CN109966595B - Pen needle assembly apparatus and method of coupling a pen needle to a delivery pen - Google Patents

Abstract

The present disclosure relates to a pen needle assembly apparatus including a housing, a movable support for supporting a pen needle, an ejector to eject a used pen needle from the support, and an actuator. The support rotates relative to the housing to index the pen needle to a position where the pen needle can be accessed and coupled to the delivery device. The used pen needle is returned into the well of the support and the support is rotated towards the ejector, where the used pen needle is ejected into a compartment in the housing for disposal. A cover on the housing includes at least one opening for accessing the pen needle when the support is rotated to position the pen needle relative to the opening in the cover. The present disclosure also relates to a method of coupling a pen needle to a delivery pen.

Description

Pen needle assembly apparatus and method of coupling a pen needle to a delivery pen

technical field

The present invention relates generally to a pen needle assembly apparatus and an apparatus for attaching a pen needle assembly to a pen delivery device. The device has a well-shaped cavity or opening for holding the hub with the inner shield before and after use to reduce the risk of inadvertent needle sticks. The device is capable of moving used pen needles to a compartment or removable tray for disposal. The device has a second well to receive the inner guard for separating the inner guard of the pen needle from the needle hub without manipulating the inner guard.

Background technique

Insulin and other injectable medications are commonly delivered with a medication delivery pen, in which a disposable pen hub is attached to the pen to aid in the retrieval of the medication container and to allow fluid to exit the container through the needle and into the patient.

Various pen needle delivery devices are known in the art for dispensing substances to patients. Delivery devices typically use a disposable 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 hub is coupled to the pen delivery device for delivering the substance to the patient.

Hub assemblies are typically packaged in a container that contains a number of loose hubs. The needle hub is selected from the packaging and attached to the pen needle delivery device used to administer the injection to the patient, and then removed for disposal. The hub package includes an outer cover enclosing the hub, and a removable seal that peels away from the outer cover to open the cavity to enable removal of the hub. The hub can have a threaded non-patient end that is threaded onto the delivery device. The delivery device with the hub attached is thereafter removed from the outer cover. An inner needle guard is attached to the hub so as to cover the cannula until the delivery device is ready for use. The guard is removed to expose the cannula for delivering the substance to the patient. After use, the hub can be inserted back into the outer cover to encapsulate the exposed cannula. The pen delivery device is separated from the hub, leaving the hub in the outer cover.

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

Prior pen needle assemblies are disclosed in U.S. Patent Application Publication Serial No. 2006/0229562 in the name of Marsh et al. and U.S. Patent Application Publication Serial No. 2007/0149924 in the name of R. Marsh, the entire contents of which are herein This application is incorporated by reference.

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

Contents of the invention

The present invention relates to a pen needle assembly 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 present invention relates to an apparatus for a pen needle assembly that can be used in the following manner: in attaching and removing the pen needle assembly to a delivery pen and disposing of a used pen Reduces the risk of unintentional needle sticks during acupuncture. The pen needle device can include a mechanism for advancing the pen needle to a position where the pen needle can be coupled to a delivery pen and for advancing the used pen needle to a position where the used pen needle can be transferred to a storage tray or The location of the storage box.

In one embodiment of the invention, the device is provided with a support having an opening or well for a pen needle. Typically, the support has a plurality of well-shaped cavities for receiving pen needles. A pen needle includes an outer cover, a hub for supporting the cannula or needle, and an inner shield covering the cannula. A removable seal closes the open end of the outer cover, the seal being removed prior to attaching the hub to the delivery pen. The apparatus holds and supports the pen needle assembly and hub and cannula while attached to a delivery pen or other delivery device. The device is capable of storing used hubs and outer covers for disposal.

The device has a recess or well for receiving and retaining the inner shield covering the cannula of the pen needle so that the inner shield can be removed from the hub without manipulation of the inner shield by the operator. The used needle hub can be inserted back into the outer cover and transferred to a compartment with a storage tray or internal sharps container for disposal. The inner shield can be discarded in the storage tray. The actuator moves the support and pen needle into position for attachment to a delivery device, such as a delivery pen. The ejector transfers the used pen needles from the corresponding well to a suitable tray, container or disposable storage case, eg, a sharps container.

In one embodiment, the inner guard is insertable into an opening forming a well in the device to engage an extractor with a gripping member located within the device such that the inner guard is retained by a friction or interference fit. The hub and cannula can then be pulled apart to separate from the inner shield without requiring manipulation of the inner shield by the user, while retaining the inner shield within the well. The inner guard can be pushed past the gripping member into a tray or cavity in the device forming a sharps container.

