WO2022246260A1

WO2022246260A1 - Pen needle assembly

Info

Publication number: WO2022246260A1
Application number: PCT/US2022/030346
Authority: WO
Inventors: David POGANSKI
Original assignee: Embecta Corp.
Priority date: 2021-05-21
Filing date: 2022-05-20
Publication date: 2022-11-24

Abstract

A pen needle includes a needle hub assembly having a needle extending from a distal end and a movable needle shield. A biasing member in the form of a spring member extends between the needle shield and the needle hub assembly. The needle shield is received in the needle hub for sliding movement between an extended position and a retracted position. A locking element is positioned between a side wall of the needle hub assembly and the inner shield and moves from a proximal position to a distal position to lock the needle shield in an extended position to cover the needle. The locking element in the distal position engages the needle hub assembly to lock the locking element in the distal position.

Description

PEN NEEDLE ASSEMBLY

Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63/191,417, filed May 21, 2022, which is hereby incorporated by reference in its entirety.

Field

[0002] The disclosure is directed to a pen needle assembly adapted for attachment to a medication delivery, such as a medication delivery pen.

Description of the Related Art

[0003] Pen needles are used to attach to a medication pen and are especially useful for delivering self-administered injectable medications such as insulin. In one known commercial device, a needle-bearing hub is provided inside a funnel-shaped outer cover, sometimes referred to as the outer shield, or simply as the cover. The needle or cannula is affixed in an axial bore of the hub with one end protruding from the distal or patient side of the hub and the other end of the needle is recessed in a cavity on the proximal or non-patient side of the hub, adapted for attachment to the medication pen. A paper and foil teardrop shaped label is heat sealed on the edge of the open end of the funnel shaped outer cover. In addition, the medication pen may have a cap received over the distal end of the medication pen, over the opening where the pen needle is installed. To install the pen needle on a medication pen, the user removes the medication pen cap. The user then removes the label on the pen needle outer cover and holds the outer cover to install the hub, typically threading the hub onto the pen. Once the hub is installed on the medication pen, the outer cover can be removed by pulling the outer cover distally off the hub. A separate inner needle shield sits over the needle, which the user must remove to administer an inj ection. The inner shield generally sits on the hub and simply helps the user locate the needle without forming a sterility barrier. After use, the user may use the outer cover to unthread the hub from the pen and dispose of the pen needle.

[0004] Pen needles typically include a hub and a needle extending from the hub for inj ecting the medication into the patient. In some devices, the outer cover is placed over the used pen needle to assist in removing the pen needle from the delivery device and covering the used needle after use.

[0005] Other pen needle devices include a retractable needle shield that retracts during use and moves to an extended position after use to cover the needle and prevent inadvertent needle stick. Some of the prior pen needles include a retractable needle shield that locks in place after use.

[0006] While the prior devices are generally suitable for the intended use, there is a need in the industry for improvements to the pen needles.

SUMMARY

[0007] The disclosure is directed to a pen needle assembly that can have a pen needle with a retractable needle shield, wherein the needle shield can be retracted during use and extended to a locked position after use to cover the needle.

[0008] In some aspects, the techniques described herein relate to a pen needle including: a housing having a side wall with a proximal end and a distal end, a needle hub in the housing, a needle extending from the needle hub and the distal end of the housing, wherein the proximal end of the housing is configured for coupling to a delivery device; a needle shield received in the housing and movable from a first extended position covering the needle to a retracted position exposing the needle, and movable to a second extended position in which the needle shield is configured to lock with the housing in the second extended position such that the needle shield is prevented from retracting; and a biasing member extending between the housing and the needle shield to retain the needle shield in the first extended position and to bias the needle shield in a distal direction with respect to the housing from the retracted position to the second extended position, the biasing member translating from a first configuration retaining the needle shield in the first extended position to a second configuration when the needle shield is in the retracted position.

[0009] In some aspects, the techniques described herein relate to a pen needle, further including a locking element positioned in the housing, the locking element being in a proximal position when the needle shield moves to the retracted position, and wherein the locking element is movable to a distal position when the needle shield moves to the second extended position to lock the needle shield in the second extended position. [0010] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member has a first portion coupled to the side wall and a second portion coupled to the needle shield, and wherein the biasing member extends substantially radially between the side wall and the needle shield.

[0011] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member is a torsion spring.

[0012] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member is in a contracted configuration when the needle shield is in the first extended position and in a second configuration when the needle shield in the retracted position.

[0013] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member is in a first plane substantially perpendicular to a center axis of the needle hub and wherein the first portion and second portion are in the first plane when the needle shield is in the first extended position, and wherein the second portion of the biasing member is spaced proximally from the first portion when the needle shield is in the retracted position. [0014] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member has a serpentine configuration extending between the first portion and the second portion.

