US20030028208A1

US20030028208A1 - Safety lancet assembly

Info

Publication number: US20030028208A1
Application number: US09/923,020
Authority: US
Inventors: Eric Thiriez
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-08-06
Filing date: 2001-08-06
Publication date: 2003-02-06
Also published as: CO5560629A2; US6755623B2; TR200400327T2; WO2003014574A1; BR0211768A; ZA200401778B; US20030143082A1; CA2456560C; AU2002355497B2; MXPA04001181A; BR0211768B1; PL206512B1; RU2298693C2; RU2004104320A; ES2445581T3; EP1417416B1; CA2456560A1; PL367816A1; NO20040519L; EP1417416A1

Abstract

A lancet assembly comprising an elongated lancet and a plurality of cooperative members at least some of which are movable relative thereto so as to selectively orient the lancet in a covered position, operative position or protected position. The plurality of members each comprise at least one coded structure visually indicative of the lancet being in one of the aforementioned positions dependent at least in part on which one or more of the coded structures are predominantly observable. The coded structures may comprise color codings which may be visually distinguishable or visually indistinguishable from one another. Coded structures other than color codings may be utilized.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a lancet assembly including a lancet capable of being selectively disposed in any of a plurality of positions and further including a coded structure associated with operative components or members of the lancet assembly which are visually indicative of the position of the lancet.

2. Description of the Related Art

Lancets have long been employed to pierce or prick a patient's skin to provide a small outflow of blood that can be used in various medical tests. At least one conventional lancet device generally includes an elongated rod or shaft, generally defining the lancet itself, having a sharp sterile tip, a plastic retainer member molded directly about the lancet and from which the sharp tip extends outwardly, and a removable cap connected to the plastic retainer member and in which the sterile tip is encased to prevent contamination prior to use.

Lancets are used both at home by the patient or in medical offices and hospitals by health care professionals, and can be used to prick the patient's skin either by manual penetration or in conjunction with a mechanical device into which the lancet unit is installed and then removed after use. In the home setting, most lancets are used by the patient with the mechanical device, which is designed to accept lancets of various sizes. In the medical office and hospital setting, lancets are often used manually in order to avoid the necessity of having to re-sterilize the mechanical device after each use. After the lancet unit has been used to prick the patient's skin, either manually or by means of the mechanical device, the sharp lancet tip is contaminated with the patient's blood. Because of the various high-risk, life-threatening diseases that are currently prevalent throughout the world, used lancet units constitute an extremely hazardous form of waste. It is therefore essential that contaminated lancet tips be completely and securely shielded upon disposal of the used lancet units to prevent others, such as sanitation employees who routinely are unknowingly exposed to such types of hazardous waste, from being accidentally jabbed.

Thus, when used in the home patients are typically advised to discard used lancet units in a rigid container such as a coffee can or milk carton. However, many patients frequently fail to follow such advice. In addition, although it is possible to dispose of a used lancet device, such as the type described above, by inserting the sharp contaminated tip back into the cap which was removed prior to use, this is generally not done. One reason for this is because the cap is fairly small and the hole in it is minuscule. Accordingly, the person attempting to recap the used lancet is exposed to the risk of inadvertently jabbing himself with the contaminated lancet tip before it is finally inserted into the cap. Also, the cap can be lost or misplaced after being removed from the lancet unit prior to use, thereby precluding its replacement. Even if the lancet tip is replaced back into such a cap, however, there is a possibility that the cap can accidentally fall or be knocked off because the cap is not designed to be securely reconnected to the retaining member or the tip after the lancet has been used.

More recently, lancet units have been designed with protective caps that include a mouth, sized and adapted to fit securely over the end face of the lancet retainer member from which the tip extends, and pocket into which the tip of a used lancet can be inserted and protectively enclosed. Although the enlarged mouth decreases the possibility that a person may accidentally jab himself when replacing this type of cap, the risk of such an occurrence still exists because the user's hand which grasps the cap is required to move in the direction of the sharp lancet tip in order to re-cap the lancet unit. Thus, if the user becomes momentarily distracted from the task, for example, the mouth of the cap may not be replaced precisely over the end face of the lancet retainer member and the user can still inadvertently jab himself with the contaminated lancet tip. In addition, a used lancet unit protected with such a cap might be mistaken for an unused unit.

In order to overcome the problems set forth above it would be desirable to have a lancet assembly which includes a lancet having a sharpened tip, and otherwise at least partially structured to include a plurality of components or members, operatively associated with the lancet. At least some of the plurality of members would be disposable relative to the lancet and the sharpened tip in particular, such that the lancet could be oriented in anyone of a plurality of positions. In order to provide further protection of a user of such a preferred lancet assembly and at the same time provide a clear indication as to which of the plurality of positions the lancet is oriented, such an improved lancet assembly could include a coded structure disposed on at least some of the plurality of members operatively associated therewith. Such coded structure could take a variety of different forms such as a colored coding, indicia or other structures.

