CN209900309U

CN209900309U - Pen type needle assembly device

Info

Publication number: CN209900309U
Application number: CN201820549944.8U
Authority: CN
Inventors: 周君瑜; 曾曦; 胡炜; 黄华盛
Original assignee: Becton Dickinson and Co
Current assignee: Enbeckta
Priority date: 2018-04-18
Filing date: 2018-04-18
Publication date: 2020-01-07
Anticipated expiration: 2028-04-18

Abstract

A pen needle assembly device includes a tray (34), a movable clamping assembly (36) for clamping a pen needle assembly (18), and an actuator assembly (38). The tray (34) has a top end (42), a bottom end (40) and an interior cavity for storing used pen needle assemblies. In one embodiment, the grip assembly (36) includes at least one movable grip member (48) that is movable between a first position in which it engages and grips the outer cover (22) of the pen needle assembly (18) so that the needle hub (16) can be separated from the outer cover (22) and replaced into the outer cover (22) after use of the pen needle. An actuator assembly (38) is connected to the movable clamping member (48), wherein movement of the actuator releases the movable clamping member to move to the open position and release the outer cover of the pen needle assembly. The base (32) of the device may include an opening for engaging the inner shield (24) of the pen needle assembly to assist in removing the inner shield (24) from the needle hub (16).

Description

Pen type needle assembly device

Technical Field

The present invention relates generally to an apparatus for mounting and attaching a pen needle assembly to a delivery device (e.g., a pen delivery device). The device has a well or opening with a movable gripping member for holding the needle hub, the movable gripping member having an inner shield covering the cannula on the needle hub and holding the needle hub after use to reduce the risk of inadvertent needle sticks. The device has a second well to receive the inner shield for separating the inner shield from the needle hub without the need to dispose of the inner shield.

Background

Insulin and other injectable medicaments are commonly delivered with drug delivery pens whereby a disposable pen hub is attached to the pen to facilitate entry of a drug container and allow fluid to flow out of the container through the needle and into the patient.

Various pen needle delivery devices are known in the art for dispensing substances to a patient. Delivery devices typically use a disposable needle hub having a cannula or needle extending from a patient end of the needle hub for insertion into a patient. The non-patient end of the needle hub is coupled to a pen delivery device for delivering a substance to a patient.

The needle hub assembly is typically packaged in a container containing several loose needle hubs. The needle hub is selected from the packaging and attached to the pen needle delivery device for injection into a patient and then removed for disposal. The needle hub package includes an outer cover enclosing the needle hub and a removable seal that is peeled away from the outer cover to open the cavity so that the needle hub can be removed. The needle hub may have a threaded non-patient end that is threaded onto the delivery device. The delivery device with the needle hub attached is then removed from the outer cover. The inner needle shield is attached to the needle hub to cover the cannula until the device is ready for use. The shield is removed to expose the cannula for delivery of the substance to the patient. After use, the needle hub may be inserted back into the outer cover to enclose the exposed cannula. The pen delivery device is detached from the needle hub, leaving the needle hub inside the outer cover.

Existing devices require the use of two hands to connect and remove the needle hub from the delivery device. During placement back into the outer cover, the cannula is exposed, increasing the risk of accidental needle sticks. Manual manipulation of the outer cover while retaining the used needle hub and cannula in the cavity of the outer cover can be difficult to perform without accidental needle sticks.

Existing pen needle assemblies are disclosed in U.S. patent application publication No. 2006/02295622 to Marsh et al and 2007/0149924 to r.

While existing devices have been adapted for the intended use, there remains a need in the industry for improved packaging of pen needle hub assemblies.

SUMMERY OF THE UTILITY MODEL

The present invention relates to a device and apparatus for receiving and supporting at least one pen needle assembly for attaching the pen needle assembly to a delivery apparatus, such as a delivery pen. In particular, the device is for a pen needle assembly that can be used in a manner that reduces the risk of inadvertent needle sticks when attaching and removing the pen needle assembly to and from a delivery pen.

The apparatus includes a movable clamp assembly and an actuator mechanism that operates the clamp assembly. In one embodiment, the device is provided with an opening or well for a pen needle assembly. The pen needle assembly includes an outer cover, a needle hub supporting a cannula or needle, and an inner shield covering the cannula. A removable seal closes the open end of the outer cap, which is removed prior to connecting the needle hub to the delivery pen. The device holds and supports the pen needle assembly as well as the hub and cannula when attached to a delivery pen or other delivery device. The device is capable of storing the used needle hub and outer cover for disposal. The device has a recess or well for receiving and retaining an inner shield covering the cannula so that the inner shield can be removed from the needle hub without the need for an operator to handle the inner shield. The used needle hub may be inserted back into the outer cover and transferred to a storage tray or an internal sharps container for disposal. The inner shield may be reattached to the needle hub or discarded in the storage tray. An actuator is provided to operate the clamping assembly and release the needle hub, outer cover and inner shield into a suitable disposal bin or container, such as a sharps container.

