WO2006000792A1

WO2006000792A1 - An automated motorized apparatus and method for dispensing test strips

Info

Publication number: WO2006000792A1
Application number: PCT/GB2005/002497
Authority: WO
Inventors: Andrea Besana; Alessandro Spina
Original assignee: Lifescan Scotland Limited
Priority date: 2004-06-28
Filing date: 2005-06-28
Publication date: 2006-01-05
Also published as: WO2006000815A1; WO2006000809A1; WO2006000794A1; WO2006000805A1; WO2006004627A1; WO2006000801A1; WO2006000806A1; WO2006000826A1; WO2006000818A1; WO2006000807A1; AU2005202624A1

Abstract

The present invention is directed to an automated motorized apparatus for dispensing test strips. In one embodiment of an automated motorized apparatus for dispensing test strips according to the present invention, the apparatus comprises a primary kinematic chain and a secondary kinematic chain. The present invention is further directed to an automated method for dispensing test strips. In one embodiment of a method of operating an automated motorized apparatus for dispensing test strips according to the present invention, the automated motorized employs a first kinematic chain and a second kinematic chain.

Description

TΓΓLE OF THE INVENTION-. AN AUTOMATED MOTORIZED APPARATUS AND METHOD FOR DISPENSING TEST STRIPS

FIELD OF THE INVENTION:

The present invention is directed to an automated motorized apparatus and method for dispensing test strips, and, more particularly to an automated motorized apparatus and method for dispensing test strips including a primary kinematic chain and a secondary kinematic chain.

BACKGROUND OF THE INVENTION:

A variety of analyte test meters employ containers to, for example, protect the test strips stored in the test meter from damage prior to use, to maintain sterility of the test strips and to isolate the test strips from potentially adverse environmental factors such as humidity and ultra-violet (UV) light. Exemplary of such test strips are single-use test sensors (e.g., electrochemical and photometric test sensors) that are employed with an associated analyte test meter for measuring an analyte in a bodily fluid (such as glucose in whole blood).

It is common for a plurality of single-use test sensors to be stored in a container separate from an associated meter. These containers often have tight fitting lids to isolate the test strips within the container from environmental factors. However, opening the tight fitting lid of such conventional containers can require a user to apply substantial force to the lid. In addition, subsequent manual extraction of a test sensor from the opened container can be a cumbersome process. Furthermore, due to the substantial force required to open such conventional containers, users may fail to properly close the container in order to more easily facilitate the extraction of another test sensor at a later time. Unfortunately, failure to properly close the container can lead to the potentially deleterious exposure of test sensors within the container to environmental factors. Individual test sensors can also be wrapped in foil to protect the test sensors from unfavorable environmental conditions. However, the dexterity and vision required to extract a test sensor from the foil can be lacking in some users. In addition, manual unwrapping of a foil to extract a test sensor for each and every use, and subsequent insertion of the extracted test sensor into an associated meter for analyte measurement can be a cumbersome process.

Many methods and apparatus have been designed to facilitate the storage of test strips in analyte test meters. Storage methods known in the art, include, for example a disk format or a drum format or a stacked format. However, both approaches provide less efficient storage per unit volume with respect to the size of the container compared to a stack of strips 24 as described herein. Using a disc is undesirable because the number of strips is limited by the size of the disk and shape of the strips. The diameter dimension of the disc therefore dictates the width dimension of the meter. Using a drum is also undesirable because the number of stored strips is limited by the size of the drum and the size and shape of the strips in the drum. The dimensions of the drum therefore dictate the depth dimension of the meter. When strips are stacked, it becomes difficult to arrange the stack in an orientation which minimizing the size of the meter while facilitating the presentation of the strip in an orientation which aids the user. It would, therefore, be advantageous to design a meter useful in analyzing an analyte in blood or other bodily fluids wherein the meter uses a test strip vial wherein the test strips are stacked to minimize the size of the meter. It would, further be advantageous to design a meter useful in analyzing an analyte in blood or other bodily fluids wherein the meter uses a test strip vial wherein the test strips are stacked and automatically dispensed from the test strip vial in an orientation most useful to the user while storing the stacked test strips in an orientation which minimizes the size of the meter.

SUMMARY OF THE INVENTION:

The present invention is directed to an automated motorized apparatus for dispensing test strips. In one embodiment of an automated motorized apparatus for dispensing test strips according to the present invention, the apparatus comprises a primary kinematic chain and a secondary kinematic chain. In one embodiment of the present invention, the primary kinematic chain comprises: a motor; a reduction gear box connected to the motor; a first star gear connected to the reduction gear box; a cam gear connected to the first star gear; a follower connected to the cam gear; and a cassette with a cap connected to the motor. In a further embodiment of the present invention a secondary kinematic chain, the secondary kinematic chain comprises: a first star gear; a semicircular sliding interface connected to the first star gear; a pick-up pin connected to the semicircular sliding interface; a pusher drum; and a flexible pusher wound around the pusher drum.

The present invention is directed to an automated method for dispensing test strips. In one embodiment of a method of operating an automated motorized apparatus for dispensing test strips according to the present invention, the automated motorized apparatus has a first kinematic chain. In this embodiment of the method according to the present invention, the method comprises the steps of: using a motor to provide a high¬ speed rotational motion to a reduction gearbox; using the reduction gear box to provide a low-speed rotational motion to a first star gear; using the first star gear to transfer rotational motion to the cam gear; and using the cam gear to lift a follower,, transmitting linear motion to a vial cap.

In a further embodiment of the method of operating an automated motorized apparatus for dispensing test strips described above the automated motorized apparatus further includes a second kinematic chain. In this embodiment of a method according to the present invention, the method further comprises the steps of: holding the second star gear at rest using a semicircular sliding interface until the vial cap is lifted to a predetermined height above a vial body, thereby forming a gap between the vial cap and the vial body; releasing the semicircular sliding interface after the vial cap is lifted; using a pick up pin to start a second star gear; meshing the second star gear with the first star gear; using the second star gear to rotate a pusher drum, whereby a flexible pusher is unrolled from the pusher drum, the flexible pusher moving through the gap. In a further embodiment of the method of operating an automated motorized apparatus for dispensing test strips described above, the method further comprising the steps of reversing the pusher drum to roll up the flexible pusher and closing the vial cap. BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

Figure 1 is a simplified perspective front view of a meter with which the exemplary embodiment of a dispensing mechanism according to the present invention can be employed;

Figure 2 is a simplified perspective rear view of the meter of Figure 1 showing a large, single door.

Figure 3 is an internal view through the meter of Figure 1 with the main housing removed and the dispenser and feeding mechanism revealed;

Figure 4 is a simplified exploded perspective view of the resealable vial of Figure 3;

Figure 5 is a perspective view of the meter of Figures 1 and 2, shown from the rear side with the door removed;

Figure 6 is an enlarged perspective view of an exemplary embodiment of a latch;

Figure 7 shows a cross-section plan view of the meter of Figure 1, seen through cross-section;

Figure 8 is a perspective view of the cap lifting mechanism of Figure 3 with the vial removed; Figure 9 is a detailed perspective view of a gear train that operates the feeding mechanism of Figures 3 and 8;

Figure 10 is a perspective view of the strip feeding mechanism located within the meter housing;

Figure 11 is a close-up side elevation view of the interaction between star gears 208 and 210 and components of the gear train 200 of Figures 9 and 10;

Figure 12 shows a side elevation view of the strip feeding mechanism showing the interaction of the first and second star gears and the cap lifter;

Figure 13 is a side elevation view of the mechanism of Figure 12 showing the cap lifter partially raised and the second star gear beginning to be turned by the first star gear;

