WO2023004142A1

WO2023004142A1 - Retractable sleeve for pen needle assembly

Info

Publication number: WO2023004142A1
Application number: PCT/US2022/038057
Authority: WO
Inventors: Todd SACK; Kenneth James; David Schiff; Sergey Grigoryants
Original assignee: Embecta Corp.
Priority date: 2021-07-23
Filing date: 2022-07-22
Publication date: 2023-01-26

Abstract

A pen needle includes a housing having a needle hub received within, the needle hub having a needle with a distal end extending from the distal end of the needle hub and a proximal end extending from a proximal end of the needle hub. The pen needle further includes a distal needle shield received in the housing and movable between a retracted position to expose the distal end of the needle and an extended position to cover the distal end of the needle, a proximal needle shield received in the housing and movable between a retracted position to expose the proximal end of the needle and an extended position to cover the proximal end of the needle, and a spring extending between the needle shields to bias the needle shields to the respective extended position. The needle shields are lockable in the extended position.

Description

RETRACTABLE SLEEVE FOR PEN NEEDLE ASSEMBLY

Cross-Reference to Related Application

[001] This application claims the benefit of and priority to U.S. Provisional Application No. 63/225,106, filed July 23, 2021, and the content of this application is hereby incorporated herein by reference in its entirety.

Field

[002] The present disclosure is directed to medical devices for inj ecting a medication to a patient. The device can be a pen needle including a needle hub, which can have a patient-contacting surface or skin shaping surface, at least one sleeve covering a cannula or the needle, and an outer cover. The pen needle hub can be installed on a medication pen to administer medications to the patient.

Background

[003] A medication pen for delivering self-administered medications generally includes a pen body, which houses a medication compartment, and a separate pen needle which may 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 some cases, 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 current 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 having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub received in the axial passage and coupled to the housing, the needle hub having a needle with a distal end extending from the distal end of the needle hub for introducing a medication to a patient, and a proximal end extending from a proximal end of the needle hub for piercing a septum of a delivery device; a distal needle shield received in the housing and being movable between a retracted position to expose the distal end of the needle and an extended position to cover the distal end of the needle; a proximal needle shield received in the housing and being movable between a retracted position to expose the proximal end of the needle and an extended position to cover the proximal end of the needle; and a spring extending between the distal needle shield and the proximal needle shield to bias the distal needle shield and the proximal needle shield to the respective extended position, wherein the distal needle shield and proximal needle shield are lockable in the extended position.

[009] In some embodiments, the present disclosure relates to a pen needle, further including: a distal traveler received in the housing and movable from a first position where the distal needle shield can move from the extended position to the retracted position, and a second position where the distal needle shield is locked in the extended position; and a proximal traveler received in the housing and movable from a first position where the proximal needle shield can move from the extended position to the retracted position, and a second position where the proximal needle shield is locked in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein: the distal needle shield couples to the distal traveler when moved to the retracted position where the distal needle shield carries the distal traveler to the extended position where the distal traveler locks with the housing 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 has a coupling member for coupling with the distal traveler. In some embodiments, the present disclosure relates to a pen needle, wherein the coupling member for coupling with the distal traveler includes a flexible hook. In some embodiments, the present disclosure relates to a pen needle, wherein the distal traveler has a body with an axially extending member that is visible through an opening in the housing when the distal traveler is in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the distal traveler has a flexible latching member received in an opening in the housing to lock the distal traveler and distal needle shield in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield couples to the proximal traveler when moved to the retracted position where the proximal needle shield carries the proximal traveler to the extended position where the proximal traveler locks with the housing to lock the proximal needle shield in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield includes at least one axially extending member that projects through an opening in the needle hub a distance to protect the proximal end of the needle. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield includes a hook for coupling to the proximal traveler, and where the proximal traveler has a flexible latching member received in an opening in the housing when the proximal traveler is in extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal traveler has a body with at least one axially extending member that is visible through an opening in the housing when the proximal traveler in in the extended position.

[0010] The present disclosure relates to a pen needle including: a housing having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub having a body with a post extending distally from the body, and at least one opening extending axially through the body, and a needle with a distal end extending from a distal end of the post for introducing a medication to a patient, and a proximal end extending from a proximal end of the needle hub for penetrating a septum of a delivery device; a distal needle shield having an axial passage for sliding on the post between a retracted position to expose the distal end of the needle and an extended position to cover the distal end of the needle; and a proximal needle shield having an axial passage for sliding on the post between a retracted position to expose the proximal end of the needle and an extended position to cover the proximal end of the needle; a spring on the post and extending between the distal needle shield and the proximal needle shield to bias the distal needle shield and the proximal needle shield to the respective extended position, wherein the distal needle shield and the proximal needle shield are lockable in the extended position.

