WO1986005966A1 - Blood sampling and analyzing system - Google Patents

Abstract

Hand-held shirt-pocket portable medical diagnostic system for checking measurement of blood glucose, urea nitrogen, hemoglobin, blood components or other body qualities. The system includes the engagement of a disposable needle or lance probe package (12) which carries a chemical reagent strip (94) such as blood reacting chemistry. The system includes a pen structure (14) having a visual readout (18), a microcomputer, and photosensing circuitry (50, 52) which measures the change of color of the blood reacting chemistry of the disposable probe package. The pen also includes a spring arrangement (42, 44) for actuating a needle or lance (90) into the skin for transferring blood from a finger or other area to the chemical reagent strip. A disposable probe structure package includes configurations for transferring of the blood to the reagent strip or the reagent strip to the blood.

Description

Blood Sampling and Analyzing System.

CROSS REFERENCES TO CO-PENDING APPLICATIONS This application is a continuation-in-part of U.S. Serial No. 720,906, filed April 8, 1985.

BACKGROOND OP THE INVENTION 1. Field of the Invention - The present invention pertains to medical system for sampling and analyzing blood or any components of the blood for specific read¬ ings as to qualities of the blood. One specific use of the present invention is for sensing the accumulation of blood glucose for diabetics. The system is a portable, pocket-size, battery operated, diagnostic system for de¬ tection and measurement of blood qualities or of other predetermined qualities.

2. Description of the Prior Art - Prior art blood glucose devices have operated on the principle of taking blood from an individual by a variety of methods, such as by needle or lance. An individual then had to coat a pa¬ per strip carrying chemistry with the blood, and insert the blood-coated strip into a blood glucose meter or vi- sual comparison against a color standard. There are nu¬ merous blood glucose meters on the market, but are in¬ struments which consume space and are not pocketable. The instruments usually have to be carried in a large

SUBSTITUTE SHEET handbag, or an individual's briefcase, or left at home such as in the bathroom or the bedroom.

Further, the prior art medical apparatus for sensing blood glucose required that an individual have separately available a needle or lance for extracting blood from the individual, strips carrying blood chemistry for creating a chemical reaction with respect to the blood glucose and changing color, and a blood glucose meter for reading the change in color indicating the blood glucose level. The level of blood glucose, when measured by glucometer, is read from a strip carrying the blood chemistry through the well-known process of reflectometers for glucose oxi¬ dation.

Monitor/reagent strip systems that are now available on the market have multiple sequential steps that the pa¬ tient must follow at exact time intervals. Each step is subject to error by the patient. As in most monitors, it is the patient's responsibility to periodically calibrate the monitor against known color standards; validate the efficacy of their reagent strips and technique by .immers¬ ing the strips in a control solution of known glucose content; and, then comparing the color change visually against the color standard or by using a calibrated moni¬ tor. in the prior art, the procedure for obtaining accu¬ rate results from the time a drop of blood is placed on a reagent strip pad to the time the pad color change is read in the monitor is as follows. The patient must stick himself/herself with a lancet. A drop of blood must be squeezed to the surface of the skin. The drop of blood must then be carefully placed on the reagent pad, making sure to cover the pad completely and the pad must never be touched by the finger of the patient to prevent contamination. Once the sample has been applied to the

SUBSTITUTE SHE EET surface of the reagent pad, the patient must press a timer on the monitor. At the end of the timing, the pa¬ tient must wipe, blot or wash the strip off, using a careful technique. And for most strips, the patient must place the reacted reagent strip into the monitor, and press a test button or close a hatch to obtain results. Prior art commercially available comparable reagent strips or monitors require operator intervention in a prescribed sequence at exact time intervals. The prior art is subject to operator error, sequence, timing, and technique errors. The prior art reagent strips are also subject to contamination which will affect accuracy of measurement.

The present invention overcomes the disadvantages of the prior art by providing a hand-held pocketable medical system which includes an attachable disposable probe package carrying a chemical reagent chemistry for ex¬ tracting blood from an individual, delivering the blood to the blood sensing,- or vice versa, in the disposable. needle package, and resulting in a readout of a level such as blood glucose. The system includes a microcom¬ puter which is software controlled by an internal program and, of course, provisions can be provided for external programming of the microcomputer. The computer controls all timing functions thereby eliminating human error. The medical system can also assume a rectangular shape and include a slidable diagnostic point for measuring any predetermined quantity which causes a reagent strip reac¬ tion. SUMMARY OF THE INVENTION

One general purpose of the present invention is a portable, shirt-pocket-size, battery-operated diagnostic device/system for use by health professionals and/or lay patients for the detection and measurement of certain se-

SUBSTITUTE SHEET lected chemical agents or substances for the purpose of diagnosis and/or treatment of disease. The application is not restricted to use with human beings. It may also be extended to veterinary medicine animals, and can also have uses in the agricultural field, such as measurement of glucose in grapes in the wine industry. One first ap¬ plication is for insulin dependent and non-insulin depen¬ dent diabetics for the measurement of glucose in serum, plasma, and/or whole blood. The particular quantity to be measured is glucose through the principles of either reflectance, absorption or potentiometriσ by electronic circuitry although other quantities can be measured.

Another purpose of the present invention is to pro¬ vide a hand-held pocketable medical system or measurement system including an engaging disposable needle or lance probe carrying the blood sensing reagent for sensing readings of the blood, such as blood glucose level. The medical system is^*cost effective and simple to operate by an individual. The reading, such as an individual's glu- cose level, is displayed on an LCD display on the side of a tubular or rectangular like pen barrel of the medical system which approximates the size of an ordinary ink pen which can be carried in an individual's shirt pocket. The disposable needle probe packages can be carried in a corresponding hollow tubular pencil carrying a plurality of disposable probe packages for use as needed. The tubular or rectangular structure resembling a pen con¬ tains the hand-held pocketable medical system, and the tubular or rectangular structure resembling a pencil car- rier the extra supply of disposable needles. The pen- and-pencil design provides for the utmost peace of mind for the individual.

