CN216536421U

CN216536421U - Packaging system for safety needles

Info

Publication number: CN216536421U
Application number: CN202120480383.2U
Authority: CN
Inventors: L·桑德斯; E·P·布劳卡; P·史密斯; A·K·布拉科尼茨基; A·王; R·海伍德
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2020-03-05
Filing date: 2021-03-05
Publication date: 2022-05-17
Anticipated expiration: 2031-03-05
Also published as: CA3170267A1; BR112022017689A2; WO2021178173A1; MX2022010933A; JP2023516352A; CN115243740A; CN115243740B; AU2021229378A1; CA3170267C; EP4114481A1

Abstract

The present application is entitled "packaging system for a safety needle". Single and dual packages for filling and safety needles are described herein. Such packaging may include a hard pack or a blister pack. Such packages may include an anti-premature activation element disposed on an inside wall of a compartment of the package to nest within a recess of a connector of the safety needle device to prevent accidental activation of the safety needle device prior to use by a user.

Description

Packaging system for safety needles

Cross Reference to Related Applications

This application is a continuation of part of U.S. patent application serial No. 15/837,018 filed on 12/11/2017, which claims priority from U.S. patent application No. 62/433,044 filed on 12/2016, U.S. provisional application No. 62/479,507 filed on 31/3/2017, and U.S. provisional application No. 62/479,563 filed on 31/3/2017, in 2016, in accordance with 35u.s.c § 119(e), the disclosures of which are incorporated herein by reference in their entirety.

Technical Field

The present disclosure relates generally to packaging for medical devices, and more particularly to double packaging for passive safety needles that require rotation of a connector (tether) or housing for passive actuation.

Background

Cleaning or sterile articles that are particularly useful for medical applications are packaged to maintain their sterility. The packaging of these articles is intended to provide a barrier to prevent microorganisms from entering the interior of the package and contaminating its contents. In most cases, the package is opened immediately prior to use of the article, such as by housing the syringe or needle with a blister pack, in order to minimize the period of time that the article is exposed to non-sterile conditions.

Typically, the practitioner who fills and injects the syringe may use a single needle technique or a two needle technique. In the single needle technique, the practitioner fills the syringe from a container (e.g., a vial) having a liquid therein and performs an injection using the same needle. In the two needle technique, the practitioner fills the syringe with a first needle, but replaces the needle with a new needle prior to injection.

Both the single needle technique and the two needle technique have certain advantages and disadvantages. For example, the single needle technique is convenient because the practitioner does not have to change the needle between filling and injection, but the needle may become contaminated between filling and injection. The two needle technique allows for a dedicated needle optimized for filling and injection, but is cumbersome for the practitioner.

Accordingly, there is a need for alternative packaging systems for providing needles to users in a sterile state. It is also desirable to provide packaging for preventing accidental actuation of passive safety needles that require rotation of a connector or housing for passive actuation.

SUMMERY OF THE UTILITY MODEL

One aspect of the present disclosure is directed to a packaging system that includes a safety needle device having a connector and a retractable sleeve. The connector includes a recess disposed on a distal end of the connector, and the retractable sleeve is advanceable within the connector. The packaging system further includes a hardpack having a closed distal end, an open proximal end, and a compartment extending between the closed distal end and the open proximal end. The anti-premature activation element of the compartment nests within the recess of the safety needle device. The removable seal is disposed against the open proximal end, wherein the compartment and the removable seal define a sealing area within which the safety needle device is disposed. In one or more embodiments, the safety needle device is a passive safety needle or an active safety needle.

In one or more embodiments, the anti-premature actuation element includes at least one track having a projecting lug (projecting ridge) extending from an inner sidewall of the compartment, the projecting lug extending toward a center of the compartment.

In one or more embodiments, the width of the protruding lug is slightly less than the width of the recess of the safety needle device. The protruding lug prevents rotation of the safety needle device when the safety needle device is disposed within the compartment.

