CN101208120A - Verification method and system for medical treatment - Google Patents

Abstract

A system for the collection, treatment and delivery of an autologous blood sample, comprising a first syringe for drawing an untreated blood sample from a patient, a blood sample treatment chamber having a chamber inlet for receiving untreated blood from the first syringe and chamber outlet for passage of treated blood to a second syringe coupled thereto. The second syringe includes a releasable lock means for allowing discharge of the treated blood to the patient in response to a release signal. The release signal is issued following a positive outcome from a verification process dependent upon temporal data from certain events in the collection, treatment and delivery of the blood sample, and identity data of the patient and the second syringe with the treated blood.

Description

Verification mechanism that is used for the treatment of and system

The cross reference of related application

It is the U.S. Provisional Patent Application 60/682 on May 19th, 2005 that the application requires the applying date, 969 and the applying date be the U.S. Provisional Patent Application 60/683 on May 19th, 2005,280 priority, and the applying date is the priority of the U.S. Provisional Patent Application 60/683,333 on May 19th, 2005.

Technical field

The present invention relates to the management of Drug therapy, more particularly relate to a kind of conveying equipment for fluid substances based on permission.

Background technology

Although people have made significant headway in HCT and dispensing, still have many patients dead or disable because of malpractice.These accidents appear in many links of health care, and in hospital, clinic, sanatorium, emergency center, infirmary, pharmacy and home care, these accidents come from systematic problem but not one behavior or decision-making usually simultaneously.

For many years, bar coded sticker has become a technology of guaranteeing patient safety.Recently, Food and Drug Admistraton (Food and Drug Administration FDA) has issued a new regulation, and it requires some human medicine and biological product labels to have bar code.The result, the bar code of human drug products and biological product (except blood, blood constituent and the equipment that adjusted by Biological Development research center (Center for Biologics Evaluation andResearch)) must comprise the linear code form national drug code (National Drug Code, NDC).This regulation is intended to make the health care expert can use bar code scanning equipment to examine correct medicine (with correct dosage and correct mode) thereby having given correct patient in the correct time reduces the quantity that occurs malpractice in hospital and other health care facility.Thereby this regulation also requires to use the auxiliary malpractice that reduces of machine readable information on the label of blood and blood constituent container.

Yet bar code needs reader directly to see just to read, and they can not preserve the out of Memory except that simple identification data such as serial number and SKU.For example, patient's bar code wrist strap is on one's body being rested the head on this arm when sleeping at it when being drenched or patient, or all is not easy to be read when patient lies on first aid wheel bed or the operating-table; Be easy to occur malpractice or blood transfusion mistake under these situations.

One object of the present invention is to reduce or eliminate at least one above-mentioned shortcoming.

Summary of the invention

One aspect of the present invention provides a kind of system, and it is used for gathering, handling and carry a blood sample, and this system comprises:

The article that are associated with patient, this patient has patient identifier;

First syringe, it has:

First syringe inlet, it is used for from the untreated blood sample of patient's withdraw;

The first syringe cavity, it is used for receiving not processed blood;

First syringe outlet, it is used for untreated blood sample is transferred out from first cavity;

First accumulator register, it is used for writing down the time data of the blood incident that is untreated that relates to blood collection;

First syringe is unique with one, first identifier is associated, and this unique identifier can be associated with patient's sign;

Be used for the container of processing blood sample, this container has:

Blood sample process chamber, this container have cavity inlet; Thereby first syringe outlet can be gone into the interruption-forming dedicated first fluid with this cavity and is connected a kind of not processed blood sample is transported to the blood sample process chamber in operation; This container has a cavity outlet, and it is used for a kind of blood sample of handling is transported to second syringe after handling,

Second syringe has:

Second syringe inlet, thus its in operation, can form that the second special-purpose fluid is connected with cavity outlet will be from blood sample process chamber reception blood sample;

Second cavity, it is used for receiving the blood of handling;

Second syringe outlet;

The passage that communicates with second cavity and second syringe outlet;

Second accumulator register, it is used for writing down and blood treatment incident, the incident of handling blood and the corresponding time data of conveying incident; This second accumulator register can be independent of first accumulator register and asynchronous with first accumulator register in operation;

Second syringe is unique with one, second identifier is associated, and this unique identifier is associated and can be associated with the first unique identifier with first syringe in operation;

Releasable lock, it is formed in the passage, and the outlet that is used for operating second syringe is changed between a plurality of states;

Processor, it has:

Comparator, thus it is used for the patient identifier and unique first identifier are compared the relatedness of determining between the two; And thereby second unique identifier and patient identifier compared the relatedness of determining between the two, this comparator sends output signal;

Logic circuit, thus it is used for receiving the time that output signal and time data determine between the incident and prolongs to the greatest extent, and determine this time delay whether in predetermined scope;

The release signal generator, it is connected to and is used on the logic circuit sending release signal to above-mentioned releasable lock;

Thus, relatedness and relatedness patient identifier and unique second identifier between of this release signal between the patient identifier and unique first identifier sent when obtaining confirming, condition is that time delay is within predetermined scope.

Another aspect of the present invention provide a kind of recognition device in case identification be untreated blood sample original patient, validation apparatus so as to examine original patient and the blood sample handled between coupling, and the release signal generating means, it is used for producing in response to the positive verification result of validation apparatus and produces release signal.This recognition device and/or release signal generating means can be arranged on the second injection body or on the external object.This external object can be by patient worn, be with, in the connection or swallow, as pin joint or from bonding label or coated article etc.As preferably, this external object includes removable part, includes the examination data of the blood sample that relates to patient and/or handled in it.For example, this external object can be a kind of routine, by the wrist strap of patients wore.

Another aspect of the present invention is that second syringe body also can include filtering blow vent so that one or more gas componants in the blood sample that will handle are discharged in passage.

Another aspect of the present invention provides a kind of method to monitoring from patient's sample of material, and it may further comprise the steps:

(a) gather sample with first collecting device from patient;

(b) with patient and first signal correction connection, first signal wherein is loaded with the data of expression sample;

(c) first collecting device is associated with secondary signal, this secondary signal is loaded with the data of expression sample;

(d) sample is transported to the sample process chamber;

(e) thus handling sample forms the sample of handling;

(f) with this sample collection in second collecting device;

(g) with second collecting device and the 3rd signal correction connection, the 3rd signal wherein is loaded with the data of the sample that expression handled;

(h) thus the data in the first and the 3rd signal are compared the sample that will handle to link with patient; And afterwards;

(i) in the step (a) to (h) at least one is associated with time data;

(j) thus determine at least one time delay with this time data and determine in the step (a) to (h) at least that step whether in the acceptable time scope;

(k) sample after step (h) and result (j) will handle for certainly the time flows to patient; And

(l) gather an examination record, it has the time data from step (i), from result and the data related with sample of step (h) and (j).

The incident relevant with the blood collection that is untreated followed the trail of by first accumulator register, and processing and post processing incident are then followed the trail of by second accumulator register simultaneously, so just can determine time delay by time data.These two enumerators are preferably worked independently of one another, and do not need each other to be different from real-time clock synchronously.Therefore these enumerators only can not need electric power substantially in above-mentioned step (a) to (j) operation.Like this, battery just is enough to keep the basic accuracy of clock in step (a) in the time interval of (f), so the problem not free or that clock accuracy descends that occurs along with the consumption of battery electric power will be eliminated substantially.

Another aspect of the present invention is, this system includes releasable locking mechanism, and it can be operated by solenoid, and solenoid wherein can receive release signal in configuration.

Another aspect of the present invention is, this system includes releasable locking mechanism, and it can be operated by electric device, and this electric device can receive release signal in configuration.

