AU2005202624A1

AU2005202624A1 - Resealable vial and dispensing mechanism for test sensor

Info

Publication number: AU2005202624A1
Application number: AU2005202624A
Authority: AU
Inventors: Neil Gair; Allan Orr; Bryan Tissington
Original assignee: LifeScan Scotland Ltd
Current assignee: LifeScan Scotland Ltd
Priority date: 2004-06-28
Filing date: 2005-06-16
Publication date: 2006-01-12
Also published as: WO2006000807A1; WO2006000801A1; WO2006000818A1; WO2006000826A1; WO2006004627A1; WO2006000805A1; WO2006000794A1; WO2006000809A1; WO2006000815A1; WO2006000792A1; WO2006000806A1

Description

P/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

TO BE COMPLETED BY APPLICANT Name of Applicant: Actual Inventors: Address for Service: Invention Title: LIFESCAN SCOTLAND LIMITED Bryan Tissington; Neil Gair; and Allan Orr CALLINAN LAWRIE, 711 High Street, Kew, Victoria 3101, Australia RESEALABLE VIAL AND DISPENSING MECHANISM FOR TEST SENSORS The following statement is a full description of this invention, including the best method of performing it known to us:- 16/06/05,eh15055.cov,1 -2- RESEALABLE VIAL AND DISPENSING MECHANISM FOR TEST

SENSORS

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates, in general, to containers for medical devices and, in particular, to containers for test sensors.

2. Description of the Related Art A variety of medical devices employ containers to, for example, protect the medical device from damage prior to use, to maintain sterility of the medical device and to isolate the medical device from potentially adverse environmental factors such as humidity and ultra-violet (UV) light. Exemplary of such medical devices are single-use test sensors electrochemical and photometric test sensors, also referred to as "test strips") that are employed with an associated 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 forcerequired 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.

Still needed in the field, therefore, is a container for test sensors that provides isolation from environmental factors, convenient and easy opening and closing of the container, and that facilitates the extraction of a test sensor from the container.

16/06/05,eh 1 5055.spc,2 SUMMARY OF THE INVENTION Embodiments of resealable vials according to the present invention provide isolation from environmental factors for test sensors contained therein, as well as convenient and easy opening and closing resealing) of the resealable vial by a dispensing mechanism.

Embodiments of dispensing mechanisms according to the present invention facilitate easy opening and closing of resealable vials, as well as the extraction of test sensor(s) from the reseal able vial.

A resealable vial for containment of test strips and automated dispensement of the test sensors therefrom by action of a dispensing mechanism according to an embodiment of the present invention includes a vial body for the containment of a plurality of test sensors and a vial cap. The vial body and vial cap are configured such that when the vial body and vial cap are in a closed position, test sensors within the vial body are essentially sealed against the environment against humidity in the environment outside of the resealable vial). Furthermore, when the vial body and vial cap are in an open position, a gap for the dispensing of a test strip therethrough is created between the vial body and the vial cap.

The vial body and vial cap are also configured for movement between the open position and the closed position by action of a dispensing mechanism.

An embodiment of a dispensing mechanism for the dispensing of a test sensor from a resealable vial with a vial body and a vial cap according to the present invention includes means for disengaging the vial body from the vial cap opening the resealable vial) and creating a gap therebetween and for reengaging the vial body and vial cap closing the resealable vial). The dispensing mechanism also includes means for dispensing a test sensor from the vial body by moving the test sensor through the gap.