A second aspect of the present disclosure is directed to a packaging system that includes a safety needle device having a connector and a retractable sleeve. The connector includes a recess disposed on a distal end of the connector, and the retractable sleeve is advanceable within the connector. The packaging system further includes a hardpack including a first compartment and a second hardpack having a closed distal end, an open proximal end, and a second compartment extending between the closed distal end and the open proximal end. An anti-premature activation element disposed on an interior sidewall of the compartment is removably nested within a recess of a connector of the safety needle device. The anti-premature activation element is at least one track having a protruding lug nested within a recess of the safety needle device. The removable seal is disposed against the open proximal end, wherein the compartment and the removable seal define a sealing area within which the safety needle device is disposed. The second removable seal seals against the second compartment. The second removable seal defines a second sealing area within which the safety needle is disposed. The first hard pack is attached to the second hard pack.

In one or more embodiments, at least one track disposed on the inner side wall of the compartment extends at least partially the length of the compartment from the closed distal end of the compartment.

In one or more embodiments, at least one track is disposed on an interior sidewall of the compartment, the at least one track extending from the closed distal end to the open proximal end of the compartment.

In one or more embodiments, the width of the at least one track is less than the width of the recess of the safety needle device.

In one or more embodiments, the first hardpack is connected to the second hardpack via a press fit, adhesive bond, solvent bond, ring connector, snap fit, C-snap, heat staking, or ultrasonic weld.

In one or more embodiments, the first hardpack has a perforated attachment to the second hardpack.

In one or more embodiments, the first removable portion includes a first pull tab and the second removable portion includes a second pull tab.

In one or more embodiments, the first removable seal includes a graphic, symbol, chart, text, or instruction indicating that the first removable seal is to be opened first.

In one or more embodiments, the second removable seal includes a graphic, symbol, chart, text, or instructions indicating that the first removable seal is to be opened next.

In one or more embodiments, the first hard pack has a first color and the second hard pack has a second color.

A third aspect of the present disclosure is directed to a packaging system having a needle, a safety needle device, and a blister pack having a first cavity and a second cavity. The second chamber has an anti-premature activation element to nest within the recess of the safety needle device. The first cavity and the second cavity are sealed against the backing, and the first cavity and the backing define a first sealed area, and the second cavity and the backing define a second sealed area. The distal end of the needle is disposed within the first sealed region and the distal end of the second needle is disposed within the second sealed region.

In one or more embodiments, the needle is a blunt filling needle.

In one or more embodiments, the safety needle device is a passive safety needle or an active safety needle.

In one or more embodiments, the recess has a width slightly larger than a width of the protruding actuation element of the compartment, the protruding actuation element preventing rotation of the safety needle device when the protruding actuation element is nested within the recess.

In one or more embodiments, the cap is disposed about the distal end of the needle.

In one or more embodiments, the blister pack comprises a peel flap.

Drawings

FIG. 1 shows a single package for the safety needle device;

FIGS. 2A and 2B illustrate the safety needle device of FIG. 1;

FIG. 3A shows the compartment of the single package of FIG. 1;

FIG. 3B shows a cross-sectional view of the single-packaged compartment of FIG. 1;

FIG. 3C shows a detailed cross-sectional view of the single-packaged compartment of FIG. 1;

FIG. 4A shows the safety needle device disposed within the compartment of the single pack of FIG. 1;

FIG. 4B shows a detailed view of the safety needle device disposed within the compartment of the single package of FIG. 1;

FIG. 4C shows a detailed side perspective view of the safety needle device disposed within the compartment of the single package of FIG. 1;

FIG. 4D illustrates an exploded view of the safety needle device and the single compartment of FIG. 1;

FIG. 5 shows a dual package having two pull tabs;

FIG. 6 shows a hardpack having two removable portions with two pull tabs;

fig. 7 shows a blister pack containing a blunt filling needle and a safety needle.

Detailed Description

Before describing several exemplary embodiments of the present disclosure, it is to be understood that the embodiments of the present disclosure are not limited to the details of construction or process steps set forth in the following description. Embodiments of the present disclosure are capable of other embodiments and of being practiced or of being carried out in various ways.

With respect to the terms used in this disclosure, the following definitions are provided.

