Lancet device

[0001] The present application is a Continuation-In-Part application of previously filed, now pending application having Ser. No. 09/296,346 which was filed on Apr. 22, 1999 which matured into U.S. Pat. No. 6,190,398 on Feb. 20, 2001, which is a Continuation-In-Part of United States patent application having Ser. No. 09/025,292 filed Feb. 13, 1998, also incorporated herein by reference, which matured into U.S. Pat. No. 5,908,434 Jun. 1, 1999.

[0002] 1. Field of the Invention

[0003] The present invention relates to a lancet device, and in particular a mini lancet device which is structured in such a manner as to be manufacturable in a small, compact configuration, yet which is substantially easy to use and is effective to pierce a user's skin, such as at a finger for conducting a blood test. Furthermore, the lancet device is easy to manipulate and actuate, is structured in a manner which facilitates accurate determination that the device is in a ready to use orientation, and is further configured to be adaptable into a more elongate, extended configuration or a more compact, storable configuration, as desired by the user.

[0004] 2. Description of the Related Art

[0005] The field of art associated with lancet devices is quite crowded, with a variety of often complex and intricate structures being utilized to drive a piercing tip of a lancet into the flesh of a patent. In particular, the typical lancet device generally utilizes a disposable lancet, often of a standard dimension, contained in a housing for firing. As such, a variety of different, full size lancet devices have been provided, some providing for re-use through internal or external cocking of the firing mechanism and providing an actuation button on a side thereof for triggering of the piercing action.

[0006] In addition to the conventional, elongate, full-size lancet devices, however, there is also the need for compact “mini” lancet devices which are substantially small and manageable, yet which are equally as effective as the larger, full size lancet devices. For example, when designing either a full-size or a mini lancet device, some primary concerns associated therewith include its economy of use and manufacture, the minimizing of malfunctions or mis-fires, and various safety considerations such as those associated with inadvertent usage, incorrectly perceived malfunctions or accidental re-use of a used and possibly contaminated lancet. While many designs do seek to address one or more of these concerns, however, there is still a need for a device which effectively addresses all of these concerns, and which can be effectively configured in both a full size or a mini configuration.

[0007] In particular, a primary drawback associated with the mini lancet devices relates to its limited internal space, and as such, its inability to utilize various existing design features associated with the larger, full-size devices. For example, known mini devices have not been able to utilize or incorporate a safe and effective structure to enable facilitated cocking or re-cocking of the lancet device. Specifically, as with the larger full-size lancet devices, it would be beneficial if a user were able to cock the assembly without having to internally actuate the mechanism in close proximity to the piercing tip of the lancet, especially in a re-cocking situation wherein removal of the lancet from the device prior to re-cocking is not practical. Moreover, existing devices, both full-size and mini have not been able to provide effective structures to clearly and effectively indicate to a user, and especially an infirmed user with some vision limitations, in a tactile and easy to identify manner, that the lancet device has been effectively cocked and is ready for use, or that it has been used such that re-cocking or removal of the lancet is necessary.

[0008] As such, despite the many features which have been incorporated into full-size devices, the generally small, compact nature of the mini lancet devices, substantially limits the ability of conventional structures, a majority of which require intricate internal designs and button actuation at a top or side of a housing, to be merely shrunk to define a mini device. Accordingly, there is a need for an effective lancet device which is sufficiently simple in design, yet which is highly effective for use as a mini lancet device, incorporating a variety of necessary and effective features from full size devices. Moreover, there is a need for a lancet device which is substantially easy and effective to actuate, whether in a full-size or mini form, and which enables a user to clearly and safely identify the ready status of the device in either a cocked orientation or a fired orientation. Further, such a device should be cost effective to manufacture, conveniently re-useable, easily manipulable, and minimally susceptible to accidental firing as is often the case with side actuated devices.

