ZA200504220B - Medical treatment control system - Google Patents

Description

MEDICAL TREATMENT CONTROL SYSTEM

REFERENCE TO CO-P ING APPLICATIONS 3

The entire subject matter of U.S. Provisional application serial number 60/428,942 filed November 26, 2002 and entitled BLOOD TREATMEINT CONTROL SYSTEM is incorporated by reference. The applicant claims priority benefit under Title 35, United States Code, Section 119(e) of U.S. Provisional application serial number 60/428,942 filed November 26, 2002 and entitled BLOOD TREATMENT :

CONTROL SYSTEM.

The entire subject matter of U.S. Provisional application serial number 60/464,659 filed April 23, 2003 and entitled DISPENSING SYSTEMS is incorporated by reference. The applicant claims priority benefit under Title 35, United States Code, Section 119(e) of U.S. Provisional application serial number 60/464,659 filed April 23, 2003 and entitled DISPENSING SYSTEMS.

The entire subject matter of U.S. Provisional application serial number 60/482,725 filed June 27, 2003 and entitled MEDICAL TREATMENT CONTROL SYSTEM is incorporated by reference. The applicant claims priority benefit under Title 35, United States Code, Section 119(e) of U.S. Provisional application serial number 60/482,725 filed June 27, 2003 and entitled MEDICAL TREATMENT CONTROL

SYSTEM.

BACKGROUND OF THE INVENTION

1. FIELD OF THE INVENTION

The present invention relates to the controlling of medical treatments. 2. DESCRIPTION OF THE RELATED ART

The field of medicine has worked diligently over the years to improve the safety of blood collection and delivery in patient care. The consequen.ces of an error, for example in delivering a blood sample to the wrong patient, can be serious, if not sev-ere. A current technique uses a series of four identically numbered decals that are used to track the two syringes, the disposable and the patient during the blood treatment. The . blood treatment involves: 1 Removing the blood frorm the patient to a syringe. 2 Transporting that syringe to & blood treatment disposable within which the treatment occurs. 3 Removing the treated bleood from the disposable to the blood delivery syringe and 4 Returning the blood to the patient.

The serial number on the decals are cormpared to one another at each transfer step by the operator to ensure that the correct blood is tracked througkhout the process to eventually ensure the correct blood is given to each patient.

At each comparison a decision is mades and at each decision point there exists a potential for human error.

An Intensive Care Unit (ICU) at a British hospital has gained recognition for its efforts to reduce errors in blood treatments. The system require.s that a new patient entering a ward on the ICU receive a new wristband that contains the informatiom of Date of Birth (DOB), Name, Hospital ID number and a 2D barcode that contains the same information as well as any allergies, blood type and medications that the patient is currently receiving. This information is also stored on the hospital database.

The ICU nurse can then order autologous or donated blood to be delivered to the ICU for the patient. The blood information is confirmed on the Tblood bank computer monitor and the correct blood is selected. New barcodes are printed and placed on thosse blood bags. The blood bags are delivered to the patient.

At the bedside, the belood bag barcode and patient barcode are scanned to see if the blood sand patient match.

If they match, the operator or nurse is granted approval to proceed with the transfusion. If" the match is not made, the nurse is not provided with approval and is given a warning not to transfuse the blood. The barcode reader and printed labels facilitates a machine assisted blood matching.

Despite the advances that have been made in the control of medical treatments, improvenents are still needed.

SUMMARY OF THE INVENTION

In one of its aspects, the present invention provides a device for controlling the collectiorm and delivery of blood, comprising a syringe-engaging portion, the syringe-engaging portion being operabBe in a release position to receive a syringe when the syringe is in a blood-containing configuration, the sSyringe-engaging portion being operable in a lock position for locking the syringe therewith, and access comatrol means for controlling the release and lock positions according to a blood transaction condition.

In one embodiment, the syringe-engaging portion has a side wall containing a cavity to receive the syringe.

The syringe is of the type having a body having a first end flange on one end thereof and = plunger slidably engaged with the body, the plunger having a second end flange on a remote end thereof, the cavity having a first formation to re«ceive the first end flange.

In one embodiment, the access control means further comprises at least one barrier portiomn to extend at least partially across the cavity in the lock position. In one example, the access control means has a pair of barrier members with opposing free end regions, the barrier members being movable between an open position wherein thes free ends are separated to permit the syringe to pass therebetween aned 2 closed position wherein thes free ends are positioned sufficiently close to one another to prevent tie removal or the addition of the syrimge from the cavity. The barrier members are pivotally coupled to the syringe-engaging portion .

In one embodiment, the device has a control portion, the syringe-engaging portion being removably attached to the control portion. Actuating means are mounted in the control portion and are releassably coupled to the barrier mmembers for actuating the barrier members between the open and closed po sitions.

In addition, a second lenck means is provided for locking the syringe engaging portion with the control portion, for reasons whilich will be described herein below.

In one embodiment, thes control portion includes a data transfer unit. The data transfer unit is operable to receive patient identification data representative of a subject patient and thereby to establish a firs-t blood transaction condition, tHhe control portion being operable in the first blood transaction condition tos transfer the barrier members to the release position to receive a first syringe containing blood from the suzbject patient and to transfer the barrier members to the lock position to lock the first syringe in the cavity.

In one embodiment, thes data transfer unit includes data transmitting means, data receiving means and data storage means for recomrding data received by the data receiving means. Either the data transmitting means, the data receiving meaxas, or both, may each include a wired or wireless data port. The wireless dlata port may include, for example, a barcode reader, or an RF signal receiver.

In one embodiment, thee data transfer unit is operable to transfer the patient identification data to & blood treatment unit and thereeby to establish a second blood transaction condition, the control portion beeing operable in the second “blood transaction condition in which the barrier members are movable to the release position to relesase the first syringe to a first syringe station in the blood treatment unit.

In one embodiment, thee data transfer unit is operable to receive treated blood identification data rom the blood treatment unit, tie data transfer unit also being operable to receive treated blood verificatioen data from a second syringe «Containing treated blood from the subject patient and positioned at a second syringe station in the blood treatment unit, thereby to establish a third blood transaction condition, the control portion being operable in the third blood transaction condition to transfer the barrier members to the relesase position to receive the second syringe.

In thais case, the second lock means is operable to release the syringe engaging portion at the end of a blood treatment procedure to permit the second syringe to be transported to the subject patient while still being positioned in the syringe engaging portion.

In ome embodiment, the data transfer unit is operable to receive patient vearification data to establish a fourth , blood transaction condition, the control portion being operable in the fourth blood transaction condition wherein the barrier members are movable to the release position to release the second syringe.

In amother of its aspects, there is provided a system for blood processing, comprising: : - a first syringe to receive a blood sample from a subject pa-tient; - a patient identifier attachable to the subject patient; - a blood treatment unit; - a syringe carrier for transferring the first syringe containirag the blood sample to the blood treatment unit, the syringe carrier being operable in a release position to receive the first syringe when the first syringe is in a blood-containing confSiguration, the syringe carrier being operable in a Jock position for locking the first syringe ther-ewith, and access control means for controlling the release and lock positions to control access to the first syringe according to a blood sample transfer condition.

- a second syringe to receive the blood sample after treatment in tHhe blood treatment unit to form a treated blood sample; and -the syringe carrier being operable in the release position to receive the second syringe when the second syringe is in a blood-containing configuration, the syringe carrier being operable . inthe lock position for locking the second syringe therewith, sa=id access control means being operable to controlling the release and lock positions to comtrol access to the second syringe according to a treated blood transfer condition.

Preferabl-y, the syringe carrier has provision to receive or record indicia indicaive of a patients name ox other patent identifying data, in manner readable to the operator or the patient or both. Preferably, the syringe c-arier is also provided with a mechanism allowing the operator to trarasfer the carrier to the release position to release the syringe. .

In still amother of its aspects, there is provided a method of controlling the trarasfer of blood between a subject patient and a blood treatment unit, comprising the steps of: - providing a first syringe containing a sample of untreated bloosd from a subject patient; - providing a syringe carrier which is operable in a release positzion to receive the first syringe; the syringe carrier being operable ina lock position for= locking the first syringe therewith, the carrier having an access controller for controllin=g the release and lock positions according to a blood transaction condition, the access controller including a data transfer unit which is operable to receive patient identification data representative of a subject patient; - in a first blood transaction step, delivering patient identificatieon data representative ofa subject patient to the data transfer unit, thereby teo place the syringe carrier in a release position to receive the first syringe and thereaftex to place the syringe carrier in a lock position to lock the first syringe therein; in a second blood transaction step , transferring the patient identification data to a blood treatment unit, thereby to place the syringe carrier in the release position to release the first syringe to a first syringe station in the blood trezatment unit; - in a third blood transaction step, delivering treated blood identification data from the blood treatment unit to the syringe carrier, and delivering treated blood verification data from a second syringe containing treated blood from the subject patient and which is positioned ata second syringe station in the blood treatment uit, and placing the syringe carrier in the release position to receive the second syringe; and - in a fourth blood transaction step, delivering patient verification data to the syringe carrier and placing the syringe carrier in the release pOsition to release the second syringe.

