HK1055234B - A single use lancet assembly - Google Patents

Description

Disposable lancet assembly

Technical Field

The present invention relates to a single use lancet assembly that is relatively small, yet effective for lancing a patient's finger or other body part to obtain a blood sample. The single use lancet device is also configured to be relatively safe to transport and to ensure that the contaminated lancet tip is no longer used.

Background

Lancets are not only a medical device used by individuals such as diabetics, but are also widely used in hospitals and other medical facilities to puncture or pierce a patient's skin, typically the skin on a patient's finger, to collect a blood sample for testing. Because of the wide range of uses for such lancets, there are a variety of lancet devices available and utilized by patients and/or practitioners in a variety of different situations.

For example, a typical lancet device may simply include a housing with a sharp piercing end that can be pushed into the patient's skin. More generally, however, lancet devices have been developed that house a piercing end and/or lancet that effectively surrounds and projects the lancet into the patient's skin, thereby eliminating the need for a person to actually push the piercing tip into the skin for sampling.

Among the various types of specialized lancet devices, one type is generally configured for multiple and/or repeated uses, while the other type is specifically configured for single use, with the entire device disposed of after use. Of particular interest are single use disposable lancet devices, which typically include a housing that contains and directs or drives a piercing tip into a patient's skin, which is disposed of along with the used lancet. Naturally, in order to make such disposable devices cost-effective for regular use, such devices are often too simple to provide only sufficient mechanisms for launching (fire), without unduly complicating the design in order to minimize cost.

While existing single-use devices are generally effective for achieving the skin puncture required for effective operation, such single-use disposable devices are generally not equipped with a large number of safety devices for ensuring safe use and disposal of the device. For example, one major safety factor that must be addressed for all lancet devices is preventing the purposeful and/or inadvertent reuse of a contaminated lancet. Unfortunately, most of the structures of presently available single use lancet devices allow the device to be re-cocked by the patient after it has been used, thereby rendering the device subsequently improperly used.

It would therefore be highly advantageous to provide a single use lancet device which is relatively small and disposable, which is relatively inexpensive to manufacture, which is safe to use, and which, once contaminated, is positively prevented from being reused.

Disclosure of Invention

The present invention relates to a single use lancet device configured to pierce a patient's skin and be only for single use, thereby preventing reuse of a contaminated lancet tip. In particular, the single use lancet device of the present invention includes a housing having an open interior cavity and an access opening defined therein. The housing is preferably small and has a lancet disposed in its open interior.

Referring to the lancet, it is preferably of the type comprising a body and a piercing tip. The needle tip has a sharp structure configured to penetrate or pierce the skin of a patient for drawing blood. In addition, a lancet may be cooperatively disposed within the open interior of the housing such that the lancet is movable at least between a cocked orientation and a puncturing orientation wherein the patient's skin is penetrated by the piercing tip.

Also operatively associated with the lancet is a drive assembly. The drive assembly is configured to move or drive the lancet at least temporarily from the cocked orientation into the piercing orientation. Preferably, however, the device is configured such that the armed position is normally maintained until positively released by the user. In these aspects, the single use lancet device of the present invention further comprises an actuation button operably associated with the lancet. The actuation button is structured to extend from the housing to be effectively actuatable, at least when the lancet is in the cocked orientation. When the lancet is in the cocked orientation, the actuation assembly retains the lancet in the cocked orientation, however, when it is actuated, such as by being pushed inwardly, the lancet is released from the cocked orientation and the drive assembly at least temporarily advances the lancet into its piercing orientation with the piercing tip extending through the entrance opening of the housing.

To ensure that the lancet device can only be used once, the single use lancet device of the present invention further includes an abutment structure cooperatively disposed between the housing and the lancet. The abutment structure is configured to prevent movement of the lancet into the cocked orientation after movement into the puncturing position. Preferably, the abutment structure includes a shoulder element and a restrictor panel operatively associated with the lancet and the housing. In particular, the shoulder element is configured to clear the restrictor panel when the lancet is moved from its cocked orientation to its puncturing orientation. Conversely, however, when the user attempts to move the lancet back into the cocked orientation after moving into the puncturing position, the restrictor panel abuts the shoulder to prevent further movement. As a result, once the lancet has been used once, the lancet is prevented from moving to the cocked orientation, thereby preventing the contaminated lancet from being reused.

