WO2023164509A2

WO2023164509A2 - Pen needle assembly with needle shield

Info

Publication number: WO2023164509A2
Application number: PCT/US2023/063070
Authority: WO
Inventors: Todd SACK; David Schiff; Paul Murray; Sergey Grigoryants
Original assignee: Embecta Corp.
Priority date: 2022-02-22
Filing date: 2023-02-22
Publication date: 2023-08-31
Also published as: WO2023164509A3

Abstract

A pen needle includes a housing and a needle hub received in the housing, where the needle hub includes a needle with a proximal end and a distal end, where the distal end of the needle extends from a distal end of the housing. The pen needle includes a distal needle shield received in the housing, where the distal needle shield is configured to move from a retracted position, where the distal end of the needle is exposed, to an extended position, where the distal end of the needle is covered, and where the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position to the extended position to rotate the distal needle shield from a first angular position to a second angular position.

Description

PEN NEEDLE ASSEMBLY WITH NEEDLE SHIELD

Cross-Reference to Related Applications

[001] This application claims the benefit of and priority to U.S. Provisional Application No. 63/312,725, filed February 22, 2022, the content of which is hereby incorporated herein by reference in its entirety.

Field

[002] The present disclosure is directed to medical devices for delivering and/or injecting a medication. The device can be configured for the injection of a medication, such as insulin, to a patient. The device can be a pen needle including a needle hub and a distal needle shield with a distal surface where the distal needle shield is retractable during use to expose the needle. A proximal needle shield is included that moves to an extended position after use to cover the proximal end of the needle. The device has a biasing member to move the distal needle shield in a distal direction and move the proximal needle shield in a proximal direction relative to the hub.

Background

[003] A medication pen for delivering self-administered medications generally includes a pen body, which houses a medication compartment. A separate pen needle can be attached to and detached from the pen body. The pen needle includes a needle hub having a recess on the proximal side for receiving the pen body and a proximal (non-patient end) needle accessing the medication compartment, typically piercing the septum of a medication cartridge in the pen body. The distal patient end of the pen needle includes the needle or cannula that is inserted into the injection site. [004] Injections may be performed in the intradermal (ID) region, the subcutaneous (SC) region and the intramuscular (IM) region. For many types of injectable medications, including insulin, the SC region is preferred for administering an injection.

[005] Shorter needles, such as 4 mm and 5 mm needles, are adapted to achieve injection to a specified target depth in a subcutaneous region. In one aspect, the needle hub ensures that a needle is inserted to a desired target depth, regardless of the angle at which the user may approach the injection site with the medication pen or delivery device.

[006] In certain pen needles, the cannula is supported in an axially positioned post on the needle hub. The post forms a narrow portion extending distally from the relatively wider portion in which the pen body is received. In other pen needles, a distal face of the needle hub placed against the injection site may have a slight taper at the edge. However, the edge of the needle hub engages the skin when the cannula is inserted at an angle, interfering with the injection. The slight taper is not functional during an injection, or is only at the edge of the distal face of the needle hub.

[007] While the current devices are generally suitable for the intended use, there is a continuing need for improved devices for controlling the penetration of a cannula for delivering a drug or medicament.

SUMMARY

[008] The present disclosure relates to a pen needle including: a housing; a needle hub received in the housing, the needle hub including a needle with a proximal end and a distal end, wherein the distal end of the needle extends from a distal end of the housing; a distal needle shield received in the housing, wherein the distal needle shield is configured to move from a retracted position of the distal needle shield, where the distal end of the needle is exposed, to an extended position of the distal needle shield, where the distal end of the needle is covered, and wherein the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position.

[009] In some embodiments, the present disclosure relates to a pen needle, wherein the needle hub includes: a post configured to support the needle; at least two sections, wherein each of the at least two sections includes: an inclined surface; and a distal surface including a recess; a first rib extending between a first of the at least two sections and the post; a second rib extending between a second of the at least two sections and the post; and open passages on either side of the post, wherein: the distal needle shield contacts the inclined surface of at least one of the at least two sections by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from the first angular position to the second angular position; and the distal needle shield contacts the recess of the distal surface of at least one of the at least two sections to lock the distal needle shield in the extended position of the distal needle shield. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield includes: a body having a proximal end; and one or more legs extending proximally from the proximal end of the body, wherein each of the one or more legs includes a free end at a proximal end of the one or more legs, wherein: the free end of each of the one or more legs contacts a respective inclined surface of the at least two sections of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from the first angular position to the second angular position; and the free end of each of the one or more legs contacts a respective recess of the distal surface of the at least two sections to lock the distal needle shield in the extended position of the distal needle shield. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield including: a proximal end configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the needle can fluidly connect to a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to the proximal end of the needle; and a flexible tab with a distal end oriented to engage a proximally facing surface on a ledge of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield.

[010] The present disclosure relates to a pen needle including: a housing; a biasing member; a needle hub received in the housing, the needle hub including: a post configured to support a needle; an inclined surface; and a distal surface; a distal needle shield received in the housing, wherein: the distal needle shield is configured to move from a retracted position of the distal needle shield, where a distal end of the needle is exposed, to an extended position of the distal needle shield, where the distal end of the needle is covered; the distal needle shield is configured to contact the inclined surface of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position; and the distal needle shield, when moved from the retracted position of the distal needle shield to the extended position of the distal needle shield, contacts the distal surface of the needle hub to lock the distal needle shield in the extended position of the distal needle shield; and a proximal needle shield received in the housing, wherein the proximal needle shield is configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the needle can fluidly connect to a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to a proximal end of the needle, wherein the biasing member is configured to bias the distal needle shield to the extended position of the distal needle shield and is configured to bias the proximal needle shield to the extended position of the proximal needle shield.

[OH] In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield is configured to move between an extended position of the distal needle shield to cover the distal end of the needle and the retracted position of the distal needle shield. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield having a proximal end configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the proximal end of the proximal needle shield is positioned distally of the proximal end of the needle, and an extended position of the proximal needle shield, where the proximal end of the proximal needle shield is positioned proximally of the proximal end of the needle. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield having a proximal end configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the needle can fluidly connect to t a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to the proximal end of the needle. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield contacts an inner surface of the needle hub when moved to the retracted position of the distal needle shield, and the distal needle shield contacts an inclined surface on the inner surface of the needle hub when the distal needle shield moves from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield to the second angular position. In some embodiments, the present disclosure relates to a pen needle, wherein the inner surface of the needle hub includes an inwardly extending ramp. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield includes a leg extending from a proximal end of a body of the distal needle shield, wherein the leg is oriented to slide over the ramp when the distal needle shield moves from the extended position of the distal needle shield to the retracted position of the distal needle shield, and wherein the leg is oriented to engage the inclined surface to rotate the distal needle shield to the second angular position. In some embodiments, the present disclosure relates to a pen needle, wherein the leg is flexible and deflects inwardly when sliding over the ramp of the needle hub. In some embodiments, the present disclosure relates to a pen needle, wherein the leg has a proximal end configured to contact a distal surface of the needle hub to lock the distal needle shield in the extended position of the distal needle shield. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield includes a distally facing recess oriented to engage a proximally facing projection on an inner surface of the housing when the distal needle shield is in the extended position and the first angular position. In some embodiments, the present disclosure relates to a pen needle, wherein the recess is angularly spaced from the projection when the distal needle shield is in the second angular position and aligned with the projection when in the first angular position. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the proximal needle shield includes an outwardly extending arm received in a longitudinally extending groove on an inner surface of the housing to prevent rotation of the proximal needle shield relative to the housing and the needle hub. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the needle hub includes a post supporting the needle, and wherein the proximal needle shield includes an axial gap configured to receive the post, where the proximal needle shield slides relative to the post. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the proximal needle shield includes a flexible tab with a distal end oriented to engage a proximally facing surface on an inner surface of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield. In some embodiments, the present disclosure relates to a pen needle, further including a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the needle hub includes a flexible tab oriented to contact a proximal end of the proximal needle shield to retain the proximal needle shield in the retracted position of the proximal needle shield, and wherein the flexible tab deflects when the needle hub is coupled to a delivery device to separate the tab from the proximal needle shield. In some embodiments, the present disclosure relates to a pen needle, further including a biasing member having a distal end contacting the distal needle shield and a proximal end contacting the proximal needle shield. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield includes a proximally extending leg, wherein the needle hub includes a first distal face oriented to align with the leg of the distal needle shield when the distal needle shield is in the first angular position, and the needle hub includes a second distal face spaced axially from the first distal face and oriented to contact a proximal end of the leg to lock the distal needle shield in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein: the distal needle shield is configured to move from a first extended position of the distal needle shield to cover the distal end of the needle to the retracted position of the distal needle shield to expose the distal end of the needle; the distal needle shield is configured to move from the retracted position of the distal needle shield to a second extended position of the distal needle shield to cover the distal end of the needle; a distal end of the distal needle shield extends a first distance from the housing in the first extended position of the distal needle shield; and the distal end of the distal needle shield extends a second distance from the housing in the second extended position of the distal needle shield, wherein the second distance is greater than the first distance.