In still another of its aspects, the present invention provides aa process of extracting a body fluid aliquot from a patient, extracorporeally treating at least a portion of #he aliquot and returning the treated portion to said patient, comprising the steps of: - equipping the patient with a body fluid aliquost identification means which includes patient - identifying indicia; - withdrawing the body fluid aliquot from the patient . labeling the aliquot or portion thereof to be treated with aliquot-identifying indicia uniquely correlating with said patient-identifying indicia; - extracorporeally treating the labeled aliquot or poxtion thereof; - establishing correlation between the aliquot-ident®fying indicia and said patient-identifying indicia in order to permit patient access to the treated aliquot or portion thereof; and - after establishing said correlation, returning the texeated aliquot or portion thereof to the patient; - whereby said patient is assured of receiving a tre=ated aliquot or portion thereof which was initially extracted from said patient.

Preferably, the aliquot is whole blood and the entire aliquot as withdrawn is treated (i.e. no fractionation step).

Preferably, the aliquot is withdrawn into a first dispenser carrying the aliquot-identifying indicia and then is transferred from said first dispenser into a treatment container for conducting the treatment. In this case, the treatment container is labeled to provide a first treated-aliquot-identifying indicia for the treated aliquot.

Following treatment, the aliquot is transferred from the treatme=nt container to a second dispenser after treatment. Similarly, the second dispenser is labeled to provide s second treated-aliquot-identifying indicia for the treated aliquot. The second treated-aliquot-identifyings indicia is checked to correlate with the patient-identifying indicia to provide patient access to the treated aliquot for return to the patient.

Preferably, the blood aliquot is treated with oxidative stress wihnich, in one instance, is ozone/oxygen gaseous mixture which is bubbled through the aliquot. In another case, the blood aliquot is treated with UV radiation, or heat, or at least two of UV, oxygen/ozone and heat. In another example, the blood aliquot is treated with UV, oxygen/ozone and heat.

Preferably, the first and/or second dispensers in<lude syringes or syringe-type devices, but may be applied to a range of other dispensers as well.

Tn still another of its aspects, the present invention provides a device for controlling the collection and delivery of materials to a patient, comprising 8 dispenser-engaging portion, the dispenser-engaging portion being operable in a release position to receive a materials dispenser when the dispenserisina materials- containing configuration, the dispenser-engagixg portion being operable in a lock position for locking the dispenser therewith, and access control means for controlling the release and lock positions according to a material transaction condition.

Preferably, the dispenser includes a syringe, IV bottle, powder and/or atomized fluid and/or gas inhalant dispenser, implant delivery dispenses, ventilator, syringe pump, intubation tube, or 8 gastrointestinal feeding tube or a plurality and/or a combination thereof.

Preferably, the dispenser-engaging portion inc Tudes a first cavity to receive the dispenser, the first cavity being accessible through a side wall or an end wall thereof. In one example, the dispenser-engaging portion has a side wall and the first cavity is located in the side wall. In this case, the access control means further comprises at least one barrier portion te extend at least partially across the first cavity in the lock position.

In still another of its aspects, the present invemtion provides a process of extracting a body fluid aliquot from a patient, extracorporeally treating at least a portion of the aliquot and returning the treated portion to said patient, comprising the steps of: - equipping the patient with a bo dy fluid aliquot identification means which includes patient -

identifying indicia; - withdrawing the body fluid alicquot from the patient; - labeling the aliquot or portion thereof to be treated with aliquot-identifying indicia uniquely correlating with said patient-idemtifying indicia; - locking the aliquot against deldvery with an indicia responsive lock; - extracorporeally treating the labeled aliquot or portion thereof; - establishing correlation between the aliquot-identifying indicia and said patient-identifying indicia in order to permit patient access to the treated aliquot or portion thereof; and - after establishing said correlation, retuming the treated aliquot or portion thereof to the patient by response of the indicia responsive lock to the correlation so established; - whereby said patient is assured of receiving a treated aliquot or portion thereof which was initially extracted from said patient.

In a further aspect, the present invention provides a device for controlling the delivery of blood, comprising a syringe-engaging portion, the syringe-enga ging portion being operable in a lock position for locking the syringe therewith when the syringe is in a blood-containing configuration, and in a release position to release the syringe, and access control means for controlling the release and lock positions according to a blood transaction condition. :

In one embodiment, the syringe-engaging portion includes a cavity to receive the syringe.

Preferably, the access control megs further comprises at least one barrier portion to extend at least partially across the cavity in the lsock position.

In one embodiment, the access ceontrol means includes 2 data transfer unit, the data transfer unit being operable to receive patient identification data representative of a subject patient and thereby to establish a blood transaction condition, the control portion being operable in a blood transaction condition to establish the release position for the barriezr member to release the syringe.

In one embodiment, the data trarmsfer unit includes data receiving means and data storage means for recording data received by the deta receiving means. The data receiving means may include a wired or wireless data port, wherein the latter may include a barcode reader, an RF signal receiver or an Infrared transmitter receiver. The data traansfer unit is operable to receive patient verification data to establish the release position for the barrier mmember to release the syringe.

In yet a further of its aspects, the present invention provides a method of controlling the transfer of blood between a subject patient and a tolood treatment unit, comprising the steps of: - providing a first syringe to receive a sample of untreated blood from a subject patient; - providing the subjecst patient with a patient RF signal processor; - providing a second sSyringe to receive the sample following treatment; - providing each of tue first syringe and the second syringe with an RF signal processor; - arranging the RF si_gnal processors on the first syringe and with the patient to issue a signal containing common Or related identity data;

- delivering the first syringe to the blood treatment unit for performing a treatme=nt step to form a treated blood sample; - reading the identity data from the first syringe and writing the identity data to the second syringe; - collecting the treated blood sample from the treatment unit in the second syringe; - bringing the second syringe within range of the patient RF signal processor to confirm a match therebetween; and thereafter ' - delivering the treated blood sample to the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

Several preferred eambodiments of the present invention will now be described, by way of «example only, with reference to thee appended drawings in which:

Figure 1 isa schematic view of a medical treatment involving a medical treatment control system;

Figure 2 is a perspective view of a several portions of the system of figure 1; )

Figure 3 presents several views of a component of the system of figure 1;

Figures 3a to 3d present several additional views of the component of figure 3;

Figure 4 presents opposite end views of the component of figure 3;

Figure 5 shows several assembly views of the component of figure 3;

Figures 5a to 5c prese=nt several additional views of the component of figure 3;

Figure 5d is a schematiic view of several operative positions of the component of figure 3.

Figure 6isa perspective view of two components of the system of figure 2;

Figures 6a to 6¢ prese=nt several additional views of one component shown in figure 6; and

Figures 7 to 9 present views of other components of figure 1.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Figure 1 of the accompanying drawings isa flow chart ofa specific preferred embodiment of t-he process of the present invention applied to the extraction of blood from a patient P, extracorporeal treat—ment of blood by way of a treatment unit 14 and return of the treated blood to the same patient P. In other words, this is an autologous blood treatment process in which it is vital that the treated blood be returned to the same patient P from whom the blood was extracted. In this process, the patient P is provided ~with a wristband 38 which iracludes an identification unique to the patient. A first syringe S1 is used ~to extract blood from the patient, and is coded for unique interaction with an ID system on the wristband 38. The first syringe S1 containingz an aliquot of the patient's blood is then received in a syringe carrier 12 wvhich is capable of receiving lata to verify the identity of the patient P and to lock the syringe therein. ‘The syringe carrier 12 is also equizpped to deliver the syringe S1 to a treatment unit 14, which withdraws tie blood from syringe S1 and performs a designated treatment on the blood. The treatment unit 14 then provides the treated blood in a second syringe S2 which is received by the syringe carrier 12 and returned to the patient for administering the treated blood thereto. In both cases, the syringe carriem 12 receives and/or transmits date to both the wrist band 38 (or its equivalent) and the blood treatment unit 14. Furthermore, the wrist ban d 38, the syringe carrier 12, the treatment unit 14, and/or an intermediate unit may be used to generate an audit record of the blood treatment. Also included are RF ID chips 100,. 102, 104 associated respectively with the wrist band 38, syringe $1 and syringe S2, to be read asd matched by outputs 106, 108 anct 110 as described below.

