CN109966595B

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

Info

Publication number: CN109966595B
Application number: CN201711456020.XA
Authority: CN
Inventors: 周君瑜; 曾曦; 胡炜; 黄华盛
Original assignee: Enbeckta
Current assignee: Enbeckta
Priority date: 2017-12-28
Filing date: 2017-12-28
Publication date: 2023-01-17
Anticipated expiration: 2037-12-28
Also published as: CN109966595A

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 generally relates 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 a needle hub with an internal shield before and after use to reduce the risk of inadvertent needle sticks. The device is capable of moving a used pen needle to a compartment or removable tray for disposal. The apparatus has a second well-shaped cavity to receive an inner shield for separating the inner shield of the pen needle from the hub without the need to manipulate the inner shield.

Background

Insulin and other injectable drugs are commonly delivered with drug delivery pens, in which a disposable pen needle hub is attached to the pen to assist in drug container access and allow fluid to exit the container through the needle into the patient.

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

The needle hub assembly is typically packaged in a container that contains several loose needle hubs. The needle hub is selected from the packaging and attached to a pen needle delivery device for administering an injection to a patient, and is then removed for disposal. The needle file packing includes: an outer cover enclosing the hub; and a removable seal that peels away from the outer cover to open the cavity so that the hub can be removed. The hub can have a threaded non-patient end that is threaded onto a delivery device. The delivery device with attached hub is thereafter removed from the outer cover. The inner shield of the needle is attached to the needle hub so as to cover the cannula until the delivery device is ready for use. The shield is removed to expose the cannula for delivery of 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 needle hub leaving the needle hub in the outer cover.

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

Existing pen needle assemblies are disclosed in U.S. patent application publication No. 2006/0229562, in the name of Marsh et al, and U.S. patent application publication No. 2007/0149924, in the name of r.

While existing devices have been adapted for intended use, there remains a need in the industry for an improved package for a pen needle holder assembly.

Disclosure of Invention

The present invention relates to a pen needle assembly device and a device for receiving and supporting at least one pen needle apparatus for assembling a pen needle assembly for attachment to a delivery device, such as a delivery pen. In particular, the invention relates to a device for a pen needle assembly, which can be used in the following manner: the risk of inadvertent needle sticks during attachment and removal of the pen needle assembly to and from the delivery pen and disposal of the used pen needle is reduced. The pen needle device can comprise 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 bin.

In one embodiment of the invention, the device is provided with a support having an open or well-shaped cavity for a pen needle. Typically, the support has a plurality of wells for receiving pen needles. The 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 the used hub and outer cover for disposal.

The device has a recess or well-shaped cavity for receiving and retaining an inner shield of the pen needle covering the cannula so that the inner shield can be removed from the needle mount without manipulation of the inner shield by an operator. The used 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 guard can be discarded in the storage tray. The actuator moves the support and the pen needle to a position for attachment to a delivery device, such as a delivery pen. The ejector transfers the used pen needle from the respective well to a suitable tray, container or disposable storage bin, e.g. a sharps container.

In one embodiment, the inner shield is insertable into an opening forming a well-shaped cavity in the device to engage an extractor with a gripping member located within the device such that the inner shield is retained by a friction or interference fit. The needle hub and cannula can then be pulled apart to separate from the inner shield while maintaining the inner shield within the well-shaped cavity without requiring the user to manipulate the inner shield. The inner guard can be pushed over 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 a plurality of pen needles for attaching the hub to a delivery device (e.g., a delivery pen) without requiring a user to manipulate the hub with an exposed cannula thereon. The pen needle is positioned in the apparatus such that the delivery device can be attached to the non-patient end of the hub. The inner needle guard on the needle hub may then be inserted into the opening of the device in order to grasp the inner guard by the extraction mechanism so that the inner guard can be separated from the needle hub without manipulating the inner guard. After use, the hub is positioned in the outer cover held in the opening of the apparatus and disconnected from the delivery device at the location where the apparatus holds the used hub and the outer cover.

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

A pen needle apparatus in one aspect includes a housing, a pen needle support, and an actuator. The housing has an interior cavity, a top end and a bottom end. The pen needle support has a plurality of well-shaped cavities for receiving pen needles. The support can be movable within the housing by actuating the actuator to move the support and the respective pen needle to a position where the delivery device can access the pen needle. The support can then be moved to a position in the housing where the used pen needle is transferred to a compartment, which can include a tray for disposal of the pen needle.

