Packaging for safety needle.
Abstract
Single and double packaging for charging needles and innocuous needles are described herein. Such containers may include hard containers or honeycomb containers. Such packages may include an early activation prevention element disposed on an interior side wall of a compartment of the package to fit within a recess of a catheter of a harmless needle device to prevent accidental activation of the harmless needle device before it the user uses it.
Term
14.4 yearsleft in the term
Expires 24 February 2041.
- Priority
- Filed
- Granted
- Today
- Expires
20 claims: 3 independent, 17 dependent
- 1Un sistema de envasado que comprende:un dispositivo de aguja inocua que tiene un catéter y un manguito retráctil, donde el catéter incluye un hueco dispuesto en un extremo distal del catéter;y un envase duro que tiene un extremo distal cerrado, un extremo proximal abierto y un compartimiento que se extiende entre el extremo distal cerrado y el extremo proximal abierto;un elemento de prevención de activación precoz del compartimiento que se encaja dentro del hueco del dispositivo de aguja inocua;y un sello extraíble dispuesto contra el extremo proximal abierto, por lo que el compartimiento y el sello extraíble definen una región sellada, donde el dispositivo de aguja inocua se dispone dentro de la región sellada.
- 2El sistema de envasado de la reivindicación 1, en donde el dispositivo de aguja inocua es una aguja inocua pasiva o una aguja inocua activa.
- 3El sistema de envasado de la reivindicación 1, en donde el elemento de prevención de activación precoz comprende al menos un riel, donde el al menos un riel tiene un saliente que sobresale y se extiende desde una pared lateral interior del compartimiento, donde el saliente que sobresale se extiende hacia el centro del compartimiento.
- 4El sistema de envasado de la reivindicación 3, en donde el saliente que sobresale tiene un ancho que es ligeramente menor que el ancho del hueco del dispositivo de aguja inocua, donde el saliente que sobresale previene la rotación del dispositivo de aguja inocua cuando el dispositivo de aguja inocua se dispone dentro del compartimiento.
- 5Un sistema de envasado que comprende:un dispositivo de aguja inocua que tiene una carcasa, un catéter y un manguito retráctil, donde el manguito retráctil puede avanzar dentro del catéter, donde el catéter tiene un hueco dispuesto en un extremo distal del catéter;un primer envase duro que comprende un primer compartimiento;un segundo envase duro que tiene un extremo distal cerrado, un extremo proximal abierto, y un segundo compartimiento que se extiende entre el extremo distal cerrado y el extremo proximal abierto;un elemento de prevención de activación precoz dispuesto en una pared lateral interior del compartimiento para encajar de forma extraíble dentro del hueco del catéter del dispositivo de aguja inocua, donde el elemento de prevención de activación precoz es al menos un riel, donde el al menos un riel tiene un saliente que sobresale, que se encaja dentro del hueco del dispositivo de aguja inocua;un primer sello extraíble sellado contra el primer compartimiento, donde el primer M A/ t/ZUZZ/U / OUOÓ compartimiento y el primer sello extraíble definen una primera región sellada, donde la aguja se dispone dentro de la primera región sellada;un segundo sello extraíble sellado contra el segundo compartimiento, donde el segundo compartimiento, el segundo sello extraíble define una segunda región sellada, donde el dispositivo de aguja inocua se dispone dentro de la segunda región sellada en donde el primer envase duro se une al segundo envase duro.
- 6El sistema de envasado de la reivindicación 5, en donde el al menos un riel dispuesto en una pared lateral interior del compartimiento se extiende desde un extremo distal cerrado del compartimiento al menos parcialmente a lo largo del compartimiento.
- 7El sistema de envasado de la reivindicación 6, en donde el al menos un riel dispuesto en una pared lateral interior del compartimiento se extiende desde un extremo distal cerrado del compartimiento a el extremo proximal abierto.
- 8El sistema de envasado de la reivindicación 5, en donde el al menos un riel tiene un ancho que es menor que el ancho del hueco del dispositivo de aguja inocua.
- 9El sistema de envasado de la reivindicación 5, en donde el primer envase duro se conecta al segundo envase duro a través de un ajuste a presión, una unión adhesiva, una unión con solvente, un conector en anillo, un cierre a presión, un cierre a presión con clip en C, encastrado térmico o soldadura ultrasónica.
- 10El sistema de envasado de la reivindicación 5, en donde el primer envase duro tiene una unión perforada al segundo envase duro.
- 11El sistema de envasado de la reivindicación 5, en donde la primera parte extraíble comprende una primera lengüeta y la segunda parte extraíble comprende una segunda lengüeta.
- 12El sistema de envasado de la reivindicación 11, en donde el primer sello extraíble incluye gráficos, símbolos, diagramas, palabras o instrucciones para indicar que el primer sello extraíble debe abrirse primero.