As used herein, the use of "a", "an" and "the" includes both the singular and the plural.

Reference to a "needle" includes a needle adapted to fill and/or inject a liquid into or out of a syringe. In this disclosure, a convention is followed wherein the portion of the needle closest to the practitioner operating the needle is referred to as "proximal" and the portion of the needle facing the patient (for injection) or the vial containing the liquid (for filling) and furthest from the practitioner is referred to as "distal". In various embodiments, the needles described herein may be blunt fill needles, safety needles, and/or conventional needles.

As used herein, "filling needle" refers to a needle that is suitable for filling a syringe, but may not be suitable for injection. For example, the filling needle may be a blunt needle that is not adapted to penetrate the skin of the patient.

As used herein, "safety needle" refers to a needle suitable for injection that includes one or more features to prevent needle stick injuries. In one or more embodiments, the safety needle includes a sheath covering a distal end of the needle. As used herein, "active safety needle" refers to a safety needle having a user-operated actuation mechanism to cover the distal end of the needle after injection of a patient. As used herein, a "passive safety needle" is a safety needle having a passive actuation mechanism that automatically covers the distal end of the needle after injection of a patient.

Any suitable needle device including a safety feature may be used in conjunction with the packages disclosed herein. Exemplary safety needle devices include, but are not limited to, those described in commonly owned U.S. patent application nos. 62/433,294, 62/433,350, 62/479,507, 62/533,786, the disclosures of which are incorporated herein by reference in their entirety. The type of safety feature varies structurally and mechanically, but generally, safety needle devices have a filling state and an injection state.

Reference to a "syringe" includes reference to a syringe used with a needle, nozzle, tube or in a flushing system. As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits tightly within a syringe or tube. The plunger rod may be pulled or pushed along the inside of the barrel, thereby enabling the syringe to draw in or expel liquid or gas through the opening at the open end of the barrel. The open end of the syringe may be fitted with a needle, nozzle or tube to help direct fluid into and out of the needle cannula. The syringe may be sterile or not, depending on the needs of the technician.

As used herein, the term "package" includes any material used to encase or protect a commodity or product, such as a syringe or needle. The packaging may be rigid or flexible. Packaging includes, but is not limited to, medical packaging, pharmaceutical packaging, and child-resistant packaging. Medical and pharmaceutical packaging may include blister packs or hard packs.

As used herein, the term "blister pack" or "blister pack" includes several types of pre-formed packages for consumer goods, food, pharmaceutical products, medical devices, and the like. The primary component of the blister pack is a cavity or bag made of a formable web material, typically a thermoformed plastic. The formable web may be rigid or flexible. The cavity or pocket is large enough to contain the merchandise contained in the blister pack. Depending on the application, the patch wrap may have a backing of thermoformable material and aluminum foil, paper, tyvek

A closure seal of plastic or other medical grade material. The blister pack may also be a hinged flip-type container, which may include a rigid backing (such as cardboard). Blister packs may provide barrier protection from contamination by microorganisms and other contaminants, and may provide a degree of tamper resistance. In-hood packaging provisionIn many of the options of (a) a blister pack must protect the product contained therein while still having the characteristics that enable automated processing.

Blister packs are commonly used as unit dose packages for pharmaceutical tablets, capsules or lozenges. The pharmaceutical product and its blister pack are used together as one entity. Blister packs protect the pharmaceutical product from external influences that would otherwise render it useless, while allowing the pharmaceutical product manufacturer to package the product using form-fill-seal equipment. The form-fill-seal process involves creating a blister pack from a rolled flat sheet or film, filling with a pharmaceutical product (e.g., pharmaceutical tablets), and then sealing (sealing). This type of blister pack is sometimes referred to as a push-through pack because the consumer can push the commodity (e.g., pharmaceutical tablets) through the backing. In the case of pharmaceutical blister packs, manufacturers must be concerned with the water vapor transmission rate of the blister pack, as many pharmaceutical products degrade and lose efficacy through hydrolysis. In addition, the blister pack must provide a barrier to oxygen to prevent degradation of the drug product by oxidation. In one or more embodiments, the blister pack is a push-in pack.

