Package for a safety needle

Abstract

Single and dual packages for filled and safety needles are described herein. Such packages can include hard packages or blister packs. Such packages can include a pre-activation element located on an inner wall of a compartment of the package to nest within a recess in the tether of the safety needle device to prevent accidental activation of the safety needle device prior to use by a user.

Description

Technical Field

[0001] The present disclosure generally relates to packaging for medical devices, and more particularly to dual packaging for passive safety needles that require rotation of a tether or housing for passive activation.

Background Art

[0002] Clean and sterile products that are particularly useful for medical purposes are packaged to maintain their sterility. The packaging of these articles is intended to serve as a barrier to prevent microorganisms from entering the package and contaminating the contents. In most cases, the package is opened immediately before use of the article, such as a blister pack containing a syringe and a needle, to minimize the time the article is exposed to a non-sterile environment.

[0003] Conventionally, an operator who fills and injects a syringe can use a one-needle method or a two-needle method. In the one-needle method, a liquid is put into a syringe from a container (such as a vial) containing the liquid, and the injection is performed with the same needle. In the two-needle method, the operator injects the syringe with the first needle, but replaces the needle with a new needle before injection.

[0004] The one-needle method and the two-needle method each have advantages and disadvantages. For example, the one-needle method is convenient because there is no need to replace the needle between filling and injection, but the needle may be contaminated between filling and injection. The two-needle method can use dedicated needles optimized for filling and injection, but it is troublesome for the operator.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Therefore, there is a need for an alternative packaging system for providing a needle to a user in a sterile state. In addition, there is a need to provide a package for preventing unintentional activation of a passive safety needle that requires rotation of a tether or housing for passive activation.

Means for Solving the Problem

[0006] One aspect of the present disclosure relates to a packaging system including a safety needle device having a tether and a retractable sleeve. The tether includes a recess disposed at the distal end of the tether and a retractable sleeve that is advanceable within the tether. The packaging system further includes a hard package having a closed distal end, an open proximal end, and a compartment extending between the closed distal end and the open proximal end. An early activation prevention element of this compartment is nested within the recess of the safety needle device. A removable seal is disposed relative to the open proximal end, the compartment and the removable seal define a sealed region, and the safety needle device is disposed within the sealed region. In one or more embodiments, the safety needle device is a passive safety needle or an active safety needle.

[0007] In one or more embodiments, the early activation prevention element comprises at least one rail, the at least one rail having a protruding edge extending from the inner wall of the compartment, the protruding edge extending towards the center of the compartment.

[0008] In one or more embodiments, the protruding edge has a width that is slightly smaller than the width of the recess of the safety needle device. The protruding edge prevents rotation of the safety needle device when the safety needle device is disposed within the compartment.

[0009] A second aspect of the present disclosure relates to a packaging system including a safety needle device having a tether and a retractable sleeve. The tether includes a recess disposed at a distal end of the tether and a retractable sleeve that is advanceable within the tether. The packaging system further includes a hard package including a first compartment and a second hard package having a second compartment extending between a closed distal end, an open proximal end, a closed distal end, and an open proximal end. An early activation prevention element disposed on an inner wall of the compartment is removably nested within the recess in the tether of the safety needle device. The early activation prevention element is at least one rail having a protruding edge for nesting within the recess of the safety needle device. A removable seal is disposed relative to the open proximal end, and the compartment and the removable seal define a sealed region, and the safety needle device is disposed within the sealed region. A second removable seal is sealed to the second compartment. The second removable seal defines a second sealed region within which the safety needle is disposed. The first hard package is attached to the second hard package.

[0010] In one or more embodiments, at least one rail disposed on an inner wall of the compartment extends for at least a portion of the length of the compartment from the closed distal end of the compartment.

[0011] In one or more embodiments, at least one rail disposed on an inner wall of the compartment extends from 、 the closed distal end of the compartment to the open proximal end.

[0012] In one or more embodiments, the at least one rail has a width that is smaller than the width of the recess of the safety needle device.

[0013] In one or more embodiments, the first hard package is connected to the second hard package via press fit, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip snap, thermal caulking, or ultrasonic welding.

[0014] In one or more embodiments, the first hard package has a scored attachment to the second hard package.

[0015] In one or more embodiments, the first removable portion consists of a first pull tab and the second removable portion consists of a second pull tab.

