Patent Application
20120116436
The present disclosures relate generally to lancets, and particularly to lancets retained with lancing devices, and to methods of loading, manufacturing, and utilization thereof.
The use of lancing devices in the determination of biological analyte concentration is of widespread importance, particularly to persons afflicted with type one diabetes. In regulating their disease, such diabetic patients may be required to perform an average of five to ten blood glucose tests per day via a process of self-monitoring to determine their blood glucose levels. As the number of patients suffering from diabetes increases, the practice of self-monitoring blood glucose levels has become routine. The process of self-monitoring typically involves diabetic patients obtaining a test strip, obtaining a sample of blood with a lancing device and applying the sample thereto, inserting the test strip into a blood glucose meter, and obtaining results by measuring the concentration of analytes.
During the process of self-monitoring, the risk of diabetic patients accidentally puncturing their skin with a lancing device is significant. This risk arises from both the limited physical dexterity of many diabetic patients and also from the design of lancing devices. While some attempts have been made to design lancing devices which provide protection to diabetic patients from accidental puncturing, these designs possess a variety of disadvantages. Generally, the designs require a diabetic patient to remove a safety cap from a lancet when loading the lancet into a lancing device by twisting the safety cap off of the lancet, thereby exposing the diabetic patient to the sharpened tip of a needle. Moreover, when replacing a used lancet in a lancing device, these designs further require a diabetic patient to remove the safety cap from a new lancet and place it on the used lancet, thereby exposing the diabetic patient to the sharpened tips of both the new and used needles.
In one embodiment, a lancet comprising a needle having a sharpened tip and a base remote from the sharpened tip, a body attached to the base of the needle, a pair of arm members attached to the body, and a tip cover attached to the pair of arm members and slidably attached to the needle is disclosed. In this embodiment, the tip cover forms an aperture which accommodates the sharpened tip of the needle, and wherein at least one of the tip cover and the body is selectively moveable between an operative configuration and a protective configuration. In the operative configuration, the at least one of the tip cover and the body is displaced such that the sharpened tip of the needle is exposed. In the protective configuration, the sharpened tip of the needle is concealed by the tip cover.
In another embodiment, a lancing device is disclosed of which may comprise a removable lancet and a lancet holder having retaining surfaces such that the removable lancet is retained with the lancet holder. The removable lancet may comprise a needle having a sharpened tip and a base remote from the sharpened tip, a body attached to the base of the needle, a pair of arm members attached to the body, and a tip cover attached to the pair of arm members and slidably attached to the needle, wherein the tip cover forms an aperture which accommodates the sharpened tip of the needle, and wherein at least one of the tip cover and the body is selectively moveable between an operative configuration and a protective configuration. In the operative configuration, the at least one of the tip cover and the body is displaced such that the sharpened tip of the needle is exposed. In the protective configuration, the sharpened tip of the needle is concealed by the tip cover.
In yet another embodiment, a method of providing selective exposure to and concealment of a sharpened tip of a needle which comprises utilizing the lancet according to the present invention is disclosed.
In yet still another embodiment, a method of loading a lancet into a lancing device having a lancet holder is disclosed. The method may comprise providing the lancet in a protective configuration and inserting the lancet into the lancet holder of the lancing device. The lancet may comprise a needle having a sharpened tip and a base remote from the sharpened tip, a body attached to the base of the needle, a pair of arm members attached to the body, and a tip cover attached to the pair of arm members and slidably attached to the needle. At least one of the tip cover and the body is selectively moveable between an operative configuration and the protective configuration, such that when in the operative configuration the at least one of the tip cover and the body is displaced such that the sharpened tip of the needle is exposed, and when in the protective configuration the sharpened tip is concealed by the tip cover.
In another embodiment, a method of manufacturing a lancet is disclosed, of which may comprise providing a needle having a sharpened tip and a base remote from the sharpened tip, providing a body attached to the base of the needle, providing a pair of arm members attached to the body, and providing a tip cover attached to the pair of arm members and slidably attached to the needle. The tip cover may form an aperture which accommodates the sharpened tip of the needle and at least one of the tip cover and the body may be selectively moveable between an operative configuration and a protective configuration. In the operative configuration, the sharpened tip of the needle may be exposed. In the protective configuration, the sharpened tip of the needle may be concealed by the tip cover.
These and other features and advantages of these and other various embodiments according to the present invention will become more apparent in view of the drawings, detailed description, and claims provided that follow hereafter.
The following detailed description of the embodiments of the present invention can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals, and in which:
Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements, as well as conventional parts removed, to help to improve understanding of the various embodiments of the present invention.
