FIELD OF THE INVENTION

This invention relates to a medical test device and method, and more particularly, to a medical test device and method for sampling and testing a bodily fluid.

BACKGROUND TO THE INVENTION

Medical test kits, devices and methods are well known and widely used.

Some of these devices are used to administer a substance to a patient or to withdraw a substance from a patient and may make use of microneedles or needles and differential pressures. They may also employ immunochromatographic detection to test a withdrawn substances and microfluidics to convey substances. Finally, a reporting system may be provided for reporting test results over communication networks. Some of such devices and methods are disclosed below. United States patent number: US 8,561 ,795 B2, entitled "Low-pressure packaging for fluid devices", discloses:

"Certain aspects of the invention are generally directed to devices for withdrawing a substance from the skin and/or from beneath the skin of a subject, and/or for delivering a substance to the skin and/or to a location beneath the skin of a subject. In some embodiments, the devices may comprise one or more skin insertion objects, such as needles or microneedles. In some cases, the device also may comprise one or more vacuum chambers. In some aspects, the device may be contained within an environment able to assist with maintenance of such pressures. For example, a package containing such an environment may also have a pressure less than atmospheric pressure, and/or the package may be molded to the device or otherwise have a shape that does not contain substantial gases that can "leak" into the device and alter the pressure of any vacuum chambers that may be contained therein. "

United States patent number: US 8,821 ,412 B2, entitled "Delivering and/or receiving fluids", discloses: "The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication. " European patent number: EP 1 798 556 B1 , entitled "Device for the early and rapid immunochromatographic detection of HIV and uses thereof, discloses:

"This invention provides a device for the simple and rapid detection of HIV in a sample that allows the detection of early human HIV infection. The device comprises a rapid immunochromatographic test for ultra sensitive p24 antigen detection. The device furthermore enables to distinguish between HIV- 1 and HIV-2 infection. The invention further provides uses of the device in a method as well as a kit for the rapid detection of HIV in a sample."

United States patent number: US 8,747,362 B2, entitled "Microneedle device", discloses:

"Provided is a microneedle device where a coating agent has been applied to microneedles having a biodegradable resin. It has been found that the application of the coating agent to microneedles of a biodegradable resin having a predetermined strength allows the microneedles to have excellent performance. Further, with regard to the coating agent, a predetermined type and amount thereof are also useful to demonstrate performance. Accordingly, when a microneedle device is arranged so that at least a part of a microneedle array provided with microneedles made from polylactic acid having a weight average molecular weight of 40,000 or more is coated with a carrier containing physiologically active ingredients, it is possible to attain excellent migration characteristics of the physiologically active ingredients to a living body."

WIPO patent number: WO 201401491 1 A1 , entitled "Point of care testing assay system using novel microfluidics", discloses: "A point of care testing assay system for determining the presence and/or amount of an analyte of interest in a sample, and methods for using such assay system, are disclosed. The system comprises a microfluidic means capable of performing testing with low sample volume in a sample matrix, and having high sensitivity and substantially a 5 -log wide dynamic range and capable of performing an assay in approximately fifteen minutes, and in which the microfluidic means comprises a microfluidic testing cartridge with associated electronics, a precision pipette, a high sensitivity detection module, a motion stage, and an on-board electronics display means that can be read by a user as an indication of the presence and/or amount of the analyte in the sample." United States patent application number: US 20130158468 A1 , entitled "Delivering and/or receiving material with respect to a subject surface", discloses:

"The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. The flow activator may be actuated in a deployment direction by a deployment actuator, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, an effector may enable fluid communication between the opening and the vacuum source and may do so in response to actuation of the flow activator. "

United States patent number: US 8,808,202 B2, entitled "Systems and interfaces for blood sampling", discloses:

"The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a "snap dome" or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member. "

United States patent number: US 9,041 ,541 B2, entitled "Monitoring or feedback systems and methods", discloses:

