CN2907683Y - System for treating one-self blood sample - Google Patents

System for treating one-self blood sample Download PDF

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Publication number
CN2907683Y
CN2907683Y CN 200420122358 CN200420122358U CN2907683Y CN 2907683 Y CN2907683 Y CN 2907683Y CN 200420122358 CN200420122358 CN 200420122358 CN 200420122358 U CN200420122358 U CN 200420122358U CN 2907683 Y CN2907683 Y CN 2907683Y
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China
Prior art keywords
syringe
blood sample
sample
valve
outlet
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Expired - Fee Related
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CN 200420122358
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Chinese (zh)
Inventor
林振铭
塔拉斯·沃罗纳
戴维斯·A·R·坎博格斯
马克·保罗·科斯塔
陈昊
戴维·G·松浦
菲利普·J·辛普森
沃尔特·迪安·吉莱斯皮
罗伊·T·赵
加贝莱·克莱因
凯瑟琳·穆勒
约翰·诺里斯·米切尔
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Vasogen Ireland Ltd
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Vasogen Ireland Ltd
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Publication of CN2907683Y publication Critical patent/CN2907683Y/en
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Abstract

Disclosed herein is a system for the collection, treatment and delivery of an autologous blood sample, comprising a first syringe having a first body portion. A first sample transfer portion has a first syringe inlet for drawing an untreated blood sample from a patient and a first syringe outlet for dispensing the untreated blood sample. A blood sample treatment chamber having a chamber inlet, the first syringe outlet being operable to establish a dedicated first fluid coupling with the chamber inlet to dispense the untreated blood sample to the blood sample treatment chamber. The blood sample treatment chamber having a chamber outlet for dispensing a treated blood sample following treatment. The second syringe has a second body portion and a second sample transfer portion, the second sample transfer portion having a passage with a first access location which is operable to form a dedicated second fluid coupling with the chamber outlet. The second body portion has a second syringe outlet, the passage having a second access location for fluid communication with the second syringe outlet, releasable lock means for forming a locked third fluid coupling between the second access location and the second syringe outlet. The lock means is operable in response to a release signal to release the third fluid coupling, the second syringe outlet being operable when released from the third fluid coupling to form a fourth fluid coupling with a blood sample delivery unit.

Description

Be used to handle the system of autoblood sample
Technical field
This utility model relates to the processing of therapeutic treatment, especially relates to a kind of system that is used to handle the autoblood sample.
Background technology
The mode for the treatment of patient has in recent years had huge variation.Most social medical systems have improved the productivity.Yet these change when taking place not is no problem.Fearful mistake has taken place in nearest heart-lung transplant operation, because the patient's of small relatively carelessness-donor and reception treatment blood group does not match.Also make this incident cover with shade to patient's medication mistakenly.This just shows that needs improve the monitoring to patient and their treatment, guarantees they are used suitable Drug therapy and/or medical procedure, and it is specific to give each patient, perhaps is unique needs.
In the prior art, there has been multiple systems next to predetermined patient's administration, to address these problems by the medicament dispenser of control locking.These systems solve the problems referred to above by data on comparison medicament before the administration and the data on patient's bracelet.Yet these systems have a lot of shortcomings, for example depend on that the medical worker compares patient data and medicament data before administration, thereby be easy to generate personal error, and the locking device on the allotter may be neglected by the medical worker.Simultaneously, this system does not preserve and handles relevant temporary transient data or checks data, and avoids the medicament administration before or after can be not at the fixed time.These systems are comparatively expensive simultaneously, and not too friendly for user.
The utility model content
The purpose of this utility model provides the medical material handling systems that overcomes above-mentioned shortcoming.
One of technical problem that this utility model solves is to avoid the administration mistakenly to patient, raising is to the monitoring of patient and their treatment, to guarantee that they are used suitable Drug therapy and/or medical procedure, give each patient specific perhaps be unique needs.
In one aspect, this utility model provides a kind of system that is used to handle the autoblood sample, it is characterized in that comprising: the blood sample process chamber, and it has the chamber inlet; First syringe, it has first main part and the first sample hop, and wherein the first sample hop has from patient and extracts first syringe inlet of untreated blood sample and distribute first syringe outlet of this untreated blood sample; Having set up special use first liquid that untreated blood sample is assigned in the blood sample process chamber between the inlet of first syringe outlet and chamber is connected; This blood sample process chamber has the chamber outlet that is used for the allocation process sample of processing blood afterwards; Second syringe, it has second main part and the second sample hop, wherein the second sample hop has passage, this passage has first entry position, its with chamber outlet between formed special use second liquid that receives from the sample of processing blood of described blood sample process chamber and be connected; This second main part has second syringe outlet; Control distributes the locking device of processing blood from described second syringe, and it combines with described second syringe; Be used to untreated blood sample discriminating source morbidity people's identification device; The calibration equipment of the coupling between the blood sample that is used for verification source morbidity people and has handled; Discharge the release signal generating means of described locking device according to definite result of processor.
In one embodiment, provide identification device to be used to untreated blood sample discriminating source morbidity people, calibration equipment be used for verification source morbidity people and the blood sample handled between coupling, the release signal generating means is used for effective verification of response check device and produces release signal.
Identification device and/or release signal generating means can be positioned on second syringe body, the second sample hop or the outer goods.Outer goods can be dressed, carry, tie up or be absorbed by patient, for example uses the label of safety pin setting fastening or self-adhesion, or cated object and analog.Preferably, outer goods comprises removable part, and this part comprises and patient and/or the relevant inspection data of blood sample handled.Outer goods also can provide with the wrist strap form easily, is dressed by source morbidity people.
In one embodiment, calibration equipment comprises the comparison means of the blood sample authentication data that is used for reference source morbidity people's authentication data and has handled, be used to receive the signal receiving device of one or more signals, this signal is relevant with source morbidity people's authentication data and/or blood sample authentication data, or comprise above-mentioned data in some cases, be used to store patient's authentication data and the storage device of the blood sample authentication data handled.Memory device stores time value data relate to the time value of scheduled event to determine at least one, and this scheduled event comprises or between untreated blood sample Collection Events and the blood sample conveying incident handled.
If desired, time value also can comprise at least one consumption time value between two scheduled events, and this scheduled event comprises or between untreated blood sample Collection Events and the blood sample conveying incident handled.In this case, surpass predetermined consumption time during maximum when consuming time value, calibration equipment can operationally stop the 3rd liquid of locking to connect to discharge.This calibration equipment also can be used in combination with blood treatment unit, to be used at blood sample process chamber processing blood sample.In this case, surpass predetermined consumption time during maximum when consuming time value, calibration equipment can operationally stop the processing of blood sample.
In one embodiment, the calibration equipment coupling between untreated blood sample and the source morbidity people in verification first syringe operationally.The designated first syringe authentication code of first syringe, the wherein untreated blood sample of this coded representation, the designated source morbidity of source morbidity people people authentication code, this source morbidity people of this coded representation, wherein first syringe comprises relevant or common data with source morbidity people authentication code.The first syringe authentication code can also comprise very first time value, and this time value represents to collect from source morbidity people the time of untreated samples and/or verification.The also designated second syringe authentication code of second syringe, the blood sample that this coded representation has wherein been handled.The second syringe authentication code also can comprise second time value, and this time value represents that the blood sample of having handled is transported to the time of second syringe and/or verification from the blood sample process chamber.
In one embodiment, identification device comprises first sender unit and first signal receiving device, and wherein discharger is used to launch first signal that carries the blood sample authentication data that is untreated, and receiving system is used to receive first signal.First sender unit can be positioned on first syringe easily.Identification device also comprises secondary signal discharger and secondary signal receiving system, wherein the secondary signal discharger is used to launch the secondary signal of carrying the blood sample authentication data of having handled, receiving system is used to receive secondary signal, and the secondary signal discharger can be positioned on second syringe easily.
In one embodiment, first main part of first syringe comprises untreated blood sample receptive cavity, the first sample hop comprises the passage that blood sample receptive cavity and first syringe inlet that is untreated is connected with first syringe outlet and is used to control blood flow crosses the first syringe inlet valve device that first syringe enters the mouth.In this case, the first syringe inlet valve device comprises distance piece, also comprises complementary piercing elements, and this piercing elements is positioned on the outside blood collecting article or therebetween, and is in the position of engagement with distance piece.