[0016] In one or more embodiments, the first removable seal includes graphics, symbols, figures, words, or instructions for indicating that the first removable seal is to be opened first.

[0017] In one or more embodiments, the second removable seal includes graphics, symbols, figures, words, or instructions for indicating that the first removable seal is to be opened second.

[0018] In one or more embodiments, the first hard package has a first color and the second hard package has a second color.

[0019] A third aspect of the present disclosure relates to a packaging system having a needle, a safety needle device, and a blister package having a first cavity and a second cavity. The second cavity has an anti-premature activation element for nesting within a recess of the safety needle device. The first and second cavities are sealed against a backing material, the first cavity and the backing material define a first sealing region, and the second cavity and the backing material define a second sealing region. The distal end of the needle is disposed within the first sealing region and the distal end of the second needle is disposed within the second sealing region.

[0020] In one or more embodiments, the needle is a blunt fill needle.

[0021] In one or more embodiments, the safety needle device is a passive safety needle or an active safety needle.

[0022] In one or more embodiments, the recess has a width that is slightly greater than the width of the protruding actuating element of the compartment, and the protruding actuating element prevents rotation of the safety needle device when the protruding actuating element is nested within the recess.

[0023] In one or more embodiments, the cap is disposed around the distal end of the needle.

[0024] In one or more embodiments, the blister pack includes a peel tab.

Brief Description of the Drawings

[0025]

Figure 1

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 3C

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5

Figure 6

Figure 7

[0026] Before describing some exemplary embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of the configurations or process steps shown in the following description. Embodiments of the present disclosure can have other embodiments and can be implemented or executed in various ways.

[0027] The following definitions are provided with respect to the terms used in the present disclosure.

[0028] As used herein, the use of "a", "an", and "the" includes the singular and plural forms.

[0029] "Needle" includes a needle suitable for filling and / or injecting a liquid into or from a syringe. In the present disclosure, the portion of the needle closest to the operator who operates 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 farthest from the operator is referred to as "distal" according to the convention. In various embodiments, the needles described herein can be blunt filling needles, safety needles, and / or conventional needles.

[0030] 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 suitable for penetrating the patient's skin.

[0031] As used herein, "safety needle" refers to a needle suitable for injection and including one or more functions for preventing needle stick injury. In one or more embodiments, the safety needle includes a sheath covering the distal end of the needle. As used herein, "active safety needle" refers to a safety needle having an actuating mechanism operated by a user to cover the distal end of the needle after a patient has been injected. As used herein, "passive safety needle" refers to a safety needle having a passive actuating mechanism that automatically covers the distal end of the needle after a patient has administered an injection.

[0032] Any suitable needle device constituting a safety function can be used in combination with the packaging disclosed herein. Exemplary safety needle devices include, but are not limited to, those described in commonly owned U.S. Patent Applications Nos. 62 / 433,294, 62 / 433,350, 62 / 479,507, and 62 / 533,786, the entire disclosures of which are incorporated herein by reference in their entirety. Although the types of safety functions differ in structure and mechanism, generally, a safety needle device has a filling state and an injection state.

[0033] "Syringe" includes syringes used for needles, nozzles, tubes, cleaning devices, etc. As used herein, the term "syringe" refers to a device such as a simple pump consisting of a plunger rod that fits tightly into a barrel or tube. By pulling or pushing the plunger rod, liquid or gas can be taken in or discharged through an opening at the open end of the barrel. Needles, nozzles, tubes, etc. are attached to the open end of the syringe to control the inflow and outflow of fluid into and out of the barrel. The syringe may be sterile or non-sterile depending on the needs of the technician.

[0034] As used herein, the term "package" or "packaging" includes any material used to wrap or protect articles or products such as syringes and needles. The packaging can be rigid or flexible. Packaging includes, but is not limited to, medical packaging, pharmaceutical packaging, and child-resistant packaging. Medical and pharmaceutical packaging can include blister packs or hard packages.

