Patent Application
20090165876
This invention relates generally to structures, devices and methods for manipulating fluid flow, optionally within structures with at least one dimension generally less than ten millimeters in size but usually less than one millimeter. More particularly, the present invention relates to a variety of fluid-handling structures allowing external manipulation of fluids within a device. A single actuator may act upon more than one fluid-handling structure. The fluid handling strategies may involve the use of moveable components, electrodes, and semi-permeable membranes or combinations thereof. The deformable components may be deformed directly into a fluid-handling structure, or indirectly act upon part of a fluid handling structure, to cause or prevent a change in pressure or shape within the fluid-handling component Gas permeable membranes can be used to restrict fluid flow within some structures for pumping, valving, chemical storage and injection, filtering, or degassing.
This invention also relates generally to structures, devices and methods for manipulating fluid flow, optionally within structures with at least one dimension generally less than ten millimeters in size but usually less than one millimeter, using deformable or moveable components. More particularly, the present invention relates to fluid-handling structures containing deformable components that may be used as pumps or valves. The deformable component may act in a variety of ways, for example it may be deformed into a fluid-handling structure, or act upon part of a fluid handling structure, to produce a restriction of flow or an increase in pressure or induce flow in the fluid contained therein.
This invention additionally relates generally to devices and methods for fabricating flow cells for measurements in devices containing structures for fluid flow, optionally with at least one dimension generally less than ten millimeters in size but usually less than one millimeter. More particularly, the present invention relates to sub-millimeter devices and structures to facilitate the measurement of the electromagnetic wave interaction with fluids flowing therein and methods of manufacturing these devices and structures.
This invention also relates generally to systems and methods for software and data handling, and more particularly, to a system and methods for upgrading, configuring or passing information to a device through the use of one or more inserts that may be used primarily for other purposes.
In the discussion that follows, reference is made to certain structures and/or methods. However, the following references should not be construed as an admission that these structures and/or methods constitute prior art. Applicant expressly reserves the right to demonstrate that such structures and/or methods do not qualify as prior art.
There has been increasing interest in the development of microscale systems for fluid analysis. These developments have been brought about by the advantages that miniaturization has to offer. In particular, performance improvements can be achieved over traditional laboratory equipment in terms of automation, reproducibility, speed, cost and size. This rapidly growing field includes micro total analytical systems (μTAS), or “lab on a chip” devices. Much of this early work was performed on silicon or glass substrates using established techniques developed in the 70's and 80's for the semiconductor industries.
There have been many different pumping and valving strategies that have been integrated into miniaturized devices. The simplest of which is capillary wicking, where the surface tension enables fluid flow in a suitable capillary environment. Unfortunately, this technique has only limited capacity for sample introduction in appropriately shaped capillaries. Electrokinetic flow is another popular technique but is limited in substrate and fluid medium choice, due to surface charge interactions with the fluid and joule heating, and use high driving voltages that are potentially dangerous for many portable diagnostic applications. Electrokinetic flow can also be used to induce flow in connecting channels that do not undergo electrokinetic pumping, see U.S. Pat. No. 6,012,902; however the same electrokinetic limitations still apply to the electro-active region and systems driving voltage.
In terms of versatility the pressure driven pump is a preferred method for fluid transport. However, to date pressure pumps integrated into microdevices have required relatively complex instrumentation systems to control actuators that operate the micropumps. Examples of this type of approach can be seen with the pneumatic operation described in U.S. Patent Publication Nos. US2002/0148992, U.S. Pat. No. 6,619,311, US2004/0209354A1, and U.S. Pat. No. 6,408,878, and the piezo driven micropumps of U.S. Pat. No. 6,073,482. In many cases this instrumentation requirement limits the device's use to that which complies with the size and cost constraints of the supporting instrumentation. Another inherent problem in the operation of known devices is the inherent inefficiency and reliability of the fluid-handling operations. Channels with deformable membranes are prone to leakage due to the need to conform the movable components to the channel dimensions. Furthermore, complex manifolds and large areas on the microdevice are required for complex fluid manipulation.
In addition, pressure pumps integrated into microdevices have typically involved complex three dimensional geometries with multiple one-way valves that are complex to manufacture and have resulting reliability problems. Examples of these types of geometries in polymer materials can be seen with U.S. Pat. Nos. 5,718,567 and 6,073,482. Similar three dimensional membrane-based valve topologies have been demonstrated in multilayer polymer films by U.S. Pat. No. 6,619,311 and U.S. Patent Application Publication US2002/0148992A1. However, the overall relative complexity of the structures and requirement for pneumatic operation introduce difficulties with bonding and interfacing, and their use is restricted to applications where a pneumatic supply can be provided.
A simpler valve design is provided with U.S. Pat. No. 6,408,878 which involves microfluidic channels cast inside an elastomer. A second channel or structure is required within the elastomer to allow deflection upon actuation into the first channel, typically by pneumatic force. This technique is not suited to mass production due to the requirements of forming microstructures within the elastomer, i.e.—the proposed multi-step casting method is a slow batch-based process.
Traveling wave type pumps have been fabricated in miniaturized silicon devices using an electrically deformable membrane, see U.S. Pat. Nos. 5,705,018 and 5,096,388. However due to the materials used, and the special processing requirements, the manufacturing methods are limited to batch-based semiconductor fabrication processes, which are relatively expensive. U.S. Pat. No. 6,408,878 discloses a polymer multi-valve pump that produces a peristaltic type motion by using three or more valves that alternately deform into a fluid channel to give a pseudo traveling wave, but the fabrication is also limited to batch-based processing.
What is required for many portable and low-cost applications are methods of improving device efficiency, and simplifying or reducing the size and cost of the supporting instrumentation. The devices and methods described in the prior art do not provide a method for small scale pumping, valving, and other fluid manipulation that is efficient, simple to use, small, lightweight, intrinsically reliable or scaleable for high throughput mass production.
Critical to the usability of microfluidic devices is the ability to analyze the characteristics of the fluids so contained. Many methods and techniques are used to measure these characteristics including electromagnetic radiation interaction such as optics and detection strategies for the same. Such absorption, transmission and luminescence (phosphorescence and fluorescence) based measurements present difficulties at the small scale used in these devices. Most of these difficulties arise from the tight dimensional constraints, reduced path length, and reduced fluid volumes leading to much smaller signal responses.
Capillary or microfluidic optical based detection techniques have typically employed instruments containing their own wave interaction elements to focus photons into the small chambers or channels of the fluidic devices. Problems with these techniques include: alignment difficulties due to the small fluidic dimensions; the size of the components used; and in cases such as fluorescence, signal losses due to the distance from the fluidic source of the focusing optics and their focusing area. Another approach that improves on some of these aforementioned limitations, is to incorporate optical elements in the same part as the fluidic elements.
