LANCET NEEDLE WITH ALIGNMENT AND RETENTION NOTCH

Abstract

A lancet needle with an alignment and engagement notch, with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point.

Claims

1. A lancet comprising: a lancet body having a length L.sub.B and comprising a head portion and a body portion; a lancing needle having a length L.sub.N no more than 75% the lancing body length L.sub.B and comprising an elongate needle body, an embedded portion having length L.sub.M no more than 50% the lancet body length L.sub.B, a sharp tip exposed from the head portion of the lancet body opposite the body portion, and a notch, wherein the embedded portion is embedded within the lancet body; wherein the notch is formed at least partially on the embedded portion; and wherein the sharp tip is formed on an end of the elongate needle body opposite the embedded portion.

2. The lancet of claim 1, wherein the head portion is positioned at a first end of the lancet body and the body portion extends perpendicularly from the center of the head portion towards a second end of the lancet body.

3. The lancet of claim 2, wherein the lancet head portion comprises a circular disk-like member and the lancet body portion comprises a generally oblong member having a first substantially flat side and a second substantially flat side opposite the first side.

4. The lancet of claim 1, wherein the needle body defines a thickness and the notch defines a notch depth of less than one-half the needle body thickness.

5. The lancet of claim 1, wherein the elongate needle body extends along a longitudinal axis.

6. The lancet of claim 1, wherein the notch defines a notch axis generally transverse to the longitudinal axis of the elongate needle body.

7. The lancet of claim 1, wherein the sharp tip forms a beveled surface.

8. The lancet of claim 7, wherein the beveled surface is aligned in a predetermined rotational orientation relative to the lancet body and the notch, the notch being oriented substantially perpendicular to the needle body and the flat sides of the lancet body.

9. The lancet of claim 7, wherein a specified registration is maintained between the notch, the beveled surface, and the lancet body.

10. The lancet of claim 7, wherein the beveled surface is aligned obliquely and transversely to the first and second substantially flat surfaces of the lancet body.

11. The lancet of claim 7, wherein a consistent registration is maintained between the beveled surface, the notch, and the lancet body when the lancet body is molded over the embedded portion of the needle body.

12. The lancet of claim 1 wherein the notch is positioned midway along an embedded length LM of the lancet needle.

13. The lancet of claim 1, wherein the lancet needle defines a needle body thickness and the notch defines a notch depth of less than one-half the needle body thickness.

14. A multi-lancet array comprising at least two lancets removably coupled together, each lancet comprising: a lancet needle and a lancet body molded over a portion of the lancet needle; wherein the lancet body has a head portion and a body portion; wherein the lancet body further comprises the head portion at a forward end of the lancet body and the body portion at a distal end of the lancet body, the distal end being positioned opposite the first end of the lancet body; wherein the lancet head portion comprises a generally circular profile and the lancet body portion comprises a generally oblong profile, the lancet body portion having a first substantially flat side and a second substantially flat side opposite the first side and extending perpendicularly from the lancet head portion; wherein the lancet needle comprises an elongate needle body having a sharp lancing tip and a notch, a portion of the needle body being embedded within the lancet body, the notch formed at least partially on the embedded portion of the needle body and engaged with a portion of the lancet body between the first and second end thereof, and the sharp lancing tip projecting from an end of the needle body opposite the embedded portion, and wherein the notch is configured for alignment with a cooperative mold tooling, the alignment providing a consistent registration between the sharp lancing tip, the notch, and the lancet body when the lancet body is molded over the embedded portion of the needle body.

15. The multi-lancet strip of claim 14, wherein every lancet of the multi-lancet strip comprises a substantially identical and predefined registration between the bevel, the notch and the lancet body.

16. The multi-lancet strip of claim 14, wherein the notch of each needle is angularly aligned with the bevel.

17. A method for manufacturing a lancet comprising: providing a lancet needle of length L.sub.N comprising a generally elongate body having a first end comprising a sharp tip portion, and a notch formed on the generally elongate body between the first end and a second end opposite the first end; aligning the notch of the lancet needle within a mold; and molding a lancet body of length L.sub.B within the mold and around the lancet needle, the lancet body comprising a head portion at a first end of the lancet body and a body portion at a second end of the lancet body, wherein the notch of the lancet needle is at least partially embedded in the lancet body.

