WO2010002741A1

WO2010002741A1 - Strip vial and cap

Info

Publication number: WO2010002741A1
Application number: PCT/US2009/048934
Authority: WO
Inventors: Yi Wang; Benjamin M. Rush; Frank D. Fujimoto; Edward J. Kupa
Original assignee: Abbott Diabetes Care, Inc.
Priority date: 2008-07-03
Filing date: 2009-06-26
Publication date: 2010-01-07
Also published as: EP2310296A1; US20100000905A1

Abstract

Containers and methods for dispensing test strips. Embodiments of the invention include a container and a cap or an insert. The container holds or stores the test strips and the test strips may be dispensed through the cap or the insert.

Description

STRIP VIAL AND CAP

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Patent Application No. 12/168,009, filed on July 3, 2008, the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

Embodiments of the invention relate to vials for test strips. More particularly, embodiments of the invention relate to storing and dispensing test strips from a vial that may be used to test analytes in bodily fluids including blood glucose levels.

2. The Relevant Technology

Diabetes is a disease that has become more manageable in recent years. Today, people with diabetes are often able to control their diabetes through exercise and proper diet. In addition to exercise and diet, another important aspect of diabetes management includes glucose monitoring. In fact, glucose monitoring is often an essential part of proper diabetes control or even diabetes prevention.

Generally, a diabetic person measures blood glucose levels several times a day. Careful monitoring of blood glucose levels can help prevent or delay the onset of debilitating complications such as cardiovascular disease, blindness, kidney disease, and nerve damage.

The process of monitoring blood glucose levels includes several steps using appropriate equipment that includes a test strip and a blood glucose monitor. In general, a small sample of blood is transferred to an appropriate location of the test strip. The monitor then measures the blood glucose level in the blood sample and displayed to the user.

While this process seems rather simple, there are certain steps that can prove difficult, particularly for people that are suffering from some of the effects of diabetes such as nerve issues and poor eyesight. For example, before transferring a small sample of blood to a test strip, a user is required to obtain a test strip. Test strips are often stored in a vial and a user opens the vial of test strips to extract a test strip.

However, this process can be difficult for various reasons. The size of test strips themselves, which are often stored loosely in the vial, can make them difficult to grasp. The size of the vial also contributes to the difficulty of extracting a single strip. In fact, some users have to take several test strips out of the vial before they can pick up a single test strip. As indicated previously, these problems can often be complicated by the fact that many people with diabetes often have problems (e.g., poor eyesight, nerve problems) or difficulty in handling the test strips.

When extracting a test strip from conventional vials, the test strips inside the vial are often subject to repeated touching, which may adversely affect the functionality of the test strips. Also, because such a user typically cannot extract a single strip without taking out several test strips, the user may inadvertently drop some of the test strips onto the floor, which can lead to damaged, contaminated, or unusable test strips. In addition, test strips can be contaminated from the user's fingers as well. In each case, the cost of the test strips is effectively increased for that user. In addition, the use of a contaminated test strip may lead to incorrect results and adversely affect the health of the user.

BRIEF SUMMARY OF THE INVENTION

These and other limitations are overcome by embodiments of the invention, which relate to systems and methods for dispensing test strips, including test strips used to test or monitor analytes. Embodiments of the invention may include a dispensing member that is generally arranged over the test strips that may be stored in container or other storage compartment. The dispensing member can be permanently or semi-permanently connected with the container or other storage compartment to form a vial. Test strips can then be dispensed from the vial through the dispensing member. By way of example only, the dispensing member can be included in various embodiments, including vials, caps, inserts, and the like.

In one embodiment, a cap for dispensing test strips includes a body configured to detachably connect with a container. The body of the cap may include a dispensing member such as a slot through which test strips are dispensed. The cap may also include a guiding member having a shape to direct test strips to the slot, where they are dispensed at least one at a time.

In another embodiment, a cap for dispensing test strips includes a body configured to connect with a container such that the test strips inside of the container are enclosed inside. The body of the cap may include a dispensing member such as a diaphragm located in a recessed portion of the body. The diaphragm can have at least one slit formed from at least one cross cut. The body may also include a guiding member that guides or directs at least one of the test strips to the slit for dispensing the test strips through the slit formed in the diaphragm. As the slit in the diaphragm expands or separates to dispense the test strips, the diaphragm exerts an inward force to hold the test strips in a dispensing position. By holding the test strips in place, a user can easily grab a single test strip.

In another embodiment, the dispensing member of the cap may include both a slot and a diaphragm with cross cuts. The slot may control how many test strips are dispensed and the diaphragm may hold the test strips in place for the user. This may prevent the dispensed test strip from falling out. In this example, the slot may be sized to accommodate more than one test strip at a time. As a result, more than one test strip may be held in a dispensing position by the diaphragm.

The cap may also include a cover that can close and open to permit access to the dispensing member. The cover can therefore seal or close the dispensing member. Also, the cover may be connected to the body of the cap or may be separate from the cap.