Figure 14 is a side elevation view of the mechanism of Figures 12 and 13 showing the cap lifter fully raised and the second star gear fully turned in order to advance the flexible pusher through the gap created between the vial body and cap;

Figure 15 is an enlarged perspective view of the cam gear of Figures 10 to 14;

Figure 16 is an enlarged perspective view of an exemplary embodiment of the cap lifting mechanism of Figure 8;

Figure 17 is an enlarged perspective view of an exemplary embodiment of a pusher drum and pusher member of the invention;

Figure 18 is a side elevation view of the middle gear of Figure 9 including a switch in the home position;

Figure 19 is a close up side elevation view of the middle gear showing the switch of Figure 18 in the home position, including a hard stop molded into the main frame; Figure 20 is a side elevation view of the middle gear of Figure 9 showing the switch of Figure 18 in the end position;

Figure 21 is a close up side elevation view of the middle gear of Figure 20 showing the switch in the end position, including the hard stop of Figure 19;

Figure 22 is a side elevation view of the mechanism of Figure 3 and Figures 8 to 17, showing the cap lifting mechanism and the strip feeding mechanism in their home positions;

Figure 23 is a side elevation view of the mechanism of Figure 22 showing the vial cap fully raised, and the strip feeding mechanism still in the retracted position;

Figure 24 is a side elevation view of the mechanism of Figures 22 and 23 showing the vial cap fully raised and the strip feeding mechanism fully advanced to dispense a test sensor to the test position ready to begin a test.

Figure 25 is a perspective view of a vial being inserted into a meter;

Figure 26 is a perspective view of a vial being inserted into a meter, showing the latch rotating to allow the vial insertion;

Figure 27 is a is a perspective view of a vial being inserted into a meter, showing the latch snapping onto the vial body to hold it in place and prevent movement in the horizontal direction;

Figure 28 is a perspective view of a vial held within the meter. A user presses a button on the latch to initiate removal of the vial;

Figure 29 is a perspective view of a vial being removed from the meter. The latch rotates and pushes on the underside of the vial body thereby raising it slightly;

Figure 30 is a perspective view of a vial being completely removed from the meter. Figure 31 is a perspective exploded view of an alternative example embodiment of a gear train that may operate the strip feeding mechanism;

Figure 32 is a perspective view of the example embodiment of a gear train of Figure 31.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE INVENTION

Figure 1 shows a meter 100 including a main housing 102, a test sensor actuation button 106, user interface buttons 108, a display panel 104, a test sensor delivery port 111, a test sensor 110 and an LED indicator 112.

Figure 1, shows a simplified perspective view of a meter 100 with which an exemplary embodiment of the dispensing mechanism according to the present invention can be employed. Such a meter is portable, hand-held and easily carried in a pocket or bag for frequent use. Meter 100 comprises a main housing 102 that serves to encapsulate and protect the functional components of a meter 100 (such as a resealable vial and a dispensing mechanism according to exemplary embodiments of the present invention), from dust particles and fluid splashes. It is contemplated that the main housing 102 would remain in place during all normal use of meter 100 for analyte measurement, and only a door portion on the rear (shown in Figure 2) would be removable for replacement of a vial of test sensors (item 500 in Figure 3) when required.

Meter 100 includes a test sensor actuation button 106 and user operable buttons 108 such as scrolling up and down arrows, and an ok button. Prior to each blood glucose measurement, the user would press the actuator button 106 to dispense a test sensor 110 to a delivery port 111, ready to receive a blood sample. An indicator 112, such as an LED for example, may be positioned close to the delivery port 111 to facilitate the users understanding of where or when to apply blood, and/or to indicate progress of the blood glucose calculation. User interface 108 provides the user with means for accessing the set¬ up menus of the meter as well as reviewing previous results stored in the meter memory. Meter 100 is operated by means of a display panel 104, which displays all information to the user (or Health Care Practitioner).

As will be evident from the descriptions below, the main function of a dispensing mechanism of the invention described herein, is to present a test sensor to the user through an opening or delivery port 111 in the outer casing of the meter 100. The test sensor is presented to the user in a position and state ready to receive a sample such as blood.

Figure 2 shows a meter 100 including a main housing 102, a single large door 105, a sprung latch 109, hinges 107 and a battery 113.

Figure 2 is a perspective rear view of the meter 100 of Figure 1 showing the location of a single, large door 105. Door 105 is essentially rectangular in shape with rounded corners, and accommodates a large portion of the rear side of meter 100. Access through door 105 is permitted to the user by pressing sprung latch 109 to release it, and simultaneously pulling door 105 outwards away from the meter 100. Once unlocked, door 105 is retained by hinges 107.

Door 105 provides the user with access into the meter 100 to replace an empty vial with a new one, or to replace a spent battery 113. Users will require access into their meter to replace the vial 500 regularly, governed by the frequency at which they test. The large number of test sensors housed within each vial 500 (typically 10, 30 or 50 test sensors) reduces the occurrence, and hence inconvenience of having to replace the vial 500. Occasionally the user will also have to change the battery 113 of their system (approximately once every six months to one year), and this is also accessed through door 105.

Figure 3 shows an internal test sensor delivery system comprising a main frame 114, a gear train 200, a pusher wheel 116, a vial 500, a vial cap 504 including holes 529, a DC motor 118, and a stereo jack connector 122.

Figure 3 is an internal view through the meter 100 of Figure 1 with the main housing 102 removed and the vial 500 and feeding mechanism revealed. Vial 500 is replaceable and accessible to the user through door 105 located on the rear face of meter 100 as discussed in relation to Figure 2. Vial 500 is held securely, within a cavity (item 410 shown in Figure 5) provided specifically for receiving vial 500, in the main frame 114 by the cooperation of offset interlocking rebates (items 510 and 126 described in more detail in relation to Figure 4) and also interaction between holes 529 in vial cap 504 and pins 125 on cap lifter 124 (described in more detail in relation to Figures 16, 23 and 24).

A stereo jack connector 122, incorporated on a PCB (not shown) allows the transfer of measured data parameters stored within the memory of meter 100 to a Personal Computer for further analysis or record keeping. Analysis of measured parameters by a user, using software written specifically for this purpose, helps the user (and/or Health Care Practitioner) understand and better control the disease.

The internal test sensor delivery mechanism consists mainly of a gear train 200 which will be described in detail in relation to Figure 9. Gear train 200 is operated by a DC motor 118, which is in turn activated by the user by depressing the test sensor actuation button 106 (shown in Figure 1). This simple, one-stage user operation causes the internal test sensor delivery mechanism to perform two operations in sequence. The first action operates to open vial 500. The second action follows in sequence to dispense a test sensor 110 to the test port 111. On delivery of a test sensor to the test port 111, the polarity of motor 118 is reversed and the sequence of events occurs in reverse order to close vial 500 and maintain the moisture semi-impermeable seal. This sequence of events is discussed in detail in relation to Figure 24.

The remainder of this description will concentrate on providing a detailed description of the components of the test sensor feeding mechanism.