18. The method of claim 17, wherein the body portion extends transversely from the head portion towards the second end of the lancet body opposite the first end.

19. The method of claim 17, wherein the notch of the lancet needle is aligned within the mold such that the notch is oriented substantially perpendicular to the needle body and the flat sides of the lancet body are aligned to the bevel in a predetermined rotational orientation relative to the lancet body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 shows a perspective view of a lancet needle according to an example embodiment of the present invention.

[0014] FIG. 2 shows a side view of the lancet needle of FIG. 1.

[0015] FIG. 3A shows a top view of the lancet needle of FIG. 1.

[0016] FIG. 3B shows a cross sectional view of the lancet needle of FIG. 3A taken along line 3A-3A.

[0017] FIG. 4 shows a lancet according to an example embodiment of the present invention, with the needle of FIG. 1 projecting therefrom.

[0018] FIG. 5 shows a top view of the lancet of FIG. 4, showing a notch of the needle of FIG. 1 engaged within a body portion of the lancet.

[0019] FIG. 6 shows a multi-lancet strip or array according to another example embodiment of the present invention.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0020] 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. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein.

[0021] 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.

[0022] With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views, FIGS. 1-3 show a lancet cannula or needle 10 according to an example embodiment of the present invention. The lancet needle 10 includes an elongate body 20 extending from a first or proximal end 12 to a second or distal end 14 along a longitudinal axis 16, and defining a lancet needle length between the first and second ends. A bevel or ground point 24 is formed at the first end 12 wherein a sharp lancing tip portion 26 is defined, and a notch or cut-out 30 is formed along a portion of the body 20 between the first and second ends 12, 14, generally proximal the second end.

[0023] The bevel 24 formed at the first end 12 defines an angle relative to a side of the body 20, which is generally laterally offset from the longitudinal axis 16 (see FIG. 2). Preferably, the angle is in the range of between about 5-10 degrees, but other angles may be used as desired. Typically, the angle being in the range of between about 5-10 degrees provides that the sharp tip portion 26 is sufficient to penetrate the skin of a human or animal subject with minimal sensation of pain. Optionally, two or more bevels may be formed at the first end 12 in any desired orientation to form a sharp lancing tip.

[0024] The notch 30 generally forms a void or indentation within a side surface of the body 20 wherein a notch axis 32 and a notch depth D are defined. In one form, the notch axis 32 is generally transverse to the longitudinal axis 16, and the notch depth D is generally less than about one-half the width or thickness of the body 20. Optionally, the notch axis 32 can be oriented relative to the longitudinal axis 16 as desired, for example, substantially parallel or at an angle relative thereto. The depth D of the notch 30 is also preferably chosen as desired. Optionally, two or more notches may be formed along the body 20 between the first and second ends 12, 14. The cross-sectional geometry of the notch 30 of the depicted embodiment is generally rectangular when viewed from the side (see FIG. 2), but in alternate embodiments may be triangular or V-shaped, rounded or U-shaped, or various other geometries all within the scope of the present invention. The configuration of the notch is optionally matched to cooperative mold tooling used to hold the needle during manufacturing, whereby interengagement of the mold tooling and the notch assists is maintaining alignment of the lancet needle during manufacturing. The notch may be formed by grinding, stamping, embossing, cutting or other fabrication methods. In alternate embodiments, two or more notches may be provided, for example spaced along the length of the needle, and/or offset at different angular positions about the periphery of the needle's sides.