- 13El sistema de envasado de la reivindicación 11, en donde el segundo sello extraíble incluye gráficos, símbolos, diagramas, palabras o instrucciones para indicar que el primer sello extraíble debe abrirse en segundo lugar.
- 14El sistema de envasado de la reivindicación 11, en donde el primer envase duro tiene un primer color y el segundo envase duro tiene un segundo color.
- 15Un sistema de envasado que comprende:una aguja que tiene un extremo distal y un extremo proximal;un dispositivo de aguja inocua que tiene un hueco dispuesto en un extremo distal del catéter;y un envase alveolado que tiene una primera cavidad y una segunda cavidad que tiene un M A/ t/ZUZZ/U / OUOÓ elemento de prevención de activación precoz para encajarse dentro del hueco del dispositivo de aguja inocua, donde la primera y la segunda cavidad están selladas contra un respaldo, la primera cavidad y el respaldo definen una primera región sellada, la segunda cavidad y el respaldo definen una segunda región sellada, el extremo distal de la aguja se dispone dentro de la primera región sellada y el extremo distal de una segunda aguja se dispone dentro de la segunda región sellada.
- 16El sistema de envasado de la reivindicación 15, en donde la aguja es una aguja de carga de punta roma.
- 17El sistema de envasado de la reivindicación 15, en donde el dispositivo de aguja inocua es una aguja inocua pasiva o una aguja inocua activa.
- 18El sistema de envasado de la reivindicación 15, en donde el hueco tiene un ancho que es ligeramente mayor que el ancho del elemento de activación sobresaliente del compartimiento, donde el elemento de activación sobresaliente previene la rotación del dispositivo de aguja inocua cuando el elemento de activación sobresaliente se encaja en el hueco.
- 19El sistema de envasado de la reivindicación 15, que comprende además una tapa dispuesta alrededor del extremo distal de la aguja.
- 20El sistema de envasado de la reivindicación 15, en donde el envase alveolado incluye una lengüeta despegadle.
Independent claims20
96 paragraphs in 4 sections, as filed
The present disclosure relates generally to packages for medical devices and, more specifically, to dual packages for passive innocuous needles that require rotation of a catheter or housing for passive activation.
BACKGROUND
Clean or sterile articles especially useful for medical applications are packaged to preserve their sterility. The packaging of these items is intended to provide a barrier to prevent microorganisms from entering the packaging and contaminating its contents. In most cases, the packaging is opened immediately before using the item, such as with a foam container containing a syringe or needle, to minimize the period of time that the item is exposed to non-sterile conditions.
Traditionally, doctors who load and inject syringes may use a one- or two-needle technique. In the one-needle technique, the doctor loads the syringe with a container (for example, a bottle) containing a liquid and uses the same needle for the injection. In the two-needle technique, the doctor loads the syringe with a first needle, but replaces the needle with a new needle before the injection.
Both the one-needle technique and the two-needle technique offer certain advantages and disadvantages. For example, the one-needle technique is convenient because the doctor does not have to change needles between loading and injection, but the needle can become contaminated between loading and injection. The two-needle technique allows the use of specialized needles that are optimized for loading and injection, but is more cumbersome for the doctor.
Consequently, there is a need for alternative packaging systems to provide the user with needles in sterile conditions. There is also a need to provide packaging to prevent unintentional activation of passive innocuous needles that require rotation of a catheter or housing for passive activation.
COMPENDIUM
One aspect of the present disclosure relates to a packaging system comprising a harmless needle device having a catheter and a retractable sleeve. The catheter includes a recess disposed at a distal end of the catheter, and the retractable sleeve can be advanced into the catheter. The packaging system further includes a hard container 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 early activation prevention element fits within the recess of the innocuous needle device. A seal is provided
MA/ t/ZUZZ/U 7 OUOÓ removable against the open proximal end, wherein the compartment and the removable seal define a sealed region, where the innocuous needle device is disposed within the sealed region. In one or more embodiments, the innocuous needle device is a passive innocuous needle or an active innocuous needle.
In one or more embodiments, the early activation prevention element comprises at least one rail, where the at least one rail has a projection that protrudes and extends from an interior side wall of the compartment, where the projection protrudes and extends towards the compartment. center of the compartment.
In one or more embodiments, the protruding projection has a width that is slightly less than the width of the gap of the innocuous needle device. The protruding projection prevents rotation of the innocuous needle device when the innocuous needle device is disposed within the compartment.
A second aspect of the present disclosure relates to a packaging system comprising a harmless needle device having a catheter and a retractable sleeve. The catheter includes a recess disposed at a distal end of the catheter, and the retractable sleeve can be advanced into the catheter. The packaging system further includes a hard container comprising a first compartment, and a second hard container 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 member disposed on an interior side wall of the compartment removably fits within the catheter recess of the innocuous needle device. The early activation prevention element is at least one rail having a protruding projection that fits within the recess of the innocuous needle device. A removable seal is disposed against the open proximal end, wherein the compartment and removable seal define a sealed region, wherein the innocuous needle device is disposed within the sealed region. A second removable seal seals against the second compartment. The second removable seal defines a second sealed region within which the innocuous needle is disposed. The first hard container joins the second hard container.