Figure 4 is an exploded view of a vial 500 comprising a U-shaped permanent clip 520, a coil spring 524, a rebate 522 with a cylinder-shaped inner surface, a vial cap 504 with offset holes 529, location pins 526, a seal 528, an inner cassette 506 with protrusions 538 and slot 540, a stack of test sensors 530, a constant force spring 532, a loader 534, a vial body 502 with offset retention wings 510, rebates 512, a seal face 514 and apertures 516 for receiving the location pins 526. Figure 4 shows an exploded perspective view of an exemplary embodiment of a vial 500 for housing a plurality of test sensors in the present invention. Vial 500 is disposable and replaceable, and typically manufactured in two parts; a vial body 502, made in one piece from a high strength material such as glass reinforced polypropylene (available from Borealis, Denmark) with triangular shaped retention wings 510, that may or may not be offset with respect to each other, on each side panel which cooperate with corresponding rebates (item 126 described in relation to Figure 8), which may or may not be correspondingly offset with respect to each other; and a vial cap 504 that includes two holes 529 (that may or may not be offset with respect to each other) located in wing regions on either side of cap 504 which cooperate with a cap lifter (item 124 in Figure 8). Holes 529 and/or wings 510 and rebates 126 may be offset with the purpose of allowing the vial 500 to be inserted into the meter in one orientation only. Although this example embodiment utilizes round shaped holes, it would be obvious to a person skilled in the art that varying shapes and sizes of holes, including slots or other means to allow fixture of the vial 500 to the cap lifter 124 is conceivable, and is not restricted. Oval or teardrop shaped holes may facilitate replacement of vial 500 when required.

Retention features 510 could be triangular shaped protrusions such as those shown in Figure 8, or other means of retaining vial body 502 rigidly within the meter to resist further upwards movement during actuation of the test sensor delivery mechanism.

A U-shaped clip 520 straddles cap 504, resting on top of a coil spring 524 located within a cylinder-shaped rebate 522. Clip 520 interlocks with vial body 502 at rebates 512 located directly under the sealing counter-face 514 of vial body 502. Clip 520 is made of steel or other suitably rigid material, and is permanently attached to the vial 500 during manufacture by means of heat staking for example, and stays attached to the vial 500 during use i.e. during opening and closing for test strip dispensing. A Santoprene® (Advanced Elastomer Systems) rubber seal 528, or alternative suitably resiliently deformable material is 2-shot moulded into, and lines the underside of vial cap 504. Rubber seal 528 also overlaps the periphery of the rim of vial cap 504 and deforms (approximately 0.4mm) when a force (approximately 7N) is applied, thereby providing a substantially moisture semi-impermeable seal when depressed against seal face 514 on vial body 502.

Location pins 526 are provided on two diagonally opposite corners of cap 504, and cooperating rebates 516 to receive location pins 526 are located on the corresponding corners of vial body 502. An inner cassette 506 is housed within vial body 502 and is manufactured in two halves that join at protrusions 538. Inner cassette 506 contains 10, 25, 50 or 100 test sensors, typically strips, usually arranged in a stack 530. A constant force spring 532 provides a force (around 1.5N) on the underside of a stack pusher 534 at the base of the stack of strips 530, thereby maintaining the test sensors in a position ready to be dispensed from within the vial 500. While the term 'strip' is used herein to describe a test sensor typically used by diabetics to determine their blood glucose concentration, it would be obvious to a person skilled in the art that test sensors of shapes different from a strip can be envisaged from this disclosure.

A vial 500 of the type described in relation to Figures 3 and 4 provides a robust means of storing a plurality of test sensors such as those used by diabetics to regularly determine their blood glucose concentration. It would be obvious to a person skilled in the art that a vial of the type described herein could be used to house test sensors used to measure the concentration of another analyte, indicator or body fluid.

The environmental conditions experienced by the test sensors within the vial 500 would typically be maintained at the correct specification to attain the expected lifetime and performance of the test sensors. These conditions would exist inside the vial 500 during both normal use within a blood glucose meter for example, and while the vial 500 is retained for future use outside the meter, provided other storage instructions such as expiry date are followed. If carried in a bag or pocket, vial 500 would remain secure, due to the closing action of clip 520, from any deleterious substances such as moisture, creams and lotions etc.

Figure 5 shows a main meter housing 102, a vial 500 secured by a U-shaped clip 520, a latch 400, an arrow 6000 indicating the direction of placement of vial 500 into meter 100, a battery 113. Figure 5 is a perspective view of the meter 100 of Figures 1 and 2, shown from the rear side with door 105 removed. Door 105 is shown totally removed for the purposes of this description only, and may be either totally removable or hinged at hinges 107 (shown in Figure 2) during normal use of a meter of this type. Vial 500 is removable and replaceable. Figure 5 (and Figures 25 to 30) shows the procedure of replacing vial 500 with a new one housing a plurality of test sensors, and held securely closed by U-shaped clip 520. To replace a vial 500, the user must first open door 105 (shown in Figure 2). Vial 500 is loosely placed into cavity 410, designed specifically for receiving vial 500, and pressed into meter 100 in a direction indicated by arrow 6000. The fit of vial 500 into meter 100 is initially relatively loose, with some clearance between securing pins 125 and holes 529, and also between retention wings 510 and cooperating rebates 126. Once vial 500 is inserted into cavity 410, retention wings 510 (located on each side of vial 500) become positioned close to, and in the same plane as cooperating rebates 126 (located on the internal surface of main frame 114, shown in Figure 8), and these engage on actuation of the strip feeding mechanism to resist any further upwards movement of vial body 502 (described in relation to Figure 23).

Latch 400 (described in detail in relation to Figures 6 and 7) pivots to secure vial 500 rigidly within meter 100 by overlapping part of vial body 502. Latch 400 is located to the right hand side of vial body 502 (in rear view), and is positioned above battery 113.

Figure 6 shows a latch 400 comprising a cantilever beam tail 402, a hook 404, a torsional spring 406, a securing pin 405, a releasing arm 408, a button 412 and an arrow 420 indicating the direction of rotation of latch 400.

Figure 6 is an enlarged perspective view of an exemplary embodiment of a latch 400 that forms part of the mechanism of the present invention. Latch 400 is essentially a 'C'-shaped cantilever beam hinged on main frame 114, that partially rotates in a counter- clockwise direction (arrow 420) on insertion of a vial 500 into the meter 100. Latch 400 may typically be formed of a rigid material. The location of latch 400 is indicated in Figure 5. Latch 400 comprises two main 'arms'. A cantilever beam tail 402 makes up the longer of the two arms, and terminates into essentially a button 412 operable by the user to replace vial 500 when necessary (see Figures 25 to 30). Button 412 may incorporate parallel ribs, or another distinguishing feature, to indicate the user function. Tail 402 also includes a hook feature 404 opposite and below button 412, which protrudes in the direction towards vial 500 (see Figure 5). Hook 404 secures vial 500 rigidly in place by overlapping a portion of the side of vial body 502 thereby providing a constraint against any movement in the direction opposing that indicated by arrow 6000 in Figure 5.

A second, slightly shorter releasing arm 408 is joined to the base of cantilever beam tail 402 by a torsional spring 406 and securing pin 405. Releasing arm 408 is curved upwards, and contacts the underside of vial body 502 when vial 500 is positioned in the meter 100.

Figure 7 is a cross-section plan view of the meter 100 of Figure 1, seen through the cross-section line X-X indicated in Figure 5. All components shown in Figure 7 have been described previously in relation to Figures 5 and 6. Figure 7 shows a meter 100, a vial body 502 including an inner cassette 506, a latch 400 comprising a cantilever beam tail 402, a button 412, a hook 404, a releasing arm 408 and a test sensor 110.

When all test sensors 110 have been dispensed and used to measure an analyte, such as blood glucose, the user is required to replace the spent vial with a new, full vial 500 before any further measurements can be performed. Access is gained to replace vial 500 through rear door 105 as described in relation to Figure 2. As space is limited within a complex sensor-dispensing meter such as the embodiment described in relation to Figure 1, there is little room to grip vial 500 in order to remove it from cavity 410. In this optional embodiment of the invention, removal of vial 500 is assisted by the cantilever effect of latch 400. The user presses button 412 downwards, which in turn raises vial 500 upwards, towards the user, thereby easing extraction from the meter.