[0035] As used herein, the terms "blister package" or "blister pack" include several types of formed packaging used for consumer goods, food, pharmaceuticals, medical devices, and the like. The main components of a blister pack are a formable web, usually a cavity or pocket made of thermoformed plastic. The formable web may be rigid or flexible. The cavity or pocket is sized to accommodate the product contained within the blister package. Depending on the application, the blister pack may have a backing material of a thermoformable material and a lid seal made of aluminum foil, paper, Tyvek® (registered trademark), plastic, or other medical materials. The blister pack is also a hinged two-fold container and can include a rigid backing material such as cardboard. The blister package can provide barrier protection against microorganisms and other contaminants and can provide a degree of tamper resistance. There are various options for blister packaging, but among them, the blister pack has the property of enabling automated processing while protecting the product contained therein.

[0036] Blister packs are commonly used as unit-dose packaging for pharmaceutical tablets, capsules, troches, etc. The pharmaceutical product and its blister pack function as a unit. The blister pack enables the pharmaceutical manufacturer to package the pharmaceutical product using a bag-making and filling device, while protecting it from external influences that would render the pharmaceutical product useless. The bag-making and filling process includes steps of creating the blister pack from a roll of flat sheet or film, filling it with a pharmaceutical product such as a tablet, and closing (sealing) it. This type of blister pack is sometimes called a push-through pack because the consumer can push the product (e.g., a pharmaceutical tablet) out of the backing material. In pharmaceutical blister packs, since many pharmaceuticals deteriorate by hydrolysis and lose their efficacy, care must be taken with the water vapor transmission rate of the blister pack. Furthermore, to prevent the deterioration of pharmaceuticals due to oxidation, the blister pack is required to have oxygen barrier properties. In one or more embodiments, the blister pack is a push-through pack.

[0037] A blister pack for storing medical devices such as syringes is different from a pharmaceutical blister pack because the medical blister pack is not a push-through package. Instead, the thermoformed base web is made of thick plastic and cannot be crushed, so it can form a strong backing material. The lid film provides a peel-open function that can be peeled using both hands, such as the knuckle roll peel method. The lid film of a medical blister pack is generally porous to enable sterilization. Medical materials such as Tyvek® are often used for medical blister packs, which are breathable and permeable to gases but not permeable to microorganisms. Also, the lid film can use medical paper or a film that is completely impermeable or non-breathable. When using a non-breathable film, sterilization is performed by radiation (e.g., electron beam (E-beam), etc.). In one or more embodiments, the blister pack is a medical blister pack.

[0038] Blister packs can be created via thermoforming or cold forming. In the case of thermoforming, the plastic film or sheet is unwound from a reel and guided to a preheating station on the blister line. The temperature of the preheating plate is the temperature at which the plastic softens and becomes flexible. Then, the warmed plastic is transported to a forming station, where the cavity of the blister is formed into a negative mold with great pressure. The mold is cooled so that the plastic hardens again and maintains its shape when removed from the mold.

[0039] In the case of cold forming, a laminated film mainly composed of aluminum is simply pushed into a mold by a punching machine. The aluminum stretches and maintains the formed shape. By using aluminum, water and oxygen can be completely blocked. However, cold-formed blister packs take more time to produce than thermoformed ones. Also, cold-formed blister packs are not transparent, so there is a possibility that consumers may not follow the drug therapy.

[0040] The thermoformable backing material of medical blister packs is generally composed of a flexible thermoformable plastic film. The film is often multilayered. The main component is usually a layer of nylon at about 15 - 30%, and the remaining layers can be composed of substances containing polyethylene, but it is not limited to this. The sealant layer can be composed particularly of ethyl vinyl acetate (EVA).

[0041] For the lid film of medical blister packs, plastics, aluminum, medical paper, etc. that allow sterilizing gas to permeate but do not allow microorganisms to permeate can be used. Tyvek® is most commonly used as the lid material for medical blister packs.

[0042] Blister packaging includes a backing material such as cardboard and a skin pack that covers the product with a thin transparent plastic sheet. The backing material is generally provided with a heat-sealing coating. The plastic film is softened by heat and draped over the product attached to the backing material. A vacuum may be used to assist in fitting snugly. Immediately after forming the blister, the blister is conveyed to a vacuum sealing station, evacuated, and the blister is sealed and fits tightly. The plastic film adheres to the heat-sealing coating applied to the backing material such as cardboard. In one or more embodiments, the blister pack is a vacuum-sealed thermoformed blister pack.