The term here " treatment facility " is meant a kind of equipment that directly or indirectly is used in the therapeutic process.It can comprise in fact the equipment that can treat or can handle the sample that extracts from patient patient on one's body, perhaps as selecting it a kind ofly can finish some and object of handling relevant functions, as delivering or transmitting that sample goes or from a processing.

Description of drawings

In conjunction with the accompanying drawings and with reference to following detailed description, these of the preferred embodiment of the present invention and further feature will be more readily apparent from, wherein:

Fig. 1 is the axonometric chart of blood processing system;

Fig. 2 is the cutaway view of first syringe 1-1 ' along the line among Fig. 1;

Fig. 3 is the axonometric chart of first syringe among Fig. 1 when being connected on the sodium citrate bag;

Fig. 4 is the axonometric chart in blood treatment chamber among Fig. 1;

Fig. 5 is the axonometric chart of second syringe among Fig. 1;

Fig. 6 is the cutaway view of second syringe 5-5 ' along the line among Fig. 5;

Fig. 7 is blood treatment chamber another axonometric chart when having first syringe and second syringe;

Fig. 8 is the cutaway view of the blood treatment chamber 7-7 ' along the line of Fig. 7;

Fig. 9 is the cutaway view of the blood treatment chamber 9-9 ' along the line of Fig. 7;

Figure 10 is the exploded view of second syringe outlet of Fig. 5;

Figure 11 is the axonometric chart of outlet valve;

Figure 12 is the cutaway view of the outlet valve member 11-11 ' along the line of Figure 10;

Figure 13 (a) is the axonometric chart that a locking mechanism part is in the lock state;

Figure 13 (b) is the axonometric chart that a locking mechanism part is in open mode;

Figure 13 (c) is the part axonometric chart that locking mechanism is in the permanent locking state;

Figure 13 (d) is the axonometric chart of locking mechanism wherein adjacent with Figure 10 exit portion part when being in the permanent locking state;

Figure 14 is a locking mechanism part and the axonometric chart that exports when matching;

Figure 15 is the whole operational flowchart of examining rules of Fig. 1 system;

Figure 16 is the flow chart of Figure 15 center real part branch operating procedure.

Figure 17 is a detailed perspective of blood processing system;

Figure 18 is a sketch map of examining rules;

Figure 19 is the axonometric chart of wrist strap before work shown in Figure 1;

Figure 20 is the axonometric chart of wrist strap when work shown in Figure 1;

Figure 21 is the axonometric chart of wrist strap before work shown in Figure 1.

The specific embodiment

As shown in Figure 1, demonstrate system 10 among Fig. 1, it is used in collection, processing and the conveying of autoblood sample.Include a plurality of parts in this system 10, these parts are used in the different stage that blood sample is handled, as first syringe 11 (S1), and sample management unit 12 (SMU), blood treatment unit 14 (BTU), second syringe 15 (S2) and wrist strap 16 (WB).This first syringe 11 is used for gathering untreated blood sample from original patient 17.After having gathered untreated blood sample, blood collection syringe 11 is connected thereto the sample management unit that blood delivery syringe 15 is housed, then this sample management unit is incorporated in the blood treatment unit, here not processed blood sample can be subjected to one or more processing, as ozone or ozone/admixture of gas, the processing of ultraviolet light (UV) and infrared (IR) energy.

After handling, processed blood sample is pumped to second syringe 15, and from sending back to original patient 17 here.On the stage of one or more keys, system 10 can provide and veritify operation, thereby reduces the possibility of makeing mistakes, and guarantees that correct blood sample turns back on one's body original that correct patient 17.This veritification comprises following operating procedure: with blood sample, no matter it is treated or undressed, mate with primary patient 17.Usually, wrist strap 16, first syringe 11, sample management unit 12, second syringe 15 all can include the recognition data that is associated with original disease, and these data can comprise labelling, or pass through the machine readable data of device of light, electricity/magnetic.

As shown in Figure 2, first syringe 11 has one first body part 18, and this body part 18 has cylindrical cavity 19, and it cooperates with syringe plunger 20, receives cavity 21 thereby form a sample.First syringe 11 also comprises a first passage part 22, and this first passage part 22 has a passage 23 and first syringe inlet 24, and the former receives cavity 21 with first sample and communicates, and the latter is used for introducing untreated blood sample from patient.First passage part 22 also comprises first syringe outlet 26, and it is used for untreated blood sample from being assigned to sample management unit 12 here.First syringe outlet 26 comprises passage 27, and it receives cavity 21 with first sample and passage 24 communicates.

First syringe inlet 24 has one first syringe inlet valve device 28 so that the control blood flow is crossed first syringe inlet 24 in passage 24.At this moment, the first inlet valve device 28 comprises housing 29, and it includes a valve 30, and this valve 30 is structurally joined valve member 31 and opened by being arranged in cover on the external equipment 32, referring to Fig. 3.This external device (ED) 32 can be a blood collection unit, as " the butterfly wing " syringe needle or sodium citrate bag etc.Outwardly directed from first syringe outlet 26 is a pair of bayonet lock 72, and it is used for first syringe 11 is connected on the sample management unit 12.A valve member 74 is arranged in the passage 27 of first syringe 11, and it pushes a closed position to facing to the valve seat 76 on the end cap 78, and end cap wherein forms the outer end of first syringe outlet 26.

Printed circuit board (PCB) (PCB) 34 is arranged in the first passage part 22, it has circuit so that the relevant data of transmission and reception and syringe and/or its inclusions or patient 17, as identification data, SKU, serial number, build date, useful life, liquid data, sanitary installation data, public health personnel's data, administration data etc.This circuit can include, but not limited to transmitter, receptor, logic device or processor, be used for computer-readable memory, timing circuit, antenna, power supply that data are preserved.In a preferred embodiment, this circuit also includes the RFID read/write device, and it is used for reading the RFID label, and the miscellaneous equipment in this label and the processing system is associated.Thereby this RFID read/write device also links to each other with other parts in the circuit and finishes one at least and examine function, and other function.Input-output apparatus such as display, LED 36, speaker and the switch in addition that link to each other with PCB 34 are as draw ring 38.First passage part 22 also includes lid 40, and it has hole 42, and this hole 42 links to each other with the opening 44 of first outlet 26.Packaging power 48 provides electric power for PCB 34 and input-output apparatus thereby first syringe 11 also comprises separate space 46.This power supply 48 has generally included one or more batteries, thereby these batteries remove after first syringe 11 uses once can continue use on another equipment, or normally reclaims to satisfy environmental requirement.The installation of battery for convenience and pulling down, battery 48 can be arranged on the carriage, and this carriage is received in the separate space 46 slidably.

As shown in Figure 4, sample management unit 12 is containers 49, and it comprises the top 51 of opening, the bottom 56 of remaining silent and rigid walls portion 58 between the two, thus and cap 54 formation cylindricalitys processing cavity 52 or process chambers.Cap 54 has chamber inlet 50, is connected thereby form first fluid special-purpose, that link to each other with first syringe outlet 26, and untreated like this blood sample just can be assigned in the processing cavity 52 of blood sample process chamber 12.Cap 54 also has: air inlet 60 is so that delivery of ozone is handled blood sample, and gas outlet 62 is so that discharge ozone and other gas.Bottom 56 has bowl body 66, thereby takes up blood sample in processing procedure.

In the processing procedure of blood sample, process chamber 52 can be handled, and handles by the foaming of blood sample as UV A, B and C ray, infrared (IR) energy and ozone.Like this, wall portion 58 and bowl portion 66 should be made by the suitable material that can send such ray, as include the low density polyethylene (LDPE) (LDPE) of a small amount of (about 5%) ethylene-vinyl acetate.