[012] The present disclosure relates to a pen needle including: a housing having an open proximal end; a needle hub, including: a post supporting a needle; an outer wall spaced radially from the post; a longitudinal passage defined between the post and the outer wall; and a flexible tab; a proximal needle shield received in the needle hub and slidable in the longitudinal passage of the needle hub from a retracted position of the proximal needle shield, where the needle can fluidly connect to a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to a proximal end of the needle, wherein: the flexible tab of the needle hub, in a first position, is configured to contact a proximal end of the proximal needle shield to maintain the proximal needle shield in the retracted position of the proximal needle shield; and the flexible tab of the needle hub, in a second position, is configured to flex radially outward to allow the proximal needle shield to move axially to the extended position of the proximal needle shield.

[013] In some embodiments, the present disclosure relates to a pen needle, wherein an inner surface of the housing includes a groove, and the proximal needle shield is configured to slide in the groove between the retracted position of the proximal needle shield and the extended position of the proximal needle shield. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield includes an arm extending radially outward and the groove is a longitudinally extending groove receiving the arm to prevent rotation of the proximal needle shield relative to the housing and the needle hub. In some embodiments, the present disclosure relates to a pen needle, further including a distal needle shield received in the housing and configured to move between an extended position of the distal needle shield to cover a distal end of the needle and a retracted position of the distal needle shield to expose the distal end of the needle. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield contacts an inner surface of the needle hub when moved to the retracted position of the distal needle shield, and the distal needle shield contacts an inclined surface on the inner surface of the needle hub to rotate the distal needle shield when the distal needle shield moves from the retracted position of the distal needle shield to the extended position of the distal needle shield. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield includes a proximally extending leg, wherein the leg is oriented to slide over a ramp on the inner surface of the needle hub when the distal needle shield moves to the retracted position of the distal needle shield, and wherein the leg is oriented to engage the inclined surface to rotate the distal needle shield from a first angular position to a second angular position. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield includes a flexible tab with a distal end oriented to engage a proximally facing surface on an inner surface of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield to lock the proximal needle shield in the extended position of the proximal needle shield.

[014] The present disclosure relates to an injection system including: a delivery device including a supply of medication; and the pen needle according to any one of the previous embodiments. [015] The present disclosure relates to a method of dispensing a fluid including: coupling a pen needle to a delivery device, the pen needle including a housing, a needle hub having a needle, a distal needle shield, and a proximal needle shield; moving the distal needle shield from an extended position of the distal needle shield to a retracted position of the distal needle shield to expose a distal tip of the needle; dispensing the fluid from the needle; moving the distal needle shield distally to lock the distal needle shield in the extended position of the distal needle shield to cover the distal tip of the needle, wherein the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position where the distal needle shield contacts a distal surface of the needle hub to retain the distal needle shield in the extended position of the distal needle shield; and moving the proximal needle shield proximally from a retracted position of the proximal needle shield, where the needle can fluidly connect to the delivery device, to an extended position of the proximal needle shield where the proximal needle shield inhibits access to the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

[016] The presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments.

[017] Fig. 1 is a side view a pen needle including an outer cover according to some embodiments; [018] Fig. 2 is a side view of a pen needle according to some embodiments;

[019] Fig. 3 is a perspective view of a pen needle according to some embodiments;

[020] Fig. 4 is a cross sectional view of a pen needle according to some embodiments; [021] Fig. 5 is a cross sectional view of a pen needle according to some embodiments;

[022] Fig. 6 is an exploded view of a pen needle according to some embodiments;

[023] Fig. 7 is a side view of the housing of a pen needle according to some embodiments;

[024] Fig. 8 is a cross sectional view of the housing of the pen needle according to some embodiments;

[025] Fig. 9 is a perspective view of the housing of the pen needle with the outer surface of the housing transparent, according to some embodiments;

[026] Fig. 10 is a perspective view of a needle hub according to some embodiments;

[027] Fig. 11 is a perspective view of the needle hub according to some embodiments;

[028] Fig. 12 is a cross sectional view of the needle hub according to some embodiments;

[029] Fig. 13 is a cross sectional view of the needle hub according to some embodiments;

[030] Fig. 14 is perspective view of a proximal needle shield according to some embodiments;

[031] Fig. 15 is a perspective view of the proximal needle shield according to some embodiments;

[032] Fig. 16 is a side view of the proximal needle shield according to some embodiments;

[033] Fig. 17 is a bottom perspective view of the proximal needle shield according to some embodiments;

[034] Fig. 18 is a side perspective view of a distal needle shield according to some embodiments;

[035] Fig. 19 is a cross sectional view of the pen needle after use with the proximal needle shield in the retracted position;

[036] Fig. 20 is a cross sectional view of the pen needle during use;

[037] Fig. 21 is a cross sectional view of the pen needle after use position with the proximal needle shield in the extended position; [038] Fig. 22 is a top view of the needle hub according to some embodiments; and

[039] Fig. 23 is an exploded view of an exemplary delivery device according to some embodiments.

[040] While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. The present disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.

DETAILED DESCRIPTION

[041] A delivery pen or delivery device is used herein to refer to a device having a medication compartment, typically containing multiple doses of medication that can be attached to a separate pen needle. The “pen needle” refers to a needle-bearing assembly which can be attached to the medication pen body so that a proximal end of the pen needle assembly accesses a medication compartment and a distal end is adapted for insertion into an injection site to perform one or more injections. The terms “needle” and “cannula” are used herein interchangeably to refer to a hollow tubular member having a lumen and a sharpened end for insertion into an injection site on a subject. As used herein, the “distal” direction is in the direction toward the patient end of the pen needle and the injection site, and the “proximal” direction is the non-patient end opposite the patient end. “Axial” means along or parallel to the longitudinal axis of the needle and the “radial” direction is a direction perpendicular to the axial direction.

[042] Reference is made to embodiments, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present disclosure by referring to the drawings. The exemplary embodiments are presented in separate descriptions, although the individual features and construction of these embodiments can be combined in any number of ways to meet the therapeutic needs of the user.