Blister packs containing medical devices, such as syringes, are different from pharmaceutical blister packs in that medical blister packs are not push-in packs. Rather, the thermoformed base web is made of a thicker plastic and cannot collapse, forming a strong backing. The lidding film provides a peelable feature that can be peeled off using two hands (e.g., a jaw-roller peel technique). The lidding film wrapped around the medical blister sheet is typically porous to allow sterilization. Typically, the medical patch is wrapped by

Or similar medical grade material that is gas permeable and permeable to gas, but impermeable to microorganisms. The lidding film may also be made of medical grade paper or a completely impermeable or gas impermeable film. In the case of using a gas impermeable film, sterilization is performed by radiation, such as electron beam (E-beam). In one or more embodiments, the patch package is a medical patch package.

The hood wrap may be produced via thermoforming or cold forming. In the case of thermoforming, the plastic film or sheet is unwound from a roll and directed through a preheating station on a hood plate line. The temperature of the preheating plates should be such that the plastic softens and becomes soft. The warm plastic then reaches the forming station where the large pressure causes the mask cavity to become a female mold. The mold is cooled so that the plastic hardens again and retains its shape when removed from the mold.

In the case of cold forming, the aluminum-based laminate film is pressed into the mold by only the press molding. The aluminum elongates and retains the formed shape. The use of aluminum provides a complete barrier to water and oxygen. However, cold formed hood plate wraps are produced for longer periods of time than hot forming. Cold-formed mask wraps are also opaque, which can lead to consumer non-compliance with medication.

The thermoformable backing about which the medical patch is wrapped typically comprises a flexible thermoformable plastic film. The film is typically multilayered. The major component is typically about 15% to 30% of the nylon layer, while the remaining layers may include materials including, but not limited to, polyethylene. The sealant layer may comprise, inter alia, Ethyl Vinyl Acetate (EVA).

The lidding film wrapped in the medical patch may be made of plastic, aluminum, or medical grade paper that is permeable to the gas used for sterilization but impermeable to microorganisms. Most often the result is that,

is used as a cover material for medical blister packs.

Blister packs may also include an outer skin wrap in which a sheet of transparent plastic is covered over the paperboard or other backing material and product. The backing typically has a heat seal coating. The plastic film is softened by heating and applied to the product on the backing. Sometimes a vacuum is used to help fit snugly. Immediately after forming the cover sheet, the cover sheet is transported to a vacuum sealing station where a vacuum is drawn and the cover sheet is sealed closed to provide a snug fit. The plastic film is bonded to a heat seal coating on a paperboard or other backing. In one or more embodiments, the mask wrap is a vacuum sealed thermoformed mask wrap.

The blister pack may be sealed in a variety of ways including, but not limited to, heat sealing and cold sealing. The lidding material may have a heat seal coating applied thereto; the lidding material is then sealed to the backing using heat, thereby activating the coating. The cover plate package can also be sealed using a cold sealing process that uses a combination of a pressure sensitive folding cover plate card and a transparent cover plate; the cover plate is sandwiched between two wooden boards joined together under pressure without using any heat. In addition, the blister pack may be sealed by appropriately orienting the multilayer film for sealing.

As used herein, the term "hardpack" or the like includes a package having a compartment with one or more openings that may be covered to form a seal. In one or more embodiments, the hardpack comprises one or more components made of a rigid material, such as a rigid polymeric material. Examples of rigid polymeric materials include, but are not limited to, polyester, polycarbonate, polyethylene, polystyrene, or polypropylene, or combinations or copolymers thereof. In one or more embodiments, the hardpack may be thermoformed or molded, for example by injection molding. The techniques described above for blister pack wrapping may be applied to the rigid portion of the hardpack and/or the removable portion of the hardpack.

As used herein, the term "microorganism" refers to a microorganism or organism that is a single cell or that lives in a colony of cellular organisms. A wide variety of microorganisms; they include, but are not limited to, bacteria, fungi, archaea, and protozoa.