It is an aspect of the present invention to provide a device or apparatus for receiving and supporting a pen needle assembly to attach a needle hub to a delivery apparatus without requiring the user to dispose of the needle hub while having an exposed cannula thereon. The needle hub assembly is positioned in the device such that the delivery apparatus can be attached to the non-patient end of the needle hub. The inner needle shield on the needle hub can then be inserted into an opening in the device to clamp the inner shield by the extraction mechanism so that the inner shield can be separated from the needle hub without having to handle the inner shield. After use, the needle hub is positioned in the outer cover, which is held in the opening of the device and disconnected from the delivery device, wherein the device holds the used needle hub and outer cover.

The device includes a housing having an interior cavity for receiving and storing a used pen needle assembly and associated components. The housing has a clamping mechanism with at least one clamping member, e.g. a movable clamping member, which is capable of clamping the outer cover of the pen needle assembly such that the needle hub can be attached to the delivery pen. The used needle hub may be inserted back into the outer cover, which is retained in the device and separated from the delivery pen. The actuator assembly may be actuated to release the cover so that the cover and used needle hub may be removed from the device or dropped directly into a storage compartment in the apparatus for storing the used pen needle assembly until ready to be disposed of.

In one aspect, a pen needle device includes a movable clamping member and an actuator. The tray forming the housing has an interior cavity, a top end and a bottom end. The movable clamping member is configured to clamp the outer cover of the pen needle assembly when the clamping member is in the first closed position and to release the outer cover when the clamping member is in the second open position. An actuator is connected to the device and the movable clamp member to enable the clamp member to move to the second open position to release the cover.

In one embodiment, the movable clamp member is spring biased to the open position. An actuator engages the movable clamp member to hold the clamp member in the closed position. The actuator is actuated to release the clamp member so that the clamp member can be moved to the open position by the biasing force of the spring.

In one embodiment, the clamp assembly includes at least one movable clamp member that is capable of clamping and holding the cover and is movable away from the fixed clamp member to release the cover. In one embodiment, the movable clamp member is slidable in a substantially linear direction away from the fixed clamp member. The assembly includes an actuator, such as a button, which may include a mechanism to release the movable clamp member to release the outer cover. The actuator mechanism may have a connecting body including a detent that cooperates with a detent on the movable clamp member to lock the movable clamp member in the closed position and release the movable clamp member for movement to the open position. The movable clamp member and the actuator may be spring biased to a starting position.

These features are also provided by a pen needle assembly device for receiving a pen needle assembly, wherein the pen needle assembly device comprises: a base having a plurality of openings, each of the openings having a fixed clamp member oriented with a first side of each of the plurality of openings; a movable clamping member coupled to the base at a second side of the opening and complementary to the fixed clamping member, the movable clamping member being movable between an open position and a closed position to clamp the pen needle assembly; and an actuator for moving the movable clamping member to the open position to release the pen needle assembly.

After use of the needle hub and cannula, the needle hub is inserted into the opening and the outer cover when attached to the delivery pen, wherein the needle hub may be clamped to the outer cover by a friction or interference fit so that the pen needle delivery device may be separated from the needle hub without the need for the operator to handle the needle hub, thereby reducing the risk of inadvertent needle sticks.

These features are also provided by a pen needle assembly device comprising: a base having a plurality of openings, each said opening having a fixed gripping member associated with a first side of each of the respective openings, the fixed gripping member having a gripping surface configured for gripping a pen needle assembly; a movable clamping member coupled to the base on a second side of each of the plurality of openings and movable between an open position and a closed position for clamping the pen needle assembly between the fixed clamping member and the movable clamping member, the movable clamping member being biased to the open position; and an actuator mechanism movable between a first position for holding the movable clamping member in the closed position and a second position for releasing the movable clamping member to bias the movable clamping member to the open position and release the pen needle assembly.

The features of the device are also achieved by a method of coupling a needle hub of a pen needle assembly to a delivery apparatus using the pen needle assembly device. This method comprises the steps of: inserting a pen needle assembly into a device having an opening sized to receive the pen needle assembly, wherein the device has a fixed gripping member oriented on a first side of the opening and a movable gripping member oriented on a second side of the opening, wherein the movable gripping member is movable between an open position and a closed position to grip an outer cover of the pen needle assembly inserted into the opening; coupling a pen needle delivery device to a needle hub of a pen needle assembly; removing the pen needle delivery device and pen needle hub to deliver the substance to the patient; returning the pen needle delivery device and the pen needle hub into the outer cover and separating the pen needle delivery device from the needle hub; and actuating the actuator to release the pen needle assembly from the opening in the assembly.

