WO2003092512A1

WO2003092512A1 - Lancet device

Info

Publication number: WO2003092512A1
Application number: PCT/US2003/011087
Authority: WO
Inventors: Steven Schraga
Original assignee: Steven Schraga
Priority date: 2002-04-29
Filing date: 2003-04-11
Publication date: 2003-11-13
Also published as: CA2484942C; US8118825B2; US20040147948A1; EP1501428A4; AU2003237803A1; EP1501428A1; US20040039407A1; CA2484942A1

Abstract

A lancet device (10) including a housing (20) with an at least partially open interior, a cocking seat (30) moveably coupled with the housing and structured to define an open interior therewith, a lancet with a piercing tip (42) moveably disposed within the open interior, and a biasing assembly (50) engaging the lancet. The cocking seat (30) is structured to engage the lancet (10) and move the lancet against a force of the biasing assembly (50) so as to increase a potential energy of the biasing assembly.(50). A release element (56) is provided to at least partially disengage the lancet from the cocking seat such that the potential energy of the biasing assembly moves the lancet relative to the cocking seat and drives the piercing tip of the lancet at least temporarily into a piercing orientation.

Description

Description A LANCET DEVICE

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a lancet device preferably configured to provide a single use, and in all embodiments configured to substantially shield and protect a piercing tip thereof before and after use, while providing for accurate and effective piercing engagement of a patient's skin when appropriate. Furthermore, the present lancet device does not require complex and/or difficult to manipulate cocking and actuation activity in order to prepare the lancet device for piercing engagement with the skin, but rather is configured so as to be easily compressed, and in doing so provide all necessary cocking and actuation required to result in appropriate engagement of the skin by the piercing tip.

Description of the Related Art

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'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 .

For example, a typical lancet may merely include a housing with a sharp piercing tip that is pushed into the patient'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's skin, thereby eliminating the need for the person taking the sample to actually push the lancet tip into the skin.

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's skin, and which is disposed of along with the used lancet. Naturally, so as 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.

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.

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.

A further drawback associated with conventionally employed single use lancet devices is that they can often be difficult and/or complicated for elderly and/or impaired individuals to manipulate in order to achieve effective use. In particular, such existing devices often require a user to perform a number of different actions, including one to cock and thereby prepare the device for use, and another to actually fire the device. As can be appreciated, those procedures, even in the simplest form, can sometimes be complex and/or difficult to effectively achieve on a small compact device by certain individuals, and especially those individuals performing self testing who necessarily only have one hand to use to manipulate the device. Indeed, to avoid these complexities, some manufactures have turned to the use of pre-cocked and ready to use devices, however, this can often result in misfires and/or pre-fires of the lancet such that a certain of percentage of the lancet devices are not usable.

As a result, it would also be beneficial to provide a lancet device, which whether single use and/or multiple use, could be very simplistic and effective to employee, not requiring a series of often complex activities to be perform in order to prepare the lancet for use and in order to actually utilize the lancet. Still, however, such a device should not comprise safety in the prevention of inadvertent use and/or re-use in exchange for the simplistic use, but rather should effectively coordinate all such beneficial characteristics. It would also be beneficial such a device could be effectively and cost effectively manufacture so as to make it available and affordable to a large variety of users, including home users.

Summary of the Invention

The present invention relates to a lancet device, and preferably a single use lancet device, utilized so as to effectively pierce a patient's skin and result in bleeding for subsequent sample collection. The lancet device of the present invention preferably includes a housing having an at least partially open interior. Furthermore, a lancet is movably disposed relative to the housing and includes a piercing tip which ultimately will penetrate the patient's skin. Similarly, a biasing assembly is interposed between the lancet and the housing. The biasing assembly engages the lancet and functions to urge the lancet into its piercing orientation, when appropriate.

