DESC:TITLE: A customized two beveled needle with a Tamper evident cap for Injection along with a flexible vial comprising bellows

FIELD OF INVENTION
The present invention discloses a sterile two beveled needle comprising tamper evident cap that has a first tip which projected from the needle-top to engage in the patient's body and a second tip disposed in the female connector or Needle top with a cap to perforate the end of the vial so that, by means of manual pressure on the container of the vial, the solution contained therein can be injected through the needle into the patient's body. The present invention also relates to a flexible vial for injection comprising an elastically deformable container wherein a solution for injection consists of a flexible bellow and a unique two bevel needle wherein the needle consists of tamper evident cap. The present invention also relates to the combination of a sterile vial that has been molded as blow-fill-seal vial and a sterile two bevel needle that can be used for subcutaneous and/or Intramuscular administration of vial solution.

BACKGROUND OF THE INVENTION
At present to perform an injection in a patient syringes consisting of a syringe body with a needle mounted in the head and a plunger slidable inside the syringe body are used. On retraction of the plunger, the solution for injection, which is generally contained in a glass vial, is drawn into the syringe body through the needle. Then, the injection is performed and by pushing on the plunger said solution is injected from the syringe body through the needle into the patient's body. It is evident that said operation is rather awkward; impractical and requires an excessive waste of time.
Prefilled syringes are known to the art, wherein to perform the injection the user must only push the plunger. However, even said syringes are excessively complex, not very versatile and not suitable for all types of medicinal solutions. Furthermore, in some cases the medicinal products that are in contact with the small steel cannula of the prefilled syringe can obstruct the inside hole of the needle.
Present invention illustrates a customized two beveled needle consisting of tamper resistant cap and a protective hub to provide single use needle configurations to prevent unauthorized access and use of a needle port.
Prior art devices of this type have relied on a variety of different closure strategies. In U.S. Pat. No. 4,286,640 a hinged tamper proof cover can be seen having a pair of hemispherical body members hinged together along adjacent sidewall edges.
U.S. Pat. No. 5,513,695 illustrates a tamper evident sleeve for IV needles that have a pair of elongated hinge covers with a hinge which is removable to access a needle by user engagement pull tab extending there from.
U.S. Pat. No. 7,678,101 is directed to a locking catheter connector and connector system.
In U.S. Pat. No. 8,091,727 a snap over clam shell protective port cap is claimed having two halves hinged together with a puncture resistant lid portion so as to cover when applied onto the end of an injection port.
US 20140364804 discloses tamper resistant/evident cap cover for IV needle configurations to provide a single use engageable cap to prevent unauthorized access and use of an IV needle port. The cap cover has a threaded IV needle receiving base and a slidably disposed inter engagement locking clasp. Oppositely disposed tamper evident latching tabs are receivably secured into the base by multiple clasp barbs defining a first position for access and a second closed locked position.
Hence an attempt was made by the authors of the present invention to develop a vial for injection and a relative safety device for a needle for a vial that are economical, simple to make and at the same time practical for the user.
U.S. Pat. No. 3308821 discloses to a connector assembly for a vial which minimizes the number of components in the connector assembly and which reduces the number of microbial barriers necessary to safeguard sterility of the system.
US Pat. No. 2012/0097707 relates to a device for packaging and dispensing fluid products, and more particularly a flexible pocket for a device for packaging and dispensing fluid products, that are liquid or pasty, of the pocket-vial type, that is to say comprising a flexible pocket placed in a rigid receptacle and associated with a pump or a valve making it possible to keep the fluid product in the flexible pocket away from the air in good conditions and to dispense if from the pocket by actuating the pump or the valve.
US Pat. No. 3288318 relates particularly to an inexpensive, unbreakable plastic vial or container for use in obtaining or receiving samples of blood and other fluids from farm animals and herds for purposes of diagnosis and subsequent treatment.
US 9108777 discloses a child resistant container made from blow-molded plastic which comprises a vial having an outlet port; a pre-determined volume of aseptic fluid disposed sealed within the vial; a cap detachable from the vial; and, a resilient guard having a first and second ends which are integral to the vial on opposing sides. The resilient guard is designed to not be separated from contact with the vial and has a mid-portion which is initially positioned above the top of the cap to prevent cap removal. The safety container is preferably single use.