[043] This disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of being modified, practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not limited to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are to aid illustration, but are not limiting. The embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other. Terms of degree, such as “substantially”, “about” and “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely present in the structure. [044] The present disclosure is directed to a medical device such as an injection device for delivery of a medication to a subject. The injection device can be a pen needle or pen needle assembly for coupling to an injection pen or other delivery device.

[045] The pen needle, in some embodiment, has a needle or cannula extending from a distal end of the pen needle and a movable shield covering the needle or cannula that can be retracted to expose the distal end of the needle or cannula for introducing the medication to the patient. In some embodiments, the needle or cannula can have a proximal end for piercing a septum on the injection pen where the proximal end is surrounded by the needle hub.

[046] In some embodiments, the pen needle assembly includes a housing, needle hub, a distal needle shield covering at least a portion of the needle and a proximal needle shield. In some embodiments, the distal needle shield moves and/or slides relative to the housing and the needle hub between a retracted position to expose the end of the needle and an extended position covering the distal end of the needle. In some embodiments, the pen needle assembly can have a biasing member that contacts a surface of the distal needle shield to bias the distal needle shield in a distal direction. In some embodiments, the proximal needle shield moves relative to the housing and needle hub to cover or block access to the proximal end of the needle after use. In some embodiments, the biasing member can contact the proximal needle shield to move the proximal needle shield to the extended position to cover the proximal end of the needle.

[047] In some embodiments, the pen needle has a needle hub with a needle or cannula and a housing where the needle hub is in a fixed position relative to the housing. In some embodiments, a distal needle shield and a proximal needle shield move relative to the needle hub and the housing to cover the respective ends of the needle. In some embodiments, a spring member contacts a distal face of the proximal needle shield and a proximal surface of the distal needle shield to move the respective needle shields to the extended positions. In some embodiments, the distal needle shield and the proximal needle shield can be held in a locked extended position after use of the pen needle.

[048] In some embodiments, the proximal needle shield is received in a cavity of the needle hub and is movable within the needle hub without rotation relative to the needle hub. In some embodiments, the proximal needle shield has a flexible finger that can spring to a locking position when activated to engage a surface on the needle hub to lock the shield in the extended position and prevent further use.

[049] In some embodiments, the distal needle shield is movable axially relative to the housing from an extended position to a retracted position to expose the needle. In some embodiments, after the injection, the distal needle shield moves axially and rotationally from the retracted position to a locked extended position. In some embodiments, the distal needle shield can be movable to an extended distal position to a locked position. In some embodiments, the proximal needle shield can be moved axially from a retracted position to an extended position when disconnected from the delivery device. In some embodiments, a spring member between the distal needle shield and the proximal needle shield allows the distal needle shield to be retracted relative to the needle hub and the housing to expose the needle. In some embodiments, the distal needle shield can be moved distally by the spring member to a locked position to cover the needle after use. In some embodiments, the proximal needle shield can move by the spring to the extended position.

[050] In some embodiments, the features of the pen needle can be attained by providing a pen needle having a housing, a needle hub, a distal needle shield and a proximal needle shield. In some embodiments, the needle hub supports a needle and is positioned in the housing. In some embodiments, the needle has a distal end projecting from a distal end of the housing. In some embodiments, the distal needle shield is received in the housing and is configured to move between an extended position covering the distal end of the needle and retracted position to expose the distal end of the needle. In some embodiments, the proximal needle shield has a proximal end configured for moving relative to the needle hub between a retracted position where a proximal end of the needle can communicate with a delivery device and an extended position to cover the proximal end of the needle.

[051] In some embodiments, a pen needle includes a housing having an open distal end, a needle hub received in a proximal end of the housing, a distal needle shield and a proximal needle shield. In some embodiments, the needle hub supports a needle and is received in the housing. In some embodiments, the distal needle shield is received in the housing and is configured to move between an extended position to cover the distal end of the needle and a retracted position to expose a distal end of the needle. In some embodiments, the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position to the extended position to rotate the distal needle shield from a first angular position to a second angular position where the distal needle shield can lock in the extended position. In some embodiments, the distal needle shield contacts a distal surface of the needle hub when the distal needle shield moves from the retracted position to the extended position to retain the distal needle shield in the extended position.

[052] In some embodiments, a method of dispensing a fluid includes coupling a pen needle to a delivery device where the pen needle has a housing, a needle coupled to a needle hub, a distal needle shield and a proximal needle shield. In some embodiments, the distal needle shield is received in the housing and configured to move between an extended position to cover the distal end of the needle and a retracted position to expose the distal end of the needle. In some embodiments, the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position to the extended position to rotate the distal needle shield from a first angular position to a second angular position where the distal needle shield contacts a distal surface of the needle hub to retain the distal needle shield in the extended position. In some embodiments, a proximal needle shield has a proximal end configured for moving relative to the needle hub between a retracted position where a proximal end of the needle can couple to the delivery device and an extended position to cover a proximal end of the needle.

[053] In some embodiments, the pen needle can have a convex distal axial surface for shaping the axial face of the distal needle shield and shape the indentation of the surface of the skin during needle insertion and drug delivery. In some embodiments, the needle hub can have an axial face with a surface area of about 5-50 mm². In some embodiments, the surface of the axial face in one embodiment can have a convex configuration with a height of about of 0.3 to 0.7 mm and a surface area of 1 -4 mm².

[054] It will be understood that each of the features of the various embodiments can be combined with other features and features described in combination with one or more particular features may also be combined with one or more other features of the other embodiments.

[055] These and other features of the present disclosure will become apparent from the following detailed description of the present concept, which in conjunction with the drawings disclose various embodiments of the present concept.

[056] In some embodiments the delivery device is a pen needle delivery device or injector pen, which typically comprises a dose knob/button, a body and a cap. The body can include a threaded end for coupling with a pen needle. A dose knob/button can allow a user to set the dosage of medication to be injected. The body can be gripped by the user when injecting medication. The cap can be used by the user to securely hold the pen needle device in a shirt pocket or other suitable location and provide cover/protection from accidental needle injury.

[057] In standard pen needle injector devices the dosing and delivery mechanisms are found within the body and is not described in greater detail here as they are understood by those knowledgeable of the art. A medicament cartridge is typically attached to a standard pen injector housing by a known attachment mechanism. The distal movement of a plunger or stopper within the medicament cartridge causes medication to be forced into the reservoir housing. The medicament cartridge is sealed by a septum and punctured by a septum penetrating needle cannula located within a reservoir or housing. In some embodiments, the reservoir housing can be screwed onto the medicament cartridge, although other attachment mechanism can be used. In some embodiments, the pen needle delivery device can be a standard pen delivery device known in the industry so that the pen needle delivery device is not shown in detail. The cannula of the pen needle, as described further below, can be a double-ended cannula beveled and/or sharpened at both ends for coupling to the delivery device and for penetrating the skin of the patient. The cannula has a lumen with a diameter sufficient to inject the medication into the patient.

[058] Referring to Fig. 23, a delivery device 200 is depicted according to some embodiments. In some embodiments, the delivery device 200 may be disposable. In some embodiments, the delivery device 200 may include an outer sleeve 213. In some embodiments, the outer sleeve 213 may contain at least some of the driving mechanisms of the delivery device 200 within. In some embodiments, the outer sleeve 213 may contain medication supply to be administered to a patient. In some embodiments, the outer sleeve 213 may provide a gripping surface for a user to grip when administering medication to a patient. In some embodiments, the delivery device 200 includes a dose knob 224 positioned at a proximal end 231 of the outer sleeve 213. The dose knob 224 may be rotatable with respect to the outer sleeve 213 of the delivery device 200. In some embodiments, the user may rotate the dose knob 224 to selectively set a desired volume of a dose of medication to be injected to a patient. In some embodiments, rotation of the dose knob 224 in a first direction may axially translate the dose knob 224 away from the proximal end 231 of the outer sleeve 213, thereby increasing the volume of a dose of medication to be administered with the delivery device 200. In some embodiments, rotation of the dose knob 224 in a second direction may axially translate the dose knob 224 toward the proximal end 231 of the outer sleeve 213, thereby decreasing the volume of a dose of medication to be administered with the delivery device 200. In some embodiments, a button 240 may be coupled to a proximal end of the dose knob 224. A user may apply an axial force to the button 240 to depress the button 240 and dose knob 224 axially toward the proximal end 231 of the outer sleeve 213, thereby activating the driving mechanism to administer a dose of medication from the delivery device 200.