Referring to
In one embodiment, the body 40 may comprise a substantially rectangular shape as depicted by
In another embodiment, the body 40 is attached to the base 24 of the needle 20. In one particular embodiment, the body 40 is attached to the base 24 of the needle 20 via insert molding. In this embodiment, the body 40 may be molded around the base 24 of the needle 20. In another embodiment, as shown in
In one embodiment, the arm members 60, 60′ are dynamically attached to the body 40, such that they may flex outwardly in a direction substantially normal to the needle axis. In a further embodiment, as best shown in
In one embodiment, the arm members 60, 60′ may flex outwardly such that the tip cover 80 translates in a direction substantially toward the body 40, exposing the sharpened tip 22 of the needle 20. In this particular embodiment, the arm members 60, 60′ may flex outwardly upon loading the lancet 1 into a lancing device (discussed below), such that the sharpened tip 22 of the needle 20 is exposed. In another embodiment, the arm members 60, 60′ may straighten from an outwardly-flexing position, such that the tip cover 80 translates in a direction substantially away from the body 40, concealing the sharpened tip 22 of the needle 20. In this particular embodiment, the arm members 60, 60′ may straighten from an outwardly-flexing position upon removing the lancet 1 from a lancing device (discussed below), such that the sharpened tip 22 of the needle 20 is concealed.
In a further embodiment, the arm members 60, 60′ may comprise plastics, polymers, rubbers, metals, composites and/or alloys. The arm members 60, 60′ may comprise a material that is different from the material of the body 40. For example, in one particular embodiment, the arm members 60, 60′ may comprise a silicone rubber overmold. In another embodiment, the arm members 60, 60′ may comprise a material that is the same as the material of the body 40. For example, in one embodiment, the arm members 60, 60′ may comprise polypropylene and/or polyethylene. However, the arm members 60, 60′ should not be limited to the materials disclosed herein, but may comprise any material wherein the arm members 60, 60′ may be dynamically or statically attached to the body 40 as described above.
In another embodiment, as shown in
In a further embodiment, the tip cover 80 forms an aperture 82 which accommodates the sharpened tip 22 of the needle 20. In one particular embodiment, the cross-sectional shapes of the aperture 82 and the needle 20 are substantially circular. However, the cross-sectional shapes of the aperture 82 and the needle 20 should not be limited to substantially circular, but may comprise any cross-sectional shape wherein the tip cover 80 is slidably attached to the needle 20 and accommodates the sharpened tip 22 of the needle 20 through the aperture 82. In a further embodiment, the tip cover 80 is slidably attached to the needle 20 via a frictional fit.
In one embodiment, the tip cover 80 may comprise plastics, polymers, rubbers, metals, composites and/or alloys. The tip cover 80 may comprise a material that is different from the material of the body 40. For example, in one particular embodiment, the tip cover 80 may comprise polypropylene and/or polyethylene. However, the tip cover 80 should not be limited to the materials disclosed herein, but may comprise any material wherein the tip cover 80 may be attached to the pair of arm members 60, 60′, may be slidably attached to the needle 20, and may accommodate the sharpened tip 22 of the needle 20.
In another embodiment, as shown in
In one embodiment, the stopper member 84 may comprise plastics, polymers, rubbers, metals, composites and/or alloys. Where the stopper member 84 is attached to the tip cover 80, the stopper member 84 may comprise a material that is different from the material of the tip cover 80. In one embodiment, the stopper member 84 may comprise an elastomer. In a further embodiment, the stopper member 84 may comprise silicone rubber. However, the stopper member 84 should not be limited to the materials disclosed herein, but may comprise any material wherein the stopper member 84 may limit the translation of the tip cover 80 toward the body 40, as discussed below.
In another embodiment, at least one of the tip cover 80 and the body 40 is selectively moveable between an operative configuration and a protective configuration. As the operative and protective configurations are discussed further in later sections, no further details are provided now, but instead another embodiment of the lancet is discussed hereafter with reference made to
As shown in
Still referring to
In another embodiment, as shown in
Operative Configuration
As shown in
In an alternative embodiment of the operative configuration (i.e. the rotary configuration), as shown in
In the operative configuration, a portion of the needle 20 is exposed such that the sharpened tip 22 of the needle 20 may puncture the skin and/or other tissues. In one particular embodiment, a portion of the needle 20 is exposed such that the sharpened tip 22 of the needle 20 may puncture the skin and/or other tissues to an appropriate depth. Moreover, in the operative configuration, a portion of the needle 20 is exposed at a substantially constant distance from the tip cover 80. In one particular embodiment, the needle 20 is exposed at a distance from the tip cover 80 ranging from about 0.5 mm to about 2.5 mm. In another embodiment, the needle 20 is exposed at a distance from the tip cover 80 ranging from about 0.5 mm to about 1.5 mm. In one specific embodiment, the needle 20 is exposed at a distance from the tip cover 80 of about 1.5 mm.
