Title of Invention

"PARENTERAL DRUG DELIVERY SYSTEM"

Abstract

•parenteral drug delivery system, which is pre-filled type syringe consisting of: a glass-cartridge.with one end moulded into a neck and sealed by a metal-clad rubber sea/; a needle-hub assembly, having a two-way needle mounted on the said moulded neck and duly proteileU by a needle-sheath; 3 rubber-burig to close the said cartridge, a flange-assembly having a hcle in its centre with same diameter as that of the catridge with a depression around it and two finger-flanges on its outer circular edge; a plunger-rod of accurate length fitted into the said rubber-bung at one end (made to slide inside the cartridge through the said central hole in the flange-assembly at the time of drug-administration) and provided with a circular disc knob at another end

Full Text

The present invention relates to an improvement over the existing .parenteral drug delivery alternates. INTRODUCTION The conventional parenteral drug delivery systems (syringes) used in Hospitals, Nursing homes, Dispensaries and by Medical Practitioners are of various types: • Reusable glass syringes • Poly-propylene (PP) disposable syringes. » Pre-filled glass syringes. The syringes mentioned above have an essentially common design, the major difference being in the materials used for manufacture. The basic structure includes: • A cylindrical barrel, having a moulded neck at one en 1 • A needle to be mounted on the moulded beck. In reusable glass syringes and poly-propylene (PP) disposable syringes, the needle is a separate entity which is mounted on the neck, prior to administration. In cnse of the pre-filled glass syringes, the needle is either pre-fixed on the moulded tip of the cylindrical barrel, with the help of a type of glue, o: is a separate entity. The separate needles used with all the three designs, as stated above, are of a common and conventional design and are freely inter¬changeable. • A cover for the needle, to avoid accidental pricking. • A rubber bung at the open end of the cylindrical barrel. In certain designs, the rubber bung is substituted by a flattened end of the plunger itself, which performs the function of pushing the contents down. • A plunger, attached to the lower end of the rubber bung. • A finger flange (grip), which is an extension in the molding of the cylindrical barrel itself and is therefore, of the same material. For filling glass syringes and poly-propylene (PP) disposable syringes, the plunger is pushed inside the barrel, till the rubber bung touches the inside surface of the cylindrical barrel's bottom. The needle, mounted on the syringe, is then inserted into the drug container (ampoule/vial). When the plunger is slowly pulled back, in the cylindrical barrel, the drug is drawn inside the cylindrical barrel. The drug is then administered by inserting the needle in the appropriate site of the patients' body and pushing the plunger down the cylindrical barrel. As the pre-filled glass syringe already contains the drug, all earlier step? in filling the syringe are avoided. The conventional syringes, as described above, have several inherent problems, which cause severe clinical complications and cause grave harm to the well-being of the patient. Physical Contamination At the stage of filling the glass and poly-propylene (PP) disposable syringes, external physical contaminants like glass and rubber particles are liable to be introduced into the drug. When the ampoule is broken, microscopic glass particles are shed within the cavity of the ampoule also and are subsequently administered to the patient, alongwith the drug. When the drug is being loaded from a multi-dose vial, repeated pricking of the rubber cap results in the rubber particles being shed, leading to their entry in the cylindrical barrel, alongwith the drug. Chemical contamination The glue used to fix the needle within the moulded tip, in pre-filled syringes, remains in contact with the drug and may introduce chemical contamination. Disease-transmittal potential The conventional syringes have tremendous disease-transmittal potential, emanating from the re-use. After each use, the glass syringes is required to be sterilized, but in practice, either because of lack of time or sheer negligence, these syringes are not sterilized at the correct temperature, time or pressure. When these contaminated glass syringes are to be used, they pose a serious health hazard. To combat these health hazards, World Health Organization (WHO) advocated the use of PP disposable syringes. These syringes are now rapidiy displacing the glass-syringes and are manufactured for one-time-use only. To avoid their re-use, the used disposable syringes, alongwith the needles, are required to be destroyed by incineration. Most hospitals, either do not have incinerators, or the same are in a state of perpetual dysfunction. The smaller nursing homes and the private practitioners, in any case, cannot afford to have their individual incinerator. The disastrous end-result is that the used disposable syringes and needles are simply discarded in the dust-bins of hospitals, clinics, dispensaries and nursing homes. These dust-bins are emptied into corporation garbage dumps. The rag-pickers collect these discarded