Abstract:
A single use lancet device having a housing, a lancet with a piercing tip movably disposed in the housing and structured to move between a cocked orientation and a piercing orientation, and a driving assembly structured to move the lancet into the piercing orientation. A retention member and an engagement hub are further provided and structured to be cooperatively engaged with one another upon the lancet being disposed in the cocked orientation so as to maintain the lancet in the cocked orientation until released by an actuation assembly. Specifically, the actuation assembly is structured to move between an actuated and an un-actuated orientation, movement into the actuated orientation releasing the retention member and the engagement hub from their cooperative engagement with one another and thereby result in movement of the lancet into the piercing orientation. The device also includes a restrictor assembly structured to substantially prevent the actuation assembly from moving out of the actuated orientation, thereby preventing re-firing of the lancet utilizing the actuation assembly.

Description:
CLAIM OF PRIORITY  
       [0001]    The present application is a patent application of previously filed, now pending patent application having Ser. No. 60/297,826, filed on Jun. 13, 2001, which is a Continuation-In-Part of U.S. patent application having Ser. No. 09/709,738 filed Nov. 10, 2000, also incorporated herein in its entirety by reference. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention relates to a single use lancet device structured to be conveniently and effectively utilized for various blood sampling procedure, but which is also substantially safe, preventing re-firing of the device after it has been used, and thereby preventing and/or substantially minimizing inadvertent contamination of a patient and/or other personnel as a result of a used and potentially contaminated lancet. Furthermore, the device is compact and easy to utilize in a cost effective and preferably fully disposable manner.  
           [0004]    2. Description of the Related Art  
           [0005]    Lancets are commonly utilized instruments which are employed both in hospitals and other medical facilities, as well as by private individuals, such as diabetics, in order to prick or pierce a patient&#39;s skin, typically on a finger of a patient, thereby leading to the generation of a blood sample which can be collected for testing. Because of the wide spread use of such lancets, there are a variety of lancet devices which are available for utilization by patients and/or practitioners in a variety of different circumstances.  
           [0006]    For example, a typical lancet may merely include a housing with a sharp piercing tip that is pushed into the patient&#39;s skin. More commonly, however, lancet devices, which house a piercing tip and/or a lancet, have been developed which effectively encase and fire the lancet into the patient&#39;s skin, thereby eliminating the need for the person taking the sample to actually push the lancet tip into the skin.  
           [0007]    Within the various types of specialized lancet devices, one variety are typically configured for multiple and/or repeated uses, while another category is particularly configured for single use, after which the entire device is disposed of. Looking in particular to the single use, disposable lancet devices, such devices typically include a housing which contains and directs or drives a piercing tip into the patient&#39;s skin, and which is disposed of along with the used lancet. Naturally, so to make such disposable devices cost effective for frequent use, such devices tend to be rather simplistic in nature providing only a sufficient mechanism for firing, and not overly complicating the design so as to minimize that cost.  
           [0008]    While existing single use devices are generally effective for achieving the piercing of the skin required for effective operation, such single use, disposable devices typically do not incorporate a large number of safety features to ensure the safe use and disposal of the device. For example, one primary area of safety which must be addressed with all lancet devices pertains to the purposeful and/or inadvertent reuse of a contaminated lancet. Unfortunately, most currently available single use lancet devices are configured such that after a use thereof has been achieved, it is possible for a patient to re-cock the device, thereby allowing for a subsequent, inappropriate use.  
           [0009]    As a result, it would be highly beneficial to provide a single use lancet device which is substantially compact and disposable, can be manufactured in a substantially cost effective manner, and which nevertheless is substantially safe to utilize, affirmatively preventing re-use, once contaminated. Additionally, it is noted that while other devices may be provided to prevent the lancet form even being cocked, it would still be beneficial to provide a device that even if the lancet is re-cocked does not allow for additional and/or secondary firing.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention is direct to a single use lancet device of the type commonly utilized for various blood sampling purposes. In particular, the single use lancet device of the present invention includes a housing and a lancet. The lancet, which also includes a piercing tip, is movably disposed in the housing and is structured to move at least between a cocked orientation and a piercing orientation. A driving assembly is provided so as to actually move the lancet at least temporarily into the piercing orientation.  
