Title of Invention

NEEDLE LESS INJECTION STOPPER ASSEMBLY

Abstract

This invention relates to a needle less injection stopper assembly for safe application of medicament outpatients by a syringe barrel of tubular shape having a co axially fitted plunger, one end of said plunger is configured as flange shaped for limiting the movement of the plunger at corresponding end of the barrel to prevent further movement of the plunger while in full forward position, the other end of said the plunger being configured with a valve to guide the movement of the plunger as well as to support the assembly in the inner end of the barrel, the said barrel is provided with an expulsion orifice of small cross sectional area at one end and configured to be adapted to the Luer back of an injection stopper assembly.

Full Text

2 INTRODUCTION: This invention relates to a needle less injection stopper. This needle less injection stopper is fitted with non return spring valve to give medication with syringe and without needle to avoid needle stick injury and to avoid spread of hospital acquired infections and also to avoid environmental hazards in its use. BACKGROUND OF INVENTION: It is now a thing of common perception that health care is one of the most relevant concerns relates to provision of safe hospital environment. Needle is used with self sealing injection stopper in current practice to give medicine to the patient, when the infusion of I.V. fluid is discontinued from non- ported I.V. Cannula and C.V. catheter. The risk associated with the needle stick injury has become a matter of great concern. Despite various safety guidelines and taking extra care to avoid needle stick injury, various devices still cause needle stick injuries. In general practice injection stopper is a medical device used with non-ported I.V. Cannula. It is fitted to the I.V. Cannula in the following manner: Medicine can be injected by syringe needle to patient when infusion of I.V. fluid is discontinued. Discarding the needle with sharp tip can cause needle stick injury if not handled properly. Whenever a needle or other sharp device is exposed, injuries can occur. Data from NaSH show that approximately 38% of percutaneous injuries occur during use and 42% occur after use and before disposal of the needle. Causes of percutaneous injuries with hollow-bore needles are: The circumstances leading to a needle stick injury depend partly on the type and design of the device used. For example, needle devices that must be taken apart or manipulated after use (e.g. prefilled cartridge syringes and phlebotomy needle/ vacuum tube assemblies) are an obvious hazard and have been associated with 3 increased injury rates. In addition, needles attached to a length of flexible tubing (e.g. winged-steel needles and needles attached to IV tubing) are sometimes difficult to place in sharps containers and thus present another injury hazard. Injuries involving needles attached to IV tubing may occur when a health care worker inserts or withdraws a needle from an IV port or tries to temporarily remove the needle stick hazard by inserting the needle into a drip chamber, IV port or bag. Risks related to device characteristics, needle stick injuries have been related to certain work practices such as recapping, transferring body fluid between containers, and failing to properly dispose of used needles in puncture-resistant sharps containers. Past studies of needle stick injuries have shown that 10% to 25% occurred when recapping a used needle. Although recapping by hand has been discouraged for some time and is prohibited under the OSHA blood borne pathogens standard unless no alternative exists, 5% of needle stick injuries in NaSH hospitals are still related to this practice. Injury may occur when a health care worker attempts to transfer blood or other body fluids from a syringe to a specimen container (such as a vacumm tube) and misses the target. Also, if used needles or other sharps are left in the work area or are discarded in a sharps container that is not puncture resistant, a needle stick injury may still result. Needle stick injuries Needle stick injuries are wounds caused by needles that accidentally puncture the skin. Needle stick injuries are a hazard for people who work with hypodermic syringes and other needle equipment. These injuries can occur at any time when people use, disassemble, or dispose of needles. When not disposed of properly, needles can become concealed in linen or garbage and injure other worker who encounter them unexpectedly. 4 Needle stick injuries transmit infectious diseases, especially blood- borne viruses. In recent years, concern about AIDS (Acquired Immune Deficiency Syndrome), hepatitis B, and hepatitis C has prompted research to find out why these injuries occur and to develop measures to prevent them. Despite published guidelines and training programs, needle stick injuries remain an ongoing problem. What are the hazards of needle stick injuries? Accidental punctures by contaminated needles can inject hazardous fluids into the body through the skin. There is potential for injection of hazardous drugs, but injection of infectious fluids, especially blood, is by far the greatest concern. Even small amounts of infectious fluid can spread certain diseases effectively. Accidental injection of blood-borne viruses is the major hazard of needle stick injuries, especially the viruses that cause AIDS (the HIV virus), hepatitis B, and hepatitis C. The risk of infection after exposure to infected blood varies by blood borne pathogen. The risk of transmission after exposure to HIV- infected blood is about 0.2%, whereas it is estimated to be up to 100 times greater for hepatitis B virus (30%) and could be as high as 10% for hepatitis C virus. HIV/ AIDS The risk of needle stick transmission of HIV, the virus that causes AIDS, is considerably less than for hepatitis B virus. Several hundred health care workers have been accidentally exposed, mostly through needle stick injures, to blood from patients infected with the HIV virus. As of June 1999, researchers report that case of occupational transmission of HIV that can be clearly linked to a needle stick injury. There have been two other cases of HIV infection in Canada that have 5 been attributed to possible occupational transmission, both involving laboratory workers. A possible occupational transmission occurred to a 75 year old Ontario biochemist who had worked in many laboratories with blood and blood products. There were no other risk factors reported. Another possible occupational transmission occurred to a Quebec laboratory technician in the early 1990s. This case is still under investigation. Hepatitis B The risk of transmission of HBV is reduced by immunization