Regardless of the specific embodiment, such a preferred coded structure would provide a clear visual indication as to the position or orientation of the lancet. Moreover, such visual indication would be determined by the relative orientation or positions of the lancet as well as the plurality of operative components or members relative thereto. An important feature of such an improved lancet assembly, including the aforementioned coded structure, would be to provide a clear visual indication to the user as to whether or not the lancet had been previously used or not.

Therefore, such an improved lancet assembly would preferably be structured to meet the needs of the individual as intended, while eliminating certain risks to which the user may be normally exposed.

SUMMARY OF THE INVENTION

The present invention is directed to a single use lancet assembly which may be used either manually or with a mechanical device of the type well known in the medical profession. It is emphasized that the lancet assembly may include a number of different structures and may vary in size, overall configuration, etc. However, in the preferred embodiment of the present invention, the lancet assembly comprises a lancet having a sharpened tip formed on one end thereof. The lancet assembly further includes a plurality of associated, cooperatively structured components or members, at least some of which are disposable relative to the lancet so as to define, with the lancet, the positioning thereof in one of a plurality of positions.

More specifically, the plurality of positions referred to herein include the lancet being disposed in an operative position and/or a protected position being distinguishable by the sharpened tip of the lancet being oriented in an exposed or non-exposed position respectively. Further, the lancet assembly could include, as one of the aforementioned plurality of components or members, a cover member. The cover member is removably disposed in overlying, covering relation to the sharpened tip of the lancet, at least initially, prior to its use. Typically, the cover member will be oriented in such a covered position when the lancet assembly is removed from the sterile packaging before it is applied to a patient.

In addition to the above, the plurality of associated members further include a retaining member which is fixedly secured to the lancet and movable therewith. The retaining member may take a variety of different configurations but in one preferred embodiment it is fixedly secured to the lancet at least adjacent one end thereof, so as to be movable therewith. Also, the retaining member may extend along a majority or at least some of the length of the lancet, which typically includes an elongated configuration. Further, the retaining member may be structured and disposed to facilitate manual gripping or manipulation thereof so as to aid in the orientation of the lancet, relative to the other plurality of members. As such the lancet is easily disposed in anyone of the aforementioned covered position, protected position or operative position.

The plurality of cooperative members further includes a protective member which is movable relative to the lancet. The protective member includes an interior channel disposed and dimensioned to extend over the sharpened tip, such that the tip is disposed on the interior of the protective member. The lancet and particularly the sharpened tip are thereby oriented in a non-exposed or protected position thereby providing assurance that the tip will not accidentally contact or penetrate the user, patient or others.

The protective member further includes a coupling assembly formed at least partially thereon wherein the coupling assembly is structured to lock or otherwise prevent the lancet in the protected position. The lancet tip is thereby prevented from inadvertently or purposely being disposed outwardly from the interior of the protective member into an exposed orientation. The coupling assembly is structured to automatically assume the locked orientation once the lancet is placed in the protected position.

Accordingly, the lancet may be selectively disposed in the covered position, operative position and protected position depending upon the current step of the procedure in which the lancet is being utilized. More specifically, and by way of example only, the aforementioned cover member will be disposed in overlying, covering relation to the sharpened tip of the lancet thereby defining the lancet in the covered position. The covered position will be assumed by the lancet when it is removed from the sterile packaging and immediately prior to its intended use. Once the use of the lancet, in its intended fashion is imminent, the cover is removed from the covered position thereby exposing the sharpened tip of the lancet.

The protective member is maintained in an initial position in which it is disposed when the lancet is removed from the original packaging. The sharpened tip extends outwardly from one end of the protective member and is freely exposed for engagement with the patient, as intended. After use, the protective member is forced longitudinally along the length of the lancet such that the lancet passes into the interior of the protective member so as to be enclosed. The aforementioned coupling assembly is automatically engaged so that the protective member can not be inadvertently or purposely moved to an orientation where the sharpened tip of the lancet is exposed.

In order to further assure the safety of the user and provide a clear indication as to the current position assumed by the lancet, a preferred embodiment of the present invention incorporates the provision of coded structures disposed on at least some of the plurality of components or members. In at least one preferred embodiment the coded structures are disposed on the cover member, retaining member, protective member and possibly the lancet itself. The physical characteristics and location of the coded structures may vary greatly depending upon the individual structural features of the lancet assembly with which the aforementioned coded structures are utilized. It is emphasized that the coded structures of the present invention is not intended to be limited to any one lancet assembly but rather are capable of being utilized with a variety of differently structured lancet assemblies and still fall within the intended spirit and scope of the present invention.

In addition, at least one preferred embodiment of the present invention could define the coded structures as a plurality of color codings at least some of which are visually distinguishable from one another. The color codings could appear on all, or at least some of the cooperative plurality of members associated with the lancet assembly as indicated above. Alternatively, the coded structures of the present invention could comprise a variety of different indicia appearing on at least some of the plurality of members. Further, some of the indicia would be visually distinguishable from one another wherein others of the indicia would be substantially the same or substantially visually indistinguishable from one another.