According to one embodiment of the present inven¬ tion, there is provided a hand-held pocketable medical

SUBSTITUTESHEET system including mechanical or electromechanical pen like structure for actuating a needle in a disposable needle or lance probe package, and for enabling a blood sample inside a finger or on the finger surface to be trans- ferred to blood sensing reagent chemistry, or the blood sensing chemistry to be transferred to the blood. The mechanical structure can assume a variety of spring actu¬ ated configurations and can further create a vacuum for drawing the blood outside of the finger. The disposable needle probe package frictionally engages onto a socket at the bottom of the tubular hand-held pocketable medical system such as by snapping, threading, or the like, in place, and is easily releasable and disposable after a single use. The hand-held tubular medical system in- eludes photosensing electronics connected to a microcom¬ puter or custom integrated circuit not only for analyzing the properties of the blood sensing chemistry in the dis¬ posable probe package, but also for displaying a readout and storing previous readouts. The electronics includes a verification sequence verifying operability of the electronics including sending of a low battery condition, verifying the condition of an unused disposable needle package, verifying the presence of a blood sample and subsequently providing multiple readings to provide for an averaging of results. The result will not be dis¬ played until the qualification sequence has been success¬ fully sequenced through verification.

According to other embodiments of the present inven¬ tion there is provided a diagnostic unit with a wicking action where the wick serves as the transport mechanism for the blood. The wick could also serve as the steril¬ ity barrier for a sterilized needle/lance. The wick can be at an angle to the needle/lance and provides for ab¬ sorption through the wick material.

SUBSTITUTE SHEET One significant aspect and feature of the present invention is a hand-held pocketable medical system or measurement system referred to as a "Med Pen" or a "Med Pen Mosquito" which is used to extract a blood sample from the body, subject the sample to chemical analysis, and display the results to the individual. A disposable needle package, referred to as a "Med-Point" carries the blood sensing chemistry consisting of a reagent strip, as well as the needle either for delivering blood to the reagent or for causing the reagent to be delivered to the blood. Additional disposable needle packages can be car¬ ried in a corresponding structure similar to that of the medical apparatus referred to as a "Med Pencil."

Another significant aspect and feature of the pre- sent invention is a pen like structure which is mechani¬ cal, and actuates upon a predetermined amount of pressure being exerted on the skin of an individual's finger. Upon this pressure being sensed, the needle will be actu¬ ated down through an individual's skin for the subsequent result of enabling a blood sample to be taken from within the finger or blood sample to occur on the surface of the finger. • In an alternative, a button can be pushed actu¬ ating the probe into the skin.

A further significant aspect and feature of the pre- sent invention is a hand-held pocketable medical system referred to as "Med-Pen Mosquito" which will provide blood glucose readings where the disposable needle probe package carries glucose-oxidase or like chemical reagent, whereby once the blood undergoes a colorimetric or poten- tiometriσ action proportional to the blood glucose con¬ centration, electronics through the reflectance colorime¬ ter provide for subsequent processing of the photosensing of the blood chemistry for displaying of the results on an LCD display.

SUBSTITUTESHEET A further significant aspect and feature of the pre¬ sent invention is a hand-held pocketable medical system which can be utilized by an individual and only requires the engagement of a disposable needle probe package, sub- sequent actuation of the apparatus causing a subsequent display on a visual readout for the desired measurement.

Another significant aspect and feature of the pre¬ sent invention is a measurement system which utilizes a slidable disposable diagnostic point unit. The diagnos- tic point unit carries a spring lance/needle and a trans¬ port mechanism for transporting a fluid or liquid to a reagent strip.

Having thus described embodiments of the present invention, it is a principal object hereof to provide a pocketable medical system, including disposable needle packages which carries blood sensing reagent which engage thereto providing a subsequent readout on a visual dis¬ play of a quality of the blood. The medical system can be broadly extended to a system for measurement of ^"a quantity of a substance in a particular fluid or material and is not to be construed as strictly limited to medical applications, as the system can be used in industry, agricultural, or even veterinary environments.

One object of the present invention is to provide a hand-held pocketable medical diagnostic system denoted as a Med-Pen Mosquito, disposable medical probe as needle packages referred to as Med-Points or Med-Probes which engage onto the Med-Pen, and a hollow tubular pencil re¬ ferred to as a Med-Pencil for carrying extra disposable needle Med-Point packages. The disposable needle pack¬ ages carry blood sensing reagent for sensing components of the blood for qualities such as glucose level. Other qualities of any substance can also include urea nitro¬ gen, hemoglobin, alcohol, protein or other qualities of the blood or in other articles such as agricultural prod¬ ucts, food, etc.

Another object of the present invention is a Med-Pen which is a reusable device containing the electronics and software programming, mechanical apparatus, battery(s) , sensor(s) , and related circuitry that cause the func¬ tional operation to be performed. The Med-Point or Med- Probe is a disposable device containing a needle/lance to obtain a blood sample, typically from a person's finger or toe, and a chemical reagent that reacts with the pres¬ ence of blood as a function of the amount of glucose pre¬ sent in blood. The chemical reagent is sealed inside the Med-Point probe housing or inside a specific housing for the chemical reagent obviating the effects of contamina- tion (from fingers) , moisture, and light, thus improving accuracy and precision of measurement by stabilizing the oxidation reduction or chemical reaction of the reagent prior to use. The sensor(s) in the Med-Pen/Point system measure/detect via colorimetric and/or potentiometric and/or absorption analysis of the amount of glucose pre¬ sent. This analog data is converted to a digital readout display quantifying glucose in milligrams per deciliter (mg/dl) or MMOL/L.

An additional object of the present invention is a self-contained automatic system. Once the Med-Pen Point is depressed against the finger (or other area) , no fur¬ ther operator intervention may be required depending upon the specific embodiment. All operations and performance of the system are performed automatically and echani- cally/electronically in the proper sequence. Accuracy and precision of the measurement is enhanced because er¬ rors due to operator interpretation, operator technique, and timing of events, are thereby removed from operator control and influence due to automatic operation.