In summary, to achieve the above objects, the present invention provides a single use lancet device comprising:

a housing having an open interior cavity and an inlet defined therein;

a lancet having a body and a piercing tip, the lancet being located within the open interior of the housing and being configured to move between a cocked position and a piercing position;

a protective cover for pushing the lancet to a cocked position;

a drive assembly configured to move the lancet briefly into the piercing position;

an actuation assembly configured to release the lancet from the cocked orientation; and

a restraint assembly configured to: after the lancet has been moved briefly into the puncturing position, the assembly may prevent the lancet from moving toward and into the cocked orientation.

Drawings

For a fuller understanding of the nature of the present invention, reference should be made to the following detailed description taken together with the accompanying figures in which:

FIG. 1 is a perspective view of one embodiment of the single use lancet device of the present invention;

FIG. 2 is a side cross-sectional view of the single use lancet device of the present invention in an unused, initial, undeployed position;

FIG. 3 is a side cross-sectional view of the single use lancet device of the present invention in the cocked orientation;

FIG. 4 is a side cross-sectional view of the single use lancet device of the present invention after the lancet has been moved from the cocked orientation to the puncturing orientation;

FIG. 5 is a front cross-sectional view of the single use lancet device of the present invention; and

FIG. 6 is a side cross-sectional view of another embodiment of the single use lancet device of the present invention after the lancet has been moved from the cocked orientation through the puncturing position.

Like reference symbols in the various drawings indicate like elements.

Detailed Description

As shown, the present invention is directed to a single use lancet device, generally designated by the numeral 10. In particular, the single use lancet device 10 of the present invention includes a housing generally designated by the numeral 20. The housing 20 is preferably relatively compact and may be formed from one or more sections preferably made of a substantially rigid, disposable material, such as plastic. The housing 20 includes an at least partially open interior cavity 28 and at least one inlet port 22 defined therein. The open interior 28 of the housing 20 is preferably sized and configured to: in which a lancet, generally indicated by the numeral 30, is effectively received.

In particular, the lancet device 10 of the present invention further includes a lancet 30. The lancet 30 preferably includes a body 32 and a piercing tip 34. The needle tip 34 will be used to pierce a person's skin to draw blood to be used as a blood sample and/or for a testing procedure. Further, body 32 may be the shaft of needle tip 34, and/or another configuration as shown. Regardless, however, the lancet 30 is configured to: is movable within the open interior 28 of the housing 20, preferably at least between a cocked position (as shown in fig. 3) and a puncturing position in which the piercing tip 34 of the lancet 30 extends at least momentarily through the access opening 22.

Referring in more detail to the lancet device 10 illustrated and the path of movement of the lancet 30 within the housing 20, when the lancet device 10 is initially accessed for use, the lancet 30 is preferably maintained in an unused, initially unsent and pre-fired position, as shown in fig. 2. In this initially un-cocked and pre-firing position, a protective shield 40 preferably extends into the open interior 28 of the housing 20 to at least partially and removably cover the piercing tip 34 of the lancet 30 to maintain the piercing tip 34 in a safe and sterile condition when not in use. In this regard, the protective cover 40 may be made of a variety of preferably rigid materials and may be configured to extend from the housing 20. In addition, the protective cover 40 may have an enlarged head 42 configured to facilitate gripping thereof.

Preferably utilizing a protective cover 40, the protective cover 40 is configured to be pushed inwardly into the housing by the user (as indicated by the arrows in fig. 2) to push the lancet 30 further into the housing 20. Pushing the lancet 30 into the housing 20 may place the lancet 30 in its cocked orientation, as shown in fig. 3. Once in the cocked orientation, the protective shield 40 may thus be configured to be removed from the needle tip 34, such as by rotating the protective shield, thereby leaving the needle tip 34 fully exposed for use.

The single use lancet device of the present invention further includes a drive assembly, generally indicated by the numeral 38. The drive assembly 38 is uniquely configured to: the lancet 30 can be moved at least momentarily into its piercing position with the piercing tip 34 extending a desired amount through the access opening 22 of the housing 20. In particular, if desired, a depth adjustment structure may be provided at the inlet to control the amount of the needle tip that protrudes from the housing 20. For example, a threaded washer-type member may be adjustably secured to the housing 20 substantially surrounding the inlet 22.

