CN110384841B - Pen type needle assembly device - Google Patents

Abstract

A pen needle assembly device comprising 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 clamping assembly (36) includes at least one movable clamping member (48) movable between a first position and a second position in which the clamping member contacts the The outer cover (22) that grips the pen needle assembly (18) is incorporated so that the needle hub (16) can be separated from the outer cover (22) and placed back into the outer cover (22) after use of the pen needle. The 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 openings for engaging the inner shield (24) of the pen needle assembly to facilitate removal of the inner shield (24) from the needle hub (16).

Description

Pen needle assembly device

technical field

The present invention generally relates to an apparatus for mounting and attaching a pen needle assembly to a delivery device, such as a pen delivery device. The device has a well or opening with a movable clamping member for retaining the needle hub, the movable clamping member having an inner shield covering the sleeve on the needle hub and retaining 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 detaching the inner shield from the needle hub without requiring manipulation of the inner shield.

Background technique

Insulin and other injectable medications are typically delivered with drug delivery pens whereby a disposable pen hub is attached to the pen to facilitate access to the drug container and to allow fluid to flow from the container through the needle into the patient.

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

Hub assemblies are usually packaged in containers containing several loose hubs. The needle hub is picked out of the package and attached to the pen needle delivery device for injection into the 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 from the outer cover to open the cavity so that the needle hub can be removed. The needle hub can have a threaded non-patient end that is threadedly connected to the delivery device. The delivery device with the hub attached is then removed from the outer cap. An inner needle shield is attached to the hub to cover the cannula until the device is ready for use. The shield is removed to expose the cannula for delivering the substance to the patient. After use, the hub can be inserted back into the outer cap to seal off the exposed cannula. The pen delivery device is detached from the needle hub, leaving the needle hub inside the outer cap.

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

Existing pen needle assemblies are disclosed in US Patent Application Publication Nos. 2006/02295622 to Marsh et al. and 2007/0149924 to R. Marsh, the entire contents of which are incorporated herein by reference.

While existing devices are adequate for their intended use, there remains a need in the industry for improved packaging of pen hub assemblies.

Contents of the invention

The present invention relates to an apparatus and apparatus for receiving and supporting at least one pen needle assembly for attaching the pen needle assembly to a delivery device, such as a delivery pen. In particular, the device is used with 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 the delivery pen. use.

The device includes a movable clamping assembly and an actuator mechanism to operate the clamping assembly. In one embodiment, the device is provided with an opening or well for the pen needle assembly. The pen needle assembly includes an outer cap, a hub supporting the 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 needle hub and cannula when attached to a delivery pen or other delivery device. The device is capable of storing used needle hubs and outer caps for disposal. The device has a recess or well for receiving and retaining an inner shield covering the cannula such that the inner shield can be removed from the needle hub without requiring an operator to handle the inner shield. The used needle hub can be inserted back into the outer cap and transferred to the storage tray or internal sharps container for disposal. The inner shield can be reattached to the hub or discarded in the storage tray. The actuator is arranged to operate the clamping assembly and release the needle hub, outer cover and inner shield into a suitable disposal box or container, such as a sharps container.

One aspect is to provide a device or apparatus for receiving and supporting a pen needle assembly for attaching a needle hub to a delivery device without requiring the user to handle the needle hub while having an exposed cannula on the needle hub. The needle hub assembly is positioned in the device such that the delivery device 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 the 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 handling the inner shield. After use, the hub is positioned in the outer cap, which remains in the opening of the device and is disconnected from the delivery device, wherein the device retains the used hub and outer cap.

The device includes a housing having a lumen for receiving and storing a used pen needle assembly and associated components. The housing has a clamping mechanism having at least one clamping member, such as a movable clamping member, capable of clamping the outer cover of the pen needle assembly to enable attachment of the needle hub to the delivery pen. The used needle hub can be inserted back into the outer cap, which remains in the device and separate from the delivery pen. The actuator assembly can be actuated to release the outer cover so that the outer cover and used needle hub can be removed from the device or dropped directly into a storage chamber in the device for storing used pen needles Components can be disposed of until ready.