In one or more embodiments, the at least one rail disposed on an interior side wall of the compartment extends from a closed distal end of the compartment at least partially along the length of the compartment.
In one or more embodiments, the at least one rail disposed on an interior side wall of the compartment extends from a closed distal end of the compartment to the open proximal end.
In one or more embodiments, the at least one rail has a width that is less than the width of the gap of the innocuous needle device.
MA/ t/ZUZZ/U / OUOÓ
In one or more embodiments, the first hard container is connected to the second hard container through a press fit, an adhesive bond, a solvent bond, a ring connector, a snap closure, a clip-on snap closure. C, thermal insertion or ultrasonic welding.
In one or more embodiments, the first hard container has a perforated connection to the second hard container.
In one or more embodiments, the first removable portion comprises a first tab and the second removable portion comprises a second tab.
In one or more embodiments, the first removable seal includes graphics, symbols, diagrams, words or instructions to indicate that the first removable seal should be opened first.
In one or more embodiments, the second removable seal includes graphics, symbols, diagrams, words or instructions to indicate that the first removable seal should be opened second.
In one or more embodiments, the first hard container has a first color and the second hard container has a second color.
A third aspect of the present disclosure relates to a packaging system having a needle, an innocuous needle device, and a honeycomb container having a first cavity and a second cavity. The second cavity has a premature activation prevention element to fit within the recess of the innocuous needle device. The first and second cavities are sealed against a backing, where the first cavity and the backing define a first sealed region, and where the second cavity and the backing define a second sealed region. A distal end of the needle is disposed within the first sealed region and a distal end of a second needle is disposed within the second sealed region.
In one or more embodiments, the needle is a blunt-point loading needle.
In one or more embodiments, the innocuous needle device is a passive innocuous needle or an active innocuous needle.
In one or more embodiments, the gap has a width that is slightly greater than the width of the protruding activation element of the compartment, where the protruding activation element prevents rotation of the innocuous needle device when the protruding activation element is engaged in the gap.
In one or more embodiments, a cap is disposed around the distal end of the needle.
In one or more embodiments, the honeycomb container includes a peel-off tab.
BRIEF DESCRIPTION OF THE FIGURES
A single package for a harmless needle device is illustrated in Figure 1;
An innocuous needle device of Figure 1 is illustrated in Figures 2A and 2B;
A compartment of the single container of Figure 1 is illustrated in Figure 3A;
MA/ t/ZUZZ/U / OUOÓ
A sectional view of the compartment of the single container of Figure 1 is illustrated in Figure 3B;
A detailed sectional view of the compartment of the single container of Figure 1 is illustrated in Figure 3C;
Figure 4A illustrates the innocuous needle device disposed within the compartment of the single package of Figure 1;
A detailed view of the innocuous needle device disposed within the compartment of the single package of Figure 1 is illustrated in Figure 4B;
A detailed side and perspective view of the innocuous needle device disposed within the compartment of the single package of Figure 1 is illustrated in Figure 4CB;
An exploded view of the innocuous needle device and single compartment of Figure 1 is illustrated in Figure 4D;
Figure 5 illustrates a double container with two tabs;
Figure 6 illustrates a hard container having two removable parts with two tabs;
Figure 7 illustrates a honeycomb package containing a blunt-tip loading needle and a harmless needle.
DETAILED DESCRIPTION
Before describing various illustrative embodiments of the present description, it should be understood that the embodiments of the present description are not limited to the construction details or process steps set forth in the following description. The embodiments of the present disclosure may have other embodiments and may be implemented or carried out in various ways.
With respect to the terms used in this description, the following definitions are provided.
As used herein, the use of “a” and “the” includes the singular and the plural.
Reference to "needle" includes needles that are suitable for loading and/or injecting liquids into or out of a syringe. In the present description, a convention is followed where the part of a needle closest to the doctor handling the needle is called "proximal" and the part of the needle towards the patient (for injection) or the bottle containing the liquid (for carrying) and further away from the doctor is called “distal”. In various embodiments, the needles described herein may be blunt-tip loading needles, innocuous needles, and/or conventional needles.
As used herein, a "loading needle" refers to a needle that is suitable for loading a syringe but may not be suitable for injection. For example, a loading needle may be a blunt-tipped needle that is not suitable for penetrating the skin of a
MA/ t/ZUZZ/U / OUOÓ patient.
As used herein, a "safe needle" refers to a needle suitable for injection that includes one or more features to prevent needle stick injuries. In one or more embodiments, a harmless needle includes a sheath that covers the distal end of the needle. As used herein, an "active harmless needle" refers to a harmless needle with an activation mechanism controlled by the user to cover the distal end of the needle after it has been injected into a patient. As used herein, a "passive harmless needle" refers to a harmless needle with a passive activation mechanism that automatically covers the distal end of the needle after it has been injected into a patient.
