kee Van (Lino Lakes, MN) |
Assignee: |
International Technidyne
Corporation (Piscataway, NH)
|
Family
ID: |
22387570 |
Appl.
No.: |
10/153,081 |
Filed: |
May 22, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60053406 |
Jul 22, 1997 |
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Reissue of: |
09119983 |
Jul 21, 1998 |
06066243 |
May 23, 2000 |
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Current U.S.
Class: |
205/792;
204/403.01; 422/82.01; 204/412 |
Current CPC
Class: |
G01N
33/48785 (20130101); G16H 40/63 (20180101) |
Current International
Class: |
G01N
27/327 (20060101) |
Field of
Search: |
;204/403.01,403.04,412
;422/82.01,82.03,82.05,58,50 ;205/777.5 |
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|
Primary Examiner: Noguerola; Alex
Attorney, Agent or Firm: Fish & Richardson P.C.
Parent Case Text
The present application is a complete application claiming priority
based on co-pending Provisional Application Ser. No. 60/053,406,
filed Jul. 22, 1997 and entitled "IMMEDIATE RESPONSE MEDICAL
ANALYZER HAVING MULTIPLE TEST MODULES".
Claims
What is claimed is:
1. A portable point of care medical analyzer that enables an
operator to rapidly obtain results for a plurality of diverse
analyses, said analyzer comprising: (a) a base unit having a main
CPU and including signal processing devices and circuitry for rapid
processing of electrical signals generated by electrical,
electrochemical, optical or mechanical sensors of one or more
associated analytical modules; (b) at least one permanent
analytical module integral with said base unit which .[.includes a
disposable.]. .Iadd.is adapted to receive a removable .Iaddend.test
device having electrochemical sensors for making .[.a plurality
of.]. determinations characteristic of a fluid .[.serum.]. sample
.Iadd.selected from blood or other body fluid.Iaddend.; (c) one or
more types of module interface units for connecting and interfacing
between one or more removable analytical module units and said base
unit; (d) one or more .[.dedicated.]. removable analytical module
units for making specific determinations and which are designed to
be plugged into said base unit and connect electrically to a
specific type of modular interface unit; (e) wherein the
combination of said base unit signal processing devices and
circuitry and said module interface units enables direct
utilization of the output signals from each of said removable
modules; and (f) .[.common output devices in said base unit for
providing visual or printed display of determinations from all
modules..]. .Iadd.the base unit including programming logic and
circuitry for receiving signals from said permanent analytical
module and one or more of said removable analytical modules and
directing an analytical information output..Iaddend.
2. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 1 wherein at
least one of said removable analytical module.[.s also.].
.Iadd.units is a module that .Iaddend.makes a determination which
utilizes a .[.disposable.]. test device .Iadd.that can be removed
from the at least one of said removable modules.Iaddend..
3. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 2 wherein said
.[.disposable.]. .Iadd.at least one of said removable module units
that makes a determination which utilizes a .Iaddend.test device
.Iadd.that can be removed from the at least one of said removable
module units .Iaddend.is a .Iadd.removable module that uses a
.Iaddend.test strip.
.[.4. The device of claim 3 wherein said test strip is used in a
glucose meter..].
5. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 2 wherein said
one or more removable analytical module.[.s.]. .Iadd.units
.Iaddend.include a glucose meter.
6. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 1 wherein at
least one .Iadd.or more types of .Iaddend.module interface
unit.Iadd.s include a unit which .Iaddend.is connected to a
communications IC.
7. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 6 wherein said
one or more removable analytical module.[.s.]. .Iadd.units
.Iaddend.include a glucose meter.
8. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 6 wherein said
one or more removable analytical module.[.s.]. .Iadd.units
.Iaddend.include a prothrombic time assay module for performing
general coagulation measurements.
9. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 6 including a
plurality of module interface units connected through a multiplexer
to said communications IC.
10. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 1 wherein at
least one module interface unit is connected directly with said
main CPU of said base unit.
11. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 1 wherein at
least one module interface unit is connected to said main CPU of
said base unit through an analog interface.
12. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 1 wherein
said one or more removable analytical module.[.s.]. .Iadd.units
.Iaddend.include a module .Iadd.unit .Iaddend.for performing
general coagulation measurements.
13. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 12 wherein
said .Iadd.module unit for performing general coagulation
measurements performs at least one measurement from
.Iaddend.general coagulation measurements .[.include.].
.Iadd.including .Iaddend.prothrombin time (PT), activated partial
thrombo-plastin time (PTT) and activated clotting time (ACT)
.Iadd.measurements.Iaddend..
14. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 11 wherein
said one or more .[.dedicated.]. removable analytical module.[.s.].
.Iadd.units .Iaddend.includes a visible fight sensing device that
makes co-oximetry measurements.
15. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 14 wherein
said .Iadd.device that makes cooximetry measurements is a device
that can make .Iaddend.co-oximetry measurements .Iadd.that
.Iaddend.include total homoglobin concentrations (tHb),
oxyhemoglobin (O.sub.2H.[.B.]. .Iadd.Q.Iaddend.)
.Iadd.measurements.Iaddend., carboxyhemoglobin (COHb)
.Iadd.measurements .Iaddend.and methemoglobin (MetHb)
.Iadd.measurements.Iaddend..