The features of the apparatus are provided by a pen needle assembly apparatus for receiving a pen needle, wherein the apparatus includes a housing, a movable support, and an actuator. The housing has an internal 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 well-shaped cavities is configured to receive a pen needle. The 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 comprises an actuator for moving the support to a position at which the pen needles are sequentially indexed to a position at which they can be accessed through the opening in the cover.

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

The features of the pen needle assembly apparatus are further achieved by providing a housing having a tip, a rotatable support positioned in the housing, a cover, and an ejector. The support has a plurality of well-shaped cavities sized to receive a pen needle. A cover is coupled to the top end of the housing, wherein the cover has an opening for accessing the pen needle assembly, wherein the support is rotatable and indexable 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 ejects the used pen needle from the well into the 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 apparatus has a pen needle housing with a rotatable support and an actuator for rotating the support. The support has a plurality of well-shaped cavities that receive the pen needles, and the housing includes an ejector for ejecting the pen needles from the well-shaped cavities after use. The method includes the steps of inserting the coupling end of the delivery device into the pen needle within the well and coupling the coupling end of the delivery device to the open end of the needle hub. The delivery device and attached hub are removed leaving the outer cover retained in the housing. The inner shield is inserted into the open or well-shaped cavity, wherein the inner shield is grasped with sufficient force such that the needle hub can be pulled out of the inner shield and separated from the inner shield to expose the cannula for delivery of the substance 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, a method of coupling a pen needle to a delivery pen is provided, 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 the compartment of the housing by the ejector.

In one embodiment of the present disclosure, 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.

In one embodiment of the present disclosure, 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.

In one embodiment of the disclosure, the ejector includes a movable arm for engaging the 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.

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

Drawings

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

FIG. 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;

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

FIG. 3 is a left side perspective view of the pen needle assembly apparatus in one embodiment;

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

FIG. 5 is an exploded view of the apparatus of FIG. 3;

FIG. 6 is a bottom perspective view of the apparatus of FIG. 3;

FIG. 7 is a top perspective view of a base member of the apparatus;

FIG. 8 is a bottom perspective view of the inner support of the apparatus;

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

FIG. 10 is a bottom perspective view of the support member of FIG. 9;

FIG. 11 is a bottom view of the support of FIG. 9;

FIG. 12 is a front view of the actuator;

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

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

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

FIG. 16 is a perspective view of a pen needle ejector;

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

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

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

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

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

fig. 22 is a cross-sectional view of the apparatus showing the inner shield extractor;

FIG. 23 is an exploded view of the tray and cover; and

fig. 24 is an exploded bottom perspective view of the cap and inner guard extractor spring clip.

In 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, and preferably a plurality of pen needles is used with a delivery device such as a delivery pen. The pen needle assembly apparatus receives a used hub, wherein the used hub can be replaced in the device after use and discarded without manipulating the hub, so as to reduce the risk of accidental needle sticks.

Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements. The embodiments described herein illustrate the invention by reference to the drawings, but do not limit the invention. The exemplary embodiments are presented in separate descriptions, although the various features and configurations of these embodiments can be combined in any manner to meet the therapeutic needs of the user.

It will be appreciated by those skilled in the art that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of modification, practice, or implementation in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specifically stated otherwise, the terms "connected," "coupled," and "mounted," and variations thereof as used herein, are used broadly and encompass both direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanical connections or couplings. Furthermore, terms such as upper, lower, bottom, and top are relative and are used to aid in explanation and not limitation.

The apparatus for pen needles facilitates assembly and removal of a needle hub on a pen delivery device with reduced manipulation of exposed needle cannulae. The apparatus for pen needles can be placed on a flat surface (e.g., a table top) so that a delivery device, such as a delivery pen, can be attached to the hub with one hand, reducing the risk of needle sticks from manipulating the hub with the needle cannula exposed.

