Pen needle

Abstract

A pen needle includes a needle hub that supports the needle, an inner shield that encloses the distal end of the needle, and an outer shield. The outer surface of the needle hub may include ribs that mate with ribs on the inner surface of the outer shield to help attach the pen needle to a delivery device while preventing over-torquing or over-tightening. In one embodiment, the inner shield is dimensioned to attach to the distal end of the needle hub after use to enclose the proximal, non-patient end of the needle. In another embodiment, the outer shield includes a closure member that can be removed during use and reattached after use to cover the proximal end of the needle.

Description

[0001] This application claims priority to U.S. Provisional Application No. 62 / 868,350, filed on June 28, 2019, and U.S. Provisional Application No. 62 / 864,116, filed on June 20, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates to a pen needle for attachment to a drug delivery device, such as a drug delivery pen. The pen needle has a needle hub and an outer protective cover that includes tactile features (such as tactile and / or audible indicators) to prevent the needle hub from being overtightened on the delivery pen. The pen needle may also have a removable closure or end cap to close the open end of the needle hub. Background Art

[0003] Pen needles are used to attach to medication pens and are particularly suitable for delivering self-administered injectable medications such as insulin. In one known commercially available device, a needle holder is located within a funnel-shaped outer protective cover, sometimes referred to as an outer shield, outer cover, or simply a cover. A cannula or needle is secured within an axial bore in the needle holder, with one end protruding from the distal, or "patient-side," side of the needle holder for administering the injection, while the other end of the needle is recessed into a cavity on the proximal, or "non-patient-side," side of the needle holder and adapted for attachment to the medication pen. A "teardrop" tab made of paper or foil seals against the edge of the open end of the funnel-shaped outer cover. Alternatively, the medication pen may have a cap that is received at the distal end of the medication pen, over the opening for mounting the pen needle. To attach the pen needle to the medication pen, the user removes the pen cap. The user then removes the tab from the pen needle outer cover and grasps the outer cover to attach the needle holder, typically by screwing it onto the pen. Once the needle hub is installed on the medication pen, the outer protective cover can be removed by pulling it distally away from the needle hub. A separate inner needle shield is placed over the needle, which the user must remove before administering an injection. The inner shield is typically placed over the needle hub and simply helps the user position the needle without forming a sterile barrier. After use, the user unscrews the needle hub from the pen using the outer protective cover and discards the pen needle.

[0004] Medication pens and related pen needles are disclosed in U.S. Patent No. 7,645,264 and U.S. Patent Application Publication Nos. 2009 / 0069755 and 2012 / 0022460, all of which are incorporated by reference in their entirety for their teachings of pen needle design and construction. U.S. Patent No. 8,057,444, also incorporated by reference, discloses a device for deploying a releasable pen needle on an injection pen and releasing the pen needle into a compatible storage or disposal container.

[0005] The pen needle may include a cap or shield covering the end of the needle to prevent reuse and accidental needle sticks. Pen needles are also known that have a shield to cover the proximal end of the needle when the pen needle is separated from the delivery device.

[0006] While existing devices are generally suitable for their intended uses, there remains a need in the industry for improved pen needles. Summary of the Invention

[0007] The present disclosure relates to a pen needle assembly for use with a drug delivery device for injecting a drug into a patient. In one embodiment, the pen needle has a needle hub with a needle, an inner needle shield, and an outer shield.

[0008] A feature of the pen needle is a needle hub and an outer protective cover, the outer protective cover including a mechanism for providing tactile feedback to the user when the needle hub is screwed onto the delivery pen. The mechanism for providing tactile feedback can be a protrusion formed on the outer surface of the needle hub and a protrusion formed on the inner surface of the outer protective cover, wherein these protrusions engage and slide over each other to prevent overtightening when attaching the pen needle to the delivery pen. When the needle hub is tightened onto the delivery pen, the protrusions slide over each other, providing a tactile and / or audible sensation to the user. The protrusions engage sufficiently to assist in removing the needle hub from the delivery pen without slipping. The protrusions have a configuration suitable for sliding over each other to resist overtightening while allowing the needle hub to be separated from the pen needle. The protrusions can be in the form of tabs, stops, ribs, or other suitable configurations.

[0009] The tactile feedback mechanism can be longitudinally extending ribs on the outer surface of the needle hub, the surface of these ribs allowing complementary ribs or stops on the outer cover to slide on these ribs on the outer surface of the needle hub in one rotational direction when the pen needle is attached to the delivery pen, and to resist sliding in the opposite rotational direction when the pen needle is separated from the delivery pen. The protrusion on the needle hub can have a face that is inclined relative to the longitudinal axis of the needle hub. The protrusion can also have a leading face that is inclined or slanted relative to the outer wall of the needle hub and a trailing face that is substantially perpendicular to the outer wall of the needle hub. The radially outer surface of the protrusion can be inclined, wherein the trailing face is radially spaced outward relative to the leading face of the protrusion.

[0010] The protrusion may be a longitudinally extending rib formed on the outer surface of the side wall of the needle hub and the inner surface of the outer shield. The rib may extend substantially parallel to the longitudinal axis of the needle hub and the outer shield and have a longitudinal length greater than the width. The rib may be spaced apart from the distal end of the outer shield and the needle hub and spaced apart from the proximal end of the outer shield and the needle hub.

[0011] During use, the inner shield can be removed to expose the patient end of the needle. After the used pen needle is removed from the delivery pen, the inner shield can then be attached to the non-patient end of the needle hub to enclose the non-patient end of the needle. The inner shield can be inserted into the open end of the needle hub and coupled to the needle hub by a friction fit or an interference fit.