An example of a microfluidic device with integrated optical components is described in U.S. Pat. No. 6,100,541. Here optical components are integrated into the body structure adjacent to the microchannels inside the body structure. A polymeric structure with an integrated lens adjacent to a microfluidic channel is described.
For measuring bulk fluid changes in such small dimensions (generally less than 10 mm) it is commonly understood that increasing the path length can improve detector response. In cases of transmission or absorption-based detection, the signal response is proportional to the path length through the fluid (Beer's Law). Likewise, a better signal can be produced with more light emitting reporters as can be used with luminescence measurements. For example, in capillary electrophoresis, improved detection has been demonstrated with an increased optical path length using a “Z cell” configuration.
Increased path length detector cells have been demonstrated in microfluidic devices using optical fiber coupling and silicon or glass etching techniques. These are typically expensive fabrication processes that do not lend themselves to high volume manufacture of disposable devices. Examples of such devices are disclosed in U.S. Pat. Nos. 5,599,503 and 6,490,034, which provide methods for fabricating microfluidic devices with a detector cell for the absorption of UV or visible radiation. The inlet and outlet radiation is redirected along the channel of the microfluidic device by reflection from the angled inlet and outlet walls with (U.S. Pat. No. 5,599,503) or without (U.S. Pat. No. 6,490,034) multiple reflections. The systems described are fabricated using silicon etching techniques. However, silicon based fabrication of disposable microfluidic devices is commercially challenging, particularly in the intrinsically high unit price and significantly low unit volumes with this particular substrate family.
An alternative approach to passing the light radiation longitudinally along the channel axis is disclosed in U.S. Pat. No. 6,224,830. The device described produces multiple passes across a fluidic channel for increased absorption in a small detector region (less than 200 μm). However, a fundamental problem with this technique is the photon energy losses incurred from multiple reflections and material boundary transitions limiting the size and sensitivity of the fluid detection cell.
A common approach to couple the light to fluidic devices is to employ optical fibers that are directly interfaced to the fluidic manifolds. These manifolds are typically machined from a single bulk material and are therefore very limited in their geometry. Microfluidic devices are typically made from multiple layers of materials forming complex fluidic manifolds. This multilayer design introduces coupling and alignment difficulties when coupling optical fibers to fluidic circuits. An approach proposed for polymer based microfluidic devices is disclosed in U.S. Pat. No. 6,867,857 and involves coupling a multilayer fluidic device to an external flow cell with fiber optic ports. However, this approach employs separate fabrication processes for each part and introduces alignment or dead volume difficulties, and adds to both the device's size and the unit cost.
A similar approach to the silicon based reflectors described earlier is provided in U.S. Pat. No. 6,900,889 where polymer microfluidic devices for fluorescent point source detection is disclosed. The disclosed method passes a laser along a trajectory, traversing the length of a micro channel, in order to excite fluorescent markers in the fluids contained in a polymer microfluidic device. Light emitted from the markers is then detected through the micro channel's cover. This technique obviates the need for a laser beam to scan along a channel to find the fluorescent marker. However this method employs a light directing member, or reflective surface, that is separate from the microfluidic device. Furthermore the device is unsuitable for transmission and absorption based measurements as it does not provide a mechanism for recovering or measuring the light characteristics after it has traversed through the sample fluid. Another limitation is that the system only provides for detection of point sources (reporters) radiating perpendicular to the fluidic channel. This further limits the technique as the point source signal response is low and there is no ability to increase the signal (and therefore the sensitivity), by concentrating the light.
U.S. Pat. No. 6,906,797 describes polymer microfluidic devices with reflective channels for guiding light across a multiplicity of channels for the purposes of fluorescent point detection. Due to measurement across the width of the channels this technique is limited in its signal response in a similar manner to the previous example and further optical losses are encountered as the light passes the different media due to the separation of the light and fluidic channels. Furthermore there is no method for concentrating the emitted signal from the point sources.
The devices and methods described above in the prior art do not provide a low cost integrated approach for adequate absorption, transmission, and luminescent detection in microfluidic devices. The current invention fulfils the need for low cost polymeric devices with increased optical performance inside flow cells that are intrinsically reliable and scaleable for high throughput mass production.
Instruments of many different descriptions are known. For example, certain types of instruments are devices that control experiments or collect information from an environment, unit or material(s) being tested. Other instruments may perform data analysis or processing of data, including display to the user and or storage of data. Examples of instruments include digital multimeters, oscilloscopes, DNA sequencers, pressure sensors, temperature sensors, pH sensors, but may also include any device which is operable with an insert, and for example may include mobile telephones, computers, personal digital assistants (PDAs), digital music players, etc.
An insert is a removable or connectable device that may be a sensor, cartridge or cassette, such as a microfluidic device, that works in association with an instrument, for example by providing some functionality to it. The insert may for example be a memory stick, smart card, or a rigid or flexible printed circuit.
Inserts are usually designed for a specific purpose or purposes such as metabolite monitoring in whole blood, electrochemistry performed on mineral samples or DNA amplification from bacteria, to name only a few such specific purposes. If the instrument is dedicated to that particular application and sensor type then all necessary program operation routines, or experimental protocols, can be contained within the instrument and no on-chip recognition is required to distinguish between the insertable devices as they are all the same.
However when multiple insert types are used in the same instrument then the instrument must distinguish between each one, so that the correct protocols are performed physically, chemically and or electronically on the insert and/or its contents.
Generally, either the user selects which inserts are in use or manually configures the instrument for use with each insert. Alternatively, the insert itself indicates to the instrument its function. This has been traditionally achieved through the use of serial or product numbers, which the instrument then references within its own internal programming code to establish the appropriate application protocols to be used with a particular insert type (e.g.,
The disadvantage of this kind of indication is that the instrument software is still required to contain all the program information for the device's operation. The instrument therefore needs to either contain all coding for all possible applications before it leaves the manufacturer, or after sales software upgrade packages need to be supplied with each new application. Similar after sales support is required in the form of software upgrades for software bug fixes and, as is often the case with scientific instruments, new calibration or operational data.
Traditionally, these upgrades have been provided to the user as new software versions or as service pack upgrades on disks or CD-ROMs. This is typically only done for major revisions or upgrades, as frequent distribution of upgrade media and the user action required to install the upgrades is considered problematic. With the development of world-wide-web installation, upgrades can be performed remotely, but only if the instrument is connected to an appropriate network.