If desired, the second blood sample hop also can comprise the filtering exhaust mouth in the passage, to be used for discharging one or more gas componants of the blood sample of having handled.
In one embodiment, in the first and second special-purpose connections one or two can be operated releasedly, with first sample hop of locking first syringe and the second sample hop of second syringe, and the blood sample process chamber is in liquid transfer open state separately.In this case, first and second connect such structure, and promptly by the relative swing offset between the first and second sample hops of blood sample process chamber and correspondence, the first and second special-purpose connections realize the liquid transfer open state of locking.
In one embodiment, second syringe outlet comprises the second syringe outlet valve gear, and this valve gear is used to control the blood sample that flows through this outlet, and all works like this two stages.In the phase I, the second syringe outlet valve gear comprises valve componentry, valve seat part and with respect to the starting drive of valve seat part starter gate valve componentry, when second main part meshed the second sample hop, this starting drive was operationally from valve seat part movement of valve element.The second sample hop comprises the shell that holds second syringe outlet, this shell has the concave member with the second entry position fluid connection, second syringe outlet comprises the protuberance that meshes this recess, starting drive comprises the actuating section near protuberance, and this actuating section is moved by recess when recess and protuberance engagement.The oversheath part separates with protuberance, accepts passage to form annular recess therein, and actuating section comprises at least one first starting element that is arranged in the circular passage.
In second stage, when second main part was separated with the second sample hop, starting drive operationally made valve element and valve seat part engagement, and the second syringe outlet end parts stretches out from second main part.In this case, actuating section comprises at least one second valve starting element, and this component side exceeds the second syringe outlet end parts to stretching out.Second port of export partly has angled end, and the second valve starting element has stub area, and this stub area is configured to mesh the angled end of second port of export part.When valve componentry and valve seat part engagement, locate the angle of the stub area of the second valve starting element, thereby entangle the angled end of second port of export part.Therefore, when valve portion moved with respect to valve seat part, the second valve starting element was arranged to move along the outer surface of second port of export part.Collar member is arranged in shell, and this collar member comprises the chamber that holds second port of export part, connects to form the 3rd liquid.The second valve starting element comprises outward extending therefrom adjacent flanges, when second syringe outlet when shift out in the chamber, this adjacent flanges is the assigned address in the chamber operationally.
In one embodiment, can discharge locking device and comprise the barrier element of placing near second entry position, this barrier element can move between locked position and off-position, mesh second port of export part at this barrier element of locked position, this barrier element is partly regained from second port of export in the off-position.This barrier element is biased into the off-position, and securing device is used for barrier element is stabilized in locked position, and wherein this securing device can discharge when having scheduled current.
On the other hand, this utility model provides a kind of material distributor, this device comprises material storage area and transmission of materials part, this transmission of materials partly comprises the passage that material is transported to the material storage area and exports from storage area, this passage has first entry position, second entry position, the second entry position control device, with the 3rd entry position, first entry position and material storage area fluid connection, the second entry position control device is used for control material and flows through second entry position, the second entry position control device comprises transparent distance piece, this distance piece is at the state of not penetrating and penetrate under the state and can operate, close at the state lower channel of not penetrating, open at the state lower channel of penetrating, the 3rd entry position comprises and is used for forming the device that dedicated liquid is connected with the medical material allotter.
This material storage area can form with transmission of materials part integral body or be separated.
In one embodiment, distance piece comprises the elastomeric material obturator with diameter and thickness, and wherein thickness and diameter are approaching.The distance piece housing parts comprises distance piece, provides penetrating member to be used to penetrate this distance piece.This penetrating member has the flange with the engagement of distance piece housing parts, and the form of this flange is preferably the outer surface complementation with housing parts.This penetrating member can provide by many forms, comprises the spike of hollow or fluting.
In one embodiment, provide locking device to enter distance piece with control.In this case, distance piece arranges that near end flange this end flange has opening, and this opening has the cross section of predetermined cross section with the coupling spike.Distance piece has the interior distance piece passage of close end flange and at least one or preferred a pair of latch member, this element is at operable position and not mobile between the operable position, distance piece passage in the operable position latch member is blocked, latch member also comprises mobile device, in the distance piece passage time, this mobile device moves to not operable position with latch member in the spike with smallest lateral dimension appears at.Each latch member has outer locking flange, and wherein at operable position, this locking flange overlaps each other.This mobile device comprises the shank that is positioned at close outer locking flange on each latch member, in this shank of operable position is arranged to mutually near distance piece passage in being placed on, when the spike with smallest lateral dimension was introduced between the shank, this shank can move to not operable position.
Aspect another, a kind of material distributor is provided, this device comprises the valve gear of chamber, outlet and control outlet, this valve gear comprises transparent distance piece, this distance piece is closed at the state cavity of resorption of not penetrating at the state of not penetrating and penetrate under the state and can operate, and opens at the state cavity of resorption of penetrating, this distance piece comprises: have the elastomeric material obturator of diameter and thickness, wherein thickness and diameter are approaching; End flange, this end flange has the opening of predetermined cross-section; And penetrating member, this penetrating member is used to penetrate distance piece with open cavity, and this penetrating member has the cross section of coupling, and the cross section of itself and described opening is with the relationship match that closely cooperates, and wherein said opening stops the penetrating member that does not mate cross section to enter distance piece.
On the other hand, a kind of material distributor is provided, this device comprises the chamber, the valve gear of outlet and control outlet, this valve gear comprises transparent distance piece, this distance piece is at the state of not penetrating and penetrate under the state and can operate, close at the state cavity of resorption of not penetrating, open at the state cavity of resorption of penetrating, this distance piece comprises the elastomeric material obturator with diameter and thickness, wherein thickness and diameter are approaching, distance piece has interior distance piece passage and at least one latch member, this element is at operable position and do not move between the operable position, distance piece passage in the operable position latch member is blocked, and latch member also comprises mobile device, in the distance piece passage time, this mobile device moves to not operable position with latch member in the spike with smallest lateral dimension appears at.
Aspect another, a kind of device of controlling the medical material allotter is provided, this device comprises: control section, this control section has the shell that inside has passage, the notch portion that transfers out on this passage and the medical material allotter forms first liquid and is connected, and forms second liquid with the medical material container and is connected; With can discharge locking device, it is used for locking first liquid and connects, the enabling signal that this locking device can the response external device produces is at locking states and remove between the locking states and operate.
In one embodiment, this passage comprises gas discharge outlet, allows to discharge by the there from the gas of medical material allotter.Can discharge locking device and comprise barrier element, this element moves between locked position and off-position, and at locked position, this barrier element engagement transfers out notch portion, and this barrier element is regained from transferring out notch portion in the off-position.Ideally, this barrier element is biased into the off-position.In addition, securing device is stabilized in locked position with this barrier element, and wherein this securing device can discharge when having scheduled current.
Aspect another, a kind of injection device is provided, this device comprises syringe body, this syringe body has first main part that wherein forms cavity, with the piston of chamber sealed engagement with formation liquid receptive cavity, this syringe body has second main part, this second main part has the passage that is formed at wherein, this passage has and first entry position of chamber fluid connection and second end that stops in second entry position, this passage has the 3rd entry position, wherein at least one in the second and the 3rd entry position comprises transparent distance piece, this distance piece is at the state of not penetrating and penetrate under the state and can operate, close at the state lower channel of not penetrating, open at the state lower channel of penetrating.
The term that uses below " therapy equipment " means the device that directly or indirectly is used for the treatment of process.In fact it can comprise patient or come from the device that patient's sample is treated, or be used to carry out and the article for the treatment of relevant function, for example be used to carry sample or other with sample delivery to treatment place or obtain the article of sample from treatment.The several examples of other of this therapy equipment are here described.
Beneficial effect of the present invention is as described below.System of the present invention comprise from source morbidity people extract the blood that is untreated first syringe, accept the blood treatment chamber of blood and accept second syringe of processing blood from the blood treatment chamber from first syringe, so that to the source people's administration of falling ill.Identification device is used for discriminating source morbidity people and blood sample.Only when following condition satisfied, blood sample was handled, and promptly source morbidity people's authenticating value is complementary with the blood sample that is untreated, the processing of blood occur in predetermined during in, and handled blood sample in the scheduled period to source morbidity people administration.By satisfying above-mentioned condition, correct patient has accepted correct processing blood sample in the correct time, thereby can guarantee patient's the safety and the effectiveness of medicament or processing.
