JPH0326235A - Fluid sample-collecting and distributing device for humoral sampling, and method therefor - Google Patents

Abstract

PURPOSE: To automatically wash the constituent elements of the whole tube and device prior to introduce humor by repeatedly collecting each of a blood sample by various conduits or tubes, and by composing it transportable to a test place or into a suitable vessel. CONSTITUTION: A catheter 4 can insert directly into a patient's blood vessel or a supply source of fluid to be analyzed located outside the body. The outlet end of a sample transporting tube 1 is connected to a sample distributing nozzle 7 combined with a blood sample analyzer 50, and the analyzer 50 actuates to analyze a distributed blood sample or carry out a test. When the blood sample is in a sample sending out nozzle 7, the existence of the blood sample is determined by a detector 31, and the sample in the test place is sent out into the blood sample analyzer 50 or into a suitable sample vessel where is in a place of sample sent. A washing fluid solution inlet 12 is connected to the transporting tube 1 connected with the sample transporting tube 1 where adjacent place to the catheter 4, and a second inlet 13 connected to the sample transporting tube from the washing fluid solution inlet 12 introduces a relatively unsaturated fluid against the blood sample and the washing fluid solution inlet 12.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application] The present invention relates to a therapy control device and method for body fluid sampling, and more particularly to collecting a sample of blood and directing the blood sample from a sample collection point. The present invention relates to a blood sampling device and method operative to distribute a blood sample for transport to a remote location and subsequent diagnostic testing of the blood in test tubes.

BACKGROUND OF THE INVENTION Modern medical methods require numerous tests to be performed on blood samples relating to coagulation properties, blood gas concentrations, blood chemistry, and various other tests.

These tests are required for patients receiving treatment in the hospital or at other facilities. In typical techniques, blood is usually manually withdrawn from a patient's veins, arteries, or from tubes through which the patient's blood is circulated outside the body. The amount of blood drawn and the number of blood draws from the patient are essentially a function of the number of tests. In any case, relatively large blood samples are often required, which is extremely inconvenient for the medical staff and unpleasant for the patient.

Monitoring of patients and conditions in hospitals, particularly those undergoing intensive care or undergoing various surgical procedures or blood transfusion procedures, is often carried out by testing blood samples drawn at regular time intervals. These procedures also require the use of needles that typically draw 3 to Ihl blood per test. These traditional methods of collecting and testing blood samples are wasteful, labor-intensive, and time-consuming. Therefore, from a practical point of view, such a sampling process can be carried out at intervals of 6 to 24 hours depending on the clinical situation, and, with considerable difficulty, in surgical operations and blood transfusion processes.
It is usually limited to short intervals of ~20 minutes.

The resulting data often misses rapidly changing physiological conditions of clinical importance.

It is therefore an object of the present invention to provide a device which allows separate blood samples to be repeatedly collected and transferred by various conduits or tubes to a test site or to a suitable container. As described below, the device operates to remove a sample of blood directly from the patient or from the reservoir under test. In this way, the device operates to direct the blood sample to a test site or suitable container that can be located remotely from the patient's physical location and where various tests can be performed on the sample.

Another object of the invention is to ensure that the entire tube and components of the device are automatically cleaned and flushed before the body fluid to be tested is introduced into the device. In this way, the whole method automatically transports the blood to the test site without risk of contamination of the patient's blood sample or contamination of the patient by the device or the method controlling the device. do.

Yet another object of the present invention is to control the size of the blood sample to meet the requirements of a test device compatible with the present invention and to limit the amount of patient blood wasted.

Yet another object of the invention is to draw a sample of blood from a source of a patient under test and then maintain an open or unobstructed route through which the sample is drawn.

It is known to transport body fluids to be analyzed diagnostically through tubular conduits. Many such systems separate separate samples of fluid by bubbles of an immiscible fluid that can be made into a gas, such as air. JIse+eeli reveals that separate blood samples can be injected from containers, separated by air bubbles and transferred continuously to an analysis system. It is noted that the action of the bubbles aids in cleaning the tube walls, thus limiting mutual contamination of successive fluid samples. Skeggs further discloses that another fluid component within the tube includes a wash solution to further wash the wall between fluid samples to be analyzed. This same principle is κ,
NBergmHh et al. ^. It has been recognized in many other cases, including the Fe+rari patent, which further shows a tubular withdrawal stylet in which air bubbles are injected following alternate immersion of the stylet tip into open containers of sample fluid and wash liquid. ing. It is also known to inject air into a tubular fluid stream to create fluid segmentation by immiscible bubbles, as disclosed by Kastel, H@dina, and W, J, S++ylhe, et al. L, P
, Lean have shown that the size of the injected air bubble can be controlled. A. Ferrsri, Jr.
have shown that proportional fluid pumping rates can be achieved by simultaneous peristaltic pumping on parallel elastomeric tubes of different internal diameters. Isreeli discloses adjusting the flow rate of a fluid controlled by a peristaltic pump to close tolerances by stretching the tube to vary the internal diameter accordingly.

SUMMARY OF THE INVENTION The present invention is an apparatus for transferring a sample of a body fluid, such as blood, from a first location to a test location, the device comprising a sample inlet at a first end and a second wash, such as a saline solution. a second wash having a fluid inlet, a third inlet for receiving a fluid relatively immiscible with the sample and the wash fluid, such as air, and also having an outlet at a second end connected to the second wash fluid inlet; a sample tubing member having a fluid tubing member; a first pump device connected to the sample tubing member operable to direct the flow of fluid to the outlet; and a first pump device connected to the sample tubing member operable to direct the flow of wash fluid to the sample tubing through the second wash fluid inlet. operatively directed toward the member and said first
said first pump in a first mode of operation in cooperation with a pumping device;
the second wash fluid to flow wash fluid from the wash fluid inlet to both the sample inlet and the outlet within the sample tubing member by controlling the ratio of the fluid volume delivered by the pump device and the second pump device; a second connected to the pipe member;
a pump device and said sample tubing member operative to prevent fluid flow to said outlet and direct control fluid flow entirely from said wash fluid inlet to said sample inlet when a second mode of operation is selected; a first valve device connected to the second wash fluid tubing member that is operative to prevent the flow of wash fluid into the sample tubing member through the second wash fluid inlet when a third operating mode is selected; a second valve device configured to eject a controlled volume of the immiscible fluid through the third inlet when selected in the first and third modes of operation to discharge a controlled volume of the immiscible fluid into the sample tube member into the body fluid or the wash; a third flow regulating pump device connected to said third inlet to generate a series of separated discrete immiscible fluid bubbles in a fluid separated by said immiscible fluid bubbles in said first mode of operation; said pumping device in a predetermined sequence such that said outlet receives a predetermined sequence of fluids as a series of cells of irrigation fluid or as a series of cells of body fluid separated by bubbles of said immiscible fluid following said third mode of operation; and a control device connected to the pump device and the valve device for selectively energizing the valve device, the outlet being directed to a remote location including the test location, and monitoring the sequence of fluid flow. said sample tube member including a detection device at said location to provide an output signal level indicative of sample and wash fluid and immiscible fluid at said remote location, and said output signal contained in a series of cells of body fluid. When indicating the presence of a sample, the sample tube and the second end are moved to the test site, such that when the second end is moved only the contents of selected cells of body fluid are directed to the test site. and further connected to the sample tube device and responsive to the output signal level to discard the body fluid, wash fluid, and immiscible fluid in response to the signal level if the selected body fluid cell is not detected. It consists of a device.