Is a composite material composed of flash spun high density polyethylene fibers (i.e., spunbond olefin fibers). The material is lightweight and strong, and tear resistant, but can be cut with a scissors or a knife. Because the material has high air permeability, water vapor and other gases can pass through

At the same time, however, the material does notIs permeable to liquid water and microorganisms.

As used herein, the term "sterilization" refers to a means of eliminating or killing microorganisms present on surfaces present in a fluid or compound (such as a biological medium) in order to achieve a sterile or aseptic microbial environment. Sterilization may be achieved by applying heat, chemicals, irradiation/radiation, high pressure, filtration, or combinations thereof. Chemical sterilization includes sterilization using: gases such as ethylene oxide, hydrogen peroxide gas and ozone, liquids such as chlorine bleach, iodine, glutaraldehyde and formaldehyde, glyoxal phthalate (OPA), hydrogen peroxide, peracetic acid, sodium hydroxide, silver and cobalt. Radiation sterilization involves the use of radiation, such as electron beam (E-beam), X-ray, gamma ray, or subatomic particles.

As used herein, the term "jaw roller peel technique" refers to a process in which a technician (such as a doctor or nurse) opens a package to release a product contained therein. The outer wrapper is peeled off with both hands by the jaw roller movement, and then the inner product is released.

Various embodiments of the present disclosure provide a two-pack system containing two needles. In one or more embodiments, this double packaging can help improve workflow and efficiency for users of two-needle technology by eliminating the need to remember to have two needles instead of one. In one or more embodiments, this dual packaging may also be helpful to clinicians who traditionally use single needle techniques for filling and injection, as such practitioners may not be accustomed to obtaining the components of the individual packaging. In one or more embodiments, this dual package may also help promote compliance in a clinical setting where the administrator wishes the clinician to use a two-needle technique, but the clinician prefers to use a more convenient single-needle technique. In one or more embodiments, a dual package is beneficial because it helps prevent a user from accidentally or intentionally injecting a patient with the device in a filled state. For passive safety, injection with the device in the filled state may prevent safety actuation. In one or more embodiments, providing two needles allows a user to inject with a second needle that has not become blunt, recapped, or experienced no risk of touch contamination. In one or more embodiments, the two needles include a filling needle (e.g., a blunt filling needle) and a needle for injection (e.g., a safety needle). In other embodiments, one or both of the needles are conventional needles.

One or more embodiments of the present disclosure relate to a single or dual compartment packaging system with a hardpack.

Fig. 1 shows an exemplary embodiment of a single compartment packaging system 100. As shown, compartment 120 may house safety needle device 130. The removable seal 140 is disposed against the open proximal end 122. As shown in fig. 1, the compartment 120 may be molded as a single piece, such as by injection molding.

Fig. 2A and 2B illustrate a safety needle device 130 comprising a retractable sleeve 134 having a protruding actuation element 132 advanceable within a coupling 136, the retractable sleeve and coupling 136 being disposed within a housing 138. In the initial state, the retractable sleeve at least partially covers the needle 135. The connector 136 includes a recess 139 disposed on a distal end of the connector. As disclosed in further detail below, the recess 139 of the connector 136 interdigitates with the premature activation prevention element 125 of the compartment 120, as shown in fig. 3A-3C, to prevent inadvertent activation of the retractable sleeve 134, typically during shipping, storage or packaging. For illustrative purposes, in fig. 2B, the housing 138 has been removed for clarity. In one or more embodiments, the protruding actuation element 132 is integral with the retractable sleeve 134. In one or more embodiments, safety needle device 130 is a passive safety needle. In one or more embodiments, safety needle device 130 is an active safety needle.

As shown in fig. 3A-3C, the single-compartment packaging system 100 may include a hardpack having a closed distal end 121, an open proximal end 122, and a compartment 120 extending between the closed distal end 121 and the open proximal end 122. The removable seal 140 is disposed against the open proximal end 122. Compartment 120 and removable seal 140 define a sealed area in which safety needle device 130 is disposed. The removable seal 140 may be a pull tab.