16. A portable point of care medical analyzer that enables an
operator to rapidly obtain results for a plurality of diverse
analyses, said analyzer comprising: (a) a base unit having a main
CPU and including signal processing devices and circuitry for rapid
processing of electrical signals generated by electrical,
electrochemical, optical or mechanical sensors of one or more
associated analytical modules; (b) at least one permanent
analytical module integral with said base unit .[.including a
disposable.]. .Iadd.which uses a removable .Iaddend.test cartridge
having electrochemical sensors for making .[.a plurality of.].
determinations characteristic of a fluid .[.serum.]. sample
.Iadd.selected from blood or other body fluids.Iaddend.; (c) one or
more types of module interface units for connecting and interfacing
between one or more removable analytical module units and said base
unit; (d) one or more .[.dedicated.]. removable analytical module
units for making specific determinations and which are designed to
plug into said base unit and connect electrically to a specific
type of modular interface unit; (e) wherein the combination of said
base unit signal processing devices and circuitry and said module
interface unit enables direct utilization of the output signals
from each of said removable modules; (f) .[.common output devices
in said base unit for providing visual or printed display of
determinations from all modules; and.]. .Iadd.the base unit
including programming logic and circuitry for receiving signals
from said permanent analytical module and one or more of said
removable analytical modules and directing an analytical
information output; and, .Iaddend. (g) wherein at least one
removable analytical module is designed to attach to another
removable analytical module in a stacked arrangement in a manner
such that both removable modules connect to a module interface
unit.
17. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 16 wherein at
least one module interface unit is connected through a multiplexer
to a communications IC.
18. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 16 wherein at
least one module interface unit is connected directly with said
main CPU of said base unit.
19. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 16 wherein at
least one module interface unit is connected to said main CPU of
said base unit through an analog interface.
20. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 16 wherein
said one or more removable analytical module.[.s.]. .Iadd.units
.Iaddend.include a glucose meter.
21. The .[.device.]. .Iadd.analyzer .Iaddend.of claim 16 comprising
a removable glucose meter mounted from a prothrombic time assay
module.
.Iadd.22. The analyzer according to claim 1 including a display for
displaying determinations from the analytical module
units..Iaddend.
.Iadd.23. The analyzer according to claim 22 wherein the display is
a video display..Iaddend.
.Iadd.24. The analyzer according to claim 23 wherein the video
display is mounted in the base unit..Iaddend.
.Iadd.25. The analyzer according to claim 23 wherein the video
display is an interactive display including a touch
screen..Iaddend.
.Iadd.26. The analyzer according to claim 22 wherein the display is
a printer..Iaddend.
.Iadd.27. The analyzer according to claim 26 wherein the printer is
mounted in the base unit..Iaddend.
.Iadd.28. The analyzer according to claim 22 wherein the display
includes both a printer and a video display..Iaddend.
.Iadd.29. The analyzer according to claim 28 wherein both the
printer and the video display are mounted in the base
unit..Iaddend.
.Iadd.30. The analyzer according to claim 1 including a
communication port for sending results to an external or remote
computer..Iaddend.
.Iadd.31. The analyzer according to claim 1 including no heating
system, per se, in the base unit..Iaddend.
.Iadd.32. A portable medical analyzer comprising: (a) a base unit
having a main CPU and including signal processing devices and
circuitry for processing of electrical signals generated by
electrical, electrochemical, optical or mechanical sensors
positioned in one or more associated analytical modules; (b) one or
more module interface units for connecting and interfacing between
one or more analytical module units and said base unit; (c) at
least one permanent analytical module integral with said base unit
which is adapted to receive a removable test device having
electrical, electrochemical, optical or mechanical sensors for
making determinations characteristic of a fluid sample selected
from blood or other body fluid; (d) the base unit being adapted to
receive at least one removable analytical module unit for making
analytical determinations of blood or other body fluid; and to
connect, through a module interface unit, to the at least one
removable analytical module; and (e) the base unit including
programming logic and circuitry for receiving signals from the at
least one removable analytical module unit, when attached thereto,
and also from the permanent analytical module, and directing an
analytical output..Iaddend.
.Iadd.33. A portable medical analyzer according to claim 32
including: (a) a removable analytical module mounted thereon; (i)
the removable analytical module mounted on the base unit being
configured to make determinations characteristic of a fluid sample
selected from blood or other body fluid..Iaddend.
.Iadd.34. A portable medical analyzer according to claim 33
wherein: (a) the analytical module permanently mounted on the base
unit includes a cartridge receptacle having a pair of guide flanges
to hold, in use, a removable sample cartridge..Iaddend.
.Iadd.35. A portable medical analyzer according to claim 32
wherein: (a) the base unit includes a temperature sensing device
positioned to determine a temperature corresponding to a sample
temperature in a removable sample cartridge, when the removable
sample cartridge is mounted in the analytical module permanently
mounted on the base unit..Iaddend.
.Iadd.36. A portable medical analyzer according to claim 32
wherein: (a) the base unit includes a heating control system and
programming, to selectively control a temperature of a sample
included in a removable sample cartridge, when the removable sample
cartridge is mounted in the analytical module permanently mounted
on the base unit..Iaddend.
.Iadd.37. A portable medical analyzer according to claim 32
wherein: (a) the analyzer includes programming logic for operating
the permanent analytical module in both a calibration mode and
sample determination mode..Iaddend.
.Iadd.38. A portable medical analyzer according to claim 32
including a display for displaying determinations from the
analytical modules..Iaddend.
.Iadd.39. A portable medical analyzer according to claim 38 wherein
the display is a video display..Iaddend.
.Iadd.40. A portable medical analyzer according to claim 39 wherein
the video display is mounted in the base unit..Iaddend.