against hepatitis B, which is 90% to 95% effective. The risk of transmission os HBV to susceptible HCWs via a needle stick injury varies from 1% to 40%. Because HBV may survive on environmental surfaces for more than a week, indirect exposure to HBV can occur via contaminated inanimate objects and appears to have been a factor in HBV outbreaks among patient and staff of hemodialysis units. Hepatitis C Needle stick injuries may also transmit hepatitis C. The risk factors for hepatitis C virus transmission in occupational settings is 1.8% (range 0% to 7%). Needle stick injuries have transmitted many other diseases involving viruses, bacteria. Fungi, and other microorganisms to health care workers, laboratory researchers, and veterinarian staff. The diseases include: * Blastomycosis * Mycoplasma caviae * Brucellosis * Rocky Mountain spotted fever 6 * Cryptococcosis * Sporotrichosis * Diphtheria * Staphylococcus aureus * Cutaneous gonorrhea * Streptococcus pyogenes * Herpes * Syphilis * Malaria * Toxoplasmosis * Mycobacteriosis * Tuberculosis Many of these diseases were transmitted in rare, isolated events. They still demonstrate. However, that needle stick injuries can have serious consequences. How common are needle stick injuries? Needle stick injuries are far too common hazard. Some hospital report that one third of nursing and laboratory staff suffer such injuries each year. Available statistics probably underestimate the severity of the problem because many workers do not report their injuries. This makes it difficult to know exactly how serious the problem is or how well prevention programs work. PRIOR ART UK Patent No. GB686343 provides a hypodermic injection device with electromagnetic mechanism for expelling liquid medicament. The body has an ampule attached to its forward end by a ring. The ampoule has an aperture or apertures through which needle less injections are made. A solenoid having a casing preferably of iron, and a tubular core is disposed within the body. On energizing the solenoid by closing a switch, an armature is moved forwardly into the core thus causing a plunger to displace a stopper of the ampule and discharge of medicament. The armature is withdrawn form the solenoid by a spring. 7 UK Patent No. GB691754 provides a needle less hypodermic injection device with a piston or plunger working in a medicament receiving chamber. A plunger in the form of a rod secured to an actuating member may be moved within a medicament chamber the length of which is at least one hundred times its diameter. The rod is provided with tubular supporting means which is also secured to the actuating member but which is moved within the casing of the apparatus and external to the medicament chamber. The forward end of the tubular supporting means is provided with a member which slidably engages the medicament chamber and which abuts against a threaded collar, secured to the rear end of the medicament chamber, when the plunger rod is retracted between the threaded collar and a cap fitted thereon sealing material is enclosed. Medicament is discharged at a skin-penetrating velocity and pressure through an orifice in a nozzle. FR 2641190 by Krantz Alfred Joseph provides a Needle less injector, characterized in that the hollow cylindrical body is closed at its rear part by a stopper flaring conically at its outer part and extending via a tubular portion defining at its inner part a seat intended to receive an injection- liquid reserve container, and in which there projects the free beveled end of the supply channel whose middle part extends on the outer periphery of the hollow cylindrical body, along one of its generatrices. The known art in the category as mentioned above does not provide a simple in construction yet effective mechanism to use whereby medication can be applied without needle to avoid needle stick injury and to avoid spread of hospital acquired infections and also to avoid environment hazards. 8 OBJECT OF INVENTION The object of the invention is to provide a safety mechanism to give medication with syringe without needle to avoid infection occurring due to needle stick injury. Another object of the invention is directed to needle less injection stopper which is simple in construction and easy to use. Yet another object of the invention is to provide a needle less injection stopper which is very cost effective and thus is affordable for patients requiring health care. STATEMENT OF THE INVENTION The invention provides: A needle less injection stopper assembly for safe application of medicament to patients by a syringe barrel of tubular shape having a co axially fitted plunger, one end of said plunger is configured as flange shaped for limiting the movement of the plunger at corresponding end of the barrel to prevent further movement of the plunger while in full forward position, the other end of said the plunger being configured with a valve to guide the movement of the plunger as well as to support the assembly in the inner end of the barrel, the said barrel is provided with an expulsion orifice of small cross sectional area at one end and configured to be adapted to the Luer back of an injection stopper assembly, the needle less injection stopper assembly comprising: Luer front at one end and Luer back at the other end, the Luer back being configured to be adapted to the small expulsion orifice of the barrel a spring mechanism comprising of a spring fitted in the inner housing of the injection stopper assembly with a washer and a washer spring holder, wherein the passage of medicament through the said assembly is effected 9 through an inner path of the assembly opened by compressing the spring by the pressure applied by pushing forward the plunger. One particular advantage of the assembly is that the spring along with the washer acts as a non return valve closing the path of flow of medicament when the plunger is detached from the assembly. BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS The foregoing aspects and many of the advantages of this invention will become more readily appreciated by following detailed description when taken in conjunction with the accompanying drawings, wherein, Fig 1. illustrates needle less injection stopper and the syringe without needle with the plunger in backward position. Fig 2. illustrates the detailed assembly with greater details of associated parts of the needle less injection stopper with syringe showing the spring mechanism assembly in open condition to apply medication as detailed below: (a) Portion marked as 1 is Luer front (b) Portion marked as 2 is Luer back (c) Portion marked as 3 is washer spring holder (d) Portion marked as 4 is washer (e) Portion marked as 5 is spring (f) Portion marked as 6 is cap (g) Portion marked