A further disadvantage of providing individual upgrades for new instrument applications is the development cost in providing the new application routines and relevant installation package. This method of upgrade also tends to introduce further possibilities for program error or system hang-ups due to the increase in the inherent complexity of the software code and the potential incompatibilities caused by numerous revisions and incomplete sequence history. In addition, allowing an instrument to be upgraded this way leaves it open to unauthorized “hacking” which introduces further reliability and warranty problems for the manufacturer or reseller.
Furthermore, there are extra logistical concerns relating to cost and technical problems with the delivery of the upgrade service, whether it be a physical disk or remotely by methods including email and the internet.
A disadvantage of the prior art method of keeping the full program coding on the instrument is the inherent security risk of containing all the instrument's operational protocols in one program. Placement of the instrument's program operation entirely in the instrument, means that reverse engineering is potentially easier, allowing unauthorized usage of the instrument and or operation with third party inserts or even duplication of an entire instrument.
Traditional methods of software protection include the use of serial numbers, remote license servers and/or files, and dongle protection. Unfortunately, these methods do not stop a skilled operator from accessing the onboard application program to operate the instrument or use foreign inserts. One such example of bypassing a program's authorization code is to ‘hack’ into the program and bypass the authorization code query, allowing full program operation without authorization.
The present invention describes new methods and systems to overcome the above-mentioned limitations by ensuring that some or all of the upgrade data, program code, experimental data, or related information is kept within the insert.
According to a first aspect of this invention, there is provided a fluid handling structure comprising: an actuation area to enable control of fluid flow within the structure; and at least one actuation component within the actuation area; wherein the actuation area is arranged to activate or control the at least one actuation component. In some embodiments, the actuation area comprises a controller to control fluid flow within the device.
In another embodiment, there is provided a microfluidic device comprising a controller to control fluid flow within the device wherein the controller is capable of simultaneously activating more than one pumping and/or valving component associated with fluid flow within the device.
According to one embodiment, the controller is manually or pneumatically operable. However, any suitable means of operation may be used. For example, the controller may be operable electromagnetically, mechanically, hydraulically, by acoustics, or by piezo electrics, etc.
According to a second aspect of this invention, there is provided a fluid handling structure comprising: an actuation area to enable control of fluid flow within the structure; at least one of a fluid chamber or channel; a semi-permeable membrane forming at least one boundary of the fluid chamber or channel, the semi-permeable membrane arranged so as to permit the passage of a control fluid therethrough and into the fluid chamber or channel, thereby promoting, restricting, or stopping fluid flow within the fluid chamber or channel. The control fluid may comprise any suitable fluid and may also for example be a liquid, a gas, or combinations thereof. One embodiment comprises a second semi-permeable membrane forming at least a second boundary of the fluid chamber, channel, or fluidic network. It is not necessary that the second boundary be in direct communication with the fluid chamber or channel. For example, it may be further along the fluidic network.
In another embodiment, there is provided a microfluidic device comprising a semi-permeable membrane which restricts passage of fluid and/or particles therethrough. According to this aspect of the invention passage of fluid (such as gas or liquid) or particles may be delayed or blocked. A membrane according to this aspect of the invention may be adapted to provide functions such as separation, de-bubbling, filtering, pumping, valving, mixing, priming, dosing, etc. For example, according to one embodiment, a fluid is unable to pass through the membrane until a certain internal pressure is reached at which time the fluid will pass through the membrane. This particular embodiment is useful for sample storage and injection, pumping, and valving.
According to another embodiment, the membrane allows gas to pass through but not liquid (which is blocked) for functions such degassing, pumping, valving, reagent storage and injection. According to another embodiment, the membrane filters particles in the fluid. Such particles might for example include cells, micro-organisms, macromolecules, antigens etc.
According to another embodiment, a recirculating fluidic network is provided. The recirculating fluid network may for example comprise an inlet; at least one of a pump or valve or a debubbler. A recirculating fluid network may also comprise a detection chamber. In some embodiments, the inlet port may in addition function as a debubbler.
According to another embodiment the instrument-card interface is configured such that the card provides some of the pneumatic plumbing. According to another embodiment the pumps and valve controllers are driven from the same pressure reservoir.
Fluid pumping, valve control, degassing, filtering, sample introduction, reagent-storage and controlled dosing are useful in performing complex chemical protocols. A common problem in microfluidics is the transport of fluids in accurate but very small quantities. The present invention comprises a variety of fluid-handling structures containing moveable components, semi-permeable membranes, electrodes, or combinations thereof. By providing a controller which is capable of simultaneously activating more than one component, it is possible to simplify device operation, and thereby instrumentation requirements for fluid handling components. The actuation may be performed manually directly by the user or with the aid of an instrument. Methods for overcoming priming, sample introduction, injection, reagent storage, mixing and bubble problems are also disclosed as part of the invention.
According to another aspect of the invention, there is provided a fluid handling structure comprising: a fluid channel; and a deformable material; wherein the fluid channel is bounded, at least in part, by the deformable material, and the deformable material is arranged to produce a restriction, or point of compression within the channel. In some embodiments, the restriction may optionally enable the creation of a traveling fluid wave within the channel. The structure may further comprise a rigid substrate wherein the fluid channel is formed, at least in part, within the rigid substrate.
In another embodiment, there is provided a device comprising a channel defined at least partially by a deformable material wherein deformation of the deformable material is capable of creating a traveling fluid wave within the channel. According to one embodiment of this aspect of the invention, the device is a microfluidic device.
According to a further embodiment of this aspect of the invention, the fluid wave is created by applying a force to the fluid at a single location along the channel at any instant in time. According to another embodiment of this aspect of the invention, the device is a microfluidic device which is not made from silicon. Preferably, it is a laminar microfluidic device, and preferably it does not utilize an electromagnetic mechanism to create the fluid wave.
According to a further aspect of the invention, there is provided a method of pumping fluid in a channel in a microfluidic device comprising utilizing a deformable material to produce a traveling fluid wave within the channel.
According to an additional aspect of the present invention, there is provided a microfluidic device comprising a microfluidic channel defined at least partially by a deformable material wherein the cross-sectional area of the deformable material is substantially larger than that of the channel and the deformable material is sufficiently deformable such that it is able to at least partially enter the channel and thereby affect fluid flow within the channel. Deformable material according to this aspect of the invention may be of any suitable type. A skilled worker will readily be able to identify appropriate materials. For example, certain elastomeric compositions have the appropriate characteristics.
Deformable materials include, but are not limited to, polymers, polymer composites, metals and glasses. Where the deformable material is too rigid to deform sufficiently then the deformable material is structured to allow deformation, and/or combined with or replaced by other materials that have more suitable elastomeric properties, such as rubbers, Santoprene™, poly(dimethylsiloxane), Nitriles, polyurethanes, silicons, polyisoprene, polybutadiene, polychloroprene, polyisobutylene, poyl(styrene-butadiene-styrene), etc.