With further reference to the drive assembly, the driving movement preferably occurs when the lancet 30 is released from its cocked orientation. In the illustrated embodiment, the drive assembly 38 includes a biasing member operatively disposed between the lancet 30 and the housing 20. Further, a spring is preferably employed in the illustrated embodiment, however, it will be appreciated that a variety of other drive assemblies may be employed, including wedge-type assemblies, hammer-type assemblies, and/or sheets, segments or extensions of elastomeric material, etc., each of which may be configured to move the lancet 30 from the cocked orientation to the puncturing orientation. Further, it is preferred that, depending on the size of the housing 20 and the nature and size of the drive assembly 38, the lancet 30 tends to retract into the housing after it has been moved into the puncturing position, wherein the piercing tip 34 extends through the access opening 22, as shown in FIG. 4. As a result, the used needle tip 34 is effectively concealed within the housing 20 after use, thus preventing accidental contact between a person and the used needle tip 34.

To retain and subsequently effectively release the lancet 30 from its cocked orientation, the single use lancet device 10 of the present invention further includes an actuation assembly, generally designated by the numeral 50. The actuation assembly 50 has an actuation button 52, although a variety of different actuation assemblies may be mounted to retain and subsequently release the lancet 30 from its cocked orientation (in the illustrated embodiment, release the drive assembly from its compressed orientation). In the illustrated embodiment, the actuator button 52 is configured to at least momentarily protrude from the housing 20, such as through an actuator aperture 24. In addition, the actuation button 52 is preferably secured directly or indirectly to the lancet 30, and substantially limits movement of the lancet 30 from its cocked orientation when it is extended from the housing body 20. As a result, the cocked position is maintained while the actuator button protrudes from the housing 20. Specifically, in the illustrated embodiment, the actuation button 52 extends from the body 32 of the lancet 30 by a biasing segment such that the lancet 30 is prevented from moving from the cocked orientation by abutting the housing 20 in the actuation aperture 24. However, when the actuation button 52 is actuated, such as by being pushed inwardly into the housing, it is at least temporarily concealed within the housing 20, removing the abutting engagement, and leaving the lancet 30 free to move within the housing 20, at least temporarily, into the puncturing position. While the foregoing forms the actuation assembly illustrated, it will be appreciated that a variety of alternative actuation assemblies may be provided, such as separate elements for retaining and releasing the lancet may be provided, and/or structures that are actually part of the drive assembly.

Referring specifically to FIG. 5, movement of the lancet 30 through the housing body 20 is preferably maintained in a substantially linear path by a guide assembly. In the illustrated embodiment, the guide assembly includes at least one guide ridge 33 extending from the body 32 of the lancet 30 and at least one corresponding guide track 25 configured to movably receive the guide ridge 33 therein. The guide track 25 preferably extends at least partially along the length of the open interior 28 of the housing 20 to effectively retain the guide ridge 33 therein throughout the necessary range of movement of the lancet 30. As shown in fig. 5, preferably a pair of guide ridges 33 are provided on opposite sides of the lancet body 32, with a corresponding pair of oppositely disposed guide tracks 25 formed in the housing. It will of course be understood, however, that the guide track 25 need not be defined directly in the housing 20, but may be an accessory secured therein, and instead the guide track may be defined in or on the lancet body 32 with the guide ridge extending inwardly from the housing 20.

The single use lancet device 10 of the present invention further includes a restrictor assembly, generally indicated by the numeral 60. The restrictor assembly 60 is structured to substantially prevent the lancet 30 from moving back into the cocked orientation shown in fig. 3 after even momentarily moving into the puncturing position, wherein the patient's skin may be punctured and the piercing tip 4 contaminated. In particular, the restrictor assembly 60 is structured to effectively move the lancet 30 rearwardly into the cocked orientation, independently of the restrictor assembly 60, when the lancet 30 is in the initial, unseated orientation, as shown in FIG. 2. However, after the lancet 30 has moved into its piercing position (where the piercing tip 34 has extended through the access opening 22 of the housing 20), the restrictor assembly is structured such that the lancet 30 is no longer pressed back into the cocked orientation. As a result, the patient cannot accidentally or purposefully reuse the single use lancet device 10 of the present invention after it has been fired.