[059] The driving and delivery mechanisms of the delivery device 200 should be understood by a person having ordinary skill in the art and are, therefore, not discussed in detail herein. Generally, however, depression of the button 240 and dose knob 224 in the distal direction injects the dosed medication via a lead screw 207 and a plunger 215 through a medicament cartridge 212, which is attached to the delivery device 200 through a lower housing 217. The distal movement of the plunger 215 within the medicament cartridge 212 causes medication to be forced into a needle 14 (Fig. 4) of the pen needle 10 (Fig. 4). The medicament cartridge 212 may be sealed by a septum 216, which may be punctured by the needle 14 (Fig. 4) located within the pen needle 10 (Fig. 4).

In some embodiments, the pen needle 10 (Fig. 2) can be screwed onto the lower housing 217, although other attachment means may be used. It should be appreciated that the foregoing description is merely one representative example of the delivery device 200, and other designs for the delivery device 200 are contemplated herein.

[060] A pen needle is described with reference to Figs. 1-22. Fig. 1 is a side view a pen needle including an outer cover according to some embodiments. Fig. 2 is a side view of a pen needle according to some embodiments. Fig. 3 is a perspective view of a pen needle according to some embodiments. Fig. 4 is a cross sectional view of a pen needle according to some embodiments. Fig. 5 is a cross sectional view of a pen needle according to some embodiments. Fig. 6 is an exploded view of a pen needle according to some embodiments. Fig. 7 is a side view of the housing of a pen needle according to some embodiments. Fig. 8 is a cross sectional view of the housing of the pen needle according to some embodiments. Fig. 9 is a perspective view of the housing of the pen needle with the outer surface of the housing transparent, according to some embodiments. Fig. 10 is a perspective view of a needle hub according to some embodiments. Fig. 11 is a perspective view of the needle hub according to some embodiments. Fig. 12 is a cross sectional view of the needle hub according to some embodiments. Fig. 13 is a cross sectional view of the needle hub according to some embodiments. Fig. 14 is perspective view of a proximal needle shield according to some embodiments. Fig. 15 is a perspective view of the proximal needle shield according to some embodiments. Fig. 16 is a side view of the proximal needle shield according to some embodiments. Fig. 17 is a bottom perspective view of the proximal needle shield according to some embodiments. Fig. 18 is a side perspective view of a distal needle shield according to some embodiments. Fig. 19 is a cross sectional view of the pen needle after use with the proximal needle shield in the retracted position. Fig. 20 is a cross sectional view of the pen needle during use. Fig. 21 is a cross sectional view of the pen needle after use position with the proximal needle shield in the extended position. Fig. 22 is a top view of the needle hub according to some embodiments. [061] Referring now to Figs. 2-6, a pen needle 10 is depicted. In some embodiments, the pen needle 10 can include a housing 18. In some embodiments, the housing 18 can contain a needle hub 12 having a needle 14. The needle 14 includes a distal end, or distal tip, and a proximal end, or proximal tip. The pen needle 10 can further include a distal needle shield 16. The distal needle shield 16 can be, at least partially, received in the housing 18. The distal needle shield 16 and the housing 18, together, can form a shell of the pen needle 10. In some embodiments, the pen needle 10 can include a proximal needle shield 20. In some embodiments, the distal needle shield 16 and the proximal needle shield 20 are configured to move and/or slide relative to the housing 18 during use. In some embodiments, the distal needle shield 16 and the proximal needle shield 20 are configured to move and/or slide relative the needle hub 12 during use. The distal needle shield 16 is configured to cover the distal end of the needle 14 and can be referred to as a patient end shield. The proximal needle shield 20 is configured to cover or inhibit access to the proximal end of the needle 14 and can be referred to as a non -patient end shield. In some embodiments, inhibiting access to the proximal end of the needle 14 can include blocking the proximal end of the needle 14 such that the proximal end of the needle 14 cannot be accessed by a user. In some embodiments, inhibiting access to the proximal end of the needle 14 can include partially blocking the proximal end of the needle 14 such that the proximal end of the needle 14 is difficult to access by a user. In some embodiments, the components of the pen needle 10 can be made of a suitable plastic material. In some embodiments, the distal needle shield 16 is made of a transparent plastic material to enable visualizing the needle 14 within the pen needle 10.

[062] In some embodiments, the distal end of the needle 14 projects in a distal direction from the needle hub 12 with a length for injecting a medication into a patient. In some embodiments, the proximal end of the needle 14 projects into an inner cavity of the needle hub 12 and an inner cavity of the proximal needle shield 20 for piercing a septum of the delivery device. The proximal end of the needle 14 is oriented within an open proximal end of the needle hub 12 and can be spaced a distance from the proximal end of the needle hub 12 to inhibit inadvertent needle stick. The proximal end of the needle hub 12 is open to receive and couple to a delivery device.

[063] Referring to Fig. 1, in some embodiments, the pen needle 10 is initially enclosed in an outer cover 22 having a removable seal 24 to retain the pen needle 10 in a clean and sterile state during shipping and prior to use. In use, the seal 24 is removed and the pen needle 10 is attached to a delivery device, such as an injection pen as known in the art.

[064] In some embodiments, the outer cover 22 has an inner dimension to receive the pen needle 10 during storage and shipping. In some embodiments, the outer surface of the outer cover 22 can include ribs 26 or other gripping surfaces to assist the user in connecting the pen needle 10 to the delivery device after the seal 24 is removed from the outer cover 22. In some embodiments, the open bottom end of the outer cover 22 has radially extending flange 28 for supporting the seal 24. [065] Referring now to Figs. 2-9, the housing 18 of the pen needle 10 is depicted. The housing 18, at least partially, defines a shell of the pen needle 10. In some embodiments, the housing 18 has a distal end with a distal opening 30 and a proximal end with a proximal opening 32. In some embodiments, the distal opening 30 has a dimension to receive the distal needle shield 16. In some embodiments, the distal opening 30 is sized such that the distal needle shield 16 can move axially within the distal opening 30 between an extended position shown in Figs. 2-5 and a retracted position shown in Fig. 20. The housing 18 has a side wall 34 with an internal dimension to receive and support the needle hub 12. As shown in Fig. 8, in some embodiments, the inner surface of the side wall 34 has a coupling feature for mating with the needle hub 12. In some embodiments, the coupling feature is a recess 36 around the circumference of the inner surface of the side wall 34 toward the proximal opening 32. In some embodiments, the distal end of the side wall 34 includes one or more windows, shown as openings 38, for providing visual indication of the position (e.g. locked or unlocked) of the distal needle shield 16.