These and other advantages and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of embodiments of the invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

Figure 1 illustrates a perspective view of one embodiment of a vial for storing test strips; Figure 2A illustrates a cross section of the vial illustrated in Figure 1;

Figures 2B-2C illustrated alternate configuration of a cap of the vial illustrated in Figure 1;

Figure 3 illustrates a top view of one embodiment of a cap that dispenses test strips in a controlled manner from a vial; Figure 4 illustrates a cross sectional view of a vial including a cap that dispenses test strips in a controlled manner;

Figure 5 illustrates one embodiment of a cap that is dispensing a single test strip from a vial; Figure 6 illustrates a perspective view of one embodiment of a cap that dispenses test strips in a controlled manner;

Figure 7 illustrates an exploded cross-sectional view of the cap illustrated in Figure 6; Figure 8 illustrates one embodiment of a cap that is dispensing a test strip;

Figure 9A and 9B illustrates one embodiment of a vial that includes a removable and/or replaceable insert for dispensing test strips;

Figure 10 illustrates additional aspects of the insert illustrated in Figure 9 including a friction fit with a container; Figure 11 illustrates a perspective view of an insert that includes gripping portions to facilitate removal of the insert from a container; and

Figure 12 illustrates a side view of an insert with an inset dispensing member.

DETAILED DESCRIPTION

Embodiments of the invention relate to systems and methods for dispensing test strips, including test strips used in testing analytes. More specifically, embodiments of the invention relate to a cap that dispenses test strips in a controlled manner, for example, dispensing the test strips one test strip at a time. An illustrative vial may include a container and a dispensing member that is configured to facilitate dispensing of test strips.

This illustrative vial includes a container that is configured to store a number of test strips, which may be loosely stored inside the container. The dispensing member, by way of example and not limitation, can be integrated with the container or vial, included in a cap for the container, as included in a replaceable insert and the like.

In addition, the container, dispensing member, cap, or insert can be of any shape and size, transparent, opaque, translucent, or colored. In additional embodiments, the container can also be adapted to be attached to a meter or can be integrated with a meter.

In one configuration, the cap includes a slot that is shaped and sized to cooperate with a guiding member to dispense test strips from within the container. As discussed in more detail below, the configuration of the slot can depend on at least the characteristics of the cap. As a result, the configuration of the cap can vary. For example, the cap can be configured to dispense test strips one at a time, or in a manner that allows a single test strip to be handled even though more than one test strip may pass through the slot or partially pass through the slot.

The cap dispenses test strips using, by way of example only, a guiding member and a slot. The cap dispenses test strips in a controlled manner. When the cap is associated with the container, a portion of the cap can be disposed inside of the container when the vial is assembled. This portion of the cap may include a guiding member that, when the cap is connected to the container, guides the test strips to the slot. In one embodiment, the cap and the container are a unitary integrated structure, which may be form molded.

When a user needs a strip, the user can open the vial's cover to expose the slot. In one example, the user can turn the vial over and gently shake the vial. During this process, the guiding member cooperates with the slot to dispense at least one test strip. This allows the user to easily handle a particular test strip. When the vial is turned over again, the cover can be replaced, thereby storing the remaining test strips within the vial's container. Alternatively, the cap and the guiding member can cooperate in a twisting manner to open or close the vial and/or the slot. Thus, the body of the cap and the guiding member may be rotationally coupled or coupled such that the body of the cap can move relative to the guiding member. In a first position, the cap and guide member may block the slot. Rotating or moving the cap and/or the guiding member to a second position opens the slot to permit test strips to be dispensed.

In another configuration, the cap can be configured as an insert that can be repeatedly used with different containers. This insert can be removed from one container and inserted into another container. The insert in this configuration can include a dispensing member (e.g., a slot, a diaphragm, a guiding member or any combination thereof) that is formed to control how test strips are dispensed and may also be formed to fit at least partially within the container. Further, the insert may not interfere with an existing cover or lid that seals or closes the vial. This allows the insert to be used with multiple containers without affecting the opening and closing of the covers of those vials. The insert may also be configured to open and close the vial without a cover.

Figure 1 illustrates one embodiment of vial 100 that can store and controllably deliver test strips 150. The vial 100 can include a container 102 that receives a cap 104. The container 102 may hold or store any desired number of test strips 150. The cap 104 is configured for dispensing the test strips 150 in a controlled manner, for example, one at a time. The test strips 150 located inside the container 102 can be loosely packed and are not usually constrained inside the container 102. As a result, the cap 104 can dispense the test strips 150 in a controlled manner without having to control how the test strips are arranged inside of the container 102. The container 102, as illustrated in Figure 2A (Figures 2A-2C may be referred to collectively as Figure 2), in this example, has a generally cylindrical configuration with a base 106 and a wall 108 extending from the base 106. The wall 108 terminates at a top edge 110 or rim spaced apart from the base 106. As such, the container 102 has a circular cross-section. It will be understood, however, that the container 102 may have any cross- sectional configuration, including, but not limited to, rectangular, square, polygonal, oval, curved, combinations thereof, or any other configuration that would allow storage of test strips and may cooperate with a cap that controls the dispensing of the test strips as contemplated by the invention described herein. Further, the container 102 is an example of a storage reservoir, storage compartment, or vessel that can hold or store items including test strips. The vial 100 may also include a moisture control element so that the test strips remain at a certain humidity.

