CN103543185A - Testing cartridge for an in vitro medical diagnostic device - Google Patents

Testing cartridge for an in vitro medical diagnostic device Download PDF

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Publication number
CN103543185A
CN103543185A CN201310322066.8A CN201310322066A CN103543185A CN 103543185 A CN103543185 A CN 103543185A CN 201310322066 A CN201310322066 A CN 201310322066A CN 103543185 A CN103543185 A CN 103543185A
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China
Prior art keywords
test card
fluid
valve
medical diagnosis
diagnosis device
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CN201310322066.8A
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Chinese (zh)
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CN103543185B (en
Inventor
林朝
保罗大卫斯旺森
赵志翔
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Edan (united States) Diagnostics Ltd
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Edan (united States) Diagnostics Ltd
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Priority claimed from US13/707,513 external-priority patent/US8986527B2/en
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Abstract

The present disclosure relates to a removable assay cartridge containing a polymer body with channels for fluid movement for an in vitro medical diagnostic device. The device also includes a removable calibration fluid cartridge.

Description

A kind of test card for external medical diagnosis device
Technical field
The present invention relates to technical field of medical instruments, particularly a kind of test card for external medical diagnosis device.
Background technology
galvanochemistry diagnostic device is the analysis apparatus that Chemical recognition parts or biochemical identification component (for example, enzyme or antibody) are combined with the physical transformation device such as platinum electrode.Chemical recognition parts or biochemical identification component can be used for optionally interacting and generating electric signal by converter with interested analyte.The selectivity of some biochemical identification component makes it can develop electrochemical sensor, and described electrochemical sensor can detect some biological analyte in blood exactly.
traditional in-vitro diagnosis test is carried out in large-scale well-equipped test center.These traditional test centers provide large volume fluid sample effectively and test accurately, but direct result can not be provided.Medical practitioner must collect fluid sample, and described fluid sample must be transported to laboratory, and then by laboratory treatment, last, result is transmitted to patient.Traditional in-vitro diagnosis test does not provide direct result.
in addition, traditional in-vitro diagnosis test needs training laboratory technician to carry out test, thereby guarantees accuracy and the reliability of test.The mistake in using being caused by the personnel of processing sample may cause surface contamination, sample to overflow or the diagnostic device that causes R and M cost to increase damages.Traditional in-vitro diagnosis test needs those skilled in the art to carry out a plurality of stages of test processes, and still has mistake in using.
the application requires the U.S. Provisional Patent Application No. 61/567 that themes as < < Diagnostic Device > > submitting on Dec 6th, 2011,585 benefit and preference, the whole open of this application is integrated into herein by reference.The application also requires in benefit and the right of priority of the U.S. Provisional Patent Application No. 61/725,476 of submission on November 12nd, 2012, and the integral body of this application merges to herein by reference.
Summary of the invention
embodiment of the present disclosure relates to diagnostic system.Diagnostic system comprises: removable test card, and described removable test card comprises fluid passage and several electrochemical sensors; Removable pack; And, diagnostic device, described diagnostic device has housing and for carrying out the processing electron device of the diagnosis in described housing.Housing further comprises: the first opening, and described the first opening is for receiving at least part of removable test card; And, the second opening, described the second opening is for receiving at least part of removable pack; The processing electron device of diagnostic device receives the signal from electrochemical sensor, removable test card and removable pack engage, intercommunication for fluid, make any surface that snaps into diagnostic device from removable test not have fluidic intercommunication, and there is not fluidic intercommunication in any surface from removable pack to diagnostic device.
in this embodiment, diagnostic system can comprise one or more valve control mechanisms.Valve control mechanism comprises cam disc, and described cam disc is configured to rotation, and described cam disc is under the control of processing electron device and have one or more locked grooves that comprise one or more lift portion.Valve control mechanism also comprises one or more valve actuators with one or more guide portion, and described guide portion is configured to align with locked groove, thereby when cam disc rotates, maintains and the contacting of locked groove.Valve actuator is configured to actuate one or more valves when guide portion runs into the lift portion of cam disc, and valve is configured at least be controlled at flowing of fluid in removable test card.
another embodiment of the present disclosure relates to diagnostic device.Described diagnostic device comprises: housing, and described housing has for receiving the test card port of removable test card; Circuit, when removable test card is fully arranged in test card port, described circuit receives the data of at least one electrochemical sensor on comfortable removable test card; Process electron device, described processing electron device is configured to receive the data that data and use from circuit receive and carries out diagnosis; And, valve control mechanism, described valve control mechanism is in the control of processing electron device, and is configured to be controlled at flowing of fluid in removable test card, and does not need the fluid of contact in removable test card.
in this embodiment, valve control mechanism can comprise cam disc, and described cam disc is configured to rotation, and described cam disc is under the control of processing electron device and have one or more locked grooves that comprise one or more lift portion.Valve is controlled mechanism well and is also comprised one or more valve actuators with one or more guide portion, and described guide portion is configured to align with locked groove, when cam disc rotates, maintains and the contacting of locked groove.Valve actuator can be configured to actuate one or more valves when guide portion runs into the lift portion of cam disc, and valve is configured at least be controlled at flowing of fluid in removable test card.
another embodiment of the present disclosure relates to the valve control mechanism for diagnostic device, and described diagnostic device is configured to receive removable test card.Valve control mechanism comprises having the engagement device that pre-determines circulation portions a little with one or more, described engagement device is configured to pre-determine and locate to engage one or more actuators circulation portions one or more, when valve actuator is engaged by engagement device, one or more valve actuators are configured to actuate one or more valves.Valve is configured at least be controlled at flowing of fluid in removable test card.
another embodiment of the present disclosure relates to the pack for diagnostic device.Pack comprises: chamber, and described chamber is used for storing untapped calibration solution; Flow channel, described Flow channel is configured to receive from the calibration solution of described chamber and calibration solution is offered to efferent; And, pinched valve, described pinched valve is configured to control flowing by the calibration solution of fluid passage.In this embodiment, pack is not carried the mechanism of actuating that controls pinched valve.
another embodiment of the present disclosure relates to the pack for diagnostic device.Described pack comprises: chamber, and described chamber is for storing the calibration solution not being used; Flow channel, described Flow channel is configured to receive from the calibration solution of described chamber and calibration solution is offered to efferent; Connecting portion, described connecting portion is for being received in the gas of fluid channel; And valve system, makes gas and calibration solution can controllably flow to efferent.
another embodiment of the present invention relates to and comprises having at least test card for external medical diagnosis device of the housing of top ends and bottom.Described top ends comprises import, described import comprise for receive comprise sample fluid can acceptance division interface.For the test card of external medical diagnosis device further comprise with for receiving the import of sample fluid to become the sample fluid channel of fluidic intercommunication, identical fluid channel is interrupted by valve, described valve Quality control fluid flows in inner fluid channel, and described inner fluid channel becomes fluidic intercommunication with following: (i) calibration solution channel; (ii) array, described array comprises several electrochemical sensors; And the (iii) downstream, discarded region of array, the downstream, discarded region of described array comprises several electrochemical sensors, described electrochemical sensor comprises for receiving the waste fluid that uses calibration solution.In this embodiment, bottom comprises: the second import, and described the second import is for being incorporated into calibration solution channel by calibration solution or air; And, outlet, described outlet is used for and forcing pump or vacuum pump intercommunication, for aspirating calibration solution, air or sample fluid.
another embodiment of the present disclosure relates to the valve control mechanism for diagnostic device, and described diagnostic device is configured to receive removable test card.Valve control mechanism comprises the cam disc that is configured to rotation, cam disc has one or more locked grooves that comprise one or more lift portion, one or more valve actuators have one or more guide portion, described guide portion is configured to align with locked groove, thereby when cam disc rotates, described guide portion maintains and the contacting of locked groove.Valve actuator is configured to actuate one or more valves when guide portion runs into the lift portion of cam disc, and valve is configured at least be controlled at flowing of fluid in removable test card.
Accompanying drawing explanation
for ease of explanation, the present invention is described in detail by following preferred embodiment and accompanying drawing.
fig. 1 is according to the external medical diagnosis device of exemplary embodiment and the skeleton view of attached test card.
fig. 2 is the skeleton view of the external medical diagnosis device of Fig. 1.
fig. 3 is the side view of the external medical diagnosis device of Fig. 1.
fig. 4 is the opposite side view of the external medical diagnosis device of Fig. 1.
fig. 5 is the opposite side view according to the external medical diagnosis device of exemplary embodiment Fig. 1.
fig. 6 is the rear view of the external medical diagnosis device of Fig. 1.
fig. 7 is inserted into test card according to exemplary embodiment the skeleton view of medical diagnosis device.
fig. 8 is the front view of the test card of Fig. 7.
fig. 9 is the rear view of the test card of Fig. 7.
figure 10 A is the schematic diagram of the system that provided by diagnostic device according to exemplary embodiment.
figure 10 B is the close up view (the B enlarged drawing in Figure 10 A) of the node on the fluid passage of test card according to exemplary embodiment.
figure 10 C is the close up view (the C enlarged drawing in Figure 10 A) of the fluid passage web member between test card and pack according to exemplary embodiment.
figure 11 A is connected to test card so that the schematic diagram of the pack of the mobile fluid passage of the fluid that is formed for being actuated by pump according to alternate embodiments.