The objects, advantages and salient features of the invention will become more apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.

Drawings

The above benefits and other advantages of various embodiments of the present invention will become more apparent from the following detailed description of exemplary embodiments of the invention and the accompanying drawings, in which:

figure 1 is an exploded perspective view of a pen needle delivery apparatus in one embodiment showing a pen needle assembly including a needle hub supporting a cannula, an inner shield and an outer cover;

FIG. 2 is a cross-sectional view of a pen needle assembly;

fig. 3 is a perspective view of the apparatus and storage device in an embodiment of the invention;

FIG. 4 is a side view of the device in one embodiment;

FIG. 5 is a front view of the device of FIG. 3;

FIG. 6 is a top view of the device;

FIG. 7 is an exploded perspective view of the device;

FIG. 8 is a top view of the base of the device without the clamping member and actuator;

FIG. 9 is a bottom view of the base of the device of FIG. 8;

figure 10 is a bottom view of the base of the device showing the end of the actuator button and the gripping members for removing the inner cover of the pen needle assembly;

FIG. 11 is a top perspective view of the fixed clamp member separated from the base;

FIG. 12 is a bottom view of the fixed clamp member of FIG. 11;

FIG. 13 is a perspective view of the device showing the actuator mechanism and collection tray removed;

FIG. 14 is a bottom perspective view of the movable clamp member of the clamping mechanism;

FIG. 15 is a top perspective side view of the movable clamp member of FIG. 14;

FIG. 16 is a top perspective view of the body of the ratchet member of the movable clamp member;

FIG. 17 is a top perspective view showing the actuator button connected to the ratchet member body;

FIG. 18 is a top perspective view of the actuator button;

FIG. 19 is a bottom perspective view of the actuator button of FIG. 18;

FIG. 20 is a top perspective view of the linkage arm and pawl of the actuating mechanism;

FIG. 21 is a perspective view of the clamping spring member;

figure 22 is a perspective view of the movable clamping member showing the spring member for clamping the pen needle hub;

FIG. 23 is a partial cross-sectional view showing the actuating mechanism;

FIG. 24 is a top perspective view of the device showing the movable clamp members in a closed position;

FIG. 25 is a partial top view of the device showing the movable clamp members in a closed position;

FIG. 26 is a partial cross-sectional view of the actuator mechanism showing the movable clamp member in an open position;

FIG. 27 is a cross-sectional view showing the movable clamp member in an open position;

FIG. 28 is a perspective view showing an actuator mechanism that holds the movable clamp member in the open position;

FIG. 29 is a cross-sectional view of the mechanism shown in FIG. 28;

FIG. 30 is a top view of the device showing the movable clamp members in a closed position;

FIG. 31 is a bottom perspective view of the device showing the movable clamp member in a closed position; while

FIG. 32 is a partial cross-sectional view showing the movable clamp member in a closed position.

Throughout the drawings, the same reference numerals will be understood to refer to the same parts, components and structures.

Detailed Description

The present invention relates to a pen needle assembly device for storing and supporting at least one and preferably a plurality of pen needle assemblies for use with pen needle delivery equipment. The present invention also relates to a storage device for used needle hubs, wherein the used needle hub can be replaced in the device after use and subsequently discarded without the need to handle the needle hub to reduce the risk of accidental needle sticks.

Reference will now be made in detail to the embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The embodiments described herein are illustrative of the present invention but are not limiting thereof with reference to the accompanying drawings. The illustrative embodiments are presented in separate descriptions, although the various features and configurations of these embodiments may be combined in any number of ways to meet the therapeutic needs of the user.

Those skilled in the art will understand that the present 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 is to 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. Further, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanical connections or couplings. Furthermore, terms such as upper, lower, bottom, and top are relative, used to aid in explanation, not limitation.

The apparatus for the needle hub assembly enables convenient and easy assembly and removal of the needle hub on the pen delivery device, reducing handling of exposed needle cannulae. The device of the needle hub assembly may be placed on a flat surface, such as a table, so that the pen needle delivery device may be attached to the needle hub assembly with one hand, thereby reducing the risk of needle sticks resulting from handling a needle hub with an exposed needle cannula.

As shown in fig. 1, the pen needle delivery device 10 generally comprises a dose knob/button, an outer sleeve 12 and a cap. The dose knob/button allows the user to set the dose of medicament to be injected. When injecting the medicament, the outer sleeve 12 is grasped by the user. The cap is used by the user to securely hold the pen needle apparatus 10 in a shirt pocket or other suitable location and to provide a cover/protection against accidental needle injury.