[0043] The blister pack can be sealed in various ways including, but not limited to, heat sealing and cold sealing. A heat-sealing coating can be applied to the lid material and the lid material can be sealed to the backing material while activating the coating with heat. The blister pack can also be enclosed by a cold-sealing manufacturing method that combines a pressure-sensitive folding blister card and a transparent blister and crimps the blister between two plates without applying heat. Also, the sealing of the blister pack can be achieved by aligning and sealing the orientations of multiple layers of film.

[0044] As used herein, terms such as "hard package" include a package having a compartment with one or more openings that can be covered to create a seal. In one or more embodiments, the hard package includes one or more components made of a rigid material such as a rigid polymer material. Examples of rigid polymer materials include, but are not limited to, polyester, polycarbonate, polyethylene, polystyrene, or polypropylene, or combinations or copolymers thereof. In one or more embodiments, the hard package is capable of thermoforming or molding by injection molding or the like. The techniques described for blister packs can also be applied to the rigid portions of the hard package and / or the removable portions of the hard package.

[0045] As used herein, the term "microorganism" refers to microorganisms or organisms that are single-celled or live in colonies of cellular organisms. Microorganisms are very diverse and include, but are not limited to, bacteria, fungi, archaea, and protozoa.

[0046] Tyvek® is a synthetic material made of flash spun high density polyethylene fibers (i.e., spunbonded olefin fibers). This material is lightweight, strong, and tear-resistant, but can be cut with scissors or a knife. Tyvek® is highly breathable, allowing gases such as water vapor to pass through, while at the same time being impermeable to liquid water and microorganisms.

[0047] As used herein, the term "sterilization" refers to means for removing or killing microorganisms present on a surface, in a liquid, or in a compound such as a biological culture medium to achieve a sterile or microbe-free environment. Sterilization can be achieved by applying heat, chemicals, irradiation / radiation, high pressure, filtration, or combinations thereof. Chemical sterilization includes sterilization with gases such as ethylene oxide, hydrogen peroxide gas, ozone, liquid chlorine-based bleaching agents, iodine, glutaraldehyde, formaldehyde, ortho-phthalaldehyde (OPA), hydrogen peroxide, peracetic acid, sodium hydroxide, silver, cobalt, etc. Radiation sterilization uses radiation such as electron beams (E-beams), X-rays, gamma rays, and elementary particles.

[0048] As used herein, the term "knuckle roll peel method" refers to the process by which technicians such as physicians and nurses open a package and release the product contained therein. In the knuckle roll operation, the outer packaging is peeled off with both hands to remove the product inside.

[0049] Various embodiments of the present disclosure provide a dual packaging system that includes two needles. In one or more embodiments, this dual packaging can be useful for improving the workflow and efficiency for users of the two-needle method by eliminating the need to remember to obtain two needles instead of one. In one or more embodiments, this dual packaging is also useful for clinicians who have conventionally used the one-needle method for filling and injection, as such clinicians may not be accustomed to obtaining separately packaged components. In one or more embodiments, this dual packaging can also be used to promote compliance in clinical settings where administrators desire that clinicians use the two-needle method, but the clinicians desire to use the more convenient one-needle method. In one or more embodiments, the dual packaging can be beneficial as it helps prevent the user from accidentally or intentionally injecting a filled device into a patient. For passive safety, injecting with a filled device may cause the safety to malfunction. In one or more embodiments, by providing two needles, the user can perform an injection with a second needle that is not dulled, not recapped, or not at risk of contact contamination. In one or more embodiments, the two needles include a filling needle (e.g., a blunt filling needle) and an injection needle (e.g., a safety needle). In other embodiments, one or both of the needles are conventional needles.

[0050] One or more embodiments of the present disclosure relate to a single-compartment or dual-compartment packaging system having a hard package.

[0051] FIG. 1 shows an exemplary embodiment of a single-compartment packaging system 100. As shown, compartment 120 can accommodate a safety needle device 130. There is a removable seal 140 disposed relative to the open proximal end 122. As shown in FIG. 1, compartment 120 can be molded as a single piece, such as by injection molding.