figure 11 B is the close up view (the B enlarged drawing in Figure 11 A) of the node on the fluid passage of test card according to alternate embodiments.
figure 11 C is the close up view (the C enlarged drawing in Figure 11 A) of the fluid passage web member between test card and pack according to substitutability embodiment.
figure 12 is the simplification rear view of the test card of Fig. 7.
figure 13 is the linear list diagram by the fluid flowing passage of the test card of Fig. 7.
figure 14 is by the cross-sectional illustration of the fluid of the electronic fluid sensor of the test card of Fig. 7 according to the stream of exemplary embodiment.
figure 15 is according to the rear view of the test card of substitutability embodiment.
figure 16 has the rear view of test card of Figure 15 of the fluid that is full of test card according to substitutability embodiment.
figure 17 is the linear list diagram by the fluid flowing passage of the test card of Figure 15.
figure 18 A is shown in the viewgraph of cross-section of the universal syringe interface of the first size syringe on test card according to exemplary embodiment.
figure 18 B is shown in the viewgraph of cross-section of the universal syringe interface of the second size syringe on test card according to exemplary embodiment.
figure 18 C is shown in the viewgraph of cross-section of the universal syringe interface of the third size syringe on test card according to exemplary embodiment.
figure 19 has the front view of the test card of the syringe being loaded from top according to substitutability embodiment.
figure 20 is the front view of the test card 90 of Figure 19.
figure 21 has kapillary and is coupled to the rear view of test card of Fig. 1 of the kapillary adapter of test card according to exemplary embodiment.
figure 22 is the rear view of test card of Figure 15 that has kapillary and be coupled to the kapillary adapter of test card.
figure 23 comprises the skeleton view of the test card of the valve actuator of actuating the pinched valve on test card according to exemplary embodiment.
figure 24 comprises the cross-sectional side view of test card of Figure 23 of the valve actuator of actuating the pinched valve on test card according to exemplary embodiment.
figure 25 A is the cross-sectional illustration of the pinched valve in off-position according to exemplary embodiment.
figure 25 B is the cross-sectional illustration of the pinched valve in open site according to exemplary embodiment.
figure 26 A actuates the skeleton view of the pinch valve actuator of the pinched valve on test card according to substitutability embodiment.
figure 26 B actuates the cross-sectional side view of the pinch valve actuator of the pinched valve on test card according to substitutability embodiment.
figure 27 A is the cross-sectional illustration of the pinched valve in off-position according to substitutability embodiment.
figure 27 B is the cross-sectional illustration of the pinched valve in open position according to substitutability embodiment.
figure 28 is the translucent skeleton view according to the pack of exemplary embodiment.
figure 29 comprises the cross-sectional side view of pack of Figure 28 of calibration solution bag according to exemplary embodiment.
figure 30 A is included in the feature viewgraph of cross-section of shape valve stem valve of pack of Figure 28 of the shape valve stem valve in open position according to exemplary embodiment.
figure 30 B is included in the feature viewgraph of cross-section of shape valve stem valve of pack of Figure 28 of the shape valve stem valve in off-position according to exemplary embodiment.
figure 31 comprises T connector and from the cross-sectional illustration of the pack of the fluid passage of pack and Figure 28 of air duct according to exemplary embodiment.
figure 32 is according to the skeleton view of exemplary embodiment pack and two pinch valve actuators.
figure 33 comprises the cross-sectional side view of pack of Figure 32 of calibration solution bag according to exemplary embodiment.
figure 34 A is the viewgraph of cross-section (the A enlarged drawing of Figure 33) of the pack pinched valve in off-position according to exemplary embodiment.
figure 34 B is the viewgraph of cross-section (the B enlarged drawing of Figure 33) in the pack pinched valve of off-position according to exemplary embodiment.
figure 35 is the translucent skeleton view according to the pack of substitutability embodiment.
figure 36 comprises the viewgraph of cross-section of pack of Figure 35 of calibration solution bag and T connector according to substitutability embodiment.
figure 37 is the skeleton view and the viewgraph of cross-section that is illustrated in the pack of the shape valve stem valve in off-position of the pack of Figure 35.
figure 38 is another skeleton view and the viewgraph of cross-section that is illustrated in the pack of the shape valve stem valve in open position of the pack of Figure 35.
figure 39 illustrates another skeleton view of pack of Figure 35 of pinch valve actuator according to exemplary embodiment.
figure 40 is the viewgraph of cross-section of the pack of Figure 39, and described pack comprises the pinch valve actuator of the pinched valve that engages pack.
figure 41 A is the feature viewgraph of cross-section in the pack pinched valve of off-position according to exemplary embodiment.
figure 41 B is the feature viewgraph of cross-section of the pack pinched valve in open site according to exemplary embodiment.
figure 42 A is according to the close-up illustration of the fluid path of exemplary embodiment pack.
figure 42 B is according to the viewgraph of cross-section of the fluid path of exemplary embodiment pack.
figure 43 A is the close-up illustration of fluid path that comprises Figure 42 of T connector.
figure 43 B is the viewgraph of cross-section of fluid path that comprises Figure 42 of T connector.
figure 44 is the figure of hardware organization according to the external medical diagnosis device of exemplary embodiment.
figure 45 is the figure of software organization according to the external medical diagnosis device of exemplary embodiment.
figure 46 is for controlling pinched valve detent and for the skeleton view of the Power Component of the heating element of diagnostic device according to exemplary embodiment.
figure 47 is for controlling the side view of engine pack of the pinched valve detent of diagnostic device according to exemplary embodiment.
figure 48 is for controlling another skeleton view of engine of the pinched valve detent of diagnostic device according to exemplary embodiment.
figure 49 is for controlling another skeleton view of engine of the pinched valve detent of diagnostic device according to exemplary embodiment.
figure 50 is for actuating the independently skeleton view of the engine of pinched valve according to exemplary embodiment.
figure 51 is for controlling another skeleton view of engine of the pinched valve detent of diagnostic device according to exemplary embodiment.
figure 52 is the skeleton view of the engine embodiment of Figure 47.
figure 53 A be according to exemplary embodiment for future self calibration liquid bag calibration solution be provided to the side view of the L shaped connector of pack.
figure 53 B is the rear view of the L shaped connector of Figure 53 A.
figure 53 C is the front view of the L shaped connector of Figure 53 A.
Embodiment
In order to make object of the present invention, technical scheme and advantage clearer, below in conjunction with drawings and Examples, the present invention is further elaborated.Should be appreciated that specific embodiment described herein, only in order to explain the present invention, is not intended to limit the present invention.
the present invention relates to comprise the external medical diagnosis device 10 of removable and vendible solution pond or pack.This device also comprises removable test card 20.In the exemplary embodiment, removable test card 20 comprises: polymer body, and described polymer body has the channel 32 for fluid motion; Valve system, described valve system is for changing or fluid-encapsulated channel; Receive port 34, described receiving port 34 is for admitting fluid sample 39; And, several sensors 57.Diagnostic device 10 can analyze from the input of sensor 57, use from the input of sensor 57 implement diagnosis and output information (for example, via display, via the report of printing, etc.).
referring to figs. 1 to 6, according to exemplary embodiment, external medical diagnosis device of the present disclosure is shown.Fig. 1 is the skeleton view that uses the external medical diagnosis device 10 shown in the removable test card 20 being inserted into fully in device 10.Fig. 2 is the skeleton view of external medical diagnosis device 10.Fig. 3 is the side view of external medical diagnosis device 10.Fig. 4 is another side view of external medical diagnosis device 10.Fig. 5 is the opposite side view according to the external medical diagnosis device of exemplary embodiment Fig. 1, and this figure shows opens the door 14 and the placement of the pack in described medical diagnosis device 30.Fig. 6 is the rear view of external medical diagnosis device 10.
external medical diagnosis device 10 has the housing 27 that shell is offered to device 10.Housing 27 can be plastics or any other material that is applicable to this application.In-vitro diagnosis device 10 is configured to admission test card 20(and further illustrates in Fig. 7 to 9).Test card 20 is inserted in test trough 22.In the illustrated embodiment of Fig. 1, fluid sample 39(is housed, biological specimen, pharmaceutical samples, etc.) syringe be used for fluid sample 39 to distribute in test card 20.Diagnostic device 10 be configured to test fluid flow sample 39 and via efferent by report the test to user.In the illustrated embodiment of Fig. 1, install 10 and be shown to comprise for the display screen 18 of efferent is provided.Yet in this embodiment or other embodiment, this result of laboratory test can also or alternatively can report to user by other efferents, comprises audio output part, data communication efferent, or printout portion, etc.
in the exemplary embodiment, once fluid sample 39 is tested, test card 20 just can be removed from installing 10.Device 10 can comprise and launches button 16, once test, launches button 16, to test card 20 is hit by a bullet and is shot out from test trough 22 described in user just can press down.When test loop completes, diagnostic device 10 can also be configured to automatically launch test card 20.In the exemplary embodiment, test card 20 is just finished and abandons (that is, test card 20 can be removed and substitute).In some exemplary embodiment, test card 20 can be disposable (that is, uses once and then just substitute with other test card 20).In other exemplary embodiments, test card 20 can be recycled and make to surpass a fluid sample 39 for test.Diagnostic device 10 is intended that portable, has for carrying handle 26 and the size of mancarried device 10 and is set to coordinate on the table.
