Updated May 24, 2019

Futuristic Safe Injection System-2020

Pratibha Rathore

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Stage 3: Proof of Concept

Our invention is a simple mechanical device. We have already completed the initial inventive work successfully and serious efforts are also undertaken to protect the Intellectual Property Rights. Our Indian and International Patent Applications (PCT) have already been published. The International Search Report issued by the European Patent Office, which is globally acclaimed International Search Authority, has found all of our claimsnovel, possessing inventive steps and industrially applicable. The Written Opinion issued by WIPO is quite favorable to us. The European Patent Office, while examining our International Patent Application (PCT/IB2016/051060) WO/2016/142799, has opined, “The technical effect of these features is that the injector is reusable while the only parts to be discarded are the needle hub and the medicament cartridge. As a result, a cheaper and friendlier to the environment system is achieved without an increased risk of needle injuries.” A 3D printed prototype has been fabricated to ensure the feasibility of innovation. The pre-commercial finished product needs further R&D.

Registered In India.

Focus Areas:

Environment, Waste Management, Healthand 4 MoreSEE ALL

Environment, Waste Management, Health, HIV/AIDS, Infectious & Vector Diseases, Non-communicable Diseases and Prevention & VaccinationSEE LESS

Mission and Vision

Impact on the current cost and quality of care for the primary end user: INJECTOR: Expensive retraction mechanism is made frequently reusable. Frequent use of injector decreases its cost almost to zero with each and every next injection. DRUG-CARTRIDGE: Single-dose of drug is packed in safe disposable packaging preventing all risks of NSI. This smart packaging may, however, increase packaging cost by 20-25% as compared to conventional packaging but it will save ‘overfill quantity’ containing 5-15% additional precious drug that wastes. It will reduce direct input cost of pharmaceutical companies. It will negate or decrease the increased packaging cost of drug. The end-user NEED NOT BUY SYRINGE and only need to buy the medicine at the same/reduced cost, which makes it cheapest and affordable for all. Overall advantages of our Innovation: (a) It provides a cheapest, greener, safer and user-friendlier substitute of conventional safe syringe, which is easy in handling/operation without any requirement of formal training to the healthcare workers/users. (b) It completely eliminates the need of conventional syringe for drug administration, thus saving entire raw material used in manufacturing conventional syringes. (c) It decreases the cost of injection process in comparison to the conventional injection process, which essentially needs a separate safety syringe to administer each and every dose of medicine. (d) It curtails the generation of at least 70-75% of hazardous bio-medical waste and produces merely 25-30% of safe and non-hazardous biomedical-waste. (e) It provides all necessary features of an efficient retractable syringe by eliminating requirement of users intervention, extra pressure to activate/trigger the retraction mechanism and probability of premature retraction or failure of retraction mechanism etc. to ensure Needle-Stick Injury reduced to zero. (f) The glow of LED indicator during the injection process confirms the completion of injection process creates awareness in patients relating to handling of injection process by healthcare workers/users and also facilitates safe administration of injection during the dark hours. (g) The packaging of drugs in proposed drug-cartridges will completely eliminate the contamination of costly life-saving drugs, which is caused by a considerable extent of entrapped air volume along with the drug for a long period in conventional drug-container. Such entrapped volume of air at least contains nitrogen, oxygen, carbon dioxide, other gases etc. (if not the other air-borne pollutants/ contaminants), which continuously interact with drugs stored in conventional vials ampules etc. to deteriorate drugs quality and efficacy adversely during entire course of storage, since packaging to the final use. The packaging of drugs in proposed drug-cartridges will preserve and maintain the original efficacy of drugs for long period of time. (h) It completely eliminates the need of separate packaging material i.e. ampules, vials or the like containers to preserve, store and supply of injectable drugs. (i) It completely eliminates all the probabilities of contamination of medicine, which occur during the transfer of drug-contents from the drug-container to the syringe for injection process. (j) It completely eliminates the unnecessary wastage of costly drug in two ways: (i) the drug contents go waste during its transfer from drug container to the syringe. (ii) Sometimes, the drug container contains 5-10 dosage but only few dosages are utilized and the rest are discarded by health worker. (k) It completely eliminates all the probabilities of administration of under-dosage and over-dosage medicine into the patients as each and every drug-cartridge shall contain a pre-defined/fixed volume of dosage