.Iadd.41. A portable medical analyzer according to claim 39 wherein
the video display is an interactive display including a touch
screen..Iaddend.
.Iadd.42. A portable medical analyzer according to claim 38 wherein
the display is a touch screen..Iaddend.
.Iadd.43. A portable medical analyzer according to claim 42 further
comprising a printer mounted in the base unit..Iaddend.
.Iadd.44. A portable medical analyzer of claim 32 including a
removable analytical module mounted on the base unit which is
configured for performing general coagulation of a blood
sample..Iaddend.
.Iadd.45. A portable medical analyzer of claim 44 wherein the
module for performing general coagulation measurements is
configured to perform at least one measurement from general
coagulation measurements including prothrombin time (PT), activated
partial thrombotlastin time (PTT) and activated clotting time (ACT)
measurements..Iaddend.
.Iadd.46. A portable medical analyzer of claim 32 including a
removable analytical module having a visible light sensing device
that makes co-oximetry measurements..Iaddend.
.Iadd.47. A portable medical analyzer of claim 46 wherein the
device that makes co-oximetry measurements is a device that can
make co-oximetry measurements that include total hemoglobin
concentrations (tHb), oxyhemoglobin (O.sub.2Hb) measurements,
carboxyhemoglobin (COHb) measurements and methemoglobin (MetHb)
measurements..Iaddend.
.Iadd.48. A portable medical analyzer of claim 32 including a
removable analytical module comprising a glucose
meter..Iaddend.
.Iadd.49. A portable medical analyzer according to claim 32
including: (a) a cassette removably engaged with the base unit, the
cassette including at least two analytical testing modules; (i)
each one of two testing modules included in the cassette being
operatively coupled to the base unit..Iaddend.
.Iadd.50. A portable medical analyzer according to claim 49
wherein: (a) each module included in the cassette is removably
mounted in the cassette..Iaddend.
.Iadd.51. A portable medical analyzer according to claim 32
including: (a) a removable and replaceable power supply, including
a battery pack, mounted on the base unit..Iaddend.
.Iadd.52. A portable medical analyzer according to claim 32
including: (a) a communication link for communicating analytical
information from the base unit to a remote computer..Iaddend.
.Iadd.53. A portable medical analyzer comprising: (a) a base unit
having a main CPU and circuitry to process electrical signals
received from electrical, electrochemical, optical or mechanical
sensors of at least two associated analytical modules if and when
one or more of the at least two analytical modules is operated to
evaluate blood or other body fluid removed from a patient; (b) one
or more module interface units for connecting and interfacing
between the base unit and at least two non-disposable analytical
modules capable of making determinations characteristic of fluid
selected from blood or other body fluid removed from a patient and
presented to the analytical modules via one or more disposable test
units; (c) the base unit including programming logic and circuitry
for receiving signals from at least two analytical modules,
operated to evaluate blood or other body fluid removed from a
patient in selected use, and directing an analytical information
output; (d) wherein the combination of the base unit and the module
interface units enables utilization of output signals from at least
two associated analytical modules, in selected operation to
evaluate blood or other body fluid removed from a
patient..Iaddend.
.Iadd.54. A portable medical analyzer according to claim 53
including: (a) an analytical module mounted thereon; (i) the
analytical module mounted on the base unit being configured to make
determinations characteristic of a fluid sample selected from blood
or other body fluid removed from a patient..Iaddend.
.Iadd.55. A portable medical analyzer according to claim 53
including: (a) two analytical modules connected thereto; (i) at
least one of the two analytical modules being removably mounted on
the medical analyzer; (ii) each one of the two analytical modules
being configured to make determinations characteristic of a fluid
sample selected from blood or other body fluid removed from a
patient..Iaddend.
.Iadd.56. A portable medical analyzer according to claim 55
wherein: (a) the base unit, one or more module interface units and
two analytical modules are configured for selected simultaneous
operation of the two analytical modules to provide output signals
to the base unit..Iaddend.
.Iadd.57. A portable medical analyzer according to claim 55
wherein: (a) the two analytical modules are configured to make
different determinations from one another, each of which is
characteristic of blood or other body fluid removed from a
patient..Iaddend.
.Iadd.58. A portable medical analyzer according to claim 53
including: (a) a first analytical module attached thereto; (i) the
first analytical module being configured to make determinations
characteristic of a fluid sample selected from blood or other body
fluid removed from a patient; (b) a second analytical module
connected to the base unit which is adapted to receive a glucose
test strip, to make a glucose determination of blood..Iaddend.
.Iadd.59. A portable medical analyzer according to claim 53
including: (a) a first analytical module attached thereto; (i) the
first analytical module being configured to make determinations
characteristic of a fluid sample selected from blood or other body
fluid removed from a patient; and, (b) a removable second
analytical module..Iaddend.
.Iadd.60. A portable medical analyzer according to claim 53
including: (a) a display for displaying determinations made from
one or more analytical modules..Iaddend.
.Iadd.61. A portable medical analyzer according to claim 60 wherein
the display is a video display..Iaddend.
.Iadd.62. A portable medical analyzer according to claim 53
including a communication port for sending results to an external
or remote computer..Iaddend.
.Iadd.63. A portable medical analyzer according to claim 53
including: (a) a removable analytical module mounted thereon; (i)
the removable analytical module mounted on the base unit being
configured to make determinations characteristic of a fluid sample
selected from blood or other body fluid removed from a
patient..Iaddend.