Use of a deformable material capable of creating a traveling fluid wave within the channel provides a simple geometry that enables the required accurate fluid delivery and at the same time facilitates low cost mass production. Furthermore, the present invention enables a more economical division between the costly actuator components and low cost fluid handling components. According to one preferred embodiment, the actuating component is external to the fluid-handling device that contains a deformable material. A fluid-handling device according to the present invention may be fabricated from polymeric material and produce fluid flow by causing all or part of the fluid-handling component to deform, to, e.g., restrict, pressurize, or induce fluid flow.
As used herein, the term “fluid” refers to either gas or liquid phase materials.
As used herein, the term “actuation area” refers to the area on the fluid-handling device upon which an actuator acts.
The present invention also provides methods and devices for systems incorporating flow cells with longitudinal optical paths (for example, microfluidic systems). In particular, devices and methods are provided for passing light longitudinally along a channel and for deliberate concentration of exiting light and thereby and through various other means, herein described, improve the signal response and therefore the sensitivity of a selected measurement system.
Accordingly, in one aspect of the invention, there is provided a fluidic device comprising: at least one channel defining a path for the travel of an electromagnetic wave. In some embodiments, the path is substantially longitudinal for at least a portion of the length of the channel. In some embodiments, the path is substantially perpendicular, or transverse, to at least a portion of the length of the channel. In other embodiments, the path is substantially perpendicular, or transverse, to at least a portion of the length of the channel. The electromagnetic wave may comprise at least one of: visible light, ultraviolet light, microwaves, radio waves, x-rays, and gamma rays.
In another aspect of the invention, there is provided a device comprising a channel adapted for electromagnetic wave-based measurement of characteristics of a fluid within the channel wherein the measurement can be undertaken by causing the electromagnetic wave to travel substantially longitudinally along at least part of the channel.
According to one embodiment, the electromagnetic wave is visible light. However, any form of electromagnetic wave may be used which is suitable for the purpose. Thus, for example ultraviolet or infrared light, microwaves, radio waves, x-rays, may be used, and so may gamma rays.
A device according to the present invention may be used for any suitable purpose involving optical sensing. According to one embodiment, the device is for microfluidic applications.
According to a further embodiment, the device is a microfluidic device and comprises layers which have been engaged (for example, bonded), so as to form the microfluidic device (a ‘laminar’ device). According to another embodiment, the device comprises at least one optical window to allow the electromagnetic wave (such as light) to enter and/or exit the channel. According to an additional embodiment, the device is not made from silicon or a silicon-based material.
In one embodiment, light enters the flow cell through an optically clear opening at one end of the channel, at which a reflective or refractive means guides the light path to one which is longitudinal along the channel or flow cell. Light levels are maintained (and losses are minimized) throughout the channel by either providing reflective surfaces, or appropriate refractive index changes to maximize total internal reflection along the length of the channel or flow cell. At the detection point a reflective and/or refractive structure guides and, if desired, concentrates the light exiting the channel for detection purposes.
In another embodiment a flow cell is provided which is capable of both longitudinal and/or transverse illumination or detection.
The methods and devices of this aspect of the invention are suitable for microfluidic devices produced by traditional batch-based and reel-to-reel fabrication processes, including but not limited to laser processing, die cutting, embossing, injection molding, and lamination methods.
As used herein, the term “microfluidic” or “fluidic” refers to fluid handling, manipulation, or processing carried out in structures with at least one dimension which may be less, than one millimeter.
As used herein, the term “light ray” refers to more than one photon of electromagnetic radiation traveling in a substantially similar direction.
As used herein, the term electromagnetic radiation refers to energy in the form of photons or waves and includes light either visible, ultraviolet, or infrared, and waves such as microwaves, radio-waves, x-rays, gamma rays and like radiation.
The present invention also provides methods for software or firmware upgrade, and methods for controlling an instrument, by using additional facilities within one or more removable inserts.
According to one aspect of the invention, there is provided a method of performing a function with an instrument, the method comprising: associating an insert with the instrument, the insert comprising one or more of program code, data, or commands, which enable performance of the function. The instrument may for example comprise a digital multimeter, an oscilloscope, spectrometer, chemical analysis instrument, biological analysis instrument, a DNA sequencer, a pressure sensor, a temperature sensor, a pH sensor, an electrochemical analysis device, a mobile telephone, a computer, a personal digital assistant or a digital multimedia player.
In another embodiment, there is provided a method of undertaking a function using an (i) instrument and (ii) an insert having function-specific data, comprising: (a) engaging the insert with the instrument, (b) transmitting data from the insert to the instrument, and (c) the instrument effecting the function.
According to another aspect of the invention, there is provided an insert configured for use with an instrument to perform a function, the insert comprising one or more of program code, data, or commands, which enable performance of the function. The insert may for example comprise a sensor, a cartridge, a cassette, a microfluidic device, a flash memory card, a memory stick, a smart card or a printed circuit or other memory storage component.
In another embodiment, there is provided an insert for use with an instrument to perform a function wherein the insert comprises function-specific data required by the instrument in order to effect the function.
According to a further aspect of the invention, there is provided a method of updating software or firmware of an instrument, the method comprising: associating an insert with the instrument; and transferring some or all of program code, data, or commands to the instrument thereby effecting the update. The instrument may for example comprise a digital multimeter, an oscilloscope, spectrometer, chemical analysis instrument, biological analysis instrument, a DNA sequencer, a pressure sensor, a temperature sensor, a pH sensor, an electrochemical analysis device, a mobile telephone, a computer, a personal digital assistant, or a digital multimedia player.
In another embodiment, there is provided a method of upgrading an instrument's software or firmware, wherein the instrument is for use with inserts, comprising (a) engaging an insert with the instrument, and (b) upgrading the instrument by means of data transmitted from the insert to the instrument.
According to an additional aspect of the invention, there is provided an insert for use with an instrument to perform a function wherein the insert comprises data for upgrading the instrument's software or firmware.
According to another aspect of the invention, there is provided a method of creating an interaction between an instrument and an insert having interaction-specific data, comprising: (a) engaging the insert with the instrument, (b) transmitting data from the insert to the instrument, and (c) the instrument performing a function.
Traditionally, the primary purpose of inserts is a consumable function necessary for the normal operation of the instrument. By providing additional functionality on the insert, user operation is simplified, new product development cycles are minimized, and product data security and product intellectual property are further protected. Generally, some or all of the data for an upgrade, or for the instrument operational protocols may be partially or wholly contained on one or more removable inserts according to the present invention.