Cavity inlet 50 comprises female ring part 68, and it has a pair of helical duct or groove 70, and this passage or groove 70 pass or be arranged in the wall, thereby is used for holding a pair of bayonet lock 72 corresponding on first syringe outlet 26.At work, advance and enter into female ring part 68 downwards along helical duct 70 thereby the rotation of first syringe 11 promotes bayonet locks 72, adjacent up to valve member 74 and valve executive item 80.As a result, thus valve executive item 80 makes valve member 74 head on valve seat 76 from its closed position to be moved and opens first fluid and connect.In case engage fully with cavity inlet 50, first syringe 11 just is supported on here by saddle type parts 79, these saddle type parts 79 can make mobile minimize of first syringe 11 around cavity inlet 50.

Thereby cap 54 has and forms the second special-purpose fluid between cavity outlet 81 and second syringe 15 and be connected, referring to shown in Figure 8.As Fig. 5 and 6 detail display, second syringe 15 has second body part 82, and it has a staving 83, and this staving has a near-end 84 and a far-end 87.The former is furnished with 85, the second outlets 86 of second inlet; Thereby the latter has one barrel of wall 88 to form the second sample reception cavity 89.This second inlet, 85 and second outlet 86 is certain angle, and is arranged between the second sample reception cavity 89 and second outlet 86.Plunger 90 be arranged in slidably far-end 87 and with bucket wall 88 fluid-tight engagement.This plunger 90 be used for fluid is pumped in the second sample reception cavity 89 and with fluid from releasing here.Second syringe 15 also comprises second channel part 92, its tool passage 94 and passage 96, and the former communicates with the second sample reception cavity 89 and second outlet 86, and the latter communicates with second inlet, the 85 and second sample reception cavity 89 by the part of passage 94.In order to prevent that big granule from entering into second outlet, 86, the second end caps 97 and being connected to movably in second outlet 86, thereby simultaneously second inlet 85 includes and slidably covers 98 and prevent that blood treatment unit 14 is contaminated before use.Blood sample after the processing is delivered to original patient 17 theres by second syringe outlet 86 from second syringe 15, and this second syringe outlet 86 can be worked between open position and closed position by releasable locking mechanism 100, will describe in detail below.

Similar with first syringe 11, printed circuit board (PCB) (PCB) 102 is arranged in second channel part 92, it has circuit so that the relevant data of transmission, reception and preservation and syringe and/or its inclusions or original patient 17, as recognition data, SKU, serial number, build date, useful life, liquid data, sanitary installation data, public health personnel's data, administration data etc.This circuit includes the RFID read/write device, and it is used for reading the RFID label, and the miscellaneous equipment in this label and the processing system is associated.Thereby this RFID read/write device also links to each other with other parts in the circuit and finishes one at least and examine function, and other function.This circuit can include, but not limited to transmitter, receptor, logic device or processor, be used for computer-readable memory, timing circuit, antenna, power supply that data are preserved.Input-output apparatus such as display, LED 103, speaker and the switch in addition that link to each other with PCB 102.In addition, PCB 102 also includes circuit, and it is used for the operation of releasable locking device 100 is controlled.Separate space 104 packaging power 106 and power circuits, the former comprises one or more batteries, the latter is arranged on the PCB 102 so that adjusting power supply and input-output apparatus here.Thereby battery 106 can remove after second syringe 15 uses once and can continue to use on another equipment, or normally reclaims to satisfy environmental requirement.The installation of battery for convenience and pulling down, battery 106 can be arranged on the carriage, and this carriage is slidably disposed in the separate space 104.

Syringe 10 remains low power state usually obsolete the time, like this, can save the electric power of battery.Yet when sample management unit 12 was incorporated in the blood treatment unit, syringe 15 was transformed into duty from low power state.This conversion can realize that this mechanical switch was closed by mechanical switch before sample management unit is inserted into blood treatment unit, or this switch is cut out by blood treatment unit after sample management unit is inserted into blood treatment unit.Other mode also includes: electrical switch, but the RF signal of its origin autoblood processing unit or DC signal drive; Or the DC reed relay, it can be driven by the magnet in the blood treatment unit.

Shown in Fig. 4 and 7 to 9, cavity outlet 81 has female ring part 108, it has a pair of helical duct or groove 110, and this passage or groove 110 pass or be arranged in the wall, thus be used for second syringe inlet 85 on outwardly directed one or more corresponding pins 112 engage.Equally, valve member 114 is arranged in the passage 96, and its valve seat 116 that heads on the end cap 118 is shifted to a closed position, and end cap 118 wherein forms the outer end of second syringe 96.Valve member 114 alignment, thus adjacent with the valve execution unit 120 in the cavity outlet 81.Therefore, thus this valve execution unit 120 can make valve member 114 head on valve seat 116 from its closed position in operation to be moved and opens second fluid and connect.Cap 54 also has saddle type parts 122 so that support second syringe 15 when second syringe 15 engages fully with cavity outlet 81.

Cap 54 tool crown caps 124 and bonding, welding or medicated cap otherwise fixed thereon lock 126.Medicated cap lock 126 is latched on the last border of bottom 56.Cavity inlet 50 and cavity outlet 81 pipeline 128,130 below valve executive item 80,120 respectively communicate with interior processing cavity 52.

Shown in Fig. 6,10,11 and 12, the second syringe body part 84 has the post chamber, and this post chamber cooperates with plunger 90 provides the second sample reception cavity 89.The passage 94 of blood sample hop 92 has second on-position 132 so that communicate with second syringe outlet 86.

Second syringe outlet 86 and blood-transmitted part 92 further have releasable locking mechanism 100, and it is used for forming the 3rd fluid connection of locking between second on-position 132 and second syringe outlet 86.As described below, connect thereby this releasable locking device 100 can discharge the 3rd fluid in response to release signal in operation, referring to Figure 13 (a) to 13 (d).When locking mechanism is opened, second syringe outlet 86 can be used in the operation with shared blood sample supply unit on liquid device form the 4th liquid and be connected, blood sample supply unit wherein has the female Luer (Luer) 31 that matches or similarly installs as syringe needle 32.

As seen from Figure 10, second syringe outlet 86 comprises 134, one outlet valve devices 136 of a public Luer insert, and it is used for opening and closing fluid passage 92, thereby the control blood sample therefrom flows through.This public affairs Luer insert 134 comprise opening 138 with screw thread so that Rule device links to each other with female female Luer 31 of syringe needle 32.This outlet valve device 136 comprises: valve body part 140, valve seat part 142 and first actuating unit, 144, the first actuating units 144 are used for driver's valve body portion 140 and move with respect to valve seat part 142.An a pair of elastomeric element 148 as a spring are pressed into the closed position with outlet valve device 136.As described below, when the second syringe body part 84 engaged with female female Luer 31 or separates, first actuating unit 144 can make valve body part 140 move towards different directions in operation.

First actuating unit 144 has a plurality of first execution units 150 in form, this first execution unit 150 from terminate in enlarged undercut portions 152 towards overhanging.First actuating unit also includes the projection 154 of second actuating unit as stretching out thus.Terminate in enlarged undercut portions 152 is fixed on the block 156 in the passage in second syringe, 15 body parts 92 94.This block 156 has centre bore 158, and tubular valve rod 160 wherein is housed, and these valve rod 160 1 ends are equipped with valve body part 140, and the other end is equipped with stem head 162, and the neighboring area of this stem head 162 has seal member such as O shape circle etc.This valve rod 160 has a pair of liquid supplying port 164, and this hole is adjacent in the back of valve body part 140, thereby forms a valve internal channel that communicates with second sample reception cavity 89, referring to Figure 11 and 12.Female female Luer 31 comprises the first supporting execution unit, and when female female Luer 31 was introduced in the public Luer insert 134, the described first supporting execution unit moved first execution unit 150.Subsequently, valve rod 160 and valve part 140 move, thereby thereby making valve rod 160 interior mesopores 158 be opened on passage 96 makes flow of liquid cross outlet 86.

