Patent Description:
Various forms of hypodermic needles are used for the delivery of injectable medications into the body through the skin of a human or animal patient, for sampling of blood, and for other medical and research purposes. Pen needles, for example, are commonly used by healthcare providers and patients for delivery of medications such as insulin for diabetes management.

Pen needles typically include a plastic hub with a hollow needle embedded therein. One end of the needle has a sharp tip for injection through the skin of the patient, and the other end is configured to receive medication delivered by an injection pen. The hub of the pen needle typically includes threaded or snap connections for removable attachment to the injection pen, so that the needle can be removed after use and replaced with a new needle for subsequent use of the injection pen.

The sharp injection point or tip geometry of a hypodermic needle may affect its function and/or play a part in user preferences. For example, different tip geometries may require more or less force to penetrate the skin during an injection, and/or different users may perceive different pain levels or different tactile feedback resulting from injections with needles having different tip geometries.

<CIT> discloses a tip portion of a needle main body having an edge point that includes a first slant surface slanted at <NUM>-<NUM> degrees with respect to the axis of the needle main body, a pair of second slant surfaces slanted at <NUM>-<NUM> degrees, and a pair of third slant surfaces slanted at <NUM>-<NUM> degrees. The ratios of the lengths of the first, second, and third slant surfaces are set to be <NUM>-<NUM>%, <NUM>-<NUM>%, and <NUM>-<NUM>%. At the time of forming the second slant surfaces and the third slant surfaces, a grinding wheel or the needle main body is turned relative to the other in a horizontal plane so that the direction of axis of the grinding wheel and the direction of axis of the needle main body are in a twisted or distorted relationship from a substantially orthogonal relationship such that the radial outer sides of the second and the third slant surfaces are included downwardly.

<CIT> discloses a multi-beveled point needle and syringe having a multi-beveled point needle. <CIT> discloses a medical bevel needle. <CIT> discloses a hollow needle. <CIT> discloses a medical hollow needle and method for producing the same.

The present invention relates to improved tip geometries for hypodermic needles or cannulas used, for example, in the delivery of medication, in blood sampling, or in other medical or research applications. In example forms, the invention relates to improved tip geometries for pen needles used in combination with injection pens, such as for example in the administration of insulin for diabetes management.

In aspects, there are provided a needle as defined in Claim <NUM>, a pen as defined in Claim <NUM> and a method as defined in Claim <NUM>.

These and other aspects, features and advantages of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following brief description of the drawings and detailed description of example embodiments are explanatory of example embodiments of the invention, and are not restrictive of the invention, as claimed.

The present invention may be understood more readily by reference to the following detailed description of example embodiments in conjunction 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 byway 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" one particular value and/or to "about" or "approximately" another 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, wherein like reference numbers represent corresponding parts throughout the several views, <FIG> shows a pen needle P in example form. <FIG> shows the pen needle P, with its needle guard G and cover C removed from the hub H, to expose the sharp needle tip N. In some example forms, the needle guard G and/or the cover C are/is color tinted.

<FIG> show a sharp point or tip geometry of a needle <NUM> according to an example embodiment of the present invention. In example forms, the needle <NUM> can comprise the needle N of a pen needle P such as is shown in <FIG>, the needle of a standard hypodermic syringe, or the needle of various other devices for injection or other medical or research applications. The needle <NUM> generally comprises a tube or cannula <NUM> defining a fluid-carrying duct or lumen <NUM> extending therethrough along a longitudinal axis A from a proximal end <NUM> to a distal end <NUM>. In typical embodiments, both the cannula <NUM> and the lumen <NUM> (i.e., the inner and outer wall surfaces of the cannula) are generally cylindrical in shape and concentrically or coaxially positioned relative to each other to generally define a substantially continuous wall thickness along the length of the cannula <NUM>. The proximal end <NUM> and/or medial portions of the needle <NUM> are configured for attachment to the hub of a pen needle, to the barrel of a syringe assembly, or to another device or fixture. The distal end <NUM> preferably comprises a multi-beveled proxi <NUM> including a plurality of beveled faces, for example as detailed herein. While generally described herein with respect to embodiments taking the form of a pen needle tip geometry, the tip geometry of the present invention may also be adapted to use in connection with various other items, such as for example hypodermic needles, lancets, catheters and the like.