The lancet device of the present invention also includes a cocking seat . The cocking seat is structured to engage the lancet and move the lancet against the force of the biasing assembly so as to increase a potential energy of the biasing assembly. In the preferred embodiment, the user's finger and/or another body part which is to be pierced, engages the cocking seat and thereby pushes the cocking seat and the lancet until it ultimately engages a release assembly that extends into the housing. The release assembly is structured to disengage the lancet from the cocking seat such that the potential energy of the biasing assembly drives the piercing tip of the lancet at least temporarily into its piercing orientation. It is the movement of the lancet by the cocking seat which ultimately moves the lancet into its releasing engagement with the release element. As a result, in the preferred, illustrated embodiment, as the cocking seat moves the lancet, simultaneously cocking it and moving it into its engaging relation with the release element for effective actuation and firing thereof to pierce the skin of the patient.

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

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:

Figure 1 is a side cross-sectional view of a preferred embodiment of the lancet device of the present invention in an unused orientation;

Figure 2 is a side cross-section view of the embodiment of Figure 1 in a substantially cocked and immanent to release orientation;

Figure 3 is a side cross-sectional view of a further embodiment of the lancet device of the present invention;

Figure 4 is an exploded view of the lancet device and cocking seat of a preferred embodiment of the present invention; and

Figure 5 is a side cross-section view of still another embodiment of the lancet device of the present invention illustrating a re-usable configuration thereof. Like reference numerals refer to like parts throughout the several views of the drawings .

Detailed Description of the Preferred Embodiment

Shown throughout the Figures, the present invention is directed towards a lancet device, generally indicated as 10. In the preferred embodiment of the present invention, as illustrated in Figures 1 through 3 the lancet device 10 is preferably a single use device such that after it is utilized for the first and only time it is configured so as to prevent subsequently use. Ultimately, however, as illustrated in Figure 5, a re-usable configuration may be provided.

Looking specifically to the Figures, the lancet device of the present preferably includes a housing 20. The housing 20 includes an at least partially open interior 22 and can be made of any variety materials, but preferably will be formed of a molded plastic type material for ease of manufacture and minimization of cost. Also in the preferred embodiment, the housing 20 preferably includes an open end 26, which may represent a general front of the lancet device 10, and may include any variety of axial configurations, including a square, triangle, oval, circle, etc., although a generally elongated, longitudinal configuration as illustrated in the Figures is preferred in conjunction therewith.

The lancet device 10 further includes a lancet 40 movably disposed at least partially within the housing 20 and including a piercing tip 42. In the single use embodiment of Figures 1 through 3 the lancet 40 is a single integral unit as shown. Alternatively, as illustrated in the embodiment of Figure 5, what is referred to as a lancet in the claims may include a lancet body 40' from which the piercing tip 42 extends, as well as a lancet receiving assembly 41, into which the lancet body 40' is disposed for movable retention. In such an embodiment, each time the lancet device 10 is to be re-used, a new lancet body 40' with piercing tip 42 is disposed within the lancet receiving assembly 41. In either embodiment, however, the lancet is movably disposed within the housing 20.

Preferably the lancet engages a biasing assembly also preferably disposed within the housing 20. In the illustrated preferred embodiments, the biasing assembly includes a biasing element 50 such as a metal or plastic spring. Preferably, the biasing element 50 is interposed between the lancet 40 and a rear end 55, 55' of the housing 20. The rear end 55, 55' may be unitary or separate from the housing 20. Moreover, positioned so as to engage the lancet 40 is a cocking seat 30. In particular, the cocking seat 30 is structured to engage the lancet 40 and move the lancet 40 against a force of the biasing assembly 50 so as to increase a potential energy of the biasing assembly 50. In the illustrated embodiments, and as best seen in Figure 2, the cocking seat 30 urges the lancet 40 towards the rear end of the lancet housing 20, thereby resulting in a compression of the biasing assembly 50 and an increase in the potential energy thereof. Further, so as to maintain effectively appropriate alignment of the lancet and the cocking seat 30 as they are moving relative to the housing 20, in the preferred embodiment, a guide track assembly 24, 32 may be provided between the cocking seat 30 and the housing 20.