[0009] Additionally, it should be noted that although in many instances a smaller “mini” type lancet device is preferred, such as when portability of storability is desired, some user's may, from time to time, still prefer the increased manipulability available from larger, more elongate lancet devices. Accordingly, it would also be beneficial to provide a lancet device and/or a component therefore which allows a length of the lancet device to be easily modified and adapted to correspond the needs of the user without requiring that the user purchase an additional device and without requiring modification or alteration to the operation of the mini device in order to accommodate the adaptability.

[0010] The present invention relates to a lancet device. In particular, the lancet device includes a lancet having a body portion and a piercing tip extending from the body portion. The lancet is preferably of a conventional configuration wherein the piercing tip is structured to be extended into piercing engagement with a user, such as at their finger, in order to penetrate the skin.

[0011] The lancet device further includes a primary housing. The primary housing includes a preferably tubular configuration and is structured to be matingly coupled with a cover assembly so as to define an interior chamber of the lancet device with the cover assembly. Further defined in the cover assembly is a piercing opening. Specifically, the piercing opening is structured to be disposed adjacent an article to be pierced, and to receive the piercing tip of the lancet therethrough upon movement of the lancet into a piercing orientation.

[0012] In particular, the lancet is driven into its piercing orientation by a lancet receiving assembly. The lancet receiving assembly may be structured and disposed to at least temporarily, and preferably removably hold the lancet therein. Of course, a hammer type structure may be provided for the lancet receiving assembly. Moreover, the lancet receiving assembly, and as such the lancet held thereby, are further structured to be movably disposed within the interior chamber of the lancet device between a cocked orientation and a fired orientation. Indeed, it is the movement of the lancet receiving assembly from the cocked orientation to the fired orientation that results in driven movement of the lancet, at least temporarily, into the piercing orientation, wherein the piercing tip of the lancet protrudes through the piercing opening of the cover assembly, prior to finally reaching the concealed and shielded fired orientation.

[0013] The lancet receiving assembly also includes a retention member. Specifically, the retention member is structured to be cooperatively engaged with an engagement hub disposed in the interior chamber. For example, at least when the lancet receiving assembly is disposed in the cocked orientation, the retention member cooperatively engages the engagement hub and thereby maintains the lancet receiving assembly in the cocked orientation until the retention member is affirmatively released from that cooperative engagement. Preferably, the retention member includes at least one generally elongate finger. Moreover, the at least one elongate finger includes an inwardly depending protrusion that is structured to engage cooperative structure on the engagement hub, when the lancet receiving assembly is disposed in the cocked orientation, until affirmatively disengaged therefrom.

[0014] The lancet device of the present invention further includes an actuation assembly. The actuation assembly is exteriorly actuatable and is structured and disposed to release the retention member from its cooperative engagement with the engagement hub. Along these lines, the actuation assembly extends at least partially into the interior chamber, when actuated, and thereby temporally urges the inwardly depending protrusion of the at least one elongate finger out of its engagement with the cooperative structure on the engagement hub. As such, the lancet receiving assembly is released from its cocked orientation by the actuation assembly, whereafter it may move at least temporarily into the piercing orientation before terminating its movement in the tip concealing, fired orientation.

[0015] Moreover, the present lancet device may also include an extension segment structured to be operably coupled with the lancet receiving assembly. Specifically, the extension segment is preferably structured to retain the lancet and move the lancet in accordance with movement of the lancet receiving assembly between the cocked and fired orientations. As a result, the extension segment functions to increase an overall length of the lancet device when desired by a user, thereby increasing the manipulability thereof, while also permitting a compact more portable configuration to be operably employed when desired.

[0016] It is an object of the present invention to provide a lancet device which is substantially easy and cost effective to utilize and manipulate.

[0017] Also an object of the present invention is to provide a lancet device which can be adjusted to two or more variable lengths, as need by the user and depending upon the number of extension segments utilized by the user, while still being fully operable.

[0018] A further object of the present invention is to provide a lancet device which can be configured in a mini configuration, yet which is highly effective and free from malfunction.