Embodiment FIG. 1 shows a block diagram of a repeatable individual blood sampling device according to the present invention. The device of the present invention is capable of delivering blood samples to a test site or suitable container, as well as being compatible with any body fluid.

Therefore, the device can be applied as a fluid sample collection and dispensing device. As shown in FIG. 1, there is shown a blood sample supply tube, or in other words a flexible sample transfer tube 1, terminating at its inlet end in a catheter 4.

The catheter 4 can be inserted directly into the patient's blood vessels or into an extracorporeal source of the fluid to be analyzed. The outlet end of the sample transfer tube 1 is connected to a sample distribution nozzle 7 which is associated with a blood sample analyzer 50. Blood sample analyzers 50 are widely available and these devices operate to analyze or perform tests on dispensed blood samples. Illustrated as connected to the sample dispensing nozzle 7 and the sample transfer tube 1 is a module 52 designated as TS/WS/SS. This module 52 connects the sample transfer tube 1 and the sample distribution nozzle 7 to the test point (TS).
a solenoid or other device that performs a similar function to push the true blood sample from the sample outlet nozzle 7 to the waste point (WS) or sample point (SS). A point in time is determined via the detector 31 and the sample present at the test site is delivered to a blood sample analyzer 50 or to a compatible sample container at the sample delivery point.In all other modes, the sample delivery nozzle 7 is Discharge the fluid into a waste container or a compatible sample container at the waste point. When a real blood sample is at the sample delivery nozzle 7, the logic controller 40 directs the TS to position the nozzle from the waste point or from the sample point to the test point. /WS/SS module 52. As is well known, many devices can perform this operation. Blood sample transfer tube 1, for example, has an outer diameter of approximately 0.21 cm and an inner diameter of 0.1 cm. It can be constructed from several plastic tubes.

The wash fluid solution inlet 12 is connected to the sample transfer tube 1 at a point substantially proximate to the catheter 4, for example about 10 cm to 15 cm. The term "cleaning fluid" includes equipotential solutions such as injectable common saline. A second inlet 13 is approximately 2.0 mm from the cleaning fluid solution inlet 12 on the side opposite the inlet end. It is connected to a sample transfer tube 1 having a length of 5 cm. A second inlet 13 is employed to introduce a fluid that is relatively immiscible with the blood sample and wash fluid solution. The impeller of the peristaltic pump 25 connects the sample transfer tube 1 shown above the section 6 near the sample distribution nozzle 7 to generate a peristaltic motion that draws fluid from the sample transfer tube 1 and discharges it into the sample distribution nozzle 7. Collaborate. Peristaltic pumps that operate to flush or draw fluid within flexible tubes are well known, and many examples of such pumps exist in the prior art. Although a single pump is illustrated as driving the wash fluid and sample tube, it is understood that separate pumps, or two pumps, may be employed. Controlling the flow rate is simple if separate pumps are employed. In this case, the impeller or fingers of the peristaltic pump 25, which is a simple pump for separating the cleaning fluid and the sample tube, can be configured to be driven by a single pump. For the purpose of minimizing cross-contamination of successive blood samples, the sample transfer tube 1 consists as nearly as possible of a single continuous length of extruded or elastomeric tubing, such as silicone or plastic. , the surface of the tube is essentially hydrophobic or otherwise non-adhesive to blood or liquid blood-containing pharmaceuticals or modified blood products. Cleaning fluid solution inlet 1
2 and the second inlet 13 and the attachment of the catheter 4 to the sample transfer tube 1 are configured to minimize the potential for stagnant areas of fluid to transfer residue between blood samples, as described below.

The cleaning fluid solution outlet tube 2 is connected to the cleaning fluid solution inlet 12 via a one-way valve 17 for transferring cleaning fluid from the cleaning fluid reservoir 9. The impeller or finger of the peristaltic pump 25 cooperates with the wash fluid solution distribution tube 2 on the corresponding region 6 as well as the sample tube to inject the wash fluid into the sample transfer tube 1 via the wash fluid inlet 12. . One-way valve 17 prevents periodic and partial backflow of flow within cleaning fluid solution distribution line 2 caused by normal operation of peristaltic pump 25. This ensures that blood in the sample transfer tube 1 cannot be drawn through the wash fluid solution inlet 12. In order to ensure that a larger volume of fluid can flow in the wash fluid solution distribution tube 2 compared to the blood sample transfer tube 1,
The portions of sample transfer tube 1 and wash fluid solution distribution tube 2 oriented along region 6 are comprised of relatively identical elastomeric tubing. A constant ratio flow between these two tubes is the sample transfer tube 1 to the wash fluid solution distribution tube 2.
This is achieved by a slight stretching of, for example 10%.

This stretching occurs in region 6, where one tube is stretched relative to the other tube for flow control. Sample transfer tube 1
and region 6 of the cleaning fluid solution distribution tube 2 are housed within a cassette member, illustrated in FIG. 3, which is combined with a pump and meter housing as described below. Accordingly, wash fluid may sometimes be injected into sample transfer tube 1 via wash fluid solution inlet 12 at a proportionately higher rate than the rate at which peristaltic pump 25 draws fluid through sample transfer tube 1 . A diaphragm-type pressure switch 33 connected to the irrigation fluid solution distribution tube 2 is used to detect an occlusion in both the sample transfer tube 1 and the irrigation fluid solution distribution tube 2 indicating an occlusion of the catheter 4 or of the blood vessel from which the blood sample is being collected. act to detect overpressure conditions at

The outlet of the constant volume diaphragm pump 14 bubbles a controlled volume of an immiscible fluid, such as air, into the sample transfer tube 1.
It is directly connected to the second inlet 13 of the sample transfer tube 1 for injection into the sample transfer tube 1 . The inlet of a constant volume diaphragm pump 14 (not shown) opens directly to the atmosphere or is led by a tubing system to a reservoir of immiscible fluid material, such as a non-volatile fluorocarbon liquid. A solenoid driven pneumatic pump 24, driven by control signals from logic controller 40, sends pressure pulses through air line 3. This pulse drives the constant volume diaphragm pump 14 resulting in the injection of a controlled volume bubble of immiscible fluid into the sample transfer tube l via the second inlet 13.