In the preferred, illustrated embodiments, an engagement assembly 34, 45 is provided and preferably interposed between the cocking seat 30 and the lancet 40 so as to maintain moving engagement between the lancet 40 and the cocking seat 30 until they are disengaged, as will be described. In the illustrated embodiments, the engagement assembly includes an engagement element 45 that extends from lancet 40 into effectively retained, engaging relation with a retention lip 34 on the cocking seat 30. As a result, as the cocking seat 30 moves inward towards the rear end 55 of the housing 20, the effective engagement between the engagement element 45 and the retention lip 34 results in movement of the lancet 40 in unison with the cocking seat 30. In this regard, it is understood that a variety of different engagement assemblies, including one in which the engagement element extends from the cocking seat into engagement with a corresponding retention lip on the lancet, may also effectively be provided, the engagement assembly being configured so as to provide for effective substantially, although not necessarily completely, unitary movement between the lancet 40 and the cocking seat 30 until effective release thereby, as will be described.

In particular, the present lancet device 10 further includes a release element 56. In the illustrated embodiments, the engagement element 45 of the engagement assembly preferably has a generally flexible and/or resilient characteristic relative to the lancet 40, and/or as will be described, includes a single use pivot 46. As a result, when the cocking seat 30 and therefore the lancet 40 are urged sufficiently into an interior 22 of housing 20, the release element 56 which also at least partially extends into an interior of the housing 20 when firing is desired, serves to engage the engagement element 45, and ultimately causes upward movement thereof for disengagement between the engagement element 45 and a retention lip 34. Moreover, this disengagement is achieved after a substantial amount of potential energy has been achieved in the biasing assembly 50. As a result, disengagement between the lancet 40 and the cocking seat 30 results in the lancet 40 moving relative to the cocking seat 30 under a force achieved by the potential energy stored in the biasing assembly 50. The guide track 32 may also serve to guide generally linear movement of the lancet 40 relative to the cocking seat 30, as the lancet 40 moves to the open interior 31 of the cocking seat 30 and ultimately protrudes through an opening 37 in an exterior end 36 of the cocking seat 30.

Looking further to the single use pivot 46, this may be defined by a reduce thickness region in the segment that ultimately defines the engagement element. The pivot 46 is configured such that when the release element 56 engages the engagement element 45, the engagement element 45 pivots on said pivot point 45 and cannot generally return to its pre-pivoted orientation. As a result, even if re-positioning of the engagement element relative to the cocking seat was attempted, the necessary engagement could not be achieved as the reduced thickness portion snaps and or deforms to prevent such repositioning. A single use of the device is therefor further ensured.

As previously indicated, the cocking seat 30, and preferably the exterior end 36 of the cocking seat 30 may be configured to engage a patient, at least in a general vicinity of a portion to be pierced. Furthermore, in the preferred, illustrated embodiment, the opening 37 at the end 36 of the cocking seat 30 is preferably aligned with a specific location to be pierced, such as on a tip of the finger. That portion of the body, such as the finger, is thereby utilized as an abutment on one of the lancet device 10, while a corresponding support element, such as another finger or a thumb of the patient, or a hand of a medical practitioner or other user, or a solid surface, engages the housing 20 of the lancet device 10. In this regard, as either or both the body section and the support element are moved towards one another such that a spacing therebetween is reduced, the cocking seat 30 moves further into the housing 20 until ultimately the engagement element 45 engages and is released by the released element 56. Once this release is achieved, the lancet 40 moves relative to the cocking seat 30 passing, therethrough such that its piercing tip 42 protrudes from the open end 37 of the cocking seat 30 and piercingly engages the patient's skin. Therefore, in the embodiments of Figures 1 and 2 the cocking movement directly results in firing of the lancet 40, requiring only a single, fluid movement to effectively utilize the present lancet device 10. Looking in further detailed to the previous description, it is understood that the effective firing can be achieved either by moving the portion of the patient, such as their finger inward against a fixed support element, by moving a support element towards a fixed portion of the body to be pierced and/or by compressing both towards one another.