and during the process of injection, complete dose shall transfer into the patient without any kind of user-intervention. (l) It completely eliminates all probabilities of reuse of used/discarded syringes because syringes are no more required for the injection process. On the other hand, reuse of drug-cartridges is not possible being the re-use more costly than the original product. (m) It ensures reduction of weight and volume of syringes per dose carried by health workers in work-field and also reduces the burden of care on them as they require carrying only the desired quantity of drug-cartridges bearing desired volumes of dosage and couple of pen-type injectors in the field. (n) It automatically reduces the overall expenses incurred on the packaging, storage, transport, carriage etc. to a very high extent. (o) It saves the invaluable time of user/healthcare worker because the proposed method shall increase the frequency of administration of injection process by several-folds. (p) The innovation, if adopted and used globally with full swing, it will reduce the rapidly increasing exorbitant Global Disease Burden (GDB) as well as Global Health Burden (GHB) to a very high extent. (q) The proposed technology being cheapest in comparison to the existing ones is equally affordable and accessible to all world-wide and hence may not impart rather bridges the technological divide existing between rich and poor. (r) It is fully compliant to guidelines laid down by WHO, FDA and NIOSH. (s) Complete elimination of syringes will ensure prevention of abuse of injectable drug. IMPACTS OF THE OUR INNOVATION Impact on Healthcare Sector • It provides a green, safer, cheapest method and device for sustainable new drug delivery system. • It will make the healthcare equally as well as easily affordable and accessible to all. • It will help in promoting the democratization of healthcare sector. • It saves 70-75% of raw material from becoming hazardous waste. • The end-user won’t need to buy syringes anymore. • It promotes ‘Single dose-Single use’ campaign. • It prevents wastage of expensive drugs by increasing its reachability to end-users in need. • Multi-fold benefits to healthcare sector by making the injection process greener, cheaper and sustainable one. Impact on Environment • It completely eliminates the hazardous bio-medical waste generated by disposal of conventional syringes. • It reduces all the costs and resources incurred in waste-management of syringes. • It negates all the hazardous consequences of syringes ranging from oceanic plastic pollution to Climate-Change. • It will zero-down the carbon footprint of syringe industry. • It reduces the consumption of raw plastic material to a large extent. • It solves the issue of solid-waste management in rural/urban areas by reducing the medical waste generation by 70-75%. • It shall prove immensely helpful for the developing and under-developed countries in achieving their Intended Nationally Determined Contributions (INDCs) and in fighting the grave challenges of Climate-Change. Impact on Society at large • The affordability of invention will prevent the existing technology divide between rich & poor, developed and developing/under-developed countries. • It effectively addresses the growing menace of drug abuse and illicit/counterfeit injectable drugs. • It will effectively reduce the growing number of cases HIV/AIDS, Hepatitis B, C etc. thus, effectively reduce Global Disease Burden as well as Global Healthcare Burden. • It will also prevent physical, mental, emotional and psychological trauma especially among women and children by preventing NSI causing spread of HIV, Hepatitis B,C etc. popularly known STDs, that are social taboo especially in Third world countries. • The significant reduction in the global healthcare burden (GHB) will generate huge financial saving for countries that can be utilized for the holistic development of humankind. • The reduction in Global Disease Burden (GDB) due to unsafe injections and medical waste will improve quality of our life with significant increase in our life-expectancy. • It will effectively protect, safeguard and ensure safe and dignified ‘Right to Life’ to all. • It will ultimately help in achieving WHO’s initiative of replacing the conventional syringes completely with proposed safety syringe by 2020, to reduce the menace of NSI almost to zero. • The proposed innovation will also help the developing and under-developed countries in meeting requisite Sustainable development Goals (SDGs). In conclusion, our disruptive technology will help in democratizing healthcare system equally affordable and accessible to all by providing cheapest, safer, greener, faster, user-friendlier and simple injection & fluid-collecting system preventing NSI, resulting drastic reduction in global disease and healthcare burden, fullest achievement of WHO’s initiatives to completely replace conventional syringes with safety syringes by 2020 to eliminate the menace of NSI, AIDS/HIV, Hepatitis B&C etc., meeting Sustainable Development Goals by multi-fold benefits to healthcare system, reducing health concerns originating from Climate-Change and most importantly, in achieving the highest goal of securing a safe, healthy and dignified ‘Right to Life’ for all.

