JP2023516352A - packaging for safety needles - Google Patents

Abstract

Single and dual packages for fill and safety needles are described herein. Such packaging can include hard packaging or blister packaging. Such packaging has previously been positioned on the inner wall of the compartment of the packaging to nest within the recess of the tether of the safety needle device to prevent accidental actuation of the safety needle device prior to use by the user. Actuation elements can be included.

Description

TECHNICAL FIELD 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 and sterile items that are particularly useful for medical use are packaged to preserve their sterility. The packaging of these articles is intended to provide a barrier to prevent microorganisms from entering the interior of the packaging and contaminating the contents. In most cases, the packaging is opened just prior to use of the article, such as a blister pack containing a syringe or needle, to minimize the time the article is exposed to non-sterile conditions.

Conventionally, practitioners filling and injecting syringes can use the one-needle method or the two-needle method. In the one-needle method, a syringe is filled with liquid from a container (such as a vial) containing the liquid, and the same needle is used to inject the liquid. In the two-needle technique, the practitioner injects into the syringe with a first needle, but replaces the needle with a new needle before injecting.

The one-needle method and the two-needle method each have advantages and disadvantages. For example, the one-needle method is convenient because it does not require changing needles between fills and injections, but the needle can become contaminated between fills and injections. The two-needle method can use 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 to prevent unintended actuation for passive safety needles that require rotation of the tether or housing for passive actuation.

One aspect of the present disclosure is directed to a packaging system that includes a safety needle device having a tether and a retractable sleeve. The tether includes a recess located at the 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. The early actuation prevention element of this compartment nests within the recess of the safety needle device. A removable seal is positioned against the open proximal end, the compartment and removable seal define a sealed area, and the safety needle device is positioned within the sealed area. 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 early deactivation element comprises 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 from the inner wall of the compartment. extending towards the center.

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

A second aspect of the present disclosure is directed to a packaging system that includes a safety needle device having a tether and a retractable sleeve. The tether includes a recess located at the distal end of the tether and a retractable sleeve advanceable within the tether. The packaging system comprises a hard package including a first compartment, a closed distal end, an open proximal end, and a second compartment extending between the closed distal end and the open proximal end. and a second hard package having. An early actuation prevention element located on the inner wall of the compartment removably nests within a recess in the tether of the safety needle device. The premature actuation prevention element is at least one rail having a protruding edge that nests within the recess of the safety needle device. A removable seal is positioned against the open proximal end, the compartment and removable seal define a sealed area, and the safety needle device is positioned within the sealed area. A second removable seal is sealed against the second compartment. A 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 at least part of the length of the compartment from the closed distal end 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 of the compartment to the open proximal end, at least one rail.

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

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

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

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.

In one or more embodiments, the first removable seal includes graphics, symbols, drawings, words, or instructions to indicate that the first removable seal is to be opened first.

In one or more embodiments, the second removable seal includes graphics, symbols, drawings, words or instructions to indicate that the first removable seal is to be opened a second time.

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 having a needle, a safety needle device, and a blister package having a first cavity and a second cavity. The second cavity has an early actuation prevention element for nesting within the recess of the safety needle device. The first and second cavities are sealed to the backing, the first cavity and the backing define a first sealing area, and the second cavity and the backing define a second sealing area. define. The distal end of the needle is positioned within the first sealing area and the distal end of the second needle is positioned within the second sealing 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 actuating element of the compartment, and the protruding actuating element has a width when the protruding actuating element is nested within the recess. Secondly, it prevents rotation of the safety needle device.

In one or more embodiments, a cap is placed around the distal end of the needle.

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

Figure 1 illustrates a single package for a safety needle device. FIG. 2A illustrates the safety needle device of FIG. 1; FIG. 2B illustrates the safety needle device of FIG. 1; 3A is a diagram showing the compartments of the single package of FIG. 1; FIG. 3B is a cross-sectional view showing the compartments of the single package of FIG. 1; FIG. 3C is a cross-sectional view of the detailed single package compartment of FIG. 1; FIG. 4A shows a safety needle device positioned within a compartment of the single package of FIG. 1; FIG. 4B is a detailed view showing the safety needle device positioned within the compartment of the single package of FIG. 1; FIG. 4CB is a detailed side perspective view showing the safety needle device positioned within the compartment of the single package of FIG. 1; FIG. 4D is an exploded view showing the safety needle device and single compartment of FIG. 1; 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. Figure 7 shows a blister pack containing a blunt fill needle and a safety needle.

