JPH0360645A - Method and device for taking blood component from human or animal body, in safety and in painlell state that penetration is minimum - Google Patents

Abstract

PURPOSE: To make it possible to collect blood safely with reduced invasion in body and without pain and concurrently conduct its transportation and specific inspection by making a part of the skin outer surface antibacterial, slightly cutting to collect a small quantity of the blood together with medium liquid and transporting and inspecting it. CONSTITUTION: When a device 20 is pressed up to the skin previously sterilized and anesthetized, medium liquid is sealed up in a reservoir 28. The skin is either cut or stabbed by a top 21 on moving a handle 23, piston 29 and a pin 30 to the left, then the handle 23 is turned to the right so that the pin 30 remains in a laboratory 32. Then the inside of the device 20 including the laboratory 32 is depressurized, which sucks the medium liquid and the blood from the cut into the laboratory 32 when the blood quickly reacts with a test tape 37. The test result is monitored visually, mechanically or with an electric means through the transparent wall of a middle part 22. The device 20 is available for supply in a sterilized state of the medium liquid which has filled the reservoir 28 beforehand, as held with a cap 38.

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to techniques for collecting and testing blood and blood components from skin areas. More specifically, the present invention relates to techniques for safely, minimally invasive, and painless transdermal simultaneous collection, separation, and testing of human or animal blood components.

(Prior Art and its Problems) Traditionally, researchers and clinicians who require blood specimens for testing animals or humans usually pierce or make an incision in the skin of the human or animal to obtain the blood specimen. specimens were then collected from veins, capillaries, or arteries. In some cases, specimens may be collected with the help of a vacuum. This blood sample is then separately processed and tested for diagnosis. However, this method is always painful.

An important part of diagnosis has been underestimated and ignored. Over the past 100 years, this archaic method of blood sampling has been employed, with little attention paid to the transmission of blood-related diseases such as hepatitis B or AIDS. Even today, with sophisticated high-tech diagnostic techniques, blood can become contaminated by the patient, the doctor performing the phlebotomy, and the environment of the specimen collection area, and contaminated used equipment is undesirable. transported or disposed of by

Therefore, blood can be painlessly collected, transported, and/or examined simultaneously in a manner that minimizes the risk of contact with the nurse or doctor performing the phlebotomy, and yet allows the patient to be treated with a wound. It would be desirable to provide a method and apparatus that does not overwhelm the patient. It would also be desirable to provide a method by which dangerous viral contaminants could be inactivated.

The overall object of the present invention is to safely, minimally and painlessly collect, transport and/or simultaneously test blood from humans or animals for the presence of certain components. It is an object of the present invention to provide a method and apparatus for.

Means for Accomplishing the Object Briefly described, the method of the present invention includes the steps of: pre-treating the external surface of a certain area of human or animal skin to render it insensible and antibacterial; A superficial incision is made on the relevant part of the skin at the stage of forming the part, at the stage of collecting an eluent containing a small amount of blood components, and in the eluent!
inactivating the IIm and transporting and/or testing the eluate for one or more diagnostic purposes. This method requires only a very small amount of blood (approximately IU microohle) from the skin area. No excess blood is collected, wasted or dispersed. Furthermore, the method is substantially painless and non-invasive.

When the device of the present invention is used, no blood or contaminated parts are exposed and can transmit disease. Additionally, the patient will not be traumatized by the needle site or lance. These may be hidden or difficult to access or see.

The device of the present invention consists essentially of a reservoir for a fluid medium for carrying a blood specimen, means extending through the reservoir and the fluid and into operable position against the patient's skin for penetrating or cutting the skin; and means for aspirating the blood specimen and the vehicle into the device to be tested. Preferred devices further include an obtuse tip that contacts the skin and desensitizes the nerve periphery by distributing pressure.

Objects and advantages other than those described above will become apparent to those skilled in the art upon reading the following description and referring to the drawings.