Any suitable needle device comprising a safety feature may be used in conjunction with the packaging described herein. Exemplary harmless needle devices include, but are not limited to, those described in co-owned U.S. Patent Application Nos. 62/433,294, 62/433,350, 62/479,507, 62/533,786, the disclosures of which are incorporated herein. present in its entirety by reference. The types of safety features vary in structure and mechanics, but in general, harmless needle devices have a charging state and an injection state.
Reference to "syringe" includes syringes that are intended for use with needles, nozzles, tubes or for use in delivery systems. As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger that fits tightly into a cylinder or tube. The plunger can be pulled or pushed into the cylinder, allowing the syringe to draw in and expel a liquid or gas through an opening in the open end of the cylinder. The open end of the syringe may be equipped with a needle, nozzle, or tube to help direct the flow of fluid into and out of the cylinder. The syringe can be sterile or non-sterile, depending on the needs of the technician.
As used herein, the terms “container” or “packaging” include any material used to wrap or protect a good or product, such as a syringe or needle. The packaging can be hard or flexible. Packaging includes, but is not limited to, medical packaging, pharmaceutical packaging, and child-resistant packaging. Medical and pharmaceutical packaging may include honeycomb packaging or hard packaging.
As used herein, the terms "foam packaging" or "blister packaging" include various types of preformed packaging used for consumer goods, foods, pharmaceuticals, medical devices, etc. The main component of a honeycomb container is a cavity or pocket made of a moldable network, usually a thermoformed plastic. The moldable network can be hard or flexible. The cavity or pocket is large enough to contain the good that is placed in the honeycomb container. According to
MA/ t/ZUZZ/U / OUOÓ application, a foam container may have a backing of thermoformable material and a lid seal of aluminum foil, paper, Tyvek®, plastic or other medical grade materials. Foam containers can also be hinged containers, which may include a hard backing, such as cardboard. Foam packaging can provide a protective barrier against microorganisms and other contaminants, and can provide a certain degree of tamper resistance. Among the many options offered by the honeycomb packaging, the honeycomb packaging must protect the product contained inside while still possessing the characteristic that makes automatic processing possible.
Foam containers are commonly used as unit dose containers for pharmaceutical tablets, capsules or lozenges. The pharmaceutical product and its foam container act together to serve as an integral unit. Foam packaging protects the pharmaceutical product from external influences that would otherwise render it unusable, while allowing the manufacturer of the pharmaceutical product to package it using form, fill and seal equipment. The form, fill and seal process involves creating the honeycomb package from rolls of flat sheets or films, loading it with the pharmaceutical product, such as a medication tablet, and closing (sealing). This type of honeycomb packaging is sometimes called “push packaging” because the consumer can push the product (for example, a medication tablet) through the backing. With pharmaceutical foam packaging, manufacturers must be concerned about the wet vapor transmission rate of the foam packaging because many pharmaceutical products degrade and lose their effectiveness through hydrolysis. Additionally, the foam container must provide an oxygen barrier to prevent degradation of the pharmaceutical product due to oxidation. In one or more embodiments, the honeycomb container is a push container.
Foam packaging containing medical devices, such as a syringe, differs from pharmaceutical foam packaging in that medical foam packaging is not a push-in packaging. Instead, the thermoformed base net is made of a thicker plastic and cannot sag, thus forming a solid backrest. The lid film provides a peel-open feature that can be opened with two hands, such as the knuckle-peel technique. The lid film of a medical foam container is generally porous to allow sterilization. Medical foam packaging is often made of Tyvek® or a similar medical grade material that is breathable and gas permeable, but is not permeable to microorganisms. The lid film may also be made of medical grade paper or a completely waterproof or non-breathable film. In cases where a non-breathable film is used, sterilization is performed by radiation (e.g., electron beams (E-beam)). In one or more modalities, the
MA/ t/ZUZZ/U / OUOÓ honeycomb container is a medical honeycomb container.
Foam containers can be created by thermoforming or cold forming. In the case of thermoforming, a plastic sheet or film is unwound from a reel and guided through a preheating station on the foam packaging line. The temperature of the preheating plates is such that the plastic will soften and become flexible. The hot plastic then arrives at a forming station where high pressure forms the cavity of the honeycomb container into a negative mold. The mold is cooled so that the plastic becomes firm again and maintains its shape when removed from the mold.
In cold forming, an aluminum laminate film is simply pressed against a mold using a die. Aluminum elongates and maintains the molded shape. The use of aluminum offers a complete barrier to water and oxygen. However, cold-formed honeycomb containers take longer to produce compared to thermoforming. Cold-formed honeycomb containers are also not transparent, which can lead to consumer non-compliance with pharmaceutical treatments.
