Patent ID: 12257423

The figures are not to scale, and some features are omitted in certain views to better illustrate other features.

DETAILED DESCRIPTION

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 is 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” refers to arranging 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.

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 thin tubular member having 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.

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. 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 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, tens 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.

Referring to the drawings, a pen needle10includes a needle hub12. A cover can be included that fits over the pen needle10during storage and assists in attaching the pen needle10to a delivery device, such as a delivery pen2shown inFIG.1. A closure or peel tab is generally provided over the open end of the cover to maintain the needle hub12is a sterile condition until ready for use. The delivery pen can be a standard delivery pen or other medication delivery device as known in the art for dispending and delivering a medication, such as insulin. An example of a suitable delivery pen is disclosed in U.S. Pat. No. 9,774,844 which is hereby incorporated by reference for this purpose.

In the embodiment shown inFIGS.1-12, the pen needle10includes the hub12, and a first distal needle shield14at a distal end of the hub12. In one embodiment, a second proximal needle shield16is provided at a proximal end of the hub12. The hub12is configured for supporting the distal needle shield14and the proximal needle shield16. The hub can be a one piece unit or made from separate component that are coupled together. In the embodiment shown, the hub12includes a hub body34and a sleeve36connected by a suitable connection. The hub12includes an open bottom end18defining the proximal non-patient end20and a distal end22forming the patient end of the pen needle. The open bottom end18formed by the hub body has a side wall with internal threads24shown inFIG.3for coupling to the delivery pen in a known manner. The distal end22has an opening26for a needle28or cannula and defines the skin contact surface during use.

Needle28can be a hollow steel needle with a sharpened tip at a distal end at a proximal end and has a gauge and length for penetrating the skin to a desired depth and delivery of a medication to a patient. The needle28has patient end forming a distal end30with a sharpened tip extending from the distal end of the hub12for penetrating the skin of the patient. A proximal end32at the proximal end of the hub12is positioned for piercing a septum in the delivery device for receiving the drug or medication from the delivery device in a usual manner. The distal end30has an exposed length extending from the distal end of the hub during the injection of about 3-10 mm and typically about 4-6 mm.

Referring toFIG.3, the pen needle10includes the distal shield14and the proximal shield16for movement relative to the hub12and the needle28. In the drawings, certain structural features and elements are not shown in each figure for clarity of the other elements. It is understood that the pen needle includes each of the elements as shown inFIGS.1and2. The hub12can be a single member or can be formed as more than one member and coupled together by mechanical couplings, adhesives, welding and the like. In the embodiment shown inFIG.1, the hub12has a hub body34with a side wall having a substantially cylindrical shape for coupling with the delivery device. As show, the threads24are formed on an inner surface of the side wall of the hub body34. The hub12includes a housing shown as a sleeve36extending from the hub body34for receiving and supporting the components of the pen needle. The sleeve36in the embodiment shown has a proximal end38coupled to the top or distal end of the hub body34by tabs with hooks40although other method for coupling the sleeve36to the hub body34can be used. The sleeve36extends from the hub body34to form the distal end22of the hub12. The opening26is formed in the end of the sleeve36to receive the first distal needle shield14. The sleeve36has a length where the distal end30of the needle28extends from the distal end of the sleeve to define the exposed length of the needle during the injection.

Referring toFIGS.2-4, the hub body34has an end wall46at the top distal end that can mate with the sleeve36. The end wall46has a distal face with a post48extending in the distal direction. The post48has an axial passage50receiving and supporting the needle28as shown inFIG.3. The needle28is fixed to the post48by an adhesive in a usual manner. In the embodiment shown, the post48has a substantially cylindrical configuration with a substantially cylindrical outer surface52as shown inFIG.7. The distal end of the needle28projects from the post to extend distally from the pen needle a distance for penetrating the skin of the patient during an injection to a selected depth in the skin. The proximal end of the needle28extends within the hub body34a distance for connecting to a reservoir of the delivery device when the pen needle is attached to the delivery device.

The distal needle shield14forms a shield for the distal end30of the needle28to prevent re-use of the pen needle and prevent advertent needle stick before and after use. The distal needle shield14in the embodiment shown is configured for sliding within the open end of the hub12defined by the sleeve36between an extended position shown inFIG.3and a retracted position shown inFIG.6. In the embodiment shown, the distal needle shield14has an axial passage54and an axial length to retract a distance to exposed the distal end30of the needle28for injecting the patient and to cover the distal end of the needle28when moved to the extended position shown inFIG.7. The distal needle shield14has an outer wall56with a distal end58forming a skin contact surface. The distal needle shield has a proximal end with a coupling mechanism for coupling with the sleeve36. In one embodiment, the coupling mechanism is an outwardly extending tab60for contacting the inwardly extending lip62at the open end of the sleeve36. As shown inFIG.7, a plurality of spaced apart tabs60are included for contacting the lip62. The tabs60have a dimension for contacting the lip62to retain the distal needle shield14in the sleeve36when the distal needle shield14is in the extended position while allowing the needle shield14to slide between the retracted position and the extended position.