Description of drawings
Describe several preferred embodiments of the present utility model for example referring now to accompanying drawing, wherein accompanying drawing is:
Fig. 1 is the perspective view of blood processing system;
Fig. 2 is the cutaway view of first syringe shown in Figure 1;
Fig. 3 is the local amplification view in the first injector tip zone among Fig. 2;
Fig. 4 a is the local amplification view of another stub area shown in Figure 3;
Fig. 4 b is the local amplification view of another stub area shown in Figure 3;
Fig. 4 c is the local amplification view of another stub area shown in Figure 3;
Fig. 5 is the fragmentary, perspective view of a locking device part in the stub area of Fig. 4 a, 4b and 4c;
Fig. 6 is the perspective view of the parts that use of first syringe with Fig. 2;
Fig. 7 is to use the precedence diagram of first injector operations of Fig. 2;
Fig. 8 is the fragmentary, perspective view in the sample treatment chamber of Fig. 1 system;
Fig. 9 is the partial sectional view in sample treatment chamber among Fig. 8;
Fig. 9 a is the partial sectional view in sample treatment chamber among Fig. 8
Figure 10 is that the sample treatment chamber is at the partial sectional view of operable position among Fig. 8, and it has first syringe of Fig. 1 and second syringe of Fig. 1;
Figure 11 is that the sample treatment chamber is at the partial sectional view of operable position among Fig. 8, and it has first syringe of Fig. 1 and second syringe of Fig. 1;
Figure 12 is the partial exploded view of first and second syringes of Fig. 1, and it has the part in the sample treatment chamber of Fig. 8;
Figure 13 shows that first and second syringes are installed to the perspective precedence diagram on the process chamber of Fig. 8;
Figure 14 is the perspective view of second syringe of Fig. 1;
Figure 15 is the partial sectional view of second syringe of Fig. 1;
Figure 16 is the partial sectional view of second syringe of Fig. 1
Figure 17 is the perspective view that is used for the replaceable component of second syringe;
Figure 18 is the fragmentary, perspective view of second syringe part;
Figure 19 is the fragmentary, perspective view of second syringe part;
Figure 20 is the fragmentary, perspective view of second syringe part;
Figure 21 is the fragmentary, perspective view of second syringe part;
Figure 22 is the fragmentary, perspective view of second syringe part;
Figure 23 is the fragmentary, perspective view of second syringe part;
Figure 24 a is the partial sectional view of second a syringe part;
Figure 24 b is the partial sectional view of second a syringe part;
Figure 25 is the perspective view of second a syringe part;
Figure 25 a is the replaceable form of parts of second syringe shown in Figure 25;
Figure 25 b is the replaceable form of parts of second syringe shown in Figure 25;
Figure 25 c is the replaceable form of parts of second syringe shown in Figure 25;
Figure 25 d is the replaceable form of parts of second syringe shown in Figure 25, and Figure 26 is the sketch map of the check part of Fig. 1 system;
Figure 27 is the sketch map of the check part of Fig. 1 system;
Figure 28 is the sketch map of verification agreement;
Figure 29 is the sketch map of verification agreement;
Figure 30 is the perspective view of wrist strap shown in Figure 1 in different operations;
Figure 31 is the perspective view of wrist strap shown in Figure 1 in different operations; With
Figure 32 is the perspective view of wrist strap shown in Figure 1 in different operations.
The specific embodiment
With reference to the accompanying drawings, especially Fig. 1 provides system 10, to be used for collecting, handling and carry the autoblood sample.This system 10 has many parts, and these parts are used for the different stages during the processing blood sample.As what will describe, this system utilizes first blood sample to collect syringe S 1, and it is used for collecting untreated blood sample from source morbidity people.After blood sample is collected, first syringe S 1 is connected to blood treatment chamber 12, this process chamber is transported to blood treatment unit 14 then, blood sample is accepted one or more stresser and is handled in this blood treatment unit, and for example serial number is PCT/CA00/01078, the applying date to be (full content of this application is quoted as a reference) that international patent application that JIUYUE 15 day, in 2000 are called " apparatus and method that are used for handling mammalian " is described.
After the processing, the blood sample of having handled is transported to second syringe S 2, the sample delivery that this syringe is used for having handled the then people that falls ill to the source.At one or more critical stages, system 10 provides checksum verification, its objective is to reduce wrong probability, returns correct source morbidity people to guarantee correct blood sample.This is by reference source morbidity people's authentication data and sample authentication data, its handled or be untreated state or two state matches blood samples and source morbidity people and realize at the same time.In order to realize above-mentioned target, system 10 has patient bracelet 16, and this wrist strap can be communicated by letter with control or communication function element in S1 syringe and/or the S2 syringe, to help verification.
Even following description major part concentrates on the processing that system 10 is used for the autoblood sample, also be to be understood that, this system, its parts and alternative, also can be used for except that the blood sample from the body sample, for example bone marrow or lymph fluid, seminal fluid, ovum liquid mixture, other body fluid or other medical fluid, it can yes or no " from body ", the liquid mixture that for example may comprise the required solid sample of patient is for example from the solid sample of organ, somatic cell and cell tissue, Skin Cell and skin samples, spinal cord.This system also can be used for medical treatment test, and it is very important that the test result that guarantees fc-specific test FC in test can be transported to source morbidity people.
With reference to Fig. 1 and 2, first syringe S 1 has first main part 20, and this is partly with cylindrical cavity, and this cavity cooperates formation sample receptive cavity 21 with syringe piston.First syringe also has channel part 22, channel part 22 provides pipeline 22a, this pipeline 22a makes sample receptive cavity 21 link to each other with first syringe inlet 24, to extract the blood sample that is untreated from patient, and this pipeline 22a also makes sample receptive cavity 21 link to each other with first syringe outlet 26, is used for from then on untreated blood sample is assigned to blood sample process chamber 12 in the exit.
First syringe inlet 24 with reference to figure 2 and 3, the first syringe S 1 has the first syringe inlet valve device 28, and this valve gear is used to control blood flow and crosses first syringe inlet 24.In this case, the first inlet valve device 28 comprises the shell 29 that comprises distance piece 30, and this distance piece is arranged to be opened by complementary penetrating member 32, and this penetrating member is positioned on the external device (ED) 34 or therebetween.This external device (ED) 34 can be blood collecting unit 34 (being expressed as the form of " butterfly ") or the adapter 36 among Fig. 6, to connect bottle 38 or analog as shown in Figure 7.In this case, adapter 36 has 32,40, one distance pieces that are used to penetrate on the syringe S 1 of a pair of relative nail, and another is used to penetrate the distance piece on the bottle 38.
With reference to figure 3, blood collection device 34 comprises pedestal 42 and the flange 44 that supports penetrating member 32, the outer surface 29a of this flange and housing parts 29 complementary and with its engagement.In this case, penetrating member 32 is the form of hollow spike, pipeline 46 with this nail staggered relatively and with its fluid connection.This nail also can have many other forms, for example has the nail of outer grooves or passage.Housing parts 29 also can have outer connecting plate 48, and shown in the dotted line among Fig. 3, this skin connecting plate and outer surface 29a separate forming peripheral cavity 50, thus the flange 44 on the containment blood collector unit 34.
With reference to figure 3, the form of distance piece 30 is the obturator with elastomeric material 52 of diameter Di and thickness De, and wherein thickness De is near diameter Di.As can be seen, when nail 32 and distance piece 30 were in engagement (or penetrating) position, blood sample (or other fluent material) can flow through nail 32 at once.In this case, nail 32 has the thickness that is equal to or greater than distance piece thickness.Yet if set up satisfied fluid connection between nail 32 and pipeline 22a, the situation that nail 32 has less than the length of distance piece thickness also can occur.