In the illustrated embodiment, the restriction assembly 60 includes an abutment structure cooperatively disposed between the housing body 20 and the lancet 30. The abutment structure is configured to physically prevent the lancet from moving back into the cocked orientation. Preferably, the abutment structure comprises a shoulder 62 and a limit seat (panel)64, which are configured: as the lancets 30 move from the cocked orientation into the puncturing orientation, they are free to pass each other; but abut each other when the lancet 30 attempts to move back into the cocked orientation after having moved into the puncturing position. As shown in FIG. 4, the illustrated shoulder element 62 has an at least partially angled and preferably biased structure, such as an elongated biased finger that is at least partially retracted inwardly toward the body 32 of the lancet 30 to facilitate its passage past the restrictor panel 64. In this regard, it is preferred to provide mating inclined surfaces on the shoulder element 62 and the restrictor panel 64 to facilitate sliding past one another and indeed to facilitate at least partial retraction of the shoulder element 62 to further facilitate passage past one another as the lancet 30 is moved in the first direction toward the access opening 22 of the housing body 20. However, the shoulder element 62 is also configured to normally expand after it has passed the restrictor panel 64, such as back into its normal unretracted and/or uncompressed position, such that it abuts the restrictor panel 64 when the lancet 30 attempts to move in a second direction opposite the access opening 22 of the housing body 20.

As is effective in a reverse configuration, in the illustrated embodiment, the biasing finger 62 of the shoulder member extends from the lancet 30, preferably generally toward the piercing tip 64 of the lancet 30, while the restrictor panel 64 extends from the housing body 20 into the open interior 28 of the housing body 20. In these aspects, the restrictor panel 64 includes a protruding member, preferably having the aforementioned angled configuration, that slopes downwardly away from the piercing tip 34 of the lancet 30 to facilitate the sliding passage of the shoulder member 62.

In order to provide generally reliable travel restriction by effective abutment, the shoulder 62 and the restrictor panel 64 each preferably include abutment surfaces 63 and 65, respectively. The abutment surfaces 63 and 65 are configured to normally engage and abut one another, as shown in fig. 4, thereby preventing the lancet 30 from moving back into the cocked orientation. In the illustrated embodiment, the abutment surfaces 63 and 65 are substantially flat, although it will be appreciated that interlocking fingers or wedges, and/or other types of engagement structures that prevent relative movement in at least one direction, may also be effectively employed.

Further with respect to the restrictor assembly of the present invention, it will be appreciated that a variety of different restrictor assemblies may be effectively employed to prevent the lancet 30 from moving back into the cocked orientation after the lancet 30 has moved sufficiently forward and/or into the puncturing position. Also, the embodiment shown in fig. 2-5 is only a preferred embodiment, and numerous alternative embodiments are possible within the scope of the inventive limiting assembly. For example, as shown in FIG. 6, the actuator button 52 itself may form part of the restriction assembly. In this embodiment, a restrictor panel 25 is defined in the housing 20, and an actuator button 52, which is part of the shoulder-like biasing finger, has an abutment surface 54 that engages an confronting surface of the restrictor panel 25. In this embodiment, the initially unseated position is provided for the actuation button 52 to initially be positioned behind the restrictor panel 25, thereby allowing the lancet 30 to move at least initially into the cocked position. Further, in this, the previous, and/or any other alternative embodiment, if desired, the protective cover 40 may be provided with an internal shield segment or other structure that extends into the housing and retains the biasing fingers of the shoulder 62 or other member of the restraining assembly in a substantially compressed and/or retracted position until the protective cover 40 is removed. As a result, in this embodiment, the lancet 30 is always able to return to the cocked orientation as long as the protective cover 40 remains over the piercing tip 34. However, it is preferred to replace the protective shield over the piercing tip in a manner that "resets" the lancet 30, thus preventing the lancet from moving into the cocked orientation again.

Since many modifications, variations and changes in detail can be made to the above-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. Accordingly, the scope of the invention should be determined by the appended claims and their legal equivalents.

Claims (24)

1. A single use lancet device comprising:

a housing having an open interior cavity and an inlet defined therein;

a lancet having a body and a piercing tip, the lancet being located in the open interior cavity of the housing and being configured to be movable between a cocked position and a piercing position;

a protective cover for pushing the lancet to a cocked position;

a drive assembly configured to move the lancet briefly into the puncturing position;

an actuation assembly configured to release the lancet from the cocked orientation; and

a restraint assembly configured to: the assembly may prevent movement of the lancet towards and into the cocked orientation after the lancet has been moved briefly into the piercing orientation.

2. A single use lancet device as recited in claim 1 wherein said drive assembly has a biasing member operatively disposed between said lancet and said housing.

3. A single use lancet device as recited in claim 2 wherein said biasing member comprises a spring.

4. The single use lancet device of claim 1, wherein the actuation assembly comprises a button configured to: the button momentarily protrudes from the housing when the lancet is in the cocked orientation.