.Iadd.64. A portable medical analyzer according to claim 53
including: (a) an analytical module mounted on the base unit
configured to make determinations characteristic of a fluid sample
selected from blood or other body fluid removed from a patient and
selected from at least one of: (i) pH; (ii) pO.sub.2; (iii)
pCO.sub.2; (iv) Na.sup.+; (v) Ca.sup.++; (vi) K.sup.+; (vii)
hematocrit; (viii) glucose; (ix) general coagulation measurements;
and (x) co-oximetry measurements..Iaddend.
.Iadd.65. A portable medical analyzer according to claim 53
including: (a) an analytical module permanently mounted on the base
unit that includes a cartridge receptacle having a pair of guide
flanges to hold, in use, a removable sample cartridge..Iaddend.
.Iadd.66. A portable medical analyzer according to claim 53
wherein: (a) the base unit includes a temperature sensing device
positioned to determine a temperature corresponding to a sample
temperature in at least one removable sample cartridge, when the
removable sample cartridge is mounted in an analytical module on
the base unit..Iaddend.
.Iadd.67. A method comprising a step of: operatively connecting a
removable analytical module having a receiver for a disposable test
unit to a portable medical analyzer comprising: (a) a base unit
having a main CPU and circuitry to process electrical signals
generated by electrical, electrochemical, optical or mechanical
sensors positioned in at least two analytical modules at least if
and when each of the at least two analytical modules is operated to
evaluate blood or other body fluid removed from a patient; (b) one
or more analytical module interface units for connecting and
interfacing between one or more analytical modules and said base
unit; (c) the base unit being adapted to receive signals from at
least two analytical modules, at least one of which is the
removable analytical module, for making analytical determinations
of blood or other body fluid removed from a patient; and, to
connect, through a module interface unit, to the at least two
analytical modules; and, (d) the base unit including programming
logic and circuitry for receiving signals from the analytical
modules when attached thereto, and directing an analytical
output..Iaddend.
.Iadd.68. A method according to claim 67 wherein: (a) said step of
operatively connecting a removable module comprises connecting the
removable module to a portable medical analyzer already including a
permanent analytical module adapted to receive a removable sample
containing test device configured to evaluate at least one of pH,
pO.sub.2, pCO.sub.2, Na.sup.+, Ca.sup.++, K.sup.+, and
hematocrit..Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed generally to a stationary or
portable diagnostic system or electroanalytical systems for
analyzing preselected characteristics of a patient's blood and
other fluids. More particularly the present invention is concerned
with a portable diagnostic device or analytic instrument that
includes a plurality of test modules for analyzing various body
fluids of a patient, wherein the modules are coupled to a common
display, printer, power supply, and communication ports. The
portable diagnostic device interfaces and utilizes disposable
cartridges, reagent diagnostic test strips, or other means to
determine, for example, a patient's blood pH, pO.sub.2, pCO.sub.2,
Na.sup.+, Ca.sup.++, K.sup.+, hematocrit, glucose and/or other
parameters including oxygen saturation, coagulation or hemoglobin
fractions. The modules may determine the parameters through a
variety of methods such as electrochemical, electrical, optical, or
mechanical analysis of a fluid biological sample extracted from the
patient. The disposable cartridge may utilize a bank of sensors for
the pertinent electroactive species to provide input in the form of
analog electrical signals for the relevant determinations.
II. Related Art
During clinical, surgical, diagnostic and other medical procedures
the measurement of certain physical/chemical characteristics or
conditions of the blood and other fluids of a patient are useful in
order to evaluate the condition of a patient. For example, a
patient's blood pH, pO.sub.2, pCO.sub.2, Na.sup.+, Ca.sup.++,
K.sup.+, hematocrit, glucose and other parameters including oxygen
saturation coagulation or hemoglobin fractions may be measured.
These conditions may provide important indications of the patient's
stability including, for example, the efficiency of the blood/gas
exchange occurring in the lungs of the patient, the relative
acid/base balance, or the concentration of certain indicative ion
species in the blood. Such determinations are particularly useful
in emergency circumstances.
In the past, the equipment provided to make such determinations has
typically been complex and permanently installed in a hospital
laboratory. Also, the user operating the equipment has been
oftentimes required to be a highly-trained and skilled technician,
which thereby increases the cost of operating the equipment and
limits the number of potential users. With such equipment, in order
to analyze a sample of fluid from the patient, a sample must be
drawn from the patient and delivered to the laboratory, avoiding
all external contacts.
During the transfer and delivery, the drawn fluids may be kept in
close proximity to ice packs in order to maintain sample integrity.
The sample is then injected into a designated receptacle of the
diagnostic equipment and the equipment operated to perform the
diagnostics on the sample. This procedure is time consuming, labor
intensive, and usually disadvantageous in the operating room,
emergency room or other area of the hospital, or outside the
hospital where time is of the essence. Hence, portable devices that
reduce the time required to make accurate blood-gas and related
determinations, in order that proper and more timely corrective
steps may be taken, are highly sought.
Many situations arise where it is impractical to deliver a
patient's fluid sample to a hospital laboratory in order to analyze
the patient's blood analytes. It would be desirable for paramedics
and in-home health care providers, for example, to analyze a sample
at the point of collection without having to first deliver a sample
to a hospital laboratory. To this end, it would also be desirable
to provide a single portable diagnostic device capable of analyzing
simultaneously several samples and/or conducting several
electrochemical, electrical, optical, or mechanical analysis
simultaneously or in rapid succession to determine, a patient's
blood pH, pO.sub.2, pCO.sub.2, Na.sup.+, Ca.sup.++, K.sup.+,
hematocrit, glucose and other parameters including oxygen
saturation, coagulation or hemoglobin fractions.