Before describing several exemplary embodiments of the present disclosure, it is to 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 disclosure are capable of other embodiments and of being practiced or of being 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 singular and plural forms.

A "needle" includes a needle suitable for filling and/or injecting a liquid into or from a syringe. For the purposes of this disclosure, the portion of the needle closest to the practitioner manipulating the needle is referred to as "proximal," and the portion of the needle furthest from the practitioner toward the patient (for injections) or vial containing liquid (for filling). Follow the convention of calling it "distal". In various embodiments, the needles described herein can be blunt fill needles, safety needles, and/or conventional needles.

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

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 the distal end of the needle. As used herein, an "active safety needle" refers to a safety needle with a user-operated actuation mechanism to cover the distal end of the needle after the patient has been injected. As used herein, "passive safety needle" refers to a safety needle with a passive actuation mechanism that automatically covers the distal end of the needle after the patient has given an injection.

Any suitable needle device that constitutes a safety feature can be used in combination with the packaging disclosed herein. Exemplary safety needle devices include commonly owned U.S. Patent Application Nos. 62/433,294; 62/433,350; The disclosures of which, including but not limited to those described in , are hereby incorporated by reference in their entirety. The types of safety functions differ in structure and mechanism, but generally safety needle devices have a filling state and an injection state.

"Syringe" also includes needles, nozzles, tubes, syringes used in washing devices and the like. 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 from an opening in the open end of the barrel. The open end of the syringe can be fitted with a needle, nozzle, tubing, etc. to control the flow of fluid into and out of the barrel. Syringes may be sterile or non-sterile, depending on the technician's needs.

As used herein, the term "package" or "wrapping" includes any material used to enclose 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, child resistant packaging. Medical and pharmaceutical packaging can include blister packs or hard packages.

As used herein, the term "blister pack" or "blister pack" includes several types of preformed packaging used for consumer goods, food, pharmaceuticals, medical devices, and the like. The main component of a blister pack is a cavity or pocket made of a moldable web, usually thermoformed plastic. Moldable webs may be rigid or flexible. The cavity or pocket is large enough to accommodate the items contained in the blister pack. Depending on the application, the blister pack may have a thermoformable material backing and a lid seal made of aluminum foil, paper, Tyvek®, plastic, or other medical grade material. A blister pack is also a hinged, clamshell container that can include a rigid backing such as paperboard. Blister packaging can provide a barrier protection from microorganisms and other contaminants and can be somewhat tamper-resistant. Among the various options for blister packaging, blister packs need to protect the product contained within while possessing properties that enable automated processing.

Blister packs are commonly used as unit dose packaging for pharmaceutical tablets, capsules, lozenges and the like. The medicine and its blister pack work together. Blister packs allow pharmaceutical manufacturers to use form-fill-seal equipment to package pharmaceutical products while protecting them from external influences that render them unusable. The form-fill process includes making a blister pack from a flat sheet or roll of film, filling with a pharmaceutical product such as a tablet, and closing (sealing). This type of blister pack is sometimes called a push-through pack because it allows the consumer to push the item (eg, pharmaceutical tablet) out of the backing. In blister packs for pharmaceuticals, since many pharmaceuticals are degraded by hydrolysis and lose efficacy, it is necessary to pay attention to the water vapor transmission rate of the blister pack. Furthermore, blister packs are required to have oxygen barrier properties to prevent deterioration of pharmaceuticals due to oxidation. In one or more embodiments, the blister pack is a push-through pack.

Blister packs for housing 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, thus forming a strong backing. The lidding film provides a peel-open feature that allows it to be peeled off using two hands, such as a knuckle roll peel method. Lid films of medical blister packs are generally porous to allow sterilization. Medical blister packs often use medical materials such as Tyvek (registered trademark), which have air permeability and gas permeability, but are impermeable to microorganisms. Also, the lidding film can be medical grade paper or a completely permeable or non-breathable film. If non-porous films are used, they are sterilized by radiation (for example, electron beam (E beam), etc.). In one or more embodiments, the blister pack is a medical blister pack.