The multi-beveled point <NUM> is generally characterized by an axial length L (see <FIG>), and the plurality of beveled faces thereof are generally formed around/along a periphery <NUM> of the lumen <NUM>. The plurality of bevels may contiguously bound the distal opening of the lumen <NUM> or may be spaced a distance from the edge of the lumen. In the embodiment of <FIG>, the multi-beveled point <NUM> comprises a proximal bevel <NUM>, a pair of intermediate bevels 32a, 32b, and a pair of distal bevels 34a, 34b. In the depicted embodiment, the pair of intermediate bevels 32a, 32b and the pair of distal bevels 34a, 34b are symmetrically formed relative to the proximal bevel <NUM>, but in alternate embodiments the bevel configuration may be asymmetric.

Optionally, a radiused, rounded, or otherwise smooth transition zone is formed between the bevels (generally axially), between the bevels and the lumen (generally radially), and/or between the bevels and the outer periphery of the cannula <NUM> (generally radially). For example, as depicted in <FIG> and <FIG>, a first smooth transition 40a is provided between the distal bevels 34a, 34b, meeting together at an longitudinal apex <NUM>. A second smooth transition 40b is provided between the distal bevel 34a and the intermediate bevel 32a, a third smooth transition 40c is provided between the distal bevel 34b and the intermediate bevel 32b, a fourth smooth transition 40d is provided between the intermediate bevel 32a and a portion of the proximal bevel <NUM>, and a fifth smooth transition 40e is provided between the intermediate bevel 32b and a portion of the proximal bevel <NUM>. In example embodiments, a smooth transition <NUM> is also provided between each of the bevels positioned along the periphery <NUM> of the lumen <NUM> and an interior surface <NUM> of the lumen <NUM> (e.g., bevel-to-intralumen transition), and a smooth transition <NUM> is provided between the intersection of each of the bevels and the outer surface or periphery of the cannula <NUM>. In example forms, the smooth transitions generally comprise a radius of curvature R of between about R <NUM> - R <NUM> millimeters, for example about R <NUM> millimeters. Preferably, the smooth transitions avoid a sharp edge or clearly defined intersection between the bevels and other surfaces of the needle tip such that transitions between the surfaces are smooth. The smooth transitions may be formed, for example, by bead blasting, grinding, polishing, coating or otherwise treating the needle surface(s).

<FIG>, <NUM> and <FIG> show further details of the multi-bevel point <NUM>. As depicted in <FIG>, the proximal bevel <NUM> is formed at a first inclination angle 30a and the intermediate bevels 32a, 32b are formed at a substantially different (i.e., not substantially equal) second inclination angle 32a, the angles 30a and 32a being defined relative to the longitudinal axis A of the needle shaft. The proximal and intermediate bevels <NUM>, 32a-b are preferably formed at the same rotational angle (i.e., with no rotational offset about the longitudinal axis A). The first inclination angle 30a may be, for example, between about <NUM>-<NUM> degrees relative to the axis A, and the second inclination angle 32a may be, for example, between about <NUM> - <NUM> degrees relative to the axis A, thus defining an angular offset or difference of about <NUM> degrees (i.e., about <NUM>% -<NUM>% relative difference in the angles 30a and 32a). In alternate embodiments, the first inclination angle 30a is, for example between about <NUM> - <NUM> degrees, and the second inclination angle 32a is, for example between about <NUM>- <NUM> degrees. Instill other embodiments, the first inclination angle 32a is about <NUM> degrees and the second inclination angle 32a is about <NUM> degrees, resulting in a difference of about <NUM> degrees (i.e., about <NUM>% different). Preferably, the angular offset or difference between the first inclination angle 30a and the second inclination angle 32a is at least about <NUM>-<NUM> degrees or more, or at least about a <NUM>%-<NUM>% difference or more. Provision of substantially unequal first and second inclination angles 30a and 32a in this manner results in a marked apex or peak at the intersections of the proximal bevel <NUM> and the intermediate bevels 32a, 32b, in the vicinity of the rounded or smooth transitions 40d and 40e.