           [0011]    The lancet may be retained in the cocked orientation by means of at least one embodiment of a retention assembly. In this embodiment of the present invention, at least one retention member and a corresponding engagement hub are cooperatively disposed. In particular, the engagement hub is structured to be cooperatively engaged with the retention member, at least when the lancet is disposed in the cocked orientation. As a result, the retention member and the engagement hub, which may be cooperatively engaged with the housing and the lancet, effectively maintain the lancet in the cocked orientation until they are released from that engagement with one another. As such, it is seen, in this embodiment, that when the lancet is ready for use, it is maintained in the cocked, ready to fire orientation until that time.  
           [0012]    In order to release the lancet, and more particularly the cooperative engagement between the retention member and the engagement hub of the illustrated embodiment, the present invention further includes an actuation assembly. Specifically the actuation assembly is structured to move between an actuated and an un-actuated orientation. In this regard, movement of the actuation assembly into the actuated orientation is structured to release at least the retention member and the engagement hub from their cooperative engagement with one another, thereby resulting in movement of the lancet into the piercing orientation.  
           [0013]    In order to substantially minimize the inadvertent re-use of the single use lancet device of the present invention, a restriction assembly is also preferably provided. Specifically, the restriction assembly is structured to substantially prevent the actuation assembly from moving from a piercing orientation towards a cocked orientation and out of the aforementioned actuated orientation. In this regard, the restriction assembly may include a stop member preferably in the form of at least one abutment structure that is fixedly mounted on the housing. In addition, the restriction assembly includes a restrictor member mounted at least on the lancet member and in abutting relation with the stop member as the restrictor member travels in the direction of the cocked orientation from the piercing orientation. As such, once the lancet device of the present invention has been fired the actuation assembly and/or lancet cannot move back into its un-actuated orientation/cocked orientation for a subsequent firing, regardless of whether the lancet itself may or may not be moved back into the cocked orientation.  
           [0014]    These and other 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  
       [0015]    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:  
         [0016]    [0016]FIG. 1 is a rear perspective illustration of an embodiment of the single use lancet device of the present invention;  
         [0017]    [0017]FIG. 2 is an interior longitudinal cross sectional view of an embodiment of the single use lancet device of the present invention in an un-cocked, un-fired orientation;  
         [0018]    [0018]FIG. 3 is an illustration of the embodiment of FIG. 2 wherein the lancet is disposed under tension and in a ready to be fire orientation;  
         [0019]    [0019]FIG. 4 is side view of the embodiment of FIG. 2 illustrating a release point between the lancet and the actuation assembly so as to permit the lancet to be fired;  
         [0020]    [0020]FIG. 5 is a side view of the embodiment of FIG. 2 illustrating the lancet disposed in a piercing orientation and the actuation assembly in a locked orientation;  
         [0021]    [0021]FIG. 6 is a side view of the embodiment of FIG. 2 illustrating a retracted orientation after the firing of single use lancet device of the present invention;  
         [0022]    [0022]FIG. 7 is a side cross sectional view of an alternative embodiment of the single use lancet device of the present invention;  
         [0023]    [0023]FIG. 8 is a side cross sectional view of yet another alternative embodiment of the single use lancet device of the present invention;  
         [0024]    [0024]FIG. 9 is a side cross sectional view of still another embodiment of the single use lancet device of the present invention; and  
         [0025]    [0025]FIG. 10 is a front, interior view of the embodiment of FIG. 9.  