The basic concept of BFS is that a vial is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus, BFS can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms. Along with that the two beveled needle is directly attached to the vial thus making this invention as an effortless and economic mode of administration.
Another part of the uniqueness of the device is to provide a customized needle attached with a flexible vial, wherein the needle can be double beveled and consists of tamper evident cap. Whenever the tamper evident cap is removed that will lead to exposure of two bevel needle and that will pierce the flexible vial. Thus the medicament is administered. Along with that the two beveled needle is directly attached to the flexible vial thus making this invention as an effortless and economic mode of administration and also safer to administer the medicaments in form of solutions or suspensions.

BRIEF DESCRIPTION OF THE FIGURES
Other features of the present invention will be more readily understood from the following detailed description of exemplary embodiments thereof when read in conjunction with the accompanying drawings.
FIG.1 is a sectional view of an exemplary flexible vial with needle containers according to embodiments of the present invention.
FIG.2describes the step 1 of needle attachment to the vial as mentioned to embodiments of the present invention. It also gives the parts of the tamper evident needle caps.
FIG.3 describes the attachment of the tamper evident needle caps with the flexible vial described in the present invention
FIG.4 describes the final step: removal of needle cap and the device ready to be used according to embodiments of the present invention.
SUMMARY OF THE INVENTION
One of the embodiments of the present invention discloses a tamper resistant/evident cap cover for two beveled needle configurations to provide a single use engageable cap to prevent unauthorized access and use of needle port.
Another embodiment of present invention relates with use of unique two bevel needle with internal threads and a protective hub.
Another embodiment of the invention provides a needle with tamper evident cap and protective hub is welded on to the vial. It is used with a simple twist and turn to 'activate' for product delivery. One anti-clockwise twist will break it open at the ring and the clockwise twist will fix the needle on to the vial by piercing through the vial top. This needle can be made unique by adding flanges to provide for better grip. The two bevel needle is being used as it is Sharp, pointed, curved, and it is recommended for septum penetration.
Another embodiment of present invention illustrates a flexible vial consisting of bellows and made of elastomeric material.
Another embodiment of present invention discloses a tamper evident needle, wherein the needle can be double bevel. Whenever the tamper evident cap is removed that will lead to exposure of two bevel needle and that will pierce the flexible vial. Thus the medicament is administered.
Another embodiment of invention is along with that the two beveled needle is directly attached to the flexible vial making it as an effortless and economic mode of administration and also safer to administer the medicaments in form of solutions or suspensions.
Another embodiment of present invention discloses the route of administration as intramuscular or subcutaneous.
Another embodiment of the present invention discloses use of wings or flanges on the shoulder of the vial for better grip.
One of the embodiments of the present invention discloses a vial for injection according to the invention comprising a flexible bellow, wherein a medicinal solution for injection is contained at an airtight manner. The body of the vial is made of an elastically deformable plastic material specifically thermo plastic material and has a male connector, suitable to be coupled with a female connector or needle top with a cap which supports an injection needle.
One of the embodiments of the present invention discloses that the present invention can be safer in presence of a tamper evident seal needle attached with flexible vial.
One of the embodiments of the present invention discloses that the present invention can innocuous in presence of a tamper evident needle attached with flexible vial, wherein the needle is double beveled.
One of the embodiments of the present invention discloses that the present invention safety is established with a tamper evident seal needle attached with flexible vial, wherein the needle is double beveled.
One of the embodiment of the present invention discloses that the present invention comprises a needle will get pierced when the tamper resistant is broken into the flexible vial.
Embodiments of the invention employ aseptic blow, fill and seal fabrication operations that do not require post-formation autoclaving for sterilization to mold the vials.
Some embodiments of the invention are directed to aseptic methods of fabricating a vial comprising a flexible bellow. The methods include: (a) forming a parison; (b) introducing flowable sterile material into the parison; (c) blow molding the parison into a container body, before, during or after the introducing step; and (d) sealing the top of the container to maintain an inner sterile environment.