SUBSTITUTESHEET Pressure of the system against a skin surface of a prede¬ termined amount based on spring constants or other prede¬ termined conditions automatically starts the system and sequences the operations dependent upon the specific embodiment.

Still another object of the present invention is a medical system which is software based and software in¬ telligent. The system is self-calibrating through con¬ trol commands by the software. A still further object of the present invention is a measurement system with a slidable self-cocking hammer, a push button, release button, and a battery carried in a top compartment.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Other objects and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connec¬ tion with the accompanying drawings, in which like ref^'er- ence numerals designate like parts throughout the figures thereof and wherein:

FIG. 1 illustrates a plan view of a hand-held pock¬ etable medical system;

FIG. 2 illustrates an obverse view of FIG. 1; FIG. 3 illustrates a plan view of the system opera¬ tion;

FIG. 4 illustrates a cross-sectional view of a first embodiment;

FIG. 5 illustrates an electrical schematic block diagram;

FIG. 6 illustrates a cross-sectional view of a sec¬ ond embodiment;

FIG. 7 illustrates a cross-sectional view of a third embodiment;

SUBSTITUTE SHEET FIG. 8 illustrates a cross-sectional view of a fourth embodiment;

FIG. 9 illustrates a cross-sectional view of a fifth embodiment, a capillary action medical system; FIG. 10 illustrates a sectional view of a first med¬ ical point embodiment;

FIG. 11-12 illustrate sectional views of a second medical point embodiment;

FIG. 13 illustrates a sectional view of a third med- iσal point embodiment;

FIG. 14-15 illustrate sectional views of a fourth medical point embodiment;

FIG. 16 illustrates a plan view of a system self- calibrating medical point; FIG. 17 illustrates a sectional view of a medical probe with self-contained optical sensors;

FIG. 18 is a flow chart of blood transfer to the reagent strip;

FIG. 19 illustrates a perspective view of.an embodi- ment of a measurement system with a disposable diagnostic point;

FIG. 20 illustrates a sectional view of the diagnos¬ tic point embodiment for the system of FIG. 19;

FIG. 21 illustrates an end view in partial cross- section of the diagnostic point; and,

FIGS. 22a and 22b are a system performance chart.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a plan view of a hand-held pock¬ etable medical system 10 and a disposable medical probe with a needle or lance .or the like carrying blood sensing reagent strip chemistry, all of the present invention. The hand-held pocketable medical system 10 includes a tubular cylindrical pen like member 14 and a clip 16 af¬ fixed to the top of the tubular member 14. The dispos-

SUBSTITUTE SHEET able medical probe 12 is a narrowing cylinder, and fits into^' a socket or similar coupling the cylindrical member as later described in detail. A visual electronic read¬ out 18, such as an LCD or the like, including a plurality of .digits displays numerical qualities of the blood, as later described in detail.

FIG. 2 illustrates an obverse plan view of FIG. 1 including an instruction panel 21 which can be affixed to the cylindrical tubular member 14 of the system 10. FIG. 3 illustrates a plan view in perspective of the hand-held pocketable medical system 10, and a disposable medical probe 12 disengaged prior to use and after use. Extra disposable medical probes 12 can be stored in a hollow tubular pencil like cylindrical member 20 which would resemble a pencil like structure.

FIG. 4 illustrates a cross-sectional view of a first embodiment 30 of the medical system 10 prior to finger engagement. The embodiment 30 includes a casing member 32 which is a pen like tubular cylindrical member, and a core portion 34 disposed therein. A button member 36 in¬ cludes two downwardly extending members 38 and 40 al¬ though the button action could be side actuated. An outer spring 42 is disposed between members 38 and 34, and an inner spring 44 is disposed between members 34 and 40. The outer spring 42 is held in position by members 68 and 70. The internal actuating spring 44 is held in position by the lower member 70 and the top of the button 36. Member 74 further limits travel of the button 36 in an upward manner and member 75 limits travel downwardly of button 36. Latch 76a and 76b provide for securing of the diaphragm housing core 46. Latches 47a and 47b are disposed at the lower portion of the downwardly extending member 40. A diaphragm housing core 46 positions in notches 48a and 48b in core part 34. A diaphragm 49 fits

SUBSTITUTE SHEET over the diaphragm housing core 46. An optical measure¬ ment means includes a light source such as LED 50 and a light sensor such as phototransistor 52 mounted in an ad¬ jacent and opposed relationship with respect to each other on the walls of the diaphragm housing core 46. The LED 50 and phototransistor 52 connect to an electronics unit 54, as later described in detail. The electronics unit 54 is powered by a battery 56 held in position in battery housing 58 by battery lid 60. A visual display, such as a LCD display 62, positions in a LCD housing 64 and is held therein by a clear viewing lens 66. The dis¬ posable probe package 12 includes a needle 90, a probe like supporting structure 92, and a reagent strip 94. The strip 94, while shown in a horizontal configuration, can be in other configurations such as vertical, etc. Release tube 96, which provides means for releasing actu¬ ator spring 44, positions in the lower portion of casing 32 and engages the inner surfaces of latches 76a and 76b. FIG. 5 illustrates an electrical schematic block di- agram 100 of the electrical circuitry for the electrome¬ chanical structure of FIG. 4. A microcomputer 102 or custom integrated circuit controls operation. A crystal 104 provides the clock signal to the microcomputer 102. A start switch 106 is actuated upon the pressure of the disposable needle 12 against the skin through pressure. An operational amplifier 108 takes an analog signal through to an A/D converter 110. A controller 112 con¬ trols power to the op amp 108 and the A/D converter 110. A piezo electric chiming at preset times for medical readings. Switches 98a and 98b set the time. A personal computer 114 can connect by a cable 116 to a plug 118 for outputting stored readings. A recall switch 120 recalls each previous reading as the switch is depressed. A voice synthesizer can also state the reading, the time,

SUBSTITUTE SHEET and the day. The microcomputer stores software to verify the electronics, verify the calibration procedural steps, and controls the measuring of the qualities as predeter¬ mined by the software commands. A power wake up switch or photoswitch 124 turns on the electronics when a probe 12 is inserted into the pen 10.