As illustrated in Figure 2A, the top end 110 may be configured to detachably connect with the cap 104. Figure 2A, for example, illustrates that the top edge 110 may fit within a corresponding groove 126 formed in the cap 104 so that the cap 104 may frictionally engage with the top edge 110. The cap 104 may then be removed from the container 102 by including, but not limited to, prying, twisting, popping, levering, screwing, turning, rotating or otherwise overcoming the engagement between the cap 104 and the container 102. The cap 104 can be removed and replaced on the container 102 repeatedly or used with other containers. In other configurations, the cap 104 and the container 102 can be frictionally or mechanically connected together through complementary structures. In another configuration, a portion of the cap 104 and the container 102 can have complementary threaded portions that engage through rotational motion to releasably connect the cap 104 and the container 102. In still another configuration, the cap 104 and/or the container 102 can be releasably connected through detents and cooperative receiving apertures or structures.

In an alternative embodiment, the cap 104 may be permanently affixed to the container 102 or may be formed as a unitary structure. The container 102 and the cap 104 may be blow molded, for example, leaving the base open. After filling the container 102 with test strips through the open base, the open base of the container 102 can then be closed with a base cap 106b. The base cap 106b can be permanently or semi-permanently connected to the walls 108 of the container 102. The base cap 106b can be attached, by way of example only and not limitation, thermal bonding, laser bonding, adhesives, or chemical bonding and the like. The test strips can then be dispensed through the slot 118. With continued reference to Figure 2A, the cap 104 has a stepped upper surface 112 having a raised peripheral portion 114 and an indentation or recessed portion 116. A slot 118 extends from the stepped upper surface 112 through the body of the cap 104 to the lower surface 120. This lower surface 120 includes a guiding member 122 that directs the strips 150 in a controlled manner to the slot 118, as will be discussed in more detail hereinafter. Disposed about and spaced apart from a portion of the guiding member 122 is a lip 124. Disposed between the guiding member 122 and the lip 124 is the groove 126 configured to receive the top edge 110 of the container 102 and selectively retain the cap 104 to the container 102. As illustrated, the guiding member 122 partially forms the groove 126, however, in other configurations, this need not be the case and the groove 126 may be spaced apart from the guiding member 122.

As mentioned above, the body of the cap 104 may include the slot 118 disposed in the recessed portion 116 of the cap 104. The slot 118 may be shaped to dispense the test strips 150 in a controlled manner. The slot 118 can be shaped to permit the passage of a single test strip at a time or to permit more than one test strip to be dispensed at a time. The cap 104 controls how the test strips 150 are dispensed and a user can obtain a test strip without removing the cap 104 and without having to handle or touch other test strips within the container 102. Further, a user can invert the vial 100 without having the test strips 150 fall out of the vial 100 in a group. The cap 104 may also further include a lid or cover 130, illustrated by dotted lines, which is configured to seal or close the cap 104 to keep the test strips 150 inside the container 102 until needed. The cover 130 can be part of or separate from the cap 104. As illustrated, the cover 130 includes a body portion 132 having tether member 134 extending from the body portion 132 to the main body of the cap 104 which connects the cover 130 to the remainder of the cap 104. Extending from the body portion 132 is a protrusion 136 that cooperates with the recess 116 to close and/or seal the cap 104. The protrusion 136 may friction fit with the recess 116 so that the slot 118 is kept closed until expressly opened. A tab or extension 138 on the cover 130 can facilitate removing the cover 130 in order to access the slot 118 and dispense one of the test strips 150. Alternatively, the cover 130 may fit over the cap 104, as illustrated by cover 230 in dotted line in Figure 2B. The cover 130 can be twisted, popped, turned, rotated, pried, leveraged, or otherwise removed from the container or the guide member or other lid/cover. The container described herein can refer to the vial, housing, an integrated device, storage compartment, and the like. With continued reference to Figure 2 A, the illustrative cap 104 includes a guiding member 122. The guiding member 122, when the cap 104 is secured to the container 102, may be disposed inside the container 102. The guiding member 122 guides one or more of the test strips 150 to the slot 118, where the test strips are dispensed through the slot 118 in a controlled manner. The guiding member 122 can control the number of test strips that approach the slot 118 when being dispensed.

As illustrated, the guiding member 122 can have a guiding surface 128 to direct the test strips to the slot 118. In this embodiment, the guiding surface 128 of the guiding member 122 slopes from the base 140 of the cap 104 to the slot 118. In other words, the guiding surface 128 slopes from an interior surface of the container 102 to the edges or lower portion of the slot 118 at a junction 146. The guiding surface 128 can be smooth to allow the test strips to slide easily towards the slot 118. In one example, the guiding surface 128 forms a funnel-like structure 144 having a cross sectional area that decreases towards the slot 118 and so guides the test strips 150 to the slot 118 in a controlled manner. The guiding funnel 144 formed by the guiding member 122 terminates at edges 142 or sides of the slot 118. Stated another way, the guide surface or the funnel-like structure may have a frustoconical configuration, which terminates at the edges or sides of the slot 118, with the sides of the funnel-like structure being convex (Figure 2B), planar (Figure 2C), combinations thereof, or other configurations to aid guide the test strips to the slot. In this manner, the guiding surface 128 may gradually constrict or reduce the area that the test strips 150 may occupy thereby reducing the number of test strips that can be dispensed through the slot 118 of the cap 104. This limits the number of test strips 150 that are able to reach the slot 118. In one example, the guiding surface 128 of the guiding member reduces the area such that only a single test strip may pass through the slot 118 at a time. In an alternative embodiment, the slot 118 is sized such that a few, such as between 1 and 3, test strips can pass through the slot 118 at the same time. In an alternative embodiment, more than one test strip may pass through the slot 118 at a time.