[0012] The needle hub may have an internally threaded sidewall for connection to the delivery pen. The sidewall may have one or more open slots extending in the longitudinal direction to form a wall segment that can be bent radially outward relative to the delivery pen to facilitate removal from the delivery pen. The open end of the outer cover can be positioned over the needle hub after use to cover the patient end of the needle, thereby reducing the risk of accidental needle sticks. The inner surface of the outer cover includes an inwardly extending lip or stop that engages the bottom edge of the needle hub when the outer cover is placed over a used pen needle. Pulling the outer cover away from the delivery pen pulls the flexible wall segment outward from the delivery pen, allowing the threads to separate from the delivery pen, allowing the used pen needle to be removed and discarded.

[0013] A removable closure or end cap can be coupled to the open end of the outer cover to enclose the pen needle. After use, the pen needle hub is returned to the outer cover, and the end cap is attached to the open end of the outer cover to enclose the used pen needle for disposal. The end cap can have a visible tamper-evident feature to indicate that the pen needle has been used. The end cap can include one or more tabs or flanges to facilitate removal of the end cap from the outer cover and replacement of the end cap with the outer cover. The end cap has an open end that complements the open end of the outer cover to couple the end cap to the outer cover.

[0014] The outer shield may have an axial length at least equal to the axial length of the needle hub and have a cavity sufficient to enclose the needle hub and the needle before and after use. The axial length of the outer shield may be less than the axial length of the needle hub, in which case the outer shield is coupled to the distal end of the needle hub to cover the needle without enclosing the open end of the needle hub.

[0015] A pen needle may include: a needle hub having a distal end and an open proximal end for attachment to a delivery device; a needle coupled to the needle hub and having a distal end extending from the distal end of the needle hub; a removable inner shield coupled to the needle hub, wherein the inner shield has a sidewall having an inner surface complementary to an outer surface of the needle hub, wherein the inner shield is configured to couple to the outer surface of the needle hub at the distal end of the needle hub for covering the distal end of the needle; and the inner shield has an outer surface sized to couple with the inner surface of the open proximal end of the needle hub.

[0016] A pen needle may include a needle hub having a sidewall, a proximal end for attachment to a delivery device, and a distal end. The sidewall includes a plurality of longitudinally extending ribs that project radially outward and have an inclined leading surface oriented in a plane parallel to the longitudinal axis of the needle hub and a trailing surface oriented in a plane parallel to the longitudinal axis of the needle hub. The needle is coupled to the needle hub and has a distal end extending from the distal end of the needle hub and a proximal end located at the proximal end of the needle hub. An outer shield includes a sidewall having an inner surface with longitudinally extending ribs. The ribs project radially inward and have a longitudinally extending leading surface oriented obliquely relative to a radius of the outer shield, and a trailing surface extending parallel to the longitudinal axis of the outer shield.

[0017] These and other aspects and features of the pen needle will become apparent from the following detailed description of the invention and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The following is a brief description of the accompanying drawings, in which:

[0019] Figure 1 This is an exploded view of the pen needle.

[0020] Figure 2 It shows Figure 1 A partial cross-sectional view of a pen needle.

[0021] Figure 3 yes Figure 2 sectional view of a pen needle showing the inner protective cover on the proximal end of the needle hub after use.

[0022] Figure 4 It is along Figure 2 an end view of a cross section of the pen needle taken along line 4-4;

[0023] Figure 5 It is along Figure 3 a side view of a partial cross-section of the needle hub taken along line 5-5 with the inner shield inserted into the open end of the needle hub;

[0024] Figure 6 is a perspective view of a pen needle according to another embodiment.

[0025] Figure 7 yes Figure 6 A partial end view of the ribs of the pen needle and the inner surface of the protective cover of an embodiment of the present invention;

[0026] Figure 8 yes Figure 6 A partial elevation view of the outer surface of the needle seat;

[0027] Figure 9 yes Figure 6 An enlarged elevation view of the ribs on the cover;

[0028] Figure 10 is an end perspective view of a needle hub and outer shield in another embodiment;

[0029] Figure 11 It shows Figure 10 an end view of the ribs on the outside of the needle hub;

[0030] Figure 12 is a cross-sectional view of the needle holder, showing Figure 10 The outer protective cover and the ribs on the needle hub of the embodiment.

[0031] Figure 13 is a partial end view of one embodiment.

[0032] Figure 14 This is a perspective view showing a needle shield on a pen needle according to still another embodiment.

[0033] Figure 15 is a perspective view showing a needle shield on a pen needle according to yet another embodiment.

[0034] Figure 16 This is a perspective view showing a needle shield on a pen needle according to still another embodiment.

[0035] Figure 17 is shown positioned on the open end of the outer shield Figure 16 A perspective view of the end cap;

[0036] Figure 18 is a perspective view showing a needle shield on a pen needle according to another embodiment.

[0037] Figure 19 It shows Figure 17 A perspective view of the pen needle after use;

[0038] Figure 20 is a perspective view of a pen needle according to another embodiment.

[0039] Figure 21 yes Figure 20 A partial cross-sectional view of a pen needle;

[0040] Figure 22 yes Figure 20 An enlarged view of the connection between the outer cover and the base of the pen needle;

[0041] Figure 23 It is shown in Figure 20 A partial cross-sectional view of a peel tab removed in an embodiment of FIG.

[0042] Figure 24 yes Figure 23 An enlarged cross-sectional view of the connection between the outer cover and the base;

[0043] Figure 25 yes Figure 20 A perspective view of a housing and a base of an embodiment of the invention;

[0044] Figure 26 is a perspective view of a pen needle according to yet another embodiment; and

[0045] Figure 27 yes Figure 26 A perspective view of the pen needle with the peel tab removed.