The present invention provides an instrumentation and insert architecture in which one or more inserts perhaps normally used for physical functionality of the instrument, become a part of the software/firmware upgrade path for the instrument. More specifically, the insert or inserts contain some or all of the upgrade information. This approach simplifies user operation as the process of updating the software is automated; there is no need to install new software from other media. Furthermore, logistic overhead is reduced by no longer requiring the production and dissemination of separate upgrade media.
The present invention provides for program code, data, or commands to be distributed, (in ratios varying, for example from 1:0 through 1:1 to 0:1) between the instrument and one or more removable inserts. More specifically, generic subroutines may be provided on the instrument and the application specific program execution, and/or operational data, are provided on one or more removable inserts whose primary function may be as a disposable consumable to contain and perform chemical experiments or analysis on certain biological samples under the physical control of the instrument.
This distributed architecture minimizes software development associated with new application developments for an instrument and its associated inserts. The generically programmed instrument can then accept new applications without the need for the user to upgrade the software and also obviates any requirement for the application and instrument designers to anticipate new “not yet invented” applications.
The present invention provides improved user operability and operational automation by the insert providing data to the instrument to automate parts or all of the application operation and provide user defined settings. Thereby simplifying user interaction, which improves system reliability and simplifies instrument operation.
Furthermore, the invention provides extra software security as the program execution instructions do not necessarily exist in the instrument. In one particular embodiment, the insert carries the instructions to configure the instrument for the specific application of the insert. According to this embodiment, the invention produces a much more difficult path to reverse engineer, as a full understanding of the program's execution is required for successful copying. If, in the unlikely event that an instrument and an insert's interaction is finally reversed engineered, then the resultant program execution reveals only data for that specific application that the specific insert was fabricated for and no others.
The invention further allows for incremental and permanent change to the usage data contained on the insert(s) such that reverse engineered instruments are unlikely to work with new inserts.
The upgrade information, or distributed program data can be encoded onto one or more inserts and can be in many different formats including, but not limited to: electrically by electrode connections; resistor values; magnetic strips; integrated circuits; optically, and mechanically.
A further advantage of having upgrade and configuration data inside the insert(s) is the extra security feature of requiring a match between the instrument, the interface and the matching insertable device.
As used herein, and for convenience, the term “consumable insert” refers also inserts having one or more use.
As used herein the words “device” and “instrument” are interchangeable in meaning and use.
a) depicts an example of an actuation area with multiple actuation components. The two center channels are connected together by the two circular one-way valves allowing a pumping action to be performed upon actuation, as shown in
b) is a transverse cross section along the channel of the same vent.
a)-13(b) illustrate the operation of a degasser where a regulation type valve is used on the outlet.
a)-14(b) illustrate combined vent and valve structures under a single actuator to effect loading of a channel/well.
a)-15(b) illustrate semi-permeable membranes used as inlet filters and barriers to sample introduction until pressure is applied to push the fluid through the membrane.
a)-17(b) shows a vented channel under applied fluid pressure, positive or negative, operating as a valve or pump.
a)-19(b) illustrate multiple permeable membranes within a micro-channel network operating as a pump or valve under an applied fluid pressure.
a)-21(b) illustrate a cross section of a button style actuator incorporating the electrode and button style interface shown in
a)-23(b) show two representations of various methods to allow pressure gradient relief to prevent bubble formation. In particular, these figures depict expanded fluidic channels.
a) and (b) illustrate plan and side views, respectively, of a card with pneumatic pumping and valving zones connected to external instrumentation.
a)-27(c) show a transverse cross section of a micro channel with at least one flexible wall, in this case the top layer.
a)-36(d) show configurations of microfluidic channels in planar view with transmissive windows separated to allow electromagnetic energy to travel longitudinally along a fluidic channel.
a) shows the cross sectional view of a three layer device with the optical windows exiting immediately between the channel and substrate surface.
a)-(c) show various 2 and 3 layer device configurations using reflective layers.
a)-(c) provide examples of lenses incorporated into a fluidic device.
a)-43(b) illustrate integration of optical fibers into the device.
a) and 44(b) show diagrams of corner cube reflectors.
a), (b) and (c) show corner cube reflectors used in or with microfluidic devices.
a) and (b) show diagrams of prismatic structures used to help collimate and guide light.
a) to (j) show examples of flow cells with prismatic and reflective structures for improved signal response and imaging.
a)-49(c) illustrate detector and source zones located proximally on a device.
a)-50(b) illustrate wave guides which can be made for example by injecting and then curing an optically transparent material, or placing an already formed light pipe into vacant structures.
Various embodiments of the present invention comprise a controller to control fluid flow in the device and a variety of fluid-handling structures containing one or more moveable components, semi-permeable membranes, electrodes, sensors or combinations thereof.
A controller according to the present invention may take any suitable form and preferably comprises an actuator to activate components associated with fluid flow within the device.
The fluid-handling or actuator components may be made from any suitable materials. For example, they may be made from a single shaped substrate or multiple substrates. The fluid-handling structure may be formed in any suitable way, for example it may be formed into the bulk of a substrate or formed from several layers of substrate.
The actuator may be external to the device or part of the fluid-handling device or formed from separate elements that are external to and part of the fluid-handling device.
Actuation may be performed by any suitable means, for example it may be performed manually directly by the user or manually or automatically and indirectly with the aid of an instrument.
According to one embodiment the actuator is pneumatic pressure supplied by interface with an external instrument.
According to other preferred embodiments described, an external mechanical actuator is used to apply pressure to a deformable structure on the device, which deforms and applies pneumatic or hydraulic pressure within the device, or manual actuation by the operator's finger is used. Therefore, according to these preferred embodiments, the deformable substrate(s) may be an integral part of the fluid handling structure, whereas the actuation mechanism is separate. Mechanical actuators may be of any suitable form, for example, they may include bearings, pins, pistons, wobble boards, cams, and wipers. Other desirable embodiments may include use of energy applied in various ways, for example, by instruments or devices containing light, electrostatic, electrical, resistive, piezo-electric, electromagnetic, pneumatic, hydraulic, linear and magnetic force actuators.
The actuator area may cover an entire surface or only a part thereof.
The actuator area may be on the outer surface of the fluid-handling component or within the fluid-handling device.
According to one embodiment, the actuation area or part thereof may be a moveable component that (for example) changes shape under applied pressure. The moveable material may be an elastomer or any other suitable moveable material which changes shape under applied pressure.