With reference to FIGURE <NUM>, the distal bevels 34a, 34b are formed at a third inclination angle 34a relative to the longitudinal axis A, of for example between about <NUM>-<NUM> degrees. In alternate embodiments, the third inclination angle 34a is between about <NUM> -<NUM> degrees relative to the longitudinal axis A, or for example between about <NUM> - <NUM> degrees. Preferably, prior to forming the distal bevels 34a, 34b, the pen needle <NUM> is rotated about the longitudinal axis A in the clockwise and counterclockwise directions respectively, to form the distal bevels 34a, 34b at substantially different rotational angles (as well as at an inclination angle as described above) relative to the proximal and intermediate bevels <NUM>, 32a, 32b. As depicted in <FIG>, the entire rotation of the needle <NUM> between the first distal bevel 34a and the second distal bevel 34b (shown as rotation angle <NUM>) is about <NUM> degrees relative to a vertical axis B. Thus, to form the first distal bevel 34a, the needle is rotated about the longitudinal axis A in the clockwise direction a rotational angle of about <NUM> degrees and inclined at the inclination angle 34a. Similarly, to form the second distal bevel 34b, the needle <NUM> is rotated about the longitudinal axis A in the counterclockwise direction (from the <NUM> degrees clockwise position) about <NUM> degrees in the counterclockwise direction while remaining at the inclination angle 34a. Thus, in example forms, the rotational angle for forming the distal bevels 34a, 34b is generally provided by rotating the needle <NUM> about <NUM> degrees in both the clockwise and counterclockwise directions about the longitudinal axis A. Optionally, the rotational angles can be between about <NUM> - <NUM> degrees in the clockwise and counterclockwise directions.

The smooth transitions between the bevels may be configured such that an angle <NUM> is defined between the vertical axis B and the smooth transitions 40d, 40e, and an angle <NUM> is provided between the vertical axis B and the smooth transitions 40b, 40c. In example embodiments, the angle <NUM> is about <NUM> degrees and the angle <NUM> is about <NUM> degrees. Preferably, since the angle of rotation between the proximal bevel <NUM> and the intermediate bevels 32a, 32b is exactly (or at least substantially) zero, the angle <NUM> will generally remain close to <NUM> degrees. And, since the needle <NUM> is rotated in the clockwise and counterclockwise directions prior to forming the distal bevels 34a, 34b, the angle <NUM> will generally be between about <NUM> degrees to about <NUM> degrees relative to the vertical axis B.

With reference to <FIG>, in example embodiments, the overall axial length L of the multi-beveled surface <NUM> is between about <NUM>- <NUM> millimeters. In further example embodiments, the length L is between about <NUM> - <NUM> millimeters. In further example embodiments, the length L is between about <NUM>- <NUM> millimeters. In example embodiments, the length <NUM> of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters, the length <NUM> of the intermediate bevels 32a, 32b is between about <NUM> - <NUM> millimeters, and the length <NUM> of the distal bevels 34a-b is between about <NUM> - <NUM> millimeters. In further example embodiments, the length <NUM> of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters, the length <NUM> of the intermediate bevels 32a, 32b is between about <NUM> - <NUM> millimeters, and the length <NUM> of the distal bevels 34a-b is between about <NUM> - <NUM> millimeters. In further example embodiments, the length <NUM> of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters, the length <NUM> of the intermediate bevels 32a, 32b is between about <NUM> - <NUM> millimeters, and the length <NUM> of the distal bevels 34a-b is between about <NUM> - <NUM> millimeters. In example embodiments, the length 30L1 of the proximal bevel <NUM> (measured between the peak and valley of the proximal bevel <NUM>) is between about <NUM> - <NUM> millimeters. In further example embodiments, the length 30L1 is between about <NUM> -<NUM> millimeters. In further example embodiments, the length 30L1 is between about <NUM> - <NUM> millimeters. As such, in typical embodiments the multi-beveled point forms an elongated distal opening in communication with the lumen, the proximal bevel extends longitudinally from a proximal-most partofthe multi-beveled point continuously along opposing elongated sides of the multi-beveled point, and the multi-beveled point has an overall axial length and the proximal bevel has an axial length that is at least half the overall axial length of the multi-beveled point.