Protective Configuration
As shown in
In yet another embodiment, the lancet 1, 1′ may comprise retaining surfaces 48. In this particular embodiment, the lancet 1, 1′ may comprise retaining surfaces 48 such that the lancet 1, 1′ is releasably retainable with a lancing device having a lancet holder, as discussed below. In this particular embodiment, the lancing holder, as discussed below, may comprise a first position and a second position. The first position provides the operative configuration of the lancet 1, 1′ and the second position provides the protective configuration of the lancet 1, 1′.
In another embodiment, a method of providing selective exposure to and concealment of the sharpened tip 22 of a needle 20 comprises utilizing a lancet 1, 1′ according any one of the various embodiments described and exemplified herein.
Lancing Device
Referring now to
In a further embodiment, the lancet 1, 1′ is releasably retained within the lancet holder 102 via a fastening mechanism (not shown) which secures the lancet 1, 1′ to the lancet holder 102 of the lancing device 100. The fastening mechanism may comprise a spring bias catch mechanism, a snap-fit mechanism, a frictional fit mechanism, or a latching mechanism. The lancet 1, 1′ may also be retained within the lancet holder 102 via latches and hooks, detents and ribs, and/or magnets. However, the fastening mechanism should not be limited to the mechanisms disclosed herein, but may comprise any mechanism capable of releasably retaining the lancet 1, 1′ with the lancet holder 102.
In one particular embodiment, as shown in
In another embodiment, referring to
In a further embodiment, the lancet holder 102 forms an aperture 106 which accommodates the sharpened tip 22 of the needle 20. In one particular embodiment, the cross-sectional shapes of the aperture 106 and the needle 20 are substantially circular. However, the cross-sectional shapes of the aperture 106 and the needle 20 should not be limited to substantially circular, but may comprise any cross-sectional shape wherein the lancet holder 102 accommodates the sharpened tip 22 of the needle 20 through the aperture 106, providing the operative configuration.
In one embodiment, the lancet holder 102 may comprise plastics, polymers, rubbers, metals, composites and/or alloys. The lancet holder 102 may comprise a material that is different from the material of the lancet 1, 1′. For example, in one particular embodiment, the lancet holder 102 may comprise polymers. In a further embodiment, the lancet holder 102 may comprise acrylonitrile butadiene styrene, polycarbonate, and/or acetal copolymer. However, the lancet holder 102 should not be limited to the materials disclosed herein, but may comprise any material wherein the lancet holder 102 may releasably retain the lancet 1, 1′.
In a further embodiment, the lancet holder 102 may comprise a first position and a second position. In this particular embodiment, the lancet holder 102 is selectively moveable between the first position and the second position, wherein the first position provides the operative configuration of the lancet 1, 1′ and the second position provides the protective configuration of the lancet 1, 1′. When in the first position, at least one of the tip cover 80 and the body 40 is displaced such that the sharpened tip 22 of the needle 20 is exposed.
Referring specifically to
In this embodiment, the lancet holder 102 may selectively move from the first position to the second position wherein the cover 108 translates in a direction substantially away from the body 110 under spring-bias. In this embodiment, the cover 108 may translate under spring-bias following the release of pressure against the skin and/or other tissues of the user.
In another embodiment wherein the lancet holder 102 selectively moves from the second position to the first position, the lancet holder 102 may comprise a cover 108 slidably attached to a body 110 and the cover 108 may be biased away from the body 110 under springs (not shown). In this embodiment, the cover 108 may translate in a direction substantially toward the body 110 until the cover 108 engages a detent position (not shown). The cover 108 may provide a detent (not shown) which may slidably engage a recess (not shown) provided by the body 110 such that the cover 108 may translate in a direction substantially toward the body 110 until the detent engages the recess (not shown). In another embodiment, the body 110 may provide a detent (not shown) which may slidably engage a recess (not shown) provided by the cover 108 such that the cover 108 may translate in a direction substantially toward the body 110 until the detent engages the recess (not shown). In this way, the translation of the cover 108 toward the body 110 is limited, exposing the sharpened tip 22 of the needle 20 such that the skin and/or other tissues may be punctured.
In this embodiment wherein the lancet holder 102 selectively moves from the first position to the second position, the cover 108 may translate in a direction substantially away from the body 110 after the detent is released from its engagement with the recess. For example, in one embodiment, the lancet holder 102 may be provided with a barrel 130 rotatably mounted on the body 110. In one embodiment, the barrel 130 may be operably connected to the portion of the body 110 which provides the recesses (not shown) and/or the detents (not shown). In this way, the barrel 130 may unseat the detents from the recesses upon rotation such that the cover 108 springs forward in a direction substantially away from the body 110. In one embodiment, the barrel 130 may be rotated in a substantially radial direction to a variety of fixed points. In another embodiment, the barrel 130 may provide a grippable surface such that the user may easily rotate the barrel 130 in a substantially radial direction.