         [0026]    Like reference numerals refer to like parts throughout the several views of the drawings. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0027]    Looking to the Figures, the present invention is directed to a single use lancet device, generally indicated as  10 . In particular, the single use lancet device  10  is structured to be utilized so as to pierce a patient&#39;s skin, such as with the piercing tip  25  of a lancet  24  in order to obtain a blood specimen from the patient. Furthermore, the present single use lancet device  10  is preferably configured to be substantially small and compact, and structured so as to permit only a single use thereof. The spread of disease and/or other contaminants from the inadvertent and/or deliberate reuse of such a single use lancet device  10  will thereby be prevented.  
         [0028]    The single use lancet device  10  of the present invention preferably includes a housing  20 . The housing  20  is preferably generally rigid and compact so as to be easily and comfortably held and manipulated by the user. In this regard, the housing  20  may be contoured and/or have any configuration that can be effectively and conveniently held and operated by a user. Movably contained within the housing is a lancet  24 . In particular, the lancet  24  preferably includes a piercing tip  25  that extends outwardly from a front or leading end  24 ′ of a movable body  24 ″, which is to be considered a part of the lancet  24 . Further, the lancet  24  is structured to be contained within an interior of the housing  20  and to move therein, as will be described in greater detail hereinafter.  
         [0029]    A driving assembly, preferably in the form of a biasing element  50 , is disposed and/or connected relative to the lancet  24  so as to force it into a piercing orientation, best illustrated in FIG. 5. Furthermore, the lancet  24  preferably only temporarily achieves the piercing orientation illustrated in FIG. 5, after which it is retracted into an interior of the housing  20 , as illustrated in FIG. 6. Once retracted, the piercing tip  25  is disposed within the housing  20  and is thereby effectively concealed and prevented from inadvertent contact with the user, patient, etc. Moreover, as will also be described hereinafter, in the retracted orientation of FIG. 6, one or more structural components are preferably incorporated in the single use lancet device  10  that prevent the lancet  24  from being effectively re-fired.  
         [0030]    In order to achieve movement of the lancet  24  into a generally cocked, under tension orientation, the single use lancet device  10  also preferably includes an actuation assembly  40 . In addition, the lancet  24  preferably moves within the housing  20  while being maintained in a properly aligned orientation by one or more guide tracks or wings  26 . Further, various embodiments of the present invention include a positioning assembly which comprises at least one positioning member. The positioning member may be in the form of a gear member  30  movably and detachably connected between the actuation assembly  40  and the lancet  24 . In particular, the positioning assembly is configured so as to move the lancet  24  rearward, compressing the biasing element  50  and placing the lancet  24  under tension, when the actuation assembly  40  is pushed forward as indicated by directional arrow  39 , such as by a thumb of the user. As a result, when an unfired lancet  24 , as illustrated in FIG. 2, is grasped, the user merely pushes forward on the actuation assembly  40 . The actuation assembly  40  at least partially extends into the interior of the housing  20 , such as by passing through an actuation access opening  21 . When moved forward, the lancet  24  is caused to move rearward toward or into the cocked orientation by virtue of the at least one positioning member such as gear  30 .  
         [0031]    Eventually, the actuation assembly  40  will be pushed forward to a sufficient degree to achieve a release point where the positioning member or gear  30  will be released or detached from concurrent inter connection with both the lancet  24  and the actuation assembly  40 , as will be described hereinafter. Upon the actuation assembly reaching the release point, the tension exerted on the lancet  24  by the biasing element  50  causes the lancet  24  to be driven forward temporarily into its piercing orientation, as illustrated in FIG. 5. Subsequently, as disclosed in FIG. 6, the biasing element  50  will return automatically to its normally relaxed position, thereby forcing the lancet  24 , and in particular the piercing tip  25 , back into the housing  20  into a retracted orientation disclosed in FIG. 6. In its retracted orientation, the piercing tip  25  will be contained within the housing  20  thereby preventing inadvertent contact or engagement of the piercing tip  20  with any person or object.  