The proximal, intermediate and distal bevels <NUM>, 32a-b, 34a-b can also be defined by their respective arc lengths 30AL, 32AL, and 34AL, as shown in <FIG>. The arc length is generally defined along the interior edges of the bevels, along the periphery <NUM> of the lumen <NUM>, between the transitions between adjacent bevels. In one example form, the arc length 30AL of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters, the arc length 32AL of the intermediate bevels 32a-b is between about <NUM> - <NUM> millimeters, and the arc length 34AL of the distal bevels 34a-b is between about <NUM> - <NUM> millimeters. In another example form, the arc length 30AL of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters, the arc length 32AL of the intermediate bevels 32a-b is between about <NUM> - <NUM> millimeters, and the arc length 34AL of the distal bevels 34a-b is between about <NUM> -<NUM> millimeters. In another example form, the arc length 30AL of the proximal bevel <NUM> can be between about <NUM> - <NUM> millimeters, the arc length 32AL of the intermediate bevels 32a-b can be between about <NUM> - <NUM> millimeters, and the arc length 34AL of the distal bevels 34a-b can be between about <NUM> - <NUM> millimeters.

The pen needle <NUM> of the present invention can be formed from a steel material, for example a stainless steel, for example by drawing, molding or other manufacturing processes. In example forms, the needle <NUM> comprises an outer diameter OD and an inner diameter ID. The outer diameter OD is measured across the outer peripheral surface of the cannula <NUM> and the inner diameter ID is measured across the inner surface <NUM> of the lumen <NUM>. In example forms, the outer diameter OD of the needle <NUM> is generally between about <NUM> - <NUM> millimeters, or for example from about <NUM> gauge to about <NUM> gauge, and the inner diameter is between about <NUM> - <NUM> millimeters. In further example forms, the outer diameter OD is between about <NUM> - <NUM> millimeters and the inner diameter ID is between about <NUM> - <NUM> millimeters. In further example forms, the outer diameter OD can be between about <NUM> - <NUM> millimeters and the inner diameter ID can be between about <NUM> - <NUM> millimeters. In example forms, the pen needle is about <NUM> - <NUM> millimeters in overall length. The chart below shows example dimensions of several gauge needles according to example embodiments of the present invention.

In example forms, the needle <NUM> of the present invention is generally manufactured in quantity, for example between about <NUM> - 1OOO needles at a time in an automated process. Typically, an arm or other articulating structure comprises a system of fixtures for holding needle blanks, each of which is ground several times for form the needle tip resulting in the needle <NUM>. In example forms, the bevels of the multi-beveled tip are ground by a disc-like grinding wheel or a belt. In example form, the arm holding the fixtures is positioned in close proximity to the grinder to allow for the grinder to provide the multi-beveled face on each of the needles sequentially or simultaneously. Preferably, the fixture system provides for rotation thereof such that the to-be needle can be rotated to form the distal bevels 34a-b. Adjustment to the inclination angle may be provided by angular movement of the arm and/or angular change of the inclination angle of each of the fixtures relative to the arm.

In example methods of manufacture, the end of a needle blank may start with a flat end face prior to being ground. The needle blank is then positioned at the inclination angle 30a relative to the longitudinal axis A and a grinder forms the proximal bevel <NUM>. While remaining at the same angle of rotation, the inclination angle of the needle blank is changed to the inclination angle 32a relative to the longitudinal axis A The grinder then forms the intermediate bevels 32a, 32b. The remaining distal bevels 34a-b are then formed, which requires adjustment to the inclination angle and the angle of rotation of the needle blank. In example form, the needle is adjusted to the inclination angle 34a and then rotated in the clockwise direction about % <NUM>, for example from the vertical axis B to the limit of <NUM> in the clockwise direction. The grinder then forms the first distal bevel 34a. The needle is then rotated the entire length of the rotation angle <NUM> in the counterclockwise direction and the grinder forms the second distal bevel 34b. Alternatively, the manufacturing process and/or the order of the steps to form the bevels can vary.