[0025] FIGS. 4 and 5 show a lancet 50 including the lancet needle 10 partially embedded within a lancet body 52. Generally, the lancet body 52 defines a length L.sub.B, extending between a first end 54 to a second end 56, and has a size and a shape configured for releasable engagement with the receiver or lancet carrier of a corresponding cooperative lancing device. The first end 12 of the needle 10 projects from the first end 54 of the lancet body 52 such that the bevel 24 having the sharp tip portion 26 is exposed. The second end 14 of the needle 10 is embedded within the lancet body 52. Preferably, the notch 30 is engaged with a portion of the lancet body 52 such that the material of the body 52 at least partially fills the void of the notch 30. For example, when manufacturing the lancet 50, the lancet body 52 (generally formed from plastic) is preferably overmolded around the lancet needle 10, which allows the lancet body 52 to substantially engage the lancet needle 10 and fill the void of the notch 30. Thus, with the void at least partially filled during molding, the notch 30 provides adequate surface area for securely mounting the lancet needle 10 to the lancet body 52, thereby providing a better hold between the lancet needle 10 and the lancet body 52. As such, the lancet needle 10 having at least one notch 30 formed thereon preferably reduces the overall length (defined between the first and second ends 12, 14) of the needle 10 that is typically required for manufacturing lancets, thereby reducing material costs.

[0026] In example forms, the lancet needle 10 has an overall needle length L.sub.N, of which an embedded length L.sub.M portion is embedded within the lancet body 52, and an extended length portion L.sub.X extends beyond the proximal end 54 of the lancet body. In example forms, the needle length L.sub.N is no more than about 75% the length L.sub.B of the lancet body, preferably no more than about 67% the length L.sub.B, and still more preferably no more than about 50% the length L.sub.B. Otherwise defined, in example embodiments the embedded length L.sub.M of the lancet needle is no more than about 50% the length L.sub.B, preferably no more than about 33% the length L.sub.B, and still more preferably no more than about 25% the length L.sub.B. In further example forms, the retention and alignment notch 30 is positioned approximately midway along the embedded length L.sub.M of the lancet needle (i.e., about 0.5L.sub.B from the proximal end 54 of the lancet body).

[0027] FIG. 6 shows a multi-lancet strip 100 according to another example embodiment of the present invention. The multi-lancet strip comprises a plurality of lancets 50 removably coupled together to form an array of lancets. The lancets 50 are generally removably coupled together by frangible or separable engagement members 110. Preferably, the engagement members 110 are formed to maintain engagement between the lancets 50 until they are desired to be separated from the array. For example, lancing devices using the multi-lancet strip or cartridge (forming an array of lancets) generally operate in a manner that indexes the strip or cartridge along as the device is being used, and enables tearing or disengaging the engagement members 110 so that a new lancet can be used to prick the subject at a lancing site for each sequential lancing procedure. Optionally, other forms of removably coupling the lancets together may be used as desired.

[0028] In example forms, the notch 30 can be used as an identifier or indication feature during manufacture to maintain registration of the needle and align the bevel 24 of each needle 10 relative to the lancet body 52 (see FIGS. 5-6) consistently across all lancets in the array. Preferably, the orientation of the notch 30 relative to the orientation of the bevel 24 is known such that the indication feature (e.g., notch) can be oriented properly within the mold, which ensures that the bevel 24 is properly aligned relative to the lancet body 52. For example, as depicted in FIG. 6, the notch 30 of each needle 10 is similarly aligned (each notch shown on right side of needle) and thereby provides that the bevel 24 of each needle 10 is consistently aligned relative to its respective lancet body 52. Consistent alignment of the bevel in every lancet of the array may permit more consistent positioning and more precise control of the lancing procedure, for example enabling more precise depth control and/or a lower sensation of pain.

[0029] The present invention further includes improved methods of manufacturing a lancet. In one form, the method includes providing a lancet needle comprising a generally elongate body extending along a longitudinal axis from a first end to a second end, the first end comprising a bevel forming a sharp tip portion, and a notch formed in a portion of the elongate body between the first and second ends, the bevel having a first orientation and the notch having a second orientation relative to the first orientation; aligning the notch of the lancet needle within a mold; and molding a lancet body within the mold and around the lancet needle while maintaining the alignment of the notch within the mold, wherein aligning the notch of the lancet needle within the mold aligns the bevel forming the sharp tip portion relative to the lancet body. Thus, since the first orientation of the bevel and the second orientation of the notch are known, the notch can be aligned accordingly within the mold to ensure the bevel is properly aligned relative to the lancet body.

[0030] 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.