"The present invention generally relates to systems and methods for monitoring and/or providing feedback for drugs or other pharmaceuticals taken by a subject. In one aspect, the present invention is directed to devices and methods for determining a species within the skin of a subject; and producing feedback to a subject based on the determination of the species. The feedback may be, for example, visual, audible, tactile, a change in temperature, etc. In some cases, information regarding the determination of the species may be transmitted to another entity, e.g., a health care provider, a computer, a relative, etc., which may then provide feedback to the subject in some fashion. In some cases, the feedback may be directly indicative of the species, e.g., whether the species is present, the concentration of the species, whether a by-product of a reaction involving the species is present, whether a compound affected by the species is present, etc. However, the feedback may also be indirect in some embodiments. For example, the subject may be presented with an external reward, e.g., based on the determination of the species within the skin. For instance, a reward such as cash, coupons, songs, discounts, personal items, etc., may be offered based on the level of compliance of the subject. Still other aspects of the invention are generally directed to kits involving such devices (with or without the drug to be monitored), methods of promoting such systems, or the like. "

Unite States patent number: US 8,414,548 B2, entitled "Method of making microneedle array and device for applying microneedle array to skin", discloses:

"Microneedle arrays and drug delivery devices are provided for transdermal^ delivering a drug formulation to a patient. The microneedle array device includes a substantially planar substrate having an array of apertures; and a plurality of microneedles projecting at angle from the planar substrate, the microneedles having a base portion integrally connected to the substrate, a tip end portion distal to the base portion, and body portion therebetween, wherein each microneedle has at least one channel extending substantially from the base portion through at least a part of the body portion, the channel being open along at least part of the body portion and in fluid communication with at least one of the apertures in the substrate. In a preferred embodiment, each microneedle has a substantially rectangular cross-sectional shape and the channel is open to two opposing surfaces of the microneedle. "

United States patent application number: US 20070023386 A1 , entitled "Hollow microneedle array", discloses:

"An inexpensive and rapid method for fabricating arrays of hollow microneedles uses a photoetchable glass. Furthermore, the glass hollow microneedle array can be used to form a negative mold for replicating microneedles in biocompatible polymers or metals. These microneedle arrays can be used to extract fluids from plants or animals. Glucose transport through these hollow microneedles arrays has been found to be orders of magnitude more rapid than natural diffusion."

OBJECT OF THE INVENTION

It is an object of this invention to provide a medical test device and method of the type described above.

SUMMARY OF THE INVENTION In accordance with this invention there is provided a medical test device comprising a housing having a test sample extraction means, a buffer and a test means.

There is provided for the test sample extraction means to be a needle or to be microneedles. There is further provided for the micro-needles to project at an angle from a support base thereof. There is also provided for the needles or microneedles to be biocompatible.

A further feature of the invention provides for the test sample extraction means to be movable between a storage position in which it is inside the housing and an extraction position in which it protrudes through an opening in the housing to collect a sample to be tested. A first activation means is used to move the test sample extraction means from its storage position to its extraction position.

The activation of the first activation means creates a pressure difference across at least part of a flow path in the extraction means.

The first or a second activation means is used to the release a fluid from a fluid chamber.

There is provided for the fluid to be a buffer fluid.

The fluid or buffer chamber is made of a flexible material or includes a seal.

There is provided for a punch means to puncture the flexible material and/or seal of the buffer chamber. In one embodiment the buffer chamber may be a blister pack and may include sealing means which sealing means is broken upon activation of the first or second activation means. Alternatively, the blister pack itself may be broken to release its contents upon activation of the first or second activation means.

A first sample channel conveys a collected sample out of the flow path inside the sample extraction means to a sample collection chamber.

A second sample channel conveys the sample or part thereof from the sample collection chamber to a mixing chamber. Alternatively, the sample moves through a needle opening and capillary action material onto a test strip.