A first tube vinci valve 21 located at the inlet to the peristaltic bomb 25 is shown in relation to sample transfer tube l. The first tube Vinci valve 21, when energized, directs the fluid in the sample transfer tube 1 to the second inlet 13 and the sample distribution nozzle 7.
prevent the flow between A second tube pinch valve 22 is also located at the inlet to the peristaltic pump 25 and is associated with the cleaning fluid solution distribution tube 2 . Second pipe pinch valve 22
prevents wash fluid from flowing into the sample transfer tube 1 through the wash fluid solution inlet 12 during excitation.

The first tube pinch valve 21 and the second tube pinch valve 22 are controlled by a logic controller 40 to allow independent fluid flow within the sample transfer tube 1 and wash fluid solution distribution tube 2 at various times.

As will be described below, the first tube pinch valve 21 and the second tube pinch valve 22 are located adjacent to the cassette shown in FIG. 3 that is associated with the pump. peristaltic pump 25
generally produces a pulsating fluid flow. This movement is used as a cleaning intersection to create a vortex of pulsating flow as well as to enhance the cleaning action. In the keep open flow mode, a relatively constant flow is achieved by compensating for the known pinch-off period of the pump 25 and maintaining a more constant flow with increasing pump speed.

This operation is accomplished by monitoring the location of the rotational location of pump 25 so that a fluid pinch-off zone is defined and using this information to optimize fluid evacuation.

Fluid detector 18 is associated with blood sample transfer tube 1 and positioned between catheter 4 and irrigation fluid solution inlet 12 . Fluid detector 18 identifies what fluid is flowing within sample transfer tube 1 and otherwise acts as a bubble detector. The second tube combined with sample transfer tube 1
The fluid detector 31 is positioned as close as possible to the sample dispensing nozzle 7, for example at about 2.5 cm to 5 cm, in order to identify what fluid is about to be dispensed.

The conductors of the logic control device 40 are connected to the drive motor 23 of the dual-channel stirring pump 25, the pneumatic pump 24, the first pipe pinch valve 21, and the second pipe pinch valve 22 through the output terminal board 41.

A logic controller 40 via a signal input terminal board 42 regulates the flow of the blood sample, wash fluid and immiscible fluid in the fluid or foam detectors 18 and 31, the sample transfer tube 1 to inlet the blood sample. or a pressure switch 33 for transferring from the end of the catheter 4 to the outlet or end of the nozzle 7
connected to and responds. Logic controller 40 may also be adapted to interface with a variety of data input and output devices as shown in FIG. These devices include a display 43, a keyboard 48, a printer (not shown), standard data interfaces such as an RS232 interface, and connections for blood testing and infusion devices.

Logic controller 40 is connectable to all essential device functions to provide the desired monitoring of said functions ensuring a high level of performance and safety. Additionally, the logic controller 40 has the ability to store monitored data in memory and recall in a predetermined format the volume of blood drawn, the volume of fluid injected, and the number of samples drawn. .

All system functions can be monitored and controlled through logic controller 40, and the system provides maximum safety, comfort, performance, accuracy and ease of use for patients and clinicians. It's designed that way.

Logic controller 40 is responsive to fluid samples and signals obtained from test and infusion devices to make consistent and reliable decisions in administering therapy.

It will be appreciated from a practical standpoint that the various device components described above may be conveniently organized into functional components to minimize hardware and patient discomfort at the sample fluid collection point. . Thus, cleaning fluid solution inlet 12, second inlet 13, constant volume diaphragm pump 14, one-way halp 17, and fluid detector 18 are all included within assembly module 11. For example, the assembly module 11 has a width of 2.5 cm and a length of 5 cm.
The thickness is 1. It has a small size of 25 cm. Such an assembly is conveniently taped to the patient's arm in close proximity to the insertion site of the catheter 4. The assembly module 11 includes, for example, a sample transfer tube 1, a washing fluid solution distribution tube 2, a pneumatic tube 3, a logic control device 40 as a fluid detection control device, a blood sample analyzer 50, pumps, valves,
It is connected via a flexible cord-like body 8 with a length of 90 cm to 240 cm, consisting of an output signal line 19 to a meter 51 (encircled by a dotted line) consisting of an excitation device and a detector. A tubing connection 16 and a manual tubing pinch clip 15 in the cleaning fluid solution distribution line 2 are provided for convenience in replacing the cleaning fluid reservoir 9 during instrument operation. Assembly module 1
1 is shown in detail in FIGS. 4 and 5 and is designated as the fluid manifold and bubble detection element.

For a clearer understanding of the process of blood sample collection and device cleaning, the steps A-F in Figure 2-1 to G-K in Figure 2-2 are used.
1 schematically shows in detail the contents and state of the sample transfer tube 1 during various stages of operation. Components that are structurally the same in these schematic drawings are labeled with the same numbers as used in FIG. 1.

FIG. 2-1A shows the sample transfer tube 1 filled with a wash fluid solution except in the area near the catheter 4. In FIG. In this phase of operation, the peristaltic pump 25 acting on the sample transfer tube 1 along region 6 of FIG. At this stage, fluid is not transferred into or out of the sample transfer tube 1 from the wash fluid solution inlet 12 and the second inlet 13. A droplet 67 of cleaning fluid discharged by the ejection action is delivered from the sample delivery nozzle 7 .

FIG. 2-1B shows the inside of the sample transfer tube 1 at a slightly slower time difference of about 0.25 seconds, for example. Blood 60 is being drawn through the wash fluid solution inlet 12 and the second inlet 13. Although blood enters the cleaning fluid solution inlet 12 due to some diffusion, the static condition of the cleaning fluid in the cleaning fluid solution distribution tube 2 otherwise prevents significant penetration of blood into the cleaning fluid solution inlet 12. It is noteworthy that

In FIG. 2-1C, the condition of FIG. 2-1B is changed by injecting a small amount of immiscible fluid, such as 7 to 10 microliters of air, through the second inlet 13. This forms a gas bubble 65 within the sample transfer tube 1 of said immiscible fluid. The air bubble 65 fills the entire cross-section of the sample transfer tube 1, but within a linear range that does not exceed the linear distance between the second inlet 13 and the wash fluid inlet 12. The air bubbles 65 form a separation barrier within the blood 60 drawn into the sample transfer tube 1 . By limiting the linear range of the bubbles 65,
As will be described later, backflow into the sample transfer tube 1 is caused by the blood vessel 10.
It becomes clear that no injection of any part of the air bubble 65 into the air bubble 65 occurs.