[0046] The figures are not drawn to scale and some features have been omitted from certain views to better illustrate other features. DETAILED DESCRIPTION

[0047] As used herein, the "distal" direction is the direction toward the injection site, while the "proximal direction" is the opposite direction. The "axial" direction is along the longitudinal axis of the device. The needle cannula is arranged generally axially in the device. "Radially" is a direction perpendicular to the axial direction and in a plane extending from the central axis of the device. Thus, "radially inward" generally means closer to the needle. "Circumferentially" means arranged around the circumference, such that the threads are arranged circumferentially on the end of the threaded fitting. A "top view" of a pen needle is viewed facing the tip of the needle. The different features of each embodiment may be combined and used with other embodiments as long as the combined parts do not conflict with or interfere with the operation of the device and assembly.

[0048] As used herein, a medication pen or delivery pen refers to a device having a medication compartment and a separate pen needle, the medication compartment typically containing a dose of medication. The term "pen needle" is a needle support assembly that can be attached to the medication pen body so that the proximal end of the pen needle assembly enters the medication compartment and the distal end is suitable for insertion into an injection site for one or more injections. The terms "needle" and "cannula" are used interchangeably herein to refer to a thin tubular member with a sharp end for insertion into an injection site of a subject. As used herein, the "distal" direction is the direction toward the injection site, while the "proximal" direction is the opposite direction. "Axial" refers to along or parallel to the longitudinal axis of the pen needle, and the "radial" direction is the direction perpendicular to the axial direction.

[0049] The application of the present disclosure is not limited to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. The embodiments herein can be modified, practiced, or implemented in various ways. It will be understood that the words and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "including," "comprising," or "having" and their variations herein is intended to cover the items listed thereafter and their equivalents as well as other items. Unless otherwise limited, the terms "connect," "couple," and "mount" and their variations herein are used in a broad sense and cover direct and indirect connections, couplings, and mountings. In addition, the terms "connect" and "couple" and their variations are not limited to physical or mechanical connections or couplings. In addition, terms such as upper, lower, bottom, and top are relative and are used to aid in explanation and are not restrictive. The various embodiments are not intended to be mutually exclusive, such that features of one embodiment can be combined with other embodiments as long as they do not conflict with each other. It should be understood by those skilled in the art that terms of degree such as "substantially," "approximately," and "approximately" refer to a reasonable range around and including a given value, as well as a range outside of a given value, such as the general tolerances associated with the manufacture, assembly, and use of the embodiments. When referring to a structure or characteristic, the term "substantially" includes most or all of the characteristics present in the structure.

[0050] Referring to the drawings, the pen needle 10 includes a needle hub 12. An outer protective cover 16 may be included that fits over the pen needle 10 during storage and assists in attaching the pen needle 10 to a delivery device, such as a Figure 1 The delivery pen 11 shown is generally provided with a closure on the open end of the outer cover to keep the needle holder 12 in a sterile state until ready for use. The closure may be as described herein. Figure 2 The closure shown may be peelable from the needle hub 12, or as described herein. Figures 18-26 The closure shown. The delivery pen can be a standard delivery pen or other drug delivery device known in the art for dispensing and delivering drugs such as insulin. An example of a suitable delivery pen is disclosed in U.S. Patent No. 9,774,844, which is incorporated herein by reference for this purpose.

[0051] like Figures 1-18As shown, the pen needle 10 includes a needle hub 12. The needle hub 12 is configured to support an internal needle shield 14. The needle hub can be a one-piece unit or made of separate parts that are coupled together. In the pen needle shown, the needle hub 12 includes a needle hub body 18 having an open bottom end that defines a proximal non-patient end 20 for coupling with the delivery pen 11 and a distal end 22 that forms the patient end of the pen needle. The open bottom end formed by the needle hub body 18 has a side wall 24 that has an internal thread 26, such as Figure 10 Threads are shown in , for coupling to the delivery pen 11 in a known manner. The distal end 22 has an opening for a needle 28 or cannula and defines a skin contacting surface during use.

[0052] Needle 28 may be a hollow steel needle having a sharp tip at its distal end and having a gauge and length suitable for penetrating the skin to a desired depth and delivering the medication to the patient. Needle 28 has a patient end, which forms a distal end 30 having a sharp tip extending from the distal end of needle hub 12 for penetrating the patient's skin. The proximal end of needle 28 is located at the proximal end of needle hub 12 and is used to pierce a septum in a delivery device for receiving a medication or drug from the delivery device in a conventional manner. The exposed length of distal end 30 extending from the distal end of the needle hub during injection is approximately 3 mm to 10 mm, typically approximately 4 mm to 6 mm.

[0053] Reference Figure 3 、 Figure 5 and Figure 6 , the needle hub body 18 has an end wall 34 at the top distal end of the side wall 24. The end wall has a distal surface having a post 36 extending in a distal direction. The post 36 has an axial channel that receives and supports the needle 28. The needle 28 is secured to the post 36 in a conventional manner by an adhesive. As shown, the post 36 has a generally cylindrical configuration with a generally cylindrical outer surface 40. The distal end of the needle 28 protrudes from the post 36 and extends distally from the pen needle a distance to penetrate the patient's skin to a selected depth in the skin during an injection. The proximal end of the needle 28 extends a distance within the needle hub body 18 to connect to the reservoir of the delivery device when the pen needle is attached to the delivery device.