A buffer channel conveys the buffer from the buffer chamber to the mixing chamber, when the first or second activation means is activated and a punch means included therewith or as part thereof pressed on the buffer chamber when the first or second activation means is activated. A test channel conveys a mixed test substance being a mixture of the test sample and the buffer from the mixing chamber to a test means.

The test means is a test strip.

There is provided for the test strip to be an immunochromatographic test pad.

The first and second activation means are manually operable, depressable buttons. Alternatively, a 1 ^st activation means causes micro-needles to puncture the skin of a subject and may cause a vacuum to be formed where after, a fluid such as a buffer fluid is automatically released.

At least part of the test strip is visible through a window in the housing.

A communication device may detect a state of a test and/or control line of the test strip and transmit information relating to and/or including an indication of the state of the test strip.

The state of the test and/or control lines is the appearance thereof due to discoloration thereof with respect to the surrounding areas of the strip. This invention relates to a medical test method comprising the steps of:

taking a sample with a sample extraction means;

mixing the sample with a buffer to form a mixed substance; and testing the mixed substance. There is provided for using a test sample extraction means including a needle or to be microneedles.

A further step includes for the test sample extraction means to be movable between a storage position in which it is inside the housing and an extraction position in which it protrudes through an opening in the housing to collect a sample to be tested. There is provided for using a first activation means to move the test sample extraction means from its storage position to its extraction position.

Activating the first activation means creates a pressure difference across at least part of a flow path in the extraction means.

Activating the first or a second activation means releases a buffer from a buffer chamber.

A further step includes providing a buffer chamber in the form of a blister pack that may include sealing means which sealing means is broken upon activation of the first or second activation means. Alternatively, the blister pack itself may be broken to release its contents upon activation of the first or second activation means.

A still further step includes conveying a collected sample through a first sample channel out of the flow path inside the sample extraction means to a sample collection chamber.

There is provided for further conveying the sample or part thereof from the sample collection chamber to a mixing chamber through a second sample channel. A yet further step includes conveying the buffer through a buffer channel from the buffer chamber to the mixing chamber, when a punch presses on the buffer chamber when the first or second activation means is activated.

Finally, there is provided for conveying of a mixed test substance being a mixture of the test sample and the buffer from the mixing chamber to a test means, through a test channel.

This aspect of the invention includes providing a test strip which may be an immunochromatographic test pad. There is also provided for the first and second activation means to be manually operable, depressable buttons.

There is provided for placing the test strip so that at least part of the test strip is visible through a window in the housing.

The method includes using a communication device to detect a state of a test and/or control line of the test strip and transmit information relating to and/or including an indication of the state of the test strip, which state may be the colour of the test and/or control lines.

The medical test device includes a housing that has puncture means to puncture the skin of a subject to be tested. The device includes a fluid in the form of a buffer fluid or test fluid as well as test means in the form of a test strip. The needles are small parallel micro-needles are arranged in an array, alternatively, needles are arranged in an array. A seal, seal paddle ring and/or adhesive may be provided on the underside of the device to seal an opening of a flow path that is defined by needle opening and that extends into the housing, over part of a subject's skin. A vacuum is caused to assist with drawing blood from the skin onto the test strip by releasing a piston in a sleeve that is loaded against a coil spring. There is thus provided for a coil spring to move the piston in the sleeve thus providing a suction or vacuum action. Capillary action on absorbent material in at least part of the flow path between the needle opening and the test strip and/or a buffer chamber and the test strip further assist with movement of the blood and/or the buffer fluid.