MODE OF OPERATION The operation of the hand-held portable medical diagnostic system 10 will now be described in detail, particularly with later reference to sensing of glucose for an insulin type of diabetic individual. This is by way of example and for purposes of illustration only and not to be construed as limiting of the structure or mode of operation of the present invention. Pushing button 36 loads inner actuator spring 44. The push button 36 locks in place by latch 47a and 47b and holds spring 44 in the compressed state as shown in FIG. 4. Diaphragm 49 is thereby compressed by diaphragm tensioner-51 which is a small projection on the central portion of core 34. By pushing the release tube 96 up¬ ward with an individual's finger, from which blood sample is to be taken, latches 76a and 76b are opened, and core 34 is forced downwardly by action of the inner actuator spring 44. Downward movement of core 34 drives the di- aphragm housing core 46 with the probe 12 /and needle 90 downwardly and simultaneously begins to load outer spring 42. Needle 90 punctures the finger. Downward motion of core 34 opens latches 47a and 47b so that ^'push button 36 can return to its neutral position by being forced upward by further expansion of inner spring 44. Outer spring 42, coaxial to inner spring 44, then can push core 34 up¬ wardly which releases the diaphragm 49, and creates a vacuum in diaphragm housing core 46. The \ vacuum draws blood up from ruptured -capillaries in the finger through

SUBSTITUTESHEET the needle 90 into the probe 92 whereupon the blood wets the reagent strip 94. Further upward movement of core part 34 pulls the diaphragm housing core 46 upward so that probe 92 and needle 90 retract from the finger. The diaphragm housing core 46 is then locked in place by the latch 76a and 76b, all mechanical action ends, and all elements are in a neutral position. The blood sample on reagent strip 94 is processed by chemical reaction inside reagent strip 94, and color change of strip is read from the opposite side of reagent strip 94 by reflection of light from LED 50 to the phototransistor 52. The signal is processed in electronics of FIG. 5 as later described in detail, and converted into a numeric value subse¬ quently displayed on LCD 62 which reflects the glucose level of the blood sample. The disposable probe 12 is removed from the device by pulling of the probe causing the skirt of casing member 32 to expand, freeing the probe from the socket..

Further operation of the system is now described. A user attaches a Med-Point probe 12 to the Med-Pen system 10 which accomplishes two functions. The first is the Med-Pen and Med-Point are engaged and made ready for use. The second is the sensor(s) can sense predefined color bands/areas located inside Med-Point as the pen and point are mated, thus automatically calibrating through an al¬ gorithm in the software. This self calibration ensures accuracy of measurement before each use; eliminates the need for operator intervention and operator induced er¬ ror; verifies that the chemical reagent inside Med-Point is the correct color, i.e., unreacted; and, causes the Med-Pen to provide a visual and/or audible alarm if the calibration "acceptance criteria" in the software is not satisfied.

SUBSTITUTESHEET The user places Med-Pen/Point on one's finger or other area from which blood sample is to be taken. The user pushes down one end of Med-Pen and holds down until a tactile response indicates Med-Pen/Point may be re- moved. The tactile response may be in various forms such as mechanical click from detent action or even an audible beep.

Med-Pen/Point performs all operations in the proper sequence and does not require user intervention. A blood sample is transported by vacuum and/or capillary action to the chemical reagent, and/or chemical reagent is transported to the blood sample on surface/within finger or other areas. The vacuum is created by the mechanical action/design of components in the Med-Pen probe. The capillary action is created by the physical dimensional design of the Med-Point probe as later described. An in¬ ternal clock/timer in the computer is initiated on pres¬ sure being exerted in the system. The chemical reagent reacts with blood/glucose. The electronic sensor(s) can detect coloriometrically and/or photoimetrically the amount of glucose present in the blood sample by measur¬ ing the change in color of the chemical reagent and/or the conductivity/impedance of the chemical reagent, re¬ spectively. The chemical reaction between the reagent and the blood/glucose is time dependent. Multiple mea¬ surements are made at specified time intervals as dic¬ tated by an internal clock, thus achieving three results. There is improved accuracy due to the resolution of the measurements over shorter time intervals rather than a single measurement at (x) seconds as in the prior art. There is improved accuracy because multiple measurements can be averaged optionally throughout the high/low read¬ ings, etc. for linear or non-linear reactions and/or equations. There is faster response time for operator

SUBSTITUTE SHEET use; i.e., one doesn't have to wait 30-60 seconds for a reading. The system takes early readings and extrapo¬ lates. The Med-Pen system electronics converts the ana¬ log data to digital format, and displays a quantitative digital readout of glucose in whole blood expressed in mg/dl or MMOL/L.

The accuracy and precision of measurements is fur¬ ther enhanced because the chemical, reaction of the chemi¬ cal reagent is stabilized. The Med-Point housing or self-contained housing for the reagent chemistry can pro¬ vide a barrier that insulates the chemical reagent from those parameters that accelerate the reaction; i.e., light, moisture, contaminants from fingertips such as salt, fluoride, etc. The electronics operates on the reflectance col¬ orimeter principal where the blood on th.e reagent strip undergoes a colorimetric or potentiometric reaction pro¬ portional to the blood glucose concentration. The elec¬ tronics provides verification of the system, the chem- istry of a reagent of an unused strip, the presence of a blood sample, and provides multiple readings to average the results. Several readings can be taken at specific intervals shortly after the blood reacts with the reagent strip. Once two measurements are made at two distinct time periods, the slope of the reaction of the chemistry can be calculated towards determining an actual final glucose value. In the alternative, the software of the microcomputer can control predetermined samplings at predetermined time intervals and average the result to determine the final glucose reading after a predetermined time period, such as 60 seconds. This improves the accu¬ racy of the final reading. The readings can also be stored and either recalled by a switch on the side of the pen, or recalled by connecting the pen through an inner-