As shown in fig. 3B-3C, compartment 120 includes an anti-premature activation element 125 nested within a recess (not shown) of safety needle device 130. In a preferred embodiment, the anti-premature activation element 125 includes at least one track 126 disposed on an interior sidewall 129 of the compartment 120 that extends at least partially the length of the compartment from the closed distal end 121. In one or more embodiments, the at least one track 126 extends to the open proximal end. The width of at least one track 126 is less than the width of recess 139 of safety needle device 130. In one or more embodiments, premature actuation prevention element 125 includes two parallel rails having a distance therebetween, wherein the two parallel rails are configured to nest within the width of recess 139 of safety needle device 130. In one or more embodiments, the anti-premature actuation element 125 comprises a single integral track.

As shown in fig. 3C, at least one track 126 includes a protruding lug 128. The projecting lug 128 projects towards the centre of the compartment 120. The protruding lugs 128 are configured to nest within the recesses 139.

As shown in fig. 4A-4D, safety needle device 130 is disposed within compartment 120. For clarity, the spring of safety needle device 130 is obscured from view to better show protruding lug 128 of anti-premature activation element 125 nested within recess 139 of safety needle device 130. When safety needle device 130 is disposed within compartment 120, protruding lug 128 of premature activation prevention element 125 of compartment 120 nests in recess 139 of housing 138 of safety needle device 130. Premature activation prevention element 125 of compartment 120 prevents premature or inadvertent activation of safety needle device 130 by preventing rotation of safety needle device 130. Since the width of at least one track 126 of the premature activation prevention element 125 is smaller than the width of the recess 139 of the connection element 136, the projecting lug 128 is located within the recess 139. In one or more embodiments, the width of at least one track 126 is slightly less than the width of recess 139, thereby allowing only minimal rotation of safety needle device 130 within compartment 10, but not free rotation thereof.

Fig. 5 illustrates an exemplary embodiment of a dual packaging system 200. The packaging system has a first compartment 220 that can house a first needle and a second compartment 250 that can house a safety needle device 230. As shown in fig. 3, the first compartment 220 and the second compartment 250 may be molded as a single piece, such as by injection molding.

The first compartment 220 has an opening covered by a first removable seal 225. The first removable seal 225 is sealed against the first compartment 220, the first compartment 220 and the first removable seal 225 defining a first sealing area. The first removable seal 225 may include a pull tab for grasping by a user to remove the first removable seal 225 to access the first compartment 220.

In one or more embodiments, the first removable seal 225 may include graphics, symbols, charts, text, or other instructions indicating that it will be opened first. For example, the first removable seal 225 may include the number "1". The first removable portion may also include graphics, symbols, charts, text, or other instructions to indicate the intended use of the needle stored in the first compartment 220. In one or more embodiments, the first removable seal 225 may include graphics, symbols, charts, text, or other instructions indicating that it is to be opened first.

The second compartment 250 has an opening covered by a second removable seal 255. Second compartment 250 includes an anti-premature activation element 235 disposed within the compartment that may nest in a recess 239 disposed on the distal end of connector 236 of safety needle device 230. In one or more embodiments, the anti-premature activation element 235 is in the form of at least one track 226 disposed on an interior sidewall of the compartment 250. In one or more embodiments, premature activation prevention element 225 interdigitates with recess 239 of protruding activation element 232. At least one of the tracks 226 includes a protruding lug 228. The projecting lug 228 projects towards the centre of the compartment 250. The protruding lug 228 is configured to nest within the recess 239.

The second removable seal 255 is sealed against the second compartment 250, the second compartment 250 and the second removable seal 255 defining a second sealed area. The second removable seal 255 may include a second pull tab 260 for grasping by a user to remove the second removable seal 255 and access the second compartment 250.

The second removable seal 255 may include graphics, symbols, charts, text, or other instructions to indicate that it is next to be opened. For example, the second removable seal 255 may include the number "2". The second removable portion may also include graphics, symbols, charts, text or other instructions to indicate the intended use of the needle stored in the second compartment 250. For example, if a needle stored in the second compartment 250 is to be used to inject a patient, the second removable seal 255 may include a graphic showing a person having a syringe. Furthermore, the second removable seal 255 may also include a locking symbol if the needle stored in the second compartment 250 is a disposable needle device that locks after use.