Figure 3 illustrates a top view of one embodiment of the cap 104. The cap 104 can be formed as an integral member and may be molded, for example from any suitable material including a polymer or plastic. The plastic used in the cap 104 may be different from the material use to form the container 102. Other materials used in either the cap 104 and/or the container 102 can include, but are not limited to, polymers and other plastics, polyethylene terephthalate, polyethylene, polyvinyl chloride, polypropylene, polystyrene, metals, alloys, and the like or any combination thereof. In some instances, the material of the container 102 and/or the cap 104 may be coated to provide strength and durability to the vial or to provide other characteristics to the surface, such as smoothness or slickness. Surfaces of the cap and/or the container may be coated, by way of example only and not limitation, with Teflon or other material that may provide a smooth or slick surface that may assist in dispensing test strips. For example, coating the guiding surface 128 can provide a surface that allows the test strips to be guided more easily to the slot 118 and slide on the surface 128.

Figure 3 illustrates an example of the slot 118 formed in a center portion 130 of the cap 104. The slot 118 could alternatively be placed at other locations on the cap 104, including off-center. In this example, the slot 118 has an oval shape that is sized to accommodate at least one test strip. Dimension D₁ of the slot 118 can be less than the sum of dimension S₁ of two test strips and dimension D₂ of the slot 118 is less that the sum of dimension S₂ of two test strips. This allows a single test strip to pass through at a time. In one example, the dimensions D₁ and D₂ are larger than the corresponding dimension S₁ and S₂ of a test strip such that a test strip can pass through the slot freely, while two test strips cannot pass through at the same time. Optionally, and as illustrated in Figures 2B and 2C, the edges 142 of the slot 118 on the stepped upper surface 112, illustrated in Figure 2B, and/or the edges 146 of the slot 118 on the lower surface 120 may be rounded to assist in dispensing a test strip. As such, the dimension D₁ of the slot 118 can be about 0.1 mm to about 5 mm. The dimension D₂ of the slot 118 can range between about 2.0 mm to about 15.0 mm. These dimensions D₁ and D₂ of the slot 118 are provided by way of example and not limitation. The dimensions D₁ and D₂ can be smaller or larger. In one example, the slot 118 is sized and configured for a desired test strip. In one embodiment, the slot 118 may have a thickness that is less than a thickness of two test strips and a width that is less than a width of two test strips.

The slot 118 is an example of a dispensing member and can be placed in any portion of the cap 104. The slot 118 may be placed, for example, on a side of the cap 104. In this case, the vial or wall of the container can form at least a portion of the slot.

Figure 4 illustrates another embodiment of the cap, identified by reference numeral 104b. In this embodiment, the guiding surface 128b slopes to the lower surface 122b of the cap 104b. A transition portion 146b is present on the lower surface 122b between the edge 142b to the slot 118 and the guiding surface 128b in this example. The width of the transition portion 146b can vary in different embodiments. Further, the junction 148b between the guiding surface 128b and the transition portion 146b can form a corner between the guiding surface 128b and the transition portion 146b or a smooth transition from the guiding surface 128b to the transition portion 146b. In addition, the slope of the guiding surface 128b can vary. In addition, at least some of the components of the vial (e.g., the container, the cap, the slot, the guiding member, or any portion thereof) can be transparent, translucent, colored, and the like. This may enable a user to view the test strips inside the vial and help the user dispense test strips therefrom.

Figure 5 illustrates an embodiment of how a test strip may be dispensed from the vial 100 of Figure 1. In this example, the vial 100 is inverted and may be shaken by a user. The funnel-like structure 144 or the guiding member 122 guides the test strips 150 towards the slot 118. As previously indicated, the funnel-like shape 144 defined by the guiding member 122 effectively reduces the area available for the test strips 150, which allows some of the test strips 150 to move towards the slot 118. Because the slot 118 can be sized to permit a single test strip to exit the cap 104 of the vial 100, a single test strip may be dispensed. In this example, the test strip 150 extends out of the slot 118 and may be easily handled by a user. A user, for example, can shake a single test strip into his or her hand. Advantageously, the user is not required to remove the cap 104 and attempt to extract a single strip from among many strips. Further, the test strip 150 that is dispensed can be grasped without interference from other test strips stored in the vial 100.

The slot 118 illustrated in Figure 5 can be relatively firm and fixed. More specifically, the slot 118 does not change shape or deform when dispensing test strips. In one embodiment, the cap 104 may therefore be rigid when connected with the container 102, although it may not be inflexible. In this example, the cap 104 can dispense the test strips in a controlled manner by configuring the shape and size of the slot 118 and/or the slope and position of the guiding member 122 relative to the slot 118. Figure 6 illustrates another embodiment of a cap 204 for a vial 200. In this example, the cap 204 has a soft diaphragm 260 formed in a recessed portion 216 of the cap 204. The diaphragm 260 has a slit 218 that is formed by cross cuts 219a and 219b. The cross cuts 219a and 219b can be of different lengths. In another example, the slit 218 is formed from a single cross cut. Alternatively, the slit 218 may be formed from two, three, four, or more cross cuts.