Fignure 2 illustrates some of the components used in the process of figure 1 to provide a system 10 for controlling the collection and delivery of materials to a patient. In this particular example, the system is used in connection with blood processing, it being understood that the present system and method may be applied to other medical treatments and dispensers therefor. The system iss based on the control of both the co lection from, and the delivery of blood to, the patient. The system 10 imchades a dispenser engaging poertion, in the form of a syringe carrier 12 which controls the transfer of a blood sample contained ina syTinge, between the patient and a blood treatment unit 14. As will be de scribed, the system is predicated ora the concept that the administration of the techmique can, in one embodiment, be governed by the syringe carrier 12 which serves as a key to the blood treatment unit 14. In other w-ords, any attempt to avoid using thee syringe carrier 12 will render the system 10 inoperable. The syringe carrier 12 is capable of receiving data to verify the identity ofa subject patient and/or the blood sample at pmredetermined stages of a blood treatment and then to lock, within its grasp, a syringe containing blood, either untreated or treated, from or to the subject patient, in a manner which renders the syringe inaccessible &and inoperable until proper verification has been made. However, the syringe carrier is not necessary in all cases. One embodiment discussed below provides for a secure method of verifying the patient and. the blood during the blood treatment by the use of RF ID tags on a wristband and two syringes, whereein the wristband includes an RF reader and an RF writer.

Figures 3, and 3a to 3c show more details of the syringe carrier 12. As besst seen in figures 3b and 3c, the syringe carrier 12 has a syringe-engaging portion 20 and 8 control portion 21 interfitting therewith and detachable therefrom. The syringe engaging portion 20 is operable in a release peosition to receive a sampele-containing syringe 26 when the syringe is in a blood-containing configur-ation. The syringe- engaging portion is operable in a lock position for locking the syringe 26 therewith and is coupled with the ¢ ontrol portion 21 as will be described. The syringe carrier 12 has, as will bee explained, an access contsrol means for controlling these release and lock positions according to a bloeod transaction condition.

As baest seen in figures 3b and 3c, the syringe-engaging portion 20 has a side wanll 22 containing a cavity 24 to resceive the syringe 26, the latter having a body 26a with a first end flange 26s) on one end thereof and a plumger 26c slidably engaged with the body 26a and having a second end flange= 26d on a remote end thereof. In this case, the cavity 24 has a first formation 24a to receive the first wend flange 26b and a second forrmnation 24b to receive the second end flange 26d.

The first formation 24a is dimensioned so that it closely approximates the outer profile of the first end flamge 26b, while the second formation 24b is in the form of a rear end wall which is shaped to shicld the second end flange 26b from being inadvertently contacted by an obstruction. Thus, when the syringe is placed in the cavity, the plunger 26c is less likely to be unintentionally depressesd relative to the body 26a, to anse an unwanted dispensing of blood from the syringe, while in the syringe carrier 12. Alternatively, the second formation 24b may be arranged to engage the second flange 26d so- that the plunger cannot be moved relative to the body, thereby causing both the plunger and the body to oe held in position, thereby preventing the syringe 26 from being removed from the syringe carrier 12 and preventing the blood sarxple from being dispensed from the first syringe $1 while in the syringe carmier 12.

Again, referring to figures 3b and 3c, the syringe carrier 12 has access control means which includes a pair of Warrier members 28 with opposing free ends 28a. The barrier members 28 aare movable between an open relesase position wherein the free ends 28a are sufficiently separated to permit he syringe 26 to pass thesyebetween and a lock position wherein the free ends 28a extend toward one another at least partially across the cavity and are locked in that position to prevent remmoval of the syringe 26 from the cavity. In this case, the barrier members 28 are arcuate in shape and ares pivotally coupled to the syringe-engaging portion near opposite sides of the cavity 24, but may also be pivotally or otherwise mounted to the syringe engaging portion 20.

Referring to figure 5b, each of the barrier members are pivoted by way of a pivot pin 28¢ received in passage 28d for mounting each of said barrier members to the body for movement between the release and lock positions.

The barrier members 28 are, in this case, spring biased towamd the lock position, by way of spring 28f. This means that even if the syringe carrier is in the release positiosn, the barrier members 28 will retain the syringe in the cavity until needed, at which time the syringe may simply be grasped from the carrier and removed therefrom, against the biasing force of the spring 238f.

Bach barrier member has an inner end region 28¢ apposite tkae outer free end region 28a and the inner end regions 28e cooperate with a latch means, as will be describesd, for establishing the release and lock positions of the barrier member 28.

Referring to figures 5a and 5b, the syringe engaging portiors 20 includes a body 20a and a trigger structure movably mounted on the body 20a. The control portion 221 further includes a solenoid actuated driver 32 (as shown in figure 5a), wherein the trigger structure 30 i_s movable relative to the body 20 under the action of the actuating driver 32, which engages the trigger structure 30 at an actuating pad shown at 30g, in figure 5b.

The trigger structure 30 is pivotally coupled with the body 2-0a. As is best seen in figure Sb, the trigger structure 30 includes a latch portion 30a providing a pair of eopposed latch surfaces 30b. The inner end regions 28e of each barrier member 28 includes a locking pi 28g which is either obstructed by the latch portion 30a (thus locking the barrier portions from being transferred to their release positions) or not, depending on the position of the trigger structure 30. The trigger structure 30 includes a first pair of support arms 30c engaging a corresponding pair of pivot locations in the body, one of which is shown at 20d in figure 5b. The trigger structure 30 has a pair of second arm 3 30d supporting a user-activated trigger pad 30e. Thus, the latch portion 30a is centrally located between the first and second arms 30c and 30d.

Referring to figures 5a and Sb, the syringe engaging portion 20 ha=s a pair of locking tabs 20e to engage a corresponding peir of complementary locking tab-receiving cavitiess 21a on the control portion 21. In addition, a pair of locking tabs 20f match a corresponding set of tamb-receiving cavities 21b on the control portion 21.

The second arms 30d have free ends with guide members 30f, each with an inclined surface which is aligned with a corresponding locking tab 20e. Therefore, when the trigger structure 30 moves downwardly, each guide member engages a corresponding locking tab 20e andl displaces it toward an engaged position with a corresponding tab-receiving cavity 21a.

The trigger structure 30 is outwardly biased from the syringe engaaging portion by way of spring 31 positioned on spike 31a, as shown in figure 5b.

Figure 5d shows the interaction of the locking tabs 20e and the gLiide members 30f taken on line 5d-5d of figure Sc (with some dimensions exaggerated therein for illustration purposes) . The trigger structure 30 is thus operable in an outer first position, as shown at A, in which tke operative portion of the guide members 30f are disengaged from the locking tabs 20e, meaning that the locking tabs 20e are also disengaged from . the cavities 21a. In this position, then, the syringe engaging portion 20 is disconnected from the control portion 21. Meanwhile, the latch member 30a is extending between the locking pins 28g, thereby placing the barrier members 28 in their lock positions. .

The trigger structure 30 is then movable to a second position, as shown at B in figure 5d, to cause the guide members 30f to displace the locking tabs 20e into the cavities 21a (when the cavities 21a are in the required position in the first place) thereby to connect the syringe engaging portion 20 with the control portion 21, while the latch member 30a remains between the locking pins 28g to maintain the barrier members 28, still, in their respective lock positions positions.

The trigger structure is moveable to its third position, as shown at C in figure 5d, in which the locking tabs remain in the cavities but the latch member 30a is no longer between the locking pins 28f, so that the barrier members may now be moved to their release position against the biasing action of the spring 28f.

Thus, the syringe engaging portion 20 enables thes syringe to be held therein by deploying the trigger structure 30 between the first, second or third positions which can be done either manually with a user- actuated pad 30e or by an actuator 32 via an actuating pad 30g. In the latter case, the solenoid actuator 32 has a retracted position, in which its free end is edither flush with or beneath a surface 21e of the control portion 21 surrounding it. This position corresponds to the first position of trigger structure 30.

The actuator 32 may then be extended to 2 middle position corresponding to the trigger structure’s second position. Finally, the actuator 32 may then be displaced to a fully extended position wherein the actuating member has displaced the trigger structure 30 to its third position.