There have been attempts at point-of-care blood-gas analysis. One
on-site analytic device, described by Enzer et al in U.S. Pat. No.
4,786,394, is designed for direct connection to a heart/lung
machine to monitor critical blood gases during open-heart surgery.
It employs a discardable sensor cartridge which contains a bank of
sensors for making the electrochemical determinations. A further
patent to Enzer et al (U.S. Pat. No. 4,397,725) also discloses a
clinical blood chemistry analyzer in which a discardable cartridge
interfaces with an analytical machine. Although the analyzer may be
utilized on-site during surgery, the device disclosed by Enzer
remains relatively stationary and immobile. Morris et al in U.S.
Pat. No. 5,325,853 (of common assignment with the present
invention) disclose a self-calibrating disposable sensor
system.
Carter et al in U.S. Pat. No. 5,628,890 describe an electrochemical
sensor for measuring the glucose concentration in a patient's
blood. Such a sensor is limited to the particular analyte being
measured and requires an interface with an electrochemical sensor.
Stark in U.S. Pat. No. 5,433,197 describes a non-invasive glucose
measurement device that requires illumination of the patient's eye
with near infrared radiation. The capability of the Stark device is
limited to determining blood glucose. Phillips et al in U.S. Pat.
No. 5,563,042 describe a device that measures glucose concentration
in whole blood optically using a reflective reading apparatus and a
whole blood glucose test strip.
A further reference is contained in U.S. Pat. No. 4,849,340 to
Oberhardt discloses a device that measures coagulation in whole
blood using a liquid assay device and method.
Although somewhat useful, such devices are limited in application
and address only part of the drawbacks of prior systems. There
remains a need for a rapidly responding, portable blood chemistry
analytical device. A need also exists for a single, portable,
self-calibrating, instant activation, rapid response diagnostic
device capable of simultaneous analysis of several samples and/or
conducting several electrochemical, electrical, optical, or
mechanical analysis simultaneously or in rapid succession to
determine, blood pH, pO.sub.2, pCO.sub.2, Na.sup.+, Ca.sup.++,
K.sup.+, hematocrit, glucose and other parameters including oxygen
saturation, coagulation or hemoglobin fractions. The present
invention meets these needs and overcomes the disadvantages of
prior devices.
SUMMARY OF THE INVENTION
The present invention provides a point-of-care medical analyzer
that enables an operator without special training or skills to
obtain rapid, accurate blood-gas, glucose, and other analyte
determinations at the time and location the sample is drawn. The
device is compact, light-weight, easily transported and ready for
immediate use. The analyzer is designed for rapid processing of
electrical signals generated by electrochemical, electrical,
optical, or mechanical sensors of an associated module having both
calibration and sample determination modes and utilizing one-time
use or disposable cartridges. The modules may be removed from the
analytic device and interchanged.
The plug-in disposable electrochemical sensor cartridge which may
be similar to that depicted in the above-cited U.S. Pat. No.
5,325,853, the entire contents of which are hereby incorporated by
reference for any purpose, employs an array of sensors, typically a
bank of aligned sensors on a ceramic chip in a flow-through
chamber. The flow-through chamber, as packaged, further contains a
calibration medium retained in situ with respect to corresponding
sensors to be calibrated such that when the disposable cartridge is
activated in conjunction with insertion into and electrical
connection with the analytical device, calibration signals are
produced by the sensors on the disposable cartridge which enables
immediate automatic calibration of the sensors. The sample may
thereafter be introduced through an entry port in a manner which
causes the calibration medium to be displaced from the flow-through
chamber and replaced by the blood or other fluid sample then in
direct contact with the sensors. The array of electrochemical
sensors then produces electrical signals in accordance with the
characteristics of the sample.
The disposable sample cartridge carries a heater in the form of a
thin or thick film resistor carried on the sensor chip itself
designed to bring the sample quickly to the temperature desired for
the analytic determination based on an optical sensor and remote
control from within the analytical device. Such a system is
depicted in Hieb et al., U.S. Pat. No. 5,232,667, assigned to the
same assignee as the present invention, the entire disclosure of
which is incorporated herein by reference for any purpose. Once the
desired temperature is reached, the electrical signals from the
electrochemical sensors are received and processed by the portable
analyzer and the results made available on a display and/or in
printed form. Other suitable "cartridges" are used in association
with the other modules.
It will be appreciated by those skilled in the art that the
analytical instrument is required to provide only the signal
processing systems for calibration and measurement. The remote
temperature sensing and control system provided in the portable
instrument, for example, controls only the electric input to a
heater located in the disposable cartridge. There is no heating
system, per se, in the analytical instrument. The heating control
system preferably includes an IR probe or other remote temperature
sensing device which is used in association with a programmed
control or set point temperature to rapidly establish and maintain
the desired temperature in the disposable cartridge. Further
details of the temperature control arrangement are contained in the
above-referenced patent issued to Hieb et al (U.S. Pat. No.
5,232,667).