[0011] In some embodiments, the present disclosure relates to a pen needle, further including: a distal traveler received in the housing and movable from a first position where the distal needle shield can move from the extended position to the retracted position, and a second position where the distal needle shield is locked in the extended position; and a second traveler received in the housing and movable from a first position where the proximal needle shield can move from the extended position to the retracted position, and a second position where the proximal needle shield is locked in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the distal needle shield couples to the distal traveler when moved to the retracted position where the distal needle shield carries the distal traveler to the extended position where the distal traveler locks with the housing 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 has a coupling member for coupling with the distal traveler. In some embodiments, the present disclosure relates to a pen needle, wherein the coupling member for coupling with the distal traveler includes a flexible hook. In some embodiments, the present disclosure relates to a pen needle, wherein the distal traveler has a body with an axially extending member that is visible through an opening in the housing when the distal traveler is in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the distal traveler has a flexible latching member received in an opening in the housing to lock the distal traveler and distal needle shield in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield couples to the second traveler when moved to the retracted position where the proximal needle shield carries the second traveler to the extended position where the second traveler locks with the housing to lock the proximal needle shield in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield includes at least one axially extending member that projects through an opening in the needle hub a distance to protect the proximal end of the needle. In some embodiments, the present disclosure relates to a pen needle, wherein the proximal needle shield includes a hook for coupling to the second traveler, and where the second traveler has a flexible latching member received in an opening in the housing when the second traveler is in the extended position. In some embodiments, the present disclosure relates to a pen needle, wherein the second traveler has a body with at least one axially extending member that is visible through an opening in the housing when the second traveler is in the extended position.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] 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. [0013] Fig. 1 is a perspective view a pen needle assembly according to one embodiment;

[0014] Fig. 2 is a perspective view of the pen needle assembly of Fig. 1 in the ready position with the outer cover removed;

[0015] Fig. 3 is a perspective view of the pen needle assembly in the deployed position;

[0016] Fig. 4 is a cross sectional view of the pen needle showing the needle shields in the activated position;

[0017] Fig. 5 is a cross sectional view of the pen needle showing the needle shields in the activated position;

[0018] Fig. 6 is an explode view of the pen needle assembly;

[0019] Fig. 7 is a perspective view of the needle hub;

[0020] Fig. 8 is a cross sectional view of the needle hub;

[0021] Fig. 9 is an end view of the needle hub;

[0022] Fig. 10 is a perspective view of the housing shell;

[0023] Fig. 11 is a front perspective view of the housing shell;

[0024] Fig. 12 is a front view of the housing shell;

[0025] Fig. 13 is side view of the housing shell;

[0026] Fig. 14 is a rear view of the shell housing;

[0027] Fig. 15 is a top perspective view of the needle shield;

[0028] Fig. 16 is a bottom perspective view of the needle shield;

[0029] Fig. 17 is a side view of the needle shield;

[0030] Fig. 18 is a cross sectional side view of the needle shield;

[0031] Fig. 19 is a perspective view of the traveler;

[0032] Fig. 20 is an elevational view of the traveler;

[0033] Fig. 21 is a side view of the traveler;

[0034] Fig. 22 is a rear view of the traveler;

[0035] Fig. 23 is perspective view of the sleeve;

[0036] Fig. 24 is a side view of the sleeve; and [0037] Fig. 25 is a cross sectional view of the sleeve.

[0038] 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

[0039] The present disclosure is directed to a medical device such as an injection device. The injection device can be a pen needle hub assembly for coupling to an injection pen or other delivery device.

[0040] The needle hub in one embodiment has a needle or cannula extending from a distal end of the hub with a retractable shield covering the needle or cannula that can be retracted to expose the distal end of the cannula for introducing the medication to the patient. The cannula can have a proximal end for piercing a septum on the injection pen where the proximal end is covered by a retractable shield on the needle hub that retracts when the needle hub is attached to the injection pen.

[0041] The pen needle in one embodiment includes needle hub, at least one sleeve covering at least a portion of the cannula, and an outer cover enclosing the needle hub and the sleeve. A seal or closure can be attached to an open end of the outer cover to enclose the needle hub and maintain the sterile condition until ready for use.

[0042] The pen needle hub assembly in one embodiment has a needle hub with a needle or cannula, a sleeve that fits over or on a portion of the needle hub to enclose the cannula. An outer cover can be included that fits over the sleeve and needle hub. A peel tab can be attached to the open end of the outer cover for closing the open end of the outer cover. The cannula may have a patient end formed by a first end of the cannula extending distally from the hub. A retractable sleeve may enclose the patient end of the needle and be coupled to the needle hub. The retractable sleeve may be positioned against the skin of the patient at the injection site where the insertion force causes the cannula to pass through the sleeve as the cannula penetrates the skin of the patient. [0043] Another feature of the needle hub may include a body with a post extending in a distal direction and supporting a spring that biases a distal needle shield and a proximal needle shield to extended positions to cover the ends of the needle. In one embodiment, a first traveler slides on the post for engaging the distal needle shield and locking in an extended position. A second traveler may slide on the post for engaging the proximal needle shield and locking in an extended position.