[0015] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member has a first end coupled to an inner surface of the side wall and a second end coupled to an outer surface of the needle shield.

[0016] In some aspects, the techniques described herein relate to a pen needle, further including a locking element positioned between a base of the needle hub and the needle shield, wherein the locking element is configured for coupling to the needle shield when the needle shield moves to the retracted position, and wherein the locking element moves distally to a locking position relative to the housing when the needle shield moves to the second extended position.

[0017] In some aspects, the techniques described herein relate to a pen needle, wherein the locking element has a member for coupling to the side wall when the locking element moves to a distal position to lock the needle shield in the second extended position. [0018] In some aspects, the techniques described herein relate to a pen needle including: a housing having as side wall, a proximal end, and a distal end; a needle hub having a body coupled to the housing and having a needle extending from the distal end; a needle shield received in the housing for movement from a first extended position to a retracted position and to a second extended position to cover the needle; and a locking element oriented between the needle shield and the needle hub, the locking element configured for moving from a proximal position to a distal position in the housing, wherein the locking element in the distal position retains the needle shield in the second extended position.

[0019] In some aspects, the techniques described herein relate to a pen needle, further including a biasing member extending between the housing and the needle shield to retain the needle shield in the first extended position and the second extended position, and to bias the needle shield from the retracted position to the second extended position.

[0020] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member has a first end coupled to an inner surface of the side wall and a second end coupled to an outer surface of the needle shield, the first end and the second end of the biasing member oriented in a first plane when the needle shield is in the first extended position, and wherein the second end is spaced proximally from the first end when the needle shield is in the retracted position.

[0021] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member has a serpentine configuration extending between the side wall and the needle shield.

[0022] In some aspects, the techniques described herein relate to a pen needle, wherein the locking element is configured for sliding from a proximal position to the distal position in the housing, and the locking element having a member for coupling with the side wall when the locking element is in the distal position.

[0023] In some aspects, the techniques described herein relate to a pen needle, wherein the member of the locking element is a projection and wherein the side wall of the housing has a recess oriented for receiving the projection when the locking element is in the distal position.

[0024] In some aspects, the techniques described herein relate to a pen needle including: a housing having a side wall, a proximal end, and a distal end; a needle hub having a body coupled to the housing, a proximal end and a distal end with a needle extending from the distal end; a needle shield movably received in the housing for covering the needle in a first extended position, exposing the needle when the needle shield is in a retracted position, and covering the needle when the needle shield is in a second extended position; and a locking element positioned between the needle shield and the needle hub, the locking element configured for coupling to the needle shield when the needle shield moves to the retracted position and for moving the locking element to a locking position when the needle shield moves to the second extended position to cover the needle.

[0025] In some aspects, the techniques described herein relate to a pen needle, wherein the side wall of the housing includes a recess, and the locking element has a projection configured to be received in the recess when the needle shield is in the second extended position.

[0026] In some aspects, the techniques described herein relate to a pen needle, further including a biasing member extending between an inner surface of the side wall of the housing and an outer surface of the needle shield, the biasing member having a first configuration retaining the needle shield in the first extended position and a second configuration to bias the needle shield from the retracted position to the second extended position.

[0027] In some aspects, the techniques described herein relate to a pen needle, wherein the biasing member has a first end and a second end oriented in a plane when the needle shield is in the first extended position, and wherein the second end is spaced proximally from the first end when needle shield is in the retracted position.

[0028] These and other aspects and features of the disclosure will be apparent from the following detailed description of the disclosure and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] 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, and some features are omitted in certain views to better illustrate other features. The following is a brief description of the drawings, in which: [0030] Fig. 1 is a perspective view of a pen needle and delivery device in some embodiments;

[0031] Fig. 2 is a perspective view of the pen needle.

[0032] Fig. 3 is an exploded side view of the pen needle showing the needle hub, housing and needle shield and locking element;

[0033] Fig. 4 is a cross sectional view of the needle hub;

[0034] Fig. 5 is a side view of the housing and needle shield;

[0035] Fig. 6 is a cross sectional view of the housing and needle shield of Fig. 5;

[0036] Fig. 7 is a perspective view of the housing, needle shield and biasing member; [0037] Fig. 8 is a perspective view of the biasing member in one embodiment;

[0038] Fig. 9 is a cross sectional view of the locking element taken along line 9-9 of Fig. 3; [0039] Fig. 10 is a cross sectional view of the locking element taken along line 10-10 of Fig. 3;

[0040] Fig. 11 is a perspective view of the pen needle in the ready position;

[0041] Fig. 12 is a perspective view of the pen needle in an activated position;

[0042] Fig. 13 is a perspective view of the pen needle in the deployed position;

[0043] Fig. 14 is a cross sectional view of the needle shield in a retracted position; and [0044] Fig. 15 is a cross sectional view of the needle shield in the extended position.