in the exemplary embodiment, diagnostic result is displayed on display screen 18.The processing electron device of this device 10 can make display 18 show the information relevant with application-specific.Display screen 18 can be that to be configured to output display can be to be maybe configured to receive and response user's the touch-screen that contacts input to user's one.In the exemplary embodiment, diagnostic device also comprises print cup 12, and described print cup 12 is configured to receive by the paper that is contained in the printer output in this diagnostic device 10.
diagnostic device 10 for example can also comprise one or more heating element 116(, goes out as shown in Figure 47).In the exemplary embodiment, heating element 116 is the one or more heating plates that are positioned in the test trough 22 of diagnostic device 10.In the illustrated embodiment of Fig. 1 to 6, two heating elements 116 are configured, and make, when test card 20 is inserted in diagnostic device 10, to have the heating element 116 on each side that is positioned in test card 20.Heating element 116 instigated fluid in the part of detecting 42 that is controlled at test card 20 (for example, fluid sample 39, calibration solution, etc.) heating, thereby make fluid maintain substantially invariable temperature.In the exemplary embodiment, heating element 116 is controlled so as to the substantially invariable temperature place that this fluid is remained on to about 37 degrees Celsius (about 98.6 deg. F.s).Along one or more plane heating element 116(part of detecting 42 can comprise several, heating plate) hole (that is, fluid pool) that is positioned.Described hole is configured to this fluid to remain in part of detecting 42, makes heating element 116 can control the temperature of this fluid.
according to the illustrated embodiment of Fig. 1 to 6, external medical diagnosis device 10 also comprises pack door 14.Pack door 14 is shown to open from diagnostic device 10.Pack door 14 and the opening after described pack door 14 are sized, to receive disposable reagent bag 30(to be further shown specifically in Figure 28 to 43).Pack door 14 is opened by bolt 13 in the illustrated embodiment, but also can be by other mechanism opening in other exemplary embodiment.Bolt 13 is adjacent to door 14 and is positioned.It after pack door 14, is the pack port that is configured to receive pack 30.
in the exemplary embodiment, diagnostic device 10 comprises the pack door lock 23 being positioned near pack door 14.Pack door lock 23 has latched position and lockset position of coupler and can be fastened between these two positions by pack door key.In some exemplary embodiment, pack door key is found in reagent clad and (describes in further detail in the following description).In other embodiments, can be found on other positions on diagnostic device 10, can to carry out the individual sheets part of self-diagnosis system 10 can be maybe pack 30 to pack door key.Pack door key can be removed and be configured to locking or untie pack door lock 23 from reagent clad or other positions.When pack door lock 23 is during in latched position, pack door 14 is locked and must not open.Pack door lock 23 is configured to prevent that pack 30 is damaged.In other embodiment, when pack door be closed and must via by user interface key (for example, the soft key on display, the hardkey of keyboard, etc.) when just obtainable password is just opened, pack door is locked acquiescence and is engaged.
in the exemplary embodiment, external medical diagnosis device 10 can comprise that one or more port 24(are shown in Figure 3).These ports 24 are configured to receive hawser or other bindiny mechanisms.Port 24 can be used for the information that diagnostic device 10 is connected to other sheet parts (for example,, via communication network) of equipment or can be used for uploading or downloading to diagnostic device 10.Comprise by Wi-Fi(wireless Internet access technology), by other wireless network, connect or exchange by any other wireless messages, diagnostic device 10 also can be configured to swap data.Diagnostic device 10 also can comprise power supply input 19, and this power supply input 19 can receive to diagnostic device 10 chargings or provide the power supply of power supply to supply web member.Diagnostic device 10 also comprises loudspeaker 21, and described loudspeaker 21 can be used for noise or sound reaction to pass to user.Diagnostic device 10 can also comprise handle 26, and described handle 26 can be used for controlling mancarried device 10.Described handle 26 depends on whether it is used and rotation between the two positions.In the illustrated embodiment of Fig. 6, handle 26 is not used, and therefore, it is rotated down, against the back of the body surface of diagnostic device 10 and depart from user.In the exemplary embodiment, diagnostic device 10 can also comprise supporting leg 11, and described supporting leg 11 is configured to allow diagnostic device 10 to rest on desktop or other surfaces.
diagnostic device 10 can also comprise light source, and (for example, LED), described light source is positioned to illuminate test card 20.Light source can be configured to illuminate test card 20, so that indication test mode, or for being suitable for any other object of application-specific.As required or expectation application-specific, light source can be that daylight lamp can be maybe the light of any other type.
in the exemplary embodiment, diagnostic device 10 also comprises bar code scanner 15, and described bar code scanner 15 is installed in the side of diagnostic device 10.Barcode scanner 15 be configured to scanning in test the bar code on test card 20, calibration solution bag 54, liquid quality control solution or have can scanning bar code and be used in any other entry of this diagnostic device 10.Barcode scanner 15 also can be used for the bar coded sticker that scanning represents patient identity or operator's identity.In the exemplary embodiment, the light beam of these scanner 15 transmitting cover strip shape codes.If bar code is successfully scanned, diagnostic device 10 is just sounded a buzzer, and light beam is just automatically closed.If bar code is not successfully scanned, diagnostic device 10 will be by making a noise or passing through a certain other efferents reminding user on display screen 18.In the exemplary embodiment, barcode scanner 15 is barcode scanners of one dimension.In other embodiments, barcode scanner 15 is two-dimentional scanners.
with reference now to Fig. 7 to 9,, according to exemplary embodiment, test card 20 is shown.Test card 20 comprises card 36.In the exemplary embodiment, card 36 is transparent at least partly.Card 36 can be made by molded plastics, other material or kit.Card 36 provides protection to test card 20.In the illustrated embodiment of Fig. 7 to 9, at least one part of card 36 is capped to be useful on the film of sealing channel or to be coated with the miscellaneous part in test card 20.Film can reduce total thermal mass to heated by diagnostic device 10.This test card has: top ends (as shown in Figure 7), and described top ends is for receiving the syringe 25 with biological specimen; And, bottom, described bottom is inserted in diagnostic device 10.The bottom of test card 20 is configured to be inserted in the test trough 22 of diagnostic device 10.
in one exemplary embodiment, test card 20 comprises stop assembly 33.Stop assembly 33 is positioned in the outside of card 36 and is thus lifted to the circumferential surface top of card 36.Stop assembly 33 is configured to test card 20 to lock in diagnostic device 10.One or more position detectors in diagnostic device 10 can be utilized to determine the position (that is, whether test card is completely in place) of test card 20.The mainboard (shown in Figure 44) with processor can be configured to use the position from the information trace test card 20 of at least one position detector.Once test card 20 is inserted in test trough 22 completely, shown in securing rod 120(Figure 50) just can actuate, thereby outstanding entering in the space for example, in the space that is adjacent to (, just up) stop assembly 33 and between stop assembly 33 and the opening of test trough 22.Once securing rod 120 is positioned at this position, test card 20 just cannot remove from diagnostic device 10, because the protuberate of actuating assembly 33 can not be cleared up the securing rod 120 being actuated.In the exemplary embodiment, user can depress and launch button 16, so that retraction securing rod 120, thereby allow test card 20 to be removed from test trough 22.In other exemplary embodiments, when test loop completes, engine pack 100(is shown in Figure 46-52) securing rod 120 that can automatically bounce back, thus allow test card 20 to be removed from test trough 22, and do not need user manually to actuate, do not launch button 16.In other exemplary embodiments, during when launching button 16 and be pressed down or when engine pack 100 other retraction securing rod 120, test card 20 is boosted and is departed from test trough 22 by automechanism.
the bottom of test card 20 is also included within the locating slot 41 and 43 on each side of test card 20.Locating slot 41 and 43 is configured to engage backstay.Illustrated in locating slot 41 and 43 intention protection pin 56(Figure 10), the outstanding test card 20 that enters into of described pin 56, to transmit fluid or air.Locating slot 41 and 43 guiding test cards 20 enter into its test position, thereby protect pin 56 to avoid bending or damage when test card 20 is flatly dislocated.
in the exemplary embodiment, test card 20 comprises the entrance 34 in the top ends that is positioned in test card 20.Entrance 34 hold for be connected to comprise fluid sample 39 can acceptance division (for example, syringe, kapillary, etc.) interface 38(pin for example).Test card 20 also comprises the C shape structure 37 being positioned in entrance 34.In the exemplary embodiment, this C shape structure 37 is the sleeves for syringe 25, thereby the tip that is held in the syringe in entrance 34.Can acceptance division fluid sample 39 be directed to the test card 20 for testing.Fluid sample 39 is received and enters into the fluid channel 32 in test card 20 by interface 38.In some exemplary embodiment, the length from the tip of interface 38 to the interface 38 of the end of C shape structure 37 is approximately 21.6 mm, but can be also other length in other embodiments.
in the exemplary embodiment, fluid channel 32 is fluidly connected to the part of detecting 42 on the bottom that is positioned in test card 20.Fluid channel 32 is configured to sample 39 to send to test position 42 by route.Part of detecting 42 comprises array, and described array comprises that several are for the electrochemical sensor 40 of test fluid flow sample 39.Electrochemical sensor 40 is configured to and hardware (illustrating in Figure 44) intercommunication in diagnostic device 10, to provide diagnostic message to user.Part of detecting 42 is fluidly connected to the abandoned stope downstream 35 of fluid channel 32.In the exemplary embodiment, the waste fluid of described abandoned stope 35 storage such as calibration solutions.