[0054] The distal side 42 of the post 36 can form a skin-contacting surface to deform the skin surface during injection. The distal side 42 can have a variety of shapes and sizes. The pen needle shown has a convex configuration to control the shape of the indentation formed in the skin and thus the depth of needle penetration. The distal side 42 has an elevated outer ring 44 and an elevated inner ring 46, thereby forming an annular recess 48 between the outer ring 44 and the inner ring 46. The outer ring and the inner ring have a curved convex surface that forms a continuous radius of curvature. The bottom surface of the surface of the annular recess has a radius of curvature that is concentric with the radius of curvature of the inner ring and the outer ring.

[0055] like Figure 2 As shown, inner shield 14 is assembled onto needle hub 12 to enclose the distal end of needle 28. Inner shield 14 and needle hub 12 are assembled within outer shield 16. A closure member, such as a tab that can be peeled off the needle hub, is provided at the open end of the outer shield to enclose the needle hub until ready for use. During use, the closure member is removed to expose the open end of needle hub 12. Needle hub 12 is screwed onto the threaded end of delivery pen 11 using outer shield 16 to assist in screwing the needle hub onto the delivery pen. Once secured to the delivery pen and fluid communication is achieved between the pen needle and the medication compartment of the delivery pen, outer shield 16 is pulled away from needle hub 12. Inner shield 14 is removed to expose the needle so that the medication can be injected into the patient. After use, outer shield 16 is placed onto the needle hub, in which case the outer shield sufficiently grips the needle hub so that the needle hub can be separated from the delivery pen, in which case the used pen needle can be discarded.

[0056] like Figure 1-Figure 3 As shown, the inner shield 14 has a generally cylindrical sidewall 50 with a closed distal end 52 and an open proximal end 54. External ribs may be included to assist the user in maneuvering the inner shield during use. The sidewall 50 has an inner surface that is sized to complement the outer dimensions and configuration of the post 36 so that the inner shield 14 fits onto the post 36 by a friction fit.

[0057] like Figure 2 and Figure 3 As shown, the proximal end of the side wall 24 of the inner shield 14 has a flange 56 protruding radially outward. Figure 2 As shown, at least one and typically a plurality of radially extending stops (shown as ribs 58) project from the side wall 24 of the inner shield 14 proximate or adjacent the flange 56. The ribs 58 may project radially outward a distance substantially corresponding to the radial dimension of the flange 56, or may extend a distance slightly greater than the radial dimension of the flange 56. The outer dimensions of the flange 56 and the ribs 58 are complementary to the inner dimensions of the needle hub body 18. In one embodiment, after use of the pen needle, the inner shield 14 may be inserted into the open end of the needle hub body 18 to cover the proximal end of the needle. The flange 56 and / or ribs 56 are sized to engage with the inner surface of the needle hub body 18 to retain the inner shield within the open end of the needle hub body by a friction fit or an interference fit, as shown. Figure 3 and Figure 5 shown.

[0058] The hub body 18 may have one or more longitudinal slots 60 to form a Figure 3 The needle hub 12 is attached to the delivery pen via internal threads on the side wall of the needle hub 12. Figure 3As shown, the outer shield 16 has an inwardly extending protrusion 64 that can engage the proximal end of the side wall and the flexible portion 62. By pulling or twisting the outer shield 16, the protrusion 64 can deflect the flexible portion 62 radially outward to separate the internal threads from the threads on the delivery pen, thereby helping to separate the needle hub from the delivery pen by a prying motion rather than just a rotational motion.

[0059] The needle hub 12 includes a ratchet mechanism between the needle hub 12 and the outer shield 16 to assist in screwing the needle hub onto the delivery pen and to provide limited slip between the outer shield and the needle hub to prevent over-tightening or over-torquing of the needle hub on the delivery pen. The ratchet mechanism can grip the needle hub to unscrew and separate the needle hub from the delivery pen.

[0060] As shown in the figure, the ratchet mechanism can be in various forms. Figure 2-Figure 4 As shown, the outer surface of the needle hub body 18 has a plurality of protrusions that mate with corresponding protrusions on the inner surface of the outer shield 16. In the ratchet mechanism shown, the protrusions on the sidewall 24 of the needle hub body 18 extend in a longitudinal direction relative to the longitudinal axis of the needle hub body 18. The protrusions form ribs 66 that project radially outward and extend in the longitudinal direction of the needle hub. In the embodiment shown, the ribs 66 are located in the central portion of the sidewall 24, but the ribs may also be located in other areas of the sidewall.

[0061] The rib 66 has a shape and size that allows the outer cover 16 to engage the needle hub 12 to rotate the needle hub 12 relative to the delivery pen to attach and detach the needle hub. The rib 66 has a leading surface 68 and a trailing surface 70. As shown, the leading surface 68 is a flat surface oriented in a plane at an oblique angle relative to the radius of the needle hub 12, such as Figure 4 As shown. Leading surface 68 extends obliquely outward from the outer surface of the side wall of needle hub 12 to form an oblique surface relative to the outer surface of the needle hub. Trailing surface 70 is oriented in a radial direction of the central axis of needle hub 12. As shown in the figure, leading surface 68 and trailing surface 70 form an acute angle relative to each other.

[0062] The outer cover 16 has inwardly extending ribs 72 that are complementary to the ribs 66. Figure 4 As shown, rib 72 projects inwardly from the inner surface of outer shield 16. Rib 72 has a leading surface 74 and a trailing surface 76. When outer shield 16 is rotated relative to needle hub in first and second directions, leading surface 74 and trailing surface 76 engage corresponding surfaces on the needle hub. Leading surface 74 of rib 72 is oriented substantially parallel to leading surface 68 of needle hub 12, while trailing surface 76 is oriented substantially parallel to trailing surface 70 of needle hub 12. Leading surface 74 is oriented at an oblique angle relative to the radius of outer shield 16 so as to project inwardly from the sidewall. Trailing surface 76 is oriented radially relative to the longitudinal axis of outer shield 16 so as to project radially inwardly relative to the outer shield.