The syringe engaging portion 20 is locked in possition on the control portion 21 by aligning, first, the locking tabs 20f with the corresponding tab receiving cavities 21b and then by aligning the locking tabs 20e with the corresponding tab-receiving cavities 21 a, with the trigger structure in its first position. The movement of the actuator, then, from its retracte=d position to its middle or fully expended positions causes the locking tabs to engage the cavities which, as. mentioned previously, correspond to the trigger structure’s second and third positions.

As mentioned earlier, the trigger structure is also conveniently operable between the first, second and third positions when the syringe engaging portion is rercioved from the control portion, simply by the user depressing the trigger structure at the user-activatesd pad 30e.

The attachment, if desired, may also be configure=d so that the syringe-engaging portion 20 must remain with the control portion during the blood treatmerat process, so that any unauthorized removal of the syringe-engaging portion may, for example, Jock the first syringe in the syringe-engaging portion.

Referring to figures 3d, Sa and 5b, the control peostion 21 includes first sensing means 34, in the form of a proximity detector, for sensing the presence of the syringe engaging portion 20, ina lock position with the control portion 21. The control portion 21 also imcludes second sensing means 36 for sensing the presence of at least one type of syringe in the syringe engaging portion 20. The second sensing means 36 is, for example, a proximity detector and the syringe emgzging portion 20 has an opening 36a (as shown in figure 3d) to align with the proximity detector 36, which makes the proximity detector 36 fully exposed to the syringe receiving cavity 24.

The syringe is then to be equipped witha label having a sector which is either dark or light, either of which registers a different result by the proximity detector 36. Furthermore, the proximity detector is capable of sensing two regions on the label in order to be able to detect either a pre-treatment syringe (referred to by the reference “S1”) carrying untreated bloed arad a post-treatment syringe (identified by the reference «S2™), by giving each corresponding label a different combination of dark regions and light regions to be detected by the proximity detector 36. The control portion 21 includes data port 37, as shown in figure 3¢, for exchanging data with a blood treatment: unit.

The system is also provided with a wristband 3 8 (shown in figure 1) which contains a barcode that shares a common data component with the first syringe SI, so that each can be linked with a common patient. The barcodes on the wristband and first syringe S1 may also each include an additional data component,

respectively identifying each as such. The wristband 38 and the first syringe S1 also include an area or location to receive indicia in printed or written form, ina mammal or automated manmer, identifying the patient with such information as the patient's name, data of birth and the like in a manner readsble to both an operator and a patient, so that a patient, for example, may be located in a busy waiting room.

Referring to figure 5, the cosntrol portion 21 includes a data transfer unit 40 in the form of a printed circuit board with various chips mosunted thereon and powered by batteries 40a. The data transfer unit 40 inclhides data receiving means 42 in tthe form ofa barcode reader and data storage means 44 in the form of a memory - chip or the like for recordings and storing data received by the data receiving means. The data receiving means 42 may include a wired or wireless data port. The wireless data port may include, as an alternative, an RF or Infrared signal tramismitter or receiver, for example.

The data transfer unit 40 is operable to receive patient identification data representative of a subject patient and thereby to establish a first blood transaction condition, namely by scanning the patient’s wristband 38 with the barcode reader 42_ The control portion 21 is operable in the first blood transaction condition to transfer the barrier members to the release position to receive the first syringe S1 containing blood from the subject patient and to transfer the barrier members to the lock position to lock the first syringe S1 in thes cavity.

Referring to figures 2 and 7, the blood treatment unit 14 has an access port 48, in the form of a drawer on the front face of the unit, which may be opened to expose an inner blood sample receiving area. A syringe platform 50 is provided to position the first syringe S1 in the inner sample receiving area. Preferably, the syringe platform 50 is disposable and forms part of a blood treatment package as will be described.

Referring to figures 6 anc} 6a to 6c, the syringe platform 50 has a first syringe station 52 to receive the first syringe “S1”and a sescond station 54 to receive a second syringe “52” as will be described herein below. The syringe platform 50 is further provided with anchor means for anchoring the first and second syringes thereto, in the fourm of a pair of upstanding anchor members 56, as shown in figure 6.

The anchor members S6 are right angled in a manner permitting the syringe flange to fit besside and beneath each. A locking tab 57 is positioned in the syringe path of each syringe to lock it in place. Referring to figures 6ato 6c, an actiasting member 58 is provided for releasing the locking tabs 57 frorm the syringe path to allow the syringe to be located in the corresponding syringe station 52, 54. Each amchor member 56 has an upright inner passage 56a and each actuating member 58 includes an actuating pest 58a which is slidably mounted in a corresponding inner passage and of sufficient length to emerge from an upper surface of the anchor member ass will be described.

The anchor members 56 are also equipped to permit the carrier 12 to establish a physical “syringe transfer link” therewith to facilit-ats proper transfer of the syringe to the appropriate station. To aclieve this, the anchor member 56 has aan alignment groove 56b which matches a corresponding ridge 20% (shown in figure 3d) in a second locating cavity 24d formed on the syringe engaging portion 20.

Referring once again to figure 6c, the actuating member 58 has a cross member 58b whick joins the lower ends of the posts 58a amd lies adjacent the respective locking tab 57, so that downward displacement of the post causes a corresponding downward movement of the cross member, in turn causing a clownward flexing movement of the locking tab 57 to open the syringe path to receive either syringe S1 or SZ. The post is displaced by a correspomding ridge 20b on the syringe engaging portion.

The syringe station 52 is also provided with at least one, in this case two, permanent lockimg tabs 57a which are unresponsive to the actuating member 58, as shown in figures 6a and 6b. These locking tabs are operable to lock the syringe S1 permanently in the platform 50.

Referring to figure 6a, each syringe station includes a spill collecting chamber 60 for collecting spilled materials from the corressponding syringe. Each station 50, 52 further includes a pair of sysringe fluid transfer terminals 62, each to establish fluid communication with a corresponding one of syringges S1, 82.

Referring to figumres 6a to 6c, the syringe platform further includes an expansible treatment chamber 64 which is shown ia its collapsed condition in figure 6a and in its expanded condition in figure &c. Each syringe fluid trarasfer terminal is in fluid communication with said treatment chamber to delivesr untreated blood thereto, or to withdraw treated blood therefrom. The syringe platform further includes = pair of conduits 66, 68, each joined atoneendtoa corresponding syringe fluid terminal.

Referring to figure 6c, the treatment chamber 64 includes an upper lid portion 64a, a lower base portion 64b, a collapsibele jacket portion 64c there between, all of which is nested in a sleeve 64d as sshown in figure 6b. The collapsible jacket portion 64c also includes at least one, in this case three, positioning rings 64e on the jacket portion to ensure an orderly collapsing of the jacket into the sleeve 64d. The base portion 640 includes a pair of fluid transfer flanges 64f for receiving one end of each of the conduits thereon, each of the fluid transfer flanges establishing fluid communication between an interior region of the treatruent chamber and ea_ch of said conduits.

Referring now wo figure 8, the blood treatment unit 14 has a positioning housing 70 with an. inner passage 70a to receive the treatment chamber 64. The positioning housing 70 includes a transparent cylindrical housing portiora 70b whose inner cross sectional arca is selected to nest the treatment chamler therein.

The lower bases portion 64b includes a number of positioning vanes 64g extending downwardly therefrom, the vanes dime nsioned to align the lower base portion relative to the inner passage,

The blood treantment unit 14 includes a syringe carrier docking bay at 72 as shown in figuress 7 and 9, which receives the syringe carrier 12 following its release of the first syringe S1. The dockiling bay 72 includes a datas port to be coupled with the complementary data port 37 (shown in figure 3c=) in the housing of the control portion 21 to establish a data link between the data transfer unit 40 and a control system within the blood treatment unit 14. The data link between the syringe carrier 12 and the tresatment unit may, alternatively, be wireless and use for example, the protocols mentioned below.

The data transfer unit 40 (figure 5) is operable to transfer the patient identification data to the blood tweatment unit 14 and thereby to establish a second blood transaction comdition, in which the control portion is operable to transfer the barrier members to the release position to reBease the first syringe S1 to the first syringe station 52. “The data transfer unit 40 (figure 5) is also operable to receive treated blood sample identification data from the blood treatment unit 14, while the syringe carrier 12 is positioned ir the docking bay 72 (figures 7 and

S). The data transfer unit 40 is also operable to receive treated blood verification data from a second syringe containing treated blood from the subject patient and positione d at a second syringe station 54 in the platform 50, thereby to establish a third blood transaction conditiort. In this case, the barcode reader 42 may be used to scan a barcode located on the second syringe S2. The «control portion is operable in this third blood transaction condition to transfer the barrier members 28 to the release position to receive the second syringe.

