WO 2006/122400 PCT/CA2006/000781 1 VERIFICATION METHOD & SYSTEM FOR MEDICAL TREATMENT 2 3 CROSS-REFERENCE TO RELATED APPLICATIONS 4 [0001] This application claims the benefit of priority to U.S. Provisional Application Ser. 5 No. 60/682,969, filed May 19, 2005, U.S. Provisional Application Ser. No. 60/683,280 filed May 6 19, 2005, and U.S. Provisional Application Ser. No. 60/683,333, filed May 19, 2005. 7 8 BACKGROUND OF THE INVENTION 9 FIELD OF THE INVENTION 10 [00021 The present invention relates to the management of medical treatments. More 11 specifically it relates to a permission-based fluid dispensing device. 12 13 DESCRIPTION OF THE PRIOR ART 14 [00031 Despite remarkable advances in health care technology and delivery, a large number 15 of patients die or are disabled as a result of medical errors. These errors occur in health care 16 settings, such as hospitals, clinics, nursing homes, urgent care centers, physicians' offices, 17 pharmacies, and the care delivered in the home, and they usually result from systems problems 18 rather than one single action or decision. 19 [0004] For many years, bar code labelling has been the technology of choice in ensuring 20 patient safety. Recently, the Food and Drug Administration (FDA) issued a new rule which 21 requires certain human drug and biological product labels to have bar codes. As such, the bar 22 code for human drug products and biological products (other than blood, blood components, and 23 devices regulated by the Center for Biologics Evaluation and Research) must contain the 24 National Drug Code (NDC) number in a linear barcode. The rule is geared toward reducing the 25 number of medication errors in hospitals and other health care settings by allowing health care 26 professionals to use bar code scanning equipment to verify that the right drug (in the right dose 27 and right route of administration) is being given to the right patient at the right time. The rule 28 also requires the use of machine-readable information on blood and blood component container 29 labels to help reduce medication errors. - 1-- WO 2006/122400 PCT/CA2006/000781 1 [00051 However, bar codes require line of sight with a reader in order to be read and they 2 cannot store additional information apart from simple identification data, such as a serial no. or 3 SKU. For example, a bar-coded wristband on a patient is not easy to read if the patient gets it wet 4 or is sleeping on top of the arm bearing the wristband, or when the patient is on an emergency 5 room gurney or operating table; these are instances where mistakes in medication or blood 6 transfusion are most prevalent. 7 8 [0006] It is an object of the present invention to mitigate or obviate at least one of the above 9 mentioned disadvantages. 10 11 SUMMARY OF THE INVENTION 12 In one of its aspects, the present invention provides a system for the collection, treatment and 13 delivery of a blood sample, the system comprising: 14 an article for association with a patient having a patient identifier; 15 a first syringe having: 16 a first syringe inlet for drawing an untreated blood sample from the patient, 17 a first fluid chamber for receiving the untreated blood, 18 a first syringe outlet for dispensing the untreated blood sample from the first 19 chamber, 20 a first incremental counter for recording temporal data corresponding to untreated 21 blood events related to the collection of blood, 22 the first syringe being associated with a first unique identifier correlatable to the 23 patient identifier; 24 a vessel for processing the blood sample, the vessel having: 25 a blood sample processing chamber, the vessel having a chamber inlet; the first 26 syringe outlet being operable to establish a dedicated first fluid coupling with the 27 chamber inlet to dispense the untreated blood sample to the blood sample processing 28 chamber; the vessel having a chamber outlet for dispensing a treated blood sample 29 following treatment to a second syringe, 30 the second syringe having: -2- WO 2006/122400 PCT/CA2006/000781 1 a second syringe inlet operable to form a dedicated second fluid coupling with the 2 chamber outlet to receive the blood sample from the blood sample treatment chamber; 3 a second chamber for receiving the treated blood; 4 a second syringe outlet; 5 a passage in communication with the second chamber and the second syringe 6 outlet; 7 a second incremental counter for recording temporal data corresponding to blood 8 treatment events, treated blood events and delivery events; the second incremental 9 counter being operable independently of the first incremental counter and being non 10 synchronized with the first incremental counter; 11 the second syringe being associated with a second unique identifier, the second 12 unique identifier operatively associated with the first syringe and correlatable to the first 13 unique identifier; 14 a releasable lock formed within the passage for operating the second syringe 15 outlet between a plurality of states; 16 a processor having: 17 a comparator for comparing the patient identifier to the first unique identifier to 18 determine the correlation between same; and comparing the second unique identifier to 19 the patient identifier to determine the correlation between same, the comparator issuing 20 an output signal; 21 logic for receiving the output signal and the temporal data to determine time 22 delays between the events and for determining whether the time delays are within 23 predefined ranges; 24 a release signal generator coupled to the logic for issuing a release signal to the releasable 25 lock; 26 whereby the release signal is issued upon confirmation of the correlation between the patient 27 identifier and the first unique identifier, and the correlation between the patient identifier and the 28 second unique identifier, and provided that the time delays are within predetermined ranges. 29 [00071 In another of its aspects, the present invention provides identification means for 30 identifying an originating patient of the untreated blood sample, verification means for verifying -3- WO 2006/122400 PCT/CA2006/000781 1 a match between the originating patient and the treated blood sample, and release signal 2 generating means for generating a release signal in response to a positive verification by the 3 verification means. The identification means and/or the release signal generating means may be 4 located on the second syringe body, or on an external article. The external article may worn, 5 carried, attached or ingested by the patient, such as a pinned or self adhesive label, or a coated 6 object, and the like. Preferably, the external article contains a removable portion containing 7 audit data relating to the patient and/or the treated blood sample. For example, the external 8 article may be conveniently provided as a wristband to be worn by the originating patient. 9 [0008] In yet another of its aspects, the second syringe body may also include a filtered vent 10 outlet in the passage for expelling one or more gas constituents in the treated blood sample. 11 [0009] As a further aspect, the present invention provides a method of monitoring a material 12 sample from a patient, comprising the steps of: 13 (a) collecting the sample from the patient with a first collection device; 14 (b) associating the patient with a first signal carrying data representative of the sample; 15 (c) associating the first collection device with a second signal carrying data representative 16 of the sample; 17 (d) delivering the sample to a sample treatment chamber; 18 (e) processing the sample to form a processed sample; 19 (f) collecting the sample in a second collection device; 20 (g) associating the second collection device with a third signal carrying data 21 representative of the processed sample; 22 (h) comparing the data in the first and third signals to link the processed sample with the 23 patient; and thereafter; 24 (i) associating at least one of the steps (a) to (h) with temporal data; 25 (j) determining at least one time delay using the temporal data to determine whether the 26 at least one of the steps (a) to (h) occurs within acceptable time limits; 27 (k) delivering the processed sample to the patient upon a positive outcome from step (h) 28 and step (j); and 29 (1) assembling an audit record having temporal data collected from step (i), the outcome 30 from step (h) and step (j), and data associated with the sample. -4- WO 2006/122400 PCT/CA2006/000781 1 [00101 The events related to the collection of untreated blood are tracked by the first 2 incremental counter, while the treatment and post treatment events are tracked by the second 3 incremental counter, such that time delays may be determined from the temporal data 4 Advantageously, these two counters operate independently of one another and do not require to 5 be synchronized with each other, unlike real-time clocks. The counters only operate during the 6 steps (a) to (j) described above, and thus do not require substantial battery power. As such, the 7 battery is sufficient to maintain substantial accuracy of the clock within the time period from 8 steps (a) to (f), and thus the possibility of losing time or decreasing clock accuracy as the 9 battery's power runs down is substantially eliminated. 