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 coupled to the device and movable clamping member to enable movement of the clamping member to a second open position to release the cover.

In one embodiment, the movable clamping member is spring biased into the open position. An actuator engages the movable clamping member to maintain the clamping member in a closed position. Actuating the actuator releases the clamping member to enable the clamping member to move to the open position by the biasing force of the spring.

In one embodiment, the clamping assembly includes at least one movable clamping member capable of clamping and retaining the cover and movable away from the fixed clamping member to release the cover. In one embodiment, the movable clamping member is slidable in a substantially linear direction away from the fixed clamping member. The assembly includes an actuator, such as a button, which may include a mechanism to release the movable clamping member to release the cover. The actuator mechanism may have a coupling body including a detent that cooperates with a detent on the movable clamping member to lock the movable clamping member in the closed position and release the movable clamping member to move to Open location. The movable clamping member and actuator may be spring biased to a home position.

These features are also provided by a pen needle assembly device for receiving a pen needle assembly, wherein the pen needle assembly device includes a base having a plurality of openings, each opening having a The fixed clamping members are oriented together with the first sides of each of the openings. A movable clamping member is coupled to the base on a second side of the opening and is complementary to the fixed clamping member, wherein the movable clamping member is movable between an open position and a closed position to clamp the pen needle assembly. An actuator is included to move the movable clamp member to the open position to release the pen needle assembly.

After using 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 can be clamped to the outer cover by a friction fit or an interference fit, making the pen needle delivery device Can be detached from the hub without requiring the operator to handle the hub, 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 of the openings having a first side associated with each of the openings. A fixed clamping member is connected, and the fixed clamping member has a clamping surface configured for clamping the pen needle assembly. A movable clamping member is coupled to the base on a second side of each of the openings and is movable between an open position and a closed position for clamping the pen between the fixed clamping member and the movable clamping member needle assembly. The movable clamping member is biased to an open position. The actuator mechanism is movable between a first position for holding the movable clamping member in a closed position and a second position for releasing the movable clamping member to move the movable clamping member to a second position. The clamping member is biased to the open position and releases the pen needle assembly.

The device is also characterized by a method of coupling a needle hub of a pen needle assembly to a delivery device using the pen needle assembly device. The method includes 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 second side of the opening. A movable clamping member oriented on two sides, wherein the movable clamping member is movable between an open position and a closed position to clamp the outer cover of the pen needle assembly inserted into the opening; transporting the pen needle The device is coupled to the hub of the pen needle assembly; the pen needle delivery device and pen hub are removed to deliver the substance to the patient; the pen needle delivery device and pen hub are returned to the outer cap, and the pen The needle delivery device is separated from the needle hub; and the actuator is actuated to release the pen needle assembly from the opening in the assembly.

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

Description of drawings

The above benefits and other advantages of various embodiments of the 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 device in one embodiment showing a pen needle assembly including a hub supporting a cannula, an inner shield and an outer cover;

Figure 2 is a cross-sectional view of the pen needle assembly;

Figure 3 is a perspective view of an apparatus and a storage device in one embodiment of the present invention;

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

Figure 5 is a front view of the device of Figure 3;

Fig. 6 is the top view of this device;

Figure 7 is an exploded perspective view of the device;

Figure 8 is a top view of the base of the device without clamping members and actuators;

Figure 9 is a bottom view of the base of the device of Figure 8;

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

Figure 11 is a top perspective view of the stationary clamp member separated from the base;

Figure 12 is a bottom view of the stationary clamping member of Figure 11;

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

Figure 14 is a bottom perspective view of the movable clamping member of the clamping mechanism;

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

16 is a top perspective view of the main body of the ratchet member of the movable clamping member;

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

Figure 18 is a top perspective view of the actuator button;

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

Figure 20 is a top perspective view of the connecting arm and pawl of the actuating mechanism;

Figure 21 is a perspective view of a clamping spring member;

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

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

Figure 24 is a top perspective view of the device showing the movable clamping member in a closed position;