FIGS. 2-1 D and E show that a second bubble 69 and a third bubble 70 are introduced into the sample transfer tube 1 to separate blood columns 62.6 of, for example, IO to 100 microliters each.
3 depicts the situation within the same apparatus at a relatively later point in time when forming 3.

The main purpose of the blood column 62 in this action is the second air bubble 6
The purpose is to collect any residue of the cleaning fluid remaining in contact with the inner surface of the sample transfer tube 1 after passing through step 9. Second bubble 6
9 further ensures that any additional residue present on the inner surface of the sample transfer tube 1 is removed from the separated blood column 6 after passing through the blood column 62.
3 ensures that only the characteristics of the blood 60 itself as contained within the blood 60 are represented. The number and linear range of separated blood columns such as blood column 72 are determined by the number and linear range of separated blood columns 6 to be analyzed.
It is clear that the conditioning of the sample transfer tube 1 and the inner surface before the passage of 3 can be selected to best achieve this.

F in FIG. 2-1 represents the contents of the same device approximately 0.1 seconds later. Wash fluid solution 71 begins to flow into sample transfer tube 1 through wash fluid solution inlet 12 at a rate slightly higher than the rate at which fluid is drawn in by peristaltic pump 25 through sample transfer tube 1 . Blood 60 is thus reversed in flow within the sample transfer tube 1 at the entry point of the wash fluid solution inlet 12 and passed through the catheter 4 to the blood vessel lo
re-injected into the body. The intention of such backflow is to clear the sample transfer tube 1 and to clean the wash fluid solution inlet 12 and the catheter 4.
The aim is to keep all traces of blood 60 between the catheters 4 and the catheter 4 itself as clean as possible.

At G in FIG. 2-2, the blood trains 62 and 63 are directed further along the sample transfer tube 1 to the point where the second bubble 69 is detected by the bubble detector 31, thus leading to the front boundary of the sample blood train 63. Identify the location of the department. The immiscible fluid bubble column 66 is connected to the immiscible fluid second inlet 13 and the blood column 6.
3 into the wash fluid contained within the sample transfer tube 1. An array of bubbles 66 is employed to provide a cleaning action on the inner surface of the sample transfer tube 1 from the second inlet 13 to remove any residual blood 60 that may affect subsequent blood samples. The backflow of irrigation fluid between catheter 4 and irrigation fluid solution inlet 12 reinjects into blood vessel 10 any blood 60 previously contained within this tube section. Continuous backflow then injects irrigation fluid through the catheter 4 into the blood vessel 10, clearing the tube, the catheter 4, and its interior surfaces to maintain an ``open flow'' condition.

At H in FIG. 2-2, the fluid is moved further within the sample transfer tube 1 to the point where the front and border of the sample blood column 63 advances to the open end of the sample distribution nozzle 7 to form a blood test device. It is ready to be dispensed to the blood sample analyzer 50. Before that, drops of cleaning fluid such as droplets 67 in A-F in FIG. 2-1 to G and H in FIG. 2-2 are discharged into a waste reservoir (not shown). Once a sample blood train 63 is detected, the end of the flexible tube and the sample dispensing nozzle 7
is actuated by a solenoid or other device under the control of logic controller 4o to direct sample dispensing nozzle 7 to the test location. The positioning of the blood sample array is therefore carried out by the logic controller 4o shown in FIG. This is done by considering the predetermined distance between the detector 31 and the open end of the sample distribution nozzle 7 and the known peristaltic pump 25Q characteristics.

2-2, the measuring portion 59 of the sample blood train 63 is a blood sample analyzer, which is a blood test device, located at a test location determined by the control of the peristaltic pump 25 by the logic controller 40 in FIG. 50. The entire process represented by A to F in FIG. 2-1 to G to G in FIG. 2-2 can be accomplished, for example, in 15 seconds for a sample transfer tube 1 having a length of 180 cm.

At J in FIG. 2-2, all the blood remaining in the sample transfer tube 1 from before has been discharged to the waste site, as shown in (■) in FIG. 2-2. The entire volume of the sample transfer tube is now filled with a wash fluid and a combination of wash fluid and bubble array 66 as in FIG. 2-2G.

The number of bubbles and the distance between the bubbles in the bubble row 66 shown in G in FIG. It is clear that variations are possible with the aim of best achieving the removal of blood residues within the tube 1.

At K in FIG. 2-2, the first tube pinch valve 21 actuated by the logic controller 40 causes the continuous inflow of irrigation fluid through the irrigation fluid solution inlet 12 so that all of the irrigation fluid flows through the catheter 4. The inlet of the sample transfer tube 1 to the peristaltic pump 25 is occluded so as to be directed into the blood vessel 10 . At this point the pulsating action of the peristaltic pump 25 acting on the cleaning fluid solution distribution pipe 2 is reduced, e.g.
Maintain the normal open irrigation fluid flow rate within the catheter 4 on the order of 5n+1 per hour. This is easily accomplished by logic controller 40.

The process steps represented by A-F in Figure 2-1 to G-K in Figure 2-2 draw the blood sample to be tested;
The sample is distributed to a test device located at a location remote from the sample collection point, maintaining the purity of the blood sample such that removal from the source blood vessel 10 substantially leaves the blood sample unaffected by the overall analysis. to a blood sample analyzer 50, which is a blood test device, and cleaning surfaces that came into contact with the blood sample following the transfer step;
It may be intended to achieve functions such as establishing an open flow condition within the catheter 4 and maintaining the removal of material, such as clotted blood, within the blood vessel 10 after the sampling process is completed. be understood.

Additionally, the constant volume diaphragm pump 14 in FIG.
It will be appreciated that the constant volume of the fluid serves to prevent potentially dangerous air or other immiscible fluids from being injected into the blood supply blood vessel 10. Furthermore, it will be appreciated that air bubbles may actually flow from the cleaning fluid reservoir 9 through the cleaning fluid solution distribution line 2. Accordingly, the fluid detector 18, the bubble detector in FIG. prevent.