10 [0011] In yet another of its aspects, the system includes a releasable lock means operable by 11 a solenoid configured to receive the release signal. 12 [0012] In yet another of its aspects, the system includes a releasable lock means operable by 13 a motorized means configured to receive the release signal. 14 [0013] The term "treatment device" used herein below is intended to mean a device used 15 directly or indirectly in the course of a treatment. It may include devices which actually perform 16 a treatment on the patient or a patient-derived sample, or alternatively be an article for 17 performing functions associated with treatments, such as carrying or otherwise transferring the 18 sample to or from a treatment. 19 20 BRIEF DESCRIPTION OF THE DRAWINGS 21 [0014] These and other features of the preferred embodiments of the invention will become 22 more apparent in the following detailed description in which reference is made to the appended 23 drawings wherein: 24 [0015] Figure 1 is a perspective view of a blood treatment system; 25 [0016] Figure 2 is a sectional view of a first syringe shown in Figure 1, taken along line 1-l'; 26 [00171 Figure 3 is a perspective view of the first syringe of Figure 1 coupled to a sodium 27 citrate bag; 28 [0018] Figure 4 is a perspective view of a blood treatment chamber of Figure 1; 29 [0019] Figure 5 is a perspective view of a second syringe of Figure 1; 30 [00201 Figure 6 is a sectional view of the second syringe of Figure 5 taken along line 5-5'; -5- WO 2006/122400 PCT/CA2006/000781 1 [00211 Figure 7 is another perspective view of the blood treatment chamber carrying the first 2 syringe and the second syringe; 3 [00221 Figure 8 is a sectional view of the blood treatment chamber of Figure 7 taken along 4 line 7-7'; 5 [00231 Figure 9 is a sectional view of the blood treatment chamber of Figure 7 taken along 6 line 9-9'; 7 [00241 Figure 10 is an exploded view of an outlet port of the second syringe of Figure 5; 8 [00251 Figure 11 is a perspective view of a outlet valve; 9 [0026]1 Figure 12 is a sectional view of the outlet valve element of Figure 10 taken along line 10 11-1l'; 11 [0027] Figure 13(a) is a perspective view of the a portion of locking mechanism in a locked 12 state; 13 [0028] Figure 13(b) is a perspective view of the a portion of locking mechanism in an open 14 state; 15 [0029] Figure 13(c) is a perspective view of the portion of locking mechanism in a 16 permanently locked state; 17 [0030] Figure 13(d) is a perspective view of the portion of locking mechanism adjacent to 18 the outlet port of Figure 10, in a permanently locked state; 19 [00311 Figure 14 is a perspective view of the portion of locking mechanism in a cooperating 20 arrangement with the outlet port; 21 [0032] Figure 15 is a flowchart outlining a verification protocol of the system of Figure 1; 22 [0033] Figure 16 is a flowchart outlining a verification portion protocol of Figure 15; 23 [00341 Figure 17 is a detailed perspective view of the blood treatment system; 24 [00351 Figure 18 is a schematic view of a verification protocol; 25 [00361 Figure 19 is a perspective view of a wristband as shown in Figure 1, prior to 26 operation; 27 [0037] Figure 20 is a perspective view of a wristband as shown in Figure 1, in operation; 28 and; 29 [0038] Figure 21 is a perspective view of a wristband as shown in Figure 1, prior to 30 operation. -6- WO 2006/122400 PCT/CA2006/000781 1 2 DESCRIPTION OF THE PREFERRED EMBODIMENTS 3 [00391 As shown Figure 1, there is provided a system 10 for the collection, treatment and 4 delivery of an autologous blood sample. The system 10 includes a plurality of entities which are 5 used at different stages during the handling of the blood sample, such as, a first syringe 11 (S 1), 6 a sample management unit 12 (SMU), a blood treatment unit 14 (BTU), a second syringe 15 7 (S2), and a wristband 16 (WB). The first syringe 11 is used to collect an untreated blood sample 8 from an originating patient 17. Following collection of the untreated blood sample, the blood 9 collection syringe 11 is coupled to the sample management unit with the blood delivery syringe 10 15 already mounted thereon, and the sample management unit is introduced into the blood 11 treatment unit, in which the untreated blood sample is subjected to one or more stressors, such as 12 ozone or ozone/gas mixture, ultra-violet (UV) light and infra-red (IR) energy. 13 14 [0040] Following treatment, the treated blood sample is delivered to a second syringe 15, 15 from which the treated blood sample is administered to the originating patient 17. At one or 16 more critical stages, the system 10 provides for a verification check, aimed at reducing the 17 possibility of error, and thus ensure that the correct blood sample is returned to the correct 18 originating patient 17. The verification check includes the steps of matching the blood sample, 19 either in its treated or untreated form or both, with the originating patient 17. Typically, the 20 wristband 16, the first syringe 11, the sample management unit 12, the second syringe 15, 21 include identification data associated with the originating patient, the data may include indicia, 22 or may be machine-readable via optical or electro/magnetic means. 23 [0041] As shown in Figure 2, the first syringe 11 has a first body portion 18 which provides a 24 cylindrical cavity 19 which in cooperation with a syringe plunger 20 forms a sample receiving 25 chamber 21. The first syringe 11 includes a first channel portion 22 with a channel 23 in 26 communication with the first sample receiving chamber 21, and a first syringe inlet port 24 for 27 ingress of the untreated blood sample from the patient 17. The first channel portion 22 also 28 includes a first syringe outlet port 26 for dispensing the untreated blood sample therefrom to the 29 sample management unit 12. The first syringe outlet port 26 includes a channel 27 in 30 communication with the first sample receiving chamber 21 and channel 24. -7- WO 2006/122400 PCT/CA2006/000781 1 100421 The first syringe inlet port 24 is provided with a first syringe inlet valve means 28 in 2 channel 24 for controlling the flow of blood through the first syringe inlet 24. In this case, the 3 first inlet valve means 28 includes a housing 29 containing a valve 30 arranged to be opened by a 4 complementary valve member 31, located on an external device 32, as shown in Figure 3. The 5 external device 32 may be a blood collection unit, such as a "butterfly" needle or a sodium citrate 6 bag, and so forth. Extending outwardly from the first syringe outlet port 26 is a pair of bayonet 7 pins 72 for coupling the first syringe 11 to the blood treatment chamber 12. Included within the 8 channel 27 of the first syringe 11 is a valve element 74 biased to a closed position against a valve 9 seat 76 on an end cap 78 which forms the outer end of the first syringe outlet port 26. 