On insertion of a new vial 500 into meter 100, vial 500 is pressed down onto release arm 408 against the force of torsional spring 406. As release arm 408 and cantilever beam tail 402 are connected at torsional spring 406, tail 402 springs upwards, and hook 404 locks over vial body 502 thereby holding it securely within the meter 100.

Figure 8 shows the internal test sensor delivery mechanism comprising a main frame 114 with retention features 126, a cap lifter 124, a pusher wheel 116, a DC motor 118, a worm gear 214, a worm 212, a worm wheel 206, a middle gear 204, a cam gear 202, a releasing arm 408 and a button 412 of a latch 400.

Figure 8 is a perspective view of the internal feeding mechanism of Figure 3 with vial 500 removed to reveal cap lifter 124. The interaction of cap lifter 124 with cam gear 202 will be described in detail in relation to Figures 15 and 16. Figure 8 shows the small amount of space occupied in one embodiment of the test sensor delivery mechanism of the invention described herein, and a possible orientation of the strip feeding mechanism within an exemplary embodiment of a meter, such as the embodiment of a blood glucose meter shown in Figure 1.

Figure 9 shows the motorized gear mechanism of Figure 8 seen from the opposing direction to that in Figure 8, shown with portions of the meter e.g. outer housing 102 and main-frame 114 removed. Figure 9 shows a DC motor 118, a gear train 200 comprising a pinion gear 216, a worm gear 214, a worm 212, a worm wheel 206 having first gear teeth 218 and second gear teeth 220 on a common shaft 211, a middle gear 204 including first actuating element 602 and second actuating element 606, a cam gear 202 with teeth 207, a first star gear 208, a second star gear 210 (seen in Figure 10), a pusher drum 116, a flexible pusher 300, an arrow 1000 indicating the direction of rotation of cam gear 202 to dispense a strip, an arrow 3000 indicating the direction of rotation of first star gear 208 to dispense a test strip and an arrow 5000 indicating the direction of rotation of pinion gear 216.

Figure 10 shows the gear train 200 of Figure 9 positioned within a main frame 114, including a worm gear 214, a worm 212, a worm wheel 206, a middle gear 204, a cam gear 202, a first star gear 208, a second star gear 210 located on a common shaft 211.

Figure 11 is a close-up side elevation view of the interaction between star gears 208 and 210 - components of the gear train 200 of Figures 9 and 10. Figure 11 shows a pinion gear 216, a worm gear 214, a worm 212, a worm wheel 206, a middle gear 204, a cam gear 202, a cam follower 130, securing pins 125, a first star gear 208 including smooth area 208a, a first engaging tooth 208b and a protruding tooth 208c, a second star gear 210 including a smooth area 210a, a first engaging tooth 210b and a cam form 210c, a length 'A' representing the cap lifter delay, a length 'B' representing the pusher delay, an arrow 1000 indicating the direction of rotation of cam gear 202, an arrow 3000 indicating the direction of rotation of middle gear 204 and first star gear 208, and an arrow 4000 indicating the direction of rotation of second star gear 210 to dispense a test sensor.

Figure 11 shows the gear train 200 in the home or rest position prior to dispensing a test sensor, and corresponds to the meter state described in relation to Figures 18 and 19. In this home position, the test sensor delivery mechanism is essentially static, and the meter 100 may be in stand-by mode. Cap lifter 124, and hence vial cap 504, are in lowered positions, and cam follower 130 is located at the base of cam surface 203 on cam gear 202. Smooth area 208a of first star gear 208 is engaged with smooth area 210a on second star gear 210.

Figure 12 is a close-up side elevation view of the interaction between star gears 208 and 210 - components of the gear train 200 of Figure 9. Figure 12 shows all the same elements described in relation to Figure 11.

Figure 12 shows gear train 200 in operation to dispense a test sensor. As first star gear 208 and middle gear 204 are fixed together, middle gear 204 also rotates in the direction indicated by arrow 3000 and engages with cam gear 202 turning it in the direction of arrow 1000. As cam gear 202 rotates, follower 130 travels over cam surface 203 to lift cap lifter 124 (see also Figures 15 and 16). Subsequently vial cap 504 (not shown) is disengaged from vial body 502 due to the cooperation of holes 529 and securing pins 125. At this stage in the dispensing process, smooth area 208a travels over smooth area 210a for a length of time represented by length 'B' in Figure 11, causing no rotation to second star gear 210. Second star gear 210 (and hence pusher drum 116 and flexible pusher 300) remains stationary at this stage. Length 'B' is a first delay mechanism built in to gear train 200 to allow movement of cap lifter 124 to create a gap between vial cap 504 and vial body 502, with no corresponding advancement of flexible pusher 300. Figure 13 contains all elements listed previously in relation to Figures 11 and 12. Figure 13 is a side elevation view of the mechanism of Figures 11 and 12 showing the cap lifter 124 partially raised and the second star gear 210 beginning to be turned in a direction indicated by arrow 4000. Protruding tooth 208c on first star gear 208 engages with cam- form 210c causing second star gear 210 to rotate until first engaging tooth 208b (on first star gear 208) engages with the first engaging tooth 210b of second star gear 210.

Figure 14 also contains all elements described previously in relation to Figures 11 to 13. Figure 14 is a side elevation view of the mechanism of Figures 11 to 13 showing the cap lifter 124 fully raised and the second star gear 210 fully turned in order to advance the flexible pusher (item 300 seen in Figure 17) through the gap created between the vial body 502 and cap 504 i.e. the 'end' state. The view shown in Figure 14 corresponds to the meter state described in relation to Figures 20 and 21.

Rotation of cam gear 202 in the direction indicated by arrow 1000 causes cam follower 130 to travel over cam surface 203 and along the entire length 'A' depicted in Figures 11 (see also Figure 15). As cam surface 203 is constant over length 'A', vial cap 504 remains disengaged from vial body 502 while flexible pusher 300 is advanced through the gap created by subsequent interaction of teeth 208b and 210b on first (208) and second (210) star gears respectively.

Referring now to Figures 9 to 14, Figure 9 is a perspective view of a gear train 200 that operates the test sensor feeding mechanism of Figures 3 and 8. Gear train 200 provides a dual action. As will be discussed further, gear train 200 operates to initially open vial 500 (incorporating delay length 'B¹), followed by feeding a pushing member through the gap created between the vial cap 504 and vial body 502 to dispense a test sensor 110 to the test position 111, followed by closure of vial 500 (incorporating delay length 'A').

Actuation of test sensor actuation button 106 by the user causes activation of a DC motor 118. DC motor 118 turns a pinion gear 216 in a direction indicated by arrow 5000, which acts sequentially to turn a worm gear 214. Worm gear 214 turns worm 212, which engages with primary teeth 218 and turns worm wheel 206. Secondary teeth 220 on worm wheel 206 engage with and turn middle gear 204, which engages with teeth 207 thereby turning cam gear 202.- The mechanism of cap lifting enabled by rotation of cam gear 202 is described in detail in relation to Figures 15, 16 and 23.

Middle gear 204 forms part of a double gear system with first star gear 208, therefore first star gear 208 rotates in conjunction with middle gear 204 on interaction with worm wheel 206. First star gear 208 cooperates with a second star gear 210 which acts to turn pusher drum 116, causing flexible pusher 300 to uncoil from around pusher drum 116. Flexible pusher 300 is fed through the gap created between vial cap 504 and vial body 502 to dispense a test sensor 110 to test position 111 (shown in Figure 1).