Embodiment FIGS. 1-5 illustrate a first embodiment of an apparatus that can be used to carry out the method of the invention. This device 20 has a sampling tip 2, as shown in FIG.
1, a tubular intermediate portion 22, and a handle 23.

1, 2, 4 and 5, the collection tip 21 has a central tubular bore 24 and a tubular intermediate section 22.
The hole 22a accommodates a number of components.

As shown in FIGS. 4 and 5, the hole 2 in the intermediate portion 22
2a comprises a porous 7-lit diaphragm 25 and a matrix adsorbent 26 insertable to fit loosely between member 25 and a filter or affinity disk 27.

As shown in FIG.
1 a and the inner wall of the intermediate section 22 adjacent the tip 21 to form a fluid-receiving reservoir 28 .

Referring to FIG. 1, a close-fitting piston 29 is positioned within the bore 22a of the intermediate portion 22 on the other side of the disk 27. The face 29a of the piston 29 adjacent the disc 27 is provided with a piercing or scoring pin 30 extending through the piston head. This pin 30 can be friction film fitted to the open end of the rod 31. The other end of this mouth/throat 31 is connected to the handle 23.

When the piston 29 is properly positioned within the intermediate section 22, there is a test chamber 3 between the piston surface 29a and the disk 27.
2 exists.

The inside of the other end of the rod 31 is shown only in FIG. (preferably) can be fixed to the other end of the rod 31. A spring 34 is attached to the step 35 of the bead (shown in FIG. 3) and the tubular intermediate portion 22 (shown in FIG. 2) at 7.
It is positioned between rungs 36. The piston 29 is moved to the disk 2 by moving the handle left and right.
It can be moved left and right relative to 7. The spring 34 is compressed when the handle 23 is moved to the left and pierces the skin, and when the handle 23 is moved to the right it pulls the piston and facilitates the formation of a vacuum, causing the handle 2
3 to easily return to its initial position.

In use, the fully assembled device 20 confines the mediating fluid within the reservoir 28 when the device 20 is pressed against previously sterilized and anesthetized skin as shown in FIG. The obtuse tip of the device 20 is effective in numbing nerve endings in the skin and eliminating pain.
It is desirable that the tip 21 is obtuse-angled. By moving the needle 23, piston 29 and pin 30 to the left, the skin is cut or pierced as shown in FIG. While the tip 21 is still pressed against the skin, the pin 30 is inserted into the fifth position when cutting or piercing the skin.
Return the handle 23 to the right so that it is in the position shown in the figure. As a result, a vacuum or reduced pressure is created inside the assembled device 20, including the test chamber 32. As a result of this vacuum or reduced pressure, the media and blood from the incision are drawn into the test chamber 32 where the blood simultaneously reacts with a test element such as the test tape 37. The test results can be read visually through the transparent wall of the intermediate section 22 or by mechanical or electrical means. The device 20 can be supplied in a sterile condition and with the media prefilled in the reservoir 28 and retained by the cap 38.

Although a particular device has been described for piercing or incising the skin and testing blood components, those skilled in the art will appreciate that other configurations of the device of the present invention are possible. Devices that have been constructed and successfully tested include those in which the sampling tip is formed from elastomeric rubber or rigid plastic in a tuple or conical configuration.

A second embodiment of the device according to the invention is illustrated in FIGS. 6 to 1O. The device 40 illustrated in FIG.
Separate ring 41 and lid cap 43 for holding
The device differs from device 20 in that it has a threaded connector 42 for receiving the receptacle. The device 40 is
Another difference is that the piercing member is a hollow cannula 44 (although this cannula is driven by the piston 29, it is not directly connected to the piston 29).

A third embodiment of the device according to the invention is illustrated in FIGS. 11-15. This device 50 uses an elastic suction cap 51 as the vacuum source rather than a piston pump assembly.
It differs from device 20.40 in that it uses . Components of the third device 50 that correspond to components of the device 20 are indicated by the same reference numerals as in FIGS. 1 to 5. device 50
The various components are housed within a dowel housing 52 consisting of a top member 52a and a bottom member 52b.