SUB_STITUTESHEET connecting cable to a personal computer for outputting the readings for specific times on specific days to a video display or stored for subsequent display or print¬ outs. DESCRIPTION OF ALTERNATIVE EMBODIMENTS

FIG. 6 illustrates a cross-sectional view of a sec¬ ond embodiment of a medical pen 130. The medical pen 130 includes a housing 131, a button structure 132 including a spring seat 134, a central core 136 including a detent 137, a spring seat 138 and a rolling diaphragm 140 con¬ nected between points 142 and 144 of the core 136. Vertically linerally aligned upper actuator spring 146 and lower spring 148 are between spring seats 134 and 138, respectively, and 138 and 150. Upper latch 152 and lower latch 154 engage at point 156. A latch 158 is part of housing 131. A push button extension 160 extends downwardly from the push button 132. The electronics in¬ clude a battery 164, a battery cover 166, and the micro¬ computer assembly 168. An LCD display 170 mounts to the internal portion of a battery cover 166 and includes a clear lens 171. A combined optical sensor 172 provides for illumination, as well as detection, of the color of the chemical change. A release tube 174 includes catches 176 and 178. A probe structure 180 includes a needle 182 and a reagent strip 184 and a probe housing 186.

MODE OF OPERATION

Pushing the button 132 downwardly loads spring 146 and locks button 132 in place by action of latch 158 in detent 137. Air inside button 132 is pushed out through core 136, the porous reagent strip 184, probe 186, and the needle 182. The finger from which blood sample is to be taken pushes the release tube 174 upwards, latch 158 is opened so that loaded actuator spring 146 can drive

SUBSTITUTE SHEET the core 136 down which loads spring 148 and drives nee¬ dle 182 of probe 186 into finger. Needle 182 ruptures capillaries in finger. When the core 136 has moved all the way down, latch 154 clips into a detent 151 and re- leases the latch 152 from engagement at point 156. This releases button 132 which is forced back to the neutral position by spring 146. Upward movement of the button 132 creates a vacuum inside button 132 and the core 136 by action of rolling diaphragm 140, that vacuum then reaches probe 186 and needle 182 through porous reagent strip 184, thus sucking blood from capillaries in the finger into the needle 182 through the probe 186 so as to wet the reagent strip 184. Extension 160 of button 132 retracts latch 154 from detent 151 after a mechanical de- lay and finite time delay defined by distance between latch 158 and extension 160, thus releasing core 136 which is forced upwards by spring 148 which is then locked in place by latch 158. This action retracts, probe 186 with needle 182 from finger. The blood sample on the reagent strip 184 reacts with the reagents in the reagent strip 184 and the re¬ sulting color change is read from the opposite side by optical sensor 172, whose signals are converted by elec¬ tronics into a numerical readout on display which re- fleets the glucose level of the blood sample. Disposable probe unit 180 is then removed from device.

DESCRIPTION OF ALTERNATIVE EMBODIMENT FIG. 7 illustrates a cross-sectional view of a third embodiment 200." The medical pen 200, an alternative embodiment, includes a casing 202, a spring tensioner 204, a spring 206, a diaphragm tensioner 208, a diaphragm plunger 210, a diaphragm 212, all positioned about a di¬ aphragm housing core 214. This embodiment operates with a single spring 206, which secures between the spring

SUBSTITUTESHEET tensioner 204 and the diaphragm tensioner 208. A slide button 216 secures to the diaphragm tensioner 208. The spring tensioner 204 includes an extension 218 extending downwardly therefrom. The diaphragm tensioner 208 in- eludes upper latches 220a and 220b and at junctions 228a and 228b. The probe 234 includes a needle 236 and a reagent strip 238. The electronics include an optical sensor 240, electronic circuitry 242, a battery 244 with a battery cover 246, and an LCD display 248 with a clear lens 250.

MODE OF OPERATION

The probe 234, needle 236, release tube 224, and reagent strip 238 are a single disposable unit which is inserted into the socket in the pen 200. Upward thrust of extension 218 at release tube 224 during insertion pushes spring tensioner 204 upward which loads spring 206. The disposable unit 234 locks into place by action of latch- 222a and 222b. Upward thrust of a finger• from which blood sample is to be taken opens junction 228a and 228b between release tube 224 and probe 234 because probe 234 stops at the fixed diaphragm housing core 214. Sudden release of the release tube 224 drives the needle 236 into the finger where it ruptures capillaries. At its upper stop, release tube 224 opens latch 220a and 222b on diaphragm tensioner 208 which is forced upward pulling diaphragm tensioner 208 which is forced upward pulling the diaphragm plunger 210 and the diaphragm 212 upward, thus creating a vacuum inside fixed diaphragm housing core 214. The vacuum reaches needle 236 through diaphragm housing core.214 and draws blood from the fin¬ ger through the needle 236 which wets the reagent strip 238.

The pen 200 has to be manually removed from the fin¬ ger and reset by means of the slide button 216. The

SUBSTITUTESHEET color change of reagent strip 238 is read from the oppo¬ site side by the optical sensor 240, and the electronics unit 242 converts the color change into a numerical read¬ out on the display 248. DESCRIPTION OF ALTERNATIVE EMBODIMENT

FIG. 8 illustrates a cross-sectional view of a fourth embodiment of a pen 250. The pen 250 includes a casing 252, a diaphragm plunger 254, a diaphragm ten¬ sioner 256, and a ^'diaphragm 258. The diaphragm housing core 260 supports the diaphragm 258. Upper latch 262 and lower latches 264a and 264b secure to the diaphragm ten¬ sioner 256. A slide button 266 also mounts on the di¬ aphragm tensioner. Internal to the casing 252 are the electronics 268, a battery 270, a screw-on battery cover 272, a display 274, such as an LCD display, and a clear plastic lens 276 inside the casing. Optical sensors 278 connect to the electronics 268. A disposable probe 280 including a needle 282 and a release tube 284 having latch detents 286a and 286b secured to latches 264a and 264b at junctions 288a and 288b. A reagent strip 290 mounts in the probe housing 292.