syringes and needles, only to sell them to unscrupulous traders, who simply wash the syringes as well as needles and recycle them into hospitals, clinics, dispensaries and nursing homes. The use of these recycled disposable syringes and needles expose the patients to serious and dreaded diseases. Likewise, the emptied pre-filled syringes also have a re-use potential, leading to likely disease-tr&nsmission. Thus, when any of the three conventional syringes, described above, are used, the un-suspecting, innocent patient runs the risk of being injected with pathogens, responsible for causing serious diseases like AIDS, Hepatitis etc., owing to the standard configurations of the sizes of tne moulded tips and conventional needles, there is total compatibility of fitting, which further encourages and enhances recycling and reuse. Besides, the barrel of the conventional syringes do not have an absolute and perfect smooth internal surface. The microscopic undulations and crevices retain physical, chemical and microbiological contaminants. At times, even after deploying the most stringent cleaning and sterilization techniques, it may not be possible to completely and satisfactorily eliminate all these contaminants. Jerky plunger movements The said crevices also impede the smooth functioning of the plunger inside the barrel of the syringe, making the drug administration painful and difficult. Doubtful Sterility Yet another handicap of the poly-propylene (PP)- disposable syringes is the doubtful status of sterility, even in the new pieces. Several reports highlight that the disposable syringes sold are not actually 'sterile1 and microbiological culturing demonstrates the presence of pathogenic micro¬organisms. Pin-pointing complaints impossible An additional problem with the conventionally deployed re-usable glass syringes and poly-propylene (PP) disposable syringes originates from the components (the syringe, the needle, the ampoule, the drug or the diluent) being separate entities. !n the event of any pro9duct complaint, pertaining to contamination, it is impossible to identify the responsible component -the syringe, the needle, the ampoule, the drug or the diluent (in case of solid drugs, requiring reconstitution). Drug mix-up in hospitals Owing to deceptively similar appearance of the conventional syringes, there exists a risk of inadvertent administration of the wrong drug to a patient. Delay in emergency situations Certain medical emergencies demand that treatment be instituted without any delay and each second is precious. In these situations, the multiple steps involved in preparing the injection, using the glass syringes or poly¬propylene (PP) disposable syringes, can prove detrimental to the patient's well-teing. Complicated self-administration Certain ailments like diabetes warrant self-administration of drugs by the patients, at their homes The glass syringes or po!y-propylene (PP) disposable syringes make the process of self-administration complicated and cumbersome. OBJECTIVE OF THE PRESENT INVENTION In present invention of 'one time usable auto-disposable advanced parenteral drug delivery system' there are provisions to overcome the above mentioned drawbacks associated with the conventional glass syringes as well as poly-propylene disposable syringes. The new drug delivery system is advanced in fol'owing senses: (i) It is free from any type of physical and chemical contamination; as it is a pre-filled type system and the drug content is safely preserved in its pre-sterilized highly inert region. (ii) It has zero disease-transmittal potential as; it has unique and strong provisions for its one time use and at the same time the siliconization of the syringe at a high temperature at 300° ± 5°C insures 100% sterilization. (iii) it is provided with a novel and unique locking arrangement and 100% workable auto-destruction facility. Moreover, the needle of the syringe can also be winded manually before discarding it to deform needle's shape, which will further reduce the probability of re-use of the needle. (iv) Siliconization performed in the new piece of syringe, during its manufacture and packing, not only insures its sterility but also remove microscopic undulation as well as crevices from the inside surface of syringe, making the movement of the plunger inside the cartridge jurk-free and very smooth. This advancement in the drug delivery system makes the drug-administration more comfortable and less-painful to the patient. (v) in the present drug delivery system there is no need of glue to mount the needle-hub assembly, reducing the possibility of chemical contamination of drug content to zero. (vi) This new drug delivery system is equipped with a novel 'system-activation mechanism carried out through the specially designed needle-hub assembly, which is different from that of the conventional syringes. (vii) As the present drug delivery system is a pre-filled type syringe with zero re-use potential it saves the time in emergency situations and at the same time reduces the risk of inadvertent administration of the wrong drug to the patient, owing to deceptively similar appearance of the conventional syringes. The improved parenteral drug delivery system, according to the present invention, consists