When in use, the housing 52 becomes flat, and the cap 53,
Disk 27', matrix 26' and spacing! cannula 30 through the media in reservoir 28' located within 25'.
' is advanced to pierce the skin (as illustrated in Figure 15). When the housing 52 is able to return to its normal shape due to the elasticity of the suction cap 51, the cannula 30 is retracted to the position shown in FIG. is carried into the test chamber 32 through the matrix 26 and disk 27' due to the reduced pressure of the sample. Since the bottom 52b of the device 50 is transparent,
The results can be read on the test tape 37'. Alternatively, the bottom portion 52b may be removed and the test tape 3
7' may be accessible.

The device of Figures 1-15 has a larger obtuse tip than the other embodiments and is more effective in numbing the nerve periphery and reducing pain associated with cutting or piercing. It is.

All three devices can be pre-tagged for specific testing purposes by ring barcodes or other means.

The devices described above use a piston pump or suction cap to provide the vacuum, but if desired, the vacuum can be provided by a vacuum pump (mechanical, electrical aspirator), hydraulic fluid movement, syringe, chemical vacuum source or oral It is even possible to supply by suction.

However, blood collection and processing appears to be facilitated by lowering the atmospheric pressure acting on the skin within the region of the glove tip.

the pin assembly is simply a groove or tube with a piercing tip;
The grooves or tubes can also be of the type with control cams or clamps that operate similar to a ballpoint pen. Additionally, the test chamber can be a series of chambers connected by a narrow section, a port leading to a diagnostic device, or simply a piece of spongy material. This spongy piece of material could be used as in a regenerated diagnostic test, and the sampled blood components could be recovered from this piece of material and used in a later test.

Although the use of a single pretreatment solution is described, it is also possible to use additional pretreatment solutions.

These solutions can be sprayed or used as a gel binder.
Alternatively, it can be applied using a bandage-like application means. The solution may contain a special antiviral agent or Tsunoxylu-9 (Decon Laboratories, Inc.) and formalin or beta-propiolactone, bibacterial ethylenediamine, and psoralen photochemical inert agent (Hyclone Laboratories, Inc.).
Art to 5cieace, Volume 5, Noj: 4
-5) can contain general antibacterial, antiviral, and antifungal agents. The choice of chemical inert agent depends on the type of test to be performed on the specimen.

In a preferred embodiment of the method of the invention, the skin is first pretreated with a solution containing an anesthetic and a nucleocide, such as lidocaine hydrochloride and penzarconilam chloride, respectively.

The medium contains surfactants, such as nonionic dispersants such as sodium heparin and saline, and anticoagulants, which fluidize the specimen and prevent clotting and hemolysis. This solution also contains solvents such as polyvinyl acetate and DMSO (dimethyl sulfoxide) to alter the chemistry of the specimen, and has a high viscosity to help the probe tip form a seal against the skin. Contains analgesics and gels or creams. The vehicle fluid may also contain other anticoagulants or chelating agents to buffer the vehicle fluid molecules to prevent non-specific losses due to binding or degradation and to promote preservation. Viruses can be inactivated.

The vehicle fluid can also contain chemical agents that inactivate other pathogens. Alternatively, pathogens for testing or non-pathogens as a means of detection can be promoted or grown.

A suitable vehicle solution contains the following ingredients:

In addition, even vasodilatory components such as EDTA or phenylephrine hydrochloride can be used. If you want to compare more blood cells to immunoglobulins,
Use of vasodilators is preferred.

Vasotonic drugs may also be used to prevent further bleeding from the incision.

In addition, Triton
0 or other agents can also be used. Examples of such surfactants are:

Nonidet P-40 (Shell Oil Co.), Guanidine Chloride - Journal of Virology, 1972, 614.69
Stromber J published on page 7, rsurlice Active that isolates the core components of avian myeloblastosis virus.
A(entsforlsol*jion of t
he Core ComponCnjs ol
Avis++Myeloblistosis Vir
Mercaptoethanol or other nonionic dispersants such as nsJ).