Some embodiments of the invention are directed to the process. Thermoplastic resin is extruded as hollow tube known as parison. When the parison reached to a proper length the holding jaw is closed and the parison is cut. The bottom of the parison is pinched closed, while the top is held in place. The blow fill nozzle is lowered into the parison forming a seal with the neck of the mold. Sterile, filtered compressed air is blown into the parison expanding it then vented out. The sterile product can be metered in through the fill Nozzles. Separate sealing molds close to form the top and hermetically seal the container. The mould then opens and the formed, filled and sealed containers are conveyed out of the machine.
One of the embodiments of the present invention discloses that the present invention can be used to carry a wide range of aqueous solution or suspension.
It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any features of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.
DETAILED DESCRIPTION
The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, this embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
Like numbers refers to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. Broken lines illustrate optional features or operations unless specified otherwise. One or more features shown and discussed with respect to one embodiment may be included in another embodiment even if not explicitly described or shown with another embodiment.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."
The term “Tamper Evident” thereof means a device or process that makes unauthorized access to the protected object easily detected. Seals, markings or other techniques may be tamper indicating.
The term “Needle” discloses an object that is any thin and cylindrical object which has a sharp bevel on its end. A medical needle is hollow and has a hole in the middle to allow the flow of medication into the body of a human being or animal. Medical needles consist of three parts made of stainless steel because of its high resistance to corrosion. The three parts of a needle are the shaft, which is the longest part of the needle, the bevel, which is the slanted tip of the needles, and the hub, which fits firmly onto the tip of the syringe or the vials.
When a needle penetrates into the body of a human being or animal, the bevel, which is the slanted tip of the needle, creates a narrow hole in the skin of a person to allow the fluid in the syringe to be injected into the person.
Once the needle is withdrawn from the skin of a person, the slit closes to limit the leakage of medication or blood.
For intramuscular injections (IM), a 21 and 23 gauge needles which are 1 to 1.5 inches long are preferred or recommended for an adult while a 25 to 27 gauge needle which is 1 inch long is recommended for a child.
For subcutaneous (SQ) injections, a 25 to 27 gauge needle which is 3/8 to 5/8 inches long is recommended for both children and adults. However, some medications such as Byetta for diabetes recommend the use of a 30 to 31 gauge needle which is 1/3 inch long. These types of needles are chosen because, for one reason, the subcutaneous medications are injected and deposited on the loose connective tissues which are supplied with fewer blood vessels hence low absorption rate of the medication into the blood stream of a person. Another reason is that this layer of tissue consists of many pain receptors which dictate the use of non-irritating, water-soluble medications in small doses.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
The term "sterile" and derivatives thereof means that the noted device or material meets or exceeds defined (e.g., food or medical) guidelines of sterility so as to be substantially (if not totally) free of contaminants for at least a defined shelf life so as to be suitable for intended uses, e.g., clinical, health, or consumer product testing for the presence of toxins, microbes, microorganisms or other target constituents in a sample undergoing analysis. The sample can undergo analysis while held in the container. The sample may be transferred after transport and/or culturing in the container for analysis.
The term "aseptic" is used interchangeably with the word "sterile". In some embodiments, the aseptic processing or fabrication complies with GMP (Good Manufacturing Practice) industry guidelines such as those associated with Guidance for Industry--Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice, U.S. Department of Health and Human Services Food and Drug Administration, September 2004. The term "sterile environment" refers to an environment that complies with his GMP and can be defined using a suitable clean room.
The term "parison" refers to a preform of material that is subsequently blown into a shape defined by an enclosed mold using pressurized gas using conventional blow molding processes (typically extrusion-based methods) as is well known to those of skill in the art.