The outlet 86 of second syringe 15 can be operated on three states by releasable locking mechanism such as locking mechanism 100, lock-out state, open mode and permanent locking state, referring to Figure 13 (a) to 13 (d).Locking mechanism 100 comprises ratchet 168, controls being connected between female female Luer 31 and second syringe, the 15 public Luer insert 134 on the outlet valve device 136 thereby it is connected to.One end 170 of ratchet 168 has opening 172, and it is used for receiving pivot pin 174, thereby these pivot pin 174 slave plates 176 stretch out and can rotate around its pivot.This ratchet 168 is arranged between first spring leaf 178 and second spring leaf 180 so that its swing is controlled.Usually, first spring leaf 178 is made by a kind of fusible material, it can temporarily change its concordance when the scheduled current signal occurs, as NiTi naval permission experiment intermetallic material (nickel titaniumnaval ordinance laboratory intermetallic material, NITINOL).Nitinol has superelevation elasticity and shape memory, so the current signal heating that nitinol can be scheduled, thereby is deforming under certain stress on the specified temp, and it can be got back to again and add upper stress position before when stress relieved.

The other end 182 at ratchet 168 is first pawl 184 and second pawl 186, forms the groove 188 that has opening 189 between the two.The next door of groove 188 is stamped groove 190, and it includes a plurality of grooves that are connected with each other 192,194 and 196.These interconnective grooves 192,194 and 196 correspond respectively to above-mentioned lock-out state, open mode and permanent locking state.Groove 192 and 196 is in opposite two, and is separated by the ratchet 198 of groove 190 1 sides, and is connected with each other by the groove 194 on groove 190 other ends.Groove 192 is L shaped, and comprises an arm 200 and another arm 202, and wherein arm 202 is connected on the groove 194.

One end of first spring leaf 178 is fixed on the plate 176, and it comprises arcuate section 204 on ratchet 168.This arcuate section 204 approximately curves 90 degree here at point 208, and on point 208 next doors adjacent side 210 is arranged, and this adjacent side 210 is meshed with the arm 200 of groove 192 when latched position, shown in Figure 13 (a).The determining positions of adjacent side 210 duty of syringe 15.

Describe below how ratchet 168 to move between three diverse locations.Beginning is in resting position, and adjacent side 210 is arranged in the arm 200 of groove 192.In a single day receive release signal after examining step, just have a predetermined electric signal and flow through first spring leaf 178, this signal of telecommunication is enough to make first spring leaf 178 to unclamp.After first spring leaf 178 fully unclamped, second spring leaf 180 will force adjacent side 210 to shift out and move on to the arm 202 from arm 200, and finally moved on in the groove 194, and this position is corresponding to open position, referring to Figure 13 (b).Now just female female Luer 31 of syringe needle 32 can be connected on second syringe 15, the blood of handling the just outlet valve through opening flow in patient's 17 bodies, referring to Figure 14 from the second sample reception cavity 89.

After preset time was as 20 minutes, form a predetermined electric signal once more and make it to flow through first spring leaf 178, first spring leaf 178 is unclamped.Second spring leaf 180 forces adjacent side 210 to shift out and be moved into the groove 196 from groove 194, and it is corresponding to the permanent locking position, referring to Figure 13 (c) and 13 (d).Above if female female Luer 31 still was connected in when release signal sends, adjacent side 210 just can not slide into the permanent locking position so, and till this mother's female Luer 31 is taken off.For good and all lock the follow-up use that second syringe 15 just can prevent second syringe 15, thus risk that just can basic pollution abatement.

Referring now to Figure 10 to 14, the situation that outlet valve device 136 and locking mechanism 100 combine work is described.When second syringe 15 was in latched position, projection 154 was sitting on the pawl 184, limited terminate in enlarged undercut portions 152 thus and longitudinally left opening 138.Can not connect this moment and go up female female Luer 31, because first execution unit that cooperates can not make first execution unit 150 produce displacement, therefore female female Luer 31 and public Luer insert 134 just can not engage.Corresponding with it, when outlet valve device 136 was applied pair of resilient members 148 on terminate in enlarged undercut portions 152 and promotes to close, the mesopores 158 in the valve rod 160 just were closed.

In case first spring leaf 178 has had energy, ratchet 168 is rotated toward the clockwise direction, simultaneously adjacent side 210 is forced to shift out and be moved into the arm 202 from arm 200, slide into then corresponding to unclamp or the groove 194 of open position in.Meanwhile, the pawl 184 of ratchet 168 leaves projection 154, and projection 154 is just alignd with groove 188 like this.Present female female Luer 31 just can be incorporated in the public Luer insert 134.Equally, the first supporting actuating unit and first actuating unit 150 are adjacent.The power that is used for female female Luer 31 is engaged on the public Luer insert 134 that is added will make first actuating unit 150 leave opening 138.Terminate in enlarged undercut portions 152 moves thereupon, and projection 154 enters into groove 188 through opening 189, and moves along the length direction of groove 188.Being used for of being added is enough to extrusion spring parts 148 with the power that female Luer 31 and 134 couples together, thereby the mesopore in the valve rod 160 158 is opened.

Because processed blood has generally included bubble, these bubbles can be used in processing procedure, therefore second syringe 15 includes a froth breaking system or bubble removal mechanism, thereby the blood sample after processing is discharged gas before being sent to original patient 17 from syringe.As selection, join with Luer insert 134 thereby an independent exhaust cap can be connected on the near-end 84.Thereby this exhaust cap comprises an air-locked film of detesting water and prevents that blood from flowing out.Usually, merge mutually with existing bubble, assist in removing other little bubble thus thereby more air can be incorporated in the second sample reception cavity 89.Therefore, thus the blood sample after transparent cylindrical shell 83 can make customer inspection processed examine bubble and whether be removed.

After processed blood transport was given patient 17, female female Luer 31 was along with taking off also of syringe needle 32 taken off from public Luer insert 134.Because supporting first execution unit has been got from public Luer insert 134, thereby so spring members 148 will open and push terminate in enlarged undercut portions 152 to opening 138, projection 154 shifts out and facing to slot opening 189 from groove 188 simultaneously.Within the predetermined time, have a predetermined electric signal generation and flow through first spring leaf 178, and abutment flange 210 is forced to shift out groove 194 and is moved into groove 196.Now, projection 154 is just adjacent with pawl 186, and terminate in enlarged undercut portions 152 can not move away opening 138 along the longitudinal thus.Because adjacent side 210 is return slot 194 under external force, therefore second syringe 15 is just by permanent locked, and female female Luer just can not be connected on the public Luer insert 134 for 31 this moments, shown in Figure 13 (d).

As described below, thus the rules of examining that system 10 provides relate to a plurality of veritifications and guarantee: and handling later, correct blood sample flows to that original correct patient 17; And the particular event in patient's 17 blood sample collections, processing and conveying appears in the preset time section.So far, as shown in figure 15, this system has: recognition device 211 is so that discern not processed blood sample in that the original patient 17 and first syringe 11; Validation apparatus 212, whether it is used for examining the blood sample of handling in the original patient 17 and second syringe 15 and mates; And release signal generating means 214, it is used for producing a release signal in response to the positive result of validation apparatus.Thereby this release signal sends releasable locking mechanism 100 to predetermined current is transferred to first spring leaf 178, thereby makes 15 work of second syringe that processed blood sample is transferred to that original patient 17 thus.