BRIEF DESCRIPTION OF THE DRAWINGS 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 (wherein like numerals represent like elements), of which: FIG. 1 is a simplified perspective view of a resealable vial according to an exemplary embodiment of the present invention that includes a removable transport clip; 16/06/05,eh 15055.spc,3 r -4- FIG. 2 is a simplified perspective view of a meter with which various exemplary embodiments of resealable vials and dispensing mechanisms according to the present invention can be employed; FIG. 3 is a simplified perspective view of the meter of FIG. 2 with the resealable vial of FIG. 1 inserted therein, with an outer lid of the meter removed and an inner lid of the meter rotated away from the main housing of the meter; FIG. 4 is a simplified perspective view of a portion of the meter of FIG. 2 with the resealable vial of FIG. 1 inserted therein, the inner lid of the meter in a closed position, the transport clip removed, and the resealable vial in a sealed closed) position; FIG. 5 is another simplified perspective view of a portion of the meter of FIG. 2 with the resealable vial of FIG. 1 inserted therein, the inner lid of the meter in a closed position, the transport clip removed, and the resealable vial in a sealed a closed position); FIG. 6 is an enlarged depiction of a section of the portion of FIGs. 4 and FIG. 7 is a simplified perspective view of a portion of the meter of FIG. 2 with the resealable vial of FIG. 1 inserted therein, the inner lid of the meter in a closed position, the transport clip removed, and the resealable vial in an unsealed dispensing position an open position); FIG. 8 is an enlarged depiction of a section of the portion of FIG. 7; FIG. 9 is a simplified perspective view of a resealable vial according to another exemplary embodiment of the present invention; FIG. 10 is a simplified perspective view of a resealable vial according to yet another exemplary embodiment of the present invention; FIG. 1 A is a simplified perspective view of a resealable vial according to still another exemplary embodiment of the present invention; FIG. 1 1B is a simplified cross-sectional perspective view of a portion of the resealable vial of FIG. 11 A; FIG. 12 is a simplified exploded view of the reseal able vial of FIG. 11A; FIG. 13 is a simplified, transparent perspective view of a dispensing mechanism according to an exemplary embodiment of the present invention; FIG. 14 is a simplified perspective view of a variation of the dispensing mechanism of FIG. 13; 16/06/05,eh 15055.spc,4 FIG. 15A is a simplified perspective view of a dispensing mechanism according to another exemplary embodiment of the present invention operatively attached to the resealable vial of FIG. 9 in a sealed closed) position; FIG. 15B is a simplified perspective view of the dispensing mechanism of FIG.

15A operatively attached to the resealable vial of FIG. 9 in a sealed closed) position with the return spring and plunger spring exposed; FIG. 15C is a simplified perspective view of the reverse side of the dispensing mechanism of FIG. 15A operatively attached to the resealable vial of FIG. 9 in a sealed closed); FIG. 16A is a simplified perspective view of the dispensing mechanism of FIG. with the resealable vial of FIG. 9 in an unsealed dispensing open) position; FIG. 16B is a simplified perspective view of the dispensing mechanism of FIG.

16A operatively attached to the resealable vial of FIG. 9 in an unsealed open) position with the return spring and plunger spring exposed; FIG. 17 is a simplified exploded view of the dispensing mechanism of FIG FIG. 18 is a simplified perspective view of a dispensing mechanism according to yet another exemplary embodiment of the present invention operatively attached to the resealable vial of Fig. 9 in a sealed position; FIG. 19 is a simplified perspective view of the dispensing mechanism of with the resealable vial of FIG. 9 in an unsealed dispensing position; FIG. 20 is a simplified exploded view of the dispensing mechanism of FIGs. 18 and 19; FIG. 21 is a simplified perspective view of a dispensing mechanism according to still another exemplary embodiment of the present invention operatively attached to the resealable vial of FIGs. 11 and 12 in a sealed position; FIG. 22 is a simplified perspective view of the dispensing mechanism of FIG. 19 with the reseal able vial of FIGs. 11 and 12 in an unsealed dispensing position; FIG. 23 is a simplified perspective view of a dispensing mechanism according to a further exemplary embodiment of the present invention operatively attached to the resealable vial of FIGs. 11 and 12 in a sealed position; FIG. 24 is a simplified perspective view of the dispensing mechanism of FIG. 21 with the resealable vial of FIGs. 11 and 12 in an unsealed dispensing position; and FIG. 25 is a simplified exploded perspective view of the dispensing mechanism of FIGs. 21 and 22.

1 6/06/05,eh I 5055.spc,5 -6- DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 is a simplified perspective view of a resealable vial 100 for containment of test strips and automated dispensement of the test strips therefrom by action of a dispensing mechanism dispensing mechanism 600 described below with respect to FIGs. 13 and 14 below) according to an exemplary embodiment of the present invention.

Resealable vial 100 includes a vial body 102 for the containment of a plurality of test strips (not shown) and a vial cap 104.

In the embodiment of FIG. 1, vial body 102 and vial cap 104 are configured such that when vial body 102 and vial cap 104 are in a closed sealed) position, test stripes) within vial body 102 are sealed against environmental factors. Furthermore, when vial body 102 and vial cap 104 are in an open position, a gap is created between vial body 102 and vial cap 104 (as is described in further detail below) for dispensing a test sensor therethrough. Moreover, vial body 102 and vial cap 104 are also configured for movement between the open position and the closed position by action of the dispensing mechanism.

Although, for the purpose of explanation only, vial body 102 is illustrated as essentially an open-ended rectangular container, resealable vials according to embodiments of the present invention can have any suitable shape. Vial body 102 is made of, for example, glass-filled polypropylene or other suitably rigid material, and includes a vial body sealing counterface (not shown in FIG. 1) at the open end of vial body 102.