Blister packs can be made via thermoforming or cold forming. For thermoforming, the plastic film or sheet is unwound from a reel and directed to a preheating station on the blister line. The temperature of the preheat plate is the temperature at which the plastic softens and becomes pliable. The warmed plastic is then transported to a molding station where, under great pressure, the blister cavity is molded into a negative 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, a laminated film containing aluminum as a main component is simply pushed into a mold by a hammer. The aluminum stretches and maintains the molded shape. By using aluminum, it is possible to completely block water and oxygen. However, cold-formed blister packs are slower to produce than thermoformed ones. Also, cold-formed blister packs are not transparent, potentially compromising consumer compliance with medication.

The thermoformable backing of medical blister packs is generally composed of a flexible thermoformable plastic film. Films are often multilayered. The main component is typically a layer of about 15-30% nylon and the remaining layers can be composed of materials including but not limited to polyethylene. The sealant layer can in particular consist of ethyl vinyl acetate (EVA).

Lid films for medical blister packs can be made of plastic, aluminum, medical paper, etc. that are permeable to sterilizing gas but impermeable to microorganisms. Tyvek® is most commonly used as a lidding material for medical blister packs.

Blister packs also include skin packs, which have a backing such as paperboard and a sheet of clear plastic covering the product. The backing is generally provided with a heat seal coating. The plastic film is softened by heat and draped over the product attached to the backing. A vacuum may be used to help ensure a tight fit. Immediately after forming the blister, the blister is transported to a vacuum sealing station and a vacuum is drawn to seal the blister and form a tight fit. The plastic film adheres to a heat seal coating applied to a backing such as paperboard. In one or more embodiments, the blister pack is a vacuum sealed thermoformed blister pack.

Blister packs can be sealed in a variety of ways including, but not limited to, heat sealing and cold sealing. A heat seal coating can be applied to the lidstock and the lidstock can be sealed to the backing while heat activates the coating. The blister pack can also be sealed by a cold seal method that combines a pressure-sensitive folded blister card and a transparent blister and seals the blister with two plates without applying heat. In addition, the blister pack can be sealed by aligning the directions of the multiple layers of film.

As used herein, the terms "hard package" and the like include packages having compartments with one or more openings that can be covered to create a seal. In one or more embodiments, a hard package includes one or more components made of rigid materials, such as rigid polymeric materials. 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 can be thermoformed or molded, such as by injection molding. The techniques described for blister packs can also be applied to rigid portions of hard packaging and/or removable portions of hard packaging.

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

Tyvek® is a synthetic material composed of flashspun high density polyethylene fibers (ie, spunbonded olefinic fibers). The material is lightweight, strong, tear-resistant, and can be cut with scissors or a knife. Tyvek (registered trademark) has excellent breathability, so it allows gases such as water vapor to pass through, but at the same time it is impermeable to liquid water and microorganisms.

As used herein, the term "sterile" refers to the removal of microorganisms present on a surface, in a liquid, or in a compound such as a biological medium to achieve a sterile or sterile microbial environment. means to remove or kill. Sterilization can be accomplished by applying heat, chemicals, irradiation/radiation, high pressure, filtration, or combinations thereof. Chemical sterilization includes gases such as ethylene oxide, hydrogen peroxide gas, ozone, chlorine bleach, liquids such as iodine, glutaraldehyde, formaldehyde, orthophthalaldehyde (OPA), hydrogen peroxide, peracetic acid, hydroxide Sterilization with sodium, silver, cobalt, etc. is included. Radiation sterilization uses radiation such as electron beams (E-beams), X-rays, gamma rays, and elementary particles.

As used herein, the term "knuckle roll peel" refers to the process of opening a package by a technician, such as a doctor or nurse, to release the product contained therein. With a knuckle roll action, peel off the outer wrapping material with both hands and take out the product inside.