A biasing member is included for biasing the distal needle shield axially to the extended position. In the embodiment shown, the biasing member is a spring64positioned within the sleeve36of the hub12for biasing the needle shield14and the needle shield16outwardly in the axial direction to the respective extended positions. As shown inFIG.3, the spring64is a first end66engaging the needle shield14and a second end68engaging the needle shield16. The spring64is shown as a coil spring extending between the distal needle shield14and proximal shield16although other biasing members can be used for biasing needle shields to the extended position. In other embodiments, separate biasing members can be used to bias the distal needle shield and the proximal needle shield.

Referring toFIG.8, the inner surface of the sleeve36can include an inclined cam surface70formed at an incline with respect to the longitudinal axis of the sleeve. The inclined cam surface70is formed by a protrusion72projecting radially inward from the inner surface of the sleeve. The cam surface70is formed on a first leg74of the protrusion72. A second leg76extends in a substantially axial direction relative to the longitudinal axis of the sleeve36. As shown inFIG.8, a detent91on the needle shield14engages the cam surface70whereby moving the needle shield14axially inward causes the detent91to engage the inclined cam surface and rotate the needle shield14about the longitudinal axis of the pen needle.

As shown inFIG.8the inner surface of the sleeve36includes a guide channel78spaced circumferentially from the inclined cam surface70. In the embodiment shown, a guide channels78is formed on opposite sides of the inner surface of the sleeve36. The guide channel in the embodiment shown is formed between axially extending parallel ribs80. A stop member82is formed in the guide channel78and is provided with an inclined surface84facing the proximal end of the hub12. The stop member forms a recess86at the distal end portion of the guide channel78. As shown in the embodiment ofFIG.10, the recess86can be an opening extending thought wall of the sleeve36. In the embodiment shown, the guide channel78is formed by parallel ribs80. In other embodiments, the channel78can be an axially extending recess formed on the inner surface of the sleeve where the opening in the side wall forms the stop member.

As shown inFIG.8, the distal needle shield14includes a leg88forming a locking member for locking the needle shield14in a fixed position after use. The leg88extends axially from the proximal end of the distal needle shield14. The leg88includes an outwardly extending tab90. As shown inFIG.8, the tab90is positioned on an outer surface of the axial rib80of the sleeve36in the initial position before use of the pen needle. During use, the needle shield14is pressed against the skin of the patient to retract the needle shield14while the needle28pierces the skin the patient. The needle shield14moves axially from the extended position shown inFIG.3to the retracted position shown inFIG.6. As shown inFIG.8, the detent91of the distal needle shield14engages the inclined cam surface70causing rotation of the distal needle shield14so that the tab90slides from the position shown inFIG.8into the guide channel78indicated by arrows92so that the tab90slides within the guide channel78to the retracted position shown inFIG.6. The outer surface81of the rib80is formed at an incline to assist in guiding the tab90into the guide channel78by the rotational movement of the distal needle shield14relative to the hub. After the injection of the medication to the patient, the needle28is withdrawn from the patient whereby the distal needle shield14is biased to the extended position to cover the tip of the distal end of the needle28. The tab90slides in the guide channel78and over the inclined surface84of the stop member82and into the recess86. The stop member82has an inner face configured to contact the tab90and prevent the needle shield14from sliding to the retracted position after use of the pen needle. The tab90mates with the recess86to resist axial movement of the distal needle shield. In the embodiments where the recess in the guide channel78is an opening as inFIG.10, the tabs90are visible through the opening providing a visual indicator to the user that the distal needle shield in the extended locked position. The tabs90can have a contrasting color relative to a color of the shield36to enhance the visualization of the tab in the locked position.

Referring toFIGS.3-7, an indicator94can be positioned within the cavity of the hub12to provide a visual indication to the user or patient after use of the pen needle10. The indicator94can be visualized through the distal needle shield when the distal needle shield is in the extended position. In the embodiment shown, the indicator94is a substantially cylindrical shaped sleeve96having an annular sidewall. In one embodiment, the sleeve96has a contrasting color with respect to the other components of the needle or other visual indicia. The indicator sleeve96has a proximal end98with an inner dimension complementing the outer dimension of the post48. The indicator sleeve96fits on the post48by a friction fit to retain the sleeve96in position during manufacture and storage of the pen needle and to inhibit movement of the indicator sleeve until deployed. In the embodiment shown, the indicator94is surrounded by the spring64.