[0045] While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This 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

[0046] The disclosure is directed to a pen needle assembly that can have a pen needle with a retractable needle shield wherein the needle shield can be retracted during use and extended to a locked position after use to cover the needle. The needle shield can lock in an extended position to cover the end of the needle after use. The needle shield can lock in the extended position after use by a linear movement of the needle shield without rotation of the needle shield relative to the needle hub to a locked position. [0047] In some embodiments, the pen needle includes a needle shield that can be placed in an extended position over the needle by a biasing member that can be produced at a lower cost than the prior biasing members while maintaining the efficiency and simplicity of the operation of the pen needle and the deployment of the needle shield after use. In some embodiments, the biasing member can be a resilient element connected to the needle shield. The biasing member can expand when the needle shield is retracted and contract to the original rest condition to move the needle shield to the extended position.

[0048] In some embodiments, the biasing member can be coupled to and extends between the housing of the pen needle and the movable needle shield. The biasing member can be attached to the housing and needle shield by a suitable connection or can be integrally formed as a one-piece molded assembly.

[0049] The biasing member can be a spring-like member that can be coupled to an inner surface of a side wall of the housing and to an outer surface of the needle shield. The biasing member can be a torsion spring or leaf spring that extends between the housing and the needle shield. In some embodiments, the biasing member can be a spring member having a serpentine configuration with a first end coupled to the inner surface of the housing and a second end coupled to an outer surface of the needle shield. In some embodiments, the biasing member can be in the rest condition retaining the needle shield in the extended position and in the loaded and expanded condition when the needle shield is retracted. [0050] The needle shield can be configured to move axially within a housing from a first extended position covering the distal end of the needle to a retracted position when the biasing member expands axially or translates to a configuration so that the needle can be exposed for use. The biasing member may be able to return the needle shield to the original position in a second extended position where the needle can be covered by the needle shield and the needle shield locks in the second extended position to prevent re-use of the pen needle.

[0051] The pen needle, in some embodiments, can include a locking element to lock the needle shield in the second extended position after use. The locking element can be a separate member that moves relative to the housing and/or the needle hub when the biasing member returns to the original shape and the needle shield is in the second extended position. In some embodiments, the latching member can slide within the housing from a first position to a second locked position relative to the housing. The locking element in the second position can prevent the needle shield from retracting to prevent further use of the pen needle.

[0052] The locking element in a first position can be proximal to the distal end of the housing and in a second position can be oriented toward or at the distal end of the housing. The locking element can include a coupling or latching mechanism that couples to the needle shield when the needle shield is retracted so that when the biasing member returns the needle shield to the second extended position, the locking element moves to a distal position relative to the housing of the pen needle, wherein a projection engages the housing to prevent retracting the needle shield and the locking element.

[0053] In some embodiments, the locking element can have a mechanism that cooperates with the housing to retain the locking element in a proximal position during an injection. Retracting the needle shield can engage the needle shield with the locking element so that the needle shield carries the locking element to a distal position when the needle shield moves to the second extended position. The locking element can lock in the distal position relative to the housing to retain the needle shield in the second extended position.

[0054] In some embodiments, a needle hub can have a needle received in a proximal end of a housing, wherein the needle extends from a distal end of the housing. A locking element can be positioned in the housing for moving between a proximal position with respect to the housing and an extended position with respect to the housing. A needle shield can be coupled to the housing in a first extended position covering the distal end of the needle. The needle shield can be held in the first position by a biasing member so that movement of the needle shield in a proximal direction retracts the needle shield and moves the needle shield against the biasing force of the biasing member. The biasing member can be coupled to the needle shield and to the housing so that the needle shield can be biased from the retracted position to the second extended position.

[0055] In some embodiments, a pen needle can comprise a housing having a side wall with a proximal end and a distal end, a needle hub in the housing, a needle extending from the needle hub and the distal end of the housing, wherein the proximal end of the housing can be configured for coupling to a delivery device. A needle shield can be received in the housing and can be movable from a first extended position covering the needle, to a retracted position exposing the needle, and movable to a second extended position where the needle shield locks with the needle hub assembly in the second extended position. A biasing member can extend between the needle hub and the needle shield to retain the needle shield in the first extended position and to bias the needle shield in a distal direction with respect to the housing from the retracted position to the second extended position. The biasing member can translate from a first configuration retaining the needle shield in the first extended position to a second configuration when the needle shield is in the retracted position.