Regardless of the specific structural embodiments of the coded structures being utilized, the color codings, indicia, etc. which are predominantly observable by a user, or others, would be visually indicative of the position in which the lancet and in particular the sharpened tip would be oriented. A change in the relative positions or orientations of the plurality of members including the cover member, retaining member, protective member and the lancet itself would provide a different visual indication to the user due to the fact that different ones of the coded structures would be predominantly observable.

These and other objects, features and advantages of the present invention will become more clear when the drawings as well as the detailed description are taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which: [0022]
FIG. 1 is a longitudinal sectional view showing a lancet assembly of the present invention in a covered position. [0023]
FIG. 2 is a longitudinal sectional view of the lancet assembly of the present invention including a cover member thereof removed and the lancet being disposed in an operative position. [0024]
FIG. 3 is a longitudinal sectional view of the lancet assembly of the present invention as it is being disposed from an operative position of FIG. 2 into a protected position. [0025]
FIG. 4 is a longitudinal section view of the lancet assembly of the present invention disposed in the protected position. [0026]
FIG. 5 is a longitudinal sectional view of another preferred embodiment of the lancet assembly of the present invention disposed in an un-exposed operative position. [0027]
FIG. 6 is a longitudinal sectional view of the embodiment of FIG. 5 wherein the lancet assembly is disposed in an exposed, operative position. [0028]
Like reference numerals refer to like parts throughout the several views of the drawings.[0029]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As shown in the accompanying drawings, the present invention is directed to a lancet assembly generally indicated as [0030] 10. The lancet assembly 10 includes a lancet 12 preferably having an elongated configuration and a sharpened tip 14 formed on one end thereof. The lancet 12 and tip 14 is used, in the conventional fashion, to prick or jab a patient's skin for purposes of obtaining a sample of blood. Depending upon the specific structural features and configuration of the lancet assembly 10, it comprises a plurality of associated components or members. The plurality of members cooperate with one another and with the lancet 12 so as to allow the selective orientation of the lancet 12, and in particular the sharpened tip 14, into one of a plurality of positions.
For purposes of clarity and as will be explained in greater detail hereinafter, at least some of the plurality of positions are defined in FIGS. 1, 2 and [0031] 4. More specifically, in the position of FIG. 1, the lancet 12 and the tip 14 is disposed in a covered position. The position of FIG. 2 is that of an operative position, wherein the tip 14 is exposed for engagement with the patient. It is emphasized that depending upon the specific structure and intended operation of a given lancet assembly 10, positions of the lancet 12 and penetrating tip 14 may be included, other than those set forth above.
Accordingly, the [0032] lancet assembly 10 and the aforementioned plurality of cooperative members include, in addition to the lancet 12, a cover member 16 having a somewhat hollow interior and a sleeve like configuration terminating in an open end 18 and preferably a closed end 20. The cover member 16 is disposed to slide over and frictionally engage a protective member 22 as best shown in FIG. 1. A manual, pulling force exerted on the cover member 16 in the direction indicated by directional arrow 23 will serve to easily remove the cover member 16 from its covered position. In such covered position, penetrating tip 14 is enclosed within the interior of the cover member 16 and is thereby prevented from inadvertently coming into contact with a user, patient or others. Further, the cooperative orientation of the plurality of cooperative components or members as shown in FIG. 1 may preferably be the overall position and configuration which the lancet assembly 10 may assume as it is removed from sterile packaging, immediately prior to use.
Additional structural features of the [0033] lancet assembly 10 include the protective member 22 preferably including an outwardly extending flange 24 which may have a substantially annular configuration as it extends radially outward from the outer surface of the protective member 22. In addition, and as shown in FIG. 1, the flange 24 may be disposed beyond the exterior surface of the cover 16 and may be dimensioned and configured to facilitate gripping and positioning of the protective member 22 relative to the lancet 12.
In addition, the plurality of members of the [0034] lancet assembly 10 include a retaining member 26. The retaining member 26 is fixedly secured to the lancet 12 at least along a portion of its length and at least adjacent an end 13 which is oppositely disposed to the penetrating tip 14. The retaining member 26 has an inner portion 28 and an outer, barrel-like portion 30. An at least partially open space 32 is disposed there between and may vary in both dimension and configuration, dependent at least in part on the size, disposition and configuration of at least a portion of the protective member 22. The space 32 may have an annular configuration or be defined by separate spaced apart segmented spaces.
In either of the aforementioned structures, or in any other structural equivalent thereto, the [0035] space 32 is dimensioned and configured to receive outwardly extending arm members 34 which are fixedly and/or integrally secured to the protective member 22. The arm members 34 define at least a portion of a coupling assembly, the details of which will be explained in greater detail hereinafter. The one or more arms 34 may vary in size, dimension, configuration and number and may be spaced from one another as shown or may include an annular or semi-annular skirt like structure. Each of the one or more arms 34 includes a coupling head 36 formed at a free end thereof. The coupling heads 36 are intended to cooperate with grooves 38 and 38′ integrally formed in the interior portion 28 of the retaining member 26. As such the grooves 38 and 38′ also comprise at least a portion of the of the aforementioned coupling member.