Figure 25 is a partial top view of the device showing the movable clamping member in a closed position;

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

Figure 27 is a cross-sectional view showing the movable clamping member in an open position;

Figure 28 is a perspective view showing the actuator mechanism holding the movable clamping member in an open position;

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

Figure 30 is a top view of the device showing the movable clamping member in a closed position;

Figure 31 is a bottom perspective view of the device showing the movable clamping member in a closed position; and

32 is a partial cross-sectional view showing the movable clamping 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 ways

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 a pen needle delivery device. The present invention also relates to a storage device for used needle hubs, wherein used needle hubs can be replaced in the device after use and subsequently discarded without the need to dispose of the needle hubs to reduce accidental needle sticks risks of.

Reference will now be made in detail to the embodiments of the present invention which are illustrated in the drawings, wherein like reference numerals refer to like elements throughout. The embodiments described here illustrate the present invention by referring to the drawings but do not limit the present invention. Exemplary embodiments are presented as separate descriptions, although the individual features and configurations of these embodiments can be combined in any number of ways to meet the therapeutic needs of the user.

It will be understood by those skilled in the art that the disclosure is not limited in its application to the details of configuration and arrangement of components set forth in the following description or shown in the drawings. The embodiments herein can be modified, practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising", "comprising" or "having" and variations thereof herein means including the items listed thereafter and their equivalents as well as additional items. Unless otherwise limited, the terms "connected", "coupled" and "mounted" and variations thereof herein are used broadly and include direct and indirect connections, couplings and mountings. Furthermore, the terms "connected" and "coupled" and variations thereof are not limited to physical or mechanical connections or couplings. Furthermore, terms such as upper, lower, bottom and top are relative and are used to aid in description and are not limiting.

The device 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 cannula. The device of the hub assembly can be placed on a flat surface, such as a table, so that the pen needle delivery device can be attached to the hub assembly with one hand, thereby reducing needle trauma caused by handling a hub with an exposed needle cannula. stabbing risk.

As shown in FIG. 1 , the pen needle delivery device 10 generally includes 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. The outer sleeve 12 is grasped by the user when injecting the medicament. The cap is used by the user to securely hold the pen needle device 10 in a shirt pocket or other suitable location and to provide cover/protection from accidental needle damage.

In a standard pen needle device, both the dosing and delivery mechanisms are located within the outer sleeve 12 and are not described in further detail here as they are understood by those skilled in the art. The cartridge is usually attached to a standard pen-injector housing by known attachment means. Distal movement of the plunger or bung within the cartridge causes medicament to be forced into the reservoir housing. The cartridge is sealed by a septum and pierced by a septum piercer cannula located within the reservoir or housing. The reservoir housing is preferably screwed onto the cartridge, but other means of attachment may also be used. The pen needle delivery device may be a standard pen delivery device known in the industry and therefore the pen needle delivery device is not shown in detail. Pen needle assembly 18 as shown in FIG. 2 includes needle hub 16 supporting cannula 20 , outer cover 22 and inner shield 24 . As shown in Figure 2, a protective seal 26 is attached to the open end of the outer cap to seal off the hub and cannula to maintain cleanliness and sterility. Seal 26 may be a tab or other closure member that can be easily peeled off the outer cover to gain access to the needle hub during use.

The pen needle delivery device 10 is connected to a needle hub 16 shown in FIG. A needle cannula 20 extends from the patient end of the needle hub 16 for delivering a substance to the patient. An outer cover 22 may be configured to cover the needle cannula to protect the patient from accidental needle sticks before and after use. The outer cover 22 includes ribs 23 to assist in gripping the outer cover during use. An inner shield 24 is provided on a post extending from the end of the hub 16 to enclose the sleeve. During use, the needle hub 16 is connected to the pen delivery device and the inner shield is removed. After use, the outer cap is usually placed back on the needle hub to cover the needle cannula. The needle hub with cap is then removed from the pen needle delivery device and discarded.