[0052] Figures 2A and 2B show a safety needle device 130 including a retractable sleeve 134 having a protruding actuating element 132 that is movable forward within a tether 136. The retractable sleeve and the tether 136 are disposed within a housing 138. The retractable sleeve at least partially covers the needle 135 in an initial state. The tether 136 includes a recess 139 disposed at the distal end of the tether. As will be disclosed in further detail below, the recess 139 of the tether 136 generally prevents inadvertent actuation of the retractable sleeve 134 during transportation, storage, or packaging, as shown in FIGS. 3A - 3C of compartment 120, for early actuation Prevent is interlocked with element 125. In FIG. 2B, for purposes of illustration, the housing 138 has been removed. In one or more embodiments, the protruding actuating element 132 is integral with the retractable sleeve 134. In one or more embodiments, the safety needle device 130 is a passive safety needle. In one or more embodiments, the safety needle device 130 is an active safety needle.

[0053] As shown in FIGS. 3A - 3C, the single - compartment packaging system 100 can include a hard package 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. There is a removable seal 140 disposed relative to the open proximal end 122. The compartment 120 and the removable seal 140 define a sealed area in which the safety needle device 130 is disposed. The removable seal 140 can be a pull tab.

[0054] As shown in FIGS. 3B - 3C, compartment 120 includes an early - activation prevention element 125 that nests within a recess (not shown) of safety needle device 130. In a preferred embodiment, the early - activation prevention element 125 includes at least one rail 126 disposed on the inner wall 129 of compartment 120 and extending at least partially the length of the compartment from the closed distal end 121. In one or more embodiments, the at least one rail 126 extends to an open proximal end. The at least one rail 126 has a width that is less than the width of the recess 139 of safety needle device 130. In one or more embodiments, the early - activation prevention element 125 comprises two parallel rails having a distance therebetween configured to nest within the width of the recess 139 of safety needle device 130. In one or more embodiments, the early - activation prevention element 125 is composed of a single integral rail.

[0055] As shown in FIG. 3C, the at least one rail 126 includes a protruding edge 128. The protruding edge 128 protrudes towards the center of compartment 120. The protruding edge 128 is configured to nest within the recess 139.

[0056] As shown in FIGS. 4A - 4D, the safety needle device 130 is disposed within the compartment 120. For clarity, the spring of the safety needle device 130 is made invisible in order to better illustrate that the protruding edge 128 of the early - activation prevention element 125 fits into the recess 139 of the safety needle device 130. When the safety needle device 130 is disposed within the compartment 120, the protruding edge 128 of the early - activation prevention element 125 of the compartment 120 is disposed in a nested manner within the recess 139 of the housing 138 of the safety needle device 130. The early - activation prevention element 125 of the compartment 120 prevents the early or inadvertent activation of the safety needle device 130 by preventing its rotation. Since at least one rail 126 of the early - activation prevention element 125 has a width smaller than the width of the recess 139 of the tether 136, the protruding edge 128 fits within the recess 139. In one or more embodiments, the width of at least one rail 126 is slightly smaller than the width of the recess 139, thereby allowing only minimal rotation rather than free rotation of the safety needle device 130 within the compartment 10.

[0057] FIG. 5 shows an exemplary embodiment of a dual - packaging system 200. The packaging system has a first compartment 220 capable of accommodating a first needle and a second compartment 250 capable of accommodating a safety needle device 230. As shown in FIG. 3, the first compartment 220 and the second compartment 250 can be integrally molded, such as by injection molding.

[0058] The first compartment 220 has an opening covered by a first removable seal 225. The first removable seal 225 is sealed to the first compartment 220, and the first compartment 220 and the first removable seal 225 define a first sealing region. The first removable seal 225 can include a pull tab for the user to grip in order to remove the first removable seal 225 to access the first compartment 220.

[0059] In one or more embodiments, the first removable seal 225 can include a graphic, symbol, figure, word, or other indication to indicate that it is to be opened first. For example, the first removable seal 225 can include the number "1". Also, the first removable portion may include a graphic, symbol, figure, word, or other indication to indicate the purpose of the needle stored in the first compartment 220. In one or more embodiments, the first removable seal 225 can include a graphic, symbol, figure, word, or other indication to indicate that it is to be opened first.

[0060] The second compartment 250 has an opening covered by a second removable seal 255. The second compartment 250 includes an early activation prevention element 235 disposed within the compartment that can nest a recess 239 disposed at the distal end of the tether 236 of the safety needle device 230. In one or more embodiments, the early activation prevention element 235 is in the form of at least one rail 226 disposed on the inner wall of the compartment 250. In one or more embodiments, the early activation prevention element 225 is interlocked with the recess 239 of the protruding activation element 232. The at least one rail 226 includes a protruding edge 228. The protruding edge 228 protrudes towards the center of the compartment 250. The protruding edge 228 is configured to be nested within the recess 239.