In at least one embodiment of the present invention another structural feature of the retaining [0036] member 26 includes an elongated sleeve or shaft 29 which extends along and substantially encloses a portion of the length of the lancet 12. The sleeve like shaft 29 may be fixedly molded or otherwise integrally secured to the retaining member 26 so as to extend along the interior thereof and more particularly the interior of the inner portion 28. As will be more fully explained hereinafter, the shaft 29 may therefore, in at least one preferred embodiment, be considered a part of the retaining member 26. However, as shown in the accompanying Figures the shaft 29 is dimensioned to extend along most, if not all, of the lancet 12 accept, of course, for the penetrating tip 14. Accordingly, the sleeve 29 may be considered a part of the lancet 12 rather than the retaining member 26, although it remains fixedly attached to the retaining member 26.
Accordingly, it is emphasized that whether the sleeve-like shaft [0037] 29 is considered a part of the retaining member 26 or a part of the lancet 12, both structural variations are to be considered structural equivalents in terms of the intended spirit and scope of the present invention. As such, the shaft 29 is clearly observable when the lancet 12 is oriented in the protected position of FIG. 4 and non-observable when the lancet is oriented in the covered and operative positions of FIGS. 1 and 2, respectively.
Further, as the [0038] lancet assembly 10 is removed from its sterile packaging, the lancet is oriented in the covered position of FIG. 1, as long as the cover member 16 remains in place. Once the lancet is ready for use, the cover member 16 is removed by exerting the aforementioned force in the direction indicated by directional arrow 23. The lancet 12 and penetrating tip 14 thereby assumes the operative position as clearly disclosed in FIG. 2.
In the operative position of the embodiment of FIG. 2, the penetrating [0039] tip 14 extends outwardly from the opening 27 formed in an outer most end of an elongated channel 25 extending along the length of the retaining member 22. As shown, the protective member 22 is slidably movable relative to at least a portion of the lancet 12 and the shaft 29 as the are disposed within the channel 25. When the lancet assembly 10 is in the operative position of FIG. 2 it may be applied to a patient either manually or using a mechanical triggering mechanism, as set forth above.
The operative position may further include the one or [0040] more arms 34 and the corresponding coupling heads 36 engaging the retaining member 26 and the slots or recesses 38. In such a position the arms 34 of the protective member are substantially covered by the barrel or outer portion 30 of the retaining member 26 and therefore are not visually observable by a user of the lancet assembly 10.
However, after contact with the patient it is important that the penetrating [0041] tip 14 not be exposed so that inadvertent penetration or contact with others may be prevented. Therefore, as shown in FIG. 3 the plurality of members associated with the lancet assembly 10 are selectively disposed, relative to one another and to the lancet 12 and penetrating tip 14 so that the tip 14 is disposed in the protected position, as set forth above. In doing so the user of the lancet assembly 10 may grip or otherwise manually engage the outwardly extending flange 24, or other portion of the protective member 22, and exert a force thereon in the direction indicated by directional arrow 27. This will serve to disengage the coupling heads 36 from the slots 38 and allow longitudinal travel of the protective member 22 outwardly along the length of the lancet 12 and the shaft 29 in enclosing relation to the penetrating tip 14.
With reference to FIG. 4, the protected position is thereby disclosed, wherein the penetrating [0042] tip 14 passes into the interior of the channel 25 extending within and along the length of the protective member 22. The penetrating tip 14 is disposed such that it does not extend outwardly through the open end 27 but is maintained on the interior of the protective member 22 as shown. Further, the lancet 12 and tip 14 are locked or secured in the protected position by virtue of locked the orientation of the coupling assembly.
More specifically, the one or [0043] more arms 34 extend outwardly as they slide along the interior space or opening 32 between the interior portion 28 and barrel 30 of the retaining member However, once the coupling heads 36 reach a position which coincides with a one or more slots 38′, they are received therein. Due to the cooperative configuring, dimensioning, etc. of the coupling heads 36 and the correspondingly positioned receiving slots 38′, the protective member 22 is prevented from moving inwardly in the direction of arrow 31 of FIG. 4. Therefore, it is extremely difficult, if not impossible to again expose the penetrating tip 14 beyond the open end 25 of the protective member, once the lancet 12 is oriented in the aforementioned protected position of FIG. 4.
As indicated above, it is important that the operators, patients and others associated with the use of the [0044] lancet assembly 10 be protected from inadvertently coming into contact with the tip 14, particularly after the lancet assembly has been used in the intended fashion. Also, it is believed to be equally important to provide a clear visual indication as to the condition and/or position of the lancet assembly 10, particularly, but not exclusively, in terms of being ready for use or having been previously used.
Accordingly, a feature of the various preferred embodiments of the present invention comprises a plurality of coded structures disposed on or directly associated with all or at least some of the plurality of members which comprise the [0045] lancet assembly 10. As will be explained in greater detail hereinafter the coded structures of one preferred embodiment of the present invention comprises a plurality of color codings disposed on the plurality of members. It is emphasized that indicia other then color codings can define the coded structures disposed on each or at least some of the plurality of members of the lancet assembly 10. Such indicia can include any type of visually discernable marking, design, display, alpha/numeric indicator or the like. Further, for purposes of fully describing the coded structures, the term indicia may also encompass surface texturing or discernable configuring in a manner which allows one of the plurality of members, or a portion thereof to be distinguished, at least in part, from at least one other of the plurality of members included in the lancet assembly 10.