Innovation Description

Our disruptive technology provides a cheapest, safer, greener, ergonomic injection and fluid-collectingsystem. The European Patent Office, while examining our International Patent Application, has opined, “The technical effect of these features is that the injector is reusable while the only parts to be discarded are the needle hub and the medicament cartridge. As aresult,a cheaper and friendlier to the environment system is achieved without an increased risk of needle injuries.”
How does your innovation work?
Our disruptive technology provides two variants of reusableinjector and 18 variants of safely disposable drug cartridge, providing a cheapest, safer, greener and user-friendly method & device for sustainable drug delivery system. Drug cartridge contains a pre-fixed dosage of injectable drugs sandwiched betweenpiston-headand retractable needle. Neither of the two partsaresyringe but constitute an efficient self-retractable safety syringe when coupled together, which is operable likean ordinarysyringe. On completion ofinjectionprocess, needle retracts automatically withinemptycartridge, which is safelydisposed-off. It ensures prevention of Needle-stickInjury (NSI), saves approximately 70-75% raw material and generates only 25-30% non-hazardous medical waste. The LED feature not only illuminates injection site to facilitate injection during dark hours but also keeps vigil on complete process. The injector may also be attached with Fluid-collector to safely collect fluid samples without any risk of NSI. Unique feature of innovation:
  1. It provides a smart packaging technology to pharmaceuticals to pack injectable drugs in drug-cartridge dose-wise. The drug-cartridge is designed in such a manner that it may not be refilled and eliminates all the possibility of NSI.
  2. It adapts and utilizes the drug container conventionally used by pharmaceutical industry to store the injectable medicine i.e. vile, ampoules etc. as a barrel of syringe.
  3. It adapts the vital and costly retraction mechanism to make it an integral part of frequently reusable injector, which ultimately reduces the over-all cost of whole injection process.
  4. Neither the disposable drug-cartridge nor the reusable Injector per seis syringe but an efficient self-retractable safety syringe is constituted when both parts are coupled together. This syringe is operable like an ordinary conventional syringe without any requirement of special training to the user or healthcare worker.
  5. The injector is provided with an illumination system to illuminate the injection site visible in dark hours. It serves as anindicator to regulate and keep vigil on the entire injection process.
  6. Our invention also provides a specially designed fluid collector which may be coupled with the reusable injector to collect the sample fluids safely without any risk of needle stick injury for pathological/examination purposes.
Constructional Details: In accordance with an embodiment of the invention, injector as shown in figure 1(a) and (b) comprises an injector body (1), a plunger assembly (2) and a plunger shaft (3). The injector body is a uniformly hollow, regular cylindrical body, opening at both ends, having a partition ring (4) and a flange ring (10) at a proximal end. It further comprises of a finger flange (6) at a distal end, inner and outer engagement means (20) at the proximal end to firmly hold thedrug-cartridgeof smaller or larger diameter, respectively during an injection process. The plunger assembly consists of uniformly regular and hollow cylindrical inner plunger barrel (7) and an outer plunger barrel (8), wherein, the inner plunger barrel is slidable within the outer plunger barrel. The outer plunger barrel possesses thumb-rest (9) and an interiorly protruded flange rim (5), havinginnerdiameter equal toouterdiameter of the inner plunger barrel to facilitate smooth slidable axial movement of outer plunger barrel over the inner plunger barrel. The inner plunger barrel is provided with a piston seal holder (11) to hold piston seal (12) between inner and outer plunger barrels. It holds plunger shaft through engagement means. Further, it is provided U-clip locking means (13) containing conical lock-notch (14), which protrudes out passing through a longitudinal slot (22). When outer plunger barrel is pulled inbackwarddirection, its flange rim slidably passes over conical lock-notch pressing it inwardly, which thereafter opens to retains its original state and restricts movement of outer plunger barrel inforwarddirection. Thus, U-clip locking means facilitates to unite the two plunger barrels to constitute a united plunger barrel. This action generates vacuum (V) between these barrels. The plunger shaft is attached with inner plunger barrelpossesesaxially furrowed forceps-lock head (15) containing two outwardly protruded flaps (16) at proximal end on both sides. The plunger assembly is housed insidedistalchamber of injector and plunger shaft is housed axially atcenterofproximalchamber. The forceps-lock head passes through flange ring (10) through central passage and remains initially inclosedposition due to pressed flaps. In another embodiment of injector, the plunger shaft may be a pointedneedle likestructure as shown in figure 1(b). The proximal end of inner plunger barrel possesses button cells (17) and a LED indicator (18) enablinginjectablesite to be visible by Tyndall effect on an injectable fluid facilitating injection process in dark hours. The LED is configured to switch-on as and when outer plunger barrel is pulled inbackwarddirection and vacuum (V) is created, which switches off on completion ofinjectionprocess, as and when the vacuum is released. Further, the injector is having a push-button (19), placed on septum (4) ofinjector, used to restrict and conveniently control the backward movement of united plunger barrelduring fluidcollection process by pressing it. Thedrug-cartridgeas shown in figure 2, comprises the injectable fluid (18) sandwiched between piston assembly (2) and needle assembly (3) in drug container. The body of drug container (1) possesses engagement means (9) atdistalend (M) to firmly engage within engagement means (20) of the injector body. The piston assembly comprises a piston flange (6) and a conical cavity (5) to receive and retain the forceps-lock head (15) duringinjectionprocess. The piston flange is provided with an axially furrowed needle catch projection (8) atcentreof the piston assembly atproximalend. The rim of the piston flange (6) holds piston seal (7) between piston flange anddrug-container. The opening diameter ofconicalcavity is slightly greater thanouterdiameter ofclosedforceps-lock head to receive it conveniently, whereas inner diameter is greater to engage it conveniently. The needle assembly (3) comprises needle hub (10) configured to hold hypodermic needle (12), needle-guard (11), needle holder (16) configured to hold needle hub, O-ring (17) and cap (16) having horizontally extended pins towardsdistalend. The needle hub (9) comprisesofa conical cavity (12) to conveniently receive and fixedly engage with needle catch projection (7). Further, itholds hypodermicneedle encapsulated inside the needle guard with the help of a locking means disposed inside drug container, which may be removed to expose needle by drawing it out with the help of a knob (11) and rotating it inanti-clockwisedirection at 90-degree angle. The horizontally extended pins of the cap are configured to pass through clefts of O-ring (17) to slidably hold conical cavity ofcap. It is configured to hold needle holder havingouterdiameter equal to inner diameter of the O-ring and cap. Figures (a), (a’), (b), (b’), (c) and (c’) illustrate various variants offluid-cartridgeshaving different needle retraction mechanisms in accordance with an embodiment of the present invention. Operational Details: The distal end ofdrug-cartridgecontainingdesireddose of medicament is coupled throughproximalend ofinjectorto constitute a self-retractable syringe. The hypodermic needle is drawn out by pulling knob ofneedleguard, which is unlocked and removed to exposeneedle. The outer barrel is pulled inbackwarddirection unless it passes over lock notch of U-clip and locks therein to constitute single plunger unit. Simultaneously,vacuumis created between two plunger barrels and LED glows to illuminate injection area. The single plunger unit is pushed inforwarddirection. The closed forceps-lock head enters intoconicalcavity ofdrug-cartridgeand opens to get engage insidecavity. Hypodermicneedle is pricked intopatientand