Fig. 4 a-4c and Fig. 5 show another the first syringe inlet 60 on another syringe S 1, and the flexible distance piece 62 of this instrument used for injection, this distance piece have the interior distance piece passage 64 with pipeline 22a fluid connection.Interlock assembly 66 is arranged in distance piece 62, only is used to control those and has the cross section of requirement and the spike of lateral dimension can enter distance piece pipeline 62.With reference to figure 5, interlock assembly 66 has the end flange 68 that has opening 70, and this opening has the cross section of predetermined cross section with coupling nail 32.End flange 68 can be uniquely according to one or more nail 32 structures, the spitting image of the mode of lock ﹠ key thus.This layout prevents that unauthorized nail is used for distance piece 62, and so that first order protection to be provided, wherein unauthorized nail has unapproved cross section.
Interior distance piece passage 64 is aimed at the opening 70 of end flange 68.As second level protection, interlock assembly 66 is equipped with a pair of eclipsed latch member 72, and this latch member is at operable position and not removable between the operable position, distance piece passage 64 in this element blocks when operable position.Will describe, interlock assembly 66 also comprises mobile device, and in the distance piece passage 64 time, this mobile device is used for interlock assembly is moved to not operable position in the nail with smallest lateral dimension appears at.
Each latch member 72 comprises outer locking flange 74, and it overlaps each other at operable position.Mobile device comprises shank 76, and this shank is positioned on each latch member 72 near outer locking flange 74, and this mobile device and end flange 68 form whole.Be arranged in distance piece passage 64 adjacent to each other at operable position shank 76, when the nail with smallest lateral dimension entered between the shank 76, shank can move to not operable position.
Therefore, if unauthorized small articles is used in trial, for example pin enters distance piece passage 64, and it otherwise is fit to by opening 70, and the width of this unauthorized wisp can not mesh and horizontal outside mobile shank 76 fully so.As a result, synergetic latch member 74 is still as the obturator that leads to distance piece passage upstream.On the other hand, engageable this shank 76 of the nail of suitable dimension also moves enough distances with them, so that latch member 72 breaks away from is overlapping, thus open space part passage 64.
With reference to figure 1 and 8-12, blood sample process chamber 12 has chamber inlet 80, with form with first syringe outlet 26 between first liquid of special use be connected so that untreated blood sample can be assigned in the blood sample process chamber 12.Blood sample process chamber 12 has distensible processing cavity 82, and this cavity is by cap 84, and bottom 86 and the flexible walls portion between them 88 form.Chamber 12 also has gas access end 90, gas outlet end 92 and expansion gas exchange port 94, the gas access end is used for delivery of ozone or other stresser with the processing blood sample, gas outlet end is used to discharge ozone, expansion gas exchange port provides pressure source, with (or afterwards) expansion (or evacuation contraction) this chamber before handling.The further feature of this process chamber can find in common unsettled United States Patent (USP) provisional application, and the serial number of this application is 60/482,725, and the applying date is on June 27th, 2003, and name is called " medical care control system ".
Flexible walls portion is made by the low density polyethylene (LDPE) (LDPE) that comprises a small amount of (about 5%) vinylacetic acid ethylene, and it can be at UVA, B and C, and infra-red range transmission radiation.Other parts of process chamber 12 also should can transmit the radiation of this wavelength similarly, and especially cylinder 178, and it is the containment blood sample during handling.
Chamber inlet 80 has spill collar portion 100, and this collar portion has the passage or the groove 102 of a pair of helical form orientation, and this passage extends through its wall or in wall, and is corresponding one or more from first syringe outlet, 26 outward extending pins 104 to mesh.
Valve element 106 is arranged in the pipeline 22a of syringe S 1 and is biased into the closed position of the valve seat 108 on end cap 109, and this end cap forms the outer end of first syringe outlet 26.Locate this valve element 106 and make it in abutting connection with valve starting element 110, this valve starting element is placed in the chamber inlet 80.Can operate this valve starting element 110, valve element 106 from supporting moving from its closed position of valve seat 108, is connected to open liquid.
By aiming at first syringe outlet 26 and spill collar portion 100, syringe S 1 interconnects with chamber inlet 80 thus, thereby sells 104 meshing spiral shape path 10s 2.Syringe S 1 is rotated in mode shown in Figure 13 then, advances and enters the spill collar portion downwards along spirality channel 102 thereby carry pin 104, in abutting connection with valve starting element 110, this valve element 106 is opened up to valve element 106.This process chamber 12 also has bearing element 112, is used to support syringe S 1, and it is in and chamber inlet 20 complete position engaged.
Blood sample process chamber 12 has chamber outlet 120, with form with second syringe S 2 between second liquid of special use be connected.With reference to figure 1,14 and 15, syringe S 2 has the second syringe body part 122 and blood sample hop 124.Blood sample hop 124 has the passage 126 that has first entry position 128, can operate this first entry position, with form with only between the chamber outlet 120 second liquid of special use be connected, its for blood sample in case can be assigned to after handling among the second injection S2, to be transported to morbidity people in source after being used for.
Refer again to Fig. 1,8,11 and 12, chamber outlet 120 has spill collar portion 140, this collar portion has the passage or the groove 142 of a pair of helical form orientation, and this passage extends through its wall or in wall, one or morely goes out 128 outward extending pins 144 from second syringe accordingly to mesh.Similarly, valve element 146 is arranged in passage 126 and is biased into the closed position of the valve seat 148 on end cap 149, and this end cap forms the outer end of second syringe outlet 128.Locate this valve element 146 in abutting connection with valve starting element 150, this valve starting element is placed in the chamber outlet 120.Thereby can operate this valve starting element 150, and valve element 146 is moved from the closed position of supporting valve seat 108, connect with open second liquid.Process chamber 12 also has bearing element 152, is used to support syringe S 2, and it is in and chamber inlet 120 complete position engaged.
With reference to the accompanying drawings 8,9 and 9a, cap 84 has cap member 160 and body element 162, and this body element 164 is fixed on the cap member in the cross point with bonding, welding or alternate manner.Body element 162 has outward extending therefrom flange 166, and has many locking passages 168, each passage be used to hold on the locking sleeve 172 to top connection 170, as shown in Figure 8.This sleeve 172 has many locking flanges 173, and wherein each locking flange is formed by local line of weakness 174 in the sleeve and a pair of adjacent vertical trench, and one of them groove is shown in 176.The lower end of each locking flange 173 is locked on the upper periphery of bottom 86.
Bottom 86 has the cylinder 178 of containment blood sample, and outer wall 178a stretches out therefrom.The vertical part of ring 180 engagement outer wall 178a also has circumference crimping 180a (Fig. 9), and the size of this crimping forms the seat that is fit to locking flange 173 lower ends.
Shown in Fig. 9 a, locking flange 173 can outwards move with respect to flange 166.Each locking flange 173 has brake(-holder) block 182, and this brake(-holder) block stretches out with the part of adjacency duct wall 184, and blood sample process chamber 12 is placed in this duct wall 184 in the sample treatment unit 14.Therefore, when process chamber was reduced in the processing unit 14, locking flange 173 caused bottom 86 to discharge from locking sleeve 172 with contacting of duct wall part 184.
By the conduit 190,192 that below valve starting element 110,150, extends respectively, chamber inlet 80 and chamber outlet 120 all with inter-process cavity 82 fluid connections.Conduit 190 is fixed on the column 194 that is formed on 86 inner surfacies of bottom.Conduit 190 has opening 190a from its nearer distance in upper end on its sidewall, this opening allows blood sample in conduit 190 by opening 190a and arrive the bottom of inter-process cavity 82.This minimizes the blood sample that remains in the conduit 190 after the processing.196 whiles of the 3rd conduit and gas outlet end 92 and expansion gas exchange port 94 fluid connections are provided.
With reference to figure 9, flexible walls portion 88 is upper periphery 88a cylindrical and that have body element of being adhered to 162, and is adhered to outer wall 178a and encircles the following peripheral 88b of the bottom 86 between 180.This flexible walls portion folds in the process chamber of not expansion as shown in Figure 9 then.
With reference to figure 9 and 10, cap member 160 also has by what inside and outside wall 197a and 197b limited and overflows collecting chamber 197.Overflow collecting tank 198 and be positioned to cover and overflow collecting chamber top on 160, this overflows collecting tank and is outwards limited by outer wall 198a.This overflows collecting tank 198 and overflows collecting chamber 197 and be connected by many passages that separate regularly 199.Therefore, overflow all will be collected in and overflow in the collecting chamber by any blood that causes that is connected between first or second syringe and the chamber entrance and exit.