The thermoformable backing of medical foam packaging is generally composed of a flexible thermoformable plastic film. The film often has several layers. The main component is typically a layer of approximately 15-30% nylon, while the remaining layers may comprise substances including, but not limited to, polyethylene. The sealant layer may comprise, among others, ethyl vinyl acetate (EVA).
The lid film of a medical foam container can be made of plastic, aluminum, or medical grade papers that are gas permeable for sterilization, but impermeable to microorganisms. Most commonly, Tyvek® is used as a lid material for medical foam packaging.
Foam packaging can also include packaging known as skin pack, where a cardboard or other backing material and the product are covered with a thin sheet of transparent plastic. The backing usually has a heat-sealed coating. The plastic film is softened with heat and placed over the product on the backing. Vacuum is sometimes used to aid in a tight fit. Immediately after forming the foam container, the foam container is transported to a vacuum sealing station where vacuum is applied and seals the foam container, providing a tight fit. The plastic film adheres to the heat-sealed liner of the cardboard or other backing. In one or more embodiments, the foam container is a vacuum-sealed thermoformed foam container.
Foam containers can be sealed in a variety of ways, including, but not limited to, heat sealing and cold sealing. Lid materials can have a
MA/ t/ZUZZ/U / OUOÓ heat-sealing coating; The lid is then sealed to the shell using heat, which activates the coating. Foam containers can also be sealed using a cold sealing process, which uses a combination of a pressure-sensitive foam packaging folding card and a transparent foam; The alveolus is trapped between two pieces of cardboard that are joined by pressure without using heat. Additionally, honeycomb containers can be sealed by correctly orienting several layers of film to generate a seal.
As used herein, the term "hard container" or the like includes containers that have a compartment with one or more openings that can be covered to create a seal. In one or more embodiments, the hard packaging includes one or more components made of a hard 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 of these. In one or more embodiments, a hard package may be thermoformed or molded, for example by injection molding. The techniques described above for honeycomb containers can be applied to the rigid parts of hard containers and/or to removable portions of hard containers.
As used herein, the term "microorganism" refers to a microbe or organism that is unicellular or that lives in a colony of cellular organisms. Microorganisms are very diverse; They include, but are not limited to, bacteria, fungi, archaea and protozoa.
Tyvek® is a synthetic material consisting of evaporative-spun high-density polyethylene fibers (i.e., a continuous filament olefin fiber). The material is light and strong, and is resistant to breakage, but can be cut with scissors or a knife. Water vapor and other gases can pass through Tyvek® as the material is highly breathable, but at the same time, the material is impermeable to liquid water and microorganisms.
As used herein, the term "sterilization" refers to a means of eliminating or killing microorganisms present on a surface, contained in a fluid or in a compound such as a biological culture medium, to achieve asepsis or an environment sterile microbial. Sterilization can be achieved by applying heat, chemicals, irradiation/radiation, high pressure, filtration, or combinations of these. Chemical sterilization includes sterilization with gases such as ethylene oxide, hydrogen peroxide gas and ozone, liquids such as chlorine bleach, iodine, glutaraldehyde and formaldehyde, ortho-phthalaldehyde (OPA), hydrogen peroxide, peracetic acid, sodium hydroxide , silver and cobalt. Radiation sterilization involves the use of radiation such as electron beams (E-beam), x-rays, gamma rays, or subatomic particles.
As used herein, the term “knuckle peel technique” refers to the process by which a technician, such as a doctor or nurse, opens a package to
ΜΛ/ t/ZUZZ/U / OUOÓ release the product it contains. With a twisting motion of the knuckles, the outer packaging material is separated with both hands and the product inside is released.
Various embodiments of the present disclosure provide double packaging systems containing two needles. In one or more embodiments, this double packaging can help improve workflow and efficiency for users of the two-needle technique by eliminating the need to remember to obtain two needles instead of one. In one or more embodiments, this double packaging may also be useful for physicians who traditionally use a one-needle technique for loading and injecting, as these physicians may not be accustomed to obtaining a separately packaged component. In one or more embodiments, this double packaging can also help boost compliance in clinical settings where managers want physicians to use a two-needle technique but physicians prefer to use the more convenient one-needle technique. In one or more embodiments, double packaging may be beneficial because it helps prevent a user from injecting a patient with a device in the charging state, either accidentally or on purpose. For passive safety, injection with a device in a charging state could prevent the safety from being activated. In one or more embodiments, providing two needles allows a user to perform the injection with a second needle that has a blunt tip, has been recapped, or has not been at risk of contact contamination. In one or more embodiments, the two needles include a loading needle (e.g., a blunt-tipped loading needle) and an injection needle (e.g., a harmless needle). In other embodiments, one or both needles is a conventional needle.
One or more embodiments of the present disclosure relate to a single-compartment or two-compartment packaging system having a hard packaging.