[066] In some embodiments, the inner surface of the side wall 34 of the housing 18 has longitudinal recesses shown as grooves 40 or slots extending from the proximal opening 32 of the housing 18 toward the distal opening 30. In some embodiments, toward the distal end of the grooves 40, longitudinal ribs 41 are provided on the inner surface of the side wall 34 extending radially inward on opposite sides of the grooves 40. The ribs 41 provide for alignment between the housing 18 and the proximal needle shield 20, and particularly between the grooves 40 and the arms 94 of the proximal needle shield 20. An inwardly extending ledge 42 separates an upper section and a lower section of the internal cavity of the housing 18 as shown in Fig. 9. In some embodiments, the ledge 42 includes projections 44 spaced around the periphery of the ledge 42 for cooperating with the proximal needle shield 20. In some embodiments, the distal end of the side wall 34 has an inwardly extending ledge 46 forming a stop member to retain the distal needle shield 16 in the housing 18. In some embodiments, a projection 48 extends proximally from the proximal face of the ledge 46 to cooperate with the distal needle shield 16. In some embodiments, as shown in Fig. 9, the projection 48 has parallel side edges 50 and an inclined distal end 52.

[067] Referring now to Figs. 4-6, 10-13, and 22, the needle hub 12 supports the needle 14. The needle 14 can be attached to the needle hub 12 by any suitable mechanism, such as by an adhesive. In some embodiments, the needle hub 12 has a substantially cylindrical body 54 with an open proximal end and an open distal end. The inner surface of the body 54 can include internal threads 56 for mating with the threaded end of an injection pen or other delivery device. In some embodiments, the outer surface of the body 54 includes an annular rib 58 for mating with the recess 36 (Fig. 8) in the housing 18 for coupling the needle hub 12 to the housing 18 by a snap or interference fit.

[068] In some embodiments, the body 54 has one or more inwardly extending ribs 60 supporting a post 62 that supports the needle 14. In some embodiments, the ribs 60 are oriented to form two open passages 61 on opposite sides of the post 62. The open passages 61 may be referred to as a longitudinal passage. The post 62 has an axial passage 64 for receiving the needle 14. In some embodiments, the needle 14 can be fixed to the post 62 by an adhesive in a usual fashion. In some embodiments, the needle 14 has a distal end projecting from the distal end of the needle hub 12 and housing 18 and a proximal end projecting proximally from the post 62 and positioned in the cavity of the body 54 for piercing a septum of the injection pen or delivery device to supply the medication to the needle 14.

[069] The body 54 of the needle hub 12 is formed with two sections 66 forming a gap 68 between the sections 66. In some embodiments, the body 54 includes at least one flexible tab 70 in the gap 68. The tab 70 projects radially inward at an incline toward the distal end of the needle hub 12 a distance to contact the proximal end of the proximal needle shield 20, as discussed below. In some embodiments, the two sections 66 are each formed with a ledge 72 next to the inwardly extending rib 60 of each section 66 that support the post 62. In some embodiments, each section 66 includes a second ledge 74 spaced distally from the ledge 72 toward the distal end of the needle hub 12. In some embodiments, a distal surface 76 of each section 66 of the needle hub 12 is configured to contact the distal needle shield 16 when the distal needle shield 16 is in the extended position, as discussed in more detail below. In some embodiments, the distal surface 76 is spaced distally of the ledge 74 and forms the distal end of the needle hub 12. In some embodiments, the distal surface 76 is provided with a recess 78 forming a notch configured for receiving a proximal end of the distal needle shield 16.

[070] In some embodiments, adjacent the ledge 74, each section 66 of the needle hub 12 can include a ramp 80 forming a sloped surface that is inclined from the distal edge of the ledge 74 toward the center of the needle hub 12, such that the proximal end of the ramp 80 is radially inward the distal end of the ramp 80. The ramp 80 is an inner surface of the needle hub 12. In some embodiments, each section 66 of the needle hub 12 can include an inclined surface 82 proximal of the ramp 80. The inclined surface 82 is an inner surface of the needle hub 12. The inclined surface 82 can be inclined at an angle relative to the center axis of the needle hub 12 from a first point 83 aligned with the ledge 74 to a second point 85 aligned with the distal surface 76. In other words, the inclined surface 82 can be inclined at an angle from the first point 83, which is positioned beneath the ledge 74 and the ramp 80, to the second point 85, which is positioned beneath the distal surface 76. The inclined surface 82 forms a guide to rotate the distal needle shield 16 from a first angular position to a second angular position when the distal needle shield 16 moves from the retracted position to the extended position. In some embodiments, the needle hub 12 includes an overhang 73, or an inner ledge.

[071] Referring now to Figs. 5, 6, and 14-17, the proximal needle shield 20 can have a shape and configuration to receive the post 62 of the needle hub 12 and move axially relative to the needle hub 12 and the housing 18. In some embodiments, the proximal needle shield 20 has a substantially cylindrical body 84 forming a distal end with an axial passage 86 for enabling the needle 14 to extend through the proximal needle shield 20 and to allow the proximal needle shield 20 to move axially relative to the needle 14. In some embodiments, the proximal needle shield 20 includes two proximal longitudinal sections 88 that are spaced apart to form a gap 90 between the sections 88. The gap 90 can be configured to receive the post 62 (Fig. 10) of the needle hub 12 so that the proximal needle shield 20 can slide over the post 62 where the ribs 60 (Fig. 10) that support the post 62 slide through the gap 90, and the sections 88 slide through the open passages 61 (Fig. 22) on either side of the post 62.

[072] In some embodiments, each section 88 of the proximal needle shield 20 includes a proximal flange 92 configured to be received in and move axially within needle hub 12 between a retracted position shown in Figs. 5, 19, and 20 and an extended position shown in Fig. 21. Each flange 92 in conjunction with the sections 88 can have a shape and dimension to block or inhibit access to the proximal end of the needle 14 when deployed in the extended position. In some embodiments, each section 88 of the proximal needle shield 20 has a radially outward projecting arm 94 that extends in a longitudinal direction relative to the body 84 of the proximal needle shield 20. In some embodiments, the arms 94 have a length and width to slide in a respective groove 40 (Figs. 8 and 9) of the side wall 34 of the housing 18 to guide the proximal needle shield 20 from the retracted position to the extended position. In some embodiments, each section 88 of the proximal needle shield 20 further includes a flexible tab 96 extending from the proximal end of the proximal needle shield 20 toward the distal end of the proximal needle shield 20. In some embodiments, the flexible tabs 96 have proximal ends fixed to their respective section 88 and free distal ends 98. In some embodiments, the distal ends 98 of the tabs 96 project at an incline outwardly and are configured to be able to flex radially inward. In some embodiments, the flexible tabs 96 are oriented to contact a surface of the needle hub 12 to lock the proximal needle shield 20 in the extended position. In some embodiments, the distal ends of the flexible tabs 96 are oriented to contact a proximal surface of an overhang 73 (Fig. 12) of the needle hub 12 (Fig. 12) to lock the proximal needle shield 20 in the extended position. [073] Referring now to Figs. 4-6 and 18, in some embodiments, the distal needle shield 16 has a cylindrical body 100 with an end wall forming a distal face 102 and the skin contact surface of the distal needle shield 16. In some embodiments, the distal face 102 is formed to have a substantially convex configuration with a radius of curvature to deform the skin surface when an insertion force is applied to the pen needle to control the depth of penetration of the needle 14. In some embodiments, the distal face 102 is formed by a raised inner ring 104 surrounding the needle 14 and a raised outer ring 106 spaced radially outward from the inner ring 104. In some embodiments, the inner ring 104 is spaced axially from the outer ring 106 in a distal direction to form the convex curvature. In some embodiments, the inner ring 104 and outer ring 106 project distally to form an annular recess 108 between the inner ring 104 and the outer ring 106. In some embodiments, the recess 108 has a curved bottom surface with a radius of curvature corresponding to the radius of curvature formed by the inner ring 104 and outer ring 106. In some embodiments, the distal surfaces of the inner ring 104 and outer ring 106 are at an incline corresponding to the radius of curvature formed by the inner ring 104 and outer ring 106.