[0044] The pen needle assembly may include a housing with an axial passage for receiving distal needle shield and a proximal needle shield, a needle hub and a spring for biasing the needle shields. The housing can be formed in two halves that are the same or substantially the same that snap together to form the housing. [0045] The housing may have an open distal end and an open proximal end for the respective needle shield. The housing may have a distal opening for receiving a locking component when the distal needle shield is in the locked position providing an indication that the distal needle shield is in the locked position. The housing can have a proximal opening for receiving a locking component when the proximal needle shield in the locked position providing an indication that the proximal needle shield is in the locked position.

[0046] The features of the pen needle can be attained by providing a housing having an axial passage with a proximal end having an opening and a distal end having an opening, a needle hub received in the axial passage and coupled to the housing. The needle hub may have a needle with a distal end extending from the distal end of the needle hub for introducing a medication to a patient, and a proximal end extending from a proximal end of the needle hub for piercing a septum of a delivery device. A distal needle shield may be received in the housing and be movable between a retracted position to expose the distal end of the needle and an extended position to cover the distal end of the needle. A proximal needle shield may be received in the housing and be movable between a retracted position to expose the proximal end of the needle and an extended position to cover the proximal end of the needle. A spring may extend between the distal needle shield and the proximal needle shield to bias the distal needle shield and the proximal needle shield to the respective extended position. A first traveler may be received in the housing and be movable from a first position where the distal needle shield can move from the extended position to the retracted position, and a second position where the distal needle shield is locked in the extended position. A second traveler may be received in the housing and be movable from a first position where the proximal needle shield can move from the extended position to the retracted position, and a second position where the proximal needle shield is locked in the extended position.

[0047] The pen needle in various embodiments can have a convex distal axial surface for shaping the axial face of the sleeve and shape the indentation of the surface of the skin during needle insertion and drug delivery. The needle hub can have an axial face with a surface area of about 5- 50 mm². 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.

[0048] The pen needle can have a convex surface with a height of about 0.5 to 6.0 mm and a cannula with a length of about 4-10 mm and typically about 5-6 mm proj ecting from the hub. The convex surface can have a radius of curvature of about 5.0 to 8.0 mm. The cannula can be located in the center of the surface so that the surface surrounds the cannula. In one embodiment, the convex surface can have a height of at least about 0.5 and typically at least about 1.0 mm relative to the outer edge of the hub and width of about 5.0 to 7.0 mm to provide sufficient surface area and a suitable shape and angle with respect to the axis of the cannula to shape the end surface of the sleeve and the skin and provide the controlled depth of penetration by the cannula into the skin. In one embodiment, the cannula can have a length of about 4.2 mm.

[0049] It will be understood that each of the preferred or optional features of the various embodiments may 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.

[0050] These and other features of the present concept will become apparent from the following detailed description of the concept, which in conjunction with the drawings disclose various embodiments of the present concept.

[0051] A medication pen or delivery device is used herein to refer to a device having a medication compartment, typically containing multiple doses of medication, and a separate pen needle. The phrase “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 injection site, and the “proximal” direction is the opposite direction. “Axial” means along or parallel to the longitudinal axis of the needle and the “radial” direction is a direction perpendicular to the axial direction.

[0052] 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.

[0053] 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.

[0054] In some embodiments, the delivery device may be a pen needle delivery device, which may comprise a dose knob/button, a body and a cap. The body may include a threaded end for coupling with pen needle hub. A dose knob/button allows a user to set the dosage of medication to be injected. The body may be gripped by the user when injecting medication. The cap may 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.

[0055] In standard pen needle devices, the dosing and delivery mechanisms are found within the body and are not described in greater detail here as they are understood by those knowledgeable of the art. A medicament cartridge may be attached to a standard pen injector housing by 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 may be sealed by a septum and punctured by a septum penetrating needle cannula located within a reservoir or housing. A reservoir housing may be screwed onto the medicament cartridge, although other attachment mechanism can be used. 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 can be a double-ended cannula beveled and sharpened at both ends for coupling to the pen needle assembly and for penetrating the skin of the patient. The cannula has a lumen with a diameter sufficient to inject the medication into the patient.

[0056] A pen needle assembly 10 and pen needle 12 are discussed with reference to FIGS. 1-25. Fig. 1 is a perspective view a pen needle assembly according to one embodiment. Fig. 2 is a perspective view of a pen needle, in a ready position, of the pen needle assembly of Fig. 1. Fig. 3 is a perspective view of the pen needle in a deployed position. Figs. 4 and 5 are a cross sectional views of the pen needle showing needle shields in an activated position. Fig. 6 is an exploded view of the pen needle assembly. Fig. 7 is a perspective view of a needle hub. Fig. 8 is a cross sectional view of the needle hub. Fig. 9 is an end view of the needle hub. Fig. 10 is a perspective view of a housing shell. Fig. 11 is a front perspective view of the housing shell. Fig. 12 is a front view of the housing shell. Fig. 13 is side view of the housing shell. Fig. 14 is a rear view of the housing shell. Fig. 15 is atop perspective view of the needle shield. Fig. 16 is a bottom perspective view of the needle shield. Fig. 17 is a side view of the needle shield. Fig. 18 is a cross sectional side view of the needle shield. Fig. 19 is a perspective view of a traveler. Fig. 20 is an elevational view of the traveler. Fig. 21 is a side view of the traveler. Fig. 22 is a rear view of the traveler. Fig. 23 is perspective view of a sleeve. Fig. 24 is a side view of the sleeve. Fig. 25 is a cross sectional view of the sleeve.