One aspect of the present invention provides an apparatus for receiving and supporting multiple pen needles for attaching a hub to a pen without requiring the user to manipulate the hub having an exposed cannula thereon. Delivery device (eg delivery pen). The pen needle 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 guard on the hub can then be inserted into the opening of the device so that the inner guard is grasped by the extraction mechanism so that the inner guard can be separated from the hub without manipulation of the inner guard. After use, the hub is positioned in the outer cover held in the opening of the device and is disconnected from the delivery device at the point where the device retains the used hub and outer cover.

The device includes a housing having an interior cavity for receiving and storing used pen needles and associated components. The housing has an opening to access the pen needle so that the needle hub can be attached to the delivery pen. The used needle hub can be inserted back into the outer cover held in the device and separated from the delivery pen.

A pen needle device in one aspect includes a housing, a pen needle support and an actuator. The housing has an inner cavity, a top end and a bottom end. The needle support has a plurality of wells for receiving needles. The support can be moved within the housing by actuating the actuator to move the support and corresponding pen needle to a position where the delivery device can acquire the pen needle. The support can then be moved to a position in the housing where the used pen needles are transferred to a compartment, which can include a tray for disposal of the pen needles.

Features of the device are provided by a pen needle assembly device for receiving a pen needle, wherein the device includes a housing, a movable support and an actuator. The housing has an inner compartment that receives a used pen needle for disposal. The support is disposed in a housing in which the support has a plurality of well-shaped cavities. Each of the wells is configured to receive a pen needle. A cover is coupled to the housing and has an opening for accessing at least one of the pen needles stored in the support. The apparatus includes an actuator for moving the support to a position in which the stylus is sequentially indexed to a position where the stylus is accessible through the opening in the cover.

After use of the hub and cannula, the hub, while attached to the delivery pen, is inserted into the opening and into the outer cover, where the needle can be grasped by a friction or interference fit with the outer cover The hub allows the pen needle delivery device to be detached from the hub without the operator manipulating the hub, thereby reducing the risk of inadvertent needle sticks. The support for the needles can then be moved to a position where the used needles are ejected into the used needle compartment for disposal.

The features of the pen needle assembly device are further obtained by providing a housing having a tip, a rotatable support positioned within the housing, a cover and an ejector. The support has a plurality of wells sized to receive pen needles. A cover is coupled to the top end of the housing, wherein the cover has an opening for accessing the needle assembly, wherein the support can be rotated and indexed to a position to access each pen needle through the opening in the cover. The well is capable of receiving a used pen needle for disposal. The ejector expels the used pen needle from the well into a compartment of the housing by rotation of the support relative to the housing.

In other embodiments, a method of attaching a hub of a pen needle to a delivery device using a pen needle assembly apparatus is provided. The device has a needle housing with a rotatable support and an actuator for rotating the support. The support has a plurality of wells for receiving needles, and the housing includes an ejector for ejecting the needles from the wells after use. The method includes the steps of inserting the coupled end of the delivery device into the pen needle within the well and coupling the coupled end of the delivery device to the open end of the hub. The delivery device and attached hub are removed, leaving the outer cover retained in the housing. The inner shield is inserted into the opening or well, wherein the inner shield is grasped with sufficient force so that the needle hub can be pulled out of the inner shield and separated from the inner shield to expose the cannula for use in The substance is delivered to the patient. After use, the hub is inserted into the outer cover held in the well of the support and separated from the delivery device. The actuator is then actuated to rotate the support into engagement with the ejector, wherein the used pen needle is ejected from the well into the compartment for disposal.

In one aspect of the present disclosure, there is provided a method of coupling a pen needle to a delivery pen, the method comprising: providing a pen needle device having a housing, a rotatable support, an actuator, and a pen needle ejector, the support having a plurality of wells for receiving pen needles; rotating the support to a position to capture the pen needles, and coupling the delivery device to the pen needles; returning the used pen needle to the corresponding well in the support; and rotating the support to another position in which the used pen needle is removed from the The well is expelled into a compartment of the housing.

In one embodiment of the present disclosure, the pen needle device includes a cover on the open top end of the housing, the cover having at least one opening for accessing the pen needle, the method comprising The support is rotated to orient the needle in a position relative to the opening in the cover to access the needle.

In one embodiment of the present disclosure, the cover has a recess forming a channel oriented relative to the ejector, the method comprising rotating the support relative to the ejector to pass through The channel ejects used pen needles to the compartment.

In one embodiment of the present disclosure, the ejector includes a movable arm for engaging the distal end of the pen needle, the method comprising rotating the support to actuate the ejector , to expel the used pen needle from the well into the compartment.