After the bevels are formed on the tip of the needle <NUM>, the needle preferably goes through a bead blasting process whereby very small glass beads are projected onto the multi-beveled point such that any edges, intersections or transitions between bevels and adjacent surfaces are radiused, rounded, or otherwise smoothed. In one form, the projection of glass beads is not necessarily concentrated on a particular portion of the multi-beveled point <NUM>, but instead generally projected at the point <NUM> in a direction generally perpendicular to the longitudinal axis A In example forms, the spray of glass beads is controlled by the equipment and can be adjusted from a direction generally parallel to the extension of the needle <NUM> to a direction generally perpendicular to the extension of the needle <NUM> (including any angle therebetween). According to one example form, the angle of the spray of the glass beads is configured to be at about <NUM> degrees relative to the extension of the needle <NUM> (e.g., from being parallel therewith). The needle <NUM> then goes through an alkaline bath, an ultrasonic cleaning process, an acid bath, an electropolishing process, a cleaning process, and a passivation process. Preferably, these processes ensure that the needle is polished, smooth, free from burrs, and less resistant to corrosion. Optionally, after processing the needle (e.g., electropolishing, cleaning, and passivation), the needle undergoes a visual or machine inspection process to ensure that quality standards have been met. Generally, the inspection process comprises comparing the needle and its multi-beveled point against a sample or image of a satisfactory needle having targeted specifications. For example, in some example forms, the needle <NUM> is measured and the measurements are compared to a <NUM>-dimensional dimensioned print of the needle. If the needle is within a specified range or tolerance of the target specifications, the needle passes the inspection and is assembled to form a pen needle, syringe or other item, and further treated and/or packaged for delivery.

<FIG> show a pen needle <NUM> according to another example embodiment of the present invention. The pen needle <NUM> is in many aspects substantially similar to the pen needle <NUM> as described above, but comprises a three-bevel tip geometry rather than the five-bevel tip geometry described above. The pen needle <NUM> comprises a proximal bevel <NUM> and a pair of distal bevels 134a, 134b. Generally, the pen needle <NUM> comprises an elongate cannula <NUM> having a lumen <NUM> extending therethrough, which extends along a longitudinal axis A from a proximal end <NUM> to a distal end <NUM>.

A rounded, radiused, or otherwise smooth transition is optionally provided between the bevels, between the bevels and the lumen, and/or between the bevels and the outer periphery of the cannula <NUM>. For example, as depicted in <FIG>, a first smooth transition 140a is provided between the distal bevels 134a, 134b, which meet together at a longitudinal apex <NUM>. A second smooth transition 140b is provided between the distal bevel 134a and a portion of the proximal bevel <NUM>, and a third smooth transition 140c is provided between the distal bevel 134b and a portion of the proximal bevel <NUM>. A smooth transition <NUM> is also optionally provided between each of the bevels positioned along the periphery <NUM> of the lumen <NUM> and an interior surface <NUM> of the lumen <NUM> (e.g., bevel to intralumen transition), and a smooth transition <NUM> provided between the intersection of each of the bevels and the outer surface or periphery of the cannula <NUM>.