Vial cap 104 can, for example, also be made of glass-filled polypropylene or other suitably rigid material. A seal (not shown in FIG. 1) formed, for example, from Santoprene® rubber or other suitable resiliently deformable material, is situated between vial body 102 and vial cap 104 when resealable vial 100 is in a closed position such that vial cap 104 seals the otherwise open end of vial body 102. The seal can, for example, be manufactured by a 2-shot molding technique onto the underside of vial cap 104. The seal can include, for example, a slight overhang around the periphery of vial cap 104.

Resealable vial 100 also includes a transport clip 106, a ball joint 108, location pins 110 (disposed on vial cap 104), cooperating rebates 112 (disposed on vial body 102), smart chip 114 and cam protrusion 116.

Location pins 110 and cooperating rebates 112 (which are adapted for receiving location pins 110) facilitate alignment of the vial body and vial cap during opening and closing of resealable vial 100. In this regard, location pins 110 engage with cooperating rebates 112 when resealable vial 100 is closed. However, vial cap 104 can be disengaged 16/06/05,eh I 5055.spc,6 from vial body 102 resealable vial 100 can be opened) by concurrently sliding location pins 110 out of cooperating rebates 112.

Smart chip 114 is adapted for communication with an associated meter on full insertion of resealable vial 100 into the associated meter. Cam protrusion 116 is configured to operatively cooperate with a dispensing mechanism to dispense a test strip from resealable vial 100 (as is described in detail below with respect to FIGs. 13 and 14).

Transport clip 106 is configured to grip and securely hold both vial body 102 and vial cap 104 in a closed sealed) position during, for example, handling of resealable vial 100 prior to use. The force required to grip and securely hold vial body 102 and vial cap 104 is provided by the bent shape of transport clip 106 and the resilient nature of the material from which transport clip 106 is formed resilient plastic).

It is envisioned that embodiments of resealable vials (and dispensing mechanisms) according to the present invention can be employed with an associated meter for measuring an analyte glucose) in a bodily fluid (such as blood or interstitial fluid). FIG. 2 is a simplified perspective view of a meter 200 with which various embodiments of reseal able vials and dispensing mechanisms according to the present invention can be employed.

Meter 200 includes a main housing 202, a removable outer lid 204, a user interface 206, a display panel 208, a test sensor delivery port 210, a panel 212 and an inner lid 214 (not shown in FIG. FIG. 3 is a simplified perspective view of meter 200 with resealable vial 100 inserted therein, with removable outer lid 204 removed and inner lid 214 of the meter rotated away from main housing 202.

Referring to FIGs. 2 and 3, inner lid 214 is pivotally attached to main housing 202 at pivot point 216. Furthermore, inner lid 214 includes a socket 218 that cooperates with ball joint 108 of resealable vial 100 to serve as a ball-and-socket joint. The cooperation of socket 218 and ball joint 108 provide for a slight articulation of vial cap 104 during closure resealing) of resealable vial 100.

Removable outer lid 204 serves to protect components within meter 200 a resealable vial or dispensing mechanism according to embodiments of the present invention) from dust particles and fluid splashes. It is contemplated that removable outer lid 204 would remain in place during use of meter 200 for analyte measurement, and would only be removed during replacement of resealable vial 100.

FIGs. 2-5 and 7 also depict a reciprocating pusher 220 that is aligned with vial body 102 such that horizontal travel of reciprocating pusher 220 on actuation of a dispensing mechanism by arm 222 dispenses a single test strip through test sensor delivery port 210 16/06/05,eh 15055.spc,7 from a plurality of strips within resealable vial 100. As will be evident from the descriptions below, reciprocating pusher 220 and arm 222 are components of the aforementioned dispensing mechanism, with arm 222 being presented to a user through an opening (not shown) in meter 200 (see FIG. 2).

FIG. 4 is a simplified perspective view of a portion of the meter 200 with the resealable vial 100 inserted therein, inner lid 214 in a closed position, transport clip 106 removed, and resealable vial 100 in a sealed closed) position. FIG. 5 is another simplified perspective view of a portion of the meter 200 with resealable vial 100 inserted therein, inner lid 214 in a closed position, transport clip 106 removed, and the resealable vial in a sealed a closed) position (with the arrow indicating the direction in which vial body 102 is displaced during opening of reseal able vial 100). FIG. 6 is an enlarged depiction of a segment of FIGs. 4 and 5. FIG. 7 is a simplified perspective view of a portion of meter 200 with resealable vial 100 inserted therein, inner lid 214 in a closed position, transport clip 106 removed, and resealable vial 100 in an unsealed dispensing position an open position). FIG. 8 is an enlarged depiction of a segment of FIG. 7.

Referring to FIGs. 1-8, the manner in which resealable vial 100 is opened and closed "resealed") is described. During this description, various features and elements of meter 200 and resealable vial 100 will be identified in addition to those described above.