As described below, recognition device 211 and release signal generating means 214 are arranged on second syringe 15, but also can be arranged on the aforesaid equipment.Releasable locking device 100 has a signal receiving device 216 so that receive this release signal.

As shown in figure 16, validation apparatus 212 comprises: comparison means 218, and it is used for the identity data of patient identity data with the blood sample of handling compared, and these two data all are kept in the storage device 220; And signal receiving device 216, it is used for receiving one or more and original that patient identity data and/or the relevant signal of blood sample identity data (untreated, as handled, or the both to have).At this moment, include that original patient the identity data and/or the identity data of blood sample in these one or more signals.Yet as a kind of selection, these one or more signals also can comprise those data that are associated or relate to patient 17 or blood sample identity data.For example, the data in the signal can comprise one or more codes, and the recognition data that this code can make patient's identity data or blood sample obtains as a question blank from a data structure in storage device 220 or other place.

This validation apparatus 212 also comprises counting assembly 221, it provides the time data relevant with scheduled event, and scheduled event wherein comprises blood sample conveying incident and/or the scheduled event between the two that the collection event and of the blood sample that is untreated was handled.This time data also can comprise at least one of the numerical value between two scheduled events time delay, and scheduled event wherein comprises the collection event of the blood sample that is untreated and the conveying incident of the blood sample handled or scheduled event between the two.This counting assembly 221 can be made one first accumulator register 222 on first syringe 11, and second accumulator register 224 on second syringe 15 is used for following the trail of time delay simultaneously.First accumulator register 222 is followed the trail of those and is related to the incident of the blood collection that is untreated, and processing and post processing incident are then followed the trail of by second accumulator register 224.These two accumulator registers 222 and 224 are independently of one another in operation, do not need each other synchronously.Power supply should be enough to keep the basic accuracy that the blood sample of handling is fed to internal clocking in patient's 17 these time durations that collects of processing blood sample never.Therefore, along with the consumption of battery electric power, clock accuracy reduces or not free situation can not take place substantially.

Be released when in this case, validation apparatus 212 the 3rd fluid that can prevent to lock in operation time of being connected delay has surpassed predetermined value.Before untreated blood sample was processed, validation apparatus 212 can also prevent in the operation that blood sample is still processed when the time that postpones has surpassed predetermined value.Equally, after handling, this validation apparatus 212 can be examined untreated blood sample in first syringe 11 in operation and whether original patient 17 mates.

This examines operation can multiple way of realization, certainly present highly preferred one or more radio frequency signal transmitters and receptor and the RFID label of being to use.As shown in figure 17, have a passive RFID label such as WB RFID label 226 on the wrist strap 16, first syringe 11 and second syringe 15 then include above-mentioned printed circuit board (PCB) (PCB) 102, have circuit on this circuit board 102 so that the relevant data of transmission, reception and preservation and syringe and/or its inclusions or original patient 17, it includes a S1 RFID read/write device 228 and a S2 RFID read/write device 230 respectively.This passive WB RFID label 226 comprises an aerial coil and a silicon wafer, includes modulation circuit and nonvolatile storage in this silicon wafer.This passive WB RFID label 226 provides energy by time dependent electromagnetic radio frequency (RF) ripple of an outside, and rf wave is wherein sent by a RFID read/write device such as S1 RFID read/write device 228 or S2 RFID read/write device 230.Therefore, S1 RFID read/write device 228 or S2 RFID read/write device 230 can be write data on the WB RFID label 226, and by the detection of backscattered modulation data are read from WB RFID label 226.

Thereby blood treatment unit 14 also is furnished with a BTU RFID read/write device 232 and receives the pretreatment identity data from S1 RFID read/write device 228, and receives the post processing data from S2 RFID read/write device 230.Equally, thus blood treatment chamber 12 also be furnished with a passive SMU RFID label 234 cognizance code be provided.Thereby this BTU RFID read/write device 232 sends request signal to SMU RFID label 234 determines whether this blood treatment chamber 12 can be used in this processing procedure, whether promptly whether this blood treatment chamber 12 is the products through authentication, or used before it.

Shown in Figure 19 and 21, wrist strap 16 (WB) comprises a free section 236, and this part 236 includes WB RFID label 226 and the verification data that are written on this label, the blood sample that these data relate to patient 17 and/or handled.Wrist strap 16 also comprises a clasp 238, and this clasp has a bottom 240 and a cap 241.Integral body is formed with a belt 242 of being made by elastomeric material on the bottom 240, thereby has a plurality of hole shape through holes 244 to be used for receiving clasp 238 on this belt.Bottom 240 has pin 246,247,248, and these pins can pass through hole 244 in size.Cap 242 is hinged on the bottom 240 by a hinge 250.Cap 242 also has a pair of cavity 252, and wherein each cavity all is used for receiving a pin 246 or 248.Thereby pin 247 can be pressed onto on the switch (not shown) of bottom in 240 circuit part that activates wrist strap 16 when wrist strap 242 is fixed on patient 17 the arm.

Referring now to Fig. 1 to 21, the method for a kind of monitoring of the present invention one sample of material is described.This is examined rules and has used a plurality of cognizance codes, as be used for representing wherein dress the be untreated first syringe identity code of blood sample and the wrist strap identity code that is used for representing original patient 17.For the transmission of reducible data, the first syringe identity code and wrist strap identity code can comprise common identity data, and data between the two also can be different certainly, or according to circumstances need to be relative to each other.The first syringe identity code can comprise a very first time value if desired, its expression to be untreated sample gather from original patient 17 theres (or before or after the sample collection allocate event) and/or its time of examining.

Therefore, this S1 RFID read/write device 228 is as first sender unit, and it is used for sending one first signal, and this first signal is loaded with the first syringe cognizance code data and/or shared identity data.Simultaneously, the WB RFID label 226 on the wrist strap 16 is as first signal receiver, and it is used for receiving first signal.Second syringe 15 is assigned with one second syringe identity code, its expression be processed blood sample in second syringe.The second syringe identity code comprises one second time, its expression to be the sample handled deliver to here (or before or after the sample of handling is transferred an allocate event) and/or its time of examining from process chamber 52.

Therefore, S2 RFID read/write device 230 is as a secondary signal transmitter, and it is used for sending a secondary signal, and this secondary signal is loaded with the identity data of the blood sample of handling.And WB RFID label 226 is as a secondary signal receiving system, and it is used for receiving secondary signal, and the data of the blood sample that validation apparatus 212 wherein can be handled first signal data and representative in operation compare.

Referring to Figure 18, rules and the typical blood treatment program examined described now.As shown in Figure 1, assemble a workbox that is used for blood treatment, it includes wrist strap 16, first syringe 11, second syringe 15, sample management unit 12 and a plurality of ready label 258 that is printed on patient identification information on it.Beginning of operation sequence is to activate first syringe 11 by an actuating unit such as T-Ring 38.In case activate, the circuit on the PCB 34 will by battery 48 electric power is provided and carry out a startup test oneself (power-on-self-test, POST) program, then first syringe 11 just all set, unless in the POST program, found what fault.Being that S1 RFID read/write device 228 is activated and sends request signal then, is the affirmation response of waiting for from passive WB RFID label 226 then.First accumulator register 222 also is activated and the output time data, its with logic device associate the incident of following the trail of the blood that is untreated and with the relevant daily record time mark of the blood incident that is untreated of being scheduled to.So far, the time mark TS0 that has represented the incident that starts is just noted and is saved in the memorizer by second accumulator register 224.S1 RFID read/write device 228 all includes identical patient identity data or sample process data with WB RFID label 226, and it is encoded to ID1.