<FIG>, <NUM> and <FIG> show greater details of the multi-bevel point <NUM>. In the depicted embodiment of <FIG>, the proximal bevel <NUM> is formed at a first inclination angle 130a, defined relative to the longitudinal axis A. For example, in one example embodiment, the first inclination angle 130a is between about <NUM> - <NUM> degrees relative to the axis. In alternate embodiments, the first inclination angle 130a is between about <NUM> - <NUM> degrees. In the depicted embodiment of Figure <NUM>, the distal bevels 134a, 134b are formed at a second inclination angle 134a relative to the longitudinal axis A, for example between about <NUM> - <NUM> degrees. In alternate embodiments, the second inclination angle 134a is between about <NUM> - <NUM> degrees. Optionally, the second inclination angle 134a is between about <NUM>-<NUM> degrees relative to the longitudinal axis A. Preferably, prior to forming the distal bevels 134a, 134b, the pen needle <NUM> is rotated about the longitudinal axis A in both the clockwise and counterclockwise directions respectively, such that the distal bevels 134a, 134b are formed at a substantially different rotational angle (and at a different inclination angle as described above) relative to the proximal bevel <NUM>. As depicted in <FIG>, the entire rotation of the needle <NUM> between the first distal bevel 134a and the second distal bevel 134b (shown as rotation angle <NUM>) is about <NUM> degrees relative to a vertical axis B. Thus, to form the first distal bevel 134a, the needle is rotated about the longitudinal axis A in the clockwise direction about <NUM> degrees and inclined at the inclination angle 134a. Similarly, to form the second distal bevel 134b, the needle <NUM> is rotated about the longitudinal axis A in the counterclockwise direction (from the <NUM> degrees clockwise position) about <NUM> degrees in the counterclockwise direction while remaining at the inclination angle 134a. Thus, in example forms, the rotational angle for forming the distal bevels 134a, 134b is generally provided by rotating the needle <NUM> about <NUM> degrees in both the clockwise and counterclockwise directions about the longitudinal axis A Optionally, the rotational angle can be between about <NUM> - <NUM> degrees in the clockwise and counterclockwise directions.

As depicted, the smooth transitions between the bevels may be configured such that an angle <NUM> is defined between the vertical axis B and the smooth transitions 140b, 140c. In example forms, the angle <NUM> is about <NUM> degrees. Since the needle <NUM> is rotated in the clockwise and counterclockwise directions prior to forming the distal bevels 134a, 134b, the angle <NUM> will generally be between about <NUM> degrees to about <NUM> degrees relative to the vertical axis B.

As depicted in <FIG>, in example embodiments, the length L of the multi-beveled surface <NUM> is between about <NUM> - <NUM> millimeters. In further example embodiments, the length L is between about <NUM> - <NUM> millimeters. In further embodiments, the length L can be between about <NUM> - <NUM> millimeters. In example embodiments, the length <NUM> of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters and the length <NUM> of the distal bevels 134a-b is between about <NUM> - <NUM> millimeters. In further example embodiments, the length <NUM> of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters and the length <NUM> of the distal bevels 34a-b is between about <NUM> - <NUM> millimeters. In further example embodiments, the length <NUM> of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters and the length <NUM> of the distal bevels 134a-b is between about <NUM> - <NUM> millimeters. In example embodiments, the length 130L1 of the proximal bevel <NUM> (measured between the peak and valley of the proximal bevel <NUM>) is generally between about <NUM> - <NUM> millimeters. In further example embodiments, the length 130L1 is between about <NUM> - <NUM> millimeters. And in further example embodiments, the length 130L1 is between about <NUM>-<NUM> millimeters.

The proximal and distal bevels <NUM>, 134a-b can also be defined by their respective arc lengths 130AL, 134AL. The arc length is generally defined along the interior edges of the bevels around the periphery <NUM> of the lumen <NUM>, between transitions between the bevels. In one example form, the arc length 130AL of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters and the arc length 134AL of the distal bevels 134a-b is between about <NUM> - <NUM> millimeters. In example form, the arc length 130AL of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters and the arc length 134AL of the distal bevels 134a-b is between about <NUM> - <NUM> millimeters. In further example form the arc length 130AL of the proximal bevel <NUM> is between about <NUM> - <NUM> millimeters and the arc length 134AL of the distal bevels 134a-b is between about <NUM>-<NUM> millimeters.