For example, vial body 102 includes a lower lip 118 and vial cap 104 includes an upper lip 120. In addition, vial body 102 includes a vial body sealing counterface 122 and vial cap 104 includes a seal 124.

Ball joint 108 located centrally on top of vial cap 104 and cooperating socket 218 on an underside of inner lid 214 engage one another when inner lid 214 is securely closed.

Reciprocating pusher 220 is operatively aligned with vial body 102 and configured to travel horizontally in the orientation of FIG. 2.

In the closed position of, for example, FIG. 6, seal 124 of vial cap 104 is in contact with vial body sealing counterface 122 such that test strips contained within vial body 102 are isolated sealed) from potentially deleterious environmental factors humidity).

In the open position of, for example, FIGs. 7 and 8, vial body 102 is disengaged from vial cap 104 and seal 124 is not in contact with vial body sealing counterface 122.

Therefore, a gap G is created between vial body 102 and vial cap 104. Gap G exposes an inner cassette (IC) within vial body 102 and provides an opening for the dispensement of a test sensor from within vial body 102 from within inner cassette IC).

16/06/05,eh I 5055.spc,8 -9- FIG. 9 is a simplified perspective view of a reseal able vial 300 for containment of test strips and automated dispensement of the test strips therefrom by action of a dispensing mechanism according to an exemplary embodiment of the present invention.

Resealable vial 300 includes a vial body 302 for the containment of a plurality of test strips (not shown). Resealable vial 300 also includes a vial cap 304 and vial body 302 includes a lip 305.

In the embodiment of FIG. 9, vial body 302 and vial cap 304 are configured such that when vial body 302 and vial cap 304 are in a closed position, test sensor(s) contained within vial body 302 are sealed against environmental factors (such as humidity).

Furthermore, when vial body 302 and vial cap 304 are in an open position, a gap is created between vial body 302 and vial cap 304 for dispensing a test sensor therethrough.

Moreover, vial body 302 and vial cap 304 are configured for movement between the open position and the closed position by action of the dispensing mechanism (such as dispensing mechanisms 700 and 800 according to the present invention and described below).

Resealable vial 300 also includes a transport clip 306 and a smart chip 308.

Transport clip 306 is configured to securely seal vial cap 304 to vial body 302 prior to insertion of resealable vial 300 into a dispensing mechanism and/or associated meter.

Transport clip 306 is of a size, shape and material that provides for vial cap 304 to be secured to vial body 302, while providing for transport clip 306 to be removed from resealable vial 300 once resealable vial 300 has been inserted into a dispensing mechanism and/or associated meter.

Transport clip 306 is formed from a metal rod(s) that has been bent into the configuration depicted in FIG. 9. Portion 306A of transport clip 306 can serve as a handle for transport clip 306. Portions 306B and 306C of transport clip 306 are disposed on top of vial cap 304. End portions 306D of transport clip 306 are disposed underneath lip 305 of vial body 302. Transport clip 306 is configured such that portions 306B, 306C and 306D cooperate to resiliently secure vial cap 304 to vial body 302. The force applied to vial body 302 and vial cap 304 by transport clip 306 can, for example, be in the range of 5N to 9N.

FIG. 10 is a simplified perspective view of a resealable vial 400 for containment of test strips (not shown) and automated dispensement of the test strips therefrom by action of a dispensing mechanism according to an exemplary embodiment of the present invention.

Resealable vial 400 includes a vial body 402 for the containment of a plurality of test strips (not shown). Resealable vial 400 also includes a vial cap 404.

16/06/05,eh 15055.spc,9 In the embodiment of FIG. 10, vial body 402 and vial cap 404 are configured such that when vial body 402 and vial cap 404 are in a sealed closed) position, test strips within vial body 402 are isolated from environmental factors. Furthermore, when vial body 402 and vial cap 404 are in an open position, a gap is created between vial body 402 and vial cap 404 for dispensing a test sensor therethrough. Moreover, vial body 402 and vial cap 404 are configured for movement between the open position and the closed position by action of the dispensing mechanism (such as dispensing mechanisms 600 and 800 according to the present invention and described below).

Vial body 402 of resealable vial 400 includes a sealing counterface 406, at least one protruding hard stop 408 (one of which is shown in FIG. 10), and at least one latch 410 (one of which is shown on FIG. 10) and a smart chip 412. Vial cap 404 includes two clips 414 (one of which is depicted in FIG. 10 and each with a latch member 416), two hinges 418 (one of which is depicted in FIG. 10), a ball joint 420 and a seal 422.

