Endcap for a Sampling Device

Abstract

A tip portion or endcap for a lancing device having a non-circular opening to provide tension and pressure upon the patient's skin before and/or during lancing of the skin for sample collection. In example embodiments, the endcap is shaped to prevent the lancet body from sticking within the hole or passing through the hole. The endcap may also be shaped to allow it to be used at various lancing sites on the body without changing the endcap.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a partial cross sectional view of a lancing device having an endcap according to one example embodiment of the present invention.

FIG. 2 shows a perspective view of the endcap of FIG. 1.

FIG. 3 shows a front view of the endcap of FIG. 1.

FIG. 4 shows a perspective view of an endcap having a “star” shaped or multi-lobed opening in accordance with yet another example embodiment of the present invention.

FIG. 5 shows a front view of an endcap having a raised rim disposed around a non-circular opening according to another example embodiment of the present invention.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.

With reference now to the drawing figures, an endcap 10 for a lancing device 12 housing a lancet 14 therein is shown by way of example embodiments of the present invention. As shown in FIGS. 1-2, the endcap 10 preferably is formed of a substantially rigid body 16 having a first end 20 and a second end 22, wherein the first end 20 is sized and/or shaped to attach to the lancing device 12. The attachment of the endcap 10 to the lancing device 12 can be accomplished by way of a releasable or permanent coupling such as for example a threaded screw coupling, a socket, snap fittings, adhesive or welding, one or more screws or other connectors, or the like; or the endcap 10 can comprise an integral portion of the overall housing of the lancing device 12. In an example embodiment, at least a portion of the endcap 10 is formed of a transparent material to allow the patient and/or clinician to view the puncture site during lancing of the skin and collection of the bodily fluid, and thereby monitor the sample size.

As shown in FIGS. 2 and 3, the second end 22 of the body 16 defines a non-circular opening 24 through which a sharp tip 26, such as the tip of the lancet 14, projects to lance the skin of the subject and form a wound at the sample site from which a sample of body fluid is expressed and collected. The non-circular opening 24 is preferably defined by one or more inwardly directed lobes 28 extending from the second end 22 of the body 16. In further embodiments, additional lobes are used to further increase the surface area of the endcap that is applied to the skin. In still further embodiments, shapes which increase the tension of the endcap upon the skin are incorporated into the design. In one preferred form, the non-circular opening 24 is sized and/or shaped to have an inside diameter that is smaller than the average outside diameter of the lancet to prevent “sticking” of the lancet body within the hole or passage of the lancet body through the hole. In further embodiments, the opening 24 is shaped to prevent bodily fluids blood from contacting the body 16 of the endcap 10 during lancing and subsequent collection.

In various example embodiments, the opening 24 comprises an irregular or non-circular opening having one or more inwardly and/or outwardly projecting lobes or teeth for engaging the skin surrounding the lancing site. For example, and as seen best with reference to FIGS. 2 and 3, four inward lobes and four outward lobes are provided, relative to a reference circle 30 shown in broken lines. In the depicted embodiments, the lobes are rounded, having a smoothly-radiused curvature. In alternate embodiments, the lobes comprise one or more inwardly and/or outwardly projecting teeth having sharp angles rather than smooth curves. It will also be understood that, while the depicted embodiment comprises four inward lobes and four outward lobes, alternate forms of the invention comprise one, two, three or more lobes and/or teeth to define an irregular or non-circular opening. Indeed, there are many different shapes, sizes and configurations, and/or combinations thereof, such as an endcap 10 having a “star” shaped pattern having five inwardly and five outwardly projecting lobes, as depicted in FIG. 4, that are within the scope of the present invention, and will increase the surface area of tissue around the puncture site for contact and compression. It will also be understood that the invention encompasses a separate endcap for mounting to a lancing device, as well as a lancing device with an integral housing comprising an endcap portion thereof.

The lobes 28 can be planar (all within the same plane) or non-planar (having surface features projecting inwardly and/or outwardly relative to a reference plane coincident with the overall forward surface of the endcap or the lancing device housing). As depicted in FIG. 4, non-planar lobes can be provided to further increase the total skin surface area that can be captured and placed in tension and/or compression during lancing and to continually apply surface pressure or intermittently pump the area surrounding the lancing site following lancing.