In another embodiment, the actuation area contains a bi-stable or astable material such as a polymer or composite material that can change shape from a predetermined geometry to another predetermined geometry, and may then change back or be encouraged to return to the original state and position once a stimulus (such as an actuator force) has been removed or reversed. Examples of such an arrangement include button type actuators which may be for example manually, thermally, electrically or mechanically operated, that have been suitably formed to allow movement under the actuator force.
Moveable components may be deformed directly into a fluid-handling structure, or indirectly act upon part of a fluid-handling component, to cause or prevent a change in pressure or shape within the fluid-handling component.
The actuation area may be larger than the actuation components.
Actuation component operations include but are not limited to, flow control, pumping, valving, diffusing, droplet delivery, mixing, separating, switching, dosing, injection, sensing, catalyzing, hydrating, dehydrating, and other fluid handling operations that are activated or prevented from activation upon an actuator force. For illustration purposes,
More than one actuation components may be operated from the same actuator. Examples are shown in
Schematic representations of where more than one actuation component, of the same type, is operated from one actuation area are shown in
Schematic representations of where more than one actuation component, of more than one type, is operated from one actuation area are shown in
The pumping schematics shown in
According to the invention, actuation components may operate differently depending on their composition and geometry even when activated by the same actuator. Examples of this include: pumps operating at different flow rates due to their geometry, and valves, where some are turned to their OFF state while others are turned ON during actuation, or variable valves that are set to restrict the flow to different levels, or components that are activated at different times by the same actuator. Examples of arrangements which provide for controlled dosing are shown in
According to another aspect of the invention actuation components may operate differently depending on their configuration with the same actuator.
In another embodiment multiple valves can be operated from the same actuator to induce fluid flow by alternating their on/off states to produce a peristaltic motion. A peristaltic type pump configured from three differently activated valves operated by the same actuator is shown in
Multiple actuation areas may be combined to perform fluid-handling operations. An example of such an arrangement is illustrated in
a) illustrates an embodiment of such an actuation area (33) in which the two center channels are connected together by the two circular one-way valves (34) allowing a pumping action to be performed upon actuation, as shown in
Another aspect of the present invention may include one or more semi-permeable membranes that can act as vents or check valves to allow for example, air passage but prevent liquid flow under low pressures. Examples include, but are not limited to perforated film or fibrous membranes, that have a bubble point pressure greater than >0 psi. A preferred embodiment uses hydrophobic membranes with pore sizes less than 0.9 μm, preferably less than 0.5 μm and most preferably less than 0.2 μm. Where the pore size is less than 0.2 μm, then preferably the membrane is suitable for biological organism trapping. Semi-permeable membranes may be, used for example, as vents for debubbling the fluid handling structures caused from priming, dead volumes and operations such as pumping, an example of which is depicted in
In another embodiment a vent (50) is placed to degas a structure (49) to ensure full packing of the channel and or chamber (52,53). Packing materials may be of any-suitable type, for example they may be fluid or solid. The example in
In another embodiment the use of surface tension and geometric structures can be used to help guide the liquid past the vent while the gas is removed.
In another embodiment the vents can be combined with a deformable structure and a one-way valve, or restriction, for liquid loading or pumping. For example,
In another embodiment, the vents can be configured to sample introduction filtering and fluid control.
In another embodiment the semi-permeable membranes (72) can be used to effect a controlled volume dispense and storage.
In another embodiment the fluid can be introduced through a semi-permeable membrane to perform valve or pumping functions.
In another embodiment the vent (78) can be combined with one-way valves (75) to form a pumping system. An example of such a system is illustrated in
In another embodiment more than one semi-permeable membranes are used for fluid control within the structured network.
In another embodiment electrodes are included in the actuation area to provide electronic switching for sensor operation, circuit operation or detection of actuation events. An example is shown in
In another embodiment a button, or other deformable structure is combined with a semi-permeable membrane. This offers advantages for chemical storage, injection, pumping, valving and other fluid manipulation operations by providing a controlled actuation volume. For example,
In an alternative situation the deformable actuation structure (87) may act as an injection pump by containing a fluid in the actuation volume (90) that is kept out of the channels of the device until actuation upon the deformable structure causes the internal pressure to rise above the membranes retention point.
In another embodiment a recirculating fluid system is provided. With the use of a degassing component the outlet can be connected to the inlet and air that is introduced into the system is removed before the fluid passes through to a functional area. In this manner the fluid can be mixed more effectively and pass the functional area multiple times. This has advantages in many applications including sample preparation, such as cross flow filtration, solid phase chemistry, and detection in microfluidic systems.
In other embodiments internal pressure relief structures (97) are used to prevent bubbles from forming in undesired regions. For example
In another embodiment,
In one embodiment the onboard pumping and valving of the device is actuated from external pneumatic instrumentation with a configurable pneumatic interconnection provided by the card (126). The configuration provides a robust and very flexible platform that can be configured to take cards for a variety of different applications because the card configures not only the internal valve and pump set-up but also the external valve connections (131).
The present invention also comprises a variety of fluid-handling structures containing deformable components that may be used as pumps or valves. The deformable component may be deformed into a fluid-handling structure, or act upon part of a fluid handling structure, to produce a restriction of flow or an increase in pressure.
Either a portion of or all of the fluid-handling structure may be deformed. This restriction can be used to control fluid movement in a stationary singular valve, multiple valve, or in a moving valve operation, see
According to one embodiment, an external component contains the actuating parts that are in contact with the fluid handling component enabling deformation of part of the channel, causing the channel to be pinched off, thereby allowing valve operations to be performed by causing the channels to be open (
The deformable material according to this aspect of the invention may be of any suitable type. One preferred embodiment comprises a deformable material which is an elastomer. Preferably, the deformable material is resilient so as to turn to its pre-deformation shape and position once a stimulus to deform has been removed. Thus, for example, a deformable elastomeric material which is depressed into a channel with an actuator would most preferably automatically return to a position which is outside the channel after removal of the actuator.
In another embodiment the deformable material is a bi-stable or astable material such as a polymer or composite metal that can change shape from a predetermined geometry to another predetermined geometry, and may then return or be encouraged to return to the original state and position once the stimulus has been removed or reversed. Such examples can include button type actuators, either manually, thermally, electrically or mechanically operated, that have been suitably formed into raised or relief structures.
The fluid-handling component may be made of a single shaped substrate or multiple substrates. The fluid-handling structure may be formed into the bulk of a substrate or formed by the definition of several layers of substrate.
The fluid handling structure (211) may be partially or wholly formed inside the deformable material (212), as shown in
The deformable material may be a membrane thinner than the deflection distance, or a bulk deformable material where the depth of the deformable material is larger then the deflection required. A larger deformable material provides advantages for simplifying the actuator mechanism by allowing a larger applied pressure zone, which may induce deformation into smaller structures.