An exemplary embodiment of a single compartment packaging system 100 is illustrated in Figure 1. As illustrated, compartment 120 may house a harmless needle device 130. A removable seal 140 is disposed against the open proximal end. 122. As shown in Figure 1, the compartment 120 can be molded in a single piece, for example by injection molding.
Illustrated in Figures 2A and 2B is an innocuous needle device 130 comprising a retractable sleeve 134 having a protruding activation element 132 that can be advanced into a catheter 136, where the retractable sleeve and catheter 136 are disposed within a housing 138. The retractable sleeve at least partially covers a needle 135 in an initial state. The catheter 136 includes a recess 139 disposed at a distal end of the catheter. As described in more detail below, the recess 139 of the catheter 136 is interlocked with an early activation prevention element 125, as shown in Figures 3A-3C of the compartment 120 to prevent inadvertent activation of the retractable sleeve 134 during the transport,
MA/ t/ZUZZ/U / OUOÓ storage or packaging in general. For illustrative purposes, in Figure 2B, housing 138 has been removed for clarity. In one or more embodiments, the protruding activation element 132 is an integral part of the retractable sleeve 134. In one or more embodiments, the innocuous needle device 130 is a passive innocuous needle. In one or more embodiments, the innocuous needle device 130 is an active innocuous needle.
As shown in Figure 3A-3C, the single compartment packaging system 100 may include a hard container 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. A removable seal 140 is disposed against the open proximal end 122. The compartment 120 and the removable seal 140 define a sealed region in which the innocuous needle device 130 is disposed. The removable seal 140 may be a tab.
As shown in Figure 3B - 3C, the compartment 120 includes an early activation prevention element 125 that fits within the recess (not shown) of the innocuous needle device 130. In the preferred embodiment, the activation prevention element Early activation 125 includes at least one rail 126 disposed on an interior side wall 129 of the compartment 120 that extends from the closed distal end 121 at least partially along 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 gap 139 of the innocuous needle device 130. In one or more embodiments, the early activation prevention element 125 comprises two parallel rails, where the two parallel rails have a distance between them where the two parallel rails are configured to fit within the width of the gap 139 of the innocuous needle device. 130. In one or more embodiments, the early activation prevention element 125 comprises a single unitary rail.
As shown in Figure 3C, the at least one rail 126 includes a protruding projection 128. The protruding projection 128 extends toward the center of the compartment 120. The protruding projection 128 is configured to fit within the recess 139.
As shown in Figures 4A - 4D, the innocuous needle device 130 is disposed within the compartment 120. For clarity, a spring of the innocuous needle device 130 has been hidden from view to better illustrate the protruding projection 128. of the early activation element 125 that fits inside the gap 139 of the innocuous needle device 130. When the innocuous needle device 130 is disposed within the compartment 120, the protruding flange 128 of the early activation prevention element 125 of the compartment 120 fits within the recess 139 of the housing 138 of the innocuous needle device 130. The innocuous needle device 130 Early activation 125 of compartment 120 prevents early or inadvertent activation of the innocuous needle device 130 by preventing rotation of the needle device 130.
MA/ t/ZUZZ/U / OUOÓ harmless needle 130. Because at least one rail 126 of the early activation element 125 has a width that is less than the width of the gap 139 of the catheter 136, the protruding projection 128 sits within the gap 139. In one or more embodiments, the width of the at least one rail 126 is slightly less than the width of the gap 139, allowing only minimal rotation, but not free rotation of the innocuous needle device 130 within the compartment 10.
An exemplary embodiment of a dual packaging system 200 is illustrated in Figure 5. The packaging system has a first compartment 220 that can house a first needle and a second compartment 250 that can house a harmless needle device 230. As As shown in Figure 3, the first compartment 220 and the second compartment 250 can be molded in one piece, for example by injection molding.
The first compartment 220 has an opening that is covered by a first removable seal 225. The first removable seal 225 is sealed against the first compartment 220, whereby the first compartment 220 and the first removable seal 225 define a first sealed region. The first removable seal 225 may include a 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 graphics, symbols, diagrams, words, or other instructions to indicate which should be opened first. For example, the first removable seal 225 may include the number "1." The first removable portion may also include graphics, symbols, diagrams, words, or other instructions to indicate the intended use of the needle stored in the first compartment 220. In one or more embodiments, the first removable seal 225 may include graphics, symbols, diagrams, words, or other instructions to indicate which should be opened first.
The second compartment 250 has an opening that is covered by a second removable seal 255. The second compartment 250 includes a premature activation prevention element 235 disposed within the compartment that can fit into a recess 239 provided at a distal end of a catheter 236. of the harmless 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 an interior side wall of the compartment 250. In one or more embodiments, the early activation prevention element 225 is interspersed with the recess 239 of the protruding activation element 232. The at least one rail 226 includes a protruding projection 228. The protruding projection 228 does so towards the center of the compartment 250. The protruding projection 228 is configured to fit within the recess 239.