Various embodiments of the present disclosure provide dual packaging systems that include two needles. In one or more embodiments, this dual packaging helps improve workflow and efficiency for users of the two-needle method by eliminating the need to remember to obtain two needles instead of one. can be done. In one or more embodiments, this dual packaging is also useful for clinicians who traditionally use the one-needle method for filling and injection, allowing such clinicians to store separately packaged components. This is because they may not be accustomed to getting it. In one or more embodiments, this dual packaging provides compliance in clinical settings where administrators want clinicians to use the two-needle method, but clinicians want to use the more convenient one-needle method. can also help promote In one or more embodiments, dual packaging may be beneficial as it helps prevent a user from accidentally or intentionally injecting a filled device into a patient. Due to passive safety, injecting with a filled device may cause the safety to fail. In one or more embodiments, providing two needles allows the user to inject with a second needle that has not been blunted, recapped, or exposed to the risk of contact contamination. will be able to run In one or more embodiments, the two needles include a filling needle (eg, blunt filling needle) and an injection needle (eg, safety needle). In other embodiments, one or both of the needles are conventional needles.

One or more embodiments of the present disclosure relate to single-compartment or dual-compartment packaging systems with hard packages.

FIG. 1 illustrates an exemplary embodiment of a single compartment packaging system 100. As shown in FIG. As shown, compartment 120 can accommodate safety needle device 130 . There is a removable seal 140 positioned against open proximal end 122 . As shown in FIG. 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, the retractable sleeve and tether 136 disposed within a housing 138. It is The retractable sleeve at least partially covers the needle 135 in the initial state. Tether 136 includes a recess 139 located at the distal end of the tether. As disclosed in more detail below, recesses 139 in tether 136 are generally configured as shown in FIGS. , are interdigitated with the early actuation elements 125 . In FIG. 2B, housing 138 has been removed for clarity. In one or more embodiments, protruding actuation element 132 is integral with 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 FIGS. 3A-3C, single compartment packaging system 100 includes closed distal end 121, open proximal end 122, and closed distal end 121 and open proximal end 122. can include a hard package having a compartment 120 extending between the There is a removable seal 140 positioned against open proximal end 122 . Compartment 120 and removable seal 140 define a sealed area in which safety needle device 130 is placed. Removable seal 140 can be a pull tab.

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

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

As shown in FIGS. 4A-4D, safety needle device 130 is positioned within compartment 120 . For clarity, the spring of safety needle device 130 is not visible to better illustrate that protruding edge 128 of early actuation prevention element 125 nests within recess 139 of safety needle device 130. It is made like this. When safety needle device 130 is positioned within compartment 120 , protruding edge 128 of early actuation prevention element 125 of compartment 120 nests within 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 . At least one rail 126 of early actuation prevention element 125 has a width less than the width of recess 139 of tether 136 so that protruding edge 128 fits within recess 139 . In one or more embodiments, the width of at least one rail 126 is slightly less than the width of recess 139 , thereby minimizing free rotation of safety needle device 130 within compartment 10 rather than free rotation of safety needle device 130 . Allows rotation only.

FIG. 5 shows an exemplary embodiment of a dual packaging system 200. As shown in FIG. The packaging system has a first compartment 220 that can contain a first needle and a second compartment 250 that can contain a safety needle device 230 . As shown in FIG. 3, first section 220 and second section 250 may be integrally formed, such as by injection molding.

First compartment 220 has an opening covered by a first removable seal 225 . A 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. First removable seal 225 may include a pull tab for a user to grasp to remove first removable seal 225 to access first compartment 220 .

In one or more embodiments, first removable seal 225 can include a graphic, symbol, drawing, language, or other indication to indicate that it is to be opened first. For example, first removable seal 225 may include the number "1". The first removable portion may also include graphics, symbols, drawings, words, or other instructions to indicate the intended use of the needles housed in the first compartment 220 . In one or more embodiments, first removable seal 225 can include a graphic, symbol, drawing, language, or other indication to indicate that it is to be opened first.

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

A second removable seal 255 is sealed against the second compartment 250, the second compartment 250 and the second removable seal 255 defining a second sealing area. Second removable seal 255 may include a second pull tab 260 for a user to grasp to remove second removable seal 255 and access second compartment 250 .

Second removable seal 255 may include graphics, symbols, drawings, words, or other instructions to indicate the second opening. For example, second removable seal 255 may include the number "2." The second removable portion may also include graphics, symbols, drawings, words, or other instructions to indicate the intended use of the needles housed in the second compartment 250. FIG. 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. Additionally, if the needle housed 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.

