JP7717084B2 - safety needle packaging - Google Patents

Description

This disclosure relates generally 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 actuation.

Clean or sterile items, particularly those useful in medical applications, are packaged to preserve their sterility. The packaging for these items is intended to provide a barrier to prevent microorganisms from entering the package and contaminating the contents. In most cases, the packaging is opened just before the item is used, such as a blister pack containing a syringe or needle, to minimize the time the item is exposed to non-sterile conditions.

Traditionally, practitioners filling and injecting syringes can use either the one-needle or two-needle technique. With the one-needle technique, the syringe is filled with liquid from a container (such as a vial) and then injected using the same needle. With the two-needle technique, the practitioner fills the syringe with one needle, but then replaces it with a new needle before injecting.

The one-needle and two-needle methods each have their advantages and disadvantages. For example, the one-needle method is convenient because it does not require changing needles between filling and injection, but there is a risk of the needle becoming contaminated between filling and injection. The two-needle method allows the use of dedicated needles optimized for filling and injection, but is cumbersome for the practitioner.

Therefore, there is a need for alternative packaging systems for providing needles to users in a sterile condition. There is also a need to provide packaging for passive safety needles that require rotation of the tether or housing for passive activation to prevent unintentional activation.

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 a distal end of the tether and a retractable sleeve 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. A premature activation prevention element of the compartment nests within the recess of the safety needle device. A removable seal is disposed against the open proximal end, the compartment and the removable seal defining 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.

In one or more embodiments, the premature activation prevention element includes 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.

In one or more embodiments, the raised edge has a width slightly less than the width of the recess in the safety needle device. The raised edge prevents rotation of the safety needle device when the safety needle device is placed within the compartment.

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 the distal end of the tether and a retractable sleeve advanceable within the tether. The packaging system further includes a hard package including a first compartment and 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. A premature activation prevention element disposed on an inner wall of the compartment removably nests within the recess in the tether of the safety needle device. The premature activation prevention element is at least one rail having a protruding edge that nests within the recess in the safety needle device. A removable seal is disposed against the open proximal end, the compartment and the removable seal defining a sealed area, and the safety needle device is disposed within the sealed area. A second removable seal is sealed against the second compartment. The second removable seal defines a second sealed area within which the safety needle is disposed. The first hard package is attached to the second hard package.

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

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

In one or more embodiments, at least one rail has a width that is less than the width of the recess in the safety needle device.

In one or more embodiments, the first hard package is connected to the second hard package via a press fit, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip snap, heat staking, or ultrasonic welding.

In one or more embodiments, the first hard package has perforated attachment to the second hard package.

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

In one or more embodiments, the first removable seal includes a graphic, symbol, drawing, wording, or instruction to indicate that the first removable seal is to be opened first.

In one or more embodiments, the second removable seal includes a graphic, symbol, drawing, wording, or instruction to indicate that the first removable seal has been second opened.

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

A third aspect of the present disclosure relates to a packaging system including a needle, a safety needle device, and a blister package having a first cavity and a second cavity. The second cavity has a premature activation prevention element for nesting within a recess of the safety needle device. The first and second cavities are sealed against a backing, with the first cavity and the backing defining a first sealed area and the second cavity and the backing defining a second sealed area. The distal end of the needle is disposed within the first sealed area, and the distal end of the second needle is disposed within the second sealed area.

In one or more embodiments, the needle is a blunt fill 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 greater than the width of the protruding actuation element of the compartment, which prevents 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 around the distal end of the needle.

In one or more embodiments, the blister package includes a peel tab.

FIG. 1 illustrates a single package for a safety needle device. FIG. 2A illustrates the safety needle device of FIG. FIG. 2B illustrates the safety needle device of FIG. FIG. 3A shows a compartment of the single package of FIG. 3B is a cross-sectional view of a compartment of the single package of FIG. 1. FIG. 3C is a cross-sectional view of a compartment of a detailed single package of FIG. 1. FIG. 4A shows a safety needle device positioned within a compartment of the single package of FIG. 1. FIG. FIG. 4B is a detailed view showing the safety needle device positioned within a compartment of the single package of FIG. FIG. 4C is a detailed side perspective view showing the safety needle device positioned within a compartment of the single package of FIG. 1. FIG. 4D is an exploded view of the safety needle device and single compartment of FIG. FIG. 5 shows a dual package with two pull tabs. FIG. 6 shows a hard package having a removable portion with two pull tabs. FIG. 7 shows a blister pack containing a blunt fill needle and a safety needle.