Further characteristics of the invention will be made clearer by the detailed description that follows, referring to a purely exemplary and therefore non-limiting embodiment thereof, illustrated in the appended drawings, in which:
Fig 1 illustrates an exemplary Customized needle comprising a Tamper evident Needle Cap (1), a protective hub with cap (2), a ring (3), and a flexible vial with below (4) and the vial contains a threaded male connector (5). The uniqueness of the design lies on use of unique two bevel needle with internal threads that fit into the vial below. This needle with a protective hub is welded on to the vial. It is being used with a simple twist and turn to 'activate' for product delivery. One anti-clockwise twist will break it open at the ring and the clockwise twist will fix the needle on to the vial by piercing through the vial top. This needle can be made unique by adding flanges to provide for better grip. The design can also be enhanced by use of wings or flanges on the shoulder of the vial for better grip.
• Fig 2 describes the parts of the tamper evident needle guard
• Fig 3 describes the attachment of the tamper evident needle guard with the flexible vial described in the present invention.
• Fig 4 describes removal of needle cap (1) and the Two-bevel needle (6) is fixed. After this the device is ready for use.
The uniqueness behind using a two bevel needle particularly is that it is Sharp, pointed, curved, non-coring needle bevel recommended for septum penetration. As the intended route of administration is Intramuscular or subcutaneous so above are qualities that a needle must possess.
Another part of the uniqueness of the device is to provide a flexible vial with a tamper evident cap, wherein the needle can be double bevel. Whenever the tamper evident cap is removed that will lead to exposure of two bevel needle and that will pierce the flexible vial. Thus the medicament is administered. Along with that the two beveled needle is directly attached to the flexible vial thus making this invention as an effortless and economic mode of administration and also safer to administer the medicaments in form of solutions or suspensions.
The tamper evident cap has four projections that kept pierced inside the protective hub that have four aperture where the projections fit accurately thus forming a strong anchorage between the protective hub of the needle and the tamper evident cap. At the time of use that tamper evident cap is removed and the device becomes ready to use.
One of the embodiments of the present invention describes the Blow-Fill-Seal process. Blow-fill-seal (BFS) packaging is a process wherein extruded resin, such as polyethylene (PE) or polypropylene (PP), is blown in a sterile and pyrogen-free state into a mold shaped in the desired form of a container. Following the formation of a container, the container cools and is then filled with product and sealed.
A plastic parison, extruded from polymer, is accepted by the opened blow mould and cut below the die of the parison head. The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum. By way of the special mandrel unit, the product is precisely measured by the dosing unit and liquid is filled into the container. After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum. With the opening of the blow mould, the container exits from the machine and the cycle repeats itself.
The basic concept of BFS is that a vial is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus, BFS can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.
The examples of Pharmaceutical solutions that can be packaged and delivered through this invention are injectable solutions, antibiotics, suspensions, infusion solutions, solution for dialysis, solutions for irrigation and solutions for hemofiltration.
The antibiotics include and not limited to Amikacin, Gentamicin, Kanamycin A, Neomycin, Netilmicin, Tobramycin, Paromomycin, Streptomycin, Spectinomycin, Geldanamycin, Rifaximin, Ertapenem, Doripenem, Imipenem, Meropenem , Cefadroxil, Cefazolin, Cefalexin, Clindamycin, Lincomycin, Daptomycin, Azithromycin, Erythromycin, Roxithromycin, Ampicillin/sulbactam, Ceftaroline fosamil, Nafcillin sodium, Norfloxacinetc and related compounds.
The present invention is also useful for the administration of Potential actives like Insulin, Heparin, Epinephrine, and Vitamin B-12 and not limited to former agents but also can be utilized for the administration of following agents.
The present invention is also suitable for the administration of pharmaceutical agents include, but are not limited to, anticancer agents or antineoplastics, antimicrotubule agents, immunosuppressive agents, anesthetics, hormones, agents for use in cardiovascular disorders, antiarrythmics, antibiotics, antifungals, antihypertensives, antiasthmatics, analgesics, anti-inflammatory agents, anti-arthritic agents, and vasoactive agents. The invention is useful with many other drug classes as well. More specifically, suitable pharmaceutical agents include, but are not limited to, taxanes, (e.g., Taxol® (paclitaxel), and Taxotere™ (docetaxel)), epothilones, camptothecin, colchicine, amiodarone, thyroid hormones, vasoactive peptides (e.g., vasoactive intestinal peptide), amphotericin, corticosteroids, propofol, melatonin, cyclosporine, rapamycin (sirolimus), tacrolimus, mycophenolic acids, ifosfamide, vinorelbine, vancomycin, gemcitabine, SU5416, thiotepa, bleomycin, diagnostic radiocontrast agents, and derivatives thereof.