[074] In some embodiments, the body 100 of the distal needle shield 16 has a mid-section with longitudinally extending ribs 110 forming indicia. In some embodiments, the ribs 110 are oriented to align with the opening 38 (Figs. 2, 3, 7, and 8) of the housing 18 when the distal needle shield 16 is in the extended position relative to the housing 18 and locked to indicate to the status of the pen needle 10. The proximal end 112 of the body 100 is open to receive the proximal needle shield 20 when the proximal needle shield 20 is in the retracted position of the proximal needle shield 20 so that the distal needle shield 16 can move axially between the extended position of the distal needle shield 16 and the retracted position of the distal needle shield 16. In some embodiments, the distal needle shield 16 includes an outward projection 114 on the outer surface of the body 100 at the proximal end of the body 100. In some embodiments, the projection 114 is formed with a distally facing recess 116 with a dimension to cooperate with the projection 48 (Figs. 8 and 9) on the inner surface of the housing 18. Particularly, in the extended position of the distal needle shield 16 and prior to use (e.g. application of the distal needle shield 16 to skin of a patient), the projection 48 (Figs. 8 and 9) is received in the recess 116 for parking the distal needle shield 16 in the preuse extended position of the distal needle shield. During use, as described below, proximal movement and rotation of the distal needle shield 16 disengages the recess 116 from the projection 48.

[075] In some embodiments, the distal needle shield 16 includes a pair of legs 118 extending from the proximal end 112 of the body 100. In some embodiments, the legs 118 have a first end formed with the proximal end 112 of the body 100 and a free end 120 with a proximal face 122 and an outwardly projecting tab 124. In some embodiments, the legs 118 are integrally formed with the body 100. In some embodiments, the legs 118 can flex inward when a force is applied and spring back to an original position.

[076] Referring to Figs. 4-6, in some embodiments, the pen needle 10 includes a biasing member 126. In some embodiments, the biasing member 126 can be a coil spring. As shown in Fig. 19, in some embodiments, the biasing member 126 has a distal end contacting a proximally facing surface of the distal needle shield 16 and a proximal end contacting a collar of the proximal needle shield 20.

[077] The assembled pen needle 10 is shown in Figs. 4 and 5. Figs. 4 and 5 depict the pen needle 10 with the proximal needle shield 20 in the retracted position of the proximal needle shield 20 and the distal needle shield 16 in the extended position of the distal needle shield 16. In some embodiments, the needle hub 12 is positioned in the open proximal end of the housing 18 and retained by the interaction between recess 36 (Fig. 8) of the housing 18 and rib 58 (Figs. 10-13).

The proximal needle shield 20 can be oriented in the cavity of the housing 18 such that the proximal end of the proximal needle shield 20 contacts the distal end of the tab 70 of the needle hub 12 (as shown in Fig. 19, for instance). More particularly, the proximally facing surface of one or more of the flanges 92 of the proximal needle shield 20 can contact the distal end of the tab 70 of the needle hub 12 (as shown in Fig. 19, for instance). Such contact between the proximal end of the proximal needle shield 20 and the tab 70 of the needle hub 12 can maintain the proximal needle shield 20 in the retracted position of the proximal needle shield 20. The biasing member 126 can bias the proximal needle shield 20 in a proximal direction against the tab 70. In some embodiments, the distal needle shield 16 is positioned in the housing 18 distally of the proximal needle shield 20. In some embodiments, the biasing member 126 biases the distal needle shield 16 to the extended position of the distal needle shield 16. Figs. 4 and 5 show the pen needle 10 in the ready position (e.g. pre-use) for coupling to the injection pen. In the ready position, the distal needle shield 16 can be in a first extended position of the distal needle shield 16 (e.g. covering the distal end of the needle 14), but limited in its distal extension relative the housing 18. For instance, interaction between the projection 48 (Fig. 9) and the recess 116 (Fig. 18), and particularly, the proximal force applied by the projection 48 on the recess 116 when the projection 48 is received in the recess 116 can limit the distal advancement of the distal needle shield 16 under the biasing force from the biasing member 126 pre-use. In some embodiments, in this parked configuration, the ribs 110 (Fig. 18) cannot be visible through the openings 38 of the housing 18.

[078] The pen needle 10 is connected to the injection pen by threading the needle hub 12 onto a threaded end of the injection pen. The injection pen is not shown in the drawings for clarity. The injection pen can be a standard injection pen as known in the art for coupling with the pen needle 10 for injecting a medication into a subject. Connecting the injection pen to the needle hub 12 via the threads 56 (Figs. 12, 13) of the needle hub 12 flexes the tab 70 of the needle hub 12 outwardly such that the tab 70 no longer contacts the proximal end of the proximal needle shield 20. The proximal needle shield 20 is still retained in the retracted position of the proximal needle shield 20 by contact between the injection pen and the proximal needle shield 20 (particularly, in some embodiments, between the injection pen and one or more of the flanges 92 of the proximal needle shield 20) when the injection pen is connected to the needle hub 12.

