Patent Application
20220081147
The present invention relates to systems and methods for containing and dispensing fluids, including a container for fluid attachable to one or more different dispensing devices.
There is a need in the fields of pharmaceutical, cosmetic, diagnostic, dental, veterinary, food and chemical, for example, for dispensing a fluid (liquid or other flowable product such as a gel or paste) through a dispensing aperture, typically in a specific dose (weight or volume) and typically requiring sterility of the product and its system for delivery. Prior art systems have one or more problems relating to breakage of glass components, use of different materials that require different disposal methods (e.g., not easily recyclable), contamination (bacterial or lubricants) from system components or method of use, expense of manufacture, and injury to the user (e.g., via needle injuries or glass breakage). The present invention addresses this need.
A container for fluid is provided that is configurable for use with a variety of dispensing devices, such as a needle or syringe, the latter being attachable to the container for delivery of the fluid product
In one embodiment, an integral container (a vial) comprises a flexible plastic body having a neck portion, open at the top end, for delivery of the fluid from the container body. The neck portion includes an internal membrane, within a delivery passage in the neck that first seals the passage and after puncture of the membrane by a needle or luer (of a separate dispensing device) allows passage of the fluid from the body through the neck passage and needle or luer. An attachment member (e.g., thread or snap lock mechanism) on the neck enables attachment of the separate dispensing device.
Preferably, the integral container body and neck form a vial, for delivery of a single dose of the fluid product.
Preferably a strip of such vials is formed as an integral injection molded strip comprising a plurality of vials and frangible connecting members that temporarily connect the vials to form the integral strip, but which frangible connecting members can be broken (e.g., by bending or twisting) to release a vial from the strip.
Preferably, the strip of vials are filled with the fluid product simultaneously, in a single filling step where all vials are filled with a desired dose of the fluid product. In one embodiment, the container body (of each injection molded vial in the strip) is injection molded with an open bottom end, opposite the neck portion, and the filling step comprises simultaneous filling of all vials in the strip by introducing the fluid product into the open bottom ends. The filled containers can then each be sealed by closing (e.g., heat sealing) the bottom ends. The strip of vials can be sterilized (e.g., by Gamma or Eto sterilization) prior to filling and sealing of the container bottoms. The open neck end of each container can be temporarily closed by attaching a closure cap with a mating attachment member (e.g., thread or snap lock), to keep the membrane space sterile prior to uncapping and attaching the dispensing device (e.g., inserting a dual needle luer into the top end of the vial to pierce the membrane).
In use, a single fluid filled and capped vial is separated from the strip and is ready for use. The cap is readily removed by for example unscrewing the threaded cap, and the dispensing device, such as a needle or syringe, is attached to the neck portion of the container. The dispensing device has an attachment portion (e.g. a thread or snap on locking mechanism) that allows it to be attached to the neck portion in fluid tight engagement, and includes a needle or luer that punctures the internal membrane of the neck to allow passage of the fluid from the container body, into and through the first end of the needle or luer that punctures the membrane, and out the opposite open end of the needle or luer. The flexible container body is made of a soft plastic material (such as polyolefin, e.g. polyethylene or polypropylene, including copolymers and blends thereof) or the like of a thickness and flexibility such that dispensing can be activated by squeezing the container body with the user's finger pressure to force the fluid product from the container body and into and through the needle or luer that has punctured the membrane, and out the other open end of the needle or luer for delivery to a person or animal, or to a syringe for subsequent dispensing from the syringe.
The separate delivery device 60 has a hollow cylindrical needle (66), open at both ends (63,62), with an open delivery channel (67) extending between the opposing ends (63, 62). The needle has a first patient injection end (63) (e.g., for injection of the single fluid dose from the vial to a patient) that extends from an attachment portion (61) on the other end of the delivery device; the injection needle (63) may be housed in a removable protective sheath (e.g., as shown in
The needle (66) may be configured for injection to a person or animal (depending on the intended use). A protective sheath or cap (if provided) is temporarily positioned over the needle delivery end (63) for protecting a user from needle injury. A user unscrews the protective cap (40) of the vial (20) and opens the first end (62) of the needle (66). The user screws the attachment portion (61) onto the vial neck thereby inserting the second end (62) of the needle into the delivery channel (23) and piercing the membrane (34) of the vial neck portion. The user then uncaps the primary injection needle (63) and allows the flow of the fluid dose (50) into the patient.