The data transfer unit 40 is operable to receive patient verification dataa such as by using the barcode reader 42 to scan a barcode on the patient's wristband to establish a fourth bl ood transaction condition. The control portion is operable in the fourth blood transaction condition tos release the syringe engaging portion from the control portion 21, thereby permitting the operator to cary the second syringe conveniently in the syringe engaging portion 20 to the patient. Alternatively, if desire=d, the control portion may be operable in the fourth blood transfer condition to transfer the barrier embers to the release position to release the second syringe.

The control portion 21 includes a controller to control the functions o=f the syringe carrier 12 under the control of a number of preset instructions provided to the control porftion 21 by a key pad having one or more buttons, such as that shown at 80 with a single button, located con an external portion of its housing, as shown in figure 4. Alternatively, the controller may be responsive to the «data being received by the barcode reader which may include specific operational instructions. Alternatively, the data received by the barcode reader may initiate a preset sequence of events where the sequence includes one or more of the blood transaction conditions as described above.

The control portion 21 may include a programmed logic controller or somme other form of controller. It may be included in a software program configured torun ona general purposse computer, such as personal computer, of On a more substantial computer mainframe. The control peortion 21 may include a computer which is operable to work within a network, for example so that the syrtnge carrier can be remotely programmed and its collected data uploaded to a central database. The network may thus involve several general purpose computers, for example those sold under the trade nam-es APPLE ™ or IBM = or clones . thereof, which are programmed with operating systems known by the trade names WINDOWS wm LINUX or other well known or lesser known equivalents of these. The system may involve pre-programmed software using a number of possible languages or a custom designed version of a programming software sold under the trade name ACCESS ™ or similar programming softwares. The computer network may be a wired local area network, or a wide area network such as the Internet, Or a combination of the two, with or without added security, authentication protocols, or under “peer-to-peser” or “client-server” or other networking architectures. The network may also be a wireless network< or a combination of wired and wireless networks. The wireless network may operate under frequencilies such as those dubbed ‘radio frequency’ or “RF” using protocols such as the 802.11, TCP/IP, BLUES TOOTH and the like, or other well known Internet, wireless, satellite or cell packet protocols. The controel function of the control portion 21 may, alternatively, be executed ona single custom built computer whi_ch is dedicated to the function of the system alone.

The system may be used in the following manner to control the transfeer of blood between a subject patient and the blood treatment unit 14.

A first package is prepared including the pati ent wristband 38 and the first “blood retrieval” syringe Si.

If desired, the first package may also include a disposable or reusable syringe engaging portion 20. A second package may also be prepared including the syringe platform 50 and a second “blood delivery” syringe S2. If desired, both the first and second packages may be prepared in advance with the second syringe S2 locked on the second station 54 of the syringe platform 50, in which the second syringe S2 may only be removed by the syringe carrier 12 during the blood treatment process as will be described.

The first “blood retrieval” syringe S! contains a barcode similar to the wristband 38 but different enough from the wristband to be acknowledged as such. In other words, both the wristband 38 and the first syringe S1 are provided with a common or gzeneric data component, while the wristband contains a unique data component identifying it as a wristband and the first syringe contains a unique data component identifying it as a first syringe. The second “blood delivery” syringe S2 is fitted with a separate unrelated barcode. Further, a human readable name patching system is also used to follow a blood sample through the steps of the treatment. In other words, the wristband 38 and first syringe S1 are each provided with a label where the patient's name can be added} as indicia recognizable to the operator conducting the treatment. The syringe carrier 12 is provided to take control of the delivery of the blood samples to the treatment device and then return to the patient.

The procedure begins with blood being drawn into the first syringe S1, following a previous treatment with sodium citrate, and then the first syringe S1 is capped. The syringe engaging portion 20 is attached to the control portion 21 of the syringe carrier 12, before or after which the control portion 21 is activated and the barcode on the wristband is scanned with the barcode reader. Since the wristband 38 and the first . syringe S1 have a common data component, it may be sufficient siaply to scan the wristband 38, though the first syringe S1 may also be scanned, if required, for further verification.

As a result, the syringe carrier 12 now has, within its memory, the common data component read by the barcode reader 42. The syringe carrier 12 then unlocks the barrier members and the filled syringe is then positioned in the cavity by spreading apart the now unlocked -inwardly syringe biased barrier members 28, with the first and second end flanges in their corresponding frst and second formations. The syringe carrier 12 is then activated and the barrier members are actuated to their lock positions to lock the first syringe S1 in place, thus signifying that the first blood transaaction condition has been met. This may, for example, occur as a result of a sensor located within the syrirage receiving cavity, that senses the presence of syringe S1 and possibly an additional scan of the bar code= on syringe S1 for verification purposes.

The syringe carrier 12 is then positioned adjacent the platforam 50 so that the first syringe S1 canbe delivered to the first station 52 thereon and beld by the ancheor tabs 56 using a sliding action.

Now free of the first syringe S1, the syringe carrier 12 is installed in the syringe carrier docking bay 72 and then transfers patient identification data thereto over the dat=a link which is established between the syringe cartier 12 and the blood treatment unit 14, The blood treatment unit 14 then proceeds to carry out a designated blood treatment on the blood sample, such as th=at described in as that disclosed in PCT application serial number PCT/CA00/01078 filed Septembest 15, 2000 entitled APPARATUS AND

PROCESS FOR CONDITIONING MAMMALIAN BLOOBD (the entire contents of which are incorporated herein by reference).

Thereafter, the blood treatment unit 14 delivers the treatecd blood to the second syringe S2 already positioned in the second station 54 of the platform 50. The second syringe $2 has its own barcode containing a unique data component, which is unrelated to the common data component in the barcode of the first syringe S1 and the wristband 38. The treatment umit then reads the barcode on the second syringe

S2 and transfers the treated blood sample identification data contained in the barcode to the syringe carrier 12 through the data transfer port of the docking bay 72. Then, the syringe carrier is positioned so that the barcode reader can scan the treated sample identification on the second syringe S2 to confirm a match, at which point the barrier members 28 are released and the second syringe S2 is transferred from the second station 54 in the platform 50 to the cavity and held thereinz by the barriers 28 in the lock position.

The syringe carrier 12 is then retumrned to the patient where the barcode reader is scanned over the wristband 38 to confirm 2 match between time treated blood sample and the subject patient. With the match established, the barrier members 28 may be transferred to their release position and the second syringe removed so that the treated blood may be delivered to the patient, to complete the process. At this point, the syringe engaging portion 20 Enay be released from the control portion 21 and the syringe engaging portion 20 discarded, along with the S1, S2 syringes and the platform 50. This ensures that all working parts of the system which are intimately associated with a blood sample can be disposed of while retaining other components of the system for re-use.

Thus, the data contained in the barcode and written or printed on the labels of the wristband 38 and the syringes are used to match and track the patient and the blood sample. The wristband contains the subject patient’s name and Barcode ID. The syringe carrier 12 obtains and contains the barcode matching information as well as the written or printed patient name information thereon and the operator uses the barcode reader as a secondary mnatching device. .

In addition, the syringe carrier 12 obtains data relating to the blood treatment which may merely record the time at which the blood treatment occurred. If desired, the syringe carrier 12 may also be configured to lock the syringe carrier, if a sutosequent step in the blood treatment procedure has not been executed. For example, the syringe carrier may have a lock function triggered by the lack of a status signal received at each stage in the process. In timis case, the syringe carrier may also be configured to release the lock after a predetermined access sequences is entered in the carrier, for example via the docking bay 72.

Thus, in addition to the control of untreated and treated blood samples, the syringe carrier may also accumulate audit trail data which may be uploaded to the blood treatment unit or some other intermediate device following a blood treatrment procedure, wherein the audit trail data may be used to monitor the blood treatment to be sure that: it was appropriate for the patient's particular condition. The audit trail data may, for instance, be analyzed. over the course of a patients short term or long term treatment program, as needed.

THE RF ID-ASSISTED TRACKING WITH NAME LABEL

In this example, the subject patient is fitted with a disposable RF ID scanner on his wrist, or elsewhere inside or outside his body, either attached with or spaced therefrom and the first and second syringes zare equipped with RF ID chips within them, for example as shown schematically at 100, 102, 104 in fignmre 1.

If desired, written or printed name labels may be affixed on the wristband as well as the first and second syringes.