Apparatus 30 is configured to receive and support at least one pen needle assembly 18 at a location where delivery device 10 can be coupled to needle hub 16 for injecting a substance into a patient without requiring the user to handle the sheath with an exposed The needle hub 16 of the tube. The spent needle hub 16 and cannula 20 can then be positioned back into the outer cap 22, which remains in the device and separate from the delivery device. The used outer cap and hub and inner shield remain in the device.

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

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

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

Referring to Figures 3-6, a clamp 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. Clamp assembly 36 is a movable assembly that is movable between an open position for receiving the cover of the pen needle assembly and a closed position for engaging and clamping the cover of the pen needle assembly.

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

The stationary clamping member 46 in the illustrated embodiment is formed as a separate member attached to the base 32 by a suitable fastening mechanism, such as adhesive or mechanical fasteners. As shown in FIGS. 7 , 11 and 12 , the stationary clamp member 46 has a front face 50 with 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 generally flat for mating with the movable clamping member 48 . The recessed regions 52 are spaced apart from each other and have a generally U-shaped inner surface 58 sized to receive the pen needle assembly 118 . In the embodiment provided, the inner surface 58 has an arcuate flange 60 capable of gripping the outer surface of the pen needle assembly. A slot 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 hub without requiring a technician to manually remove the inner shield. Referring to Figure 12, an aperture 66 is formed in one end of the stationary clamp member 46, the aperture 66 being sized to receive the inner shield 24 of the pen needle assembly. A collar 67 extends from top surface 54 and surrounds bore 66 . A clamping member, shown as a spring metal clip 68 , is attached to the bottom surface of the stationary clamping member 46 proximate 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 stationary clamp member 46 and a second free end 74 extending a slight distance into the opening defined by the bore 66 . In the illustrated embodiment, two spring metal clips 68 are oriented on opposite sides of the hole 66 with the free ends 74 extending into the hole 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 holes 66, with the spring clips 68 gripping the outer edge of the inner shield with sufficient force to enable separation of the needle hub 16 from the inner shield by pulling upwardly on the needle hub 16 , while retaining the inner shield in the bore. During subsequent use, the new inner shield is pushed down against the inner shield captured by the spring clips 68 to push the original inner shield through the hole, dropping into the tray 34 below the hole.

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

FIG. 9 is a bottom view of base 32 showing opening 76 surrounded by collar 84 . Each opening 76 includes a pair of guide slots 86 for cooperating with the movable clamping member 48 . The elongated slot 88 extends away from the corresponding opening 76 to cooperate with the movable clamping member 48 .

Referring to FIGS. 14 and 15 , the movable clamping member 48 has a front face 90 for mating with the front face 50 of the stationary clamping member 46 . The recessed area 92 has a generally U-shaped shape to complement the U-shaped recess 52 of the fixed clamping member 46 to form a well 94 or opening for receiving and clamping the pen needle assembly, as shown in FIGS. 6 and 13 . Show. As shown in FIG. 15, the U-shaped recess 92 includes an angled flange 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 clamping member 48 includes spaced apart posts 100 . Post 100 is positioned for attaching spring metal clamping member 64 to movable clamping member 48 . As shown in FIG. 21 , spring metal clip 64 includes a pair of legs 102 having holes 104 for mating with posts 100 and corresponding posts 106 of clamping member 48 . The spring metal clamping member 64 has a beveled end 108 forming a clamping edge 110 that extends through the slot 98 to engage the pen needle assembly. As shown in FIG. 21, the clamping edge 110 acts as a concave recessed area 112 for mating with the outer surface of the pen needle assembly. The angled end 108 is angled downward relative to the well 94 to enable the cover to slide over the clamping edge 110 while preventing removal of the cover in an upward direction.

Referring to FIG. 14 , the movable clamping member 48 includes two spaced apart posts 114 having a length extending through the guide slot 86 of the base 32 . The distal end of post 114 includes a notch 116 for mating with actuator assembly 38 . The legs 118 extend from the movable clamping member 48 in a direction opposite to the recessed area 92 . The distal end of the leg 118 includes a downwardly extending tab 124 for mating with the 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 and a leg 128 that passes through an opening 130 in the base 32 to enable the actuator button 122 to reciprocate in an up and down direction. In the illustrated embodiment, two legs 128 are provided, although a single leg could 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 , post 134 is provided in the underside of actuator button 122 to cooperate with and position spring 132 on actuator button 122 between legs 128 .