10 [00431 Within the first channel portion 22, is a printed circuit board (PCB) 34 having 11 circuitry for transmitting and receiving data related to the syringe and/or its contents, or a patient 12 17, such as identification data, SKU, serial no., manufacturing date, expiry date, fluid data, 13 health facility data, health practitioner data, medication data, and so forth. The circuitry includes, 14 but is not limited to, a transmitter, a receiver, logic means or processor, a computer readable 15 memory for data storage, a timing circuit, an antenna and a power source. In the preferred 16 embodiment, the circuitry also includes an RFID reader/writer for reading RFID tags associated 17 with other entities within the treatment system. The RFID reader/writer is also coupled to other 18 elements of the circuitry to perform at least one verification check, and other functions. Also 19 coupled to the PCB 34 are input/output devices such as a display, an LED 36, a speaker, and a 20 switch, such as pullout tab 38. The first channel portion 22 also includes a cover 40 with a bore 21 42 contiguous with an opening 44 of the first outlet port 26. The first syringe 11 also includes a 22 compartment 46 for housing a power supply unit 48 to provide electrical power to the PCB 34 23 and the input/output devices. The power supply unit 48 typically comprises one or more batteries 24 which may be removed following the single use of the first syringe 11, in order to enable use in 25 another device or allow for proper recycling in compliance with current environmental 26 regulations. In order to facilitate easy battery installation or removal, the batteries 48 may be 27 placed on a tray which is slidably received by the compartment 46. 28 [00441 As shown in Figure 4, the sample management unit 12 is a vessel 49 having an open 29 top portion 51, a closed bottom portion 56 and a rigid walled portion 58 therebetween, and a 30 cover portion 54 to define a cylindrical treatment cavity 52, or treatment chamber. The cover -8- WO 2006/122400 PCT/CA2006/000781 1 portion 54 has a chamber inlet 50 to form a dedicated first fluid coupling with the first syringe 2 outlet port 26, such that the untreated blood sample may be dispensed into the treatment cavity 3 52 of the blood sample treatment chamber 12. The cover portion 54 also has a gas inlet port 60 4 for delivery of ozone to treat a blood sample, a gas outlet port 62 for the discharge of the ozone, 5 and other gases. The bottom portion 56 has a bowl 66 to receive the blood sample during 6 treatment. 7 [00451 In the course of the treatment of the blood sample, the treatment cavity 52 is 8 subjected to stressors, such as, UV A, B and C radiation, infrared radiation and ozone is bubbled 9 through the blood sample. As such, the walled portion 58 and the bowl 66 are made from 10 appropriate materials capable of transmitting such radiation, such as low density polyethylene 11 (LDPE) containing a small amount (about 5%) of ethylene vinyl acetate. 12 [0046] The chamber inlet 50 has a female collar portion 68 with a pair of helically oriented 13 passages or grooves 70 extending through its wall, or in its wall, to receive the pair of 14 corresponding bayonet pins 72 of the first syringe outlet port 26. In operation, the first syringe 11 15 is rotated to urge the bayonet pins 72 along the helical passages 70 and downwardly into the 16 female collar portion 68 until the valve element 74 abuts the valve-actuating element 80. 17 Subsequently, the valve element 74 is displaced by the valve-actuating element 80 from its 18 closed position against the valve seat 76 to open the fluid coupling. Once fully engaged within 19 the chamber inlet 50, the first syringe 11 is supported in place by a saddle member 79, which 20 minimizes motion of the first syringe about the chamber inlet 50. 21 [0047] The cover portion 54 has a chamber outlet 81 to form a dedicated second fluid 22 coupling with the second syringe 15, as shown in Figure 8. The second syringe 15, shown in 23 more detail in Figure 5 and Figure 6, has a second body portion 82 having a barrel 83 with a 24 proximal end 84, at which is disposed a second inlet port 85, a second outlet port 86; and a distal 25 end 87 with a cylindrical wall 88 therebetween to define a second sample receiving chamber 89. 26 The second inlet port 85 is disposed at an angle to the second outlet port 86, and intermediate the 27 second sample receiving chamber 89 and the second outlet port 86. A plunger 90 is slidably 28 disposed at the distal end 87 and is in tight fluid engagement with the cylindrical wall 88. The 29 plunger 90 serves to draw fluid into the second sample receiving chamber 89 and urge the fluid 30 therefrom. The second syringe 15 also includes a second channel portion 92 with a channel 94 in -9-- WO 2006/122400 PCT/CA2006/000781 1 communication with the second sample receiving chamber 89 and the second outlet port 86, and 2 a channel 96 in communication with the second inlet port 85 and the second sample receiving 3 chamber 89 via a portion of the channel 94. In order to prevent large particulate from entering 4 the second outlet port 86, a second end cap 97 is removably attached thereto, while the second 5 inlet port 85 includes a slidable cap 98 to prevent contamination prior to use with the blood 6 treatment unit 14. The treated blood sample is dispensed from the second syringe 15 to the 7 originating patient 17 via the second syringe outlet port 86 operable between an open position 8 and a closed position by a releasable lock means 100, as will be described below. 9 [0048] Similar to the first syringe 11, within the second channel portion 92 is a printed 10 circuit board (PCB) 102 having circuitry for transmitting, receiving and storing data related to 11 the syringe and/or its contents or the originating patient 17, such as identification data, SKU, 12 serial no., manufacturing date, expiry date, fluid data, health facility data, health practitioner 13 data, medication data, and so forth. The circuitry includes RFID reader/writer functionality for 14 reading RFID tags associated with other entities within the treatment system. The RFID 15 reader/writer is also coupled to other elements of the circuitry to perform at least one verification 16 check, and other functions As such, the circuitry includes, but is not limited to, a transmitter, a 17 receiver, logic means or processor, a computer readable medium for data storage, a timing 18 circuit., an antenna and a power source. Also coupled to the PCB 102 are input/output devices 19 such as a display, LED 103, a speaker or a button. In addition, the PCB 102 also includes 20 circuitry for controlling the operation of the releasable lock means 100. A compartment 104 21 houses a power supply unit 106 comprising one or more batteries, and a power circuit resident on 22 the PCB 102 for regulating the power therein and input/output devices. The batteries 106 may 23 be removed after the single use of the second syringe 15, in order to enable use in another device 24 or allow for proper recycling in compliance with current environmental regulations. In order to 25 facilitate easy battery installation or removal, the batteries 106 may be placed on a tray which is 26 slidably received by the battery compartment 104. 27 [00491 The syringe 10 is typically maintained in a low power state, when not in use, to 28 conserve battery energy. However, when the sample management unit 12 is introduced into the 29 blood treatment unit, the syringe 15 is placed into an operating state from the lower power state. 30 Such a transition may be effected via a mechanical switch which is closed before insertion of the -10- WO 2006/122400 PCT/CA2006/000781 1 sample management unit into the blood treatment unit, or the switch is closed by the blood 2 treatment unit following insertion of the sample management unit into the blood treatment unit. 3 Other ways include an electronic switch actuable by an RF signal or a DC signal from the blood 4 treatment unit, or a DC magnetic reed relay enabled by a magnet in the blood treatment unit. 5 [00501 As shown in Figures 4 and 7 to 9, the chamber outlet 81 has a female collar portion 6 108 with a pair of helically oriented passages or grooves 110 extending through or in its wall to 7 engage a corresponding one or more pins 112 extending outwardly from the second syringe inlet 8 port 85. Similarly, a valve element 114 is located in the channel 96 and biased to a closed 9 position against a valve seat 116 on an end cap 118 forming the outer end of the second syringe 10 outlet 96. The valve element 114 is also aligned for abutment with a valve actuating element 120 11 which is positioned in the chamber outlet 81. The valve actuating element 120 is thus operable 12 to displace the valve element 114 from its closed position against the valve seat 116 to open the 13 second fluid coupling. The cover portion 54 is also provided with a saddle member 122 for 14 supporting the second syringe 15 when it is in a fully engaged position with chamber outlet 81. 