BRPI0611364A2 - blood sample collection, treatment and administration system, coverage and method for monitoring a patient's material sample - Google Patents

Abstract

SYSTEM FOR COLLECTION, TREATMENT AND ADMINISTRATION OF A SAMPLE OF BLOOD, COVER, AND METHOD FOR MONITORING A PATIENT MATERIAL SAMPLE A system for the collection, treatment, and administration of an autologous blood sample comprising a first syringe for extracting a patient's blood and untreated sample from a blood sample treatment chamber having a chamber inlet for receiving untreated blood from the first syringe and chamber outlet for treated blood passage to a second syringe coupled to the same. The second syringe includes a release locking means to allow discharge of the treated blood to the patient in response to a release signal. The release signal is emitted upon a positive exit from the verification process dependent on temporal data from certain events. in the collection, treatment and administration of the blood sample, and patient identification data and the second syringe with the treated blood.

Description

SYSTEM FOR COLLECTION, TREATMENT AND ADMINISTRATION OF A BLOOD SAMPLE, COVERAGE AND METHOD FOR MONITORING A SAMPLE OF PATIENT REFERENCE MATERIAL AT CORRECT PATENT APPLICATIONS

This Patent Application claims the superiority benefit for US Provisional Patent Application Serial No. 60 / 682,969, filed March 19, 2005, US Provisional Patent Application Serial No. 60 / 683,280, filed May 19, 2005, and US Provisional Patent Application Serial No. 60 / 683,333, filed May 19, 2005.

BACKGROUND OF THE INVENTION

FIELD OF INVENTION

The present invention relates to the management of medical treatment. More specifically it relates to a permit-based fluid delivery device.

DESCRIPTION OF TECHNICAL STATE

Despite notable advances in healthcare technology and administration, large numbers of patients die or become disabled as a result of medical errors. These errors occur in health care facilities, such as hospitals, clinics, nursing homes, emergency centers, doctor's offices, pharmacies, and home care, and usually result from system problems rather than a single action or decision.

For many years, barcode labeling has been the technology of choice to ensure patient safety. Recently, the Food and Drug Administration (FDA) has published a new rule requiring certain human medicine and biological product labels to have barcodes. As such, the barcode for human pharmacological and biological products (other other than blood, blood components, and devices regulated by the Centerfor Biologics Evaluation and Research) must contain the NationalDrug Code (NDC) number in a linear barcode. The rule is intended to reduce the number of medication errors in hospitals and other healthcare facilities by allowing healthcare professionals to use barcode tracking equipment to verify that the correct medicine (at the right dose and through the correct administration route) is in place. being given to the right patient at the right time. The rule also requires the use of machine readable information on blood labels and blood components to help reduce medication errors.

However, barcodes require line of sight with a reader in order to be read and barcode cannot store additional information beyond simple identifying data such as a serial number or SKU. For example, a barcode wrist band in a patient is not easy to read if the patient gets wet or is sleeping on the arm with the wrist band, or when the patient is in an emergency room bed or operating table; These are the circumstances in which medication or blood transfusion errors are more prevalent.

It is an object of the present invention to reduce or eliminate at least one of the disadvantages mentioned above.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a system for the collection, treatment and administration of a blood sample, the system comprising:

an article for association with a patient who has a patient identifier;

a first syringe that has:

a first syringe inlet to draw a sample of untreated blood from the patient,

a first fluid chamber to receive untreated blood,

a first syringe outlet to dump the sample of untreated blood from the first chamber,

a first incremental counter for time records that correspond to untreated blood events related to blood collection,

the first syringe being associated with a unique identifier correlating with the patient identifier;

a vial for processing the blood sample, a vial containing:

a blood sample processing chamber, the vial having a chamber inlet; the first syringe outlet being operable to establish a first dedicated fluid coupling with the chamber inlet to pour the sample of untreated blood into the blood sample processing chamber; having a chamber outlet to dump a sample of treated blood following treatment to a second syringe, the second syringe having:

a second operable syringe inlet to form a second dedicated fluid coupling with the chamber inlet to receive the blood sample from the blood sample treatment chamber;

a second chamber for receiving treated blood, a second syringe outlet;

a passage in communication with the second chamber and the second syringe outlet;

a second incremental counter for temporal recordings corresponding to blood-staining events, treated blood events, and administration events; the second incremental counter being operable independently of the first incremental counter and being unsynchronized with the first incremental counter;

the second syringe being associated with a second unique identifier, the second unique identifier operatively associated with the first syringe and correlating to the first unique identifier;

a release lock formed within the passageway to operate the second syringe outlet between multiple states;

a processor that has:

a comparator for comparing the patient identifier to the first unique identifier to determine the correlation between them; and comparing the second unique identifier to the patient identifier to determine the correlation between the same, the comparator emitting an output signal;

logic for receiving the output signal and temporal data to determine time delays between events and to determine if time delays are within predefined ranges;

a logic-coupled release signal generator to output a release signal for release delay;

whereby the release signal is output after confirming the correlation between the patient identifier and the first unique identifier, and the correlation between the patient identifier and the second unique identifier, and provided such that the time delays are within pre-defined ranges. determined.

In another aspect, the present invention provides an identification means for identifying an initial patient from the untreated blood sample, a means for verifying a match between the original patient and the treated blood sample, and a release signal generation means for generating a deliberation signal in response to a positive verification by the verification medium. The means of identification and / or means of generating the release signal may be located on the body of the second syringe, or on an external article. The external article may be used, carried, fixed or ingested by the patient, such as a pin or self-adhesive label, or a coated object, and the like. Preferably, the external article contains a removable portion containing examination data related to the patient and / or sample of treated blood. For example, the external article may be conveniently provided as a pulse strip for use by the original patient.

In yet another aspect, the second barrel may also include a filtered outlet outlet in the passage to expel one or more gas constituents in the treated blood sample.

As a further aspect, the present invention provides a method for monitoring a sample of material from a patient comprising the steps of:

(a) collect the patient sample with a first device;

(b) associate the patient with the first signal-deporting data representative of the sample;

(c) associating the first collection device with the second representative signal bearer data of the sample;

(d) handing the sample to a sample sample chamber;

(e) processing the sample to form a processed sample;

(f) collect the sample on a second collection device;

(g) associating the second collection device with a third signal carrying representative data from the processed sample;

(h) compare the data at the first and third signs to link the processed sample to the patient; and after that;

(i) associate at least one of the steps (a) to

(h) with time data;

(j) determining at least one time delay using the time data to determine if at least one of steps (a) to (h) occurs within acceptable time limits;

(k) deliver the processed sample to the patient after a positive exit from step (h) and step (j) and

(1) gather an examination record that has temporal data collected from step (i), wing from step (h) and step (j), and data associated with the sample.

Events related to untreated blood collection are tracked by the first incremental counter, although treatment and posttreatment events are tracked by the second incremental counter so that time delays can be determined from the temporal data. Advantageously, these two counters operate independently of one another and do not need to be synchronized with one another unlike temporal clocks. Counters only operate during steps (a) to (j) described above, and thus do not require substantial debate energy. As such, the battery is sufficient to maintain the substantial accuracy of the watch within the time period from steps (a) to (f), and thus the possibility of wasting time or decreasing the accuracy of the watch as the battery power runs out is substantially deleted.

