Patent Application
20130143246
1. Field of the Invention
The present invention relates, in general, to medical devices and, in particular, to test meters and related methods.
2. Description of Related Art
The determination (e.g., detection and/or concentration measurement) of an analyte in a fluid sample is of particular interest in the medical field. For example, it can be desirable to determine glucose, ketone bodies, cholesterol, lipoproteins, triglycerides, acetaminophen and/or HbA1c concentrations in a sample of a bodily fluid such as urine, blood, plasma or interstitial fluid. Such determinations can be achieved using a hand-held test meter in combination with analytical test strips (e.g., electrochemical-based analytical test strips).
During use, a single analytical test strip is typically inserted into a hand-held test meter. Following determination of an analyte in a bodily fluid sample applied to the analytical test strip, it is conventional for the analytical test strip to be manually removed from the hand-held test meter by a user and discarded. Conventional approaches to inserting and removing a test strip from a hand-held test meter are described in, for example, U.S. Pat. Nos. 5,266,179; 5,366,609; and 5,738,244; and U.S. Patent Application Number 2009/0108013, each of which is hereby incorporated in full by reference.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings, in which like numerals indicate like elements, of which:
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict exemplary embodiments for the purpose of explanation only and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.
In general, hand-held test meters for use with an analytical test strip in the determination of an analyte (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) according to embodiments of the present invention include a housing (with an outer surface) and an analytical test strip ejection mechanism. The analytical test strip ejection mechanism has an actuation button disposed in the outer surface of the housing, a motion amplification and rotation assembly operatively connected to the actuation button, and a test strip slider operatively connected to the motion amplification and rotation assembly. The actuation button is configured for movement by a user's digit in a first direction and the motion rotation and amplification assembly and test strip slider are configured to convert the movement in the first direction into an amplified (i.e., greater movement) of the test strip slider in a second direction with the second direction being rotated with respect to the first direction. In addition, the test strip slider is further configured for operative engagement with an analytical test strip inserted into the hand-held test meter in an engaged state such that movement of the test strip slider in the second direction from the engaged state to an ejected state ejects the analytical test strip from the hand-held test meter.
Such hand-held test meters are particularly beneficial in that a user is able to eject and, therefore, discard a used analytical test strip without directly contacting the analytical test strip. This reduces the risk of user exposure to blood-born pathogens or other contaminants that may be present on the surface of the used analytical test strip. Since the distance of movement of the actuation button is amplified (i.e., increased by, for example, a factor of two) by the motion amplification and rotation mechanism, movement of the actuation button a relatively small distance suffices to move the test strip slider a greater distance sufficient to eject the analytical test strip. This eases operation of the hand-held test meter for a user. In addition, since the ejection of the analytical test strip is mechanically controlled by a user's initiation of the actuation button, the user can beneficially determine the timing, force and speed of analytical test strip ejection.
Referring to
A test strip ejection mechanism 104 includes an actuation button 108 disposed in the outer surface of housing 102 (see
Actuation button 108 is configured for movement by a user's digit (i.e., a user's finger or thumb) in a first direction (see arrow B of
Motion amplification and rotation assembly 110 (numbered only generally in
Motion rotation and amplification assembly 110 and test strip slider 112 (e.g., a plastic slider) are configured to mechanically convert movement of actuation button 108 in the first direction (for example, the direction of arrow B in
In the embodiment of hand-held test meter 100, motion rotation and amplification assembly 110 includes a lever, a lever pin, a cam, a cam pin and returning springs. However, once apprised of the present disclosure, one skilled in the art could devise other equivalent mechanical configurations that serve the same purpose of converting movement of an actuation button in one direction into greater movement of a test strip slider in a second direction.
In the embodiment of
Test strip slider 112 further configured for operative engagement with an analytical test strip (TS) inserted into strip port connector 106 of hand-held test meter 100 in an engaged state such that movement of the test strip slider in the second direction from the engaged state to an ejected state ejects the analytical test strip from the hand-held test meter. Such an engaged state is depicted in
Test strip slider 112 moves along ejection mechanism frame 128 and encounters a hard stop against the ejection mechanism frame when in the ejected state. Upon release of actuation button 108 by a user, test strip slider 112 is returned to the engaged state by a helical spring (not shown) that acts between the test strip slider and the ejection mechanism frame. To optimize the force of this helical spring, lever 118 and, therefore, actuation button 108 are acted on by lever returning springs 126a and 126b.
Strip port connector 106 is configured to operatively receive an analytical test strip and, in the embodiment of
The components of hand-held test meter 100 described herein can be formed of any suitable materials known to one skilled in the art. For example, actuation button 108, lever 118, cam 122, ejection mechanism frame 128 and test strip slider 122 can be formed of a suitable plastic material and lever pin 120, cam pin 124, button support plate 116, and lever returning springs 126a and 126 be can be formed of a suitable stainless steel. In addition, membrane 114 can be formed of a suitable rubber material.
At step 620, movement of the actuation button in the first direction is converted into amplified movement of the test strip slider in a second direction via action of the test strip ejection mechanism. Method 600 also includes ejecting the analytical test strip from the hand-held test meter as a consequence of the amplified movement of the test strip slider in the second direction to an ejected state (see step 630).
Once apprised of the present disclosure, one skilled in the art will recognize that method 600 can be readily modified to incorporate any of the techniques, benefits and characteristics of test strip ejection mechanisms and hand-held test meters according to embodiments of the present invention and described herein.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. 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 the following claims define the scope of the invention and that devices and methods within the scope of these claims and their equivalents be covered thereby.