MODE OF OPERATION FIG. 8 illustrates the diaphragm tensioner 256 being pushed downward, thus depressing diaphragm 258. / Diaphragm tensioner 256 locks into place by the latches 262a and 262b. Probe 280 with the needle 282 and release tube 284 are then inserted and held in place by latches 264a and 264b. Upward thrust of the finger breaks the junction 288 between the probe 280 and the release tube 284 which exposes the ^"needle 282. The needle 282 punc¬ tures the finger rupturing the capillaries. At its upper \ stop, the release tube 284 opens the latches 262a and n the diaphragm tensioner 256 so that by action of

SUBSTITUTESHEET the elastic diaphragm 258, the diaphragm tensioner 256 is pushed back. This creates a vacuum in the diaphragm housing core 260 which sucks blood from finger through needle 282 into the probe 280 where the blood wets reagent strip 290. The pen 250 is then manually removed and reset by means of the slide button 266 before the next use. The blood is chemically processed on the reagent strip 290 whose color change is optically read from the opposite side and converted in the electronics unit 268 into a visual readout on display 274. Probe 280 with release tube 284 and needle 282 are held by fric- tional engagement until removed and disposed of.

DESCRIPTION OF ALTERNATIVE EMBODIMENT FIG. 9 illustrates a cross-sectional view of a fifth embodiment, a capillary action medical system 300. The capillary action medical system 300 includes a case 302 with a tope 304, a knob 306 with a shaft 308, and a plunger 310 fits through a hole 312 in the top 304. A button 314 pivots about a point 316^* and includes a latch 318. A lance holder 320 includes a lance 330 therein. An upper spring 332 fits between the top 304 and the top of the plunger 310. A lower spring 334 engages between the bottom of the lance holder 320 and surface 336. A probe 340 includes a capillary duct 342 and a reagent strip 344 therein. Optical sensor 346, microprocessor electronics 348 and an LCD display 350 mount on a board 352. A clear lens 354 fits into the case 302. Likewise, a battery 356 applies power to the electronics unit 348 and includes a battery cover 358. MODE OF OPERATION

Pulling upwardly on knob 306 loads actuator spring 332, and the plunger 310 then locks in place by latch 318. Disposable unit 340 consisting of the lance 330,

SUBSTITUTESHEET probe 340 and reagent strip 344 insert into the system 300. The top end of lance 330 is held by lance holders 320. Pushing the button 314 releases the latch 318. The plunger 310 is forced down, hitting lance holder 320. The lance 330 punctures the finger and ruptures capillary blood vessels. By action of the spring 334, the lance holder 320 returns immediately to its neutral position, retracting the lance 330. Blood starts accumulating in the wound channel, and forms a drop on the skin's surface which is drawn into capillary duct 342 by capillary ac¬ tion. Blood rests on the reagent strip 344 and starts the chemical reaction. Color change is then read from the opposite side by the optical sensors 346 connected to the electronics unit 348. The electronics unit converts signals to a digital readout on display 350.

ALTERNATIVE EMBODIMENTS OF MED POINT FIG. 10 illustrates a sectional view of a first embodiment of a medical point 400. A release tube 402 triggers a mechanism in the system 10 which drives a nee- die 404 into the finger thereby rupturing capillary blood vessels. The blood which accumulates in the wound chan¬ nel is drawn through the needle 404 into a probe 406 by a vacuum generated in the system, and subsequently onto a reagent strip 408 which can be porous. FIGS. 11-12 illustrate a sectional view of embodi-?' ments of a medical point 420 having a release tube 422 which is triggered by the system which drives the needle 424 into the finger, thereby rupturing capillary blood vessels. The needle 424 is then retracted half-way in order to allow the blood to accumulate in the wound chan¬ nel and to avoid being obstructed by the tissue. The blood which, accumulates in the wound channel is theri drawn through the halfway withdrawn needle into the probe's

SUBSTITUTE SHEET 426 by the vacuum generated in the device and onto the porous reagent strip 428.

FIG. 13 illustrates a sectional view of a third med¬ ical point embodiment 440 where the needle 442 includes a side hole 444. The needle includes a side hole which provides that the blood can be drawn despite a poten¬ tially plugged tip of the needle such as by skin or flesh.

FIGS. 14-15 illustrate sectional views of a fourth medical point embodiment 460 where a needle 464 is en¬ closed by a side guide tube 466. The side guide tube touches the surface of the finger. After puncturing the finger, the needle 464 is fully retracted in the guide tube 466 and blood is drawn in through the guide tube and the needle as illustrated in FIB. 15. In the alterna¬ tive, a lance can be utilized in lieu of the needle of FIGS. 14 and 15. The lance can even include a side hole to act as a carrier for carrying the blood in the side hole of the lance. FIG. 16 illustrates a plan view of a self-calibra¬ tion medical point which includes automatic calibration strips for the optical sensors and microcomputer in the system. The medical point 500 includes color strips 502, 504, and 506 about a probe housing 508. Color strips 502-506 have different shades of grey which reflect three defined levels of glucose in the blood for purposes of calibration. During insertion of the Med-Point, the color strips are read by an optical sensor unit 514. Signals are coupled to the electronics unit for calibra- tion of the Med-Point 500 prior the Med-Point reaching its final position. In the final position, the sensor 514 reads the strip 510, which is impregnated with blood through the needle 512.

SUBSTITUTE SHEET FIG. 17 illustrates a section view of a medical probe 540 including an optical sensing unit 548 with con¬ tacts 550 and 552 mounted in a probe housing 542. A nee¬ dle 544 connects to the reagent strip 546. The optical sensing unit 548 reads the reagent strip and provides electronic information to the Med-Pen device. The metal¬ lic contacts 550 and 552 connect the sensing device to the electronics in the Med-Pen. The entire unit is con¬ sidered disposable based on low cost of volume integrated circuits.