Before describing some example embodiments of the present disclosure, it should be understood that the present disclosure is 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 carried out in various ways.

The following definitions are provided for terms used in this disclosure:

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

"Needle" includes a needle suitable for filling and/or injecting a liquid into or from a syringe. This disclosure follows the convention of referring to the portion of the needle closest to the practitioner manipulating the needle as "proximal" and the portion of the needle furthest from the practitioner, toward the patient (for injection) or vial containing the liquid (for filling), as "distal." In various embodiments, the needles described herein can be blunt filling needles, safety needles, and/or conventional needles.

As used herein, a "filling needle" refers to a needle that is suitable for filling a syringe but may not be suitable for injection. For example, a filling needle may be a blunt needle that is not suitable for penetrating a patient's skin.

As used herein, a "safety needle" refers to a needle suitable for injection that includes one or more features to prevent needlestick injuries. In one or more embodiments, a safety needle includes a sheath that covers the distal end of the needle. As used herein, an "active safety needle" refers to a safety needle with a user-operated actuation mechanism that covers the distal end of the needle after a patient has been injected. As used herein, a "passive safety needle" refers to a safety needle with a passive actuation mechanism that automatically covers the distal end of the needle after a patient has given an injection.

Any suitable needle device comprising a safety feature may 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 Application Nos. 62/433,294, 62/433,350, 62/479,507, and 62/533,786, the disclosures of which are incorporated herein by reference in their entireties. While safety feature types vary in structure and mechanism, generally, safety needle devices have a fill state and an inject state.

"Syringe" also includes syringes used in needles, nozzles, tubing, cleaning devices, etc. As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits tightly into a barrel or tube. The plunger rod can be pulled or pushed to draw in or expel liquids or gases through an opening in the open end of the barrel. A needle, nozzle, tubing, etc. can be attached to the open end of the syringe to control the flow of fluid into and out of the barrel. Syringes can be sterile or non-sterile, depending on the needs of the technician.

As used herein, the terms "package" or "packaging" include any material used to encase or protect an article or product, such as a syringe or needle. 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 packaging.

As used herein, the term "blister package" or "blister pack" includes several types of preformed packaging used for consumer goods, food, pharmaceuticals, medical devices, and the like. The primary component of a blister pack is a cavity or pocket made of a formable web, usually a thermoformed plastic. The formable web may be rigid or flexible. The cavity or pocket is large enough to accommodate the product contained within the blister package. Depending on the application, a blister pack may have a backing made of a thermoformable material and a lid seal made of aluminum foil, paper, Tyvek®, plastic, or other medical-grade material. Blister packs are also hinged, bi-fold containers that may include a rigid backing such as paperboard. Blister packages can provide a barrier against microorganisms and other contaminants and can have a degree of tamper resistance. While there are various blister package options, blister packs must protect the product contained within while possessing properties that allow for automated processing.

Blister packs are commonly used as unit-dose packaging for pharmaceutical tablets, capsules, lozenges, and the like. The pharmaceutical product and its blister pack function as a single entity. The blister pack allows pharmaceutical manufacturers to package the pharmaceutical product using form-fill-fill equipment while protecting the pharmaceutical product from external influences that could render it unusable. The form-fill-fill process involves creating a blister pack from a flat sheet or roll of film, filling it with pharmaceutical products such as tablets, 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., pharmaceutical tablets) through the backing. Pharmaceutical blister packs require careful consideration of the blister pack's moisture vapor transmission rate, as many pharmaceutical products degrade and lose potency due to hydrolysis. Additionally, blister packs must provide an oxygen barrier to prevent pharmaceutical product degradation due to oxidation. In one or more embodiments, the blister pack is a push-through pack.

Blister packs containing medical devices such as syringes differ from pharmaceutical blister packs because medical blister packs are not push-through packages. Instead, the thermoformed base web is made of thick plastic and cannot be crushed, thereby forming a strong backing. The lidding film provides a peel-open feature that can be peeled using both hands, e.g., a knuckle roll peel method. The lidding film of medical blister packs is typically porous to enable sterilization. Medical blister packs often use medical-grade materials such as Tyvek®, which are permeable to breath and gases but not to microorganisms. Alternatively, the lidding film can be medical-grade paper or a completely permeable or non-permeable film. When a non-permeable film is used, sterilization is performed by radiation (e.g., electron beam (E-beam)). In one or more embodiments, the blister pack is a medical blister pack.