fluid channel 32 can whole fluid path (that is, and fluid passage 32, abandoned stope 35, etc.) some some place there is greater or lesser diameter.For example, fluid passage 32 can promote before it enters into part of detecting 42 or at that time, thereby less flow regimes or less diameter are provided.Then fluid channel can be opened in part of detecting 42, thereby creates larger region channel or larger diameter channel above sensor 40, and described sensor 40 is for storage and test fluid flow sample 39.Fluid channel 32 can also be included in these " inclination " districts in the part of abandoned stope 35 (that is, wherein fluid channel changes the region of diameter).These tilting zones in abandoned stope can be configured to greater amount to use the calibration solution of volume to remain in abandoned stope, thereby prevent that fluid sample 39 is contaminated.Angled section can be shown, so that the fluid slowing down in the region of fluid channel 32 is mobile.
fig. 7 is for being inserted into the skeleton view of the test card of medical diagnosis device according to exemplary embodiment.Fig. 8 is the front view of the test card of Fig. 7.Fig. 9 is the rear view of the test card of Fig. 7.
with reference now to Figure 10 A-C,, the schematic diagram of the system being provided by diagnostic device 10 is shown according to exemplary embodiment, described system comprises test card 20, fluid passage and the pump being inserted in diagnostic device 10.According to the illustrated embodiment of Figure 10 A, test card 20 is fluidly connected to the pack 30 on the first side and is connected to the vacuum pump 50 on the second side.In the exemplary embodiment, pack 30 is configured to illustrate in greater detail in Figure 28-43 by T connector 52() gas or fluid guiding are entered into test card 20.T connector (that is, air colligator) 52 can be connected to test card 20 by pin 56 or other bindiny mechanism.
one or more pinched valve 46-48 control gas from pack 30 to test card 20 or the sequence of flow of fluid.In the exemplary embodiment, two pinched valve 47 and 48 pairs are incorporated into test card 20 by calibration solution and air and regulate, and meanwhile, 46 pairs of a pinched valve is incorporated into part of detecting 42 by fluid sample and regulates.In other embodiments, the different system of pinched valve can be adjusted in flowing of fluid in test card 20.
figure 10 A illustrates the fluid Flow channel by test card 20.In the exemplary embodiment, entrance to receive and to fill up fluid sample 39(be biological specimen) syringe 25 or such as capillaceous other can acceptance division.The interface 38 of entrance 34 enters into the most advanced and sophisticated of syringe 25 and is projected into fluid sample 39.Interface 38 is fluidly connected to the fluid sample 39 in syringe 25 and fluidly fluid sample 39 is connected to fluid channel 32.
figure 10 B illustrates for flowing through fluid channel 32 and entering into the linear path of the fluid sample 39 of part of detecting 42.In the exemplary embodiment, the mobile of this fluid is unidirectional.Fluid can acceptance division from syringe 25(or other) flow to the pinched valve 46 test card 20.Fluid flows in one direction from pinched valve 46.Pinched valve 46 is configured to open and close, thereby fluid sample 39 is controlled (for example, allow or stop) to the introducing of part of detecting 42.And if this fluid passes fluid channel 32, need to just enter into abandoned stope 35 by test portion 42.
once fluid channel 32 is filled, the pressure in this fluid passage 32 just disperses, and fluid is just prevented from flowing out from the test card 20 for external medical diagnosis device.The volume of fluid channel 32 can be learnt, the supplementary volume that is therefore allowed to enter the fluid in this fluid channel 32 can be controlled to prevent that test card 20 from overflowing.In the exemplary embodiment, the fluid using in test process (for example, fluid sample 39, calibration solution, etc.) be fully comprised in test card 20.In the diagram of Figure 10 A, can see, any surface from test card 20 to diagnostic device 10 does not have fluidic intercommunication, and any surface from pack 30 to diagnostic device 10 does not have fluidic intercommunication.Test card 20 is removable with disposable.Therefore, in the inner side of diagnostic device 10, there is no fluid circuit, this just can reduce potential risks and the clean requirement relevant with fluid circuit.Test card 20 intention of providing for oneself prevents repairing or the maintenance that the electron device due to the fluid leakage in diagnostic device 10 and corrosivity sensitivity causes, and has therefore reduced potentially the maintenance cost relevant with this diagnostic device 10.Fluid sample 39(or other fluids) one direction ground is through test card 20, be fully comprised in (at test period, even after test) in test card 20 and must not enter into any other part of diagnostic device 10.
in the exemplary embodiment, vacuum pump 50 is also fluidly connected to fluid channel 32.Vacuum pump 50 can be switched on power supply and cuts off the electricity supply and controllably operated by diagnostic device 10.When vacuum pump 50 is electrified, it can produce the negative pressure of controlling in test card 20, thereby drive fluid sample 39 flows to fluid channel 32 from syringe 25.Pinched valve 146 can be used for opening or closing fluid channel 32, thereby allows fluid sample 39 to flow to part of detecting 42.Atmosphere and calibration solution that pinched valve 48 and 47 also can be used for being incorporated into test card 20 from pack 30 are respectively controlled.Pinched valve 46 to 48 can be controlled by the control hardware in diagnostic device 10 (shown in Figure 44), and is opened or closed according to priority, to complete test loop.
by control vacuum pump 50 power supply switch on or off and open or close pinched valve 46 to 48, calibration solution, atmosphere (or other gas) and fluid sample 39 can enter into test card 20 by specified order.In the exemplary embodiment, first calibration solution enters test card 20.Pinched valve 47 is controllably opened, and pinched valve 46 and 48 is controllably closed.Then calibration solution is drawn into test card 20 from pack 30, then enters part of detecting 42.Calibration solution is reached be held at predetermined a period of time, is heated to predetermined temperature and is used for calibrating diagnostic device 10 in part of detecting 42.Once diagnostic device 10 is calibrated, pinched valve 48 is just controllably opened, and pinched valve 46 and 47 is just controllably closed.Then air is extracted and is entered part of detecting 42 from pack 30.Air push calibration solution enters into abandoned stope 35, thus cleaning part of detecting 42.Once calibration solution is removed from part of detecting 42, pinched valve 46 is just controllably opened, and pinched valve 47 and 48 is just controllably closed.Then fluid sample 39 is extracted in test zone 42, and wherein, fluid sample 39 is heated and tests.Once fluid sample 39 is tested by diagnostic device 10, test loop just completes and test card 20 just can be launched.
in some exemplary embodiment, pinched valve 46 to 48 can be integrated pinched valve, and described pinched valve has film, described thin flexible film ground biasing and can be by exerting pressure and be closed to test card 20 or pack 30.Pinched valve 46 to 48 can consist of polyethylene terephthalate at least in part.Pinch valve actuator 78(for example, removable lever) can be applied to pinched valve 46 to 48, to open or close pinched valve 46 to 48.Pinch valve actuator 78 can open or close pinched valve 46 to 48 by exerting pressure or removing pressure.Pinched valve 46 to 48 can be closed and not have and be opened under pressure under pressure.Once pinched valve 46 is opened, then fluid sample 39 just can arrive part of detecting 42 by fluid channel 32 from syringe 25 streams.
with reference now to Figure 10 C, shown the web member (for example, gas inlet and outlet) between test card 20 and pack 30.In the exemplary embodiment, the web member between test card 20 and pack 30 comprises rubber packing portion 53, and described rubber packing portion 53 forms Fluid Sealing portions at pin 56 places.In these embodiments, rubber packing portion 53 is attached to T connector 52 and is configured to guarantee being tightly connected of fluid flow passages between test card 20 and pack 30.In the exemplary embodiment, rubber packing portion 53 is pierced, to set up fluidic intercommunication between calibration solution channel 88 and test card 20.Rubber seal portion 53 can be made by any other material that comprises the barrier film of silicones or be applicable to this application.
fluid web member between test card 20 and vacuum pump 50 is similar to the web member shown in Figure 10 C.Web member between test card 20 and vacuum pump 50 comprises rubber packing portion 53, and described rubber packing part 53 forms Fluid Sealing portion at pin 56 places.Rubber packing portion 53 is attached to vacuum pump 50(, forms pumping system) and be configured to provide fluid flowing passage between test card 20 and vacuum pump 50.Fluid flowing passage can fluidly be sealed.In the exemplary embodiment, the test card 20 between two web members also becomes taper gradually, to receive pin 56 and be configured to set up Fluid Sealing portion.Rubber seal portion 53 can be made by any other material that comprises the barrier film of silicones or be applicable to this application.
with reference to figure 11A to 11C, according to substitutability embodiment, show the schematic diagram of the pack 30 that is connected to alternative test card 60 briefly.Web member is formed for the mobile fluid passage of fluid of being actuated by pump 50.Alternative test card 60 more specifically illustrates and being described below at this instructions in Figure 15 to 17.
with reference now to Figure 12,, the simplification rear view of test card 20 is shown according to exemplary embodiment.Test card 20 is configured to by interface 38 admitting fluid samples 39.Then fluid sample 39 arrives part of detecting 42 by certain path through fluid channel 32.Part of detecting 42 comprises several sensors 57, and described sensor 57 comprises electronic sensor 571 and 572.In the illustrated embodiment of Figure 12, electronic sensor 571 and 572 is configured to control the directed volume that enters the fluid in test card 20.In the exemplary embodiment, test card 20 comprises the overflow prevention sensor 573 being positioned in abandoned stope 35.Overflow prevention sensor 573 is configured to, when fluid arrives overflow prevention sensor 573, one or more signals are sent to processing electron device.Processing apparatus is configured to stop fluid to flow in test card 20.One or more signals are received from sensor 573.