During opening and closing of resealable vial 400, clips 414 and latch members 416 travel between protruding hard stop 408 and latch 410. Therefore, the distance between protruding hard stop 408 and latch 410 a distance in the range of 2 mm to 4 mm) is equal to the distance by which vial cap 404 is moved away from vial body 402 upon opening of resealable vial 400 for the dispensement of a test strip. Clips 414 provide a relatively light force that acts to hold vial cap 404 and vial body 402 in the closed position.

However, the force generated by action of the dispensing mechanism during opening of resealable vial 400 is sufficient to overcome the relatively light force of clips 414.

Seal 422 is resiliently deformable when a force is applied between vial cap 404 and vial body 402. For example, a closing force in the range of 5N to O10N can be applied between vial cap 404 and vial body 402 to compress seal 422 onto sealing counterface 406 of vial body 402. Such a force is sufficient to ensure a substantially moisture semiimpermeable seal between vial cap 404 and vial body 402 and, thereby, provide environmental isolation for test sensors within vial body 402.

FIGs. 11 A, 11B and 12 are simplified perspective, cross-sectional perspective and exploded views, respectively, of a resealable vial 500 according to an exemplary embodiment of the present invention. Resealable vial 500 includes a vial body 502, a vial cap 504 and an inner cassette 506, as illustrated in FIGs. 11 A, 11 B and 12.

Vial body 502, vial cap 504 and inner cassette 506 are configured such that when vial body 502 and vial cap 504 are in a closed position, test strips within inner cassette 506 are sealed against environmental factors. Furthermore, when vial body 502 and vial cap 16/06/05,eh 15055.spc, -11 504 are in an open position, a gap is created between vial body 502 and vial cap 504 for dispensing a test strip therethrough. Moreover, vial body 502 and vial cap 504 are also configured for movement between the open position and the closed position by action of a dispensing mechanism (such as the dispensing mechanism of FIGs. 19 and 20 or the dispensing mechanism of FIGs. 21-23 described below).

Vial body 502 includes retention wings 510, rebates 512, sealing counterface 514, aperture portions 516 and smart chip 518. Vial cap 504 includes a clip 520, rebate 522, a spring coil 524, locating pins 526, seal 528, and offset openings 529. Inner cassette 506 includes a plurality of test strips 530 in a stacked configuration, a constant force spring 532 a stack pusher 534, panels 536 and protrusions 538.

Rebate 522 of vial cap 504 partially houses spring coil 524. Clip 520 rests on coil spring 524, as shown in FIG. 12. In addition, clip 520 is interlocked with vial body 502 at rebates 512, which are located beneath sealing counterface 514. Clip 520 stays attached to the remainder of resealable vial 500 during use during opening and closing of resealable vial 500). Location pins 526 and aperture portions 516 cooperate to align vial body 502 and vial cap 504 during use.

Vial cap 504 includes seal 528 formed of, for example, Santoprene® rubber or other suitable resiliently deformable material. Seal 528 abuts with sealing counterface 514 of vial body 502 when resealable vial 500 is closed to provide a resiliently deformable seal therebetween. In addition, seal 528 is resiliently deformable when a force is applied between vial cap 504 and sealing counterface 514 of vial body 502.

Inner cassette 506 is housed within a cavity (not shown) of vial body 502. Inner cassette 506 includes two panels 536 that are joined by protrusions 538. Constant force spring 532 provides a constant force a constant force of approximately 1.5N) on the underside of a stack pusher 534.

As noted above, resealable vial 500 is configured to be opened and closed by action of a dispensing mechanism. In this regard, retention wings 510 are configured to maintain resealable vial 500 in a relatively fixed position as resealable vial 500 is opened and offset openings 529 serve as dispensing mechanism engagement features. Furthermore, coil spring 524 provides a compressive force that seals vial cap 504 and vial body 502, and constant force spring 532 provides a force for an upward movement of remaining test strips as test strips are dispensed from resealable vial 500. Stack pusher 534 is configured to transfer the force of constant force spring 532 to the stacked configuration of test strips within resealable vial 500.

16/06/05,eh15055.spc, I I -12t FIGs. 13 and 14 depict two variations of a dispensing mechanism 600 for opening Sand closing a resealable vial and dispensing a test sensor contained in the resealable vial.

g As described below, the variation of dispensing mechanism 600 depicted in FIG. 13 n employs a pusher track 608 as a link between a cam mechanism 602 and a reciprocating

INO

pusher 220, while the variation of dispensing mechanism 600 depicted in FIG. 14 employs a teeth bar 606 as a link between cam mechanism 602 and reciprocating pusher 220.

SDispensing mechanism 600 can be employed, for example, with resealable vial 100 Nof FIGs. 1 and 4-8 and with, for example, a meter such as meter 200 of FIGs. 2 and 3. For purposes of illustration only, FIG. 13 depicts mechanism 600 in use with various components of meter 200 and FIG. 14 depicts mechanism 600 in use with components of resealable vial 100 and an inner cassette (IC).