[0057] Reference is now made with respect to FIGS. 1 and 2. The pen needle assembly 10 as shown in the drawings includes the pen needle 12 received in an outer cover 14 having an open end. The outer cover 14 has a tab 16 for closing the open end to maintain the sterility of the pen needle.

[0058] Reference is now made with respect to FIGS. 2-6. The pen needle 12 in the embodiment shown includes a housing 18, a needle hub 20, a distal needle shield 68 and a proximal needle shield 70. The distal needle shield 68 includes a sleeve 26 forming a skin contact surface during use. A distal traveler 94 is oriented to engage the distal needle shield 68. A proximal traveler 95 is oriented to engage the proximal needle shield 70. A spring 134 extends between the needle shields 68, 70 to bias the needle shields 68, 70 to an extended position. The housing 18 in the embodiment shown is formed from a clamshell structure having two housing halves 28. The housing halves 28 are symmetrical and identical for convenience of manufacture.

[0059] The housing 18 is now described with reference to FIGS. 10-14. The housing halves 28 shown in Figs. 10-14 have a semi-circular shape that snap together to form the cylindrical shaped housing 18 (FIGS. 2-5). The housing halves 28 have latching tabs 30 on each side edge that are connected to a complementing tab 32. In the embodiment shown, the housing halves 28 are formed with two latching tabs 30 on a first side edge and a single latching tab 30 on the opposite side edge. The complementing tabs 32 are formed between the two latching tabs 30 on the first side edge and on each side of the single latching tab 30 on the opposite side. The assembled housing 18 as shown in Figs. 2 and 3-4 has a substantially cylindrical shape with a distal end 34 having an opening and a proximal end 36 having an opening. The latching tabs 30 have an inwardly projecting hook portion that snaps into a complementing tab 32 of the opposing housing half 28. [0060] Referring to FIGS. 2-4, the distal end 34 of the housing 18 has a collar 38 forming the opening and an inner ledge 40. The proximal end 36 of the housing has a collar 42 forming an inner ledge. As shown in Figs. 11 and 12, the inner surface of the housing has axially extending ribs 46 on opposite side of the cavity formed in the housing 18.

[0061] Referring now to FIGS. 7-9, the needle hub 20 includes a body 50 with a substantially flat top surface having a distally extending post 52. In the embodiment shown, the post 52 has flat surfaces on opposite sides. The body 50 has a cylindrical shape to fit within the proximal end 36 of the housing 18 (FIGS. 3 and 4). The body 50 in the embodiment shown includes lugs 54 projecting radially outward from opposite sides of the body 50. The lugs 54 have a shape and dimension to fit in the respective recess or opening 56 (FIGS. 11 and 12) in the housing 18 (FIGS. 2-4) to couple the hub 20 to the housing 18 and prevent axial and rotational movement relative to the housing 18. The body 50 further includes an open proximal end with internal threads 58 for coupling with the delivery device. The post 52 has an axial passage 60 for receiving and supporting the needle or cannula 62 (FIGS. 4 and 5).

[0062] Referring now to FIGS. 4, 5, and 7-9, the needle or cannula 62 as shown is a double ended cannula secured in the axial passage 60 of the post 52. The cannula 62 has a distal end portion 64 extending from the distal end of the post 52 a distance to provide a desired depth of penetration into the patient, as shown in Figs. 4 and 5. The exposed length of the distal end portion 64 extending from the distal end of the post 52 and housing 18 can have a length of about 4-10 mm and generally about 4-6 mm. The exposed length of the distal end portion 64 of the cannula 62 can be selected to provide a selected depth of penetration of the cannula 62. The cannula 62 terminates at a sharpened tip at a distal end. The distal end portion 64 of the cannula 62 forms the patient end of the cannula 62.

[0063] Still referring to FIGS. 4, 5, and 7-9, the cannula 62 has a proximal end portion 66 terminating at a sharpened proximal tip. The proximal end portion 66 extends from the post 52 and body 50 a distance for piercing the septum of the delivery device. The proximal end portion 66 of the cannula 62 forms a non-patient end of the cannula 62. Although a single cannula 62 is shown having the opposite ends with a sharpened tip, separate needles or cannulas can be mounted on the needle hub 20 to form the patient end and the non-patient end.