[0063] During use, the proximal end of the opening of the needle hub 12 is screwed onto the threaded end of the delivery pen. The needle hub 12 is retained in the outer protective cover 16, and the outer protective cover rotates relative to the delivery pen in the direction of arrow 78 to screw the needle hub 12 onto the delivery pen. When the needle hub 12 is screwed onto the delivery pen, the inclined leading surfaces 68 and 74 contact each other. When the needle hub 12 is tightly placed on the delivery pen, the resistance relative to the outer protective cover 16 enables the inclined leading surfaces 69 and 74 to slide over each other to prevent the needle hub 12 from being too tight on the delivery pen. The leading surfaces 69 and 74 slide over each other to produce a tactile and / or audible indication that the needle hub is tightly screwed onto the delivery pen. Then, the outer protective cover 16 is removed to expose the needle for injecting the patient.

[0064] After the injection, the outer shield 16 can be placed on the needle hub 12 and rotated in the direction of arrow 79. The trailing edges 70 and 76 engage each other without slipping, separating the needle hub from the delivery pen. The outer shield and needle hub can then be discarded. The needle hub and outer shield are made of a suitable plastic material that is sufficiently rigid to support the needle and attach to the delivery pen. This plastic material allows the ribs to flex and deform sufficiently to allow them to slide over each other while maintaining integrity to enable removal from the delivery pen.

[0065] Figure 6-Figure 9 Another embodiment of a ratchet mechanism between outer shield 80 and needle hub 82 is shown. Figures 6 to 9 The ratchet mechanism shown can be used in Figures 1 to 5 The needle hub 82 includes a generally cylindrical sidewall 84 having an open bottom end 86 and a top end 88. The distal end and contact surface of the needle hub 82 are similar to those of the needle hubs of the previous embodiments, such that similar elements are identified with the same reference numerals where necessary. The sidewall 84 includes a plurality of spaced-apart recesses 90 that form raised ribs 92 that are used to assist the patient in gripping the outer surface of the needle hub 82. The ribs 92 have a generally V-shape, thereby forming a V-shaped recess that extends to the distal end of the needle hub and converges toward the proximal end of the needle hub. The ribs 92 have a leading surface 94, a trailing surface 96, and a distal end 98.

[0066] The leading surface 94 is inclined relative to the outer radial surface 100 of the rib 92 to form an inclined surface extending between the face of the recess 90 and the outer surface 100. The trailing surface 96 is also inclined relative to the radial outer surface of the sidewall 84 to form an inclined surface extending between the face of the recess 90 and the outer surface 100. Figure 6As shown, the leading surface 94 and the trailing surface 96 are further oriented obliquely relative to the longitudinal axis of the needle hub 82 and obliquely relative to the radius of the needle hub. The leading surface and the trailing surface are inclined relative to each other, wherein the leading surface of a first rib faces the trailing surface of a second adjacent rib, so that the ribs form a cam-like surface. The distal ends of the leading surface and the trailing surface have a Figure 7 The rounded surfaces are shown, converging at the distal tip 101 .

[0067] The outer shield 80 has a cylindrical sidewall 102 that is complementary to the sidewall 84 of the needle hub 82. The sidewall 102 has an open proximal end 104 and a distal end 106. The inner surface 108 of the sidewall 102 includes a plurality of spaced-apart protrusions 110 for engaging with the ribs 92 of the needle hub 82. The protrusions 110 form a rib extending from the distal end 106 to the proximal end 104 of the sidewall 102. In the illustrated embodiment, the protrusions 110 have a generally triangular shape, with a leading face 112 converging toward a trailing face 114 to form an apex that forms a distal end 118. The leading face 112 forms an inclined surface extending between the inner surface 108 and the outer surface 116 of the protrusion 106. The leading face 112 is inclined relative to the longitudinal axis of the outer shield 80 and relative to the inner surface of the sidewall.

[0068] In the illustrated embodiment, the trailing surface 114 of the protrusion 110 extends substantially parallel to the longitudinal axis of the outer shroud and is oriented to extend radially outward in a plane parallel to a radius of the outer shroud. Figure 7 is an end view of protrusion 110 showing trailing face 114 and leading face 112 and orientation relative to rib 92 .

[0069] During use, by rotating the outer protective cover in the direction of arrow 116, the needle hub is screwed onto the threaded end of the delivery pen, in which case the leading edge 112 of the outer protective cover engages with the leading edge 94 of the needle hub 82. Inclined leading edges 94 and 112 contact each other to rotate the needle hub and screw the needle hub onto the delivery pen. Once the needle hub is tightened onto the delivery pen, the resistance of the outer protective cover relative to the needle hub enables the inclined surface of the projection 110 to slide on the inclined surface of the rib 92 to prevent the needle hub from being overtightened and over-twisted on the delivery pen. The sliding of the projection 110 on the rib 92 produces a tactile and / or auditory perception to the user, indicating that the needle hub is correctly screwed onto the delivery pen. The outer protective cover is removed to expose the needle that is used to deliver the drug to the patient. After delivering the drug, the outer protective cover is put back on the needle hub, in which case the projection engages with the rib on the needle hub. The outer cover is rotated in the direction of arrow 118, whereupon the protrusions and the trailing edges 96 and 114 of the ribs engage to unscrew the needle hub from the delivery pen. The needle hub is separated from the delivery pen and discarded.