FIG. 13 illustrates a spring (SP) that can be considered to be a component of meter 200. Spring SP is configured to provide a force that maintains a substantially moisture semi-impermeable seal between vial body 102 and vial cap 104 when resealable vial 100 is in a closed position and transport clip 106 has been removed.

Dispensing mechanism 600 includes a cam mechanism 602 (with a slot 602a), a lever pivot 604, and a teeth bar 606 (in the variation of FIG. 14) or a pusher track 608 (in the variation of FIG. 13). Cam protrusion 116 (not shown in FIGs. 13 and 14) fits into slot 602a, and travels within slot 602a when cam mechanism 602 operates by pivoting about lever pivot 604 due to actuation of arm 222 (shown in FIGs. 2 and 3) by a user. Actuation of cam mechanism 602 initially pulls vial body 102 (not shown in FIGs. 13 and 14) downwards (thereby opening resealable vial 100) with no corresponding movement of reciprocating pusher 220. The pulling of vial body 102 downward creates a gap an equidistant gap) between vial body 102 and vial cap 104.

Cam mechanism 602 subsequently engages with either teeth bar 606 (in the embodiment of FIG. 14) or pusher track 608 (in the embodiment of FIG. 13), causing forward horizontal movement of reciprocating pusher 220. During this movement, cam mechanism 602 holds vial body 102 static with a constant force, while reciprocating pusher 220 moves forward to engage a test sensor within resealable vial 100. Reciprocating pusher 220 then pushes the engaged test sensor to test sensor delivery port 210 in panel 212 of inner lid 214. Therefore, a single actuation of arm 222 by a user causes opening of resealable vial 100 and movement of reciprocating pusher 220 to dispense a strip.

In the embodiment of FIGs. 13 and 14, vial cap 104 remains essentially fixed with respect to the inner lid 214 by the ball and socket joint whilst vial body 102 experiences a 16/06/05,eh15055.spc,12 13 temporary downward displacement away from vial cap 104 against the force of coil spring

SP.

Following dispensement of a test strip to test sensor delivery port 210, release of arm 222 results in closure of gap G and vial body 104 is re-sealed with vial cap 104. Slight articulation is provided by ball joint 108 and socket 218 to account for any slight misalignment of vial cap 104 with vial body 102.

FIGs. 15A through 17 depict a dispensing mechanism 700 for opening and closing a resealable vial and dispensing a test sensor contained in the resealable vial. Dispensing mechanism 700 can be employed, for example, with resealable vial 300 of FIG. 9 and with, for example, a meter such as meter 200 of FIGs. 2 and 3. Therefore and for purposes of illustration only, FIGs. 15A through 17 depict mechanism 700 along with various components of meter 200 and resealable vial 300; Dispensing mechanism 700 includes a cylinder housing 702 with a spring loaded plunger 703, a T-bar 704, a plunger spring 705, a two-stage lever arm 706, and a return spring 707. Cylinder housing 702 houses spring-loaded plunger 703 and plunger spring 705 centrally above vial cap 304. Reciprocating pusher 220 is operatively aligned with resealable vial 300 and is attached to two-stage lever arm 706 by T-bar 704.

During use, an initial lifting actuation of two-stage lever arm 706 (in the direction of arrow A in FIGs. 15A and 16A) causes spring-loaded plunger 703 to be forced into cylinder housing 702, lifting disengaging) vial cap 304 away from vial body 302 (since spring-loaded plunger 703 is operatively engaged with a ball joint of vial cap 304 as depicted in FIG. 15C). This disengagement of vial cap 304 from vial body 302 provides a gap G (such as an equidistant gap) and reveals an inner cassette IC within resealable vial 300.

Inner cassette IC holds a plurality of test sensors in a stacked array. A subsequent horizontal sliding movement of two-stage lever arm 706 (in the direction of arrow B in FIGs. 15 and 16) drives reciprocating pusher 220, guided by T-bar 704, through gap G, such that a test sensor is engaged and delivered dispensed) to the test sensor delivery port of meter 200. On release of the two-stage lever arm 706, reciprocating pusher 220 retracts (due to the action of return spring 707) and vial body 302 and vial cap 304 are closed sealed).

FIGs. 18-20 depict a dispensing mechanism 800 for opening and closing a resealable vial and dispensing a test sensor contained in the resealable vial. Dispensing mechanism 800 can be employed, for example, with resealable vial 300 of FIG. 9 and with, 16/06/05,eh 15055.spc, 13 -14for example, a meter such as meter 200 of FIGs. 2 and 3. Therefore, and for purposes of illustration only, FIGs. 18-208 depict mechanism 800 along with various components of meter 200 and resealable vial 300.