In yet another aspect, the system includes a trip lock means operable through a solenoid configured to receive the release signal.

In yet another aspect, the system includes a release lock operable via a half-motor configured to receive the release signal.

The term "treatment device" as used herein refers to a device used directly or indirectly in the course of a treatment. It may include devices that actually perform a patient treatment or a patient-derived sample, or alternatively is an article for performing treatment-associated functions, such as transporting or otherwise transferring the sample to or from a treatment.

BRIEF DESCRIPTION OF DRAWINGS

These and other features of the preferred embodiments of the invention will become more apparent from the following detailed description in which reference is made to the accompanying drawings in which:

Figure 1 is a perspective view of a blood treatment system;

Figure 2 is a sectional view of a first syringe shown in Figure 1, taken along line 1-1 ';

Figure 3 is a perspective view of the first syringe of Figure 1 coupled to a desodium citrate pouch;

Figure 4 is a perspective view of a blood treatment chamber of Figure 1;

Figure 5 is a perspective view of a second syringe of Figure 1;

Figure 6 is a sectional view of the second syringe of Figure 5 seen along line 5-5 ';

Figure 7 is another perspective view of the blood-treating chamber carrying the first syringe and the second syringe;

Figure 8 is a sectional view of the blood-treating chamber of Figure 7 seen along line 7-7 ';

Figure 9 is a sectional view of the blood treatment chamber of Figure 7 seen along line 9-9 ';

Figure 10 is an exploded view of an outlet port of the second syringe of Figure 5;

Figure 11 is a perspective view of an outlet valve;

Figure 12 is a sectional view of the outlet valve element of Figure 10 seen along line 11-11 ';

Figure 13 (a) is a perspective view of a locking mechanism portion in a locked state;

Figure 13 (b) is a perspective view of a locking mechanism portion in an open state;

Figure 13 (c) is a perspective view of a locking mechanism portion in a permanently locked state;

Figure 13 (d) is a perspective view of the locking mechanism portion adjacent to the exit port of Figure 10 in a permanently locked state;

Figure 14 is a perspective view of the locking mechanism portion in a cooperative arrangement with the knockout door;

Figure 15 is a flowchart highlighting a system verification protocol of Figure 1;

Figure 16 is a flow chart highlighting a verification portion protocol of Figure 15;

Figure 17 is a detailed perspective view of the blood treatment system;

Figure 18 is a schematic view of a verification protocol;

Figure 19 is a perspective view of a wrist band as shown in Figure 1, prior to operation;

Figure 20 is a perspective view of a wrist band as shown in Figure 1 in operation and

Figure 21 is a perspective view of a wrist band as shown in Figure 1, prior to operation.

DESCRIPTION OF PREFERRED EMBODIMENTS

As shown in Figure 1, a system 10 is provided for the collection, treatment and administration of an autologous blood sample. System 10 includes several entities that are used at different stages during blood sample handling, such as a first syringe 11 (Sl), a sample maintenance unit 12 (SMU), a blood treatment unit 14 (BTU), a second syringe 15 (S2), a pulse band 16 (WB). The first syringe 11 is used to collect an untreated blood sample from an original patient 17. Following collection of the untreated blood sample, the blood collection syringe 11 is coupled to the sample maintenance unit with the delivery syringe. blood already mounted thereon, and the sample maintenance unit is introduced into the blood treatment unit, in which the untreated blood sample is subjected to one or more stressors, such as ozone or ozone / gas mixture, energy ultraviolet (UV) and infrared (IR) light.

Following treatment, the untreated blood sample is delivered to a second syringe 15, from which the treated blood sample is administered to the initial patient 17. At one or more critical stages, the system 10 provides a verification check intended for reducing the likelihood of error, and thereby ensuring that the correct blood sample is returned to the right initial patient 17. The verification check includes the steps of combining the blood sample, either in its treated or untreated form or both, with the initial patient. 17. Typically, pulse band 16, first syringe 11, sample maintenance unit 12, second syringe 15, include identification data associated with the initial patient, which data may include clues, or may be machine readable by optical or electromagnetic means. .

As shown in Figure 2, the first syringe 11 has a first body portion 18 which provides a cylindrical cavity 19 which in cooperation with a plunger 20 forms a sample receiving chamber 21. The first syringe 11 includes a first channel portion 22 with a channel 23 in communication with the first sample receiving chamber 21, and a first firing inlet port 24 for entering the untreated blood sample from patient 17. The first channel portion 22 also includes a first syringe outlet port 26 for dumping the Untreated blood sample from the same sample to the sample maintenance unit 12. The first syringe outlet 26 includes a channel 27 in communication with the first sample receiving chamber 21 and channel 24.

The first syringe inlet port 24 is provided with a first syringe inlet valve means 28 in channel 24 to control blood flow through the first syringe inlet 24. In this case, the first inlet valve means 28 includes a housing 29 which contains a valve 30 arranged to be opened by a complementary valve member 31 located on an external device 32 as shown in Figure 3. The external device 32 may be a blood collection unit such as a "butterfly" needle or a decitrate bag sodium, and so on. Extending outside the first syringe outlet port 26 is a bayonet pin pair 72 for coupling the first syringe11 to the blood chamber 12. Included within the first syringe window 27 is a valve member 74 intended for a closed position. against a valve seat 76 over an end cap 78 forming the outer end of the first syringe outlet port 26.

Within the first channel portion 22 is a printed circuit board (PCB) 34 which has circuits for transmitting and receiving data related to the syringe and / or its contents, or to a patient 17, such as identification data, SKU, serial number, data. manufacturing date, expiration date, fluid data, health facility data, healthcare provider data, medication data, and so on. The circuit includes a transmitter, receiver, logic or processor, computer readable memory for storing data, a synchronization circuit, an antenna and a power source, but is not limited to them. In the preferred embodiment, the circuit also includes an RFID reader / writer for reading RFID tags associated with other institutions within the processing system. The RFID reader / writer is also coupled to other circuit elements to perform at least one verification check, and other functions. Also coupled to PCB 34 are input / output devices such as a monitor, an LED 36, a speaker and a switch, such as a drawer flap 38. The first channel portion 22 also includes a cover 40 with a hole 42 adjoining an opening 44 of the first outlet port 26. First syringe 11 also includes a housing 46 for housing a power supply unit 48 for providing electrical power to the PCB 34 and the input / output devices. Power supply unit 48 typically comprises one or more batteries which may be removed following single use of the first syringe 11 to allow use on another device or to allow proper recycling in accordance with current environmental regulations. In order to facilitate easy installation or battery removal, the 48 batteries can be placed over a tray that is slidably received by the compartment 46.

As shown in Figure 4, sample maintenance unit 12 is a vial 49 having an open upper portion 51, a closed lower portion 56 and a rigid dividing portion 58 therebetween, and a cover portion 54 for defining a cylindrical treatment cavity 52 , or treatment chamber. The cover portion 54 has a chamber inlet 50 to form a first fluid coupling with the first syringe outlet 26 so that the blood-treated sample can be poured into the detonation cavity 52 of the sample treatment chamber. blood12. The cover portion 54 also has an ozone delivery port 60 for treating a blood sample, a gas outlet port 62 for ozone depletion and other gases. The lower portion 56 has a bowl 66 for receiving the blood sample during treatment.