The diaphragm 260 may a flexible material that permits one or more test strip to be dispensed. While the cap 104 includes a slit 118 that is relatively fixed, the slit 218 of the cap 204 has flexibility that can be controlled, in one example, by the length of the cross cuts 219a and 219b or by the material and its thickness used to form the diaphragm, or by a combination thereof. At the same time, the diaphragm 260 may be rigid enough to exert a force that allows one or more test strips to be dispensed while preventing the test strips from falling out of the vial 200.

In other words, the cap 204, and in particular the diaphragm 260, tends to grip the test strips as they exit the vial such that a user may grasp one of the test strips from those gripped or held in place in a dispensing position by the diaphragm 260 of the cap 204. The diaphragm 260 may returns to its original shape and form after being deformed. The diaphragm 260 may be formed of a suitable material, such as natural or synthetic rubber, silicon, or polymer, and the like or any combination thereof. Turning to Figure 7, illustrated is an exploded version of the cap 204. As shown, the cap 204 includes a first cap portion 262, a second cap portion 264, and the diaphragm 260. Generally, the first cap portion 262 receives the diaphragm 260 and the second cap portion 264, with the second cap portion 264 aiding to retain the diaphragm 260 within the first cap portion. The first cap portion 262 has a generally annular configuration have a generally planar upper portion 270. An aperture 272 extending from the upper portion 270 to a lower stepped portion 274 having a peripheral portion 276 and a recessed portion 278. The recessed portion 278 is configured to receive the diaphragm 260 within.

The recessed portion 278 is also configured to receive at least a portion of the second cap portion 264. The second cap portion 264 also includes a generally planar upper portion 280. An aperture 282 extending from the upper portion 280 to a lower guiding member 284, which can be similar to the other guiding members described herein including a guiding surface 284. The aperture 282 can have a similar configuration to the slots of described previously, including, but not limited to, slot 118 of Figures 2A-4.

In another configuration , the aperture 282 defined by the second cap portion 264 may have a generally annular shape, as indicated by the member 292. The member 292 thus defines an annular shaped opening beneath the diaphragm 260. The diameter of the opening 282 defined by the annular guiding member 292 may be greater than the length of the cross cuts in the slit 218. As a result, the guiding member 292 may allow more than one test strip to reach the slit 218. The slit 218 may control how the test strips are dispensed. Thus, the guiding member 292 may provide support for the diaphragm 260 to hold the diaphragm relative to the test strips.

In one example, several test strip may partially pass through the slit 218 and are then held in a dispensing position. A user may select a specific test strip from those that extend through the diaphragm 260 and the remaining test strips are returned to the container. In this example, the aperture 282 may provide access to the diaphragm 260, through which at least one test strip may be dispensed at a time. In this example, the second cap portion 264 provides a base portion on which the diaphragm 260 is placed. In this example, the diaphragm can be retained by adhesive bonding, thermal bonding, and the like. The base portion receives the diaphragm 260 and forms an aperture 282 that allows test strips to reach the slit 218 of the diaphragm. The diaphragm 260 can also be over molded on the second cap portion 264, in which case the first cap portion 262 may not be required to form the cap 204.

About a periphery of the second cap portion 264 is a stepped sidewall 286 that includes an upper sidewall portion 288 and a lower sidewall portion 290 separated by a transition or step 292. Upper sidewall portion 288 is configured to couple with the stepped lower portion 278 of first cap portion 262, while lower sidewall portion 290 may be configured to frictionally engage with an interior of the container 102 to retain the container 102 to the cap 204. The top edge 110 of the container 102 can engage with the transition or step 292 and/or a portion of the first cap portion 262 upon the cap 204 being formed from the diaphragm 260, the first cap portion 262, and the second cap portion 264. In this configuration, therefore, the outer diameter of upper sidewall portion 288 is greater than that of the lower sidewall portion 290. In other configurations, however, this need not be the case and upper sidewall portion 288 can have a smaller or equal diameter to that of the lower sidewall portion 290.

Figure 8 illustrates an example of a vial 200 with a cap 204 that dispenses test strips 150 in a controlled manner. In this example, the vial 200 has been inverted. The vial 200 in Figure 8 illustrates the strips 150, which may include one or more test strips 152, extending out of the cap 204. As the test strips 150 begin to pass through the slit 218, the diaphragm 260 deforms and exerts an inward force on the test strips 150. The diaphragm 260 thus holds the test strips 152 in place or in a dispensing position, allowing a user to grasp and withdraw a particular test strip. In this example, the diaphragm 260 may be assisted by the guiding member 284, which guides or directs the test strips 150 toward the slit 218 in the diaphragm 260. Alternatively, the guiding member 284 provides structure to support the diaphragm 260 and may define an aperture to provide access to the slit 218. As a result, embodiments of the guiding member can direct test strips to a slit or provide access to the slit while providing structural support to retain the diaphragm in a particular position. The aperture formed by the guiding member 284 is typically located adjacent to the inner surface of the container 102 and provide a support ledge to the diaphragm 260. Figure 8 illustrates that the diaphragm 206 controls how the test strips are dispensed.

In one example, the guiding member 284 may control the number of test strips

150 that are allowed to pass through the slit 218 of the cap 204. Alternatively, the opening defined by the structure 284 may allow multiple test strips access to the slit 218.

