JPS61286738A - Medical system - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a medical system for sampling and analyzing blood or its constituent components in order to make specific decisions regarding the properties of the blood.

A particular use of the invention is to detect glucose accumulation in the blood due to diabetes. The system is a portable, pocket-sized, electrically powered diagnostic system for detecting and measuring blood characteristics and other predetermined characteristics.

In the prior art, devices for detecting glucose in blood operate on the principle of taking blood from an individual by various methods, such as, for example, by a needle or a lancet. The individual then applies the blood to the chemical-containing strip and inserts the blood-applied strip into a glucose meter or makes a visual comparison against a color standard.

Although there are various devices on the market for measuring blood glucose, they are not portable and require a large amount of space. These devices are typically carried in large handbags or personal briefcases, or must be left at home, such as in the bathroom or bedroom. Furthermore, conventional devices for detecting glucose in blood required the following conditions.

That is, an individual may use a needle to extract blood or
a lancet and a strip having a blood chemical for producing a chemical reaction in association with glucose in the blood and causing a change in color; and also a color indicating the level of glucose in the blood. It must be used separately from a blood glucose measuring device to read changes in blood glucose.

When measured by a glucose meter, the level of glucose in the blood is read from a chemical strip by a conventionally known process using a reflectometer to measure the oxidation of glucose.

The monitor or reagent strip systems currently available on the market have a large number of sequential steps that the patient must follow at precise time intervals. Each step follows the error caused by the patient. For most monitors, the efficacy of the reagent strip is checked by periodically calibrating the monitor against a known color standard and by dipping the strip in a known dextrose-containing conditioning solvent; It is the patient's responsibility to visually compare color changes by utilizing the color reference or calibrated monitor.

In the prior art, the procedure for obtaining accurate results from the time a drop of blood is placed on a reagent strip until the change in color of the strip is read by a monitor is as follows.

First, the patient inserts the lancet into himself or herself. A drop of blood must be squeezed out onto the surface of the skin. This drop of blood is carefully placed onto a reagent pad, which is then checked to ensure complete coverage and which is touched again by the patient's finger to prevent it from contaminating. Once the sample is placed on the surface of the reagent pad, the patient presses the monitoring timer. Over time, the patient must use careful technique to wipe, blot or clean the debris.

For most strips, the patient places the reacted reagent strip on the monitor, presses the test button or closes the hatch, and obtains the results. Prior art reagent strips or monitors that are commercially available require operator involvement because they require predetermined continuity at precise time intervals. With conventional technology, operator error,
Continuity, time intervals and technical errors must be followed. Prior art reagent strips are also susceptible to contamination, which affects accurate measurements.

The present invention has been made to overcome the aforementioned disadvantages of the prior art and includes a package of wearable and disposable needles having chemical reagents for extracting blood from an individual. It is an object of the present invention to provide a portable medical system for supplying blood detection reagents from or to blood in a possible needle pancage and for obtaining a reading of the level of glucose in the blood, for example. shall be.

This system includes a microcomputer with software controlled by an internal program, and conditions can be provided to programming external to the microcomputer. Computers control all timing functions, which eliminates human errors.

The medical system according to the invention is rectangular in shape and includes a slidable diagnostic needle head for measuring a predetermined amount of a reagent strip that causes a reaction.

The general object of the present invention is to detect and measure certain selected chemicals or their substitutes for diagnostic purposes and/or treatment of diseases.
Another object of the present invention is to provide a diagnostic device/or system that is sized to fit in a portable shirt pocket used by a patient and is powered by a battery. Applications of the device are not limited to use on humans.

The device according to the invention can also be extended to animals treated by veterinarians and can also be used in the agricultural field, such as in the determination of glucose content in grapes in wineries.

In a first application, the device can be used to collect lymph plasma and/or
Or it can be used for insulin-related or non-insulin-related diabetes to measure glucose in whole blood. The specific amount is the amount of glucose to be measured by an electrical circuit using reflection, absorption, or position principles.

Of course, other quantities can also be measured.

Another object of the invention includes an engageable and disposable needle or lancet having chemicals for blood detection reagents, for detecting blood-related parameters such as, for example, the level of glucose in the blood. The purpose is to provide a portable medical system or measurement system. This medical system is cost effective and simple in structure for individual use.

Judgment information such as an individual's glucose level is stored in a ring-shaped pen body or a
The display is displayed by a liquid crystal display located on the side of the rectangle. In this case, the body of the pen is approximately the size of a regular fountain pen that can be carried in a person's shirt pocket.

The disposable needle head package can be carried by a hollow, annular pencil member having a plurality of disposable probe packages that can be used as needed. An annular or rectangular structure resembling a pen includes a portable medical system;
Also, an annular or rectangular structure similar to a pencil carries a disposable needle head for refills. Pen and pencil-shaped shapes have the most calming effect on individuals.

According to one embodiment of the invention, in a disposable needle head or lancet pancage, a sample of the inside of the finger or the surface of the finger is used for driving the needle head and for chemical reagents for blood detection. A portable medical system is provided that includes a mechanical or electromechanical pen-shaped structure capable of transferring blood or transferring said blood detection chemical to blood. .

The mechanical structure can be of various shapes driven by an elastic body. Additionally, this mechanical structure creates a vacuum to draw blood to the outside of the finger. the needle head package is operatively engaged to the bottom of the annular portable medical system, for example by snapping into place or the like;
It can be easily opened and disposable after one use. This portable medical system not only analyzes the characteristics of detected chemicals in blood, but also displays and stores the results in a disposable needle head package. It includes a photoelectric detection element connected to a microcomputer or integrated circuit. The photoelectric sensing element evaluates electrical operability, including detecting conditions of reduced battery function, evaluates the condition of an unused disposable needle head package, evaluates the presence of a blood sample, and It includes an evaluation sequence that is followed by a number of decisions provided to average the results.