[0070] Figure 10-12Another embodiment of a needle hub 120 and outer shield 122 is shown. Figure 10 The needle hub 120 shown in FIG. 1 is similar to the needle hubs of the previous embodiments, having a skin-contacting surface during injection and a needle extending from a distal end. As in the previous embodiments, the needle hub 120 has a sidewall 124 with an open proximal end 126 and a distal end 128. An outer surface 130 of the sidewall 124 includes a plurality of spaced-apart protrusions 132 that form ribs extending from the distal end 128 of the sidewall toward the proximal end. The protrusions 132 project radially outward from the outer surface 130 and extend in a direction generally parallel to the longitudinal axis of the needle hub 120.

[0071] The protrusions 132 have outer radial surfaces 134 extending between leading surfaces 136 and trailing surfaces 138. Outer radial surfaces 134 are oriented at an oblique angle relative to the outer surface 130 of the sidewall 124, such that the radial dimension of the trailing surface 138 is greater than the radial dimension of the leading surface 134. The leading surface 134 is formed obliquely relative to the outer surface 130 of the hub 120 and is also formed obliquely relative to the outer surface 134. As shown, the oblique leading surface 136 forms an oblique surface between the outer surface 130 of the hub 120 located between adjacent protrusions 132 and the oblique outer surfaces 134 of the protrusions.

[0072] In the embodiment shown, the outer shield 122 has a sidewall 140 that is complementary to the sidewall 124 of the needle hub 120 to fit over the needle hub 120. The sidewall 140 has an inner surface 142 having a plurality of ribs 144 that mate with the protrusions 132. In the embodiment shown, the ribs 144 extend in a longitudinal direction that is generally parallel to the longitudinal axis of the needle hub 120. In other embodiments, the ribs 144 can be oriented at an angle relative to the longitudinal axis of the outer shield. Figure 13 As shown, the rib 144 has a rounded convex outer surface formed into a generally semicircular shape.

[0073] As in the previous embodiment, the needle hub 120 is attached to the threaded end of the delivery device by rotating the outer protective cover 122 in the direction of arrow 146 to screw the needle hub 120 onto the delivery device. Ribs 144 engage the leading edge 136 of protrusion 132 to screw the needle hub onto the delivery pen. After the needle hub is tightened onto the delivery pen, the ribs 144 slide on the inclined leading edge 136 to limit the torque applied to the needle hub and prevent overtightening. The sliding movement of the ribs 144 on the leading edge 136 creates a tactile and / or audible sensation indicating that the needle hub is in place on the delivery pen and ready for use. The outer protective cover 122 is removed to expose the needle used to inject the drug into the patient. After use, the outer protective cover is placed on the needle hub to unscrew the needle hub from the delivery pen. By rotating the outer cover 122 in the direction of arrow 148, the ribs 144 engage the trailing surfaces 138 of the corresponding protrusions 132 to separate the needle hub from the delivery pen.

[0074] Figures 14-19 Various forms of outer covers for pen needles having features that help the user grip the outer cover are shown. Figure 14 In the embodiment of the present invention, the pen needle includes a needle hub 150 having a generally similar construction to the previous embodiment and includes an outer shield 152. The needle hub supports the needle as shown in the previous figures. The outer shield 152 has a side wall 154 with a distal end 156 and an open proximal end 158. The open proximal end 158 has a friction fit or interference fit as shown in FIG. Figure 14 The dimensions shown are for assembly on the needle support post of the needle hub. Figure 14 As shown, a radial flange 160 extends outwardly from the proximal end 158 to assist the user in manipulating the outer cover. Figure 14 As shown, the radial flange 160 has an outwardly extending protrusion 162 that extends outward a distance greater than the radial dimension of the post to assist the user in removing the outer shield 152 from the needle hub after threading the hub onto the delivery pen.

[0075] The sidewall 154 has a recessed portion 164 extending from the distal end 156 to the proximal end. The recessed portion 164 has a concavely curved configuration that forms a teardrop-shaped recess to help the user grasp the outer shield to remove the outer shield from the needle hub and replace the outer shield on the needle hub after use.

[0076] like Figure 14As shown, the needle hub 150 has a closure 166 that mates with the open proximal end of the needle hub to cover the proximal end of the needle until ready for use. The closure 166 has a cylindrical sidewall that complements the inner surface of the needle hub and mates with the needle hub through a friction fit or interference fit. An outwardly extending flange 168 mates with the end of the sidewall of the needle hub to position the closure 166 on the needle hub. As shown, the flange 168 has an enlarged lip 170 extending in the distal direction to help the user manipulate the closure 166.

[0077] Figure 15 and Figure 16 Another embodiment of a pen needle is shown in which an outer shield 172 encloses a needle hub and a removable closure 174 is connected to the outer shield 172 to enclose the needle hub. The needle hub supports the needle, which is not shown for clarity. The closure 174 can be connected to the outer shield 172 to enclose the needle hub. Figure 1-Figure 5 The stylus shown in Figure 6-Figure 9 The stylus shown in Figure 10-13 The outer shield 172 has a proximal end 176 with a generally cylindrical sidewall portion 178 and has a distal end 180. The distal end 180 is formed with converging surfaces that form an outer flat portion 182 for gripping the outer shield. A stop 189 may be included on the inner surface of the wall 178 and extends inwardly to engage the closure member such as Figure 15 The outer shield 172 may include a protrusion 110 for interacting with the outer surface of the needle hub, such as Figure 6-Figure 9 As shown in the pen needle.