In a standard pen needle device, both the dosing and delivery mechanisms are located within outer sleeve 12 and will not be described in further detail herein as they will be understood by those skilled in the art. The cartridge is typically attached to a standard pen injector housing by known connection means. Distal movement of the plunger or stopper within the cartridge causes the medicament to be forced into the reservoir housing. The cartridge is sealed by a septum and pierced by a septum piercing needle cannula located within the reservoir or housing. The reservoir housing is preferably screwed onto the cartridge, but other attachment means may be used. The pen needle delivery device may be a standard pen delivery device known in the art and therefore is not shown in detail. The pen needle assembly 18 as shown in fig. 2 includes a needle hub 16 supporting a cannula 20, an outer cover 22 and an inner shield 24. As shown in fig. 2, a protective seal 26 is attached to the open end of the outer cap to close the needle hub and cannula, thereby maintaining cleanliness and sterility. The seal 26 may be a label or other closure member that can be easily peeled away from the outer cover to access the needle hub during use.

The pen needle delivery device 10 is connected to a needle hub 16 as shown in figure 1, the needle hub 16 having a connection non-patient end with internal threads that screw onto a threaded end 18 of the delivery device 10. A needle cannula 20 extends from the patient end of the needle hub 16 for delivering a substance to a patient. An outer cap 22 may be provided to cover the needle cannula to protect the patient from accidental needle sticks before and after use. The outer lid 22 includes ribs 23 to aid in gripping the outer lid during use. The inner shield 24 is disposed on a post extending from the end of the needle hub 16 to enclose the cannula. During use, the needle hub 16 is connected to the pen delivery device and the inner shield is removed. After use, the outer cover is typically placed back over the needle hub to cover the needle cannula. The covered needle hub is then removed from the pen needle delivery device and discarded.

The device 30 is configured for receiving and supporting at least one pen needle assembly 18 in a position where the delivery apparatus 10 is coupleable to the needle hub 16 for injection of a substance into a patient without requiring the user to handle the needle hub 16 with the exposed cannula. The used needle hub 16 and cannula 20 can then be positioned back into the outer cover 22, the outer cover 22 being retained in the device and separated from the delivery apparatus. The used outer cover and needle hub and inner shield are retained in the device.

A means 30 is provided for receiving the pen needle assembly 18 to couple the pen needle hub 16 to the pen needle device and for separating the pen needle hub from the pen needle delivery device after use. In one embodiment, the device 30 includes a base 32 coupled to a tray 34 forming a housing, a retention and clamping assembly 36, and an actuator assembly 38. The tray 34 has a top end 40 and a bottom end 42 as shown in fig. 3. The bottom end 42 may have a bottom surface with a non-slip surface. The non-slip surface may be molded directly onto the bottom surface or may be a non-slip material, such as an elastomeric material, applied to the bottom surface to hold the housing in a stable position on a table or other flat surface during use.

As shown, the device 30 is configured to receive multiple pen needle assemblies simultaneously. The apparatus 30 includes a plurality of gripper assemblies 36 with respective actuator assemblies 38 positioned adjacent to each other, wherein each gripper assembly 36 and actuator assembly 38 is independently operable. Each grip assembly 36 of the device 30 is capable of supporting a pen needle assembly until ready for use and can be individually discarded after use. The pen needle delivery device may be connected to a corresponding pen needle assembly and stored in the device 30 until ready for use, as shown in figure 5. At this point, the pen needle delivery device and needle hub are removed for use.

The tray 34 has an interior cavity of sufficient size to hold and store a plurality of used pen needle assemblies. In the illustrated embodiment, tray 34 is formed to be coupled to base 32 by hooks 44 extending from base 32, hooks 44 being for mating with complementary tabs or hooks within tray 34. As shown, the base 32 defines a removable cover for the tray 34.

Referring to fig. 3-6, a clamping assembly 36 is provided for supporting and clamping the pen needle assembly to connect the needle hub 16 to the delivery pen and to disconnect the needle hub from the delivery pen after use. The clamping assembly 36 is a movable assembly that is movable between an open position for receiving the outer cover of the pen needle assembly and a closed position for engaging and clamping the outer cover of the pen needle assembly.

In the illustrated embodiment, clamp assembly 36 includes two opposing clamp members or jaws, at least one of which is movable relative to the other. In one embodiment, the clamp assembly 36 includes a fixed clamp member 46 coupled to the base 32 and a movable clamp member 48 movable relative to the base 32 and the fixed clamp member 46. The base 32 has an opening 50, the opening 50 being of a size complementary to the outer dimensions of the pen needle assembly so that the pen needle assembly can slide through when released by the grip assembly 36. As shown, one opening 50 is provided for each clamp assembly 36.