[0064] Referring now to FIGS. 4-6 and 15-18, the pen needle 12 includes within the housing 18 a distal needle shield 68 and a proximal needle shield 70 that are movable axially relative to the housing 18 between an extended position covering the ends of the cannula 62 to a retracted position to expose the ends of the cannula 62. The distal needle shield 68 is configured and positioned in the distal end of the housing 18 to cover the distal end of the cannula 62. The proximal needle shield 70 is configured and positioned in the proximal end of the housing 18 to cover the proximal end of the cannula 62. The distal needle shield 68 and the proximal needle shield 70 may have the same shape and configuration for ease of manufacture. The needle shields 68, 70 have a shape and configuration to move or slide axially in the housing 18 to move between an extended position covering the respective end of the cannula 62 and a retracted position to expose the end of the cannula 62.

[0065] The features of the distal needle shield 68 and the proximal needle shield 70 are described herein using the same reference numbers since the elements are the same. Figs. 15-18 depict the distal needle shield 68. It should be appreciated that the same description may apply to the proximal needle shield 70.

[0066] Still referring to FIGS. 4-6 and 15-18, the distal needle shield 68 includes a body 72 having a top face 74 and a bottom face 76. The distal needle shield 68 may be made of a plastic material that is able to retain the shape while allowing some flexibility of the parts. The top face 74 includes a collar 78 extending in an axial direction with an axial passage 80 having a configuration complementing the outer dimension and shape of the post 52 of the hub 20 (FIGS. 7 and 8). The axial passage 80 has flat surfaces to complement the flat surfaces of the post 52. The post 52 has a length to extend between the distal end and proximal end of the housing 18 for supporting the needle shields 68, 70. The post 52 extends through the axial passage 80 of the needle shields 68, 70 so that the needle shields 68, 70 can slide axially relative to the post 52 and the housing 18. The flat surfaces of the needle shields 68, 70 and the post 52 prevent the rotation of the needle shields 68, 70 relative to the post 52 while allowing axial movement of the needle shields 68, 70. [0067] The top face 74 of the body 72 also include a coupling and latching member 82. The coupling member 82 in the embodiment shown includes a flexible leg 84 having an outwardly projecting hook 86. The legs 84 are sufficiently flexible to bend radially inwardly relative to the body 72 and spring back to the original configuration. The hook 86 has a substantially flat bottom surface 88 facing the body 72 and an inclined top surface 90. The bottom face 76 includes legs 92 forming shield members extending axially from the body 72. In the embodiment shown, two legs 92 forming the shield members are provided on opposite sides of the opening formed by the axial passage 80. The legs 92 have a length and width to extend a distance to cover and protect the end of the cannula 62 during use. The legs 92 are spaced apart a distance to allow the needle shield 68 to move axially over the cannula 62. In the embodiment shown, the legs 92 have flat outer surfaces. The outer surface of the body 72 has a recess 73 between the latching members 82 for sliding in respective guides or ribs 46 (FIGS. 10-12) on the inner surface of the housing 18. [0068] The distal needle shield 68 and the proximal needle shield 70 are associated with a complementing distal traveler 94 and a proximal traveler 95, respectively, for locking the respective needle shield 68, 70 in the extended position when deployed. Referring now to FIGS. 19-22, the distal traveler 94 is depicted. While only the distal traveler 94 is depicted and discussed, it should be appreciated that the same description may apply to the proximal traveler 95. The distal traveler 94 as shown Figs. 19-22 has a shape and figuration to fit within the housing 18 (FIGS. 2-

5) and slide axially within the axial passage of the housing 18 (FIGS. 2-5). The distal traveler 94 includes a body 96 having a semi-circular configuration forming an axial passage for receiving the post 52 (FIGS. 7 and 8) and moving axially relative to the post 52 (FIGS. 7 and 8). The body 96 has a bottom end 98 with axially extending legs 100 formed on opposite sides of the body 96. The legs 100 also have a curved shape corresponding to the curvature of the body 96. The legs 100 are spaced radially outward from the body 96 as shown in Fig. 19. The distal traveler 94 and the proximal traveler 95 are configured to slide within the housing 18 (FIGS. 2-5) and slide axially independently of the other. The distal traveler 94 and the proximal traveler 95 are configured to fit on opposite sides of the housing 18 (FIGS. 2-5) and the post 52 (FIG. 5) to move or slide axially without interference from one another.

[0069] Still referring to FIGS. 19-22, the body 96 includes two longitudinally extending ribs 102 that proj ect radially outward and form a recess 104 between the ribs 102. The recess 104 is formed with a top edge 106 in the traveler body 96 with a dimension for mating with the hooks 86 (FIGS. 15-18) of the distal needle shield 68 (FIGS. 15-18). Axially extending latching members 107 are provided at each side edge of the body 96. The latching members 107 are flexible to bend inwardly by a biasing force and spring back to the original shape and configuration. The latching members 107 have a distal end with an outwardly extending hook 110 formed by a flat top surface 112 and an inclined bottom surface 114. The distal traveler 94 is oriented relative to the distal needle shield 68 (FIGS. 4-6) where the legs 100 extend toward the distal needle shield 68 (FIGS. 4-6) and toward the distal end of the housing 18 (FIG. 5). The axially extending latching members 107 project toward the proximal end of the housing 18 (FIG. 5). The proximal traveler 95 (FIG.