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

Description of drawings

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

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

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

Figure 3 is a left side perspective view of the pen needle assembly device in one embodiment;

Figure 4 is a right side perspective view of the device of Figure 3 showing the pen needle positioned in the opening of the cover;

Figure 5 is an exploded view of the device of Figure 3;

Figure 6 is a bottom perspective view of the device of Figure 3;

Figure 7 is a top perspective view of the base member of the device;

Figure 8 is a bottom perspective view of the inner support of the device;

Figure 9 is a top perspective view of the pen needle support ring;

Figure 10 is a bottom perspective view of the support of Figure 9;

Figure 11 is a bottom view of the support of Figure 9;

Figure 12 is a front view of the actuator;

Figure 13 is a bottom perspective view showing the actuator of the ratchet mechanism;

Figure 14 is a bottom perspective view of the support and ratchet mechanism without the base member;

Figure 15 is a bottom perspective view of the support and ratchet mechanism;

Figure 16 is a perspective view of a pen needle ejector;

Figure 17 is a bottom perspective view of the support and ejector mechanism;

Figure 18 is a bottom perspective view showing the support of the ejector mechanism;

Figure 19 is a bottom perspective view showing the support of the ejector mechanism;

Figure 20 is a top perspective view of the cover, support and ejector mechanism;

FIG. 21 is a partial cross-sectional view showing an apparatus for an inner shield extractor for an inner shield;

Figure 22 is a cross-sectional view of the device showing the inner shield extractor;

Figure 23 is an exploded view of the tray and cover; and

Figure 24 is an exploded bottom perspective view of the cover and spring clip of the inner shield extractor.

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

detailed description

A pen needle assembly apparatus for storing and supporting at least one, preferably a plurality of pen needles for use with a delivery device such as a delivery pen. The pen needle assembly device receives a used needle hub, wherein the used needle hub can be replaced in the device after use and discarded without manipulation of the needle hub in order 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 like elements. The embodiments described herein illustrate the present invention by referring to the drawings, but do not limit the present invention. The exemplary embodiments are presented in separate descriptions, although the individual features and configurations of these embodiments can be combined in any manner to meet the therapeutic needs of the user.

It should be understood by those skilled in the art that the application of the present disclosure is not limited to the details of construction and arrangement of the components set forth in the following description or shown in the drawings. The embodiments herein can be modified, practiced or implemented 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. Here, "comprising", "comprising" or "having" and variations thereof mean that the items listed thereafter and their equivalents and other items are encompassed. As used herein, unless expressly stated otherwise, the terms "connected", "coupled" and "mounted" and variations thereof are used broadly and encompass direct and indirect connections, couplings and mountings. Additionally, 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 used to aid in description rather than limitation.

An apparatus for pen needles can facilitate assembly and removal of a needle hub on a pen delivery device with reduced manipulation of the exposed needle cannula. Devices for pen needles can be placed on a flat surface (e.g., a tabletop), allowing a delivery device, such as a delivery pen, to be attached to the hub with one hand, reducing the risk of manipulation with the needle cannula exposed. Risk of needle stick due to needle hub.

The delivery device is shown as delivery pen 10 in FIG. 1 . A delivery pen typically includes a dosing knob/button, an outer sleeve 12 and a cap. The dosing knob/button allows the user to set the dose of drug to be injected. When injecting the drug, the outer sleeve 12 is grasped by the user. The cap is used by the user to securely hold the pen-injector device 10 in a shirt pocket or other suitable location, and to provide coverage/protection from accidental needle injury.

In a standard delivery pen or pen needle delivery device, a dosing and delivery mechanism is provided in the outer sleeve 12, and it is not described in more detail here, because those skilled in the art understand the dosing and delivery mechanism. delivery mechanism. The drug cartridge is usually attached to a standard pen-injector housing by known attachment means. Distal movement of the plunger or stop within the drug cartridge causes the drug to be pushed into the reservoir housing. The drug 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 threaded onto the drug cartridge, although other attachment means can be used. The pen needle delivery device can be a standard pen delivery device known in the industry, so the pen needle delivery device is not shown in detail. Pen needle assembly 18 as shown in FIG. 2 includes hub 16 supporting sleeve 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 cover to encapsulate the hub and cannula so as to maintain a clean and sterile condition. Seal 26 can be a label or other closure member that can be easily peeled off from the outer cover to gain access to the hub during use.

The pen needle delivery device 10 is connected to a needle hub 16 shown in FIG. End 18. A needle cannula 20 extends from the patient end of hub 16 for delivering a substance to the patient. Outer cover 22 can be configured to cover the needle cannula to prevent inadvertent needle sticks to the patient before and after use. Outer cover 22 includes ribs 23 to assist in gripping the outer cover during use. An inner shield 24 is provided on a strut extending from the end of the hub 16 to enclose the cannula. During use, hub 16 is connected to the pen delivery device and the inner shield is removed. After use, the outer cover is usually put back on the hub to cover the needle cannula. Subsequently, the hub and cover are removed from the pen needle delivery device and discarded.

The apparatus in one embodiment is configured to receive and support at least one pen needle, typically a plurality of pen needles, in a position where a delivery device can be coupled to a needle hub for The substance is injected into the patient without requiring the user to manipulate the hub with the exposed cannula. The used hub and cannula can then be positioned back into the outer cover retained in the device and separated from the delivery device. The used outer cover and hub and inner shield are transferred to a compartment in the device for disposal.