Fig. 6 illustrates an exemplary embodiment of a dual packaging system 300. The packaging system has a first compartment 320 that can house a first needle and a second compartment 350 that can house a safety needle device 330. As shown in fig. 4, the first compartment 320 and the second compartment 350 may be molded separately and joined by an attachment 375. In one or more embodiments, the first compartment 320 may be attached to the second compartment 350 via a press fit, adhesive bond, solvent bond, ring connector, snap fit, C-clip, heat staking, or ultrasonic weld. In one or more embodiments, the first compartment 320 may be attached to the second compartment 350 by perforation or temporary attachment.

In one or more embodiments, the first compartment 320 and the second compartment 350 are composed of different materials or have different colors. For example, in one or more embodiments, the first compartment 320 may be colored to indicate a particular use (e.g., red to indicate a blunt filling needle), while the second compartment 350 may be transparent, translucent, or have a different color to indicate a particular use. In other embodiments, both the first compartment 320 and the second compartment 350 are transparent or translucent, or the same color.

The first compartment 320 has an opening covered by a removable portion 325. The first removable seal 325 is sealed against the first compartment 320, the first compartment 320 and the first removable seal 325 defining a first sealing area. The first removable seal 325 may include a first pull tab for grasping by a user to remove the first removable seal 325 to access the first compartment 320.

The second compartment 350 has an opening covered by a second removable seal 355. The second removable seal 355 is sealed against the second compartment 350, the second compartment 350 and the second removable seal 355 defining a second sealed region. The second removable seal 355 may include a second pull tab 360 for grasping by a user to remove the second removable seal 355 and access the second compartment 350.

Second compartment 350 includes an anti-premature activation element 335 in the compartment that nests within recess 339 of connector 336 of safety needle device 330. In one or more embodiments, premature activation prevention element 335 interdigitates with recess 339 of connector 336 of safety needle device 330. The second removable seal 355 is sealed against the second compartment 350, the second compartment 350 and the second removable seal 355 defining a second sealed region. The second removable seal 355 may include a second pull tab 360 for grasping by a user to remove the second removable seal 355 and access the second compartment 350.

The first removable seal 325 and the second removable seal 355 may include any of the features described above for the first removable seal 325 and the second removable seal 355, such as graphics, symbols, charts, text or other instructions indicating the order in which the compartments are opened or the intended use of the needles stored in the compartments.

One or more embodiments of the present disclosure relate to a dual package system having a blister pack. An exemplary embodiment of a two-pack system 400 is shown in fig. 7. First lumen 420 houses at least a portion of needle 405 and second lumen 450 houses at least a portion of safety needle device 435. In one or more embodiments, the first lumen 420 houses a syringe and a pre-attached blunt filling needle. Safety needle device 435 has a protruding actuation element 436. In one or more embodiments, the needle 405 and the safety needle device 435 may be packaged side-by-side in a dual panel packaging system 400.

In one or more embodiments, the second cavity 450 has a recess 460 to nest the protruding actuation element of the safety needle device. The distal portion 410 of the needle 405 may be covered by a more rigid material than the proximal portion 415 of the first needle. The distal portion 410 of the needle 405 may be covered by a cap 490. Similarly, distal portion 440 of safety needle device 435 may be covered by a rigid material. The distal portion 445 of the safety needle device 435 may be covered by a cap 490. The backing 485 may provide a seal against the first chamber 420 and the second chamber 450. The blister pack may also include a peel strip 495 to open the blister pack. In one or more embodiments, the direction of peeling is on the right hand side of the package to reduce the chance of contamination. In another embodiment, the direction of peeling is on the left hand side of the package.