single plunger unit is pressed through thumb rest to operate it just like an ordinary syringe. The medicament is injected intobodyas usual. At the laststagepiston flange comes in close contactofpins of cap-rings, which is pushed inforwarddirection and dislodges needle fromneedleholder. Simultaneously, needle catch projection engages into needle cavity and conical lock notch is pressed to allow flange rim of outer plunger barrel to pass over it,which disengagesunited plunger assembly. It initiates release of vacuum due to movement of inner plunger barrel inbackwarddirection along with the dislodged needle. The LED switch-offs. When vacuum is released completely, the forceps-lock passes inbackwarddirection through theflange-ringpassage inclosedstate, dislodging itself fromcavityofdrug-cartridge.Needleis encapsulated within empty drug-cartridge, which is removed anddisposed-offsafely. The Injector becomes ready for next injection process. The injector containing forceps-lock head may be used with (a), (b) and (c) variants ofdrug-cartridges, whereas injector having pointed needle shaft may only be used with (a’), (b’) and (c’) type ofdrug-cartridges. The injector may also be coupled withspeciallydesigned fluid collector which may be used to collect body fluid safely, conveniently and efficiently. The step by step schematicoperational-detailsoffluidinjecting system and fluid collector are shown in figures. Principleinvolved in the invention: The invention basically involves the retraction of used hypodermic needle with the help of the vacuum created between two barrels of the injector. It is evident from the description of technical details embodied herein that the injector as shown in figure 1(a) and (b) comprises an injector body (1), a plunger assembly (2) and a plunger shaft (3), wherein the plunger assembly consists of uniformly regular and hollow cylindrical inner plunger barrel (7) and an outer plunger barrel (8). The outer plunger barrel is slidable over the inner plunger barrel. A U-clip locking means (13) containing conical lock-notch (14), protruding out throughlongitudinalslot (22) of the inner plunger barrel, which is disposed within the inner plunger barrel. The proximal end of inner plunger barrel is provided with plunger shaft having axially furrowed forceps-lock head (15) containing flaps (16). On the other hand, in drug-cartridge,conicalcavity (5) is provided at distal end of piston flange (6) to receive and retain the forceps-lock head (15). To execute the injection process, thedrug-cartridgeis coupled withinjectorto constitute self-retractable syringe. When outer plunger barrel is pulled inbackwarddirection, its flangerim slidablymoves and passes over conical lock-notch pressing it inwardly, which thereafter opens to retains its original state and restricts movement of outer plunger barrel inforwarddirection. Thus, U-clip locking means facilitates to unite the two plunger barrels to constitute a united plunger barrel. This action generates vacuum (V) between these barrels. On increasing pressure on the united plunger barrel through thumb rest, the axially furrowed forceps-lock head (15) inserts intocavity(5) and fixedly retains insidecavity. The further movement of united plunger barrel inforwarddirection pushes the medicament from drug cartridge into the body throughhypodermicneedle. As soon as the injection process completes, the needle gets dislodged from the needle assembly due to the movement of horizontally extended pins of the cap (16) inforwarddirection. Simultaneously, the conical lock presses inwardly while passing through partition ring (4) of the injector, which dislodges the united plunger barrel. Itresultsmovement of inner plunger barrel in backward direction due toreleaseof vacuum (V) to bring the plunger assembly ininitialstate. Further, while passing through the passage of flange ring (10), outwardly protruded flaps offorceps-lockhead are pressed inwardly to close the forceps lock head, which dislodges the forceps-lock head fromcavity(5) of piston flange, leaving behind the encapsulated needle in empty drug-cartridge. It separates injector fromdrug-cartridge. The needle is encapsulated within the emptydrug-cartridgemay be removed and safelydisposed-off.The injection retains initial state for next injection process.