In the course of treatment of the blood sample, the treatment cavity 52 is subjected to stressors such as UV radiation A, B and C, infrared radiation and ozone bubbled through the blood sample. As such, the partition 58 and bowl 66 are made of suitable material capable of transmitting such radiation, such as low density polyethylene (LDPE) which contains a small amount (approximately 5%) of vinylethylene acetate.

The chamber inlet 50 has a female rim portion68 with a pair of helically oriented passages or slots 70 extending through its wall or wall to receive the matching bayonet pin pair 72 of the first syringe outlet port26. . In operation, the first syringe 11 is rotated to propel bayonet pins 72 along the helical passages 70 and downwardly into the female rim portion 68 until the valve member 74 abuts on the valve actuation member 80. Thereafter, the valve element 74 is displaced by valve actuation element 80 from its closed position against valve seat 76 to open the fluid coupling. Once fully engaged within the chamber inlet 50, the first syringe 11 is held in place by a saddle member 79, which minimizes the movement of the first syringe around the chamber inlet 50.

The cap portion 54 has a chamber outlet 81 for forming a second dedicated fluid coupling with the second syringe 15, as shown in Figure 8. The second syringe 15, shown in detail in Figure 5 and Figure 6, has a second body portion 82 having a cylinder 83 with a proximal end 84 in which a second inlet port 85 is placed, a second outlet port 86; and a distal end 87 with a wall 88 between them to define a second sample receiving chamber 89. The second inlet port 85 is angled to the second outlet port86. A plunger 90 is slidably disposed at the distal end 87 and is in tight fluid engagement with the cylindrical wall 88. Plunger 90 serves to drain fluid into the second sample receiving chamber89 and pushes fluid therefrom. The second syringe15 also includes a second channel portion 92 with a channel 94 in communication with the second sample receiving chamber 89 and the second output port 86, and a channel 96 in communication with the second input port 85 and the second receiving chamber. 89 through a channel portion 94. In order to prevent large particles from entering the second outlet port 86, a second end cap 97 is removably attached thereto, although the second inlet port 85 includes a sliding cover 98 to prevent contamination. prior to use with the blood treatment unit 14. The treated blood sample is poured from the second syringe 15 to the initial patient 17 through the second syringe outlet port operable 86 between an open position and a closed position by a release lock means 100, as described below.

Similarly to the first syringe 11, within the second channel portion 92 is a printed circuit board (PCB) 102 which has circuits for transmitting, receiving and storing data related to the syringe and / or its contents or the initial patient 17, such as data identification, SKU, serial number, manufacturing data, expiration date, fluid data, health facility data, healthcare provider data, medication data, and so on. The circuit includes RFID reader / writer functionality for reading RFID tags associated with other institutions within the treatment system. The RFID writer / recorder is also coupled to other elements of the circuit to perform at least one checking, checking and other functions. As such, the circuit includes transmitter, receiver, logic or processor, computer readable memory for data storage, synchronization circuit, antenna and power source, but is not limited to them. Also connected to the PCB 102 are input / output devices such as a display, an LED 103, a speaker or a button. In addition, PCB 102 also includes circuitry for controlling operation of release locking means 100. Compartment 104 houses a power supply unit 106 comprising one or more batteries, and a power circuit resident in PCB 102 for regulating power therein. and input / output devices. Batteries 106 may be removed after single use of the second syringe 15 to allow use on another device or to allow proper recycling in accordance with current environmental regulations. In order to facilitate easy installation or removal of batteries, the batteries 106 may be placed on a tray that is slidably received by the battery compartment 104.

The syringe 10 is normally kept in a low power state when not in use to conserve battery power. However, when the sample maintenance unit 12 is introduced into the bleed treatment unit, the syringe 15 is placed in a lower energy state operating state. Such a transition may be accomplished by a mechanical switch that is closed prior to insertion of the maintenance unit and shows in the blood treatment unit, or the switch is closed by the blood treatment unit following insertion of the sample maintenance unit within the blood unit. blood treatment. Other modes include an electronic switch actuated by an RF signal or a DC signal from the blood care unit, or a DC magnetic vane relay enabled by a magnetone blood care unit.

As shown in Figures 4 and 7 to 9, the chamber outlet 81 has a female rim portion 108 with a pair of helically oriented passages or grooves 110 extending through or in its walls to engage one or more corresponding pins 112 extending towards each other. Second syringe inlet port 85 is formed. Similarly, a valve member 114 is located in channel 96 and biased toward a closed position against a valve seat 116 on an end cap 118 which forms the outer end of the second syringe outlet 96.0. valve 114 is also aligned to support a valve actuation member 120 which is positioned in the chamber outlet 81. The valve actuation member 120 is thereby operable to move the valve element114 from its closed position against the valve seat 116to open the second fluid coupling. The cover portion 54 is also provided with a saddle member 122 for holding the second syringe 15 when it is in a fully engaged position with the chamber outlet 81.

The cover portion 54 has a top cover 124 and a cover lock 126 bonded, welded or otherwise attached thereto. Covering latch 126 locks over an upper periphery of the lower portion 56. Chamber inlet 50 and chamber outlet 81 are individually in fluid communication with internal treatment cavity 52 by means of conduits 128,130 extending below valve actuating elements 80 , 120 respectively.

As shown in Figures 6, 10, 11 and 12, the second syringe barrel 84 has a cylindrical cavity which in cooperation with the plunger 90 provides a second sample receiving chamber 89. The passage 94 of the blood sample transfer portion 92 has a second access location 132 for fluid communication with the second syringe outlet port 86.

The second syringe outlet port 86 and the blood transfer portion 92 are further provided with the release lock means normally shown at 100 to form a third locked fluid coupling between the second access location 132 and the second outlet port 86. As will be described, the locking means 100 is operable in response to a deliberate signal to release the third fluid coupling, as shown in Figures 13 (a) to 13 (d). With the release lock locked, the second outlet port 86 is operable to form a fourth fluid coupling with a fluid fit over a common blood sample delivery unit with a LUER 31 or the like, such as needle 32 .

As best shown in Figure 10, the second syringe outlet port 86 includes a male Luer insert 134, an outlet valve means normally shown at 136 to open and close access to the fluid channel 92 to control the flow of blood sample therethrough. . The male Luer insert 14 includes an opening 138 and a thread for the LUER fit to mate with a female Luer 31 of a needle 32. Outlet valve means 136 includes a valve member portion 140 and a valve seat portion 142 and the first means actuation generally shown at 144 to actuate the valve member portion 140 relative to the valve seat portion 142. A pair of elastic elements 148, such as a spring, propitiates the outlet valve 136 to a closed position. As will be described, the first actuation means 144 is operable to move the valve member portion 140 in different directions when the second firing body portion 84 is either engaged or disengaged with a female Luer 31.