A preferred anticoagulant solution contains heparin sodium. However, other anticoagulants that can be used include: Ethylenediaminetetraacetic acid (EDTA) (0,
14%), ammonia heparin, sodium citrate,
Streptokinase or streptokinase. A carrier molecule is added to prevent non-characteristic adsorption of the desired component or to heal the cut.

Anesthetics and insecticides other than lidocaine (2.5% V/W), benzalkonium chloride (0.H% v/v) can also be used. Methyl salicylate (15,0%) in ethanol (70% v#) Ethanol, parabens, methylparaben, povidone iodine, phenol (U, 5%
Other agents such as antibiotics), dimethyl sulfoxide, acetone, polyvinyl acetate, polyvinyl alcohol, mineral oil, propylene glycol or polyethylene glycol can also be used. Additionally, anti-foaming agents such as Porite (registered trademark of Analytical Products Incorporated - US App. No. 4,089,748) may be added.

If desired, an analgesic such as pensicaine or triethanolamine salicylate or a thermal stimulant such as methyl salicylate can be added along with a volatile solvent such as ether.

Additionally, depending on the blood components desired in the eluate, a mild enzyme solution such as trypsin can be added (to inactivate degraded enzymes).

A preferred method of collecting and testing blood components comprises the following steps.

A. Applying an anesthetic and bactericidal pretreatment solution using a pad for a few seconds to a hairless skin area, such as a fingertip or upper arm; B. Applying a buffered heparin-mediated solution to the reservoir 28 of the device. Filling stage; C0 tip (pre-filled with the solution used in B) is processed; press firmly against the skin to form a seal; D: remain in contact with the skin for 1-2 seconds. while maintaining
Stage II of advancing the piston or incising the skin and creating a vacuum until the pin 30 pierces the septum 25; E. above by releasing the pressure when the blood has been transferred to the porous frit matrix 26; Stopping the operation; the device is then pulled apart and the blood cells are separated to produce a plasma or serum-like solution that reacts with the chemical agent on the test strip 37 in the test chamber 32. F. Wiping the skin area with alcohol or a suitable disinfectant.

As a result of this preferred method, the skin is visibly affected. The skin becomes red and small cuts form.

No further bleeding occurs. Only the microcapillaries are ruptured, the cut area heals rapidly, and the risk of infection is significantly reduced. A small amount of vehicle fluid and blood (eluate) is collected in the test chamber 32 and reacts simultaneously with the chemical agent on the test strip 37.

No continuous bleeding was observed. A small scab forms, but no infection occurs. There is no pain at all, just a pinched sensation and a small cut that usually disappears within two days. Compared to lances and hypodermic needles, the risk of disease transmission or infection is significantly reduced.

The diluted blood contains red blood cells, cells (e.g. 10'/cc) that can be viewed under a light microscope and chemically tested.
or 10-" whole blood). This blood also contains immunoglobulins that can be confirmed by immunoassays (eg, radial immunodiffusion).

Cells or their components can be separated, isolated or identified by a treatment site comprising a septum 25, a matrix 26 and an affinity disc 27.

The eluate can be analyzed for protein components by electrophoretic or chemical methods and for carbohydrates by colorimetric or amperometric methods and special agents and chemicals, respectively. The test components can be mixed with the vehicle solution, dried, or reconstituted by eluate.

In addition to the illustrated special devices for making incisions, other types of mechanical devices for making superficial incisions, such as light pinching or squeezing devices, with or without vacuum. It is also possible to use the following equipment.

Post-treating the bruised skin area with 70% Inglovir alcohol is effective in preventing infection or pain. Furthermore, automatic and simultaneous processing of eluates is advantageous in preparing and preserving specimens used in diagnostic tests. For example, the eluent may be phosphate, tri-HCL,
Further dilutions can be made with buffers such as HEPES, sodium acid borate. The eluate or trap column contains a protein inhibitor (i.e. dithiothretol, l*M)
or other components to purify the component to be tested (i.e., Bio-Rad's Affi-Gel Blue to remove albumin; protein A1 fibrin from Staphylococcus A to immobilize 11G; calcium chloride to facilitate removal, binding affinity lectins or sawbats to facilitate attachment of cellular components; each of these was specifically formulated for a particular test).