With reference to figure 14-17, the second syringe body part 122 has cylindrical cavity, and this cavity cooperates with sampling receptive cavity 200 with piston.The second syringe body part 122 has second syringe outlet 202, and this outlet has the outer sleeve portion 204 around interior protuberance 206.The passage 126 of blood sample hop 124 has second entry position 210, and it is used for and second syringe outlet, 202 fluid connections.
Second syringe outlet 202 and blood-transmitted part 124 also have can discharge locking device, represents with 220 usually, connects with the 3rd liquid that is used for forming between second entry position 210 and second syringe outlet 202 locking.Will describe, the response release signal is operated this and can be discharged latch member 220, connects to discharge the 3rd liquid.When carrying out such release, can operate second syringe outlet 202, with form with normal blood sample delivery unit on liquid device between the 4th liquid be connected, wherein normal blood sample delivery unit has complementary LUER or similar device, for example syringe needle 222 as shown in figure 17.
With reference to Figure 18, second syringe outlet 202 comprises the second syringe outlet valve gear, represents with 230 usually, and this valve gear is used to control blood sample and passes flowing of outlet.Comprise valve componentry 232 and valve seat part 234 and be used for starting drive 236 with reference to Figure 21,22, the second syringe outlet valve gears 230 with respect to valve seat part 234 starter gate valve componentries 232.Will describe, when the second syringe body part 122 with 124 engagements of blood sample hop or when breaking away from, but operation start device 236, with at different direction movement of valve componentries 232.
With reference to Figure 16 and 21, blood sample hop 124 has shell 240, and this shell holds second syringe outlet 202.This shell 240 has the inwall 242 of exposed vias 126, and this pipeline is from stopping in resilient seal 244 places.Collar member 246 is placed in the shell 240 against sealing 244, and this collar member has central passage 248, and this central passage is by concave member 250 limited boundaries.This collar member 246 also has center cavity 252, to hold outer sleeve portion 204.
With reference to Figure 21, starting drive 236 comprises first actuating section 260 near protuberance 206, and when second syringe outlet 202 operationally was arranged in the collar member 246, this actuating section was moved by concave member 250.Screw thread oversheath 262 is positioned at second syringe outlet, 202 places, thereby for the LUER device provides screw thread, to connect syringe needle 222.This sheath 262 separates with protuberance 206, accepts passage 264 to form annular recess therein.First actuating section 260 adopts the form of a plurality of first starting elements 266, and these elements stretch out and are positioned the circular passage 264 from middle connecting plate 268.Can find out that from Figure 16 this middle connecting plate 268 is fixed to obturator 270, this obturator is placed in the passage 271 of main part 122 of syringe S 2 slidably.This obturator 270 has the centre bore 272 that holds tubular valve rod 274, and this valve rod one end carries valve componentry 232, and the other end carries stem head 276, and this stem head has the peripheral edge area that has circle of O shape for example or similar sealing member.This valve rod has a pair of liquid transfer hole 277 near valve componentry 232, thereby forms the inner valve passage, shown in dotted line 278, and this passage and chamber 200 fluid connections.
Therefore, when admission passage 264, concave member 250 contacts are also moved first starting element 266, and mobile successively valve rod 272 of this first starting element and valve componentry 232 make 278 pairs second pipelines of valve passage 126 in the valve rod 272 open thus.
Can find out that from Figure 21 and 22 starting drive 236 comprises second actuating section 282, this actuating section has side direction and stretches out and exceed a plurality of second valve starting elements 284 of sheath 262 peripheries.Will describe, with the functions reversed of the first valve starting element, 266 open to the outside world, the second outlet valve device 230, when second syringe S 2 is separated with blood sample hop 124, " closing " of the second valve starting element, 284 controls, the second outlet valve device 230.
Sheath 262 has angled end zone 262a, each second valve starting element 284 all has intilted free terminal zone 284a, this free terminal zone is nested together with stub area 262a when valve componentry 232 and valve seat part 234 mesh together, and provide firm but releasable connected mode, thereby when syringe S 2 when shell 240 is removed, valve componentry 232 is remained on against the position of valve seat part 234.Therefore, in use, when valve componentry 232 was removed with respect to valve seat part 234, the second valve starting element 284 moved along the outer surface of sheath 262.
The second valve starting element 284 comprises outward extending therefrom adjacent flanges 284b, can operate this adjacent flanges, to rely on the ring uplift 290 on the collar portion 246.With reference to Figure 22, can see this ring uplift 290 with angled or spiral helicine path along center cavity 252 circumference.Can see that this adjacent flanges is along 292 extensions of the longitudinal groove in second syringe outlet 202, as Figure 17, shown in 21 and 22.Also can design the size of this adjacent flanges 284b like this, make its protruding groove 292 (as shown in figure 21) when valve componentry 232 separates with valve seat part, but it is positioned at the below (as shown in figure 22) of layer height outside the groove 292 when valve componentry and valve seat part 234 mesh.This has considered the additional function that is started by the user, to close the second syringe outlet valve gear 230, for example when syringe S 2 is separated with syringe needle 222.In this case, in case syringe needle 222 has been removed, user can be held the adjacent flanges 284 exposed and extract these flanges out along groove 292, to close the second syringe outlet valve starting drive 230.
With reference to Figure 23, second syringe outlet 202 has one or more grooves 294, and these grooves extend along outer sleeve portion 204 with the part spiral way.The pin 296 that these grooves 294 are aimed in the center cavity 252 that stretches into collar member 246, thus need reverse and traction (as the banded arrow among Figure 23) syringe S 2 simultaneously, with from shell 240 retract syringes S2.Outer sleeve portion 204 also has hole 300, and when syringe operationally was arranged in shell 240, this hole was aimed at the hole 302 in the collar member 246.Aligned hole 300 and 302 can see in Figure 16, and as the part of latch member 220 and provide, promptly realizes by locking pin 304 is contained in wherein.This locking pin 304 is installed in the locking shell 306, and this locking shell has the sleeve pipe 308 that holds the head 310 of pin 304 with sliding relation.
In Figure 24 a, 24b and 25, can see the more details that can discharge locking device 220.Spring 311 is biased into head 310 in the sleeve pipe 308, thereby in the face of the off-position, removes from hole 300 at this off-position locking pin 304.This locking pin 304 has the groove 312 of receiving ring 314, and this ring is to the existence sensitivity of electric current, and this ring will shorten to second diameter from first diameter (shown in the solid line Figure 25) when electric current exists, shown in the dotted line among Figure 25.At its first diameter, this ring 314 is supported locking pin as support, is located at the full extended position in the hole 300,302.Accept scheduled current in case encircle 314, thereby its diameter reduces, ring 314 no longer has enough width to support locking pin 304 against sleeve pipe 308.Therefore, spring 311 is biased into position darker in the sleeve pipe with locking pin 304, thereby 300 discharges these locking pins 304 from the hole, thereby allows syringe S 2 to withdraw from shell 240.
Also have other layout can discharge the locking function by using release signal to provide similarly.For example, ring 314 can be replaced by ring or the circle that fuse materials is made, and this material is vaporized when having scheduled current or changed density, for example can be with known NITINOL electric fuse material manufacture.Select as another kind, ring 314 can be replaced by the bar (shown in dotted line 316) of identical fuse materials, and it is between the rear wall of the head 310 of locking pin 304 and sleeve pipe 308.Therefore, action bars 316 temporarily, so that locking pin 304 is supported on its full extended position.In this case, can provide scheduled current, thereby cause the bar vaporization and allow pin to discharge bar 316.
Figure 25 a-25d shows another layout, wherein locking pin 304 remains in the plate 317, spring latching device 318 is installed on the plate 317, and has a spring catch member 318a, this spring catch member is pivotally mounted on the pivot element 318b, at operating position, the spring bias voltage of its antagonistic spring element 318c is latched in the groove 312.In this case, provide fuse materials with the form that triggers element 31S1, this triggers element shortening when scheduled current exists or heat, and discharges this snap close, thereby allows pin 304 to discharge under the effect of spring 311.