The stationary clamp member 46 in the illustrated embodiment is formed as a separate member that is attached to the base 32 by a suitable fastening mechanism, such as an adhesive or mechanical fastener. As shown in fig. 7, 11 and 12, the fixed clamp member 46 has a front face 50, the front face 50 having a plurality of recessed regions 52 extending between a top surface 54 and a bottom surface 56. In the illustrated embodiment, the front face 54 is substantially flat for mating with the movable clamp member 48. The recessed regions 52 are spaced apart from one another and have a generally U-shaped inner surface 58, the inner surface 58 being sized to receive a pen needle assembly 118. In the embodiment provided, the inner surface 58 has an arcuate ledge 60, the ledge 60 being capable of gripping the outer surface of a pen needle assembly. A groove 62 is formed in the inner surface 58 to receive a spring metal clamping member 64, as shown in fig. 21.

An extractor mechanism may be provided for separating the inner shield from the needle hub without requiring a technician to manually remove the inner shield. Referring to fig. 12, an aperture 66 is formed at one end of the fixed clamp member 46, the aperture 66 being sized to receive the inner shield 24 of a pen needle assembly. A collar 67 extends from the top surface 54 and surrounds the aperture 66. A clamping member, shown as a spring metal clip 68, is attached to the bottom surface of the fixed clamp member 46 immediately adjacent the aperture 66. The spring metal clip 68 has a first end 70 attached to a boss 72 extending from the bottom surface 56 of the fixed clamp member 46 and a second free end 74 extending a slight distance into the opening defined by the hole 66. In the illustrated embodiment, two spring metal clips 68 are oriented on opposite sides of the bore 66, with the free ends 74 extending into the bore opening a distance sufficient to grip the outer surface of the inner shield 24. During use, the inner shield 24 is manually pushed through the aperture 66 with the spring clip 68 gripping the outer edge of the inner shield with sufficient force to enable the needle hub to be separated from the inner shield by pulling the needle hub 16 upward while retaining the inner shield within the aperture. During subsequent use, the new inner shield is pushed downwardly against the inner shield captured by the spring clip 68 to push the original inner shield through the aperture to drop into the tray 34 below the aperture.

The base 32 is sized for mating with the open top end of the tray 34 to define an enclosure for receiving a used pen needle assembly. Referring to fig. 7-9, the base 32 has a generally rectangular configuration with a plurality of openings 76 associated with each of the fixed clamp member 46 and the movable clamp member 48. Fig. 8 is a top view of the base 32 showing the openings 76 aligned adjacent to each other and cooperating at one end with the holes 66 of the stationary clamp members 46 to enable the used inner shield to fall into the opening 78 in the tray 34. A plurality of holes 82 are provided on the base 32 to receive corresponding bosses 82 on the underside of the fixed clamp member 46 for coupling the fixed clamp member 46 to the base 32.

Fig. 9 is a bottom view of the base 32 showing the opening 76 surrounded by the collar 84. Each opening 76 includes a pair of guide slots 86 for cooperating with the movable clamp member 48. The elongated slots 88 extend away from the respective openings 76 to cooperate with the movable clamp member 48.

Referring to fig. 14 and 15, the movable clamp member 48 has a front face 90 for mating with the front face 50 of the fixed clamp member 46. The recessed region 92 has a generally U-shaped shape to complement the U-shaped recess 52 of the fixed gripping member 46 to form a well 94 or opening for receiving and gripping a pen needle assembly, as shown in figures 6 and 13. As shown in FIG. 15, the U-shaped recess 92 includes an angled ledge 96 for gripping the pen needle assembly. A slot 98 is provided in the recess 92 for receiving the metal spring clip 64.

As shown in fig. 14, the bottom surface of the gripping member 48 includes spaced apart posts 100. The post 100 is positioned for attaching the spring metal clamping member 64 to the movable clamp member 48. As shown in fig. 21, the spring metal clip 64 includes a pair of legs 102, the legs 102 having apertures 104 for mating with the posts 100 and corresponding posts 106 of the clip member 48. The spring metal clamping member 64 has an angled end 108 forming a clamping edge 110, the clamping edge 110 extending through the slot 98 to engage the pen needle assembly. As shown in fig. 21, the gripping edge 110 acts as a recessed area 112 for mating with the outer surface of a pen needle assembly. The beveled end 108 is angled downwardly relative to the well 94 to enable the outer cover to slide over the gripping edge 110 while preventing removal of the outer cover in an upward direction.

Referring to fig. 14, the movable clamp member 48 includes two spaced apart posts 114, the posts 114 having a length that extends through the guide slots 86 of the base 32. The distal end of the post 114 includes a notch 116 for mating with the actuator assembly 38. Legs 118 extend from the movable clamp member 48 in a direction opposite the recessed region 92. The distal end of leg 118 includes a downwardly extending tab 124 for mating with actuator assembly 30.