FIG. 3 shows a practical apparatus for blood sample collection, remote evacuation and diagnostic analysis. Briefly, the system is divided into permanent and disposable components. The permanent instrument portion includes a visual monitor and data input module, display 43, a blood sample collection and distribution system module, instrument 51, and a blood testing system module, blood sample analyzer 50.

These modules are housed within an instrument housing 49 that is designed to be suspended or placed on a horizontal surface. Disposable elements include a fluid manifold, a bubble detection assembly module l1, tubing and electrical tube bundle 8,
A cassette 34 and a wash fluid reservoir 9 are included. The blood test device cassette located behind the instrument access door 54 and the waste fluid container located behind the access door 53 are not shown.

For the convenience of the operator, disposable blood samples are collected by a fluid manifold and bubble detector assembly 11 connected to a cassette 34 via a catheter 4 and tubing connected directly to the sample transfer tube 1 and an electrical cord bundle 8. Available as a single assembly including: In use, cassette 34 is positioned within cutout 30 of instrument housing 49.

The cord tube bundle 8 is then placed at the sampling location. After inserting the catheter 4 into the blood vessel containing the blood to be sampled, the fluid manifold and bubble detector assembly 11 is taped or otherwise attached to a structure adjacent the insertion site of the catheter 4. The insertion point is, for example, the patient's arm, thus eliminating excessive stress on the sample transfer tube 1, catheter 4, and cord-shaped tube bundle 8. The cleaning fluid reservoir 9 is a conventional bottle or bag of normal cleaning fluid. The wash fluid reservoir 9 is attached to the cassette 34 by a conventional tubing connection 16 and is positioned adjacent to the west terminal mounted instrument housing 49 on the same terminal to which the instrument housing 49 is attached.

When properly positioned within the cutout 30 of the instrument housing 49, the sample cassette 34 is maintained in direct contact with the interface surface 35, establishing a positional relationship between the sample transfer tube 1 and the wash fluid solution distribution tube 2. Establish. Sample transfer tube 1 and wash fluid solution distribution tube 2 are connected to cassette 34
It interfaces with the fingers of the peristaltic pump 25, the first tube Vinci valve 21, the second tube Vinci valve 22, and the bubble detector 31. Electrical contact between the bubble detector 18 and the output signal line 19 shown in FIG.
and the cassette 34. A pneumatic connection between the air pump control line 3 and the pneumatic pump 24 shown in FIG. 1 is likewise established via the interface surface 35.

As indicated above, the essence of the device and method is that the device draws a sample of blood from a blood vessel of the patient, such as an artery or a vein, or from an extracorporeal tube through which fluid is continuously passed. The device can be employed in cardiac surgery, where the tubes lead to an oxygen saturation device, or in dialysis, where the fluid exits the body and enters a treatment unit that cleans the blood. A unique feature of the device previously noted as different from prior art devices is that the collection point is a closed point rather than an open cuvette (Ciyette). To keep the inlet clean, the device utilizes compatible non-toxic irrigation fluids, such as irrigation fluids or non-toxic isotonic fluids, to backflow into the patient's body.

FIG. 4 shows, for example, a fluid manifold and bubble detector assembly 11 such as that schematically represented in FIG. Assembly module 11 contains sample transfer tubing 1, pneumatic pump control tubing 3, control solution or wash fluid solution distribution tubing 2, as well as power and signal lines 19 for bubble detector 18. These tubes and wires are grouped together to form a cord tube bundle 8 shown in FIG. As can be seen in FIG. 4, the fluid manifold and bubble detection assembly 11 is located at Ll. L2. It is made up of five flat interlocking layers of plastic labeled L3, L4 and L5. These planar plastic members are prefabricated and preformed and have a series of tubes inserted between the various levels as shown in FIG. 1, as will be described below. Planar members L1-L5 also include one-way valves 17 and constant volume diaphragm pumps 14. As shown, L1 and L2 are sandwiched between 264. One tube is the sample transfer tube 1 and the other tube is represented as a bubble of air within the tube.

This tube is an air intake that enters the sample tube and supplies air under the control of a constant volume diaphragm pump 14.

The tube is positioned between L1 and L2 with matching grooves or channels 91, 92, 93 and 94.

Module L2 includes two check valves as well as two small inlets that interface with valves as described below. Essentially a check valve 170.171
is a disk-shaped valve and operates to ensure unidirectional flow of wash fluid into the sample tube and output of the diaphragm pump 14 of immiscible fluid into the sample tube.

Check valves 170 and 171 are made of silicone rubber and are molded so that during assembly the check valves provide a through-face seal (Ibro) for fluid and air.
It is equipped with a built-in compression seal that provides a ngh-lace seal.

These check valves 170, 171 allow unidirectional flow of air and wash fluid into the sample transfer tube 1, while not allowing backflow of fluid into the air pump or backflow of fluid into the wash fluid supply tube. do not have. Cleaning fluid check valve 171 is shown as one-way valve 17 in FIG.

Assembly module 11 includes a diaphragm air pump 172 located within planar member L3. A diaphragm air pump is connected closely to the sample tube on its output side. The diaphragm air pump 172 is basically a flapper valve-in.
glwe in) 1 7 3 and flapper valve out 171. The volume through which the diaphragm moves limits the size of the bubble that can be injected into the sample transfer tube 1 no matter how much pneumatic drive air pressure is applied to the diaphragm.

A diaphragm bomb is a small disc that resembles a very small pump. For example, the amount of air bubbles injected into the sample tube 1 is less than 50 millionths of a liter. A small diaphragm with a matching seal connects the planar member L.
It is fitted into the groove or recess of No.3.

As previously indicated, valves 170, 171 and 173 and diaphragm bump 172 each include an annular resilient polymer disk or membrane with a circumferential flange. The flange acts as a seal. Drive air flows through the mouth 174 of L4, which seats on the diaphragm of the pump. The mouth 174 is directed to the drive air in the tube 3 sandwiched between L4 and G5. Actual pump operation is performed by first creating a slight vacuum pulling the diaphragm upwards, which only requires a slight reduction in air pressure. Essentially, the diaphragm operates to produce a constant volume bubble as long as it operates during its entire reciprocating period. Therefore, there is a unique bubble size independent of the amount of air pressure driving the diaphragm. As can be seen, the cleaning fluid solution distribution tube 2 is inserted and sandwiched between the planar members L4 and L5 and opens directly into the planar members L3 and L2 through a check valve 170 and a matching hole. . As shown, check valve 170
The purpose of this is to prevent backflow into the cleaning fluid line.