The deformable material may be on the outer surface of the fluid-handling component or within the fluid-handling device.
The deformable material may cover the entire surface or part thereof. For example, it may include gasket or o-ring geometries.
The deformable material may be flush with the surface or extend above the surface of the channel.
The deformable material may deform into one or more fluid-handling structures.
In another embodiment multiple stationary valves formed from the deformable material may be used to induce fluid flow by alternating their on/off states to produce a peristaltic type motion (
The deformable or microfluidic structure may be combined with other fluid restricting elements, such as diffuser nozzles or valves, to form pumps or part of a pumping mechanism. These valving structures may be disposed proximally to the pumping chambers, as indicated by the arrows in
According to another embodiment, movement of an actuator that induces deformation in a fluid-handling structure may create a pumping action by inducing a wavelike motion that forces fluid to flow along the channel.
These particular embodiments use a mechanical actuator to apply pressure onto the deformable channel structure perpendicular to the channel direction, and zero or low force parallel to the deformed substrate layer to reduce frictional forces. The deformable substrate(s) may be an integral part of the microfluidic chip, whereas the rotating part or actuator may be a part of an attached or accompanying instrument or such controlled device. Examples of mechanical actuators are shown in
The following description of certain preferred embodiments focuses on light as the electromagnetic wave used in the device. However, the person skilled in the art will appreciate that certain embodiments are equally applicable to other electromagnetic waves.
A purpose of an optical fluid detection cell is to guide light rays in or out of the channel to improve detection sensitivity and therefore improve detector response when analyzing fluids, and materials processed by fluid flowing through or contained within the cell. The structures, devices and methods disclosed herein are both applicable to measuring longitudinally and transversely inside fluid detection cells.
For analyzing the incident light after it has traversed a fluid contained in a detection cell, analytical methods include, but are not limited to, in-channel colorimetric, luminescence (phosphorescence and fluorescence), absorption, and transmission.
The fluid in the detection cell may be stationary or moving.
The molecules being analyzed may be anywhere within the channel, for example, they may be within the fluid, bound to the detection cell walls, or attached to another substance within the detection cell.
Off-chip optical elements such as lenses and filters may also be used to focus and condition the rays of light incident to or transmitted from the device.
A device according to the present invention may incorporate any known electromagnetic radiation transmissive, reflective, refractive, modifying, or splitting component. Examples of these include, but are not limited to, the following absorbing, reflective, refractive, or diffractive components as singlets or part of multiple optical elements; diffusers (from material inhomegenity, surface microstructuring), lenses (concave, convex, spheric, aspheric, fresnel), prisms (for guiding or separating light, beamsplitters, collimators), refractive surfaces (materials with different refractive indexes, moths eye microstructuring to reduce reflections at surfaces), surface coatings for refractive index changes (optical coatings such as thin metallic layers), diffractive gratings, reflectors (planar, spheric, aspheric, Fresnel, corner cube) and filters (absorbing, dichroic, binary).
According to one embodiment the device is a multilayer device, and the bulk of the device is partially or entirely polymeric. The fluidic or optic components may be made by removing or displacing material in the bulk or cutting entirely through a layer. Devices according to the present invention can be fabricated by either batch, serial, or continuous manufacturing techniques. Such techniques include, but are not limited to, embossing, injection molding, stamping, roller cutting, plasma or chemical etching, laser processing, and thermoforming.
In one embodiment, either or both of the light source S and detector D can be located perpendicular to the fluid carrying channel.
Cross sections of devices with longitudinal detection zones are shown in
In one embodiment, reflective components (either mirror surfaces or higher refractive index materials) are added to the walls of the microfluidic channel to avoid losses through the channel walls.
In a further embodiment light pipes, or waveguides, are created within the device to guide light rays to the detection cell, and in some cases along the length of the detection cell. The cross sections illustrated in
Dichroic, absorption and other filters may also be incorporated, for example by coating a surface of one or more of the layers of the device.
In other embodiments different refractive components are incorporated including, but not limited to, prisms and materials with different refractive indexes.
According to another aspect of the invention, integrated lens components can be fabricated in single or multilayer systems. These lens systems may be either in-plane or out-of-plane with the microfluidic channels. In many cases this allows simple fabrication of the lens components with the same method used for forming the channel.
Other embodiments can include the light-transposing elements outside the fluid carrying channel, or detection cell. For example,
Multiple lens systems may also be fabricated within the device to improve light guidance, see
Certain embodiments use optical fibers, which may be used with or without additional lens components for improved signal coupling.
Other prismatic and reflective structures can be used focus or guide the photons for improved signal response. For example corner cube reflectors, as shown in
Collimators (349, 353, 357) are used to help guide the radiation so that the photons are approximately parallel and normal to the surface.
Similarly, other combinations of reflectors and prismatic surfaces can improve photon density by guiding radiation.
Some examples of where prismatic or collimating surface structures may be used in a fluidic device are shown in
a) illustrates the use of collimating structures (365) located proximally to a fluidic channel (371). This reduces photon loss from scattering and random emission by collimating the photons passing through these surface structures.
b) illustrates the use of collimating structures (365) located proximally to a fluidic channel (371) with reflective walls (366). In this example photons entering the channel at the ends of the collimated structures (365) are reflected by the angled walls to travel inside the channel (371). The reflective walls (366) improve photon containment within the channel (371). The photons exit the channel (371) proximal to the reflective angled walls at the ends of the channel where the photons are again collimated by (365) while leaving the device. This method is not suitable for imaging segments of the channels (371) but improves photon yield when acquiring data from the entire channel (371).
c) illustrates the use of prismatic structures (367) inside the channel (371). These structures (367) may also be used to help collimate the photons passing through their structure by reflecting photons that are of too large an incident angle to the normal of their surfaces. Therefore the angle of the prismatic surface structures determines the photon acceptance angle. This can be particularly useful for improving the signal-to-noise response in applications such as luminescence by separating the excitation and emission photons. Collimated excitation photons incident normal to the structured surface are reflected while a portion of the random emission photons pass through the prismatic structures.
In
g) and 47(h) include prismatic layers (367) proximal to and on the surface of a channel (371), respectively. In
Lenses may also be combined within the structures to focus light into or from the fluidic device. The examples in
The example in
In one embodiment detector and source zones are located proximally on a device.
a) and 50(b) illustrates further embodiments for the fabrication of waveguides. A waveguide operates by reflecting, or transmitting, incident light at a material boundary. In the past typical fabrication methods in microfluidic devices have involved using the entire planar material, inserting a fiber optic directly into the sensor system, or lithographically patterning the surface in a similar manner to the fabrication of semiconductor devices. In this example of
A method for improving the wave-guiding properties of a transparent material is to increase the difference in refractive indices at the material boundaries. Changes to the surface properties at these boundaries can induce refractive index changes for improved reflection or transmission. In particular deposition of thin films can provide improved surfaces for waveguides and reflective surfaces, for example, deposition of a thin (a few tens or hundred of nanometers) silver coating to provide a negative refractive index.