6) is oriented relative to the proximal needle shield 70 (FIGS. 4-6) where the legs 100 of the proximal traveler 95 extend toward the proximal end of the housing 18 (FIG. 5). The axially extending latching members 107 of the proximal traveler 95 project toward the end of the distal end of the housing 18 (FIG. 5).

[0070] Referring now to FIGS. 23-25, the sleeve 26 is depicted. The sleeve 26 has a shape and configuration to slide within the open distal end of the housing 18 (FIG. 2) between the extended position shown in Fig. 2 to a retracted position during use. As shown in Fig. 5, the sleeve 26 has a length sufficient to cover the distal end of the cannula 62 in the extended position. The sleeve 26 has a cylindrical body with a side wall 116, an end wall 118 and an open bottom end 120 having an outwardly extending flange 122 for mating with the inner surface of the housing 18 as shown in Fig. 5 for retaining the sleeve 26 in the housing 18. The end wall 118 forms a skin contact surface for the device to control the depth of penetration of the cannula 62 (FIG. 5). The end wall 118 includes a central opening 124 for the cannula 62 (FIG. 5). The side wall 116 has an open proximal end to receive the legs 92 (FIGS. 15-18) of the distal needle shield 68 as shown in Fig. 4.

[0071] Still referring to FIGS. 23-25, the outer face of the end wall 118 of the sleeve 26 in the embodiment shown has a substantially convex or conical shape forming a continuous and uniform curvature extending from the outer edge of end wall 118 of the sleeve 26 to the distal end or outermost portion at the center of the sleeve 26 so that the surface has a substantially convex, semispherical, or dome shape. In the embodiment shown, the outer face of the end wall 118 is formed with an inner ring 126 around the opening 124, an outer ring 128 spaced radially outward from the inner ring 126 and an annular recess 130 between the inner ring 126 and outer ring 128. The annular recess 130 has a bottom surface with a radius of curvature corresponding to the radius of curvature of the axial face of the outer ring 128. As shown in Fig. 25, the inner ring 126 is spaced axially outward from the outer ring 128.

[0072] Referring now to FIGS. 7-9 and 23-25, the convex surface of the axial face of the post 52 for deforming the surface of the skin when pressed against the skin can have a width or diameter of greater than 3.0 mm and typically about 5.0 to 8.0 mm and a height of about 0.5 to about 1.5 mm measured from the outer peripheral edge of the surface to the outermost center portion of the surface surrounding the cannula 62 (FIGS. 4 and 5) and spaced axially from the peripheral edge. In another embodiment, the convex surface has a radius of curvature of about 5.0 to 8.0 mm. In one embodiment the convex surface has a height of about 1.0 mm and a diameter of about 7.0 mm. The convex surface can have a radius of curvature of 6.0 to 16.0 mm. In various embodiments, the convex surface has radius of curvature of 6.0 to 9.0 mm. In other embodiments, the convex surface can have a radius of curvature of 6.0 to 7.0 mm. In one embodiment, the convex surface has a radius of curvature equal to or greater than the diameter of the surface. The radius curvature can be about 1 to 1 1/2 times the diameter of the convex surface.

[0073] The ratio of the diameter (D) to the height (H) of the surface influences the depth of penetration of the cannula 62 (FIGS. 4 and 5) on insertion into the skin. Generally, the larger the ratio provides more surface area of the sleeve 26 that will contact the skin and provide greater control of the depth of penetration. A smaller ratio D:H provides a smaller surface area that can compress the skin on insertion and result in a deeper penetration of the cannula 62 (FIGS. 4 and 5). In certain embodiments, the ratio of the diameter to the height of the surface area can range from about 2:1 to 10:1. In other embodiments the ratio can range from about 5:1 to 8:1. The shape and contour of the axial face of the post 52 controls the shape and contour of the end wall 118 of the sleeve 26 when pressed against the surface of the skin.