         [0032]    Looking to the embodiment of FIGS. 1 through 6, the actuation assembly  40  includes an exterior portion  42  which is structured to be manipulated by a user, such as by engagement with the user&#39;s thumb. As such, the actuation assembly  40  preferably slides relative to the housing  20  in a generally parallel orientation to the movement of the lancet  24 , preferably through the provision of a guide track or wing  48 . Exposed, preferably on an underside of the actuation assembly  40 , however, is a track element  44 .  
         [0033]    More specifically, the track element  44  is structured to operatively engage the rotating gear  30  of the positioning assembly. The gear  30  is connected to the housing  20 , but freely rotates therein. Moreover, the lancet  24  preferably also includes a corresponding track  28  which also engages the interconnecting, rotating gear  30 . Accordingly, as the track  44  on the actuation assembly  40  moves forward, the gear  30  rotates clockwise and because of its engagement with the track  28 , causes the lancet  24  to be pulled or moved rearward within the housing  20 . The track  44  on the actuation assembly  40 , however, has only a predetermined limited length, and as such, when a clearance point is reached, as in FIG. 4, the track  44  no longer engages the gear  30 . The gear  30  can then freely rotate allowing the lancet  24  to be urged forward into the piercing orientation as a result of the force exerted thereon by the biasing element  50 . In this regard, one fluid, forward pushing movement of the actuation assembly  40  achieves a movement of the lancet  24  first into the cocked orientation and then into the piercing orientation. In the piercing orientation the piercing tip  25  engages a patient as intended.  
         [0034]    In order to prevent the single use lancet device  10  of the present invention from being re-used, one or more safety structures have been provided. In particular, a restriction assembly is preferably provided and cooperatively disposed between the lancet  24  and the housing  20 . In the embodiment of FIG. 2, the restriction assembly comprises a restrictor member, which may take the form of a biasing element  27  protruding from the movable body  24 ″ of the lancet  24 . When moving in a forward direction (see directional arrow  39 ), the biasing element  27  is structured to freely pass over a stop member or abutment  33  preferably fixedly disposed on the interior of the housing  20 . As the lancet  24  is forced into its piercing orientation, the biasing element  27  does not restrictively engage abutment  33 . However, as the lancet  24  is retracted in a rearward direction, back into the interior of the housing  20 , the biasing element  27  and the stop member or abutment  33  are relatively disposed and cooperatively structured to restrictively engage one another and limit the rearward movement of the lancet  24 . As a result, the lancet  24  can not be pushed rearward into a generally cocked orientation and therefore can not be re-fired.  
         [0035]    As an additional safety measure, however, the actuation assembly  40  is preferably configured such that it may fire the single use lancet device  10  only a single time. Looking to the embodiment of FIG. 2, the actuation assembly  40  may include a trailing portion  46  within an abutment head  47 . In particular, the abutment head  47  is preferably generally angled, or otherwise configured, to move freely over a corresponding abutment element  34  in the housing  20  when the actuation assembly  40  is moved forward (see directional arrow  39 ) during firing of the lancet  24 . Accordingly, when the actuation assembly  40  has moved forward sufficiently so as to release or be disconnected from the gear  30 , the lancet  24  will be forced forward, into the piercing orientation. The abutment head  47  will then have passed over the cooperatively structured stop or abutment element  34 . Subsequent to the firing of the lancet  24 , restrictive engagement between the abutment element  34  and the abutment head  47  will limit rearward movement of the actuation assembly  40  to a point where it cannot re-engage the gear  30  of the positioning assembly. Re-firing of the single use lancet device  10  is thereby further provided.  