To guide electromagnetic energy in complex geometries, channels can be formed with pre-structured layers. The channels formed may then be filled if required. These structures may either be filled by; injecting and then curing a transparent material, or placing an already formed wave guide into the vacant structures, as shown in
The present invention also provides methods whereby all, or some, of the upgrade information, operational data, or software architecture for an instrument can be contained within or on an insert, whereby the instrument may contain some or all of the software modules for templates and basic program operation but does not contain all data that is required to operate the instrument in full, some of this data being provided by the removable inserts. The inserts can be recognized upon connection to the instrument and the program operation is performed according to the data coded into one or more inserts.
The inserts may or may not be primarily used for other purposes necessary for the normal operation of the instrument such as a SIM card for a mobile telephone or a microfluidics chip for an analytical device. The inserts are recognized upon insertion into the matching instrument and the functional program of the instrument is performed according to the cooperation of the functionality of the instrument and the data coded into the insert(s).
In one embodiment the insert contains access or authorization information allowing the user to access certain functions or features of the instrument, such as new application and protocol data, user settings, device characteristics or functionality.
In another embodiment the present invention provides improved user operability and operational automation from the insert providing data to the instrument to automate parts or all of the application operation and provide user defined settings, thereby simplifying user interaction, which improves system reliability and simplifies instrument operation.
In another embodiment the insert contains access or authorization information allowing the user to access remote features. These remote features can include internet sites for upgrade, experimental or application information, or local area networks for instrument and computer system access.
Embodiments of the invention may include data contained within the insert relating to the insert's or instrument's use. This data can be stored on the insert during the time of manufacture and may contain user, experimental, instrument and application information. Examples of this type of data include factory settings, calibration information, user information, device usage, collected data, sensor data, settings, sampling or operational location information (for example, GPS tracking of samples), time and date stamps, production data and quality control, tracking, and other information that may be used by the instrument, user or the manufacturer of the instrument/device/insert.
In another embodiment the data may be written to, or updated, in the field by the user or the instrument prior to, during, or after use. This field written information may also contain user data, sampling or operational location information input by the user or by the instrument from a global positioning system, results, instrument settings, experimental conditions, application information, and other user or instrument data.
In another embodiment the insert contains information for user profiling. Allowing the user to automatically configure the instrument based on the user's personal settings, or teaching the instrument about operations the user typically performs or requires. This can be performed directly by instructions on the insert, or through learning algorithms on the instrument's software analyzing either the current user's, or another user's, previous operations.
One embodiment of the invention describes an instrumentation and insert architecture in which one or more inserts become a part of the software upgrade path for the instrument, more specifically, the insert or inserts contain the upgrading information. An example of which is shown in
Another embodiment of the present invention provides operating system software that is structured with core machine management functions and inbuilt application specific templates, which are controlled by the insert to configure the instrument to meet market or customer needs as and when required.
In one embodiment an Object Orientated approach is taken in which the instrument contains the programming subroutines and functions to perform all the common and low level operations, such as acquiring data, selecting acquisition channels, pumping, switching valves, setting temperatures, template GUIs etc. In one embodiment, the generic subroutines in the instrument are operative to perform one or more of the following actions: acquire data, select acquisition channels, control pumping, control valve switching, set temperatures, graphical user interface configuration, and one or more of program code, data or commands of the insert enable instrument operation for a particular application.
One or more inserts contain the application's specific calls and variables to the instrument's subroutines and functions. This approach is represented by the example shown in
In another embodiment a non-object orientated approach can be taken in which the instrument contains the program code to perform all common and low level operations, such as acquiring data, selecting acquisition channels, pumping, switching valves, setting temperatures, template GUIs, etc. One or more inserts contain the code and or variables to enable the instruments operation for the inserts particular application. This approach allows the inserts to control the instruments operation and GUI for the inserts particular application.
This distributed architecture (e.g.,
Furthermore, the invention provides extra software security as the program execution instructions do not exist in the instrument. With the inserts carrying only the instructions to configure the instrument for that particular insert's specific application. This method provides a much more difficult path to reverse engineer as a full understanding of the program's execution is required. If an instrument and an insert's interaction is reversed engineered, then the resultant program execution reveals only data for that specific application for which the insert was fabricated.
It is a further object of this invention that the information or data contained within inserts may be either or both, written to or read from.
According to another embodiment the insert may transfer all of its operational coding to volatile memory on the instrument, retaining only its identification and data storage and data reading functionality, thereby making it a “one use only” device and all operational coding is destroyed once the insert is removed from the instrument. This prevents unauthorized access to the proprietary coding contained in the insert as it can only be read by the matching instrument and it only exists in volatile erasable memory of that matching instrument while the insert is inserted and is automatically erased permanently once the instrument is switched off or the insert removed or the operational program is completed, whichever occurs first.
The inserts described herein may be either singular or multiple. The inserts may be a removable memory device, such as Flash Disks, sensors or microfluidic cartridges. The data on the inserts may be stored in many different formats, including but not limited to, barcodes, onboard memory, microprocessors and other integrated circuits, electrical interconnects or resistivity, radiofrequency, optical, mechanical or electromagnetic formats.
The foregoing descriptions are specific embodiments of the present invention, particularly those related to microfluidics. It should be appreciated that such embodiments are described for purposes of illustration only, that numerous alterations and modifications may be practiced by those skilled in the art without departing from the spirit and scope of the invention. It is intended that all such modifications and alterations be included insofar as they come within the scope of the invention as claimed or the equivalents thereof.
Throughout this specification (including any claims which follow), unless the context requires otherwise, the word ‘comprise’, and variations such as ‘comprises’ and ‘comprising’, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2005906474 | Nov 2005 | AU | national |
| 2005906475 | Nov 2005 | AU | national |
| 2005906476 | Nov 2005 | AU | national |
| 2005906477 | Nov 2005 | AU | national |
| 2006903101 | Jun 2006 | AU | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB2006/003311 | 11/22/2006 | WO | 00 | 12/30/2008 |
| Number | Date | Country | |
|---|---|---|---|
| 60738609 | Nov 2005 | US | |
| 60738610 | Nov 2005 | US | |
| 60738611 | Nov 2005 | US | |
| 60738612 | Nov 2005 | US | |
| 60786715 | Mar 2006 | US |