Blister packs can be made via thermoforming or cold forming. In thermoforming, a plastic film or sheet is unwound from a reel and directed to a preheating station on the blister line. The preheating plate is at a temperature where the plastic softens and becomes pliable. The warmed plastic is then conveyed to a forming station where great pressure is used to form the blister cavities into a negative mold. The mold is then cooled so that the plastic hardens again and retains its shape when removed from the mold.

In cold-forming, an aluminum-based laminated film is simply pressed into a mold by a punching machine. The aluminum stretches and maintains the formed shape. The use of aluminum completely blocks water and oxygen. However, cold-formed blister packs take longer to produce than thermoformed ones. Additionally, cold-formed blister packs are not transparent, which can lead to consumer non-compliance with medication.

The thermoformable backing of medical blister packs is generally composed of a flexible, thermoformable plastic film. The film is often multi-layered. The primary component is usually about 15-30% nylon, with the remaining layers being composed of materials including, but not limited to, polyethylene. The sealant layer may be composed of ethyl vinyl acetate (EVA), among others.

Lidding films for medical blister packs can be made of plastic, aluminum, medical paper, or other materials that are permeable to sterilizing gases but impermeable to microorganisms. Tyvek (registered trademark) is the most commonly used lid material for medical blister packs.

Blister packaging also includes skin packs, which consist of a backing, such as paperboard, and a thin sheet of clear plastic covering the product. The backing typically has a heat-seal coating. The plastic film is softened with heat and draped over the product attached to the backing. Vacuum is sometimes used to assist in creating a tight fit. Immediately after forming the blister, the blister is transported to a vacuum sealing station, where a vacuum is applied, sealing the blister and creating a tight fit. The plastic film adheres to the heat-seal coating on the backing, such as paperboard. In one or more embodiments, the blister pack is a vacuum-sealed thermoformed blister pack.

Blister packs can be sealed using a variety of methods, including, but not limited to, heat sealing and cold sealing. A heat-seal coating can be applied to the lidstock, which is then sealed to the backing while heat is used to activate the coating. Blister packs can also be sealed using a cold-seal process, combining a pressure-sensitive, fold-over blister card with a clear blister, where two plates seal and press the blister together without the need for heat. Blister packs can also be sealed using multiple layers of film that are aligned and sealed together.

As used herein, the term "hard package" or the like includes 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 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 hard package is thermoformable or moldable, such as by injection molding. The techniques described for blister packs can also be applied to rigid portions of the hard package and/or removable portions of the hard package.

As used herein, the term "microorganism" refers to a microorganism or organism that is unicellular or lives in a colony of cellular organisms. Microorganisms are highly diverse and include, but are not limited to, bacteria, fungi, archaea, and protozoa.

Tyvek® is a synthetic material made from flash-spun high-density polyethylene fibers (i.e., spun-bonded olefin fibers). The material is lightweight, strong, and tear-resistant, yet can be cut with scissors or a knife. Tyvek® is highly breathable, allowing gases such as water vapor to pass through, but is impermeable to liquid water and microorganisms.

As used herein, the term "sterilization" refers to a means of 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 aseptic microbial environment. Sterilization can be achieved by applying heat, chemicals, irradiation/radiation, high pressure, filtration, or a combination thereof. Chemical sterilization includes sterilization with gases such as ethylene oxide, hydrogen peroxide gas, and ozone; liquids such as chlorine bleach, iodine, glutaraldehyde, and formaldehyde; orthophthalaldehyde (OPA), hydrogen peroxide, peracetic acid, sodium hydroxide, silver, cobalt, and the like. Radiation sterilization uses radiation such as electron beam (E-beam), X-rays, gamma rays, and elementary particles.

As used herein, the term "knuckle roll peel" refers to the process by which a technician, such as a doctor or nurse, opens a package to release the product contained therein. Using a knuckle roll motion, both hands peel away the outer wrapping material, releasing the product inside.