With reference to Figure 11, the blood sample hop 124 of second syringe S 2 comprises the filtering exhaust mouth 320 in the passage 126, to be used for discharging one or more gas components of blood sample of having handled.In this case, air vent 320 comprises blocking layer 322, and its sample that allows the gas component in the blood sample will handle simultaneously from syringe S 2 discharges is retained in wherein.The more details of filtering exhaust mouth 320 can be 60/421 at serial number, 781, the applying date is on October 29th, 2002, name is called the U.S. Provisional Patent Application of " being used for the apparatus and method of gas from the controlled discharge of medical fluid output system ", with the applying date be on October 28th, 2003, serial number is PCT/CA03/01645, and name is called the international application of " being used for the apparatus and method of gas from the controlled discharge of medical fluid output system " and finds.
When system 10 uses syringe S 1 and S2, be to be understood that other device also can use, for example the liquid of one or more syringes alone or in combination, IV bottle, powder and/or atomizing and/or gas suck allotter, transplant and carry allotter, respiratory organ, syringe pump, intubate, gastrointestinal carrier pipe or their one and/or a plurality of combination.One of these therapy equipments also can comprise blood processor, for example serial number is PCT/CA00/01078, the applying date is JIUYUE in 2000 15 days, and name is called (full content of this application is quoted as a reference) that the international patent application of " apparatus and method that are used for handling mammalian " is described.As another selection, can equip a therapy equipment, carry out to invade or the non-intruding therapeutic domain, for example treatment for cancer and detection or diagnosis research, for example X ray, cat scan, MRI ' s or the like of operation, disease for example.
Will describe, this system provides a kind of verification agreement, and this agreement comprises that verification is checked several times, to guarantee that the suitable sample delivery of processing blood is to suitable source morbidity people.For this reason, as shown in figure 26, this system has identification device 350, to be used for the untreated blood sample of discriminating source morbidity people " P " in syringe S 1, with identification device 352, to be used for coupling and the release signal generating means 354 between the blood sample that verification source morbidity people " P " and syringe S 2 handled, produce release signal with the effective verification that is used for the response check device.This release signal is sent to and can discharges locking device 220, carrying scheduled currents to encircling 314, thereby syringe S 2 is operated, and is transported to source morbidity people with the blood sample that will handle.
Will describe, identification device 350 and release signal generating means 354 are positioned on the wrist strap 16.Can discharge locking device and have the signal receiving device 358 that receives release signal.At least some functions in the calibration equipment 352 are also contained in the wrist strap 16, as will be described.
With reference to Figure 27, calibration equipment 352 comprises the comparison means 360 of the blood sample authentication data that is used for comparison patient authentication data and has handled, one or more (perhaps untreated with reception with source morbidity people's authentication data and/or blood sample authentication data, perhaps handled, perhaps both) signal receiving device 364 of relevant signal, wherein patient's authentication data and processing blood sample authentication data all be stored in the storage device 362.In this case, these one or more signals comprise source morbidity people's authentication data and/or blood sample authentication data.Yet, to select as another, these one or more signals can comprise with patient or blood sample authentication data and interrelate or relevant data.For example, the data in this signal can comprise one or more codes, and this code allows data structure or some other position from storage device 362 to obtain patient's authentication data or blood sample authentication data, for example with the form of question blank.
Storage device 362 can comprise the time value data, and determining at least one time value relevant with scheduled event, this scheduled event comprises and/or between the blood sample conveying incident that is untreated the blood sample Collection Events and has handled.This time value also can comprise at least one consumption time value between two scheduled events, and these two incidents comprise and/or between the blood sample conveying incident that is untreated the blood sample Collection Events and has handled.In this case, exceeded predetermined consumption time during maximum, but the functional check device connects with the 3rd liquid that prevents locking and to discharge when consuming time value.
Before untreated blood sample is handled, exceeded predetermined consumption time during maximum when consuming time value, but also functional check device 352, in case the processing of hemostasis liquid sample.Similarly, in processing, but functional check device 352, with the coupling between untreated blood sample and the source morbidity people in verification first syringe.
The verification agreement can realize in a variety of forms, although present most preferred mode is to use one or more emission of radio frequency signals devices and receptor, with the form of chip or centreless (chipless), it is commonly referred to RFID chip or label (tag).In this case, as shown in figure 28, wrist strap 16 has " initiatively " WB RFID chip 370 and syringe S 1 and S2 have " passive " S1 RFID chip 372 (also with reference to figure 3) and S2 RFID chip 374 (also with reference to Figure 16) respectively.Term " initiatively " expression WB RFID chip 370 can send request signal to S1 RFID chip 372 and S2 RFID chip 374, and latter two chip can respond this request signal and operate, and perhaps transmits or reception and record data.This WB RFID chip 370 is initiatively, because it sends request signal to S1 RFID chip 372, to write the blood sample discriminating/checking data that is untreated thereon.
Can obtain the RFID chip of many " initiatively ", " passive " and centreless form now, comprise that trade mark is called TEXAS INSTRUMENTS, the chip of ISO 15693 RE Tag inlay; MELEXIS, the MLX90127 transponder; PHILIPS, the HT1DC2OS3O transponder; And Microchip, MCRF45S chip and comprise that trade mark is called SENSORMATIC, the no core pattern of Ultra.Strip  III; And CHECKPOINT ' sEAS label and labelling.At present, several coml chip tag can not stand to be used for medical components disinfectant gamma ray.Chipless Tag is better than chip tag usually aspect the gamma ray standing.Yet, consider its relative higher data capacity, chip tag is more attractive.Can expect that is to say chip tag is wrapped up with anti-gamma ray technology, thereby label can stand gamma ray by chip tag being used hard relatively coating solve the tender subject of gamma ray.Select as another, the development of Chipless Tag can improve their data capacity and data are write ability on it.Use other sterilizing gas for example other sterilization method of EtO (ethylene oxide,1,2-epoxyethane) also be suitable.
Blood treatment unit 14 has also been equipped RE communication, receives pretreated authentication data by active RFID chip 376 from S1 RFID chip 372, and the post processing data are write on the S2 RFID chip 374.Similarly, blood treatment chamber 12 is equipped with RFID chip 378 so that authentication code to be provided, and its reason will be described.
With reference to Figure 28, wrist strap 16 comprises removable part 380, and this removable part comprises WB RFID chip 370 and the inspection data of writing thereon, and these data are relevant with the blood sample of patient and/or processing.
As another selection, wrist strap can have the startup joint.For example, this startup joint can be included on the wrist strap, for wrist strap being worn on one's body the patient, must removing, cut off in some mode or forbid this startup joint.
Another is selected shown in Figure 30-32, and wherein wrist strap 381 comprises Belt with clasp assembly 382, and this Belt with clasp assembly has bottom 384 and cap 386.Bottom 384 forms with 388 integral body of being with of elastomeric material, and Belt with clasp assembly 382 is admitted in the perforation of many formation passages 390.This bottom 384 has pair of pin 392,394, and this size to pin is fit to by passage 390.This cap 386 is hinged to bottom 384 by active hinge 396.This cap 386 also has pair of holes 398, and each is used for admitting of pin 392,394.Start button 400 is between pin 392,394, and in the time of above band is positioned at, this start button can move to the enable position that flushes with base from the extended position of base top.When in enable position, but operation start button 400 with startup RFID chip 370, thereby begins S1 is broadcast request signal.Cap also has the LED light 402,404,406 of some (being 3) here, and these display lamps are with one or more different combination operations.Two LED 402,404 can be green, and LED 402 is used for syringe S 1, and LED 404 is used for syringe S 2.Each LED can operate, and to glimmer a stage, this stage represents that the verification agreement is at S1 or S2 treatment step.Can provide the 3rd LED 406 to be used for alarm condition.This wrist strap 381 also has removable part 408, and this removable part comprises the RFID chip and result from wherein inspection data when handling.
This verification agreement comprises many following authentication codes.First syringe S, the 1 designated first syringe authentication code, the wherein untreated blood sample of this coded representation, wrist strap 16 designated wrist strap authentication codes, this source morbidity people of this coded representation.For reducible data transmits, first syringe and wrist strap authentication code can comprise common data, although in that the data between them can be different or relevant in some cases.If desired, the first syringe authentication code can comprise very first time value, and this time value represents to collect from source morbidity people the time of untreated samples (or the allocate event before or after the sample collection step) and/or verification.