In one embodiment, the apparatus is configured for receiving a pen needle, for coupling the pen needle hub 16 to the delivery pen, and for detaching the pen needle hub 16 from the delivery pen after use. In one embodiment, the device includes a housing 30 and a support 40 for holding a plurality of pen needles. As shown in FIGS. 3 and 4 , the housing 30 has side walls 48 , a top end 34 and a bottom end 36 . As shown in FIG. 6 , bottom end 36 has a bottom surface that can include a non-slip surface. The non-slip surface can be molded directly onto the bottom surface or can be a non-slip material, such as an elastomeric material, applied to the bottom surface to hold the housing in place on a table or other flat surface during use.

As shown in FIG. 6 , the housing 30 has a bottom wall with an opening receiving a base 100 as shown in FIGS. 5 and 7 in order to support the movable parts of the assembly. Base 100 has a bottom wall 106 configured for coupling to the bottom wall of housing 30 as shown in FIG. 6 . A central post 102 extends upwardly from a bottom wall 106 of the base 100 and is centrally located within the housing 30 . A plurality of guide pins 104 extend from the base around the central post 102 and have an axial length that is less than the axial length of the central post 102 .

The inner support 110 shown in FIG. 8 is attached to the base 100 and the bottom wall of the housing 30 . The inner support 110 has a top wall 112 and a central opening 114 formed by a generally cylindrical wall 116 spaced inwardly from the outer peripheral edge of the top wall 112 . Central opening 114 defines a passageway sized to receive central post 102 and guide pin 104 of base 200 and actuator 56 . The top wall 112 has an opening 118 formed by the side walls 120 for receiving the tray 94 for storing used pen needles. The guide rail 122 extends around a portion of the outer peripheral edge on the inner face of the top wall 112 for guiding the support 40 . In the illustrated embodiment, the guide track 122 is positioned opposite the side wall 120 and spaced inwardly from the peripheral edge.

The inner cylindrical wall 116 has a top end integrally formed with the top wall 112 and a bottom end for coupling to the base 100 and/or the bottom wall of the housing 30 . As shown, the cylindrical wall 116 has a slot 124 oriented in a plane perpendicular to the longitudinal axis and extending in a circumferential direction around the wall 116 . In the illustrated embodiment, two slots 124 are formed on opposite sides of the cylindrical wall 116 and include longitudinal leg portions 126 for accessing the slots 124 .

As shown in FIGS. 5 and 9-11 , a support member 40 forming a support ring or carousel is provided for supporting a plurality of pen needles 18 . The support 40 in one embodiment has a top surface 130 with a plurality of wells 42 each shaped and dimensioned to support and receive the pen needle 18 . The support 40 can have a suitable shape to be received in the housing 30 . In one embodiment, the support 40 is movable to rotate to multiple angular positions to allow access to each of the stylus 18 for subsequent use by the user when the stylus 18 is aligned with the opening 64 in the cover 60 . The support 40 is shown as having a circular ring shape mounted in the housing 30 for rotation about a central axis, although other shapes could be used.

Well 42 in support 40 is defined by an open top end sized to receive pen needle 18 such that the non-patient end and needle hub of the pen needle are oriented at the top end of well 42 . The well-shaped cavity 42 is formed by a circular side wall 44 having an open bottom 46 as shown in FIG. 11 . The side wall 44 is tapered to complement the shape of the outer cover 22 of the pen needle 28, and the axial length of the side wall 44 is less than the axial length of the outer cover so that the outer cover passes through the open bottom end 46. The opening protrudes, as shown in Figure 10 and Figure 15. For purposes of illustration, in each of the figures, the pen needles are not shown installed in the wells of the support, although it should be understood that each of the wells can be loaded with new ones prior to use. pen needle. The inner surface of the sidewall includes at least one rib or recess shown in FIG. 9 that is capable of engaging the rib 23 on the outer surface of the outer cover 22 to prevent rotation of the outer cover 22 within the well 42 .

In the embodiment shown in FIGS. 9 to 11 , the support 40 is in the form of a ring having a top surface 130 with openings formed by well-shaped cavities 42 and spaced around the circumference of the support 40 . The bottom side 132 of the support 40 includes the side walls 44 of the corresponding well 42 as shown in FIG. 10 . A plurality of angled teeth 134 are disposed around the peripheral edge of the support 40 and protrude from the bottom side in the axial direction, as shown in FIG. 10 . The teeth 134 form a ratchet mechanism for allowing the support to rotate in one direction relative to the housing 30 and operate the ejector mechanism 80 . The teeth 134 are spaced around the peripheral edge and include an inclined face 136 and a vertical face 138 .