[079] Referring to Figs. 4, 5, and 20, during use, the pen needle 10 is pressed against the skin surface of the subject to move the distal needle shield 16 from the extended position of the distal needle shield 16 shown in Figs. 4 and 5 to the retracted position of the distal needle shield 16 shown in Fig. 20 to expose the distal end of the needle 14 such that the distal end of the needle 14 can penetrate the skin surface. In other words, the proximal force applied to the distal needle shield 16 by the skin surface overcomes the distal biasing force applied to the distal needle shield 16 by the biasing member 126 to move the distal needle shield 16 into the retracted position of the distal needle shield 16. In the original ready position (i.e. in the extended position of the distal needle shield 16 shown in Fig. 4 and 5 prior to the pen needle 10 being applied to a skin surface), the distal needle shield 16 is in a first angular position where the legs 118 are axially aligned with the ramps 80 (Figs. 10 and 13) of the needle hub 12. The proximal movement of the distal needle shield 16 causes the legs 118 (Fig. 18) of the distal needle shield 16 to slide over the surface of the ramps 80 linearly in a proximal direction without rotation of the distal needle shield 16. More particularly, the tabs 124 (Fig. 18) of the legs 118 slide over the ramps 80, and following traversal of the proximal end of the ramp 80, flex radially outward such that the free ends 120 (Fig. 18) of the legs 118 contact the inclined surface 82 (Fig. 13) at or near the first point 83 (Fig. 13). [080] After the injection, the needle 14 and the distal face 102 of the distal needle shield 16 are withdrawn from the subject and the biasing member 126 biases the distal needle shield 16 distally to the extended position of the distal needle shield 16 shown in Figs. 19 and 21. As the biasing member 126 moves the distal needle shield 16 distally, tabs 124 (Fig. 18) of the legs 118 contact and ride the inclined surfaces 82 (Fig. 13) toward the second point 85 to rotate the distal needle shield 16 to a second angular position. In the second angular position, the tabs 124 (Fig. 18) are aligned with the distal surface 76 (Figs. 10-13). Once in the second angular position, further distal movement of the distal needle shield 16 via the biasing force of the biasing member 126 allows the tabs 124 (Fig. 18) to slide on the inner surface of the needle hub 12 and flex radially outward once the tabs 124 (Fig. 18) pass over the distal surfaces 76 (Figs. 10-13). When the tabs 124 (Fig. 18) flex radially outward, the tabs 124, and particularly the proximal face 122 of the free ends 120 (Fig. 18) contact the distal surfaces 76 (Figs. 10-13) to prevent the distal needle shield 16 from moving proximally. Contact between the free ends 120 (Fig. 18) and the distal surfaces (Figs. 10- 13) can prevent proximal movement of the distal needle shield 16 relative the needle hub 12 and/or the housing 18 and lock the distal needle shield 16 in the extended position of the distal needle shield 16, as shown in Fig. 21, to cover the distal end of the needle 14 and prevent needle stick. Particularly, in some embodiments, the recesses 78 (Figs. 10-13) of the distal surfaces (Figs. 10- 13) can receive the tabs 124 (Fig. 18) of the legs 118 (Fig. 18) to prevent rotation of the distal needle shield 16 once the distal needle shield is in the post-use extended position. In the extended position of the distal needle shield 16 after use, the tabs 124 (Fig. 18) can be proximally adjacent to the ledge 42 of the housing 18 to prevent over extension of the distal needle shield 16 in the distal direction. When rotated to the second angular position and in the extended position of the distal needle shield 16 (i.e. when locked in the extended position shown in Figs. 19 and 21), the ribs 110 (Fig. 18) of the distal needle shield 16 can align with and be viewable through the openings 38 (Figs. 7 and 8) of the housing 18, forming indicia that is visible to indicate the used status of the pen needle 10 to a user (as seen in Figs. 2 and 3). In some embodiments, when the distal needle shield 16 is in the first angular position, the ribs 110 (Fig. 18) are not aligned with and viewable through the openings 38 (Figs. 7 and 8), such that a user can distinguish between the distal needle shield 16 being in the extended position of the distal needle shield 16 and the pen needle being ready for use (as shown in Figs. 4 and 5) and the distal needle shield 16 being in the extended position of the distal needle shield 16 and locked (as shown in Figs. 19 and 21) to prevent re-use of the pen needle 10. Similarly, in some embodiments, when the distal needle shield 16 rotates to the second angular position, the projection 48 (Fig. 8) and the recess 116 (Fig. 18) become misaligned such that the distal biasing force of the biasing member 126 can advance the distal needle shield 16 distally a further extent in the post-use extended configuration (shown in Figs. 19 and 21) than the pre-use extended configuration (shown in Figs. 4 and 5) (i.e. because the projection 48 (Fig. 8) does not catch the recess 116 (Fig. 18)). The greater extent of distal advancement can make the ribs 110 visible through the openings 38 when they otherwise would not have been in the pre-use extended configuration. Therefore, in some embodiments, in a first or pre-use extended position, the distal needle shield 16 extends a first distance distally from the housing 18, and in a second or post-use extended position, the distal needle shield 16 extends a second distance greater than the first distance distally from the housing 18.

[081] After use, the injection pen is separated from the needle hub 12. Therefore, the injection pen is no longer present to provide a distal force on the proximal needle shield 20, and the proximal needle shield 20 is proximally biased by the biasing member 126 to the extended position of the proximal needle shield 20, as shown in Fig. 21. Without rotation, the proximal needle shield 20 can move proximally within the needle hub 12 and housing 18 to the extended position of the proximal needle shield 20. Particularly, the arms 94 (Figs. 14-17) can slide within the grooves 40 (Figs. 8 and 9) of the housing 18, and the flanges 92 can of the proximal needle shield 20 can slide through the two openings on either side of the post 62 (Fig. 10) of the needle hub 12 to move toward the proximal end of the needle 14 at the proximal opening 32 (Fig. 8) of the housing 18. The proximal end (e.g. the flanges 92) of the proximal needle shield 20 is configured to cover the proximal end of the needle 14 to block or inhibit access to the needle 14 to prevent inadvertent needle stick after use. In some embodiments, the proximal needle shield 20 in the extended position can block access to the proximal end of the needle 14 such that a delivery device cannot be re-coupled to the needle hub 12 and fluidly connected to the proximal end of the needle 14. In some embodiments, in the retracted position of the proximal needle shield, the proximal end of the proximal needle shield 20 is positioned distally of the proximal end of the needle 14. In some embodiments, in the extended position of the proximal needle shield, the proximal end of the proximal needle shield 20 can be positioned proximally of the proximal end of the needle 14. The flexible tabs 96 (Figs. 14-17) of the proximal needle shield 20 can flex radially inwardly as the proximal needle shield 20 moves proximally through the needle hub 12 and spring radially outward when the proximal needle shield 20 is in the extended position of the proximal needle shield 20. When the flexible tabs 96 spring outward, the distal ends of the flexible tabs 96 can contact a proximal-facing surface of the overhang 73 on an inner surface of the needle hub 12 to lock the proximal needle shield 20 in the extended position of the proximal needle shield 20.

[082] The above description of the preferred embodiments is not to be deemed as limiting the disclosure. The disclosure is intended to enable the artisan of ordinary skill to practice variants of the invention described without departing from the scope of the disclosure. Numerical limitations herein, in the specification and in the claims, are understood to be limited by the modifier “about,” such that minor departures yielding equivalent results is within the scope of the disclosure. Features or dependent claim limitations disclosed in connection with one embodiment or independent claim may be combined in another embodiment or with a different independent claim without departing from the scope of the disclosure.

Claims

1. A pen needle comprising: a housing; a needle hub received in the housing, the needle hub comprising a needle with a proximal end and a distal end, wherein the distal end of the needle extends from a distal end of the housing; a distal needle shield received in the housing, wherein the distal needle shield is configured to move from a retracted position of the distal needle shield, where the distal end of the needle is exposed, to an extended position of the distal needle shield, where the distal end of the needle is covered, and wherein the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position.

2. The pen needle of claim 1, wherein the needle hub comprises: a post configured to support the needle; at least two sections, wherein each of the at least two sections comprises: an inclined surface; and a distal surface comprising a recess; a first rib extending between a first of the at least two sections and the post; a second rib extending between a second of the at least two sections and the post; and open passages on either side of the post, wherein: the distal needle shield contacts the inclined surface of at least one of the at least two sections by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from the first angular position to the second angular position; and the distal needle shield contacts the recess of the distal surface of at least one of the at least two sections to lock the distal needle shield in the extended position of the distal needle shield.

3. The pen needle of claim 2, wherein the distal needle shield comprises: a body having a proximal end; and one or more legs extending proximally from the proximal end of the body, wherein each of the one or more legs comprises a free end at a proximal end of the one or more legs, wherein: the free end of each of the one or more legs contacts a respective inclined surface of the at least two sections of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from the first angular position to the second angular position; and the free end of each of the one or more legs contacts a respective recess of the distal surface of the at least two sections to lock the distal needle shield in the extended position of the distal needle shield.

4. The pen needle of claim 2, further comprising a proximal needle shield comprising: a proximal end configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the needle can fluidly connect to a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to the proximal end of the needle; and a flexible tab with a distal end oriented to engage a proximally facing surface on a ledge of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield.

5. A pen needle, comprising: a housing; a biasing member; a needle hub received in the housing, the needle hub comprising: a post configured to support a needle; an inclined surface; and a distal surface; a distal needle shield received in the housing, wherein: the distal needle shield is configured to move from a retracted position of the distal needle shield, where a distal end of the needle is exposed, to an extended position of the distal needle shield, where the distal end of the needle is covered; the distal needle shield is configured to contact the inclined surface of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position; and the distal needle shield, when moved from the retracted position of the distal needle shield to the extended position of the distal needle shield, contacts the distal surface of the needle hub to lock the distal needle shield in the extended position of the distal needle shield; and a proximal needle shield received in the housing, wherein the proximal needle shield is configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the needle can fluidly connect to a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to a proximal end of the needle, wherein the biasing member is configured to bias the distal needle shield to the extended position of the distal needle shield and is configured to bias the proximal needle shield to the extended position of the proximal needle shield.