The actuator assembly 38 in the illustrated embodiment includes an actuator button 122 and a ratchet assembly 124. As shown in FIG. 18, the actuator button 122 includes a top portion and legs 128, the legs 128 passing through openings 130 in the base 32 to enable the actuator button 122 to reciprocate in an up-down direction. In the illustrated embodiment, two legs 128 are provided, although a single leg may be used. In one embodiment, a spring 132 is positioned between the base 132 and the actuator button 122 for biasing the actuator button 122 in an upward direction. As shown in FIG. 19, a post 134 is provided in the bottom surface of the actuator button 122 to mate with the spring 132 and position the spring 132 on the actuator button 122 between the legs 128.

Ratchet assembly 124 as shown in fig. 20 includes a ratchet connection member having a body 136 with a leg 138 extending from one end. In the illustrated embodiment, two parallel legs 138 are provided, although a single or more legs may be used. The distal end of each leg 138 includes an aperture for receiving a pivot pin 142, the pivot pin 142 for connecting the leg 138 to the leg 128 of the corresponding actuator button 122, as shown in fig. 17. The opposite end of the body 136 includes a leg 144, the leg 144 having an aperture 16, the aperture 16 for receiving a pivot pin 148, the pivot pin 148 for pivotally connecting the body 136 to the base 32. As shown in fig. 20, the body 136 includes at least one detent 150. In the illustrated embodiment, two spaced apart detents are provided to cooperate with the movable clamp member 48. In the illustrated embodiment, the pawl 150 has an inclined face 152 that forms a cam surface and an opposing flat face 154 that is oriented substantially perpendicular to the longitudinal dimension of the body 136. Referring to fig. 9, the bottom surface of the base 32 includes two raised posts 156 at one end of the respective guide slots 86. Each post 156 includes an aperture 158 for receiving a pivot pin 142, the pivot pin 142 for pivotally connecting the leg 144 of the body 136 to the base 32, as shown in fig. 23.

A complementary ratchet member 160, shown in fig. 16 and 21, is attached to the bottom side of the movable clamp member 148. In the illustrated embodiment, the ratchet member 160 is fixed to the movable clamp member 160. Referring to fig. 16, the ratchet member 160 includes a body 162 with a leg 166 extending from one end of the body 162. In the illustrated embodiment, two spaced apart and parallel legs 166 are provided. Each leg 166 has an outwardly extending tab 168 for coupling with a respective movable clamp member 48. The opposite end of the body 162 includes a hole 170 for mating with the hole 120 on the movable clamp member 48.

Detents 172 are provided on opposite sides of the aperture as shown in fig. 16. The pawl 172 has an inclined face 174 that forms a cam surface and a flat face 176 that extends substantially perpendicular to the longitudinal dimension of the body 62. As shown in fig. 26, the ratchet member 160 is coupled to the movable clamp member 48 by the tab 68 mating with the notch 116 formed in the post 114 of the movable clamp member 48. A fastener, such as a screw, may extend through the hole 170 formed in the body 162 to mate with a hole 178 formed in the bottom surface of the tab 120. In the illustrated embodiment, two spaced apart detents 172 are provided to mate with corresponding detents 150 on the body 136. It should be appreciated that the number of pawls may vary, although the number of pawls 150 of the body 136 generally corresponds to the number of pawls 172 of the ratchet member 160. As seen in fig. 22, 23, 26 and 27, the inclined surface 174 of the pawl 172 of the ratchet member cooperates with the inclined surface 152 of the pawl 150 of the body 136 to be able to slide past each other. The flat face 176 of the ratchet member 160 engages the flat face 154 of the body 136 to hold the movable clamp member 48 in the closed position as shown in fig. 31 and 32 until released by the actuator mechanism.

As shown in fig. 26 and 27, the post 114 and leg 118 of the movable clamp member 48 extend through the respective guide slot 86 and elongated slot 88 in the base 32. The main body 136 of the ratchet assembly 124 is coupled to the respective post 114 and leg 118 to trap the base 32 between the movable clamp member 148 and the main body 136 and to couple the movable clamp member 48 to the base 32 while allowing the movable clamp member 48 to slide in a linear direction relative to the guide slot 86, the elongated slot 88, and the fixed clamp member 46.

The legs 128 of the button 122 extend through corresponding openings 130 formed in the base 32, as shown in fig. 26 and 27. Leg 138 of body 136 of ratchet assembly 124 is pivotally connected to leg 128 of actuator button 122 by pivot pin 142 to trap actuator button 122 to base 32. The legs 144 of the body 136 are connected by pivot pins 148 to corresponding posts 156 on the bottom surface of the base 32. As shown, the actuator button 122 slides in an up-down direction and is biased upward by the spring 132. Downward movement of the actuator button 122 pivots the body 136 in a downward direction relative to the base 32.