The cleaning fluid solution distribution pipe 2 is e.g.
, a corresponding hole 176 in L3.
4, through holes located in L3 and L2 and L2
The sample tube is opened through a valve 170 through a hole in the sample tube, at which point the sample tube is punctured by a pin or other device to provide an inlet for wash fluid. This inlet allows connecting the wash fluid tube to the sample tube through a hole in the wash fluid tube and a hole in the sample tube, both of which communicate with corresponding holes in the planar modules L1 to L5.

As can be seen from FIG. 1, constant volume diaphragm pump 14, diaphragm air pump 172 of FIG.
is driven directly by pneumatic pump 24 which is controlled by logic controller 40 of FIG. In any case, the inlet to the pneumatic pump control tube 3 is also sandwiched between modules L5 and L4 and is shown as the drive air internal tube 3, which functions as tube 3 in FIG. Air flowing through tube 3 also connects diaphragm 176 through a hole in module L4. It is, of course, understood that diaphragm air pump 172 is completely similar to constant volume diaphragm pump 14 of FIG.

Thus, as indicated above, the diaphragm pump controls the size of the air bubble directed into the sample tube. A typical bubble size is approximately Q. 6c @ or about 7 micro
liter, but by controlling the volume of the constant volume diaphragm pump 14, it can be made as large as 50 microliters. In its relaxed state, the diaphragm covers the inlet to air output valve 171, thus also acting as a check valve by prohibiting air from being drawn into the sample tube during sampling.

Referring again to FIG. 4, three fluid tubes are sandwiched between planar modules L4 and L5. There is a cleaning fluid solution distribution pipe 2, a drive air inlet pipe 3 and a pipe designated as the fourth one. The tube is attached to module 11 where the user can return the tube to the pump assembly.
It is a through-hole inside. This may be done, for example, if the hospital wishes to set up an intravenous line as a fourth line without providing another line. In any case, the fourth through tube can be used within the fluid manifold and bubble detection assembly 11, and can actually be operated by a peristaltic pump or another pump.

As can be seen in FIG. 4, within the planar member L4 is a module designated by the reference numeral 180, which corresponds to the bubble detector 18 of FIG. The bubble detector lead emanating from module L4 is designated by the reference numeral 185.

Bubble detectors are known per se and may also typically include LEDs and photovoltaic cells or other devices.

Air bubble detectors such as the one designated by the reference numeral 180 can in principle operate under clean air, so that when an air bubble passes through the detector 80, the maximum amount of light is detected and the blood is Since it is darker, the lowest amount of light will be detected when blood passes through. Such detectors, as illustrated, are very well known in the art, and there are a large number of different types of devices that can be employed. The bubble detector 80 is combined with a differentiator circuit, thus electronically monitoring the rate at which changes occur between one bubble type and another. The rate of change sends a pulse upon the occurrence of a bubble to detect air, blood or cleaning fluid.

FIG. 5 shows various planar members L1 to L5 shown in FIG.
A side view of is shown. For example, 187,188,18
The portion shown as 9 in FIG. 5 is each planar member L1.
~L5 are the actual pins that allow them to be interconnected via pins 187, 188 and via corresponding holes. Accordingly, each module L1-L5 is precisely aligned and interlocked by the bins and holes to form the module◆assembly 11. Various types of tubes may be used or inserted between the planar members through channels within the member that fit the tubes.

The various layers L1-L5 are connected together by openings or holes in each layer so that the sample transfer tube 1 can be connected to an air source as previously shown, as well as to a wash fluid tube.

FIG. 6 shows a disposable cassette 34 of the blood sample collection system as shown in FIG. The sample transfer tube 1 is directed through a cassette such as a pneumatic pump control tube 3 and a wash solution or wash fluid distribution tube 2. The cassette has a front plate 29 that essentially includes a series of recesses.

The recesses define wash fluid exit tube guides or grooves 27 and sample transfer tube guides or grooves 28. These guide grooves 27 and 28 are adapted to the wash fluid solution distribution tube 2 and the sample transfer tube 1. Grooves 27 and 28 have flat bottom surfaces that allow the fingers of the peristaltic pump to cooperate with the tube to control fluid flow. As is clear, the cassette is composed of a front plate 29, which is a planar member, which is the rear cover of the cassette, and a front planar member 47, which is the front cover of the cassette. Member 47 includes a plurality of channels for use with the various tubes shown.

For example, it is also shown that the tubes can simply be connected together by suitable members. Pump cassette assembly 3
4 or an occlusion detector pressure sensor●interface opening 45. A sample dispensing nozzle pivot arm 36 is shown for removability from within the housing 40, as shown, for example, in FIG.

The sample distribution nozzle pivot arm 36 connects a portion of the sample transfer tube 1 to the bubble detector 31 shown in FIG. 1 positioned within the blood sample collection and distribution system module 51 shown in FIG. relatively located. This bubble detector 31 is used for the purpose of detecting the position of the fluid at the output end of the sample tube 1.

The front cover of the cassette assembly 47 has an aperture 39 through which the fingers of the peristaltic pump are directed and which engage the sample tubes. It engages the cleaning fluid tube at regions 5 and 6 to discharge fluid within the tube as shown and described at K. Therefore, as can be seen from the foregoing, the device utilizes two disposable modules. One module used as the fluid manifold detection assembly 11 is completely disposable and can be attached to the patient's arm. The module 11 is small and has a cord-like tube bundle 8 directed therefrom. The cord tube bundle 8 can also be discarded. Thus, after the patient has been monitored, the assembly module 11 and the cord bundle 8 are released. The second disposable module shown in FIG. 6 is a therapy control or pump cassette assembly 34. It also includes disposable tubes and various other parts. It will be appreciated, of course, that the module 34 need not be disposable, but can be assembled in two parts as a cassette assembly and ready again for each patient, for example by placing a new tube into the cassette assembly. .

The sample tube is extended at region 6 with respect to the wash fluid tube for the purpose of varying the rate of flow under the influence of a similar peristaltic impeller action. This stretch is typically 0% to 25%,
change the flow.

[Effects of the Invention] Accordingly, as indicated above, the present invention is a blood sampling device which is capable of taking a sample of blood from a patient's blood vessels or from an extracorporeal intake port, and which continuously flows this sample to a test site. An inventive device has been described. The whole device is based on the fact that the inlet or collection point is a closed place. The entry point can be cleared with a backflush operation, thus reversing the fluid flow and allowing the entire monitoring operation to operate continuously utilizing the same blood vessel. This device eliminates the need to remove a blood sample from a patient through a patient's finger clip or other standard device while allowing for the desired continuous monitoring and testing.