5. A single use lancet device as recited in claim 4 wherein said button is secured to said lancet and is configured to: abutting the housing when protruding therethrough so as to retain the lancet in the cocked orientation until disengaged from the abutting engagement.

6. A single use lancet device as recited in claim 5 wherein said button is configured to: the button is concealed from view by the housing shortly after the lancet has been moved out of the cocked orientation.

7. A single use lancet device as recited in claim 1 wherein said restrictor assembly comprises an abutment structure cooperatively disposed between said housing and said lancet, said abutment structure being structured to: after the lancet is moved into the puncturing position, the lancet is prevented from moving back into the cocked orientation.

8. A single use lancet device as recited in claim 7 wherein said abutment structure comprises a shoulder element and a restrictor panel, said restrictor panel and said shoulder element being configured to: passing the lancet through one another as the lancet is moved from the cocked orientation to the puncturing orientation; the two abut each other when attempting to move back to the cocked orientation after the lancet has moved into the piercing orientation.

9. A single use lancet device as recited in claim 8 wherein said shoulder element has a ramped and biased structure configured to: retracting so that the restrictor panel and the shoulder pass one another in a first direction corresponding to movement of the lancet from the cocked orientation to the puncturing orientation; after passing each other in said first direction, expands such that the shoulder and the restrictor panel abut each other when moved toward each other in a second direction generally opposite to said first direction.

10. A single use lancet device as recited in claim 8 wherein said shoulder element comprises a biasing finger extending from said lancet and said restrictor panel comprises a protruding element protruding into an interior cavity of the housing.

11. A single use lancet device as recited in claim 10 wherein said protruding element has a sloped configuration that slopes downwardly away from said piercing tip of said lancet to facilitate passage of said protruding element past said biasing finger when said lancet is moved in a first direction toward said access opening.

12. A single use lancet device as recited in claim 11 wherein said biasing finger comprises an actuation button configured to release said lancet from said cocked orientation.

13. A single use lancet device as recited in claim 1 further comprising a guide assembly operatively disposed between said lancet and said housing, said assembly being structured to guide said lancet for substantially linear movement through said housing.

14. A single use lancet device as recited in claim 13 wherein said guide assembly comprises a guide ridge extending from said body of said lancet and a corresponding guide track configured to movably receive said guide ridge therein and extending along the length of said open interior cavity of said housing.

15. A single use lancet device as recited in claim 1 wherein said protective cover is configured to: the protective cover removably covers the piercing tip of the lancet prior to the lancet being moved into the cocked orientation.

16. A single use lancet device as recited in claim 15 wherein said protective cover is configured to: extending from the inlet of the housing; and is structured to be urged by a user to place the lancet into the cocked orientation.

17. The lancet device of claim 4, further comprising a shoulder element and a restrictor panel operatively associated with the lancet and the housing, the shoulder element configured to: passing the restrictor panel when the lancet is moved from the cocked orientation to the piercing orientation; and when attempting to move into the cocked orientation after the lancet has moved into the puncturing orientation, abutting the restrictor panel to prevent the lancet from moving toward and into the cocked orientation after the lancet has moved into the puncturing orientation for a brief period of time.

18. A single use lancet device as recited in claim 17 wherein said shoulder element comprises said actuation button.

19. A single use lancet device as recited in claim 17 wherein said shoulder extends from said lancet and said restrictor panel is secured to said housing.

20. A single use lancet device as recited in claim 17 wherein said protective cover is configured to: the protective cover removably covers the piercing tip of the lancet prior to the lancet being moved into the cocked orientation.

21. A single use lancet device as recited in claim 20 wherein said protective cover is configured to: extending from the inlet of the housing; and is configured to be pushed by a user to place the lancet into the cocked orientation.

22. A single use lancet device as recited in claim 17 wherein said shoulder element comprises a biasing finger extending from said lancet substantially toward said piercing tip of said lancet and said restrictor panel comprises a protruding element disposed in said housing.

23. A single use lancet device as recited in claim 22 wherein said protruding element has a sloped configuration that slopes downwardly away from said piercing tip of said lancet to facilitate passage of said protruding element past said biasing finger when said lancet is moved in a first direction toward said access opening.

24. A single use lancet device as recited in claim 17 further comprising a guide ridge extending from said body of said lancet and a corresponding guide track configured to movably receive said guide ridge therein and extending along the length of said open interior cavity of said housing for guiding said lancet for substantially linear movement within said housing.