The support 40 shown in FIG. 10 has a central opening 140 forming an annular inner surface 142 . A plurality of ratchet teeth 144 project radially inwardly from the annular inner surface 142 as shown in FIGS. 10 and 11 . The ratchet tooth 144 has an inclined surface 146 and a vertical surface 148 for cooperating with a rotating body in order to rotate the support relative to the housing.

An actuator 56 is connected to the housing for operative connection to the support 40 for moving and indexing the support 40 to a position where the stylus 18 is accessible and connected to the Delivery pen, as shown in Figure 4. The actuator 56 in the illustrated embodiment moves in a linear direction relative to the housing 30 and support 40 . The actuator 56 can be in the form of a button that is manually depressed to cause the support 40 to rotate relative to the housing 30 . In one embodiment, the actuator 56 moves in a linear up and down direction relative to the housing 30 . In other embodiments, the actuator 56 can be located in other suitable locations.

The actuator 56 in the illustrated embodiment forms a button that is manually pushed down by the user to rotate the support 40 and index and advance a new stylus relative to the cover 60 to a position , in which position the pen needle can be coupled to the delivery pen. The actuator 56 shown in FIG. 12 has a cylindrical side wall 150 with a top wall 152 and an open bottom end 154 . The outer dimensions and configuration of the actuator 56 are such that it slides within the central opening 114 of the inner support 110 and in the opening of the cover 60 . Outwardly extending tabs 156 project from the outer surface of sidewall 150 and are positioned at open bottom end 154 . In the illustrated embodiment, four lugs 156 are provided which slide within slots 158 formed in the cylindrical side wall 116 of the inner support 110 . The lugs 156 cooperate with the inner support 110 to enable the actuator 56 to slide in a linear up-down direction and prevent rotation relative to the support 100 and housing 30 . A spring 160 is generally disposed between the actuator 56 and the bottom wall or base 100 of the housing to bias the actuator 56 relative to the housing 30 into an extended upper position, as shown in FIG. 3 . The bottom end 154 of the actuator 56 can be provided with a plurality of cylindrical guides with axial channels 155 forming guide holes for receiving corresponding guide pins 104 on the base 100 in order to The actuator slides in a linear direction.

Referring to Figures 12 and 13, the side wall 150 of the actuator 56 includes a slot 162 forming a cam surface. The slot 162 has a first portion extending obliquely with respect to the longitudinal axis of the actuator 56 . The sloped segments form sloped cam surfaces 164 and 166 . In the illustrated embodiment, an open horizontal leg portion 168 extends circumferentially from the bottom end of slot 158 . A cutout 170 is formed at one end of the leg for access to and from the slot 162 .

As shown in Figures 13 to 15, the rotating body 180 is operatively connected to the actuator 56 for connecting the actuator 56 to the support 40 and causing the support to rotate relative to the housing. The rotating body 180 in the illustrated embodiment has a cylindrical collar 182 which is rotatable on the central column 102 . A first rod 184 extends from a first side of a ring 188 on the ferrule 182 and a second rod 186 extends from a second side of the ring 188 of the ferrule 182 . As shown in FIG. 13 , rods 184 and 186 are received in slot 162 and coupled to actuator 56 . In one embodiment, a spring 160 , such as a coil spring, is disposed on post 102 to bias actuator 56 in the upward position.

The first rod 184 of the rotator 180 extends a distance from the side wall 150 of the actuator to engage the teeth 144 on the annular inner surface 142 of the support 40 . As shown in FIG. 13 , the distal end of the first rod 184 includes a ratchet member 190 for engaging the ratchet teeth 134 on the annular inner surface of the support 40 . Ratchet 190 includes a flexible leg forming a pawl connected to body 194 by a flexible hinge portion 196 to bias leg 192 radially outward from actuator 56 into engagement with the teeth of support 40 . 134 contacts. In the illustrated embodiment, the first lever 184 and the second lever 186 include a ratchet 190 . In other embodiments, one of the legs does not include a ratchet or pawl for engaging teeth on the annular inner surface of the support. For ease of illustration, the ratchet and pawl on the second lever are not shown in each of the figures.

As shown in FIGS. 14 and 15 , linear movement of the actuator 56 causes the first rod 184 and the second rod 188 to rotate in the forward direction indicated by the arrow 193 by engaging the inclined cam surface 136 such that the flexible legs The distal end of 192 engages a corresponding tooth 134 on the annular inner surface of support 40 to rotate support 40 in the direction of arrow 195 . Spring 160 biases actuator 56 back to the original position. The upward movement of the actuator 56 causes the flexible leg 192 to move back to the original position and slide over the corresponding tooth in the direction opposite to the arrow 193 to engage the next adjacent tooth 148 for allowing the support 40 to move each time. In both cases the actuator 56 is pressed forward.