[Brief explanation of drawings]

FIG. 1 is a block diagram illustrating an apparatus for repeatedly and separately sampling body fluids according to the present invention; FIGS. 3 is an illustration of the actual device for blood sample collection, remote site dispensing and diagnostic analysis; FIG. 4 shows a series of interlocked planar members. FIG. 5 is a side plan view of the fluid manifold of FIG. 4, and FIG. 6 is a bomb employed with a therapy control device according to the present invention;
FIG. 3 is a schematic top perspective view of the cassette assembly. 1... Sample transfer tube 2... Washing fluid solution distribution tube 3... Tube 4... Catheter 5, 6.
...Area 7...Sample distribution nozzle 8...
Cord-shaped duct bundle 9... Reservoir 10... Blood vessel l
DESCRIPTION OF SYMBOLS 1... Assembly module 12... Cleaning liquid solution inlet 13... Second inlet 14... Constant volume diaphragm pump 15... Tube pinch clip 16... Tube connection body 17... one way valve
18... Fluid detector 19... Output signal line
21... First pipe vinci valve 22... Second pipe vinci valve 23... Drive motor 24...
Pneumatic pump 25...Peristaltic pump 27.28...
Groove 29...Front plate 30...Notch 31...
・Detector 33...Pressure switch 34...Cassette 35...Interface surface 36...
・Pivot●Arm 40...Logic control device 41・
... Output terminal board 42 ... Input terminal board 43 ... Display device 45 ... Interface opening 4
7... Planar member 48... Keyboard 49...
・Instrument housing 50...Blood sample analyzer 5
1... Instrument 52... TS/WS/SS module 5
3.54...Inspection n 59...Measurement part 60.
...Blood 62.63...Blood column 65.66...
Bubbles 67...Droplets 69...Second bubbles
70... Third bubble 71... Cleaning fluid solution 171, 173... Check valve 172...
Diaphragm air pump 174...mouth portion 175
．． 176...hole 180...module 185.
... Conductor 187,188.189...Post (
Pin') 191.192, 193.194...
・Groove (channel) Ll~L5...flat plate member

Claims (35)