[0019] Yet another object of the present invention is to provide a lancet device which provides for substantially easy to recognize, tactile and/or visual indication if the lancet device is in a cocked and ready to fire orientation, or if it is in the fired orientation.

[0020] Also an object of the present invention is to provide a lancet device which provides for effective re-cocking thereof in a safe and effective manner, and which provides for facilitated index finger or thumb actuation when configured in a mini form.

[0021] Another object of the present invention is to provide a lancet device which is adaptable for use as a mini-device or a more elongate standard sized device depending upon the needs of the user.

[0022] A further object of the present invention is to provide a lancet device which can be extended into a longer overall length without requiring modification or alteration to the mechanical operation of the lancet device.

[0031] Like reference numerals refer to like parts throughout the several views of the drawings.

[0032] Shown throughout the Figures, the present invention is directed towards a lancet device, generally indicated as 10. Specifically, the lancet device is preferably of substantially small compact configuration, thereby being generally classified as a mini lancet device, and is of the type that is utilized to prick a patient, such as on their finger, in order to do a variety of blood tests.

[0033] The lancet device 10 of the present invention includes principally a lancet 30. The lancet 30 may be of any of a number of conventional or modified configurations which are usually provided in large bulk packages in order to encourage a single use after which it may be safely discarded. In particular, the lancet 30 generally includes a body portion 31, preferably of an enlarged, tubular configuration, and a sharpened, preferably metallic piercing tip 32 extending from the body portion 31. Also, in most embodiments, the piercing tip 32 will be covered by a removable and disposable cap which is removed once the lancet 30 is presented for use in the present device.

[0034] The lancet device 10 further includes a primary housing 20. The primary housing 20 which is preferably formed of a generally rigid, tubular configuration, such as from plastic or a like material. Moreover, the primary housing 20 preferably includes a generally triangular configuration, as illustrated in the Figures, so as to facilitate grasping and manipulation thereof by a user, and so as to prevent accidental rolling thereof when the lancet device 10 is put down on a generally flat support surface.

[0035] Structured to be matingly coupled, at generally an open end 22 of the primary housing 20, is a cover assembly 35. Specifically, the cover assembly 35, which preferably includes a mating triangular configuration, is structured to be removably coupled with the primary housing 20, and terminates in a conical tip wherein a piercing opening 37 is defined. The piercing opening 37 is preferably generally centrally aligned in the cover assembly 35 and is sized so as to receive the piercing tip 32 of the lancet 30 therethrough without resistance. Moreover, the open end 36 of the cover assembly may include a flange, lip or any other conventional mating configuration to provide for effective coupled engagement with corresponding structure at the open end 22 of the primary housing 20, while also being removable if necessary for the removal and replacement of the lancet 30.

[0036] The cover assembly 35 and the primary housing 20 are further structured to define an interior chamber 39 there between. Furthermore, disposed within that interior chamber 39 is a lancet receiving assembly 40. Specifically, the lancet receiving assembly 40 is structured to engage the lancet, and in one embodiment to at least temporarily hold and maintain the lancet 30 movably within the interior chamber 39. Of course, a hammer type configuration may also be employed. Looking to the illustrated embodiment, the lancet receiving assembly 40 preferably includes a holding portion 41 wherein the body portion 31 of the lancet 30 may be snugly introduced. It is understood that a variety of configurations of this holding portion 41 of the lancet receiving assembly 40 may be provided so as accommodate minor variations in the actual dimension of the body portion 31 of the lancet 30, and so as to effectively grasp the lancet 30 during utilization thereof, while also permitting safe and easy removal of the lancet 30 therefrom when use has been completed.