Referring specifically to
In one embodiment, the lancet holder 102 selectively moves from the second position to the first position wherein the cover 108 is rotated in a substantially radial direction (i.e. forward rotation) about its attachment to the body 110 (as shown by double sided arrow 126a in
In one particular embodiment, the gripping members 46, 46′ may slide along the tracks 114, 114′ in a direction substantially toward the aperture 106 of the body 110 (as shown by arrow 128a in
In another embodiment wherein the body 40 of the lancet 1′ is biased away from the tip cover 80 of the lancet 1′ with springs (not shown), the tip cover 80 of the lancet 1′ may be translationally fixed but may be free to rotate about its attachment to the body 40. In this way, the body 40 and the tip cover 80 may rotate relative to each other such that the pair of arm members 61, 61′ may slidably engage the guide track 44. Upon the arm members 61, 61′ engaging the guide track 44, the body 40 is displaced as previously described and exemplified, exposing the needle 20 such that the sharpened tip 22 of the needle 20 may puncture the skin and/or other tissues as previously discussed.
In another embodiment wherein the lancet holder 102 selectively moves from the first position to the second position, the cover 108 of the lancet holder 102 may be rotated in a direction substantially opposite to its forward rotation about its attachment to the body 110 (as shown by double sided arrow 126a in
In another embodiment, as shown in
In one embodiment, the lancet 1, 1′ is as previously described and exemplified. In another embodiment, the lancet 1, 1′ is inserted 220 into the lancet holder 102 of the lancing device 100. The lancet holder 102 is as previously described and exemplified. In one particular embodiment wherein the lancet 1 comprises the translational configuration, the lancet 1 is inserted 220 into the lancet holder 102 of the lancing device 100 such that the tip cover 80 is displaced as described and exemplified above. In this embodiment, the tip cover 80 is displaced when the tip cover 80 engages the receiving surfaces 104 of the lancet holder 102, causing the tip cover 80 to translate via flexing of the pair of arm members 60, 60′ in a direction substantially toward the body 40, exposing the sharpened tip 22 of the needle 20.
In another embodiment wherein the lancet 1′ comprises the rotary configuration, the body 40 is displaced such that the sharpened tip 22 of the needle 20 is exposed. In this embodiment wherein the lancet 1′ is inserted into the lancet holder 102 of the lancing device 100, the body 40 is displaced when the body 40 is rotated (i.e. forward rotation) and translated relative to the pair of arm members 61, 61′. More particularly, the body 40 is rotated in a substantially radial direction and translated in a direction substantially toward the tip cover 80, as described and exemplified above. In this particular embodiment, the body 40 is rotated and translated such that it engages the receiving surfaces 104 of the lancet holder 102, exposing the sharpened tip 22 of the needle 20.
As previously discussed, the lancet holder 102 is selectively moveable between the first position and the second position, wherein the first position provides the operative configuration of the lancet 1, 1′ and the second position provides the protective configuration of the lancet 1, 1′. The lancet holder 102 is selectively moveable between the first position and the second position as previously discussed. In another embodiment, the method may further comprises operating 230 the lancet holder 102 by selectively moving at least one of the tip cover 80 and the body 40 from the protective configuration to the operative configuration, exposing the sharpened tip 22 of the needle 20, as previously discussed.
In a further embodiment, the lancet 1, 1′ is removed 240 from the lancet holder 102 in the protective configuration, such that the sharpened tip 22 is concealed by the tip cover 80. In this particular embodiment, at least one of the tip cover 80 and the body 40 reverses its displacement from the protective configuration to the operative configuration, such that the lancet 1, 1′ is removed from the lancet holder 102 in the protective configuration. In one particular embodiment wherein the lancet 1 comprises the translational configuration, removal of the lancet 1 requires the tip cover 80 to disengage the receiving surfaces 104 of the lancet holder 102, such that the tip cover 80 translates via flexing of the pair of arm members 60, 60′ in a direction substantially away from the body 40 (as indicated by arrow 120c in
In still another embodiment, as shown in
For the purposes of describing and defining the present invention it is noted that the terms “about” and “substantially” are utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms “about” and “substantially” are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.
The above description and drawings are only to be considered illustrative of exemplary embodiments, which achieve the features and advantages of the present invention. Modification and substitutions the features and steps described can be made without departing from the intent and scope of the present invention. Accordingly, the invention is not to be considered as being limited by the foregoing description and drawings, but is only limited by the scope of the appended claims.