The treatment may proceed as before, except that the syringe carrier does not fimetion to lock the fiz=st or second syringes in place. Rather, thes verification function occurs between the wristband, the first syringe, the treatment unit and the second syr-inge. ’

The RF ID treatment procedure is proposed as follows. First, the wristband 38 and the first blood re=trieval syringe S1 are arranged so that each emits a common RF signal. The patient name and date of birth are written on the wristband as well as cen the first and second syringes. A blood sample is then drawn from the patient using the first syringe and thee wristband is attached to the wrist of the subject patient.

The syringe is delivered to the first station of the platform which is now in position in the treatment wnt.

At this point, the second delivery syringe is already installed in the second station of the platform. The treatment occurs where the treated blood sample is injected into the second delivery syringe. As shown by the dashed arrow at 106, the treatment unit reads the RE ID on the first syringe and writes that ID omito the

RF Tag of the second delivery syrimmge (as shown by the dashed arrow at 108), as well as other data &s described above such as a time stan indicative of when the treatment occurred or other steps in thes process as the case may be. This process of ID writing may only be done once, with current RF ID chips, though other devices may be availalble to make the writing process repeatable

The treatment is comprleted and the treatment unit opens to deliver a platform with an attached and empty= first syringe and the attached second syringe containing the now treated blood sample. The second syringe is removed from the p-latform in the access port and is then transported to the patient. The patient is identified by name using the patient label on the second syringe.

The operator confirms the subject patient's identification by attempting to match RF ID data in the syringe with that contained ira the patient’s wristband by placing them in close proximity to one another. The wristband RF ID reacier will emit a signal to confirm the match. The signal may be a sound or light emission, such as from a signal generator, an LED or the like.

The treated blood is then delivered to the patient. The wristband is removed from the patient and is taken to the treatment unit to close the audit trail and confirm that the treatment was completed.

THE RF ID ASSIST ED TRACKING WITHOUT NAME LABEL

In this case, the RF XD based treatment procedure is as follows. First, a package is prepared containingg a : wristband, syringe czarrier and first blood retrieval syringe. The wristband and the blood retrieval syringe have the same factoxry-installed and matching RF ID’s. The patient’s name and date of birth are writtemn on the wristband and om a label provided on the syringe carrier.

The first syringe is wised to draw a blood sample from the subject patient. The wristband is attached to the subject patient.

The syringe carrier is used, as before, to deliver the blood to the first station on the platform which is carrying the second syringe in the second station and the platform is itself located in the blood sample receiving area in the access port 48. The treatment unit is then activated to conduct a designated treatment on the blood sampl.e. Thereafter, the treated blood is delivered to the second syringe.

The treatment unit reads the RE ID on the first syringe and writes that ID onto the RF ID of the second syringe. With the treatment completed, the treatment unit opens to deliver the platform with the two syringes. The operator manipulates the syringe carrier to transfer the barriers to the release position and then fixes the second syringes in the cavity, then transfers the barrier members to the lock position, then removes the second syringe from the disposable. The syringe carrier is then taken to the patient, as identified by the informatiora contained on the syringe carrier label.

The operator confirms the paatient’s identification by attempting to match the second syringee’s RF ID to the wristband RF ID by placing them in close proximity to one another. The wristband RF ID wreader will emit a signal, such as a beep andor a light pulse, a signal over a wired or wireless data network... or the like to confirm a match, at which p oint the syringe carrier may be activated to transfer the barrier rnembers to the release position so that the s econd syringe may be removed and the treated blood sample adkministered to the patient.

The wristband is removed fiom the patient and is taken to the treatment unit to close the auclit trail and confirm that the treatment wras completed.

While the present invention has been described for what are presently considered the prefer—red embodiments, the invention isnot so limited. To the contrary, the invention is intended to c over various modifications and equivalemt arrangements included within the spirit and scope of the appemded claims.

The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalemt structures and functions.

While the syringe carrier 12 uses barrier members 28 which physically grasp or block the fi-xst and second syringes in the cavity, other forms of barriers may be employed, such as those utilizing othe=r physical barrier arrangements or non—physical barrier arrangements. For example, the barrier may bes provided as an electromagnet to clamp the syringe in the cavity by way of a magnet coupling witha ferromagpetic band on "the syringe body.

The system is applicable t-o other medical dispensers such as IV bottles, powder and/or atomized fluid and/or gas inhalant dispermser, implant delivery dispenser, ventilator, syringe pump, intubation tube, or 2 gastrointestinal feeding tumbe or a plurality and/or a combination thereof, In this case, the dispenser- engaging portion may hawe a housing with an internal cavity in which the dispenser is entirely or partially concealed and locked the Tein, or an external cavity or some other formation which grips the dispenser im such a manner that the dispenser is rendered inoperable and/or, inaccessible under controlled treatmen® . conditions. :

Claims (100)

CLAIMS:

1. A device for controlling the collection and delivery of blood, comprising a syringe-eng=aging portion, the- syringe-engaging portion being operable in a release position to receive a syringe when the syringe is in a blood-containing configuration, the syringe-engaging portion Tbeing operable in. a lock position for locking the syringe therewith, and access control means= for controlling the release and lock positions according to a blood transaction condition.

2. A device ass defined in claim 1 wherein the syringe-engaging portion includes a cavity to receive the syringe=.

3. A device a s defined in claim 2 wherein the syringe-engaging portion has a side wall amd the cavity is located &in the side wall.

: 4. A device aus defined in claim 3 wherein the first syringe has a body having a first end flange on one end thereofand a plunger slidably engaged with the body, the plunger having a seconed end flange on a remote end thereof, the cavity having a first formation to receive the first end flamnge.

5. A device ms defined in claim 2, wherein the access control means further comprises a® least one barrier portion to extend at least partially across the cavity in the lock position.

6. A device ms defined in claim 5 wherein the access control means further comprises a gpzir of barrier members with opposing outer free end regions, the barrier members being movable b-etween a release position wherein the free ends are separated to permit the syringe to pass theresbetween and a lock position wherein the outer free ends are positioned sufficiently close to one amother to prevent removal of the syringe from the first cavity.

7. A device as defined in claim 6, further comprising a control portion, the syringe-engaging portion being removably attached to the control portion.

8. A device as defined in claim 6, further comprising pivot means for pivoting each barrier member between the release and lock positions. ’

9. A device as defined in claim 8 wherein the pivot means inclucles pivot pin for mounting each of said barrier members to the body for movement between the release and lock positions.

10. A device as defined in claim 9, further comprising biasing me=ans for biasing the barrier members toward their respective lock positions.

11. A device as defined in claim 10 wherein each barrier member has an inner end region opposite the outer free end regions, further comprising latch means for latching the barrier members in their lock positions.

12. A device as defined in claim 11, wherein the syringe engaging portion further comprises a body, a trigger structure movably mounted on the body, the control peortion further comprising an actuating driver , wherein the trigger structure is movable relative to the body under the action of an actuating driver.

13. A device as defined in claim 12 wherein the trigger structure is pivotally coupled with the body and the latch means includes a latch member to obstruct the peath of the inner end regions of the barrier members in their lock positions.

14. A device as defined in claim 13 wherein the trigger structure Includes a latch portion, the inner end regions of each barrier member each including a locking pin which is obstructed by the latch member in the lock position.

15. A device as defined in claim 14 wherein the trigger structure includes a first pair of support arms engaging a corresponding pair of pivot locations in the body.

16. A device as defined in claim 15 wherein the trigger structure incl=udes at least one second arm including a user-activated trigger pad.

17. A device as defined in claim 16 wherein the cam portion is centraally located between the second arm on one side thereof and the two first arms on another side theereof.

18.” A device as defined in claim 12 wherein the trigger structure is osperable in a first position to disconnect the syringe engaging portion from the control portions, a second position to connect the syringe engaging portion with the control portion with the barrie=x members in their respective lock positions and a third position to cormect the syringe engaging posrtion with the control portion with the barrier members in their respective release positions.

19. A device as defined in claim 18 wherein the syringe engaging portion has at least one locking formation to engage at least one first complementary locking forrmation on the control portion, the syringe engaging portion further comprising at least one second locking member to engage at least one second locking formation on the control portion, wherezin the second locking member is movable to an engaged condition with the second locking formamtion when the trigger structure is in the second or third positions.

20. A device as defined in claim 19, further comprising a pair of opposed second locking members, the trigger structure further including a pair of abutment portionas each arranged to engage a : corresponding second locking member.