Various embodiments of the present disclosure provide a dual-packaged system that includes two needles. In one or more embodiments, the dual packaging can help improve workflow and efficiency for users of two-needle methods by eliminating the need to remember to obtain two needles instead of one. In one or more embodiments, the dual packaging can also be useful for clinicians who traditionally use the one-needle method for filling and injecting, as such clinicians may not be accustomed to obtaining separately packaged components. In one or more embodiments, the dual packaging can also help promote compliance in clinical settings where administrators want clinicians to use the two-needle method, but the clinician prefers to use the more convenient one-needle method. In one or more embodiments, the dual packaging can be beneficial because it helps prevent a user from accidentally or intentionally injecting a patient with a pre-filled device. Due to passive safety, injecting with a pre-filled device can disable the safety. In one or more embodiments, providing two needles allows the user to perform the injection with a second needle that is not blunted, recapped, or otherwise subject to the risk of contact contamination. In one or more embodiments, the two needles include a filler needle (e.g., a blunt filler needle) and an injection needle (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-compartment or dual-compartment packaging system having a hard package.

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

2A and 2B show a safety needle device 130 including a retractable sleeve 134 having a protruding actuation element 132 advanceable within a tether ("tether") 136, with the retractable sleeve and tether 136 disposed within a housing 138. The retractable sleeve initially at least partially covers a needle 135. The tether 136 includes a recess 139 disposed at a distal end thereof. As disclosed in further detail below, the recess 139 in the tether 136 interlocks with a premature activation prevention element 125, as shown in FIGS. 3A-3C of the compartment 120, to generally prevent inadvertent activation of the retractable sleeve 134 during shipping, storage, or packaging. In FIG. 2B, the housing 138 has been removed for illustrative purposes. In one or more embodiments, the protruding actuation 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.

As shown in Figures 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 against 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.

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

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

4A-4D, the safety needle device 130 is positioned within the compartment 120. For clarity, the spring of the safety needle device 130 has been obscured to better illustrate that the protruding edge 128 of the premature activation prevention element 125 nests within the recess 139 of the safety needle device 130. When the safety needle device 130 is positioned within the compartment 120, the protruding edge 128 of the premature activation prevention element 125 of the compartment 120 nests within the recess 139 of the housing 138 of the safety needle device 130. The premature activation prevention element 125 of the compartment 120 prevents rotation of the safety needle device 130, thereby preventing premature or inadvertent activation of the safety needle device 130. The protruding edge 128 fits within the recess 139 because at least one rail 126 of the premature activation prevention element 125 has a width that is less than the width of the recess 139 of the tether 136. In one or more embodiments, the width of at least one rail 126 is slightly less 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.

Figure 5 shows 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 Figure 3, the first compartment 220 and the second compartment 250 can be integrally molded, 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 to the first compartment 220, and the first compartment 220 and the first removable seal 225 define a first sealed area. The first removable seal 225 may include a pull tab for a user to grasp 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 a graphic, symbol, drawing, word, or other indication to indicate that it has been first opened. For example, the first removable seal 225 may include the number "1." The first removable portion may also include a graphic, symbol, drawing, word, or other indication 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 a graphic, symbol, drawing, word, or other indication to indicate that it has been first opened.

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

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

The second removable seal 255 may include a graphic, symbol, drawing, word, or other indication to indicate the second opening. For example, the second removable seal 255 may include the number "2." The second removable portion may also include a graphic, symbol, drawing, word, or other indication to indicate the intended use of the needle stored in the second compartment 250. For example, if the needle stored in the second compartment 250 is to be used to inject a patient, the second removable seal 255 may include a graphic depicting a person holding a syringe. Furthermore, if the needle stored in the second compartment 250 is a disposable needle device that locks after use, the second removable seal 255 may also include a lock symbol.

FIG. 6 illustrates 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 molded separately and joined by an attachment 375. In one or more embodiments, the first compartment 320 can be attached to the second compartment 350 via a press fit, adhesive bonding, solvent bonding, a ring connector, a snap fit, a C-clip snap, heat staking, or ultrasonic welding. In one or more embodiments, the first compartment 320 can be attached to the second compartment 350 via a perforated or temporary attachment.

In one or more embodiments, the first compartment 320 and the second compartment 350 are constructed 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 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 to the first compartment 320, and the first compartment 320 and the first removable seal 325 define a first sealed area. The first removable seal 325 may include a first pull tab for a user to grasp 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 to the second compartment 350, and the second compartment 350 and the second removable seal 355 define a second sealed area. The second removable seal 355 may include a second pull tab 360 for a user to grasp to remove the second removable seal 355 and access the second compartment 350.