[0074] Referring now to FIGS. 2-6, the assembly and operation of the pend needly 12 will be discussed. The pen needle 12 is assembled where the two halves 28 are snapped together to form the housing 18. The sleeve 26 is positioned over the distal end of the distal needle shield 68 and oriented within the housing 18 where the sleeve 26 and the distal needle shield 68 extend through the distal opening of the housing 18. Fig. 4 shows the ready position of the distal needle shield 68. As shown in Fig. 4, the distal end of the cannula 62 extends past the distal end of the distal needle shield 68 and is enclosed within the sleeve 26 to protect the needle and prevent inadvertent needle stick. The distal traveler 94 as shown in Fig. 5 is spaced proximally of the distal needle shield 68. The distal traveler 94 is retained in the ready position as shown in Fig. 5 where the hook 110 of the traveler is received in a recess 138 or opening in the wall of the housing 18. [0075] The proximal needle shield 70 is positioned as shown in Fig. 4 where the two legs 92 extend through openings 132 (FIGS. 7 and 9) in the body 50 (FIGS. 7-9) of the needle hub 20 on opposite sides of the cannula 62. As shown, the legs 92 have an axial length to extend over the proximal end of the cannula 62 to protect the cannula 62. As shown in Figs. 5 and 6 a biasing member is included to bias the needle shields 68, 70 axially outward. In the embodiment shown, the biasing member is a coil spring 134 extending between the distal needle shield 68 and the proximal needle shield 70. The spring 134 is mounted on the post 52 and the needle shields 68, 70 slide on the post 52 between the extended position shown in Figs. 4 and 5 and a retracted position. The proximal traveler 95 is positioned distally from the proximal needle shield 70 in the ready position.

[0076] Still referring to FIGS. 2-6, during use of the pen needle 12, the hub 20 is coupled to the delivery device by threading the hub 20 onto the threaded end of the delivery device. The axial movement of the pen needle 12 relative to the delivery device acts against the spring forces of the proximal needle shield 70, causing the proximal needle shield 70 to retract to expose the proximal end of the cannula 62 so that the cannula 62 pierces the septum of the delivery device to provide fluid communication between the pen needle 12 and the delivery device. The axial movement of the proximal needle shield 70 in the distal direction moves the hook 86 (FIGS. 15-18) of the proximal needle shield 70 into engagement with the top edge 106 (FIGS. 19-22) of the proximal traveler 95 where at least one hook 86 (FIGS. 15-18) couples with the proximal traveler 95. The pen needle 12, when coupled to the delivery device, and when fluid communication between the delivery device and the pen needle 12 is established, is ready for use.

[0077] During use, the sleeve 26 is pressed against the surface of the injection site to retract the sleeve 26 and the distal needle shield 68 against the force of the spring. The sleeve 26 and distal needle shield 68 retract to expose the distal end of the cannula 62 where the cannula 62 penetrates the skin and the delivery device can dispense the medication. In the retracted position of the distal needle shield 68, the hook 86 (FIGS. 15-18) of the distal needle shield 68 engages the top edge 106 (FIGS. 19-22) of the distal traveler 94 to couple the distal needle shield 68 to the distal traveler 94. After the medication is delivered to the patient, the cannula 62 is withdrawn from the skin where the spring 134 biases the distal needle shield 68 and the sleeve 26 to the extended position. The distal needle shield 68, being coupled to the distal traveler 94, carries the distal traveler 94 in a distal direction where the hook 110 of the distal traveler 94 engages a recess 136 or opening in the wall of the housing 18 to lock the distal traveler 94 in the extended position. By locking the distal traveler 94, the distal needle shield 68 and the sleeve 26 are locked in the extended position to cover the distal end of the cannula 62 and prevent re-use of the pen needle 12. The legs 100 of the body 96 (FIGS. 19-22) of the distal traveler 94 have an axial length so that the legs 100 are visible through an axial opening 140, as shown in FIG. 3, so that the distal traveler 94 is visible to the user to provide an indication that the pen needle 12 is deployed and locked to prevent re-use. In one embodiment, the legs 100 have a length to project from the axial opening 140.

[0078] The pen needle 12 is then separated from the delivery device where the spring 134 biases the proximal needle shield 70 to the extended position to cover the proximal end of the cannula 62. The proximal needle shield 70 couples to the proximal traveler 95 to slide the proximal traveler 95 to the proximal position where the hook 110 (FIGS. 19, 20, 22) of the proximal traveler 95 engages a recess 138 or opening in the housing 18 to lock the proximal traveler 95 and the proximal needle shield 70 in the extended position to prevent re-use of the pen needle 12. The legs 100 (FIGS. 19-22) of the body 96 (FIGS. 19-22) have a length to be visible through the axial opening 142 when deployed to provide an indication that the proximal needle shield 70 is in the locked position. In one embodiment, the legs 100 (FIGS. 19-22) of the body 96 (FIGS. 19-22) of the proximal needle shield 170 have a length to proj ect from the axial opening 142 when deployed. [0079] The above description of the preferred embodiments is not to be deemed as limiting the disclosure, which is defined by the appended claims. The disclosure is intended to enable the artisan of ordinary skill to practice variants of the present concept 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 having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub received in the axial passage and coupled to the housing, the needle hub having a needle with a distal end extending from the distal end of the needle hub for introducing a medication to a patient, and a proximal end extending from a proximal end of the needle hub for piercing a septum of a delivery device; a distal needle shield received in the housing and being movable between a retracted position to expose the distal end of the needle and an extended position to cover the distal end of the needle; a proximal needle shield received in the housing and being movable between a retracted position to expose the proximal end of the needle and an extended position to cover the proximal end of the needle; and a spring extending between the distal needle shield and the proximal needle shield to bias the distal needle shield and the proximal needle shield to the respective extended position, wherein the distal needle shield and proximal needle shield are lockable in the extended position.