of: • A glass cartridge with one end moulded into a neck. This end is sealed by a metal-clad rubber seal. • A needle hub assembly consisting of specially-designed two-way needle, which can be mounted on the cylindrical barrel, without involving the use of glue. • A needle sheath adapted to be mounted over the needle. • A rubber bung to plug the open end of the cartridge. This rubber bung has a threaded cavity in the center. • A thermoplastic finger flange (grip) moulded on the cylindrical barrel. • A plunger adapted to slide inside the cartridge. At the lower end of the plunger rod is a circular disc knob for operating the plunger. This disc engages itself onto the locking device at the base of the finger flange assembly and enables the 'auto-destruction feature of the system. According to another embodiment of the present invention, the inside surface of the cartridge, the rubber bung and all other inner surfaces which are liable to come into contact with the drug, are siliconized. The objective of this is to fill-in all microscopic crevices, thereby ensuring a smooth motion of the plunger inside the cartridge, as well as to achieve complete elimination of all types of contaminants - physical, chemical or microbiological. The components of the system are sprayed with silicon oil, in a hot environment, at a temperature of 300° ± 5°C, for 2-5 minutes. This treatment ensures proper silicon fixation and sterility. A further embodiment of the present invention is a 'system-activation mechanism carried out through the specially designed needle-hub, which is different from that of the conventional syringes. The needle-hub assembly, having a two-way-needle, is mounted in a manner, so as to retain sterility of the drug contents, till the time the contents have to be administered to the patient. At that stage, the needle hub assembly, is pushed towards the cylindrical barrel, whereby the inner end of the needle pierces through the metal-clad rubber seal and comes in contact with the drug contents. Because the usage of each system involves only a single piercing of the metal-clad rubber seal. There is no shedding of rubber particles. This mechanism ensures retention of sterility of the contents and is an additional safe-guard for the patients' well-being. This needle-hub assembly is unique to the improved parenteral drug delivery system, to the extent that neither can this needle-hub assembly be fitted onto any conventional and existing parenteral drug delivery alternates, nor can any conventional needles be fitted onto the improved parenteral drug delivery system. Beside, the auto-destruction mechanisms ensures that the total system does not have any re-use potential. Hence, both the individual components as well as the total system are truly for 'one-time' use. The said invention is pie-filled with the drug to be administered and as such, there is no gray area on the lack of sterility of individual components, as with the conventional syringes. After it has been used once, the circular knob of the plunger gets engaged in the depression provided around the central hole in the cover, thus rendering the system in-operative for subsequent use. Thus the improved parenteral drug delivery system is auto-destructive after a single use. The improved parenteral drug delivery system, according to the present invention, may be a used as a single or double chamber syringe. In case of a double chamber syringe, the cylindrical barrel is partitioned into two chambers, using an additional rubber bung and the two chambers can contain a combination of solid and liquid (used as a diluent), or two separate liquids. This modification considerably enhances the stability and self-life of the contents, when used for two different liquids in the individual compartments. Comparison between present advanced drug delivery system and the conventional syringes (Table Remvoed) The improved parenteral drug delivery system, according the present invention, is illustrated in the accompanying drawings, wherein: Figure 1 shows the improved parenteral drug delivery system, according to the present invention. Figure 2 shows the cylindrical barrel with the moulded neck. Figure 3 shows the metal-clad rubber seal. Figure 4 shows the needle sheath. As shown in the accompanying drawings, the improved parenteral drug delivery system consists of a cartridge (1) having a moulded neck with a metal-clad rubber seal (2, 3), on which is mounted a needle-hub assembly - consisting of a two-way needle (4). On the open end of the cartridge is mouned a finger flange assembly (5). The flange assembly has a hole in its center and a depression (6) around the hole. On its outer circular edge there are two finger flanges (7). Through the said central hole provided in the flange (5), passes a plunger rod (8) which has at its one end a rubber bung (9) having the same diameter as that of the inside of the cartridge. The plunger rod has at its other end, a circular disc knob (10) for operating the plunger inside the cartridge with the help of the said finger flanges. A needle sheath (11) is provided, which is adapted to be mounted over the needle. In operation, when the improved parenteral drug delivery system is to be used, the sheath (11) protecting the