[0078] In the illustrated embodiment, the closure 174 has an end wall 184 having an annular sidewall 186 that mates with the proximal end of the opening of the outer shroud 172. The sidewall 186 has an interior dimension to fit onto the outer surface of the sidewall portion 178 by a friction fit. A tab 188 extends from the annular sidewall 186 for gripping the closure to aid removal. In the illustrated embodiment, the tab 188 has a curvature corresponding to the curvature of the annular sidewall 186. The sidewall 186 is connected to the end wall 184 by a frangible line or break line 189. A user pulls on the tab 188 to separate the sidewall 186 from the end wall 184 along the break line 189, in which case the end wall 184 can be separated from the outer shroud 182.

[0079] Figure 17-Figure 19 Another closure for the outer cover is shown. Figure 17-Figure 19 The outer protective cover in the embodiment is basically the same as Figure 16 The closure 190 can be used with Figure 1-Figure 5 Pen needle, Figure 6-Figure 9 Pen needle and Figure 10-13The closure 190 has an end wall 192 having an inner annular wall 194 and an outer annular wall 196 that form an annular space for receiving the proximal end of the outer shroud and attaching the closure to the outer shroud 196. The annular wall 194 includes a bottom portion 206 attached to the end wall 192 and a removable portion 208 connected to the end wall 194 by a frangible line 210. The outer shroud 196 includes a tamper-evident feature 198 to indicate the use of the pen needle. The tamper-evident feature 198 includes a finger-like tab 204 attached to the removable portion 208 of the side wall 194. Pulling the finger-like tab 204 separates the removable portion 208 from the bottom portion 206, allowing the end wall 192 to be separated from the outer shroud 182 and providing an indication that the pen needle has been used or opened. The tab 200 is connected to the outer annular wall 194 by a flexible hinge line 202. The tab 200 is attached to the side wall of the outer cover 196 by adhesive, welding, or other attachment means. In one embodiment, the tab 200 is permanently fixed to the side wall of the outer cover 196. During use, the end wall 192 is pivoted to the open position to allow access to the pen needle. After use, the used pen needle can be returned to the outer cover, and the end wall 192 is pivoted to the closed position to enclose the used pen needle. Figure 19 The underside of the end wall 192 may include desired engraved markings, such as markings identifying the needle size.

[0080] Figure 20-25 Another embodiment of a pen needle is shown, which includes an outer protective cover 210 and a closure 212. The outer protective cover can be Figures 1-6 Pen needle, Figure 6-Figure 9 stylus or Figure 10-13 The outer protective cover 210 has a similar shape to the previous embodiment. In the embodiment shown, the outer protective cover 210 has a side wall 214 and an open proximal end connected to the closure member 212. Figure 20 and Figure 21 As shown, the side wall 214 has a band portion 216 that is integrally formed with the side wall 214 and forms an open slot 218 in the side wall. Figure 21 As shown, the outer surface of the sidewall 214 at the proximal open end includes an outwardly extending flange 220 having an inclined bottom surface 222 and a flat top surface 224. An intermediate flange 226 is axially spaced distally from the flange 220 and has a similar configuration with an inclined bottom surface 228 and a flat top surface 230. Axially oriented ribs 231 on the outer surface of the outer shroud 210 assist a user in manipulating the outer shroud.

[0081] The closure 212 has a bottom wall 232 with an inner annular flange 234 having outer dimensions complementary to the inner dimensions of the wide wall 214 of the outer cover 210, such as Figure 21The outer annular flange 236 is spaced radially outward from the inner flange 234 by a distance that generally corresponds to the thickness of the sidewall 214 and the flanges 229 and 226. Figure 21 As shown. The outer annular flange 236 has an outer surface 238 and an inner surface 240. The inner surface 240 has an annular recess 242 defined by a proximal inwardly extending flange 244 and a distal inwardly extending flange 246 spaced apart from the flange 242. The recess 242 forms a thin, fragile line in the outer annular flange 236. Figure 21 As shown, the proximal flange 244 has a proximal side for mating with the flange 220 , while the distal flange 246 has a proximal side for mating with the intermediate flange 226 .

[0082] Reference Figure 20 and Figure 21 , the outer annular wall 234 has a tab 248 that is received in the slot 218 to restrain the closure 212 to the outer cover 210. The tab 248 is sufficiently flexible to allow the tab to bend so that the closure can be pivoted to the open position. The tab 248 can be coupled to the outer cover by a friction fit or interference fit in the slot 218 or by an adhesive. In one embodiment, the tab 248 can be retained by a friction fit and can be removed and separated from the slot as needed.

[0083] A pull tab 250 is coupled to the distal end of the outer wall 236. In the illustrated embodiment, the pull tab 250 is integrally formed with the outer wall 236. Inwardly extending flanges 244 and 246 on the outer wall engage flanges 222 and 224 of the outer cover to couple the closure to the outer cover. A user can pull the pull tab 250 to separate the distal portion of the outer wall defined by the frangible line 243 along the recess 242, as shown. Figure 23-Figure 25 The tab 248 remains attached to the outer wall 236 and is received in the slot 218, as shown. Figure 25 As shown. The closure 212 can be separated from the protective cover 210 while being restrained to open the protective cover so that the pen needle can be removed for use in drug injection. After use, the pen needle is returned to the outer protective cover and the closure is closed to Figure 25 The pull tab 250 is removed to provide a tamper-evident indicator to show the user that the pen needle has been previously opened. The closure can be separated from the protective cover to open the protective cover so that the pen needle can be removed for use in drug injection. After use, the pen needle is returned to the outer protective cover and the closure is closed to Figure 26 Position shown.