[0037] The lancet receiving assembly 40 is structured to be movable within the interior chamber 39 between a cocked orientation, as illustrated in FIG. 3 and a fired orientation as illustrated in FIG. 2. In particular, the cocked orientation of FIG. 3 is structured to maintain the piercing tip 32 of the lancet 30 retracted within the interior chamber 39 and in a ready to fire position. Once released from that cocked orientation, however, the lancet receiving assembly 40 is structured so as to move, at least temporarily, into a piercing orientation wherein the piercing tip 32 of the lancet 30 protrudes through the piercing opening 37 of the cover assembly 35 and into engagement with the desired surface to be pricked by the piercing tip 32. Subsequent to that temporary movement into the piercing orientation, however, the lancet receiving assembly 40 is further structured to once again generally retract into the fired orientation of FIG. 2. Accordingly, in the fired orientation, the piercing tip 32 is generally concealed within the interior chamber 39 and accidental pricking of an individual cannot occur, either as a result of a minor protrusion of the piercing tip 32 through the piercing opening 37 or of firing the lancet device 10. This retraction will be discussed in greater detail subsequently.

[0038] Looking in greater detail to the preferred structure of the lancet receiving assembly 40, it also includes a retention member 45. The retention member 45, which includes at least one, but preferably a pair of generally elongate fingers 45′, is structured to be maintained within the interior chamber 39 and generally extends towards a base 24 of the primary housing 20. Moreover, each of the elongate fingers 45′ of the retention member further includes an inwardly depending protrusion 47 at a tip 46 thereof. In particular, the inwardly depending protrusion 47 is structured to be cooperatively engaged with an engagement hub 50 also disposed in the interior chamber 39. Preferably, the engagement hub 50 extends into the interior chamber 39 from the base 24 of the primary housing 20. Moreover, the engagement hub 50 preferably includes a generally enlarged head 52 which defines cooperative structure that is to be cooperatively engaged by the inwardly depending protrusions 47 at the tip 46 of the elongate fingers 45′ when the lancet receiving assembly 40 is disposed in its cocked orientation, as in FIG. 3. As such, the lancet receiving assembly 40 is maintained within that cocked orientation until the retention member 45, as defined by the elongate fingers 45′, is affirmatively released from its cooperative engagement with the enlarged head 52 of the engagement hub 50. Moreover, since preferably two or more of the elongate fingers 45′ are employed, more effective retention in the cocked orientation can be achieved, and the device is much less susceptible to accidental firing, such as if accidentally dropped and the interior components are jarred.

[0039] As illustrated in the Figures, the lancet device 10 of the present invention preferably includes a biasing element 44. The biasing element 44, which is preferably in the form of a coil spring, is structured to be disposed about the lancet receiving assembly 40. Moreover, the spring 44 is structured to be compressed within the interior chamber 39, such as between a rim 42 on the lancet receiving assembly 40 and an interior wall 26 of the primary housing 20, when the lancet receiving assembly 40 is disposed in the cocked orientation. Once the retention member 45 is released from its engagement with the engagement hub 50, however, the compressed spring 44 is free to expand and thereby fires the lancet receiving assembly 40 forward with its expansion until the piercing tip 32 of the lancet 30 protrudes through the piercing opening 37 of the cover assembly 35 to define the piercing orientation. As such, the retention member 45, as preferably defined by the elongate fingers 45′, must be structured to engage the engagement hub 50 in a manner which will effectively resist the normal tendencies of the biasing element 44 to expand when the lancet receiving assembly 40 is the cocked orientation. Of course, it is clear that upon release of the retention member 45 from its cooperative engagement with the engagement hub 50, the spring 44 will expand unhindered and result in the firing of the lancet receiving assembly 40. It is noted in the Figures, that in the embodiment wherein the biasing element is compressed between the rim 42 on the lancet receiving assembly 40 and the interior wall 26 of the primary housing 20, a pair of openings 25 are preferably defined in the interior wall 26 so as to permit the free passage and slided movement of the elongate fingers 45′ therethrough.