15 [0051] The cover portion 54 has a top cap 124 and a cap lock 126 bonded, welded or 16 otherwise fixed thereto. The cap lock 126 latches on an upper periphery of the bottom portion 56. 17 The chamber inlet 50 and the chamber outlet 81 are each in fluid communication with the inner 18 treatment cavity 52 by way of conduits 128, 130 extending below the valve actuating elements 19 80, 120 respectively. 20 [0052] As shown in Figures 6, 10, 11 and 12, the second syringe body portion 84 has a 21 cylindrical cavity which in cooperation with the plunger 90 provides a second sample receiving 22 chamber 89. The passage 94 of the blood sample transfer portion 92 has a second access 23 location 132 for fluid communication with the second syringe outlet port 86. 24 [00531 The second syringe outlet port 86 and the blood transfer portion 92 are further 25 provided with the releasable lock means shown generally at 100 for forming a locked third fluid 26 coupling between the second access location 132 and the second syringe outlet port 86. As will 27 be described, the releasable lock means 100 is operable in response to a release signal to release 28 the third fluid coupling, as shown in Figures 13(a) to 13(d). With the releasable lock means 29 unlocked, the second syringe outlet port 86 is operable to form a fourth fluid coupling with a -11- WO 2006/122400 PCT/CA2006/000781 1 fluid fitting on a common blood sample delivery unit with a complementary LUER 31 or similar 2 fitting, such as the needle 32. 3 [00541 As best shown in Figure 10, the second syringe outlet port 86 includes a male Luer 4 insert 134, an outlet valve means generally shown at 136 for opening and closing the access to 5 the fluid channel 92 to control the flow of the blood sample therethrough. The male Luer insert 6 134 includes an opening 138 and a thread for the LUER fitting for coupling with female Luer 31 7 of a needle 32. The outlet valve means 136 includes a valve element portion 140 and a valve 8 seat portion 142 and first actuating means generally shown at 144 for actuating the valve element 9 portion 140 relative to the valve seat portion 142. A pair of resilient members 148, such as a 10 spring, biases the outlet valve means 136 in a closed position. As will be described, the first 11 actuating means 144 is operable to displace the valve element portion 140 in different directions 12 when the second syringe body portion 84 is either engaged or disengaged with a female Luer 31. 13 [00551 The first actuating means 144 takes the form of a plurality of first actuating elements 14 150 which extend outwardly from a central web 152, and also second actuating means such as a 15 tab 154 extending therefrom. The central web 152 is fixed to a block 156 positioned in a channel 16 94 in the body portion 92 of the second syringe 15. The block 156 has a central bore 158 17 carrying a tubular valve stem 160 having one end carrying the valve element portion 140 and an 18 opposite end carrying a valve stem head 162, which has a peripheral edge region with a sealing 19 element such as an O-ring or the like. The valve stem 160 has a pair of fluid transfer holes as 20 shown at 164 immediately beside the valve element portion 140, thereby forming an inner valve 21 passage which is in fluid communication with the second sample receiving chamber 89, as 22 shown in Figures 11 and 12. The female Luer 31 includes complementary first actuating 23 elements which displace the first actuating elements 150, when the female Luer 31 member is 24 introduced into the male Luer insert 134. Consequently, the valve stem 160 and the valve 25 element portion 140 are caused to open the central bore 158 within the valve stem 160 to the 26 channel 96 to allow fluid flow through the outlet port 86. 27 [0056] The outlet port 86 of the second syringe 15 is operable between three states, a locked 28 state, an open state and permanently locked state, by a releasable lock means, such as locking 29 mechanism 100, as shown in Figures 13(a) to 13(d). The locking mechanism 100 includes a pawl 30 168 coupled to the outlet valve means 136 to control the coupling of the female Luer 31 to the -12- WO 2006/122400 PCT/CA2006/000781 1 male Luer insert 134 of the second syringe 15. The pawl 168 has one end 170 with an opening 2 172 for receiving a pivoting pin 174, protruding from a board 176, to allow pivoting thereabout. 3 The pawl 168 is positioned between a first spring plate 178 and a second spring plate 180 which 4 control its swinging motion. Typically, the first spring plate 178 is made from fuse material 5 which temporarily changes consistency under the presence of the predetermined electric current 6 signal, such as nickel titanium naval ordinance laboratory intermetallic material (NIT1NOL). 7 Nitinol exhibits superelasticity and shape memory, such that nitinol is caused to heat up due to 8 the predetermined electric current signal, as such it is mechanically deformed under stress above 9 a specific temperature, and returns to the pre-stressed position when the stress is removed. 10 [00571 On the other end 182 of the pawl 168 is a first finger 184 and a second finger 186 11 defining a recess 188 with an opening 189. Adjacent to the recess 188 is a punched out slot 190 12 which includes a plurality of interconnected slots 192, 194, 196. These interconnected slots 192, 13 194, 196 correspond to the above-mentioned locked state, the open state and the permanently 14 locked state, respectively. The slots 192 and 196 are opposite each other and separated by a pawl 15 tooth 198 on one side of slot 190 and linked to one another by slot 194 on the other side of slot 16 190. The slot 192 is L-shaped and includes one arm 200 and another arm 202 which links to slot 17 194. 18 100581 The first spring plate 178 is secured to the board 176 at one end and includes an 19 arcuate portion 204 positioned above the pawl 168. The arcuate portion 204 is bent at 20 approximately 90 degrees at point 208, and adjacent to the point 208 is an abutment flange 210 21 which engages the arm 200 of slot 192, in the locked position, as shown in Figure 13(a). The 22 subsequent positioning of the abutment flange 210 determines the operating state of the syringe 23 15. 24 100591 The motion of the pawl 168 through the three different positions will now be 25 described. Starting in the rest position, the abutment flange 210 is positioned in the arm 200 of 26 slot 192. Upon receipt of the release signal following the verification process, a predetermined 27 electric signal is caused to flow through the first spring plate 178, and the electric signal is 28 sufficient to cause the first spring plate 178 to relax. The first spring plate 178 is sufficiently 29 relaxed such that the second spring plate 180 forces the abutment flange 210 out of the arm 200 30 into arm 202, and finally into slot 194 corresponding to the open position, as shown in Figure - 13- WO 2006/122400 PCT/CA2006/000781 1 13(b). A female Luer 31 of a needle 32 can now be attached to the second syringe 15 and the 2 treated blood is expressed from the second sample receiving chamber 89 via the open outlet 3 valve into the patient 17, as shown in Figure 14. 4 [00601 After a predetermined time, such as 20 minutes, the predetermined electric signal is 5 once again caused to flow through the first spring plate 178, and causes the first spring plate 178 6 to relax. The second spring plate 180 forces the abutment flange 210 out of the slot 194 into slot 7 196 corresponding to the permanently locked position, as shown in Figure 13(c) and 13(d). If 8 the female Luer 31 is still attached when the release signal is issued, then the abutment flange 9 210 is prevented from sliding into the permanently locked position until the female Luer 31 is 10 removed. By permanently locking the second syringe 15, subsequent use of the second syringe 11 15 is precluded, thus substantially eliminating contamination risks. 