The first actuation means 144 takes the form of the various first actuation elements 150 extending out of the central web 152, and also of the second actuation means such as a tab 154 extending from the same. The central web 152 is fixed to a block 156 positioned in a channel 94 in the body portion 92 of the second syringe 15. The block 156 has a central hole 158 which carries a tubular valve stem 160 having an end carrying the valve element portion 14. The opposite end carries a valve stem head 162, which has a common peripheral edge region sealing member such as an O-ring or the like. Valve rod 160 has a pair of fluid transfer holes as shown immediately on the side of the valve member portion 140, thereby forming an internal valve passage that is in fluid communication with the second sample receiving chamber 89, as shown. Figures 11 and 12. Female Luer31 includes first complementary actuating elements which displace first actuating elements 150, whereby female Luer element 31 is inserted into Luermacho insert 134. Consequently, valve stem 160 and valve element attachment 140 are made to open central port 158 within valve stem 160 through channel 96 to allow fluid flow through outlet port 86.

The outlet port 86 of the second syringe 15 is operable between three states, a locked state, an open state, and a permanently locked state by a locking means such as locking mechanism 100, as shown in Figures 13 (a) to 13 ( d). Locking mechanism 100 includes a mid-coupled tongue 168 and outlet valve 136 to control the coupling of the female Luer 31 to the male luer insert 134 of the second syringe 15. The tongue 168 has an end 170 with an opening 172 for receiving a pivot pin 174, which projects from a plate176 to allow articulation around it. Vane 168 is positioned between a first spring plate178 and a second spring plate 180 which controls its alternating movement. Typically, the first demolition plate 178 is made of fusible material that temporarily changes consistency under the presence of the predetermined current signal, such as nickel titanium naval regulatory laboratory intermetallic material (NITINOL). Nitinol exhibits super elasticity and deformed memory, so that warming of donitinol due to a predetermined electrical current is caused, so it is mechanically deformed under tension above a specific temperature, and returns to the pre-tensioned position when tension is removed. .

On the other end 182 of the tongue 168 is a first finger 184 and a second finger 186 defining a recess 188 with an opening 189. Adjacent to the recess 188 is a perforated slot 190 which includes several interconnected slots 192, 194, 196. These interconnected slots 192, 194, 196 correspond to the locked state, the open state and the permanently locked state mentioned above, respectively. The slots 192e 196 are opposite each other and separated by a tongue tooth 198 on one side of slot 190 and interconnected by slot 194 on the other side of slot 190. Slot 192 is L-shaped and includes arm 200 and the other arm 202 that connects to slot 194.

The first spring plate 178 is secured to plate 176 at one end and includes an arcuate portion 204 positioned over tongue 168. Arcuate portion 204 is bent approximately 90 degrees at point 208, adjacent to point 208 is a bearing flange 210 which engages slot arm 200, in the locked position, as shown in Figure 13 (a). The subsequent positioning of the bearing flange 210 determines the operating state of the syringe 15.

The movement of the tongue 168 through the three different positions will now be described. Starting at rest position, the bearing flange 210 is positioned in the slot 200 of slot 192. Upon receipt of the deliberation signal following the verification process, an electrical signal is made to flow through the first demolishing plate 178, and the electrical signal is enough to make the first spring plate 178 relax. The first spring plate 178 is sufficiently relaxed that the second spring plate 180 forces support flange 210 out of arm 200 into arm 202, and finally into slot 194 corresponding to the open position, as shown in Figure 13 ( B). A female needle luer 31 can now be attached to the second syringe 15 and treated blood is directed from the second sample receiving chamber 89 through the outlet valve into patient 17, as shown in Figure 14.

After a predetermined time, such as 20 minutes, the predetermined electrical signal is once again forced to flow through the first spring plate 178, and cause the first spring plate 178 to relax. The second demolishing plate 180 forces the bearing flange 210 out of slot194 into slot 196 corresponding to the permanently locked position, as shown in Figures 13 (c) and 13 (d). If the female Luer 31 is still secured when the release signal is issued, then the bearing flange 210 is prevented from sliding into the permanently locked position until the Luer 31 is removed. By permanently locking the second syringe 15, subsequent use of the second syringe 15 is prevented, thereby substantially eliminating contamination risks.

Operation of outlet valve means 136 in conjunction with locking mechanism 100 will now be described with specific reference to Figures 10-14. In the locked position of the second syringe 15, flap 154 rests on finger 184 and thereby restricts the central web 152 of longitudinal displacement away from opening 138.

Any attempt to couple a female Luer 31 fails, as the first complementary actuating elements cannot displace the first actuating elements 150 and therefore the female Luer 31 and the male Luer insert134 do not fit together. Correspondingly, the outlet valve means 136 is provided closed by the pair of elastic elements 148 acting on the central web 152, and thus the central hole 158 within the valve stem 160 is closed.

On energizing the first spring plate 178, the lug168 is rotated in a clockwise direction and the bearing flange 210 is forced out of the arm 200 into the arm 202, and slides into the slot 194 corresponding to the unlocked or open position. Concurrently, finger 184 of tongue 168 moves away from tab 154 so that tab 154 is now aligned with recess 188. Female Luer 31 is now inserted into male Luer insert 134, and first complementary actuation elements support first actuation elements 150 The force applied to match the female Luer 31 to the male Luer insert 134 moves the first actuating members 150 away from the aperture 138 and the central web 152 moves together. Aaba 154 enters recess 18 8 through opening 18 9 and runs the length of recess 188. The force applied to couple the Luers 31 and 134 is sufficient to compress elastic members 148 and thereby open the orifice 158 within the valve stem 160. Since treated blood often includes bubbles of gases used during treatment, the second syringe 15 includes a bubble extractor system or bubble removal mechanism to expel gas from the syringe before the treated blood sample is administered to the initial patient 17. Alternatively, a The separate discharge cover is attached to the proximal end 84 to interface with the Luer 134. The discharge cover includes a gas permeable hydrophobic membrane to prevent blood from escaping. Typically, more air may be introduced into the second sample receiving chamber 89 to agglomerate existing bubbles, thereby facilitating the removal of otherwise small bubbles.

Thus, the cylinder 83 is transparent so that a user can inspect the treated blood sample to verify that the bubbles have been removed.

After treated blood has been administered to patient 17, female Luer 31 is uncoupled from the male Luuer insert 134 as the needle is removed. With the first complementary actuation elements removed from the male Luer insertion 134, the elastic elements 48 extend to push the central web 152 toward the opening 138 and the tab 154 moves out of the recess 188 and back to the recess opening 189. At a predetermined time, a predetermined electrical signal is required to flow through the first spring plate 178, and the support flange 210 is forced out of the slot 194 to each slot 196. The tab 154 now supports the finger 186, and without any longitudinal displacement of the web. away from opening 138 is prevented. With the backing flange 210 unable to be forced back into the slot194, the second syringe 15 is now permanently locked, and likewise the female Luer 31 cannot subsequently be coupled to the male Luer insert 134, as shown in Figure 13 (d ).

As will be described, system 10 provides a verification protocol involving the number of verification checks to ensure that the appropriate blood sample is administered to the appropriate initial patient 17, and that certain events in the collection, treatment, and administration of the blood sample to the patient 17 occur. of prescribed time periods. To this end, as shown in Figure 15, the system has identification means 211 to identify an initial patient 17, and the untreated blood sample in the first syringe 11, verification means 212 to verify a combination of the initial patient 17 and the patient. blood sample treated in the second syringe 15, and release signal generating means214 to generate a release signal in response to a positive output by the verification means. The deliberation signal is transmitted to the release lock means 100 to deliver the predetermined current to the first spring plate 178, thereby producing the second operable syringe 15 for administering the initial patient treated blood sample 17.