Figure 12 details the small delay mechanism built into the gear train 200 between first star gear 208 and second star gear 210, by means of a smooth area 208a on first star gear 208 depicted by length 'B'. Just prior to dispensing a test sensor, smooth area 208a on first star gear 208 is initially engaged with smooth area 210a on second star gear 210 (see Figure 11). First star gear 208 rotates in a direction indicated by arrow 3000, and at this stage it does not induce any rotation of second star gear 210 (see Figure 12). Protruding tooth 208c (located on first star gear 208) engages with cam-form 210c (located on second star gear 210) causing second star gear 210 to rotate in a direction indicated by arrow 4000, until teeth 208b engage with teeth 210b (see Figure 13). Pusher drum 116 is driven by second star gear 210, therefore the combined rotation (both rotating in the direction indicated by arrow 4000) of second star gear 210 with pusher drum 116 causes flexible pusher 300 to uncoil and travel through the gap created between vial cap 504 and vial body 502 to dispense a test sensor 110 to the test position 111. Flexible pusher 300 is described in more detail in relation to Figure 17.

Lengths 'A' and 'B' represent two delay or lag mechanisms incorporated within gear train 200 to ensure that pusher 300 will not be advanced until a sufficient gap is first created between vial cap 504 and vial body 502. Length 'A' ensures that cap 504 is held disengaged from vial body while flexible pusher advances to feed a strip and subsequently retracts, and length 'B' ensures that second star gear 210, and hence pusher drum 116 and flexible pusher 300, are not advanced until cap lifter 124 has raised vial cap 504 away from vial body 502 thereby creating the required gap. Following delivery of a test sensor to the test position (i.e. the end state), the system is returned to the home or rest state by reversing the polarity of DC motor 118. The series of events described in relation to Figures 11 to 14 then occurs in reverse order, as will be discussed in relation to Figure 24.

Figure 15 shows a cam gear 202 including a cam surface 203, a hook 205 and a length 'A' representing the cap lifter delay. Figure 15 is a side elevation view of a cam gear 202.

Figure 16 shows a cam gear 202 and a cap lifter 124 including a follower 130 and securing pins 125. Figure 16 is a perspective view of an exemplary embodiment of the cap lifting mechanism of Figure 8.

Referring now to Figures 15 and 16, cam gear 202 forms part of the cap lifting operation of the test sensor delivery mechanism and operates on engagement of teeth 207 with middle gear 204 (described in relation to Figure 9). Cap lifter 124 includes two securing pins 125 that interact with correspondingly located holes 529 in cap 504, and forms an integral component of the cap lifting operation. Optionally, pins 125 and holes 529 may be offset relative to one another so that only one orientation of cap 504 is possible. Optionally holes 529 may be in the form of slots. Optionally pins 125 and holes 529 may be differently shaped i.e. non-circular.

To dispense a test sensor, cam gear 202 turns in a direction indicated by arrow 1000 as a result of a movement of the succession of gears comprising gear train 200. Gear train 200 is optionally operated by DC motor 118 on actuation of strip actuation button 106. Cam gear 202 comprises an inwardly protruding cam surface 203 that follows the perimeter of cam gear 202, however the circumference increases in radius as the cam gear 202 rotates in a direction indicated by arrow 1000, creating a slope. A follower 130, positioned close to the top surface of the cap lifter 124, is engaged with cam surface 203 at all times. As cam gear 202 rotates in direction 1000, follower 130 travels along cam surface 203 which acts to raise cap lifter 124 in a direction indicated by arrow 2000, and hence disengages cap 504 away from vial body 502 to enable a test sensor to be dispensed by the strip feeding mechanism. The displacement caused by the cam surface 203 is in the range 2mm to 5mm deployed over 180°, and may be closer to 3mm. Once cap 504 is sufficiently raised, cam gear 202 continues to rotate in direction 1000, however the slope of cam surface 203 is zero at this point to prevent any further displacement of the cap lifter 124 or hence cap 504. Optionally, cam gear 202 includes a hook 205 that interacts with a cooperating feature on cam follower 130 to retain cam follower 130 and hence cap lifter 124 on cam gear 202 when in the home position (see Figure 16). Hook 205 prevents cam follower traveling up step 201 on cam surface 203 and causing the vial to open inadvertently.

Figure 17 shows a pusher drum 116 including stop pins 304, a cavity 306 for receiving a flexible pusher 300, and a pusher tip 302.

Figure 17 is a side elevation view of an exemplary embodiment of a pusher drum 116 and a flexible pusher member 300. Pusher drum 116 comprises protruding stop pins 304 towards the base on either side, that protrude out of the plane and act as mechanical stops. A cavity 306 is formed around the perimeter of pusher drum 116 for receiving the flexible pusher 300 when retracted. Flexible pusher 300 coils around pusher drum 116 within cavity 306, which is designed specifically for this purpose.

Flexible pusher 300 is essentially a flat, rectangular elongate structure that may be composed of a resiliently deformable material such as polyamide (e.g. Zytel available from Du Pont) or acetal (e.g. Delrin also available from Du Pont). Flexible pusher 300 is approximately 37mm in length, 4mm wide and approximately l-2mm in thickness. The flexible pusher 300 is press-fixed into pusher drum 116 at one end, and includes an inverted T-shaped tip 302 extending beyond the pusher drum 116 at its second end. Tip 302 comprises of a central rib approximately 10mm long and 2 mm high. Flexible pusher 300 is wound around pusher drum 116 when in the retracted position, and only the inverted T-shaped tip 302, which is substantially thicker and therefore less flexible, remains visible at the base of pusher drum 116.

Figure 18 shows a middle gear 204 including a switch 600, a first (large) actuating element 602 and an arrow 'A' indicating the direction of rotation. Figure 19 shows a middle gear 204 including first actuating element 602, an arrow A indicating the direction of rotation of middle gear 204 and a dashed line depicts the internal form of main frame 114 including a molded hard stop 115. Figure 19 is a close up side elevation view of middle gear 204 showing the first actuation element 602 in contact with the left side of hard stop 115. First actuating element 602 contacts hard stop 115 after interacting with switch 600 (see Figure 18) moving it to the 'home' position.

Figure 20 shows a middle gear 204 including a switch 600, a second (smaller) actuating element 606 and an arrow 'B' indicating the direction of rotation.

Figure 21 shows a middle gear 204 including a first actuating element 602 and a second (smaller) actuating element 606, a hard stop 115 and an arrow B indicating the direction of rotation of middle gear 204. Figure 21 is a close up side elevation view of middle gear 204 showing the first actuating element 602 contacting the right side of hard stop 115. First actuating element contacts hard stop 115 following the interaction of second actuating element 606 with switch 600 (see Figure 20) moving it to the 'end' position.

Figures 18 to 21 show the operation of a detect switch 600. Switch 600 is combined with middle gear 204, and provides interaction between the mechanical components of the strip feeding operation and the electrical components. Switch 600 tracks the 'state' of the strip feeding mechanism, and is in communication with the meter software. Detect switch 600 incorporates two different activation positions, and is activated by features on the same link in the mechanism (middle gear 204 in the example embodiment described) and allows both the 'home' and the 'end' state to be sensed by the system. Figure 18 shows switch 600 in the 'home' state, and Figure 20 shows switch 600 in the 'end' state.

In the process of dispensing a test sensor, middle gear 204 rotates in a direction indicated by arrow 'A', and causes subsequent rotation of cam gear 202 (to raise the cap) and first star gear 208 (to enable strip feeding). Furthermore, middle gear 204 cooperates with a mechanical switch 600 that may be optionally located on the PCB (not shown) towards the rear of the meter. A first (larger) actuating element 602 and a second (smaller) actuating element 606 are both located on middle gear 204 (shown in Figure 9), however they protrude out-with the plane of rotation of middle gear 204 in order to cooperate with switch 600.