as 7 is barrel (h) (h) Portion marked as 8 is valve (i) (i) Portion marked as 9 is plunger DETAILED DESCRIPTION AND PREFERRED EMBODIMENT OF THE NEEDLE LESS INJECTION STOPPER IN REFERENCE TO DRAWING 10 The assembly according to the invention and various essential components of the device are described below in reference to the accompanying drawings fig. 1 to fig. 3. According to the invention, the injection apparatus has a plunger working in a chamber of small transverse dimension relatively to its length, the plunger basically consists of manual operable means for projecting the plunger in the chamber to expel medicament there from. As shown in Figure 2, the assembly basically consists of a plunger (9) coaxially disposed in a tubular shaped syringe barrel (7). Dimension of the plunger (9) is made in accordance to the dimension of the barrel so that the plunger can retractably moved within the barrel essentially in coaxial manner. The length of the plunger can be substantially equal to the length of the barrel while in fully forward position. The plunger is slidably movable within the barrel upon application of force. Adjustment of the amount of medicament ejected from the syringe barrel is effected by movement of the inside edge of the plunger and by applying varying amounts of additional pressure to the fluid in the syringe by the degree of inward movement of the plunger. On completion of the ejection from the syringe barrel, the plunger is withdrawn backward as detailed in figure 1 of accompanying drawings. The barrel is provided with an expulsion orifice of small cross sectional area at one end and configured to be adapted to the Lurer back (2) of the injection stopper. One end, more specifically the outside end of the plunger (9) is configured to have flange shape which contacts the corresponding end of the barrel to prevent further movement of the plunger while in full forward position. Inside end disposed within the barrel consists of the valve (8) to guide the movement of the plunger as well as to support the assembly in the inner end of the apparatus. 11 The needle less injection stopper, as shown in Figure 2 of accompanying drawings, consists of Luer front (1) at one end and Luer back (2) at the other end. The Luer back (2) of the injection stopper is configured to be adapted at the front end of the barrel (7). Inside the housing of the injection stopper, there is provided a spring mechanism comprising of a spring (5) fitted in the inner housing of the injection stopper with a washer (4) and a washer spring holder (3). The spring mechanism is pushed, more specifically by compression of the spring, while connecting the syringe with the needle less injection stopper to open the inner path for flow of medicament. The flow of medicament is effected by pushing forward the plunger of the syringe to enter the medicine to the patient. When the plunger is detached from the needle less injection stopper, the spring comes back to its original position and closes the path with the washer acting as a non return valve. Figure 3 of the accompanying drawing shows the needle less injection stopper and the syringe with the plunger in detached state from the needle less injection stopper. ADVANCES OF THE INVENTION: The needle less injection stopper according to the invention offers maNy advances apart from medical safety as disclosed in earlier descriptions 1. The device is needle less. 2. The safety feature is an integral part of the device. 3. The device performs reliably. 4. The device is easy to use and practical. 5. The device is safe and effective for patient care. 6. The device is cost effective. 12 INDUSTRIAL APPLICATION: The needle less injection stopper assembly according to this invention provides safety against needle stick injury and can be widely used with syringe without needle to avoid associated problems of transmission of deadly diseases. The needle less injection stopper assembly is simple in construction and use yet being cost effective. WE CLAIM: 1. A needle less injection stopper assembly for safe application of medicament to patients by a syringe barrel, (7) of tubular shape having a co axially fitted plunger (9), one end of said plunger (9) is configured as flange shaped for limiting the movement of the plunger at corresponding end of the barrel to prevent further movement of the plunger while in full forward position, the other end of the said plunger (9) being configured with a valve (8) to guide the movement of the plunger as well as to support the assembly in the inner end of the barrel, the said barrel is provided with an expulsion orifice of small cross sectional area at one end and configured to be adapted to the Luer back (2) of an injection stopper assembly, the needle less injection stopper assembly comprising: Luer front (1) at one end and Luer back (2) at the other end, the Luer back being configured to be adapted to the small expulsion orifice of the barrel (7). a spring mechanism comprising of a spring (5) fitted in the inner housing of the injection stopper assembly with a washer (4) and a washer spring holder (3), wherein the passage of medicament through the said assembly is effected through an inner path of the assembly opened by compressing the spring (5) by the pressure applied by pushing forward the plunger (9). 13 2. A needle less injection stopper assembly as claimed in claim 1, wherein the spring (5) along with the washer (4) acts as a non return valve closing the path of flow of medicament when the plunger (9) is detached from the assembly. 3. A needle less injection stopper assembly as claimed in claim 1, wherein the assembly can be used as Luer cap when the infusion of I.V. fluid is discontinued. 4. A needle less injection stopper assembly as claimed in claim 1, wherein the spring mechanism is fitted with cap for compressing the spring by spring nozzle to give medication to patients. 5. A needle less injection stopper assembly substantially as herein described, particularly with reference to the accompanying drawings. This invention relates to a needle less injection stopper assembly for safe application of medicament outpatients by a syringe barrel of tubular shape having a co axially fitted plunger, one end of said plunger is configured as flange shaped for limiting the movement of the plunger at corresponding end of the barrel to prevent further movement of the plunger while in full forward position, the other end of said the plunger being configured with a valve to guide the movement of the plunger as well as to support the assembly in the inner end of the barrel, the said barrel is provided with an expulsion orifice of small cross sectional area at one end and configured to be adapted to the Luer back of an injection stopper assembly.