The second removable seal 255 is sealed against the second compartment 250, whereby the second compartment 250 and the second removable seal 255 define a second sealed region. The second removable seal 255 may include a second tab 260 so that a
MA/ t/ZUZZ/U / OUOÓ user grabs it to remove the second removable seal 255 and access the second compartment 250.
The second removable seal 255 may include graphics, symbols, diagrams, words or other instructions to indicate that it should be opened second. For example, the second removable seal 255 may include the number "2." The second removable portion may also include graphics, symbols, diagrams, words, or other instructions 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 showing a person with a syringe. Additionally, if the needle stored in the second compartment 250 is a single-use needle device that is locked after use, the second removable seal 255 may also include a lock symbol.
An exemplary embodiment of a dual packaging system 300 is illustrated in Figure 6. The packaging system has a first compartment 320 that can house a first needle and a second compartment 350 that can house a harmless needle device 330. As As shown in Figure 4, the first compartment 320 and the second compartment 350 may be molded separately and joined by a joint 375. In one or more embodiments, the first compartment 320 can be joined to the second compartment 350 through a press fit, an adhesive bond, a solvent bond, a ring connect, a snap closure, a clip snap closure. in C, thermal insertion or ultrasonic welding. In one or more embodiments, the first compartment 320 may be joined to the second compartment 350 by a perforated or temporary joint.
In one or more embodiments, the first compartment 320 and the second compartment 350 are composed of different materials or have different colors. For example, in one or more embodiments, the first compartment 320 may be colored to indicate a specific use (e.g., red to indicate a blunt-tipped charging needle) and the second compartment 350 may be transparent, semi-transparent, or have a colored different that indicates a specific use. In other embodiments, both the first compartment 320 and the second compartment 350 are transparent or semi-transparent, or are the same color.
The first compartment 320 has an opening that is covered by a removable portion 325. The first removable seal 325 is sealed against the first compartment 320, whereby the first compartment 320 and the first removable seal 325 define a first sealed region. The first removable seal 325 may include a first 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 that is covered by a second seal
removable MA/ t/ZUZZ/U / OUOÓ 355. The second removable seal 355 is sealed against the second compartment 350, so the second compartment 350 and the second removable seal 355 define a second sealed region. The second removable seal 355 may include a second 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 an early activation prevention element 335 in the compartment that fits within a recess 339 of a catheter 336 of the innocuous needle device 330. In one or more embodiments, the early activation prevention element 335 is inserted with gap 339 of catheter 336 of harmless needle device 330<sub>Λ</sub> The second removable seal 355 is sealed against the second compartment 350, whereby the second compartment 350 and the second removable seal 355 define a second sealed region. The second removable seal 355 may include a second 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, diagrams, words or other instructions to indicate the order of opening of the compartments or the intended use of the needles stored in the compartments.
One or more embodiments of the present description relate to a double packaging system having a honeycomb container. An exemplary embodiment of a dual packaging system 400 is shown in Figure 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 harmless needle device 435. In one or more embodiments, the first cavity 420 houses a syringe and a pre-installed blunt tip loading needle. The innocuous needle device 435 has a protruding activation element 436. In one or more embodiments, the needle 405 and the innocuous needle device 435 can be packaged side by side in a double honeycomb packaging system 400.
In one or more embodiments, the second cavity 450 has a recess 460 to accommodate the protruding activation element of the innocuous needle device. The distal portion 410 of the needle 405 may be covered with a harder material than the proximal portion 415 of the first needle. The distal portion 410 of the needle 405 may be covered by a cap 490. Similarly, the distal portion 440 of the innocuous needle device 435 may be covered with a hard material. The distal portion 445 of the innocuous needle device 435 may be covered with a cap 490. A backing 485 may provide a seal against the first cavity 420 and the second cavity 450. The honeycomb package may also include a peel-off tab 495 for opening the package.
MA/ / OUOÓ honeycomb. In one or more embodiments, the peel direction is on the right side of the container to reduce the possibility of contamination. In another embodiment, the direction for taking off is on the left side of the container.
Reference throughout this specification to "a modality", "certain modalities", "one or more modalities" or "a modality" means that a specific feature, structure, material or characteristic described with respect to the modality is included in at least one embodiment of the description. Therefore, the appearance of phrases such as "in one or more modalities", "in certain modalities", or "in a modality" in various passages throughout this specification do not necessarily refer to the same modality of the description. Furthermore, particular features, structures, materials or characteristics may be combined in any suitable manner in one or more embodiments.
While the disclosure herein 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 of the present disclosure may be made without departing from the spirit or scope thereof. Therefore, it is intended that this description includes modifications and variations that are within the scope of the attached claims and their equivalents.