As shown in fig. 27, a spring 182 is positioned in the longitudinal slot 88 and extends between the post 120 and the inner edge of the slot 88 to bias the movable clamp member 48 to the position shown in fig. 27 and an open position relative to the fixed clamp member 146. During use, the movable clamp member 48 is manually urged toward the fixed clamp member 146 against the biasing force of the spring 182 to the position shown in fig. 30 and 32. As shown in fig. 27, the inclined surface 174 of the ratchet member 160 attached to the movable clamp member 48 opposes the inclined surface 152 of the pawl 150 on the body 136. The movable clamp member 48 is slidable toward the fixed clamp member 46 such that the

inclined surfaces

152 and 174 can slide past each other by pivoting the main body 136 downward relative to the pivot pin 142 to disengage the pawls, thereby allowing the movable clamp member 48 to slide toward the fixed clamp member 46. Once the ramped surface 174 slides past the ramped surface 152, the biasing force of the spring 132 returns the body 136 to the original position to lock the moveable clamp member 48 in the closed position, as shown in FIGS. 31 and 32. As shown in fig. 32, manually sliding the movable clamp member 48 to the closed position relative to the fixed clamp member 46 enables the flat face 176 of the pawl 172 to engage the flat face 154 of the pawl 150, thereby preventing the movable clamp member 48 from disengaging relative to the fixed clamp member 46.

Once the movable clamping member 48 is locked in the closed position relative to the fixed clamping member 46, the device may be used to couple the pen needle assembly 18 to a delivery device such as a pen needle 10. The pen needle assembly 18 may be positioned in one or more wells 94 formed by the closed gripping

members

46 and 48. The pen needle assembly 18 may be manually placed in the respective well 94 and pushed downward until the

flanges

60 and 96 and the spring clip 64 engage the outer cover 22. Typically, the cover 22 is secured while an audible sound or click provides an indication of proper connection of the pen needle assembly to the well 94.

The flange 60 and spring metal clips 64 can grip the outer surface of the outer cover 22 to resist rotation of the outer cover relative to the gripping members and resist removal of the outer cover from the well 94. Label 26 may then be peeled away from cover 22 to expose needle hub 16 for use. The delivery device (e.g., pen needle 10) is then inserted into the needle hub 16 and threaded onto the needle hub in the usual manner. The delivery device with attached needle hub 16 is removed from outer cover 22 to expose inner shield 24. The inner shield 24 is then inserted through the aperture 66 to engage the spring clip 68. The delivery device is pulled upward to separate the inner shield 24 from the needle hub 16. The inner shield 24 may be manually pushed through an opening in the base 32 into the tray 34 for disposal. Alternatively, a subsequent inner shield may be pushed into the aperture 66, with the previous inner shield being pushed into the tray 34 through the opening.

The delivery device with attached needle hub can be prepared for use by a technician, for example, by adjusting the dose and expelling air from the delivery device and cannula 20. At this stage, the needle hub 16 and delivery device may be inserted back into the respective outer cover 22 until ready for use. The delivery apparatus may be prepared for each pen needle assembly positioned in the corresponding well bore 94. The corresponding actuator buttons 122 may include indicia, such as numbers or letters, to designate a selected patient, a dose contained in the delivery device, or a medicament. Each of the respective wells formed by the gripping

members

46 and 48 receives one pen needle assembly for preparing the delivery device for use. In this manner, multiple delivery devices may be prepared for use simultaneously, with each delivery device positioned within a respective well identified by indicia on the actuator button.

Each of the individual delivery devices may be used to deliver a medicament to a patient. After use, the needle hubs 16 are inserted back into the respective outer covers 22 while still attached to the delivery apparatus, wherein the delivery apparatus can be separated from the respective needle hubs and leave the used needle hubs in the well formed by the gripping

members

46 and 48. Then, the respective actuator button 122 for the respective well 94 may be depressed, causing the body 136 of the ratchet mechanism 124 to pivot downward to disengage the pawl 150 on the body 136 from the pawl 172 on the body 166 of the ratchet member attached to the movable clamp member 48. The spring 182 then biases the movable clamping member 48 to the open position, allowing the used pen needle assembly to separate from the clamping

members

46 and 48 and fall into the tray 34 for safe disposal. The movable clamping member 48 may then be manually pushed to the closed position to receive a new pen needle assembly. In this way, the used pen needle assembly may be discarded into the tray after use without requiring a technician to handle the needle hub, thereby reducing the risk of needle sticks during use and disposal of the delivery device and needle hub.

