received by the International Bureau on 13 July 2015 (13.07.15)

1. A pen needle, comprising

a needle-bearing hub having threads for attachment to a medication delivery device and at least one circumferentially oriented flexible tab located proximally of the threads; an outer cover received over the hub covering the needle and having at least one radially inward rib engaging the at least one flexible tab on the hub to provide sensory feedback for the user when the hub is installed on the medication delivery device.

2 The pen needle according to Claim 1. wherein the sensory feedback is an audible click, a tactile sensation, or a combination of an audible click and tactile sensation caused by contact of the rib on the outer cover with the flexible tab.

3. The pen needle according to Claim 1 , wherein engagement of the hub with the outer cover prevents the outer cover from moving distally with respect to the hub until after the outer cover rotates with respect to the hub.

4, A pen needle, comprising

a needle-bearing hub having threads for attachment to a medication delivery device. at least one circumferentially oriented flexible tab on the hub located proximally of the threads, the end of each flexible tab having a radially outward projection;

at least one stop member on the hub located proximally of the threads projecting in a radially outward direction and a circumferential gap separating the radially outward projection on the flexible tab from the stop member;

an outer cover received over the hub covering the needle having at least one radially inward projecting rib; and wherein

engagement of the rib on the outer cover with the projection on the flexible tab causes the hub to rotate with the outer cover when the hub offers low resistance to applied rotational force; and wherein the projection on the flexible tab rides over the rib on the outer cover when the hub offers higher resistance to applied rotational force when the outer cover rotates with respect to the hub creating sensory feedback that the hub is fully installed on the medication pen; and wherein

engagement of the inward projecting rib against the stop member prevents rotation of the outer cover with respect to the hub when the hub is fully seated on the medication pen.

5. The pen needle according to Claim 4, wherein

the at least one inward projecting rib is located in the circumferential gap between the stop member and the projection on the flexible tab when the hub is rotated to a position fully seated on the medication pen.

6. The pen needle according to Claim 4, wherein

the flexible tab has a plurality of radially outward projections which engage the at least one inwardly projecting rib on the cover to create sensory feedback.

7. The pen needle according to claim 4, wherein said at least one radially inward projecting rib comprises a set of two to three inwardly projecting ribs on an inside surface of the outer cover engaging a projection on the flexible tab, each said set of ribs received in the circumferential gap between the stop member and the radially outward projection on the end of the flexible tab.

8. The pen needle according to claim 7, comprising two circumferentially oriented flexible tabs on the hub located proximally of the threads, each said flexible tab having a radially outward projection on respective end thereof; and two sets of two to three inwardly projecting ribs on the inside circumferential surface of the outer cover.

9. The pen needle according to Claim 4, comprising

25 a circumferentially oriented ramp on the flexible tab having an increased diameter in the direction of the end of the flexible tab, which increases the force required to turn the cover with respect to the hub as an inwardly projecting rib on the outer cover rides on the ramp.

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10- The pen needle according to Claim 4, comprising

a beveled surface on the projection on the flexible tab engaging a beveled surface on the inwardly projecting rib.

11 , A pen needle, comprising

] 0 a needle-bearing hub having threads for attachment to a medication delivery device and at least one circumferentially oriented flexible tab located proximally of the threads; each flexible tab having a radially outward surface with a projection, and each proj ection having a beveled side;

an outer cover having at least one radially inward projecting rib, each rib having a 15 beveled surface engaging the beveled surface of the projection on the flexible tab; and wherein

engagement of the rib on the outer cover with the projection on the flexible tab causes the hub to rotate with the outer cover when the hub offers low resistance to applied rotational force; and wherein

20 the projection on the flexible tab deflects and rides over the rib on the outer cover when the outer cover rotates with respect to the hub at increased resistance to applied rotational force, creating an audible and/or tactile indication that the hub is fully installed on the medication pen.