[0040] In order to release the retention member 45 from its cooperative engagement with the engagement hub 50, the lancet device 10 of the present invention further includes an actuation assembly 60. In particular, the actuation assembly 60 is exteriorly actuatable and is structured and disposed to extend at least partially into the interior chamber 39, upon actuation thereof, so as to at least temporarily urge the elongate fingers 45′ out of engagement with the cooperative structure on the engagement hub 50. Specifically, the actuation assembly 60 includes an actuation head 62 which is structured to be actuated or pushed by a user, and at least one, but preferably a pair, of wedge elements 64 that extend into the interior chamber 39. The wedge elements 64 are preferably structured to generally correspond to the structure and orientation of the inwardly depending protrusion 47 on the elongate fingers 45′ such that when the actuation assembly 60 is pushed down into the interior chamber 39, the wedge element 64 tends to urge the elongate fingers 45′ at least temporarily into spaced relation from the engagement hub 50. As a result, when the wedge elements 64 outwardly urge the elongate fingers 45′, the inwardly depending protrusion 47 will no longer be retained behind the enlarged head 52 of the engagement hub 50 and the lancet receiving assembly 40 is free to move into the piercing orientation and subsequently the fired orientation under the force of the biasing element 44.

[0041] Although the lancet receiving assembly 40 may normally return into the fired orientation under the natural expansion and contraction of the biasing element 44, in the preferred embodiment the lancet device 10 further includes a retraction assembly. The retraction assembly preferably includes a pair of resilient material elements 49. Moreover, these resilient material elements 49 preferably protrude from the elongate fingers 45′ and are disposed so as to engage the primary housing 20, such as at the interior wall 26. Accordingly, as the lancet receiving assembly 40 is driven into its piercing orientation the driving force of the biasing element 44 is sufficient to overcome the resistance of the resilient material elements 49. However, once the piercing orientation has been reached and the biasing element 44 returns to its normal unstressed configuration, the abutted engagement of the resilient material elements 49 with the primary housing 20 results in the retraction of the lancet receiving assembly 40 into the fired orientation of FIG. 2, wherein the piercing tip 32 of the lancet 30 is substantially concealed within the cover assembly 35.

[0042] Also as illustrated in the Figures, the lancet device 10 of the present invention further includes a cocking assembly, generally indicated as 70. The cocking assembly 70 is structured to extend at least partially into the interior of the primary housing 20 so as to move the lancet receiving assembly 40 into its cocked orientation from the fired orientation. As such, the cocking assembly 70 permits exterior cocking of the lancet device 10 in order to provide for use or re-use of the lancet device 10 without having to remove the cover assembly 35 or manipulate the lancet receiving assembly 40 directly from a vicinity of the lancet 30 and the exposed piercing tip 32. In the preferred embodiment, the cocking assembly 70 includes an exterior head 72 and at least one, but preferably a pair of cocking elements 74 that extend into the interior chamber 39 through the base 24 of the primary housing 20. The cocking elements 74 are structured to extend into selective, cooperative engagement with the elongate fingers 45′ of the retention member so as to urge or pull the lancet receiving assembly 40 into the cocked orientation. To achieve the selective, cooperative engagement, each of the cocking elements 74 preferably includes an inwardly depending abutment 76 that is structured to engage an outwardly extending abutment 48 disposed on the elongate fingers 45′ of the retention member. This engagement, however, is structured to be achieved only when the cocking assembly 70 is pulled outwardly away from the primary housing 20. As illustrated in the Figures, the inwardly depending abutments 76 of the cocking assembly 70 are disposed in a generally spaced apart relation from the outwardly extending abutments 48 on the elongate fingers 45′ when the lancet receiving assembly 40 is in the cocked orientation, as in FIG. 3. As such, upon release of the lancet receiving assembly 40 from its cocked orientation and its driven movement into the piercing orientation and subsequent fired orientation, the inwardly depending abutments 76 are sufficiently spaced from the outwardly expanding abutments 48 so as to not restrict or in any way hinder the movement of the lancet receiving assembly 40 into that piercing orientation. When, however, the exterior head 72 of the cocking assembly 70 is grasped and pulled, the cocking elements 74 are pulled at least partially out of the interior chamber 39 and the inwardly extending abutments 76 move up and into engagement with the outwardly extending abutments 48 of the retention member 45 such that upon continued movement of the cocking assembly 70 the retention member 45, and accordingly the entire lancet receiving assembly 40, is pulled towards the engagement hub 50 until it is affirmatively coupled with the engagement hub 50. Also in the preferred embodiment of FIG. 3, at least one, but preferably a pair of biased elements 78 are disposed between the base 24 and an outwardly depending element 79 extending from each cocking element 74. These biased elements serve to return and maintain the cocking assembly 70 in its normally retracted orientation when not actually being used for cocking the device, thereby ensuring that the cocking assembly 70 does not hinder or obstruct firing movement of the lancet receiving assembly 40.