Before first syringe 11 is used for extracting blood from patient 17 there, prevent condensing of blood thereby a kind of blood anticoagulant such as sodium citrate solution need be drawn onto in the first sample reception cavity 21, referring to Fig. 3.Extract blood sample from patient 17 theres then, after taking out, first syringe 11 is put in the RF scope of wrist strap 16.Thereby whether S1 RFID read/write device 228 can inquiry WB RFID labels 226 examines the data that read or send from WB RFID label 226 from WB RFID label 226 corresponding to shared patient identity data ID1 on the S1 RFID read/write device 228.If when not having relatedness between the data on the wrist strap 16 and first syringe 11, should operation stop so.Yet, if the result of relatedness for certainly, so S1 RFID read/write device 228 just with " time data labelling " TS1 label record on S1 RFID read/write device 228, and this time mark write WB RFID label 226.Therefore, S1 RFID read/write device 228 and WB RFID label 226 existing TS0, TS1 and the ID1 of all being loaded with.For example, data on S1 RFID read/write device 228 and WB RFID label 226 can be expressed as now: S1 ID1 TS0 TS1, its expression be to have the patient of identification Information ID 1 to be pumped into untreated blood sample first syringe 11 from a bit strip, first syringe 11 starts at time T S0, and the match is successful at time T S1 for common patient identity data ID1 on while first syringe 11 and the wrist strap 16.

First syringe, 11 logic devices receive the time data from first accumulator register 222, and determine the moment that same patient identity data ID1 mates on time that operation (TS0) is postponed till now and first syringe 11 and the wrist strap 16.As long as the time difference between TS0 and the TS1 is in predetermined receivable scope, operation just continues.

Next step installs to (at this moment, second syringe 15 has been fixed on above this) on the blood treatment chamber 12 with first syringe 11, is sent to blood treatment unit 14 theres then.Like this, S1 RFID read/write device 228 is just issued data TS0, TS1, ID1 BTU RFID read/write device 232.These data also comprise a time value TS2, the time started that its expression is handled.Blood treatment unit 14 calculates the TS1 of first syringe 11 and the time delay between the TS2 then.In addition, the SMU RFID label 234 of blood treatment unit 14 on sample management unit 12 sends a request signal, and in response, this SMU RFID label 234 sends a signal that includes its cognizance code for blood treatment unit 14.Be to determine whether this SMURFID label 234 is effective then, and whether this delay can be accepted.If SMU RFID label 234 is invalid, and/or postpones and can not accept, program just stops so, otherwise program continues.In this case, this cognizance code includes " permission " code, and its expression blood treatment chamber 12 be not used for blood treatment in the past, had so just reduced the contaminated possibility of the current blood sample SI that is untreated.As selection, SMURFID label 234 also can send one and allow code, and only is to send a signal that includes data such as identity data such as SKU.

If the time delay between TS1 and the TS2 can be accepted, blood treatment unit 14 just continues operation sequence so, and the untreated blood sample in first syringe 11 is delivered to process chamber 52 through cavity inlet 50 and pipeline 128.Thereby S1 RFID read/write device 228 tightens and includes a dead code with that and forbid that it is used again.In addition, after blood sample is sent to blood treatment chamber 12, thereby the SMU RFID label on this blood treatment chamber 12 234 can receive that a dead code prevents the repeated use in blood treatment chamber 12 from BTU 14.As selection, SMU RFID label 234 can also lose efficacy with the alternate manner that writes outside the dead code.For example, can send a signal to SMU RFID label 234 makes blown fuse wherein and SMU RFID label 234 can't be worked.

In the process of handling, 15 energisings of second syringe and beginning are to BTU RFID read/write device 232 data queries.New being used for represents that the time mark " TS3 " that the blood sample processing finishes writes BTU RFID read/write device 232, and this TS3 is read and is saved in here by S2 RFID read/write device 230.Then, blood after the processing is delivered to second syringe 15 from process chamber 52 through pipeline 130, simultaneously if desired, blood treatment unit 14 also can comprise the TS1 labelling, that is to say that the data of writing S2 RFID read/write device 230 just include ID1, TS0, TS1, TS2 and TS3.At this moment, second syringe 15 comprises processing starting time TS2 and handles concluding time TS3.As selection, or in addition, TS2 or TS3 can include the processing duration, or other the expression front all examine the code that operation all completes successfully.

For example, blood treatment unit 14 can be noted following data:

S1?ID1?TS0?TS1

Patient (PATIENT) ID

Handle beginning TS2

Processing finishes TS3

S1?ID1?TS0?TS1?TS3

In this case, patient (PATIENT) ID code can comprise the data that other is relevant with patient, and these data are by manually or automatically being input in the blood treatment unit 14.As selection, the data relevant with patient are transferred to blood treatment unit 14 from a central data store center, server, thesaurus etc.

Second syringe 15 sends back to patient 17 there that originally has on wrist strap 16 then, and S2 RFID read/write device 230 continues test WB RFID labels 226, be within the scope of request signal up to this WB RFID label 226 till.As the response to request signal, WB RFID label 226 can send the ID1 data in the moment " TS4 ".Then, S2 RFID read/write device 230 calculates TS3 data and second syringe 15 and sends back to arriving at the time between the TS4 constantly of wrist strap 16.If should the time surpass expection, second syringe 15 is just locked by locking mechanism 100 so, otherwise program continues.

Second syringe 15 is noted ID1, and time mark " TS4 ".In addition, second syringe 15 can comprise patient (PATIENT) ID data and ID1, TS1, TS2, TS3.Then, these data are written on the WB RFID 226.In this stage, thereby thereby S2 RFID read/write device 230 sends a release signal to locking mechanism 100 to be sent a predetermined current for spring leaf 178 abutment flange is pushed into opens second syringe 15 in the groove 194 second syringe 15 can be injected.

By way of example, the following data of WB RFID label 226 records:

S1?ID1?TS0?TS1

S2?15?ID1?TS0?TS1?TS2

Sample matches TS3

S2 release TS4

Then, when TS4 was recorded in the WB RFID label 226, after the ID1 data on S2 RFID read/write device 230 and WB RFID label 226 had been finished sample matches, the procedure of verification finished.Then, as shown in figure 21, the free section 236 of wrist strap 16 is pulled down and is mated with original patient's record from wrist strap, finishes the examination index thereby simultaneously patient's record is turned back to blood treatment unit 14 so that carry out exchanges data between WB RFID label 226 and blood treatment unit 14.

As selection, can be on patient 17 next door or the patient record district of hospital be equipped with a RF and read the examination record and catch the station, thereby do not need the patient record is turned back to blood treatment unit 14.In this case, thus this examination record catch the station and can download the patient record and finish the examination index.This RF reads examination record and catches the part that the station can be hospital's Intranet, and it both can realize by wired or wireless FPDP, also can make a part of the LAN of one or more blood treatment unit system in the hospital.But its image data also can make batch data record on the computer-readable medium, on CD, hard disk or other memory device.It can be connected to or be made of one with following equipment: computing equipment, personal digital assistant, mobile phone etc.The form that it can also software realizes that thereby computing equipment wherein is connected with a RFID reader in computing equipment operation.

Data ID 1 and TS4 are transferred to blood treatment unit 14 or thereby other system finishes this examination index.Labelling also can include " incident " code constantly, and it can include five sides and want incident:

1) the S1 time started

2) WB is to the affirmation of S1

3) handle beginning

4) processing finishes

5) mated between processing back sample and the original patient

Time mark also can comprise one or more in following a plurality of error event:

1) do not match

2) S1 before gathering/do not match with WB afterwards

3) S2 after handling when returning and WB do not match

4) time delay of blood collection-overtime

5) sample flows to the time delay of BTU-overtime

6) return to patient's time delay-overtime

TS3 labelling constantly also can comprise following " coupling " code:

01 coupling

02 does not match

In another embodiment, wrist strap includes circuit and battery, and the former is connected on the passive WB RFID label 226, and the latter is used for providing electric power to circuit.As shown in figure 20, wrist strap 16 includes output device, and as 260,262,264 or speaker (not shown)s of LEDs, these output devices are worked in its one or more various combination mode.For example, LEDs 260,262 is used in operation according to predetermined circulation and bright showing, cyclic representation wherein be to examine the relevant communication of operation with first syringe 11 and second syringe 15.The 3rd LED 264 can be used to report to the police.