Reference throughout this specification to "one embodiment," "certain embodiments," "various embodiments," "one or more embodiments," or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases such as "in one or more embodiments," "in certain embodiments," "in various embodiments," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

Although the disclosure herein provides a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit and scope of the utility model. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims

1. A packaging system for a safety needle, the packaging system comprising:

a safety needle device having a connector and a retractable sleeve, the connector including a recess disposed on a distal end of the connector; and

a hardpack having a closed distal end, an open proximal end, and a compartment extending between the closed distal end and the open proximal end;

an anti-premature activation element of the compartment for nesting within the recess of the safety needle device; and

a removable seal disposed against the open proximal end, the compartment and the removable seal defining a sealing area, the safety needle device being disposed within the sealing area.

2. The packaging system of claim 1, wherein the safety needle device is a passive safety needle or an active safety needle.

3. The packaging system of claim 1, wherein the anti-premature activation element comprises at least one track having a protruding lug extending from an inner sidewall of the compartment, the protruding lug extending toward a center of the compartment.

4. The packaging system of claim 3, wherein a width of the protruding lug is less than a width of the recess of the safety needle device, the protruding lug preventing rotation of the safety needle device when the safety needle device is disposed within the compartment.

5. A packaging system for a safety needle, the packaging system comprising:

a safety needle device having a housing, a connector, and a retractable sleeve advanceable within the connector, the connector having a recess disposed on a distal end of the connector;

a first hard pack comprising a first compartment;

a second hardpack having a closed distal end, an open proximal end, and a second compartment extending between the closed distal end and the open proximal end;

an anti-premature activation element disposed on an interior sidewall of the compartment to removably nest within the recess of the connector of the safety needle device, the anti-premature activation element being at least one track having a protruding lug nested within the recess of the safety needle device;

a first removable seal sealed against the first compartment, the first compartment and the first removable seal defining a first sealing area, the needle disposed within the first sealing area;

a second removable seal sealed against the second compartment, the second compartment and the second removable seal defining a second sealing area, the safety needle device being disposed within the second sealing area

Wherein the first hardpack is attached to the second hardpack.

6. The packaging system of claim 5, wherein the at least one track disposed on the interior side wall of the compartment extends at least partially the length of the compartment from the closed distal end of the compartment.

7. The packaging system of claim 6, wherein the at least one track disposed on the interior side wall of the compartment extends from the closed distal end to the open proximal end of the compartment.

8. The packaging system of claim 5, wherein a width of the at least one track is less than a width of the recess of the safety needle device.

9. The packaging system of claim 5, wherein the first hard pack is attached to the second hard pack via a press fit, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip, heat staking, or ultrasonic welding.

10. The packaging system of claim 5, wherein the first hard pack has a perforated attachment to the second hard pack.

11. The packaging system of claim 5, wherein the first removable portion comprises a first pull tab and the second removable portion comprises a second pull tab.

12. The packaging system of claim 11, wherein the first removable seal comprises a graphic, symbol, chart, text, or instructions to indicate that the first removable seal is to be opened first.

13. The packaging system of claim 11, wherein the second removable seal includes a graphic, symbol, chart, text, or instructions to indicate that the first removable seal is to be opened next.

14. The packaging system of claim 11, wherein the first hard pack has a first color and the second hard pack has a second color.

15. A packaging system for a safety needle, the packaging system comprising:

a needle having a distal end and a proximal end;

a safety needle device having a protruding actuation element; and

a blister pack having a first cavity and a second cavity, the second cavity having a recess to nest the protruding actuation element of the safety needle device, the first cavity and the second cavity being sealed against a backing, the first cavity and the backing defining a first sealed area, the second cavity and the backing defining a second sealed area, the distal end of the needle being disposed within the first sealed area, and the distal end of a second needle being disposed within the second sealed area.

16. The packaging system of claim 15, wherein the needle is a blunt filling needle.

17. The packaging system of claim 15, wherein the safety needle device is a passive safety needle or an active safety needle.

18. The packaging system of claim 15, wherein a width of the recess is greater than a width of the protruding actuation element of the safety needle device, the protruding actuation element preventing rotation of the safety needle device when nested within the recess.

19. The packaging system of claim 15, further comprising a cap disposed about the distal end of the needle.

20. The packaging system of claim 15, wherein the blister pack comprises a peel flap.