21. A device as defined in claim 7 wherein the control portion includes a data transfer unit, the data transfer unit being operable to transmit and receive patient identification data representative of a subject patient and thereby to establisha first blood transaction condition, the control portion being operable in the first blood transaction condition to activate the actuating driver to establish the release position for the barrier members to receive a first syringe containing blood from the subject patient and to establish the lo ck position for barrier members to lock the first syringe in the first cavity.

22. A device as defined in claim 21 wherein the data transfer unit includes data transmitting and receiving means and data storage means for recording data received by the data receiving means.

23. A device as defined in claim 22 wherein the data receiving means includes a wired or wireless data port.

24, A device as defined in claim 23 wherein the wireless data port includes a barcode reader, an RF signal receiver or an Infrared transmitter receiver.

25. A device as defined in claim 21 wherein the data transfer unit is operable to transfer the patient identification data to a blood treatment unit and thereby to establish a second blood transaction condition, the control portion being operable in the second blood transaction condition to activate the actuating driver to establish the zelease position for the barrier members to release the first syringe to a first syringe station in the blood treatment unit.

26. A device as defined in claim 25 wherein the data transfer unit is operable to receive treated blood identification data from the blood treatment unit, the data transfer unit also being operable to receive treated blood verification dexta from a second syringe containing treated blood from the subject patient and positioned at a second syaringe station in the blood treatment unit, thereby to establish a third blood transaction condition, the control portiop being operable in the third blood transaction condition to activate the actuatin_g driver to establish the release position for the barrier members to receive the second syringe.

27. A device as defined in claim 26 wherein thes data transfer unit is operable to receive patient verification data to establish a fourth blood transaction condition, the control portion being operable in the fourth blood transaction con dition to activate the actuating driver to establish the release position for the barrier members to release the second syringe.

28. A device as defined in claim 27 wherein the control portion includes first sensing means for sensing the presence of the syringe engaging portion.

29. A device as defined in claim 28 wherein thes control portion includes second sensing means for sensing the presence of at least one type of syringe in the syringe engaging portion.

30. A device as defined in claim 29 wherein thee second sensing means includes a proximity detector, the syringe engaging portion having an ope=ning to align with the proximity detector.

31. A device as defined in claim 30 wherein th-e contro} portion includes data port for exchanging data with a blood treatment unit.

32. A system for blood processing, comprisings: - a first syringe to receive a blood sample from a subject patient; - a patient identifier attachable to the subject patient;

- a blood treatment unit; - a syringe carrier for transferring the first syringe containing the blood sample to the blood treatment unit, the syringe carrier being operable in a release position to receive the first syringe when th e first syringe is in a blood-containing configuration, the syringe carrier being operable in a lock position for locking the first syringe therewith, and access control means for controlling the release and lock positions to control access to the first syringe according toe a blood sample transfer condition. - a second syrincge to receive the blood sample after treatment in the blood treatment unit to form a treated telood sample; and -the syringe carrier being operable in the release position to receive the second syringe when the second syrizage is in a blood-containing configuration, the syringe carrier being operable ) in the lock position for locking the second syringe therewith, said access control means being operable to controlling the release and lock positions to control access to the second syringe according to a treated blood transfer condition.

33. A systemas defined inclaim 32 wherein the patient identifier includes a patient wristband.

34. A system as defined in claim 33 , wherein the syringe carrier includes a syringe-engaging portion with a first cavity to receive the syringe.

35. A systemas defined in claim 34 wherein the syringe-engaging portion has a side wall and the firs® cavity is formed in thre side wall.

36. A system as defined in claim 35 wherein the first syringe has a body having a first end flange on one end thereof and a plunger slidably engaged with the body, the plunger having a second end flange on a remote end thereof, the first cavity having a first formation to receive the first end flange.

37. A system as defined in claim 36 wherein the access control means further comprises at least one barrier portion fo extend at least partially across the first cavity in the lock position.

38. A system as defined in claim 37 wherein the access control means further c comprises a pair of barrier members with opposing free end regions, the barrier members being movable between a release positior wherein the free ends are separated to permit the first or second syringes to pass therebetween aand a lock position wherein the free ends are positioned sufficiently close to one another to prevent removal of the syringe from the cavity.

39, A system as defined in claim 38, wherein the syringe carrier further compri ses a control portion, the syringe-en gaging portion being removably attached to the control portion.

40. A system as deefined in claim 39, further comprising actuating means for actuating the barrier members betweveen the release and lock positions.

41. A system as dkefined in claim 40° wherein the control portion includes a data transfer unit, the data transfer unit beeing operable to transmit and receive patient identification d=ata representative of a subject patient and thereby to establish an untreated blood sample transfer condition, the control portion being operable in the untreated blood sample transfer condition to transfer the barrier members to tFae release position to receive the first syringe containing bloed from the subject patient and tos transfer the barrier members to the lock position to lock the first syringe therein.

42. A system as defined in claim 41 wherein the data transfer unit includes data recseiving means and data storage means for recording data received by the data receiving means.

43. A system as defined in claim 42 wherein the data receiving means includes a wired or wireless data port.

44. A system as defined in claim 43 wherein the wireless data port includes a barcode reader or an RF signal receiver.

45. A system as defined in claim 42 wherein the data transfer unit is operable to receive treated blood identification data from the blood treatment unit, the data transfer unit also being operable to receive treated blood verification data from the second syringe containing treate=d blood from the subject patient and positioned at a second syringe station in the blood treatment unit, thereby to establish a treated blood transfer condition, the control portion being operable in the treated blood transfer condition to transfer the barrier members to the release position to recezive the second syringe and to transfer the barrier members to the lock position to lock the first syringe therein.

46. A system as defined in claim 32, wherein the treatment unit includes a housing, further comprising a syringe platform removably mounted in the housing, the platform further comprising a first syringe station to receive the first syringe and a second syringe station tas receive the second syringe.

47. A system as defined in claim 46 wherein the syringe platform further comprisees an anchor raeans for anchoring the first and second syringes at the first and second syringe staticons respectively.

48. A system as defined in claim 47 wherein each anchor means includes at least sone upstanding anchor tab which engages the first end flange on the first syrin_ge.

49. A system as defined in claim 48, further comprising an actuating member for displacing the tabs for locating the corresponding syringe in the corresponding syringe station.

50. A system as defined in claim 49 wherein the actuating member includes at least one release pin which is oriented to make contact with the syringe engaging portion for displacing the release pins when the syringe engaging portion is in a syringe delivering Orientation adjacent the corresponding syringe station.

51. A system as defined in claim 50, further comprising a pair of ~ actuating pins for each syringe station, a pair of alignment flanges on oppose sides of each ssyringe station, each of said alignment flanges including a longitudinal passage locating one of said release pins.

52. A system as defined in claim 51 wherein each alignment flarmge includes an upstanding post.

53. A system as defined in claim 52 wherein each alignment flarge includes a groove to receive a corresponding ridge formed on the syringe engaging portion...

54. A system as defined in claim 53 wherein the ridge is located ina second locating cavity formed on the syringe engaging portion.

55. A system as defined in claim 50, further comprising at least one permanent locking flange which is unresponsive to the release pins.

56. A system as defined in claim 55, whetein each syringe station includes an exposed spill collecting chamber for collecting spilled materials from the corresponding syringe.

57. A system as defined in claim 46 wherein the syringe platforren further includes a pair of syringe fluid transfer terminals, each to establish fluid communicatiosn with a corresponding one of said first and second syringes.

58. A system as defined in claim 57 wherein the syringe platforem further comprises a treatment chamber, each syringe fluid transfer termina being in fluid communication with said treatment chamber.

59. A system as defined in claim 58 wherein the treatment chanmber is expansible.

60. A system as defined in claim 59 , wherein the syringe platform further includes a pair of conduits, each joined at one end to a corresponding syringe fluid ternminal.

61. A system as defined in claim 60 wherein the treatment charnber includes an upper lid portion, & Jower base portion and a collapsible portion there between.

62. A system as defined in claim 61 wherein he collapsible po=rtion includes a sleeve.

63. A system as defined in claim 62 wherein the collapsible portion includes at least one positioning ring between the upper lid portion and the lower base porti-on.

64. A system as defined in claim 63 wherein the base portion includes a pair of fluid transfer flanges for receiving one end of each of said conduits thereon, each of said fluid transfer flanges establishing fluid communication between an interior regicon of the treatment chamber and each of said conduits.

65. A system 8s defined in claim 64, further comprising a positioning housing with an inner passage to receive the treatment chamber.