In yet another embodiment, the opening 24 is surrounded by a raised rim 32, as depicted in FIG. 5, or one or more raised projections projecting outwardly from the body 16 to apply pressure upon the skin when lancing. In still another embodiment, the non-circular opening 24 is flat.

In operation, the non-circular opening 24 of the lancing device 12 is placed against the patient's skin, either at a fingertip or at an alternate lancing site. The patient or clinician then applies sufficient pressure on the lancing device 12 to impart pressure upon the skin within the non-circular opening, which creates an irregular compression zone. The patient then triggers the device 12, which causes the lancet 14 to pierce the skin, and continues to apply pressure upon the skin with the device 12 while fluid, such as blood, is extracted so that an increased volume of fluid is acquired. In alternate manners of operation, the lancing device is pumped, rocked and/or twisted with the irregular surface features surrounding the non-circular opening in contact with the skin surrounding the sampling site, thereby alternating points of tension and compression at the sampling site, to increase sample size and assist in preventing premature wound closure.

An unexpected advantage of the present invention may be a decreased sensation of pain by at least some subjects, believed to result from confusion or distraction of the nerves at and around the sampling site due to contact by the irregular lobed periphery of the opening against the skin surrounding the sampling site. This advantage may be enhanced in embodiments of the invention incorporating one or more outwardly-projecting, non-planar lobes with sharply-pointed distal tips for contact with the skin surface.

While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.

Claims

1. A lancing device for collecting a sample of body fluid from a sampling site on the skin of a subject, said lancing device comprising an outer body housing and a lancet, the lancet being movable between a first position within the outer body housing and a second position wherein at least a sharp tip portion of the lancet extends through an opening in the outer body housing, and wherein the opening in the outer body housing has a non-circular periphery comprising a plurality of inwardly and outwardly directed lobes.

2. The lancing device of claim 1, wherein the periphery of the opening is non-planar.

3. The lancing device of claim 1, further comprising a raised rim around the opening.

4. The lancing device of claim 1, wherein the opening is generally cross-shaped, comprising four lobes.

5. The lancing device of claim 1, wherein the opening is generally star-shaped, comprising five lobes.

6. The lancing device of claim 1, wherein the lobes are smoothly-rounded.

7. The lancing device of claim 1, wherein the lobes comprise teeth with sharp points.

8. The lancing device of claim 7, comprising at least one outwardly-projecting, non-planar lobe having a sharply-pointed distal tip.

9. The lancing device of claim 1, wherein at least a portion of the outer body housing near the opening comprises a transparent material.

10. The lancing device of claim 1, wherein the opening has an inside dimension that is smaller than a corresponding outside dimension of the lancet, thereby preventing the lancet from becoming stuck in the opening.

11. An endcap for a lancing device, said endcap comprising a first end for connection to the lancing device, and a second end defining an opening through which a sharp tip of a lancet can pass, the opening having a non-circular periphery comprising a plurality of inwardly and outwardly directed lobes.

12. The endcap of claim 11, wherein the periphery of the opening is non-planar.

13. The endcap of claim 11, further comprising a raised rim around the opening.

14. The endcap of claim 11, wherein the opening is generally cross-shaped, comprising four lobes.

15. The endcap of claim 11, wherein the opening is generally star-shaped, comprising five lobes.

16. The endcap of claim 11, wherein the lobes are smoothly-rounded.

17. The endcap of claim 11, wherein the lobes comprise teeth with sharp points.

18. The endcap of claim 17, comprising at least one outwardly-projecting, non-planar lobe having a sharply-pointed distal tip.

19. The endcap of claim 11, further comprising a transparent portion near the opening.

20. A method for acquiring an increased volume of analytic fluid from a sampling site, the method comprising the steps of: providing a lancing device with an endcap defining a non-circular opening;placing the lancing device against the skin so that the skin is in communication with the non-circular opening;applying sufficient pressure on the lancing device to cause tension upon the skin within the non-circular opening;triggering the lancing device; andcontinuing to apply pressure upon the skin with the lancing device while fluid is extracted from the sampling site.

21. (canceled)

22. A method of reducing the sensation of pain by a subject during a lancing procedure, said method comprising contacting a skin surface at or adjacent a sampling site with an irregular lobed contact surface, wherein the step of contacting a skin surface at or adjacent a sampling site with an irregular lobed contact surface comprises contacting the skin surface with at least one outwardly-projecting, non-planar lobe having a sharply-pointed distal tip.