As will be described, the identification means 211 and release signal generation means 214 are located in the second syringe 15, but may be located in the above-mentioned entities. The release lock means 100 has a signal receiving means 216 for receiving the release signals.

As shown in Figure 16, verification means 212 includes comparison means 218 for comparing patient identity data with treated blood sample identity data, both stored in memory medium 220, and in signal receiving memory medium 216 to receive. one or more signals associated with initial patient identity data and / or blood sample identity data (either untreated, treated or both). In this case, one or more signals contain the initial patient identity data and / or the blood sample identity data. However, as an alternative, one or more signals may contain data that is associated with or related to patient 17 or blood sample identity data. For example, the data in the signals may include one or more codes that allow patient identity data or blood sample identity data to be obtained from the memory name data structure 220 or some other location, for example in the form of an observation table.

Verification means 212 also includes a counting means 221 which provides time data related to a predetermined event including and / or between an untreated blood sample collection event and a treated blood sample administration event. Temporal data may also include at least one time value between two predetermined events that includes or between the untreated blood sample collection event and the blood sample administration event. Counter means 221 may be implemented as a first incremental counter 222 in first syringe 11 and a second incremental counter 224 in second syringe 15 are used to track time delay. The first incremental counter 222 tracks events related to untreated blood collection, although treatment and posttreatment events are tracked by the second incremental counter 224. These incremental counters 222 and 224 operate independently of each other and do not need to be synchronized with each other. Battery power is sufficient to maintain the substantial accuracy of your internal clock within the time period from collection of untreated blood sample to administration of the treated blood sample to patient 17. Therefore, the possibility of losing time or decreasing the accuracy of the clock as battery power runs out is substantially eliminated.

In this case, the verification means 212 may be operable to prevent release of the third locked fluid coupling when the elapsed time value has exceeded a predetermined value. Prior to treatment of the untreated blood sample, verification means 212 is also operable to prevent treatment of the blood sample when the elapsed time has exceeded a predetermined value. Similarly, following treatment, verification means 212 is operable to verify a combination of the untreated blood sample in the first syringe 11 and the initial patient 17.

The verification protocol can be implemented in a number of ways, although most preferred herein is through the use of one or more radio frequency signal transmitters and receivers and RFID tags. As shown in Figure 17, the wristband 16 is provided with a tag. Passive RFID, such as a WB RFUD226 tag, although first syringe 11 and second syringe 15 include the aforementioned printed circuit board (PCB) 102 which has circuits for transmitting, receiving and storing data related to the syringe and / or its contents or the patient. 17 including a Sl RFID 228 reader / writer and an S2 RFID230 reader / writer respectively. The passive WB RFID tag 226 comprises an antenna coil and a silica chip that includes modulation circuits and nonvolatile memory. The WB RFID 226 tag is powered by an external time-varying electromagnetic radio frequency (RF) wave that is transmitted by an RFID reader / writer, such as the Sl RFID 228 reader / writer or the S2RFID 230 reader / writer. Sl RFID 228 recorder or S2 RFID reader / writer 230 is capable of writing data about the WB RFID 226 tag, and reading data back from the WBRFID 226 tag by detecting reflective scatter modulation.

Blood treatment unit 14 is also equipped with a BTU RFID reader / writer 232 to receive pretreatment identification data from the SLID 228 reader / writer and to receive aftertreatment data from the S2 RFID 230 reader / writer. , the blood treatment chamber 12 is equipped with a passive RFID SMU tag 234 to provide an identification code. The BTU RFID reader / writer 232 question marks for the SMU RFID tag 234 determine whether the blood treatment chamber 12 is valid for use in the treatment process, that is, whether the blood treatment chamber 12 is an authentic product or was previously used.

As shown in Figures 19 to 21, the wristband 16 (WB) contains a removable portion 236 containing the WB RFID tag 226 and recorded data about it related to patient 17 and / or the treated blood sample. The wrist band 16 may also include a clamping assembly 238 which has a base portion 240 and a covering portion 241. The base portion 240 is integrally formed with a strip 242 of various perforation passages 244 to receive the clamping assembly Base portion 240 has pins 24, 247, 248 that are sized to fit in passages 244. Cover portion 242 is articulated to base portion 240 through a joint shown at 250. Cover portion 242 also has a pair of wells 252, each of which receiving one of pins 246 or 248. Pin 247 may be pressed against a base (not shown) switch 250 to activate portions of the wristband 16 circuit, over band 242 safety. around the patient arm 17.

The method of monitoring a sample of materials will now be described with reference to Figures 1 to 21. The verification protocol makes use of several identification codes, such as a first syringe identification code representative of the untreated blood sample therein, and the code. pulse-band identification code representative of the initial patient 17. To simplify data transfer, the first syringe identification code and pulse-band identification code may include common identification data, although the data between them may differ from one another as they may be. be the case. The first syringe identification code may, if desired, include a first time value representative of the untreated sample collection time from the initial patient 17 (or a designated event both before and after the sample collection step) and / or verification of the same.

As such, the Sl RFID 228 reader / writer operates as a first signal emitter to output a first signal that carries the first syringe identification code data, and / or common identity data, although the WB RFID 226 tag over the wristband 16 operates as a first signal receiver to receive the first signal. The second syringe 15 receives a second identification code, which is representative of the blood sample treated therein. The second syringe identification code includes a second time value representative of the time of administration of the treated sample to it from the treatment well 52 (or an event designated both before and after the treated sample administration step) and / or verification thereof.

Accordingly, the S2 RFID reader / writer 230 operates as a second signal emitter to output a second signal carrying the treated blood sample identification data and the WB RFID 226 tag functions as a second signal receiving means to receive the second signal, wherein The verification means 212 is operable to compare the first signal data to the representative data of the treated blood sample.

Referring to Figure 18, the verification protocol will now be discussed in conjunction with a typical blood treatment procedure. As shown in Figure 1, a kit for a blood treatment procedure is assembled including, among other things, a wrist band 16, the first syringe 11, the second syringe 15, the sample maintenance unit 12, and various prepared labels258 identifying the patient printed on it. The procedure starts by activating the first syringe 11 through an actuation means such as the vial flap button 38. Once activated, the circuit on PCB 34 is triggered by batteries 48 and conducts a self-test trigger (POST) procedure and subsequently the first syringe 11 is ready for use unless any failures detected during the POST procedure. Sl RFID 228 writer / reader is then activated and initiates transmission of questioning signals and awaits a response from the WB RFID226 tag. The first incremental counter 222 is also started and sends time data, and keeps track of untreated blood events and time records associated with predefined untreated blood events in association with the logic. To this end, a TSO time register indicative of the trigger event is recorded by the second incremental counter 224 stored in memory. The Sl RFID 228 writer / reader and WB RFID 226 tag individually contain common patient identification data or sample treatment data, encoded as IDl.