Turning to the embodiment of Figure 3, it is also understood, that for further safety reasons, if desired, the release element 56 may not necessarily be positioned at all times in an appropriate location to effectively release the lancet 40 from its engagement with the cocking seat 30. For example, in the embodiment of Figure 3 a stopper 25 is position such that movement of the cocking seat 30 and therefore the lancet 40 towards the rear end 55' will not result in a sufficient travel distance such that the engagement element 45 is released by the release element 56. Rather, in this illustrated embodiment actuation of the rear end 55 ' inwardly is required so as to effectively move the release element 56 into a position where it may engage the engagement element 45 and provide for appropriate release of the lancet 40 from the cocking seat 30. Also in this embodiment a spring or a stopper may be provided so as to also restrict movement of the actuation element 55', as it is ultimately preferred that actuation thereof be utilized only so as to effectively position the release element 56 in a position and orientation such that the previous or subsequent movement of the cocking seat 30 and/or the housing 20 in the manner previously described for cocking and firing results in the releasing engagement between the release element 56 and the engagement element 45. Also on such an embodiment is recognized that a variety of different actuation assemblies 55' may be effectively provided so as to position the release element 56 in its appropriate position. For example, a side, spring loaded button and/or resilient button may be provided such that the release element 56 is retained at least partially out of the housing and/or out of engaging relation with the engagement element 45 until it is actuated and moved at least partially into the interior of the housing 20.

Looking again to Figure 1, further features that may be provided with the present invention may be the inclusion of a cover element 43 which is structured to protect and shield the piercing tip 42 of the lancet 40 prior to use. The cover element 43 preferably extends out from the open interior 31 of the cocking seat 30, out through the opening 37 so as to be effectively grasped by a user for removal thereof when preparing the lancet device 10 for use. Alternately, and exterior cover that covers the cocking seat and/or surrounds the piercing tip may also be provided. It is also noted, that the cocking seat 30 is configured such that even when the cover element 43 is removed, the piercing end 42 is protected and/or shielded within the interior 31 thereof unless and until use. Indeed, it is only when the driving force of the biasing assembly 50 urges the lancet's movement relative to the cocking seat 30 that the piercing tip 42 temporarily passes through the opening 37. Still, as a final safety measure, although a single biasing assembly 50 may be sufficient so as to both drive the lancet 40 into its piercing orientation and so as to generally retracted back into its protective shielding within the cocking seat 30, in some embodiments a secondary biasing assembly 52 may also be positioned and interposed between the lancet 40 and the cocking seat 30, the secondary biasing assembly 52 being structured and disposed so as to not hinder movement of the piercing tip 42 into its piercing orientation, but so as to effectively retract the lancet 40 back into its protective containment within the cocking seat 30. Moreover, that retraction should not be sufficient so as to return the lancet 40 into its engagement relation with the cocking seat 30 for unitary movement therebetween.

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.

Now that the invention has been described,

Claims

Claims A lancet device comprising: a) a housing, said housing including an at least partially open interior; b) a lancet moveably disposed at least partially within said housing and including a piercing tip; c) a biasing assembly engaging said lancet; d) a cocking seat, said cocking seat structured to engage said lancet and move said lancet against a force of said biasing assembly so as to increase a potential energy of said biasing assembly; e) a release element structured to at least partially disengage said lancet from said cocking seat such that said potential energy of said biasing assembly drives said piercing tip of said lancet at least temporarily into a piercing orientation; and f) said cocking seat structured to move said lancet into releasing engagement with said release element.

A lancet device as recited in claim 1 wherein said lancet includes an engagement assembly interposed between said cocking seat and said lancet and structured to maintain said moving engagement between said lancet and said cocking seat until disengaged by said release element .

A lancet device as recited in claim 2 wherein said engagement assembly includes an engagement element extending from said lancet into engaging relation with a retention lip on said cocking seat .