needle is removed. The system is then activated by pressing the needed-hub assembly towards the. cartridge, so that the two-way needle pierces the metal-clad rubber seal and one end of the needle enters into the cartridge (1). Holding the system with the help of finger flanges (7), the disc knob (10) is pressed down, pushing the plunger down the cartridge, thus administering the contained drug into the patient. When the drug contained in the cartridge has been administered to the patient, the rubber bung (9) of the plunger touches the inside bottom of the cartridge and the circular disc knob (1)of the plunger is engaged into the depression (6) provided around the central hole in the flange assembly, thus rendering the system inoperative for a time. The precise advantages of the improved parenteral drug delivery system, according to the present invention, are: • It is auto-destructive - after being used once it is rendered in operative. All the individual components, by virtue of their distinctive design, are incompatible with any of the existing systems, resulting in a zero-re-use potential. • Because of the silicon layer, the cleaning and sterilization processes are rendered more effectiveness, thus ansuring that there are no residual physical, chemical or microbiological contaminants. • The operation of the plunger in the cartridge is smoother, as compared to the conventional syringes, owing to stliconization. • Because of the needle-activation system, the contents retain their sterility till the stage of administering the drug. • In case of the two-camber system, there is considerable prolonging of the stability and self-life of the contents, when two liquids are used. • As all components are presented as a single sterile entity, there is no gray area on the sterility of individual components. • The clear identification of the drug contents eliminates any risk of inadvertent mix-up and administration of the wrong drug. • In medical emergencies, the present invention helps in saving precious seconds vasted in preparing the injection. All the above superiority features are proposed to be brought to the service of the medical fraternity, as v/ell as the patient community at large, at a price comparable to that of the conventional systems. Since many apparently different embodiments of the present invention could be made without departing from the spirit and s cope thereof, it is intended that the description of the invention herein be interpreted as being illustrative only and not limiting in any manner whatsoever. We claim: (1) parenteral drug delivery system, which is pre-filled type syringe consisting of: a glass-cartridge_with one end moulded into a neck and sealed by a metal-clad rubber seal; a needle-hub assembly having a two-way needle mounted on the said moulded neck and by a needle-sheath; 3 rubber-bung to close the said cartridge, 3 flange-assembly having a hole in its centre with same diameter as that of the catridge with a depression around it and two finger-flanges on its outer circular edge; a plunger-rod of accurate length fitted into the said rubber-bung at one end (made to slide inside the cartridge through the said central hole in the flange-assembly at the time of drug-administration) and provided with a circular disc knob at another end (2) The parenteral drug delivery system, as claimed in claim 1, wherein the needle-hub assembly having a two-way needle with the ability to pierce the said metal-clad rubber seal, is mounted on the moulded neck of the cartridge of the syringe, without using any type of glue. (3) The parenteral drug delivery system as claimed in claim 1, wherein the metal-clad rubber-seal fixed at the moulded neck of the said cartridge, holds the needle-hub assembly separated from said pre-filled cartridge of the syringe. (4] The parenteral drug delivery system, as claimed in claim 1, wherein all the component surfaces that are liable to come into contact with drug (inside surface of the cartridge, rubber-bung and inner portion of metal clad rubber seal) have-been silicoiiized. (5) The parenteral drug delivery system, as claimed in claim 1, wherein the rubber bung attached at one end of plunger rod has a threaded cavity in the centre, which has siliconized inner surface and same diameter as that of the inside of cartridge to properly close the open end of the said cartridge. (6] The parenteral drug delivery system, as claimed in claim 1, wherein the circular disk-knob of the plunger rod, has the same diameter and thickness as those of the said depression of the central hole of finger-flunge assembly to be engaged tightly into the said depression. (7) The parenteral drug delivery system as claimed in claim 1, optionally contain two chambers and' an additional rubber-bung in spite of one cylindrical cartridge and single rubber-bung. (8) The parenteral drug delivery system, substantially as herein described and illustrated in the accompanying drawings.

Documents:

453-del-1997-abstract.pdf

453-del-1997-claims.pdf

453-del-1997-correspondence-others.pdf

453-del-1997-correspondence-po.pdf

453-del-1997-description (complete).pdf

453-del-1997-drawings.pdf

453-del-1997-form-1.pdf

453-del-1997-form-19.pdf

453-del-1997-form-2.pdf

453-del-1997-petition-others.pdf