Results are not displayed until the qualitative sequence progresses continuously through the evaluation.

According to another embodiment of the present invention, there is provided a diagnostic unit that performs a suction or wicking action. Here, the wicking action acts as a transport mechanism for the blood. The suction action acts as a disinfectant protector for the disinfected needle head or lancet. Further, the wick has a predetermined angle with respect to the needle head or lancet, and performs an absorption function through the wick material.

The features of the present invention are as follows:
The purpose of the present invention is to provide a portable medical system or measurement system referred to as a "quit". The Medven or Mendopen Mosquito is used to extract blood from the human body to obtain blood samples for chemical analysis and to display individual results. A disposable needle head package, hereinafter referred to as a metpoint, consists of a strip of reagent containing a blood detection chemical and a blood supply to said chemical or a chemical to the blood. It carries a needle head etc. that functions as a needle. A package of surplus disposable needle heads is carried on a corresponding structure similar to the package of a medical device, hereinafter referred to as a mefdo pencil.

Another feature of the invention is a pen-shaped structure that is mechanical and operates when a predetermined amount of pressure is applied to the skin of an individual's finger. When this pressure is detected, the needle acts under the skin of the individual and then allows a sample of blood to be taken from within the finger or a sample of blood that has formed on the surface of the finger. do. Alternatively, it is also possible to press a button to cause the probe to act inside the skin.

Another feature of the invention is a portable medical system hereinafter referred to as the Mendoven Mosquito. The MedVen Mosquito provides information on glucose in the blood when the disposable needle package carries glucose oxide or similar chemicals. As a result, the blood once shows various changes in color or electrically in proportion to the concentration of glucose in the blood, and the results are displayed electrically on a liquid crystal display via a reflection colorimeter. We will post the next process for photoelectrically detecting the chemical components of blood.

Still other features of the invention can be used by an individual,
In a portable medical system that only requires engagement with a disposable needle pancage, subsequent operation of the device provides a relatively readable indication for the desired measurement.

Another feature of the invention is a measuring device that can use a slidable disposable diagnostic needle head unit. This diagnostic needle head unit has a lancet or needle head with elastic force and a transfer mechanism for transferring fluid or liquid to a reagent strip.

In the embodiments described in detail in the present invention, the basic purpose includes a package of disposable needle heads, carrying reagent chemicals for blood detection and engaging said package to characterize the blood. An object of the present invention is to provide a portable medical system capable of presenting the following materials for visual display. This medical system is a system for measuring the amount of something present in a particular fluid (
It should not be construed to be limited to medical applications only, as it is scalable and the system can be used in industrial, agricultural, or even livestock environments.

One object of the present invention is to provide a portable medical diagnostic system, referred to as a MendPenMosquito, a disposable medical needle head, referred to as a MetPoint or MetBrobe, as a needle head pancage for engaging said MedPen, and a backup and The object of the present invention is to provide a hollow pencil, hereinafter referred to as a med pencil, for carrying a package called a medpoint consisting of a disposable needle head.

The disposable needle head package carries blood detection chemicals, for example, to detect blood components such as glucose levels.

Other substances include those present in other substances such as urea nitride, hemoglobin, alcohol, proteins or agricultural products, food, etc. or present in other blood.

Another object of the present invention is to provide a reusable device that is electrically controllable and includes software programming and includes mechanical mechanisms, as well as batteries, sensors, and associated electrical circuitry. Each of the above performs the functional operation to be accomplished.

A metpoint or metdrobe typically contains a needle head or lancet that obtains a sample of blood from the human body and/or the extremities and contains chemical reagents that react with the presence of the blood as a function of the amount of glucose present in the blood. include. The chemical reagents are sealed inside a special housing for the chemical reagents to eliminate contamination from the metpoint probe housing or fingers, moisture, and effects from light. This has the advantage of achieving accurate measurements by reducing the degree of oxidation of the reagents or by stabilizing the chemical reaction before use.

In the method/point system, the sensor measures or detects the amount of glucose present chromatically and/or positionally and also analytically by absorption. This analog data is digitally converted and it becomes possible to read out the amount of glucose in mm g in a on a display device. MMOL this
/L may also be displayed.

Yet another object of the invention is to provide a self-contained automated system. Once the foot vent/point is pressed against a finger or other part, no separate operator intervention is required depending on the particular embodiment. All operation and performance of this system is accomplished automatically and mechanically or electrically with appropriate continuity. Operator interpretation, operator skill, and timing of the occurrence of events are achieved with great precision, thereby making it possible to eliminate operator control and influence in accordance with automatic action. When the system is pressed against a predetermined amount of skin surface with a certain spring force or other predetermined condition, the system automatically begins and continues to operate depending on the particular embodiment.

Another object of the invention is to provide a medical system comprising software and software intelligence. The system is self-measuring via software control instructions.

Yet another object of the invention is to provide a measurement system having a slidable disposable diagnostic point. The measurement system has a self-closing, slidable hammer, a bushing button, a release button, and a power supply carried in the upper compartment.

Other objects and advantages of the present invention will become more apparent from the following detailed description of embodiments of the invention with reference to the accompanying drawings.

FIG. 1 is a top view of a portable pocketable medical system 10 and a disposable medical probe having a needle head or lancet carrying chemicals for a blood detection reagent strip, all of which are shown in FIG. It is related to the present invention.

The portable and pocketable medical system 10 includes a tubular pen member 14 and a clip 16 secured to the head of the annular member 64. The disposable medical probe 12 is comprised of a small-diameter cylinder, and fits into engagement with a member on the cylinder at position W14, as will be explained in detail later. The visible electrical readout section 18 is composed of, for example, a liquid crystal display or an equivalent device, and as will be explained in detail later, it has a plurality of display units capable of numerically displaying blood characteristics. Includes digital display.