In operation, the fully portable analytical instrument is brought
to the point of sampling, i.e., the location of the patient. A
predetermined number of disposable cartridges are removed from a
temperature-stabilized packaging and inserted or plugged into
corresponding modules of the analyzer. The instrument is activated;
the sensors are calibrated automatically and the calibration
electronically compensated with respect to an ensuing set of
measurement signals. A sample of interest is obtained from the
patient and a portion may immediately be transferred to the sample
inlet port of the calibrated sensor system on each disposable
cartridge. The sample displaces the calibration medium to a storage
chamber and avails the electrochemical sensors for an immediate
sensing of the corresponding species of interest in the sample.
Other types of sensors including electrochemically active reagent
test strips may be exposed to the sample and inserted into a
corresponding module.
The user determines the particular needs for testing and determines
which modules to attach to the base unit of the immediate response
medical analyzer. Plugging the disposable cartridges and inserting
relevant sample strips into the respective module of the portable
medical analyzer activates the system. The activation of the system
also activates the temperature control system which maintains the
sensor chip, or equivalent, at the desired calibration and analysis
temperature for those determinations that require temperature
control. If the sample within the cartridge is at a different
temperature, the temperature control system reacts quickly and
controls the sensors to restore the desired temperature to the
system. Of course, some determinations, including glucose
measurement, do not require temperature control.
After the determinations have achieved equilibrium and the
corresponding signals have been read by the analyzer, the analyzer
computes the results based on the sensor outputs. The results are
made immediately available on a combination touch screen LCD
display and as a printed record using an integral printer. It is
anticipated that the entire operation from first insertion of the
cartridges and activation of the system until printout of the
results, assuming the immediate availability of the sample, can be
achieved in less than three minutes. In addition to the rapid
availability, the results are also stored by the device in memory
for later retrieval by touch screen, printer or to be sent via a
communications port to an external or remote computer or
laboratory.
OBJECTS
It is accordingly a principal object of the present invention to
provide a portable, rapidly responding, point-of-care medical
device having several modules capable of independently determining
a plurality of predetermined analytes from a fluid biological
sample.
Another object of the present invention is to provide a rapidly
responding, portable medical analytical instrument capable of
interfacing with several self-contained, self-calibrating, or
pre-calibrated, disposable fluid sample devices of varying
construction.
Yet another object of the present invention is to provide a
portable sophisticated medical analyzer capable of simplistic user
friendly operation.
A further object of the invention is to provide a self-contained
point-of-care blood analyte analyzer capable of instant activation
and almost immediate response in determining a patient's blood pH,
pO.sub.2, pCO.sub.2, Na.sup.+, Ca.sup.++, K.sup.+, hematocrit,
glucose and other parameters including oxygen saturation,
coagulation or hemoglobin fraction.
These and other objects, as well as these and other features and
advantages of the present invention will become readily apparent to
those skilled in the art from a review of the following detailed
description of the illustrated embodiment in conjunction with the
accompanying claims and drawings in which like numerals in the
several views refer to corresponding parts.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1a is a perspective view of the multiple module portable
point-of-care analyzer of the present invention;
FIG. 1b is a perspective view of a multiple module similar to the
analyzer of FIG. 1a with an additional module attached;
FIG. 2 is a partially exploded perspective view of the device of
FIG. 1 showing a module removed;
FIG. 3 is a fragmentary, partially exploded, lower perspective view
of the device showing a module removed from the analyzer;
FIG. 4 is a partially exploded perspective view of the top section
of the device of FIGS. 1 or 2, without the removed module and
including a non-contact temperature sensor probe and print
roll;
FIG. 5 is a schematic system block diagram for one embodiment of
the multi-module or multiple module portable medical analyzer of
the invention;
FIG. 6 is an electrical schematic illustrating the connection
between a glucose module and the integrated circuit of the
analyzer;
FIG. 7 is a fragmentary perspective view of a cartridge receptacle
interface with a cartridge inserted;
FIG. 8 is a perspective view of a disposable cartridge for use with
the analyzer of the invention;
FIG. 9 is a schematic diagram of an analog interface subsystem
associated with FIG. 5;
FIG. 10 is a partially exploded perspective view of an alternate
embodiment of the portable point-of-care analyzer of the present
invention; and
FIGS. 11-13 depict schematic block diagrams of examples of modules
that interface with each of the modular interface system types
depicted in FIG. 5.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention includes a point-of-care and immediate
response portable medical analyzer that features automated
calibration and analysis for a variety of uses. The analyzer
includes several interchangeable modules that allow the user to
analyze several samples or analyze one sample for several
predetermined criteria at the point-of-care without extended
delays. Thus blood-gas analysis results can be made available to
the attending physician, surgeon, or other health care provider
within a minute or two after the drawing of a sample. Moreover, it
takes no particular skill to operate the portable medical analyzer
inasmuch as both calibration and sample analysis have been
automated in conjunction with a unique self-calibrating system. A
disposable plug-in cartridge unit interfaces with the medical
analyzing device or a reagant strip is automatically interfaced
with an output system. While the illustrated embodiments described
below are directed to blood-gas and blood-electrolyte analysis, it
will occur to those skilled in the art that these are meant as
examples and are in no way intended to introduce limitations to the
scope of the invention and that the system can be adapted to other
analyses involving blood or other body sera without departing from
the essential premises of the invention. It will be appreciated
from the views of FIGS. 1a-4 that one advantage of the portable
analyzer of the invention is that it is mechanically simple and
eliminates the need for medical personal to transport samples to a
plurality of diagnostic analyzers.