In another embodiment, wrist strap includes circuit and battery, and the former is connected on the passive WB RFID label 226, and the latter is used for providing electric power to circuit.As shown in figure 20, wrist strap 16 includes output device, and as 260,262,264 or speaker (not shown)s of LEDs, these output devices are worked in its one or more various combination mode.For example, LEDs 260,262 is used in operation according to predetermined circulation and bright showing, cyclic representation wherein be to examine the relevant communication of operation with first syringe 11 and second syringe 15.The 3rd LED 264 can be used to report to the police.

Wrist strap 16 also can some other can be replaced by the object that patient 17 wears, carries, connects or absorbs by, as pin joint or from bonding label 258 etc.

Thereby, second syringe 15 whether within predetermined being suitable for is expelled to patient 17 scope, provides required treatment thereby also can including blood that one second sample reception cavity 89 volume detectors determine the processing that receives from process chamber 52.

In another embodiment, system 10 includes a blood sample process chamber, it is similar to the blood sample process chamber 12 among Fig. 4, and has an expandable process chamber 52, this chamber 52 by a cap 54, bottom 56 and between the two the wall portion 58 of a flexibility constitute.

In another embodiment, this system includes a locking mechanism 100, and this locking mechanism 100 can be driven by calutron or electric device in operation, and electromagnetism wherein or electric device can receive release signal in configuration.

In another embodiment, this system comprises the wrist strap 16 that has circuit, circuit wherein is used for transmitting, receive and preserve the data relevant with original patient 17, as identification data or marker character, SKU, serial number, build date, useful life, sanitary installation data, public health personnel's data, administration data etc.This circuit includes, but not limited to transmitter, receptor, logic device or processor, is used for computer-readable memory, timing circuit, antenna and power supply that data are preserved.This circuit also includes the RFID read/write device, and it is used for reading the RFID label, and the miscellaneous equipment in this label and the processing system is associated as first syringe 11, second syringe 15 or sample management unit 12.One wristband label.Therefore this wrist strap 16 can provide the examination index in case finish dealing with as the file data memorizer of entire process.These data can be kept in the computer-readable medium, as RAM, ROM, flash memory etc., data can be write in this label thereby wrist strap also can comprise the RFID label.

First syringe 11 and second syringe 15 include printed circuit board (PCB) (PCB), it has circuit so that the relevant data of transmission, reception and preservation and syringe and/or its inclusions or original patient 17, as recognition data or identifier, SKU, serial number, build date, useful life, liquid data, sanitary installation data, public health personnel's data, administration data etc.This circuit can be made active RFID label, and it has transmitter, receptor, logic device or processor, is used for computer-readable memory, timing circuit, antenna and power supply such as battery that data are preserved.Input-output apparatus such as display, LED, speaker or the button in addition that link to each other with PCB 102.Second syringe 15 also includes circuit, thereby it is used for the operation of releasable locking device or electronic mutual interlocking gear do not controlled when wrist strap 16 identifiers and the second syringe identifier match and prevents that the blood of handling from being re-injected.

Similar with preferred embodiment, this system comprises the BTU read/write device, and it can carry out communication (read and write) with the RFID label and the label on the sample management unit 12 of first syringe 11 and second syringe 15.The RFID label preservation of first syringe 11 and the record data relevant with patient, as taking out blood so that the time of handling etc.It will guarantee that also syringe 11 can not reuse.The RFID label of first syringe 11 also includes delay counter and matching identification symbol, and it just is written in the wrist strap when the manufacturing of wrist strap or packing.The RFID label of second syringe 15 includes similar function, thereby and includes logic and circuit can drive an electronic mutual interlocking gear.

The flow process of processing events is similar to above-mentioned flow process.Before getting blood,, the active label that makes first syringe 11 checks whether unique blood processor ID number of examining in the wrist strap 16 and first syringe 11 mates so that carry out one thereby sending out data to the read/write device of wrist strap 16.If coupling, wrist strap is just noted this incident so, and extracts blood from patient.Simultaneously, the delay counter in first syringe, 11 labels and the wrist strap 16 begins counting.

Then, first syringe 11 is installed on the sample management unit (SMU) 12, disposable second syringe 15 has been housed on the SMU 12 wherein.Then, the SMU 12 that will have two syringes 11,15 be put into have a BTU read/write device blood treatment unit (BTU) 14 here.At this moment, relevant patient's detailed data just is input in the BTU reader.Blood treatment unit 12 read/write devices can read the label of first syringe 11 and these detailed datas (comprising unique ID) are write in the label of second syringe 15.Thereby the BTU read/write device also can be write an information and show on the SMU label that it was used.This BTU read/write device can read the detailed data in the time delay and the processing time of calculating from the label of first syringe 11 there.Then these are written on the label of second syringe 11 with patient ID.

After blood treatment, the BTU read/write device is write the entire process time on the label of second syringe 15.SMU 12 is removed from BTU.The S2 syringe is removed from SMU 12, and SMU 12 and S1 syringe are lost.The wrist strap 12 that then second syringe 15 is put into patient here, if the time of unique here ID coupling and delay is also within the parameter area that is provided with, the locking mechanism of second syringe 15 just discharges so, and this second syringe 15 is expelled in the patient body with regard to the blood that can be used to handle.The read/write device of wrist strap 12 is written to the detailed data of patient data and process in the label or computer-readable medium of wrist strap 12, so that preserve and later taking away with the patient record.Then, the read/write device of wrist strap 12 was lost efficacy, wrist strap is taken off on hand and lost from patient thereby its bandage sheared off.But the RFID reader of an available networking reads the enciphered data in the wristband label memory element computer-readable medium so that it is transferred among the health care data base on computer or the network.

In another embodiment, a BTU read/write device or an outer read/write device can provide all verifications.

Although above-mentioned explanation mainly all concentrates on system 10 and is used in the processing to the autoblood sample, but obvious system 10, and spring parts and its equivalents also can be used for other sample except that blood sample, as bone marrow or, lymph fluid, seminal fluid, ovum-liquid mixture, other body fluid, or other medicinal liquid, it can be similar, can be not similar yet, as containing the required solid sample of patient in the fluid mixture, as solid sample from organ, somatic cell, cell tissue, epidermis cell and epidermis sample, spinal cord.System 10 also can be used for drug test, the most important thing is that here the test result of guaranteeing a certain fc-specific test FC can be transported to original patient 17 theres.

Although what system 10 used is syringe 11 and 15; but obviously also can adopt other equipment; as alone or in combination, one or more syringes, IV bottle; the fluid of powder and/or grain refined and/or gas suck allotter; transplant carrier, breather, syringe pump; intubate, the intestines and stomach feedback pipe or their combination.Treatment facility can comprise that also a blood processing apparatus such as name are called the international patent publication WO0119318A1 of " APPARATUS AND PROCESSFOR CONDITIONING MAMMALIAN BLOOD " (it is incorporated into by reference in full) here.As selection, treatment facility can be finished intrusive mood and treatment non-intrusion type, detects or checks as the surgical intervention of some disorders such as cancers and some, as X ray, cat scan, MRI etc.

Although the front is described in conjunction with specific embodiment of the present invention, various conspicuous versions obviously of the present invention for a person skilled in the art are also within protection domain of the present invention and design scope.