12 [0061] The operation of the outlet valve means 136 in conjunction with the locking 13 mechanism 100 will now be described with particular reference to Figures 10-14. In the locked 14 position of the second syringe 15, the tab 154 rests on the finger 184 and thus restricts the central 15 web 152 from longitudinal displacement away from the opening 138. Any attempt to couple a 16 female Luer 31 fails, since the complementary first actuating elements cannot displace the first 17 actuating elements 150 and therefore the female Luer 31 and male Luer insert 134 cannot mate. 18 Correspondingly, the outlet valve means 136 is biased closed by the pair of resilient members 19 148 acting on the central web 152, and thus the central bore 158 within the valve stem 160 is 20 closed. 21 [0062] Upon energising the first spring plate 178, the pawl 168 is caused to rotate in a 22 clockwise direction and the abutment flange 210 is forced out of the arm 200 into arm 202, and 23 slides into slot 194 corresponding to the unlocked or open position. Concurrently, the finger 184 24 of the pawl 168 moves away from the tab 154 such that the tab 154 is now aligned with the 25 recess 188. The female Luer 31 is now be introduced into the male Luer insert 134, and the 26 complementary first actuating elements abut the first actuating elements 150. The force applied 27 to mate the female Luer 31 to the male Luer insert 134 displaces the first actuating elements 150 28 away from the opening 138, the central web 152 moves in sympathy. The tab 154 enters the 29 recess 188 via the opening 189 and travels the length of the recess 188. The force applied to -14- WO 2006/122400 PCT/CA2006/000781 I couple the Luers 31 and 134 is sufficient to compress the resilient members 148 and thus open 2 the central bore 158 within the valve stem 160. 3 [00631 As the treated blood often includes bubbles of gases used during treatment, the 4 second syringe 15 includes a de-bubbling system or bubble removal mechanism to expel gas 5 from syringe, before the treated blood sample is administered to the originating patient 17. 6 Alternatively, a separate vent cap is attached to the proximal end 84 to interface with the Luer 7 134. The vent cap includes a hydrophobic gas permeable membrane to prevent blood from 8 escaping. Generally, more air can be introduced into the second sample receiving chamber 89 to 9 coalesce the existing bubbles, thus facilitating removal of otherwise small bubbles. Thus, the 10 barrel 83 is transparent such that a user can inspect the treated blood sample to verify that gas 11 bubbles have been removed. 12 [0064] After the treated blood has been administered to the patient 17, the female Luer 31 is 13 uncoupled from the male Luer insert 134, as the needle 32 is removed. With the complementary 14 first actuating elements removed from the male Luer insert 134, the resilient members 148 15 expand to push the central web 152 towards the opening 138 and the tab 154 travels out of the 16 recess 188 and faces the recess opening 189. At the predetermined time, a predetermined electric 17 signal is caused to flow through the first spring plate 178, and the abutment flange 210 is forced 18 out of the slot 194 into slot 196. The tab 154 now abuts the finger 186, and thus any longitudinal 19 displacement of the central web 152 from away from the opening 138 is precluded. With the 20 abutment flange 210 unable to be forced to return to slot 194, the second syringe 15 is now 21 permanently locked, and so a female Luer 31 can not be subsequently coupled to the male Luer 22 insert 134, as shown in Figure 13(d). 23 [00651 As will be described, the system 10 provides a verification protocol which involves 24 number of verification checks to be sure that the proper treated blood sample is delivered to the 25 proper originating patient 17, and that certain events in the collection, treatment and delivery of 26 the blood sample to the patient 17 occurs within prescribed time periods. To that end, and as 27 shown in Figure 15, the system has identification means 211 for identifying an originating 28 patient 17, and the untreated blood sample in the first syringe 11, verification means 212 for 29 verifying a match between the originating patient 17 and the treated blood sample in second 30 syringe 15, and release signal generating means 214 for generating a release signal in response - 15 - WO 2006/122400 PCT/CA2006/000781 1 to a positive outcome by the verification means. The release signal is transmitted to the 2 releasable lock means 100 to deliver the predetermined current to the first spring plate 178, 3 thereby to render the second syringe 15 operable to deliver the treated blood sample to the 4 originating patient 17. 5 [0066] As will be described, the identification means 211 and the release signal generating 6 means 214 are located on the second syringe 15, but may be located in the aforementioned 7 entities. The releasable lock means 100 has a signal receiving means 216 for receiving the 8 release signal. 9 [00671 As shown in Figure 16, the verification means 212 includes comparison means 218 10 for comparing patient identity data with treated blood sample identity data, both stored in 11 memory means 220, and signal receiving means 216 to receive one or more signals associated 12 with the originating patient identity data and/or the blood sample identity data (either untreated, 13 treated or both). In this case, the one or more signals contain the originating patient identity data 14 and/or the blood sample identity data. However, as an alternative, the one or more signals may 15 contain data which is associated with or related to the patient 17 or blood sample identity data. 16 For example, the data in the signals may include one or more codes which allow the patient 17 identity data or the blood sample identify data to be obtained from a data structure in the memory 18 means 220 or some other location, for example in the form of a look up table, for instance 19 100681 The verification means 212 also includes a counter means 221 which provides 20 temporal data related to a predetermined event including and/or between an untreated blood 21 sample collection event and a treated blood sample delivery event. The temporal data may also 22 include at least one elapsed time value between two predetermined events including or between 23 the untreated blood sample collection event and the treated blood sample delivery event. The 24 counter means 221 may be implemented as a first incremental counter 222 on first syringe 11 25 and a second incremental counter 224 on the second syringe 15 are used to track time delay. The 26 first incremental counter 222 tracks the events related to the collection of untreated blood, while 27 the treatment and post treatment events are tracked by the second incremental counter 224. These 28 two incremental counters 222 and 224 operate independently of one another and do not require 29 to be synchronized with each other. The battery power is sufficient to maintain substantial 30 accuracy of their internal clock within the time period from collection of the untreated blood -16- WO 2006/122400 PCT/CA2006/000781 1 sample to the delivery of the treated blood sample to the patient 17. Therefore, the possibility of 2 losing time or decreasing clock accuracy as the battery's power runs down is substantially 3 eliminated. 4 [0069] In this case, the verification means 212 may be operable to prevent release of the 5 locked third fluid coupling when the elapsed time value has exceeded a predetermined value. 6 Before treatment of the untreated blood sample, the verification means 212 is also operable to 7 prevent treatment of the blood sample when the elapsed time value has exceeded a 8 predetermined value. Similarly, following treatment, the verification means 212 is operable to 9 verify a match between the untreated blood sample in the first syringe 11 and the originating 10 patient 17. 11 [00701 The verification protocol may be implemented in a number of forms, although the 12 most preferred at present is by the use of one or more radio frequency signal transmitters and 13 receivers and RFID tags. As shown in Figure 17, the wristband 16 is provided with a passive 14 RFID tag, such as WB RFID tag 226, while the first syringe 11 and the second syringe 15 15 include the aforementioned printed circuit board (PCB) 102 having circuitry for transmitting, 16 receiving and storing data related to the syringe and/or its contents or the originating patient 17, 17 including a SI RFID reader/writer 228 and a S2 RFID reader/writer 230, respectively. The 18 passive WB RFID tag 226 comprises an antenna coil and a silicon chip that includes modulation 19 circuitry and non-volatile memory. The passive WB RFID tag 226 is energized by an external 20 time-varying electromagnetic radio frequency (RF) wave that is transmitted by a RFID 21 reader/writer, such as the S1 RFID reader/writer 228 or the S2 RFID reader/writer 230. 