FIG. 6 shows an exemplary embodiment of a dual packaging system 300. As shown in FIG. The packaging system has a first compartment 320 that can contain a first needle and a second compartment 350 that can contain a safety needle device 330 . As shown in FIG. 4, first section 320 and second section 350 can be separately molded and joined by attachment 375 . In one or more embodiments, first section 320 is attached to second section 350 via press fit, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip snap, heat staking or ultrasonic welding. can be installed. In one or more embodiments, the first compartment 320 can 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 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 application (e.g., red to indicate a blunt filling needle) and the second compartment 350 can It can be transparent, translucent, or have a different color indicating a particular application. In other embodiments, both first compartment 320 and second compartment 350 are transparent or translucent, or are the same color.

A first compartment 320 has an opening covered by a removable portion 325 . A 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. First removable seal 325 may include a first pull tab for a user to grasp to remove first removable seal 325 to access first compartment 320 .

A second compartment 350 has an opening covered by a second removable seal 355 . A second removable seal 355 is sealed against the second compartment 350, the second compartment 350 and the second removable seal 355 defining a second sealing area. Second removable seal 355 may include a second pull tab 360 for a user to grasp to remove second removable seal 355 and access second compartment 350 .

The second compartment 350 includes within the compartment an early actuation prevention element 335 nested within a recess 339 of the tether 336 of the safety needle device 330 . In one or more embodiments, early deactivation prevention element 335 interdigitates with recess 339 in tether 336 of safety needle device 330 . A second removable seal 355 is sealed against the second compartment 350, the second compartment 350 and the second removable seal 355 defining a second sealing area. Second removable seal 355 may include a second pull tab 360 for a user to grasp to remove second removable seal 355 and access second compartment 350 .

The first removable seal 325 and the second removable seal 355 may include a second label, such as a graphic, symbol, drawing, word, or other instruction to indicate the order of opening the compartments or the intended use of the needles contained in the compartments. Any of the features described above for one removable seal 325 and second removable seal 355 can be included.

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

In one or more embodiments, the second cavity 450 has a recess 460 for nesting the protruding actuation element of the safety needle device. The distal portion 410 of the needle 405 may be covered with a stiffer material than the proximal portion 415 of the first needle. Distal portion 410 of needle 405 may be covered by cap 490 . Similarly, distal portion 440 of safety needle device 435 may be covered with a rigid material. Distal portion 445 of safety needle device 435 may be covered by cap 490 . Backing 485 can provide a seal for first cavity 420 and second cavity 450 . The blister package can 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 potential for contamination. In another embodiment, the peel direction is to the left of the package.

References to "one embodiment," "particular embodiment," "various embodiments," "one or more embodiments," or "an embodiment" throughout this specification may refer to embodiments. is included in at least one embodiment of the present disclosure. Thus, references to "in one or more embodiments," "in certain embodiments," "in various embodiments," "in one embodiment," or "in an implementation" appearing in various places throughout this specification "in form" do not necessarily refer to the same embodiment in this disclosure. Moreover, the particular features, structures, materials, or features may be combined in any suitable manner in one or more embodiments.

Although the 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 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 its spirit and scope. Thus, it is intended that the present disclosure include modifications and variations that come within the scope of the appended claims and their equivalents.

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 to the open proximal end.

Figure 1 illustrates a single package for a safety needle device. FIG. 2A illustrates the safety needle device of FIG. 1; FIG. 2B illustrates the safety needle device of FIG. 1; 3A is a diagram showing the compartments of the single package of FIG. 1; FIG. 3B is a cross-sectional view showing the compartments of the single package of FIG. 1; FIG. 3C is a cross-sectional view of the detailed single package compartment of FIG. 1; FIG. 4A shows a safety needle device positioned within a compartment of the single package of FIG. 1; FIG. 4B is a detailed view showing the safety needle device positioned within the compartment of the single package of FIG. 1; FIG. 4C is a detailed side perspective view showing the safety needle device positioned within the compartment of the single package of FIG. 1; FIG. 4D is an exploded view showing the safety needle device and single compartment of FIG. 1; 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. Figure 7 shows a blister pack containing a blunt fill needle and a safety needle.