In summary, an injection plastic vial (20) is linked by frangible connecting members (38) to a plurality of other vials designed to compose a strip (10), each vial (20) has a hollow body chamber (23) for containing a single dose of fluid (50). The vial may include:
The vials (20) are manufactured by injection molding a strip of vials (e.g., between a pair of injection molds that form the outer and inner surfaces of the vials and connecting members 38), and the vials of the strip are then assembled to the caps (40) as shown in
In one embodiment, the strip (10) of plastic vials is configured for injectable preparations, like vaccines, aimed to replace current glass vials and syringes to improve safety and user experience. The neck (30) of the vial is designed to fit a commercial needle (60) for dental anesthesia. The inner membrane (34) will be pierced by the needle (62) and allow the flow of product (50). The strip (10) is made of five vials (20), all vials being filled simultaneously, and then heat sealed and closed simultaneously.
As shown in
Optionally, a cap (140) is provided that mates with the thread (136) of the neck portion (130) and allows the vial neck area to remain clean. The thread (136) of the neck (130) of the vial is compatible with the neck of commercial syringes (180). The vial is manufactured by injection molding and the preassembled with caps (140) before filling. The vial strip is then supplied to the filling plant, where all vials (120) of the strip are simultaneously filled, and simultaneously heat sealed. Prior to filling and heat sealing, the vials (120) may be sterilized as necessary. In use, a user screws the syringe male luer (183) end into the vial open top end (132). The syringe made luer 1(83) breaks the inner membrane (134) and allows the flow of the fluid product (150). By moving back the syringe plunger (181) the fluid dose (150) is withdrawn from the vial (120) and goes into the syringe body (182). The syringe can then be connected with a needle to inject the fluid into the patient.
The vials (220) are manufactured as part of a strip (210) of vials, similar to what is described and shown in the first embodiment A. The third embodiment illustrates an alternative type of temporary closure or cap for use with the vial. The unit-dose vials (220) of the strip each have a male luer fitting (235) for connection with a needle device (260) or other delivery device.
Each plastic vial (220) is linked to a plurality of other vials in the form of an integral injection molded strip (210) connected by frangible connecting members (238), each vial (220) having a neck portion (230) with a delivery passage (231) and internal membrane (234), the delivery passage being connected to a hollow body portion (222) having an internal chamber (223) for containing a single dose of fluid (250). The vial (220) includes:
The vials (220) are manufactured by injection molding technology (in a mold at elevated temperature and pressure). The vial strip (210) is then supplied to the filling plant, where all vials (220) of the strip (210) are simultaneously filled and then simultaneously heat sealed. Prior to filling and sealing, the vials may be sterilized if necessary. The final product can be sold together with commercial needles, or the final user procure the needle (e.g. a delivery device (260) having a double ended needle (266), hub (261) and needle protective sheath (PS)).
In use, the user opens the vial (220) by breaking off the frangible closure (239), inserts the second needle end (262) into the now open top end (224) of the vial to pierce through the membrane (234), and then uncaps the opposing first injection needle end (263) by removing the protective sheath (PS). Then the user injects the first needle end (263) into the patient body and squeezes the vial body portion (222) to dispense the fluid dose (250) into the patient.
Single dose vials are provided according to the invention, made by injection molding, that can be assembled to a separate delivery device, to be used to dispense fluid (flowable) substances by squeezing the vial itself.
The single use vial, to be used in connection with a needle delivery device, may include a protection mechanism against needle injuries (e.g., protruding radial ring (21) and/or bore (64)).
The above described technology can be useful for different production volumes, i.e., number of vials produced and size of fluid dose. In other embodiments, the container can be connected with another device such as a bag, connector, applicator or the like, to be used in different applications in the fields of pharmaceutical, cosmetic, dental, veterinary, food and chemical fluid products.
By manufacturing the vials as an integral strip of multiple vials, the time, cost and equipment costs are substantially reduced. In addition, the time, cost and equipment costs for filling and heat sealing are substantially reduced.
The disposal of the vials can be made in a sustainable way, with the entire strip of vials made of a single recyclable material. The additional components (cap and delivery device) can be easily disassembled, and thus need not be part of a single recycle material stream
The filling can be done at room temperature, allowing the filling of heat-sensitive products.
Once filled, the vial neck portion remains hermetically closed until its use.
The vial has the superior quality of an injection molded article (no flashes, no sharp edges, repeatable dimensions, excellent surface finish).
This solution is user friendly, requiring a lower number of steps compared to other solutions and the steps being easy to understand and to perform by a non-professional user.
The injection can also be auto-administered (by the patient).
Being composed of a lower number of components, and produced with a cost effective injection molding technology, the cost of the device is lower than other options.
| Number | Date | Country | |
|---|---|---|---|
| 63192162 | May 2021 | US | |
| 63078765 | Sep 2020 | US |