The elasticity of the slit 218 holds the test strips that at least partially pass through the slit

218 in a dispensing position and one of the exposed test strips may be selected.

After a test strip is selected by the user, the vial 200 may be inverted, causing the strips to fall back into the container 102. Alternatively, gently shaking the vial 200 may return the test strips into the container 102 from the dispensing position. As with the cap 104 (Figure 2A), a cover 130 may then be replaced to close or seal the vial 200.

As mentioned above, the aperture 282 of the second cap portion 264 can have a similar configuration to that of slot 118 of Figures 2A-4. Alternatively, the aperture 282 may be larger and define an annular shaped opening, although the aperture 282 can be configured to provide structure that supports the diaphragm and partially guides strips toward the slot. When combined with the slit 218 formed in diaphragm 260 multiple test strips may be able pass through the aperture 282 to the slit 218. In this alternate example, the guiding member 284, similar to the other guiding members described herein, may guide some of the test strips 150 towards the slit 218 or may provide structure to support the diaphragm 260 on the cap 204. The diaphragm 260 allows some of those test strips to pass through the slit 218. Test strips are then held by the diaphragm 260 and a user can easily grasp a single test strip.

In another embodiment, the aperture 282 may be sized to permit a single test strip to pass thorough it at a time. The diaphragm 260 then grips that single test strip such that it can be handled by a user. Thus, the slit 218 in the diaphragm 260 and/or the guiding member 284 may cooperate to dispense a single test strip. In this embodiment, the diaphragm may prevent the test strip from simply falling out into a user's hand, but allows the user to grasp the test strip instead. In one embodiment, the diaphragm 260 controls how the test strips are dispensed from the container while the guiding member can assist in dispensing the test strips or be enlarged to provide a ledge or support such that the diaphragm 260 is retained in the cap 204.

Figures 9A and 9B illustrate another embodiment of a vial 300 in a closed position and in an expanded view. In this example, the vial 300 includes a container 302 similar to the container 102 illustrated at least in Figure 1. The container 302 includes an additional layer 304 disposed on an interior surface of the container 302. The layer 304 may be formed of a desiccant plastic and is configured to absorb at least water to protect any test strips held, stored, or supported by the container 302 or to control the humidity of the test strips. The layer 304 may be located on any portion of the interior surface of the container 302. In this example, the layer 304 is disposed on the base and on the walls of the container 302. The layer 304 terminates inside the container 302 to form a shoulder 316 near a top end of the container 302. The shoulder 316 may alternatively be formed of polymer or may be thicker than the layer 304.

Figure 9A further illustrates an example of an insert 350 that can be used with one or more containers and that is inserted into a container. The insert 350 in this example is configured to be removable or changeable with other containers. Figure 9B, for example, illustrates an insert 350 that has been removed from the container 302 or that can be inserted into the container 302.

In this example of Figures 9A and 9B, the insert 350 cooperates with the container 302 to control how test strips are dispensed. The insert 350 may be configured to be disposed inside the container 302 such that the existing cover 312 that may be attached to the container 302 can be used to close the vial 300 and prevent test strips from exiting the container through the slot 356 inadvertently. Test strips can be stored in the container 302 with or without the presence of the insert 350. However, the insert 350 can control how the test strips are dispensed from the container 302.

The insert 350 can be configured to cooperate with the container 302 in multiple configurations. In this example, the top surface 318 of the insert 350 is flush with the rim or top end 310 of the container 302. Alternatively, the insert 350 may be inset with respect to the rim or top end 310. In either example, the cover 312 functions the same to close the container 302 whether or not the insert 350 is associated with the container 312. In the example of Figure 9A, the insert 350 is inserted into the container 302 such that the ridge 308 of the cover 312 engages with corresponding ridge 310 to close or seal the slot 356 in the insert 350 of the vial 300. Using the tab 358, the cover 312 can be opened to expose the slot 356 of the insert 350 and dispense a test strip. The guiding member 352 and guiding surface 354 can be similar to other embodiments disclosed herein.

In Figures 9A and 9B, the layer 304 is configured to present a shoulder 316. The shoulder 316 positions the insert 350 within the container 302 or controls the depth to which the insert 350 may be inserted in the container 302. In this example, the insert 350 is positioned such that the cover 312 can seal or close the container 302. In Figure 9A, the insert 350 is separate from the cover 312 can be used with more than one container. In other words, the insert 350 is removable such that it can be removed from the container 302 as illustrated in Figure 9B and placed in another container. At the same time, the insert 350 can be properly positioned within each separate container, for example by using the shoulder 316 to control how far the insert 350 is inserted inside the container 302. Further, the shoulder 316 may be positioned to prevent the insert 350 from damaging the test strips during insertion of the insert 350 into a container.

Figure 9A also illustrates a grip portion 372 that is formed, in this example, in the guiding member 352. The grip portion 372 can be grasped by a user when removing the insert 350 from the container 302. Alternatively the tool 370, which has an extraction member 376 on one end, may be used to remove the insert 350. The extraction member 376 can be inserted into the container 302 through the slot 356. The extraction member 376 has dimensions that allow it to be inserted and removed from the slot 256 when in a particular orientation. When the tool is turned, the extraction member 376 cooperates with the bottom surface of the insert 350 to pull the insert 350 out of the container 302. The insert 350 can then be pushed or inserted into another container. In this example, the grip portion 372 may include a ledge 374 that allows a user to use the tool 370 as a lever to pry the insert 350 out of the container. Figure 11, by way of example, is a perspective view of the grip portion 372 that can be used to extract the insert 350 from the container 302.