#: Loss of desired eluate components due to specific adsorption can be prevented by pre-coating the inner surface of the collection device with silicone, protein or similar chemically inert material. Disinfectants such as parabens or antibiotics may be used to increase the stability of the solution.

The method of the present invention, which utilizes pre-treatment and mediating fluids, allows for the proper adjustment of fluid properties and the ability to obtain and immediately test samples of blood fluid directly from the incision site without pain or discomfort. becomes.

Hereinafter, the present invention will be explained in more detail with reference to some embodiments.

Example T Subject - Male, 44 years old. Part of the skin on the forearm (approximately 2c1
) was treated with lidocaine benzalkonium chloride for 10 seconds. Reservoir 28 of device 20 was filled with 200 microliters of buffered heparin. The tip 21 of the device illustrated in FIGS. 1-5 (pre-filled with the solution described above) was pressed against the skin. The piston 29 is connected to the cylindrical intermediate portion 22.
The tube was moved internally to the left to energize the vacuum and further incisions were made in the skin. Suction was applied for 1-2 seconds to pull the tip 21 away from the skin and stop the absorption. The eluate was then automatically processed and transferred to the testing laboratory.

The skin was not broken. A slightly small superficial notch remained which disappeared within 48 hours.

The eluate obtained in the test chamber was automatically adsorbed onto a chemical strip 37, and this strip 37 was tested for blood components. The results were as follows.

Test I Hemoglopin and myoglobin were detected by their strong pseudoperoxidase action which produced a chromogen (Chemistribe, a registered trademark of Biodynamics Poehringer Manno, Inc.). The color changed to dark green.
Indicates that there are more than 250 red blood cells per n (other red blood cells remained at the treated site as indicated by the red band)
.

Test ■ Leukocytes were detected using esterase, which catalytically converts the hydrolyzate of indoxyl carbonate to indoxyl. The indoxyl formed reacted with diazonium and gave a purple color.

Test ■ Glucose is tested using a special glucose-oxidase/peroxidase and Sheatzke staining method (Strip 2014).
It was determined to be approximately 5 rag/dl by colorimetric reaction.

Test ① Protein was determined to be approximately 100 mg #ffi by color change of the indicator 3', 3", 5', 5"-tetrachlorophenol-3,4,5,6-titrabromsulfophthalein.

Many of the measurements were made using the various mechanical devices described above, and the appropriate concentration of the solution was determined empirically. Blood cells were naturally recruited by the treatment site containing bitroxylmethyl as matrix 26.

Those skilled in the art will appreciate many reasons why the present invention may be preferable to methods of piercing the skin with a lance or needle and then separately processing and testing. The method of the present invention is minimally invasive to the living body, and therefore, if the components are sterilized beforehand and used in a hygienic manner, the risk of secondary infection is much reduced. Moreover, this method is painless. The eluate (ie, vehicle fluid and blood or blood components) can be obtained from a donor or other person in a one-handed, non-skilled manner and in a substantially fail-proof manner. The sampling location does not need to be as precise as required by the angiotomy surgeon.

It is therefore possible to more easily obtain blood specimens from children or people with small or damaged blood vessels or from patients in an emergency situation. Infection of the patient or the angiotomy surgeon can be prevented since excess blood is not collected or wasted. Instead of visually detecting changes in test results as described above, it is also possible to use electronic detectors. A hand-held colorimeter allows visualization of test strips in the test chamber.

Additionally, the present invention could potentially be very useful for diagnostic tests requiring diluted plasma/serum for doctor/office, home care, and patient self-diagnosis. A device specifically constructed for a given test is supplied fully assembled and sterile, pre-filled with the vehicle liquid by the manufacturer and the test tape in place. Therefore,
The user only needs to use the device and read the measurement results. The device can then be disposed of without the need for further processing to eliminate the risk of contamination by viruses.