A lancet device as recited in claim 3 wherein said release element is structured to engage said engagement element upon substantial movement of said lancet against said force of said biasing assembly so as to release said engagement element from said engaged relation with said retention lip. A lancet device as recited in claim 4 wherein said release element extends at least partially into an interior of said housing and is structured to inwardly bias said engagement element .

6. A lancet device as recited in claim 4 further comprising a single use pivot operatively associated with said engagement element, said release element structured pivot said engagement element about said single use pivot so as to release said engagement element from said engaged relation with said retention lip, and so as to result in deformity of said single use pivot sufficient to prevent repositioning of said engagement element in engaging relation with said retention lip.

7. A lancet device as recited in claim 1 wherein said cocking seat is structured to engage a body section in a vicinity of a portion to be pierced by said piercing tip, and said housing is structured to engage a support element, such that a decrease in a relative spacing between the body section and the support element results in movement of said cocking seat, and accordingly said lancet, against said force of said biasing assembly.

8. A lancet device as recited in claim 1 wherein said biasing assembly includes a spring.

9. A lancet device as recited in claim 1 further comprising a secondary biasing element between said cocking seat and said lancet and structured to return said lancet to a retracted orientation after said piercing tip has moved into said piercing orientation.

10. A lancet device as recited in claim 1 further comprising a removable cover element structured to cover said piercing tip prior to use.

11. A lancet device as recited in claim 10 wherein said cover element is structured to protrude from said cocking seat so as to be grasped for removal thereof .

12. A lancet device as recited in claim 11 wherein said cocking seat is structured to shield said piercing tip of said lancet after said cover assembly is removed and before said lancet is driven into said piercing orientation.

13. A lancet device as recited in claim 1 further comprising a guide track structured to guide generally linear movement of said lancet into said piercing orientation.

14. A lancet device as recited in claim 1 wherein said release element is structured to be exteriorily actuated so as to disengage said lancet from said cocking seat, said release element further structured to disengage said lancet from said cocking seat only after substantial movement of said lancet against said force of said biasing assembly results in positioning of said lancet in a releasable orientation.

15. A lancet device comprising: a) a housing, said housing including an at least partially open interior; b) a cocking seat moveably coupled with said housing and structured to define an open interior therewith; c) a lancet moveably disposed at least partially within said open interior and including a piercing tip; d) a biasing assembly engaging said lancet; e) said cocking seat structured to engage said lancet and move said lancet against a force of said biasing assembly so as to increase a potential energy of said biasing assembly; and f) a release element structured to at least partially disengage said lancet from said cocking seat such that said potential energy of said biasing assembly moves said lancet relative to said cocking seat and drives said piercing tip of said lancet at least temporarily into a piercing orientation.

16. A lancet device as recited in claim 15 wherein said cocking seat structured to move said lancet into releasing engagement with said release element.

17. A lancet device as recited in claim 15 wherein said release element is structured to be exteriorily actuated so as to disengage said lancet from said cocking seat .

18. A lancet device as recited in claim 15 wherein said cocking seat is structured to move said lancet against said force of said biasing assembly and into a releasable orientation.

19. A lancet device as recited in claim 18 wherein said release element is structured to be exteriorily actuated so as to disengage said lancet from said cocking seat only when said lancet is disposed in said releasable orientation.

20. A lancet device as recited in claim 19 further comprising a stopper element structured to prevent further movement of said lancet against said force of said biasing assembly upon movement of said lancet into said releasable orientation.

21. A lancet device as recited in claim 20 wherein said stopper element is structured to abut said cocking seat.

22. A lancet device as recited in claim 15 wherein said lancet comprises a lancet receiving assembly and a lancet body removably coupled thereto, said lancet body containing said piercing tip.

23. A lancet device as recited in claim 15 further comprising a single use pivot operatively associated with said cocking seat, said single use structured to be deformed upon said release element disengaging said lancet from said cocking seat so as to prevent repositioning of said lancet in engaged, pre-fired relation with said cocking seat.