FIG. 2 is a front plan view of the system 10 shown in FIG. 1, including a support panel 20 that may be secured to the cylindrical annular member 14. FIG.

FIG. 3 is a perspective view of the portable and pocketable medical system 10 and the disposable medical probe 12 separated before and after use.

FIG. 4 is a longitudinal cross-sectional view showing the first embodiment 30 of the medical system 10 according to the present invention before it is engaged with a finger. This embodiment includes a pen-shaped tubular casing member 32 and a core portion 34 disposed inside the casing member 32 .

The button member 36 includes two downwardly oriented extension members 38 and 40, although button operation will occur from the side. An outer spring 42 is disposed between members 38 and 34 and an inner spring 44 is disposed between members 34 and 4.
0. The outer spring 42 is connected to the member 68
and 70 to hold it in place. Inner spring 44 is held in place by lower member 72 and the top of button 36. Member 74 restricts upward movement of button 36 and member 75 prevents downward movement of button 36.

Latches 76a and 76b are connected to the diaphragm housing core 4.
Hold 6. Latches 47a and 47b are located at the bottom of downwardly extending member 40.

Diaphragm housing core 46 is located in notches 48a, 48b in core portion 34. diaphragm 4
9 fits into the diaphragm housing core 46. The light emitting device 50 and the phototransistor 52 are mounted on the wall of the diaphragm housing core 46 in close proximity to each other and on opposite sides.

The light emitting element 50 and the phototransistor 52 are connected to an electronic unit 54. The details will be described later.

The electronic unit 54 is located within the battery housing 58 and includes one
Power is provided by a battery 56 which is held in place by I60. A visible display device, such as a liquid crystal display 62, is located within a liquid crystal display housing 64 and retained therein by a lens 66. Disposable needle head or lancet puff cage 12 displays a structure from a horizontal perspective that includes a needle head 90, a support 92 and a reagent strip 94, which strips 94, for example, when viewed from a vertical perspective. take on a different shape. Release tube 96 is positioned at the bottom of casing 32 and engages the inner surfaces of latches 76a and 76b.

FIG. 5 shows a block diagram 100 of an electrical circuit for use with the electromechanical structure shown in FIG. A microcomputer 102 or rc controls its operation. A crystal oscillator 104 supplies a clock signal to the microcomputer 102. Start switch 10
6 is driven when pressing the disposable needle head 12 against the skin through pressure. Operational amplifier 108 sends an analog signal to A/D converter 110. Controller 1
12 is an operational amplifier 108 and an A/D converter 110
Control the power to. Chimi
The piezoelectric transducer 98 for ng) is connected to the internal clock circuit of the microcomputer for chiming at preset time intervals for medical recording data. Switches 98a and 98b set the time. Personal computer 114 is connectable to plug 118 by cable 116 for outputting stored recording data. Recall switch 12
0 recalls the respective previous recorded data when the switch is pressed. The speech synthesizer is capable of vocalizing the recorded data and the passage of time.

The microcontroller stores software for verifying the electronic operation and verifying the steps in the adjustment procedure and controls the measurement of the characteristics as predetermined by the instructions of the software. A power switch or photoswitch 124 energizes the electrical circuit when the probe 12 is inserted into the interior of the pen.

The operation of the portable medical diagnostic system 10 will now be described in detail with particular reference to glucose detection for insulin-type diabetics.

This is merely an example and is disclosed for purposes of explanation only, and therefore should not be construed as limiting the structure or mode of operation of the invention.

Pressing button 36 loads internal spring 44 . Bush button 36 is locked in place by latches 47a and 47b. The diaphragm 49 is pressed thereby. When the release tube 96 is pushed upwardly by an individual's finger, a sample of blood is taken from the latch 76a.
and 76b are opened, and the core 34 is forced to displace downwardly by the action of the internal spring.

The downward displacement of core 34 loads outer spring 42 and causes diaphragm housing core 46 to move downward along with probe 12 and needle head 90. Needle head 90
makes a hole in the finger. Movement of core 34 opens latches 47a and 47b, so that bushing button 36 is forced upwardly by inner spring 44 to return to its neutral position. The outer spring 42, which is coaxial with the inner spring 44, is then attached to the core 3.
4 upwardly, thereby opening the diaphragm 49 and creating a vacuum in the diaphragm housing core 46. This vacuum draws blood from the ruptured capillary through the needle head 90 within the probe 92. At this time, the blood moistens the reagent strip 94. Furthermore, upward displacement of core portion 34 causes diaphragm housing core 46 to be pulled upwardly, thereby causing probe 9
2 and needle head 90 are removed from the finger. Diaphragm housing core 46 is then locked in place by latches 76a and 76b. That is, all mechanical movements are completed and all components return to their neutral positions.

The blood sample in the reagent strip 94 is treated by a chemical reaction inside the reagent strip 94, and the change in chromaticity of the strip is caused by the reflection of light from the light emitting element 50 to the phototransistor 52. be read.

The signal is processed by the electrical circuitry of FIG. 5, as will be explained in detail below, and converted to a numerical value displayed on the liquid crystal display 62 corresponding to the level of glucose in the blood sample. The disposable probe 12 is removed from the device by withdrawing the probe.

Furthermore, the operation of the system according to the present invention will be explained.

Medpen system 1 where users achieve two functions:
Attach the met point probe 12 to the 0. 1st
As a function of this, the MedVen and MetPoint engage each other and are thereby ready for use. The second function is the ability to detect predefined color bands or sections located within the metpoint when the method pen and metpoint are matched.