Therefore S1 RFID chip 372 plays the effect of first signal projector, and being used to launch first signal that carries source morbidity people authentication data, and the WB RFID chip 370 on the wrist strap 16 plays the effect of first signal receiver, to be used to receive first signal.Second syringe S, the 2 designated second syringe authentication codes, the blood sample that this coded representation has wherein been handled.The second syringe authentication code comprises second time value, and this time value represents that the blood sample handled delivers to the time of there (or the allocate event before or after the sample delivery step of having handled) and/or verification from blood sample process chamber defeated 12.
Therefore, S2 RFID chip 374 plays the effect of secondary signal emitter, to be used to launch the secondary signal of carrying the blood sample authentication data of having handled, WB RFID chip 370 plays the effect of secondary signal receptor, to be used to receive secondary signal, but functional check device wherein, the data of the blood sample of having handled with relatively first signal data and expression.
With reference to Figure 29, will discuss the verification agreement in conjunction with typical blood treatment program now.
At first, installation component except other article, comprises a wrist strap 16, S1 syringe, S2 syringe, sample treatment chamber 12 and many ready labels (shown among Fig. 1 410), has patient's authentication data of printing on the label.Start WB RFID chip 370 then for using.In this specific example, each S1RFID chip 372 and WB RFID chip 370 comprise common patient's authentication data, and these data are encoded to ID1.By at first in syringe, inject solution for example sodium citrate to come be that sample is prepared syringe S 1, as shown in Figure 7.
Syringe S 1 is used to extract out blood sample then.In case fill with, syringe S 1 is in the RE scope of wrist strap, and WB RFID chip 370 verifications of this wrist strap go out from S1RFID chip 372 to read or the data and the patient's authentication data ID1 that launch meet.In case drawn effect relationship, this WB RFID chip 370 writes " time data labelling " TS1 labelling on S1 RFID chip 372, thereby it carries Di+TS1 simultaneously now.In this case, the TS1 data are at that instantaneous time numerical value.
WB RFID chip 370 is worked by the request signal that sends rule to syringe S 1.S1 replys this request signal at last and returns the feedback signal that comprises S1 ID1 data, and these S1 ID1 data and wrist strap ID1 data are relatively.Then, in case obtained effect relationship, WB RFID chip 370 sends tracer signal, and this tracer signal comprises as the ID1 data of its " stem " and the time mark TS1 in its " payload (payload) " (being somebody's turn to do " stem " and " payload (payload) " is the known part in the type TS1 signal).The TS1 data will change along with the delay that increases, so the TS1 signal depends on that S1 syringe that blood sample is filled with after collecting replys time of wrist strap and difference.Wrist strap is measured when this program begins the consumption time of (just TS0, in this case, it is instantaneous for the WB startup) and the time point that S1 RFID chip is received this request signal then.In this case, if the consumption time between TS0 and TS1 surpasses predetermined maximum time, if desired, WB RFID chip 370 can suspend this process.
For example, now the code in the S1 RFID chip 372 can be expressed as: S1 ID112/31/03 14:00, the sample among this expression S1 from patient ID1 and this sample collection at 12/31/03 14:00 point record.
Time data TS1 can be measuring any time, but for convenience and based on " Internet time " or standard time, Greenwich Mean Time (GMT) for example, or other consumes time counting.
After S1 RFID chip 372 was received the TS1 data, the S1 syringe was installed to (the S2 syringe also navigates on it) on the chamber, and this chamber is transported to blood treatment unit (or BTU) 14 then.Here, the request signal that S1 RFID chip 372 receives from BTU RFID chip 376, and response with it send data ID 1+TS1.Delay between the time of BTU 14 calculating TS1 and arrival S1 then.In addition, the RFID chip 378 of BTU on blood treatment chamber 12 sends request signal, response with it, and FRID chip 378 sends the signal that comprises its authentication code to BTU.In this case, this authentication code comprises " permission " code, and its expression process chamber 12 also was not used in blood treatment in the past, had therefore reduced to pollute the risk of current untreated blood sample S1.As another selection, RFID chip 378 does not need to send the permission code, but only sends the signal that comprises authentication data, for example Item Number etc.
After having calculated time delay, BTU determines whether this time delays exceeds predetermined maximum value then, if like this, BTU 14 closes this program.Otherwise, being recorded among the BTU from the ID1 and the TS1 data of syringe S 1, this program is proceeded, and presses down piston on the syringe S 1 by the actuator among the BTU, untreated blood sample is transported to handles in the cavity 82.BTU 14 forbids S1 RFID chip 372 by writing prohibition code thereon then.In addition, the RFID chip 378 on the blood treatment chamber 12 comprises authentication code, and when blood sample is transported to it or receive the code of forbidding from BTU 14 afterwards, thereby prevent that process chamber 12 is used again.As another selection, RFID chip 378 can be forbidden with other method, and not need writing prohibition code thereon.For example, can use other technology that RFID chip 378 can not be operated, for example by sending signal, to cause fuse fusion wherein to RFID chip 378.
BTU 14 carries out the processing blood sample then, and this sample is transported to S2 then.This BTU writes S2 RFID chip 374 with D1 data and new time mark then, and this time mark is represented the end of blood sample processing " TS3 ".If desired, BTU 14 also can comprise the TS1 labelling, and the data that S2 RFID chip 374 is write in this expression can comprise ID1+TS1+TS2+TS3.In this case, TS2 comprises the processing time started, and TS3 comprises the processing concluding time.Additional as another selection or conduct, TS2 or TS3 can comprise the processing persistent period, or some other code, and all prior checking procedures of this coded representation are successfully carried out.
For example, BTU can write down following data:
S1?D1?12/31/03?14:00
Patient ID
Handle beginning 12/31/03 14:02
Processing finishes 12/31/03 14:20
S2?ID1?12/31/03?14:20
In this case, patient ID code can comprise that other the patient who manually or automatically imports BTU is equal to information, or is sent to other data of BTU from central data storage area, server computer, memory element etc.
In this case, BT ' LT then can be in S2 RFID chip 374 record: S2 ID1 12/31/03 14:20.
Syringe S 2 is carried back the source morbidity people who wears wrist strap then, WB RFID chip 370 constantly inquire about S2 RFID chip 374 up to the latter in scope, send D1 data and TS3 data then, these D1 data are read by WB RFID chip 370 subsequently.Wrist strap calculates the TS3 data and arrives time delay between time of S2 then, and the result is returned wrist strap.If exceed the time delay of expectation, wrist strap does not allow the work of S2 syringe.
Wrist strap Record ID 1 and time mark " TS4 ", this time mark represent that verification and ID1 confirm.In addition, if desired, wrist strap also can write down patient ID data and ID1+TS1+TS2+TS3.In this stage, WB RFID chip 370 sends release signal to S2 RFID chip 374, receive this signal after, S2 RFID chip 374 produces predetermined current at ring on 314, discharging locking pin 304, thereby makes S2 can carry out injection operation.
For example, WB RFID chip 370 therefore can record:
S1?ID1?12/31/03?14:00
S2?ID1?12/31/03?14:20
Sample mates 12/31/03 14:30
S2 removes locking 12/31/03 14:30
After the sample coupling between the ID1 data on its execution S2 RFID chip 374 and the WB RFID chip 370, when TS4 was recorded in the WB RFID chip 370, this verification agreement was finished.Then, WB RFID chip 370 is added to ID1 data (patient ID data and TS0, TS1, any one in TS2 and the TS3 data if desired) with the TS4 data.The removable part of wrist strap separate therefrom then and with source morbidity people's record coupling, this patient record returns BTU and is used for exchanges data between WB RFID chip 370 and the BTU14.
As another selection, can provide RF to read the inspection record gathering station, this gathering station is arranged in the patient record district of patient or armarium, thereby does not need the patient record is turned back to BTU.In this case, the inspection record gathering station can be downloaded the patient record to finish the inspection index.This RF reads the part that the inspection record gathering station can be the internal network of the armarium by wired or wireless FPDP, perhaps can be the part of the LAN of the one or more BTU system in the armarium.It can be collected data and allow and record on the medium later in batches, for example CD or other memory or storage device.It can append to that notebook computer, personal digital assistant, cellphone etc. are gone up or with its formation integral body.It also can show as the form of software of operation on computers, has RF on it and reads attachment device.