Before the first syringe 11 is used to draw blood from patient 17, an anticoagulant such as sodium citrate solution is also extracted into the first sample receiving chamber 21 to prevent blood clogging, as shown in Figure 3. A sample Blood is then extracted from patient 17, and once prepared, the first syringe 11 is brought into the wristband RF band 16. The Sl RFID 228 reader / writer questions the WB RFID226 tag to verify that the data read from issued by the WB RFID tag correspond to the common patient identification data ID1 or SlRFID reader / writer 228. The process is terminated if there is no correlation between the data in pulse range 16 and the first syringe11. However, if a positive correlation has been made, the Sl RFID 228 reader / writer records a "time stamp" TSl record on the Sl RFID 228 reader / writer, and writes the same time stamp to the WB RFID226 tag. Therefore, the RFID reader Sl 228 and WB RFID tag 226 now carry TSO, TS1, and ID1. As an example, the data now on the Sl RFID 228 reader / writer and the WB RFID 226 tag can be represented as: Sl Il TSO TSl meaning that the blood-treated sample extracted into the first syringe 11 is from a patient with the identification ID1, the first syringe 11 was triggered in TSO time, and the common patient identification data ID1 in the first syringe11 and pulse range 16 were combined at the time TS1. The first syringe logic 11 receives time data from the first incremental counter 222 and determination time elapsed from the beginning of the procedure (TSO) and it is important to note that the common patient identification data ID1 in the first syringe 11 and pulse band 16 are combined. The process proceeds as long as the time unit difference between TSO and TS1 is within an acceptable predefined range.

In the next step, the first syringe 11 is installed in the blood treatment chamber 12 (with the second syringe 15 already positioned therein), which is then administered to the blood treatment unit 14. As such, the Sl RFID 228 reader / recorder issues the TSO, TS1, ID1 data for the BTU RFID 232 reader / writer. The data also includes a TS2 time value denoting a treatment start time. The following blood treatment unit 14 calculates the time delay between TS1 and TS2 of the first syringe 11. In addition, the blood treatment unit 14 issues a query signal for SMU RFID tag 234 on the sample maintenance unit 12 and, In response to this, the EFID 234 SMU tag emits a signal that contains its identification code for blood donor unit 15. A determination as to whether the RFID 234 SMU tag is valid, as well as the delay is acceptable. If the SMU RFID 234 tag is invalid, and / or the delay is unacceptable, then the process ends, otherwise the process continues. This identification code in this case includes a "training" code indicating that the blood treatment chamber 12 was not previously used for a blood treatment, thereby reducing the risk of contamination of the current untreated blood sample SI. Alternatively, the SMU RFID tag 234 does not need to issue a disabling code, but merely emits a signal that contains identifying data such as a similar SKU.

If the time delay between TS1 and TS2 is acceptable, blood treatment unit procedure 14 continues with the untreated blood sample in the first syringe 11 being administered to treatment well 52 through chamber 50 and conduit 128. The reader SlRFID / Writer 228 is subsequently unable to prevent further use by including a disability code itself. In addition, an SMU RFID tag 234 in the blood chamber 12 receives a BTU disability code 14 after the blood sample is administered in the same manner, thereby preventing the reuse of the blood-trapping chamber 12. Alternatively, the SMU tag RFID 234 can be disabled in other ways without writing a disability code in it. For example, the SMU RFID 234 tag can be produced inoperably by issuing on the SMU RFID 234 tag a signal causing a fuse to blow on it.

In the course of treatment, the second syringe 15 is triggered and initiates a query to the BTURFID 232 reader / writer for data. A new time stamp which means the end of the "TS3" blood sample treatment is recorded on the SFID 232 BTU reader / writer, and subsequently TS3 is read by and stored in the S2 RFID230 reader / writer. The treated blood is then delivered from the treatment well 52 through conduit 130 and to the second syringe 15, and if desired, the blood treatment unit 14 may also include the TS1 record, meaning that the recorded data on the writer / recorder S2 RFID 230 would include ID1, TSO, TS1, TS2, and TS3. In this case, the second syringe 15 includes treatment start time TS2 and treatment end time TS3. Alternatively, or in addition, TS2 or TS3 may include a duration of treatment, or some other code indicating that all previous verification steps have been performed successfully.

For example, blood processing unit 14 may record the following data:

Sl IDl TSO PATIENT TSlIDTREATMENT START TS2TREATMENT END TS3Sl IDl TSO TSl TS3

In this case, the PATIENT ID code may include other patient-related data that is manually or automatically entered into the bleed treatment unit 14. Alternatively, patient-related data is transferred to bleed treatment unit 14 from the storage center. data center, an auxiliary computer, a similar memory bank.

The second syringe 15 is then transported back to the initial patient 17 wearing the wristband 16 and the S2 RFID reader / writer probes the WB RFID tag 226 until the latter is within the range of the scrambling signals. In response to the questioning signals, the WB RFID tag 226 then outputs ID1 data in time "TS4". The S2 RFID reader / writer 230 then calculates the time delay between data TS3 and the arrival time, TS4, of the second syringe 15 back to pulse range 16. If the expected time delay is exceeded, then the second syringe 15 remains. locked by the locking mechanism 110, otherwise the process continues.

The second syringe 15 registers IDl, and the time register "TS4". In addition, the second syringe 15 may include PATIENT ID data as well as IDI, TS1, TS2, TS3. These data are subsequently recorded over WB RFID226. At this stage, the S2 RFID reader / writer 230 issues a release signal to the locking mechanism 110 to lock the second syringe 15 by emitting a predetermined current to the spring plate 178 to force the bearing flange into the slot 194, thereby rendering the locking mechanism free. second operable 15 syringe for injection.

As an example, the SMU RFID 226 tag, as follows:

51 IDl TSO TSl52 15 IDl TSO TSl TS2 SAMPLE COMBINATION TS3DESENGATE S2 TS4

The verification protocol is then terminated when TS4 is recorded on the WB RFID 226 tag after the same sample combination is made between the ID2 data on the S2 RFID 230 reader / writer and the WB RFID 226 tag.

As shown in Figure 21, the removable portion 236 of the wristband 16 is then separated from it and matched with the initial patient record and the patient record is returned to the blood care unit 14 for data exchange between the WB tag. RFID 226e Blood Treatment Unit 14 to finalize the verification tab.

Alternatively, an RF read verification record capture station may be provided which is local to the patient 17 or to a patient registration area in a medical institution, thereby eliminating the need for patient registration to be returned to the patient care unit. blood 14. In this case, the verification log capture station may be able to lower the patient record to finalize the verification trail. The RF read-only registration capture station may be part of the medical institution's in-house network, either through a wired or wireless data port, or may be part of a relocated location in one or more blood unit treatment systems in the facility. medical institution. It can collect data and enable later batch recording to a computer readable medium, such as an optical disk, hard disk, or other storage device. It may be attached or integrally formed with a computing device, personal digital assistant, a mobile phone or the like. It may be embodied as software configured to run a computing device, together with an RFID reader attachment thereon.

The ID1 and TS4 data are administered to the blood donor unit 14 or other system to finalize the verification tab. The time stamp may also include an "event" code, which may comprise five major events:

1) Start time Sl

2) WB acknowledgments with Sl

3) Beginning of Treatment

4) End of Treatment

5) Combination between Treated Sample and Initial Patient.