Figure 10 illustrates additional aspects of the insert 350 and/or container 302. The insert 350 also includes a diaphragm 362 disposed on the upper surface 318 of the guiding member 352. In this example, the container 302 includes a shoulder 316b that is formed as a ledge on an interior surface of the container 302. The shoulder 316b may provide a stop to prevent the insert 350 from being inserted too far inside the container 302 or to properly position the insert 350 inside the container 302 or to prevent inadvertent damage to any test strips stored therein. The shoulder 316b may also control the distance between the aperture 320 and a cover (such as the cover 312) or between the top surface 318 of the insert 350 and a top end 310 of the container 302. When inserted in a container, the insert 350 may be flush with the top end of the container 302 such that the cover can be closed as illustrated in Figure 9. Alternatively, the top surface 318 insert 350 may be below the level of the top end 310 of the container 302. In this example the insert 350 further includes a retention member 360 disposed on or around at least a portion of a periphery surface of the guiding member 352. The retention member 360 may be integrated with the diaphragm 362 or be separate from the diaphragm 362. The retention member 360 is typically formed of rubber, silicone, or other suitable material that can grip the inner surface of the container 302 and prevent the insert 350 from becoming inadvertently dislodged from its dispensing position. Gripping the inner surface of the container 302 or creating a friction fit between the insert 350 and the container 302 ensures that the insert 350 does not fall out of the container 302, but is held in position until specifically removed from the container 302. The retention member 360 may have a smooth surface, a textured surface, a ridged surface, or any other configuration that allows the retention member 360 to grip the inner surface of the container 302 or to be held in place relative to the container 302. The retention member 360 may also be serrated, have different thicknesses at different locations, and the like or any combination thereof. The retention member 360 may be disposed on the periphery surface of the insert 350 that is adjacent the interior surface of the container 302 when associated with the container 302. Alternatively, the retention member 360 may be disposed on a portion of the periphery surface. Thus, the retention member 360 may be continuous on the periphery surface or in distinct non-continuous segments. In another example, the periphery of the insert may include a recessed portion configured to receive the retention member 360.

In addition, the retention member 360 may be formed of a compressible material that enables the insert 350 to account for containers that have different dimensions. As the dimensions (e.g., diameter, circumference, perimeter) of the container may change from one container to the next, the retention member 360 may allow the insert 350 to be used with multiple containers.

Figure 12 illustrates additional aspects of the insert 350b, which includes grip portions 372. In this example, the guiding member 352b includes a ledge 378 that provides support for the diaphragm 362. The diaphragm 362 may be connected to the ledge 278 via adhesive bonding, thermal bonding, and the like. The aperture 380 formed by the guiding member 352b provides access to the cross cuts or slot in the diaphragm 362, which dispenses test strips similarly to other embodiments of the diaphragm described previously. The grip portions 372 allow a user to remove the insert 350b from a container using a tool such as the tool 370 or with his or her fingers. In this embodiment the top surface of the diaphragm 362 may be substantially flush with the surface 318. The shape of the aperture 380 defined by the guiding member 352b, by way of example only and not limitation, can be annular, partially conical, and the like or any other shape identified herein.

As described herein, the dispensing member can be formed as a slot, a slot and a guiding member, a diaphragm with a slit, and the like and combinations thereof. Additional embodiments of the dispensing member include bristles arranged over the aperture formed by the guiding member. The bristles can be arranged in adjacent rows connected to opposite sides of the insert or cap. The bristles extend over the aperture of the guiding member and may overlap or touch in the middle. The bristles have flexibility such that the junction between the rows of bristles allows one or more test strips to pass through the junction. The bristles typically have sufficient stiffness to exert a force on the test strips that pass partially through the junction to hold the test strips in the dispensing position such that a user may grasp a particular test strip, the remaining test strips are then returned to the container. Alternatively, the bristles can be arranged in an annular configuration such that the ends of the bristles meet in a center portion of the aperture.

The method for dispensing test strips can be similar for various embodiments of the vial's caps. The vial may be inverted and then shaken. A user can then handle a test strip that is dispensed through the slot of the cap. In some embodiments, the cap can be removed and the vial can be refilled with additional test strips at any time. Alternatively, the vial can be disposable when empty.

Inverting the vial moves a plurality of test strips toward a slot formed in a portion of a cap of the vial. The guiding member then guides or directs the plurality of test strips towards the slot and may reduce the number of test strips that approach the slot. Then, the slot dispenses at least one test strip. Generally, the vial, and the cap, can be fabricated from various materials that are compatible with dispensing test strips for testing analytes. For instance, medical grade polymers and plastic are applicable. In addition, the materials can include polymers such as, by way of example only, polyethylene terephthalate, polyethylene, polyvinyl chloride, polypropylene, polystyrene, metals, alloys, and the like or any combination thereof. The diaphragm can be fabricated from various materials including, but not limited to, silicone, natural and synthetic rubbers, and the like or any combination thereof. Reference has been made to mechanical or frictional engagement of cap to container and of cap portions to one another and/or to the diaphragm. It will be understood by those skilled in the art that sonic welding, thermal welding, adhesives, can be used to releasably, permanently, or semi-permanently join or attach one or more of the elements or portions of the vials, caps, diaphragms, and/or inserts together. In addition, the ability of a cover or cap to seal a vial can use various forms to join or attach elements of portions of the vials.