Referring toFIGS.3-7, in the embodiment shown, the distal needle shield14has an inner annular wall100defining the axial opening54of the needle shield14. The annular wall100is spaced radially inward and concentric with the outer wall56of the needle shield14. An annular recess102for receiving the spring64is formed between the outer wall56and the inner wall100. The annular wall100has an outer surface with a dimension complementing the inner dimension of the indicator sleeve96. The proximal end of the annular wall100has a chamfered surface or edge104for guiding the annular wall into the axial passage of the sleeve96. The outer surface of the annular wall100has a dimension to form a friction fit with the inner surface of the sleeve96for coupling the sleeve to the annular wall. The outer surface of the annular wall100forms a gripping friction fit with the sleeve96having a gripping force greater than the gripping force between the sleeve96and the post48so that the sleeve96is retained on the annular wall100and separates the sleeve from the post48so that the indicator is carried by the distal needle shield when the distal needle shield slides to the extended position.

The distal needle shield14in the embodiment shown can be sufficiently transparent or translucent so that the indicator sleeve96is visible to the patient through the outer wall of the distal needle shield when the sleeve96is positioned within the annular recess102as shown inFIG.10. The indicator sleeve96initially is oriented within the sleeve36of the hub body12and is not visible to the patient. Typically the sleeve36is opaque so that the indicator sleeve96is not visible. During use, the distal needle shield14is pressed against the skin of the patient to move the needle shield to the retracted position shown inFIG.6where the annular wall100slides into the axial passage of the indicator sleeve96. The gripping force between the distal needle shield14and the indicator sleeve96enables separation of the sleeve96from the post48as the needle shield14is biased to the extended position shown inFIG.7where the tab90of the distal needle shield is captured by the recess86to lock the distal needle shield after use. The sleeve96positioned in the annular recess102is visible through the outer wall56of the needle shield14providing a visible indication to the patient or user that the pen needle has been used and the needle shield14is deployed to the locked position.

The proximal needle shield16is positioned in the hub body34and includes a base106oriented between the end wall46and the open proximal end38. The base106has a central opening108for sliding around the proximal end of the needle28. Legs110extend from the base106through the openings109in the end wall46of the hub body in a distal direction to engage the proximal end of the spring46.

As shown inFIG.12, the flexible arm120has an end connected to the leg110and extends toward the base106. A detent forming a clip122projects inwardly from the arm120to engage a top surface of the end wall46of the hub body34. The clip122contacts the end wall46to retain the needle shield16in the retracted position against the force of the spring64. Referring toFIG.12, a frangible member112extends between the base106and a flexible arm120to retain the base106and the proximal needle shield16in the retracted position against the biasing force of the spring as shown inFIG.4andFIG.12. An outer distal end of the arm120has an inwardly extending tab124oriented on a bottom surface of the end wall46. The end of the tab124is formed with a frangible member112as shown inFIG.12. The distal face of the tab124forms an inclined cam surface126that engages the bottom surface of the end wall46. The delivery device is connected to the hub body34so that the end of the delivery device engages the base106and forces the base106toward the end wall46. The movement of the base106forces the cam surface126into contact with the edge of the opening109in the end wall46forcing the arm120outwardly and separating the clip122from the end wall46and breaking the frangible member112. The arm120is biased radially outward so that breaking the frangible member112spring the arm120radially outward to separate the clip122from the end wall46allowing the proximal needle shield to move to the extended position. When the delivery device separates from the hub body34, the spring biases the needle shield16to the extended position shown inFIG.7.

The legs110have a distal end with a stop member114for engaging the distal face of the wall of the hub body when the proximal needle shield16is deployed thereby limiting the distance the needle shield16travels when deployed. Flexible ribs116extend radially outward from the legs110. The base106of the proximal needle shield16is initially spaced from the wall of the hub body as shown inFIG.4. The hub body is attached to the delivery device by the threaded connection24so that the base106engages the end of the delivery device. Threading the hub body onto the delivery device compresses the base106toward the wall46of the hub body to break the frangible member112. After injecting the patient with the medication from the delivery device, the hub body is separated from the delivery device. The spring64biases the proximal needle shield toward the proximal end of the hub body to slide the base106over the proximal end of the needle as shown inFIG.8. The stop member114engages the top face of the end wall46of the hub body to prevent further sliding movement of the needle shield to the extended position. The flexible ribs116slide through the opening109in the end wall46and are biased outwardly to spring outwardly when the flexible ribs clear the end wall of the hub body. The flexible ribs116have a distal face118that spring outwardly to engage the bottom surface of the end wall of the hub body when the proximal needle shield is in the extended position to prevent retraction of the shield16after use as shown inFIG.11.

In the embodiments, the components of the hub and shield are typically injection molded plastic, such as acrylonitrile butadiene styrene (ABS), polyethylene, polypropylene, or the like. The needle can be a 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 invention. To assemble the parts, the hub assembly may be constructed with the needle separately, with adhesive applied in the interface area to secure the cannula to the hub, and this sub-assembly may then be assembled with the other components.

The foregoing description of the preferred embodiments is not to be deemed limiting of the invention, 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 invention.