Second actuating element 606 is smaller in size than the first actuating element 602 as it is required to rotate past a hard stop 115 on mainframe 114 (shown in Figures 19 and 21) without any interaction. Only first actuation element 602 interacts with this hard stop. Referring to Figures 18 and 20, as middle gear 204 rotates approximately 320° in direction 'A', second actuating element 606 triggers switch 600 and the system recognizes that the 'end' state is reached. The larger, first actuating element 602 simultaneously contacts hard stop 115 at this point in the cycle. Hard stop 115 may optionally be molded into main¬ frame 114, and provides a stop position for the rotation of middle gear 204, which in turn prevents rotation of cam gear 202 even if DC motor 118 is still turning. DC motor 118 continues to rotate middle gear 204 in direction 'A' for a further short time to absorb any positional tolerance of switch 600. Such a delay, before the system acts on the signal received from detect switch 600, checks that first actuating element 602 is always driven against hard stop 115, thereby ensuring that the meter software recognizes this end state.

Figure 22 shows a main frame 114, a vial 500, a first star gear 208 and a second star gear 210, a DC motor 118, a pinion gear 216, a worm gear 214, a worm 212, a pusher drum 116, a cap lifter 124, a cam gear 202, a U-shaped clip 520, a vial cap 504, a vial body 502, a coil spring 524, a seal 528, and a seal counter-face 514.

Figure 22 is an elevation view of the internal test sensor dispensing mechanism of Figures 2 to 21, showing the dispensing mechanism in an initial rest position (before or after completing dispensing a strip) including a vial 500 in the closed position. A meter 100, such as the embodiment shown in Figure 1 is intended to remain in the rest (or standby or off) state for most of the time, and typically may be operated to either dispense a test sensor prior to making a blood glucose measurement, or to interrogate the memory of the meter for viewing or subsequent analysis of stored results. Access to the memory of the meter is enabled via the user interface buttons 108. The user would be encouraged to navigate around the software following commands or prompts displayed on the screen 104. Optionally the internal test sensor delivery mechanism is activated by actuation of the strip actuation button 106. When vial 500 is closed, the entire gear train 200, and test sensor feeding mechanism is in a rest position. In the rest position, flexible pusher 300 remains in the fully retracted position, housed within cavity 306 around the periphery of pusher drum 116. Only the thicker, inverted T-shaped tip 302 portion of flexible pusher 300 protrudes from pusher drum 116, in a position ready to be advanced through the gap created between vial cap 504 and vial body 502 on actuation of the internal test sensor delivery system. Follower 130 of cap lifter 124 is retained in the home position by hook 205 on cam gear 202. With cap lifter 124 in the lowered position, the force of coil spring 524 compressed between vial cap 504 and clip 520 acts to compress seal 528 against sealing counter-face 514 of vial body 502.

Figure 23 shows a vial 500 comprising a vial cap 504 with holes 529, a coil spring 524, a vial body 502 and an inner cassette 506 including a slot 540, a gear train 200 comprising a first star gear 208 and a second star gear 210, a pusher drum 116, a flexible pusher 300, a cap lifter 124 including securing pins 125, a cam gear 202, a DC motor 118, a U-shaped clip 520, a seal 528, a sealing counter-face 514, retention features 510 and an arrow 2000 indicating the direction of movement of vial cap 504 to dispense a test sensor 110.

Figure 23 is a side elevation view of the mechanism of Figure 22 showing vial cap 504 now fully raised, and the strip feeding mechanism still in the retracted position. When a user decides to perform a measurement, such as a blood glucose measurement for example, a test sensor is obtained by pressing the test sensor actuation button 106 (shown in Figure 1). Initially, the meter may perform various checks, both of the system and the conditions of the testing environment. Assuming all checks return positive information to the meter software, the test is allowed and the internal test sensor delivery system continues to dispense a test sensor from inside the previously sealed vial 500.

Actuation of the test sensor actuation button 106 by a user to dispense a test sensor, initiates movement of gear train 200, powered by DC motor 118. A detailed description of the events comprising the gear train 200 is provided in relation to Figure 9. The internal test sensor delivery system of the present invention combines a sequence of events, which can be divided into two main operations, namely a primary cap lifting step, followed sequentially by a secondary strip feeding operation.

Referring to Figure 23, vial cap 504 is lifted in a direction indicated by arrow 2000 against the force of coil spring 524 located within a cylinder-shaped recess 522 on the upper side of cap 504 (obscured by clip 520 in this view, but shown in more detail in Figure 4). Initially, the lifting movement takes up the clearance between holes 529 and securing pins 125, then the entire vial 500 is pulled upwards by pins 125 until retention wings 510 engage with cooperating rebates 126, thereby resisting any further vertical movement of vial body 502. These retention features hold vial body 502 firmly while cap 504 is opened against the force of coil spring 524.

U-shaped permanent clip 520 straddles cap 504 resting on top of coil spring 524, and interlocks with vial body 502 at rebates 512 located directly under the sealing counter face 514 of vial body 502. Vial cap 504 is disengaged from vial body 502 at the interface between the Santoprene® rubber seal 528 and sealing counter-face 514. When vial 500 is in an open position, sealing face 514 of vial body 502 is exposed and inner cassette 506 is revealed through the gap. The uppermost surface of inner cassette 506 typically sits proud of the plane containing seal face 514 by approximately 2 to 3mm to facilitate strip feeding. Thus when vial 500 is closed, the inner cassette 506 is partially located within the cavity formed by cap 502.

Cap lifter 124 cooperates with cam gear 202 (part of gear train 200) to raise vial cap 504 in a direction indicated by arrow 2000. At this stage in the operation, pusher drum 116 remains stationary due to the 'lag' effect built into the gear train between the first star gear 208 and the second star gear 210 (described previously in relation to Figure 12). Flexible pusher 300 is positioned level with inner cassette 506, ready to be advanced through slot 540 to engage with the first test sensor presented by the stack and deliver the single test sensor to the test position. The sequence of events that make up the secondary strip feeding operation are shown and discussed in relation to Figure 24.

Figure 24 shows a main frame 114, a vial 500 comprising a vial cap 504 with holes 529, a vial body 502 and an inner cassette 506 including a slot 540, a first star gear 208 and a second star gear 210, a middle gear 204, a pusher drum 116, a cavity 306 for receiving a flexible pusher 300, a T-shaped tip 302 of flexible pusher 300, a cap lifter 124 including securing pins 125, a cam gear 202, a DC motor 118 and an arrow 2000 indicating the direction of movement of vial cap 504 to dispense a test sensor 110.

Figure 24 is a side elevation view of the mechanism of Figures 2 to 23, with vial 500 in the open position, and the test sensor feeding mechanism fully advanced. DC motor 118 is activated by the user pressing the test sensor actuation button 106, which in turn operates gear train 200. Middle gear 204 and first star gear 208 together forming a double gear, and turn simultaneously as they are fixed on shaft 213. Middle gear 204 performs two functions, cooperating initially with cam gear 202 to raise vial cap 504, and subsequently interacting with first star gear 208 and second star gear 210 to feed a test sensor out of vial 500 to the test position. Such a system can be defined in terms of a primary and secondary cinematic chain. The primary chain transmits motion from the motor to the cap lifter, and works throughout the mechanism cycle, while the secondary chain is linked into the primary chain by means of star gear 210, and is active for only part of the cycle.

Middle gear 204 sequentially interacts with first star gear 208 which turns second star gear 210 and subsequently pusher drum 116. Flexible pusher 300 uncoils from around pusher drum 116, and is driven through the gap created when cap 504 is vertically displaced away from vial body 502 by cap lifter 124 at the interface between seal 528 and seal surface 514. The T-shaped tip 302 of flexible pusher 300 engages with the first test sensor presented by the stack of sensors housed within inner cassette 506, and pushes a single test sensor out of vial 500, delivering it to the strip port connector (not shown) ready to receive a sample of blood. The alignment of vial 500 within cavity 410 provided by the interlocking of retention wings 510 and cooperating rebates 126 ensures a consistent position of vial 500 with respect to the feeding mechanism. In one example embodiment, this can facilitate repeated accurate dispensing of test sensors.