Dispensing mechanism 800 includes a lever arm 802 (with slot 802a), a guide pin 804, a two-stage slider button 806, a lever arm pivot 808, a return block 810, a coil spring 812 (within a plunger 813) and a return spring 814. Slot 802a engages guide pin 804.

Reciprocating pusher 220 is coupled to the lever arm 802 and operatively aligned with vial cap 304. Lever arm 802 is in a lowered position when resealable vial 300 is closed. In the embodiment of FIGs. 18-20, it is assumed that vial body 302 is securely held such that upward movement of vial body 302 is prevented.

An initial upward movement of two-stage slider button 806 raises lever arm 802 and, thereby, pulls guide pin 804 upwards. This movement serves to simultaneously lift vial cap 304 vertically against the force of coil spring 812 and away from vial body 302 providing gap G and revealing inner cassette IC. A subsequent horizontal movement of two-stage slider button 806 (in the direction of lever arm pivot 808) drives reciprocating pusher 220 through gap G such that reciprocating pusher 220 engages a test sensor presented by the inner cassette IC and dispenses the test sensor to a test sensor delivery port (not shown).

Release of two-stage slider button 806 results in an automatic retraction of reciprocating pusher 220, as well as return of two-stage slider button 806 and lever arm 802 to their initial positions due to return spring 814 located inside return block 810. This return movement causes vial cap 304 to be lowered and re-engaged closed) with vial body 302. Decompression of the return spring within return block 810 provides a force between vial cap 304 and vial body 302 to securely establish a seal therebetween.

FIGs. 21 and 22 depict a dispensing mechanism 900 for opening and closing a resealable vial and dispensing a test sensor contained in the resealable vial. Dispensing mechanism 900 can be employed, for example, with resealable vial 500 of FIGs. 11 and 12 and with, for example, a meter such as meter 200 of FIGs. 2 and 3. Therefore, and for purposes of illustration only, FIGs. 21 and 22 depict mechanism 900 along with various components of meter 200 and resealable vial 500.

Dispensing mechanism 900 includes a vial block 902 (for holding vial body 502), a slider button 904, a lever arm 906 (with slot 906a), a pivot 908, a return block 910, a lifter 912, a gear wheel pusher 914, a gear block 916, a slider block 918 and a guide pin 920.

When resealable vial 500 is in a closed position, slider button 904 remains in a 16/06/05,eh15055.spc, 14 lowered position at one end of lever arm 906 due to, for example, a return spring (not shown) located inside return block 910. Slot 906a engages with guide pin 920 to assist in the opening of resealable vial 500. Slider block 918 remains at the far right end of a slot (not shown) within return block 910. Offset openings 529 in vial cap 504 engage with lifter 912.

In the embodiment of FIGs. 21 and 22, a flexible sensor pusher (not shown) is provided. The flexible sensor pusher is wound around gear wheel pusher 914 located in gear block 916.

During use, slider button 904 is first lifted by the user, and then pushed in the forward direction to the left on FIGs. 21 and 22). The lifting of slider button 904 causes lever arm 906 to pivot about pivot 908. Guide pin 920 and slot 906a interact to pull lifter 912 upwards. As vial cap 504 is coupled to lifter 912 by offset openings 529, vial cap 504 is lifted away from vial body 502 against the force of, for example, a spring. Vial cap 504, therefore, becomes disengaged from vial body 502 revealing inner cassette IC and creating gap G.

As the slider button 904 is moved forward, a rack feature (not shown) engages with a gear wheel (not shown) and rotates gear wheel pusher 914 located in gear block 916. As gear wheel pusher 914 rotates, the flexible sensor pusher (not shown) uncoils and is driven through gap G. In doing so, the flexible sensor pusher engages with a test strip presented by inner cassette IC and delivers dispenses) the test strip from resealable vial 500.

Release of slider button 904 by a user results in an automatic retraction of the flexible pusher. Slider button 904 and lever arm 906 return to their initial positions due to, for example, decompression of a return spring (not shown) located inside return block 910.

Therefore, vial cap 504 is lowered and re-engaged with vial body 502.

FIGs. 23-25 depict a dispensing mechanism 1000 for opening and closing a resealable vial and dispensing a test sensor contained in the resealable vial. Dispensing mechanism 1000 can be employed, for example, with resealable vial 500 of FIGs. 11 and 12 and with, for example, a meter such as meter 200 of FIGs. 2 and 3. Therefore, and for purposes of illustration only, FIGs. 23 through 25 depict mechanism 1000 along with various components of meter 200 and resealable vial 500.