with reference now to Figure 13 to 14,, show the function of electronic fluid sensor 57.Figure 13 shows the linear list diagram by the fluid flowing passage of test card 20.Fluid stream is by fluid channel 32 a plurality of sensors 57 of stream process.Sensor 57 is positioned in part of detecting 42 and is configured to make the fluid that pre-determines volume to be distributed exactly influent stream body channel 32.Electronic fluid sensor 57 comprises the conduction utmost point 59, and the described conduction utmost point 59 is configured to detect high impedance or Low ESR (that is, no matter whether fluid flows through sensor).At fluid stream, by before fluid channel 32, two utmost points 59 of the first electronic sensor 571 are in high impedance closed condition (referring to the fluid state in Figure 14).When fluid flows through electronic sensor 571, it is high that impedance keeps, until the space between two utmost points 59 is filled two utmost points 59 of fluid and fluid covering first sensor 571.At that place, sensor 571 " is opened " state (referring to the fluid state B in Figure 14) in Low ESR.In the illustrated embodiment of Figure 12, test card 20 comprises the second electronic sensor 572, and described the second electronic sensor 572 function classes are similar to the function of the first electronic sensor 571.In other exemplary embodiments, when test card 20 needs for specific application, test card 20 can comprise any amount of electronic sensor 57.
in the exemplary embodiment, diagnostic device 10 comprises mainboard (shown in Figure 44).Mainboard is a part (that is, processing electron device) for treatment circuit, and it has processor and storer.Mainboard receives the one or more signals from sensor 57, and is configured to open or close vacuum pump 50 according to the signal that is received from electronic sensor 57.In the illustrated embodiment of Figure 12, electronic sensor 571 and 572 is configured to control the directed volume that enters the fluid in test card 20.For example, once sensor 571 is in " opening " state, mainboard just can transmitted signal, to close vacuum pump 50, thereby eliminates the negative pressure in fluid channel 32 and stops fluid to flow.Test card 20 can comprise any amount of electronic sensor 57, and described electronic sensor 57 is configured to be controlled at the volume of the fluid in test card 20.Sensor 57 can be positioned in difference place on fluid flowing passage (for example, in part of detecting 42, in abandoned stope 35, etc.), thereby according to the principle that is applicable to this application-specific, be controlled at the volume of the fluid in test card 20.
or with reference to figures 13 to 14, in the exemplary embodiment, test card 20 also can comprise overflow prevention sensor 573.Overflow prevention sensor 573 has two utmost points 59, and described two utmost points 59 are configured to detect high impedance or Low ESR.When Low ESR that overflow prevention sensor 573 detects between its two-stage 59, mainboard can send to signal vacuum pump 50(or in alternate embodiments, send to controlled injection device 25), to stop immediately fluid to flow to fluid channel 32.In the exemplary embodiment, overflow prevention sensor 573 is as the operation of emergent stopping part, and intention is just used while only breaking down in system somewhere.In these exemplary embodiments, sensor 571 and 572 is configured to contribute to control the volume that is introduced into the fluid in test card 20.When fluid arrives sensor 571 and 572, sensor 571 and 572 can be configured to and mainboard intercommunication.Then mainboard can be sent out from signal, to close vacuum pump, elimination negative pressure and the prevention fluid in fluid channel 32, flows.Overflow prevention sensor 573 plays safety, to stop fluid to flow and prevent test card 20 overflows.In other exemplary embodiments, overflow prevention sensor 573 can provide signal to mainboard, thereby stops calibration solution to flow out from test card 20.At fluid sample 39, be sent to part of detecting 42 for before testing, calibration solution is pushed into abandoned stope 35.Overflow prevention sensor 573, by providing signal to mainboard, can contribute to prevent that calibration solution is compared to pre-determining in abandoned stope and a little has further mobile.In response to the signal from overflow prevention sensor 573, mainboard can transmitted signal, to close vacuum pump 50, thereby eliminates the negative pressure in test card 20 and stops fluid to flow to test card 20.Therefore, overflow prevention sensor 573 intentions guarantee not have fluid sample 39 or other fluids can leak in the remainder of diagnostic device 10.In other exemplary embodiments, mainboard can transmitted signal, so that the flow direction of reversing vacuum pump 50, thereby fluid is promoted backward through fluid channel 32 and prevents fluid over-flow to cross test card 20.Test card 20 can comprise any amount of electronic sensor 57, and described electronic sensor 57 is configured to provide signal to mainboard, so that prevention fluid over-flow.For example, test card 20 can be included in a plurality of overflow prevention sensors 573 staggered in whole abandoned stope 35, and when fluid arrives each overflow prevention sensor 573, overflow prevention sensor 573 is configured to stop fluid to flow.
the alternative test card 60 of Figure 15 to 16 diagram.In Figure 15 to 16, the placement of electronic sensor 57a is shown according to substitutability embodiment.In the illustrated embodiment of Figure 15 to 16, test card 20 comprises four electronic sensor 571a, 572a, 573a and 574a.The fluid that electronic sensor 571a, 572a and 573a are configured to allow to pre-determine quantity enters into the fluid channel 32a of test card 60.The test card 60 of Figure 15 diagram when fluid arrives the first electronic sensor 571a, and the test card 60 of Figure 16 diagram when fluid arrives overflow prevention sensor 573a.Figure 17 illustrates wherein fluid sample 39 according to the alternate embodiments of Figure 15 to 16 can flow the linear path through fluid channel 32a and stream process electronic sensor 57a.
with reference now to Figure 18 A, Figure 18 B, Figure 18 C,, the receiver 34 of test card 20 has universal design, make its be configured to receive to surpass one a certain size can acceptance division (that is, syringe).For example, receiver 34 can receive the syringe 25 of 1ml, 3ml or 5ml.Yet in other exemplary embodiment, receiver 34 can be arranged to different sizes or be configured in addition receive the syringe 25 of any other certain size.Syringe 25 can be inserted in receiver 34.Once in receiver 34 inner sides, the tip of syringe 25 just fits within C shape structure 37, thereby is connected with interface 38.Then fluid sample 39 is inhaled in interface 38.In the exemplary embodiment, then Air Flow enters in the tip and the region between interface 38 of syringe 25 by C shape structure 37, thereby substitute, is inhaled into the sample 39 in fluid channel 32.Receiver 34 can also be configured to receive kapillary (more specifically shown in Figure 21).In the exemplary embodiment, interface 38 be adapted to be not be exactly directly by adapter with can acceptance division (that is, and syringe 25, capillary, etc.) coordinate.
referring to figures 19 through 20, according to exemplary embodiment, show alternative syringe configuration.Figure 19 has the front view of the test card 90 of the syringe 25 being loaded from top according to substitutability embodiment.Figure 20 is the front view of the test card 90 of Figure 19.Alternative test card 90 comprises the receiver 34b of the opening having on the top of test card 90.In this embodiment, sliding part 62 is vertically introduced and be connected to syringe 25.Test card 90 has the pin 66 of the end that is attached to fluid channel 32b, the end of described engaged at end syringe 25.Test card 90 also comprises rubber seal 64, and described rubber seal 64 is sealed in the web member between syringe 25 and pin 66.In the exemplary embodiment, when pressure, to be applied to syringe 25(shown in Figure 20) time, sliding part 62 vertically moves with respect to the remaining part of test card 90, and, the outstanding fluid sample 39 that enters into of pin 66.When vacuum pump 50 is energized, from the fluid sample 39 of syringe 25, flow in fluid channel 32b.
with reference now to Figure 21 to 22,, according to exemplary embodiment, kapillary is shown as and is connected to test card.Figure 21 has kapillary 74 and is coupled to the rear view of test card 20 of the kapillary adapter 72 of test card 20 according to exemplary embodiment.Figure 22 has kapillary 74 and is coupled to the rear view of test card 60 of the kapillary adapter 72 of test card 20 according to exemplary embodiment.In these embodiments, rubber or silicones kapillary adapter 72 can be placed in receiver 34 or 34a, make to use kapillary 74 to carry small size sample.An end of kapillary adapter 72 is connected with kapillary 74, and another end is connected to pin 56 or 56a, to form fluid passage.Vacuum pump 50 can be switched on, thereby in test card 20 or 60, produces negative pressure and force fluid sample 39 streams by pin 56 and enter into fluid channel 32 or 32a.Kapillary 74 can be used for testing small volumes flowable sample or be used in other application that wherein kapillary is used.The end wall of import 34 has one or more holes, and described hole is configured to allow discharged air (, do not allow fluid to pass through) when kapillary adapter 72 is inserted by kapillary 74.