Embodiments of the invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. Embodiments of the invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMSWhat is claimed is:

1. An insert for dispensing test strips from a container, the insert comprising: a body configured to be removable from an associated container; a dispensing member formed in a center portion of the body; and a guiding member extending from the body and defining an aperture between the dispensing member and the test strips, wherein test strips are dispensed through the dispensing member at least one at a time.

2. The insert recited in claim 1, further comprising a retention member formed on at least a portion of a periphery surface of the body, wherein the retention member holds the body in a particular position when inserted into the container.

3. The insert recited in claim 1, wherein the dispensing member further comprises a diaphragm supported by the guiding member, the diaphragm having a slit that includes one or more cross cuts.

4. The insert recited in claim 3, wherein the diaphragm and the retention member are integrated.

5. The insert recited in claim 3, wherein the retention member has a textured surface to grip an inner surface of the container and wherein the guiding member comprises a guiding surface that directs some of the test strips toward the slit.

6. The insert recited in claim 1, wherein the dispensing member exerts an inward force on the test strips to hold test strips that partially pass through the dispensing member in a dispensing position.

7. The insert recited in claim 6, wherein the dispensing member flexes to hold the test strips in the dispensing position when dispensing the at least one test strip.

8. The insert recited in claim 1, wherein the body comprises at least one grip portion configured for extracting the insert from the associated container.

9. The insert recited in claim 3, wherein the guiding member comprising a recess configured to receive the diaphragm, wherein the diaphragm attaches to a ledge formed in the recess such that the a surface of the diaphragm is substantially flush with a top surface of the body.

10. The insert recited in claim 1, wherein the dispensing member comprises s slot formed in a center portion of the body and wherein the guiding member comprises a guiding surface that directs test strips toward the slot.

11. The insert recited in claim 1, wherein the slot is dimensioned and configured to dispense a single test strip at a time.

12. The cap recited in claim 11, wherein the slot has a width less than a width of two test strips and a thickness less than a thickness of two test strips.

13. A cap for dispensing test strips from a vial, the cap comprising: a body associated with a container, the body comprising: a dispensing member associated with the body portion, the dispensing member passes a portion of the test strips partially through the dispensing member to a dispensing position, wherein a particular test strip is selected; and a guiding member that supports the dispensing member in the container, wherein particular test strip is dispensed through the dispensing member.

14. The cap recited in claim 13, wherein the dispensing member comprises a diaphragm having a slit formed from at least one cross cut.

15. The cap recited in claim 14, wherein the guiding member forms an aperture between the dispensing member and the test strips, wherein the aperture is wider than the at least one cross cut.

16. The cap recited in claim 14, wherein the at least one cross cut exerts an inward force on a test strip that is being dispensed through the dispensing member.

17. The cap recited in claim 13, further comprising a cover connected with the body portion, wherein the cover comprises a member that operatively cooperates with the cap to close the dispensing member.

18. The cap recited in claim 13, wherein the guiding member comprises a guiding surface that slopes from an inner surface of the container to the dispensing member to gradually reduce a cross sectional area of a region defined by the guiding member.

19. The cap recited in claim 13, wherein the body is integrated with the container.

20. A vial for dispensing test strips in a controlled manner, the vial comprising: a container for holding test strips, the container having an inner surface; and a removable insert configured to dispense the test strips from the container in a controlled manner, the insert comprising: a dispensing member configured in a center portion of the insert, the dispensing member configured to hold some of the test strips in a dispensing position such that a particular test strip is dispensed through the dispensing member.

21. The vial as recited in claim 20, wherein the dispensing member comprises a slot that is dimensioned and configured to a single desired test strip and the removable insert further comprises a guiding member that defines a funnel-shaped region inside the container, the guiding member having a guiding surface that guides at least one test strip to the slot.

22. The vial as recited in claim 21, wherein the guiding surface slopes from an inner surface of the container to a bottom surface of the center portion and wherein the guiding surface is coated with a material to increase a slickness of the guiding surface.

23. The vial as recited in claim 20, wherein the dispensing member comprises a diaphragm, the diaphragm having a slit formed from at least one cross cut arranged over the slot, wherein the exerts an inward force on the test strips that pass partially through the slit when the particular test strip is dispensed.

24. The vial as recited in claim 20, wherein the dispensing member comprises a plurality of bristles arranged over a guiding member, the bristles arranged to form a junction that allows some of the test strips to at least partially pass through the bristles to hold the test strips in the dispensing position.

25. A method for dispensing test strips from a vial, the method comprising: inverting the vial to move at least one test strip toward a dispensing member formed in a portion of a cap of the vial; guiding the at least one test strip with a guiding member, the guiding member reducing a number of strips that approach the dispensing member; and dispensing at least one of the test strips through the slot.

26. The method of claim 25, further comprising loading the vial with the plurality of test strips and associating the cap with a container to form the vial.

27. The method of claim 25, further comprising the guiding member holding the at least one test strips in a dispensing position while dispensing at least one of the test strips.