Documents:

00716-kol-2007-abstract.pdf

00716-kol-2007-claims.pdf

00716-kol-2007-description complete.pdf

00716-kol-2007-drawings.pdf

00716-kol-2007-form 1.pdf

00716-kol-2007-form 18.pdf

00716-kol-2007-form 2.pdf

00716-kol-2007-form 3.pdf

00716-kol-2007-form 5.pdf

00716-kol-2007-form 9.pdf

00716-kol-2007-gfa.pdf

716-KOL-2007-ABSTRACT.pdf

716-KOL-2007-CLAIMS.pdf

716-KOL-2007-CORRESPONDENCE-1.1.pdf

716-KOL-2007-CORRESPONDENCE.pdf

716-KOL-2007-DESCRIPTION COMPLETE.pdf

716-KOL-2007-DRAWINGS.pdf

716-KOL-2007-FORM 1.pdf

716-KOL-2007-FORM 2.pdf

716-KOL-2007-FORM 26.pdf

716-KOL-2007-FORM 5.pdf

716-kol-2007-granted-abstract.pdf

716-kol-2007-granted-claims.pdf

716-kol-2007-granted-description (complete).pdf

716-kol-2007-granted-drawings.pdf

716-kol-2007-granted-examination report.pdf

716-kol-2007-granted-form 1.pdf

716-kol-2007-granted-form 18.pdf

716-kol-2007-granted-form 2.pdf

716-kol-2007-granted-form 26.pdf

716-kol-2007-granted-form 3.pdf

716-kol-2007-granted-form 5.pdf

716-kol-2007-granted-reply to examination report.pdf

716-kol-2007-granted-specification.pdf

716-KOL-2007-OTHERS 1.1.pdf

716-KOL-2007-OTHERS-1.2.pdf

716-KOL-2007-REPLY TO EXAMINATION REPORT.pdf