These and other features of the invention are described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention are described below, by way of example only and with reference to the drawings in which:

Figure 1 shows a front perspective view of a 1 ^st embodiment of medical test device; Figure 2 shows a rear perspective view of the device of figure 1 ;

Figure 3 shows a front view of the device of figures 1 and 2;

Figure 4 shows a side view of the device of figure 1 to 3;

Figure 5 shows a rear view of the device of figures 1 to 4;

Figure 6A shows an enlarged schematic view of section A along IV-IV (as indicated in figures 3 and 4) of the device of figures 1 to 5;

Figure 6B shows an enlarged schematic view of sections B along IV-IV (as indicated in figures 3 and 4) of the device of figures 1 to 6A;

Figure 7 shows a perspective schematic view of a test strip used in the device of figures 1 to 6B;

Figure 8 shows an underside perspective view of a 2 ^nd embodiment of a medical test device; Figure 9 shows an underside perspective view of the medical test device of figure 8 from a different angle;

Figure 10 shows a top perspective view of the medical test device of figures 8 and 9; Figure 1 1 shows a top perspective view of the medical test device of figures 8 to 10, from a different angle is the angle of figure 10;

Figure 12 shows a 1 ^st end view of the medical test device of figures 8 to 1 1 ; Figure 13 shows a 2 ^nd end view of the medical test device of figures 8 to 12; Figure 14 shows a 1 ^st side view of the medical test device of figures 8 to 13 from a vacuum chamber side thereof; Figure 15 shows a 2 ^nd side view of the medical test device of figures 8 to 14 from a test strip side thereof;

Figure 16 shows an underside view of the medical test device of figures 8 to 15; Figure 17 shows a top view of the medical test device of figures 8 to 16;

Figure 18 shows a side view and cross sectional end views of the medical test device of figures 8 to 17; Figure 19 shows a side view and a top cross sectional view of the medical test device of figures 8 to 18;

Figure 20 shows an exploded view of the medical test device of figures 8 to 19 from a 1 ^st angle;

and

Figure 21 shows an exploded view of the medical test device of figures 8 to 20 from a 2 ^nd angle.

DETAILED DESCRIPTION OF THE DRAWINGS

With reference to the drawings, a 1 ^st embodiment of a medical test device is generally indicated by reference numeral 1 .

The medical test device 1 includes a housing 3 in which all its components are housed and supported. Manually depressable buttons 1 a and 1 b are located in an upper front side or cover of the housing. A window 22 is located below the buttons 1 a and 1 b. A test strip 15 having a test line 16 and a control line 17 is visible through the window 22. Microneedles 5 are visible through an opening in a rear cover of the housing.

The microneedles are movable from a storage position as shown in figures 2, 4, 5 and 6 to a sample extraction position (not shown) in which the needles protrude through the opening in the rear of the housing to penetrate the skin of a patient. This is described in further detail below.

The microneedles are hollow, as is known in the art, and thus include flow paths from their tips to their bases. Manual depression of the first button 1 a causes the microneedles to move from their storage position to their sample extraction position in which they penetrate a skin of a patient and, at the same time, creates a vacuum in the flow path of the microneedles. The vacuum is formed by the existing negative pressure within the collection chamber, which is released when the needles come into contact with blood. This ensures that a sample can easily be extracted from a patient. The vacuum thus created causes bodily fluids such as blood to be sucked into the flow path of the microneedles.

A first sample channel 6 is situated between the microneedles and a sample collection chamber 7. A second sample channel 8 connects the sample collection chamber 7 with a mixing chamber 13.

A sealed buffer chamber 1 0 in the form of a blister pack is located behind the second button 1 b. The second button 1 b includes a blister punch 12 which, when button 1 b is depressed, forces a buffer fluid in the buffer chamber 10 through a buffer channel 1 1 into the mixing chamber 13. Depression of the button may cause a seal of the buffer chamber or the buffer chamber itself, to break and to release the buffer into the buffer channel, or directly into the mixing chamber in an alternative embodiment.

The mixing chamber receives both the buffer fluid and the collected sample to form a mixed substance therein. The punch 12 applies pressure on both the mixing chamber and sample collection chamber to achieve this. From the mixing chamber 13, the mixed substance is conveyed via channel 14 to the test strip 15.

The test strip is a known prior art test strip which includes a backing card 20 a sample pad 18, a conjugate pad 19, the test line 16, the control line 17 and a wicking pad 21 .