Therefore, in the preferred embodiment shown in the accompanying Figures, the coded structures of the present invention is represented by a plurality of color codings. Moreover, various ones of the plurality of members may include substantially the same color coding or a color coding which is substantially indistinguishable from color codings of other of the plurality of members. Alternatively the color codings of one or more of the plurality of members may be clearly distinguishable from color codings of others of the plurality of members. Accordingly, dependent on which of the color codings (or other indicia defining the coded structures) are visually observable, and in certain instances predominantly observable, the user or others associated with the use of the [0046] lancet assembly 10 are provided with a clear visual indication of which of the plurality of positions the lancet 12 and the penetrating tip is disposed. Concurrently, a user is provided with a visual indication as to whether or not the lancet assembly 10′ is ready for initial use or has already been used.
For purposes of clarity the color codings defining the coded structure of the preferred embodiments of FIGS. 1 through 4 includes the visually discernable colors green (G), yellow (Y) and red (R). However, it should be clear that any colors or combination of colors may be used to define the color codings of the coded structures of the present invention. The colors green, yellow and red are used by way of example only in order to further clarify the intended use and structure of the present invention. These colors are universally recognized as being representative of various conditions of use or readiness. For example, green is well recognized as being representative of a “safe” condition. Yellow is recognized as being representative of a condition of caution. Finally, red is universally recognized as an alert or danger condition. [0047]
Therefore, with primary reference to FIG. 1, the [0048] lancet assembly 10 is in a covered position with the lancet 12 and particularly the penetrating tip 14 being disposed within the interior of the cover member 16. As such, the predominantly observable color is green in that the coded structures of the various members comprise the cover member being green, the majority and/or exterior portion of the retaining member 26 also being green and the gripping flange 24 having a yellow color coding. Therefore, one associated with the use of the lancet assembly 10 would observe a predominantly green color indicating somewhat of a safe or unused condition of the lancet assembly 10.
With reference to FIG. 2, the [0049] lancet assembly 10 is disposed in an operative position, with the cover 16 being removed from the protective member 22 and the tip 14 being exposed and ready for use. The color coding defining the coded structure of the protective member 22 is yellow thereby indicating to an observer that a certain amount of caution must be exercised. In this operative position, yellow would be the more predominantly observable color by those associated with the use of the lancet assembly 10. It is of course noted that the exposed portions of the barrel 30 and remainder of the retaining member 26 is green. However, the color coding of yellow, being the most recently exposed color coding and indicating a caution condition, would be considered the predominantly observable color as long as the lancet 12 and the penetrating tip 14 are in the operative position of FIG. 2.
After use, including penetration of the [0050] tip 14 into an intended patient, the lancet assembly 10 and the various members thereof are manipulated so as to dispose the lancet 12 and the penetrating tip 14 into the aforementioned protected position. In doing so the flange 24 or other portion of the protective member 22 are gripped so as to move the protective member in a direction indicated by directional arrow 27. In doing so a space 50 will be created between the protective member 22 and the retaining member 26. The space 50 will be sufficiently sized and disposed in cooperative relation with the shaft 29 (whether the shaft 29 is considered a part of the retaining member 26 or lancet 12) such that the shaft 29 can be visually observed.
FIG. 3 indicates an intermediate position as the [0051] protective member 22 is being disposed into the protected position. As shown in FIG. 4 the lancet assembly 10 is fully oriented in the protected position and the opening or space 50 assumes its larger dimension. Space 50, therefore, allows for clear, visual observation of the shaft 29 which includes a color coding of red as the defined coded structure thereon. In addition, another preferred embodiment of the lancet assembly 10 may include one or more windows or openings 52 formed in the barrel 30. The windows 52 are located so as to observe the interior space 32, the position of the arms 34 (Y) therein or alternatively the exposure of the inner portion 28 (R) of the retaining member 26.
As disclosed in the various Figures, the coded structure of the [0052] inner portion 28 of the retaining member 26 is defined by a color coding of red. Therefore, when the lancet assembly 10 is in the protected position of FIG. 4 the color coding red is observable on the shaft 29, through the space 50, as well as on the inner portion 28 of the retaining member 26, as through the one or more windows 52. Therefore, in the protected position of the lancet 12 and penetrating tip 14, as shown in FIG. 4, the predominantly observable color coding is red and provides a clearly alert or danger indication that the lancet assembly 10 has been previously used.
It is also emphasized that the term “predominantly observable” is not necessarily indicative of which of the plurality of color codings, green, yellow or red, is most present. To the contrary, in the protected position of FIG. 4, the fact that the color coding of the shaft [0053] 29 and interior portion 28 is red and becomes observable as the lancet 12 and tip 14 is positioned in the protected position serves to define it as the predominantly observable color coding. An observer is thereby provided with a clear indication of an alert or even danger condition to the extent that the lancet assembly 10 has been previously used and should not be adjusted or otherwise manipulated to attempt re-use.