Claims (20)

1. system, it is used for gathering, handling and the pumping blood sample, and this system comprises:

With the article that a patient is associated, this patient has patient identifier;

First syringe, it has:

First syringe inlet, it is used for from the untreated blood sample of patient's withdraw;

The first syringe cavity, it is used for receiving not processed blood;

First syringe outlet, it is used for untreated blood sample is transferred out from first cavity;

First accumulator register, it is used for writing down the time data corresponding to relating to blood collection in the blood incident that is untreated;

First syringe is unique with one, first identifier is associated, and this unique identifier can be associated with patient's sign;

Be used for the container of processing blood sample, this container has:

Blood sample process chamber, this container have cavity inlet; First syringe outlet can be gone into the interruption-forming dedicated first fluid with this cavity and is connected in operation, thereby not processed blood sample is transported to the blood sample process chamber; This container has cavity outlet, and its blood sample that is used for handling is transported to second syringe after handling,

Second syringe has:

Second syringe inlet, thus it can be connected from blood sample process chamber reception blood sample with second fluid that cavity outlet forms a special use in operation;

Second cavity, it is used for receiving the blood of handling;

Second syringe outlet;

The passage that communicates with second cavity and second syringe outlet;

Second accumulator register, it is used for writing down and blood treatment incident, the incident of handling blood and the corresponding time data of conveying incident; This second accumulator register can be independent of first accumulator register and asynchronous with first accumulator register in operation;

Second syringe is unique with one, second identifier is associated, and this second unique identifier is associated and can be associated with the first unique identifier with first syringe in operation;

Releasable lock, it is formed in the passage, and the outlet that is used for operating second syringe is changed between a plurality of states;

Processor, it has:

Comparator, thus it is used for the patient identifier and unique first identifier are compared the relatedness of determining between the two; And thereby second unique identifier and patient identifier compared the relatedness of determining between the two, this comparator sends output signal;

Logic circuit, thus it is used for receiving the time that output signal and time data determine between the incident and prolongs to the greatest extent, and determine this time delay whether in predetermined scope;

The release signal generator, it is connected to and is used on the logic circuit sending a release signal to above-mentioned releasable lock;

Thus, relatedness and relatedness patient identifier and unique second identifier between of this release signal between the patient identifier and unique first identifier sent when obtaining confirming, condition is that time delay is within predetermined scope.

2. system as claimed in claim 1, first syringe wherein further comprises:

The inlet valve assembly, it communicates with first-class body cavity; And

The outlet valve assembly, it is arranged between first-class body cavity and the inlet valve assembly;

The inlet valve assembly comprises:

The import valve member, it is operable on open position and the closed position;

Elastic component, it pushes the import valve member to its closed position;

The outlet valve assembly comprises:

Outlet valve member, it is operable on open position and the closed position; And

Sealing member, and

Anchoring piece, thus the engagement of itself and outlet valve assembly is maintained in its closed position the outlet valve assembly;

Thus, when outlet valve member was in the closed position, the import valve member was just entered into open position under the pushing of elastic component, thereby fluid is flow in the cavity;

And when fluid cavity was filled, outlet valve member can make separating and seal fails of anchoring piece in operation, and the import valve member is on the closed position;

Fluid is discharged from fluid cavity.

3. system as claimed in claim 1, discharging wherein is locked in the operation and can the syringe outlet valve is operated between open mode and the closed condition in response to a release signal.

4. system as claimed in claim 3, discharged lock wherein comprises:

Pivotable pallet piece;

The groove that is coupled to each other, it is corresponding to closed condition, open mode and permanent closed state;

First elastic component, it has nib, this nib is limited and can only moves in the above-mentioned groove that is coupled to each other, first elastic component wherein is a kind of spring of being made by a fusible material, this fusible material can temporarily change its concordance under the release signal effect, the state of outlet valve has been represented in the position of nib in the described groove that is coupled to each other.

5. system as claimed in claim 4, fusible material wherein is NiTi naval permission experiment intermetallic material (NITINOL)

6. system as claimed in claim 5, thus discharged lock wherein comprise second elastic component can force nib enter into one with the corresponding groove of permanent closed state in.

7. system as claimed in claim 6, it includes described object, first syringe, second syringe, container, circuit is so that transmission, reception and the preservation data relevant with autohemic collection, processing and conveying.

8. system as claimed in claim 7, circuit wherein comprises following any one: transmitter; Receptor; Antenna; Processor; Computer-readable medium; Timing circuit, it is used for just safeguarding the time data relevant with collection, processing and the conveying of autoblood sample; Power supply and input-output apparatus.

9. system as claimed in claim 8, wherein the circuit of first syringe and second syringe includes an active RFID label, and it obtains electric power from battery.

10. system as claimed in claim 9, object wherein includes the RFID read/write device, and the active RFID tag on itself and first syringe and second syringe carries out communication.

11. system as claim 10, object wherein comprises processor, comparator, thereby logic and release signal generator send release signal to releasable lock when the relatedness of having confirmed between relatedness between the patient identifier and unique first identifier and patient identifier and unique second sign, condition is that time delay is all within predetermined scope.

12. system as claimed in claim 8, wherein the circuit of object and container comprises a passive RFID label.

13. as the system of claim 12, first syringe wherein and second syringe comprise a RFID read/write device, the passive RFID tags on itself and object and the container carries out communication.

14. system as claim 13, second syringe wherein comprises processor, comparator, thereby logic and release signal generator are when the relatedness of having confirmed between relatedness between the patient identifier and unique first identifier and patient identifier and unique second sign, send release signal to releasable lock, condition is that time delay is also all within predetermined scope.

15. as the system of claim 11 or 14, container wherein further comprises:

Body, it has:

Top, bottom and be positioned between the two wall portion;

Cap, it is tightly connected by body openings, thus the adjacent formation in this body openings and top blood sample process chamber;

Cap has: an air inlet, thus it is used at least a gas is loaded in the blood sample process chamber with untreated sample on connecting and contacts, the gas outlet, and it is sent at least a gas on connecting from the blood sample process chamber; The cavity import, thus it is used for being releasably connected to untreated sample is provided on first syringe; And cavity outlet, it is used for being releasably connected on second syringe so that second syringe receives a sample of handling; And

Temperature sensor, it is used for determining at least a fluidic temperature in the process chamber.

16. as the system of claim 15, wall portion wherein is inflexible.

17. as the system of claim 15, wall portion wherein is flexible.

18. as the system of claim 15, wherein said opening has at least one to include Rule adapter so that be connected on supporting Rule adapter.

19. as the system of claim 15, wherein said opening has at least one to include the bayonet lock link, so that be connected on the supporting bayonet lock link.

20. the method to monitoring from patient's sample of material, it may further comprise the steps:

(a) gather sample with first collecting device from patient;

(b) with patient and one first signal correction connection, first signal wherein is loaded with the data of expression sample;

(c) first collecting device is associated with secondary signal, this secondary signal is loaded with the data of expression sample;

(d) sample is transported to the sample process chamber;

(e) thus handling sample forms the sample of handling;

(f) with this sample collection in second collecting device;

(g) with second collecting device and the 3rd signal correction connection, the 3rd signal wherein is loaded with the data of the sample that expression handled;

(h) thus the data in the first and the 3rd signal are compared the sample that will handle to link with patient; Then

(i) in the step (a) to (h) at least one is associated with time data;

(j) thus determine at least one time delay with this time data and determine in the step (a) to (h) at least one step whether in the acceptable time scope;

(k) sample after step (h) and result (j) will handle for certainly the time flows to patient; And

(l) sum up the examination record, it has the time data from step (i), from result and the data related with sample of step (h) and (j).

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