22 Therefore, SI RFID reader/writer 228 or the S2 RFID reader/writer 230 is capable of writing 23 data onto the WB RFID tag 226, and reading data back from WB RFID tag 226 by detecting the 24 backscatter modulation. 25 [0071] The blood treatment unit 14 is also equipped with a BTU RFID reader/writer 232 to 26 receive a pre-treatment identity data from the SI RFID reader/writer 228 and to receive post 27 treatment data from the S2 REID reader/writer 230. Similarly, the blood treatment chamber 12 is 28 equipped with a passive SMU RFID tag 234 to provide an identification code. The BTU RFID 29 reader/writer 232 issues query signals to the SMU RFID tag 234 to determine whether the -17- WO 2006/122400 PCT/CA2006/000781 I blood treatment chamber 12 is valid for use in the treatment process, that is, whether the blood 2 treatment chamber 12 is an authentic product or whether it has been previously used. 3 [00721 As shown in Figures 19 to 21, the wristband 16 (WB) contains a removable portion 4 236 containing the WB RFID tag 226 and audit data written onto it relating to the patient 17 5 and/or the treated blood sample. The wristband 16 may also include a buckle assembly 238 6 having a base portion 240 and cover portion 241. The base portion 240 is integrally formed with 7 a band 242 of resilient material which a number of perforations forming passages 244 to receive 8 the buckle assembly 238. The base portion 240 has pins 246, 247, 248 that are dimensioned to 9 fit through the passages 244. The cover portion 242 is hinged to the base portion 240 by way of a 10 hinge shown at 250. The cover portion 242 also has a pair of cavities 252, each for receiving one 11 of the pins 246 or 248. The pin 247 may press against a switch (not shown) in the base portion 12 240 to activate portions of the circuitry of the wristband 16, upon securement of the band 242 13 around the patient's 17 arm. 14 100731 The method of monitoring a material sample will now be described with reference to 15 the Figures 1 to 21. The verification protocol makes use of a number of identification codes, 16 such as a first syringe identity code representative of the untreated blood sample therein, and the 17 a wristband identity code representative of the originating patient 17. To simplify the data 18 transfer, the first syringe identity code and the wristband identity code may include common 19 identity data, though the data between them may be different or related as the case may be. The 20 first syringe identity code may, if desired, include a first time value representative of the time of 21 untreated sample collection from the originating patient 17 (or a designated event either before or 22 after the sample collection step) and/or verification thereof. 23 100741 Thus, the S I RFID reader/writer 228 functions as a first signal emitter for emitting a 24 first signal carrying the first syringe identification code data, and/or common identity data, while 25 the WB RFID tag 226 on the wristband 16 functions as a first signal receiver to receive the first 26 signal. The second syringe 15 is assigned a second syringe identity code, which is representative 27 of the treated blood sample therein. The second syringe identity code includes a second time 28 value representative of the time of the treated sample delivery thereto from the treatment cavity 29 52 (or a designated event either before or after the treated sample delivery step) and/or 30 verification thereof. -18- WO 2006/122400 PCT/CA2006/000781 1 [00751 Thus, the S2 RFID reader/writer 230 functions as a second signal emitter for emitting 2 a second signal carrying the treated blood sample identity data and the WB RFID tag 226 3 functions as a second signal receiver means to receive the second signal, wherein the verification 4 means 212 is operable to compare the first signal data with data representative of the treated 5 blood sample. 6 [00761 Referring to Figure 18, the verification protocol will now be discussed along with a 7 typical blood treatment procedure. As shown in Figure 1, a kit for a blood treatment procedure is 8 assembled including, among other things, the wristband 16, the first syringe 11, the second 9 syringe 15, the sample management unit 12 and a number of prepared labels 258 with patient 10 identification printed thereon. The procedure starts with the activation of the first syringe 11 via 11 an actuating means such as the pullout tab button 38. Once activated, the circuitry on PCB 34 is 12 powered on by the batteries 48 and conducts a power-on-self-test (POST) procedure and 13 subsequently the first syringe 11 is ready for use, barring any detected faults during the POST 14 procedure. The S 1 RFID reader/writer 228 is then activated and starts transmitting query signals 15 and waits for an acknowledgement response from the passive WB RFID tag 226. The first 16 incremental counter 222 is also initiated and outputs temporal data, and keeps track of the 17 untreated blood events and log time stamps associated with predefined untreated blood events, in 18 association with the logic means. To that end, a timestamp TSO indicative of the event of power 19 on is recorded by the second incremental counter 224 and stored in memory. The S1 RFID 20 reader/writer 228 and the WB RFID tag 226 each contain common patient identity data or 21 sample treatment data, coded as ID1. 22 [00771 Before the first syringe 11 is used to draw blood from the patient 17, a blood anti 23 coagulant, such as sodium citrate solution, is also drawn into the first sample receiving chamber 24 21 to prevent clotting of the blood, as shown in Figure 3. A sample of blood is then withdrawn 25 from the patient 17, and once primed, the first syringe 11 is brought to within RF range of the 26 wristband 16.The Sl RFID reader/writer 228 queries the WB RFID tag 226 to verify that the 27 data read from or emitted by the WB RFID tag 226 corresponds to the common patient identity 28 data ID1 on Sl REID reader/writer 228. The process is terminated if there is no correlation 29 between the data on the wristband 16 and the first syringe 11. However, if a positive correlation 30 has been made, the SI RFID reader/writer 228 records a "time data stamp" TS1 stamp on the SI -19- WO 2006/122400 PCT/CA2006/000781 1 RFID reader/writer 228, and writes the same time-stamp to the WB RFID tag 226, Therefore the 2 Sl RFID reader/writer 228 and the WB RFID tag 226 now carry TSO, TSI and IDI. As an 3 example, the data now on the SI RFID reader/writer 228 and the WB RFID tag 226, the may be 4 represented as: Sl ID1 TSO TSI meaning that the untreated blood sample drawn into the first 5 syringe 11 is from a patient with the identification ID 1, the first syringe 11 was powered on at 6 time TSO, and the common patient identity data ID1 on the first syringe 11 and the wristband 16 7 was matched at time TS 1. 8 [0078] The first syringe 11 logic means receives temporal data from the first incremental 9 counter 222 and determines the elapsed time from the start of the procedure (TSO) and the instant 10 that the common patient identity data ID1 on the first syringe 11 and the wristband 16 is 11 matched, The process advances as long as the time unit difference between TSO and TS1 is 12 within an acceptable predefined range. 