[0043] As an additional advantage of the present invention, as the elongate fingers 45′ are urged up into their cooperative engagement with the engagement hub 50, if no pressure is being placed on the actuation assembly 60, the elongate fingers 45′ tend to urge the actuation assembly 60 up through the cocking assembly 70 into a ready to actuate orientation, as in FIGS. 1 and 3, wherein the actuation head 62 protrudes above a plane of the exterior head 72 of the cocking assembly 70. In particular, in the preferred embodiment the exterior head 72 of the cocking assembly 70 is disposed in generally surrounding relation to the actuation head 62 of the actuation assembly 60. As such, when the lancet device 10 is in the cocked orientation, the actuation head 62 of the actuation assembly 60 at least partially protrudes beyond a plane of the exterior head 72 of the cocking assembly 70 and provides a substantially clear and easy to identify, tactile identification that the lancet device 10 is in a ready to fire or cocked orientation. When, however, the actuation assembly 60 is actuated or depressed, the actuation assembly 60 tends to retract such that the actuation head 62 drops at least even with, but preferably below a plane of the exterior head 72 of the cocking assembly 70 and is concealed thereby so that the user can easily identify that the lancet device 10 is not ready to fire. Turning to FIG. 4 so as to achieve the effective positioning orientation of the cocking assembly 70 and the actuation assembly 60, it is noted that the base 24 of the primary housing 20 preferably includes a series of apertures 27 and 28 defined therein. In particular, the exterior apertures 27 are structured to receive the cocking elements 74 therethrough, while the interior apertures 28 are structured to receive the wedge elements 64 of the actuation assembly 60 therethrough. Moreover, the base 24 may be integrally molded with the side walls of the primary housing 20, or may comprise a separate element that is secured to the side walls, such as by gluing, a snap fit or any conventional procedure employed on the material(s) utilized to manufacture the primary housing 20.

[0044] Turning to FIGS. 5, 6 and 7, in a further embodiment of the lancet device 10, a preferably removable lancet extension segment 80 is provided. The lancet extension segment 80 is structured to be removably coupled to the remainder of the lancet device 10, such as by press or snap fitting, threaded coupling, or clipping, so as to extend an overall length thereof and make the lancet device 10 more manipulable, such as may be necessary by a person with limited or impaired dexterity. Preferably the extension segment 80 includes a moveable element 82. The moveable element 82 preferably includes a proximal end 84 and a distal end 86. As illustrated in the figures, when the extension segment 80 of the present invention 80 is utilized, the lancet 30 is preferably disposed at the proximal end 84 of the moveable element 82. As such, the proximal end 84 of the moveable element preferably includes a socket type structure similar to that of the lancet receiving assembly 40 and can at least temporarily hold and retain the lancet 30 during its full range of movement. Looking to the distal end 86 of the moveable element 82, it preferably includes a configuration similar to that of the body portion 31 of the lancet 30, but regardless is structured to be fitted into the lancet receiving assembly 40 so as to generally couple the moveable element 82 with the lancet receiving assembly 40. Accordingly, upon movement of the lancet receiving assembly 40 into and out of its cocked and fired orientations the moveable element 82 also moves, placing the lancet 30 into its piercing orientation. As illustrated, if desired a collar or stopper type structure 87 or 87′ can be provided so as to facilitate fitting of the distal end 86 into the lancet receiving assembly 40.