One alternative embodiment of the present invention is that the blood chemistry can be positioned at the site of the blood rather than taking the blood to the blood chemistry reagent strip. Disposable structures can be provided which would snap in place, although a needle or capillary action would not be required in that the reagent strip would touch blood located on one's skin and commence the process. The mode of operation would be that as previously discussed in pushing the system down- wardly so that the release tube would apply upper pres¬ sure causing a reagent strip to come into contact with the blood. While all of the previous embodiments have illustrated the blood flowing to the chemical sensing reagent strip, the alternative embodiment can take the reagent strip to the blood, such as by having the reagent strip positioned on a lower portion of the disposable probe. The permutations of whether the blood is taken to the reagent strip or the reagent strip is taken to blood, is illustrated in FIG. 18 in a flow chart diagram. The teachings of the present invention can be expanded such as by having the probe include structure for first prick¬ ing and bringing blood from below the skin to the surface of the skin, and then having structure for moving the

SUBSTITUTE SHEET reagent strip to the blood on the surface of the skin for subsequent transfer of the reagent strip to the blood.

FIG. 18 illustrates the flow chart of the blood or liquid flow in the system. The permutations are outlined in the figure. Another permutation is wicking action which can occur where the blood or liquid is delivered to the chemistry by wicking action or by other processes such as vacuum action, capillary action, natural flow, absorption, or any other flow or transport process. DESCRIPTION OF MEASUREMENT SYSTEM WITH DISPOSABLE

DIAGNOSTIC POINT UNIT FIG. 19 illustrates a perspective view of an embodi¬ ment of a measurement system 600 of the present inven¬ tion, including a slidable disposable diagnostic point unit 602, as later described; The housing 603 is rectan¬ gular so as to conveniently accommodate flat pack IC's such as memory. Preferred dimensions are 130mm length by 24mm width by 12mm depth providing a pocket profile by way of example. A battery housing 604 frictionally and electrically engages on the top of housing 603, such as by a snap fit, although other engaging structures can be utilized. A cap 605 carrying a pocket clip 605a engages into the battery housing. A LED display 606 displays the measured quantity, such as glucose. A sliding door 608 in opposing grooves 609a and 609b actuates the electron¬ ics, as well as cocking a hammer mechanism, as later de¬ scribed. An actuating button 610 releases the hammer mechanism thereby actuating the lance, as later de¬ scribed. A protective cover approximating the size and shape of point 602 slides into opposing point receiving channels 611a and 611b when a diagnostic point 602 is not inserted into the channel. LED source 612 and photodiode sensor 614 position in the housing, as illustrated in

SUBSTITUTESHEET FIG. 20, and corresponds to the electrical circuitry of FIG. 5. Sliding door 608 activates the start switch 106 of FIG. 5.

FIG. 20 illustrates a sectional view of the dispos- able diagnostic point unit 602 for the system of FIG. 19. The point 602 includes a housing 630, an opaque top cover 632, and an opaque bottom cover 634. A hammer aperture hole 636 is disposed opposite of which aperture hole 638. A lance 640 with a point 642 and including a spring mem- ber 644 secures at one end to the housing 646. Wick mem¬ ber 648, as later described in detail, mounts between members 632 and 634 and within housing members 630a and 630b. The wick 648d transports by wicking action blood or liquid from the lance 640 to a reagent strip 650 pro- tected by a transparent plastic cover 652 where LED 612 and phototransistor 614 measure readings to be processed by internal microprocessor circuitry, as shown in FIG. 5. Optional foil covers 654 and 656 with peel off adhesive can be applied to the top and/or bottom covers 632 and 634 providing sterility for the lance 640. Also, the wicking material member 648 can provide4 sterility pro¬ tection to the lance by not having an aperture hole in the material where the material would be a solid piece or material. The wick aperture 638, which is optional, and cover aperture 657 position over the finger in this exam¬ ple for taking a blood sample for determining glucose levels as illustrated in the figure. In the alternative, the apertures could position over an other article for a quantitative analysis, such as a grape, an animal, a so- lution in an industrial setting, etc.

FIG. 21 illustrates an end view in partial cross section of the diagnostic point unit 602 where all numer¬ als correspond to those elements previously described. The opposing channel members 658a and 658b provide for

SUBSTITUTE SHEET insertion into channel receptors 611a and 611b and the lower recess area of the rectangular housing 603.

FIG. 22a and 22b are a system performance chart of events corresponding to the graphics of FIG. 3. MODE OF OPERATION

The disposable diagnostic point unit provides for personal hygiene and an infection barrier, in that the only part touching the patient is the wick portion of the diagnostic unit 602. The wick portion can be sterilized prior to usage and protected by at least one if not two foil covers 654 and 656 with peel off adhesives. The di¬ mensions of the wick material, as well as the wick mate¬ rial itself, are chosen such as to transfer a minimal amount of fluid from the skin puncturing lance 640 to the reagent material 650. The reagent material 650 is of such a minimal size so as to provide a sufficient photo- diode illumination, as well as viewing area. The lance 640 is driven by a hammer cocking mechanism, such as those previously described in FIGS. 4, 6', 7, 8, or 9, to a penetrable depth which can include two settings, one for a child and one for an adult. The specific setting requires deliberate action by an individual. The medical system itself is rectangular in cross-section and light tight for accurate photodiode viewing. The battery hous- ing 604 provides easy replacement of the batteries with¬ out even requiring any tools whatsoever.

The sliding door 608 of the diagnostic point unit provides for: 1. insertion and removal of either a pro¬ tective cover or the disposable diagnostic point unit; 2. cocking of the hammer mechanism; and, 3. activation and setting of the electronics including providing: a) power on condition, b) automatic calibration of the electron¬ ics, c) a provision for an audio beep from an acoustic piezo electrical transducer as illustrated in FIG. 5, and

SUBSTITUTESHEET d) a visual display of a power condition corresponding to graphics on the side of the system, as illustrated in FIG. 2.