[0084] Figure 26 and Figure 27 Another embodiment of a cover 260 and closure 262 is shown which is similar to the embodiment of the present invention except that the tabs secure the closure to the outer cover. Figure 20-25The closure 262 has an outer wall 264 with an inwardly extending annular flange that is shaped to mate with the pen needle. Figure 23 The pull tab 266 is included in a similar manner to the previous embodiment shown. The annular recess formed between the flanges on the outer wall defines a breakable breaking line. Figure 27 As shown, the user pulls the pull tab 266 to separate the breakable portion of the outer wall 264, in which case the closure 262 can be separated from the outer cover 262. Figure 26 and Figure 27 In the embodiment shown, the break wire completely surrounds the outer wall of the closure, allowing the top of the outer wall to be removed, as shown. Figure 27 shown.

[0085] In these embodiments, the components of the needle hub and shield are typically injection molded plastics such as acrylonitrile butadiene styrene (ABS), polyethylene, polypropylene, etc. The needle can be surgical grade stainless steel. Other manufacturing methods and materials known to those of ordinary skill in the art of medication pen technology may also be suitable for use herein without departing from the scope of the present invention. To assemble the parts, the needle hub assembly can be constructed separately from the needle, and adhesive can be applied in the interface area to secure the cannula to the needle hub, and then this subassembly can be assembled with the other components.

[0086] The foregoing description of the preferred embodiments should not be considered as limiting the invention, which is defined by the appended claims. The foregoing description should provide the skilled person with sufficient information to practice variations of the described embodiments. Features of different embodiments may be used in combination with features of other embodiments. By way of example, various embodiments of the outer shield may be used together with various embodiments of the connection between the outer shield and the needle hub. Features and improvements described in a dependent claim or in connection with one embodiment may be combined with features and improvements of another independent claim or of another embodiment, provided that they are not inconsistent, without departing from the scope of the invention.

Claims

1. A pen needle, comprising: a needle hub having a distal end and an open proximal end for attachment to a delivery device; a needle coupled to the needle hub and having a distal end extending from the distal end of the needle hub and a proximal end extending from the proximal end of the needle hub; a removable inner shield coupled to the needle hub, the inner shield having a sidewall having an inner surface complementary to an outer surface of the needle hub, and wherein the inner shield is configured to couple to a distal end of the outer surface of the needle hub for covering the distal end of the needle, the outer surface of the inner shield being sized to couple to an inner surface of a proximal end of the opening of the needle hub for covering the proximal end of the needle; as well as an outer shield sized to accommodate the needle hub and the inner shield, The needle hub has a sidewall, an inner surface of the sidewall of the needle hub includes threads configured to be coupled to a drug delivery device, and an outer surface of the sidewall of the needle hub includes a plurality of ribs extending longitudinally relative to the needle hub and projecting radially outward, wherein the ribs on the needle hub include: a leading surface that is inclined relative to a longitudinal axis of the needle hub and inclined relative to a radius of the needle hub; a trailing surface oriented in a plane parallel to a radius of the hub and parallel to a longitudinal axis of the hub; and an outer radial face oriented in a plane inclined relative to the outer radial surface of said needle hub, The outer shield has a side wall, and the inner surface of the side wall of the outer shield has a plurality of ribs protruding radially inward, the ribs of the outer shield being configured to engage with corresponding ribs on the needle hub to connect the needle hub to the delivery device by rotating the outer shield in a first direction and to separate the needle hub from the delivery device by rotating the outer shield in a second direction, wherein when the outer shield is rotated in the first direction, the ribs on the outer shield engage with the leading surfaces of the ribs on the needle hub.

2. The pen needle according to claim 1, wherein The inner shield has exterior dimensions that are complementary to interior dimensions of the open proximal end of the needle hub.

3. The pen needle according to claim 2, wherein: The inner shield is coupled to an inner surface of the open proximal end of the needle hub by a friction fit.

4. The pen needle according to claim 3, wherein: The sidewall of the inner shield includes at least one outwardly extending stop, wherein the at least one stop engages the inner surface of the needle hub to retain the inner shield in the proximal end of the needle hub.

5. The pen needle according to claim 1, wherein The radial dimension of the trailing surface of the rib of the needle hub is greater than the radial dimension of the leading surface of the rib of the needle hub.

6. The pen needle according to claim 5, wherein: The rib of the outer cover has a rounded convex shape.

7. The pen needle of claim 1, further comprising a closure coupled to the open end of the outer shield, and wherein a cap of the closure has a tamper evident member.

8. The pen needle according to claim 7, wherein: The closure includes an end wall, an annular sidewall having an interior dimension for coupling with the open end of the outer cover, and a tab extending from the annular sidewall.

9. The pen needle according to claim 8, wherein The annular side wall of the closure has a frangible portion to separate the annular side wall from the end wall.

10. The pen needle according to claim 8, wherein The annular side wall has a bottom portion attached to the end wall and a removable portion formed by a frangible portion located between the bottom portion and the removable portion.

11. The pen needle according to claim 10, wherein: The bottom portion is coupled to the outer cover by a hinge.

12. The pen needle according to claim 10, wherein The bottom portion of the annular side wall has an inwardly extending flange for engaging an outwardly extending flange on the outer cover.

13. The pen needle according to claim 1, wherein The side wall of the needle hub has a flexible portion that is capable of flexing radially outward to separate the needle hub from the threaded end of the delivery device.

14. The pen needle according to claim 13, wherein The side wall of the needle hub has a longitudinally extending slot to define the flexible portion.

15. The pen needle according to claim 13, wherein The outer shield has an inwardly extending protrusion to engage the proximal end of the flexible portion to assist in separating the needle hub from the delivery device.

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