On the other hand, simply by provide the TS3 data can reduce the quantity of data to BTU, this BTU coupling is mated these data and ID1 data, and this shows the fact that the ID1 data must be mated based on TS4, just exists because TS4 has only when initial WB ID data and S2 Data Matching.
Be transported to BTU by ID1 and TS4 then or other system finishes the inspection index.
Time mark also can comprise " incident " code, and it can comprise five main incidents:
1) the WB time started
2) S1 replys WB
3) begin to handle
4) end process
5) coupling between blood sample of having handled and the source morbidity people.
This time mark also can comprise in a plurality of error events any one or a plurality of:
1) do not match
2) collect before/the S1 WB that do not match afterwards
3) the S2 WB that do not match during returning after handling
4) time delay-exceed the blood collecting time
5) time delay-exceed sample delivery is to the time of BTU
6) time delay-exceed the time of returning patient.
The TS3 time mark also can comprise following " coupling " code:
01 coupling
02 does not match
Discriminating means that calibration equipment and/or release signal generating means can be positioned at several possible positions.For example, calibration equipment and/or release signal generating means can be positioned on second syringe S 2, for example in locking shell 306.In this case, S2 RFID chip 374 can be worked, thereby sends request signal to receive the signal that comprises WB ID signal therefrom to wrist strap 16, carries out the comparison between WB ID data and the ID1 data then.
As another selection, calibration equipment, identification device and/or release signal generating means can be positioned on blood sample hop or the blood treatment unit.
Wrist strap 16 can be replaced by some other article, and these article can be dressed, carry, tie up or be absorbed by patient, for example use the label of safety pin setting fastening or self-adhesion etc.
Although this utility model is described by the form of thinking preferred embodiment at present, this utility model is not limited to this.On the contrary, this utility model wants to cover various modifications and the equivalent structure in the spirit and scope that are included in accessory claim.The scope of following claim is consistent with its most wide in range explanation, thereby comprises all such modifications and equivalent structure and function.

Claims (24)

1. system that is used to handle the autoblood sample is characterized in that comprising:
The blood sample process chamber, it has the chamber inlet;
First syringe, it has first main part and the first sample hop, and wherein the first sample hop has from patient and extracts first syringe inlet of untreated blood sample and distribute first syringe outlet of this untreated blood sample;
Having set up special use first liquid that untreated blood sample is assigned in the blood sample process chamber between the inlet of first syringe outlet and chamber is connected;
This blood sample process chamber has the chamber outlet that is used for the allocation process sample of processing blood afterwards;
Second syringe, it has second main part and the second sample hop, wherein the second sample hop has passage, this passage has first entry position, its with chamber outlet between formed special use second liquid that receives from the sample of processing blood of described blood sample process chamber and be connected;
This second main part has second syringe outlet;
Control distributes the locking device of processing blood from described second syringe, and it combines with described second syringe;
Be used to untreated blood sample discriminating source morbidity people's identification device;
The calibration equipment of the coupling between the blood sample that is used for verification source morbidity people and has handled;
Discharge the release signal generating means of described locking device according to definite result of processor.
2. the system as claimed in claim 1 is characterized in that:
Described passage in described second hop has second entry position with the described second syringe outlet fluid connection;
Described locking device forms locking between described second entry position and second syringe outlet the 3rd liquid connects;
Described locking device discharges described the 3rd liquid in response to release signal and connects; With
Second syringe outlet connects from described the 3rd liquid and discharges, and second syringe outlet forms the 4th liquid with the blood sample supply unit and is connected.
3. system as claimed in claim 2 is characterized in that: identification device and/or release signal generating means are positioned on second syringe body.
4. system as claimed in claim 3 is characterized in that: identification device and/or release signal generating means are positioned on the second sample hop, and locking device further comprises the signal receiving device that receives this release signal.
5. system as claimed in claim 3 is characterized in that: identification device and/or release signal generating means are positioned on the outer goods, and locking device further comprises the signal receiving device that receives this release signal.
6. system as claimed in claim 5, it is characterized in that: outer goods comprises wrist strap.
7. system as claimed in claim 6 is characterized in that: outer goods comprises a removable portion that contains the inspection data relevant with patient and/or the blood sample handled.
8. system as claimed in claim 5 is characterized in that calibration equipment comprises the data comparison means; Data sink; And data storage device.
9. system as claimed in claim 8 is characterized in that: described identification device comprises sender unit.
10. system as claimed in claim 9 is characterized in that: described sender unit is positioned on first syringe, wrist strap and second syringe.
11. the system as claimed in claim 1, it is characterized in that: first main part of first syringe comprises untreated blood sample receptive cavity, the first sample hop comprises the passage that connects this be untreated blood sample receptive cavity and first syringe inlet and first syringe outlet and is used to control the first syringe inlet valve device that blood flow is crossed first syringe inlet.
12. system as claimed in claim 11 is characterized in that: the first syringe inlet valve device comprises distance piece, also comprises complementary piercing elements, and this element is positioned on the outside blood collecting article or therebetween, and is in the position of engagement with it.
13. system as claimed in claim 12 is characterized in that: the second blood sample hop comprises the filtering exhaust mouth of one or more gas componants that are arranged in this passage and are used for discharging the blood sample of having handled.
14. system as claimed in claim 13, it is characterized in that: special-purpose first and second one or two first sample hop of locking first syringe and second sample hops of second syringe releasedly in connecting, and the blood sample process chamber is in liquid transfer open state separately.
15. system as claimed in claim 14, it is characterized in that: swing offset relatively between the blood sample process chamber and the corresponding first and second sample hops, and special-purpose first and second in connecting one or two have formed the liquid transfer open state of locking.
16. system as claimed in claim 15 is characterized in that: second syringe outlet comprises the second syringe outlet valve gear of the blood sample that control is flow through.
17. system as claimed in claim 16 is characterized in that: the second syringe outlet valve gear comprises valve componentry, valve seat part and with respect to the starting drive of valve seat part starter gate valve componentry;
Second main part meshes the second sample hop, and this starting drive is removed the valve element from valve seat part.
18. system as claimed in claim 17, it is characterized in that: the second sample hop comprises the shell that can hold second syringe outlet, this shell has the concave member with the second entry position fluid connection, and second syringe outlet comprises the protuberance that meshes this recess;
Starting drive comprises the actuating section near protuberance, recess and protuberance engagement, and this actuating section is moved by recess.
19. system as claimed in claim 18 is characterized in that further comprising the oversheath part that separates with protuberance, and forms annular recess therein and accept passage, actuating section comprises at least one first starting element that is arranged in the circular passage.
20. system as claimed in claim 19 is characterized in that: the second syringe outlet valve gear comprises valve componentry, valve seat part and with respect to the starting drive of valve seat part starter gate valve componentry;
Second main part separates with the second sample hop, and this starting drive makes valve element and valve seat part mesh, and the second syringe outlet end parts stretches out from second main part.
21. system as claimed in claim 20 is characterized in that: actuating section comprises at least one second valve starting element, and this component side exceeds the second syringe outlet end parts to stretching out.
22. system as claimed in claim 21 is characterized in that: second port of export partly has angled end, and the second valve starting element has stub area, and this stub area meshes the angled end of second port of export part.
23. the system as claimed in claim 22 is characterized in that: valve componentry and valve seat part engagement, and the inclination of the stub area of the second valve starting element, entangle second port of export angled end partly.
24. system as claimed in claim 23 is characterized in that further comprising the collar member that is arranged in shell, this collar member comprises holds second port of export part to form the chamber that the 3rd liquid connects.
CN 200420122358 2003-11-21 2004-11-22 System for treating one-self blood sample Expired - Fee Related CN2907683Y (en)

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US60/523,701 2003-11-21

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TW200519382A (en) 2005-06-16
CN1901955A (en) 2007-01-24
HK1076350A2 (en) 2006-01-13
AR048660A1 (en) 2006-05-17

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