The relevant graphics, as well as the event, audio beeps and visual display are further described in FIGS. 22a and 22b with respect to the operation of the medical system or measurement system which are synonymous, and each providing a readout of quantity of a specific qual¬ ity which is to be measured. When the hammer mechanism is armed by the sliding door, the push button provides for releasing of the ham¬ mer and driving of the lance into the finger once a dis¬ posable diagnostic point unit 602 has been inserted into the channels 611a and 611b and positioned into place. The protective cover must be removed, the sliding door moved downwardly and then upwardly to cock the hammer, as well as activate the electrical circuitry for self-cali¬ bration as well as measurement, and subsequent insertion of a disposable unit for providing for release of the hammer cocking mechanism which further activates the electronics out of the calibration mode into the sensing mode for photodiode viewing and subsequent computation of the characteristics of the material.

Previously, the electronics has provided for self- calibration through measurement of a predefined color standard, as well as a battery check. After read out is provided of the quantity, such as the glucose level, a button can be pushed to provide the previous readings. The medical system of FIGS. 19-21 provide for slidable action of the disposable diagnostic point unit 602 into a channel, slidable action of a sliding door 608 for the actuation of the electronics, as well as cocking of the hammer, and a push button 610 action for actuation of the hammer.

SUBSTITUTE SHEET The wicking unit 648 can include the adhesive-back foil which stabilizes the enzyme in the reagent. The wick 648 can also act as a sterility barrier. The wick can be embedded into a capillary tunnel which operates under an absorption principle. The lance 640, which con¬ nects into the housing 630, will include a spring action which is dependent upon the spring modulus of the lance or needle, which includes a right angle or other angular bend between the spring arm and the point. The wicking material 648 will be adjacent to pick up and transporting of the blood from the lance 640 or needle to the reagent strip 652 through a filter 650 for red blood cells. While the wick 648 has been disclosed as having an aper¬ ture 638, depending upon the type of specific wicking ma- terial, it may not be necessary to have an aperture in the material as the lance 640 or needle could puncture through the wick 648.

FIGS. 22a and 2-2b illustrate a flow chart including corresponding column entries to graphics of FIG. 2; events; audio beeps, as well as visual, displays corre¬ sponding to the electronics of FIG. 5; and the duration, as well as application notes. The events, as well as the display duration and application notes, are explanatory in operation of the medical system or measurement system. The system performance chart provides for operational events of the system.

Finally, the wicking action can have a dual purpose in that the wick material can provide a filter media for separating components of a liquid or fluid, in addition to being a sterility barrier for a sterilized needle or lance. One such example of the wicking material acting as a filtering media may be where the wicking material separates certain components of the blood from other com¬ ponents of the blood, by way of example and for purposes

SUBSTITUTESHEET of illustration and not to be construed as limiting of the present material. The wicking material can serve more than one purpose, such as wicking for transporting of fluid to chemistry such as a reagent strip, but also can serve as a filter, as well as a sterility barrier.

SUBSTITUTESHEET

Claims

Having thus described the invention, what is claimed is:

1. Hand-held pocketable measurement system including: a. rectangular housing member including spring ac¬ tuated hammer means contained therein for actu¬ ating downwardly at a predetermined pressure, microcomputer means contained therein, and electromechanically connected to said hammer means, electrical sensing means connected through an A/D converter to said microcomputer means, display means connected to said micro¬ computer means providing visual readout of qualitative analysis of said electrical sensing means, and said member including channel means; and, b. disposable diagnostic unit including a housing member with opposing tabs for engaging in said channel means, reagent chemistry supported ei- ther in a horizontal to vertical configuration therein, a springy lance means for withdrawing a substance and supported in said housing, and wicking transportation means for carrying said substance from spring means to reagent means whereby said springy means drives into an ob¬ ject causing a substance to flow to said reagent chemistry causing chemical reaction and subsequent color change of said reagent chem¬ istry for color change as sensed by said elec¬ tronic sensing means thereby providing qualita¬ tive readout on said visual display means.

2. System of claim 1 comprising: a. means for cocking said spring actuating hammer means; and,

SUBSTITUTE SHEET b. means for turning on said electronics and cali¬ brating said electronics prior to actuating of a spring release means.

3. Disposable diagnostic unit comprising: a. housing; b. springy puncturing means supported in a portion of said housing; c. reagent means supported in a portion of said housing; and, ^• d. means for transporting a substance from said puncturing means to said reagent means.

4. Unit of claim 3 wherein said puncturing means is a needle.

5. Unit of claim 3 wherein said puncturing means is a lance.

6. Unit of claim 3 wherein said reagent strip is at a substantial right angle with respect to said punc¬ turing means.

7. Unit of claim 3 comprising calibrating means in said unit.

8. In combination, a hand-held pocketable medical diagnostic system comprising: a. slidable disposable diagnostic unit including springy means for drawing a sample of blood from a finger, wicking means for transporting blood from below said finger to a reagent strip, and chemical on said reagent strip for reacting with said blood and changing to a pre¬ determined color on reaction; and, b. rectangular medi.cal housi.ng i.ncludi.ng light emitting diode and photocell sensor positioned adjacent said reagent strip, A/D converter con¬ nected to said photocell sensor, visual display means connected to said A/D and converter.

SUBSTITUTE SHEET power source means connected to said A/D con¬ verter and visual display means, and cockable hammer means for driving said spring means downwardly into the finger.

9. Process for measuring a blood quality compris¬ ing the steps of: a. sliding a disposable unit into a hand-held pocketable medical system; b. engaging the medical system including the dis- posable unit against an individual's skin; c. transporting blood outside of the individual's skin for qualitative analysis by blood sensing chemistry carried by the disposable needle package; and, d. reading the qualitative results on a display of the hand-held pocketable medical system.

10. Process of claim 9 wherein said transporting action is by wicking.

SUBSTITUTE SHEET