This automatically performs scale adjustments via electronic algorithms in the software. This self-calibration feature ensures the accuracy of measurements before each use, eliminates the need for operator intervention and operator errors, and ensures that the chemical reagents inside the metpoints have the correct color display, i.e. , the method pen is operative to check for non-responsiveness and to generate a visible and/or audible alarm signal if validation of acceptance criteria in the software is insufficient.

The user places the hoodben/point on the finger or other area where the blood sample is to be taken. The user presses down on the end of the Medven and holds it down until a tactile response indicates that the Medven/Point may be removed. The tactile response may take various forms, such as movement from a stop member or an audible alarm. The Hoodven/Point performs all operations in a proper sequence and requires no user intervention.

The sample of blood may be transferred to the chemical reagent by vacuum and/or capillary action, and or the chemical reagent may be transferred to the blood sample on or within the finger or elsewhere. It is. The vacuum is created by the mechanical operation or design of the Medpen probe components. Capillary action is
The method point is generated by the physical design of the probe, as described below. The internal clock/timer in the computer is started by the application of pressure in the system. Chemical reagents react with blood or glucose. The electronic sensor is capable of colorimetrically and/or photometrically detecting the amount of glucose present in a sample of blood.

This is measured by a change in the color of the chemical reagent and/or a change in the conductivity or impedance of the chemical reagent, respectively. The chemical reaction between the reagent and blood or glucose is time dependent.

Composite measurements are taken at specific time intervals as dictated by an internal clock.

This achieves three results. The accuracy is improved by following measurements over shorter time intervals rather than taking a single measurement at X seconds as in the prior art. Composite measurements are even more accurate because the data recorded at high or low precision can be averaged as a whole at any time for linear or non-linear reactions and/or parallel conditions. A rapid reaction time is obtained for operator use. In other words, for reading recorded data, 3
There is no need to wait for 0 to 60 seconds. This system provides quick reading and estimation. In the electrical circuit in the methodoven system, the analog data is converted to digital format, mu g / d! Or MMOL/L
Quantitative digital readout of glucose in the whole blood displayed by.

Due to the stability of the chemical reactions of the chemical reagents, the accuracy of the measurements must be further emphasized. Mehdpoint housing or self-contained housing for reagent chemicals has parameters to promote the reaction, i.e. light, moisture or other salts,
It is used as a protective band to separate reagents made of the above chemical substances from substances such as fluorides.

The electronic circuit operates according to the reflective colorimetric principle if the blood in the reagent strip causes a colorimetric or positional reaction in proportion to the glucose concentration of the blood. Electronic circuitry provides recorded data that is combined to confirm the presence of the system and the chemicals that make up the unused strip reagents and the blood sample and to average the results. Some recorded data is obtained at specific short time intervals after the blood has reacted with the reagent strip. Once the two measurements are taken at different time intervals, the chemical reaction trends are calculated to determine the actual final glucose value.

Conversely, the microcomputer software determines predetermined sampling at preset time intervals and ultimately determines glucose recording data after a predetermined time interval, such as 60 seconds. Average the results. This improves the accuracy of the final recorded data. The recorded data can also be stored and recalled by a switch provided on the side of the pen or via a connecting cable to output said recorded data to a video display device at a specific time on a specific day. Recalled by connecting the pen to a personal computer. Alternatively, it may be stored for later display or printing.

FIG. 6 shows a medical pen 130 according to a second embodiment of the present invention.
A vertical cross-sectional view is shown. The medical pen 130 has a housing 13
1 and a spring seat 134.
and a central core 136 including a pawl 137 and a spring seat 1
38 and points -142 and 144 of core 136 . Vertically and linearly aligned upper spring 146 and lower spring 148 are connected to spring seats 134 and 13.
8 and between 138 and 150, respectively. Upper latch 152 and lower latch 154 engage at point 156. Lunch 158 forms part of housing 131 . The extension part 160 of the button button is the button button 13
It extends downward from 2. The electric circuit is a battery 156,
Battery cover 166 and microcomputer assembly 1
68 included. Liquid crystal display 170 is attached to the interior portion of battery cover 166 and includes a fog-free lens 171 . An optically combined sensor 172 is provided for detecting chemical changes photometrically as well as chromatically. Release tube 174 includes retainers 176 and 178. Probe structure 180
includes a needle head 182, a reagent strip 184, and a probe housing 186.

In the above configuration, when the button 132 is pressed downward, a load is applied to the spring 146, and the claw 137
Button 1 in place under the action of latch 158 of
32 is locked. The air inside the button 132 is connected to the core 136, the porous reagent strip 184, and the probe 1.
86 and needle head 182.

The finger from which the blood sample is taken is the release tube 174
is pushed up, and the launch 158 is opened.

As a result, the loaded spring 146 is
is actuated downward to apply a load to the spring 148, thereby placing the needle head 1 of the probe 186 inside the finger.
Insert 82. The needle head 182 ruptures the capillary tube in the finger. As the core 136 moves downward, the latch 154 engages inside the pawl 151 and the latch 15 at point ]56
2 is released from its engaged state. This is spring 14
6 releases the button 132 which is forced toward the neutral position.

The upward movement of button 132 creates a vacuum inside button 132 and core 136 under the action of rolling up diaphragm 140 . The vacuum then reaches probe 186 and needle head 182 through porous reagent strip 134 . This draws blood from the finger capillary through the probe 186 and onto the needle head 182, resulting in wetting of the reagent strip 184.

Extended portion 160 of button 132 disengages latch 154 from pawl 151 after a mechanical delay constrained by the distance between extended portion 160 and latch 158 as well as a limited time delay.

This releases the core 136 which is forced upwardly by the sub-IJ ring 148 and is then locked in place by the latch 158. This action starts from the finger to the needle 1.
82 and the probe 186 is operated to clock out.