The structure of the vial according to the invention and the manufacturing process thereof allow injectable drugs to be inserted therein, ready for use and in single-dose disposable package.
The vial includes a body that is blow molded as will be discussed further below. The body can be a molded polymeric body (e.g., a thermoplastic material body) which can be made from a single layer of polymeric (plastic) material. The material used to form the container body can be selected so that the container body is visually transmissive and substantially impermeable at normal environmental pressures allowing for a suitable shelf life. Unlike conventional containers, the container body is not required to have the necessary characteristics to be autoclaved (e.g., withstand the high temperature, high pressure and steam of autoclaving). Examples of useful materials include, but are not limited to polycarbonate, polyolefin such as polypropylene (PP), polyethylene (PE), or cyclic olefin (COC), polyester such as polyethylene terephthalate (PET) or polyethylene napthalate (PEN), polyamide (nylon), or other well-known materials in the plastics art. Within Polyethylene, LDPE (Low density poly ethylene) as well as HDPE (High density polyethylene) both can be used as the polymeric body. Amorphous plastics such as amorphous nylon exhibit high transparency and may also be suitable.
The forgoing is illustrative of embodiments of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention relating to tamper evident needle cap attached to flexible vial comprising bellows.
Example 1: A customized needle with a tamper evident cap and protective hub attached with a flexible vial for aqueous solution: A plastic parison, extruded from polymer, is accepted by the opened blow mould and cut below the die of the parison head. The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum. By way of the special mandrel unit, the product is precisely measured by the dosing unit and passed through a 0.2 µ filter just to make that aqueous solution aseptic and then filled into the container. After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum. With the opening of the blow mould, the container exits from the machine. The needle can be terminally sterilized by using Autoclave technique.
Example 2: A customized needle with a tamper evident cap and protective hub attached with a flexible vial: A plastic parison, extruded from polymer, is accepted by the opened blow mould and cut below the die of the parison head. The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum. By way of the special mandrel unit, the product is precisely measured by the dosing unit and then filled into the container. After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum. With the opening of the blow mould, the container exits from the machine. Then the whole container experiences the terminal sterilization process as well as the unique two bevel needle using autoclave.
Comparative Examples:
A study was conducted in which 20 healthy volunteers were provided with Tamper evident needle with Flexible Vial of drug solution/ Suspension to testify and validate the usability of instant device in comparison of Conventional Prefilled Syringe without Tamper evidence in terms of ease of handling, safety related to needle and differentiation or identification of unauthorized access and results are documented below:

With Tamper Evidence Without Tamper Evidence
Patient Compliance (easy handling) Acceptable Acceptable with difficulty
Safety Acceptable Not Acceptable
Identification (Used/ To be used) Acceptable Not Acceptable
,CLAIMS:We Claim
1. A tamper evident cap cover for two beveled needle configurations to prevent unauthorized access and use of needle port, wherein the two bevel needle comprises of internal threads and protective hub.
2. The tamper evident cap cover for two beveled needle configurations according to claim 1, wherein flanges can be attached to the needle for better grip.
3. The tamper evident cap cover for two beveled needle configurations according to claim 1, wherein the two beveled needle is directly attached to the flexible vial.
4. The tamper evident cap cover for two beveled needle configurations according to claim 1, wherein the vial can be made of, but not limited to, Polyethylene, Polypropylene, specifically Polyethylene by Blow-Fill-Seal technique.
5. The tamper evident cap cover for two beveled needle configurations according to claim 1, wherein the needle is welded on to the vial and is used with a simple twist and turn technique to activate for product delivery, wherein the twist and turn technique comprising of
i. One anti clockwise twist to break the seal at ring(3) and
ii. Fixing the needle on to the vial by piercing through the vial top.