In example embodiments, the outer diameter OD of the needle <NUM> is generally between about <NUM> - <NUM> millimeters, or for example between about <NUM> gauge to about <NUM> guage, and the inner diameter is between about <NUM> - <NUM> millimeters. In further example embodiments, the outer diameter OD is between about <NUM> - <NUM> millimeters and the inner diameter ID is between about <NUM> - <NUM> millimeters. In still further example embodiments, the outer diameter OD can be between about <NUM> -<NUM> millimeters and the inner diameter ID can be between about <NUM> - <NUM> millimeters. In example forms, the pen needle is about <NUM> - <NUM> millimeters in overall length. The chart above (see paragraph [<NUM>]) shows example dimensions of several gauge needles according to example embodiments of the present invention.

<FIG> show additional features and embodiments of pen needles and needle tip geometries according to further example forms of the invention. In example forms, a pen needle <NUM> comprises a needle cannula <NUM> attached to a hub <NUM>, a shield <NUM> and a container or cover <NUM>. The needle <NUM> has a distal end <NUM> comprising a multi-beveled point <NUM>. The multi-beveled point <NUM> comprises a plurality of beveled faces including a proximal bevel <NUM>, a pair of intermediate bevels <NUM>, one or more distal bevel(s) <NUM>, and a back bevel <NUM>. In example embodiments, the proximal bevel <NUM>, intermediate bevels <NUM>, and distal bevel <NUM> can be configured substantially similar to the respective bevels of the embodiments described above. In further example embodiments, one or more of the proximal bevel <NUM>, the intermediate bevels <NUM>, and the distal bevel(s) <NUM> are formed at different angles of inclination relative to one another and/or at rotational angles relative to one another.

The back bevel <NUM> is preferably formed on the rotationally opposite side or face of the needle cannula <NUM> (i.e., at a rotational orientation of about <NUM>° about the axis C of the cannula) from the proximal bevel <NUM>, intermediate bevels <NUM>, and distal bevel <NUM>. The back bevel <NUM> is preferably ground to a depth into the wall thickness of the cannula <NUM> sufficient to define a sharp leading edge <NUM> at the tip of the point <NUM> where the plane of the back bevel intersects the plane of the distal bevel <NUM>, defining a chisel-tip geometry. Optionally, the back bevel <NUM> is formed at a slightly angularly offset (from <NUM>°) rotational orientation relative to the distal bevel <NUM>, to form an obliquely angled (relative to the axis C of the cannula) leading edge <NUM>. In the embodiment depicted in <FIG>, the back bevel is ground at a rotational offset of about <NUM>° from the distal bevel <NUM>. In alternate embodiments, the rotational offset can be, for example, within a range of +/- <NUM>°, +/- <NUM>°, +/- <NUM>°, +/- <NUM>° and/or other offset from exactly <NUM>°, to vary the angle of the leading edge <NUM> relative to the axis C of the cannula. Or alternatively, the back bevel <NUM> can be formed at a <NUM>° rotational offset from the distal bevel <NUM> to form a leading edge perpendicular or transverse to the axis C of the cannula. The needle <NUM> can be formed in similar fashion as described above, in various different gauges, lengths, needle formats, etc., as well as various different bevel geometries and tip configurations, in example embodiments within the scope of the invention.

Claim 1:
A needle (<NUM>), comprising:
a cannula (<NUM>) having proximal end (<NUM>), a distal end (<NUM>), a longitudinal axis extending between the proximal and distal ends, an elongate lumen (<NUM>) extending axially therethrough along the longitudinal axis, and a multi-beveled point at the distal end,
wherein the multi-beveled point (<NUM>) includes a proximal bevel (<NUM>), a pair of intermediate bevels (32a, 32b), and a pair of distal bevels (34a, 34b), the proximal bevel being formed at a first angle of inclination relative to the longitudinal axis, the pair of intermediate bevels being formed at a second angle of inclination relative to the longitudinal axis, and the pair of distal bevels being formed at a third angle of inclination and differing angles of rotation relative to a vertical axis, characterized in that the second angle of inclination is substantially different from the first angle of inclination,
wherein at least one smooth transverse transition zone (40b, 40c, 40d, 40e) is formed between adjacent ones of the proximal, intermediate, and distal bevels,
wherein the third angle of inclination is substantially different from the second angle of inclination.