Cover 60 is provided over housing 30 to enclose support 40 and pen needle 18 until ready for use. In the illustrated embodiment, the cover is connected to the housing 30 by a hinge 62, although other mechanisms could be used to attach the cover to the housing. As shown in FIG. 3 , the cover 60 includes at least one opening 64 for accessing the pen needle 18 when the needle is advanced into the opening 64 . The opening 64 can have a generally U-shaped shape, sized to enable removal of a needle hub from a corresponding pen needle in the well 42 of the support 40 . In one embodiment, the size of the opening 64 is smaller than the size of the outer cover 22 of the pen needle 18 such that the outer cover 22 is retained in the well of the support 40 while allowing the needle hub to be removed. The actuator 56 is capable of rotating and indexing the support 40 such that the stylus 18 enters the opening 64 of the cover each time the actuator 56 is depressed.

As shown in the embodiment of FIG. 3 , the cover 60 includes a dome-shaped projection 65 that protrudes from a top surface of the cover adjacent or adjacent to the opening 64 . The protruding portion 65 forms a recess 66 in the bottom surface of the cover 60 shown in FIG. 21 . Recess 66 has a first end 68 overlying support 40 , and a second end 70 extending inwardly from inner wall 52 of housing 30 and Wherein, the concave portion 66 has a size to receive the pen needle 18 . A compartment 72 is provided in the housing which has a storage tray 74 or storage bin for receiving used pen needles 18 .

Referring to FIGS. 16 to 19 , an ejector 80 is provided in the housing 30 for ejecting a used pen needle from a corresponding well 42 by rotating the support 40 relative to the housing 30 and the ejector 80 18. The ejector in one embodiment includes a base 200 as shown in FIG. 16 which fits in an opening in the bottom wall of housing 30 as shown in FIG. 6 . A vertical support 202 extends from the base 200 and supports a pivot arm 204 . The arm 204 forms an inclined member with an inclined surface 206 . Arm 204 is biased away from base 200 by spring 207 such that arm 204 pivots about pivot pin 209 relative to support 202 . Arm 204 has a first end 208 and is positioned for contacting a used pen needle protruding from well 42 through the bottom surface of support 40 , as shown in FIG. 15 . Arm 204 is shaped and dimensioned to contact the distal end of outer cover 22 protruding from the bottom end of the corresponding well 42 as support 40 rotates the pen needle into engagement with ejector 80 . The ejector 80 is attached to the housing 30 and is secured to the housing generally below the support 40 . As shown, cover 60 is oriented relative to housing 30 such that opening 64 in cover 60 is adjacent or adjacent to ejector 80 and recess 66 is oriented at the end of sloped surface 206 of ejector 80 .

The ejector 80 is spring biased to the position shown in FIG. 16 . The distal end 208 is provided with a detent 211 shown as a pin protruding from the side of the arm 204 . The detent 211 is positioned to engage the teeth 134 of the support 40 to move the arm in an up and down motion and acts as a ratchet to allow the support 40 to rotate in the forward direction but prevent it from rotating in the opposite direction. Referring to FIG. 18 , as the support 40 is rotated relative to the ejector 80 and housing 30 , the detent 211 slides along the inclined surface 136 of the tooth 134 . As the support 40 rotates, the detent 211 slides up the inclined surface 136 to the position shown in FIG. 40. FIG. 19 shows the ejector and ring 40 without the ratchet teeth 134 .

As shown in FIG. 20 , the support 40 is advanced such that the detent 211 is spring biased into the valley 139 between adjacent teeth 134 . In one embodiment, the arm 204 is snapped to the extended position shown in FIG. 20 by a spring 207 so as to strike the distal end of the pen needle protruding from the opening 46 at the bottom of the well 42 to move the used needle along the The upward direction is expelled into the recess 66 defining the dome 64 shown in FIGS. 21 and 22 . As the support 40 rotates again to advance a new needle to the position of the opening 64 of the cover 60, the used needle advances while the teeth 134 on the support 40 push the ejector's needle against the biasing force of the spring 207. Arm 204 is pressed into the loaded position.

As shown, actuator 56 is depressed to advance and index stylus 18 into view of opening 64 of cover 40 , as shown in FIG. 3 . The seal is removed so that the pen needle can then be attached to the pen delivery device for use. After use, hub 16 is inserted back into outer cover 22 through opening 64, enabling delivery pen 10 to be disconnected by unscrewing and detaching from the hub. The used needle is then advanced by depressing the actuator 56 so that the distal end of the outer cover 22 is positioned relative to the ejector 80 such that the needle 18 is pushed upward into the recess 66 formed in the cover 60, And is directed into a compartment for used pen needles.

As shown in FIGS. 21-24 , housing 30 , cover 40 and tray 74 cooperate to form extraction mechanism 210 to aid in removal of inner shield 24 of the pen needle assembly without requiring manipulation of the inner shield by the patient. The extractor 210 is configured to remove the inner shield 24 from the hub 16 prior to use and for disposal after use. The extractor 210 includes a gripping mechanism capable of gripping the inner shield so that the needle hub can be pulled apart, and wherein the used inner shield can be placed into a tray 74 or other storage container for for disposal.