It is therefore seen that the coded structures may be defined by a plurality of color codings to the extent that at least some or all of the [0054] cover member 16, the protective member 22, and the retaining member 26 may have at least one color codings thereon. As explained above, the retaining member 26 has more than one color coding defining the coded structures, wherein the inner portion 28 and shaft 29 is red and the outer and/or barrel portion 26, 30, is green.
Yet another preferred embodiment as shown in FIGS. 5 and 6, wherein the [0055] lancet assembly 10′ has an almost identical structure with the exception of a modification of the aforementioned coupling assembly. In addition, the additional preferred embodiment of FIGS. 5 and 6 includes a coded structure including a plurality of color codings as described in detailed reference to the embodiment of the FIGS. 1 through 4.
More specifically, the [0056] lancet assembly 10′ includes a lancet 12 including a penetrating tip 14 and an elongated sleeve or shaft 29 which, as set forth above, may be considered part of the retaining member 26 or the lancet 12, itself. Similarly, the lancet assembly 10 includes a protective member 22 selectively positionable relative to the lancet 12 and shaft 29 so as to be positionable in the protected position referred to above and describe in detailed with specific reference to FIG. 4. In addition, the protected member 22 includes at least one but preferable a plurality of elongated arms 34 movable within the opening or space 32 which serves to separate the inner portion 28 of the retaining member 26 from the outer or barrel portion 30.
However, one structural modification included in the additional preferred embodiment of FIGS. 5 and 6 is the coupling assembly including two receiving recesses or slots [0057] 38′ and 38″ correspondingly positioned to receive a coupling head 36 of a respective of the arms 34. As is evident, the recesses or slot 38′ has a significantly larger longitudinal dimension than that of the slot 38′. This dimension allows movement of a respective one of the coupling heads 36, associated arm 34 and protective member 32 in a longitudinal direction relative to the lancet 12 and shaft 29, while the coupling head 36 is maintained within the enlarged slot or recess 38″. In addition, the preferred embodiment of FIGS. 5 an 6 also includes a biasing assembly 60 disposed between interior surfaces 22′ and 28′ of the protective member 22 and the inner portion 28 of the retaining member 26.
The biasing assembly [0058] 60 may take a variety of different structural configurations such as, but not limited to a biasing member having a somewhat coiled or other configuration having opposite ends engaging the aforementioned surfaces 22′ and 28′. In such a positioned the biasing assembly 60 serves to normally biased or force the protective member 22 outwardly, away from the inner portion 28 of the retaining member 26 while maintaining each of the one or more coupling heads 36 within the enlarged recess or slot 38″. In addition, the biasing force exerted on the protective member 22, as shown in FIG. 5, will serve to position the protective member in surrounding protecting position relative to the penetrating tip 14.
However, it is emphasized that the operative position of FIG. 5 defines an operative position of the [0059] lancet 12 and penetrating 14 in that the lancet assembly 10′ has not been used but is in a position which is assumed when the lancet assembly 10′ is removed from its packaging and a cover member 16, when utilized, has been removed.
Another feature of the embodiment of FIGS. 5 and 6 is the structuring or configuring of the biasing assembly [0060] 60 to generate sufficient force to normally biased the protective member 22 in the outwardly oriented position as shown in FIG. 5. However, the biasing member 60 is such as to relatively easily allow the protective member 22 to be forced into the position of FIG. 6 in order to clearly expose the penetrating tip 14, for use on the patient in the intended manner. The positioning of the protective member 22 can be radially accomplish using a mechanical triggering device, as discussed above, or by merely placing the outer most end 22″, while the lancet assembly 10′ is in the position of FIG. 5, in physical contact with the skin of the patient. When so positioned a pushing force exerted on the retaining member 26 will easily allow for the exiting and exposure of the penetrating tip 14 outwardly through the open end 27 of the interior channel 25 and into penetrating relation to the patient. Therefore, the biasing force exerted by the biasing assembly 60 can be radially overcome when it is intended to use the lancet assembly 10′.
Accordingly, the [0061] lancet assembly 10′ may also be defined as including an operative position which is more specifically described as including a non-exposed tip position as represented in FIG. 5 and an exposed tip position as represented in FIG. 6. The length or increased dimension of the recess 38″ is such as to freely allow movement of the protective member 22 between the non-exposed tip position of FIG. 5 and the exposed tip position of FIG. 6 so as to be operative in the intended fashion, as described above.
After use, the [0062] lancet assembly 10′ and more particularly the lancet 12 and penetrating tip 14 are selectively positioned into the protected position of FIG. 4 by enforcing the protective member 22 outwardly as represented by directional arrow 27 of FIG. 3 such that the coupling heads 36 are lockingly received within corresponding ones of the recesses 38′.
As also represented in FIG. 5 viewing of the appropriately positioned coded structures may be accomplish through the openings or spacing [0063] 50 existing between the correspondingly disposed surfaces 22′ and 28′ when the lancet assembly 10′ is in the operative, non-exposed tip position of FIG. 5 or in the protective position of FIG. 4.
Also it should be apparent that, regardless of which of the above noted preferred embodiments is utilized, visual exposure of the various coded structures, in sequence, is at least partially indicative of the relative orientations or a change in such relative orientations of the plurality of the members as they are selectively disposed in the various predetermined covered position, operative position and/or protected position. [0064]
Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents. [0065]
Now that the invention has been described, [0066]