The ratchet assembly 124 as shown in FIG. 20 includes a ratchet connection member having a main 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 could be used. The distal end of each leg 138 includes a hole for receiving a 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 having an aperture 16 for receiving a 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 clamping member 48 . In the illustrated embodiment, the pawl 150 has an inclined face 152 forming a camming surface and an opposing flat face 154 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 located at one end of the corresponding guide slots 86 . Each post 156 includes an aperture 158 for receiving a pivot pin 142 for pivotally connecting the leg 144 of the body 136 to the base 32 as shown in FIG. 23 .

Attached to the bottom side of the movable clamping member 148 is a complementary ratchet member 160 as shown in FIGS. 16 and 21 . In the illustrated embodiment, the ratchet member 160 is fixed to the movable clamping member 160 . Referring to Figure 16, the ratchet member 160 includes a main body 162 having a leg 166 extending from one end. 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 corresponding movable clamping member 48 . The opposite end of the body 162 includes an aperture 170 for mating with the aperture 120 on the movable clamping 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 forming a camming surface and a flat face 176 extending substantially perpendicular to the longitudinal dimension of the body 62 . As shown in FIG. 26 , ratchet member 160 is coupled to movable clamping member 48 by tab 68 that cooperates with notch 116 formed in post 114 of movable clamping member 48 . Fasteners, such as screws, may extend through holes 170 formed in the body 162 to mate with holes 178 formed in the bottom surface of the tab 120 . In the illustrated embodiment, two spaced apart detents 172 are provided to cooperate 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 shown in FIGS. 22 , 23 , 26 and 27 , the sloped surface 174 of the pawl 172 of the ratchet member cooperates with the sloped surface 152 of the pawl 150 of the body 136 to slide past each other. The flat face 176 of the ratchet member 160 engages the flat face 154 of the body 136 to maintain the movable clamping member 48 in the closed position shown in FIGS. 31 and 32 until released by the actuator mechanism.

As shown in FIGS. 26 and 27 , the posts 114 and legs 118 of the movable clamping member 48 extend through corresponding guide slots 86 and elongated slots 88 in the base 32 . The main body 136 of the ratchet assembly 124 is coupled to corresponding posts 114 and legs 118 to capture the base 32 between the movable clamping member 148 and the main body 136 and to couple the movable clamping member 48 to the base 32 , while allowing the movable clamping member 48 to slide in a linear direction relative to the guide groove 86 , the elongated groove 88 and the fixed clamping member 46 .

The legs 128 of the button 122 extend through corresponding openings 130 formed in the base 32 as shown in FIGS. 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 capture 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 and down direction and is biased upward by a 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 Figure 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 clamping member 48 to the position shown in Figure 27 and relative to the fixed position. Open position of clamping member 146 . In use, the movable clamping member 48 is manually urged toward the fixed clamping member 146 against the biasing force of the spring 182 to the position shown in FIGS. 30 and 32 . As shown in FIG. 27 , the sloped surface 174 of the ratchet member 160 attached to the movable clamping member 48 opposes the sloped surface 152 of the pawl 150 on the body 136 . The movable clamping member 48 is slidable toward the fixed clamping member 46 so that the inclined surfaces 152 and 174 can slide past each other by pivoting the body 136 downward relative to the pivot pin 142 to disengage the pawls, thereby allowing the movable The clamping member 48 slides towards the fixed clamping member 46 . Once the inclined surface 174 slides over the inclined surface 152, the biasing force of the spring 132 returns the body 136 to the original position to lock the movable clamping member 48 in the closed position, as shown in FIGS. 31 and 32 . As shown in FIG. 32 , manually sliding the movable clamping member 48 into the closed position relative to the fixed clamping member 46 enables the flat surface 176 of the pawl 172 to engage the flat surface 154 of the pawl 150, thereby preventing the movable clamping member from clamping. The holding member 48 is separated from the fixed holding member 46 .