Contents4
105 members in 10 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 16810476 | United States of America | – | |
| 202016810476 | United States of America | A | |
| 2021019381 | United States of America | W |
Members105
| Document | Office | Kind | |
|---|---|---|---|
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| US2018161491A1 | United States of America | A1 | |
| US2018161492A1 | United States of America | A1 | |
| US2018161515A1 | United States of America | A1 | |
| US2018161520A1 | United States of America | A1 | |
| US2018161521A1 | United States of America | A1 | |
| US2018161522A1 | United States of America | A1 | |
| US2018161523A1 | United States of America | A1 | |
| CA3046932A1 | Canada | A1 | |
| CA3046933A1 | Canada | A1 | |
| CA3046934A1 | Canada | A1 | |
| CA3046935A1 | Canada | A1 | |
| CA3046952A1 | Canada | A1 | |
| CA3187947A1 | Canada | A1 | |
| WO2018111796A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018111797A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2018111798A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018111799A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018111800A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018111814A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018111815A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018111816A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2018111797A3 | World Intellectual Property Organization (WIPO) | A3 | |
| WO2018111816A3 | World Intellectual Property Organization (WIPO) | A3 | |
| AU2017375773A1 | Australia | A1 | |
| AU2017375774A1 | Australia | A1 | |
| AU2017378133A1 | Australia | A1 | |
| AU2017378134A1 | Australia | A1 | |
| AU2017378135A1 | Australia | A1 | |
| CN110072575A | China | A | |
| CN110072576A | China | A | |
| CN110072577A | China | A | |
| CN110072578A | China | A | |
| CN110072589A | China | A | |
| EP3554592A2 | European Patent Office (EPO) | A2 | |
| EP3554593A1 | European Patent Office (EPO) | A1 | |
| EP3554594A1 | European Patent Office (EPO) | A1 | |
| EP3554595A2 | European Patent Office (EPO) | A2 | |
| EP3554610A1 | European Patent Office (EPO) | A1 | |
| JP2020501671A | Japan | A | |
| JP2020501672A | Japan | A | |
| JP2020501673A | Japan | A | |
| JP2020501675A | Japan | A | |
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| JP2020512043A | Japan | A | |
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| AU2017375773B2 | Australia | B2 | |
| AU2017375774B2 | Australia | B2 | |
| AU2017378135B2 | Australia | B2 | |
| US2020215272A1 | United States of America | A1 | |
| US2020238020A1 | United States of America | A1 | |
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| US10792439B2 | United States of America | B2 | |
| US11103651B2 | United States of America | B2 | |
| CN110072589B | China | B | |
| CA3170267A1 | Canada | A1 | |
| WO2021178173A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US11147910B2 | United States of America | B2 | |
| CN110072577B | China | B | |
| US11173253B2 | United States of America | B2 | |
| CN113797409A | China | A | |
| CN113952554A | China | A | |
| JP7008707B2 | Japan | B2 | |
| CN110072575B | China | B | |
| JP7034161B2 | Japan | B2 | |
| CN110072578B | China | B | |
| JP7042827B2 | Japan | B2 | |
| CN110072576B | China | B | |
| CN216536421U | China | U | |
| EP3554610B1 | European Patent Office (EPO) | B1 | |
| EP3554595B1 | European Patent Office (EPO) | B1 | |
| JP7093775B2 | Japan | B2 | |
| US11413402B2 | United States of America | B2 | |
| ES2924554T3 | Spain | T3 | |
| JP7149943B2 | Japan | B2 | |
| AU2021229378A1 | Australia | A1 | |
| ES2925387T3 | Spain | T3 | |
| BR112022017689A2 | Brazil | A2 | |
| CN115243740A | China | A | |
| MX2022010933AThis record | Mexico | A | |
| EP4114481A1 | European Patent Office (EPO) | A1 | |
| US11559631B2 | United States of America | B2 | |
| CA3046933C | Canada | C | |
| JP2023516352A | Japan | A | |
| US2023201483A1 | United States of America | A1 | |
| CN113797409B | China | B | |
| EP3554592B1 | European Patent Office (EPO) | B1 | |
| EP3554592C0 | European Patent Office (EPO) | C0 | |
| EP3554594B1 | European Patent Office (EPO) | B1 | |
| EP3554594C0 | European Patent Office (EPO) | C0 | |
| EP4233939A2 | European Patent Office (EPO) | A2 | |
| ES2951120T3 | Spain | T3 | |
| ES2951465T3 | Spain | T3 | |
| EP4233939A3 | European Patent Office (EPO) | A3 | |
| EP3554593B1 | European Patent Office (EPO) | B1 | |
| EP3554593C0 | European Patent Office (EPO) | C0 |
Numbers
- Publication
- 2022010933
- Application
- 2022010933
Titles2
- Spanish
- ENVASE PARA AGUJAS INOCUAS
- English
- PACKAGING FOR HARMLESS NEEDLES
Classification
- CPC, 4
- A61M5/002
- A61M2005/3247
- A61M5/3271
- A61M5/3276
- IPC, 1
- A61M5 00