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

In a standard pen or needle delivery device, dosing and delivery mechanisms are provided within the outer sleeve 12 and are not described in further detail herein, as they are known to those skilled in the art. The drug cartridge is typically attached to a standard pen injector housing by known attachment means. Distal movement of the plunger or stopper within the medicament cartridge causes the medicament to be pushed into the reservoir housing. The drug cartridge is sealed by a septum and is penetrated by a septum-penetrating needle cannula located within the reservoir or housing. The reservoir housing is preferably threaded onto the medicament cartridge, although other attachment members can be used. The pen needle delivery device can be a standard pen delivery device known in the industry and is therefore not shown in detail. The pen needle assembly 18 as shown in fig. 2 includes a hub 16 supporting a cannula 20, an outer cover 22 and an inner shield 24. As shown in fig. 2, a protective seal 26 is attached to the open end of the outer cover to enclose the hub and cannula and thereby maintain a clean and sterile condition. The seal 26 can be a label or other closure member that can be easily peeled away from the outer cover to access the hub during use.

The pen needle delivery device 10 is connected to a hub 16 shown in fig. 1, the hub 16 having a connecting non-patient end with internal threads that screw into the threaded end 18 of the delivery device 10. A needle cannula 20 extends from the patient end of the needle hub 16 for delivery of a substance to a patient. The outer cover 22 can be provided to cover the needle cannula to prevent inadvertent needle sticks to the patient before and after use. The outer cover 22 includes ribs 23 to assist in gripping the outer cover during use. The inner shield 24 is disposed on a post extending from the end of the hub 16 to enclose the cannula. During use, the needle hub 16 is connected to the pen delivery device and the inner shield is removed. After use, the outer cover is typically placed back over the 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 for receiving and supporting at least one pen needle, typically a plurality of pen needles, in a position where a delivery device can be coupled to a hub for injecting a substance into a patient without requiring a user to manipulate the hub with an exposed cannula. The used hub and cannula can then be positioned back into the outer cover held in the device and separated from the delivery device. The used outer cover and hub and inner shield are transferred into a compartment in the apparatus for disposal.

In one embodiment, the apparatus is configured for receiving a pen needle, for coupling the pen hub 16 to a delivery pen, and for separating the pen hub 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 fig. 3 and 4, the housing 30 has a side wall 48, a top end 34, and a bottom end 36. As shown in fig. 6, the 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 that receives a base 100 as shown in fig. 5 and 7 in order to support the movable components of the assembly. The base 100 has a bottom wall 106, the bottom wall 106 being configured for coupling to a bottom wall of the housing 30 as shown in fig. 6. The central post 102 extends upwardly from the bottom wall 106 of the base 100 and is centrally located in the housing 30. A plurality of guide pins 104 extend from the base about the central post 102 and have an axial length 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, the central opening 114 being formed by a generally cylindrical wall 116 spaced inwardly from the outer peripheral edge of the top wall 112. The central opening 114 defines a channel sized to receive the central post 102 and guide pin 104 of the base 200 and the actuator 56. The top wall 112 has an opening 118 formed by side walls 120 for receiving the tray 94 for storing used pen needles. A guide track 122 extends around a portion of the peripheral edge on the inner face of the top wall 112 for guiding the support 40. In the illustrated embodiment, the guide tracks 122 are positioned opposite the side walls 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 slots 124, the slots 124 being 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 fig. 5 and 9-11, a support 40 forming a support ring or carousel is provided for supporting the plurality of pen needles 18. The support 40 in one embodiment has a top surface 130 with a plurality of well-shaped cavities 42, wherein each well-shaped cavity is shaped and dimensioned for supporting and receiving 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 so as to rotate to a plurality of angular positions in order to subsequently allow access to each of the pen needles 18 when the pen needle 18 is aligned with the opening 64 in the cover 60 for use by a user. The support 40 is shown as having a circular, ring-like shape mounted in the housing 30 for rotation about a central axis, although other shapes can be used.

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

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

The support 40 as shown in fig. 10 has a central opening 140, the 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 teeth 144 have an inclined surface 146 and a vertical surface 148 for cooperating with the rotator 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 pen needle 18 can be accessed and the pen needle 18 connected to a delivery pen, as shown in fig. 4. The actuator 56 in the illustrated embodiment moves in a linear direction relative to the housing 30 and the 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 positions.