Once the movable clamping member 48 is locked in the closed position relative to the fixed clamping member 46, the arrangement may be used to couple the pen needle assembly 18 to a delivery device such as the pen needle 10. Pen needle assembly 18 may be positioned in one or more wells 94 formed by closed gripping members 46 and 48 . The pen needle assembly 18 can be manually placed in the corresponding well 94 and pushed down until the flanges 60 and 96 and the spring clip 64 engage the outer cover 22 . Typically, outer cap 22 is secured when an audible sound or click provides an indication of proper connection of the pen needle assembly to well 94 .

The flange 60 and spring metal clip 64 are capable of gripping the outer surface of the outer cover 22 to resist rotation of the outer cover relative to the clamping member and to resist removal of the outer cover from the well 94 . The label 26 can then be peeled off the outer cover 22 to expose the needle hub 16 for use. The delivery device, such as the pen needle 10, is then inserted into the hub 16 and screwed onto the hub in the usual manner. The delivery device with the needle hub 16 attached is removed from the outer cover 22 to expose the inner shield 24 . The inner shield 24 is then inserted through the hole 66 to engage the spring clip 68 . The delivery device is pulled upwards to separate the inner shield 24 from the hub 16 . The inner shield 24 may be manually pushed through the opening in the base 32 and into the tray 34 for disposal. Alternatively, subsequent inner shields may be pushed into holes 66 , with previous inner shields pushed through openings into tray 34 .

The delivery device with the hub attached can be prepared for use by a technician, for example by adjusting the dose and venting air from the delivery device and cannula 20 . At this stage, the needle hub 16 and delivery device can be inserted back into the corresponding outer cap 22 until ready for use. A delivery device may be prepared for each pen needle assembly positioned in a corresponding well 94 . The corresponding actuator button 122 may include indicia, such as numbers or letters, to designate the selected patient, dose or medicament contained in the delivery device. Each of the respective wells formed by gripping members 46 and 48 receives a pen needle assembly for preparing the delivery device for use. In this way, multiple delivery devices can be prepared for use at the same time, with each delivery device positioned within a respective wellbore identified by the indicia on the actuator button.

Each of the various delivery devices may be used to deliver a medicament to a patient. After use, the needle hub 16 is inserted back into the corresponding outer cover 22 while still attached to the delivery device, wherein the delivery device can be detached from the corresponding needle hub and the used needle hub is left by the delivery device. The wells formed by the clamping members 46 and 48. The corresponding actuator button 122 for the corresponding well 94 can then be depressed, causing the main body 136 of the ratchet mechanism 124 to pivot downward to connect the pawl 150 on the main body 136 to the movable clamping member 48 The pawl 172 on the main body 166 of the ratchet member disengages. The spring 182 then biases the movable clamp member 48 to the open position, allowing the spent pen needle assembly to separate from the clamp members 46 and 48 and drop into the tray 34 for safe disposal. The movable clamping member 48 can then be manually pushed into the closed position to receive a new pen needle assembly. In this way, the used pen needle assembly can be discarded into the tray after use without requiring a technician to handle the needle hub, thereby reducing the risk of needlesticks 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, where the clip includes sharp edges 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 dimension of the inner shield 24 so that the inner shield can pass through without interference. The distal end of the longitudinal opening may include at least one tooth projecting inwardly relative to the circular opening. The teeth may have inclined surfaces forming sharp tips and sloping in a generally downward direction to allow sliding of the inner shield 24 on the tips and to prevent removal of the inner shield in an upward direction. The teeth may be sufficiently flexible that the inner shield may be pushed through the opening to access the tray or other vessel in the housing.