with reference now to Figure 23 to 25,, according to exemplary embodiment, illustrate for being controlled at fluid sample 39(in test card 20, valve control mechanism) pinched valve 46 and relevant pinch valve actuator 78.Test card 20 comprises the pinched valve 46 opening and closing, thereby fluid sample 39 flows to fluid channel 32, controls.Pinch valve actuator 78 in diagnostic device 10 can operate pinched valve 46, thereby pushes and valve 46 is is controllably opened or closed against valve 46.Figure 24 according to exemplary embodiment diagram pinch valve actuator 78 how to contact valve 46, how by promoting valve-off 46 against it and how by test card 20 and valve 46 are pulled open to open valve 46.When pinch valve 46 is closed, as Figure 25 A, fluid sample 39 is prevented from arriving the fluid channel 32 for testing.Yet when pinched valve 46 is opened, as shown in Figure 25 B, fluid sample 39 is allowed to enter part of detecting 42.In the exemplary embodiment, fluid sample 39 is pushed into fluid channel 32 by the negative pressure being produced by vacuum pump 50.
figure 23 comprises the skeleton view of test card 20 of the valve actuator 78 of the pinched valve 46 being bonded on test card 20 according to exemplary embodiment.Figure 24 comprises the cross-sectional side view of test card 20 of Figure 23 of the valve actuator 78 of the pinched valve 46 of actuating on test card 20 according to exemplary embodiment.Figure 25 is the cross-sectional illustration of the pinched valve in off-position and open site 46 according to exemplary embodiment.Figure 26 A to 27B is shown in the interaction between pinch valve actuator 78 and pinched valve 46 according to substitutability embodiment.
figure 28 is according to the translucent skeleton view of the pack 30 of exemplary embodiment.Figure 29 comprises the cross-sectional side view of pack 30 of Figure 28 of calibration solution bag 54 according to exemplary embodiment.Figure 30 A and 30B are included in the feature viewgraph of cross-section of shape valve stem valve 83 of pack 30 of Figure 28 of the shape valve stem valve 83 in opening and closing position according to exemplary embodiment.Figure 31 comprises T connector and from the cross-sectional illustration of the pack 30 of the fluid passage of pack 30 and Figure 28 of air duct according to exemplary embodiment.
, in more detail with reference to Figure 28 to 31, according to exemplary embodiment, pack is shown now.Pack 30 is disposable and removable.Pack 30 comprises the housing 82 of intention protection calibration solution bag 54.In the exemplary embodiment, housing 82 is made of plastics, but also can be made by other material or kit.Pack 30 also can comprise reagent clad (not shown).In the exemplary embodiment, described pack cover is connected to the forward part (according to Figure 28) of pack 30.When pack 30 is not used (that is, not being inserted in diagnostic device 10), reagent clad intention protection pack 30.
calibration solution bag 54 or chamber are fluidly connected to T connector 52.The soft flexible fluid pouch that calibration solution bag 54 can be full of by untapped calibration solution.T connector 52 comprises fluid Flow channel 84 or fluid flow pipe.Fluid Flow channel 84 is configured to receive the calibration solution from calibration solution bag 54, and described calibration solution is provided to the fluid channel 88 that is connected to test card 20.In the exemplary embodiment, and when pack 30 is fluidly connected to test card 20, the height of fluid Flow channel 84 is greater than the height of pinched valve 46.T connector 52 also comprises the Air Flow channel 86 that T connector 52 is connected to atmosphere (for example, surrounding air), thereby makes when needed T connector 52 air can be transported to test card 20.Fluid Flow channel 84 and Air Flow channel 86 meet at T web member 52 places, thereby form joint portion.In the exemplary embodiment, pack 30 comprises cap portion, and described cap portion is transmitting and memory period is closed air port and fluid port simultaneously.In the exemplary embodiment, pack 30 can also comprise that L shaped connector 122(is as further illustrated in Figure 53 A-C).L shaped connector 122 is configured to fluidly calibration solution bag 54 is connected to T connector 52, thereby provides fluid web member to test card 20.L shaped connector 122 is being described below in further detail.
in the exemplary embodiment, calibration solution stream arrives the pin 56 of pack 30 by T connector 52.In these embodiments, pin 56 is inserted into test card 20 and is configured to provides calibration solution to test card 20.In the exemplary embodiment, rubber insert 61 provides sealing, and described sealing is centered around web member between pin 56 and test card 20 around.Flowing of calibration solution and atmosphere controlled by pinched valve 47 and 48 respectively.Pinched valve 47 is positioned in fluid Flow channel 84 places, and pinched valve 48 is positioned in Air Flow channel 86 places. Pinched valve 47 and 48 is configured to open and close, thereby convection cell and gas (for example, atmosphere, calibration solution, etc.) be introduced in test card 20 and regulate.In the exemplary embodiment, when vacuum pump 50 is controllably switched on, fluid or gas flow are by channel 84 or 86, through pin 56 entering in test card 20.In some exemplary embodiment, fluid channel 88 is provided to the potpourri of fluid and gas in test card 20.In other exemplary embodiments, fluid channel 88 is not that fluid is offered gas to test card 20 exactly.Pack 30 can be introduced air bubble, to substitute, has previously been introduced at least part of any calibration solution in calibration solution channel 88.
or with reference to Figure 30, the shape valve stem valve of pack is shown according to exemplary embodiment.Pack comprises shape valve stem valve 83, and described shape valve stem valve 83 moves between open position and off-position.At production, transportation and memory period, during shape valve stem valve 83 can be maintained in its closed position, as shown in Figure 30 A.When in off-position, make shape valve stem valve 83 against fluid Flow channel 84(for example, via spring biasing) closely press down, thus before engaging with test card 20, be sealed in the calibration solution in calibration solution bag 54 and stop it to flow to pin 56.After pack 30 has been installed to diagnostic device 10, shape valve stem valve 83 is arranged in open position.Then calibration solution can be introduced in test card 20.When calibration solution bag 54 engages with test card 20, shape valve stem valve 83 is removed and is arranged in open position, and still, calibration solution does not flow, because pinch valve 47 maintains sealing by clamping T connector 52.
with reference now to Figure 32 to 34,, pinch valve 47 and 48 aligns with calibration solution Flow channel 84 and Air Flow channel 86 respectively.The pinched valve 47 and 48 that pinch valve actuator 78 is configured to be resisted against in pack 30 promotes, thereby closes pinched valve 47 and 48, and stops fluid or air to leave T connector 52.Figure 33 shows pinched valve 47 in pack 30 and 48 position.In the exemplary embodiment, pinched valve 48 and 47 alignment are to clamp respectively the fluid path for air and calibration solution.Figure 34 A-B is illustrated in off-position (Figure 34 A) and the pinched valve 47 in open position (Figure 34 B) and 48 xsect.Figure 32 is according to the skeleton view of exemplary embodiment pack 30 and two pinch valve actuator 78.Figure 33 is the cross-sectional side view that comprises the pack 30 of calibration solution bag 54.Figure 34 is the pack pinched valve 47 in opening and closing position or 48 viewgraph of cross-section according to exemplary embodiment.
figure 35 is according to the translucent skeleton view of the pack 80 of substitutability embodiment.Figure 36 is the viewgraph of cross-section that comprises the alternative pack 80 of calibration solution bag 54a and T connector 52.Figure 37 is the skeleton view of alternative pack 80 and the viewgraph of cross-section that is illustrated in the alternative pack of the shape valve stem valve 83a in off-position.Figure 38 is the skeleton view of alternative pack 80 and the viewgraph of cross-section that is illustrated in the alternative pack of the shape valve stem valve 83a in open position.
with reference now to Figure 35 to 36,, alternative pack 80 is shown.Alternative pack 80 has alternative shape valve stem valve 83a, and described alternative shape valve stem valve 83a is illustrated in greater detail in Figure 37 to 38.In the illustrated embodiment of Figure 37, shape valve stem valve 83a closely presses down, prevents that against channel 83a fluid from flowing out and sealing calibration solution from channel 84a stops it to flow to fluid output part (that is, pin 56a).In order to allow calibration solution to flow, shape valve stem valve 83a is disengaged.For example, once pack 80 is inserted in diagnostic device 10, shape valve stem valve 83a just discharges, and pressure is released and flows not to be restricted, thereby allow calibration solution to flow out from channel 84a.In Figure 38, shape valve stem valve 83a is released, thereby opens channel 84a, for calibration solution stream, passes through this channel 84a.Once pack 30 is removed from diagnostic device 10, just make shape valve stem valve 83a turn back to off-position (for example, via spring biasing), to residue calibration solution is remained in pack 80.
with reference now to Figure 39 to 41,, according to alternate embodiments, pack 80 is shown.At Figure 39 to 41, pinch valve actuator 78a is shown to pinched valve 47a and 48a and aligns.Pinch valve actuator 78a is configured to by clamping the part separately of fluid path 85a, pinched valve 47a and 48a are closed.Pinched valve 48a and 47a can comprise elastic membrane region, and described elastic membrane region can flexibly press down towards pack 80, thereby close flowing of pinched valve 48a and 47a limit fluid and/or air.In the exemplary embodiment, pinched valve 48a and 47a are closed by pinch valve actuator 78a.Figure 39 is the other skeleton view that the alternative pack 80 of pinch valve actuator 78a is shown, and described pinch valve actuator 78a engages pinched valve 48a and the 47a of pack 80, to regulate flowing of fluid and/or gas.Figure 40 is the viewgraph of cross-section of pack 80, and described pack 80 comprises the joint pinched valve 48a of pack 80 and the pinch valve actuator of 47a.Pinched valve 48a and 47a comprise rubber spacer 96, and described rubber spacer 96 is configured to set up fluid path 85a.Figure 41 A and 41B be the fluid path in open position and off-position pinched valve 47a feature viewgraph of cross-section and be the viewgraph of cross-section that forms the T connector 52 of the fluid path with rubber spacer 96.