The actuator 56 in the illustrated embodiment forms a button that is manually pushed downward by the user to rotate the support 40 and index and advance a new pen needle relative to the cover 60 into a position in which 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 actuator 56 is sized and configured to slide within the central opening 114 of the inner support 110 and within the opening of the cover 60. Outwardly extending tabs 156 extend from the outer surface of the sidewall 150 and are positioned at the open bottom end 154. In the illustrated embodiment, four lugs 156 are provided, the four lugs 156 sliding within slots 158 formed in the cylindrical sidewall 116 of the inner support 110. Lugs 156 cooperate with inner support 110 to enable actuator 56 to slide in a linear up and down direction and prevent rotation relative to 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 into an extended, upward position relative to the housing 30, as shown in fig. 3. The bottom end 154 of the actuator 56 can be provided with a plurality of cylindrical guides having axial channels 155, the axial channels 155 forming guide holes for receiving corresponding guide pins 104 on the base 100 in order to slide the actuator in a linear direction.

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

As shown in fig. 13-15, the rotating body 180 is operatively connected to the actuator 56 for connecting the actuator 56 to the support 40 and rotating the support relative to the housing. The rotator 180 in the illustrated embodiment has a cylindrical collar 182, which cylindrical collar 182 is rotatable on the center post 102. First rod 184 extends from a first side of ring 188 on collar 182 and second rod 186 extends from a second side of ring 188 of collar 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 provided on the post 102 to bias the actuator 56 in the upward position.

The first rod 184 of the rotating body 180 extends a distance from the actuator sidewall 150 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 flexible legs forming detents connected to body 194 by flexible hinge portions 196 to bias legs 192 radially outward from actuator 56 into contact with teeth 134 of support 40. In the illustrated embodiment, the first and

second levers

184, 186 include a ratchet 190. In other embodiments, one of the legs does not include a ratchet and 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 fig. 14 and 15, linear movement of the actuator 56 causes the first and

second rods

184, 188 to rotate in the forward direction indicated by arrow 193 by engaging the ramped cam surface 136 such that the distal ends of the flexible legs 192 engage the corresponding teeth 134 on the annular inner surface of the support 40 to rotate the support 40 in the direction of arrow 195. The spring 160 biases the actuator 56 back to the original position. Upward movement of the actuator 56 causes the flexible legs 192 to move back to the original position and slide past the respective tooth in the direction opposite arrow 193 to engage the next adjacent tooth 148 for advancing the support 40 with each depression of the actuator 56.

The cover 60 is disposed on the housing 30 so as to enclose the support 40 and the 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 can 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 as the pen needle is advanced into the opening 64. The opening 64 can have a generally U-shaped shape sized to enable removal of a 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 so that the outer cover 22 is retained in the well-shaped cavity of the support 40 while allowing the hub to be removed. The actuator 56 is capable of rotating and indexing the support 40 so that the pen needle 18 enters the opening 64 of the cover each time the actuator 56 is pressed.

As shown in the embodiment of fig. 3, the cover 60 includes a dome-shaped projection 65, the projection 65 projecting from a top surface of the cover adjacent or contiguous to the opening 64. The protruding portion 65 forms a recess 66 in the bottom surface of the cover 60 shown in fig. 21. The recess 66 has: a first end 68, said first end 68 overlying the support 40; and a second end 70, the second end 70 extending inwardly from the inner wall 52 of the housing 30, and wherein the recess 66 is sized to receive the pen needle 18. A compartment 72 is provided in the housing having a storage tray 74 or bin for receiving a used pen needle 18.

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

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 extending from the side of the arm 204. The pawl 211 is positioned to engage the teeth 134 of the support 40 to move the arm in an up-and-down motion and act as a ratchet to allow the support 40 to rotate in a forward direction but prevent it from rotating in the opposite direction. Referring to fig. 18, as support 40 rotates relative to ejector 80 and housing 30, latch 211 slides along angled surface 136 of teeth 134. As the support 40 rotates, the catch 211 slides up the ramped surface 136 to the position shown in fig. 18 to deflect the arm 204 away from the support 40 as a used pen needle is advanced from the opening 64 in the cover 60. Fig. 19 shows the ejector and ring 40 without ratchet teeth 134.

As shown in fig. 20, the support 40 is advanced such that the detents 211 are spring biased into the valleys 139 between adjacent teeth 134. In one embodiment, the arm 204 is snapped into the extended position shown in fig. 20 by a spring 207 to strike the distal end of the pen needle protruding from the opening 46 at the bottom of the well 42 to eject the used pen needle in an upward direction into the recess 66 defining the domed portion 64 shown in fig. 21 and 22. As the support 40 is rotated again to advance a new pen needle to the position of the opening 64 of the cover 60, the used pen needle advances while the teeth 134 on the support 40 press the arms 204 of the ejector to the loaded position against the biasing force of the spring 207.