In the illustrated embodiment, extractor 210 is coupled to lid 212 of tray 74, as shown in FIGS. 21-24. The cover 60 of the device includes an opening 214 having chamfered edges sized to receive the inner shield and prevent passage of the needle hub through the opening. Lid 212 and tray 74 are positioned in the device below opening 214 as shown in FIG. 21 . The cover 212 includes an opening 216 that has a chamfered edge on the top surface and is aligned with the opening 214 in the cover 60 . The opening 216 in the cover and the opening 214 in the cover form a well-shaped cavity for receiving the inner shield. Opening 216 is also sized to receive an inner shield.

In the illustrated embodiment, the extractor 210 includes a gripping member, shown as resilient metal clips 218 mounted on the bottom surface of the cover 212 on opposite sides of the opening 216 . Each clip 218 has a body 220 with an aperture 221 coupled to a corresponding post 222 on the bottom surface of cover 212 . The distal end of clip 218 includes an angled tab 224 having an edge 226 that projects into the channel defined by opening 216 as shown in FIGS. 21 and 22 . In use, the inner shield 24 is inserted through the openings 214 and 216, wherein the edge 226 of the resilient clip 218 grips the inner shield to prevent movement of the inner shield in an outward direction relative to the cover 60 such that the needle hub Can be separated from the inner guard. The body 220 and/or angled tabs 224 are sufficiently flexible to flex inwardly so as to allow transfer of the inner shield to the tray while resisting pulling the inner shield in an upward direction. The inner guard of a new pen needle can then be inserted through the opening so that the previous inner guard is pushed through the spring clip 218 into the tray 74 so that the spring clip can grip the new inner guard for the needle hub. separate from the inner guard.

In one embodiment, the shape of the tray 74 and cover 212 is complementary to the shape of the device. As shown in FIG. 23 , the tray and cover have the generally curved shape of the housing 30 . The cover 212 has a top wall 228 and a peripheral side wall 230 . A molded handle 232 is formed in the top wall 228 to facilitate separation from the tray. Opening 234 is provided for receiving a pen needle expelled from the well through channel 66 in the cover.

The tray 74 in the illustrated embodiment has a bottom wall 236 , side walls 238 and an open top end 240 for mating with the lid 212 . The bottom wall 236 can be formed with a sloped surface to slope away from the opening 234 in the cover 212 to prevent used pen needles from collecting directly under the opening.

The assembly is capable of receiving a pen needle assembly to assist the user in attaching the hub to the delivery pen while requiring the user to manipulate the hub and exposed cannula. During use, the actuator is depressed so that the support 40 and needle 18 are advanced to a position aligned with the opening 64 in the cover 60 in which the needle can be seen and accessed. pick up from

The outer cover of the pen needle received in the well of the support 40 removes the tab.

The delivery pen is then inserted through the opening 64 in the cover of the housing to engage the hub of the pen needle. The delivery pen is rotated to engage internal threads on the hub for coupling to the delivery pen. The delivery pen and attached hub 16 can be pulled away from the outer cover, leaving the outer cover retained in the well 42 .

An inner shield 24 is attached to the hub to cover the cannula when detached from the outer cover. The inner guard of the pen needle is then inserted into the extractor 210, as shown in Figures 21 to 24, wherein the inner guard 24 passes through the opening such that the edge 226 of the clip engages the outer surface of the inner guard for gripping the inner guard And prevent upward movement. The delivery pen can then be removed, leaving the inner shield 24 retained in the extractor.

After use of the delivery pen and needle, the delivery pen can then be inserted through the opening 64 in the cover 60 , wherein the needle hub is again received in the outer cover 22 held in the well 42 . The delivery pen can then be rotated such that the delivery pen is disconnected from the inner thread of the hub and removed from the device. The actuator 56 can then be depressed causing the support 40 to rotate so as to index the well 42 and the used pen needle towards the ejector 80 . Movement of the support causes the spring-biased arm 204 of the ejector to strike the distal end of the outer cover 22 to expel the pen needle upwardly and out of the well 42 . The used needle 18 then passes through the passageway defined by the recess 66 and into the tray 74 received in a compartment of the housing. The cover can be opened to allow removal of the tray 74 for disposal of used pen needles.

The foregoing embodiments and advantages are exemplary only and should not be considered as limiting the scope of the invention. The description of the exemplary embodiments of the present invention is intended to explain rather than limit the scope of the present invention. Various modifications, substitutions and variations will be apparent to those skilled in the art and fall within the scope of the present invention. It is especially noted 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 apparatus comprising:

a housing having an internal cavity, a top end and a bottom end, and a support having a plurality of well-shaped cavities, each configured to receive a pen needle;

a cover coupled to the housing and having an opening for accessing at least one of the pen needles; and

an actuator connected to move the support to a position at which the pen needle is sequentially indexed to a position for accessing the pen needle;

wherein the support is rotatable within the housing, and wherein the actuator is connected to the support so as to rotate the support to the position in which each of the pen needles is accessed through the opening of the cover;

wherein the support comprises a ratchet that rotates the support in a first direction and restricts rotation of the support in a second direction; and is provided with

Wherein the support is configured to receive a used pen needle in the well after use of the pen needle, and wherein the pen needle assembly apparatus comprises an ejector proximate the opening of the cover, wherein rotation of the support ejects the used pen needle from the well via the second opening.