[0061] The second removable seal 255 is sealed against the second compartment 250, and the second compartment 250 and the second removable seal 255 define a second sealed region. The second removable seal 255 can include a second pull tab 260 for the user to grip to remove the second removable seal 255 and access the second compartment 250.

[0062] The second removable seal 255 can include graphics, symbols, diagrams, words, or other instructions for indicating a second opening. For example, the second removable seal 255 can include the number "2". Also, the second removable portion may include graphics, symbols, diagrams, words, or other instructions for indicating the purpose of the needle stored in the second compartment 250. For example, if the needle stored in the second compartment 250 is used to inject a patient, the second removable seal 255 can include a graphic showing a person holding a syringe. Further, if the needle stored in the second compartment 250 is a disposable needle device that is locked after use, the second removable seal 255 can also include a lock symbol.

[0063] FIG. 6 shows an exemplary embodiment of a dual packaging system 300. The packaging system has a first compartment 320 that can accommodate a first needle and a second compartment 350 that can accommodate a safety needle device 330. As shown in FIG. 4, the first compartment 320 and the second compartment 350 can be separately formed and joined by an attachment 375. In one or more embodiments, the first compartment 320 can be attached to the second compartment 350 via press fitting, adhesive bonding, solvent bonding, ring connectors, snap fits, C-clip snaps, heat caulking, or ultrasonic welding. In one or more embodiments, the first compartment 320 can be attached to the second compartment 350 by means of a perforation or a temporary attachment.

[0064] 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 can be colored to indicate a particular use (e.g., red to indicate a blunt filling needle), and the second compartment 350 can be transparent, translucent, or have a different color indicating a particular use. In other embodiments, both the first compartment 320 and the second compartment 350 are transparent or translucent, or have the same color.

[0065] 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, and the first compartment 320 and the first removable seal 325 define a first sealing region. The first removable seal 325 can include a first pull tab for the user to grip in order to remove the first removable seal 325 to access the first compartment 320.

[0066] 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, and the second compartment 350 and the second removable seal 355 define a second sealing region. The second removable seal 355 can include a second pull tab 360 for the user to grip in order to remove the second removable seal 355 and access the second compartment 350.

[0067] The second compartment 350 includes within the compartment an early activation prevention element 335 that is nested within a recess 339 of a tether 336 of the safety needle device 330. In one or more embodiments, the early activation prevention element 335 is interlocked with the recess 339 of the tether 336 of the safety needle device 330. The second removable seal 355 is sealed against the second compartment 350, and the second compartment 350 and the second removable seal 355 define a second sealing region. The second removable seal 355 can include a second pull tab 360 for the user to grip in order to remove the second removable seal 355 and access the second compartment 350.

[0068] The first removable seal 325 and the second removable seal 355 can include any of the features described above for the first removable seal 325 and the second removable seal 355, such as graphics, symbols, figures, words, or other instructions indicating the order in which to open the compartments or the purpose of use of the needles stored in the compartments.

[0069] One or more embodiments of the present disclosure relate to a dual packaging system having a blister package. An exemplary embodiment of the dual packaging system 400 is shown in FIG. 7. The first cavity 420 houses at least a portion of the needle 405, and the second cavity 450 houses at least a portion of the safety needle device 435. In one or more embodiments, the first cavity 420 houses a syringe and a pre-attached blunt fill needle. The safety needle device 435 has a protruding activation element 436. In one or more embodiments, the needle 405 and the safety needle device 435 can be packaged side by side within the dual blister packaging system 400.

[0070] In one or more embodiments, the second cavity 450 has a recess 460 for nesting the protruding activation element of the safety needle device. The distal portion 410 of the needle 405 can be covered with a material that is more rigid than the proximal portion 415 of the first needle. The distal portion 410 of the needle 405 can be covered by a cap 490. Similarly, the distal portion 440 of the safety needle device 435 can be covered with a rigid material. The distal portion 445 of the safety needle device 435 can be covered by a cap 490. The backing material 485 can provide a seal for the first cavity 420 and the second cavity 450. The blister package can also include a peel tab 495 for opening the blister package. In one or more embodiments, the direction of peeling is on the right side of the package to reduce the potential for contamination. In another embodiment, the direction of peeling is on the left side of the package.