[0045] Also in the embodiments of FIGS. 5, 6 and 7, the extension segment 80 preferably includes an extension housing 90. The extension housing 90 is structured to generally contain the moveable element 82 and preferably includes a configuration similar to that of the primary housing 20. The extension housing 90 is structured to be coupled at the open end 22 of the primary housing 20 in much the same manner that the cover assembly 35 is coupled to primary housing, or if desired by more secure or alternate means, such as a threaded interconnection. Moreover, the extension housing 90 is structured such that the preferred cover assembly 35 can be coupled thereto. As such, when a normal mini configuration is employed, the lancet 20 is introduced into the lancet receiving assembly 40 and the cover assembly 35 is secured at the open end 22 of the primary housing. When, however, a more elongate configuration is desired, the distal end 86 of the moveable element 82 is introduced into the lancet receiving assembly 40, the lancet 20 is introduced into the proximal end 84 of the moveable element 82, the extension housing 90 is coupled at the open end 22 of the primary housing 20, and the cover assembly 35 is secured to the extension housing 90. The lancet device 10 can then be used as previously described, with the preferably rigid structure of the extension housing 90 providing a further gripping surface for a user. Indeed, if desired, more than one of the extension segments 80 can be provided, and coupled in-line with one another so as to achieve an even longer configuration or so as to provide greater adjustability is shorter individual extension segments 80 are used. To facilitate such a use of multiple extension segments 80, the preferred extension housing 80 is configured so as to be coupled to another, adjacent extension housing 90 in much the same manner, or a more secure manner as described, as the first extension segment 80 is coupled to the primary housing or the cover assembly. Further, the proximal end 84 of each moveable element may include a threaded interior, which while not generally required to receive most conventional lancets, can be structured so as to not hinder receipt of the lancet, but to be threadingly coupled with a correspondingly threaded distal end 86 of an adjacent extension segment 80. Further, in such an embodiment, it may be advantageous to also include a biased return element operably engaged with between the moveable element 82 and the extension housing 90, and structured to withdraw the moveable element 82 and therefore the piercing tip from the piercing orientation to the fired orientation. Although not necessary, such a return element provides added assurances that the used piercing tip will not remain exposed after firing. Although the biased return element may include a separate spring or other element disposed, such as, between a restrictor element 88 and restrictor panel 94, both to be discussed in detail subsequently, or between the restrictor panel 94 and the proximal end 84 of the moveable element 82, as shown in the embodiment of FIG. 7, one or more fingers 89 can be provided so as to achieve the biasing effect. Moreover, such a finger 89 can be used either in addition to or in place of the restrictor element to be discussed.

[0046] Specifically, so as to ensure that the moveable element 82 does not become lost or separated from the preferred extension housing 90, the preferred embodiment also includes a restriction assembly which movably couples the moveable element 82 with the primary housing 90. Preferably the restriction assembly includes at least one restrictor segment 88 or 89 protruding from the moveable element 82. This restrictor segment 88 can include a rigid or flexible finger type element or a collar type structure. Furthermore, coupled to the extension housing 90 is at least one, but preferably a pair of spaced apart restrictor panels 92 & 94, as in the embodiment of FIGS. 5 and 6. The restrictor panels 92 and 94 each preferably include an aperture 93 & 95, respectively, defined therein so as to permit movement of the moveable element 82 therethrough. However, the restrictor segment 88 is preferably large or elongate enough so as to abut the restrictor panels 92 and 94 and be contained, thereby preventing or at least limiting complete removal of the moveable element 82 from the extension housing 90. Alternatively, as in FIG. 7, a single restrictor panel 94′ may be provided and sandwiched between one or more restrictor segments 88. In the illustrated embodiment, the proximal end 84 of the moveable element 82 has a generally enlarged diameter so as to accommodate the lancet 30, and thereby act as the second restrictor segment. As such, the aperture 95′ of the restrictor panel 94′ is generally smaller so as to prevent passage of the proximal end 84 of the moveable element 82 therethrough.

[0047] 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.