The blood sample on reagent strip 184 reacts with the reagent on reagent strip 184 and the resulting color change is read by optical sensor 172 . optical 1
The signal at 72 is converted by electronic circuitry into a numerical output and displayed as the glucose level of the blood sample on a display. Disposable probe unit 180 is then removed from the device.

FIG. 7 shows a longitudinal section through a third embodiment 200 of the system according to the invention. In this example, medical Ben 20
0 is a cable 202, a spring tensioner 204, a spring 206, and a diaphragm tensioner 208 is a diaphragm flange 210 is a diaphragm 212
and a diaphragm housing core 214. These are all arranged around the diaphragm housing core 214. This embodiment uses a single spring 206
Operates by. The spring 206 has a spring tensioner 204 and a diaphragm tensioner 208.
It is fixed between. Spring tensioner 204 includes an extension 218 extending downwardly therefrom. The diaphragm tensioner 208 has upper latches 220a, 22
0b and lower latches 222a, 222b. Release tube 214 connects latches 222a and 222b to connecting portions 228a and 22 at points 226a and 226b.
8b. The probe 234 is the needle 23
6 and a reagent strip 238. The electronic system is an optical sensor 24
0, electronic circuit 242) battery 2 with cover member 246
44 and a liquid crystal display 248 having a lens 250. Probe 234, needle 236, release tube 23
4 and reagent strip 238 constitute a single disposable unit that is inserted into pen 200. Pushing upward on the extension in release tube 224 during insertion forces spring tensioner 204 upward and loads spring 206 . Disposable unit 234 is locked in place under the action of latches 222a and 222b.

A forceful upward push on the finger from which the blood sample is taken opens the joints 228a and 228b between the release tube 224 and the probe 234.

That is, the probe 234 stops at the fixed diaphragm housing core 214. Suddenly opening the release tube 224 causes the needle 236 to actuate into the finger where the capillary tube is ruptured. In its upper end stop position, release tube 224 opens latches 224a, 224b on diaphragm tensioner 208, which pulls on diaphragm plunger 210 and diaphragm 212, forcing them upwardly. This creates a vacuum inside the fixed diaphragm housing core 214. The vacuum state reaches the needle head 236 via the diaphragm housing core 214, and the vacuum state reaches the needle head 236 from the I point.
6 to moisten the reagent strip 238.

Ben 200 is manually removed from the finger and reset by slide button 216. Reagent strip 2
38 chromaticity changes are read by an optical sensor 240, and an electronic system unit 242 numerically reads and outputs the chromaticity changes on a display device 248 for display.

FIG. 8 is a longitudinal sectional view of a fourth embodiment of pen 250. Pen 250 includes a casing 252) a diaphragm plunger 254, a diaphragm tensioner 256, and a diaphragm 258. Diaphragm housing core 260 supports diaphragm 258. Upper latches 262a, 262b and lower latches 264a, 264
b is fixed to the diaphragm tensioner 256. A sliding button 266 is attached to the diaphragm tensioner 256. Inside the casing 252 there is an electronic system 2.
68, battery 270, battery cover 27 that is screwed on
2) For example: □Includes a liquid crystal display device 274 and a plastic lens 276 inside the casing. Optical sensor 278 connects to electronic system 268. needle 2
82 and a release tube 284 having latching pawls 286a and 286b.
latches 264 at junctions 288a and 288b.
a and 264b. Reagent strip 290 is mounted inside probe housing 292 . FIG. 8 shows the diaphragm tensioner 256 being pressed downward. This causes the diaphragm 258 to be pushed down. diaphragm tensioner 256
are locked in place by latches 262a and 262b. Probe 280, having needle 282 and release tube 284, is then inserted and releases latch 2.
64a and 264b. The junction 288 between the probe 280 and the release tube 284 surrounding the needle 282 is opened by an upward pressing motion of the finger. The needle head 282 pierces the finger, thereby causing the capillary tube to burst. In its upper stop position, the release tube 284 is connected to the diaphragm sensor 2
56 latches 262a and 262b are opened, so that diaphragm tensioner 256 is pushed back by the action of telescoping diaphragm 258. This creates a vacuum in the diaphragm housing core 260 and draws blood from the finger into the interior of the probe 280 through the needle head 282. Therefore, this blood is collected from the reagent strip 29.
Moisten 0. Benn 250 is then manually removed before next use and reset by slide button 266 before next use. The blood is chemically treated in the reagent strip 290 and its chromaticity changes are converted in the electronic unit 268 and displayed on the display 274.

Probe 280 with release tube 284 and needle head 282 is removed and held in frictional engagement until it is deployed.

FIG. 9 shows a longitudinal sectional view of a medical system 300 using capillary action, which is a fifth embodiment of the present invention.

Capillary-based medical system 300 includes a case 302 having a top 304 and a knob 306 having a shaft 308.
It further includes a plunger 310 that fits into the top portion 304 through a hole 312. Button 314 is pivotable about point 316 and includes a latch 318 . Lancet holder 320 includes a lancet 330 therein.

Upper spring 332 connects top 304 and plunger 310
It is placed between the top of the Lower spring 334
is engaged between the bottom of lancet holder 320 and surface 336. Probe 340 includes a capillary duct 342 and a reagent strip 344 therein.

Optical sensor 346 and microprocessor electronic system 34
8 and a liquid crystal display 350 are attached to the board 352.

A lens 354 fits into the case 302.