The time stamp also includes one or more error events.

1) No combination

2) Sl does not match WB before / after collection

3) S2 does not match WB in return after treatment.

4) Time Delay - Time Exceeded for Blood Collection

5) Delay time - sample administration time exceeded for BTU

6) Delay time - Exceeds patient return time

The TS3 time stamp may also include a "combination" code as follows:

01 Combination

02 No Combination

In another embodiment, the pulse band includes electronic circuits coupled with the passive WB RFID 2226 tag, and a battery to power the electronic circuits. As shown in Figure 20, pulse strip 16 includes means of outputs, such as LEDs 260, 262, 264, or a speaker (not shown), which are operated in different combinations of one or more of them. For example, LEDs 260, 262 may be operable to illuminate according to a predetermined communication cycle associated with the verification process with the first syringe 11 and the second syringe 15. The third LED264 may be provided for alarm situations.

In another embodiment, the bandwidth includes electronic circuits coupled with the passive WB RFID266 tag, and a battery to provide power to the electronic circuit. As shown in Figure 20, the wristband 16 includes a means of outputs such as LEDs 260, 262, 264, or a speaker (not shown), which are operated in different combinations of one or more of them. For example, LEDs 260, 262 may be operable to illuminate according to a predetermined communication cycle associated with the verification process with the first syringe 11 and the second syringe 15. The third LED264 may be provided for alarm situations.

The wristband 16 may be replaced by some other article to be worn, carried, attached or ingested by patient 17, such as a pin-attached label or self-adhesive 258 and the like.

The second syringe 15 may also include a second sample receiving chamber volume detector 89 to determine if treated blood is received from the detachment well. 52 is within a pre-defined range suitable for injection into patient 17 to provide the desired medical treatment.

In another embodiment, system 10 includes a blood sample treatment chamber, similar to the sample blood treatment chamber 12 of Figure 4, with an expandable treatment cavity 52 formed by a cover portion 54, a lower portion 56, and a flexible divider portion. 58 among them.

In yet another embodiment, the system includes a locking mechanism 100 operable by a solenoid or half-motorized configured to receive the release signal.

In yet another embodiment, the system includes a wristband 16 with electronic circuits for transmitting, receiving and storing initial patient-related data17, such as identification data or an identifier, SKU, serial number, manufacturing data, due date, data fluid, health facility data, health professional data, medication data, and so on. The circuit includes a transmitter, receiver, logic or processor, computer readable memory for storing data, a synchronization circuit, an antenna and a power source, but is not limited to them. The circuit also includes an RFID reader / writer for reading RFID tags associated with other institutions within the treatment system, such as the first syringe 11, the second syringe 15, or the sample maintenance unit 12. A wristband tag. This pulse band 16 acts as the archive data store for the entire treatment and therefore provides the verification trail once the treatment has been completed. The data may be stored in computer readable media such as RAM, ROM, flash memory, and so on, or the pulse strip may include an RFID tag on which the data is recorded. The first syringe 11 and the second syringe 15 include a board circuit board (PCB) having circuitry for transmitting, receiving and storing syringe and / or patient-related data 17, such as identification data or identifiers, SKU, serial number, manufacturing data, expiration date, fluid, health institution data, health professional data, medication data, and so on. The circuit is implemented as an active RFID tag having a transmitter, receiver, logic or processor, computer readable medium for storing data, a synchronization circuit, an antenna and a power source such as batteries. Also coupled to the PCB are input / output devices such as a display, LED, a speaker or a button. The second syringe 15 also includes circuits for controlling the operation of a disengage locking or electromechanical interlocking means to prevent re-injection of treated blood in which case the wristband identifier 16 and the second syringe identifiers do not match.

Similar to the preferred embodiment, the system includes a BTU reader / writer that can communicate (read and write) RFID tags from the first syringe 11 and second syringe15 and with a tag on the sample maintenance unit12. The first syringe RFID tag 11 stores and records patient-related data, for example, the time when blood was removed for treatment. Also ensure that the syringe 11 cannot be reused. The first syringe RFID tag 11 will also include an elapsed time counter and a matching identifier for that contained in the recorded pulse band at the time of manufacture or packaging. The Syringe 15 RFID tag includes similar functions and includes logic and circuitry to trigger an electromechanical interlock.

The flow of treatment events is similar to that described above. Prior to blood removal, a removal is performed to verify that the unique treatment-set ID numbers contained in the wristband 16 and the first syringe 11 match, with the active deserter label 11 issued the data to the wristband reader / writer 16. If there is a combination, this event is recorded by the wristband and blood is drawn from the patient. At the same time the elapsed time counters on syringe label 11 and pulse band 16 will start.

The first syringe 11 is then fitted over the sample maintenance unit (SMU) 12, which is already fitted with a second single use syringe. The SMU 12 with both syringes 11, 15 is then brought to the blood-donation unit (BTU) 14 with a BTU reader / writer.

The patient details are entered into the BTU reader at this stage. The blood treatment unit reader / writer 12 will read the first syringe label 11 and write details (including the unique ID) on the second syringe label 15. The BTU reader / writer will also write a message to the SMU label to indicate that it has been used. The BTU reader / writer will also read the elapsed time from the first syringe label 11 and calculate the treatment time details. These are then engraved on the second syringe label 15 with the patient ID.

Following the blood treatment, the BTU reader / writer writes the finalized treatment time on the second syringe label 15. SMU 12 is removed from the BTU. Syringe S2 is removed from SMU 12, and SMU 12 and syringe SL are discarded. The second syringe 15 is then presented to the patient's wristband 16 and, provided that the combination of unique IDs and elapsed time is within set parameters, the locking mechanism of the second syringe 15 is released and the second syringe can be used to inject the treated blood. on the patient. The pulse strip reader 16 writes patient data and procedural details to the computer readable or wristband tag 12 for subsequent removal for storage with the patient records. Wristband reader / writer 12 is then activated and its strip is cut to allow patient removal and disposal. A network RFID reader is used to read encrypted data on the computer-readable wristband or memory tag unit for transfer to the health facility database on a computer or network.

In another embodiment, the BTU reader / writer or an external reader / writer provides all necessary verification.

Even if the above description is largely focused on the use of system 10 in the treatment of autologous blood samples, it will be appreciated that the system10, its components and alternatives thereof, may be used for samples other than blood samples such as bone marrow or lymphatic fluids, semen, ova-fluid mixtures, other body fluids or other medical fluids that may or may not be "autologous", for example, fluid mixtures perhaps containing a desired solid patient sample such as from organs, body cells and tissue cells, skin cells and skin samples, spinal chords. System 10 may also be used for medical testing where it is important to ensure that test results from a specific test can be delivered to the initial patient 17.