[0056] In some embodiments, a pen needle can comprise a housing having a side wall, a proximal end and a distal end, a needle hub having a base coupled to the housing and having a needle extending from the distal end of the housing. A needle shield can be received in the housing for movement from a first extended position to a retracted position and to a second extended position to cover the needle. A locking element can be oriented between the housing and the needle hub. The locking element can be configured for moving from a proximal position to a distal position in the housing where the locking element in the distal position retains the needle shield in the second extended position.

[0057] In some embodiments, a pen needle can comprise a housing having a side wall, a proximal end and a distal end and a needle hub having a body coupled to the housing, a proximal end and a distal end with a needle extending from the distal end. A needle shield can be movably received in the housing for covering the needle in a first extended position, exposing the needle when the needle shield can be in a retracted position, and covering the needle when the needle shield is in a second extended position. A locking element can be positioned between the needle shield and the needle hub. The locking element can be configured for coupling to the needle shield when the needle shield moves to the retracted position and for moving the locking element to a locking position when the needle shield moves to an extended position to cover the needle.

[0058] As used herein, the “distal” direction is in the direction of the injection site, and the “proximal direction” is the opposite direction. The “axial” direction is along the longitudinal axis of the injection device. The needle cannula can be generally arranged axially in the device. “Radially” is a direction perpendicular to the axial direction. Thus, “radially inward” generally means closer to the needle. “Circumferentially” means arranged around the circumference, so that threads are arranged circumferentially on the end of a threaded fitting. The “top” view of a pen needle is looking at the pointed end of the needle. The different features of the embodiments can be used in combination with and used with other embodiments as long as the combined parts are not inconsistent with or interfere with the operation of the device and assembly. The term “substantially” refers to a characteristic that possessed the characteristic or mostly the characteristic, but not necessary entirely the characteristic.

[0059] Referring to the drawings, the pen needle assembly includes a pen needle 10. An outer cover and a seal covering the open end of the outer cover enclosing the pen needle until ready for use may be generally included but not illustrated for simplicity. The pen needle can be configured for attaching to a delivery pen or injection device in a known manner. The delivery pen is not shown in the drawings for clarity. The outer cover can be coupled to the distal end of the pen needle. The closure or peel tab can be generally provided over the open end of the cover to maintain the needle hub assembly in a sterile condition until ready for use. The delivery pen can be a typical delivery pen or other medication delivery device as known in the art for dispensing and delivering a medication or pharmaceutical such as insulin. An example of a suitable delivery pen is disclosed in U.S. Patent No. 9,774,844, which is hereby incorporated by reference in its entirety.

[0060] In some embodiments, the components of the needle hub and outer cover may be typically injection molded plastic, such as acrylonitrile butadiene styrene (ABS), polypropylene, or the like while the cannula can be surgical grade stainless steel. Other materials and methods of manufacture known to those of ordinary skill in the art of medication pen technology may be adapted for use herein without departing from the scope of the disclosure. To assemble the parts, the needle hub may be constructed with the needle separately, with adhesive applied in the interface area to secure the cannula to the needle hub and fit by interference into an outer cover.

[0061] The pen needle assembly as shown in Fig. 1 can include the pen needle 10 connected to a delivery device 12. In some embodiments, the delivery device 12 can be configured for delivering a controlled dose of a medication to the pen needle and to the patient. As shown in Fig. 1, Fig. 2 and Fig. 3, the pen needle 10 can include a body defining a housing 14, a needle shield 16, a needle hub 18, a biasing member 36, and a locking element 20. [0062] In some embodiments, the needle shield 16 can be oriented in a first extended position covering the distal end of the needle 30. The needle 30 can extend through the opening in the locking element 20 and past the distal end of the housing 14. In some embodiments, the needle 30 can be received in a proximal end of the housing 14. The needle 30 can extend a length suitable for piercing the skin of the patient to a selected depth for delivering the medication.

[0063] In use, the pen needle 10 can be assembled as shown in Fig. 3 where the needle hub 18 can be coupled to the housing 14 within the cavity. In some embodiments, the needle hub 18 has a base coupled to the housing 14.

[0064] In some embodiments, the locking element 20 can be positioned between the base of the needle hub 18 and the needle shield 16. In some embodiments, the locking element 20 can be positioned in the cavity of the housing 14 between the needle hub 18 and the needle shield 16. In some embodiments, the locking element 20 can be positioned between the housing 14 and the needle hub 18. In some embodiments, the locking element 20 can be oriented between the housing 14 and the needle hub 18.