6. The pen needle of any one of claims 1-5, wherein the distal needle shield is configured to move between an extended position of the distal needle shield to cover the distal end of the needle and the retracted position of the distal needle shield.

7. The pen needle of any one of claims 1-5, further comprising a proximal needle shield having a proximal end configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the proximal end of the proximal needle shield is positioned distally of the proximal end of the needle, and an extended position of the proximal needle shield, where the proximal end of the proximal needle shield is positioned proximally of the proximal end of the needle.

8. The pen needle of any one of claims 1-5, further comprising a proximal needle shield having a proximal end configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the needle can fluidly connect to t a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to the proximal end of the needle.

9. The pen needle of any one of claims 1-5, wherein the distal needle shield contacts an inner surface of the needle hub when moved to the retracted position of the distal needle shield, and the distal needle shield contacts an inclined surface on the inner surface of the needle hub when the distal needle shield moves from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield to the second angular position.

10. The pen needle of claim 9, wherein the inner surface of the needle hub comprises an inwardly extending ramp.

11. The pen needle of claim 10, wherein the distal needle shield comprises a leg extending from a proximal end of a body of the distal needle shield, wherein the leg is oriented to slide over the ramp when the distal needle shield moves from the extended position of the distal needle shield to the retracted position of the distal needle shield, and wherein the leg is oriented to engage the inclined surface to rotate the distal needle shield to the second angular position.

12. The pen needle of claim 11, wherein the leg is flexible and deflects inwardly when sliding over the ramp of the needle hub.

13. The pen needle of claim 12, wherein the leg has a proximal end configured to contact a distal surface of the needle hub to lock the distal needle shield in the extended position of the distal needle shield.

14. The pen needle of any one of claim 1-5, wherein the distal needle shield comprises a distally facing recess oriented to engage a proximally facing projection on an inner surface of the housing when the distal needle shield is in the extended position and the first angular position.

15. The pen needle of claim 14, wherein the recess is angularly spaced from the projection when the distal needle shield is in the second angular position and aligned with the projection when in the first angular position.

16. The pen needle of any one of claims 1-5, further comprising a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the proximal needle shield comprises an outwardly extending arm received in a longitudinally extending groove on an inner surface of the housing to prevent rotation of the proximal needle shield relative to the housing and the needle hub.

17. The pen needle of any one of claims 1-5, further comprising a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the needle hub comprises a post supporting the needle, and wherein the proximal needle shield comprises an axial gap configured to receive the post, where the proximal needle shield slides relative to the post.

18. The pen needle of any one of claims 1-5, further comprising a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the proximal needle shield comprises a flexible tab with a distal end oriented to engage a proximally facing surface on an inner surface of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield.

19. The pen needle of any one of claims 1-5, further comprising a proximal needle shield axially movable within a cavity of the needle hub from a retracted position of the proximal needle shield to an extended position of the proximal needle shield, wherein the needle hub comprises a flexible tab oriented to contact a proximal end of the proximal needle shield to retain the proximal needle shield in the retracted position of the proximal needle shield, and wherein the flexible tab deflects when the needle hub is coupled to a delivery device to separate the tab from the proximal needle shield.

20. The pen needle of any one of claim 1-5, further comprising a biasing member having a distal end contacting the distal needle shield and a proximal end contacting a proximal needle shield.

21. The pen needle of any one of claims 1-5, wherein the distal needle shield comprises a proximally extending leg, wherein the needle hub comprises a first distal face oriented to align with the leg of the distal needle shield when the distal needle shield is in the first angular position, and the needle hub comprises a second distal face spaced axially from the first distal face and oriented to contact a proximal end of the leg to lock the distal needle shield in the extended position.

22. The pen needle of any one of claims 1-5, wherein: the distal needle shield is configured to move from a first extended position of the distal needle shield to cover the distal end of the needle to the retracted position of the distal needle shield to expose the distal end of the needle; the distal needle shield is configured to move from the retracted position of the distal needle shield to a second extended position of the distal needle shield to cover the distal end of the needle; a distal end of the distal needle shield extends a first distance from the housing in the first extended position of the distal needle shield; and the distal end of the distal needle shield extends a second distance from the housing in the second extended position of the distal needle shield, wherein the second distance is greater than the first distance.

23. A pen needle, comprising: a housing having an open proximal end; a needle hub, comprising: a post supporting a needle; an outer wall spaced radially from the post; a longitudinal passage defined between the post and the outer wall; and a flexible tab; a proximal needle shield received in the needle hub and slidable in the longitudinal passage of the needle hub from a retracted position of the proximal needle shield, where the needle can fluidly connect to a delivery device, and an extended position of the proximal needle shield, where the proximal needle shield inhibits access to a proximal end of the needle, wherein: the flexible tab of the needle hub, in a first position, is configured to contact a proximal end of the proximal needle shield to maintain the proximal needle shield in the retracted position of the proximal needle shield; and the flexible tab of the needle hub, in a second position, is configured to flex radially outward to allow the proximal needle shield to move axially to the extended position of the proximal needle shield.

24. The pen needle of claim 23, wherein an inner surface of the housing comprises a groove, and the proximal needle shield is configured to slide in the groove between the retracted position of the proximal needle shield and the extended position of the proximal needle shield.

25. The pen needle of claim 24, wherein the proximal needle shield comprises an arm extending radially outward and the groove is a longitudinally extending groove receiving the arm to prevent rotation of the proximal needle shield relative to the housing and the needle hub.

26. The pen needle of claim 23, further comprising a distal needle shield received in the housing and configured to move between an extended position of the distal needle shield to cover a distal end of the needle and a retracted position of the distal needle shield to expose the distal end of the needle.

27. The pen needle of claim 26, wherein the distal needle shield contacts an inner surface of the needle hub when moved to the retracted position of the distal needle shield, and the distal needle shield contacts an inclined surface on the inner surface of the needle hub to rotate the distal needle shield when the distal needle shield moves from the retracted position of the distal needle shield to the extended position of the distal needle shield.

28. The pen needle of claim 27, wherein the distal needle shield comprises a proximally extending leg, wherein the leg is oriented to slide over a ramp on the inner surface of the needle hub when the distal needle shield moves to the retracted position of the distal needle shield, and wherein the leg is oriented to engage the inclined surface to rotate the distal needle shield from a first angular position to a second angular position.

29. The pen needle of any one of claims 23-28, wherein the proximal needle shield comprises a flexible tab with a distal end oriented to engage a proximally facing surface on an inner surface of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield to lock the proximal needle shield in the extended position of the proximal needle shield.

30. An injection system, comprising: a delivery device comprising a supply of medication; and the pen needle according to any one of claims 1-29.

31. A method of dispensing a fluid comprising: coupling a pen needle to a delivery device, the pen needle comprising a housing, a needle hub having a needle, a distal needle shield, and a proximal needle shield; moving the distal needle shield from an extended position of the distal needle shield to a retracted position of the distal needle shield to expose a distal tip of the needle; dispensing the fluid from the needle; moving the distal needle shield distally to lock the distal needle shield in the extended position of the distal needle shield to cover the distal tip of the needle, wherein the distal needle shield is configured to contact a surface of the needle hub by movement from the retracted position of the distal needle shield to the extended position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position where the distal needle shield contacts a distal surface of the needle hub to retain the distal needle shield in the extended position of the distal needle shield; and moving the proximal needle shield proximally from a retracted position of the proximal needle shield, where the needle can fluidly connect to the delivery device, to an extended position of the proximal needle shield where the proximal needle shield inhibits access to the needle.