Similarly, a battery 356 powers electronics unit 348 and includes a battery cover 358. Pulling knob 306 upward loads spring 332 and plunger 310 is then locked in place by latch 318. A disposable unit 340 consisting of a lancet 330, a probe 340 and a reagent strip 344 are inserted into the interior of the system 300. Pressing button 314 releases latch 318. The plunger 310 is forcibly lowered and comes into pressure contact with the lancet holder 320. The lancet 330 punctures the finger and ruptures the blood-containing capillary. Spring 33
4, the lancet holder 320 immediately returns to its neutral position, causing the lancet 330 to move out. Blood begins to accumulate at the injured site and a drop of blood forms on the surface of the skin. This is drawn into the duct 342 on the capillary tube by capillary action. The blood reaches reagent strip 344, which initiates a chemical reaction. The color change is then performed by electronic unit 348.
is read by an optical sensor 346 connected to. The electronic unit converts the electric signal and displays it on a digital display device 350.

FIG. 10 is a longitudinal sectional view of a first embodiment of a medical needle head 400. Release tube 402 triggers a mechanism in system IO. This forces the needle 404 into the interior of the finger, thereby rupturing the capillary blood conduit. Blood that accumulates at the injury site is drawn through the needle 404 to the probe 406 under the action of the vacuum created by the system. The blood then reaches reagent strip 408, which can be porous.

11 and 12 show longitudinal cross-sectional views of an embodiment of a medical needle head 420. FIG. Medical needle head 420 includes a system-triggered release tube 422. This forces the needle 424 into the finger and ruptures the capillary blood conduit. The needle 424 then undergoes a semi-retraction motion to allow blood to accumulate at the injured site and to avoid being blocked by tissue.

The blood that accumulates at the injury site is then drawn into the interior of the probe 426 under the action of the vacuum created in the device through the semi-retracted needle and reaches the porous reagent strip 428.

FIG. 13 is a longitudinal cross-sectional view of a third embodiment of a medical needle head 440, in which needle 442 includes a side bore 444. FIG.

The needle 442 includes side holes that allow blood to be aspirated even though the needle tip is inserted, eg, through the skin or internally.

14 and 15 show an embodiment of a fourth needle head 460, in which the needle 464 is attached to the side guide tube 460.
66. After forming the hole in the finger, the needle 4
64 is generally withdrawn from the guide tube 466, and blood is aspirated through the guide tube and needle, as shown in FIG. Conversely, lancets can be used in place of the needles in FIGS. 14 and 15. The lancet can include sides of the lancet as carriers for transporting blood on the sides of the lancet.

FIG. 16 shows a perspective view of a self-calibrating medical needle head that includes a strip that allows automatic calibration to the optical sensor and microcomputer in the system. The medical needle head 500 has a collared strip 502.5 around the probe housing 508.
04 and 506 included. Collared strips 502 to 50
6 has different shades of gray corresponding to the three defined levels of glucose in the blood for calibration purposes. During introduction of the metpoint, the colored strip is read by optical sensor unit 514. A signal is sent to the electronic system to scale the metpoint 500 before it reaches its final position. In the final position the sensor 514 is connected to the strip 510
, in which case the strip 510 is saturated with blood delivered through the needle 512.

FIG. 17 shows a longitudinal cross-sectional view of a medical probe 540.

The medical probe 540 includes a probe housing 542.
includes an optical detection unit 548 having contacts 550 and 552 mounted inside it. The needle 544 is the reagent strip 5
Connect to 46. Optical detection unit 548 reads the reagent strip and provides atomic information to the MedPen device.

Metal contacts 550 and 552 connect the sensing device to the med pen's electrical circuitry. The entire unit is constructed from low-cost integrated circuits and is disposable. Rather than taking the blood, it is possible to place it on the side of the blood for a reagent strip containing chemicals for the blood. The disposable structure can be arranged to stay in place. In this case, no needle or capillary action is required. That is, according to these, the reagent strip must come into contact with the blood located on the human skin to initiate the treatment. As previously explained, in the operating mode the system is pushed downwards so that the release tube applies pressure from above and the reagent strip comes into contact with the blood. Although all of the above embodiments described blood flowing against a chemically detectable reagent strip, alternative embodiments may include, for example, disposing the reagent at the bottom of a disposable probe. It is also possible to carry this reagent strip relative to the blood so as to position the reagent strip. The exchange conditions in which blood is transferred to the reagent strip, or reagent strip is transferred to the blood, are illustrated in the flowchart shown in FIG.

According to the invention, the suggestion is, for example, to have a probe, a structure that first penetrates and draws blood from below the skin to the surface of the skin, and a strip for the reagent into the skin. It is also possible to move the reagent strip against the blood on the surface of the reagent strip and spread it onto a structure that transfers the reagent strip to the blood.

FIG. 18 is a flow chart showing the flow of blood or fluid in the system. Another example of modification is the wicking operation. This wicking operation may occur if blood or fluid is transferred to the chemical by the wicking operation, or may occur, for example, by vacuum action, capillary action, normal flow operations, absorption or other flow or transfer processing actions. do.

FIG. 19 shows a perspective view of another embodiment of the measurement system 600 according to the present invention.

According to this embodiment, a slidable and disposable diagnostic infiltration unit 602 is included. Details will be described later. The housing 603 has a rectangular shape, which is convenient for accommodating flat packed ICs such as memory. According to the example, the preferred specifications are a length of 130 fins and a width of 2 fins.
4111 If the depth is 1211, the shape is such that it can be inserted into a pocket. Battery housing 604 frictionally and electronically engages housing top 603 with a snap fit, although other engagement structures may be used. A cap 605 carrying a pocket clip 605a mates with the buffer housing. A light emitting device display 606 displays a measured quantity such as glucose. Sliding doors 608 in opposite grooves 609a, 609b bias the electronics to cock the hammer mechanism as described below. Button 610 for biasing
releases the hammer mechanism, which energizes the lancet as described below. The diagnostic needle head 602 is attached to the protective cover 600 which has the same shape and size as the needle head 602.
When the needle is not inserted into the groove, it slides into the needle head receiving grooves 611a and 611b on the opposite side. A light source 612 consisting of a light emitting element and a sensor 614 consisting of a photodiode are arranged inside the housing, as shown in FIG. 20, and correspond to the electric circuit shown in FIG. Sliding door 608 energizes start switch 106 in FIG.