[0071] References to "one embodiment", "a particular embodiment", "various embodiments", "one or more embodiments", or "an embodiment" throughout this specification mean 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 "in one or more embodiments", "in a particular embodiment", "in various embodiments", "in one embodiment", or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment in the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0072] Although the present disclosure has been described with reference to particular embodiments, it should 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 to the invention without departing from the spirit and scope. Accordingly, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A packaging system comprising: A safety needle device having a tether and a retractable sleeve, the tether including a recess disposed at a distal end of the tether, the safety needle device; A hard package having a closed distal end, an open proximal end, and a compartment extending between the closed distal end and the open proximal end; An early activation prevention element of the compartment for nesting within the recess of the safety needle device; A removable seal disposed relative to the open proximal end, the compartment and the removable seal defining a sealed region, the safety needle device being disposed within the sealed region, the removable seal; Comprising: The early activation prevention element includes at least one rail, the at least one rail having a protruding edge extending from an inner wall of the compartment, the protruding edge extending toward the center of the compartment, the packaging system.

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

3. The protruding edge has a width slightly smaller than a width of the recess of the safety needle device, the protruding edge preventing rotation of the safety needle device when the safety needle device is disposed within the compartment, the packaging system according to claim 2.

4. A packaging system comprising: A needle; A safety needle device having a housing, a tether, and a retractable sleeve, the retractable sleeve being advanceable within the tether, the tether having a recess disposed at a distal end of the tether, the safety needle device; A first hard package consisting of a first compartment; A second hard package 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 early activation prevention element disposed on an inner wall of the second compartment for removably nesting within the recess of the tether of the safety needle device, the early activation prevention element being at least one rail, the at least one rail having a protruding edge for nesting within the recess of the safety needle device, the early activation prevention element. A first removable seal sealed with respect to the first compartment, wherein the first compartment and the first removable seal define a first sealing region, and the needle is disposed within the first sealing region; a first removable seal. A second removable seal sealed with respect to the second compartment, wherein the second compartment and the second removable seal define a second sealing region, and the safety needle device is disposed within the second sealing region; a second removable seal. Comprising The packaging system, wherein the first hard package is attached to the second hard package.

5. The packaging system according to claim 4, wherein the at least one rail disposed on the inner wall of the compartment extends over at least a part of the length of the compartment from the closed distal end of the compartment.

6. The packaging system according to claim 5, wherein the at least one rail disposed on the inner wall of the compartment extends from the closed distal end of the compartment to the open proximal end.

7. The packaging system according to claim 4, wherein the at least one rail has a width smaller than the width of the recess of the safety needle device.

8. The packaging system according to claim 4, wherein the first hard package is attached to the second hard package via press fitting, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip snap, heat caulking or ultrasonic welding.

9. The packaging system according to claim 4, wherein the first hard package has a perforated attachment to the second hard package.

10. The packaging system according to claim 4, wherein the first removable part consists of a first pull tab and the second removable part consists of a second pull tab.

11. The packaging system according to claim 10, wherein the first removable seal includes a graphic, symbol, figure, word, or instruction for indicating that the first removable seal is first opened.

12. The packaging system according to claim 10, wherein the second removable seal includes a graphic, symbol, figure, word, or instruction for indicating that the first removable seal is second opened.

13. The packaging system according to claim 10, wherein the first hard package has a first color and the second hard package has a second color.

14. A packaging system comprising: a needle having a distal end and a proximal end; a safety needle device having a recess disposed at the distal end of the tether; a skin pack having a first cavity and a second cavity formed with an anti-early actuation element for nesting within the recess of the safety needle device; and a backing material removably disposed relative to the skin pack, the blister pack, wherein the first and second cavities are sealed relative to the backing material, the first cavity and the backing material define a first sealing region, the second cavity and the backing material define a second sealing region, the distal end of the needle is disposed within the first sealing region, and the distal end of the safety needle device is disposed within the second sealing region; A packaging system comprising the same.

15. The packaging system according to claim 14, wherein the needle is a blunt filling needle.

16. The packaging system according to claim 14, wherein the safety needle device is a passive safety needle or an active safety needle.

17. The packaging system according to claim 14, further comprising a cap disposed around the distal end of the needle.

18. The packaging system according to claim 14, wherein the blister pack includes a peel tab.

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