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

In another embodiment shown in FIGS. 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 the hub 16 attached can be inserted through the collar and housing such that the hub 16 is received in the outer cap 22 . The actuator 108 may then be depressed to disengage the clamping members to release the outer 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 illustrative only and should not be construed as limiting the scope of the invention. The description of the exemplary embodiments of the present invention is intended to illustrate, not to limit, the scope of the invention. Various modifications, substitutions and changes would be apparent to those of ordinary skill in the art and are intended to fall within the scope of the present invention. It should be noted in particular that the features of different embodiments and claims can be combined with each other, as long as they do not contradict each other. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.

Claims (18)

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, the movable clamping member being spring biased to the open position; and

an actuator mechanism for moving said movable clamping member to said open position to release said pen needle assembly, wherein said actuator mechanism comprises an actuator movable between a first position and a second position and comprises a ratchet member to hold said movable clamping member in said closed position when said actuator is in a first position and said actuator is movable to a second position to release said movable clamping member.

2. The pen needle assembly device according to claim 1, wherein the ratchet member comprises a pawl for engagement with a pawl on the movable clamping member.

3. The pen needle assembly device according to claim 2, wherein the actuator comprises a movable button coupled to the ratchet member, and wherein moving the button to an actuated position disengages the pawl on the ratchet member from the pawl of the movable clamping member.

4. The pen needle assembly device according to claim 3, wherein said ratchet member has a body having a first end pivotally connected to said base to pivot about a fixed pivot point relative to said base, and a second end pivotally connected to said button, wherein said body includes said pawl for engaging said pawl of said movable clamping member.

5. The pen needle assembly device according to claim 1, wherein the device comprises a collecting tray located below the base, and wherein the pen needle assembly falls into the collecting tray when released by the movable gripping member.

6. The pen needle assembly device according to claim 1, wherein each opening of the plurality of openings with the base is associated with a respective fixed gripping member and a respective movable gripping member.

7. The pen needle assembly device according to claim 6, further comprising a spring member engaging the movable clamping member to bias the movable clamping member to the open position.

8. The pen needle assembly device according to claim 7, wherein said actuator includes a ratchet member to engage a pawl on said movable clamping member.

9. The pen needle assembly device according to claim 7, wherein said actuator includes a body having a first end pivotally connected to said base to define a fixed pivot point of said body and a second end pivotally connected to said actuator.

10. The pen needle assembly device according to claim 9, 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.

11. The pen needle assembly device according to claim 10, wherein said movable clamping member is spring biased to said open position in which said detent on said body engages said detent on said movable clamping member, and wherein said actuator is movable to said second position to disengage said detent on said body from said detent on said movable clamping member, whereby said movable clamping member is biased to said open position.

12. The pen needle assembly device according to claim 1, wherein the movable clamping member is configured to be manually moved to the closed position by a user.

13. The pen needle assembly device according to claim 1, wherein said ratchet member is pivotally connected to said actuator and said base.

14. A method of assembling a pen needle assembly to a pen needle delivery device comprising:

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 a cover of the pen needle assembly inserted into the opening, the movable gripping member being spring biased to the open position;

coupling a pen needle delivery device to a needle hub of the pen needle assembly;

removing the pen needle delivery device and pen needle hub to deliver a substance to a patient;

returning the pen needle delivery device and pen needle hub into the outer cover and separating the pen needle delivery device from the needle hub; and

actuating an actuator to release the pen needle assembly from an opening in the assembly;

wherein the actuator is movable between a first position and a second position and includes a ratchet member to retain the movable clamp 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 clamp member.

15. The method according to claim 14, wherein the device comprises a plurality of openings for receiving respective pen needle assemblies, each of the openings having a fixed gripping member, a movable gripping member and an actuator, the method comprising inserting a pen needle assembly into each opening to couple to a respective pen needle delivery device and selectively actuating the actuator to release the pen needle assembly after use.

16. The method according to claim 15, wherein the device includes a tray located below the opening and the method includes actuating a selected actuator to release and drop a used pen needle assembly into the tray.

17. The method of claim 14, wherein the movable clamp member is configured to be manually moved to the closed position by a user.

18. The method of claim 14, wherein the ratchet member is pivotally connected to the actuator and the device.

Images