         [0036]    Looking to the embodiment of FIG. 7, the actuation assembly differs from the embodiment of FIGS. 1 through 6 and comprises a rotationally mounted actuation member  31  that protrudes outwardly from housing  20  through an access opening  21 ′. In this embodiment, the positioning member of the of the positioning assembly comprises a gear segment  32  formed along a portion of the periphery of actuation member  31 . As such, as the actuation member  31  is rotated by exerting a pushing force thereon, as indicated by directional arrow  39 ′, the lancet  24  is moved rearwardly and placed under tension by the biasing element  50 . Eventually, however, the forward rotation of the large central gear  31  will be such that the gear segment  32  will be disengaged from the track  28  on the lancet  24 . The lancet  24  will thereby be released causing it to be effectively fired and move into its piercing orientation. In such an embodiment, any of a variety of different components could be utilized so as to prevent subsequent movement of the large central gear  31 . However, a restriction assembly comprising a restrictor member or biasing element  27  and stop member or abutment element  33 , as described above will provide sufficient safety to prevent re-firing of the lancet  24 .  
         [0037]    [0037]FIG. 8 represents yet another embodiment of the present invention, wherein the actuation assembly may be configured as a rear push button, generally indicated as  60 . In this embodiment, the rear push button actuation assembly  60  includes an elongate element  62  mounted on the interior of the housing  20  and provided with a gear track  63  formed thereon. This gear track  63  is disposed and configured to movably engage and manipulate the positioning member or gear  30 . The gear  30  is also disposed in movably engaging relation with the gear track  28 ′ fixedly secured to lancet  24 . Forward movement of the push button actuation assembly  60  and the track  63 , in accordance with directional arrow  39 , causes the appropriate rearward movement of the lancet  24  due to the interconnection of the gear  30  with both the tracks  63  and  28 . The lancet  24  is thereby compressed against the biasing element  50  of the driving assembly and then subsequently released causing the firing of the lancet  24 .  
         [0038]    In such an embodiment, the restriction assembly may comprise a restrictor member in the form of an abutment head  64  and a corresponding stop member in the form of an abutment element  65  associated with the elongated element  62  or with an oppositely disposed element  62 ′, as illustrated in FIG. 8. In either such embodiment, after lancet  24  has been fired due to sufficient forward movement of the push button actuation assembly  60  into a compressed position, the push button actuation assembly  60  can not be withdrawn from its compressed position within the housing  20  and it can not be re-used.  
         [0039]    Moreover, in the embodiment of FIGS. 9 and 10, the actuation assembly  40 ′ may also be configured to achieve a degree of sliding stability for the lancet  24 . In this embodiment, a gear  30 ′ protrudes from either one or both sides of the lancet  24  into movable engagement with one or more downwardly depending track segments  41  secured to the actuation assembly  40 ′. Interconnection and moveable engagement of the gear  30 ′ with the gear tracks  41  and  28  cause the corresponding movement of the lancet  24  rearward into a compressed position from which it is subsequently released into the fired position.  
         [0040]    Also, in the embodiment of FIGS. 9 and 10, a slot  68  may be provided within the lancet  24  so as to effectively receive the gear  30 ′. Of course, an open top or bottom configuration may also be effectively achieved, so long as the gear track  28  is appropriately positioned. Indeed, if desired the gear track  28  may be configured on the same side of the gear  30 ′ as the actuation assembly  40 ′. However, in such a variation of this embodiment further modification of the actuation assembly  40 ′ may be desired.  
         [0041]    Further included in the embodiment of FIG. 9, is a restriction assembly which may comprise, in addition to or instead of biasing element  27  and abutment  33 , abutment head  64 ′ and housing abutment  65 ′. The actuation assembly  40 ′ may thereby be locked in a position by interaction of the abutment elements  64 ′ and  65 ′ in a manner similar to that described with reference to the embodiment of FIG. 8, after it is been used to fire the lancet  24 . Accordingly, whether positioned to the forward or rear end of the actuation assembly  40 ,  40 ′, it is seen that a trigger lock assembly may be provided which can effectively achieve securement of the actuation assembly  40 ′ and prevent intended and/or accidental re-use of the single use lancet device  10  of the present invention.  
         [0042]    In addition, at least some if not all of the embodiments of the present invention includes the side track or wing  26  preferably disposed and structured to achieve stability for the lancet  24  during the movement thereof.  
         [0043]    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.