[0065] The needle hub 18 as shown in Figs. 3 and 4 has a shape and configuration for fitting within the housing 14 and can be attached to the housing 14 by an adhesive, welding or other suitable attachment mechanism. The needle hub 18 can be attached to the housing 14 at a location distally spaced from the internal threads 26 and proximally spaced from the biasing member 36 and the needle shield 16 at the distal end of the housing 14.

[0066] In reference to Fig. 4, the needle hub 18 has a body 46 with a post 48 extending from the distal side of the body and a post 50 extending from the proximal side of the body. An axial passage 52 extends through the hub body 46 receiving the needle 30 and for receiving an adhesive for attaching the needle 30 to the hub body 46.

[0067] The body forms the housing 14 for enclosing the needle hub 18 and the locking element 20. The needle 30 can extend axially from the needle hub 18. As shown, for example, in Fig. 5, the housing 14 can have a side wall 22 with an open proximal end 24 and a distal end 28. The side wall 22 at the open proximal end 24 can include an internal surface with internal threads 26 for coupling with the delivery device 12. In some embodiments, the housing 14 has a substantially cylindrical configuration with an internal cavity having a configuration and dimension for supporting the needle hub 18 and the locking element 20. As shown in Fig. 6, the side wall 22 can include an elongated slot 84 with a proximal end 86 and an inclined distal end 88.

[0068] The housing 14 as shown can include an open distal end 28 that receives the needle shield 16. In some embodiments, the needle shield 16 has a substantially cylindrical shape with an open proximal end 32 that can slide over the needle 30 to cover the needle 30. In some embodiments, the needle shield 16 has an open distal end 34 with a dimension so that the needle 30 can project from the needle shield 16 during use. For example, the needle shield 16 can be retracted during use and extended to a locked position after use to cover the needle 30.

[0069] In some embodiments, the biasing member 36 can be a spring-like member having sufficient resilience, flexibility and memory to bend or deflect when the needle shield 16 is depressed and retracted to and to bias the needle shield 16 to the original position. As shown in Fig. 6, the biasing member 36 can be spaced proximally from the distal end 28 of the side wall 22. In some embodiments, the biasing member 36 can be a resilient element connected to the needle shield 16. In some embodiments, the biasing member 36 has a first portion 38 at a first end coupled to the housing 14 and a second portion 40 at a second end coupled to the needle shield 16.

[0070] In some embodiments, the biasing member 36 can extend between the housing 14 and the needle shield 16. Figs. 2, 3 and 7 show embodiments where the biasing member 36 can be coupled directly to the housing 14 and the needle shield 16. The biasing member can be coupled to the needle shield 16 and to the housing 14 so that the needle shield 16 can be biased from the retracted position to the extended position. In some embodiments, the biasing member 36 can be coupled to and extends between the housing 14 of the pen needle 10 and the movable needle shield 16.

[0071] In some embodiments, the ends of the biasing member 36 can be directly coupled to the housing 14 and the needle shield 16 without the use of a supporting ring. In some embodiments, the biasing member 36 can be attached to the housing 14 and needle shield 16 by a suitable connection or can be integrally formed as a one-piece molded assembly. The biasing member 36 can be integrally formed with the housing 14 and the needle shield 16 as shown in Fig. 7 where the ends of the biasing member 36 are directly coupled to the housing 14 and the needle shield 16. In some embodiments, the biasing member 36 can be an integral part of the side wall and the outer portion can form part of the side wall.

[0072] As shown in Fig. 8, in some embodiments, the biasing member 36 can have cylindrical outer portion 42 shown as a ring having a dimension to fit within the open distal end of the housing 14 so the outer portion 42 can be coupled to the housing 14 by an adhesive or welding. In some embodiments, the biasing member 36 can be a spring member having a serpentine configuration with a first end coupled to the inner surface of the housing 14 and a second end coupled to an outer surface of the needle shield 16.

[0073] The biasing member 36 can include two legs 44 that extend between the outer portion 42 and an outer surface of the needle shield 16 at a proximal end of the needle shield. In some embodiments, the legs 44 can have a winding, serpentine shape to provide a length greater than the radial dimension between the outer ring and the needle shield. The legs 44 can have a length to reverse directions a number of times to allow the needle shield to deflect out of the plane of the biasing member and the outer ring when the needle shield is moved to the retracted position. In some embodiments, the biasing member 36 can be a torsion spring or leaf spring that extends between the housing 14 and the needle shield 16. For example, the serpentine shape of the legs 44 of the biasing member 36 can form a torsion spring-like member.