Optionally, during opening of vial 500, cap lifter 124 lifts vial cap 504 away from vial body 502. Optionally cap 504 and vial body 502 typically move apart in opposite directions, each at approximately 90° to the plane in which they meet. Optionally seal 528 and face 514 move apart in opposite directions i.e. at approximately 180° to one another. By optionally moving apart in a manner to provide a substantially equidistant gap between them, access is enabled for firstly a strip inside the inner cassette 506 to be delivered to a position adjacent face 514 without fouling a hinge or part of seal 528, and secondly for a pusher (such as the flexible pusher 300 described herein) to move along face 514 to engage such a strip without fouling a hinge or part of seal 528. Optionally seal 528 and face 514 also move apart in opposite directions, each at approximately 90° to the plane in which these meet. Optionally the gap created between vial cap 504 and vial body 502 is usually substantially the same between seal 528 and face 514 at all points around the periphery of seal 528 and face 514. Cap 504 and vial body 502 are usually not hinged together although they may be. Optionally, if hinged, for example by the provision of a triple hinged interconnecting member, cap 504 and vial body 502 would move apart during opening and closing as described above.

Flexible pusher 300 becomes fully extended and contacts a stop member on the strip port connector (not shown). As the flexible pusher 300 hits the stop member, the test sensor is delivered to its final position. In the extended position, flexible pusher 300 travels completely through vial 500 engaging with the first test sensor presented by the stack. It would be obvious to a person skilled in the art that different arrangements of flexible pusher 300 are possible, including those that travel either primarily through and/or over the top surface of the inner cassette 506.

The stack of test sensors housed within inner cassette (shown in Figure 4) is maintained under compression against a strip datum surface located under the rim of the inner cassette. The test strip to be dispensed is guided by the strip datum surface, and the flexible pusher 300 is guided by a pusher datum surface when it enters into and retracts from the inner cassette 506. The test sensor is driven out of the inner cassette 506 and delivered to the test position 111 (strip port connector) within the main outer housing 102 of meter 100. Alignment of vial 500, the feeding mechanism and strip port connector is critical as associated dimensions of the strip feeding channels, pusher and connector are small in magnitude relative to potential misalignment. All components of the gear train 200, cap lifting and test sensor feeding mechanisms cooperate to reliably dispense a test sensor to the user for use in obtaining a blood glucose measurement, with minimal handling of the test sensor. The short delay mechanism provided by the two star gears (described in relation to Figure 12) ensures that the vial cap 504 is sufficiently disengaged from vial body 502 before the flexible pusher 300 is driven through the inner cassette 506 to engage with the first test sensor. By optionally providing a delay mechanism in one embodiment, it is unlikely that the pushing member 300 could be advanced into the dispenser before a sufficiently large gap was created. This could reduce the risk of damage to the internal mechanism or lead to a jamming of the test sensor delivery system. Optionally dispensing a single test sensor 110 from a moisture impermeable vial 500 in such a manner virtually eliminates the possibility of a test sensor 110 being partially dispensed from the vial 500 and therefore reduces the risk of a test sensor being trapped between the cap 504 and vial body 502 causing an obstruction of the moisture semi-impermeable seal 528.

Following delivery of a test sensor to the test port, the sequence of events previously described occurs in reverse order, by reversing the polarity of DC motor 118. Initially, worm wheel 206 rotates in a direction opposite to arrow 4000, causing middle gear 204 to rotate in a direction opposing arrow 3000. Cam gear 202 rotates in a direction opposing arrow 1000, and cam follower 130 travels over length 'A' of cam surface 203, maintaining the gap between vial cap 504 and vial body 502. As first star gear 208 is fixed with respect to middle gear 204, star gear 208 also rotates in a direction opposing arrow 3000. Teeth 208b engage with teeth 210b to rotate second star gear in a direction opposing arrow 4000, thereby retracting flexible pusher 300 which re-coils within cavity 306 of pusher drum 116. When flexible pusher 300 is fully retracted, smooth area 208a re-engages with smooth area 210a via protruding tooth 208b, second star gear 210 returns to its home position while first star gear 208 continues to rotate in a direction opposing arrow 3000. Cam follower travels over decreasing cam surface 203 as cam gear 202 rotates to its home position, with a concurrent lowering of vial cap 504 and re-engagement with sealing counter face 514. The lowering of cap lifter 124 is the last stage of the return movement, closing the gap and providing re-engagement of cap 504 with vial body 502 thereby maintaining the moisture semi-impermeable seal within vial 500 to retain the test sensors within the correct environmental conditions. In this closed state, the clearances between securing pins 125 and holes 529, and also between retention wings 510 and cooperating rebates 126 are reinstated, allowing vial 500 to be easily removed from meter 100 if required.

As middle gear 204 rotates in the direction indicated by arrow 'B' in Figure 20 during the return cycle, first actuating element 602 moves away from the hard stop while second actuating element 606 disengages from switch 600. The home position is achieved when first (larger) actuating element 602 contacts and subsequently triggers switch 600.

The delay mechanism represented by length 'B' allows first star gear 208 to rotate (to close vial 500) without any corresponding rotation of second star gear 210 or pusher drum 116, thereby ensuring that flexible pusher 300 is fully retracted prior to any attempt being made to close the gap by re-engaging vial cap 504 with vial body 502. By optionally combining the two actions of opening/closing the vial and extending/retracting the flexible pusher into a single operation by the user in one example embodiment of the invention, extension of the pusher when the vial is closed, or closure of the vial when the pusher is extended ensuring that two potential failure modes, are much less likely to occur.

Optionally, a dispenser for dispensing a plurality of test sensors, such as those used by diabetics to measure their blood glucose concentration, that incorporates a novel test sensor feeding mechanism that ensures repeatable and reliable test sensor delivery is provided by the invention. Such a motorized sensor delivery system including accurate alignment of the dispenser, strip feeding mechanism and strip port connector provides the user with an intuitive, trustworthy, fast and reliable method of obtaining a single test strip that is ready to receive a blood sample prior to each blood glucose concentration determination. Accurate positioning in the through thickness direction of the test sensor is critical to ensure the invention reliably dispenses a single strip at a time, with little risk of jamming.

This embodiment of a test sensor feeding mechanism provides a single stage operating cycle that allows the internal test strip delivery system to be almost effortlessly actuated by the user. To help with the dexterity problems and impaired vision suffered by diabetics, a test sensor delivery mechanism such as that described herein operates by pressing a single button to dispense a test strip to the test position. A large, obvious button or lever with a simple method of operation to dispense a test strip to the test position facilitates users with reduced feeling in their finger tips, and assists those with impaired vision. Reduced handling of the test strip minimizes frustration to the user.

Figure 25 shows a perspective view of a vial being inserted into a meter 100, including a main housing 102, a battery 113, a vial 500, a cavity 410 for receiving vial 500, a latch 400 and an arrow 6000 indicating the direction in which vial 500 is placed into meter 100.

Figures 25 to 27 show the series of steps carried out by a user to insert a vial 500 into meter 100 (also described in relation to Figures 5 to 7) and Figures 28 to 30 show the series of steps carried out by a user to remove a vial 500 from meter 100.

Figure 26 shows a perspective view of a vial 500 being inserted into a meter 100, including a latch 400, a battery 113, a vial 500 and an arrow 7000 indicating the direction of rotation of latch 400 as vial 500 is pressed into a cavity 410 for receiving vial 500. Figure 26 shows latch 400 rotating automatically in the direction indicated by arrow 7000 as vial 500 is received into cavity 410.