In another embodiment, the extractor may be formed from a sheet metal clip attached to the base, wherein the clip includes a sharp edge to engage the inner shield. The extractor may have a generally keyhole shaped slot with an enlarged generally circular opening and a longitudinally extending opening having a width less than the diameter of the circular opening. The size of the circular opening may be slightly larger than the outermost size of the inner shield 24 so that the inner shield may pass through without interference. The distal end of the longitudinal opening may comprise at least one tooth projecting inwardly relative to the circular opening. The teeth may have a ramped surface forming a sharp tip and ramped in a generally downward direction to allow the inner shield 24 to slide over the tip and resist removal of the inner shield in an upward direction. The teeth may be sufficiently flexible so that the inner shield may be pushed through the opening to access a tray or other vessel in the housing.

These steps may be repeated by placing a new pen needle assembly in the housing and the delivery pen may be attached to the needle hub. A new needle hub with an inner shield 24 may be inserted into the opening of the extractor with the tip of the inner shield engaging the top end of the previous shield so that the downward force pushes the previous shield past the flexible edge of the spring clip. The inner shield 24 can then be dropped down into the tray.

In another embodiment shown in fig. 21 and 22, the outer cover 22 can be reattached to the needle hub 16 without detaching the needle hub from the delivery pen. The delivery pen with attached needle hub 16 can be inserted through the collar and housing such that needle hub 16 is received in outer cap 22. Actuator 108 can then be depressed to disengage the gripping members to release cover 22. The delivery pen can then be withdrawn with the outer cover protecting the sleeve to avoid accidental needle sticks.

The foregoing embodiments and advantages are merely exemplary and are not to be construed as limiting the scope of the invention. The description of the exemplary embodiments of the present invention is intended to be illustrative, but not limiting, of the scope of the invention. Various modifications, substitutions, and variations will be apparent to those of ordinary skill in the art and are intended to fall within the scope of the present invention. It is to be expressly noted that the features of the different embodiments and claims can be combined with one another as long as they are not mutually contradictory. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims and their equivalents.

Claims

1. A pen needle assembly device, comprising:

a base having a plurality of openings, each of the openings having a fixed clamp member oriented with a first side of each of the plurality of openings; a movable clamping member coupled to the base on a second side of the opening and complementary to the fixed clamping member, the movable clamping member being movable between an open position and a closed position to clamp a pen needle assembly; and

an actuator mechanism for moving said movable jaw to said open position to release said pen needle assembly.

2. The pen needle assembly device according to claim 1, wherein the movable clamping member is spring biased to the open position.

3. The pen needle assembly device according to claim 2, wherein the actuator mechanism comprises an actuator movable between a first position and a second position and includes a ratchet member to retain the movable clamping member in the closed position when the actuator is in the first position and the actuator is movable to the second position to release the movable clamping member.

4. The pen needle assembly device according to claim 3, wherein the ratchet member comprises a pawl for engaging a pawl on the movable clamping member.

5. The pen needle assembly device according to claim 4, wherein the actuator comprises a movable button coupled to the ratchet, and wherein moving the button to an actuated position disengages the pawl on the ratchet member from the pawl of the movable clamping member.

6. The pen needle assembly device according to claim 5, wherein the ratchet member has a body having a first end pivotally connected to the base to pivot relative to the base about a fixed pivot point and a second end pivotally connected to the button, wherein the body includes the pawl for engaging the pawl of the movable clamping member.

7. The pen needle assembly device according to claim 1, wherein the device comprises a collection tray located below the base, and wherein the pen needle assembly drops into the tray when released by the movable clamping member.

8. A pen needle assembly device, comprising:

a base having a plurality of openings, each said opening having a fixed gripping member associated with a first side of each of said plurality of openings, said fixed gripping member having a clamping surface configured to clamp a pen needle assembly;

a movable clamping member coupled to the base on a second side of each of the plurality of openings and movable between an open position and a closed position to clamp the pen needle assembly between the fixed clamping member and the movable clamping member, the movable clamping member biased to the open position; and

an actuator movable between a first position for holding said movable clamping member in said closed position and a second position for releasing said movable clamping member to bias said clamping member to said open position and release said pen needle assembly.

9. The pen needle assembly device according to claim 8, further comprising a spring member engaging the movable clamping member to bias the clamping member to the open position.

10. The pen needle assembly device according to claim 9, wherein the actuator includes a ratchet member to engage a pawl on the movable clamping member.

11. The pen needle assembly device according to claim 9, wherein the actuator includes a body having a first end pivotally connected to the base to define a fixed pivot point of the body and a second end pivotally connected to the actuator.

12. The pen needle assembly device according to claim 11, wherein the body includes a pawl oriented between the first end and the second end for releasably engaging a pawl on the movable clamping member.

13. The pen needle assembly device according to claim 12, wherein the movable actuator member is spring biased to the open position in which the detent on the body engages the detent on the movable clamping member, and wherein the movable actuator is movable to a second position to disengage the detent on the body from the detent on the movable clamping member, whereby the movable clamping member is biased to the open position.