[0074] The biasing member 36 can support the needle shield 16 within the housing 14 while allowing axial movement of the needle shield 16 during use. In some embodiments, the biasing member 36 can translate from a first configuration retaining the needle shield 16 in the extended position to a second configuration when the needle shield 16 is in the retracted position. The biasing member 36 can allow the needle shield 16 to move axially within the housing 14 so that the biasing member 36 deforms or translates to an elongated and expanded configuration where the second end of the biasing member 36 at the needle shield 16 is spaced axially from the first end. In some embodiments, the needle shield 16 can be configured to move axially within the housing 14 from the extended position covering the distal end of the needle 30 to the retracted position when the biasing member 36 expands axially or translates to a configuration so that the needle 30 can be exposed for use.

[0075] In some embodiments, the needle shield 16 can be held in the ready or rest position by the biasing member 36 so that movement of the needle shield 16 in a proximal direction retracts the needle shield 16 and moves the needle shield 16 against the biasing force of the biasing member 36. The biasing member 36, in some embodiments, can have a configuration to retain the needle shield 16 in a ready or rest position where the second end of the biasing member 36 at the needle shield 16 is in a plane with the first end of the biasing member 36. For example, the plane can be substantially perpendicular to the center axis of the pen needle 10.

[0076] In some embodiments, the biasing member 36 can be in the rest condition retaining the needle shield 16 in the extended position and in the loaded and expanded condition when the needle shield 16 is retracted. In some embodiments, the biasing member 36 expands when the needle shield 16 is retracted and contracts to the original rest condition to move the needle shield 16 to the extended position. In some embodiments, the biasing member 36 can bias the needle shield 16 in a distal direction with respect to the housing 14 from the retracted position to the second extended position. In some embodiments, the biasing member 36 can move the needle shield 16 to the original position in a second extended position where the needle 30 can be covered by the needle shield 16 and the needle shield 16 locks in the second extended position to prevent re-use of the pen needle 10.

[0077] The locking element 20 as shown in Figs. 9 and 10 has a body 54 with a side wall 56 extending proximally from a top wall 58. As shown, the side wall 56 can have a substantially cylindrical shape that can move and/or slide in the housing 14. The side wall 56 can include a latching member 60 in the form of an axially extending leg 62. As shown in Fig. 9, two legs can be provided on opposite sides of the body 54. The leg 62 can be connected to and formed with the side wall 56 with a free end 64 having an outwardly extending projection 66. The projection 66 as shown in Fig. 3 and Fig. 9 can have a flat end surface and an inclined upper surface 68. The leg 62 can be flexible to be deflected inwardly and then spring back to the original shape and configuration. As shown in Fig. 3, the leg 62 can be formed in an open portion of the side wall and has a distal end coupled to the side wall to form a living hinge to allow the leg to flex radially inward and spring back to the original position. The proximal free end 64 of the leg can be aligned with the proximal edge of the side wall 56 as shown in Fig. 10.

[0078] The inner surface of the top wall 58 can include a collar 70 extending in a proximal direction toward the open proximal end of the locking element 20. The collar 70 can have an inner dimension to receive and mate with the distal post 48 of the needle hub 18. As shown in Figs. 9 and 10, the collar 70 can include notched portions to allow the locking element 20 to release from the distal post 48. The collar 70 can have an internal dimension to grip the distal post 48 by a friction fit to retain the locking element 20 in a ready position on the distal post and to release the locking element 20 to activate the locking mechanism. [0079] The distal surface of the top wall 58 of the locking element 20 can include a central opening 72 to receive the needle 30. A coupling mechanism can be provided for coupling with the needle shield 16. Projections 74 can extend distally from the top wall 58 on opposite sides of the opening to form the coupling mechanism. The projections 74 can have a distally extending leg 76 with a projecting member 78 at a distal end of the leg 76. The projecting member 78 can have a flat bottom surface 80 facing proximally and a distally facing inclined surface 82 forming a pointed end of the projection 74.

[0080] Referring to Fig. 11, the pen needle 10 can be in the ready position when coupled to the delivery pen and when the needle shield 16 is in the extended position to cover the needle 30. In some embodiments, needle shield 16 can be movable from an extended position covering the needle 30 to a retracted position exposing the needle 30. The pen needle 10 can be pressed against the surface of the skin to retract the needle shield 16 in the direction of arrow 92 in Figs. 11 and 12 to expose the distal end of the needle 30 where the needle pierces the skin to a depth for delivering the medication to the patient.

[0081] As shown in Fig. 12 and Fig. 14, the needle shield 16 can retract and the biasing member 36 can expand. The legs of the biasing member 36 can bend and deflect to allow the needle shield 16 to retract in a proximal direction. As shown in Fig. 6, the inner edge of the needle shield 16 can include an inwardly extending projection 94 to form a hook member.