Claims

What is claimed is:

1. A lancet assembly comprising:

a) a lancet having a penetrating tip formed on one end thereof,

b) a plurality of members disposable relative to said lancet to define at least an operative position and a protected position of said lancet, and

c) at least some of said plurality of members including a coded structure disposed thereon and being indicative of said lancet being at least in said operative position or said protected position.

2. A lancet assembly as recited in claim 1 wherein said plurality of members including said coded structures disposed thereon are structured to be visually indicative of a change in orientation of respective ones of said plurality of members.

3. A lancet assembly as recited in claim 2 wherein said coded structures of respective ones of said plurality of members are disposed in a visually observable position or a visually non-observable position dependent on the orientation of said plurality of members relative to said lancet.

4. A lancet assembly as recited in claim 1 wherein said coded structures comprise a plurality of color codlings at least some of which are visually distinguishable from one another.

5. A lancet assembly as recited in claim 3 wherein said coded structures comprise a plurality of indicia at least some of which are distinguishable from one another.

6. A lancet assembly as recited in claim 1 wherein at least some of said plurality of members are movable relative to said lancet to define said operative position and said protected position.

7. A lancet assembly as recited in claim 6 wherein at least some of said plurality of members are selectively movable relative to said lancet to further define a covered position of said lancet.

8. A lancet assembly as recited in claim 7 wherein said coded structures on at least some of said plurality of members are disposed and structured to provide a visual indication of the relative orientation of said plurality of members and said lancet being in said operative position, said protected position or said covered position.

9. A lancet assembly as recited in claim 8 wherein at least some of said coded structures are visually distinguishable from one another.

10. A lancet assembly as recited in claim 9 wherein said coded structures comprise a plurality of color codlings at least some of which are visually distinguishable from one another.

11. A lancet assembly as recited in claim 9 wherein at least some of said coded structures are visually indistinguishable from one another.

12. A lancet assembly as recited in claim 11 wherein said coded structures comprise a plurality of color codlings at least some of which are visually distinguishable from one another.

13. A lancet assembly as recited in claim 11 wherein said coded structures comprise a plurality of indicia.

14. A lancet assembly comprising:

a) a lancet having a penetrating tip formed on one end thereof,

b) a retaining member fixedly secured to said lancet in spaced relation to said penetrating tip,

c) a protective member being at least initially movable relative to said lancet and positionable between an operative position and a protected position, and

d) a plurality of coded structures formed on said retaining member and said protective member and being indicative of said lancet being in at least said operative position or said protected position.

15. A lancet assembly as recited in claim 14 wherein said plurality of coded structures are structured and disposed to provide a visual indication of said lancet being in said operative position or said protected position.

16. A lancet assembly as recited in claim 15 wherein at least some of said coded structures are visually distinguishable from one another.

17. A lancet assembly as recited in claim 16 wherein at least some of said coded structures are visually indistinguishable from one another.

18. A lancet assembly as recited in claim 17 wherein at least one of said retaining member or protective member includes said coded structures thereon being both visually distinguishable and visually indistinguishable from others of said plurality of coded structures.

19. A lancet assembly as recited in claim 14 further comprising a cover member movably disposed relative to said lancet and positionable into and out of a covered position.

20. A lancet assembly as recited in claim 19 wherein at least one of said plurality of coded structures is formed on said cover member, said one coded structure being at least partially indicative of said lancet being in said covered position.

21. A lancet assembly as recited in claim 20 wherein said plurality of coded structures comprise a plurality of color codings disposed on said retaining member, said protective member and said cover member, said plurality of color codings are disposed in either a substantially observable position or a substantially non-observable position dependent on the relative orientation of said retaining member, said protective member and said cover member.

22. A lancet assembly as recited in claim 21 wherein one or more of said plurality of color codings disposed in said observable positions being indicative of said lancet being in one of said operative position, covered position or protected position.

23. A lancet assembly as recited in claim 22 wherein said covered position is defined by said penetrating tip extending outwardly from said protective member and in enclosed relation by said cover member.

24. A lancet assembly as recited in claim 23 wherein said covered position is further defined by color codings of both said cover member and said retainer member being predominantly observable.