FIG. 20 shows a cross-sectional view of a disposable diagnostic needle head unit 600 for the system shown in FIG. 19. Needle head 6
02 includes a housing 630, an opaque top cover 632, and an opaque bottom cover 634. Hammer hole 636
is provided on the opposite side of the absorption hole 638. Needle head 6
42 and having a spring member 644 is secured to one end of the housing 646. The wicking member 648 includes member 6, as will be described in detail later.
32 and 634 and mounted inside housing members 630a and 630b. Wicking member 648 transfers blood or fluid from lancet 640 to reagent strip 650 protected by transparent plastic cover 652 under wicking action. Therefore, the light emitting element 612
and phototransistor 614, as shown in FIG.
The data is measured to be processed by an internal microprocessor circuit. Optical foil covers 654 and 656 with removable glue are used over top cover 632 and/or bottom cover 634 to provide sterility to lancet 640. The member 648 of wicking material also provides sterile protection for the lancet by having no pores in the material, in which case the material is comprised of a solid piece or material. It is possible.

The optional wicking hole 638 and cover hole 657 are used in this example for obtaining a sample of blood for determining glucose levels, as illustrated in the drawings. is positioned against. Alternatively, it is also possible to arrange the holes for quantitative analysis of other substances, such as, for example, grapes, animals or solvents in industrial equipment.

FIG. 21 shows a partially cutaway vertical cross-sectional view of the needle head unit 602 for diagnosis. All reference numerals herein correspond to the respective components already described in detail. Groove members 658a and 658 on opposite sides of each other
b is inserted into the groove receiving members 611a and 611d and the bottom recess of the rectangular housing 603.

22a and 22b are the resulting system performance charts corresponding to FIG. Disposable diagnostic needle head units provide personal hygiene or infection protection. That is, the only part that comes into contact with the patient is the absorbent part of the diagnostic unit 600. The absorbent part is disinfected before use and protected by at least one of the two foil covers 654 and 656 with a removable glue. The specifications of the absorption material are the same as the absorption material itself, for example, from the lancet 640 that makes a hole in the skin to the reagent material 65.
0 to transfer the least amount of liquid. Because the reagent material 650 is of such minimal size, the lancet 40, which provides sufficient light to the photodiode as well as a visible section, can be used, for example, in FIGS. As already explained in FIG. 8 or FIG. 9, it is driven by a hammercock mechanism reaching a penetrating depth that can include two sets, one for children and one for adults. Certain assemblies require a personal transport action. The medical system itself is rectangular in cross section and optically dense for accurate detection of the photodiode. The battery housing 604 facilitates battery replacement without requiring any tools. The sliding door 608 constituting the diagnostic needle head unit is used primarily for insertion and removal of a protective cover or disposable diagnostic needle head unit, and secondly for cocking the hammer mechanism. and thirdly, the power is turned on and the electronic system is automatically adjusted to provide an audible warning sound from the acoustic piezoelectric transducer as described in FIG. It is used to energize and position the electronic system that makes the display visible in the on state, corresponding to the drawings on the side of the system, as shown in FIG. Audio alarms and visual displays as well as associated images are further illustrated in Figures 22a and 22b in connection with operation of a medical or measurement system.

Medical systems and measurement systems are synonymous, each providing a readout of a quantity of a property to be measured. Once the hammer mechanism is prepared by the sliding door, the push button releases the hammer and activates the lancet against the finger, and once the disposable diagnostic needle head unit 602 is inserted into the groove 611a.
Then, it is inserted into the inside of 611b and positioned at a predetermined position. The protective cover is removed and the sliding door is moved downwards and then upwards to cock the hammer. This activates the electrical circuit for self-adjustment as well as for measurement.

The disposable unit is then inserted to power the electronic system from a calibration mode to a detection mode for photodiode detection and subsequent calculation of material properties.

In advance, the electronic system is provided for self-calibration through the measurement of already limited color standards as well as a battery check. For example, after a quantity, such as a glucose level, has been read, a button can be pressed to provide previously recorded data.

The medical system shown in FIGS. 19 to 21 has a diagnostic needle head unit 60 which is disposable like a hammer cock.
2 into the groove, sliding the sliding door 608 to energize the electronic system, and actuating the bushing button 610 to drive the hammer. Absorption unit 648 can include an adhesive backing foil to stabilize the enzyme in the reagent. Absorption unit 648 also acts as a sterile protector.

The absorption unit is placed in a capillary channel which operates under absorption action. A lancet 640 coupled to the interior of the housing 630 exerts an independent elastic action on the lancet or needle elastic module. The elastic action includes bending at a right angle or other angle between the spring arm and the needle head. Absorbent material 648 is disposed proximate for removal and proximate for transporting blood from the lancet 640 or needle to the reagent strip 650. Although absorbent member 648 is disclosed as having a hole 638, depending on the particular type of absorbent member, the hole does not necessarily have to be in the material so that a lancet 640 or needle can be pierced through the absorbent member 640. There is no need to have one. Figures 223 and 22b show the corresponding column entries, events, and visual indications corresponding to the electronics in Figure 5 as well as audio warnings and durations similar to the applicable codes for the drawings shown in Figure 2. shows a flowchart including; Events, as well as display periods and application codes, are descriptions of the operation of a medical or measurement system.