12. The pen needle according to Claim 11 , further comprising a plurality of inward 5 projecting ribs, wherein the hub has two flexible tabs, each having a radially outward

projection, said outward projections located about 180 degrees apart, radially opposite each other on the proximal end of the hub.

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13. The pen needle according to Claim 12, wherein each radially outward projection on the hub and each radially inward projection on the outer cover has a straight side perpendicular to a circumferential direction; and wherein said straight sides on the radially outward projection on the hub and radially inward projection on the outer cover engage the other respectively when the outer cover and hub are rotated to remove the hub from the medication pen.

14. A pen needle, comprising:

a needle-bearing hub having threads for attachment to a medication delivery device and at least one circumferentially oriented flexible tab located proximally of the threads; the hub having a radially outward surface including a step portion forming a locking surface on the hub perpendicular to the axis of the needle;

an outer cover received over the hub having a closed distal end and an open proximal end, and a locking rib at the open proximal end projecting radially inwardly and abutting the locking surface on the hub; wherein

The flexible tab having a radially outward projection positioned at one end of the step portion on the hub; wherein

the locking rib engages the projection on the flexible tab on the hub and causes the outer cover to rotate together with the hub when the hub is rotated for installation on the medication pen; and wherein

when sufficient force develops between the outer cover and the hub during installation of the hub on the medication pen, the locking rib rides over the projection on the flexible tab on the hub where it is freed from the locking surface.

15. The pen needle according to Claim 14, wherein an audible and or tactile feedback is generated in the form of a single click from the locking rib riding over the projection on the flexible tab on the hub.

16. The pen needle according to Claim 14, further comprising:

a pair of circumferentially disposed surfaces converging toward a channel at one

27 end of the step portion on the hub, where the radially inward projection on the outer cover is inserted to install the outer cover over the hub.

17. A pen needle, comprising:

a needle bearing hub having a wider proximal end portion having a proximal opening for receiving a medication pen and a narrower distal end portion meeting the wider proximal end portion at a step;

a needle bearing post of the hub recessed within the distal end portion;

an outer cover received over the hub; wherein

the hub receives a medication pen cap over the hub when the hub is installed on a medication pen.

18. The pen needle according to Claim 17, further comprising at least one

circumferentially oriented flexible tab on the distal portion at the step portion; and

an outer cover received over the hub covering the needle and having at least one radially inward rib engaging the at least one flexible tab on the hub to provide sensory feedback for the user when the hub is installed on the medication delivery device.

19. The pen needle according to Claim 17, further comprising an opening in the distal face of the proximal end portion of the hub including an axially extending slot defining a free corner of the flexible tab. 20. The pen needle according to Claim 17, further comprising an outer cover received over the narrower distal portion of the hub, abutting the wider proximal portion of the hub and sealed to the hub with a labyrinth seal.

21. The pen needle according to Claim 17, further comprising a foil or paper-foil label closure heat sealed to the proximal end of the hub prior to installation on the medication delivery device.

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22. A pen needle, comprising:

a needle bearing hub having a patient side and a non-patient side, a post on the patient side of the hub and a patient end cannula extending from the post, and a cavity on the non-patient side having threads on an interior surface and a non-patient end cannula extending within the cavity.

a non-patient side shield having a cylindrical body covering the non-patient end needle and a lateral extension on the non-patient end of the cylindrical body having threads that mate with, the threads on the inside surface of the cavity,

a patient side shield having a contour on an interior surface mating with a second contour on an outward surface of the post together providing a tortuous path sterile barrier around the patient side needle.

23. The pen needle according to Claim 22, further comprising:

lateral extensions on the proximal end of the non-patient end shield to facilitate gripping. 24. The pen needle according to Claim 22, further comprising indicia on the cylindrical portion of the non-patient end shield.

25. The pen needle according to Claim 22, wherein the non-patient end shield and the patient end shield each has a diameter one-third to one tenth the diameter of the hub to form a spindle configuration.

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