Furthermore, those skilled in the art will appreciate that the device of the present invention makes it readily possible to collect blood without the pin or needle being visible to the person being collected. Using the device of the present invention, the person having the blood sample taken cannot see the needle or pin.

Those skilled in the art will appreciate that numerous modifications and adaptations are possible without departing from the spirit and scope of the invention. Therefore, the scope of the present invention is not limited by anything other than as set forth in the apparatus claims.

[Brief explanation of drawings]

1 is a perspective view of a preferred embodiment of the apparatus of the present invention, FIG. 2 is an exploded view showing the front parts of the apparatus shown in FIG. 1, and FIG. 3 is an exploded view of the apparatus shown in FIG. 1. FIG. 4 is a schematic representation of the device of the invention applied to the skin during operation; FIG. 5 is a schematic representation of the device in contact with the skin after incision or piercing; Schematic diagrams similar to FIG. 4 showing the apparatus, FIGS. 6 to 10
The figures are similar to FIG. 5 regarding the second embodiment of the device, and FIGS. 11 to 15 are similar to FIG. M1 to FIG. 5 regarding the third embodiment of the device of the present invention. 20.40.
50...Blood component sampling device 21...Sampling tip 2
2... Tubular intermediate portion 23... Handle 25.25'... Frit diaphragm 26.26'... Matrix adsorbent 27.27'.
...Affinity disk 28...Reservoir 29...Piston 29a...Piston surface 30.
30' 44...Piercing pin (canyule) 31.3
1'...Rod 32...Test chamber 37.37'...Test tape 38.43.53...Cap 41...Ring 42...Connector 51...
Suction cap 52...Housing 52a...Top member 52b...Bottom member. Figure 4 Figure 5 Figure 2 Figure 11 Figure 14 Figure 15

Claims (1)

[Claims] 1. A method for safely collecting blood components from a human or animal in a painless state with minimal invasion, the method comprising pretreating the external surface of the relevant part of the skin of the human or animal and anesthesia. coating the skin with a medium liquid and piercing or cutting the skin, and taking a specimen from the skin that has been cut or pierced. A method comprising the steps of: transferring the specimen and vehicle liquid to an isolated testing chamber; and testing the specimen. 2. Method according to claim 1, characterized in that the skin is pretreated with a liquid containing a disinfectant and an anesthetic. 3. The method according to claim 1, characterized in that the skin is treated with a solution containing a vasodilator or an anticoagulant. 4. A method according to claim 1, characterized in that the specimen is treated with a solution containing an antiviral agent. 5. A method according to claim 1, characterized in that the specimen and the medium are transferred with the aid of vacuum force. 6. A device for use in a method for safe, minimally invasive, and painless collection of blood components from humans or animals, the device comprising: an open tip having a reservoir for a medium fluid and extending through said reservoir; a pin for making a puncture or incision in the animal's skin and then being withdrawn through the reservoir; and means for collecting the specimen and vehicle fluid and transferring it to an internal chamber within the device for testing. A device characterized by: 7. Apparatus according to claim 6, characterized in that the means for collecting and transporting the medium liquid and the specimen is a vacuum. 8. The device according to claim 6, wherein the open tip is provided with an obtuse-angled tactile pressure dispersion member. 9. A device used in a method for collecting blood and/or blood components from humans or animals with minimal invasion and testing them to detect the presence or absence of specific components, which disperses pressure. an obtuse-angled tip for desensitizing the nerve periphery by causing nerve periphery; means for penetrating or cutting into the skin within the relevant portion of the skin affected by said tip; a reservoir for retaining a medium fluid within the tip; means for being attached and forming a seal against the skin around the outside of the incision, and a test chamber provided within the device for transferring the collected specimen and vehicle fluid thereto for testing. A device that does this. 10. Apparatus according to claim 9, characterized in that it comprises vacuum means for transferring the specimen to be tested and the medium liquid.