[Claims] (1) An apparatus for transferring a sample of body fluid from a first location to a test location, the first end having a first sample inlet, a second wash fluid inlet, and a relatively immiscible immiscible with the sample and the wash fluid. a sample tubing member having a third inlet for receiving fluid and having an outlet at a second end; a wash fluid tubing member connected to the second wash fluid inlet; and a wash fluid tubing member operable to direct fluid flow toward the outlet. a first pumping device connected to the sample tubing device; a pumping device operative and cooperative with the first pumping device to direct a flow of wash fluid to the sample tubing member through the second wash fluid inlet; and controlling the ratio of fluid volumes delivered by the first pump device and the second pump device in a first mode of operation to direct wash fluid within the sample tube member from the wash fluid inlet to the sample inlet and the outlet. a second pumping device connected to said second cleaning fluid member for flow to said second cleaning fluid member; and when selected in a second mode of operation, inhibiting fluid flow to said outlet and directing all flow of cleaning fluid from said cleaning fluid inlet. a first valve device connected to the sample tubing member operable to direct the flow of wash fluid into the sample tubing member through the second wash fluid inlet when selected in a third mode of operation; a second valve arrangement connected to said second cleaning fluid conduit member operative to impede said third cleaning fluid conduit when selected in said first and third modes of operation;
the third inlet for injecting a controlled volume of the immiscible fluid through the inlet to generate a dispersed series of discrete immiscible fluid bubbles within the body fluid or wash fluid within the sample tube member; a third regulating pump device connected; and as a series of cells of cleaning fluid separated by bubbles of said immiscible fluid in said first mode of operation;
selectively energizing each pump device and each valve device in a predetermined sequence such that the outlet receives a predetermined sequence of fluids as a series of cells of body fluid separated by bubbles of the immiscible fluid following a mode of operation; a control device connected to said pump device and said valve device, said outlet being directed to a remote location including said test location, monitoring said sequence of fluids and controlling said sample, wash fluid and fluid at said remote location; a detection device connected to the sample tube device at the remote location to deliver an output signal level indicative of an immiscible fluid; moving the tube and said second end to said test site, directing only the contents of selected cells of body fluid to said test site as said second end is moved; a fluid sample for body fluid sampling comprising a device connected to the sample tubing member and responsive to the output signal level to discard the body fluid and a wash fluid and an immiscible fluid in response to the signal level if a cell is not detected; Collection and distribution equipment. (2) A fluid sample collection and dispensing device for a body fluid sample according to claim 1, wherein the immiscible fluid is air and the body fluid sample is blood. (3) said first and second pump devices dispel fluid within the tube toward a remote location through a first channel adapted to receive said sample tubing member and a second channel adapted to receive said wash fluid tubing member; a peristaltic pump device having a series of fingers operative to operate, said channels being relative to said fingers for causing said pump to expel sample and wash fluid through said sample tubing member and wash fluid tubing member; A fluid sample collection and dispensing device for body fluid sampling according to claim 1. (4) A fluid sample collection and dispensing device for bodily fluid sampling according to claim (2), wherein the cleaning solution is a dispensable conventional saline. (5) said first pump device and said second pump device direct fluid within the tube toward a remote location through a first channel adapted to receive said sample tubing member and a second channel adapted to receive said wash fluid tubing member; 4. A peristaltic pump device having a series of fingers operative to dispense, wherein said channels are positioned relative to said fingers to cause said pump to dispense said sample and said wash fluid through said tubing member. A fluid sample collection and dispensing device for body fluid sampling according to paragraph (1). (6) A body fluid sampling fluid according to claim 3, wherein the diameter of the sample tube device is different from the diameter of the wash fluid tube device, thus providing a different flow rate of sample to wash fluid. Sample collection and distribution equipment. 7. The fluid sample collection and dispensing device for body fluid sampling according to claim 1, wherein the first sample inlet is connected to a catheter inserted into a blood vessel of a patient. 8. A fluid sample collection and dispensing device for bodily fluid sampling as set forth in claim 1, wherein said sample tubing member and said wash fluid tubing member are flexible plastic tubing compatible with said fluid. 9. A fluid sample collection and dispensing device for body fluid sampling according to claim 1, wherein said irrigation fluid inlet is connected to a irrigation fluid reservoir via a flexible plastic tube. (10) The body fluid sampling device according to claim (6), wherein the first valve device is a pinch valve that operates to block the flow of fluid to the outlet when the first valve device is selected to pinch the sample tube member. Fluid sample collection and distribution equipment. 11. A fluid sample collection and dispensing device for body fluid sampling according to claim 1, wherein said second valve device is a pinch valve that is activated when selected to occlude the flow of irrigation fluid from said reservoir. . (12) a diaphragm pump, wherein the third regulating pump device is connected to a pressure pump that operates the diaphragm to provide a controlled volume of immiscible fluid directed to the sample tube member through the third inlet; A fluid sample collection and dispensing device for body fluid sampling according to certain claim (2). 13. Fluid sample collection for body fluid sampling according to claim 1, wherein said detection device is a bubble detector operative to detect transitions between said cells of sample and wash fluid and immiscible fluid. distribution device. 14. The fluid sample collection and dispensing device for body fluid sampling according to claim 1, further comprising a fluid dispensing nozzle connected to the outlet of the sample tube member. (15) Claim 5 further comprising a bubble detector connected to the vicinity of the catheter and to the sample tube device for detecting bubbles.
) A fluid sample collection and dispensing device for body fluid sampling as described in paragraph 1. (16) An apparatus for transferring a sample of body fluid from a first location to a test location, the device comprising a first sample inlet, a second wash fluid inlet, and a third inlet receiving an immiscible medium that is relatively immiscible with the sample and the wash fluid. a fluid manifold device having an inlet and a sample tubing member connecting the first, second and third inlets; the fluid manifold device positioning a selectively actuatable first pump device; the first pump device; is connected to the third inlet and the first pump device is connected to direct the immiscible fluid cell into the sample tubing member upon actuation of the cell operative to separate sample from wash fluid. and a first pumping device, wherein the sample tubing member has a first volume of wash fluid, a second volume of immiscible medium, and a third volume of body fluid.
selectively activating the pump device in a predetermined sequence to receive a volume, a fourth volume of immiscible medium, a fifth volume of body fluid, a sixth volume of immiscible medium, and a seventh volume of irrigation fluid; a controller for energizing; the sample tubing being directed from the manifold apparatus to a remote location including the test location, the sample tubing monitoring the sequence and indicating sample, wash fluid, and immiscible materials at the remote location; a detection device at said remote location for transmitting an output signal level; responsive to the signal level to move the output end to the test location, such that when the output end of the sample tube is moved, only sample is directed to the test location and no sample is detected; and a device for dispensing said wash fluid and an immiscible medium accordingly. (17) The fluid sample collection and dispensing device for bodily fluid sampling according to claim (16), wherein the immiscible medium is air and the bodily fluid is blood. (18) The fluid sample collection and dispensing device for body fluid sampling according to claim (16), wherein the cleaning fluid is a dischargeable normal salt. 19. The fluid sample collection and dispensing device for bodily fluid sampling according to claim 16, wherein the first sample inlet is connected to a catheter inserted into a patient's blood vessel. 20. The fluid sample collection and dispensing device for body fluid sampling according to claim 16, wherein the first sample inlet is connected to an extracorporeal blood flow source. (21) The fluid sample collection system for body fluid sampling according to claim (16), wherein the second cleaning fluid inlet is connected to one end of the flexible tube and the other end is connected to a cleaning fluid reservoir. distribution device. 22. The fluid sample collection and dispensing device for body fluid sampling of claim 16, wherein said sample tubing member includes a second pump device for moving said sequence of material from said sample outlet. (23) The fluid sample collection and dispensing device for body fluid sampling according to claim 22, wherein the second pump device is a peristaltic pump. (24) The sample tube member has a nozzle located at the output end for dispensing the material.
Fluid sample collection for body fluid sampling as described in section 6)
distribution device. (25) when the tubing member includes a cassette housing holding a sample tubing member and a wash fluid tubing portion between an inlet and an outlet of the housing, and when the cassette is set in position in conjunction with the pump device; 17. A fluid sample collection system for body fluid sampling according to claim 16, wherein the sample tube and the wash fluid tube section have transversely oriented holes to enable the tube to be accessed by a second pumping device. distribution device. (26) a detection device positioned proximate said first inlet and operative to detect bubbles within said fluid manifold device to provide a signal output indicative of a problem condition; and said first pump device connected to said controller. 17. A fluid sample collection and dispensing device for bodily fluid sampling as claimed in claim 16, including a device responsive to said signal to prevent said excitation of a second pump device. (27) the fluid manifold device includes a valve device to ensure unidirectional flow to the wash fluid tube and the sample tube and includes the first pump device to direct a predetermined volume of air into the sample tube; Claim No. 1
Fluid sample collection for body fluid sampling as described in section 6)
distribution device. (28) A method for transferring a sample of body fluid from a first location to a remote location including a test location, the method comprising: directing a flexible tube representing a body fluid sample transfer tube between the first location and the remote location; , connecting the tubing at the first location to a source of bodily fluid at one location, a source of immiscible fluid at another location, and a source of irrigation fluid at another location; and first flowing irrigation fluid through the tubing to remove the irrigation fluid. through the tube and into the first location while simultaneously directing cleaning fluid to the remote location;
then removing body fluid from the first location and directing the body fluid to the remote location; then directing a first volume of immiscible fluid into the tube and providing a barrier between the sample and the wash fluid; , continuing to flow the sample through the tube and then directing a second volume of immiscible fluid into the tube to position the sample between the barriers to provide another barrier; flowing a volume into the tube; detecting the sample positioned between the barrier at the remote location and placing the detected sample at the test location; then flowing a cleaning fluid through the tube. , simultaneously moving the cleaning fluid from the source of cleaning fluid toward the first location and the remote location and introducing a series of the immiscible bubbles into the fluid as directed toward the remote location; washing said sample tube of body fluid precipitate before repeating the step of flowing said sample tube through said tube. 29. The method of claim 28, wherein the step of flowing an immiscible fluid includes discharging a volume of fluid into the tube to provide a volumetric barrier. . 30. The method of claim 28, wherein the step of flowing includes discharging the fluid through the tube as directed into the tube. (31) A fluid sample collection and dispensing method for body fluid sampling according to claim (29), wherein the ejection action is adapted by a peristaltic ejection action. (32) The step of detecting includes detecting all fluid within the tube at the remote location to determine which fluids are not the sample fluid, and draining the fluid or waste from the tube at the remote location. The method for collecting and dispensing a fluid sample for body fluid sampling according to item (29). (33) Claim No. 3, wherein the waste liquid is discharged at a waste liquid site.
Fluid sample collection for body fluid sampling described in section 2)
Distribution method. (34) The method of collecting and dispensing a fluid sample for body fluid sampling according to claim 32, wherein the sample fluid is discharged at the test site. (35) A fluid sample collection and dispensing method for body fluid sampling according to claim (34), wherein the sample fluid is discharged at the sample location.