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, the retractable sleeve and tether 136 disposed within a housing 138. It is The retractable sleeve at least partially covers the needle 135 in the initial state. Tether 136 includes a recess 139 located at the distal end of the tether. As disclosed in more detail below, recesses 139 in tether 136 are generally configured as shown in FIGS. , are interdigitated with the early actuation prevention element 125 . In FIG. 2B, housing 138 has been removed for clarity. In one or more embodiments, protruding actuation element 132 is integral with 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.

Claims (20)

A packaging system,
a safety needle device having a tether and a retractable sleeve, the tether including a recess located 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;
an early actuation prevention element of said compartment for nesting within said recess of said safety needle device;
A removable seal disposed against the open proximal end, wherein the compartment and the removable seal define a sealed area, the safety needle device disposed within the sealed area. , with a removable seal,
A packaging system comprising: 2. The packaging system of claim 1, wherein the safety needle device is a passive safety needle or an active safety needle. Said early prevention element comprises at least one rail, said at least one rail having a protruding edge extending from an inner wall of said compartment, said protruding edge extending towards the center of said compartment. 2. The packaging system of claim 1, extending. The protruding rim has a width slightly less than the width of the recess of the safety needle device, and the protruding rim has a width corresponding to the safety needle device when the safety needle device is placed in the compartment. 4. The packaging system of claim 3, wherein rotation of the needle device is prevented. A packaging system,
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 located at a distal end of the tether. , a safety needle device,
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; ,
an early deactivation element disposed on an inner wall of the compartment for removably nesting within the recess of the tether of the safety needle device, the early deactivation element being at least one rail; an early actuation prevention element, wherein said at least one rail has a protruding edge that nests within said recess of said safety needle device;
A first removable seal sealed to the first compartment, wherein the first compartment and the first removable seal define a first sealing area, the needle a first removable seal disposed within the first sealing area;
a second removable seal sealed to said second compartment, said second compartment and said second removable seal defining a second sealing area, said safety needle a second removable seal disposed within the second sealing area;
with
The packaging system, wherein the first hard package is attached to the second hard package. 6. The packaging of claim 5, wherein said at least one rail disposed on an inner wall of said compartment extends from a closed distal end of said compartment over at least part of the length of said compartment. system. 7. 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 at least one rail. The packaging system described in . 6. The packaging system of claim 5, wherein said at least one rail has a width less than the width of said recess of said safety needle device. 6. The first hard package is to the second hard package via press fit, adhesive bonding, solvent bonding, ring connector, snap fit, C-clip snap, heat staking or ultrasonic welding. packaging system. 6. The packaging system of claim 5, wherein said first hard package has a perforated attachment to said second hard package. 6. The packaging system of claim 5, wherein said first removable portion comprises a first pull tab and said second removable portion comprises a second pull tab. 12. The packaging of Claim 11, wherein said first removable seal includes a graphic, symbol, drawing, language, or instruction to indicate that said first removable seal is to be opened first. system. 12. The packaging system of claim 11, wherein said second removable seal includes a graphic, symbol, drawing, words or instructions to indicate that said first removable seal is to be opened a second time. . 12. The packaging system of claim 11, wherein said first hard package has a first color and said second hard package has a second color. A packaging system,
a needle having a distal end and a proximal end;
a safety needle device having a recess located at the distal end of the tether;
A blister package having a first and second cavity having an early deactivation element for nesting within the recess of the safety needle device, the first and second cavities being a backing material said first cavity and said backing define a first sealing area; said second cavity and said backing define a second sealing area; a blister package having a distal end disposed within said first sealed area and said distal end of a second needle disposed within said second sealed area;
A packaging system comprising: 16. The packaging system of Claim 15, wherein the needle is a blunt fill needle. 16. The packaging system of Claim 15, wherein the safety needle device is a passive safety needle or an active safety needle. The recess has a width 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 nested within the recess. 16. The packaging system of claim 15, wherein: 16. The packaging system of claim 15, further comprising a cap positioned around the distal end of the needle. 16. The packaging system of Claim 15, wherein the blister package includes a peel tab.

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