The system's performance chart presents the system's operational events. Finally, the absorbing action can have the dual purpose of providing a filter means for the absorbent material to separate the components of the liquid or fluid and being present as a sterile protector for the needle or lancet. In the above-described embodiments of absorbent members operating as filter means, the absorbent members are illustrated as separating certain components of blood from other components of the blood, but this is for illustrative purposes only. and should not be construed as limiting the substance.

Absorbent materials can be used for more than one purpose.

For example, the absorbent material can be used to transfer fluids to chemicals, such as reagent strips, and can also be utilized as a filter, such as as a sterile protector.

Although the present invention has been described above with reference to preferred embodiments, the present invention is not limited to these embodiments, and various improvements and changes in design are possible without departing from the gist of the present invention. Of course.

[Brief explanation of drawings]

Figure 1 is a plan view of a medical system that can be inserted into a portable pocket, Figure 2 is a front view of Figure 1, Figure 3 is an exploded perspective view of the assembled configuration of the system, and Figure 4 is an exploded perspective view of the system. Fig. 5 is a block diagram of the control system; Fig. 6 is a longitudinal sectional view of the second embodiment; Fig. 7 is a longitudinal sectional view of the third embodiment; Fig. 8 is a longitudinal sectional view of the third embodiment; 9 is a longitudinal sectional view of the fifth embodiment of the medical system that utilizes capillary action, and FIG. 10 is a longitudinal sectional view of the first embodiment of the medical needle head.・ Figures 11 and 12 are longitudinal sectional views of the second embodiment of the medical needle head, Figure 13 is a longitudinal sectional view of the third embodiment of the medical needle head, and Figures 14 and 15 are the longitudinal sectional views of the second embodiment of the medical needle head. 16 is a perspective view of a medical needle head with self-scale adjustment; FIG. 17 is a longitudinal sectional view of a medical probe having a self-contained optical sensor; FIG. 18 is a longitudinal sectional view of a fourth embodiment of a medical needle head; 19 is a perspective view of an embodiment of a measuring device with a disposable diagnostic needle head; FIG. 20 is a flowchart showing the transfer of blood to the reagent strip; FIG. 20 is a perspective view of an embodiment of a measuring device with a disposable diagnostic needle head; FIG. 21 is a longitudinal cross-sectional view of an embodiment of the diagnostic needle head; FIG.
Figures a and 22b are performance charts of the system. 10... Medical system 12... Probe 32
...Casing 34...Core 36...Button member 5o...Light emitting element 54...Electronic unit 102...Microcomputer Patent applicant Audio Bionics Incorporated'-\lX FIG, 12 μJ μJ

Claims (10)

[Claims] (1) Consisting of a housing member insertable into a rectangular pocket and a disposable diagnostic unit, the housing member having a hammer means biased by a spring;
an optical measuring means including a light source; and an optical measuring means having optical properties for a component of a liquid to be measured when irradiated by the light source, and corresponding to a change in color of a reagent and a component to be measured when in contact with the liquid. an optical sensor for measuring light modified by a reagent to generate an electrical signal; and a display for providing a display in relation to said electrical signal to provide a visible readout representative of the analysis. groove means for receiving a disposable diagnostic unit, the disposable diagnostic unit having a housing member having opposing tabs in engagement with the groove means; a reagent means having an optical color characteristic depending on the composition of the liquid to be treated; and a spring passing through the body for being positioned by being struck by said hammer means and for allowing the fluid to flow out from within said reagent means. A method for extracting and analyzing a liquid in a body, characterized by comprising: a lancet means equipped with a lancet means; and a reagent means located between the lancet means and the reagent means, for transferring a fluid flowing out from the inside of the body to the reagent means. A portable pocket-insertable measurement system for (2) In the system according to claim 1,
A measuring system further comprising cocking means for said hammer means. (3) In the system according to claim 1,
A measuring system, the system comprising means for releasing said hammer means. (4) In the system according to claim 1,
The measuring system wherein the absorbing means is arranged at a position where the absorbing means is to be penetrated by the lancet means when the lancet means is struck by the hammer means. (5) In the system according to claim 1,
A measurement system in which the absorption means selectively transports components of the fluid and acts as a filter between the body and the reagent. (6) In the system according to claim 1,
The reagent means includes transparent support means such that the reagent means remains in contact with the absorption means and is corrected by a change in color of the reagent emitted from the light source and passing through the transparent support means. A measuring device consisting of light. (7) a housing having a tab for engaging a groove within the portable measurement system and a reagent means having optical properties corresponding to the component of the liquid to be measured;
a lancet means positioned to be biased by an element of the housing of the portable measurement system and mounted with a spring extending through the body to permit fluid flow from the body; and between the lancet means and the reagent means; Disposable device for use with a portable measurement system for extracting and analyzing components of a liquid inside a body, characterized in that it comprises an absorption means for transferring a flow of fluid from inside the body to the reagent means. diagnostic unit. (8) In the unit according to claim 7,
A diagnostic unit, wherein the absorption means selectively transports components of the fluid and acts as a filter between the body and the reagent. (9) In the unit according to claim 7,
A diagnostic unit wherein said reagent means comprises transparent support means for maintaining said reagent means in contact with said absorption means. (10) A slidable unit for engaging a pocket-insertable medical diagnostic system for detecting glucose in blood, the unit being substantially substantially the same as the pocket-insertable medical diagnostic system; A piercing needle means using a slidable rectangular housing that slides on a rectangular housing member, and a spring that is supported and pressed by a portion of the housing to make a hole in the skin of an individual and enter the inside thereof. a reagent means about the reagent hole and carried by another part of the housing; a means for transferring blood from the skin of the individual to the reagent means; and about the reagent means. and a window means located within said housing for supporting the level of glucose in the blood of the individual by reading changes in said reagent means; a disposable sterile diagnostic unit, each of said holes being configured to be present in a bottom plate of said unit.