[0082] The retracting movement of the needle shield 16 can bring the projections 94 of the needle shield 16 into engagement with the proj ections 74 of the locking element 20 as shown in Fig. 12 and Fig. 14. In some embodiments, the locking element 20 can be a separate member that moves relative to the housing 14 and/or the needle hub 18. In some embodiments, the locking element 20 can be in a proximal position with respect to the housing 14 when the needle shield 16 is in the retracted position. In some embodiments, the projections 74 engage with the housing 14 to maintain the locking element 20 in a proximal position during an injection.

[0083] After delivering the medication to the patient, the needle 30 can be withdrawn from the patient where the biasing member 36 contracts and moves the needle shield 16 to the extended position shown in Fig. 13 and Fig. 15. The needle shield 16 can lock in the extended position to cover the end of the needle 30 after use. In some embodiments, needle shield 16 can be movable to the extended position in which the needle shield 16 can be configured to lock with the housing 14 in the extended position such that the needle shield 16 can be prevented from retracting, which prevents reuse of the needle. In some embodiments, the needle shield 16 can lock in the extended position after use by a linear movement of the needle shield 16 without rotation of the needle shield 16 relative to the needle hub 18 to a locked position. In some embodiments, the needle shield 16 locks with the needle hub 18.

[0084] The locking element 20 can lock the needle shield 16 in the extended position after use to prevent reuse of the needle. In some embodiments, the locking element 20 can be coupled to the needle shield 16 so that the movement of the needle shield 16 to the extended position carries the locking element 20 distally to the locked position shown in Fig. 15. In some embodiments, the locking element 20 moves when the biasing member 36 returns to its original shape and the needle shield 16 is in the extended position.

[0085] In some embodiments, the locking element 20 can be movable to a distal position with respect to the housing 14 when the needle shield 16 moves to the extended position to lock the needle shield 16 in the extended position. Retracting the needle shield 16 can cause the needle shield 16 to engage with the locking element 20 so that the needle shield 16 moves the locking element 20 to the distal position when the needle shield 16 moves to the extended position. The locking element 20 can lock in the distal position relative to the housing 14 to retain the needle shield 16 in the extended position.

[0086] The locking element 20 can include the latching member 60 that couples to the needle shield 16 when the needle shield 16 is retracted so that when the biasing member 36 returns the needle shield 16 to the extended position, the locking element 20 moves to the distal position relative to the housing 14 of the pen needle 10. In some embodiments, the latching member 60 can be a coupling or latching mechanism. In some embodiments, the latching member 60 can be a projection configured to engage the housing 14 to prevent retracting the needle shield 16 and the locking element 20. In some embodiments, the side wall of the housing 14 has a recess oriented for receiving the projection when the locking element 20 is in the distal position.

[0087] In some embodiments, the latching member 60 slides within the housing 14 from a first position to a second locked position relative to the housing 14. In some embodiments, the latching member 60 in the first position can be proximal to the distal end of the housing 14. In some embodiments, the latching member 60 in a second position can be oriented toward or at the distal end of the housing 14. The latching member 60 in the second position can prevent the needle shield 16 from retracting to prevent further use of the needle 30. [0088] In the initial ready position shown in Fig. 2, the latching member 60 of the locking element 20 can be received in the slot 84. The distal movement of the latching member 20 can separate the latching member 60 from the slot 84 by deflecting the latching member 60 inwardly to slide along the inner surface of the housing until the latching member 60 slides into a lock opening 90 as shown in Fig. 13 and Fig. 15. The locking opening 90 can be axially aligned with and spaced distally from the slot 84. The locking opening can have a length less than the slot 84 and a flat proximal end surface and a distal end surface. The latching member 60 can be received in the lock opening 90, thereby locking the locking element 20 in the distal position and locking the needle shield 16 in the distal extended position to prevent re-use of the pen needle 10 as shown in Fig. 15.

[0089] The foregoing description of some embodiments is not to be deemed limiting of the disclosure, which is defined by the following claims. The foregoing description should provide the artisan of ordinary skill with sufficient information to practice variants of the embodiments described. Features and improvements described in dependent claims or in connection with one embodiment may be combined with those of another independent claim or another embodiment, provided they are not inconsistent therewith, without departing from the scope of the disclosure.

Claims

Claims What is claimed is:

1. A pen needle comprising: a housing having a side wall with a proximal end and a distal end, a needle hub in the housing, a needle extending from the needle hub and the distal end of the housing, wherein the proximal end of the housing is configured for coupling to a delivery device; a needle shield received in the housing and movable from a first extended position covering the needle to a retracted position exposing the needle, and movable to a second extended position in which the needle shield is configured to lock with the housing in said second extended position such that the needle shield is prevented from retracting; and a biasing member extending between the housing and the needle shield to retain the needle shield in the first extended position and to bias the needle shield in a distal direction with respect to the housing from the retracted position to the second extended position, the biasing member translating from a first configuration retaining the needle shield in the first extended position to a second configuration when the needle shield is in the retracted position.