figure 39 illustrates the other skeleton view of the pack 80 of pinch valve actuator 78a according to exemplary embodiment, described pinch valve actuator 78a engages pinched valve 48a and the 47a of pack 80, to regulate flowing of fluid and/or gas.Figure 40 is the viewgraph of cross-section of pack 80, and described pack 80 comprises the joint pinched valve 48a of pack 80 and the pinch valve actuator 78a of 47a.Figure 41 A to B is according to the exemplary embodiment feature viewgraph of cross-section of the pack pinched valve 48a in off-position and open site and 47a respectively.
with reference now to Figure 42 A to 43B,, the substitutability embodiment of T connector 52 is shown.Figure 42 is the feature viewgraph of cross-section according to the fluid path of exemplary embodiment pack 30, and described pack is included in the film being formed on two rubber spacers 96.Figure 43 is the feature viewgraph of cross-section that uses the film 95 formation fluid paths above Inserting Tube.In this embodiment, T connector 52 comprises that the pipe 94(inserting between film 95 is shown in Figure 43 B).Figure 42 B illustrates the xsect of T connector 52.Two rubber spacers 96 are sealed by film 95, thereby at the interior air channel 97 of setting up of T connector 52.In the exemplary embodiment, air channel 97 is by distributing silicon to make, but also can be made by any other material that is suitable for applying in other exemplary embodiments.In the exemplary embodiment, pinched valve can closely press down against air channel 97, thereby regulates the opening and closing of air channel 97.
in the illustrated embodiment of Figure 42 to 43, rubber spacer 96 is made by silicon, and film 95 is made by plastic-aluminum.Yet in other exemplary embodiments, rubber spacer 96 can be made by polymkeric substance or other suitable materials of any other type, and film 95 can be made by any material that is suitable for application-specific.Film 95 can or be sealed in the top of rubber spacer 96 by " hot pressing " (a kind of by applying constantly metallurgical technology of heat and pressure acquisition) by any other device that is suitable for sealing air channel 97.In the exemplary embodiment, rubber spacer 96 has indenture, and described indenture is configured to guide needle 56 and pierces through film 95, rather than thorn is through rubber spacer 96.
with reference now to Figure 44,, according to exemplary embodiment body, show the hardware organization's chart for outer medical diagnosis device 10.In the exemplary embodiment, ADC and DAC and 40 intercommunications of several electrochemical sensors, and with any other input media or output unit intercommunications such as alignment sensor or heating element 116.Electrochemical sensor 40 is positioned in the part of detecting 42 of test card 20.Sensor 40 is used by the processing electron device of diagnostic device, to analyze the chemical composition of the fluid in part of detecting 42.ADC is configured to process the simulating signal from electrochemical sensor 40.Once ADC processes the output from electrochemical sensor 40, it just passes to mimic control panel by these data.When here with accompanying drawing in mimic control panel while being named as " mimic control panel ", it should be understood that mimic control panel can comprise digital processing.Mimic control panel can utilize DAC to convert numeral output (opening/closing modulated signal) to simulating signal (for example,, for electrochemical sensor).For example, DAC is used for controlling for measuring the externally-applied potential of the sensor of electric current.
still with reference to Figure 44, shown each plate (that is, web joint, mimic control panel, power board and mainboard, etc.) can as printed circuit board (PCB) (PCB) independently with, can be on identical PCB integrated or additionally integrated and distribution combine to use.Each plate can be regarded as processing electron device or treatment circuit.Process electron device and can comprise discrete parts and/or integrated circuit.For example power board can comprise all discrete electronic components.Each plate can comprise one or more processors.Processor can as general processor, special IC (ASIC), one or more field programmable gate array, ((FPGA), one group of processing element or other applicable electronic processing components etc. be operated in many aspects.Each plate also can comprise one or more memory storages.The storer of each plate can be one or more for store data and/or computer code device (for example, RAM, ROM, flash memory, harddisk memory, etc.), for completing and/or realize various program described herein.Storer can be or comprise non-transient volatile memory and/or nonvolatile memory.Storer can comprise database element, object code parts, script parts or any other type for supporting message structure and the message structure described herein of comings and goings.Storer can be propagated and is connected to processor and comprises for carrying out the computer code module of one or more programs described herein.
still with reference to Figure 44, mimic control panel can be coupled to the Stepping motor that surpasses.When being coupled to pump, a Stepping motor is shown, and meanwhile, other Stepping motor can be coupled to the engine for engine pack 100, and described engine pack for example has cam disc 102(, and Figure 46 to 52 is shown).Engine pack 100 can be configured to control one or more valves 46 to 48, thereby convection cell is introduced into test card 20, regulates.Engine pack 100 is further shown in Figure 46 to 52 and be described further below.In other embodiments, mimic control panel can be coupled to the solenoid for its control.Mainboard can comprise general processor and storer.The storer of mainboard can comprise Linux environment or another operating system.Mainboard can differently trigger routine and be present in other softwares on mimic control panel.It should be noted, mimic control panel can comprise the operating system of himself and for carrying out its movable software module described herein.
mainboard and time plate can carry out consistent operation as illustrated in Figure 45.Data software keeper can exist under the operating environment of web joint.In other embodiments, data administrator can exist across mainboard and web joint.Mimic control panel can receive from the order of mainboard and function and notify from a phone call.Power control panel also can receive from the order of mainboard and function and notify from a phone call.It should be noted, power board can be controlled various input activities and output activity, and not only only device is carried out to power management.For example, can manage intercommunication.UART scanner can be as described herein barcode scanner (for example, ID, 2D, etc.).Data from any plate can be received at mainboard place.
with reference now to Figure 46,, according to exemplary embodiment, show for controlling the skeleton view of the engine pack 100 of pinch valve actuator 78.Engine pack 100 comprises cam disc 102.In the exemplary embodiment, four pistons 108 and 106(, pinch valve actuator 78) align with one or more pinched valve 46 to 48 or other valves.Piston 108 and 106 is adjacent and be configured to receive cam disc 102, and this depends on the concentric ring 104 on cam disc 102.Three pistons 108 align and are configured with pinched valve 46 to 48, to open and close pinched valve 46 to 48, this depends on the stage of diagnostic device 10 in testing sequence.Piston 108 is pressed down against pinched valve 46 to 48, closes, until piston 108 is actuated thereby cause them to maintain.The 4th piston 106 is shown in Figure 47 with test probe 114() and heating element 116(is, the heating plate going out as shown in Figure 47 or heating cushion) alignment.The 4th piston 106 is configured to make heating element 116 to close part of detecting 42 when piston 106 is actuated, thus the fluid (for example, fluid sample 39) of heating in part of detecting 42.Heating element 116 intentions make substantially invariable temperature move closer to temperature between the two or more heating elements 116 on each side at test card 20.The 4th piston 106 is also configured to actuate test probe 114, thereby test card 20 is locked in test position.
cam disc 102 is configured to rotation.When cam disc 102 rotation, piston 108 and 106 concentric ring 104 " RUN "s along cam disc 102 (that is,, when its rotation of profile along cam disc 102, rising and whereabouts, it contacts with cam disc 102).While moving above in the lift portion 112 of concentric ring 104 one of in piston 108 one, piston 108 just departs from from its associated pinched valve 46,47 or 48, and this will cause associated valve 46,47 or 48 to be opened.
with reference now to Figure 47,, according to exemplary embodiment, show for control piston 108 and 106(pinch valve actuator) the side view of engine pack 100.Heating element 116 is associated with the 4th piston 106 with test probe 114.When moving above its lift portion 1123 at cam disc 102, the 4th piston 106 can be actuated heating element 116 and test probe 114, thus cause heating element 116 simultaneously with two contacts side surfaces of part of detecting 42.The 4th piston can also make the electrochemical sensor 57 of test probe 114 engaged test cards 20.When the 4th piston 106 is actuated by cam disc 102, piston 106 just makes the heating element 116 on test card 20 close, thus the fluid (for example, fluid sample 39) of heating in part of detecting.
with reference now to Figure 48,, according to exemplary embodiment, isolate and the piston 108 associated with pinched valve 46 for test card 20 is shown.When cam disc 102 rotation, piston 108 is along an operation in the concentric ring 104 on cam disc 102.When diagnostic device 10 setup test fluid sample 39, cam disc 102 rotates until the lift portion 112 of concentric ring 104 starts to contact with piston 108.Then piston 108 is raised part 112 and forces disengaging pinched valve 46, thereby causes pinched valve 46 to be opened, and allows fluid sample to flow to part of detecting 42.
with reference now to Figure 49,, according to exemplary embodiment, isolate with illustrate with respectively for pinched valve 47 and the 48 associated pistons 108 of calibration solution and air.When cam disc 102 rotation, piston 108 is along concentric ring 104 operations.When cam disc 102 rotate to above lift portion 112 pre-determine position time, piston 108 departs from pinched valve 47 and 48.Piston 108 departs from pinched valve 47 and 48, thereby causes pinched valve 47 and 48 to be opened.Pinched valve 47 is opened, to calibration solution is transported to test card 20.Pinched valve 48 is opened, to air is transported in test card 20.