13 [00791 In the next step, the first syringe 11 is installed on the blood treatment chamber 12 14 (with the second syringe 15 already positioned thereon), which is then delivered to the blood 15 treatment unit 14. As such, the S1 RFID reader/writer 228 emits the data TSO, TS1, IDI to the 16 BTU RFID reader/writer 232. The data also include a time value TS2 denoting a treatment start 17 time. The blood treatment unit 14 then calculates the time delay between TSl and TS2 of the 18 first syringe 11. In addition, the blood treatment unit 14 issues a query signal to the SMU RFID 19 tag 234 on the sample management unit 12 and, in response thereto, the SMU RFID tag 234 20 issues a signal containing its identification code to the blood treatment unit 14. A determination 21 as to whether the SMU RFID tag 234 is valid, and also whether the delay is acceptable. If the 22 SMU RFID tag 234 is invalid, and/or the delay is unacceptable then the process ends, otherwise 23 the process continues. This identification code, in this case, includes an "enable" code indicating 24 that the blood treatment chamber 12 has not been previously used for a blood treatment, thus 25 reducing the risk of contamination the current untreated blood sample SI. Alternatively, the 26 SMU RFID tag 234 need not issue an enable code, but rather merely emit a signal containing 27 identity data such as a SKU or the like. 28 [0080] If the time delay between TS1 and TS2 is acceptable, the blood treatment unit 14 the 29 procedure continues with the untreated blood sample in the first syringe 11 being delivered to the 30 treatment cavity 52, via the chamber inlet 50 and conduit 128. The S1 RFID reader/writer 228 is - 20 - WO 2006/122400 PCT/CA2006/000781 1 subsequently disabled to prevent further use by including a disable code thereon. In addition, a 2 SMU RFID tag 234 on the blood treatment chamber 12 receives a disable code from the BTU 14 3 after the blood sample is delivered to it, thereby preventing the reuse of the blood treatment 4 chamber 12. Alternatively, the SMU RFID tag 234 may be disabled in other ways without 5 writing a disable code thereon. For example, the SMU RFID tag 234 may be rendered 6 inoperable by issuing the SMU RFID tag 234 a signal causing a fuse to be blown therein. 7 100811 In the course of the treatment, the second syringe 15 is powered on and starts 8 querying the BTU RFID reader/writer 232 for data. A new time stamp signifying the end of the 9 blood sample treatment "TS3" is written to the BTU RFID reader/writer 232, and subsequently 10 TS3 is read by the S2 RFID reader/writer 230, and stored thereon. The treated blood is then 11 delivered from the treatment cavity 52 via the conduit 130 and to the second syringe 15, and. If 12 desired, the blood treatment unit 14 may also include the TS 1 stamp, meaning that the data 13 written to the S2 RFID reader/writer 230 would include ID1, TSO, TSI, TS2, and TS3. In this 14 case, the second syringe 15 includes the treatment start time TS2 and the treatment end time TS3. 15 Alternatively, or in addition, TS2 or TS3 may include a treatment duration time, or some other 16 code indicating that all previous verification steps have been successfully carried out. 17 [00821 For example, the blood treatment unit 14 may record the following data: 18 Sl IDI TSOTS1 19 PATIENT ID 20 TREATMENT START TS2 21 TREATMENT END TS3 22 S1 ID1 TSO TSI TS3 23 [00831 In this case, the PATIENT ID code may include other patient-related data that is 24 manually or automatically entered into the blood treatment unit 14. Alternatively, the patient 25 related data is transferred to the blood treatment unit 14 from a central data storage centre, a 26 server computer, a memory bank or the like. 27 [0084] The second syringe 15 is then transported back to the originating patient 17 wearing 28 the wristband 16 and the S2 RFID reader/writer 230 continually polls the WB RFID tag 226 until 29 the latter is within range of the query signals. In response to the query signals, the WB RFID tag 30 226 then emits ID1 data, at time "TS4". The S2 RFID reader/writer 230 then calculates the time -21- WO 2006/122400 PCT/CA2006/000781 1 delay between TS3 data and the time of arrival, TS4, of the second syringe 15 back to the 2 wristband 16. If the expected time delay is exceeded, then the second syringe 15 remains locked 3 by the locking mechanism 100, otherwise the process continues. 4 [0085] The second syringe 15 records ID1, and the time stamp "TS4". In addition, the 5 second syringe 15 may include the PATIENT ID data as well as the ID1, TSI, TS2, TS3. This 6 data is subsequently written onto the WB RFID 226. At this stage, the S2 RFID reader/writer 230 7 issues a release signal to the locking mechanism 100 to unlock the second syringe 15, by issuing 8 a predetermined current to the spring plate 178 to force the abutment flange into slot 194, 9 thereby rendering the second syringe 15 operable for injection. 10 100861 As an example, the WB RFID tag 226 therefore records: 11 Sl IDl TSO TS1 12 S2 15 IDI TSO TS1 TS2 13 SAMPLE MATCH TS3 14 S2 UNLOCK TS4 15 [0087]1 The verification protocol is then completed when the TS4 is recorded in the WB 16 RFID tag 226 after it performs a sample match between the IDI data on the S2 RFID 17 reader/writer 230 and the WB RFID tag 226. As shown in Figure 21, the removable portion 236 18 of the wristband 16 is then separated therefrom and matched with the originating patient's record 19 and the patient record is returned to the blood treatment unit 14 for a data exchange between the 20 WB RFID tag 226 and the blood treatment unit 14, to complete the audit trail. 21 [0088] Alternatively, an RF reading audit record capture station may be provided which is 22 local to the patient 17 or to a patient record area in a medical facility, thereby eliminating the 23 need for the patient record to be returned to the blood treatment unit 14. In this case, the audit 24 record capture station may be capable of downloading the patient record to complete the audit 25 trail. The RF reading audit record capture station may be part of the internal network of the 26 medical facility, either through a wired or wireless data port, or may be part of a network 27 localized to one or more blood treatment unit systems in the medical facility. It may collect data 28 and allow for later batch recording to a computer readable medium, such as an optical disc, hard 29 drive or other storage device. It may be attached to or integrally formed with a computing 30 device, personal digital assistant, a mobile phone or the like. It may also be embodied as - 22 - WO 2006/122400 PCT/CA2006/000781 1 software configured to run on a computing device, together with an RFID reading attachment 2 thereon. 3 [00891 The data IDI and TS4 is delivered to blood treatment unit 14 or other system to 4 complete the audit trail. The time stamp may also include an "event" code, which may comprise 5 five major events: 6 [00901 7 1) S I start time 8 2) WB acknowledges with Si 9 3) Start of Treatment 10 4) End of Treatment 11 5) Match between the Treated Sample and the Originating Patient. 12 13 The time stamp may also include any one or more of a number of Error events 14 1) No match 15 2) S1 does not match with WB at before/after collection 16 3) S2 does not match with WB on return after Treatment. 17 4) Time Delay- exceed time to collect of blood 18 5) Time Delay- exceed time to deliver sample to BTU 19 6) Time Delay- exceeds time to return to patient. 20 The TS3 time stamp may also include a "match" code as follows: 21 01 Match 22 02 No match 23 [0091] In another embodiment, the wristband includes electronic circuitry coupled to the 24 passive WB RFID tag 226, and a battery for providing power to the electronic circuitry. As 25 shown in Figure 20, the wristband 16 includes outputs means, such as LEDs 260, 262, 264, or a 26 speaker (not shown), which are operated in different combinations of one or more thereof. For 27 example, the LEDs 260, 262 may be operable to illuminate in accordance to a predetermined 28 cycle indicative of the communication associated with verification process with the first syringe 29 11 and the second syringe 15. The third LED 264 may be provided for alarm situations. 30 - 23 - WO 2006/122400 PCT/CA2006/000781 1 [00921 In another embodiment, the wristband includes electronics circuitry coupled to the 2 passive WB RFID tag 226, and a battery for providing power to the electronic circuitry. As 3 shown in Figure 20, the wristband 16 includes outputs means, such as LEDs 260, 262, 264, or a 4 speaker (not shown), which are operated in different combinations of one or more thereof. For 5 example, the LEDs 260, 262 may be operable to illuminate in accordance to a predetermined 6 cycle indicative of the communication associated with verification process with the first syringe 7 11 and the second syringe 15. The third LED 264 may be provided for alarm situations. 