2. A pen needle assembly apparatus according to claim 1, wherein said actuator is movable in a linear direction, said actuator having a cam surface operatively connected to said support, whereby linear movement of said actuator rotates said support.

3. The pen needle assembly apparatus according to claim 1, wherein said ejector includes a spring biased arm to contact a used pen needle in said well cavity and transfer the ejected pen needle into a compartment of said housing by rotation of said support.

4. The pen needle assembly apparatus according to claim 3, wherein said cover has a second opening oriented with respect to said ejector and communicating with said compartment for guiding an ejected pen needle from said well-shaped cavity into said compartment.

5. The pen needle assembly apparatus according to claim 4, wherein said support has a plurality of teeth configured to engage said spring biased arm to compress said spring biased arm and release said spring biased arm to impact a distal end of a used pen needle in order to eject said used pen needle from a corresponding well.

6. The pen needle assembly apparatus according to claim 5, wherein said support comprises a plurality of teeth configured to contact said spring biased arm to move said spring biased arm to a loading position and release said spring biased arm to impact a used pen needle.

7. The pen needle assembly device according to claim 1, further comprising a tray for receiving an inner shield of the pen needle, said tray having an extractor for grasping the inner shield and guiding the inner shield into the tray.

8. A pen needle assembly apparatus comprising:

a housing having a top end;

a rotatable support positioned in the housing, the support having a plurality of well-shaped cavities sized to receive a pen needle;

a cover coupled to the top end of the housing, the cover having at least one opening for accessing a pen needle, wherein the support is rotated so as to sequentially index each of the pen needles to a position for accessing the pen needle through the opening in the cover, and wherein the well-shaped cavity is configured to receive a used pen needle after use of the pen needle;

an ejector for ejecting a used pen needle from a respective well into a compartment of the housing by rotating the support relative to the ejector and housing; and

an actuator to rotate the support relative to the housing and cover;

wherein the actuator is connected to the support so as to rotate the support to the position in which each of the pen needles is accessed through the opening of the cover.

9. The pen needle assembly apparatus according to claim 8, wherein said ejector contacts a used pen needle received in said well-shaped cavity by rotating said support relative to said housing.

10. The pen needle assembly apparatus according to claim 9, wherein each said well-shaped cavity in said support has: an open top end configured to receive a pen needle; and an open bottom end at which a distal end of the pen needle protrudes from the open bottom end to contact the ejector.

11. The pen needle assembly apparatus of claim 10, wherein the ejector includes a movable arm configured to contact a distal end of a pen needle received in a respective well cavity by rotation of the support, and wherein the arm ejects the pen needle from an open top end of the well cavity into the compartment of the housing.

12. The pen needle assembly apparatus according to claim 10, wherein the cover has an open recessed area forming a channel aligned with the ejector to deliver the ejected pen needle to the compartment.

13. The pen needle assembly apparatus according to claim 8, wherein said actuator has a ratchet operatively connected to said support so as to rotate said support in a first direction and prevent rotation of said support in a second direction.

14. The pen needle assembly apparatus according to claim 8, wherein said actuator is movable in a linear direction and comprises a cam surface and a rotating member contacting said cam surface, and wherein said actuator is configured to rotate said support by linear movement of said actuator.

15. A method of coupling a pen needle to a delivery pen, the method comprising:

providing a pen needle apparatus having a housing, a rotatable support, an actuator, and a pen needle ejector, the support having a plurality of well-shaped cavities that receive a pen needle;

rotating the support to a position to capture a pen needle and coupling a delivery device to the pen needle;

returning a used pen needle to a respective well-shaped cavity in the support; and

rotating the support to another position in which a used pen needle is expelled from the well cavity into a compartment of the housing by the ejector.

16. The method of claim 15, wherein the pen needle apparatus includes a cover on the open top end of the housing, the cover having at least one opening for accessing the pen needle, the method including rotating the support to orient the pen needle in a position relative to the opening in the cover to access the pen needle.

17. The method of claim 16, wherein the cover has a recess forming a channel oriented relative to the ejector, the method including rotating the support relative to the ejector so as to eject a used pen needle through the channel into the compartment.

18. The method of claim 17, wherein the ejector includes a movable arm for engaging a distal end of the pen needle, the method including rotating the support to actuate the ejector to eject a used pen needle from the well-shaped cavity into the compartment.

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