An adhesive section is provided on part of the rear surface of the housing. The adhesive is used to stick and keep the device onto the skin for the administration of the test. The test can only be done properly when the device is in contact with the skin.

In use, the rear surface of the housing is placed on a patient's skin. The first button is depressed so that the microneedles are ejected to penetrate the skin of the patient. Depression of the first button also causes a vacuum or negative pressure inside the microneedles to ensure that blood flows from the patient's skin into the microneedles and through the first sample channel 6 into the sample collection chamber 7. The second button is now depressed to force the buffer to break the seal of the buffer blister pack or buffer chamber 10 itself so that the buffer fluid moves through the buffer channel 1 1 into the mixing chamber 13. At the same time, the blister pack punch 12 also, indirectly, through the buffer chamber 10, applies pressure on the collection chamber 7 to force the collected sample through the second sample channel 8 into the mixing chamber 13. From the mixing chamber 13 the mixed substance, being the patient's blood and the buffer fluid, flows through the test channel 14 to the test strip.

All the channels described for the specific embodiment herein are microfluidic channels and the test strip is an immunochromatographic sample pad as is known in the art.

The state of the test strip, is the appearance thereof due to the discolouration of the test line 1 6 and/or control line 17 with respect to the surrounding areas of the strip. This may be sensed and recorded by communication device such as a smart phone. The smart phone is used to detect the appearance of the test line 16 and possibly also the appearance of the control line 17 and to transmit information relating to the appearance, or otherwise, or a photograph of these lines to a remote station such as a doctor's rooms or other healthcare service provider.

A 2 ^nd embodiment of the invention is shown in figures 8 to 21 . In this embodiment, the device 23 a to part sealable inner housing. This housing consists of an upper part 35 and a lower part 34. These parts are held together with a clip or clips 40 and may be glued together if required. These housing parts are preferably made of a plastics material. These housing parts are shaped and configured to house the functional parts of the medical test device and, once assembled, will preferably be housed in an outer housing. For example, housing part 25B forms a thin elongate strip to house a test strip such as an HIV test strip there in. The outer housing is not shown herein.

The device 23 includes a cylindrical vacuum chamber 24 and has a piston 41 sealingly engaged therein. The piston 41 is movable from a charged position in which the piston is secured in a position towards a 1 ^st end of the chamber, pressed against a bias such as a coil spring 39 of the vacuum chamber and a vacuum generating position in which the piston has been released and has moved, under force from the coil spring, to a vacuum position towards a 2 ^nd end of the vacuum chamber 24, i.e. away or spaced apart from the 1 ^st end of the vacuum chamber.

The piston 41 as an annular rebate for receiving a ball 42 therein to hold the piston in its charged position.

The vacuum chamber 24 is in flow communication with a needle opening 31 in the lower part 34 of the housing of the device 23. A seal 29 in the form of a ring-shaped pad is attached to the outer underside of the lower part 34 of the housing, around the needle opening 31 , to provide a seal between a subject's skin and the flow path extending from the needle opening 31 to the vacuum chamber 24.

The underside of the housing 30 also includes an adhesive attached thereto. The hypodermic microneedle button 25 is sealingly movable between an inoperative position in which it extends out of a button housing 25A to a depressed position in which the button is pushed down into the housing 25A. As the button is moved downwards, and annular rebate 48 in the housing also moves downwards and when the rebate aligns with the ball 42, the ball 42 moves into the rebate thus releasing the piston 41 from its charged position. In a similar fashion, a ball 43 moves into the annular rebate as follows: all 43 is engaged in a rebate 46 of a needle securing mechanism which, on the one side thereof presses and is coaxial with a coil spring 47 and on the other side thereof is coaxial with a needle support 45 which supports the array of micro-needles 44. As button 25 is moved downwards the ball, under force of coil spring 47 is moved out of engagement with the securing means 46 into the rebate 48 of the button 25. This causes the spring 47 to relax thus pushing the needles 44 downwards so that they protrude momentarily through the needle opening as the spring extends past its rest condition and then again retract into the needle opening as the spring moves back towards its rest position.