8 [0093] 9 [00941 The wristband 16 may be replaced by some other article to be worn, carried, attached 10 or ingested by the patient 17, such as a pinned or self adhesive label 258 and the like. 11 [00951 The second syringe 15 may also include a second sample receiving chamber 89 12 volume detector to determine whether the received treated blood from the treatment cavity 52 is 13 within a predefined range suitable for injection into the patient 17 to provide the desired medical 14 treatment. 15 [0096] In another embodiment, the system 10 includes a blood sample treatment chamber, 16 similar to the sample blood treatment chamber 12 of Figure 4, with an expandable treatment 17 cavity 52 formed by a cover portion 54, a bottom portion 56 and a flexible walled portion 58 18 therebetween. 19 [00971 In yet another embodiment, the system includes a locking mechanism 100 operable 20 by a solenoid or motorized means configured to receive the release signal. 21 [00981 In another embodiment, the system includes a wristband 16 with electronic circuitry 22 for transmitting, receiving and storing data related the originating patient 17, such as 23 identification data or an identifier, SKU, serial no., manufacturing date, expiry date, health 24 facility data, health practitioner data, medication data, and so forth. The circuitry includes, but is 25 not limited to, a transmitter, a receiver, logic means or processor, a computer readable memory 26 for data storage, a timing'circuit, an antenna and a power source. The circuitry also includes an 27 RFID reader/writer for reading RFID tags associated with other entities within the treatment 28 system, such as the first syringe 11, the second syringe 15, or the sample management unit 12. A 29 wristband tag. This wristband 16 acts as the archive data storage for the entire treatment and 30 therefore provides the audit trail once the treatment has been completed. The data may be stored - 24 - WO 2006/122400 PCT/CA2006/000781 1 in the computer readable medium, such as RAM, ROM, flash memory, and so forth. or the 2 wristband may include an RFID tag to which the data is written. 3 [00991 The first syringe 11 and the second syringe 15 include a printed circuit board (PCB) 4 having circuitry for transmitting, receiving and storing data related to the syringe and/or its 5 contents or the originating patient 17, such as identification data or identifiers, SKU, serial no., 6 manufacturing date, expiry date, fluid data, health facility data, health practitioner data, 7 medication data, and so forth. The circuitry is implemented as an active RFID tag having a 8 transmitter, a receiver, logic means or processor, a computer readable medium for data storage, a 9 timing circuit, an antenna and a power source such as a batteries. Also coupled to the PCB are 10 input/output devices such as a display, LED, a speaker or a button. The second syringe 15 also 11 includes circuitry for controlling the operation of a releasable lock means or electromechanical 12 interlock to prevent re-injection of treated blood in the event that the wristband 16 identifier and 13 second syringe identifiers do not match. 14 [001001 Similar to the preferred embodiment, the system includes a BTU reader/writer which 15 can communicate (read and write) to RFID tags of the first syringe 11 and the second syringe 15 16 and to a tag on the sample management unit 12. The first syringe 11 RFID tag stores and record 17 data relating to the patient for example, the time blood was removed for treatment. It will also 18 ensure that the syringe 11 cannot be re-used. The first syringe 11 RFID tag will also include an 19 elapsed time counter and a matching identifier to that contained in the wristband written at the 20 time of manufacture or packaging. The second syringe 15 RFID tag includes similar functions 21 and includes logic and circuitry to drive an electromechanical interlock. 22 [001011 The flow of treatment events are similar to the one described above. Prior to removal 23 of blood, a check is performed to verify that the unique treatment set ID numbers contained in 24 the wristband 16 and in the first syringe 11 match, by having the syringe 11 active tag emit the 25 data to the wristband 16 reader/writer. If there is a match, this event is recorded by the wristband 26 and blood is withdrawn from the patient. At the same time the elapsed time counters in the 27 syringe 11 tag and wristband 16 will start. 28 [00102] The first syringe 11 is then be fitted onto the sample management unit (SMU) 12, 29 which is already fitted with a single-use second syringe 15. The SMU 12 with both syringes 30 11,15 is then taken to the blood treatment unit (BTU) 14 with a BTU reader/writer. The patient -25- WO 2006/122400 PCT/CA2006/000781 1 details are entered into the BTU reader at this stage. The blood treatment unit 12 reader/writer 2 will read the first syringe 11 tag and write the details (including the unique ID) to the second 3 syringe 11 tag. The BTU reader/writer will also write a message to the SMU tag to indicate it has 4 been used. The BTU reader/writer will read the elapsed time from the first syringe 11 tag and 5 calculate treatment time details. These are then written to the second syringe 11 tag along with 6 patient ID. 7 [00103] Following the blood treatment, the BTU reader/writer writes the completed treatment 8 time to the second syringe 15 tag. The SMU 12 is removed from BTU. S2 syringe is removed 9 from the SMU 12, and the SMU 12 and SI syringe are discarded. The second syringe 15 is then 10 presented to the wristband 12 on the patient and, provided the unique IDs match and elapsed 11 time is within set parameters, the second syringe 15 locking mechanism is released and the 12 second syringe 15 can be used to inject the treated blood into the patient. The wristband 12 13 reader/writer writes the patient data and procedure details to the wristband 12 tag or computer 14 readable medium, for subsequent removal for storage with patient records. The wristband 12 15 reader/writer is then deactivated and its strap is cut to allow removal from the patient and 16 disposal. A network RFID reader is used to read the encrypted data in the wristband tag memory 17 unit or computer readable medium for transfer to the health facility database on a computer or 18 network. 19 [00104] In another embodiment, the BTU reader/writer or an external reader/writer provides 20 all the verification checks 21 [001051 Even though the description above is in large part focused on the use of system 10 in 22 the treatment of autologous blood samples, it will be understood that the system 10, its 23 components and alternatives thereof, may be used for samples other than blood samples, such as 24 bone marrow or, lymphatic fluids, semen, ova- fluid mixtures, other bodily fluids or other 25 medical fluids which may or may not be "autologous", for example fluid mixtures perhaps 26 containing a patient's desired solid sample such as from organs, body cells and cell tissue, skin 27 cells and skin samples, spinal cords. The system 10 may also be used for medical testing where 28 it is important to ensure that test results of a particular test can be delivered to the originating 29 patient 17. -26- WO 2006/122400 PCT/CA2006/000781 1 [001061 While the system 10 makes use of syringes 11 and 15, it will be understood that other 2 devices may be used such as, alone or in combination, one or more syringes, IV bottles, powder 3 and/or atomized fluids and/or gas inhalant dispensers, implant delivery dispensers, ventilators, 4 syringe pumps, intubation tubes, gastrointestinal feeding tubes, or a plurality and/or a 5 combination thereof. One of the treatment devices may also comprise a blood treatment device 6 such as that disclosed in International Publication No. WO0 119318A1 entitled "APPARATUS 7 AND PROCESS FOR CONDITIONING MAMMALIAN BLOOD" (the entire contents of 8 which are incorporated herein by reference). Alternatively, one treatment device may be 9 equipped to perform a range of invasive and non-invasive treatments such as surgeries, 10 treatments for diseases such as cancer, as well as exploratory or diagnostic investigations such as 11 X-rays, CAT Scans, MRI's and the like. 12 [00107] Although the invention has been described with reference to certain specific 13 embodiments, various modifications thereof will be apparent to those skilled in the art without 14 departing from the spirit and scope of the invention as outlined in the claims appended hereto. -27-