Figure 27 shows a perspective view of a vial 500 inserted into meter 100, including a latch 400, a vial 500, a battery 113 and an arrow 8000 indicating the direction of movement of latch 400 as vial 500 locks into place within cavity 410. A detailed description of latch 400 is provided in relation to Figures 5 to 8, along with a description of the locking mechanism between latch 400 and vial body 502. Latch 400 holds vial 500 within cavity 410 of meter 100 and prevents any horizontal movement of vial 500. Vertical movement is still however enabled on actuation of the test sensor delivery mechanism.

Figure 28 shows a perspective view of a vial 500 held within meter 100, including all elements described previously in relation to Figures 25 to 27, including arrow 6000 that indicates the direction in which a user is required to press latch 400 in order to release vial 500. Due to the space limitations of such a dispensing meter, there is little room around vial 500 for a user to grip vial 500 to remove it from the meter when empty. Figure 29 shows a perspective view of vial 500 unlocked and subsequently raised by latch 400 as the user presses latch 400 in the direction indicated by arrow 6000. Base portion 508 of vial 500 becomes available for the user to grip the released vial 500. As latch 400 is pressed in the direction indicated by arrow 6000, the cantilever effect of latch 400 operates to push vial body 502 on the underside thereby raising it slightly out of cavity 410.

Figure 30 shows a perspective view of a vial 500 being completely removed from meter 100. Vial 500 moves freely and may be easily lifted and rotated in a direction indicated by arrow 9000 by the user to remove vial 500 from meter 100. Latch 400 returns to its initial position shown in Figure 25 ready to accept a new vial 500.

Figure 31 is a perspective exploded view of an alternative example embodiment of a gear train including a mid-frame 114, a worm-gear pulley 230 comprising a worm gear portion 232 and a pulley portion 234, a belt 236, a motor pulley 238 and a motor 118.

Figure 31 shows a perspective exploded view of an alternative example embodiment of a gear train that may optionally operate the strip feeding mechanism of the present invention. In this embodiment, worm-gear pulley 230 comprises an uppermost worm portion 232 and a lower pulley portion 234. Pulley portion 234 is therefore integrated with worm portion 232, and is driven by motor pulley 238 via belt 236 on actuation of the test sensor delivery mechanism.

Figure 32 is perspective view of the example embodiment of a gear train of Figure 31 including a worm gear portion 232, a pulley portion 234, a belt 236, a motor pulley 238, a motor 118 and a worm wheel 204. Figure 32 shows these components mounted within mid-frame 114, and their relative positions with respect to motor 118 and worm wheel 206.

Referring now to Figures 31 and 32, in the assembled configuration, pulley portion 234 of worm-gear pulley 230, and motor pulley 238 have parallel axes of rotation. Motor pulley 238 is fixed to motor 118 by an interference fit, and the torque is generated from motor 118. Pulley portion 234 of worm-gear pulley 230 is driven by belt 236 that interconnects motor pulley 238 to pulley portion 234, thereby transmitting the torque from motor 118. Motor pulley 238 is therefore the driving pulley, and pulley portion 234 is subsequently driven. Belt 236 is typically made of a rubber material that transmits the torque due to the friction on the contact area of the pulley groove. Tension on belt 236 may be obtained by using a belt with a length shorter (approximately 10-15% shorter) than the nominal path. Belt 236 may have a square cross-section, although oval, 'V-shaped, hexagonal or other shapes of cross-section would be obvious to a person skilled in the art and is not restricted by those described herein. Correspondingly, the groove in motor pulley 238 and/or pulley portion 234 may typically be 'V-shaped although curved, square or any other shape that accommodates belt 236 are also conceivable to someone skilled in the art.

Figures 31 and 32 show an alternative example embodiment of the first step of the gear train 200 of Figures 3, 8 to 14. Worm 212, worm gear 214 and pinion gear 216 of Figures 3 and 8 to 14, have been replaced by a worm-gear pulley 230, a belt 236 and a motor pulley 238 in this alternative embodiment. Mid-frame 114 serves the function of fixing the motor 118 and worm-gear pulley 230 inter-axis, as well as maintaining orientation and alignment of the essential components of the gear train. Worm-gear pulley 230 and motor pulley 238, driven by belt 236, provide relatively noise-free torque and motion transmission between motor 118 and worm gear portion 232.

One of the main advantages provided by this test sensor delivery mechanism is the single-action operation. A flexible pusher 300 such as the embodiment described herein, can be configured such that, in its resting state, the overall dimensions can be kept to a minimum. The use of only one motor to motorize the cap lifting and pusher functions simultaneously also reduces space consumption and cost, and alleviates the additional energy consumption incurred due to the transition phases of starting and stopping two motors. Use of a single switch 600, with multiple actuators positioned on a single rotating element to detect more than one system state, also reduces costs and is less space- consuming. Switch 600 as described herein is a robust and easily to implement space- conserving solution to the need for multiple switches. Furthermore, a mechanical latch 400 of the type described herein provides two functions, namely a mechanical lock of vial 500 when in the working position, and cantilever lifting of vial 500 for subsequent release, both integrated into one space-saving solution. A releasing movement, opposite to the locking mechanism, is not sufficient to enable removal of an empty vial 500. A raising movement combined with the releasing function is an advantage for the user who can easily pick up the vial 500. Release button 412 is also 'user-friendly' due to distinguishing markings making it easy to locate, and it does not require a large actuation effort.

A further advantage of the present invention is the reduced likelihood of failures such as strip jamming or seal obstruction occurring due to the combined opening/closing of the vial with the extending/retracting of the flexible pusher, into a single operation by the user.

It will be recognized that equivalent structures may be substituted for the structures illustrated and described herein and that the described embodiment of the invention is not the only structure that may be employed to implement the claimed invention. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to hose skilled in the art without departing from the invention.

Claims

CLAIMS:

1. An automated motorized apparatus for dispensing test strips, said apparatus comprising: a primary kinematic chain, said primary kinematic chain comprising: a motor; a reduction gear box connected to said motor; a first star gear connected to said reduction gear box; a cam gear connected to said first star gear; a follower connected to said cam gear; a cassette with a cap connected to said motor; a secondary kinematic chain, said secondary kinematic chain comprising: a first star gear; a semicircular sliding interface connected to said first star gear; a pick-up pin connected to said semicircular sliding interface; a pusher drum; and a flexible pusher wound around said pusher drum.

2. A method of operating an automated motorized apparatus for dispensing test strips having a first kinematic chain, said method comprising the steps of: using a motor to provide a high-speed rotational motion to a reduction gearbox; using said reduction gear box to provide a low-speed rotational motion to a first star gear; using said first star gear to transfer rotational motion to said cam gear; and using said cam gear to lift a follower, transmitting linear motion to a vial cap.

3. A method of operating an automated motorized apparatus for dispensing test strips according to Claim 2, said automated motorized apparatus further including a second kinematic chain, said method further comprising the steps of: holding said second star gear at rest using a semicircular sliding interface until said vial cap is lifted to a predetermined height above a vial body, thereby forming a gap between said vial cap and said vial body; releasing said semicircular sliding interface after said vial cap is lifted; using a pick up pin to start a second star gear; meshing said second star gear with said first star gear; and using said second star gear to rotate a pusher drum, whereby a flexible pusher is unrolled from said pusher drum, said flexible pusher moving through said gap.

4. A method of operating an automated motorized apparatus for dispensing test strips according to Claim 3, said method further comprising the steps of reversing said pusher drum to roll up said flexible pusher and closing said vial cap.