With this in mind attention is directed first to FIGS. 1a and 1b
where a portable analytic device in accordance with the present
invention is shown generally at 10. The base unit device 10
includes a housing 12, a first integrator permanent module 14, a
second removable module 16, a touch screen interactive display 18,
a printer 20, and a replaceable power supply 22. The base unit
enclosed in the housing 12 also includes an upper section 24 and a
lower section 26, and includes a void area to define a handle 28.
An attached removable second module is shown at 16. The first
integrator permanent module 14 includes a cartridge receptacle 30
having a pair of guide flange 32 to hold and guide the sides of a
disposable cartridge 140 (see FIG. 8) into the receptacle 30. As
shown in FIG. 1b, an additional module 33 may be interposed between
the module 16 and the basic analytical device 10. The embodiment of
FIG. 1b notably further includes an additional interface section 34
which includes a plug receptacle 35 represents another interface to
receive yet another measurement module having an input and output
integrated into the basic analytical unit 10.
A remote temperature sensor 36 is positioned in the receptacle 30
(see FIG. 4) beneath an opening 37, thereby providing for
temperature measurements of the cartridge 140 as further described
below. As best seen in connection with FIG. 4, the interactive
display 18 includes a touch screen with an 8.times.8 grid mask 42
associated with an output LCD window or cover 44 which is fastened
beneath an opening 46 in the top housing member 24.
The power supply 22 includes a battery pack, which supplies power
through ON-OFF control to the microprocessor, cartridge interface
and the touch screen 18. Common voltages are supplied as needed
within the processing circuitry through a variety of voltage
converters which also supply the liquid crystal display bias and
the back lighting for the touch screen 18. This system is
considered conventional to those skilled in the art, and further
explanation is believed unnecessary.
Module 16 is a glucose meter that includes a receptacle 48 for
insertion of a test strip. Without any limitation intended, the
module 16 may utilize, for example, the motherboard and test
receptacle of a SURESTEP glucose meter available from Lifescan,
Inc. Milipitis, Calif. The motherboard and test strip receptacle
are mounted to the module and are electrically coupled to a
connector that interconnects a communication line and power supply
to the internal electrical components contained within housing 12.
A relay and control line may be added to allow control of the power
supplied to the module 16.
Module 33 may be capable of performing a coagulation assay such as
PT (prothrombin time), PTT (activated partial thrombo-plastin time)
or ACT (activated clotting time). This module may measure whole
blood coagulation time and includes a system for receiving a liquid
sample into a reaction chamber containing a reagent material which
reacts with the sample to perform the detmination. The reaction can
be monitored optically to determine the assay time. Such a system
is illustrated and described in U.S. Pat. No. 4,849,340 to
Oberhardt, the details of which are deemed incorporated by
reference herein for any purpose. The output signals from that
module are digitized and processed within the module itself prior
to being communicated to the base unit.
Those skilled in the art will appreciate that modules 14, 16 and 33
may represent different modular units of suitable construction
modified as needed to interface with electrical components of the
present invention. Optionally, additional modular units may be
added in stacked or separate arrangements. The appropriate
interconnects including communication and power supply links can be
provided as direct plug-in linkages from the base unit and through
other sensor modules. Without any limitation intended, dedicated
removable modular units may include a visible light sensing device
that makes co-oximetry measurements such as total hemoglobin
concentrations (tHb), oxyhemoglobin (O.sub.2Hb), carboxyhemoglobin
(COHb) and methemoglobin (MetHb) of a blood sample contained in a
cartridge or cuvette may be mounted in a module and interconnected
with the present invention. Modules of this type are available from
AVOX Systems Incorporated of San Antonio, Tex. Those skilled in the
art will appreciate that the mother board and optical bench of such
a sensor may be removed and electrically connected within the
housing 12 of the analytic device 10. An external connector may be
used to interconnect the sensor module's communication lines and
power supply to the device 10. A relay with one control line and
may be added to allow control over the module by the device 10.
Also, the controlling software may be modified to allow control of
the module via the device 10.
FIGS. 2 and 3 illustrate the removeability of the second module 16.
The module 16 locks onto the housing 12 (FIG. 1a) may utilize a
male and female quick release lock of known suitable construction.
When the module 16 is locked in place, the electrical contacts 38
of the module engage with the electrical contacts 40 protruding
from the housing 12. Those skilled in the art will appreciate that
a plurality of electrical contacts may be utilized to form a serial
port or other electrical connection of known suitable construction
to thereby interconnect the internal electrical components of the
module 16 with an integrated circuit and central processing unit
(CPU) contained within the housing 12. The module 16 includes a
receptacle 48 adapted for receiving a disposable diagnostic test
strip or electrochemical sensor of known suitable construction. The
module 33 of FIG. 1b attaches to the housing 12 in a similar manner
and includes pass-through interfaces and housing lock system to
accommodate the module 16 in a piggyback or tandem stacked
arrangement. Note that module 33 also has a further plug receptacle
35a situated to accommodate yet annother modular sensor.
In accordance with the operation of the portable medical analyzer
of the invention, a typical operating system is shown in block
diagram in FIG. 5. Additional details of subsystems are illustrated
in FIGS. 6 and 9. The interface of module 16 with the integrated
circuit contained within housing 12 is depicted in FIG. 6 and the
analog interface system is depicted in FIG. 8.
Additional information can be gleaned with reference to the
schematic block diagram of FIG. 5. The system is operated by a
programmed central processing unit 70 which operates in conjunction
with a voltage controlled oscillator 72, real-time clock 74 with
associated non-volatile random access memory (novram) 76 random
access memory (RAM) 78 and erasable programmable read only memory
(EPROM) 80. The system further includes a communication integrated
circuit 82 (RS232 with interface 84 and a typical circuit connector
86). Also included is an interface 88 for the interactive touch
screen display 18. A printer interface 90 for printer output and
LCD interface 92 are also shown. Various switches and an alarm or
beeper device 94 are connected through a bit output device at 96.