2. The pen needle of claim 1, further comprising a locking element positioned in the housing, the locking element being in a proximal position when the needle shield moves to the retracted position, and wherein the locking element is movable to a distal position when the needle shield moves to the second extended position to lock the needle shield in the second extended position.

3. The pen needle of any one of claims 1-2, wherein the biasing member has a first portion coupled to the side wall and a second portion coupled to the needle shield, and wherein the biasing member extends substantially radially between the side wall and the needle shield.

4. The pen needle of claim 3, wherein the biasing member is a torsion spring.

5. The pen needle of claim 4, wherein the biasing member is in a contracted configuration when the needle shield is in the first extended position and in a second configuration when the needle shield in the retracted position.

6. The pen needle of claim 5, wherein the biasing member is in a first plane substantially perpendicular to a center axis of the needle hub and wherein the first portion and second portion are in the first plane when the needle shield is in the first extended position, and wherein the second portion of the biasing member is spaced proximally from the first portion when the needle shield is in the retracted position.

7. The pen needle of claim 3, wherein the biasing member has a serpentine configuration extending between the first portion and the second portion.

8. The pen needle of claim 3, wherein the biasing member has a first end coupled to an inner surface of the side wall and a second end coupled to an outer surface of the needle shield.

9. The pen needle of any one of claims 1-2, further comprising a locking element positioned between a base of the needle hub and the needle shield, wherein the locking element is configured for coupling to the needle shield when the needle shield moves to the retracted position, and wherein the locking element moves distally to a locking position relative to the housing when the needle shield moves to the second extended position.

10. The pen needle of claim 9, wherein the locking element has a member for coupling to the side wall when the locking element moves to a distal position to lock the needle shield in the second extended position.

11. A pen needle comprising: a housing having as side wall, a proximal end, and a distal end; a needle hub having a body coupled to the housing and having a needle extending from the distal end; a needle shield received in the housing for movement from a first extended position to a retracted position and to a second extended position to cover the needle; and a locking element oriented between the needle shield and the needle hub, the locking element configured for moving from a proximal position to a distal position in the housing, wherein the locking element in the distal position retains the needle shield in the second extended position.

12. The pen needle of claim 11, further comprising a biasing member extending between the housing and the needle shield to retain the needle shield in the first extended position and the second extended position, and to bias the needle shield from the retracted position to the second extended position.

13. The pen needle of claim 12, wherein the biasing member has a first end coupled to an inner surface of the side wall and a second end coupled to an outer surface of the needle shield, the first end and the second end of the biasing member oriented in a first plane when the needle shield is in the first extended position, and wherein the second end is spaced proximally from the first end when the needle shield is in the retracted position.

14. The pen needle of claim 13, wherein the biasing member has a serpentine configuration extending between the side wall and the needle shield.

15. The pen needle of any one of claims 11-12, wherein the locking element is configured for sliding from a proximal position to the distal position in the housing, and the locking element having a member for coupling with the side wall when the locking element is in the distal position.

16. The pen needle of claim 15, wherein the member of the locking element is a projection and wherein the side wall of the housing has a recess oriented for receiving the projection when the locking element is in the distal position.

17. A pen needle comprising: a housing having a side wall, a proximal end, and a distal end; a needle hub having a body coupled to the housing, a proximal end and a distal end with a needle extending from the distal end; a needle shield movably received in the housing for covering the needle in a first extended position, exposing the needle when the needle shield is in a retracted position, and covering the needle when the needle shield is in a second extended position; and a locking element positioned between the needle shield and the needle hub, the locking element configured for coupling to the needle shield when the needle shield moves to the retracted position and for moving the locking element to a locking position when the needle shield moves to the second extended position to cover the needle.

18. The pen needle of claim 17, wherein the side wall of the housing includes a recess, and the locking element has a projection configured to be received in the recess when the needle shield is in the second extended position.

19. The pen needle of claim 18, further comprising a biasing member extending between an inner surface of the side wall of the housing and an outer surface of the needle shield, the biasing member having a first configuration retaining the needle shield in the first extended position and a second configuration to bias the needle shield from the retracted position to the second extended position.

20. The pen needle of claim 19, wherein the biasing member has a first end and a second end oriented in a plane when the needle shield is in the first extended position, and wherein the second end is spaced proximally from the first end when needle shield is in the retracted position.