66. A system as defined in claim 65 wherein the positioning housing includes a transparent cylindrical housing portion whose inner cross sectional area is selected to nest the treatment chamber therein.

67. A system as defined in claim 66 wherein the lower base portion includes a number of positioning vanes extending downwardly therefrom, the vanes dimensioned to align the lower base portion relative to the inner passage.

68. A method of controlling the transfer of blood between a subject patient and a blood treatment unit, comprising the steps of: - providing a first syringe containing a sample of untreated blood from a subject patient; - providing a syringe carrier which is operable in a release position to receive the first syringe; the syringe carrier being operable in a lock position for locking the first syringe therewith, the carrier having an access controller for controlling the release and lock positions according to a blood transaction condition, the access controller including a data transfer unit which is operable to receive patient identification data representative of a subject patient; - in a first blood transaction step, delivering patient identification data representative of a subject patient to the data transfer unit, thereby to place the syringe carrier in a release position to receive the first syringe and thereafter to place the syringe carrier in a lock position to lock the first syringe therein;

- in a second blood transaction condi. tion, transferring the patient identification data to a blood treatment unit, thereby to places the syringe carrier in the release position to release the first syringe to a first syringe station in the blood treatment unit; - in a third blood transaction step, delivering treated blood identification data from the blood treatment unit to the syringe carrier, and delivering treated blood verification data from a second syringe containing tresated blood from the subject patient and which is positioned at a second syringe station in the blood treatment unit, and placing the syringe carrier in the release position to receive the second syringe; - in a fourth blood transaction step, delivering patient verification data to the syringe carrier and placing the syringe carriier in the release position to release the second syringe.

69. A process of extracting a body fluid aliquot from a patient, extracorporeally treating at least a portion of the aliquot and returning the treated portion to said patient, comprising the steps oft - equipping the patient with a body fluid aliquot identification means which includes patient - identifying indicia; - withdrawing the body fluid aliquot from the patient; - labeling the aliquot or portion thereof™ to be treated with aliquot-identifying indicia uniquely correlating with said patient-identifyingg indicia; . - rendering the aliquot inaccessible; - extracorporeally treating the labeled aliquot or portion thereof; - establishing correlation between the aliquot-identifying indicia and said patient-identifying : indicia; - causing the establishment of the correlation to permit access to treated aliquot or portion thereof to the patient; and returning thes treatment aliquot or portion thereof to the patient;

- whereby s aid patient is assured of receiving a treated aliquot or portion thereof whic_h was initially extracted from said patient.

70. A process as defined in claim 69 wherein the identifying indicia are RF transmitted-receiveed signals. :

71. A process as defined in claim 69 wherein the identifying indicia are bar codes.

72. A process as defined in claim 69 wherein the identifying indicia are mutually interfitting mechanical inteerlocks.

73. A process as defined in claim 69 wherein the aliquot is whole blood.

74. A process as defined in claim 73 wherein the entire aliquot as withdrawn is treated (i.e. no i fractionation step).

75. A process as d-efined in claim 74 wherein the aliquot is withdrawn into a first dispenser carrying the aliquot-idemtifying indicia. )

76. A process as defined in claim 75 wherein the aliquot is transferred from said first disperser into a treatment container for conducting the treatment, said treatment container being labeled to provide a first treated--aliquot-identifying indicia for the treated aliquot.

77. A process as clefined in claim 76 wherein the aliquot is transferred from the treatment container to b a second dispeenser after treatment, the second dispenser being labeled to provide a secomd treated- aliquot-identi fying indicia for the treated aliquot.

78. A process as defined in claim 77 wherein the second treated-aliquot-identifying indicia is checked to correlate with the patient-identifying indicia to provide patient access to the treated aliquot for return to the patient.

79. A process as define~d in claim 78 wherein the blood aliquot is treated with oxidative stress.

80. A process as define=d in claim 79 wherein the oxidative stress is ozone/oxygen gase-ous mixture bubbled through thee aliquot. d

81. A process as definexd in claim 80 wherein the blood aliquot is treated with UV radiation.

82. A process as defined in claim 80 wherein the blood aliquot is treated with heat.

83. A process as defin=ed in claim 80 wherein the blood is treated simultaneously with at least two of 5 UV, oxygen/ozone and heat.

84. A process as defined in claim 83 wherein the first and/or second dispensers include syringes or syringe-type deviczes. 0

85. A device for controlling the collection and delivery of materials to a patient, comporising a dispenser-engagimg portion, the dispenser-engaging portion being operable in a release position to receive a materials dispenser when the dispenser is in a materials-containing confl guration, the dispenser-engagirmg portion being operable in a lock condition for locking the dispenser therewith, and access control means for controlling the release and lock positions according to a material 5 transaction conditzion.

86. A device as defined in claim 85 wherein the dispenser includes a syringe, IV bottle, powder and/or= atomized fluid and/or gas inhalant dispenser, implant delivery dispenser, =entilator, syringe pump, intubation tube, or 2 gastrointestinal feeding tube or a plurality and/or 8 combination thereof.

87. A de=vice as defined in claim 86 wherein dispenser-engaging portion includes a first cavity to receive the dispenser, the first cavity being accessible through a side wall or an ed wall thereof.

88. A device as defined in claim 87 wherein the dispenser-engaging portion has & sicie wall and the first «cavity is located in the side wall. . 0

89. A device as defined in claim 88, wherein the access control means further comprises at least one barrier portion to extend at least partially across the first cavity in the lock position.

90. A process of extracting a body fluid aliquot from a patient, extracorporeally treamting at least a 5 portion of the aliquot and returning the treated portion to said patient, comprisirag the steps of: - equipping the patient with a body fluid aliquot identification means which includes patient - identifying indicia; :

’ . - withdrawing the body fluid aliquot from the patient; 0 - labeling the aliquot or portion thereof to be treated with aliquot-identifyirg indicia uniquely correlating with said patient-identifying indicia; - locking the aliquot against delivery with an indicia responsive lock; - extracorporeally treating the labeled aliquot or portion thereof; - establishing correlation between the aliquot-identifying indicia and said poatient-identifying 5 indicia in order to permit patient access to the treated aliquot or portion theereof; and - after establishing said correlation, returning the treated aliquot or portiomn thereof to the patient by response of the indicia responsive lock to the correlation so estzablished,

- whereby said patierat is assured of receiving a treated aliquot or portion thereof whic was initially extracted fromm said patient. :

91. A device for controlling tthe delivery of blood, comprising a syringe-engaging portion, the syringe- engaging portion being osperable in a lock position for locking the syringe therewith whem the syringe is in a blood-cont-aining configuration, and in a release position to release the syrirage, and access control means for controlling the release and lock positions according to a blood transaction condition.

92. A device as defined in ckaim 91 wherein the syringe-engaging portion includes a cavity to receive the syringe.

93. A device as defined in cJaim 92, wherein the access control means further comprises at least one barrier portion to extendl at least partially across the cavity in the lock position.

94. A device as defined in claim 91 wherein the access control means includes a data transfer unit, the data transfer unit being operable to receive patient identification data representative of a subject patient and thereby to establish a blood transaction condition, the control portion being operable in a blood transaction condition to establish the release position for the barrier member to release the syringe.

95. A device as defined in «claim 94 wherein the data transfer unit includes data receiving means and data storage means for recording data received by the data receiving means.

96. A device as defined in claim 95 wherein the data receiving means includes a wireless data port.

97. A device as defined in claim 95 wherein the data receiving means includes a wired dats port.

08. A device as defined in claim 96 wherein the wireless data port includes a barcode reader, an RF . signal receiver or an Infrared transmitter receiver.

99. A device as defined in claim 94 wherein the data transfer unit is operable to receive patient verification data to esta blish the release position for the barrier member to release the syringe.

100.A method of controlling the transfer of blood between a subject patient and a blood treatment unit, comprising the steps of: } - providing a first syringe to receive a sample of untreated blood from a subject patient; - providing the subject patient with a patient RF signal processor; 3 - providing au second syringe to receive the sample following treatment; - providing each of the first syringe and the second syringe with an RF signal processor; - arranging the RF signal processors on the first syringe and with the patient to issuc a J signal conta_ining common or related identity data; - delivering the first syringe to the blood treatment unit for performing a treatment step to form a treat=ed blood sample; - reading thme identity data from the first syringe and writing the identity data to the second syringe;

- collecting the treated blood sample from the treatment unit in the second syringe; - bringing the second syringe within range of the patient RF signal processor to confirm a match therebetween; andl thereafter

- delivering the treated blood sample to the patient.