The second compartment 350 includes a premature activation prevention element 335 nested within a recess 339 in the tether 336 of the safety needle device 330. In one or more embodiments, the premature activation prevention element 335 interlocks with the recess 339 in the tether 336 of the safety needle device 330. A second removable seal 355 is sealed to the second compartment 350, and the second compartment 350 and the second removable seal 355 define a second sealed area. The second removable seal 355 may include a second pull tab 360 for a user to grasp 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, drawings, words, or other instructions to indicate the order in which the compartments should be opened or the intended use of the needles stored in the compartments.

One or more embodiments of the present disclosure relate to a dual packaging system having a blister package. An exemplary embodiment of a dual packaging system 400 is shown in FIG. 7. A first cavity 420 houses at least a portion of a needle 405, and a second cavity 450 houses at least a portion of a safety needle device 435. In one or more embodiments, the first cavity 420 houses a syringe and a pre-attached blunt filler needle. The 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 the dual blister packaging system 400.

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

References throughout this specification to "one embodiment," "particular embodiment," "various embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an 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," "various embodiments," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment of the present disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

Although the present disclosure has been described 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 to the present invention without departing from the spirit and scope of the present disclosure. Therefore, it is intended that the present disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims (18)

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;
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;
a compartment premature activation prevention element for nesting within the recess of the safety needle device;
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;
Equipped with
The premature activation prevention element comprises at least one rail having a protruding edge extending from an inner wall of the compartment, the protruding edge extending toward a center of the compartment. The packaging system of claim 1, wherein the safety needle device is a passive safety needle or an active safety needle. The packaging system of claim 2, wherein the protruding edge has a width slightly less than the width of the recess in the safety needle device, and the protruding edge prevents rotation of the safety needle device when the safety needle device is placed within the compartment. 1. A packaging system comprising:
Needles and
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;
a first hard package comprising 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;
a premature 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 premature activation prevention element being at least one rail having a protruding edge that nests within the recess of the safety needle device;
a first removable seal sealed to the first compartment, the first compartment and the first removable seal defining a first sealing area, the needle being disposed within the first sealing area;
a second removable seal sealed to the second compartment, the second compartment and the second removable seal defining a second sealed area, the safety needle device being disposed within the second sealed area;
Equipped with
The packaging system wherein the first hard package is attached to the second hard package. The packaging system of claim 4, wherein the at least one rail disposed on the inner wall of the compartment extends from the closed distal end of the compartment along at least a portion of the length of the compartment. The packaging system of 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. The packaging system of claim 4, wherein the at least one rail has a width that is less than the width of the recess in the safety needle device. The packaging system of claim 4, wherein the first hard package is attached to the second hard package via a press fit, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip snap, heat staking, or ultrasonic welding. The packaging system of claim 4, wherein the first hard package has a perforated attachment to the second hard package. The packaging system of claim 4, wherein the first removable portion comprises a first pull tab and the second removable portion comprises a second pull tab. The packaging system of claim 10, wherein the first removable seal includes a graphic, symbol, drawing, word, or instruction to indicate that the first removable seal is to be opened first. The packaging system of claim 10, wherein the second removable seal includes a graphic, symbol, drawing, word, or instruction to indicate that the first removable seal has been second opened. The packaging system of claim 10, wherein the first hard package has a first color and the second hard package has a second color. 1. A packaging system comprising:
a needle having a distal end and a proximal end;
a safety needle device having a recess disposed at a distal end of the tether;
a blister package comprising: a skin pack having a first cavity and a second cavity formed therein, the skin pack having a premature activation prevention element for nesting within the recess of the safety needle device; and a backing removably disposed on the skin pack, wherein the first and second cavities are sealed against the 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 the safety needle device being disposed within the second sealed area;
A packaging system comprising: The packaging system of claim 14, wherein the needle is a blunt fill needle. 15. The packaging system of claim 14, wherein the safety needle device is a passive safety needle or an active safety needle . The packaging system of claim 14, further comprising a cap disposed around the distal end of the needle. The packaging system of claim 14, wherein the blister package includes a peel tab.