A test strip, such as an HIV test strip 36 locates or is attached at one end thereof to a ring shaped section 37 of a plastics material strip. The ring-shaped section has a lateral flow support strip section 27 extending therefrom and terminating an operatively upper right puncture section 38. Absorbent material may be located on an operatively upper side of the parts of this plastic materials strip i.e. on parts 37, 27 and 38. The absorbent material may be made from a nitrocellulose membrane, similarly to the test strip 36, which functions in absorbing the liquid and using capillary action, to direct the flow of the buffer onto the HIV test strip. The strip part 38 may conveniently terminate in a sharpened point (not shown).

Button housing column 33 sealingly receives a fluid button, and preferably a buffer fluid button, 26 therein. Button 26 is movable from a rest position in which it protrudes out of the column housing 33 a depressed position in which there is pushed into the button housing 33. The button 26 itself is hollow and includes a fluid such as a buffer fluid or any other test or required fluid. The lower end of the button 26 is sealed with a foil or other material seal. When the button is pushed downwards, the upper end of strip part 38 punches the seal thus releasing the fluid inside the button 26. The fluid exits button 26 under force of gravity and under vacuum, as described further below, downwards along strip part 38 over lateral flow support strip part 27 and via the ring-shaped section of the strip towards the HIV test strip 36. A gel -like substance may be located on an operatively outer surface of seal 29 and covered with a removable cover. Viewing columns 26A, extend from a needle housing end of the upper housing part 35 and terminate in an opening openings of an outer housing (not shown).

In use, the device is removed from packaging and the cover over seal 29 is removed to expose the gel on the outer surface of seal 29. The adhesive on the under surface 30 of the device may also have a cover that may be removed at this stage. The underside of the device is placed on a subject's skin so that the adhesive contact the skin and so that the gel on the seal assists in sealing the skin of the subject around the needle opening to the device. Button 25 is deep pressed thus simultaneously releasing the piston to cause a vacuum that exists in the flow path from the piston chamber towards the needle opening and causing the micro-needles to punch the skin underneath the needle opening and then to retract back into the needle opening. Within a few moments the subject's blood is released through the micro-holes made by the micro-needles as a result of the subject's blood pressure as well as a result of the vacuum formed by the vacuum chamber. The blood is sucked into the needle opening onto the absorbent material that is located on top of the strip ring-shaped part 37 from way the blood, under capillary action moves onto the HIV test strip 36. Discolouration of the test stri p by the subject's blood can be viewed through the viewing columns 26B. As soon as discolouration is discerned, button 26 may be depressed so that the buffer fluid therein is released as is explained above. The buffer fluid also travels under capillary action towards the HIV test strip where it comes in contact with a subject's blood. The test strip is viewable through both the outer and inner housing and the test results are thus immediately available. The device may now be removed from the subject's skin.

A small amount of blood will remain on the subject's arm. The puncture marks from the needle array will be barely visible if not completely invisible due to the small size thereof. The blood on the subject skin can be wiped away after the device is removed. It is envisaged that the device and method described herein will be convenient to use. The device has been designed for simplified HIV testing. The method of testing is quick, simple and painless and is contained in one single device. The test results may easily be recorded and transmitted to healthcare providers who may act upon the test results, should it be necessary.

The invention is not limited to the precise details as described herein. It will be appreciated by those skilled in the art that many other embodiments are possible without departing from the scope of the invention. For example, instead of using two separate buttons one single button may be used to effect all the functions of the two buttons described above. In addition, the collection chamber 7 and/or the mixing chamber 13 could possibly be omitted from the device, depending on the application. Instead of being an HIV immunochromatographic test strip any other test strip may be used. Many other embodiments are possible without departing from the scope of the invention.