25. A lancet assembly as recited in claim 24 wherein said color codings of both said cover member and said retainer member are substantially visually indistinguishable.

26. A lancet assembly as recited in claim 22 wherein said operative position is defined by said penetrating tip extending outwardly from said protective member in an exposed orientation.

27. A lancet assembly as recited in claim 26 wherein said operative position is further defined by said color codings of said retaining member and said protective member being predominantly observable.

28. A lancet assembly as recited in claim 27 wherein said color codings of both said retaining member and said protective member are visually distinguishable from one another.

29. A lancet assembly as recited in claim 22 wherein said protected position is defined by said penetrating tip disposed in a covered, non-exposed orientation within said protective member.

30. A lancet assembly as recited in claim 29 wherein said protected position is further defined by said color codings of said retainer member and said protected member being predominantly observable and said retainer member including at least two color codings visually distinguishable from one another.

31. A lancet assembly as recited in claim 30 wherein said color coding of said protective member is visually distinguishable from each of said at least two color codings of said retainer member.

32. A lancet assembly comprising:

a) a lancet including a penetrating tip formed on one end thereof,

c) a protective member being at least initially movable relative to said lancet and positionable between an operative position and a protected position,

d) a cover member movably disposed relative to said lancet and positionable into and out of a covered position,

e) each of said retaining member, protective member, and covered member including at least one coded structure positionable in either a substantially observable or a substantially non-observable position dependent on the orientation of said protective member and said cover member relative to said lancet, and

f) predominantly observable ones of said coded structures being indicative of said lancet being disposed in said operative position, said covered position or said protected position.

33. A lancet assembly as recited in claim 32 wherein said coded structures comprise at least one color coding disposed on each of said retaining member, said protective member and said cover member.

34. A lancet assembly as recited in claim 32 wherein said covered position is defined by said penetrating tip extending outwardly from said protective member and in enclosed relation by said cover member.

35. A lancet assembly as recited in claim 34 wherein said covered position is further defined by said coded structure of both said covered member and said retainer member being predominantly observable.

36. A lancet assembly as recited in claim 35 wherein said coded structure of both said cover member and said retainer member are substantially the same.

37. A lancet assembly as recited in claim 32 wherein said operative position is defined by said penetrating tip extending outwardly from said protective member in an exposed orientation.

38. A lancet assembly as recited in claim 37 wherein said operative position is further defined by said coded structures of said retaining member and said protective member being predominantly observable.

39. A lancet assembly as recited in claim 38 wherein said coded structures of both said retaining member and said protective member are different.

40. A lancet assembly as recited in claim 32 wherein said protective position is defined by said penetrating tip disposed in a covered, non-exposed orientation within said protective member.

41. A lancet assembly as recited in claim 40 wherein said protective position is further defined by said coded structures of said retainer member and said protective member being predominantly observable; said retainer member including at least two coded structures being visually distinguishable from one another; said coded structure of said protective member being visually distinguishable from each of said at least two coded structures of said retainer member.

42. A lancet assembly as recited in claim 32 further comprising a coupling assembly disposed at least partially on both said retainer member and said protective member and structured to fixedly dispose said protective member in said protected position.

43. A lancelet assembly comprising:

a) a lancet having a penetrating tip formed on one end thereof,

b) a plurality of members disposable relative to said lancet to define a protected position in at least two operative position of said lancet, and

c) said two operative positions comprising a non-exposed tip positioned and an exposed tip positioned.

44. A lancet assembly as recited in claim 43 further comprising a biasing assembly disposed to normally biased at least some of said plurality of members into one of said non-exposed tip position or said exposed tip position.

45. A lancet assembly as recited in claim 44 further comprising a coupling assembly interconnected between at least some of said plurality of members and structured to fixedly orient said lancet in said protected position.

46. A lancet assembly as recited in claim 44 wherein said coupling assembly is further structured to allow selective orientation of said lancet between said non-exposed tip position and said exposed tip position.

47. A lancet assembly as recited in claim 44 wherein said biasing assembly is disposed to normally orient said lancet into said non-exposed tip position; said biasing assembly structured to permit selective orientation of said lancet from said non-exposed tip position into said exposed tip position.

48. A lancet assembly as recited in claim 43 wherein at least some of said plurality of members include a coded structure disposed thereon and being indicative of said lancet being at least in said protected position or at least one of said operative positions.

49. A lancet assembly as recited in claim 43 further comprising a coupling assembly interconnected between at least some of said plurality of members and structured to selectively maintain orientation of said lancet in either said two operative positions or said protected position.

50. A lancet assembly as recited in claim 49 wherein said coupling assembly is structured to fixedly orient said lancet in said protected position.

51. A lancet assembly as recited in claim 49 wherein said coupling assembly is further structured to allow selective orientation of said lancet between said non-exposed tip position and said exposed tip position.

52. A lancet assembly as recited in claim 51 wherein at least some of said plurality of members include a coded structure disposed thereon and being indicative of said lancet being at least in said protected position or at least one of said operative positions.