As shown, the actuator 56 is depressed to advance and index the pen needle 18 into view of the opening 64 of the cover 40, as shown in fig. 3. The seal is removed so that the pen needle can then be connected to a pen delivery device for use. After use, the hub 16 is inserted back into the outer cover 22 through the opening 64, enabling the pen 10 to be disconnected by unscrewing and separating from the hub. Then, the actuator 56 is pressed to advance the used pen needle such that the distal end of the outer cover 22 is positioned relative to the ejector 80 such that the pen needle 18 is pushed up into the recess 66 formed in the cover 60 and guided into the compartment for the used pen needle.

As shown in fig. 21-24, the housing 30, the cover 40, and the tray 74 cooperate to form an extraction mechanism 210 to assist in removing the inner shield 24 of the pen needle assembly without requiring the patient to manipulate the inner shield. Extractor 210 is configured to remove inner shield 24 from hub 16 prior to use and for disposal after use. Extractor 210 includes a gripping mechanism that can grip the inner shield so that the needle hub can be pulled apart, and wherein the used inner shield can be disposed into a tray 74 or other storage container for disposal.

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

In the illustrated embodiment, the extractor 210 includes a gripping member, shown as resilient metal clips 218 mounted on the underside 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 respective post 222 on the underside of the cover 212. The distal end of the clip 218 includes an angled tab 224, the tab 224 having an edge 226, the edge 226 extending into the channel defined by the opening 216, as shown in fig. 21 and 22. In use, the inner guard 24 is inserted through the

openings

214 and 216 with the edge 226 of the resilient clip 218 gripping the inner guard to inhibit moving the inner guard in an outward direction relative to the cover 60 so 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 to allow the inner guard to be transferred to the tray while preventing the inner guard from being pulled in an upward direction. The inner shield of the new pen needle can then be inserted through the opening to push the previous inner shield through the resilient clip 218 into the tray 74 so that the resilient clip can grip the new inner shield for separating the needle hub from the inner shield.

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 general curved shape of the housing 30. The lid 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. The opening 234 is provided for receiving a pen needle expelled from the well through the 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 an inclined surface to slope away from the opening 234 in the cover 212 to prevent used pen needles from being collected directly below the opening.

The assembly is capable of receiving a pen needle assembly to assist a user in attaching a hub to a delivery pen without requiring the user to manipulate the hub and exposed cannula. During use, the actuator is depressed so that the support 40 and the pen needle 18 are advanced to a position aligned with the opening 64 in the cover 60, in which position the pen needle can be seen and accessed. From the connection

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

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 the 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.

The inner shield 24 is attached to the hub to cover the cannula when separated from the outer cover. The inner shield of the pen needle is then inserted into the extractor 210 as shown in fig. 21-24, with the inner shield 24 passing through the opening such that the edge 226 of the clip engages the outer surface of the inner shield so as to grip the inner shield and prevent upward movement. The delivery pen can then be removed, leaving the inner guard 24 retained in the extractor.

After use of the delivery pen and pen needle, the delivery pen can then be inserted through the opening 64 in the cover 60, with the hub again being received in the outer cover 22 held in the well 42. The delivery pen can then be rotated so that the delivery pen is disconnected from the internal threads of the hub and removed from the device. Actuator 56 can then be depressed causing support 40 to rotate so as to index well 42 and the used pen needle toward ejector 80. Movement of the support causes spring-biased arms 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 pen needle 18 then passes through the channel defined by the recess 66 and into the tray 74 received in the compartment of the housing. The cover can be opened to remove the tray 74 for disposal of the used pen needle.

The foregoing embodiments and advantages are merely exemplary and are not to be construed as limiting the scope of the invention. The description of the exemplary embodiments of the present invention is intended to be illustrative, and not to limit the scope of the invention. Various modifications, alternatives, and variations will be apparent to those skilled in the art and fall within the scope of the invention. It is particularly noted that features of different embodiments and claims may be combined with each other as long as they are not mutually contradictory. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims and their equivalents.

Claims

1. A pen needle assembly 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.