An analog interface 98 interconnects the heater system 100, sensor
interface 102 and module interfaces 104-110. Those skilled in the
art will appreciate that additional module interfaces 112-116 may
be interconnected with integrated circuit 82 via a multiplexor 118.
Additionally, module interfaces 120-124 may be directly connected
to the central processing unit 70. In this manner, those skilled in
the art will appreciate that a variety of modules having various
processing components may be rendered compatible with the present
portable device 10.
For example, FIG. 6 shows a glucose measuring module of common
known construction electrically coupled to an immediate response
medical analyzer (IRMA). FIG. 11 depicts a typical module of a
class designed to interface with the instrument 10 through any of
interface modules and may include a CPU 150 connected to the module
interface through a serial input/output device. The module further
typically includes a sensor interface 154 with associated
measurement circuitry 156 signal conditioning system 158 and A/D
signal converter 160. A CPU controlled DAC signal generator 162
provides an analog interface with a temperature control system and
sensor interface 154. The module depicted in FIG. 12 is of a class
that are designed to connect to a module interface through a
multiplexer and communication IC as at 118 and 82. This includes
any of the module interfaces 112, 116. It will be appreciated that
the modules 16 and 33 are compatable with this type of interface.
FIG. 13 depicts yet another type of connected device compatable
with the module interfaces 104-110.
With respect to FIG. 9, it will be appreciated that once the
disposable cartridge is plugged into the analyzer and the analyzer
is turned on, calibration signals are almost immediately available
on a clock controlled or prioritized channel selective interface
bus as at 130 such that by employing a serial clock, the serially
obtained data available on the bus 130 can be processed by a serial
to parallel converter 132 interfacing with the central processing
unit 70 to sort out the multiple signals being received from A-to-D
converters 134-142. Corrective data where applicable and reference
measurements are provided via the A-to-D converter 142 from a
multiplexer channel control 144 that receives input from a variety
of sources including barometric pressure sensor, temperature,
reference electrode signals and an oxygen bias signal, if used,
from the sensor interface 102. The clock controlled CPU interfaces
with both the multiplexer channel control and the remaining
electrochemical sensors via the serial to parallel converter in a
manner which uses the signals together with the available
calibration condition data from the multiplexer via A-to-D
converter 142 to accurately calibrate each of the species sensors
for subsequent use in making a determination in the sample.
It will be appreciated that in this manner, each disposable
cartridge is automatically individually calibrated with respect to
the measurements to be made once connected to the analyzer and
activated. Determination of each sample is then made pursuant to an
individualized calibration based on the disposable cartridge itself
and not based on calibration of any of the components in the
portable analytical device.
FIG. 8 depicts a perspective view of the disposable cartridge 34
designed for use in association with the medical analyzer 10 of the
invention. The cartridge 34 includes a substantially planar base
member or plate 146 and a housing 148 fixed to the base member 146.
One end of the cartridge is formed to include a handle with a
gripping flange 150 to obtain a better grasp of the cartridge 34.
Side flange members 152 extend from the sides of the planar base
and slide under guide flanges 32 of the cartridge receptacle 30.
FIG. 7 shows the cartridge 34 aligned and engaged with receptacle
30 and having an injection syringe 154 positioned to introduce a
sample into a sample port 156.
The cartridge is further provided with an array of electrical leads
or terminals as at 158 configured to connect with corresponding
terminals in the analytical instrument cooperating in the exchange
of electrical signals between the analytical instrument and
cartridge in a well-known manner. These terminals connect to
corresponding conductors (not shown) of the receptacle 30 which
provide all necessary input and output connections to control the
functions and transmit the necessary signals between the cartridge
and the analytical instrument. The cartridge housing 148 further
defines a flow-through analytical cell chamber or volume containing
an array of electrochemical sensors 160-168 connected to a
relatively larger waste receptacle chamber 170. The cartridge waste
volume 170 includes a retention maze in the form of a plurality of
partitions as at 172. As recognized above, the cartridge and module
14 are described in greater detail in U.S. Pat. No. 5,325,853, the
entire disclosure of which has been incorporated herein by
reference.
An alternate embodiment of the portable device 10 is shown
generally at 200 in FIG. 10. The device is adapted for receiving a
cassette 202 in which is electrically integrated a plurality of
testing modules 204-208. The cassette 202 is provided with a cover
that engages with the base of cassette 202. A rechargeable,
replaceable battery pack 212 is shown elevated above the portable
device 200. The device 200 also includes an interactive display 214
and printer 216. The cassette 202 includes electrical connectors
that electrically interconnect each module 204-208 with the
electrical components contained within the device 200 (including a
central processing unit and integrated circuit). The modules
204-208 may be removed from the cassette 202 and are
interchangeable. In this manner, the user may either analyze
several samples using similar modules or may select different
modules to perform varying analysis and diagnostics of a single
sample.
This invention has been described herein in considerable detail in
order to comply with the Patent Statutes and to provide those
skilled in the art with the information needed to apply the novel
principles and to construct and use embodiments of the example as
required. However, it is to be understood that the invention can be
carried out by specifically different devices and that various
modifications can be accomplished without departing from the scope
of the invention itself.
* * * * *
References