Dispensing mechanism 1000 includes a single-action slider button 1002 (with internal ramps 1004), a vial block 1006 (for holding vial body 502), a guide pin 1008, a gear wheel pusher 1010, a gear block 1012, a lifter 1014, a return block 1016, flexible 16/06/05,eh15055.spc, -16sensor pusher 1018, a slider block 1020, a return spring 1022, a rack 1024, a gear wheel 1026 and a rod 1028.

During use with resealable vial 500 in a closed position, single-action slider button 1002 is in a rest position on return block 1016 above gear block 1012 and gear wheel pusher 1010 due to the force of a return spring (not shown) located inside return block 1016. A flexible sensor pusher 1018 is wound around gear wheel pusher 1010 located in gear block 1012. Lifter 1014 includes features that slot into offset openings 529 of vial cap 504 to assist with the opening and closing of resealable vial 500.

When single-action slider button 1902 is pushed in the forward direction along return block 1016 to the left in FIGs. 23 and 24), vial cap 504 is lifted away from disengaged from) vial body 502 by cam action due to internal ramps 1004 on single-action slider button 1002 engaging with guide pins 1008 located on each side of lifter 1014. As single-action slider button 1002 moves forward, guide pins 1008 travel along internal ramps 1004 pulling vial cap 504 away from vial body 502 to create a gap G between vial body 502 and vial cap 504.

Additional forward movement of single-action slider button 1002 engages singleaction slider button 1002 with slider block 1020. Slider block 1020, which is attached to a rack 1024, then moves in the forward direction. As single-action slider button 1002 and slider block 1020 move forward, rack 1024 engages gear wheel 1026 (see Figure 24) causing gear wheel pusher 1010 to rotate. Thus, initially single-action slider button 1002 causes opening of resealable vial 500, and it is only when single-action slider button 1002 engages slider block 1020 that flexible sensor pusher 1018 uncoils and is driven through gap G to engage with and dispense a test strip.

When a user releases single-action slider button 1002, flexible sensor pusher 1018 retracts and coils around gear wheel pusher 1010 under a bias of return spring 1022, singleaction slider button 1002, slider block 1020 and rack 1024 return automatically to their original locations, and lifter 1014 lowers with a concurrent re-engagement of vial cap 504 with vial body 502 to re-seal resealable vial 500.

FIG. 25 depicts the manner in which single-action slider button 1002 is attached to slider block 1020 (that is configured to move along rod 1028 and compresses return spring 1022 located inside return block 1016).

It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that 16/06/05,eh 15055.spc, 16 -17the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

16/06/05,ehl5055.spc,17

Claims

1. A resealable vial for containment of test strips and automated dispensement of the test sensors therefrom by action of a dispensing mechanism comprising: a vial body for the containment of a plurality of test sensors; and a vial cap, wherein the vial body and vial cap are configured such that when the vial body and vial cap are in a closed position, test sensors within the vial body are sealed against the environment and when the vial body and vial cap are in an open position, a gap is created between the vial body and vial cap for dispensing a test strip therethrough; and wherein the vial body and vial cap are also configured for movement between the open position and the closed position by action of a dispensing mechanism.

2. The resealable vial of claim 1 further including a resilient seal disposed between the vial body and vial cap.

3. The resealable vial of claim 1 further including a transport clip configured to securely grip and hold the vial body and vial cap in the closed position.

4. The resealable vial of claim 1, wherein the vial body and vial cap are configured such that an equidistant gap is created when the vial body and vial cap are in the open position.

The resealable vial of claim 1, wherein the vial cap includes a ball joint.

6. A dispensing mechanism for the dispensing of test sensor from a resealable vial with a vial body and a vial cap comprising: means for disengaging the vial body from the vial cap and creating a gap therebetween and for reengaging the vial body and vial cap; and means for dispensing a test sensor from the vial body by moving the test sensor through the gap.

7. The dispensing mechanism of claim 6, wherein the means for disengaging and reengaging the vial body and vial cap includes a cam mechanism configured for 16/06/05,eh15055.spc, 18 -19- disengaging the vial cap and vial body, and wherein the means for dispensing the test sensor includes a reciprocating pusher.

8. The dispensing mechanism of claim 6, wherein the means for disengaging the vial body and vial cap includes a lever arm, and wherein the means for dispensing the test sensor includes a reciprocating pusher.

9. A releasable vial, substantially as hereinbefore described with reference to the accompanying drawings. A dispensing mechanism, substantially as hereinbefore described with reference to the accompanying drawings. Dated this 16 th day of June, 2005 LIFESCAN SCOTLAND LIMITED By Their Patent Attorneys CALLINAN LAWRIE \A 16/06/05,eh15055.spc,19