with reference now to Figure 50,, according to exemplary embodiment, show engine pack 100 and for actuating the separate views of the piston 108 of test card pinched valve 46.In Figure 56, also show the substitutability embodiment of piston 108.In the exemplary embodiment, then cam disc 102 rotations are also configured to launch test card 20.Cam disc 102 is configured, and piston 108 and 106 is actuated in order, and described order is matched with the testing sequence of diagnostic device 10.When test card 20 is inserted into, securing rod 120 locking test cards 20.In the end of this order, cam disc 102 is configured to loosen securing rod 120, thereby discharges test card 20.In the exemplary embodiment, the spring 118 that flicks of locating in the bottom of test card 20 flicks test card 20 and is also used as the identification mechanism inserting for test card 20.
with reference now to Figure 51,, according to exemplary embodiment, show for control piston 108 and 106(pinch valve actuator) the skeleton view of engine pack 100.
with reference now to Figure 52,, according to exemplary embodiment, show for control piston 108 and 106(pinch valve actuator) the skeleton view of engine pack 100.
with reference now to Figure 53 A to C,, according to exemplary embodiment, show the L shaped connector for pack 30.In the exemplary embodiment, L shaped connector 122 is connected to the bottom of the calibration solution bag 54 of pack 30.L shaped connector 22 is configured to transport the calibration solution from calibration solution bag 54.L shaped connector 122 comprises the nozzle 124 that is configured to transport calibration solution.L shaped connector also comprises calibration solution bag end 128, and described calibration solution bag end 128 is fluidly connected to calibration solution bag 54 by L shaped connector 122.L shaped connector 122 also comprises one or more wings that extend out from connector 122 126.When the coated compression of calibration solution, the described wing 126 intentions allow fluid stream by L shaped connector 122.
as utilized here, term " generally ", " approximately ", " substantially " and similar terms intention have approve with those skilled in the art general and can accept the broad sense that usage is consistent, and main body of the present disclosure belongs to described general and acceptable usage.Check of the present disclosurely to it will be understood by those skilled in the art that these terms intention allows described and require some feature of preference to describe, and the scope of these features is not restricted in set accurate numerical range.Therefore, these terms should be interpreted as, and the non-essence of the main body of the described and right of priority that requires or incoherent correction or modification should be regarded as within the scope of the invention, and are illustrated by appended claims.
it should be noted, that uses herein refers to for describing term " exemplary " intention of different embodiment, and this embodiment is possible example, representative and/or diagram (this term is not intended to imply that this embodiment must be unusual example or five-star example) that may embodiment.
term as used herein " coupling " and " connection " and analog thereof refer to two members and directly or are indirectly bonded to each other.This combination can be static (for example, permanent property) or removable (for example, removable or releasable).By two members or be integrally formed each other described two members and any additional intermediate member of single whole main body, or, by described two members or described two members and any additional intermediate member that are attached to one another, can obtain this combination.
only illustrate the structure of this system and layout and for providing as the test card shown in various exemplary embodiments and the method for external medical diagnosis device.Although, only in the disclosure, describe some embodiments of the present invention in detail, but consulting those skilled in the art of the present disclosure should easily understand, (for example can there be many corrections, the change of the size of various elements, size, structure, shape and ratio, the use of parameter value, mounting arrangements, material, color and directed change, etc.), and do not depart from substantially novel teachings and the advantage of theme disclosed herein.For example, the element illustrating as integrally formed can consist of many parts or element, and the position of element can be reversed or additionally be changed, and, can change or change character, quantity or the position of discrete component.Therefore, these all corrections are all intended to be included in as in defined scope of the present invention in appended claims.The order of any process or method step or order can be changed or by minor sort again according to alternate embodiment.The design of various exemplary embodiments, operating conditions and layout can be made other and replace, revise, change and omit, and do not depart from the scope of the present invention.
this diagnostic device is normally shown as comprising the treatment circuit that comprises storer.Treatment circuit can comprise processor, and as general processor, special IC (ASIC), one or more field programmable gate array, ((FPGA), one group of processing element or other applicable electronic processing components are operated described processor.Storer be one or more for store data and/or computer code device (for example, RAM, ROM, flash memory, harddisk memory, etc.), for completing and/or realize various program described herein.Storer can be or comprise non-transient volatile memory and/or nonvolatile memory.Storer can comprise database element, object code parts, script parts or any other type for supporting message structure and the message structure described herein of comings and goings.Storer can be connected to processor to intercommunication and comprise for carrying out the computer code module of one or more programs described herein.
the foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, all interior done any modifications in the spirit and principles in the present invention, be equal to and replace and improvement etc., all should be included in protection scope of the present invention in.

Claims (20)

1. for a test card for external medical diagnosis device, the described test card for external medical diagnosis device comprises having at least housing of top ends and bottom,
Described top ends further comprises import, described import comprise for receive comprise sample fluid can acceptance division interface;
Sample fluid channel with for receiving the described import of sample fluid to become fluidic intercommunication, described sample fluid channel is interrupted by valve, described valve flows to inner fluid channel to described sample fluid and controls, described inner fluid channel becomes fluidic intercommunication with following: (i) calibration solution channel, (ii) array, described array comprises several electrochemical sensors, and, (iii) the abandoned stope downstream of described array, the abandoned stope downstream of described array comprises several electrochemical sensors, and described electrochemical sensor comprises for receiving the waste fluid that uses calibration solution;
Described bottom comprises: the second import, and described the second import is for being incorporated into calibration solution channel by calibration solution or air; And, outlet, described outlet is used for and forcing pump or vacuum pump intercommunication, for aspirating calibration solution, air or sample fluid.
2. the test card for external medical diagnosis device according to claim 1, it is characterized in that, the described array that comprises described several electrochemical sensors is positioned in place, described bottom, described electrochemical sensor is positioned in array, to detect one or more predetermined fluid volumes.
3. the test card for external medical diagnosis device according to claim 1, is characterized in that, described array further comprises one or more heating elements.
4. the test card for external medical diagnosis device according to claim 1, it is characterized in that, described array further comprises one or more plane heating elements, and described plane heating element comprises the hole that several are positioned along described one or more described plane heating elements.
5. the test card for external medical diagnosis device according to claim 1, it is characterized in that, institute's interface comprises blank pipe, an end of described blank pipe becomes fluidic intercommunication with described sample fluid channel, and opposite end can be used for and is comprised in described sample fluid in can acceptance division and becomes fluidic intercommunication.
6. the test card for external medical diagnosis device according to claim 1, it is characterized in that, described interface comprises C shape tubular sleeve, the end abutment walls of closing of described C shape tubular sleeve is mounted, and the end of opening of described C shape tubular sleeve is suitable for coordinating with a described end that can acceptance division.
7. the test card for external medical diagnosis device according to claim 6, it is characterized in that, described C shape tubular sleeve is partly around the hollow tube being mounted through described wall, an end of described hollow tube can be used for becoming fluidic intercommunication with one or more fluid channels of the described test card for external medical diagnosis device, and opposed end can be used for and is comprised in described described sample fluid in can acceptance division and becomes fluidic intercommunication.
8. the test card for external medical diagnosis device according to claim 7, is characterized in that, the described C shape being formed by described tubular sleeve provides the opening substantially moving along the length of described tubular sleeve.
9. the test card for external medical diagnosis device according to claim 1, it is characterized in that, described interface comprises hollow tube and comprises further the cylindrical chamber of opening, and the described cylindrical chamber of opening is sealed described hollow tube and had and is large enough to hold described diameter that can acceptance division.
10. the test card for external medical diagnosis device according to claim 1, is characterized in that, described interface is applicable to or directly or by adapter can coordinates by acceptance division with described.
11. test cards for external medical diagnosis device according to claim 1, is characterized in that, describedly can comprise syringe by acceptance division.
12. test cards for external medical diagnosis device according to claim 1, is characterized in that, describedly can comprise kapillary by acceptance division.
13. test cards for external medical diagnosis device according to claim 1, is characterized in that, described valve comprises pinched valve.
14. test cards for external medical diagnosis device according to claim 1, is characterized in that, described valve comprises pinched valve, and described pinched valve is closed and do not had and opens under pressure under pressure.
15. test cards for external medical diagnosis device according to claim 1, is characterized in that, described valve comprises pinched valve, and described pinched valve is constructed by polyethylene terephthalate at least in part.
16. test cards for external medical diagnosis device according to claim 1, is characterized in that, described valve comprises pinched valve, and described pinched valve is closed under being exerted pressure by removable lever.
17. test cards for external medical diagnosis device according to claim 16, is characterized in that, described removable lever is controlled by processing electron device.
18. test cards for external medical diagnosis device according to claim 1, is characterized in that, described the second import allows to introduce air bubble, to substitute, has previously been introduced at least part of any calibration solution in calibration solution channel.
19. test cards for external medical diagnosis device according to claim 1, it is characterized in that, each is sealed described the second import and described the second outlet by rubber shape separator, described rubber shape separator can be pierced, to obtain and become fluidic intercommunication with described calibration solution channel with external pressure or vacuum pump respectively.
20. test cards for external medical diagnosis device according to claim 1, is characterized in that, described the second import and described opening are respectively by the diaphragm seal that comprises silicones.
CN201310322066.8A 2012-12-06 2013-07-29 Testing cartridge for an in vitro medical diagnostic device Active CN103543185B (en)

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