Competitive Advantage

The advanced technologies like jet injections, pre-filled syringes, auto-injectors are quiet expensive and unaffordable technologies, available to less than 1% of global population; they are responsible for creating technological divide between rich and poor, developed and developing/under-developed countries. They may negate successfully some of the problems associated with conventional syringes but their very low prevalence and reachability together with increased medical waste creation compensateall its advantages. Our disruptive innovation provides the path-breaking technology which is greener, cheaper, safer, more effective, efficient and ergonomic as compared to the recently commercialized advanced injection systems. The packaging of dosage of drugs in proposed drug-cartridge ensures direct transfer of drug from manufacturing unit to the body of patient with no risk of contamination, under-dosage or over-dosage and Needle-stickInjury (NSI). It prevents need of 10-15% overfilling of extra drugs in containers during packaging, which shall amount a great saving of precious drugs and unnecessary cost incurred on the pharmaceutical industry ultimately payable by end-users. ‘Single-dose single-drug-cartridge’ prevents the chances of infections acquired from exposed drug of used-vials. Over and above the end-user shall get rid of purchasing separate syringe for every dose anymore. The cost of frequently re-usable injector shall go on decreasing with each and every single use to become almost zero after multiple usages. Its unique LED feature illuminates injection site to conveniently facilitate injection during dark hours and keeps vigil on injection process. It may also be attached with Fluid-collector to safely collect fluid samples with no risk of NSI. Since no separate syringe is required in our injection system and injectable drug is packed in proposed drug-cartridge, the entire raw material, particularly plastic, shall be saved turning into hazardous bio-medical waste and on the contrary only 20-25% safe waste is generated in the form of empty drug-cartridges containing encapsulated used needle, which makes our system far cheaper, greener, safer, user-friendlier and more sustainable than conventional system.

Planned Goals and Milestones

We are seriously planning to enter in national phase and file patent applications in more than 50 countries, particularly USA, European Union, Africa, ARIPO, OAPI, China, Australia, Japan, Russia etc. in due course. Simultaneously, our sincere efforts are underway to commercially exploit our invention, so that the real benefits of the technology may reach to the end-users. We are also in need of global network and resources, expertise etc. to commercialize our innovation. For this purpose, we need to arrange the necessary funds by exploiting all possible resources and avenues. Our start-up, RESCITECH VISION PVT. LTD. envisions raising requisite funds for IPR protection worldwide and commercialization through awards, grants, seed funding licensing etc. We seriously plan to commercialize innovation in India. We have planned to secure finance through licensing technology in various PCT jurisdictions to raise necessary funds through various accessible means under ‘Make in India’ initiative of Govt. of India. We will license our ‘smart packaging technology’ to Pharmaceuticals manufacturing injectable drugs, and injector and/or fluid collector to Medical Device manufacturers. The technology is of no consequence, if not affordable to the end-users at their pace and doorsteps. Soon after the publication of our International Patent Application by WIPO, all the inventors at the outset voluntarily decided to grant “an unconditional free of cost license worldwide” in favor of WHO, UNICEF and Red Cross Society to utilize our meager efforts for the welfare of mankind at large in need. We have also communicated our intention to them. In rest of jurisdictions, we plan to implement the licensing business model for commercialization. We fervently expect a grand success in our business.
Market Potential: Safety in relation to fluid injections are a major issue worldwide spreading diseases such as hepatitis B/C, HIV/AIDS, other communicable diseases and infections leading to pre-mature deaths of 1.3 million people and medical costs of over 500 million USD. More than 2.5 billion syringes were used in 2011 and is forecasted to grow by 10% annually. The syringe market is expected to grow from USD 10.56 billion (2016) to USD 15.99 billion in 2021 at a growth rate of 8.7%. Market key drivers are increasing adoption of safety syringes, increasing demand for vaccines, high prevalence of chronic diseases, increasing awareness and requirements on safety syringes. Market constraints like cost and procurement structure will be negated by our disruptive innovation to meet rising global demand effectively. Business model: We shall adopt Licensing model for pre-commercial prototyping, R&D, revenue generation and commercialization. Partnership Opportunities: We also have partnership opportunities with Pharmaceutical industry (providing smart packaging technology for injectable), Medical device industry (injector andfluid-collector), NGOs (spreading awareness about NSI and medical waste hazards), Governments (collaboration in Immunization programs), and entrepreneurial ventures (initial seed-funding for commercialization and R&D).
Funding Goal10,000,000

Milestone

Date Unknown
Created
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In The News
TITLEFuturistic Safe Injection System- A fluid injecting system with needle retraction by Vacuum