While system 10 makes use of syringes 11 and 15, it will be appreciated that other devices may be used such as one or more syringes, IV bottles, powder and / or atomized fluid and / or inhalant containers, implant delivery containers, fans, syringe pumps, intubation tubes, gastrointestinal feeding tubes, or miscellaneous and / or a combination of the same, alone or in combination. One of the tapping devices may also comprise a blood tapping device such as that described in International Publication No. W00119318A1 Titled "APPARATUS ANDprocess for conditioning mammalian blood" (the full contents of which are incorporated herein by means of mid-reference). Alternatively, a treatment device may be equipped to perform a range of invasive and noninvasive treatments such as surgeries, treatments for diseases such as cancer, as well as exploratory and diagnostic investigations such as X-rays, CAT scans, MRIs and the like. If the invention has been described by reference to certain specific embodiments, various modifications thereof will become apparent to those of skill in the art without departing from the inventive concept and scope of the invention as set forth in the meanings of the invention.

Claims (20)

1. A blood sample collection, treatment and administration system comprising: an article for association with a patient having a patient identifier, a first syringe having: a first syringe inlet to extract a sample of untreated blood from the patient, a first chamber of fluid to receive untreated blood, a first syringe outlet to dump the sample of untreated blood from the first chamber, a first incremental counter for time records corresponding to collection-related untreated blood events the first syringe associated with a unique identifier correlating with the patient identifier: a vial for processing the blood sample, the vial having: a blood sample processing chamber, the vial having a chamber inlet; the first syringe outlet being operable to establish a first dedicated fluid coupling with the chamber inlet to pour the untreated blood sample into the blood sample processing chamber; the vial having a chamber outlet for discharging a treated blood sample following treatment to a second syringe, the second syringe having: a second operable syringe inlet to form a second dedicated fluid coupling with the chamber inlet to receive the blood sample from the chamber blood sample treatment; a second chamber for receiving treated blood; a second syringe outlet; a passage in communication with the second chamber and the second syringe outlet; a second incremental counter for time-stamped events corresponding to blood-staining events; treated blood events and administration events; the second incremental counter being operable independently of the first incremental counter and being unsynchronized with the first incremental counter, the second syringe being associated with a second unique identifier, the second unique identifier operatively associated with the first syringe and corresponding to the first unique identifier; inside the passageway to operate the second syringe outlet between various states, a processor having: a comparator for comparing the patient identifier to the first unique identifier to determine the correlation between them; and comparing the second identifier to the patient identifier to determine the correlation between them, the comparator emitting an output signal, logic to receive the output signal, and temporal data to determine time delays between events and to determine if time delays are within. range, a logic-coupled release signal generator to output a release signal to the disengage lock, whereby the release signal is issued upon confirmation of the correlation between the patient identifier and the first unique identifier, and the correlation between the patient identifier and the second unique identifier, and provided so that time delays are within predetermined ranges. System according to Claim 1, characterized in that the first syringe further comprises: an inlet valve assembly communicating with the first fluid chamber; a valve outlet assembly located intermediate the first fluid chamber and inlet valve assembly; an inlet valve assembly comprising: an inlet valve member operable in an open position and a closed position, a sturdy member biasing the member inlet valve to its closed position; the outlet valve assembly including: an outlet valve element operable between a closed position and an open position; and a sealing element; an anchor member engaging the outlet valve assembly to hold the outlet valve member in a closed position, whereby with the outlet valve member closed position, the inlet valve member is placed in the open position under compression of the resistor member. to allow fluid to flow into the chamber, and an outlet member is operable by disengaging the anchor member and breaking the sealing member when the fluid chamber is prepared, although the inlet valve member is in a closed position; fluid chamber discharge. System according to claim 1, characterized in that the release lock is operable in response to a release signal to operate the syringe outlet valve between an open state and a closed state. System according to Claim 3, characterized in that the release lock comprises: a hinged tongue member, interconnected grooves corresponding to the closed state, open state, and permanently closed state, a first resilient member having a restricted flanging member. moving within interconnected grooves, wherein the first spring-resistant element from fusible material that temporarily changes its consistency under the presence of the release signal, the position of the flange within interconnected grooves that dictate the state of the outlet valve. System according to Claim 4, characterized in that the fusible material is a titanium-nickel naval regulatory laboratory (NITINOL) intermetallic material. System according to Claim 5, characterized in that the release lock includes a second sturdy member to force the flange into a slot corresponding to a permanently closed state. System according to claim 6, characterized in that it includes the article, the first syringe, the second syringe, the container, the electronic circuit for transmitting, receiving and storing data relating to the collection, treatment and administration of the blood doctor. System according to claim 7, characterized in that the circuit includes any of the following: a transmitter, a receiver, an antenna, a processor, a computer readable medium, a synchronization circuit for maintaining temporal data related to collection, treatment and administration. blood sample, a power source and input / output devices. System according to Claim 8, characterized in that the circuit of the first syringe and the second syringe include an energy-active RFID tag from the power source. System according to claim 9, characterized in that the article includes an RFID reader / recorder in communication with the active RFID tags on the first syringe and the second syringe. System according to claim 10, characterized in that the article includes the processor, comparator, logic and release signal generator to output a release signal to the release lock upon confirmation of the correlation between the patient identifier and the first unique identifier, and the correlation between the patient identifier and the second unique identifier, and provided with the fact that time delays are within predetermined ranges. System according to claim 8, characterized in that the article circuit and the container include a passive RFID tag. System according to claim 12, characterized in that the first syringe and the second syringe include an RFID reader / writer communicating with the passive RFID tags on the article and the container. System according to claim 13, characterized in that the second syringe includes the processor, the comparator, the logic and the signal generator deliberating to emit a release signal to the disengage lock after confirming the correlation between the patient identifier. and the first unique identifier, and the correlation between the patient identifier and the second unique identifier, and provided with the fact that the time delays are within predetermined ranges. System according to claim 11 or -14, characterized in that the container further comprises: a body having: an upper portion, a lower portion and a dividing portion therebetween; a cover portion seal received by an opening of body adjacent to the upper portion to define the blood sample processing chamber; the cover portion having a gas inlet port for charging at least one gas into the blood sample processing chamber for interfacing with the untreated sample, a door outlet outlet coupled to charge at least one gas from the blood sample processing chamber; a first syringe release coupling chamber inlet port for supplying the untreated sample, and a second syringe release coupling chamber outlet for receiving a treated sample; It is a temperature sensor for determining the temperature of at least one fluid in the tapping cavity. System according to Claim 15, characterized in that the dividing portion is rigid. System according to claim 15, characterized in that the dividing portion is flexible. System according to Claim 15, characterized in that at least one of said doors includes a Luer connector for coupling to a complementary Luer connector. The cover of claim 15 characterized in that the at least one of said ports includes a bayonet coupling part for coupling to a complementary bayonet coupling part. A method for monitoring a patient sample of material comprising the steps of: (a) collecting the patient sample with a first device, (b) associating the patient with the first representative signal-deporting data of the sample, (c) associating the first sampling device with the second signal carrier data representative of the sample (d) delivering the sample to a sample treatment chamber (e) processing the sample to form a processed sample (f) collecting the sample on a second collecting device (g) associating the second third collection device with signal carrier data representative of the processed sample, (h) comparing the data in the first and third signals to connect the processed sample to the patient; and (i) associate at least one of steps (a) with (h) temporal data, (j) determine at least one time delay that uses time data to determine at least one of steps (a) to (h) occur within acceptable time limits, deliver the processed sample to the patient on a positive output from step (h) and step (j) and compile an examination record that has time data collected from step (i), step (h) and step output (j), and data associated with the sample.