2. The pen needle of claim 1, further comprising: a distal traveler received in the housing and movable from a first position where the distal needle shield can move from the extended position to the retracted position, and a second position where the distal needle shield is locked in the extended position; and a proximal traveler received in the housing and movable from a first position where the proximal needle shield can move from the extended position to the retracted position, and a second position where the proximal needle shield is locked in the extended position.

3. The pen needle of claim 2, wherein: the distal needle shield couples to the distal traveler when moved to the retracted position where the distal needle shield carries the distal traveler to the extended position where the distal traveler locks with the housing to lock the distal needle shield in the extended position.

4. The pen needle of claim 3, wherein the distal needle shield has a coupling member for coupling with the distal traveler.

5. The pen needle of claim 4, wherein the coupling member for coupling with the distal traveler comprises a flexible hook.

6. The pen needle of claim 3, wherein the distal traveler has a body with an axially extending member that is visible through an opening in the housing when the distal traveler is in the extended position.

7. The pen needle of claim 6, wherein the distal traveler has a flexible latching member received in an opening in the housing to lock the distal traveler and distal needle shield in the extended position.

8. The pen needle of any one of claims 2-7, wherein the proximal needle shield couples to the proximal traveler when moved to the retracted position where the proximal needle shield carries the proximal traveler to the extended position where the proximal traveler locks with the housing to lock the proximal needle shield in the extended position.

9. The pen needle of claim 8, wherein the proximal needle shield includes at least one axially extending member that projects through an opening in the needle hub a distance to protect the proximal end of the needle.

10. The pen needle of claim 9, wherein the proximal needle shield includes a hook for coupling to the proximal traveler, and where the proximal traveler has a flexible latching member received in an opening in the housing when the proximal traveler is in extended position.

11. The pen needle of claim 10, wherein the proximal traveler has a body with at least one axially extending member that is visible through an opening in the housing when the proximal traveler in in the extended position.

12. A pen needle comprising: a housing having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub having a body with a post extending distally from the body, and at least one opening extending axially through the body, and a needle with a distal end extending from a distal end of the post for introducing a medication to a patient, and a proximal end extending from a proximal end of the needle hub for penetrating a septum of a delivery device; a distal needle shield having an axial passage for sliding on the post between a retracted position to expose the distal end of the needle and an extended position to cover the distal end of the needle; and a proximal needle shield having an axial passage for sliding on the post between a retracted position to expose the proximal end of the needle and an extended position to cover the proximal end of the needle; a spring on the post and extending between the distal needle shield and the proximal needle shield to bias the distal needle shield and the proximal needle shield to the respective extended position, wherein the distal needle shield and the proximal needle shield are lockable in the extended position.

13. The pen needle of claim 12, further comprising: a distal traveler received in the housing and movable from a first position where the distal needle shield can move from the extended position to the retracted position, and a second position where the distal needle shield is locked in the extended position; and a second traveler received in the housing and movable from a first position where the proximal needle shield can move from the extended position to the retracted position, and a second position where the proximal needle shield is locked in the extended position.

14. The pen needle of claim 13, wherein the distal needle shield couples to the distal traveler when moved to the retracted position where the distal needle shield carries the distal traveler to the extended position where the distal traveler locks with the housing to lock the distal needle shield in the extended position.

15. The pen needle of claim 14, wherein the distal needle shield has a coupling member for coupling with the distal traveler.

16. The pen needle of claim 15, wherein the coupling member for coupling with the distal traveler comprises a flexible hook.

17. The pen needle of any one of claim 14-16, wherein the distal traveler has a body with an axially extending member that is visible through an opening in the housing when the distal traveler is in the extended position.

18. The pen needle of claim 17, wherein the distal traveler has a flexible latching member received in an opening in the housing to lock the distal traveler and distal needle shield in the extended position.

19. The pen needle of claim 13, wherein the proximal needle shield couples to the second traveler when moved to the retracted position where the proximal needle shield carries the second traveler to the extended position where the second traveler locks with the housing to lock the proximal needle shield in the extended position.

20. The pen needle of claim 13, wherein the proximal needle shield includes at least one axially extending member that projects through an opening in the needle hub a distance to protect the proximal end of the needle.

21. The pen needle of claim 19, wherein the proximal needle shield includes a hook for coupling to the second traveler, and where the second traveler has a flexible latching member received in an opening in the housing when the second traveler is in the extended position.

22. The pen needle of any one of claims 19-21, wherein the second traveler has a body with at least one axially extending member that is visible through an opening in the housing when the second traveler is in the extended position.